<?xml version="1.0"?>
<feed xmlns="http://www.w3.org/2005/Atom" xml:lang="zh-Hans-CN">
	<id>https://wiki.swarma.org/api.php?action=feedcontributions&amp;feedformat=atom&amp;user=%E6%9D%8E%E6%98%8A%E8%BD%A9</id>
	<title>集智百科 - 复杂系统|人工智能|复杂科学|复杂网络|自组织 - 用户贡献 [zh-cn]</title>
	<link rel="self" type="application/atom+xml" href="https://wiki.swarma.org/api.php?action=feedcontributions&amp;feedformat=atom&amp;user=%E6%9D%8E%E6%98%8A%E8%BD%A9"/>
	<link rel="alternate" type="text/html" href="https://wiki.swarma.org/index.php/%E7%89%B9%E6%AE%8A:%E7%94%A8%E6%88%B7%E8%B4%A1%E7%8C%AE/%E6%9D%8E%E6%98%8A%E8%BD%A9"/>
	<updated>2026-11-03T02:30:08Z</updated>
	<subtitle>用户贡献</subtitle>
	<generator>MediaWiki 1.35.0</generator>
	<entry>
		<id>https://wiki.swarma.org/index.php?title=%E9%9A%8F%E6%9C%BA%E5%AF%B9%E7%85%A7%E8%AF%95%E9%AA%8C&amp;diff=24418</id>
		<title>随机对照试验</title>
		<link rel="alternate" type="text/html" href="https://wiki.swarma.org/index.php?title=%E9%9A%8F%E6%9C%BA%E5%AF%B9%E7%85%A7%E8%AF%95%E9%AA%8C&amp;diff=24418"/>
		<updated>2021-07-14T20:12:24Z</updated>

		<summary type="html">&lt;p&gt;李昊轩：&lt;/p&gt;
&lt;hr /&gt;
&lt;div&gt;此词条暂由彩云小译翻译，翻译字数共2766，未经人工整理和审校，带来阅读不便，请见谅。&lt;br /&gt;
&lt;br /&gt;
{{Short description|Experimental method designed to reduce bias, typically accomplished by randomly allocating subjects to two or more groups, with one being a control group}}&lt;br /&gt;
&lt;br /&gt;
[[File:Flowchart of Phases of Parallel Randomized Trial - Modified from CONSORT 2010.png|thumb|upright=1.5|Flowchart of four phases (enrollment, allocation, intervention, follow-up, and data analysis) of a parallel randomized trial of two groups (in a controlled trial, one of the interventions serves as the control), modified from the CONSORT (Consolidated Standards of Reporting Trials) 2010 Statement&amp;lt;ref name=&amp;quot;Schulz-2010&amp;quot;&amp;gt;{{Cite journal | author = Schulz KF, Altman DG, ((Moher D; for the CONSORT Group)) | title = CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials | journal = [[Br Med J]] | volume = 340 | pages = c332 | year = 2010 | doi = 10.1136/bmj.c332 | pmid = 20332509 | pmc = 2844940 }}&amp;lt;/ref&amp;gt;|链接=Special:FilePath/Flowchart_of_Phases_of_Parallel_Randomized_Trial_-_Modified_from_CONSORT_2010.png]]&lt;br /&gt;
&lt;br /&gt;
[来源：图片] Flowchart of four phases (enrollment, allocation, intervention, follow-up, and data analysis) of a parallel randomized trial of two groups (in a controlled trial, one of the interventions serves as the control), modified from the CONSORT (Consolidated Standards of Reporting Trials) 2010 Statement.&lt;br /&gt;
&lt;br /&gt;
据修改的2010年CONSORT (综合报告试验标准)要求，流程图包括：两组平行随机试验分为登记、分配、干预、随访和数据分析四个阶段，在对照试验中，需要其中一项干预作为对照处理措施。 &lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
A '''randomized controlled trial''' (or '''randomized control trial''';&amp;lt;ref name=&amp;quot;Chalmers-1981&amp;quot;&amp;gt;{{Cite journal |vauthors=Chalmers TC, ((Smith H Jr)), Blackburn B, Silverman B, Schroeder B, Reitman D, Ambroz A | title = A method for assessing the quality of a randomized control trial | journal = [[Controlled Clinical Trials]] | volume = 2 | issue = 1 | pages = 31–49 | year = 1981 | doi = 10.1016/0197-2456(81)90056-8 | pmid = 7261638 }}&amp;lt;/ref&amp;gt; '''RCT''') is a type of ''[[scientific experiment]]'' (e.g. a ''[[clinical trial]]'') or ''intervention study'' (as opposed to ''[[observational study]]'') that aims to reduce certain sources of bias when testing the effectiveness of new treatments; this is accomplished by [[Random assignment|randomly allocating]] subjects to two or more groups, treating them differently, and then comparing them with respect to a measured response. One group—the experimental group—receives the intervention being assessed, while the other—usually called the control group—receives an alternative treatment, such as a [[placebo]] or no intervention. The groups are monitored under conditions of the trial design to determine the effectiveness of the experimental intervention, and efficacy is assessed in comparison to the control. &amp;lt;ref&amp;gt;{{cite web|url=https://www.nice.org.uk/glossary?letter=r|publisher=National Institute for Health and Care Excellence, London, UK|title=Randomised controlled trial|date=2019|access-date=3 June 2019}}&amp;lt;/ref&amp;gt; There may be more than one treatment group or more than one [[Treatment and control groups|control group]].&lt;br /&gt;
&lt;br /&gt;
A randomized controlled trial (or randomized control trial; RCT) is a type of scientific experiment (e.g. a clinical trial) or intervention study (as opposed to observational study) that aims to reduce certain sources of bias when testing the effectiveness of new treatments; this is accomplished by randomly allocating subjects to two or more groups, treating them differently, and then comparing them with respect to a measured response. One group—the experimental group—receives the intervention being assessed, while the other—usually called the control group—receives an alternative treatment, such as a placebo or no intervention. The groups are monitored under conditions of the trial design to determine the effectiveness of the experimental intervention, and efficacy is assessed in comparison to the control.  There may be more than one treatment group or more than one control group.&lt;br /&gt;
&lt;br /&gt;
随机对照试验(A randomized controlled trial, RCT)是一种科学实验(例如:临床试验)或干预研究(区别于观察性研究) ，其目的是在测试新治疗的有效性时减少某些偏倚来源。通过受试者随机分配到两个或两个以上的组，经过不同的处理，产生的效应再与一个有可控的处理效应相比较。即一组或多组(实验组)接受正在评估的干预措施，而另一组(通常称为对照组)接受替代治疗，如安慰剂或无干预措施。在试验设计的条件下对这些组进行监测，以确定实验干预的有效性，并与对照组进行疗效比较评估。当然这也包括一个以上的治疗组或一个以上的对照组。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
The trial may be [[blinded experiment|blinded]], meaning that information which may influence the participants is withheld until after the experiment is complete. A blind can be imposed on any participant of an experiment, including subjects, researchers, technicians, data analysts, and evaluators. Effective blinding may reduce or eliminate some sources of experimental [[bias]].&lt;br /&gt;
&lt;br /&gt;
The trial may be blinded, meaning that information which may influence the participants is withheld until after the experiment is complete. A blind can be imposed on any participant of an experiment, including subjects, researchers, technicians, data analysts, and evaluators. Effective blinding may reduce or eliminate some sources of experimental bias.&lt;br /&gt;
&lt;br /&gt;
试验可能采用了盲法，这意味着影响参与者的信息在试验完成后才会公布。试验的任何参与者，包括受试者、研究人员、技术人员、数据分析人员和评估人员，都可能被强加盲。有效的盲法可以减少或消除某些试验偏差的来源。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
The randomness in the assignment of subjects to groups reduces [[selection bias]] and allocation bias, balancing both known and unknown prognostic factors, in the assignment of treatments.&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;&amp;gt;{{Cite journal |vauthors=Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG | title = CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials | journal = [[Br Med J]] | volume = 340 | pages = c869 | year = 2010 | doi = 10.1136/bmj.c869 | pmid = 20332511 | pmc = 2844943 }}&amp;lt;/ref&amp;gt; Blinding reduces other forms of [[Observer-expectancy effect|experimenter and subject biases]].&lt;br /&gt;
&lt;br /&gt;
The randomness in the assignment of subjects to groups reduces selection bias and allocation bias, balancing both known and unknown prognostic factors, in the assignment of treatments. Blinding reduces other forms of experimenter and subject biases.&lt;br /&gt;
&lt;br /&gt;
在分配治疗方案时，受试者随机地被分配到不同组。这个随机化过程减少了选择偏差和分配偏差，平衡了已知和未知的预后因素。盲法减少了其他形式的实验者和主体偏见。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
A well-blinded RCT is often considered the [[Gold standard (test)|gold standard]] for [[clinical trial]]s. Blinded RCTs are commonly used to test the [[Efficacy#Medicine|efficacy]] of medical [[Health intervention|intervention]]s and may additionally provide information about adverse effects, such as [[adverse drug reactions|drug reactions]]. A randomized controlled trial can provide compelling evidence that the study treatment causes an effect on human health.&amp;lt;ref name=&amp;quot;hannan&amp;quot;&amp;gt;{{cite journal | vauthors = Hannan EL | title = Randomized clinical trials and observational studies: guidelines for assessing respective strengths and limitations | journal = JACC. Cardiovascular Interventions | volume = 1 | issue = 3 | pages = 211–7 | date = June 2008 | pmid = 19463302 | doi = 10.1016/j.jcin.2008.01.008 | doi-access = free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
A well-blinded RCT is often considered the gold standard for clinical trials. Blinded RCTs are commonly used to test the efficacy of medical interventions and may additionally provide information about adverse effects, such as drug reactions. A randomized controlled trial can provide compelling evidence that the study treatment causes an effect on human health.&lt;br /&gt;
&lt;br /&gt;
一个良好盲法的 RCT 通常被认为是临床试验的黄金标准。盲法随机对照试验通常用于检测医疗干预措施的效果，并且还可能提供关于药物反应等不良反应的信息。随机对照试验可以提供令人信服的证据，证明研究治疗对人类健康产生了影响。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
The terms &amp;quot;RCT&amp;quot; and &amp;quot;'''randomized trial'''&amp;quot; are sometimes used synonymously, but the latter term omits mention of controls and can therefore describe studies that compare multiple treatment groups with each other in the absence of a control group.&amp;lt;ref name=&amp;quot;Ranjith-2005&amp;quot;&amp;gt;{{Cite journal | author = Ranjith G | title = Interferon-α-induced depression: when a randomized trial is not a randomized controlled trial | journal = [[Psychother Psychosom]] | volume = 74 | issue = 6 | pages = 387; author reply 387–8 | year = 2005 | doi = 10.1159/000087787 | pmid = 16244516 | s2cid = 143644933 }}&amp;lt;/ref&amp;gt; Similarly, the [[initialism]] is sometimes expanded as &amp;quot;'''randomized clinical trial'''&amp;quot; or &amp;quot;'''randomized comparative trial'''&amp;quot;, leading to ambiguity in the [[scientific literature]].&amp;lt;ref name=&amp;quot;Peto-1976&amp;quot;&amp;gt;{{Cite journal |vauthors=Peto R, Pike MC, Armitage P, Breslow NE, Cox DR, Howard SV, Mantel N, McPherson K, Peto J, Smith PG | title = Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design | journal = [[Br J Cancer]] | volume = 34 | issue = 6 | pages = 585–612 | year = 1976 | pmc=2025229 | pmid = 795448 | doi = 10.1038/bjc.1976.220 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Peto-1977&amp;quot;&amp;gt;{{Cite journal |vauthors=Peto R, Pike MC, Armitage P, Breslow NE, Cox DR, Howard SV, Mantel N, McPherson K, Peto J, Smith PG | title = Design and analysis of randomized clinical trials requiring prolonged observation of each patient. II. Analysis and examples | journal = [[Br J Cancer]] | volume = 35 | issue = 1 | pages = 1–39 | year = 1977 | pmc=2025310 | pmid = 831755 | doi = 10.1038/bjc.1977.1 }}&amp;lt;/ref&amp;gt; Not all randomized clinical trials are randomized ''controlled'' trials (and some of them could never be, as in cases where controls would be impractical or unethical to institute). The term '''randomized controlled clinical trial''' is an alternative term used in [[clinical research]];&amp;lt;ref name=&amp;quot;Wollert-2004&amp;quot;&amp;gt;{{Cite journal |vauthors=Wollert KC, Meyer GP, Lotz J, Ringes-Lichtenberg S, Lippolt P, Breidenbach C, Fichtner S, Korte T, Hornig B, Messinger D, Arseniev L, Hertenstein B, Ganser A, Drexler H | title = Intracoronary autologous bone-marrow cell transfer after myocardial infarction: the BOOST randomised controlled clinical trial | journal = [[The Lancet|Lancet]] | volume = 364 | issue = 9429 | pages = 141–8 | year = 2004 | doi = 10.1016/S0140-6736(04)16626-9 | pmid = 15246726 | s2cid = 24361586 }}&amp;lt;/ref&amp;gt; however, RCTs are also employed in other research areas, including [[#In social science|many of the social sciences]].&lt;br /&gt;
&lt;br /&gt;
The terms &amp;quot;RCT&amp;quot; and &amp;quot;randomized trial&amp;quot; are sometimes used synonymously, but the latter term omits mention of controls and can therefore describe studies that compare multiple treatment groups with each other in the absence of a control group. Similarly, the initialism is sometimes expanded as &amp;quot;randomized clinical trial&amp;quot; or &amp;quot;randomized comparative trial&amp;quot;, leading to ambiguity in the scientific literature. Not all randomized clinical trials are randomized controlled trials (and some of them could never be, as in cases where controls would be impractical or unethical to institute). The term randomized controlled clinical trial is an alternative term used in clinical research; however, RCTs are also employed in other research areas, including many of the social sciences.&lt;br /&gt;
&lt;br /&gt;
“ RCT”和“随机试验”这两个术语有时被用作同义词，但后一个术语没有提到对照，因此可以描述在没有对照组的情况下相互比较多个治疗组的研究。科学文献中常有“随机临床试验”或“随机比较试验”这类引发歧义的术语。并非所有的随机临床试验都是随机对照试验(其中一些试验永远不可能成为随机对照试验，因为实施控制是不切实际或不道德的)。随机对照临床试验这个术语是临床研究中使用的另一个术语; 然而，随机对照临床试验也被用于其他研究领域，包括许多社会科学。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
{{toc limit}}&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
== History ==&lt;br /&gt;
&lt;br /&gt;
The first reported clinical trial was conducted by James Lind in 1747 to identify treatment for scurvy.[10] The first blind experiment was conducted by the French Royal Commission on Animal Magnetism in 1784 to investigate the claims of mesmerism. An early essay advocating the blinding of researchers came from Claude Bernard in the latter half of the 19th century. Bernard recommended that the observer of an experiment should not have knowledge of the hypothesis being tested. This suggestion contrasted starkly with the prevalent Enlightenment-era attitude that scientific observation can only be objectively valid when undertaken by a well-educated, informed scientist.[11] The first study recorded to have a blinded researcher was conducted in 1907 by W. H. R. Rivers and H. N. Webber to investigate the effects of caffeine.[12]&lt;br /&gt;
&lt;br /&gt;
据报道，1747年James Lind进行了第一个临床试验，目的是确定治疗坏血病的方法。1784年，French Royal Commission on Animal Magnetism进行了第一次盲法实验，以调查催眠术的说法。19世纪下半叶，一篇提倡研究人员失明的早期文章来自Claude Bernard。Bernard建议实验的观察者不要知道正在被测试的假设。这一建议与启蒙时代流行的态度形成鲜明对比，即科学观察只有由受过良好教育、消息灵通的科学家进行才能客观有效。1907年，W. H. R. Rivers和H. N. Webber进行了第一项有记录的盲法研究，研究咖啡因的作用。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
[[Randomized experiment]]s appeared in [[experimental psychology|psychology]], where they were introduced by [[Charles Sanders Peirce]] and [[Joseph Jastrow]] in the 1880s,&amp;lt;ref&amp;gt;{{cite journal| author=[[Charles Sanders Peirce]] and [[Joseph Jastrow]]|year=1885|title=On Small Differences in Sensation| journal=Memoirs of the National Academy of Sciences|volume=3|pages=73–83|url=http://psychclassics.yorku.ca/Peirce/small-diffs.htm}} http://psychclassics.yorku.ca/Peirce/small-diffs.htm&amp;lt;/ref&amp;gt; and in [[school of education|education]].&amp;lt;ref&amp;gt;{{cite journal|doi=10.1086/354775|first=Ian|last=Hacking|author-link=Ian Hacking | title=Telepathy: Origins of Randomization in Experimental Design|journal=[[Isis (journal)|Isis]]|series=A Special Issue on Artifact and Experiment|volume=79|issue=3|date=September 1988 |pages=427–451|jstor=234674|mr=1013489|s2cid=52201011}}&amp;lt;/ref&amp;gt;&amp;lt;ref&amp;gt;{{cite journal|doi=10.1086/444032|author=Stephen M. Stigler|title=A Historical View of Statistical Concepts in Psychology and Educational Research| journal=American Journal of Education| volume=101|issue=1|date=November 1992|pages=60–70|s2cid=143685203|author-link=Stephen M. Stigler}}&amp;lt;/ref&amp;gt;&amp;lt;ref&amp;gt;{{cite journal|doi=10.1086/383850|author=Trudy Dehue|title=Deception, Efficiency, and Random Groups: Psychology and the Gradual Origination of the Random Group Design|journal=[[Isis (journal)|Isis]]|volume=88|issue=4|date=December 1997|pages=653–673|pmid=9519574|s2cid=23526321|url=https://pure.rug.nl/ws/files/71855616/237831.pdf}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Randomized experiments appeared in psychology, where they were introduced by Charles Sanders Peirce and Joseph Jastrow in the 1880s, and in education.&lt;br /&gt;
&lt;br /&gt;
在19世纪80年代，Charles Sanders Peirce和Joseph Jastrow在心理学和教育学领域引入随机实验。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
In the early 20th century, randomized experiments appeared in agriculture, due to [[Jerzy Neyman]]&amp;lt;ref&amp;gt;Neyman, Jerzy. 1923 [1990]. &amp;quot;On the Application of Probability Theory to AgriculturalExperiments. Essay on Principles. Section 9.&amp;quot; ''Statistical Science'' 5 (4): 465–472. Trans. Dorota M. Dabrowska and Terence P. Speed.&amp;lt;/ref&amp;gt; and [[Ronald A. Fisher]]. Fisher's experimental research and his writings popularized randomized experiments.&amp;lt;ref name=&amp;quot;Conniffe&amp;quot; /&amp;gt;&lt;br /&gt;
&lt;br /&gt;
In the early 20th century, randomized experiments appeared in agriculture, due to Jerzy Neyman and Ronald A. Fisher. Fisher's experimental research and his writings popularized randomized experiments.&lt;br /&gt;
&lt;br /&gt;
在20世纪早期，Jerzy Neyman和Ronald A. Fisher将随机实验引入农业研究。Fisher的实验研究和他的著作普及了随机实验。&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;The first published RCT in medicine appeared in the 1948 paper entitled &amp;quot;[[Streptomycin]] treatment of pulmonary [[tuberculosis]]&amp;quot;, which described a [[Medical Research Council (UK)|Medical Research Council]] investigation.&amp;lt;ref name=&amp;quot;MRC-1948&amp;quot;&amp;gt;{{Cite journal | author = Streptomycin in Tuberculosis Trials Committee | title = Streptomycin treatment of pulmonary tuberculosis. A Medical Research Council investigation| journal = [[Br Med J]] | volume = 2 | issue = 4582 | pages = 769–82 | year = 1948 | doi = 10.1136/bmj.2.4582.769 | pmid = 18890300 | pmc = 2091872 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Brown-1998&amp;quot;&amp;gt;{{cite news |title= Landmark study made research resistant to bias |author= Brown D |newspaper= [[Washington Post]] |date=1998-11-02 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Shikata-2006&amp;quot;&amp;gt;{{Cite journal |vauthors=Shikata S, Nakayama T, Noguchi Y, Taji Y, Yamagishi H | title = Comparison of effects in randomized controlled trials with observational studies in digestive surgery | journal = [[Ann Surg]] | volume = 244 | issue = 5 | pages = 668–76 | year = 2006 | doi = 10.1097/01.sla.0000225356.04304.bc | pmc=1856609 | pmid = 17060757 }}&amp;lt;/ref&amp;gt; One of the authors of that paper was [[Austin Bradford Hill]], who is credited as having conceived the modern RCT.&amp;lt;ref name=&amp;quot;Stolberg-2004&amp;quot;&amp;gt;{{Cite journal |vauthors=Stolberg HO, Norman G, Trop I | title = Randomized controlled trials | journal = [[Am J Roentgenol]] | volume = 183 | issue = 6 | pages = 1539–44 | year = 2004 | pmid = 15547188 | doi=10.2214/ajr.183.6.01831539}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;The first published RCT in medicine appeared in the 1948 paper entitled &amp;quot;Streptomycin treatment of pulmonary tuberculosis&amp;quot;, which described a Medical Research Council investigation. One of the authors of that paper was Austin Bradford Hill, who is credited as having conceived the modern RCT.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;医学上首次发表的随机对照试验出现在1948年题为“Streptomycin treatment of pulmonary tuberculosis”的论文中，这篇论文描述了医学研究理事会的一项调查。这篇论文的作者之一是Austin Bradford Hill，被认为是构想出了现代 RCT理论。 &lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt; &lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;Trial design was further influenced by the large-scale [[International Studies of Infarct Survival|ISIS]] trials on [[heart attack]] treatments that were conducted in the 1980s.&amp;lt;ref&amp;gt;{{cite web| author1=Georgina Ferry |title= Peter Sleight Obituary |url=https://www.theguardian.com/society/2020/nov/02/peter-sleight-obituary |website=The Guardian |date=2 November 2020 |access-date=3 November 2020}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;Trial design was further influenced by the large-scale ISIS trials on heart attack treatments that were conducted in the 1980s.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;20世纪80年代进行的大规模 ISIS 心脏病治疗试验进一步影响了试验设计。&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;By the late 20th century, RCTs were recognized as the standard method for &amp;quot;rational therapeutics&amp;quot; in medicine.[24] As of 2004, more than 150,000 RCTs were in the Cochrane Library.[22] To improve the reporting of RCTs in the medical literature, an international group of scientists and editors published Consolidated Standards of Reporting Trials (CONSORT) Statements in 1996, 2001 and 2010, and these have become widely accepted.[1][4] Randomization is the process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce the bias.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;By the late 20th century, RCTs were recognized as the standard method for &amp;quot;rational therapeutics&amp;quot; in medicine. As of 2004, more than 150,000 RCTs were in the Cochrane Library. To improve the reporting of RCTs in the medical literature, an international group of scientists and editors published Consolidated Standards of Reporting Trials (CONSORT) Statements in 1996, 2001 and 2010, and these have become widely accepted. Randomization is the process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce the bias.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;到20世纪后期，随机对照试验被公认为医学“合理疗法”的标准方法。截至2004年，美国 Cochrane图书馆有超过15万本随机对照试验的参考资料。为了改进医学文献中对随机对照试验的报道，一个由科学家和编辑组成的国际小组在1996年、2001年和2010年发布了Consolidated Standards of Reporting Trials (CONSORT)声明，这些声明已被广泛接受。随机化是将试验受试者分配到治疗组或对照组的过程，使用机会因素来确定分配，以减少偏差。&lt;br /&gt;
&lt;br /&gt;
== Ethics ==&lt;br /&gt;
&lt;br /&gt;
Although the principle of clinical equipoise (&amp;quot;genuine uncertainty within the expert medical community... about the preferred treatment&amp;quot;) common to clinical trials[25] has been applied to RCTs, the ethics of RCTs have special considerations. For one, it has been argued that equipoise itself is insufficient to justify RCTs.[26] For another, &amp;quot;collective equipoise&amp;quot; can conflict with a lack of personal equipoise (e.g., a personal belief that an intervention is effective).[27] Finally, Zelen's design, which has been used for some RCTs, randomizes subjects before they provide informed consent, which may be ethical for RCTs of screening and selected therapies, but is likely unethical &amp;quot;for most therapeutic trials.&amp;quot;[28][29]&lt;br /&gt;
&lt;br /&gt;
Although the principle of clinical equipoise (&amp;quot;genuine uncertainty within the expert medical community... about the preferred treatment&amp;quot;) common to clinical trials has been applied to RCTs, the ethics of RCTs have special considerations. For one, it has been argued that equipoise itself is insufficient to justify RCTs. For another, &amp;quot;collective equipoise&amp;quot; can conflict with a lack of personal equipoise (e.g., a personal belief that an intervention is effective). Finally, Zelen's design, which has been used for some RCTs, randomizes subjects ''before'' they provide informed consent, which may be ethical for RCTs of screening and selected therapies, but is likely unethical &amp;quot;for most therapeutic trials.&amp;quot;&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;尽管临床平衡原则已经被广泛应用于RCT，但随机对照试验的伦理问题具有特殊性。首先，有人认为平衡本身不足以证明随机对照试验的合理性。另一方面，“集体均势”可能与缺乏个人均势相冲突(例如，个人认为干预是有效的)。最后，Zelen 的设计已经被用于一些随机试验，在受试者提供知情同意之前随机化，这对于筛选和选择性治疗的随机试验来说可能是合乎道德的，但是对于“大多数治疗试验”来说可能是不道德的。&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Although subjects almost always provide [[informed consent]] for their participation in an RCT, studies since 1982 have documented that RCT subjects may believe that they are certain to receive treatment that is best for them personally; that is, they do not understand the difference between research and treatment.&amp;lt;ref name=&amp;quot;Appelbaum-1982&amp;quot;&amp;gt;{{Cite journal |vauthors=Appelbaum PS, Roth LH, Lidz C | title = The therapeutic misconception: informed consent in psychiatric research | journal = [[Int J Law Psychiatry]] | volume = 5 | issue = 3–4 | pages = 319–29 | year = 1982 | doi = 10.1016/0160-2527(82)90026-7 | pmid = 6135666 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Henderson-2007&amp;quot;&amp;gt;{{Cite journal |vauthors=Henderson GE, Churchill LR, Davis AM, Easter MM, Grady C, Joffe S, Kass N, King NM, Lidz CW, Miller FG, Nelson DK, Peppercorn J, Rothschild BB, Sankar P, Wilfond BS, Zimmer CR | title = Clinical trials and medical care: defining the therapeutic misconception | journal = [[PLoS Med]] | volume = 4 | issue = 11 | pages = e324 | year = 2007 | doi = 10.1371/journal.pmed.0040324 | pmid = 18044980 | pmc = 2082641 }}&amp;lt;/ref&amp;gt; Further research is necessary to determine the prevalence of and ways to address this &amp;quot;[[therapeutic misconception]]&amp;quot;.&amp;lt;ref name=&amp;quot;Henderson-2007&amp;quot; /&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Although subjects almost always provide informed consent for their participation in an RCT, studies since 1982 have documented that RCT subjects may believe that they are certain to receive treatment that is best for them personally; that is, they do not understand the difference between research and treatment. Further research is necessary to determine the prevalence of and ways to address this &amp;quot;therapeutic misconception&amp;quot;. &lt;br /&gt;
&lt;br /&gt;
一般来说，受试者要为参加随机对照试验提交了知情同意书，但1982年以来的研究记录表明，随机对照试验的受试者可能认为他们肯定会接受对他们个人最好的治疗; 也就是说，他们不理解研究和治疗之间的区别。需要进一步研究，以确定这种”治疗性误解”的流行程度和解决方法。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
The RCT method variations may also create cultural effects that have not been well understood.[32] For example, patients with terminal illness may join trials in the hope of being cured, even when treatments are unlikely to be successful.&lt;br /&gt;
&lt;br /&gt;
RCT方法的变种也可能产生尚未被很好理解的文化效应。例如，患有晚期疾病的病人可能会加入临床试验以希望治愈，即使治疗不太可能成功的情况下也是如此。&lt;br /&gt;
&lt;br /&gt;
=== Trial registration ===&lt;br /&gt;
&lt;br /&gt;
In 2004, the [http://www.icmje.org/ International Committee of Medical Journal Editors] (ICMJE) announced that all trials starting enrolment after July 1, 2005 must be registered prior to consideration for publication in one of the 12 member journals of the committee.&amp;lt;ref name=&amp;quot;pmid15356289&amp;quot;&amp;gt;{{cite journal  |vauthors=De Angelis C, Drazen JM, Frizelle FA, etal |title=Clinical trial registration: a statement from the International Committee of Medical Journal Editors |journal=The New England Journal of Medicine |volume=351 |issue=12 |pages=1250–1 |date=September 2004 |pmid=15356289 |doi=10.1056/NEJMe048225 }}&amp;lt;/ref&amp;gt; However, trial registration may still occur late or not at all.&amp;lt;ref name=&amp;quot;pmid22147862&amp;quot;&amp;gt;{{cite journal|vauthors=Law MR, Kawasumi Y, Morgan SG | title=Despite law, fewer than one in eight completed studies of drugs and biologics are reported on time on ClinicalTrials.gov. | journal=Health Aff (Millwood) | year= 2011 | volume= 30 | issue= 12 | pages= 2338–45 | doi=10.1377/hlthaff.2011.0172 | pmid=22147862  | doi-access=free }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;pmid19724045&amp;quot;&amp;gt;{{cite journal|vauthors=Mathieu S, Boutron I, Moher D, Altman DG, Ravaud P | title=Comparison of registered and published primary outcomes in randomized controlled trials. | journal=JAMA | year= 2009 | volume= 302 | issue= 9 | pages= 977–84 | doi=10.1001/jama.2009.1242 | pmid=19724045  | doi-access=free }}&amp;lt;/ref&amp;gt;Medical journals have been slow in adapting policies requiring mandatory clinical trial registration as a prerequisite for publication.&amp;lt;ref&amp;gt;{{cite journal|last1=Bhaumik|first1=S|title=Editorial policies of MEDLINE indexed Indian journals on clinical trial registration.|journal=Indian Pediatr.|date=Mar 2013|volume=50|issue=3|pages=339–40|pmid=23680610|doi=10.1007/s13312-013-0092-2|s2cid=40317464}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
In 2004, the [http://www.icmje.org/ International Committee of Medical Journal Editors] (ICMJE) announced that all trials starting enrolment after July 1, 2005 must be registered prior to consideration for publication in one of the 12 member journals of the committee. However, trial registration may still occur late or not at all. Medical journals have been slow in adapting policies requiring mandatory clinical trial registration as a prerequisite for publication.&lt;br /&gt;
&lt;br /&gt;
2004年， 医学杂志编辑国际委员会(ICMJE)宣布，所有在2005年7月1日之后考虑在该委员会12种杂志上发表之前，必须对试验进行注册。尽管如此，试验登记可能仍然延迟或根本不会发生。医学期刊将强制性临床试验登记作为发表的先决条件进展缓慢。&lt;br /&gt;
== Classifications ==&lt;br /&gt;
=== By study design ===&lt;br /&gt;
&lt;br /&gt;
One way to classify RCTs is by [[study design]].  From most to least common in the healthcare literature, the major categories of RCT study designs are:&amp;lt;ref name=&amp;quot;Hopewell-2010&amp;quot;&amp;gt;{{Cite journal |vauthors=Hopewell S, Dutton S, Yu LM, Chan AW, Altman DG | title = The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed | journal = BMJ | volume = 340 | pages = c723 | year = 2010 | doi = 10.1136/bmj.c723  | pmid = 20332510 | pmc = 2844941 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
通过研究设计对 RCT 进行分类。从最常见到最不常见，RCT 研究设计的主要类别是&lt;br /&gt;
&lt;br /&gt;
* [[Parallel study|Parallel-group]] – each participant is randomly assigned to a group, and all the participants in the group receive (or do not receive) an intervention.&amp;lt;ref&amp;gt;{{cite journal |last1=Kaiser |first1=Joerg |last2=Niesen |first2=Willem |last3=Probst |first3=Pascal |last4=Bruckner |first4=Thomas |last5=Doerr-Harim |first5=Colette |last6=Strobel |first6=Oliver |last7=Knebel |first7=Phillip |last8=Diener |first8=Markus K. |last9=Mihaljevic |first9=André L. |last10=Büchler |first10=Markus W. |last11=Hackert |first11=Thilo |title=Abdominal drainage versus no drainage after distal pancreatectomy: study protocol for a randomized controlled trial |journal=Trials |date=7 June 2019 |volume=20 |issue=1 |page=332 |doi=10.1186/s13063-019-3442-0|pmid=31174583 |pmc=6555976 |doi-access=free }}&amp;lt;/ref&amp;gt;&amp;lt;ref&amp;gt;{{cite journal |last1=Farag |first1=Sara M. |last2=Mohammed |first2=Manal O. |last3=EL-Sobky |first3=Tamer A. |last4=ElKadery |first4=Nadia A. |last5=ElZohiery |first5=Abeer K. |title=Botulinum Toxin A Injection in Treatment of Upper Limb Spasticity in Children with Cerebral Palsy: A Systematic Review of Randomized Controlled Trials |journal=JBJS Reviews |date=March 2020 |volume=8 |issue=3 |pages=e0119 |doi=10.2106/JBJS.RVW.19.00119 |pmid=32224633|pmc=7161716 |doi-access=free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* 平行试验：每个参与者被随机分配到一个组，组中的所有参与者都接受(或不接受)干预。&lt;br /&gt;
&lt;br /&gt;
* [[Crossover study|Crossover]] – over time, each participant receives (or does not receive) an intervention in a random sequence.&amp;lt;ref&amp;gt;{{cite book  | last = Jones | first = Byron |author2=Kenward, Michael G.  | title = Design and Analysis of Cross-Over Trials | edition=Second| publisher = London: Chapman and Hall | year = 2003 }}&amp;lt;/ref&amp;gt;&amp;lt;ref&amp;gt;{{cite book  | last = Vonesh | first = Edward F. |author2=Chinchilli, Vernon G.  | chapter=Crossover Experiments| pages=111–202|title = Linear and Nonlinear Models for the Analysis of Repeated Measurements | publisher = London: Chapman and Hall | year = 1997 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* 交叉试验：随着时间的推移，每个参与者都会接受(或不接受)随机序列的干预。&lt;br /&gt;
&lt;br /&gt;
* [[Cluster randomised controlled trial|Cluster]] – pre-existing groups of participants (e.g., villages, schools) are randomly selected to receive (or not receive) an intervention.&amp;lt;ref&amp;gt;{{cite journal |last1=Gall |first1=Stefanie |last2=Adams |first2=Larissa |last3=Joubert |first3=Nandi |last4=Ludyga |first4=Sebastian |last5=Müller |first5=Ivan |last6=Nqweniso |first6=Siphesihle |last7=Pühse |first7=Uwe |last8=du Randt |first8=Rosa |last9=Seelig |first9=Harald |last10=Smith |first10=Danielle |last11=Steinmann |first11=Peter |last12=Utzinger |first12=Jürg |last13=Walter |first13=Cheryl |last14=Gerber |first14=Markus |last15=van Wouwe |first15=Jacobus P. |title=Effect of a 20-week physical activity intervention on selective attention and academic performance in children living in disadvantaged neighborhoods: A cluster randomized control trial |journal=PLOS ONE |date=8 November 2018 |volume=13 |issue=11 |pages=e0206908 |doi=10.1371/journal.pone.0206908 |pmid=30408073|pmc=6224098 |bibcode=2018PLoSO..1306908G |doi-access=free }}&amp;lt;/ref&amp;gt;&amp;lt;ref&amp;gt;{{cite journal |last1=Gladstone |first1=Melissa J. |last2=Chandna |first2=Jaya |last3=Kandawasvika |first3=Gwendoline |last4=Ntozini |first4=Robert |last5=Majo |first5=Florence D. |last6=Tavengwa |first6=Naume V. |last7=Mbuya |first7=Mduduzi N. N. |last8=Mangwadu |first8=Goldberg T. |last9=Chigumira |first9=Ancikaria |last10=Chasokela |first10=Cynthia M. |last11=Moulton |first11=Lawrence H. |last12=Stoltzfus |first12=Rebecca J. |last13=Humphrey |first13=Jean H. |last14=Prendergast |first14=Andrew J. |last15=Tumwine |first15=James K. |title=Independent and combined effects of improved water, sanitation, and hygiene (WASH) and improved complementary feeding on early neurodevelopment among children born to HIV-negative mothers in rural Zimbabwe: Substudy of a cluster-randomized trial |journal=PLOS Medicine |date=21 March 2019 |volume=16 |issue=3 |pages=e1002766 |doi=10.1371/journal.pmed.1002766|pmid=30897095 |pmc=6428259 |doi-access=free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* 聚类试验：预先存在的参与者组(例如，村庄、学校)被随机选择以接受(或不接受)干预。&lt;br /&gt;
&lt;br /&gt;
* [[Factorial experiment|Factorial]] – each participant is randomly assigned to a group that receives a particular combination of interventions or non-interventions (e.g., group 1 receives vitamin X and vitamin Y, group 2 receives vitamin X and placebo Y, group 3 receives placebo X and vitamin Y, and group 4 receives placebo X and placebo Y).&lt;br /&gt;
* 因子试验：每个参与者被随机分配到一个接受干预或非干预特定组合的组(例如，第1组接受维生素X和维生素Y，第2组接受维生素X和安慰剂Y，第3组接受安慰剂X和维生素Y，第4组接受安慰剂X和安慰剂Y)。&lt;br /&gt;
&lt;br /&gt;
An analysis of the 616 RCTs indexed in [[PubMed]] during December 2006 found that 78% were parallel-group trials, 16% were crossover, 2% were split-body, 2% were cluster, and 2% were factorial.&amp;lt;ref name=&amp;quot;Hopewell-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
An analysis of the 616 RCTs indexed in PubMed during December 2006 found that 78% were parallel-group trials, 16% were crossover, 2% were split-body, 2% were cluster, and 2% were factorial. &lt;br /&gt;
&lt;br /&gt;
对2006年12月在 PubMed 收录的616例随机对照试验的分析发现，78% 为平行组试验，16% 为交叉组试验，2% 为分体组试验，2% 为聚类组试验，2% 为因子组试验。&lt;br /&gt;
&lt;br /&gt;
=== By outcome of interest (efficacy vs. effectiveness) ===&lt;br /&gt;
&lt;br /&gt;
{{Main|Pragmatic clinical trial}}&lt;br /&gt;
&lt;br /&gt;
RCTs can be classified as &amp;quot;explanatory&amp;quot; or &amp;quot;pragmatic.&amp;quot;&amp;lt;ref name=&amp;quot;Zwarenstein-2008&amp;quot;&amp;gt;{{Cite journal | author = Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D; CONSORT group; Pragmatic Trials in Healthcare (Practihc) group | title = Improving the reporting of pragmatic trials: an extension of the CONSORT statement | journal = BMJ | volume = 337 | pages = a2390 | year = 2008 | doi = 10.1136/bmj.a2390 | pmid = 19001484 | pmc=3266844}}&amp;lt;/ref&amp;gt; Explanatory RCTs test [[Efficacy#Medicine|efficacy]] in a research setting with highly selected participants and under highly controlled conditions.&amp;lt;ref name=&amp;quot;Zwarenstein-2008&amp;quot;/&amp;gt; In contrast, pragmatic RCTs (pRCTs) test [[Effectiveness#Usage|effectiveness]] in everyday practice with relatively unselected participants and under flexible conditions; in this way, pragmatic RCTs can &amp;quot;inform decisions about practice.&amp;quot;&amp;lt;ref name=&amp;quot;Zwarenstein-2008&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
RCTs can be classified as &amp;quot;explanatory&amp;quot; or &amp;quot;pragmatic.&amp;quot; Explanatory RCTs test efficacy in a research setting with highly selected participants and under highly controlled conditions. In contrast, pragmatic RCTs (pRCTs) test effectiveness in everyday practice with relatively unselected participants and under flexible conditions; in this way, pragmatic RCTs can &amp;quot;inform decisions about practice.&amp;quot;&lt;br /&gt;
&lt;br /&gt;
随机对照试验可分为“解释性”或“实用性”。解释性随机对照试验在高度选定的参与者和高度受控的条件下测试有效性。相比之下，实用性随机对照测验(pragmatic RCTs, pRCT)在相对未经选择的参与者和灵活的条件下，在日常实践中检验有效性，这样，实用随机对照测验可以“为实践决策提供信息”。&lt;br /&gt;
=== By hypothesis (superiority vs. noninferiority vs. equivalence) ===&lt;br /&gt;
&lt;br /&gt;
Another classification of RCTs categorizes them as &amp;quot;superiority trials&amp;quot;, &amp;quot;noninferiority trials&amp;quot;, and &amp;quot;equivalence trials&amp;quot;, which differ in methodology and reporting.&amp;lt;ref name=&amp;quot;Piaggio-2006&amp;quot;&amp;gt;{{Cite journal | author = Piaggio G, Elbourne DR, [[Doug Altman|Altman DG]], [[Stuart Pocock|Pocock SJ]], Evans SJ; CONSORT Group | title = Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement | journal = JAMA | volume = 295 | issue = 10 | pages = 1152–60 |  year = 2006 | doi = 10.1001/jama.295.10.1152 | pmid = 16522836 | url = http://researchonline.lshtm.ac.uk/12069/1/Reporting%20of%20Noninferiority%20and%20Equivalence%20Randomized%20Trials.pdf }}&amp;lt;/ref&amp;gt; Most RCTs are superiority trials, in which one intervention is hypothesized to be superior to another in a [[Statistical significance|statistically significant]] way.&amp;lt;ref name=&amp;quot;Piaggio-2006&amp;quot;/&amp;gt; Some RCTs are noninferiority trials &amp;quot;to determine whether a new treatment is no worse than a reference treatment.&amp;quot;&amp;lt;ref name=&amp;quot;Piaggio-2006&amp;quot;/&amp;gt; Other RCTs are equivalence trials in which the hypothesis is that two interventions are indistinguishable from each other.&amp;lt;ref name=&amp;quot;Piaggio-2006&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Another classification of RCTs categorizes them as &amp;quot;superiority trials&amp;quot;, &amp;quot;noninferiority trials&amp;quot;, and &amp;quot;equivalence trials&amp;quot;, which differ in methodology and reporting. Most RCTs are superiority trials, in which one intervention is hypothesized to be superior to another in a statistically significant way. Some RCTs are noninferiority trials &amp;quot;to determine whether a new treatment is no worse than a reference treatment.&amp;quot; Other RCTs are equivalence trials in which the hypothesis is that two interventions are indistinguishable from each other.&lt;br /&gt;
&lt;br /&gt;
随机对照试验的另一种分类是“优越性试验”、“非劣性试验”和“等效性试验”，它们在方法和报告上有所不同。大多数随机对照试验都是优势试验，其中一种干预措施被假设在统计学意义上优于另一种干预措施。一些随机对照试验是非劣效性试验，“以确定一种新的治疗方法是否比一种参考治疗方法更差。”其他随机对照试验是等效试验，其中的假设是两种干预措施彼此不可区分。&lt;br /&gt;
&lt;br /&gt;
== Randomization ==&lt;br /&gt;
&lt;br /&gt;
The advantages of proper [[randomized experiment|randomization]] in RCTs include:&amp;lt;ref name=&amp;quot;SchulzGrimes2002&amp;quot;&amp;gt;{{Cite journal |vauthors=Schulz KF, Grimes DA | title = Generation of allocation sequences in randomised trials: chance, not choice | journal = Lancet | volume = 359 | issue = 9305 | pages = 515–9 | year = 2002 | doi = 10.1016/S0140-6736(02)07683-3 | url =https://www.who.int/entity/rhl/LANCET_515-519.pdf | pmid = 11853818 | s2cid = 291300 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
* &amp;quot;It eliminates bias in treatment assignment,&amp;quot; specifically [[selection bias]] and [[confounding]].&lt;br /&gt;
&lt;br /&gt;
* &amp;quot;It facilitates blinding (masking) of the identity of treatments from investigators, participants, and assessors.&amp;quot;&lt;br /&gt;
&lt;br /&gt;
* &amp;quot;It permits the use of probability theory to express the likelihood that any difference in outcome between treatment groups merely indicates chance.&amp;quot;&lt;br /&gt;
&lt;br /&gt;
There are two processes involved in randomizing patients to different interventions. First is choosing a randomization procedure to generate an unpredictable sequence of allocations; this may be a simple random assignment of patients to any of the groups at equal probabilities, may be &amp;quot;restricted&amp;quot;, or may be &amp;quot;adaptive.&amp;quot; A second and more practical issue is allocation concealment, which refers to the stringent precautions taken to ensure that the group assignment of patients are not revealed prior to definitively allocating them to their respective groups. Non-random &amp;quot;systematic&amp;quot; methods of group assignment, such as alternating subjects between one group and the other, can cause &amp;quot;limitless contamination possibilities&amp;quot; and can cause a breach of allocation concealment.&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
随机对照试验中适当随机化的优点包括：&lt;br /&gt;
* 它消除了治疗分配中的偏差，特别是选择偏差和混淆。&lt;br /&gt;
&lt;br /&gt;
* 它便于调查人员、参与者和评估人员对治疗人群的身份进行遮蔽。&lt;br /&gt;
&lt;br /&gt;
* 它允许使用概率理论来表达这样一种可能性，即治疗组之间结果的任何差异仅仅表明是偶然性的。&lt;br /&gt;
&lt;br /&gt;
有两个过程涉及到随机化的病人接受到不同的干预。首先是选择一个随机化程序来生成一个不可预测的分配序列；这可能是以相等的概率将患者随机分配到任何一组，可能是“受限的”，也可能是“适应性的”。第二个也是更实际的问题是隐藏分配，这是指在将患者明确分配到各自的组之前，采取严格的预防措施，以确保患者的组分配不被披露。非随机的“系统”组分配方法，如在一个组和另一个组之间交替患者，可能会造成“无限的污染可能性”，并可能导致分配隐藏的破坏。&lt;br /&gt;
&lt;br /&gt;
However empirical evidence that adequate randomization changes outcomes relative to inadequate randomization has been difficult to detect.&amp;lt;ref name=&amp;quot;Howick-2014&amp;quot;&amp;gt;{{Cite journal |vauthors=Howick J, Mebius A | title = In search of justification for the unpredictability paradox | journal = Trials | volume = 15 | pages = 480 | year = 2014 | doi = 10.1186/1745-6215-15-480 | pmid = 25490908 | pmc=4295227}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
然而，相对于不充分随机化，充分随机化改变结果的经验证据很难被发现。&lt;br /&gt;
&lt;br /&gt;
=== Procedures ===&lt;br /&gt;
&lt;br /&gt;
The treatment allocation is the desired proportion of patients in each treatment arm.&lt;br /&gt;
&lt;br /&gt;
治疗分配是每个治疗组中患者的期望比例。&lt;br /&gt;
&lt;br /&gt;
An ideal randomization procedure would achieve the following goals:&amp;lt;ref name=&amp;quot;Lachin-1988a&amp;quot;&amp;gt;{{Cite journal | author = Lachin JM | title = Statistical properties of randomization in clinical trials | journal = [[Controlled Clinical Trials]] | volume = 9 | issue = 4 | pages = 289–311 | year = 1988 | pmid = 3060315 |  doi = 10.1016/0197-2456(88)90045-1 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
An ideal randomization procedure would achieve the following goals:&lt;br /&gt;
&lt;br /&gt;
一个理想的随机化程序将实现以下目标:&lt;br /&gt;
&lt;br /&gt;
* '''Maximize [[statistical power]]''', especially in [[Subgroup analysis|subgroup analyses]].  Generally, equal group sizes maximize statistical power, however, unequal groups sizes may be more powerful for some analyses (e.g., multiple comparisons of placebo versus several doses using Dunnett's procedure&amp;lt;ref&amp;gt;{{cite web|last=Rosenberger|first=James|title=STAT 503 - Design of Experiments|url=https://onlinecourses.science.psu.edu/stat503/node/16|publisher=Pennsylvania State University|access-date=24 September 2012}}&amp;lt;/ref&amp;gt; ), and are sometimes desired for non-analytic reasons (e.g., patients may be more motivated to enroll if there is a higher chance of getting the test treatment, or regulatory agencies may require a minimum number of patients exposed to treatment).&amp;lt;ref name=&amp;quot;Avins-1998&amp;quot;&amp;gt;{{cite journal|last=Avins|first=A L|title=&amp;quot;Can unequal be more fair? Ethics, subject allocation, and randomized clinical trials&amp;quot;.|journal=J Med Ethics|year=1998|volume=24|pages=401–408|doi=10.1136/jme.24.6.401|issue=6|pmc=479141|pmid=9873981}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
* '''Minimize selection bias'''.  This may occur if investigators can consciously or unconsciously preferentially enroll patients between treatment arms.  A good randomization procedure will be unpredictable so that investigators cannot guess the next subject's group assignment based on prior treatment assignments. The risk of selection bias is highest when previous treatment assignments are known (as in unblinded studies) or can be guessed (perhaps if a drug has distinctive side effects).&lt;br /&gt;
&lt;br /&gt;
* '''Minimize allocation bias''' (or '''confounding''').  This may occur when [[covariate]]s that affect the outcome are not equally distributed between treatment groups, and the treatment effect is confounded with the effect of the covariates (i.e., an &amp;quot;accidental bias&amp;quot;&amp;lt;ref name=&amp;quot;SchulzGrimes2002&amp;quot;/&amp;gt;&amp;lt;ref name=&amp;quot;Buyse-1989&amp;quot;&amp;gt;{{Cite journal | author = Buyse ME | title = Analysis of clinical trial outcomes: some comments on subgroup analyses | journal = [[Controlled Clinical Trials]] | volume = 10 | issue = 4 Suppl | pages = 187S–194S | year = 1989 | pmid = 2605967 |  doi = 10.1016/0197-2456(89)90057-3 }}&amp;lt;/ref&amp;gt;).  If the randomization procedure causes an imbalance in covariates related to the outcome across groups, estimates of effect may be [[bias of an estimator|biased]] if not adjusted for the covariates (which may be unmeasured and therefore impossible to adjust for).&lt;br /&gt;
* '''最大化统计能力'''，尤其是在亚组分析中。一般来说，相等的组规模将最大化统计能力，然而，不相等的组规模对于某些分析来说可能更强大(例如，使用Dunnett程序对安慰剂与几个剂量进行多次比较)，并且有时由于非分析性原因而被采用(例如，如果有更高的机会获得试验治疗，患者可能更有动力登记，或者监管机构可能要求最少数量的患者接受治疗)。&lt;br /&gt;
&lt;br /&gt;
* '''最小化选择偏差'''。如果调查人员可以有意识或无意识地在治疗之间优先招募患者，就可能发生这种情况。一个好的随机化过程是不可预测的，因此研究人员不能根据先前的治疗分配来猜测下一个受试者的分组。当已知以前的治疗方案时(如在非盲法研究中)或可以猜到(如果一种药物有明显的副作用)，选择偏倚的风险最高。&lt;br /&gt;
&lt;br /&gt;
* '''最小化分配偏差(或混淆)'''。当影响结果的协变量在治疗组之间分布不均，并且治疗效果与协变量的效果混淆时(即“偶然偏差”)，可能会出现这种情况。如果随机化程序导致与各组结果相关的协变量失衡，如果不对协变量进行调整，效果估计可能会有偏差(这可能无法测量，因此无法调整)。&lt;br /&gt;
&lt;br /&gt;
However, no single randomization procedure meets those goals in every circumstance, so researchers must select a procedure for a given study based on its advantages and disadvantages.&lt;br /&gt;
&lt;br /&gt;
However, no single randomization procedure meets those goals in every circumstance, so researchers must select a procedure for a given study based on its advantages and disadvantages.&lt;br /&gt;
&lt;br /&gt;
然而，没有一个单一的随机化程序在每种情况下都能满足这些目标，因此研究人员必须根据其优点和缺点来选择一个给定的研究程序。&lt;br /&gt;
&lt;br /&gt;
==== Simple ====&lt;br /&gt;
&lt;br /&gt;
This is a commonly used and intuitive procedure, similar to &amp;quot;repeated fair coin-tossing.&amp;quot;&amp;lt;ref name=&amp;quot;SchulzGrimes2002&amp;quot;/&amp;gt; Also known as &amp;quot;complete&amp;quot; or &amp;quot;unrestricted&amp;quot; randomization, it is [[Robust statistics|robust]] against both selection and accidental biases. However, its main drawback is the possibility of imbalanced group sizes in small RCTs.  It is therefore recommended only for RCTs with over 200 subjects.&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;&amp;gt;{{Cite journal |vauthors=Lachin JM, Matts JP, Wei LJ | title = Randomization in clinical trials: conclusions and recommendations | journal = [[Controlled Clinical Trials]] | volume = 9 | issue = 4 | pages = 365–74 | year = 1988 | pmid = 3203526 |  doi = 10.1016/0197-2456(88)90049-9 | hdl = 2027.42/27041 | url = https://deepblue.lib.umich.edu/bitstream/2027.42/27041/1/0000029.pdf | hdl-access = free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
This is a commonly used and intuitive procedure, similar to &amp;quot;repeated fair coin-tossing.&amp;quot; Also known as &amp;quot;complete&amp;quot; or &amp;quot;unrestricted&amp;quot; randomization, it is robust against both selection and accidental biases. However, its main drawback is the possibility of imbalanced group sizes in small RCTs. It is therefore recommended only for RCTs with over 200 subjects.这是一个常用且直观的程序，类似于“反复公平抛硬币”，也被称为“完全”或“无限制”随机化，它对选择和意外偏差都是稳健的。然而，它的主要缺点是在小的随机对照试验中群体规模不平衡的可能性。因此，建议仅用于受试者超过200人时进行随机对照试验。&lt;br /&gt;
&lt;br /&gt;
==== Restricted ====&lt;br /&gt;
&lt;br /&gt;
To balance group sizes in smaller RCTs, some form of [[restricted randomization|&amp;quot;restricted&amp;quot; randomization]] is recommended.&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;/&amp;gt;  The major types of restricted randomization used in RCTs are:&lt;br /&gt;
&lt;br /&gt;
* '''[[Randomized block design|Permuted-block randomization]]''' or '''blocked randomization''': a &amp;quot;block size&amp;quot; and &amp;quot;allocation ratio&amp;quot; (number of subjects in one group versus the other group) are specified, and subjects are allocated randomly within each block.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt; For example, a block size of 6 and an allocation ratio of 2:1 would lead to random assignment of 4 subjects to one group and 2 to the other. This type of randomization can be combined with &amp;quot;[[stratified randomization]]&amp;quot;, for example by center in a [[multicenter trial]], to &amp;quot;ensure good balance of participant characteristics in each group.&amp;quot;&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt; A special case of permuted-block randomization is ''random allocation'', in which the entire sample is treated as one block.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt; The major disadvantage of permuted-block randomization is that even if the block sizes are large and randomly varied, the procedure can lead to selection bias.&amp;lt;ref name=&amp;quot;Lachin-1988a&amp;quot;/&amp;gt; Another disadvantage is that &amp;quot;proper&amp;quot; analysis of data from permuted-block-randomized RCTs requires stratification by blocks.&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
* '''Adaptive biased-coin randomization''' methods (of which '''urn randomization''' is the most widely known type): In these relatively uncommon methods, the probability of being assigned to a group decreases if the group is overrepresented and increases if the group is underrepresented.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt; The methods are thought to be less affected by selection bias than permuted-block randomization.&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
为了平衡较小随机对照试验中的组规模，建议采用某种形式的“限制性”随机化。随机对照试验中主要使用的限制随机化类型有:&lt;br /&gt;
&lt;br /&gt;
* '''置换区组随机化'''或'''区组随机化'''：规定了“区组大小”和“分配比例”(一组受试者相对于另一组受试者的数量)，受试者在每个区组内随机分配。例如，块大小为6，分配比例为2:1，将导致4个受试者随机分配到一个组，2个分配到另一个组。这种类型的随机化可以与“分层随机化”相结合，例如通过多中心试验中的中心，以“确保每个组中参与者特征的良好平衡。”置换块随机化的一个特殊情况是随机分配，其中整个样本被视为一个块。置换块随机化的主要缺点是，即使块大小很大且随机变化，该过程也会导致选择偏差。另一个缺点是，对置换区组随机对照试验数据的“适当”分析需要按区组分层。&lt;br /&gt;
&lt;br /&gt;
* '''自适应有偏-硬币随机化方法'''（其中瓮随机化是最广为人知的类型）：在这些相对不常见的方法中，如果一个组的代表人数过多，被分配到该组的概率会降低，如果该组的代表人数不足，被分配到该组的概率会增加。这些方法被认为比置换块随机化受选择偏差的影响更小。&lt;br /&gt;
==== Adaptive ====&lt;br /&gt;
&lt;br /&gt;
At least two types of &amp;quot;adaptive&amp;quot; randomization procedures have been used in RCTs, but much less frequently than simple or restricted randomization:&lt;br /&gt;
&lt;br /&gt;
* '''Covariate-adaptive randomization''', of which one type is '''[[Minimisation (clinical trials)|minimization]]''': The probability of being assigned to a group varies in order to minimize &amp;quot;covariate imbalance.&amp;quot;&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;/&amp;gt; Minimization is reported to have &amp;quot;supporters and detractors&amp;quot;&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt; because only the first subject's group assignment is truly chosen at random, the method does not necessarily eliminate bias on unknown factors.&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
* '''Response-adaptive randomization''', also known as '''outcome-adaptive randomization''': The probability of being assigned to a group increases if the responses of the prior patients in the group were favorable.&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;/&amp;gt; Although arguments have been made that this approach is more ethical than other types of randomization when the probability that a treatment is effective or ineffective increases during the course of an RCT, ethicists have not yet studied the approach in detail.&amp;lt;ref name=&amp;quot;Rosenberger-1993&amp;quot;&amp;gt;{{Cite journal |vauthors=Rosenberger WF, Lachin JM | title = The use of response-adaptive designs in clinical trials | journal = [[Controlled Clinical Trials]] | volume = 14 | issue = 6 | pages = 471–84 | year = 1993 | pmid = 8119063 |  doi = 10.1016/0197-2456(93)90028-C }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
在随机对照试验中，至少使用了两种类型的“适应性”随机化程序，但频率远低于简单或限制性随机化：&lt;br /&gt;
&lt;br /&gt;
* '''协变量自适应随机化'''，其中一种类型是最小化：被分配到一个组的概率是变化的，以便最小化“协变量不平衡”。据报道，最小化有“支持者和诋毁者”，因为只有第一个受试者的群组分配是真正随机选择的，该方法不一定能消除对未知因素的偏见。&lt;br /&gt;
&lt;br /&gt;
* '''应答自适应随机化'''，也称为'''结果自适应随机化：'''如果组中先前患者的应答是有利的，则被分配到一个组的概率增加。虽然有人认为，当治疗有效或无效的概率在RCT过程中增加时，这种方法比其他类型的随机化更符合伦理，但伦理学家尚未详细研究这种方法。&lt;br /&gt;
=== Allocation concealment ===&lt;br /&gt;
&lt;br /&gt;
{{main|Allocation concealment}}&lt;br /&gt;
&lt;br /&gt;
&amp;quot;Allocation concealment&amp;quot; (defined as &amp;quot;the procedure for protecting the randomization process so that the treatment to be allocated is not known before the patient is entered into the study&amp;quot;) is important in RCTs.&amp;lt;ref name=&amp;quot;Forder-2005&amp;quot;&amp;gt;{{Cite journal |vauthors=Forder PM, Gebski VJ, Keech AC | title = Allocation concealment and blinding: when ignorance is bliss | journal = Med J Aust | volume = 182 | issue = 2 | pages = 87–9 | year = 2005 | url = http://www.mja.com.au/public/issues/182_02_170105/for10877_fm.html | pmid = 15651970 | doi = 10.5694/j.1326-5377.2005.tb06584.x | s2cid = 202149 }}&amp;lt;/ref&amp;gt; In practice, clinical investigators in RCTs often find it difficult to maintain impartiality. Stories abound of investigators holding up sealed envelopes to lights or ransacking offices to determine group assignments in order to dictate the assignment of their next patient.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;&amp;gt;{{Cite journal | title = Allocation concealment in randomised trials: defending against deciphering | journal = Lancet | volume = 359 | issue = 9306 | pages = 614–8 | year = 2002 | doi = 10.1016/S0140-6736(02)07750-4 | url =https://www.who.int/entity/rhl/LANCET_614-618.pdf | pmid = 11867132 |vauthors=Schulz KF, Grimes DA | s2cid = 12902486 }}&amp;lt;/ref&amp;gt; Such practices introduce selection bias and [[Lurking variable|confounders]] (both of which should be minimized by randomization), possibly distorting the results of the study.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt; Adequate allocation concealment should defeat patients and investigators from discovering treatment allocation once a study is underway and after the study has concluded.  Treatment related side-effects or adverse events may be specific enough to reveal allocation to investigators or patients thereby introducing bias or influencing any subjective parameters collected by investigators or requested from subjects.&lt;br /&gt;
&lt;br /&gt;
“分配隐藏”(定义为“保护随机化过程的程序，以便在病人进入研究之前不知道要分配的治疗”)在随机对照试验中很重要。在实践中，临床研究人员在随机对照试验中常常发现难以保持公正性。关于调查人员将密封的信封举到灯光下或者搜查办公室来决定群组分配，以便指定下一个病人的分配的故事比比皆是。这种做法引入了选择偏差和混杂因素(这两者都应该通过随机化来减少) ，可能会扭曲研究结果。一旦研究开始并在研究结束后，充分的分配隐藏应该会阻止患者和研究者发现治疗分配。与治疗相关的副作用或不良事件可能足够具体，足以向研究者或患者揭示分配情况，从而引入偏差或影响研究者收集的或受试者要求的任何主观参数。&lt;br /&gt;
&lt;br /&gt;
Some standard methods of ensuring allocation concealment include sequentially numbered, opaque, sealed envelopes (SNOSE); sequentially numbered containers; pharmacy controlled randomization; and central randomization. It is recommended that allocation concealment methods be included in an RCT's protocol, and that the allocation concealment methods should be reported in detail in a publication of an RCT's results; however, a 2005 study determined that most RCTs have unclear allocation concealment in their protocols, in their publications, or both. On the other hand, a 2008 study of 146 meta-analyses concluded that the results of RCTs with inadequate or unclear allocation concealment tended to be biased toward beneficial effects only if the RCTs' outcomes were subjective as opposed to objective.&lt;br /&gt;
&lt;br /&gt;
一些确保分配隐藏的标准方法包括顺序编号、不透明、密封信封(SNOSE)；顺序编号的容器；药学控制的随机化；和中心随机化。分配隐藏方法被建议纳入RCT议定书，并在RCT结果的出版物中详细报告分配隐藏方法；然而，2005年的一项研究发现，大多数随机对照试验在其方案、出版物或两者中都有不清楚的分配隐藏。另一方面，2008年的一项对146项元分析的研究得出结论，分配隐瞒不充分或不明确的随机对照试验的结果往往只有在随机对照试验的结果是主观的而不是客观的情况下才会偏向于有益的结果。&lt;br /&gt;
=== Sample size ===&lt;br /&gt;
&lt;br /&gt;
{{Main|Sample size determination}}The number of treatment units (subjects or groups of subjects) assigned to control and treatment groups, affects an RCT's reliability. If the effect of the treatment is small, the number of treatment units in either group may be insufficient for rejecting the null hypothesis in the respective statistical test. The failure to reject the null hypothesis would imply that the treatment shows no statistically significant effect on the treated ''in a given test''. But as the sample size increases, the same RCT may be able to demonstrate a significant effect of the treatment, even if this effect is small.&lt;br /&gt;
&lt;br /&gt;
分配给控制组和治疗组的治疗单位(受试者或受试者组)的样本量影响 RCT 的可靠性。如果治疗的效果很小，任何一组的治疗单位的样本量都可能不足以在各自的统计检验中拒绝零假设。拒绝无效假设的失败意味着在给定的试验中，治疗对被治疗者没有统计学上的显著影响。但是随着样本量的增加，同样的RCT可能能够证明治疗的显著效果，即使这种效果很小。&lt;br /&gt;
&lt;br /&gt;
== Blinding ==&lt;br /&gt;
&lt;br /&gt;
{{main|Blinded experiment}}&lt;br /&gt;
&lt;br /&gt;
An RCT may be [[Blind experiment|blinded]], (also called &amp;quot;masked&amp;quot;) by &amp;quot;procedures that prevent study participants, caregivers, or outcome assessors from knowing which intervention was received.&amp;quot;&amp;lt;ref name=&amp;quot;Wood-2008&amp;quot;&amp;gt;{{Cite journal |vauthors=Wood L, Egger M, Gluud LL, Schulz KF, Jüni P, Altman DG, Gluud C, Martin RM, Wood AJ, Sterne JA | title = Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study | journal = BMJ | volume = 336 | issue = 7644 | pages = 601–5 | year = 2008 | doi = 10.1136/bmj.39465.451748.AD | pmid = 18316340 | pmc = 2267990 }}&amp;lt;/ref&amp;gt; Unlike allocation concealment, blinding is sometimes inappropriate or impossible to perform in an RCT; for example, if an RCT involves a treatment in which active participation of the patient is necessary (e.g., [[physical therapy]]), participants cannot be blinded to the intervention.&lt;br /&gt;
&lt;br /&gt;
一项RCT的盲法是指阻止研究参与者、照顾者或结果评估者知道哪些干预措施，这一程序也称“蒙面”。与分配隐藏不同，在RCT，致盲有时是不合适的或不可能的；例如，如果RCT涉及需要患者积极参与的治疗(例如物理治疗)，参与者不能对干预视而不见。&lt;br /&gt;
&lt;br /&gt;
Traditionally, blinded RCTs have been classified as &amp;quot;single-blind&amp;quot;, &amp;quot;double-blind&amp;quot;, or &amp;quot;triple-blind&amp;quot;; however, in 2001 and 2006 two studies showed that these terms have different meanings for different people.&amp;lt;ref name=&amp;quot;Devereaux-2001&amp;quot;&amp;gt;{{Cite journal |vauthors=Devereaux PJ, Manns BJ, Ghali WA, Quan H, Lacchetti C, Montori VM, Bhandari M, Guyatt GH | title = Physician interpretations and textbook definitions of blinding terminology in randomized controlled trials | journal = [[J Am Med Assoc]] | volume = 285 | issue = 15 | pages = 2000–3 | year = 2001 | doi =  10.1001/jama.285.15.2000| pmid = 11308438 | doi-access = free }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Haahr-2006&amp;quot;&amp;gt;{{Cite journal |vauthors=Haahr MT, Hróbjartsson A | title = Who is blinded in randomized clinical trials? A study of 200 trials and a survey of authors | journal = Clin Trials | volume = 3 | issue = 4 | pages = 360–5 | year = 2006 | doi = 10.1177/1740774506069153 | pmid = 17060210 | s2cid = 23818514 }}&amp;lt;/ref&amp;gt;  The 2010 [[Consolidated Standards of Reporting Trials|CONSORT Statement]] specifies that authors and editors should not use the terms &amp;quot;single-blind&amp;quot;, &amp;quot;double-blind&amp;quot;, and &amp;quot;triple-blind&amp;quot;; instead, reports of blinded RCT should discuss &amp;quot;If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how.&amp;quot;&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
传统上，盲法随机对照试验分为“单盲”、“双盲”或“三盲”；然而，2001年和2006年的两项研究表明，这些术语对不同的人有不同的含义。2010年CONSORT 声明明确指出，作者和编辑不应使用”单盲”、”双盲”和”三盲”等术语；相反，关于盲法 RCT 的报告应讨论”如果完成，干预分配后谁被“蒙面”了(例如，参与者、护理提供者、评估结果的人员)以及其原因”。&lt;br /&gt;
&lt;br /&gt;
RCTs without blinding are referred to as &amp;quot;unblinded&amp;quot;,&amp;lt;ref name=&amp;quot;Marson-2007&amp;quot;&amp;gt;{{Cite journal  |vauthors=Marson AG, Al-Kharusi AM, Alwaidh M, Appleton R, Baker GA, Chadwick DW, etal | title = The SANAD study of effectiveness of valproate, lamotrigine, or topiramate for generalised and unclassifiable epilepsy: an unblinded randomised controlled trial | journal = [[The Lancet|Lancet]] | volume = 369 | issue = 9566 | pages = 1016–26 | year = 2007 | doi = 10.1016/S0140-6736(07)60461-9 | pmid = 17382828 | pmc = 2039891 }}&amp;lt;/ref&amp;gt; &amp;quot;open&amp;quot;,&amp;lt;ref name=&amp;quot;Chan-1995&amp;quot;&amp;gt;{{Cite journal |vauthors=Chan R, Hemeryck L, O'Regan M, Clancy L, Feely J | title = Oral versus intravenous antibiotics for community acquired lower respiratory tract infection in a general hospital: open, randomised controlled trial | journal = [[BMJ]] | volume = 310 | issue = 6991 | pages = 1360–2 | year = 1995 | pmid = 7787537 | pmc = 2549744 | doi=10.1136/bmj.310.6991.1360}}&amp;lt;/ref&amp;gt; or (if the intervention is a medication) &amp;quot;[[Open-label trial|open-label]]&amp;quot;.&amp;lt;ref name=&amp;quot;Fukase-2008&amp;quot;&amp;gt;{{Cite journal | author = Fukase K, Kato M, Kikuchi S, Inoue K, Uemura N, Okamoto S, Terao S, Amagai K, Hayashi S, Asaka M; Japan Gast Study Group | title = Effect of eradication of Helicobacter pylori on incidence of metachronous gastric carcinoma after endoscopic resection of early gastric cancer: an open-label, randomised controlled trial | journal = Lancet | volume = 372 | issue = 9636 | pages = 392–7 | year = 2008 | doi = 10.1016/S0140-6736(08)61159-9 | pmid = 18675689 | hdl = 2115/34681 | s2cid = 13741892 | url = https://eprints.lib.hokudai.ac.jp/dspace/bitstream/2115/34681/1/asaka.pdf | hdl-access = free }}&amp;lt;/ref&amp;gt; In 2008 a study concluded that the results of unblinded RCTs tended to be biased toward beneficial effects only if the RCTs' outcomes were subjective as opposed to objective;&amp;lt;ref name=&amp;quot;Wood-2008&amp;quot;/&amp;gt; for example, in an RCT of treatments for [[multiple sclerosis]], unblinded neurologists (but not the blinded neurologists) felt that the treatments were beneficial.&amp;lt;ref name=&amp;quot;Noseworthy-1994&amp;quot;&amp;gt;{{Cite journal |vauthors=Noseworthy JH, Ebers GC, Vandervoort MK, Farquhar RE, Yetisir E, Roberts R | author-link1=John H. Noseworthy|title = The impact of blinding on the results of a randomized, placebo-controlled multiple sclerosis clinical trial | journal = Neurology | volume = 44 | issue = 1 | pages = 16–20 | year = 1994 | url = http://www.neurology.org/cgi/content/abstract/44/1/16 | pmid = 8290055 | doi=10.1212/wnl.44.1.16| s2cid=2663997}}&amp;lt;/ref&amp;gt; In pragmatic RCTs, although the participants and providers are often unblinded, it is &amp;quot;still desirable and often possible to blind the assessor or obtain an objective source of data for evaluation of outcomes.&amp;quot;&amp;lt;ref name=&amp;quot;Zwarenstein-2008&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
没有盲法的随机对照试验被称为“未盲法”，也称“开放”，或者(如果干预是一种药物)“开放标签”。2008年的一项研究得出结论，只有当随机对照试验的结果是主观的而不是客观的时候，非盲法随机对照试验的结果往往偏向于有益的结果；例如，在RCT多发性硬化症的治疗中，未盲的神经学家认为治疗是有益的。在实用的随机对照试验中，尽管参与者和提供者往往是非盲的，但是”仍然需要并且往往可能使评估者“蒙面”，以获得评估结果的客观数据来源”。&lt;br /&gt;
&lt;br /&gt;
== Analysis of data ==&lt;br /&gt;
&lt;br /&gt;
The types of statistical methods used in RCTs depend on the characteristics of the data and include:&lt;br /&gt;
&lt;br /&gt;
* For [[dichotomous]] (binary) outcome data, [[logistic regression]] (e.g., to predict sustained virological response after receipt of [[peginterferon alfa-2a]] for [[hepatitis C]]&amp;lt;ref name=&amp;quot;Manns-2001&amp;quot;&amp;gt;{{Cite journal |vauthors=Manns MP, McHutchison JG, Gordon SC, Rustgi VK, Shiffman M, Reindollar R, Goodman ZD, Koury K, Ling M, Albrecht JK | title = Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial | journal = [[The Lancet|Lancet]] | volume = 358 | issue = 9286 | pages = 958–65 | year = 2001 | doi = 10.1016/S0140-6736(01)06102-5 | pmid = 11583749 | s2cid = 14583372 }}&amp;lt;/ref&amp;gt;) and other methods can be used.&lt;br /&gt;
&lt;br /&gt;
* For continuous outcome data, [[analysis of covariance]] (e.g., for changes in blood lipid levels after receipt of [[atorvastatin]] after [[acute coronary syndrome]]&amp;lt;ref name=&amp;quot;Schwartz-2001&amp;quot;&amp;gt;{{Cite journal | author = Schwartz GG, Olsson AG, Ezekowitz MD, Ganz P, Oliver MF, Waters D, Zeiher A, Chaitman BR, Leslie S, Stern T; Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering (MIRACL) Study Investigators | title = Effects of atorvastatin on early recurrent ischemic events in acute coronary syndromes: the MIRACL study: a randomized controlled trial | journal = [[J Am Med Assoc]] | volume = 285 | issue = 13 | pages = 1711–8 | year = 2001 | pmid = 11277825 | doi = 10.1001/jama.285.13.1711 | doi-access = free }}&amp;lt;/ref&amp;gt;) tests the effects of predictor variables.&lt;br /&gt;
&lt;br /&gt;
* For time-to-event outcome data that may be [[Censoring (statistics)|censored]], [[survival analysis]] (e.g., [[Kaplan–Meier estimator]]s and [[Cox proportional hazards model]]s for time to [[coronary heart disease]] after receipt of [[Hormone replacement therapy (menopause)|hormone replacement therapy in menopause]]&amp;lt;ref name=&amp;quot;Rossouw-2002&amp;quot;&amp;gt;{{Cite journal | author = Rossouw JE, Anderson GL, [[Ross Prentice|Prentice RL]], LaCroix AZ, Kooperberg C, Stefanick ML, Jackson RD, Beresford SA, Howard BV, Johnson KC, Kotchen JM, Ockene J; Writing Group for the Women's Health Initiative Investigators | title = Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial | journal = [[J Am Med Assoc]] | volume = 288 | issue = 3 | pages = 321–33 | year = 2002 | pmid = 12117397 | doi = 10.1001/jama.288.3.321 | s2cid = 20149703 | url = https://escholarship.org/content/qt3mr6f93p/qt3mr6f93p.pdf?t=prll4c | doi-access = free }}&amp;lt;/ref&amp;gt;) is appropriate.&lt;br /&gt;
&lt;br /&gt;
随机对照试验中使用的统计方法类型取决于数据的特征，包括：&lt;br /&gt;
&lt;br /&gt;
* 对于二元结果数据，可以使用逻辑回归(例如，预测接受聚乙二醇干扰素α-2a治疗丙型肝炎后的持续病毒学应答)和其他方法。&lt;br /&gt;
&lt;br /&gt;
* 对于连续的结果数据，协方差分析(例如，急性冠状动脉综合征后接受阿托伐他汀后血脂水平的变化)可以用于检测预测变量效果。&lt;br /&gt;
&lt;br /&gt;
* 对于可能删失的时间到事件结果数据，生存分析(如绝经后接受激素替代治疗后冠心病发生时间的卡普兰-迈耶估计值和考克斯比例风险模型)是合适的。&lt;br /&gt;
Regardless of the statistical methods used, important considerations in the analysis of RCT data include:&lt;br /&gt;
&lt;br /&gt;
* Whether an RCT should be stopped early due to interim results.  For example, RCTs may be stopped early if an intervention produces &amp;quot;larger than expected benefit or harm&amp;quot;, or if &amp;quot;investigators find evidence of no important difference between experimental and control interventions.&amp;quot;&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
* The extent to which the groups can be analyzed exactly as they existed upon randomization (i.e., whether a so-called &amp;quot;[[intention-to-treat analysis]]&amp;quot; is used). A &amp;quot;pure&amp;quot; intention-to-treat analysis is &amp;quot;possible only when complete outcome data are available&amp;quot; for all randomized subjects;&amp;lt;ref name=&amp;quot;Hollis-1999&amp;quot;&amp;gt;{{Cite journal |vauthors=Hollis S, Campbell F | title = What is meant by intention to treat analysis? Survey of published randomised controlled trials | journal = [[Br Med J]] | volume = 319 | issue = 7211 | pages = 670–4 | year = 1999 | pmid = 10480822 | pmc = 28218 | doi=10.1136/bmj.319.7211.670}}&amp;lt;/ref&amp;gt; when some outcome data are missing, options include analyzing only cases with known outcomes and using [[Imputation (statistics)|imputed]] data.&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt; Nevertheless, the more that analyses can include all participants in the groups to which they were randomized, the less bias that an RCT will be subject to.&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
* Whether [[subgroup analysis]] should be performed.  These are &amp;quot;often discouraged&amp;quot; because [[multiple comparisons]] may produce false positive findings that cannot be confirmed by other studies.&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
无论使用何种统计方法，RCT数据分析中的重要考虑因素包括：&lt;br /&gt;
&lt;br /&gt;
* 由于中期结果，是否应该提前停止RCT。例如，如果干预产生“大于预期的益处或危害”，或者如果“研究者发现实验干预和对照干预之间没有重要区别的证据”，则可能会提前停止随机对照试验。&lt;br /&gt;
&lt;br /&gt;
* 这些组在多大程度上可以完全按照随机化时的状态进行分析(即，是否使用了所谓的“意向治疗分析”)。一项“纯”意向治疗分析“只有在获得所有随机受试者的完整结果数据时才有可能”；当一些结果数据缺失时，选项包括仅分析具有已知结果的病例和使用估算数据。然而，分析越能包括他们被随机分组的所有参与者，RCT受到的偏见就越少。&lt;br /&gt;
&lt;br /&gt;
* 是否应进行亚组分析。这些“通常是不鼓励的”，因为多次比较可能会产生假阳性结果，而其他研究无法证实。&lt;br /&gt;
== Reporting of results ==&lt;br /&gt;
&lt;br /&gt;
&amp;lt;li value=&amp;quot;5&amp;quot;&amp;gt;The ''CONSORT 2010 Statement'' is &amp;quot;an evidence-based, minimum set of recommendations for reporting RCTs.&amp;quot; The CONSORT 2010 checklist contains 25 items (many with sub-items) focusing on &amp;quot;individually randomised, two group, parallel trials&amp;quot; which are the most common type of RCT.&lt;br /&gt;
&lt;br /&gt;
For other RCT study designs, &amp;quot;CONSORT extensions&amp;quot; have been published, some examples are:&lt;br /&gt;
* Consort 2010 Statement: Extension to Cluster Randomised Trials&lt;br /&gt;
* Consort 2010 Statement: Non-Pharmacologic Treatment Interventions&lt;br /&gt;
&lt;br /&gt;
CONSORT 2010声明是“一套基于证据的报告随机对照试验的最低建议。”CONSORT 2010核对表包含25个项目(许多带有子项目)，重点关注“个体随机、两组、平行试验”，这是RCT最常见的类型。&lt;br /&gt;
&lt;br /&gt;
对于其他RCT研究设计，“CONSORT扩展版”已经发布，一些例子是:&lt;br /&gt;
* CONSORT 2010 声明: 扩展至聚类随机试验&lt;br /&gt;
* CONSORT 2010 声明: 非药物治疗干预&lt;br /&gt;
&lt;br /&gt;
=== Relative importance and observational studies ===&lt;br /&gt;
&lt;br /&gt;
Two studies published in ''The New England Journal of Medicine'' in 2000 found that observational studies and RCTs overall produced similar results. The authors of the 2000 findings questioned the belief that &amp;quot;observational studies should not be used for defining evidence-based medical care&amp;quot; and that RCTs' results are &amp;quot;evidence of the highest grade.&amp;quot; However, a 2001 study published in ''Journal of the American Medical Association'' concluded that &amp;quot;discrepancies beyond chance do occur and differences in estimated magnitude of treatment effect are very common&amp;quot; between observational studies and RCTs.&lt;br /&gt;
&lt;br /&gt;
Two other lines of reasoning question RCTs' contribution to scientific knowledge beyond other types of studies:&lt;br /&gt;
* If study designs are ranked by their potential for new discoveries, then anecdotal evidence would be at the top of the list, followed by observational studies, followed by RCTs.&lt;br /&gt;
* RCTs may be unnecessary for treatments that have dramatic and rapid effects relative to the expected stable or progressively worse natural course of the condition treated. One example is combination chemotherapy including cisplatin for metastatic testicular cancer, which increased the cure rate from 5% to 60% in a 1977 non-randomized study.&lt;br /&gt;
2000年发表在《新英格兰医学杂志》上的两项研究发现，观察性研究和随机对照试验总体上产生了相似的结果。2000年研究结果的作者质疑“观察性研究不应用于定义循证医疗”以及随机对照试验的结果是“最高等级的证据”的观点。然而，2001年发表在《美国医学协会杂志》上的一项研究得出结论，观察性研究和随机对照试验之间“确实会出现超越偶然的差异，估计治疗效果的差异非常普遍”。&lt;br /&gt;
&lt;br /&gt;
另外两条推理路线质疑随机对照试验对科学知识的贡献超过了其他类型的研究:&lt;br /&gt;
* 如果按照新发现的潜力对研究设计进行排序，那么轶事证据将排在首位，其次是观察性研究，然后是随机对照试验。&lt;br /&gt;
* 相对于所治疗疾病的预期稳定或逐渐恶化的自然病程而言，RCT对于具有显著和快速效果的治疗可能是不必要的。一个例子是联合化疗，包括顺铂治疗转移性睾丸癌，在1977年的一项非随机研究中将治愈率从5%提高到60%。&lt;br /&gt;
&lt;br /&gt;
=== Interpretation of statistical results ===&lt;br /&gt;
&lt;br /&gt;
与所有统计方法一样，随机对照试验同时存在ⅰ型(“假阳性”)和ⅱ型(“假阴性”)统计误差。关于第一类错误，典型的RCT将使用0.05(即20分之一)作为RCT错误地发现两种同等有效的治疗方法显著不同的概率。关于第二类错误，尽管1978年发表的一篇论文指出，许多“阴性”随机对照试验的样本量太小，无法对阴性结果做出明确的结论，但到2005-2006年，相当大比例的随机对照试验仍然有不准确或不完全报告的样本量计算。&lt;br /&gt;
&lt;br /&gt;
=== Peer review ===&lt;br /&gt;
&lt;br /&gt;
结果的同行评审是科学方法的重要组成部分。审查者检查研究结果是否存在可能导致不可靠结果的潜在设计问题(例如，通过产生系统偏差)，在相关研究和其他证据的背景下评估研究，并评估是否可以合理地认为研究已经证明了其结论。为了强调同行评审的必要性和过度概括结论的危险，两位波士顿地区的医学研究人员进行了一项随机对照试验，他们随机给23名从双翼飞机或直升机上跳下的志愿者分配了一个降落伞或一个空背包。这项研究能够准确地报告，与空背包相比，降落伞不能减少伤害。限制这一结论普遍适用性的关键背景是，飞机停在地面上，参与者只跳了大约两英尺。&lt;br /&gt;
&lt;br /&gt;
== Advantages ==&lt;br /&gt;
&lt;br /&gt;
RCTs are considered to be the most reliable form of [[scientific method|scientific evidence]] in the [[hierarchy of evidence]] that influences healthcare policy and practice because RCTs reduce spurious causality and bias. Results of RCTs may be combined in [[systematic review]]s which are increasingly being used in the conduct of [[evidence-based practice]]. Some examples of scientific organizations' considering RCTs or systematic reviews of RCTs to be the highest-quality evidence available are:&lt;br /&gt;
* As of 1998, the [[National Health and Medical Research Council]] of Australia designated &amp;quot;Level I&amp;quot; evidence as that &amp;quot;obtained from a [[systematic review]] of all relevant randomised controlled trials&amp;quot; and &amp;quot;Level II&amp;quot; evidence as that &amp;quot;obtained from at least one properly designed randomised controlled trial.&amp;quot;&amp;lt;ref&amp;gt;{{cite book |url= http://www.nhmrc.gov.au/_files_nhmrc/file/publications/synopses/cp30.pdf |title= A guide to the development, implementation and evaluation of clinical practice guidelines |author= National Health and Medical Research Council |date=1998-11-16 |publisher= Commonwealth of Australia |location = Canberra | isbn = 978-1-86496-048-8 |page= 56|access-date=2010-03-28}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* Since at least 2001, in making [[clinical practice guideline]] recommendations the [[United States Preventive Services Task Force]] has considered both a study's design and its [[internal validity]] as indicators of its quality.&amp;lt;ref name=&amp;quot;Harris-2001&amp;quot;&amp;gt;{{Cite journal | author = Harris RP, Helfand M, Woolf SH, Lohr KN, Mulrow CD, Teutsch SM, Atkins D; Methods Work Group, Third US Preventive Services Task Force | title = Current methods of the US Preventive Services Task Force: a review of the process | journal = Am J Prev Med | volume = 20 | issue = 3 Suppl | pages = 21–35 | year = 2001 | url = http://www.ahrq.gov/clinic/ajpmsuppl/review.pdf | pmid = 11306229 | doi = 10.1016/S0749-3797(01)00261-6 }}&amp;lt;/ref&amp;gt; It has recognized &amp;quot;evidence obtained from at least one properly randomized controlled trial&amp;quot; with good [[internal validity]] (i.e., a rating of &amp;quot;I-good&amp;quot;) as the highest quality evidence available to it.&amp;lt;ref name=&amp;quot;Harris-2001&amp;quot;/&amp;gt;&lt;br /&gt;
* The [[Evidence-based medicine#Grade Working Group|GRADE Working Group]] concluded in 2008 that &amp;quot;randomised trials without important limitations constitute high quality evidence.&amp;quot;&amp;lt;ref name=&amp;quot;Guyatt-2008&amp;quot;&amp;gt;{{Cite journal | author = Guyatt GH, Oxman AD, Kunz R, Vist GE, Falck-Ytter Y, Schünemann HJ; GRADE Working Group | title = What is &amp;quot;quality of evidence&amp;quot; and why is it important to clinicians? | journal = BMJ | volume = 336 | issue = 7651 | pages = 995–8 |year = 2008 | doi = 10.1136/bmj.39490.551019.BE | pmc = 2364804 | pmid = 18456631 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* For issues involving &amp;quot;Therapy/Prevention, Aetiology/Harm&amp;quot;, the [[Oxford Centre for Evidence-based Medicine]] as of 2011 defined &amp;quot;Level 1a&amp;quot; evidence as a systematic review of RCTs that are consistent with each other, and &amp;quot;Level 1b&amp;quot; evidence as an &amp;quot;individual RCT (with narrow [[Confidence Interval]]).&amp;quot;&amp;lt;ref&amp;gt;{{cite web |url= http://www.cebm.net/index.aspx?o=1025 |title= Levels of evidence |author= Oxford Centre for Evidence-based Medicine |date=2011-09-16 |access-date=2012-02-15}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
RCT被认为是影响医疗保健政策和实践的证据层次中最可靠的科学证据形式，因为RCT减少了虚假的因果关系和偏见。随机对照试验的结果可以在系统综述中结合使用，越来越多地用于循证实践。一些科学组织认为随机对照试验或随机对照试验的系统审查是现有的最高质量证据的例子有:&lt;br /&gt;
* 截至1998年，澳大利亚国家卫生和医学研究委员会将“一级”证据指定为“从所有相关随机对照试验的系统审查中获得的”，将“二级”证据指定为“从至少一项适当设计的随机对照试验中获得的”&lt;br /&gt;
* 至少自2001年以来，美国预防服务工作组在提出临床实践指南建议时，将研究的设计及其内部有效性作为其质量的指标。它承认“从至少一个适当的随机对照试验中获得的证据”具有良好的内部有效性(即“良好”评级)，是它所能获得的最高质量的证据。&lt;br /&gt;
* GRADE工作组在2008年得出结论，“没有重要限制的随机试验构成了高质量的证据。”&lt;br /&gt;
* 对于涉及“治疗/预防、病因学/危害”的问题，截至2011年，牛津循证医学中心将“1a级”证据定义为相互一致的随机对照试验的系统审查，“1b级”证据定义为“个体RCT(置信区间较窄)。”&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Notable RCTs with unexpected results that contributed to changes in clinical practice include:&lt;br /&gt;
* After [[Food and Drug Administration]] approval, the [[antiarrhythmic agents]] [[flecainide]] and [[encainide]] came to market in 1986 and 1987 respectively.&amp;lt;ref name=&amp;quot;Anderson-1997&amp;quot;&amp;gt;{{Cite journal |vauthors=Anderson JL, Pratt CM, Waldo AL, Karagounis LA | title = Impact of the Food and Drug Administration approval of flecainide and encainide on coronary artery disease mortality: putting &amp;quot;Deadly Medicine&amp;quot; to the test | journal = Am J Cardiol | volume = 79 | issue = 1 | pages = 43–7 | year = 1997 | url = http://www.ajconline.org/article/S0002-9149%2896%2900673-X/abstract | pmid = 9024734 | doi = 10.1016/S0002-9149(96)00673-X }}&amp;lt;/ref&amp;gt; The non-randomized studies concerning the drugs were characterized as &amp;quot;glowing&amp;quot;,&amp;lt;ref name=&amp;quot;Rubin-2006&amp;quot;&amp;gt;{{cite news |title= In medicine, evidence can be confusing - deluged with studies, doctors try to sort out what works, what doesn't |author= Rubin R |url= https://www.usatoday.com/news/health/2006-10-15-medical-evidence-cover_x.htm |newspaper= USA Today |date= 2006-10-16 |access-date=2010-03-22}}&amp;lt;/ref&amp;gt; and their sales increased to a combined total of approximately 165,000 prescriptions per month in early 1989.&amp;lt;ref name=&amp;quot;Anderson-1997&amp;quot;/&amp;gt;  In that year, however, a preliminary report of an RCT concluded that the two drugs increased mortality.&amp;lt;ref name=&amp;quot;CAST-1989&amp;quot;&amp;gt;{{Cite journal | doi = 10.1056/NEJM198908103210629 | title = Preliminary report: effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction. The Cardiac Arrhythmia Suppression Trial (CAST) Investigators | journal = N Engl J Med | volume = 321 | issue = 6 | pages = 406–12 |year = 1989 | pmid = 2473403 | author1 = Cardiac Arrhythmia Suppression Trial (CAST) Investigators }}&amp;lt;/ref&amp;gt;  Sales of the drugs then decreased.&amp;lt;ref name=&amp;quot;Anderson-1997&amp;quot;/&amp;gt;&lt;br /&gt;
* Prior to 2002, based on observational studies, it was routine for physicians to prescribe hormone replacement therapy for post-menopausal women to prevent [[myocardial infarction]].&amp;lt;ref name=&amp;quot;Rubin-2006&amp;quot;/&amp;gt; In 2002 and 2004, however, published RCTs from the [[Women's Health Initiative]] claimed that women taking hormone replacement therapy with estrogen plus progestin had a higher rate of myocardial infarctions than women on a placebo, and that estrogen-only hormone replacement therapy caused no reduction in the incidence of coronary heart disease.&amp;lt;ref name=&amp;quot;Rossouw-2002&amp;quot;/&amp;gt;&amp;lt;ref name=&amp;quot;Anderson-2004&amp;quot;&amp;gt;{{Cite journal  |vauthors=Anderson GL, Limacher M, Assaf AR, Bassford T, Beresford SA, Black H, etal | title = Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women's Health Initiative randomized controlled trial | journal = JAMA | volume = 291 | issue = 14 | pages = 1701–12 | year = 2004 | doi = 10.1001/jama.291.14.1701 | pmid = 15082697 | doi-access = free }}&amp;lt;/ref&amp;gt;  Possible explanations for the discrepancy between the observational studies and the RCTs involved differences in methodology, in the hormone regimens used, and in the populations studied.&amp;lt;ref name=&amp;quot;Grodstein-2003&amp;quot;&amp;gt;{{Cite journal |vauthors=Grodstein F, Clarkson TB, Manson JE | title = Understanding the divergent data on postmenopausal hormone therapy | journal = N Engl J Med | volume = 348 | issue = 7 | pages = 645–50 | year = 2003 | doi = 10.1056/NEJMsb022365 | pmid = 12584376 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Vandenbroucke-2009&amp;quot;&amp;gt;{{Cite journal | author = Vandenbroucke JP | title = The HRT controversy: observational studies and RCTs fall in line | journal = Lancet | volume = 373 | issue = 9671 | pages = 1233–5 | year = 2009 | doi = 10.1016/S0140-6736(09)60708-X | pmid = 19362661 | s2cid = 44991220 }}&amp;lt;/ref&amp;gt; The use of hormone replacement therapy decreased after publication of the RCTs.&amp;lt;ref name=&amp;quot;Hsu-2009&amp;quot;&amp;gt;{{Cite journal |vauthors=Hsu A, Card A, Lin SX, Mota S, Carrasquillo O, Moran A | title = Changes in postmenopausal hormone replacement therapy use among women with high cardiovascular risk | journal = Am J Public Health | volume = 99 | issue = 12 | pages = 2184–7 | year = 2009 | doi = 10.2105/AJPH.2009.159889 | url = http://ajph.aphapublications.org/cgi/content/full/99/12/2184 | pmid = 19833984 | pmc=2775780}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
导致临床实践改变的具有意想不到结果的显著随机对照试验包括:&lt;br /&gt;
* 美国食品药品监督管理局批准后，抗心律失常药氟卡尼和恩卡尼分别于1986年和1987年上市。关于这些药物的非随机研究被描述为“glowing”，1989年初，它们的销售额增加到每月总计约165，000张处方。然而，在那一年，一份RCT的初步报告得出结论，这两种药物会增加死亡率。这些药物的销量随后下降。&lt;br /&gt;
* 在2002年之前，基于观察性研究，医生为绝经后妇女开激素替代疗法以预防心肌梗死是常规。然而，在2002年和2004年，妇女健康倡议发表的随机对照试验声称，服用雌激素加孕激素的激素替代疗法的妇女比服用安慰剂的妇女心肌梗死的发生率更高，并且仅服用雌激素的激素替代疗法不会降低冠心病的发病率。观察性研究和随机对照试验之间差异的可能解释涉及方法学、所用激素方案和研究人群的差异。在随机对照试验发表后，激素替代疗法的使用减少了。&lt;br /&gt;
== Disadvantages ==&lt;br /&gt;
&lt;br /&gt;
Many papers discuss the disadvantages of RCTs.&amp;lt;ref name=&amp;quot;Black-1996&amp;quot;&amp;gt;{{Cite journal | author = Black N | title = Why we need observational studies to evaluate the effectiveness of health care | journal = BMJ | volume = 312 | issue = 7040 | pages = 1215–8 | year = 1996 | pmid = 8634569 | pmc = 2350940 | doi=10.1136/bmj.312.7040.1215}}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Bell &amp;amp; Peck-2012&amp;quot;&amp;gt;{{Cite journal | author = Bell, S.H., &amp;amp; Peck, L.R. | title = Obstacles to and limitations of social experiments: 15 false alarms | journal = Abt Thought Leadership Paper Series | year = 2012 | url = http://abtassociates.com/white-papers/2012/obstacles-to-and-limitations-of-social-experiments.aspx }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Sanson-Fisher-2007&amp;quot;&amp;gt;{{Cite journal |vauthors=Sanson-Fisher RW, Bonevski B, Green LW, D'Este C | title = Limitations of the randomized controlled trial in evaluating population-based health interventions | journal = Am J Prev Med | volume = 33 | issue = 2 | pages = 155–61 | year = 2007 | doi = 10.1016/j.amepre.2007.04.007 | url = http://www.ajpm-online.net/article/S0749-3797%2807%2900225-5/abstract | pmid = 17673104 }}&amp;lt;/ref&amp;gt;   Among the most frequently cited drawbacks are:&lt;br /&gt;
&lt;br /&gt;
许多论文讨论了随机对照试验的缺点。最常被提及的缺点包括:&lt;br /&gt;
&lt;br /&gt;
=== Time and costs ===&lt;br /&gt;
&lt;br /&gt;
RCTs can be expensive; one study found 28 Phase III RCTs funded by the National Institute of Neurological Disorders and Stroke prior to 2000 with a total cost of US$335 million, for a mean cost of US$12 million per RCT. Nevertheless, the return on investment of RCTs may be high, in that the same study projected that the 28 RCTs produced a &amp;quot;net benefit to society at 10-years&amp;quot; of 46 times the cost of the trials program, based on evaluating a quality-adjusted life year as equal to the prevailing mean per capita gross domestic product.&lt;br /&gt;
&lt;br /&gt;
The conduct of an RCT takes several years until being published; thus, data is restricted from the medical community for long years and may be of less relevance at time of publication.&lt;br /&gt;
&lt;br /&gt;
It is costly to maintain RCTs for the years or decades that would be ideal for evaluating some interventions.&lt;br /&gt;
&lt;br /&gt;
Interventions to prevent events that occur only infrequently (e.g., sudden infant death syndrome) and uncommon adverse outcomes (e.g., a rare side effect of a drug) would require RCTs with extremely large sample sizes and may, therefore, best be assessed by observational studies.&lt;br /&gt;
&lt;br /&gt;
Due to the costs of running RCTs, these usually only inspect one variable or very few variables, rarely reflecting the full picture of a complicated medical situation; whereas the case report, for example, can detail many aspects of the patient's medical situation (e.g. patient history, physical examination, diagnosis, psychosocial aspects, follow up).&lt;br /&gt;
&lt;br /&gt;
RCT可能很贵；一项研究发现，在2000年之前，由国家神经障碍和中风研究所资助的28个三期随机对照试验总费用为3.35亿美元，平均每个RCT花费1200万美元。尽管如此，随机对照试验的投资回报可能很高，因为同一项研究预测，根据对质量调整生命年的评估，28个随机对照试验产生的“10年社会净收益”是试验项目成本的46倍，等于当时的人均国内生产总值平均值。&lt;br /&gt;
&lt;br /&gt;
一部RCT的行为需要几年才能出版；因此，数据在很长一段时间内受到医学界的限制，在发表时可能不太相关。&lt;br /&gt;
&lt;br /&gt;
维持几年或几十年的随机对照试验成本很高，而这些试验对于评估一些干预措施是理想的。&lt;br /&gt;
&lt;br /&gt;
预防不常发生的事件(如婴儿猝死综合征)和不常见的不良后果(如药物的罕见副作用)的干预措施需要样本量极大的随机对照试验，因此最好通过观察性研究进行评估。&lt;br /&gt;
&lt;br /&gt;
由于运行随机对照试验的成本，这些通常只检查一个变量或很少的变量，很少反映复杂医疗情况的全貌；而例如病例报告可以详细描述患者医疗状况的许多方面(例如，患者病史、体检、诊断、心理社会方面、随访)。&lt;br /&gt;
&lt;br /&gt;
=== Conflict of interest dangers ===&lt;br /&gt;
&lt;br /&gt;
A 2011 study done to disclose possible conflicts of interests in underlying research studies used for medical meta-analyses reviewed 29 meta-analyses and found that conflicts of interests in the studies underlying the meta-analyses were rarely disclosed. The 29 meta-analyses included 11 from general medicine journals; 15 from specialty medicine journals, and 3 from the Cochrane Database of Systematic Reviews. The 29 meta-analyses reviewed an aggregate of 509 randomized controlled trials (RCTs). Of these, 318 RCTs reported funding sources with 219 (69%) industry funded. 132 of the 509 RCTs reported author conflict of interest disclosures, with 91 studies (69%) disclosing industry financial ties with one or more authors. The information was, however, seldom reflected in the meta-analyses. Only two (7%) reported RCT funding sources and none reported RCT author-industry ties. The authors concluded &amp;quot;without acknowledgment of COI due to industry funding or author industry financial ties from RCTs included in meta-analyses, readers' understanding and appraisal of the evidence from the meta-analysis may be compromised.&amp;quot;&lt;br /&gt;
&lt;br /&gt;
Some RCTs are fully or partly funded by the health care industry (e.g., the pharmaceutical industry) as opposed to government, nonprofit, or other sources. A systematic review published in 2003 found four 1986–2002 articles comparing industry-sponsored and nonindustry-sponsored RCTs, and in all the articles there was a correlation of industry sponsorship and positive study outcome. A 2004 study of 1999–2001 RCTs published in leading medical and surgical journals determined that industry-funded RCTs &amp;quot;are more likely to be associated with statistically significant pro-industry findings.&amp;quot; These results have been mirrored in trials in surgery, where although industry funding did not affect the rate of trial discontinuation it was however associated with a lower odds of publication for completed trials. One possible reason for the pro-industry results in industry-funded published RCTs is publication bias. Other authors have cited the differing goals of academic and industry sponsored research as contributing to the difference. Commercial sponsors may be more focused on performing trials of drugs that have already shown promise in early stage trials, and on replicating previous positive results to fulfill regulatory requirements for drug approval.&lt;br /&gt;
&lt;br /&gt;
2011年的一项研究披露了用于医学荟萃分析的基础研究中可能存在的利益冲突，该研究回顾了29项荟萃分析，发现在荟萃分析的基础研究中很少披露利益冲突。29项荟萃分析包括11项来自普通医学期刊；15篇来自专业医学期刊，3篇来自Cochrane系统综述数据库。29项荟萃分析共审查了509项随机对照试验。其中，318个随机对照试验报告了资金来源，219个(69%)得到了行业资助。509个随机对照试验中有132个报告了作者利益冲突披露，91项研究(69%)披露了与一名或多名作者的行业财务联系。然而，这些信息很少反映在荟萃分析中。只有两个(7%)报告了RCT的资金来源，没有一个报告了RCT作者与行业的联系。作者总结道，“如果由于行业资助或作者行业财务联系而不承认荟萃分析中随机对照试验的COI，读者对荟萃分析证据的理解和评估可能会受到影响。&amp;quot;一些随机对照试验完全或部分由医疗保健行业(如制药行业)资助，而不是由政府、非营利或其他来源资助。2003年发表的一项系统综述发现了四篇1986-2002年的文章，比较了行业赞助和非行业赞助的随机对照试验，在所有文章中，行业赞助和积极的研究结果之间存在相关性。2004年发表在主要医学和外科杂志上的一项关于1999-2001年随机对照试验的研究确定，行业资助的随机对照试验“更有可能与有统计学意义的亲行业发现相关。”这些结果在外科试验中得到了反映，尽管行业资助不影响试验中止率，但与完成试验的发表几率较低有关。行业资助的已发表随机对照试验中出现亲行业结果的一个可能原因是发表偏倚。其他作者认为学术和行业赞助研究的不同目标是造成这种差异的原因。商业赞助商可能会更专注于对已经在早期试验中显示出希望的药物进行试验，并复制以前的积极结果，以满足药物批准的监管要求。&lt;br /&gt;
=== Ethics ===&lt;br /&gt;
If a disruptive innovation in medical technology is developed, it may be difficult to test this ethically in an RCT if it becomes &amp;quot;obvious&amp;quot; that the control subjects have poorer outcomes—either due to other foregoing testing, or within the initial phase of the RCT itself. Ethically it may be necessary to abort the RCT prematurely, and getting ethics approval (and patient agreement) to withhold the innovation from the control group in future RCT's may not be feasible.&lt;br /&gt;
&lt;br /&gt;
Historical control trials (HCT) exploit the data of previous RCTs to reduce the sample size; however, these approaches are controversial in the scientific community and must be handled with care.&lt;br /&gt;
&lt;br /&gt;
如果医疗技术出现了颠覆性创新，如果“明显”对照受试者的结局较差，可能很难在RCT进行伦理测试——这可能是由于其他前述测试，也可能是在RCT的初始阶段。从伦理上讲，可能有必要过早地中止RCT，而获得伦理批准(和患者同意)以在未来的RCT试验中阻止对照组的创新可能是不可行的。&lt;br /&gt;
&lt;br /&gt;
历史对照试验(HCT)利用以前随机对照试验的数据来减少样本量；然而，这些方法在科学界有争议，必须小心处理。&lt;br /&gt;
&lt;br /&gt;
== In social science ==&lt;br /&gt;
Due to the recent emergence of RCTs in social science, the use of RCTs in social sciences is a contested issue. Some writers from a medical or health background have argued that existing research in a range of social science disciplines lacks rigour, and should be improved by greater use of randomized control trials.&lt;br /&gt;
&lt;br /&gt;
由于最近在社会科学中出现了随机对照试验，随机对照试验在社会科学中的使用是一个有争议的问题。一些具有医学或健康背景的作者认为，一系列社会科学学科的现有研究缺乏严谨性，应该通过更多地使用随机对照试验来改进。&lt;br /&gt;
&lt;br /&gt;
=== Transport science ===&lt;br /&gt;
Researchers in transport science argue that public spending on programmes such as school travel plans could not be justified unless their efficacy is demonstrated by randomized controlled trials. Graham-Rowe and colleagues reviewed 77 evaluations of transport interventions found in the literature, categorising them into 5 &amp;quot;quality levels&amp;quot;. They concluded that most of the studies were of low quality and advocated the use of randomized controlled trials wherever possible in future transport research.&lt;br /&gt;
&lt;br /&gt;
Dr. Steve Melia took issue with these conclusions, arguing that claims about the advantages of RCTs, in establishing causality and avoiding bias, have been exaggerated. He proposed the following eight criteria for the use of RCTs in contexts where interventions must change human behaviour to be effective:&lt;br /&gt;
&lt;br /&gt;
The intervention:&lt;br /&gt;
# Has not been applied to all members of a unique group of people (e.g. the population of a whole country, all employees of a unique organisation etc.)&lt;br /&gt;
# Is applied in a context or setting similar to that which applies to the control group&lt;br /&gt;
# Can be isolated from other activities—and the purpose of the study is to assess this isolated effect&lt;br /&gt;
# Has a short timescale between its implementation and maturity of its effects&lt;br /&gt;
&lt;br /&gt;
And the causal mechanisms:&lt;br /&gt;
# Are either known to the researchers, or else all possible alternatives can be tested&lt;br /&gt;
# Do not involve significant feedback mechanisms between the intervention group and external environments&lt;br /&gt;
# Have a stable and predictable relationship to exogenous factors&lt;br /&gt;
# Would act in the same way if the control group and intervention group were reversed&lt;br /&gt;
交通科学的研究人员认为，除非随机对照试验证明其有效性，否则在学校旅行计划等项目上的公共支出是不合理的。格雷厄姆-罗和他的同事们回顾了文献中发现的77项交通干预评估，将它们分为5个“质量等级”。他们得出结论，大多数研究质量较低，并主张在未来的运输研究中尽可能使用随机对照试验。&lt;br /&gt;
&lt;br /&gt;
Steve Melia博士不同意这些结论，他认为关于随机对照试验在建立因果关系和避免偏见方面优势的说法被夸大了。在干预措施必须改变人类行为才能有效的情况下，他提出了以下八项使用随机对照试验的标准:&lt;br /&gt;
&lt;br /&gt;
干预措施:&lt;br /&gt;
# 没有适用于一个独特群体的所有成员(例如，整个国家的人口、一个独特组织的所有雇员等)&lt;br /&gt;
# 应用于类似于应用于控制组的上下文或设置中&lt;br /&gt;
# 可以从其他活动中分离出来，本研究的目的是评估这种分离的效果&lt;br /&gt;
# 从实施到效果成熟的时间很短&lt;br /&gt;
&lt;br /&gt;
以及因果机制:&lt;br /&gt;
# 要么是研究人员已知的，要么是所有可能的替代品都可以测试&lt;br /&gt;
# 不要涉及干预组和外部环境之间的重要反馈机制&lt;br /&gt;
# 与外部因素有稳定且可预测的关系&lt;br /&gt;
# 如果对照组和干预组颠倒过来，会以同样的方式起作用&lt;br /&gt;
&lt;br /&gt;
=== Criminology ===&lt;br /&gt;
A 2005 review found 83 randomized experiments in criminology published in 1982–2004, compared with only 35 published in 1957–1981. The authors classified the studies they found into five categories: &amp;quot;policing&amp;quot;, &amp;quot;prevention&amp;quot;, &amp;quot;corrections&amp;quot;, &amp;quot;court&amp;quot;, and &amp;quot;community&amp;quot;. Focusing only on offending behavior programs, Hollin (2008) argued that RCTs may be difficult to implement (e.g., if an RCT required &amp;quot;passing sentences that would randomly assign offenders to programmes&amp;quot;) and therefore that experiments with quasi-experimental design are still necessary.&lt;br /&gt;
&lt;br /&gt;
2005年的一项审查发现，1982-2004年发表了83项犯罪学随机实验，而1957-1981年只发表了35项。作者将他们发现的研究分为五类:“警务”、“预防”、“惩戒”、“法院”和“社区”。Hollin (2008)只关注犯罪行为项目，他认为随机对照试验可能很难实施(例如，如果RCT要求“判刑时随机将罪犯分配到项目中”)，因此准实验设计的实验仍然是必要的。&lt;br /&gt;
&lt;br /&gt;
=== Education ===&lt;br /&gt;
RCTs have been used in evaluating a number of educational interventions. Between 1980 and 2016, over 1,000 reports of RCTs have been published. For example, a 2009 study randomized 260 elementary school teachers' classrooms to receive or not receive a program of behavioral screening, classroom intervention, and parent training, and then measured the behavioral and academic performance of their students. Another 2009 study randomized classrooms for 678 first-grade children to receive a classroom-centered intervention, a parent-centered intervention, or no intervention, and then followed their academic outcomes through age 19.&lt;br /&gt;
&lt;br /&gt;
RCT已被用于评估一些教育干预措施。从1980年到2016年，已经发表了1000多份随机对照试验报告。例如，2009年的一项研究随机选择了260名小学教师的教室，让他们接受或不接受行为筛查、课堂干预和家长培训，然后测量他们学生的行为和学业表现。另一项2009年的研究对678名一年级儿童进行了随机课堂，让他们接受以课堂为中心的干预、以家长为中心的干预或不干预，然后跟踪他们19岁的学习成绩。&lt;br /&gt;
&lt;br /&gt;
== Criticism ==&lt;br /&gt;
A 2018 review of the 10 most cited randomised controlled trials noted poor distribution of background traits, difficulties with blinding, and discussed other assumptions and biases inherent in randomised controlled trials. These include the &amp;quot;unique time period assessment bias&amp;quot;, the &amp;quot;background traits remain constant assumption&amp;quot;, the &amp;quot;average treatment effects limitation&amp;quot;, the &amp;quot;simple treatment at the individual level limitation&amp;quot;, the &amp;quot;all preconditions are fully met assumption&amp;quot;, the &amp;quot;quantitative variable limitation&amp;quot; and the &amp;quot;placebo only or conventional treatment only limitation&amp;quot;.&lt;br /&gt;
&lt;br /&gt;
2018年对10个引用最多的随机对照试验的回顾指出了背景特征分布不佳、致盲困难，并讨论了随机对照试验中固有的其他假设和偏见。其中包括“独特的时间段评估偏差”、“背景特征保持不变假设”、“平均治疗效果限制”、“个体水平的简单治疗限制”、“所有前提条件均完全满足假设”、“定量变量限制”和“仅安慰剂或仅常规治疗限制”。Category:Clinical research&lt;br /&gt;
&lt;br /&gt;
类别: 临床研究&lt;br /&gt;
&lt;br /&gt;
Category:Epidemiological study projects&lt;br /&gt;
&lt;br /&gt;
类别: 流行病学研究项目&lt;br /&gt;
&lt;br /&gt;
Category:Evidence-based practices&lt;br /&gt;
&lt;br /&gt;
类别: 循证做法&lt;br /&gt;
&lt;br /&gt;
Category:Design of experiments&lt;br /&gt;
[[Category:待整理页面]]&lt;br /&gt;
&amp;lt;references /&amp;gt;&lt;/div&gt;</summary>
		<author><name>李昊轩</name></author>
	</entry>
	<entry>
		<id>https://wiki.swarma.org/index.php?title=%E9%9A%8F%E6%9C%BA%E5%AF%B9%E7%85%A7%E8%AF%95%E9%AA%8C&amp;diff=24417</id>
		<title>随机对照试验</title>
		<link rel="alternate" type="text/html" href="https://wiki.swarma.org/index.php?title=%E9%9A%8F%E6%9C%BA%E5%AF%B9%E7%85%A7%E8%AF%95%E9%AA%8C&amp;diff=24417"/>
		<updated>2021-07-14T08:19:28Z</updated>

		<summary type="html">&lt;p&gt;李昊轩：/* Relative importance and observational studies */&lt;/p&gt;
&lt;hr /&gt;
&lt;div&gt;此词条暂由彩云小译翻译，翻译字数共2766，未经人工整理和审校，带来阅读不便，请见谅。&lt;br /&gt;
&lt;br /&gt;
{{Short description|Experimental method designed to reduce bias, typically accomplished by randomly allocating subjects to two or more groups, with one being a control group}}&lt;br /&gt;
&lt;br /&gt;
[[File:Flowchart of Phases of Parallel Randomized Trial - Modified from CONSORT 2010.png|thumb|upright=1.5|Flowchart of four phases (enrollment, allocation, intervention, follow-up, and data analysis) of a parallel randomized trial of two groups (in a controlled trial, one of the interventions serves as the control), modified from the CONSORT (Consolidated Standards of Reporting Trials) 2010 Statement&amp;lt;ref name=&amp;quot;Schulz-2010&amp;quot;&amp;gt;{{Cite journal | author = Schulz KF, Altman DG, ((Moher D; for the CONSORT Group)) | title = CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials | journal = [[Br Med J]] | volume = 340 | pages = c332 | year = 2010 | doi = 10.1136/bmj.c332 | pmid = 20332509 | pmc = 2844940 }}&amp;lt;/ref&amp;gt;|链接=Special:FilePath/Flowchart_of_Phases_of_Parallel_Randomized_Trial_-_Modified_from_CONSORT_2010.png]]&lt;br /&gt;
&lt;br /&gt;
[来源：图片] Flowchart of four phases (enrollment, allocation, intervention, follow-up, and data analysis) of a parallel randomized trial of two groups (in a controlled trial, one of the interventions serves as the control), modified from the CONSORT (Consolidated Standards of Reporting Trials) 2010 Statement.&lt;br /&gt;
&lt;br /&gt;
据修改的2010年CONSORT (综合报告试验标准)要求，流程图包括：两组平行随机试验分为登记、分配、干预、随访和数据分析四个阶段，在对照试验中，需要其中一项干预作为对照处理措施。 &lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
A '''randomized controlled trial''' (or '''randomized control trial''';&amp;lt;ref name=&amp;quot;Chalmers-1981&amp;quot;&amp;gt;{{Cite journal |vauthors=Chalmers TC, ((Smith H Jr)), Blackburn B, Silverman B, Schroeder B, Reitman D, Ambroz A | title = A method for assessing the quality of a randomized control trial | journal = [[Controlled Clinical Trials]] | volume = 2 | issue = 1 | pages = 31–49 | year = 1981 | doi = 10.1016/0197-2456(81)90056-8 | pmid = 7261638 }}&amp;lt;/ref&amp;gt; '''RCT''') is a type of ''[[scientific experiment]]'' (e.g. a ''[[clinical trial]]'') or ''intervention study'' (as opposed to ''[[observational study]]'') that aims to reduce certain sources of bias when testing the effectiveness of new treatments; this is accomplished by [[Random assignment|randomly allocating]] subjects to two or more groups, treating them differently, and then comparing them with respect to a measured response. One group—the experimental group—receives the intervention being assessed, while the other—usually called the control group—receives an alternative treatment, such as a [[placebo]] or no intervention. The groups are monitored under conditions of the trial design to determine the effectiveness of the experimental intervention, and efficacy is assessed in comparison to the control. &amp;lt;ref&amp;gt;{{cite web|url=https://www.nice.org.uk/glossary?letter=r|publisher=National Institute for Health and Care Excellence, London, UK|title=Randomised controlled trial|date=2019|access-date=3 June 2019}}&amp;lt;/ref&amp;gt; There may be more than one treatment group or more than one [[Treatment and control groups|control group]].&lt;br /&gt;
&lt;br /&gt;
A randomized controlled trial (or randomized control trial; RCT) is a type of scientific experiment (e.g. a clinical trial) or intervention study (as opposed to observational study) that aims to reduce certain sources of bias when testing the effectiveness of new treatments; this is accomplished by randomly allocating subjects to two or more groups, treating them differently, and then comparing them with respect to a measured response. One group—the experimental group—receives the intervention being assessed, while the other—usually called the control group—receives an alternative treatment, such as a placebo or no intervention. The groups are monitored under conditions of the trial design to determine the effectiveness of the experimental intervention, and efficacy is assessed in comparison to the control.  There may be more than one treatment group or more than one control group.&lt;br /&gt;
&lt;br /&gt;
随机对照试验(A randomized controlled trial, RCT)是一种科学实验(例如:临床试验)或干预研究(区别于观察性研究) ，其目的是在测试新治疗的有效性时减少某些偏倚来源。通过受试者随机分配到两个或两个以上的组，经过不同的处理，产生的效应再与一个有可控的处理效应相比较。即一组或多组(实验组)接受正在评估的干预措施，而另一组(通常称为对照组)接受替代治疗，如安慰剂或无干预措施。在试验设计的条件下对这些组进行监测，以确定实验干预的有效性，并与对照组进行疗效比较评估。当然这也包括一个以上的治疗组或一个以上的对照组。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
The trial may be [[blinded experiment|blinded]], meaning that information which may influence the participants is withheld until after the experiment is complete. A blind can be imposed on any participant of an experiment, including subjects, researchers, technicians, data analysts, and evaluators. Effective blinding may reduce or eliminate some sources of experimental [[bias]].&lt;br /&gt;
&lt;br /&gt;
The trial may be blinded, meaning that information which may influence the participants is withheld until after the experiment is complete. A blind can be imposed on any participant of an experiment, including subjects, researchers, technicians, data analysts, and evaluators. Effective blinding may reduce or eliminate some sources of experimental bias.&lt;br /&gt;
&lt;br /&gt;
试验可能采用了盲法，这意味着影响参与者的信息在试验完成后才会公布。试验的任何参与者，包括受试者、研究人员、技术人员、数据分析人员和评估人员，都可能被强加盲。有效的盲法可以减少或消除某些试验偏差的来源。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
The randomness in the assignment of subjects to groups reduces [[selection bias]] and allocation bias, balancing both known and unknown prognostic factors, in the assignment of treatments.&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;&amp;gt;{{Cite journal |vauthors=Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG | title = CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials | journal = [[Br Med J]] | volume = 340 | pages = c869 | year = 2010 | doi = 10.1136/bmj.c869 | pmid = 20332511 | pmc = 2844943 }}&amp;lt;/ref&amp;gt; Blinding reduces other forms of [[Observer-expectancy effect|experimenter and subject biases]].&lt;br /&gt;
&lt;br /&gt;
The randomness in the assignment of subjects to groups reduces selection bias and allocation bias, balancing both known and unknown prognostic factors, in the assignment of treatments. Blinding reduces other forms of experimenter and subject biases.&lt;br /&gt;
&lt;br /&gt;
在分配治疗方案时，受试者随机地被分配到不同组。这个随机化过程减少了选择偏差和分配偏差，平衡了已知和未知的预后因素。盲法减少了其他形式的实验者和主体偏见。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
A well-blinded RCT is often considered the [[Gold standard (test)|gold standard]] for [[clinical trial]]s. Blinded RCTs are commonly used to test the [[Efficacy#Medicine|efficacy]] of medical [[Health intervention|intervention]]s and may additionally provide information about adverse effects, such as [[adverse drug reactions|drug reactions]]. A randomized controlled trial can provide compelling evidence that the study treatment causes an effect on human health.&amp;lt;ref name=&amp;quot;hannan&amp;quot;&amp;gt;{{cite journal | vauthors = Hannan EL | title = Randomized clinical trials and observational studies: guidelines for assessing respective strengths and limitations | journal = JACC. Cardiovascular Interventions | volume = 1 | issue = 3 | pages = 211–7 | date = June 2008 | pmid = 19463302 | doi = 10.1016/j.jcin.2008.01.008 | doi-access = free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
A well-blinded RCT is often considered the gold standard for clinical trials. Blinded RCTs are commonly used to test the efficacy of medical interventions and may additionally provide information about adverse effects, such as drug reactions. A randomized controlled trial can provide compelling evidence that the study treatment causes an effect on human health.&lt;br /&gt;
&lt;br /&gt;
一个良好盲法的 RCT 通常被认为是临床试验的黄金标准。盲法随机对照试验通常用于检测医疗干预措施的效果，并且还可能提供关于药物反应等不良反应的信息。随机对照试验可以提供令人信服的证据，证明研究治疗对人类健康产生了影响。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
The terms &amp;quot;RCT&amp;quot; and &amp;quot;'''randomized trial'''&amp;quot; are sometimes used synonymously, but the latter term omits mention of controls and can therefore describe studies that compare multiple treatment groups with each other in the absence of a control group.&amp;lt;ref name=&amp;quot;Ranjith-2005&amp;quot;&amp;gt;{{Cite journal | author = Ranjith G | title = Interferon-α-induced depression: when a randomized trial is not a randomized controlled trial | journal = [[Psychother Psychosom]] | volume = 74 | issue = 6 | pages = 387; author reply 387–8 | year = 2005 | doi = 10.1159/000087787 | pmid = 16244516 | s2cid = 143644933 }}&amp;lt;/ref&amp;gt; Similarly, the [[initialism]] is sometimes expanded as &amp;quot;'''randomized clinical trial'''&amp;quot; or &amp;quot;'''randomized comparative trial'''&amp;quot;, leading to ambiguity in the [[scientific literature]].&amp;lt;ref name=&amp;quot;Peto-1976&amp;quot;&amp;gt;{{Cite journal |vauthors=Peto R, Pike MC, Armitage P, Breslow NE, Cox DR, Howard SV, Mantel N, McPherson K, Peto J, Smith PG | title = Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design | journal = [[Br J Cancer]] | volume = 34 | issue = 6 | pages = 585–612 | year = 1976 | pmc=2025229 | pmid = 795448 | doi = 10.1038/bjc.1976.220 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Peto-1977&amp;quot;&amp;gt;{{Cite journal |vauthors=Peto R, Pike MC, Armitage P, Breslow NE, Cox DR, Howard SV, Mantel N, McPherson K, Peto J, Smith PG | title = Design and analysis of randomized clinical trials requiring prolonged observation of each patient. II. Analysis and examples | journal = [[Br J Cancer]] | volume = 35 | issue = 1 | pages = 1–39 | year = 1977 | pmc=2025310 | pmid = 831755 | doi = 10.1038/bjc.1977.1 }}&amp;lt;/ref&amp;gt; Not all randomized clinical trials are randomized ''controlled'' trials (and some of them could never be, as in cases where controls would be impractical or unethical to institute). The term '''randomized controlled clinical trial''' is an alternative term used in [[clinical research]];&amp;lt;ref name=&amp;quot;Wollert-2004&amp;quot;&amp;gt;{{Cite journal |vauthors=Wollert KC, Meyer GP, Lotz J, Ringes-Lichtenberg S, Lippolt P, Breidenbach C, Fichtner S, Korte T, Hornig B, Messinger D, Arseniev L, Hertenstein B, Ganser A, Drexler H | title = Intracoronary autologous bone-marrow cell transfer after myocardial infarction: the BOOST randomised controlled clinical trial | journal = [[The Lancet|Lancet]] | volume = 364 | issue = 9429 | pages = 141–8 | year = 2004 | doi = 10.1016/S0140-6736(04)16626-9 | pmid = 15246726 | s2cid = 24361586 }}&amp;lt;/ref&amp;gt; however, RCTs are also employed in other research areas, including [[#In social science|many of the social sciences]].&lt;br /&gt;
&lt;br /&gt;
The terms &amp;quot;RCT&amp;quot; and &amp;quot;randomized trial&amp;quot; are sometimes used synonymously, but the latter term omits mention of controls and can therefore describe studies that compare multiple treatment groups with each other in the absence of a control group. Similarly, the initialism is sometimes expanded as &amp;quot;randomized clinical trial&amp;quot; or &amp;quot;randomized comparative trial&amp;quot;, leading to ambiguity in the scientific literature. Not all randomized clinical trials are randomized controlled trials (and some of them could never be, as in cases where controls would be impractical or unethical to institute). The term randomized controlled clinical trial is an alternative term used in clinical research; however, RCTs are also employed in other research areas, including many of the social sciences.&lt;br /&gt;
&lt;br /&gt;
“ RCT”和“随机试验”这两个术语有时被用作同义词，但后一个术语没有提到对照，因此可以描述在没有对照组的情况下相互比较多个治疗组的研究。科学文献中常有“随机临床试验”或“随机比较试验”这类引发歧义的术语。并非所有的随机临床试验都是随机对照试验(其中一些试验永远不可能成为随机对照试验，因为实施控制是不切实际或不道德的)。随机对照临床试验这个术语是临床研究中使用的另一个术语; 然而，随机对照临床试验也被用于其他研究领域，包括许多社会科学。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
{{toc limit}}&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
== History ==&lt;br /&gt;
&lt;br /&gt;
The first reported clinical trial was conducted by James Lind in 1747 to identify treatment for scurvy.[10] The first blind experiment was conducted by the French Royal Commission on Animal Magnetism in 1784 to investigate the claims of mesmerism. An early essay advocating the blinding of researchers came from Claude Bernard in the latter half of the 19th century. Bernard recommended that the observer of an experiment should not have knowledge of the hypothesis being tested. This suggestion contrasted starkly with the prevalent Enlightenment-era attitude that scientific observation can only be objectively valid when undertaken by a well-educated, informed scientist.[11] The first study recorded to have a blinded researcher was conducted in 1907 by W. H. R. Rivers and H. N. Webber to investigate the effects of caffeine.[12]&lt;br /&gt;
&lt;br /&gt;
据报道，1747年James Lind进行了第一个临床试验，目的是确定治疗坏血病的方法。1784年，French Royal Commission on Animal Magnetism进行了第一次盲法实验，以调查催眠术的说法。19世纪下半叶，一篇提倡研究人员失明的早期文章来自Claude Bernard。Bernard建议实验的观察者不要知道正在被测试的假设。这一建议与启蒙时代流行的态度形成鲜明对比，即科学观察只有由受过良好教育、消息灵通的科学家进行才能客观有效。1907年，W. H. R. Rivers和H. N. Webber进行了第一项有记录的盲法研究，研究咖啡因的作用。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
[[Randomized experiment]]s appeared in [[experimental psychology|psychology]], where they were introduced by [[Charles Sanders Peirce]] and [[Joseph Jastrow]] in the 1880s,&amp;lt;ref&amp;gt;{{cite journal| author=[[Charles Sanders Peirce]] and [[Joseph Jastrow]]|year=1885|title=On Small Differences in Sensation| journal=Memoirs of the National Academy of Sciences|volume=3|pages=73–83|url=http://psychclassics.yorku.ca/Peirce/small-diffs.htm}} http://psychclassics.yorku.ca/Peirce/small-diffs.htm&amp;lt;/ref&amp;gt; and in [[school of education|education]].&amp;lt;ref&amp;gt;{{cite journal|doi=10.1086/354775|first=Ian|last=Hacking|author-link=Ian Hacking | title=Telepathy: Origins of Randomization in Experimental Design|journal=[[Isis (journal)|Isis]]|series=A Special Issue on Artifact and Experiment|volume=79|issue=3|date=September 1988 |pages=427–451|jstor=234674|mr=1013489|s2cid=52201011}}&amp;lt;/ref&amp;gt;&amp;lt;ref&amp;gt;{{cite journal|doi=10.1086/444032|author=Stephen M. Stigler|title=A Historical View of Statistical Concepts in Psychology and Educational Research| journal=American Journal of Education| volume=101|issue=1|date=November 1992|pages=60–70|s2cid=143685203|author-link=Stephen M. Stigler}}&amp;lt;/ref&amp;gt;&amp;lt;ref&amp;gt;{{cite journal|doi=10.1086/383850|author=Trudy Dehue|title=Deception, Efficiency, and Random Groups: Psychology and the Gradual Origination of the Random Group Design|journal=[[Isis (journal)|Isis]]|volume=88|issue=4|date=December 1997|pages=653–673|pmid=9519574|s2cid=23526321|url=https://pure.rug.nl/ws/files/71855616/237831.pdf}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Randomized experiments appeared in psychology, where they were introduced by Charles Sanders Peirce and Joseph Jastrow in the 1880s, and in education.&lt;br /&gt;
&lt;br /&gt;
在19世纪80年代，Charles Sanders Peirce和Joseph Jastrow在心理学和教育学领域引入随机实验。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
In the early 20th century, randomized experiments appeared in agriculture, due to [[Jerzy Neyman]]&amp;lt;ref&amp;gt;Neyman, Jerzy. 1923 [1990]. &amp;quot;On the Application of Probability Theory to AgriculturalExperiments. Essay on Principles. Section 9.&amp;quot; ''Statistical Science'' 5 (4): 465–472. Trans. Dorota M. Dabrowska and Terence P. Speed.&amp;lt;/ref&amp;gt; and [[Ronald A. Fisher]]. Fisher's experimental research and his writings popularized randomized experiments.&amp;lt;ref name=&amp;quot;Conniffe&amp;quot; /&amp;gt;&lt;br /&gt;
&lt;br /&gt;
In the early 20th century, randomized experiments appeared in agriculture, due to Jerzy Neyman and Ronald A. Fisher. Fisher's experimental research and his writings popularized randomized experiments.&lt;br /&gt;
&lt;br /&gt;
在20世纪早期，Jerzy Neyman和Ronald A. Fisher将随机实验引入农业研究。Fisher的实验研究和他的著作普及了随机实验。&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;The first published RCT in medicine appeared in the 1948 paper entitled &amp;quot;[[Streptomycin]] treatment of pulmonary [[tuberculosis]]&amp;quot;, which described a [[Medical Research Council (UK)|Medical Research Council]] investigation.&amp;lt;ref name=&amp;quot;MRC-1948&amp;quot;&amp;gt;{{Cite journal | author = Streptomycin in Tuberculosis Trials Committee | title = Streptomycin treatment of pulmonary tuberculosis. A Medical Research Council investigation| journal = [[Br Med J]] | volume = 2 | issue = 4582 | pages = 769–82 | year = 1948 | doi = 10.1136/bmj.2.4582.769 | pmid = 18890300 | pmc = 2091872 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Brown-1998&amp;quot;&amp;gt;{{cite news |title= Landmark study made research resistant to bias |author= Brown D |newspaper= [[Washington Post]] |date=1998-11-02 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Shikata-2006&amp;quot;&amp;gt;{{Cite journal |vauthors=Shikata S, Nakayama T, Noguchi Y, Taji Y, Yamagishi H | title = Comparison of effects in randomized controlled trials with observational studies in digestive surgery | journal = [[Ann Surg]] | volume = 244 | issue = 5 | pages = 668–76 | year = 2006 | doi = 10.1097/01.sla.0000225356.04304.bc | pmc=1856609 | pmid = 17060757 }}&amp;lt;/ref&amp;gt; One of the authors of that paper was [[Austin Bradford Hill]], who is credited as having conceived the modern RCT.&amp;lt;ref name=&amp;quot;Stolberg-2004&amp;quot;&amp;gt;{{Cite journal |vauthors=Stolberg HO, Norman G, Trop I | title = Randomized controlled trials | journal = [[Am J Roentgenol]] | volume = 183 | issue = 6 | pages = 1539–44 | year = 2004 | pmid = 15547188 | doi=10.2214/ajr.183.6.01831539}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;The first published RCT in medicine appeared in the 1948 paper entitled &amp;quot;Streptomycin treatment of pulmonary tuberculosis&amp;quot;, which described a Medical Research Council investigation. One of the authors of that paper was Austin Bradford Hill, who is credited as having conceived the modern RCT.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;医学上首次发表的随机对照试验出现在1948年题为“Streptomycin treatment of pulmonary tuberculosis”的论文中，这篇论文描述了医学研究理事会的一项调查。这篇论文的作者之一是Austin Bradford Hill，被认为是构想出了现代 RCT理论。 &lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt; &lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;Trial design was further influenced by the large-scale [[International Studies of Infarct Survival|ISIS]] trials on [[heart attack]] treatments that were conducted in the 1980s.&amp;lt;ref&amp;gt;{{cite web| author1=Georgina Ferry |title= Peter Sleight Obituary |url=https://www.theguardian.com/society/2020/nov/02/peter-sleight-obituary |website=The Guardian |date=2 November 2020 |access-date=3 November 2020}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;Trial design was further influenced by the large-scale ISIS trials on heart attack treatments that were conducted in the 1980s.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;20世纪80年代进行的大规模 ISIS 心脏病治疗试验进一步影响了试验设计。&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;By the late 20th century, RCTs were recognized as the standard method for &amp;quot;rational therapeutics&amp;quot; in medicine.[24] As of 2004, more than 150,000 RCTs were in the Cochrane Library.[22] To improve the reporting of RCTs in the medical literature, an international group of scientists and editors published Consolidated Standards of Reporting Trials (CONSORT) Statements in 1996, 2001 and 2010, and these have become widely accepted.[1][4] Randomization is the process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce the bias.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;By the late 20th century, RCTs were recognized as the standard method for &amp;quot;rational therapeutics&amp;quot; in medicine. As of 2004, more than 150,000 RCTs were in the Cochrane Library. To improve the reporting of RCTs in the medical literature, an international group of scientists and editors published Consolidated Standards of Reporting Trials (CONSORT) Statements in 1996, 2001 and 2010, and these have become widely accepted. Randomization is the process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce the bias.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;到20世纪后期，随机对照试验被公认为医学“合理疗法”的标准方法。截至2004年，美国 Cochrane图书馆有超过15万本随机对照试验的参考资料。为了改进医学文献中对随机对照试验的报道，一个由科学家和编辑组成的国际小组在1996年、2001年和2010年发布了Consolidated Standards of Reporting Trials (CONSORT)声明，这些声明已被广泛接受。随机化是将试验受试者分配到治疗组或对照组的过程，使用机会因素来确定分配，以减少偏差。&lt;br /&gt;
&lt;br /&gt;
== Ethics ==&lt;br /&gt;
&lt;br /&gt;
Although the principle of clinical equipoise (&amp;quot;genuine uncertainty within the expert medical community... about the preferred treatment&amp;quot;) common to clinical trials[25] has been applied to RCTs, the ethics of RCTs have special considerations. For one, it has been argued that equipoise itself is insufficient to justify RCTs.[26] For another, &amp;quot;collective equipoise&amp;quot; can conflict with a lack of personal equipoise (e.g., a personal belief that an intervention is effective).[27] Finally, Zelen's design, which has been used for some RCTs, randomizes subjects before they provide informed consent, which may be ethical for RCTs of screening and selected therapies, but is likely unethical &amp;quot;for most therapeutic trials.&amp;quot;[28][29]&lt;br /&gt;
&lt;br /&gt;
Although the principle of clinical equipoise (&amp;quot;genuine uncertainty within the expert medical community... about the preferred treatment&amp;quot;) common to clinical trials has been applied to RCTs, the ethics of RCTs have special considerations. For one, it has been argued that equipoise itself is insufficient to justify RCTs. For another, &amp;quot;collective equipoise&amp;quot; can conflict with a lack of personal equipoise (e.g., a personal belief that an intervention is effective). Finally, Zelen's design, which has been used for some RCTs, randomizes subjects ''before'' they provide informed consent, which may be ethical for RCTs of screening and selected therapies, but is likely unethical &amp;quot;for most therapeutic trials.&amp;quot;&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;尽管临床平衡原则已经被广泛应用于RCT，但随机对照试验的伦理问题具有特殊性。首先，有人认为平衡本身不足以证明随机对照试验的合理性。另一方面，“集体均势”可能与缺乏个人均势相冲突(例如，个人认为干预是有效的)。最后，Zelen 的设计已经被用于一些随机试验，在受试者提供知情同意之前随机化，这对于筛选和选择性治疗的随机试验来说可能是合乎道德的，但是对于“大多数治疗试验”来说可能是不道德的。&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Although subjects almost always provide [[informed consent]] for their participation in an RCT, studies since 1982 have documented that RCT subjects may believe that they are certain to receive treatment that is best for them personally; that is, they do not understand the difference between research and treatment.&amp;lt;ref name=&amp;quot;Appelbaum-1982&amp;quot;&amp;gt;{{Cite journal |vauthors=Appelbaum PS, Roth LH, Lidz C | title = The therapeutic misconception: informed consent in psychiatric research | journal = [[Int J Law Psychiatry]] | volume = 5 | issue = 3–4 | pages = 319–29 | year = 1982 | doi = 10.1016/0160-2527(82)90026-7 | pmid = 6135666 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Henderson-2007&amp;quot;&amp;gt;{{Cite journal |vauthors=Henderson GE, Churchill LR, Davis AM, Easter MM, Grady C, Joffe S, Kass N, King NM, Lidz CW, Miller FG, Nelson DK, Peppercorn J, Rothschild BB, Sankar P, Wilfond BS, Zimmer CR | title = Clinical trials and medical care: defining the therapeutic misconception | journal = [[PLoS Med]] | volume = 4 | issue = 11 | pages = e324 | year = 2007 | doi = 10.1371/journal.pmed.0040324 | pmid = 18044980 | pmc = 2082641 }}&amp;lt;/ref&amp;gt; Further research is necessary to determine the prevalence of and ways to address this &amp;quot;[[therapeutic misconception]]&amp;quot;.&amp;lt;ref name=&amp;quot;Henderson-2007&amp;quot; /&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Although subjects almost always provide informed consent for their participation in an RCT, studies since 1982 have documented that RCT subjects may believe that they are certain to receive treatment that is best for them personally; that is, they do not understand the difference between research and treatment. Further research is necessary to determine the prevalence of and ways to address this &amp;quot;therapeutic misconception&amp;quot;. &lt;br /&gt;
&lt;br /&gt;
一般来说，受试者要为参加随机对照试验提交了知情同意书，但1982年以来的研究记录表明，随机对照试验的受试者可能认为他们肯定会接受对他们个人最好的治疗; 也就是说，他们不理解研究和治疗之间的区别。需要进一步研究，以确定这种”治疗性误解”的流行程度和解决方法。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
The RCT method variations may also create cultural effects that have not been well understood.[32] For example, patients with terminal illness may join trials in the hope of being cured, even when treatments are unlikely to be successful.&lt;br /&gt;
&lt;br /&gt;
RCT方法的变种也可能产生尚未被很好理解的文化效应。例如，患有晚期疾病的病人可能会加入临床试验以希望治愈，即使治疗不太可能成功的情况下也是如此。&lt;br /&gt;
&lt;br /&gt;
=== Trial registration ===&lt;br /&gt;
&lt;br /&gt;
In 2004, the [http://www.icmje.org/ International Committee of Medical Journal Editors] (ICMJE) announced that all trials starting enrolment after July 1, 2005 must be registered prior to consideration for publication in one of the 12 member journals of the committee.&amp;lt;ref name=&amp;quot;pmid15356289&amp;quot;&amp;gt;{{cite journal  |vauthors=De Angelis C, Drazen JM, Frizelle FA, etal |title=Clinical trial registration: a statement from the International Committee of Medical Journal Editors |journal=The New England Journal of Medicine |volume=351 |issue=12 |pages=1250–1 |date=September 2004 |pmid=15356289 |doi=10.1056/NEJMe048225 }}&amp;lt;/ref&amp;gt; However, trial registration may still occur late or not at all.&amp;lt;ref name=&amp;quot;pmid22147862&amp;quot;&amp;gt;{{cite journal|vauthors=Law MR, Kawasumi Y, Morgan SG | title=Despite law, fewer than one in eight completed studies of drugs and biologics are reported on time on ClinicalTrials.gov. | journal=Health Aff (Millwood) | year= 2011 | volume= 30 | issue= 12 | pages= 2338–45 | doi=10.1377/hlthaff.2011.0172 | pmid=22147862  | doi-access=free }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;pmid19724045&amp;quot;&amp;gt;{{cite journal|vauthors=Mathieu S, Boutron I, Moher D, Altman DG, Ravaud P | title=Comparison of registered and published primary outcomes in randomized controlled trials. | journal=JAMA | year= 2009 | volume= 302 | issue= 9 | pages= 977–84 | doi=10.1001/jama.2009.1242 | pmid=19724045  | doi-access=free }}&amp;lt;/ref&amp;gt;Medical journals have been slow in adapting policies requiring mandatory clinical trial registration as a prerequisite for publication.&amp;lt;ref&amp;gt;{{cite journal|last1=Bhaumik|first1=S|title=Editorial policies of MEDLINE indexed Indian journals on clinical trial registration.|journal=Indian Pediatr.|date=Mar 2013|volume=50|issue=3|pages=339–40|pmid=23680610|doi=10.1007/s13312-013-0092-2|s2cid=40317464}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
In 2004, the [http://www.icmje.org/ International Committee of Medical Journal Editors] (ICMJE) announced that all trials starting enrolment after July 1, 2005 must be registered prior to consideration for publication in one of the 12 member journals of the committee. However, trial registration may still occur late or not at all. Medical journals have been slow in adapting policies requiring mandatory clinical trial registration as a prerequisite for publication.&lt;br /&gt;
&lt;br /&gt;
2004年， 医学杂志编辑国际委员会(ICMJE)宣布，所有在2005年7月1日之后考虑在该委员会12种杂志上发表之前，必须对试验进行注册。尽管如此，试验登记可能仍然延迟或根本不会发生。医学期刊将强制性临床试验登记作为发表的先决条件进展缓慢。&lt;br /&gt;
== Classifications ==&lt;br /&gt;
=== By study design ===&lt;br /&gt;
&lt;br /&gt;
One way to classify RCTs is by [[study design]].  From most to least common in the healthcare literature, the major categories of RCT study designs are:&amp;lt;ref name=&amp;quot;Hopewell-2010&amp;quot;&amp;gt;{{Cite journal |vauthors=Hopewell S, Dutton S, Yu LM, Chan AW, Altman DG | title = The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed | journal = BMJ | volume = 340 | pages = c723 | year = 2010 | doi = 10.1136/bmj.c723  | pmid = 20332510 | pmc = 2844941 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
通过研究设计对 RCT 进行分类。从最常见到最不常见，RCT 研究设计的主要类别是&lt;br /&gt;
&lt;br /&gt;
* [[Parallel study|Parallel-group]] – each participant is randomly assigned to a group, and all the participants in the group receive (or do not receive) an intervention.&amp;lt;ref&amp;gt;{{cite journal |last1=Kaiser |first1=Joerg |last2=Niesen |first2=Willem |last3=Probst |first3=Pascal |last4=Bruckner |first4=Thomas |last5=Doerr-Harim |first5=Colette |last6=Strobel |first6=Oliver |last7=Knebel |first7=Phillip |last8=Diener |first8=Markus K. |last9=Mihaljevic |first9=André L. |last10=Büchler |first10=Markus W. |last11=Hackert |first11=Thilo |title=Abdominal drainage versus no drainage after distal pancreatectomy: study protocol for a randomized controlled trial |journal=Trials |date=7 June 2019 |volume=20 |issue=1 |page=332 |doi=10.1186/s13063-019-3442-0|pmid=31174583 |pmc=6555976 |doi-access=free }}&amp;lt;/ref&amp;gt;&amp;lt;ref&amp;gt;{{cite journal |last1=Farag |first1=Sara M. |last2=Mohammed |first2=Manal O. |last3=EL-Sobky |first3=Tamer A. |last4=ElKadery |first4=Nadia A. |last5=ElZohiery |first5=Abeer K. |title=Botulinum Toxin A Injection in Treatment of Upper Limb Spasticity in Children with Cerebral Palsy: A Systematic Review of Randomized Controlled Trials |journal=JBJS Reviews |date=March 2020 |volume=8 |issue=3 |pages=e0119 |doi=10.2106/JBJS.RVW.19.00119 |pmid=32224633|pmc=7161716 |doi-access=free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* 平行试验：每个参与者被随机分配到一个组，组中的所有参与者都接受(或不接受)干预。&lt;br /&gt;
&lt;br /&gt;
* [[Crossover study|Crossover]] – over time, each participant receives (or does not receive) an intervention in a random sequence.&amp;lt;ref&amp;gt;{{cite book  | last = Jones | first = Byron |author2=Kenward, Michael G.  | title = Design and Analysis of Cross-Over Trials | edition=Second| publisher = London: Chapman and Hall | year = 2003 }}&amp;lt;/ref&amp;gt;&amp;lt;ref&amp;gt;{{cite book  | last = Vonesh | first = Edward F. |author2=Chinchilli, Vernon G.  | chapter=Crossover Experiments| pages=111–202|title = Linear and Nonlinear Models for the Analysis of Repeated Measurements | publisher = London: Chapman and Hall | year = 1997 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* 交叉试验：随着时间的推移，每个参与者都会接受(或不接受)随机序列的干预。&lt;br /&gt;
&lt;br /&gt;
* [[Cluster randomised controlled trial|Cluster]] – pre-existing groups of participants (e.g., villages, schools) are randomly selected to receive (or not receive) an intervention.&amp;lt;ref&amp;gt;{{cite journal |last1=Gall |first1=Stefanie |last2=Adams |first2=Larissa |last3=Joubert |first3=Nandi |last4=Ludyga |first4=Sebastian |last5=Müller |first5=Ivan |last6=Nqweniso |first6=Siphesihle |last7=Pühse |first7=Uwe |last8=du Randt |first8=Rosa |last9=Seelig |first9=Harald |last10=Smith |first10=Danielle |last11=Steinmann |first11=Peter |last12=Utzinger |first12=Jürg |last13=Walter |first13=Cheryl |last14=Gerber |first14=Markus |last15=van Wouwe |first15=Jacobus P. |title=Effect of a 20-week physical activity intervention on selective attention and academic performance in children living in disadvantaged neighborhoods: A cluster randomized control trial |journal=PLOS ONE |date=8 November 2018 |volume=13 |issue=11 |pages=e0206908 |doi=10.1371/journal.pone.0206908 |pmid=30408073|pmc=6224098 |bibcode=2018PLoSO..1306908G |doi-access=free }}&amp;lt;/ref&amp;gt;&amp;lt;ref&amp;gt;{{cite journal |last1=Gladstone |first1=Melissa J. |last2=Chandna |first2=Jaya |last3=Kandawasvika |first3=Gwendoline |last4=Ntozini |first4=Robert |last5=Majo |first5=Florence D. |last6=Tavengwa |first6=Naume V. |last7=Mbuya |first7=Mduduzi N. N. |last8=Mangwadu |first8=Goldberg T. |last9=Chigumira |first9=Ancikaria |last10=Chasokela |first10=Cynthia M. |last11=Moulton |first11=Lawrence H. |last12=Stoltzfus |first12=Rebecca J. |last13=Humphrey |first13=Jean H. |last14=Prendergast |first14=Andrew J. |last15=Tumwine |first15=James K. |title=Independent and combined effects of improved water, sanitation, and hygiene (WASH) and improved complementary feeding on early neurodevelopment among children born to HIV-negative mothers in rural Zimbabwe: Substudy of a cluster-randomized trial |journal=PLOS Medicine |date=21 March 2019 |volume=16 |issue=3 |pages=e1002766 |doi=10.1371/journal.pmed.1002766|pmid=30897095 |pmc=6428259 |doi-access=free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* 聚类试验：预先存在的参与者组(例如，村庄、学校)被随机选择以接受(或不接受)干预。&lt;br /&gt;
&lt;br /&gt;
* [[Factorial experiment|Factorial]] – each participant is randomly assigned to a group that receives a particular combination of interventions or non-interventions (e.g., group 1 receives vitamin X and vitamin Y, group 2 receives vitamin X and placebo Y, group 3 receives placebo X and vitamin Y, and group 4 receives placebo X and placebo Y).&lt;br /&gt;
* 因子试验：每个参与者被随机分配到一个接受干预或非干预特定组合的组(例如，第1组接受维生素X和维生素Y，第2组接受维生素X和安慰剂Y，第3组接受安慰剂X和维生素Y，第4组接受安慰剂X和安慰剂Y)。&lt;br /&gt;
&lt;br /&gt;
An analysis of the 616 RCTs indexed in [[PubMed]] during December 2006 found that 78% were parallel-group trials, 16% were crossover, 2% were split-body, 2% were cluster, and 2% were factorial.&amp;lt;ref name=&amp;quot;Hopewell-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
An analysis of the 616 RCTs indexed in PubMed during December 2006 found that 78% were parallel-group trials, 16% were crossover, 2% were split-body, 2% were cluster, and 2% were factorial. &lt;br /&gt;
&lt;br /&gt;
对2006年12月在 PubMed 收录的616例随机对照试验的分析发现，78% 为平行组试验，16% 为交叉组试验，2% 为分体组试验，2% 为聚类组试验，2% 为因子组试验。&lt;br /&gt;
&lt;br /&gt;
=== By outcome of interest (efficacy vs. effectiveness) ===&lt;br /&gt;
&lt;br /&gt;
{{Main|Pragmatic clinical trial}}&lt;br /&gt;
&lt;br /&gt;
RCTs can be classified as &amp;quot;explanatory&amp;quot; or &amp;quot;pragmatic.&amp;quot;&amp;lt;ref name=&amp;quot;Zwarenstein-2008&amp;quot;&amp;gt;{{Cite journal | author = Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D; CONSORT group; Pragmatic Trials in Healthcare (Practihc) group | title = Improving the reporting of pragmatic trials: an extension of the CONSORT statement | journal = BMJ | volume = 337 | pages = a2390 | year = 2008 | doi = 10.1136/bmj.a2390 | pmid = 19001484 | pmc=3266844}}&amp;lt;/ref&amp;gt; Explanatory RCTs test [[Efficacy#Medicine|efficacy]] in a research setting with highly selected participants and under highly controlled conditions.&amp;lt;ref name=&amp;quot;Zwarenstein-2008&amp;quot;/&amp;gt; In contrast, pragmatic RCTs (pRCTs) test [[Effectiveness#Usage|effectiveness]] in everyday practice with relatively unselected participants and under flexible conditions; in this way, pragmatic RCTs can &amp;quot;inform decisions about practice.&amp;quot;&amp;lt;ref name=&amp;quot;Zwarenstein-2008&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
RCTs can be classified as &amp;quot;explanatory&amp;quot; or &amp;quot;pragmatic.&amp;quot; Explanatory RCTs test efficacy in a research setting with highly selected participants and under highly controlled conditions. In contrast, pragmatic RCTs (pRCTs) test effectiveness in everyday practice with relatively unselected participants and under flexible conditions; in this way, pragmatic RCTs can &amp;quot;inform decisions about practice.&amp;quot;&lt;br /&gt;
&lt;br /&gt;
随机对照试验可分为“解释性”或“实用性”。解释性随机对照试验在高度选定的参与者和高度受控的条件下测试有效性。相比之下，实用性随机对照测验(pragmatic RCTs, pRCT)在相对未经选择的参与者和灵活的条件下，在日常实践中检验有效性，这样，实用随机对照测验可以“为实践决策提供信息”。&lt;br /&gt;
=== By hypothesis (superiority vs. noninferiority vs. equivalence) ===&lt;br /&gt;
&lt;br /&gt;
Another classification of RCTs categorizes them as &amp;quot;superiority trials&amp;quot;, &amp;quot;noninferiority trials&amp;quot;, and &amp;quot;equivalence trials&amp;quot;, which differ in methodology and reporting.&amp;lt;ref name=&amp;quot;Piaggio-2006&amp;quot;&amp;gt;{{Cite journal | author = Piaggio G, Elbourne DR, [[Doug Altman|Altman DG]], [[Stuart Pocock|Pocock SJ]], Evans SJ; CONSORT Group | title = Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement | journal = JAMA | volume = 295 | issue = 10 | pages = 1152–60 |  year = 2006 | doi = 10.1001/jama.295.10.1152 | pmid = 16522836 | url = http://researchonline.lshtm.ac.uk/12069/1/Reporting%20of%20Noninferiority%20and%20Equivalence%20Randomized%20Trials.pdf }}&amp;lt;/ref&amp;gt; Most RCTs are superiority trials, in which one intervention is hypothesized to be superior to another in a [[Statistical significance|statistically significant]] way.&amp;lt;ref name=&amp;quot;Piaggio-2006&amp;quot;/&amp;gt; Some RCTs are noninferiority trials &amp;quot;to determine whether a new treatment is no worse than a reference treatment.&amp;quot;&amp;lt;ref name=&amp;quot;Piaggio-2006&amp;quot;/&amp;gt; Other RCTs are equivalence trials in which the hypothesis is that two interventions are indistinguishable from each other.&amp;lt;ref name=&amp;quot;Piaggio-2006&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Another classification of RCTs categorizes them as &amp;quot;superiority trials&amp;quot;, &amp;quot;noninferiority trials&amp;quot;, and &amp;quot;equivalence trials&amp;quot;, which differ in methodology and reporting. Most RCTs are superiority trials, in which one intervention is hypothesized to be superior to another in a statistically significant way. Some RCTs are noninferiority trials &amp;quot;to determine whether a new treatment is no worse than a reference treatment.&amp;quot; Other RCTs are equivalence trials in which the hypothesis is that two interventions are indistinguishable from each other.&lt;br /&gt;
&lt;br /&gt;
随机对照试验的另一种分类是“优越性试验”、“非劣性试验”和“等效性试验”，它们在方法和报告上有所不同。大多数随机对照试验都是优势试验，其中一种干预措施被假设在统计学意义上优于另一种干预措施。一些随机对照试验是非劣效性试验，“以确定一种新的治疗方法是否比一种参考治疗方法更差。”其他随机对照试验是等效试验，其中的假设是两种干预措施彼此不可区分。&lt;br /&gt;
&lt;br /&gt;
== Randomization ==&lt;br /&gt;
&lt;br /&gt;
The advantages of proper [[randomized experiment|randomization]] in RCTs include:&amp;lt;ref name=&amp;quot;SchulzGrimes2002&amp;quot;&amp;gt;{{Cite journal |vauthors=Schulz KF, Grimes DA | title = Generation of allocation sequences in randomised trials: chance, not choice | journal = Lancet | volume = 359 | issue = 9305 | pages = 515–9 | year = 2002 | doi = 10.1016/S0140-6736(02)07683-3 | url =https://www.who.int/entity/rhl/LANCET_515-519.pdf | pmid = 11853818 | s2cid = 291300 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
* &amp;quot;It eliminates bias in treatment assignment,&amp;quot; specifically [[selection bias]] and [[confounding]].&lt;br /&gt;
&lt;br /&gt;
* &amp;quot;It facilitates blinding (masking) of the identity of treatments from investigators, participants, and assessors.&amp;quot;&lt;br /&gt;
&lt;br /&gt;
* &amp;quot;It permits the use of probability theory to express the likelihood that any difference in outcome between treatment groups merely indicates chance.&amp;quot;&lt;br /&gt;
&lt;br /&gt;
There are two processes involved in randomizing patients to different interventions. First is choosing a randomization procedure to generate an unpredictable sequence of allocations; this may be a simple random assignment of patients to any of the groups at equal probabilities, may be &amp;quot;restricted&amp;quot;, or may be &amp;quot;adaptive.&amp;quot; A second and more practical issue is allocation concealment, which refers to the stringent precautions taken to ensure that the group assignment of patients are not revealed prior to definitively allocating them to their respective groups. Non-random &amp;quot;systematic&amp;quot; methods of group assignment, such as alternating subjects between one group and the other, can cause &amp;quot;limitless contamination possibilities&amp;quot; and can cause a breach of allocation concealment.&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
随机对照试验中适当随机化的优点包括：&lt;br /&gt;
* 它消除了治疗分配中的偏差，特别是选择偏差和混淆。&lt;br /&gt;
&lt;br /&gt;
* 它便于调查人员、参与者和评估人员对治疗人群的身份进行遮蔽。&lt;br /&gt;
&lt;br /&gt;
* 它允许使用概率理论来表达这样一种可能性，即治疗组之间结果的任何差异仅仅表明是偶然性的。&lt;br /&gt;
&lt;br /&gt;
有两个过程涉及到随机化的病人接受到不同的干预。首先是选择一个随机化程序来生成一个不可预测的分配序列；这可能是以相等的概率将患者随机分配到任何一组，可能是“受限的”，也可能是“适应性的”。第二个也是更实际的问题是隐藏分配，这是指在将患者明确分配到各自的组之前，采取严格的预防措施，以确保患者的组分配不被披露。非随机的“系统”组分配方法，如在一个组和另一个组之间交替患者，可能会造成“无限的污染可能性”，并可能导致分配隐藏的破坏。&lt;br /&gt;
&lt;br /&gt;
However empirical evidence that adequate randomization changes outcomes relative to inadequate randomization has been difficult to detect.&amp;lt;ref name=&amp;quot;Howick-2014&amp;quot;&amp;gt;{{Cite journal |vauthors=Howick J, Mebius A | title = In search of justification for the unpredictability paradox | journal = Trials | volume = 15 | pages = 480 | year = 2014 | doi = 10.1186/1745-6215-15-480 | pmid = 25490908 | pmc=4295227}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
然而，相对于不充分随机化，充分随机化改变结果的经验证据很难被发现。&lt;br /&gt;
&lt;br /&gt;
=== Procedures ===&lt;br /&gt;
&lt;br /&gt;
The treatment allocation is the desired proportion of patients in each treatment arm.&lt;br /&gt;
&lt;br /&gt;
治疗分配是每个治疗组中患者的期望比例。&lt;br /&gt;
&lt;br /&gt;
An ideal randomization procedure would achieve the following goals:&amp;lt;ref name=&amp;quot;Lachin-1988a&amp;quot;&amp;gt;{{Cite journal | author = Lachin JM | title = Statistical properties of randomization in clinical trials | journal = [[Controlled Clinical Trials]] | volume = 9 | issue = 4 | pages = 289–311 | year = 1988 | pmid = 3060315 |  doi = 10.1016/0197-2456(88)90045-1 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
An ideal randomization procedure would achieve the following goals:&lt;br /&gt;
&lt;br /&gt;
一个理想的随机化程序将实现以下目标:&lt;br /&gt;
&lt;br /&gt;
* '''Maximize [[statistical power]]''', especially in [[Subgroup analysis|subgroup analyses]].  Generally, equal group sizes maximize statistical power, however, unequal groups sizes may be more powerful for some analyses (e.g., multiple comparisons of placebo versus several doses using Dunnett's procedure&amp;lt;ref&amp;gt;{{cite web|last=Rosenberger|first=James|title=STAT 503 - Design of Experiments|url=https://onlinecourses.science.psu.edu/stat503/node/16|publisher=Pennsylvania State University|access-date=24 September 2012}}&amp;lt;/ref&amp;gt; ), and are sometimes desired for non-analytic reasons (e.g., patients may be more motivated to enroll if there is a higher chance of getting the test treatment, or regulatory agencies may require a minimum number of patients exposed to treatment).&amp;lt;ref name=&amp;quot;Avins-1998&amp;quot;&amp;gt;{{cite journal|last=Avins|first=A L|title=&amp;quot;Can unequal be more fair? Ethics, subject allocation, and randomized clinical trials&amp;quot;.|journal=J Med Ethics|year=1998|volume=24|pages=401–408|doi=10.1136/jme.24.6.401|issue=6|pmc=479141|pmid=9873981}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
* '''Minimize selection bias'''.  This may occur if investigators can consciously or unconsciously preferentially enroll patients between treatment arms.  A good randomization procedure will be unpredictable so that investigators cannot guess the next subject's group assignment based on prior treatment assignments. The risk of selection bias is highest when previous treatment assignments are known (as in unblinded studies) or can be guessed (perhaps if a drug has distinctive side effects).&lt;br /&gt;
&lt;br /&gt;
* '''Minimize allocation bias''' (or '''confounding''').  This may occur when [[covariate]]s that affect the outcome are not equally distributed between treatment groups, and the treatment effect is confounded with the effect of the covariates (i.e., an &amp;quot;accidental bias&amp;quot;&amp;lt;ref name=&amp;quot;SchulzGrimes2002&amp;quot;/&amp;gt;&amp;lt;ref name=&amp;quot;Buyse-1989&amp;quot;&amp;gt;{{Cite journal | author = Buyse ME | title = Analysis of clinical trial outcomes: some comments on subgroup analyses | journal = [[Controlled Clinical Trials]] | volume = 10 | issue = 4 Suppl | pages = 187S–194S | year = 1989 | pmid = 2605967 |  doi = 10.1016/0197-2456(89)90057-3 }}&amp;lt;/ref&amp;gt;).  If the randomization procedure causes an imbalance in covariates related to the outcome across groups, estimates of effect may be [[bias of an estimator|biased]] if not adjusted for the covariates (which may be unmeasured and therefore impossible to adjust for).&lt;br /&gt;
* '''最大化统计能力'''，尤其是在亚组分析中。一般来说，相等的组规模将最大化统计能力，然而，不相等的组规模对于某些分析来说可能更强大(例如，使用Dunnett程序对安慰剂与几个剂量进行多次比较)，并且有时由于非分析性原因而被采用(例如，如果有更高的机会获得试验治疗，患者可能更有动力登记，或者监管机构可能要求最少数量的患者接受治疗)。&lt;br /&gt;
&lt;br /&gt;
* '''最小化选择偏差'''。如果调查人员可以有意识或无意识地在治疗之间优先招募患者，就可能发生这种情况。一个好的随机化过程是不可预测的，因此研究人员不能根据先前的治疗分配来猜测下一个受试者的分组。当已知以前的治疗方案时(如在非盲法研究中)或可以猜到(如果一种药物有明显的副作用)，选择偏倚的风险最高。&lt;br /&gt;
&lt;br /&gt;
* '''最小化分配偏差(或混淆)'''。当影响结果的协变量在治疗组之间分布不均，并且治疗效果与协变量的效果混淆时(即“偶然偏差”)，可能会出现这种情况。如果随机化程序导致与各组结果相关的协变量失衡，如果不对协变量进行调整，效果估计可能会有偏差(这可能无法测量，因此无法调整)。&lt;br /&gt;
&lt;br /&gt;
However, no single randomization procedure meets those goals in every circumstance, so researchers must select a procedure for a given study based on its advantages and disadvantages.&lt;br /&gt;
&lt;br /&gt;
However, no single randomization procedure meets those goals in every circumstance, so researchers must select a procedure for a given study based on its advantages and disadvantages.&lt;br /&gt;
&lt;br /&gt;
然而，没有一个单一的随机化程序在每种情况下都能满足这些目标，因此研究人员必须根据其优点和缺点来选择一个给定的研究程序。&lt;br /&gt;
&lt;br /&gt;
==== Simple ====&lt;br /&gt;
&lt;br /&gt;
This is a commonly used and intuitive procedure, similar to &amp;quot;repeated fair coin-tossing.&amp;quot;&amp;lt;ref name=&amp;quot;SchulzGrimes2002&amp;quot;/&amp;gt; Also known as &amp;quot;complete&amp;quot; or &amp;quot;unrestricted&amp;quot; randomization, it is [[Robust statistics|robust]] against both selection and accidental biases. However, its main drawback is the possibility of imbalanced group sizes in small RCTs.  It is therefore recommended only for RCTs with over 200 subjects.&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;&amp;gt;{{Cite journal |vauthors=Lachin JM, Matts JP, Wei LJ | title = Randomization in clinical trials: conclusions and recommendations | journal = [[Controlled Clinical Trials]] | volume = 9 | issue = 4 | pages = 365–74 | year = 1988 | pmid = 3203526 |  doi = 10.1016/0197-2456(88)90049-9 | hdl = 2027.42/27041 | url = https://deepblue.lib.umich.edu/bitstream/2027.42/27041/1/0000029.pdf | hdl-access = free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
This is a commonly used and intuitive procedure, similar to &amp;quot;repeated fair coin-tossing.&amp;quot; Also known as &amp;quot;complete&amp;quot; or &amp;quot;unrestricted&amp;quot; randomization, it is robust against both selection and accidental biases. However, its main drawback is the possibility of imbalanced group sizes in small RCTs. It is therefore recommended only for RCTs with over 200 subjects.这是一个常用且直观的程序，类似于“反复公平抛硬币”，也被称为“完全”或“无限制”随机化，它对选择和意外偏差都是稳健的。然而，它的主要缺点是在小的随机对照试验中群体规模不平衡的可能性。因此，建议仅用于受试者超过200人时进行随机对照试验。&lt;br /&gt;
&lt;br /&gt;
==== Restricted ====&lt;br /&gt;
&lt;br /&gt;
To balance group sizes in smaller RCTs, some form of [[restricted randomization|&amp;quot;restricted&amp;quot; randomization]] is recommended.&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;/&amp;gt;  The major types of restricted randomization used in RCTs are:&lt;br /&gt;
&lt;br /&gt;
* '''[[Randomized block design|Permuted-block randomization]]''' or '''blocked randomization''': a &amp;quot;block size&amp;quot; and &amp;quot;allocation ratio&amp;quot; (number of subjects in one group versus the other group) are specified, and subjects are allocated randomly within each block.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt; For example, a block size of 6 and an allocation ratio of 2:1 would lead to random assignment of 4 subjects to one group and 2 to the other. This type of randomization can be combined with &amp;quot;[[stratified randomization]]&amp;quot;, for example by center in a [[multicenter trial]], to &amp;quot;ensure good balance of participant characteristics in each group.&amp;quot;&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt; A special case of permuted-block randomization is ''random allocation'', in which the entire sample is treated as one block.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt; The major disadvantage of permuted-block randomization is that even if the block sizes are large and randomly varied, the procedure can lead to selection bias.&amp;lt;ref name=&amp;quot;Lachin-1988a&amp;quot;/&amp;gt; Another disadvantage is that &amp;quot;proper&amp;quot; analysis of data from permuted-block-randomized RCTs requires stratification by blocks.&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
* '''Adaptive biased-coin randomization''' methods (of which '''urn randomization''' is the most widely known type): In these relatively uncommon methods, the probability of being assigned to a group decreases if the group is overrepresented and increases if the group is underrepresented.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt; The methods are thought to be less affected by selection bias than permuted-block randomization.&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
为了平衡较小随机对照试验中的组规模，建议采用某种形式的“限制性”随机化。随机对照试验中主要使用的限制随机化类型有:&lt;br /&gt;
&lt;br /&gt;
* '''置换区组随机化'''或'''区组随机化'''：规定了“区组大小”和“分配比例”(一组受试者相对于另一组受试者的数量)，受试者在每个区组内随机分配。例如，块大小为6，分配比例为2:1，将导致4个受试者随机分配到一个组，2个分配到另一个组。这种类型的随机化可以与“分层随机化”相结合，例如通过多中心试验中的中心，以“确保每个组中参与者特征的良好平衡。”置换块随机化的一个特殊情况是随机分配，其中整个样本被视为一个块。置换块随机化的主要缺点是，即使块大小很大且随机变化，该过程也会导致选择偏差。另一个缺点是，对置换区组随机对照试验数据的“适当”分析需要按区组分层。&lt;br /&gt;
&lt;br /&gt;
* '''自适应有偏-硬币随机化方法'''（其中瓮随机化是最广为人知的类型）：在这些相对不常见的方法中，如果一个组的代表人数过多，被分配到该组的概率会降低，如果该组的代表人数不足，被分配到该组的概率会增加。这些方法被认为比置换块随机化受选择偏差的影响更小。&lt;br /&gt;
==== Adaptive ====&lt;br /&gt;
&lt;br /&gt;
At least two types of &amp;quot;adaptive&amp;quot; randomization procedures have been used in RCTs, but much less frequently than simple or restricted randomization:&lt;br /&gt;
&lt;br /&gt;
* '''Covariate-adaptive randomization''', of which one type is '''[[Minimisation (clinical trials)|minimization]]''': The probability of being assigned to a group varies in order to minimize &amp;quot;covariate imbalance.&amp;quot;&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;/&amp;gt; Minimization is reported to have &amp;quot;supporters and detractors&amp;quot;&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt; because only the first subject's group assignment is truly chosen at random, the method does not necessarily eliminate bias on unknown factors.&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
* '''Response-adaptive randomization''', also known as '''outcome-adaptive randomization''': The probability of being assigned to a group increases if the responses of the prior patients in the group were favorable.&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;/&amp;gt; Although arguments have been made that this approach is more ethical than other types of randomization when the probability that a treatment is effective or ineffective increases during the course of an RCT, ethicists have not yet studied the approach in detail.&amp;lt;ref name=&amp;quot;Rosenberger-1993&amp;quot;&amp;gt;{{Cite journal |vauthors=Rosenberger WF, Lachin JM | title = The use of response-adaptive designs in clinical trials | journal = [[Controlled Clinical Trials]] | volume = 14 | issue = 6 | pages = 471–84 | year = 1993 | pmid = 8119063 |  doi = 10.1016/0197-2456(93)90028-C }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
在随机对照试验中，至少使用了两种类型的“适应性”随机化程序，但频率远低于简单或限制性随机化：&lt;br /&gt;
&lt;br /&gt;
* '''协变量自适应随机化'''，其中一种类型是最小化：被分配到一个组的概率是变化的，以便最小化“协变量不平衡”。据报道，最小化有“支持者和诋毁者”，因为只有第一个受试者的群组分配是真正随机选择的，该方法不一定能消除对未知因素的偏见。&lt;br /&gt;
&lt;br /&gt;
* '''应答自适应随机化'''，也称为'''结果自适应随机化：'''如果组中先前患者的应答是有利的，则被分配到一个组的概率增加。虽然有人认为，当治疗有效或无效的概率在RCT过程中增加时，这种方法比其他类型的随机化更符合伦理，但伦理学家尚未详细研究这种方法。&lt;br /&gt;
=== Allocation concealment ===&lt;br /&gt;
&lt;br /&gt;
{{main|Allocation concealment}}&lt;br /&gt;
&lt;br /&gt;
&amp;quot;Allocation concealment&amp;quot; (defined as &amp;quot;the procedure for protecting the randomization process so that the treatment to be allocated is not known before the patient is entered into the study&amp;quot;) is important in RCTs.&amp;lt;ref name=&amp;quot;Forder-2005&amp;quot;&amp;gt;{{Cite journal |vauthors=Forder PM, Gebski VJ, Keech AC | title = Allocation concealment and blinding: when ignorance is bliss | journal = Med J Aust | volume = 182 | issue = 2 | pages = 87–9 | year = 2005 | url = http://www.mja.com.au/public/issues/182_02_170105/for10877_fm.html | pmid = 15651970 | doi = 10.5694/j.1326-5377.2005.tb06584.x | s2cid = 202149 }}&amp;lt;/ref&amp;gt; In practice, clinical investigators in RCTs often find it difficult to maintain impartiality. Stories abound of investigators holding up sealed envelopes to lights or ransacking offices to determine group assignments in order to dictate the assignment of their next patient.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;&amp;gt;{{Cite journal | title = Allocation concealment in randomised trials: defending against deciphering | journal = Lancet | volume = 359 | issue = 9306 | pages = 614–8 | year = 2002 | doi = 10.1016/S0140-6736(02)07750-4 | url =https://www.who.int/entity/rhl/LANCET_614-618.pdf | pmid = 11867132 |vauthors=Schulz KF, Grimes DA | s2cid = 12902486 }}&amp;lt;/ref&amp;gt; Such practices introduce selection bias and [[Lurking variable|confounders]] (both of which should be minimized by randomization), possibly distorting the results of the study.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt; Adequate allocation concealment should defeat patients and investigators from discovering treatment allocation once a study is underway and after the study has concluded.  Treatment related side-effects or adverse events may be specific enough to reveal allocation to investigators or patients thereby introducing bias or influencing any subjective parameters collected by investigators or requested from subjects.&lt;br /&gt;
&lt;br /&gt;
“分配隐藏”(定义为“保护随机化过程的程序，以便在病人进入研究之前不知道要分配的治疗”)在随机对照试验中很重要。在实践中，临床研究人员在随机对照试验中常常发现难以保持公正性。关于调查人员将密封的信封举到灯光下或者搜查办公室来决定群组分配，以便指定下一个病人的分配的故事比比皆是。这种做法引入了选择偏差和混杂因素(这两者都应该通过随机化来减少) ，可能会扭曲研究结果。一旦研究开始并在研究结束后，充分的分配隐藏应该会阻止患者和研究者发现治疗分配。与治疗相关的副作用或不良事件可能足够具体，足以向研究者或患者揭示分配情况，从而引入偏差或影响研究者收集的或受试者要求的任何主观参数。&lt;br /&gt;
&lt;br /&gt;
Some standard methods of ensuring allocation concealment include sequentially numbered, opaque, sealed envelopes (SNOSE); sequentially numbered containers; pharmacy controlled randomization; and central randomization. It is recommended that allocation concealment methods be included in an RCT's protocol, and that the allocation concealment methods should be reported in detail in a publication of an RCT's results; however, a 2005 study determined that most RCTs have unclear allocation concealment in their protocols, in their publications, or both. On the other hand, a 2008 study of 146 meta-analyses concluded that the results of RCTs with inadequate or unclear allocation concealment tended to be biased toward beneficial effects only if the RCTs' outcomes were subjective as opposed to objective.&lt;br /&gt;
&lt;br /&gt;
一些确保分配隐藏的标准方法包括顺序编号、不透明、密封信封(SNOSE)；顺序编号的容器；药学控制的随机化；和中心随机化。分配隐藏方法被建议纳入RCT议定书，并在RCT结果的出版物中详细报告分配隐藏方法；然而，2005年的一项研究发现，大多数随机对照试验在其方案、出版物或两者中都有不清楚的分配隐藏。另一方面，2008年的一项对146项元分析的研究得出结论，分配隐瞒不充分或不明确的随机对照试验的结果往往只有在随机对照试验的结果是主观的而不是客观的情况下才会偏向于有益的结果。&lt;br /&gt;
=== Sample size ===&lt;br /&gt;
&lt;br /&gt;
{{Main|Sample size determination}}The number of treatment units (subjects or groups of subjects) assigned to control and treatment groups, affects an RCT's reliability. If the effect of the treatment is small, the number of treatment units in either group may be insufficient for rejecting the null hypothesis in the respective statistical test. The failure to reject the null hypothesis would imply that the treatment shows no statistically significant effect on the treated ''in a given test''. But as the sample size increases, the same RCT may be able to demonstrate a significant effect of the treatment, even if this effect is small.&lt;br /&gt;
&lt;br /&gt;
分配给控制组和治疗组的治疗单位(受试者或受试者组)的样本量影响 RCT 的可靠性。如果治疗的效果很小，任何一组的治疗单位的样本量都可能不足以在各自的统计检验中拒绝零假设。拒绝无效假设的失败意味着在给定的试验中，治疗对被治疗者没有统计学上的显著影响。但是随着样本量的增加，同样的RCT可能能够证明治疗的显著效果，即使这种效果很小。&lt;br /&gt;
&lt;br /&gt;
== Blinding ==&lt;br /&gt;
&lt;br /&gt;
{{main|Blinded experiment}}&lt;br /&gt;
&lt;br /&gt;
An RCT may be [[Blind experiment|blinded]], (also called &amp;quot;masked&amp;quot;) by &amp;quot;procedures that prevent study participants, caregivers, or outcome assessors from knowing which intervention was received.&amp;quot;&amp;lt;ref name=&amp;quot;Wood-2008&amp;quot;&amp;gt;{{Cite journal |vauthors=Wood L, Egger M, Gluud LL, Schulz KF, Jüni P, Altman DG, Gluud C, Martin RM, Wood AJ, Sterne JA | title = Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study | journal = BMJ | volume = 336 | issue = 7644 | pages = 601–5 | year = 2008 | doi = 10.1136/bmj.39465.451748.AD | pmid = 18316340 | pmc = 2267990 }}&amp;lt;/ref&amp;gt; Unlike allocation concealment, blinding is sometimes inappropriate or impossible to perform in an RCT; for example, if an RCT involves a treatment in which active participation of the patient is necessary (e.g., [[physical therapy]]), participants cannot be blinded to the intervention.&lt;br /&gt;
&lt;br /&gt;
一项RCT的盲法是指阻止研究参与者、照顾者或结果评估者知道哪些干预措施，这一程序也称“蒙面”。与分配隐藏不同，在RCT，致盲有时是不合适的或不可能的；例如，如果RCT涉及需要患者积极参与的治疗(例如物理治疗)，参与者不能对干预视而不见。&lt;br /&gt;
&lt;br /&gt;
Traditionally, blinded RCTs have been classified as &amp;quot;single-blind&amp;quot;, &amp;quot;double-blind&amp;quot;, or &amp;quot;triple-blind&amp;quot;; however, in 2001 and 2006 two studies showed that these terms have different meanings for different people.&amp;lt;ref name=&amp;quot;Devereaux-2001&amp;quot;&amp;gt;{{Cite journal |vauthors=Devereaux PJ, Manns BJ, Ghali WA, Quan H, Lacchetti C, Montori VM, Bhandari M, Guyatt GH | title = Physician interpretations and textbook definitions of blinding terminology in randomized controlled trials | journal = [[J Am Med Assoc]] | volume = 285 | issue = 15 | pages = 2000–3 | year = 2001 | doi =  10.1001/jama.285.15.2000| pmid = 11308438 | doi-access = free }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Haahr-2006&amp;quot;&amp;gt;{{Cite journal |vauthors=Haahr MT, Hróbjartsson A | title = Who is blinded in randomized clinical trials? A study of 200 trials and a survey of authors | journal = Clin Trials | volume = 3 | issue = 4 | pages = 360–5 | year = 2006 | doi = 10.1177/1740774506069153 | pmid = 17060210 | s2cid = 23818514 }}&amp;lt;/ref&amp;gt;  The 2010 [[Consolidated Standards of Reporting Trials|CONSORT Statement]] specifies that authors and editors should not use the terms &amp;quot;single-blind&amp;quot;, &amp;quot;double-blind&amp;quot;, and &amp;quot;triple-blind&amp;quot;; instead, reports of blinded RCT should discuss &amp;quot;If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how.&amp;quot;&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
传统上，盲法随机对照试验分为“单盲”、“双盲”或“三盲”；然而，2001年和2006年的两项研究表明，这些术语对不同的人有不同的含义。2010年CONSORT 声明明确指出，作者和编辑不应使用”单盲”、”双盲”和”三盲”等术语；相反，关于盲法 RCT 的报告应讨论”如果完成，干预分配后谁被“蒙面”了(例如，参与者、护理提供者、评估结果的人员)以及其原因”。&lt;br /&gt;
&lt;br /&gt;
RCTs without blinding are referred to as &amp;quot;unblinded&amp;quot;,&amp;lt;ref name=&amp;quot;Marson-2007&amp;quot;&amp;gt;{{Cite journal  |vauthors=Marson AG, Al-Kharusi AM, Alwaidh M, Appleton R, Baker GA, Chadwick DW, etal | title = The SANAD study of effectiveness of valproate, lamotrigine, or topiramate for generalised and unclassifiable epilepsy: an unblinded randomised controlled trial | journal = [[The Lancet|Lancet]] | volume = 369 | issue = 9566 | pages = 1016–26 | year = 2007 | doi = 10.1016/S0140-6736(07)60461-9 | pmid = 17382828 | pmc = 2039891 }}&amp;lt;/ref&amp;gt; &amp;quot;open&amp;quot;,&amp;lt;ref name=&amp;quot;Chan-1995&amp;quot;&amp;gt;{{Cite journal |vauthors=Chan R, Hemeryck L, O'Regan M, Clancy L, Feely J | title = Oral versus intravenous antibiotics for community acquired lower respiratory tract infection in a general hospital: open, randomised controlled trial | journal = [[BMJ]] | volume = 310 | issue = 6991 | pages = 1360–2 | year = 1995 | pmid = 7787537 | pmc = 2549744 | doi=10.1136/bmj.310.6991.1360}}&amp;lt;/ref&amp;gt; or (if the intervention is a medication) &amp;quot;[[Open-label trial|open-label]]&amp;quot;.&amp;lt;ref name=&amp;quot;Fukase-2008&amp;quot;&amp;gt;{{Cite journal | author = Fukase K, Kato M, Kikuchi S, Inoue K, Uemura N, Okamoto S, Terao S, Amagai K, Hayashi S, Asaka M; Japan Gast Study Group | title = Effect of eradication of Helicobacter pylori on incidence of metachronous gastric carcinoma after endoscopic resection of early gastric cancer: an open-label, randomised controlled trial | journal = Lancet | volume = 372 | issue = 9636 | pages = 392–7 | year = 2008 | doi = 10.1016/S0140-6736(08)61159-9 | pmid = 18675689 | hdl = 2115/34681 | s2cid = 13741892 | url = https://eprints.lib.hokudai.ac.jp/dspace/bitstream/2115/34681/1/asaka.pdf | hdl-access = free }}&amp;lt;/ref&amp;gt; In 2008 a study concluded that the results of unblinded RCTs tended to be biased toward beneficial effects only if the RCTs' outcomes were subjective as opposed to objective;&amp;lt;ref name=&amp;quot;Wood-2008&amp;quot;/&amp;gt; for example, in an RCT of treatments for [[multiple sclerosis]], unblinded neurologists (but not the blinded neurologists) felt that the treatments were beneficial.&amp;lt;ref name=&amp;quot;Noseworthy-1994&amp;quot;&amp;gt;{{Cite journal |vauthors=Noseworthy JH, Ebers GC, Vandervoort MK, Farquhar RE, Yetisir E, Roberts R | author-link1=John H. Noseworthy|title = The impact of blinding on the results of a randomized, placebo-controlled multiple sclerosis clinical trial | journal = Neurology | volume = 44 | issue = 1 | pages = 16–20 | year = 1994 | url = http://www.neurology.org/cgi/content/abstract/44/1/16 | pmid = 8290055 | doi=10.1212/wnl.44.1.16| s2cid=2663997}}&amp;lt;/ref&amp;gt; In pragmatic RCTs, although the participants and providers are often unblinded, it is &amp;quot;still desirable and often possible to blind the assessor or obtain an objective source of data for evaluation of outcomes.&amp;quot;&amp;lt;ref name=&amp;quot;Zwarenstein-2008&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
没有盲法的随机对照试验被称为“未盲法”，也称“开放”，或者(如果干预是一种药物)“开放标签”。2008年的一项研究得出结论，只有当随机对照试验的结果是主观的而不是客观的时候，非盲法随机对照试验的结果往往偏向于有益的结果；例如，在RCT多发性硬化症的治疗中，未盲的神经学家认为治疗是有益的。在实用的随机对照试验中，尽管参与者和提供者往往是非盲的，但是”仍然需要并且往往可能使评估者“蒙面”，以获得评估结果的客观数据来源”。&lt;br /&gt;
&lt;br /&gt;
== Analysis of data ==&lt;br /&gt;
&lt;br /&gt;
The types of statistical methods used in RCTs depend on the characteristics of the data and include:&lt;br /&gt;
&lt;br /&gt;
* For [[dichotomous]] (binary) outcome data, [[logistic regression]] (e.g., to predict sustained virological response after receipt of [[peginterferon alfa-2a]] for [[hepatitis C]]&amp;lt;ref name=&amp;quot;Manns-2001&amp;quot;&amp;gt;{{Cite journal |vauthors=Manns MP, McHutchison JG, Gordon SC, Rustgi VK, Shiffman M, Reindollar R, Goodman ZD, Koury K, Ling M, Albrecht JK | title = Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial | journal = [[The Lancet|Lancet]] | volume = 358 | issue = 9286 | pages = 958–65 | year = 2001 | doi = 10.1016/S0140-6736(01)06102-5 | pmid = 11583749 | s2cid = 14583372 }}&amp;lt;/ref&amp;gt;) and other methods can be used.&lt;br /&gt;
&lt;br /&gt;
* For continuous outcome data, [[analysis of covariance]] (e.g., for changes in blood lipid levels after receipt of [[atorvastatin]] after [[acute coronary syndrome]]&amp;lt;ref name=&amp;quot;Schwartz-2001&amp;quot;&amp;gt;{{Cite journal | author = Schwartz GG, Olsson AG, Ezekowitz MD, Ganz P, Oliver MF, Waters D, Zeiher A, Chaitman BR, Leslie S, Stern T; Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering (MIRACL) Study Investigators | title = Effects of atorvastatin on early recurrent ischemic events in acute coronary syndromes: the MIRACL study: a randomized controlled trial | journal = [[J Am Med Assoc]] | volume = 285 | issue = 13 | pages = 1711–8 | year = 2001 | pmid = 11277825 | doi = 10.1001/jama.285.13.1711 | doi-access = free }}&amp;lt;/ref&amp;gt;) tests the effects of predictor variables.&lt;br /&gt;
&lt;br /&gt;
* For time-to-event outcome data that may be [[Censoring (statistics)|censored]], [[survival analysis]] (e.g., [[Kaplan–Meier estimator]]s and [[Cox proportional hazards model]]s for time to [[coronary heart disease]] after receipt of [[Hormone replacement therapy (menopause)|hormone replacement therapy in menopause]]&amp;lt;ref name=&amp;quot;Rossouw-2002&amp;quot;&amp;gt;{{Cite journal | author = Rossouw JE, Anderson GL, [[Ross Prentice|Prentice RL]], LaCroix AZ, Kooperberg C, Stefanick ML, Jackson RD, Beresford SA, Howard BV, Johnson KC, Kotchen JM, Ockene J; Writing Group for the Women's Health Initiative Investigators | title = Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial | journal = [[J Am Med Assoc]] | volume = 288 | issue = 3 | pages = 321–33 | year = 2002 | pmid = 12117397 | doi = 10.1001/jama.288.3.321 | s2cid = 20149703 | url = https://escholarship.org/content/qt3mr6f93p/qt3mr6f93p.pdf?t=prll4c | doi-access = free }}&amp;lt;/ref&amp;gt;) is appropriate.&lt;br /&gt;
&lt;br /&gt;
随机对照试验中使用的统计方法类型取决于数据的特征，包括：&lt;br /&gt;
&lt;br /&gt;
* 对于二元结果数据，可以使用逻辑回归(例如，预测接受聚乙二醇干扰素α-2a治疗丙型肝炎后的持续病毒学应答)和其他方法。&lt;br /&gt;
&lt;br /&gt;
* 对于连续的结果数据，协方差分析(例如，急性冠状动脉综合征后接受阿托伐他汀后血脂水平的变化)可以用于检测预测变量效果。&lt;br /&gt;
&lt;br /&gt;
* 对于可能删失的时间到事件结果数据，生存分析(如绝经后接受激素替代治疗后冠心病发生时间的卡普兰-迈耶估计值和考克斯比例风险模型)是合适的。&lt;br /&gt;
Regardless of the statistical methods used, important considerations in the analysis of RCT data include:&lt;br /&gt;
&lt;br /&gt;
* Whether an RCT should be stopped early due to interim results.  For example, RCTs may be stopped early if an intervention produces &amp;quot;larger than expected benefit or harm&amp;quot;, or if &amp;quot;investigators find evidence of no important difference between experimental and control interventions.&amp;quot;&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
* The extent to which the groups can be analyzed exactly as they existed upon randomization (i.e., whether a so-called &amp;quot;[[intention-to-treat analysis]]&amp;quot; is used). A &amp;quot;pure&amp;quot; intention-to-treat analysis is &amp;quot;possible only when complete outcome data are available&amp;quot; for all randomized subjects;&amp;lt;ref name=&amp;quot;Hollis-1999&amp;quot;&amp;gt;{{Cite journal |vauthors=Hollis S, Campbell F | title = What is meant by intention to treat analysis? Survey of published randomised controlled trials | journal = [[Br Med J]] | volume = 319 | issue = 7211 | pages = 670–4 | year = 1999 | pmid = 10480822 | pmc = 28218 | doi=10.1136/bmj.319.7211.670}}&amp;lt;/ref&amp;gt; when some outcome data are missing, options include analyzing only cases with known outcomes and using [[Imputation (statistics)|imputed]] data.&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt; Nevertheless, the more that analyses can include all participants in the groups to which they were randomized, the less bias that an RCT will be subject to.&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
* Whether [[subgroup analysis]] should be performed.  These are &amp;quot;often discouraged&amp;quot; because [[multiple comparisons]] may produce false positive findings that cannot be confirmed by other studies.&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
无论使用何种统计方法，RCT数据分析中的重要考虑因素包括：&lt;br /&gt;
&lt;br /&gt;
* 由于中期结果，是否应该提前停止RCT。例如，如果干预产生“大于预期的益处或危害”，或者如果“研究者发现实验干预和对照干预之间没有重要区别的证据”，则可能会提前停止随机对照试验。&lt;br /&gt;
&lt;br /&gt;
* 这些组在多大程度上可以完全按照随机化时的状态进行分析(即，是否使用了所谓的“意向治疗分析”)。一项“纯”意向治疗分析“只有在获得所有随机受试者的完整结果数据时才有可能”；当一些结果数据缺失时，选项包括仅分析具有已知结果的病例和使用估算数据。然而，分析越能包括他们被随机分组的所有参与者，RCT受到的偏见就越少。&lt;br /&gt;
&lt;br /&gt;
* 是否应进行亚组分析。这些“通常是不鼓励的”，因为多次比较可能会产生假阳性结果，而其他研究无法证实。&lt;br /&gt;
== Reporting of results ==&lt;br /&gt;
&lt;br /&gt;
&amp;lt;li value=&amp;quot;5&amp;quot;&amp;gt;The ''CONSORT 2010 Statement'' is &amp;quot;an evidence-based, minimum set of recommendations for reporting RCTs.&amp;quot; The CONSORT 2010 checklist contains 25 items (many with sub-items) focusing on &amp;quot;individually randomised, two group, parallel trials&amp;quot; which are the most common type of RCT.&lt;br /&gt;
&lt;br /&gt;
For other RCT study designs, &amp;quot;CONSORT extensions&amp;quot; have been published, some examples are:&lt;br /&gt;
* Consort 2010 Statement: Extension to Cluster Randomised Trials&lt;br /&gt;
* Consort 2010 Statement: Non-Pharmacologic Treatment Interventions&lt;br /&gt;
&lt;br /&gt;
CONSORT 2010声明是“一套基于证据的报告随机对照试验的最低建议。”CONSORT 2010核对表包含25个项目(许多带有子项目)，重点关注“个体随机、两组、平行试验”，这是RCT最常见的类型。&lt;br /&gt;
&lt;br /&gt;
对于其他RCT研究设计，“CONSORT扩展版”已经发布，一些例子是:&lt;br /&gt;
* CONSORT 2010 声明: 扩展至聚类随机试验&lt;br /&gt;
* CONSORT 2010 声明: 非药物治疗干预&lt;br /&gt;
&lt;br /&gt;
=== Relative importance and observational studies ===&lt;br /&gt;
&lt;br /&gt;
Two studies published in ''The New England Journal of Medicine'' in 2000 found that observational studies and RCTs overall produced similar results. The authors of the 2000 findings questioned the belief that &amp;quot;observational studies should not be used for defining evidence-based medical care&amp;quot; and that RCTs' results are &amp;quot;evidence of the highest grade.&amp;quot; However, a 2001 study published in ''Journal of the American Medical Association'' concluded that &amp;quot;discrepancies beyond chance do occur and differences in estimated magnitude of treatment effect are very common&amp;quot; between observational studies and RCTs.&lt;br /&gt;
&lt;br /&gt;
Two other lines of reasoning question RCTs' contribution to scientific knowledge beyond other types of studies:&lt;br /&gt;
* If study designs are ranked by their potential for new discoveries, then anecdotal evidence would be at the top of the list, followed by observational studies, followed by RCTs.&lt;br /&gt;
* RCTs may be unnecessary for treatments that have dramatic and rapid effects relative to the expected stable or progressively worse natural course of the condition treated. One example is combination chemotherapy including cisplatin for metastatic testicular cancer, which increased the cure rate from 5% to 60% in a 1977 non-randomized study.&lt;br /&gt;
2000年发表在《新英格兰医学杂志》上的两项研究发现，观察性研究和随机对照试验总体上产生了相似的结果。2000年研究结果的作者质疑“观察性研究不应用于定义循证医疗”以及随机对照试验的结果是“最高等级的证据”的观点。然而，2001年发表在《美国医学协会杂志》上的一项研究得出结论，观察性研究和随机对照试验之间“确实会出现超越偶然的差异，估计治疗效果的差异非常普遍”。&lt;br /&gt;
&lt;br /&gt;
另外两条推理路线质疑随机对照试验对科学知识的贡献超过了其他类型的研究:&lt;br /&gt;
* If study designs are ranked by their potential for new discoveries, then anecdotal evidence would be at the top of the list, followed by observational studies, followed by RCTs.&lt;br /&gt;
* RCTs may be unnecessary for treatments that have dramatic and rapid effects relative to the expected stable or progressively worse natural course of the condition treated. One example is combination chemotherapy including cisplatin for metastatic testicular cancer, which increased the cure rate from 5% to 60% in a 1977 non-randomized study.&lt;br /&gt;
&lt;br /&gt;
=== Interpretation of statistical results ===&lt;br /&gt;
&lt;br /&gt;
Like all statistical methods, RCTs are subject to both type I (&amp;quot;false positive&amp;quot;) and type II (&amp;quot;false negative&amp;quot;) statistical errors. Regarding Type I errors, a typical RCT will use 0.05 (i.e., 1 in 20) as the probability that the RCT will falsely find two equally effective treatments significantly different. Regarding Type II errors, despite the publication of a 1978 paper noting that the sample sizes of many &amp;quot;negative&amp;quot; RCTs were too small to make definitive conclusions about the negative results, by 2005-2006 a sizeable proportion of RCTs still had inaccurate or incompletely reported sample size calculations.&lt;br /&gt;
&lt;br /&gt;
=== Peer review ===&lt;br /&gt;
&lt;br /&gt;
Peer review of results is an important part of the scientific method. Reviewers examine the study results for potential problems with design that could lead to unreliable results (for example by creating a systematic bias), evaluate the study in the context of related studies and other evidence, and evaluate whether the study can be reasonably considered to have proven its conclusions. To underscore the need for peer review and the danger of over-generalizing conclusions, two Boston-area medical researchers performed a randomized controlled trial in which they randomly assigned either a parachute or an empty backpack to 23 volunteers who jumped from either a biplane or a helicopter. The study was able to accurately report that parachutes fail to reduce injury compared to empty backpacks. The key context that limited the general applicability of this conclusion was that the aircraft were parked on the ground, and participants had only jumped about two feet.&lt;br /&gt;
&lt;br /&gt;
== Advantages ==&lt;br /&gt;
&lt;br /&gt;
RCTs are considered to be the most reliable form of [[scientific method|scientific evidence]] in the [[hierarchy of evidence]] that influences healthcare policy and practice because RCTs reduce spurious causality and bias. Results of RCTs may be combined in [[systematic review]]s which are increasingly being used in the conduct of [[evidence-based practice]]. Some examples of scientific organizations' considering RCTs or systematic reviews of RCTs to be the highest-quality evidence available are:&lt;br /&gt;
* As of 1998, the [[National Health and Medical Research Council]] of Australia designated &amp;quot;Level I&amp;quot; evidence as that &amp;quot;obtained from a [[systematic review]] of all relevant randomised controlled trials&amp;quot; and &amp;quot;Level II&amp;quot; evidence as that &amp;quot;obtained from at least one properly designed randomised controlled trial.&amp;quot;&amp;lt;ref&amp;gt;{{cite book |url= http://www.nhmrc.gov.au/_files_nhmrc/file/publications/synopses/cp30.pdf |title= A guide to the development, implementation and evaluation of clinical practice guidelines |author= National Health and Medical Research Council |date=1998-11-16 |publisher= Commonwealth of Australia |location = Canberra | isbn = 978-1-86496-048-8 |page= 56|access-date=2010-03-28}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* Since at least 2001, in making [[clinical practice guideline]] recommendations the [[United States Preventive Services Task Force]] has considered both a study's design and its [[internal validity]] as indicators of its quality.&amp;lt;ref name=&amp;quot;Harris-2001&amp;quot;&amp;gt;{{Cite journal | author = Harris RP, Helfand M, Woolf SH, Lohr KN, Mulrow CD, Teutsch SM, Atkins D; Methods Work Group, Third US Preventive Services Task Force | title = Current methods of the US Preventive Services Task Force: a review of the process | journal = Am J Prev Med | volume = 20 | issue = 3 Suppl | pages = 21–35 | year = 2001 | url = http://www.ahrq.gov/clinic/ajpmsuppl/review.pdf | pmid = 11306229 | doi = 10.1016/S0749-3797(01)00261-6 }}&amp;lt;/ref&amp;gt; It has recognized &amp;quot;evidence obtained from at least one properly randomized controlled trial&amp;quot; with good [[internal validity]] (i.e., a rating of &amp;quot;I-good&amp;quot;) as the highest quality evidence available to it.&amp;lt;ref name=&amp;quot;Harris-2001&amp;quot;/&amp;gt;&lt;br /&gt;
* The [[Evidence-based medicine#Grade Working Group|GRADE Working Group]] concluded in 2008 that &amp;quot;randomised trials without important limitations constitute high quality evidence.&amp;quot;&amp;lt;ref name=&amp;quot;Guyatt-2008&amp;quot;&amp;gt;{{Cite journal | author = Guyatt GH, Oxman AD, Kunz R, Vist GE, Falck-Ytter Y, Schünemann HJ; GRADE Working Group | title = What is &amp;quot;quality of evidence&amp;quot; and why is it important to clinicians? | journal = BMJ | volume = 336 | issue = 7651 | pages = 995–8 |year = 2008 | doi = 10.1136/bmj.39490.551019.BE | pmc = 2364804 | pmid = 18456631 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* For issues involving &amp;quot;Therapy/Prevention, Aetiology/Harm&amp;quot;, the [[Oxford Centre for Evidence-based Medicine]] as of 2011 defined &amp;quot;Level 1a&amp;quot; evidence as a systematic review of RCTs that are consistent with each other, and &amp;quot;Level 1b&amp;quot; evidence as an &amp;quot;individual RCT (with narrow [[Confidence Interval]]).&amp;quot;&amp;lt;ref&amp;gt;{{cite web |url= http://www.cebm.net/index.aspx?o=1025 |title= Levels of evidence |author= Oxford Centre for Evidence-based Medicine |date=2011-09-16 |access-date=2012-02-15}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
RCTs are considered to be the most reliable form of scientific evidence in the hierarchy of evidence that influences healthcare policy and practice because RCTs reduce spurious causality and bias. Results of RCTs may be combined in systematic reviews which are increasingly being used in the conduct of evidence-based practice. Some examples of scientific organizations' considering RCTs or systematic reviews of RCTs to be the highest-quality evidence available are:&lt;br /&gt;
* As of 1998, the National Health and Medical Research Council of Australia designated &amp;quot;Level I&amp;quot; evidence as that &amp;quot;obtained from a systematic review of all relevant randomised controlled trials&amp;quot; and &amp;quot;Level II&amp;quot; evidence as that &amp;quot;obtained from at least one properly designed randomised controlled trial.&amp;quot;&lt;br /&gt;
* Since at least 2001, in making clinical practice guideline recommendations the United States Preventive Services Task Force has considered both a study's design and its internal validity as indicators of its quality. It has recognized &amp;quot;evidence obtained from at least one properly randomized controlled trial&amp;quot; with good internal validity (i.e., a rating of &amp;quot;I-good&amp;quot;) as the highest quality evidence available to it.&lt;br /&gt;
* The GRADE Working Group concluded in 2008 that &amp;quot;randomised trials without important limitations constitute high quality evidence.&amp;quot;&lt;br /&gt;
* For issues involving &amp;quot;Therapy/Prevention, Aetiology/Harm&amp;quot;, the Oxford Centre for Evidence-based Medicine as of 2011 defined &amp;quot;Level 1a&amp;quot; evidence as a systematic review of RCTs that are consistent with each other, and &amp;quot;Level 1b&amp;quot; evidence as an &amp;quot;individual RCT (with narrow Confidence Interval).&amp;quot;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Notable RCTs with unexpected results that contributed to changes in clinical practice include:&lt;br /&gt;
* After [[Food and Drug Administration]] approval, the [[antiarrhythmic agents]] [[flecainide]] and [[encainide]] came to market in 1986 and 1987 respectively.&amp;lt;ref name=&amp;quot;Anderson-1997&amp;quot;&amp;gt;{{Cite journal |vauthors=Anderson JL, Pratt CM, Waldo AL, Karagounis LA | title = Impact of the Food and Drug Administration approval of flecainide and encainide on coronary artery disease mortality: putting &amp;quot;Deadly Medicine&amp;quot; to the test | journal = Am J Cardiol | volume = 79 | issue = 1 | pages = 43–7 | year = 1997 | url = http://www.ajconline.org/article/S0002-9149%2896%2900673-X/abstract | pmid = 9024734 | doi = 10.1016/S0002-9149(96)00673-X }}&amp;lt;/ref&amp;gt; The non-randomized studies concerning the drugs were characterized as &amp;quot;glowing&amp;quot;,&amp;lt;ref name=&amp;quot;Rubin-2006&amp;quot;&amp;gt;{{cite news |title= In medicine, evidence can be confusing - deluged with studies, doctors try to sort out what works, what doesn't |author= Rubin R |url= https://www.usatoday.com/news/health/2006-10-15-medical-evidence-cover_x.htm |newspaper= USA Today |date= 2006-10-16 |access-date=2010-03-22}}&amp;lt;/ref&amp;gt; and their sales increased to a combined total of approximately 165,000 prescriptions per month in early 1989.&amp;lt;ref name=&amp;quot;Anderson-1997&amp;quot;/&amp;gt;  In that year, however, a preliminary report of an RCT concluded that the two drugs increased mortality.&amp;lt;ref name=&amp;quot;CAST-1989&amp;quot;&amp;gt;{{Cite journal | doi = 10.1056/NEJM198908103210629 | title = Preliminary report: effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction. The Cardiac Arrhythmia Suppression Trial (CAST) Investigators | journal = N Engl J Med | volume = 321 | issue = 6 | pages = 406–12 |year = 1989 | pmid = 2473403 | author1 = Cardiac Arrhythmia Suppression Trial (CAST) Investigators }}&amp;lt;/ref&amp;gt;  Sales of the drugs then decreased.&amp;lt;ref name=&amp;quot;Anderson-1997&amp;quot;/&amp;gt;&lt;br /&gt;
* Prior to 2002, based on observational studies, it was routine for physicians to prescribe hormone replacement therapy for post-menopausal women to prevent [[myocardial infarction]].&amp;lt;ref name=&amp;quot;Rubin-2006&amp;quot;/&amp;gt; In 2002 and 2004, however, published RCTs from the [[Women's Health Initiative]] claimed that women taking hormone replacement therapy with estrogen plus progestin had a higher rate of myocardial infarctions than women on a placebo, and that estrogen-only hormone replacement therapy caused no reduction in the incidence of coronary heart disease.&amp;lt;ref name=&amp;quot;Rossouw-2002&amp;quot;/&amp;gt;&amp;lt;ref name=&amp;quot;Anderson-2004&amp;quot;&amp;gt;{{Cite journal  |vauthors=Anderson GL, Limacher M, Assaf AR, Bassford T, Beresford SA, Black H, etal | title = Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women's Health Initiative randomized controlled trial | journal = JAMA | volume = 291 | issue = 14 | pages = 1701–12 | year = 2004 | doi = 10.1001/jama.291.14.1701 | pmid = 15082697 | doi-access = free }}&amp;lt;/ref&amp;gt;  Possible explanations for the discrepancy between the observational studies and the RCTs involved differences in methodology, in the hormone regimens used, and in the populations studied.&amp;lt;ref name=&amp;quot;Grodstein-2003&amp;quot;&amp;gt;{{Cite journal |vauthors=Grodstein F, Clarkson TB, Manson JE | title = Understanding the divergent data on postmenopausal hormone therapy | journal = N Engl J Med | volume = 348 | issue = 7 | pages = 645–50 | year = 2003 | doi = 10.1056/NEJMsb022365 | pmid = 12584376 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Vandenbroucke-2009&amp;quot;&amp;gt;{{Cite journal | author = Vandenbroucke JP | title = The HRT controversy: observational studies and RCTs fall in line | journal = Lancet | volume = 373 | issue = 9671 | pages = 1233–5 | year = 2009 | doi = 10.1016/S0140-6736(09)60708-X | pmid = 19362661 | s2cid = 44991220 }}&amp;lt;/ref&amp;gt; The use of hormone replacement therapy decreased after publication of the RCTs.&amp;lt;ref name=&amp;quot;Hsu-2009&amp;quot;&amp;gt;{{Cite journal |vauthors=Hsu A, Card A, Lin SX, Mota S, Carrasquillo O, Moran A | title = Changes in postmenopausal hormone replacement therapy use among women with high cardiovascular risk | journal = Am J Public Health | volume = 99 | issue = 12 | pages = 2184–7 | year = 2009 | doi = 10.2105/AJPH.2009.159889 | url = http://ajph.aphapublications.org/cgi/content/full/99/12/2184 | pmid = 19833984 | pmc=2775780}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Notable RCTs with unexpected results that contributed to changes in clinical practice include:&lt;br /&gt;
* After Food and Drug Administration approval, the antiarrhythmic agents flecainide and encainide came to market in 1986 and 1987 respectively. The non-randomized studies concerning the drugs were characterized as &amp;quot;glowing&amp;quot;, and their sales increased to a combined total of approximately 165,000 prescriptions per month in early 1989. In that year, however, a preliminary report of an RCT concluded that the two drugs increased mortality. Sales of the drugs then decreased.&lt;br /&gt;
* Prior to 2002, based on observational studies, it was routine for physicians to prescribe hormone replacement therapy for post-menopausal women to prevent myocardial infarction. In 2002 and 2004, however, published RCTs from the Women's Health Initiative claimed that women taking hormone replacement therapy with estrogen plus progestin had a higher rate of myocardial infarctions than women on a placebo, and that estrogen-only hormone replacement therapy caused no reduction in the incidence of coronary heart disease. Possible explanations for the discrepancy between the observational studies and the RCTs involved differences in methodology, in the hormone regimens used, and in the populations studied. The use of hormone replacement therapy decreased after publication of the RCTs.&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
== Disadvantages ==&lt;br /&gt;
&lt;br /&gt;
Many papers discuss the disadvantages of RCTs.&amp;lt;ref name=&amp;quot;Black-1996&amp;quot;&amp;gt;{{Cite journal | author = Black N | title = Why we need observational studies to evaluate the effectiveness of health care | journal = BMJ | volume = 312 | issue = 7040 | pages = 1215–8 | year = 1996 | pmid = 8634569 | pmc = 2350940 | doi=10.1136/bmj.312.7040.1215}}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Bell &amp;amp; Peck-2012&amp;quot;&amp;gt;{{Cite journal | author = Bell, S.H., &amp;amp; Peck, L.R. | title = Obstacles to and limitations of social experiments: 15 false alarms | journal = Abt Thought Leadership Paper Series | year = 2012 | url = http://abtassociates.com/white-papers/2012/obstacles-to-and-limitations-of-social-experiments.aspx }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Sanson-Fisher-2007&amp;quot;&amp;gt;{{Cite journal |vauthors=Sanson-Fisher RW, Bonevski B, Green LW, D'Este C | title = Limitations of the randomized controlled trial in evaluating population-based health interventions | journal = Am J Prev Med | volume = 33 | issue = 2 | pages = 155–61 | year = 2007 | doi = 10.1016/j.amepre.2007.04.007 | url = http://www.ajpm-online.net/article/S0749-3797%2807%2900225-5/abstract | pmid = 17673104 }}&amp;lt;/ref&amp;gt;   Among the most frequently cited drawbacks are:&lt;br /&gt;
&lt;br /&gt;
=== Time and costs ===&lt;br /&gt;
&lt;br /&gt;
RCTs can be expensive; one study found 28 Phase III RCTs funded by the National Institute of Neurological Disorders and Stroke prior to 2000 with a total cost of US$335 million, for a mean cost of US$12 million per RCT. Nevertheless, the return on investment of RCTs may be high, in that the same study projected that the 28 RCTs produced a &amp;quot;net benefit to society at 10-years&amp;quot; of 46 times the cost of the trials program, based on evaluating a quality-adjusted life year as equal to the prevailing mean per capita gross domestic product.&lt;br /&gt;
&lt;br /&gt;
The conduct of an RCT takes several years until being published; thus, data is restricted from the medical community for long years and may be of less relevance at time of publication.&lt;br /&gt;
&lt;br /&gt;
It is costly to maintain RCTs for the years or decades that would be ideal for evaluating some interventions.&lt;br /&gt;
&lt;br /&gt;
Interventions to prevent events that occur only infrequently (e.g., sudden infant death syndrome) and uncommon adverse outcomes (e.g., a rare side effect of a drug) would require RCTs with extremely large sample sizes and may, therefore, best be assessed by observational studies.&lt;br /&gt;
&lt;br /&gt;
Due to the costs of running RCTs, these usually only inspect one variable or very few variables, rarely reflecting the full picture of a complicated medical situation; whereas the case report, for example, can detail many aspects of the patient's medical situation (e.g. patient history, physical examination, diagnosis, psychosocial aspects, follow up).&lt;br /&gt;
&lt;br /&gt;
=== Conflict of interest dangers ===&lt;br /&gt;
&lt;br /&gt;
A 2011 study done to disclose possible conflicts of interests in underlying research studies used for medical meta-analyses reviewed 29 meta-analyses and found that conflicts of interests in the studies underlying the meta-analyses were rarely disclosed. The 29 meta-analyses included 11 from general medicine journals; 15 from specialty medicine journals, and 3 from the Cochrane Database of Systematic Reviews. The 29 meta-analyses reviewed an aggregate of 509 randomized controlled trials (RCTs). Of these, 318 RCTs reported funding sources with 219 (69%) industry funded. 132 of the 509 RCTs reported author conflict of interest disclosures, with 91 studies (69%) disclosing industry financial ties with one or more authors. The information was, however, seldom reflected in the meta-analyses. Only two (7%) reported RCT funding sources and none reported RCT author-industry ties. The authors concluded &amp;quot;without acknowledgment of COI due to industry funding or author industry financial ties from RCTs included in meta-analyses, readers' understanding and appraisal of the evidence from the meta-analysis may be compromised.&amp;quot;&lt;br /&gt;
&lt;br /&gt;
Some RCTs are fully or partly funded by the health care industry (e.g., the pharmaceutical industry) as opposed to government, nonprofit, or other sources. A systematic review published in 2003 found four 1986–2002 articles comparing industry-sponsored and nonindustry-sponsored RCTs, and in all the articles there was a correlation of industry sponsorship and positive study outcome. A 2004 study of 1999–2001 RCTs published in leading medical and surgical journals determined that industry-funded RCTs &amp;quot;are more likely to be associated with statistically significant pro-industry findings.&amp;quot; These results have been mirrored in trials in surgery, where although industry funding did not affect the rate of trial discontinuation it was however associated with a lower odds of publication for completed trials. One possible reason for the pro-industry results in industry-funded published RCTs is publication bias. Other authors have cited the differing goals of academic and industry sponsored research as contributing to the difference. Commercial sponsors may be more focused on performing trials of drugs that have already shown promise in early stage trials, and on replicating previous positive results to fulfill regulatory requirements for drug approval.&lt;br /&gt;
&lt;br /&gt;
有些 rct 完全或部分由医疗保健行业(如制药行业)资助，而不是政府、非营利组织或其他来源。2003年发表的一份系统综述研究报告发现，1986年至2002年间，有4篇文章比较了行业赞助和非行业赞助的 rct，在所有的文章中，行业赞助和正面研究结果之间存在相关性。2004年发表在主要医学和外科杂志上的一项关于1999-2001年的 rct 的研究表明，工业资助的 rct“更有可能与具有统计学意义的有利于工业的发现相关联。”这些结果已经反映在手术试验中，虽然行业资金并不影响试验中止率，但是与完成试验的发表机率较低相关。支持产业的结果在产业资助的已发表的研究报告中出现的一个可能的原因是出版偏见。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
=== Ethics ===&lt;br /&gt;
If a disruptive innovation in medical technology is developed, it may be difficult to test this ethically in an RCT if it becomes &amp;quot;obvious&amp;quot; that the control subjects have poorer outcomes—either due to other foregoing testing, or within the initial phase of the RCT itself. Ethically it may be necessary to abort the RCT prematurely, and getting ethics approval (and patient agreement) to withhold the innovation from the control group in future RCT's may not be feasible.&lt;br /&gt;
&lt;br /&gt;
Historical control trials (HCT) exploit the data of previous RCTs to reduce the sample size; however, these approaches are controversial in the scientific community and must be handled with care.&lt;br /&gt;
&lt;br /&gt;
== In social science ==&lt;br /&gt;
Due to the recent emergence of RCTs in social science, the use of RCTs in social sciences is a contested issue. Some writers from a medical or health background have argued that existing research in a range of social science disciplines lacks rigour, and should be improved by greater use of randomized control trials.&lt;br /&gt;
&lt;br /&gt;
=== Transport science ===&lt;br /&gt;
Researchers in transport science argue that public spending on programmes such as school travel plans could not be justified unless their efficacy is demonstrated by randomized controlled trials. Graham-Rowe and colleagues reviewed 77 evaluations of transport interventions found in the literature, categorising them into 5 &amp;quot;quality levels&amp;quot;. They concluded that most of the studies were of low quality and advocated the use of randomized controlled trials wherever possible in future transport research.&lt;br /&gt;
&lt;br /&gt;
Dr. Steve Melia took issue with these conclusions, arguing that claims about the advantages of RCTs, in establishing causality and avoiding bias, have been exaggerated. He proposed the following eight criteria for the use of RCTs in contexts where interventions must change human behaviour to be effective:&lt;br /&gt;
&lt;br /&gt;
The intervention:&lt;br /&gt;
# Has not been applied to all members of a unique group of people (e.g. the population of a whole country, all employees of a unique organisation etc.)&lt;br /&gt;
# Is applied in a context or setting similar to that which applies to the control group&lt;br /&gt;
# Can be isolated from other activities—and the purpose of the study is to assess this isolated effect&lt;br /&gt;
# Has a short timescale between its implementation and maturity of its effects&lt;br /&gt;
&lt;br /&gt;
And the causal mechanisms:&lt;br /&gt;
# Are either known to the researchers, or else all possible alternatives can be tested&lt;br /&gt;
# Do not involve significant feedback mechanisms between the intervention group and external environments&lt;br /&gt;
# Have a stable and predictable relationship to exogenous factors&lt;br /&gt;
# Would act in the same way if the control group and intervention group were reversed&lt;br /&gt;
&lt;br /&gt;
=== Criminology ===&lt;br /&gt;
A 2005 review found 83 randomized experiments in criminology published in 1982–2004, compared with only 35 published in 1957–1981. The authors classified the studies they found into five categories: &amp;quot;policing&amp;quot;, &amp;quot;prevention&amp;quot;, &amp;quot;corrections&amp;quot;, &amp;quot;court&amp;quot;, and &amp;quot;community&amp;quot;. Focusing only on offending behavior programs, Hollin (2008) argued that RCTs may be difficult to implement (e.g., if an RCT required &amp;quot;passing sentences that would randomly assign offenders to programmes&amp;quot;) and therefore that experiments with quasi-experimental design are still necessary.&lt;br /&gt;
&lt;br /&gt;
=== Education ===&lt;br /&gt;
RCTs have been used in evaluating a number of educational interventions. Between 1980 and 2016, over 1,000 reports of RCTs have been published. For example, a 2009 study randomized 260 elementary school teachers' classrooms to receive or not receive a program of behavioral screening, classroom intervention, and parent training, and then measured the behavioral and academic performance of their students. Another 2009 study randomized classrooms for 678 first-grade children to receive a classroom-centered intervention, a parent-centered intervention, or no intervention, and then followed their academic outcomes through age 19.&lt;br /&gt;
&lt;br /&gt;
== Criticism ==&lt;br /&gt;
A 2018 review of the 10 most cited randomised controlled trials noted poor distribution of background traits, difficulties with blinding, and discussed other assumptions and biases inherent in randomised controlled trials. These include the &amp;quot;unique time period assessment bias&amp;quot;, the &amp;quot;background traits remain constant assumption&amp;quot;, the &amp;quot;average treatment effects limitation&amp;quot;, the &amp;quot;simple treatment at the individual level limitation&amp;quot;, the &amp;quot;all preconditions are fully met assumption&amp;quot;, the &amp;quot;quantitative variable limitation&amp;quot; and the &amp;quot;placebo only or conventional treatment only limitation&amp;quot;.&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Category:Clinical research&lt;br /&gt;
&lt;br /&gt;
类别: 临床研究&lt;br /&gt;
&lt;br /&gt;
Category:Epidemiological study projects&lt;br /&gt;
&lt;br /&gt;
类别: 流行病学研究项目&lt;br /&gt;
&lt;br /&gt;
Category:Evidence-based practices&lt;br /&gt;
&lt;br /&gt;
类别: 循证做法&lt;br /&gt;
&lt;br /&gt;
Category:Design of experiments&lt;br /&gt;
[[Category:待整理页面]]&lt;br /&gt;
&amp;lt;references /&amp;gt;&lt;/div&gt;</summary>
		<author><name>李昊轩</name></author>
	</entry>
	<entry>
		<id>https://wiki.swarma.org/index.php?title=%E9%9A%8F%E6%9C%BA%E5%AF%B9%E7%85%A7%E8%AF%95%E9%AA%8C&amp;diff=24416</id>
		<title>随机对照试验</title>
		<link rel="alternate" type="text/html" href="https://wiki.swarma.org/index.php?title=%E9%9A%8F%E6%9C%BA%E5%AF%B9%E7%85%A7%E8%AF%95%E9%AA%8C&amp;diff=24416"/>
		<updated>2021-07-14T05:57:07Z</updated>

		<summary type="html">&lt;p&gt;李昊轩：&lt;/p&gt;
&lt;hr /&gt;
&lt;div&gt;此词条暂由彩云小译翻译，翻译字数共2766，未经人工整理和审校，带来阅读不便，请见谅。&lt;br /&gt;
&lt;br /&gt;
{{Short description|Experimental method designed to reduce bias, typically accomplished by randomly allocating subjects to two or more groups, with one being a control group}}&lt;br /&gt;
&lt;br /&gt;
[[File:Flowchart of Phases of Parallel Randomized Trial - Modified from CONSORT 2010.png|thumb|upright=1.5|Flowchart of four phases (enrollment, allocation, intervention, follow-up, and data analysis) of a parallel randomized trial of two groups (in a controlled trial, one of the interventions serves as the control), modified from the CONSORT (Consolidated Standards of Reporting Trials) 2010 Statement&amp;lt;ref name=&amp;quot;Schulz-2010&amp;quot;&amp;gt;{{Cite journal | author = Schulz KF, Altman DG, ((Moher D; for the CONSORT Group)) | title = CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials | journal = [[Br Med J]] | volume = 340 | pages = c332 | year = 2010 | doi = 10.1136/bmj.c332 | pmid = 20332509 | pmc = 2844940 }}&amp;lt;/ref&amp;gt;|链接=Special:FilePath/Flowchart_of_Phases_of_Parallel_Randomized_Trial_-_Modified_from_CONSORT_2010.png]]&lt;br /&gt;
&lt;br /&gt;
[来源：图片] Flowchart of four phases (enrollment, allocation, intervention, follow-up, and data analysis) of a parallel randomized trial of two groups (in a controlled trial, one of the interventions serves as the control), modified from the CONSORT (Consolidated Standards of Reporting Trials) 2010 Statement.&lt;br /&gt;
&lt;br /&gt;
据修改的2010年CONSORT (综合报告试验标准)要求，流程图包括：两组平行随机试验分为登记、分配、干预、随访和数据分析四个阶段，在对照试验中，需要其中一项干预作为对照处理措施。 &lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
A '''randomized controlled trial''' (or '''randomized control trial''';&amp;lt;ref name=&amp;quot;Chalmers-1981&amp;quot;&amp;gt;{{Cite journal |vauthors=Chalmers TC, ((Smith H Jr)), Blackburn B, Silverman B, Schroeder B, Reitman D, Ambroz A | title = A method for assessing the quality of a randomized control trial | journal = [[Controlled Clinical Trials]] | volume = 2 | issue = 1 | pages = 31–49 | year = 1981 | doi = 10.1016/0197-2456(81)90056-8 | pmid = 7261638 }}&amp;lt;/ref&amp;gt; '''RCT''') is a type of ''[[scientific experiment]]'' (e.g. a ''[[clinical trial]]'') or ''intervention study'' (as opposed to ''[[observational study]]'') that aims to reduce certain sources of bias when testing the effectiveness of new treatments; this is accomplished by [[Random assignment|randomly allocating]] subjects to two or more groups, treating them differently, and then comparing them with respect to a measured response. One group—the experimental group—receives the intervention being assessed, while the other—usually called the control group—receives an alternative treatment, such as a [[placebo]] or no intervention. The groups are monitored under conditions of the trial design to determine the effectiveness of the experimental intervention, and efficacy is assessed in comparison to the control. &amp;lt;ref&amp;gt;{{cite web|url=https://www.nice.org.uk/glossary?letter=r|publisher=National Institute for Health and Care Excellence, London, UK|title=Randomised controlled trial|date=2019|access-date=3 June 2019}}&amp;lt;/ref&amp;gt; There may be more than one treatment group or more than one [[Treatment and control groups|control group]].&lt;br /&gt;
&lt;br /&gt;
A randomized controlled trial (or randomized control trial; RCT) is a type of scientific experiment (e.g. a clinical trial) or intervention study (as opposed to observational study) that aims to reduce certain sources of bias when testing the effectiveness of new treatments; this is accomplished by randomly allocating subjects to two or more groups, treating them differently, and then comparing them with respect to a measured response. One group—the experimental group—receives the intervention being assessed, while the other—usually called the control group—receives an alternative treatment, such as a placebo or no intervention. The groups are monitored under conditions of the trial design to determine the effectiveness of the experimental intervention, and efficacy is assessed in comparison to the control.  There may be more than one treatment group or more than one control group.&lt;br /&gt;
&lt;br /&gt;
随机对照试验(A randomized controlled trial, RCT)是一种科学实验(例如:临床试验)或干预研究(区别于观察性研究) ，其目的是在测试新治疗的有效性时减少某些偏倚来源。通过受试者随机分配到两个或两个以上的组，经过不同的处理，产生的效应再与一个有可控的处理效应相比较。即一组或多组(实验组)接受正在评估的干预措施，而另一组(通常称为对照组)接受替代治疗，如安慰剂或无干预措施。在试验设计的条件下对这些组进行监测，以确定实验干预的有效性，并与对照组进行疗效比较评估。当然这也包括一个以上的治疗组或一个以上的对照组。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
The trial may be [[blinded experiment|blinded]], meaning that information which may influence the participants is withheld until after the experiment is complete. A blind can be imposed on any participant of an experiment, including subjects, researchers, technicians, data analysts, and evaluators. Effective blinding may reduce or eliminate some sources of experimental [[bias]].&lt;br /&gt;
&lt;br /&gt;
The trial may be blinded, meaning that information which may influence the participants is withheld until after the experiment is complete. A blind can be imposed on any participant of an experiment, including subjects, researchers, technicians, data analysts, and evaluators. Effective blinding may reduce or eliminate some sources of experimental bias.&lt;br /&gt;
&lt;br /&gt;
试验可能采用了盲法，这意味着影响参与者的信息在试验完成后才会公布。试验的任何参与者，包括受试者、研究人员、技术人员、数据分析人员和评估人员，都可能被强加盲。有效的盲法可以减少或消除某些试验偏差的来源。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
The randomness in the assignment of subjects to groups reduces [[selection bias]] and allocation bias, balancing both known and unknown prognostic factors, in the assignment of treatments.&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;&amp;gt;{{Cite journal |vauthors=Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG | title = CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials | journal = [[Br Med J]] | volume = 340 | pages = c869 | year = 2010 | doi = 10.1136/bmj.c869 | pmid = 20332511 | pmc = 2844943 }}&amp;lt;/ref&amp;gt; Blinding reduces other forms of [[Observer-expectancy effect|experimenter and subject biases]].&lt;br /&gt;
&lt;br /&gt;
The randomness in the assignment of subjects to groups reduces selection bias and allocation bias, balancing both known and unknown prognostic factors, in the assignment of treatments. Blinding reduces other forms of experimenter and subject biases.&lt;br /&gt;
&lt;br /&gt;
在分配治疗方案时，受试者随机地被分配到不同组。这个随机化过程减少了选择偏差和分配偏差，平衡了已知和未知的预后因素。盲法减少了其他形式的实验者和主体偏见。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
A well-blinded RCT is often considered the [[Gold standard (test)|gold standard]] for [[clinical trial]]s. Blinded RCTs are commonly used to test the [[Efficacy#Medicine|efficacy]] of medical [[Health intervention|intervention]]s and may additionally provide information about adverse effects, such as [[adverse drug reactions|drug reactions]]. A randomized controlled trial can provide compelling evidence that the study treatment causes an effect on human health.&amp;lt;ref name=&amp;quot;hannan&amp;quot;&amp;gt;{{cite journal | vauthors = Hannan EL | title = Randomized clinical trials and observational studies: guidelines for assessing respective strengths and limitations | journal = JACC. Cardiovascular Interventions | volume = 1 | issue = 3 | pages = 211–7 | date = June 2008 | pmid = 19463302 | doi = 10.1016/j.jcin.2008.01.008 | doi-access = free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
A well-blinded RCT is often considered the gold standard for clinical trials. Blinded RCTs are commonly used to test the efficacy of medical interventions and may additionally provide information about adverse effects, such as drug reactions. A randomized controlled trial can provide compelling evidence that the study treatment causes an effect on human health.&lt;br /&gt;
&lt;br /&gt;
一个良好盲法的 RCT 通常被认为是临床试验的黄金标准。盲法随机对照试验通常用于检测医疗干预措施的效果，并且还可能提供关于药物反应等不良反应的信息。随机对照试验可以提供令人信服的证据，证明研究治疗对人类健康产生了影响。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
The terms &amp;quot;RCT&amp;quot; and &amp;quot;'''randomized trial'''&amp;quot; are sometimes used synonymously, but the latter term omits mention of controls and can therefore describe studies that compare multiple treatment groups with each other in the absence of a control group.&amp;lt;ref name=&amp;quot;Ranjith-2005&amp;quot;&amp;gt;{{Cite journal | author = Ranjith G | title = Interferon-α-induced depression: when a randomized trial is not a randomized controlled trial | journal = [[Psychother Psychosom]] | volume = 74 | issue = 6 | pages = 387; author reply 387–8 | year = 2005 | doi = 10.1159/000087787 | pmid = 16244516 | s2cid = 143644933 }}&amp;lt;/ref&amp;gt; Similarly, the [[initialism]] is sometimes expanded as &amp;quot;'''randomized clinical trial'''&amp;quot; or &amp;quot;'''randomized comparative trial'''&amp;quot;, leading to ambiguity in the [[scientific literature]].&amp;lt;ref name=&amp;quot;Peto-1976&amp;quot;&amp;gt;{{Cite journal |vauthors=Peto R, Pike MC, Armitage P, Breslow NE, Cox DR, Howard SV, Mantel N, McPherson K, Peto J, Smith PG | title = Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design | journal = [[Br J Cancer]] | volume = 34 | issue = 6 | pages = 585–612 | year = 1976 | pmc=2025229 | pmid = 795448 | doi = 10.1038/bjc.1976.220 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Peto-1977&amp;quot;&amp;gt;{{Cite journal |vauthors=Peto R, Pike MC, Armitage P, Breslow NE, Cox DR, Howard SV, Mantel N, McPherson K, Peto J, Smith PG | title = Design and analysis of randomized clinical trials requiring prolonged observation of each patient. II. Analysis and examples | journal = [[Br J Cancer]] | volume = 35 | issue = 1 | pages = 1–39 | year = 1977 | pmc=2025310 | pmid = 831755 | doi = 10.1038/bjc.1977.1 }}&amp;lt;/ref&amp;gt; Not all randomized clinical trials are randomized ''controlled'' trials (and some of them could never be, as in cases where controls would be impractical or unethical to institute). The term '''randomized controlled clinical trial''' is an alternative term used in [[clinical research]];&amp;lt;ref name=&amp;quot;Wollert-2004&amp;quot;&amp;gt;{{Cite journal |vauthors=Wollert KC, Meyer GP, Lotz J, Ringes-Lichtenberg S, Lippolt P, Breidenbach C, Fichtner S, Korte T, Hornig B, Messinger D, Arseniev L, Hertenstein B, Ganser A, Drexler H | title = Intracoronary autologous bone-marrow cell transfer after myocardial infarction: the BOOST randomised controlled clinical trial | journal = [[The Lancet|Lancet]] | volume = 364 | issue = 9429 | pages = 141–8 | year = 2004 | doi = 10.1016/S0140-6736(04)16626-9 | pmid = 15246726 | s2cid = 24361586 }}&amp;lt;/ref&amp;gt; however, RCTs are also employed in other research areas, including [[#In social science|many of the social sciences]].&lt;br /&gt;
&lt;br /&gt;
The terms &amp;quot;RCT&amp;quot; and &amp;quot;randomized trial&amp;quot; are sometimes used synonymously, but the latter term omits mention of controls and can therefore describe studies that compare multiple treatment groups with each other in the absence of a control group. Similarly, the initialism is sometimes expanded as &amp;quot;randomized clinical trial&amp;quot; or &amp;quot;randomized comparative trial&amp;quot;, leading to ambiguity in the scientific literature. Not all randomized clinical trials are randomized controlled trials (and some of them could never be, as in cases where controls would be impractical or unethical to institute). The term randomized controlled clinical trial is an alternative term used in clinical research; however, RCTs are also employed in other research areas, including many of the social sciences.&lt;br /&gt;
&lt;br /&gt;
“ RCT”和“随机试验”这两个术语有时被用作同义词，但后一个术语没有提到对照，因此可以描述在没有对照组的情况下相互比较多个治疗组的研究。科学文献中常有“随机临床试验”或“随机比较试验”这类引发歧义的术语。并非所有的随机临床试验都是随机对照试验(其中一些试验永远不可能成为随机对照试验，因为实施控制是不切实际或不道德的)。随机对照临床试验这个术语是临床研究中使用的另一个术语; 然而，随机对照临床试验也被用于其他研究领域，包括许多社会科学。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
{{toc limit}}&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
== History ==&lt;br /&gt;
&lt;br /&gt;
The first reported clinical trial was conducted by James Lind in 1747 to identify treatment for scurvy.[10] The first blind experiment was conducted by the French Royal Commission on Animal Magnetism in 1784 to investigate the claims of mesmerism. An early essay advocating the blinding of researchers came from Claude Bernard in the latter half of the 19th century. Bernard recommended that the observer of an experiment should not have knowledge of the hypothesis being tested. This suggestion contrasted starkly with the prevalent Enlightenment-era attitude that scientific observation can only be objectively valid when undertaken by a well-educated, informed scientist.[11] The first study recorded to have a blinded researcher was conducted in 1907 by W. H. R. Rivers and H. N. Webber to investigate the effects of caffeine.[12]&lt;br /&gt;
&lt;br /&gt;
据报道，1747年James Lind进行了第一个临床试验，目的是确定治疗坏血病的方法。1784年，French Royal Commission on Animal Magnetism进行了第一次盲法实验，以调查催眠术的说法。19世纪下半叶，一篇提倡研究人员失明的早期文章来自Claude Bernard。Bernard建议实验的观察者不要知道正在被测试的假设。这一建议与启蒙时代流行的态度形成鲜明对比，即科学观察只有由受过良好教育、消息灵通的科学家进行才能客观有效。1907年，W. H. R. Rivers和H. N. Webber进行了第一项有记录的盲法研究，研究咖啡因的作用。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
[[Randomized experiment]]s appeared in [[experimental psychology|psychology]], where they were introduced by [[Charles Sanders Peirce]] and [[Joseph Jastrow]] in the 1880s,&amp;lt;ref&amp;gt;{{cite journal| author=[[Charles Sanders Peirce]] and [[Joseph Jastrow]]|year=1885|title=On Small Differences in Sensation| journal=Memoirs of the National Academy of Sciences|volume=3|pages=73–83|url=http://psychclassics.yorku.ca/Peirce/small-diffs.htm}} http://psychclassics.yorku.ca/Peirce/small-diffs.htm&amp;lt;/ref&amp;gt; and in [[school of education|education]].&amp;lt;ref&amp;gt;{{cite journal|doi=10.1086/354775|first=Ian|last=Hacking|author-link=Ian Hacking | title=Telepathy: Origins of Randomization in Experimental Design|journal=[[Isis (journal)|Isis]]|series=A Special Issue on Artifact and Experiment|volume=79|issue=3|date=September 1988 |pages=427–451|jstor=234674|mr=1013489|s2cid=52201011}}&amp;lt;/ref&amp;gt;&amp;lt;ref&amp;gt;{{cite journal|doi=10.1086/444032|author=Stephen M. Stigler|title=A Historical View of Statistical Concepts in Psychology and Educational Research| journal=American Journal of Education| volume=101|issue=1|date=November 1992|pages=60–70|s2cid=143685203|author-link=Stephen M. Stigler}}&amp;lt;/ref&amp;gt;&amp;lt;ref&amp;gt;{{cite journal|doi=10.1086/383850|author=Trudy Dehue|title=Deception, Efficiency, and Random Groups: Psychology and the Gradual Origination of the Random Group Design|journal=[[Isis (journal)|Isis]]|volume=88|issue=4|date=December 1997|pages=653–673|pmid=9519574|s2cid=23526321|url=https://pure.rug.nl/ws/files/71855616/237831.pdf}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Randomized experiments appeared in psychology, where they were introduced by Charles Sanders Peirce and Joseph Jastrow in the 1880s, and in education.&lt;br /&gt;
&lt;br /&gt;
在19世纪80年代，Charles Sanders Peirce和Joseph Jastrow在心理学和教育学领域引入随机实验。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
In the early 20th century, randomized experiments appeared in agriculture, due to [[Jerzy Neyman]]&amp;lt;ref&amp;gt;Neyman, Jerzy. 1923 [1990]. &amp;quot;On the Application of Probability Theory to AgriculturalExperiments. Essay on Principles. Section 9.&amp;quot; ''Statistical Science'' 5 (4): 465–472. Trans. Dorota M. Dabrowska and Terence P. Speed.&amp;lt;/ref&amp;gt; and [[Ronald A. Fisher]]. Fisher's experimental research and his writings popularized randomized experiments.&amp;lt;ref name=&amp;quot;Conniffe&amp;quot; /&amp;gt;&lt;br /&gt;
&lt;br /&gt;
In the early 20th century, randomized experiments appeared in agriculture, due to Jerzy Neyman and Ronald A. Fisher. Fisher's experimental research and his writings popularized randomized experiments.&lt;br /&gt;
&lt;br /&gt;
在20世纪早期，Jerzy Neyman和Ronald A. Fisher将随机实验引入农业研究。Fisher的实验研究和他的著作普及了随机实验。&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;The first published RCT in medicine appeared in the 1948 paper entitled &amp;quot;[[Streptomycin]] treatment of pulmonary [[tuberculosis]]&amp;quot;, which described a [[Medical Research Council (UK)|Medical Research Council]] investigation.&amp;lt;ref name=&amp;quot;MRC-1948&amp;quot;&amp;gt;{{Cite journal | author = Streptomycin in Tuberculosis Trials Committee | title = Streptomycin treatment of pulmonary tuberculosis. A Medical Research Council investigation| journal = [[Br Med J]] | volume = 2 | issue = 4582 | pages = 769–82 | year = 1948 | doi = 10.1136/bmj.2.4582.769 | pmid = 18890300 | pmc = 2091872 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Brown-1998&amp;quot;&amp;gt;{{cite news |title= Landmark study made research resistant to bias |author= Brown D |newspaper= [[Washington Post]] |date=1998-11-02 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Shikata-2006&amp;quot;&amp;gt;{{Cite journal |vauthors=Shikata S, Nakayama T, Noguchi Y, Taji Y, Yamagishi H | title = Comparison of effects in randomized controlled trials with observational studies in digestive surgery | journal = [[Ann Surg]] | volume = 244 | issue = 5 | pages = 668–76 | year = 2006 | doi = 10.1097/01.sla.0000225356.04304.bc | pmc=1856609 | pmid = 17060757 }}&amp;lt;/ref&amp;gt; One of the authors of that paper was [[Austin Bradford Hill]], who is credited as having conceived the modern RCT.&amp;lt;ref name=&amp;quot;Stolberg-2004&amp;quot;&amp;gt;{{Cite journal |vauthors=Stolberg HO, Norman G, Trop I | title = Randomized controlled trials | journal = [[Am J Roentgenol]] | volume = 183 | issue = 6 | pages = 1539–44 | year = 2004 | pmid = 15547188 | doi=10.2214/ajr.183.6.01831539}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;The first published RCT in medicine appeared in the 1948 paper entitled &amp;quot;Streptomycin treatment of pulmonary tuberculosis&amp;quot;, which described a Medical Research Council investigation. One of the authors of that paper was Austin Bradford Hill, who is credited as having conceived the modern RCT.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;医学上首次发表的随机对照试验出现在1948年题为“Streptomycin treatment of pulmonary tuberculosis”的论文中，这篇论文描述了医学研究理事会的一项调查。这篇论文的作者之一是Austin Bradford Hill，被认为是构想出了现代 RCT理论。 &lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt; &lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;Trial design was further influenced by the large-scale [[International Studies of Infarct Survival|ISIS]] trials on [[heart attack]] treatments that were conducted in the 1980s.&amp;lt;ref&amp;gt;{{cite web| author1=Georgina Ferry |title= Peter Sleight Obituary |url=https://www.theguardian.com/society/2020/nov/02/peter-sleight-obituary |website=The Guardian |date=2 November 2020 |access-date=3 November 2020}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;Trial design was further influenced by the large-scale ISIS trials on heart attack treatments that were conducted in the 1980s.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;20世纪80年代进行的大规模 ISIS 心脏病治疗试验进一步影响了试验设计。&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;By the late 20th century, RCTs were recognized as the standard method for &amp;quot;rational therapeutics&amp;quot; in medicine.[24] As of 2004, more than 150,000 RCTs were in the Cochrane Library.[22] To improve the reporting of RCTs in the medical literature, an international group of scientists and editors published Consolidated Standards of Reporting Trials (CONSORT) Statements in 1996, 2001 and 2010, and these have become widely accepted.[1][4] Randomization is the process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce the bias.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;By the late 20th century, RCTs were recognized as the standard method for &amp;quot;rational therapeutics&amp;quot; in medicine. As of 2004, more than 150,000 RCTs were in the Cochrane Library. To improve the reporting of RCTs in the medical literature, an international group of scientists and editors published Consolidated Standards of Reporting Trials (CONSORT) Statements in 1996, 2001 and 2010, and these have become widely accepted. Randomization is the process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce the bias.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;到20世纪后期，随机对照试验被公认为医学“合理疗法”的标准方法。截至2004年，美国 Cochrane图书馆有超过15万本随机对照试验的参考资料。为了改进医学文献中对随机对照试验的报道，一个由科学家和编辑组成的国际小组在1996年、2001年和2010年发布了Consolidated Standards of Reporting Trials (CONSORT)声明，这些声明已被广泛接受。随机化是将试验受试者分配到治疗组或对照组的过程，使用机会因素来确定分配，以减少偏差。&lt;br /&gt;
&lt;br /&gt;
== Ethics ==&lt;br /&gt;
&lt;br /&gt;
Although the principle of clinical equipoise (&amp;quot;genuine uncertainty within the expert medical community... about the preferred treatment&amp;quot;) common to clinical trials[25] has been applied to RCTs, the ethics of RCTs have special considerations. For one, it has been argued that equipoise itself is insufficient to justify RCTs.[26] For another, &amp;quot;collective equipoise&amp;quot; can conflict with a lack of personal equipoise (e.g., a personal belief that an intervention is effective).[27] Finally, Zelen's design, which has been used for some RCTs, randomizes subjects before they provide informed consent, which may be ethical for RCTs of screening and selected therapies, but is likely unethical &amp;quot;for most therapeutic trials.&amp;quot;[28][29]&lt;br /&gt;
&lt;br /&gt;
Although the principle of clinical equipoise (&amp;quot;genuine uncertainty within the expert medical community... about the preferred treatment&amp;quot;) common to clinical trials has been applied to RCTs, the ethics of RCTs have special considerations. For one, it has been argued that equipoise itself is insufficient to justify RCTs. For another, &amp;quot;collective equipoise&amp;quot; can conflict with a lack of personal equipoise (e.g., a personal belief that an intervention is effective). Finally, Zelen's design, which has been used for some RCTs, randomizes subjects ''before'' they provide informed consent, which may be ethical for RCTs of screening and selected therapies, but is likely unethical &amp;quot;for most therapeutic trials.&amp;quot;&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;尽管临床平衡原则已经被广泛应用于RCT，但随机对照试验的伦理问题具有特殊性。首先，有人认为平衡本身不足以证明随机对照试验的合理性。另一方面，“集体均势”可能与缺乏个人均势相冲突(例如，个人认为干预是有效的)。最后，Zelen 的设计已经被用于一些随机试验，在受试者提供知情同意之前随机化，这对于筛选和选择性治疗的随机试验来说可能是合乎道德的，但是对于“大多数治疗试验”来说可能是不道德的。&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Although subjects almost always provide [[informed consent]] for their participation in an RCT, studies since 1982 have documented that RCT subjects may believe that they are certain to receive treatment that is best for them personally; that is, they do not understand the difference between research and treatment.&amp;lt;ref name=&amp;quot;Appelbaum-1982&amp;quot;&amp;gt;{{Cite journal |vauthors=Appelbaum PS, Roth LH, Lidz C | title = The therapeutic misconception: informed consent in psychiatric research | journal = [[Int J Law Psychiatry]] | volume = 5 | issue = 3–4 | pages = 319–29 | year = 1982 | doi = 10.1016/0160-2527(82)90026-7 | pmid = 6135666 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Henderson-2007&amp;quot;&amp;gt;{{Cite journal |vauthors=Henderson GE, Churchill LR, Davis AM, Easter MM, Grady C, Joffe S, Kass N, King NM, Lidz CW, Miller FG, Nelson DK, Peppercorn J, Rothschild BB, Sankar P, Wilfond BS, Zimmer CR | title = Clinical trials and medical care: defining the therapeutic misconception | journal = [[PLoS Med]] | volume = 4 | issue = 11 | pages = e324 | year = 2007 | doi = 10.1371/journal.pmed.0040324 | pmid = 18044980 | pmc = 2082641 }}&amp;lt;/ref&amp;gt; Further research is necessary to determine the prevalence of and ways to address this &amp;quot;[[therapeutic misconception]]&amp;quot;.&amp;lt;ref name=&amp;quot;Henderson-2007&amp;quot; /&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Although subjects almost always provide informed consent for their participation in an RCT, studies since 1982 have documented that RCT subjects may believe that they are certain to receive treatment that is best for them personally; that is, they do not understand the difference between research and treatment. Further research is necessary to determine the prevalence of and ways to address this &amp;quot;therapeutic misconception&amp;quot;. &lt;br /&gt;
&lt;br /&gt;
一般来说，受试者要为参加随机对照试验提交了知情同意书，但1982年以来的研究记录表明，随机对照试验的受试者可能认为他们肯定会接受对他们个人最好的治疗; 也就是说，他们不理解研究和治疗之间的区别。需要进一步研究，以确定这种”治疗性误解”的流行程度和解决方法。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
The RCT method variations may also create cultural effects that have not been well understood.[32] For example, patients with terminal illness may join trials in the hope of being cured, even when treatments are unlikely to be successful.&lt;br /&gt;
&lt;br /&gt;
RCT方法的变种也可能产生尚未被很好理解的文化效应。例如，患有晚期疾病的病人可能会加入临床试验以希望治愈，即使治疗不太可能成功的情况下也是如此。&lt;br /&gt;
&lt;br /&gt;
=== Trial registration ===&lt;br /&gt;
&lt;br /&gt;
In 2004, the [http://www.icmje.org/ International Committee of Medical Journal Editors] (ICMJE) announced that all trials starting enrolment after July 1, 2005 must be registered prior to consideration for publication in one of the 12 member journals of the committee.&amp;lt;ref name=&amp;quot;pmid15356289&amp;quot;&amp;gt;{{cite journal  |vauthors=De Angelis C, Drazen JM, Frizelle FA, etal |title=Clinical trial registration: a statement from the International Committee of Medical Journal Editors |journal=The New England Journal of Medicine |volume=351 |issue=12 |pages=1250–1 |date=September 2004 |pmid=15356289 |doi=10.1056/NEJMe048225 }}&amp;lt;/ref&amp;gt; However, trial registration may still occur late or not at all.&amp;lt;ref name=&amp;quot;pmid22147862&amp;quot;&amp;gt;{{cite journal|vauthors=Law MR, Kawasumi Y, Morgan SG | title=Despite law, fewer than one in eight completed studies of drugs and biologics are reported on time on ClinicalTrials.gov. | journal=Health Aff (Millwood) | year= 2011 | volume= 30 | issue= 12 | pages= 2338–45 | doi=10.1377/hlthaff.2011.0172 | pmid=22147862  | doi-access=free }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;pmid19724045&amp;quot;&amp;gt;{{cite journal|vauthors=Mathieu S, Boutron I, Moher D, Altman DG, Ravaud P | title=Comparison of registered and published primary outcomes in randomized controlled trials. | journal=JAMA | year= 2009 | volume= 302 | issue= 9 | pages= 977–84 | doi=10.1001/jama.2009.1242 | pmid=19724045  | doi-access=free }}&amp;lt;/ref&amp;gt;Medical journals have been slow in adapting policies requiring mandatory clinical trial registration as a prerequisite for publication.&amp;lt;ref&amp;gt;{{cite journal|last1=Bhaumik|first1=S|title=Editorial policies of MEDLINE indexed Indian journals on clinical trial registration.|journal=Indian Pediatr.|date=Mar 2013|volume=50|issue=3|pages=339–40|pmid=23680610|doi=10.1007/s13312-013-0092-2|s2cid=40317464}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
In 2004, the [http://www.icmje.org/ International Committee of Medical Journal Editors] (ICMJE) announced that all trials starting enrolment after July 1, 2005 must be registered prior to consideration for publication in one of the 12 member journals of the committee. However, trial registration may still occur late or not at all. Medical journals have been slow in adapting policies requiring mandatory clinical trial registration as a prerequisite for publication.&lt;br /&gt;
&lt;br /&gt;
2004年， 医学杂志编辑国际委员会(ICMJE)宣布，所有在2005年7月1日之后考虑在该委员会12种杂志上发表之前，必须对试验进行注册。尽管如此，试验登记可能仍然延迟或根本不会发生。医学期刊将强制性临床试验登记作为发表的先决条件进展缓慢。&lt;br /&gt;
== Classifications ==&lt;br /&gt;
=== By study design ===&lt;br /&gt;
&lt;br /&gt;
One way to classify RCTs is by [[study design]].  From most to least common in the healthcare literature, the major categories of RCT study designs are:&amp;lt;ref name=&amp;quot;Hopewell-2010&amp;quot;&amp;gt;{{Cite journal |vauthors=Hopewell S, Dutton S, Yu LM, Chan AW, Altman DG | title = The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed | journal = BMJ | volume = 340 | pages = c723 | year = 2010 | doi = 10.1136/bmj.c723  | pmid = 20332510 | pmc = 2844941 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
通过研究设计对 RCT 进行分类。从最常见到最不常见，RCT 研究设计的主要类别是&lt;br /&gt;
&lt;br /&gt;
* [[Parallel study|Parallel-group]] – each participant is randomly assigned to a group, and all the participants in the group receive (or do not receive) an intervention.&amp;lt;ref&amp;gt;{{cite journal |last1=Kaiser |first1=Joerg |last2=Niesen |first2=Willem |last3=Probst |first3=Pascal |last4=Bruckner |first4=Thomas |last5=Doerr-Harim |first5=Colette |last6=Strobel |first6=Oliver |last7=Knebel |first7=Phillip |last8=Diener |first8=Markus K. |last9=Mihaljevic |first9=André L. |last10=Büchler |first10=Markus W. |last11=Hackert |first11=Thilo |title=Abdominal drainage versus no drainage after distal pancreatectomy: study protocol for a randomized controlled trial |journal=Trials |date=7 June 2019 |volume=20 |issue=1 |page=332 |doi=10.1186/s13063-019-3442-0|pmid=31174583 |pmc=6555976 |doi-access=free }}&amp;lt;/ref&amp;gt;&amp;lt;ref&amp;gt;{{cite journal |last1=Farag |first1=Sara M. |last2=Mohammed |first2=Manal O. |last3=EL-Sobky |first3=Tamer A. |last4=ElKadery |first4=Nadia A. |last5=ElZohiery |first5=Abeer K. |title=Botulinum Toxin A Injection in Treatment of Upper Limb Spasticity in Children with Cerebral Palsy: A Systematic Review of Randomized Controlled Trials |journal=JBJS Reviews |date=March 2020 |volume=8 |issue=3 |pages=e0119 |doi=10.2106/JBJS.RVW.19.00119 |pmid=32224633|pmc=7161716 |doi-access=free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* 平行试验：每个参与者被随机分配到一个组，组中的所有参与者都接受(或不接受)干预。&lt;br /&gt;
&lt;br /&gt;
* [[Crossover study|Crossover]] – over time, each participant receives (or does not receive) an intervention in a random sequence.&amp;lt;ref&amp;gt;{{cite book  | last = Jones | first = Byron |author2=Kenward, Michael G.  | title = Design and Analysis of Cross-Over Trials | edition=Second| publisher = London: Chapman and Hall | year = 2003 }}&amp;lt;/ref&amp;gt;&amp;lt;ref&amp;gt;{{cite book  | last = Vonesh | first = Edward F. |author2=Chinchilli, Vernon G.  | chapter=Crossover Experiments| pages=111–202|title = Linear and Nonlinear Models for the Analysis of Repeated Measurements | publisher = London: Chapman and Hall | year = 1997 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* 交叉试验：随着时间的推移，每个参与者都会接受(或不接受)随机序列的干预。&lt;br /&gt;
&lt;br /&gt;
* [[Cluster randomised controlled trial|Cluster]] – pre-existing groups of participants (e.g., villages, schools) are randomly selected to receive (or not receive) an intervention.&amp;lt;ref&amp;gt;{{cite journal |last1=Gall |first1=Stefanie |last2=Adams |first2=Larissa |last3=Joubert |first3=Nandi |last4=Ludyga |first4=Sebastian |last5=Müller |first5=Ivan |last6=Nqweniso |first6=Siphesihle |last7=Pühse |first7=Uwe |last8=du Randt |first8=Rosa |last9=Seelig |first9=Harald |last10=Smith |first10=Danielle |last11=Steinmann |first11=Peter |last12=Utzinger |first12=Jürg |last13=Walter |first13=Cheryl |last14=Gerber |first14=Markus |last15=van Wouwe |first15=Jacobus P. |title=Effect of a 20-week physical activity intervention on selective attention and academic performance in children living in disadvantaged neighborhoods: A cluster randomized control trial |journal=PLOS ONE |date=8 November 2018 |volume=13 |issue=11 |pages=e0206908 |doi=10.1371/journal.pone.0206908 |pmid=30408073|pmc=6224098 |bibcode=2018PLoSO..1306908G |doi-access=free }}&amp;lt;/ref&amp;gt;&amp;lt;ref&amp;gt;{{cite journal |last1=Gladstone |first1=Melissa J. |last2=Chandna |first2=Jaya |last3=Kandawasvika |first3=Gwendoline |last4=Ntozini |first4=Robert |last5=Majo |first5=Florence D. |last6=Tavengwa |first6=Naume V. |last7=Mbuya |first7=Mduduzi N. N. |last8=Mangwadu |first8=Goldberg T. |last9=Chigumira |first9=Ancikaria |last10=Chasokela |first10=Cynthia M. |last11=Moulton |first11=Lawrence H. |last12=Stoltzfus |first12=Rebecca J. |last13=Humphrey |first13=Jean H. |last14=Prendergast |first14=Andrew J. |last15=Tumwine |first15=James K. |title=Independent and combined effects of improved water, sanitation, and hygiene (WASH) and improved complementary feeding on early neurodevelopment among children born to HIV-negative mothers in rural Zimbabwe: Substudy of a cluster-randomized trial |journal=PLOS Medicine |date=21 March 2019 |volume=16 |issue=3 |pages=e1002766 |doi=10.1371/journal.pmed.1002766|pmid=30897095 |pmc=6428259 |doi-access=free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* 聚类试验：预先存在的参与者组(例如，村庄、学校)被随机选择以接受(或不接受)干预。&lt;br /&gt;
&lt;br /&gt;
* [[Factorial experiment|Factorial]] – each participant is randomly assigned to a group that receives a particular combination of interventions or non-interventions (e.g., group 1 receives vitamin X and vitamin Y, group 2 receives vitamin X and placebo Y, group 3 receives placebo X and vitamin Y, and group 4 receives placebo X and placebo Y).&lt;br /&gt;
* 因子试验：每个参与者被随机分配到一个接受干预或非干预特定组合的组(例如，第1组接受维生素X和维生素Y，第2组接受维生素X和安慰剂Y，第3组接受安慰剂X和维生素Y，第4组接受安慰剂X和安慰剂Y)。&lt;br /&gt;
&lt;br /&gt;
An analysis of the 616 RCTs indexed in [[PubMed]] during December 2006 found that 78% were parallel-group trials, 16% were crossover, 2% were split-body, 2% were cluster, and 2% were factorial.&amp;lt;ref name=&amp;quot;Hopewell-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
An analysis of the 616 RCTs indexed in PubMed during December 2006 found that 78% were parallel-group trials, 16% were crossover, 2% were split-body, 2% were cluster, and 2% were factorial. &lt;br /&gt;
&lt;br /&gt;
对2006年12月在 PubMed 收录的616例随机对照试验的分析发现，78% 为平行组试验，16% 为交叉组试验，2% 为分体组试验，2% 为聚类组试验，2% 为因子组试验。&lt;br /&gt;
&lt;br /&gt;
=== By outcome of interest (efficacy vs. effectiveness) ===&lt;br /&gt;
&lt;br /&gt;
{{Main|Pragmatic clinical trial}}&lt;br /&gt;
&lt;br /&gt;
RCTs can be classified as &amp;quot;explanatory&amp;quot; or &amp;quot;pragmatic.&amp;quot;&amp;lt;ref name=&amp;quot;Zwarenstein-2008&amp;quot;&amp;gt;{{Cite journal | author = Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D; CONSORT group; Pragmatic Trials in Healthcare (Practihc) group | title = Improving the reporting of pragmatic trials: an extension of the CONSORT statement | journal = BMJ | volume = 337 | pages = a2390 | year = 2008 | doi = 10.1136/bmj.a2390 | pmid = 19001484 | pmc=3266844}}&amp;lt;/ref&amp;gt; Explanatory RCTs test [[Efficacy#Medicine|efficacy]] in a research setting with highly selected participants and under highly controlled conditions.&amp;lt;ref name=&amp;quot;Zwarenstein-2008&amp;quot;/&amp;gt; In contrast, pragmatic RCTs (pRCTs) test [[Effectiveness#Usage|effectiveness]] in everyday practice with relatively unselected participants and under flexible conditions; in this way, pragmatic RCTs can &amp;quot;inform decisions about practice.&amp;quot;&amp;lt;ref name=&amp;quot;Zwarenstein-2008&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
RCTs can be classified as &amp;quot;explanatory&amp;quot; or &amp;quot;pragmatic.&amp;quot; Explanatory RCTs test efficacy in a research setting with highly selected participants and under highly controlled conditions. In contrast, pragmatic RCTs (pRCTs) test effectiveness in everyday practice with relatively unselected participants and under flexible conditions; in this way, pragmatic RCTs can &amp;quot;inform decisions about practice.&amp;quot;&lt;br /&gt;
&lt;br /&gt;
随机对照试验可分为“解释性”或“实用性”。解释性随机对照试验在高度选定的参与者和高度受控的条件下测试有效性。相比之下，实用性随机对照测验(pragmatic RCTs, pRCT)在相对未经选择的参与者和灵活的条件下，在日常实践中检验有效性，这样，实用随机对照测验可以“为实践决策提供信息”。&lt;br /&gt;
=== By hypothesis (superiority vs. noninferiority vs. equivalence) ===&lt;br /&gt;
&lt;br /&gt;
Another classification of RCTs categorizes them as &amp;quot;superiority trials&amp;quot;, &amp;quot;noninferiority trials&amp;quot;, and &amp;quot;equivalence trials&amp;quot;, which differ in methodology and reporting.&amp;lt;ref name=&amp;quot;Piaggio-2006&amp;quot;&amp;gt;{{Cite journal | author = Piaggio G, Elbourne DR, [[Doug Altman|Altman DG]], [[Stuart Pocock|Pocock SJ]], Evans SJ; CONSORT Group | title = Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement | journal = JAMA | volume = 295 | issue = 10 | pages = 1152–60 |  year = 2006 | doi = 10.1001/jama.295.10.1152 | pmid = 16522836 | url = http://researchonline.lshtm.ac.uk/12069/1/Reporting%20of%20Noninferiority%20and%20Equivalence%20Randomized%20Trials.pdf }}&amp;lt;/ref&amp;gt; Most RCTs are superiority trials, in which one intervention is hypothesized to be superior to another in a [[Statistical significance|statistically significant]] way.&amp;lt;ref name=&amp;quot;Piaggio-2006&amp;quot;/&amp;gt; Some RCTs are noninferiority trials &amp;quot;to determine whether a new treatment is no worse than a reference treatment.&amp;quot;&amp;lt;ref name=&amp;quot;Piaggio-2006&amp;quot;/&amp;gt; Other RCTs are equivalence trials in which the hypothesis is that two interventions are indistinguishable from each other.&amp;lt;ref name=&amp;quot;Piaggio-2006&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Another classification of RCTs categorizes them as &amp;quot;superiority trials&amp;quot;, &amp;quot;noninferiority trials&amp;quot;, and &amp;quot;equivalence trials&amp;quot;, which differ in methodology and reporting. Most RCTs are superiority trials, in which one intervention is hypothesized to be superior to another in a statistically significant way. Some RCTs are noninferiority trials &amp;quot;to determine whether a new treatment is no worse than a reference treatment.&amp;quot; Other RCTs are equivalence trials in which the hypothesis is that two interventions are indistinguishable from each other.&lt;br /&gt;
&lt;br /&gt;
随机对照试验的另一种分类是“优越性试验”、“非劣性试验”和“等效性试验”，它们在方法和报告上有所不同。大多数随机对照试验都是优势试验，其中一种干预措施被假设在统计学意义上优于另一种干预措施。一些随机对照试验是非劣效性试验，“以确定一种新的治疗方法是否比一种参考治疗方法更差。”其他随机对照试验是等效试验，其中的假设是两种干预措施彼此不可区分。&lt;br /&gt;
&lt;br /&gt;
== Randomization ==&lt;br /&gt;
&lt;br /&gt;
The advantages of proper [[randomized experiment|randomization]] in RCTs include:&amp;lt;ref name=&amp;quot;SchulzGrimes2002&amp;quot;&amp;gt;{{Cite journal |vauthors=Schulz KF, Grimes DA | title = Generation of allocation sequences in randomised trials: chance, not choice | journal = Lancet | volume = 359 | issue = 9305 | pages = 515–9 | year = 2002 | doi = 10.1016/S0140-6736(02)07683-3 | url =https://www.who.int/entity/rhl/LANCET_515-519.pdf | pmid = 11853818 | s2cid = 291300 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
* &amp;quot;It eliminates bias in treatment assignment,&amp;quot; specifically [[selection bias]] and [[confounding]].&lt;br /&gt;
&lt;br /&gt;
* &amp;quot;It facilitates blinding (masking) of the identity of treatments from investigators, participants, and assessors.&amp;quot;&lt;br /&gt;
&lt;br /&gt;
* &amp;quot;It permits the use of probability theory to express the likelihood that any difference in outcome between treatment groups merely indicates chance.&amp;quot;&lt;br /&gt;
&lt;br /&gt;
There are two processes involved in randomizing patients to different interventions. First is choosing a randomization procedure to generate an unpredictable sequence of allocations; this may be a simple random assignment of patients to any of the groups at equal probabilities, may be &amp;quot;restricted&amp;quot;, or may be &amp;quot;adaptive.&amp;quot; A second and more practical issue is allocation concealment, which refers to the stringent precautions taken to ensure that the group assignment of patients are not revealed prior to definitively allocating them to their respective groups. Non-random &amp;quot;systematic&amp;quot; methods of group assignment, such as alternating subjects between one group and the other, can cause &amp;quot;limitless contamination possibilities&amp;quot; and can cause a breach of allocation concealment.&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
随机对照试验中适当随机化的优点包括：&lt;br /&gt;
* 它消除了治疗分配中的偏差，特别是选择偏差和混淆。&lt;br /&gt;
&lt;br /&gt;
* 它便于调查人员、参与者和评估人员对治疗人群的身份进行遮蔽。&lt;br /&gt;
&lt;br /&gt;
* 它允许使用概率理论来表达这样一种可能性，即治疗组之间结果的任何差异仅仅表明是偶然性的。&lt;br /&gt;
&lt;br /&gt;
有两个过程涉及到随机化的病人接受到不同的干预。首先是选择一个随机化程序来生成一个不可预测的分配序列；这可能是以相等的概率将患者随机分配到任何一组，可能是“受限的”，也可能是“适应性的”。第二个也是更实际的问题是隐藏分配，这是指在将患者明确分配到各自的组之前，采取严格的预防措施，以确保患者的组分配不被披露。非随机的“系统”组分配方法，如在一个组和另一个组之间交替患者，可能会造成“无限的污染可能性”，并可能导致分配隐藏的破坏。&lt;br /&gt;
&lt;br /&gt;
However empirical evidence that adequate randomization changes outcomes relative to inadequate randomization has been difficult to detect.&amp;lt;ref name=&amp;quot;Howick-2014&amp;quot;&amp;gt;{{Cite journal |vauthors=Howick J, Mebius A | title = In search of justification for the unpredictability paradox | journal = Trials | volume = 15 | pages = 480 | year = 2014 | doi = 10.1186/1745-6215-15-480 | pmid = 25490908 | pmc=4295227}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
然而，相对于不充分随机化，充分随机化改变结果的经验证据很难被发现。&lt;br /&gt;
&lt;br /&gt;
=== Procedures ===&lt;br /&gt;
&lt;br /&gt;
The treatment allocation is the desired proportion of patients in each treatment arm.&lt;br /&gt;
&lt;br /&gt;
治疗分配是每个治疗组中患者的期望比例。&lt;br /&gt;
&lt;br /&gt;
An ideal randomization procedure would achieve the following goals:&amp;lt;ref name=&amp;quot;Lachin-1988a&amp;quot;&amp;gt;{{Cite journal | author = Lachin JM | title = Statistical properties of randomization in clinical trials | journal = [[Controlled Clinical Trials]] | volume = 9 | issue = 4 | pages = 289–311 | year = 1988 | pmid = 3060315 |  doi = 10.1016/0197-2456(88)90045-1 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
An ideal randomization procedure would achieve the following goals:&lt;br /&gt;
&lt;br /&gt;
一个理想的随机化程序将实现以下目标:&lt;br /&gt;
&lt;br /&gt;
* '''Maximize [[statistical power]]''', especially in [[Subgroup analysis|subgroup analyses]].  Generally, equal group sizes maximize statistical power, however, unequal groups sizes may be more powerful for some analyses (e.g., multiple comparisons of placebo versus several doses using Dunnett's procedure&amp;lt;ref&amp;gt;{{cite web|last=Rosenberger|first=James|title=STAT 503 - Design of Experiments|url=https://onlinecourses.science.psu.edu/stat503/node/16|publisher=Pennsylvania State University|access-date=24 September 2012}}&amp;lt;/ref&amp;gt; ), and are sometimes desired for non-analytic reasons (e.g., patients may be more motivated to enroll if there is a higher chance of getting the test treatment, or regulatory agencies may require a minimum number of patients exposed to treatment).&amp;lt;ref name=&amp;quot;Avins-1998&amp;quot;&amp;gt;{{cite journal|last=Avins|first=A L|title=&amp;quot;Can unequal be more fair? Ethics, subject allocation, and randomized clinical trials&amp;quot;.|journal=J Med Ethics|year=1998|volume=24|pages=401–408|doi=10.1136/jme.24.6.401|issue=6|pmc=479141|pmid=9873981}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
* '''Minimize selection bias'''.  This may occur if investigators can consciously or unconsciously preferentially enroll patients between treatment arms.  A good randomization procedure will be unpredictable so that investigators cannot guess the next subject's group assignment based on prior treatment assignments. The risk of selection bias is highest when previous treatment assignments are known (as in unblinded studies) or can be guessed (perhaps if a drug has distinctive side effects).&lt;br /&gt;
&lt;br /&gt;
* '''Minimize allocation bias''' (or '''confounding''').  This may occur when [[covariate]]s that affect the outcome are not equally distributed between treatment groups, and the treatment effect is confounded with the effect of the covariates (i.e., an &amp;quot;accidental bias&amp;quot;&amp;lt;ref name=&amp;quot;SchulzGrimes2002&amp;quot;/&amp;gt;&amp;lt;ref name=&amp;quot;Buyse-1989&amp;quot;&amp;gt;{{Cite journal | author = Buyse ME | title = Analysis of clinical trial outcomes: some comments on subgroup analyses | journal = [[Controlled Clinical Trials]] | volume = 10 | issue = 4 Suppl | pages = 187S–194S | year = 1989 | pmid = 2605967 |  doi = 10.1016/0197-2456(89)90057-3 }}&amp;lt;/ref&amp;gt;).  If the randomization procedure causes an imbalance in covariates related to the outcome across groups, estimates of effect may be [[bias of an estimator|biased]] if not adjusted for the covariates (which may be unmeasured and therefore impossible to adjust for).&lt;br /&gt;
* '''最大化统计能力'''，尤其是在亚组分析中。一般来说，相等的组规模将最大化统计能力，然而，不相等的组规模对于某些分析来说可能更强大(例如，使用Dunnett程序对安慰剂与几个剂量进行多次比较)，并且有时由于非分析性原因而被采用(例如，如果有更高的机会获得试验治疗，患者可能更有动力登记，或者监管机构可能要求最少数量的患者接受治疗)。&lt;br /&gt;
&lt;br /&gt;
* '''最小化选择偏差'''。如果调查人员可以有意识或无意识地在治疗之间优先招募患者，就可能发生这种情况。一个好的随机化过程是不可预测的，因此研究人员不能根据先前的治疗分配来猜测下一个受试者的分组。当已知以前的治疗方案时(如在非盲法研究中)或可以猜到(如果一种药物有明显的副作用)，选择偏倚的风险最高。&lt;br /&gt;
&lt;br /&gt;
* '''最小化分配偏差(或混淆)'''。当影响结果的协变量在治疗组之间分布不均，并且治疗效果与协变量的效果混淆时(即“偶然偏差”)，可能会出现这种情况。如果随机化程序导致与各组结果相关的协变量失衡，如果不对协变量进行调整，效果估计可能会有偏差(这可能无法测量，因此无法调整)。&lt;br /&gt;
&lt;br /&gt;
However, no single randomization procedure meets those goals in every circumstance, so researchers must select a procedure for a given study based on its advantages and disadvantages.&lt;br /&gt;
&lt;br /&gt;
However, no single randomization procedure meets those goals in every circumstance, so researchers must select a procedure for a given study based on its advantages and disadvantages.&lt;br /&gt;
&lt;br /&gt;
然而，没有一个单一的随机化程序在每种情况下都能满足这些目标，因此研究人员必须根据其优点和缺点来选择一个给定的研究程序。&lt;br /&gt;
&lt;br /&gt;
==== Simple ====&lt;br /&gt;
&lt;br /&gt;
This is a commonly used and intuitive procedure, similar to &amp;quot;repeated fair coin-tossing.&amp;quot;&amp;lt;ref name=&amp;quot;SchulzGrimes2002&amp;quot;/&amp;gt; Also known as &amp;quot;complete&amp;quot; or &amp;quot;unrestricted&amp;quot; randomization, it is [[Robust statistics|robust]] against both selection and accidental biases. However, its main drawback is the possibility of imbalanced group sizes in small RCTs.  It is therefore recommended only for RCTs with over 200 subjects.&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;&amp;gt;{{Cite journal |vauthors=Lachin JM, Matts JP, Wei LJ | title = Randomization in clinical trials: conclusions and recommendations | journal = [[Controlled Clinical Trials]] | volume = 9 | issue = 4 | pages = 365–74 | year = 1988 | pmid = 3203526 |  doi = 10.1016/0197-2456(88)90049-9 | hdl = 2027.42/27041 | url = https://deepblue.lib.umich.edu/bitstream/2027.42/27041/1/0000029.pdf | hdl-access = free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
This is a commonly used and intuitive procedure, similar to &amp;quot;repeated fair coin-tossing.&amp;quot; Also known as &amp;quot;complete&amp;quot; or &amp;quot;unrestricted&amp;quot; randomization, it is robust against both selection and accidental biases. However, its main drawback is the possibility of imbalanced group sizes in small RCTs. It is therefore recommended only for RCTs with over 200 subjects.这是一个常用且直观的程序，类似于“反复公平抛硬币”，也被称为“完全”或“无限制”随机化，它对选择和意外偏差都是稳健的。然而，它的主要缺点是在小的随机对照试验中群体规模不平衡的可能性。因此，建议仅用于受试者超过200人时进行随机对照试验。&lt;br /&gt;
&lt;br /&gt;
==== Restricted ====&lt;br /&gt;
&lt;br /&gt;
To balance group sizes in smaller RCTs, some form of [[restricted randomization|&amp;quot;restricted&amp;quot; randomization]] is recommended.&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;/&amp;gt;  The major types of restricted randomization used in RCTs are:&lt;br /&gt;
&lt;br /&gt;
* '''[[Randomized block design|Permuted-block randomization]]''' or '''blocked randomization''': a &amp;quot;block size&amp;quot; and &amp;quot;allocation ratio&amp;quot; (number of subjects in one group versus the other group) are specified, and subjects are allocated randomly within each block.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt; For example, a block size of 6 and an allocation ratio of 2:1 would lead to random assignment of 4 subjects to one group and 2 to the other. This type of randomization can be combined with &amp;quot;[[stratified randomization]]&amp;quot;, for example by center in a [[multicenter trial]], to &amp;quot;ensure good balance of participant characteristics in each group.&amp;quot;&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt; A special case of permuted-block randomization is ''random allocation'', in which the entire sample is treated as one block.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt; The major disadvantage of permuted-block randomization is that even if the block sizes are large and randomly varied, the procedure can lead to selection bias.&amp;lt;ref name=&amp;quot;Lachin-1988a&amp;quot;/&amp;gt; Another disadvantage is that &amp;quot;proper&amp;quot; analysis of data from permuted-block-randomized RCTs requires stratification by blocks.&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
* '''Adaptive biased-coin randomization''' methods (of which '''urn randomization''' is the most widely known type): In these relatively uncommon methods, the probability of being assigned to a group decreases if the group is overrepresented and increases if the group is underrepresented.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt; The methods are thought to be less affected by selection bias than permuted-block randomization.&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
为了平衡较小随机对照试验中的组规模，建议采用某种形式的“限制性”随机化。随机对照试验中主要使用的限制随机化类型有:&lt;br /&gt;
&lt;br /&gt;
* '''置换区组随机化'''或'''区组随机化'''：规定了“区组大小”和“分配比例”(一组受试者相对于另一组受试者的数量)，受试者在每个区组内随机分配。例如，块大小为6，分配比例为2:1，将导致4个受试者随机分配到一个组，2个分配到另一个组。这种类型的随机化可以与“分层随机化”相结合，例如通过多中心试验中的中心，以“确保每个组中参与者特征的良好平衡。”置换块随机化的一个特殊情况是随机分配，其中整个样本被视为一个块。置换块随机化的主要缺点是，即使块大小很大且随机变化，该过程也会导致选择偏差。另一个缺点是，对置换区组随机对照试验数据的“适当”分析需要按区组分层。&lt;br /&gt;
&lt;br /&gt;
* '''自适应有偏-硬币随机化方法'''（其中瓮随机化是最广为人知的类型）：在这些相对不常见的方法中，如果一个组的代表人数过多，被分配到该组的概率会降低，如果该组的代表人数不足，被分配到该组的概率会增加。这些方法被认为比置换块随机化受选择偏差的影响更小。&lt;br /&gt;
==== Adaptive ====&lt;br /&gt;
&lt;br /&gt;
At least two types of &amp;quot;adaptive&amp;quot; randomization procedures have been used in RCTs, but much less frequently than simple or restricted randomization:&lt;br /&gt;
&lt;br /&gt;
* '''Covariate-adaptive randomization''', of which one type is '''[[Minimisation (clinical trials)|minimization]]''': The probability of being assigned to a group varies in order to minimize &amp;quot;covariate imbalance.&amp;quot;&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;/&amp;gt; Minimization is reported to have &amp;quot;supporters and detractors&amp;quot;&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt; because only the first subject's group assignment is truly chosen at random, the method does not necessarily eliminate bias on unknown factors.&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
* '''Response-adaptive randomization''', also known as '''outcome-adaptive randomization''': The probability of being assigned to a group increases if the responses of the prior patients in the group were favorable.&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;/&amp;gt; Although arguments have been made that this approach is more ethical than other types of randomization when the probability that a treatment is effective or ineffective increases during the course of an RCT, ethicists have not yet studied the approach in detail.&amp;lt;ref name=&amp;quot;Rosenberger-1993&amp;quot;&amp;gt;{{Cite journal |vauthors=Rosenberger WF, Lachin JM | title = The use of response-adaptive designs in clinical trials | journal = [[Controlled Clinical Trials]] | volume = 14 | issue = 6 | pages = 471–84 | year = 1993 | pmid = 8119063 |  doi = 10.1016/0197-2456(93)90028-C }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
在随机对照试验中，至少使用了两种类型的“适应性”随机化程序，但频率远低于简单或限制性随机化：&lt;br /&gt;
&lt;br /&gt;
* '''协变量自适应随机化'''，其中一种类型是最小化：被分配到一个组的概率是变化的，以便最小化“协变量不平衡”。据报道，最小化有“支持者和诋毁者”，因为只有第一个受试者的群组分配是真正随机选择的，该方法不一定能消除对未知因素的偏见。&lt;br /&gt;
&lt;br /&gt;
* '''应答自适应随机化'''，也称为'''结果自适应随机化：'''如果组中先前患者的应答是有利的，则被分配到一个组的概率增加。虽然有人认为，当治疗有效或无效的概率在RCT过程中增加时，这种方法比其他类型的随机化更符合伦理，但伦理学家尚未详细研究这种方法。&lt;br /&gt;
=== Allocation concealment ===&lt;br /&gt;
&lt;br /&gt;
{{main|Allocation concealment}}&lt;br /&gt;
&lt;br /&gt;
&amp;quot;Allocation concealment&amp;quot; (defined as &amp;quot;the procedure for protecting the randomization process so that the treatment to be allocated is not known before the patient is entered into the study&amp;quot;) is important in RCTs.&amp;lt;ref name=&amp;quot;Forder-2005&amp;quot;&amp;gt;{{Cite journal |vauthors=Forder PM, Gebski VJ, Keech AC | title = Allocation concealment and blinding: when ignorance is bliss | journal = Med J Aust | volume = 182 | issue = 2 | pages = 87–9 | year = 2005 | url = http://www.mja.com.au/public/issues/182_02_170105/for10877_fm.html | pmid = 15651970 | doi = 10.5694/j.1326-5377.2005.tb06584.x | s2cid = 202149 }}&amp;lt;/ref&amp;gt; In practice, clinical investigators in RCTs often find it difficult to maintain impartiality. Stories abound of investigators holding up sealed envelopes to lights or ransacking offices to determine group assignments in order to dictate the assignment of their next patient.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;&amp;gt;{{Cite journal | title = Allocation concealment in randomised trials: defending against deciphering | journal = Lancet | volume = 359 | issue = 9306 | pages = 614–8 | year = 2002 | doi = 10.1016/S0140-6736(02)07750-4 | url =https://www.who.int/entity/rhl/LANCET_614-618.pdf | pmid = 11867132 |vauthors=Schulz KF, Grimes DA | s2cid = 12902486 }}&amp;lt;/ref&amp;gt; Such practices introduce selection bias and [[Lurking variable|confounders]] (both of which should be minimized by randomization), possibly distorting the results of the study.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt; Adequate allocation concealment should defeat patients and investigators from discovering treatment allocation once a study is underway and after the study has concluded.  Treatment related side-effects or adverse events may be specific enough to reveal allocation to investigators or patients thereby introducing bias or influencing any subjective parameters collected by investigators or requested from subjects.&lt;br /&gt;
&lt;br /&gt;
“分配隐藏”(定义为“保护随机化过程的程序，以便在病人进入研究之前不知道要分配的治疗”)在随机对照试验中很重要。在实践中，临床研究人员在随机对照试验中常常发现难以保持公正性。关于调查人员将密封的信封举到灯光下或者搜查办公室来决定群组分配，以便指定下一个病人的分配的故事比比皆是。这种做法引入了选择偏差和混杂因素(这两者都应该通过随机化来减少) ，可能会扭曲研究结果。一旦研究开始并在研究结束后，充分的分配隐藏应该会阻止患者和研究者发现治疗分配。与治疗相关的副作用或不良事件可能足够具体，足以向研究者或患者揭示分配情况，从而引入偏差或影响研究者收集的或受试者要求的任何主观参数。&lt;br /&gt;
&lt;br /&gt;
Some standard methods of ensuring allocation concealment include sequentially numbered, opaque, sealed envelopes (SNOSE); sequentially numbered containers; pharmacy controlled randomization; and central randomization. It is recommended that allocation concealment methods be included in an RCT's protocol, and that the allocation concealment methods should be reported in detail in a publication of an RCT's results; however, a 2005 study determined that most RCTs have unclear allocation concealment in their protocols, in their publications, or both. On the other hand, a 2008 study of 146 meta-analyses concluded that the results of RCTs with inadequate or unclear allocation concealment tended to be biased toward beneficial effects only if the RCTs' outcomes were subjective as opposed to objective.&lt;br /&gt;
&lt;br /&gt;
一些确保分配隐藏的标准方法包括顺序编号、不透明、密封信封(SNOSE)；顺序编号的容器；药学控制的随机化；和中心随机化。分配隐藏方法被建议纳入RCT议定书，并在RCT结果的出版物中详细报告分配隐藏方法；然而，2005年的一项研究发现，大多数随机对照试验在其方案、出版物或两者中都有不清楚的分配隐藏。另一方面，2008年的一项对146项元分析的研究得出结论，分配隐瞒不充分或不明确的随机对照试验的结果往往只有在随机对照试验的结果是主观的而不是客观的情况下才会偏向于有益的结果。&lt;br /&gt;
=== Sample size ===&lt;br /&gt;
&lt;br /&gt;
{{Main|Sample size determination}}The number of treatment units (subjects or groups of subjects) assigned to control and treatment groups, affects an RCT's reliability. If the effect of the treatment is small, the number of treatment units in either group may be insufficient for rejecting the null hypothesis in the respective statistical test. The failure to reject the null hypothesis would imply that the treatment shows no statistically significant effect on the treated ''in a given test''. But as the sample size increases, the same RCT may be able to demonstrate a significant effect of the treatment, even if this effect is small.&lt;br /&gt;
&lt;br /&gt;
分配给控制组和治疗组的治疗单位(受试者或受试者组)的样本量影响 RCT 的可靠性。如果治疗的效果很小，任何一组的治疗单位的样本量都可能不足以在各自的统计检验中拒绝零假设。拒绝无效假设的失败意味着在给定的试验中，治疗对被治疗者没有统计学上的显著影响。但是随着样本量的增加，同样的RCT可能能够证明治疗的显著效果，即使这种效果很小。&lt;br /&gt;
&lt;br /&gt;
== Blinding ==&lt;br /&gt;
&lt;br /&gt;
{{main|Blinded experiment}}&lt;br /&gt;
&lt;br /&gt;
An RCT may be [[Blind experiment|blinded]], (also called &amp;quot;masked&amp;quot;) by &amp;quot;procedures that prevent study participants, caregivers, or outcome assessors from knowing which intervention was received.&amp;quot;&amp;lt;ref name=&amp;quot;Wood-2008&amp;quot;&amp;gt;{{Cite journal |vauthors=Wood L, Egger M, Gluud LL, Schulz KF, Jüni P, Altman DG, Gluud C, Martin RM, Wood AJ, Sterne JA | title = Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study | journal = BMJ | volume = 336 | issue = 7644 | pages = 601–5 | year = 2008 | doi = 10.1136/bmj.39465.451748.AD | pmid = 18316340 | pmc = 2267990 }}&amp;lt;/ref&amp;gt; Unlike allocation concealment, blinding is sometimes inappropriate or impossible to perform in an RCT; for example, if an RCT involves a treatment in which active participation of the patient is necessary (e.g., [[physical therapy]]), participants cannot be blinded to the intervention.&lt;br /&gt;
&lt;br /&gt;
一项RCT的盲法是指阻止研究参与者、照顾者或结果评估者知道哪些干预措施，这一程序也称“蒙面”。与分配隐藏不同，在RCT，致盲有时是不合适的或不可能的；例如，如果RCT涉及需要患者积极参与的治疗(例如物理治疗)，参与者不能对干预视而不见。&lt;br /&gt;
&lt;br /&gt;
Traditionally, blinded RCTs have been classified as &amp;quot;single-blind&amp;quot;, &amp;quot;double-blind&amp;quot;, or &amp;quot;triple-blind&amp;quot;; however, in 2001 and 2006 two studies showed that these terms have different meanings for different people.&amp;lt;ref name=&amp;quot;Devereaux-2001&amp;quot;&amp;gt;{{Cite journal |vauthors=Devereaux PJ, Manns BJ, Ghali WA, Quan H, Lacchetti C, Montori VM, Bhandari M, Guyatt GH | title = Physician interpretations and textbook definitions of blinding terminology in randomized controlled trials | journal = [[J Am Med Assoc]] | volume = 285 | issue = 15 | pages = 2000–3 | year = 2001 | doi =  10.1001/jama.285.15.2000| pmid = 11308438 | doi-access = free }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Haahr-2006&amp;quot;&amp;gt;{{Cite journal |vauthors=Haahr MT, Hróbjartsson A | title = Who is blinded in randomized clinical trials? A study of 200 trials and a survey of authors | journal = Clin Trials | volume = 3 | issue = 4 | pages = 360–5 | year = 2006 | doi = 10.1177/1740774506069153 | pmid = 17060210 | s2cid = 23818514 }}&amp;lt;/ref&amp;gt;  The 2010 [[Consolidated Standards of Reporting Trials|CONSORT Statement]] specifies that authors and editors should not use the terms &amp;quot;single-blind&amp;quot;, &amp;quot;double-blind&amp;quot;, and &amp;quot;triple-blind&amp;quot;; instead, reports of blinded RCT should discuss &amp;quot;If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how.&amp;quot;&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
传统上，盲法随机对照试验分为“单盲”、“双盲”或“三盲”；然而，2001年和2006年的两项研究表明，这些术语对不同的人有不同的含义。2010年CONSORT 声明明确指出，作者和编辑不应使用”单盲”、”双盲”和”三盲”等术语；相反，关于盲法 RCT 的报告应讨论”如果完成，干预分配后谁被“蒙面”了(例如，参与者、护理提供者、评估结果的人员)以及其原因”。&lt;br /&gt;
&lt;br /&gt;
RCTs without blinding are referred to as &amp;quot;unblinded&amp;quot;,&amp;lt;ref name=&amp;quot;Marson-2007&amp;quot;&amp;gt;{{Cite journal  |vauthors=Marson AG, Al-Kharusi AM, Alwaidh M, Appleton R, Baker GA, Chadwick DW, etal | title = The SANAD study of effectiveness of valproate, lamotrigine, or topiramate for generalised and unclassifiable epilepsy: an unblinded randomised controlled trial | journal = [[The Lancet|Lancet]] | volume = 369 | issue = 9566 | pages = 1016–26 | year = 2007 | doi = 10.1016/S0140-6736(07)60461-9 | pmid = 17382828 | pmc = 2039891 }}&amp;lt;/ref&amp;gt; &amp;quot;open&amp;quot;,&amp;lt;ref name=&amp;quot;Chan-1995&amp;quot;&amp;gt;{{Cite journal |vauthors=Chan R, Hemeryck L, O'Regan M, Clancy L, Feely J | title = Oral versus intravenous antibiotics for community acquired lower respiratory tract infection in a general hospital: open, randomised controlled trial | journal = [[BMJ]] | volume = 310 | issue = 6991 | pages = 1360–2 | year = 1995 | pmid = 7787537 | pmc = 2549744 | doi=10.1136/bmj.310.6991.1360}}&amp;lt;/ref&amp;gt; or (if the intervention is a medication) &amp;quot;[[Open-label trial|open-label]]&amp;quot;.&amp;lt;ref name=&amp;quot;Fukase-2008&amp;quot;&amp;gt;{{Cite journal | author = Fukase K, Kato M, Kikuchi S, Inoue K, Uemura N, Okamoto S, Terao S, Amagai K, Hayashi S, Asaka M; Japan Gast Study Group | title = Effect of eradication of Helicobacter pylori on incidence of metachronous gastric carcinoma after endoscopic resection of early gastric cancer: an open-label, randomised controlled trial | journal = Lancet | volume = 372 | issue = 9636 | pages = 392–7 | year = 2008 | doi = 10.1016/S0140-6736(08)61159-9 | pmid = 18675689 | hdl = 2115/34681 | s2cid = 13741892 | url = https://eprints.lib.hokudai.ac.jp/dspace/bitstream/2115/34681/1/asaka.pdf | hdl-access = free }}&amp;lt;/ref&amp;gt; In 2008 a study concluded that the results of unblinded RCTs tended to be biased toward beneficial effects only if the RCTs' outcomes were subjective as opposed to objective;&amp;lt;ref name=&amp;quot;Wood-2008&amp;quot;/&amp;gt; for example, in an RCT of treatments for [[multiple sclerosis]], unblinded neurologists (but not the blinded neurologists) felt that the treatments were beneficial.&amp;lt;ref name=&amp;quot;Noseworthy-1994&amp;quot;&amp;gt;{{Cite journal |vauthors=Noseworthy JH, Ebers GC, Vandervoort MK, Farquhar RE, Yetisir E, Roberts R | author-link1=John H. Noseworthy|title = The impact of blinding on the results of a randomized, placebo-controlled multiple sclerosis clinical trial | journal = Neurology | volume = 44 | issue = 1 | pages = 16–20 | year = 1994 | url = http://www.neurology.org/cgi/content/abstract/44/1/16 | pmid = 8290055 | doi=10.1212/wnl.44.1.16| s2cid=2663997}}&amp;lt;/ref&amp;gt; In pragmatic RCTs, although the participants and providers are often unblinded, it is &amp;quot;still desirable and often possible to blind the assessor or obtain an objective source of data for evaluation of outcomes.&amp;quot;&amp;lt;ref name=&amp;quot;Zwarenstein-2008&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
没有盲法的随机对照试验被称为“未盲法”，也称“开放”，或者(如果干预是一种药物)“开放标签”。2008年的一项研究得出结论，只有当随机对照试验的结果是主观的而不是客观的时候，非盲法随机对照试验的结果往往偏向于有益的结果；例如，在RCT多发性硬化症的治疗中，未盲的神经学家认为治疗是有益的。在实用的随机对照试验中，尽管参与者和提供者往往是非盲的，但是”仍然需要并且往往可能使评估者“蒙面”，以获得评估结果的客观数据来源”。&lt;br /&gt;
&lt;br /&gt;
== Analysis of data ==&lt;br /&gt;
&lt;br /&gt;
The types of statistical methods used in RCTs depend on the characteristics of the data and include:&lt;br /&gt;
&lt;br /&gt;
* For [[dichotomous]] (binary) outcome data, [[logistic regression]] (e.g., to predict sustained virological response after receipt of [[peginterferon alfa-2a]] for [[hepatitis C]]&amp;lt;ref name=&amp;quot;Manns-2001&amp;quot;&amp;gt;{{Cite journal |vauthors=Manns MP, McHutchison JG, Gordon SC, Rustgi VK, Shiffman M, Reindollar R, Goodman ZD, Koury K, Ling M, Albrecht JK | title = Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial | journal = [[The Lancet|Lancet]] | volume = 358 | issue = 9286 | pages = 958–65 | year = 2001 | doi = 10.1016/S0140-6736(01)06102-5 | pmid = 11583749 | s2cid = 14583372 }}&amp;lt;/ref&amp;gt;) and other methods can be used.&lt;br /&gt;
&lt;br /&gt;
* For continuous outcome data, [[analysis of covariance]] (e.g., for changes in blood lipid levels after receipt of [[atorvastatin]] after [[acute coronary syndrome]]&amp;lt;ref name=&amp;quot;Schwartz-2001&amp;quot;&amp;gt;{{Cite journal | author = Schwartz GG, Olsson AG, Ezekowitz MD, Ganz P, Oliver MF, Waters D, Zeiher A, Chaitman BR, Leslie S, Stern T; Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering (MIRACL) Study Investigators | title = Effects of atorvastatin on early recurrent ischemic events in acute coronary syndromes: the MIRACL study: a randomized controlled trial | journal = [[J Am Med Assoc]] | volume = 285 | issue = 13 | pages = 1711–8 | year = 2001 | pmid = 11277825 | doi = 10.1001/jama.285.13.1711 | doi-access = free }}&amp;lt;/ref&amp;gt;) tests the effects of predictor variables.&lt;br /&gt;
&lt;br /&gt;
* For time-to-event outcome data that may be [[Censoring (statistics)|censored]], [[survival analysis]] (e.g., [[Kaplan–Meier estimator]]s and [[Cox proportional hazards model]]s for time to [[coronary heart disease]] after receipt of [[Hormone replacement therapy (menopause)|hormone replacement therapy in menopause]]&amp;lt;ref name=&amp;quot;Rossouw-2002&amp;quot;&amp;gt;{{Cite journal | author = Rossouw JE, Anderson GL, [[Ross Prentice|Prentice RL]], LaCroix AZ, Kooperberg C, Stefanick ML, Jackson RD, Beresford SA, Howard BV, Johnson KC, Kotchen JM, Ockene J; Writing Group for the Women's Health Initiative Investigators | title = Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial | journal = [[J Am Med Assoc]] | volume = 288 | issue = 3 | pages = 321–33 | year = 2002 | pmid = 12117397 | doi = 10.1001/jama.288.3.321 | s2cid = 20149703 | url = https://escholarship.org/content/qt3mr6f93p/qt3mr6f93p.pdf?t=prll4c | doi-access = free }}&amp;lt;/ref&amp;gt;) is appropriate.&lt;br /&gt;
&lt;br /&gt;
随机对照试验中使用的统计方法类型取决于数据的特征，包括：&lt;br /&gt;
&lt;br /&gt;
* 对于二元结果数据，可以使用逻辑回归(例如，预测接受聚乙二醇干扰素α-2a治疗丙型肝炎后的持续病毒学应答)和其他方法。&lt;br /&gt;
&lt;br /&gt;
* 对于连续的结果数据，协方差分析(例如，急性冠状动脉综合征后接受阿托伐他汀后血脂水平的变化)可以用于检测预测变量效果。&lt;br /&gt;
&lt;br /&gt;
* 对于可能删失的时间到事件结果数据，生存分析(如绝经后接受激素替代治疗后冠心病发生时间的卡普兰-迈耶估计值和考克斯比例风险模型)是合适的。&lt;br /&gt;
Regardless of the statistical methods used, important considerations in the analysis of RCT data include:&lt;br /&gt;
&lt;br /&gt;
* Whether an RCT should be stopped early due to interim results.  For example, RCTs may be stopped early if an intervention produces &amp;quot;larger than expected benefit or harm&amp;quot;, or if &amp;quot;investigators find evidence of no important difference between experimental and control interventions.&amp;quot;&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
* The extent to which the groups can be analyzed exactly as they existed upon randomization (i.e., whether a so-called &amp;quot;[[intention-to-treat analysis]]&amp;quot; is used). A &amp;quot;pure&amp;quot; intention-to-treat analysis is &amp;quot;possible only when complete outcome data are available&amp;quot; for all randomized subjects;&amp;lt;ref name=&amp;quot;Hollis-1999&amp;quot;&amp;gt;{{Cite journal |vauthors=Hollis S, Campbell F | title = What is meant by intention to treat analysis? Survey of published randomised controlled trials | journal = [[Br Med J]] | volume = 319 | issue = 7211 | pages = 670–4 | year = 1999 | pmid = 10480822 | pmc = 28218 | doi=10.1136/bmj.319.7211.670}}&amp;lt;/ref&amp;gt; when some outcome data are missing, options include analyzing only cases with known outcomes and using [[Imputation (statistics)|imputed]] data.&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt; Nevertheless, the more that analyses can include all participants in the groups to which they were randomized, the less bias that an RCT will be subject to.&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
* Whether [[subgroup analysis]] should be performed.  These are &amp;quot;often discouraged&amp;quot; because [[multiple comparisons]] may produce false positive findings that cannot be confirmed by other studies.&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
无论使用何种统计方法，RCT数据分析中的重要考虑因素包括：&lt;br /&gt;
&lt;br /&gt;
* 由于中期结果，是否应该提前停止RCT。例如，如果干预产生“大于预期的益处或危害”，或者如果“研究者发现实验干预和对照干预之间没有重要区别的证据”，则可能会提前停止随机对照试验。&lt;br /&gt;
&lt;br /&gt;
* 这些组在多大程度上可以完全按照随机化时的状态进行分析(即，是否使用了所谓的“意向治疗分析”)。一项“纯”意向治疗分析“只有在获得所有随机受试者的完整结果数据时才有可能”；当一些结果数据缺失时，选项包括仅分析具有已知结果的病例和使用估算数据。然而，分析越能包括他们被随机分组的所有参与者，RCT受到的偏见就越少。&lt;br /&gt;
&lt;br /&gt;
* 是否应进行亚组分析。这些“通常是不鼓励的”，因为多次比较可能会产生假阳性结果，而其他研究无法证实。&lt;br /&gt;
== Reporting of results ==&lt;br /&gt;
&lt;br /&gt;
&amp;lt;li value=&amp;quot;5&amp;quot;&amp;gt;The ''CONSORT 2010 Statement'' is &amp;quot;an evidence-based, minimum set of recommendations for reporting RCTs.&amp;quot; The CONSORT 2010 checklist contains 25 items (many with sub-items) focusing on &amp;quot;individually randomised, two group, parallel trials&amp;quot; which are the most common type of RCT.&lt;br /&gt;
&lt;br /&gt;
For other RCT study designs, &amp;quot;CONSORT extensions&amp;quot; have been published, some examples are:&lt;br /&gt;
* Consort 2010 Statement: Extension to Cluster Randomised Trials&lt;br /&gt;
* Consort 2010 Statement: Non-Pharmacologic Treatment Interventions&lt;br /&gt;
&lt;br /&gt;
CONSORT 2010声明是“一套基于证据的报告随机对照试验的最低建议。”CONSORT 2010核对表包含25个项目(许多带有子项目)，重点关注“个体随机、两组、平行试验”，这是RCT最常见的类型。&lt;br /&gt;
&lt;br /&gt;
对于其他RCT研究设计，“CONSORT扩展版”已经发布，一些例子是:&lt;br /&gt;
* CONSORT 2010 声明: 扩展至聚类随机试验&lt;br /&gt;
* CONSORT 2010 声明: 非药物治疗干预&lt;br /&gt;
&lt;br /&gt;
=== Relative importance and observational studies ===&lt;br /&gt;
&lt;br /&gt;
Two studies published in ''The New England Journal of Medicine'' in 2000 found that observational studies and RCTs overall produced similar results. The authors of the 2000 findings questioned the belief that &amp;quot;observational studies should not be used for defining evidence-based medical care&amp;quot; and that RCTs' results are &amp;quot;evidence of the highest grade.&amp;quot; However, a 2001 study published in ''Journal of the American Medical Association'' concluded that &amp;quot;discrepancies beyond chance do occur and differences in estimated magnitude of treatment effect are very common&amp;quot; between observational studies and RCTs.&lt;br /&gt;
&lt;br /&gt;
Two other lines of reasoning question RCTs' contribution to scientific knowledge beyond other types of studies:&lt;br /&gt;
* If study designs are ranked by their potential for new discoveries, then anecdotal evidence would be at the top of the list, followed by observational studies, followed by RCTs.&lt;br /&gt;
* RCTs may be unnecessary for treatments that have dramatic and rapid effects relative to the expected stable or progressively worse natural course of the condition treated. One example is combination chemotherapy including cisplatin for metastatic testicular cancer, which increased the cure rate from 5% to 60% in a 1977 non-randomized study.&lt;br /&gt;
&lt;br /&gt;
=== Interpretation of statistical results ===&lt;br /&gt;
&lt;br /&gt;
Like all statistical methods, RCTs are subject to both type I (&amp;quot;false positive&amp;quot;) and type II (&amp;quot;false negative&amp;quot;) statistical errors. Regarding Type I errors, a typical RCT will use 0.05 (i.e., 1 in 20) as the probability that the RCT will falsely find two equally effective treatments significantly different. Regarding Type II errors, despite the publication of a 1978 paper noting that the sample sizes of many &amp;quot;negative&amp;quot; RCTs were too small to make definitive conclusions about the negative results, by 2005-2006 a sizeable proportion of RCTs still had inaccurate or incompletely reported sample size calculations.&lt;br /&gt;
&lt;br /&gt;
=== Peer review ===&lt;br /&gt;
&lt;br /&gt;
Peer review of results is an important part of the scientific method. Reviewers examine the study results for potential problems with design that could lead to unreliable results (for example by creating a systematic bias), evaluate the study in the context of related studies and other evidence, and evaluate whether the study can be reasonably considered to have proven its conclusions. To underscore the need for peer review and the danger of over-generalizing conclusions, two Boston-area medical researchers performed a randomized controlled trial in which they randomly assigned either a parachute or an empty backpack to 23 volunteers who jumped from either a biplane or a helicopter. The study was able to accurately report that parachutes fail to reduce injury compared to empty backpacks. The key context that limited the general applicability of this conclusion was that the aircraft were parked on the ground, and participants had only jumped about two feet.&lt;br /&gt;
&lt;br /&gt;
== Advantages ==&lt;br /&gt;
&lt;br /&gt;
RCTs are considered to be the most reliable form of [[scientific method|scientific evidence]] in the [[hierarchy of evidence]] that influences healthcare policy and practice because RCTs reduce spurious causality and bias. Results of RCTs may be combined in [[systematic review]]s which are increasingly being used in the conduct of [[evidence-based practice]]. Some examples of scientific organizations' considering RCTs or systematic reviews of RCTs to be the highest-quality evidence available are:&lt;br /&gt;
* As of 1998, the [[National Health and Medical Research Council]] of Australia designated &amp;quot;Level I&amp;quot; evidence as that &amp;quot;obtained from a [[systematic review]] of all relevant randomised controlled trials&amp;quot; and &amp;quot;Level II&amp;quot; evidence as that &amp;quot;obtained from at least one properly designed randomised controlled trial.&amp;quot;&amp;lt;ref&amp;gt;{{cite book |url= http://www.nhmrc.gov.au/_files_nhmrc/file/publications/synopses/cp30.pdf |title= A guide to the development, implementation and evaluation of clinical practice guidelines |author= National Health and Medical Research Council |date=1998-11-16 |publisher= Commonwealth of Australia |location = Canberra | isbn = 978-1-86496-048-8 |page= 56|access-date=2010-03-28}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* Since at least 2001, in making [[clinical practice guideline]] recommendations the [[United States Preventive Services Task Force]] has considered both a study's design and its [[internal validity]] as indicators of its quality.&amp;lt;ref name=&amp;quot;Harris-2001&amp;quot;&amp;gt;{{Cite journal | author = Harris RP, Helfand M, Woolf SH, Lohr KN, Mulrow CD, Teutsch SM, Atkins D; Methods Work Group, Third US Preventive Services Task Force | title = Current methods of the US Preventive Services Task Force: a review of the process | journal = Am J Prev Med | volume = 20 | issue = 3 Suppl | pages = 21–35 | year = 2001 | url = http://www.ahrq.gov/clinic/ajpmsuppl/review.pdf | pmid = 11306229 | doi = 10.1016/S0749-3797(01)00261-6 }}&amp;lt;/ref&amp;gt; It has recognized &amp;quot;evidence obtained from at least one properly randomized controlled trial&amp;quot; with good [[internal validity]] (i.e., a rating of &amp;quot;I-good&amp;quot;) as the highest quality evidence available to it.&amp;lt;ref name=&amp;quot;Harris-2001&amp;quot;/&amp;gt;&lt;br /&gt;
* The [[Evidence-based medicine#Grade Working Group|GRADE Working Group]] concluded in 2008 that &amp;quot;randomised trials without important limitations constitute high quality evidence.&amp;quot;&amp;lt;ref name=&amp;quot;Guyatt-2008&amp;quot;&amp;gt;{{Cite journal | author = Guyatt GH, Oxman AD, Kunz R, Vist GE, Falck-Ytter Y, Schünemann HJ; GRADE Working Group | title = What is &amp;quot;quality of evidence&amp;quot; and why is it important to clinicians? | journal = BMJ | volume = 336 | issue = 7651 | pages = 995–8 |year = 2008 | doi = 10.1136/bmj.39490.551019.BE | pmc = 2364804 | pmid = 18456631 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* For issues involving &amp;quot;Therapy/Prevention, Aetiology/Harm&amp;quot;, the [[Oxford Centre for Evidence-based Medicine]] as of 2011 defined &amp;quot;Level 1a&amp;quot; evidence as a systematic review of RCTs that are consistent with each other, and &amp;quot;Level 1b&amp;quot; evidence as an &amp;quot;individual RCT (with narrow [[Confidence Interval]]).&amp;quot;&amp;lt;ref&amp;gt;{{cite web |url= http://www.cebm.net/index.aspx?o=1025 |title= Levels of evidence |author= Oxford Centre for Evidence-based Medicine |date=2011-09-16 |access-date=2012-02-15}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
RCTs are considered to be the most reliable form of scientific evidence in the hierarchy of evidence that influences healthcare policy and practice because RCTs reduce spurious causality and bias. Results of RCTs may be combined in systematic reviews which are increasingly being used in the conduct of evidence-based practice. Some examples of scientific organizations' considering RCTs or systematic reviews of RCTs to be the highest-quality evidence available are:&lt;br /&gt;
* As of 1998, the National Health and Medical Research Council of Australia designated &amp;quot;Level I&amp;quot; evidence as that &amp;quot;obtained from a systematic review of all relevant randomised controlled trials&amp;quot; and &amp;quot;Level II&amp;quot; evidence as that &amp;quot;obtained from at least one properly designed randomised controlled trial.&amp;quot;&lt;br /&gt;
* Since at least 2001, in making clinical practice guideline recommendations the United States Preventive Services Task Force has considered both a study's design and its internal validity as indicators of its quality. It has recognized &amp;quot;evidence obtained from at least one properly randomized controlled trial&amp;quot; with good internal validity (i.e., a rating of &amp;quot;I-good&amp;quot;) as the highest quality evidence available to it.&lt;br /&gt;
* The GRADE Working Group concluded in 2008 that &amp;quot;randomised trials without important limitations constitute high quality evidence.&amp;quot;&lt;br /&gt;
* For issues involving &amp;quot;Therapy/Prevention, Aetiology/Harm&amp;quot;, the Oxford Centre for Evidence-based Medicine as of 2011 defined &amp;quot;Level 1a&amp;quot; evidence as a systematic review of RCTs that are consistent with each other, and &amp;quot;Level 1b&amp;quot; evidence as an &amp;quot;individual RCT (with narrow Confidence Interval).&amp;quot;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Notable RCTs with unexpected results that contributed to changes in clinical practice include:&lt;br /&gt;
* After [[Food and Drug Administration]] approval, the [[antiarrhythmic agents]] [[flecainide]] and [[encainide]] came to market in 1986 and 1987 respectively.&amp;lt;ref name=&amp;quot;Anderson-1997&amp;quot;&amp;gt;{{Cite journal |vauthors=Anderson JL, Pratt CM, Waldo AL, Karagounis LA | title = Impact of the Food and Drug Administration approval of flecainide and encainide on coronary artery disease mortality: putting &amp;quot;Deadly Medicine&amp;quot; to the test | journal = Am J Cardiol | volume = 79 | issue = 1 | pages = 43–7 | year = 1997 | url = http://www.ajconline.org/article/S0002-9149%2896%2900673-X/abstract | pmid = 9024734 | doi = 10.1016/S0002-9149(96)00673-X }}&amp;lt;/ref&amp;gt; The non-randomized studies concerning the drugs were characterized as &amp;quot;glowing&amp;quot;,&amp;lt;ref name=&amp;quot;Rubin-2006&amp;quot;&amp;gt;{{cite news |title= In medicine, evidence can be confusing - deluged with studies, doctors try to sort out what works, what doesn't |author= Rubin R |url= https://www.usatoday.com/news/health/2006-10-15-medical-evidence-cover_x.htm |newspaper= USA Today |date= 2006-10-16 |access-date=2010-03-22}}&amp;lt;/ref&amp;gt; and their sales increased to a combined total of approximately 165,000 prescriptions per month in early 1989.&amp;lt;ref name=&amp;quot;Anderson-1997&amp;quot;/&amp;gt;  In that year, however, a preliminary report of an RCT concluded that the two drugs increased mortality.&amp;lt;ref name=&amp;quot;CAST-1989&amp;quot;&amp;gt;{{Cite journal | doi = 10.1056/NEJM198908103210629 | title = Preliminary report: effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction. The Cardiac Arrhythmia Suppression Trial (CAST) Investigators | journal = N Engl J Med | volume = 321 | issue = 6 | pages = 406–12 |year = 1989 | pmid = 2473403 | author1 = Cardiac Arrhythmia Suppression Trial (CAST) Investigators }}&amp;lt;/ref&amp;gt;  Sales of the drugs then decreased.&amp;lt;ref name=&amp;quot;Anderson-1997&amp;quot;/&amp;gt;&lt;br /&gt;
* Prior to 2002, based on observational studies, it was routine for physicians to prescribe hormone replacement therapy for post-menopausal women to prevent [[myocardial infarction]].&amp;lt;ref name=&amp;quot;Rubin-2006&amp;quot;/&amp;gt; In 2002 and 2004, however, published RCTs from the [[Women's Health Initiative]] claimed that women taking hormone replacement therapy with estrogen plus progestin had a higher rate of myocardial infarctions than women on a placebo, and that estrogen-only hormone replacement therapy caused no reduction in the incidence of coronary heart disease.&amp;lt;ref name=&amp;quot;Rossouw-2002&amp;quot;/&amp;gt;&amp;lt;ref name=&amp;quot;Anderson-2004&amp;quot;&amp;gt;{{Cite journal  |vauthors=Anderson GL, Limacher M, Assaf AR, Bassford T, Beresford SA, Black H, etal | title = Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women's Health Initiative randomized controlled trial | journal = JAMA | volume = 291 | issue = 14 | pages = 1701–12 | year = 2004 | doi = 10.1001/jama.291.14.1701 | pmid = 15082697 | doi-access = free }}&amp;lt;/ref&amp;gt;  Possible explanations for the discrepancy between the observational studies and the RCTs involved differences in methodology, in the hormone regimens used, and in the populations studied.&amp;lt;ref name=&amp;quot;Grodstein-2003&amp;quot;&amp;gt;{{Cite journal |vauthors=Grodstein F, Clarkson TB, Manson JE | title = Understanding the divergent data on postmenopausal hormone therapy | journal = N Engl J Med | volume = 348 | issue = 7 | pages = 645–50 | year = 2003 | doi = 10.1056/NEJMsb022365 | pmid = 12584376 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Vandenbroucke-2009&amp;quot;&amp;gt;{{Cite journal | author = Vandenbroucke JP | title = The HRT controversy: observational studies and RCTs fall in line | journal = Lancet | volume = 373 | issue = 9671 | pages = 1233–5 | year = 2009 | doi = 10.1016/S0140-6736(09)60708-X | pmid = 19362661 | s2cid = 44991220 }}&amp;lt;/ref&amp;gt; The use of hormone replacement therapy decreased after publication of the RCTs.&amp;lt;ref name=&amp;quot;Hsu-2009&amp;quot;&amp;gt;{{Cite journal |vauthors=Hsu A, Card A, Lin SX, Mota S, Carrasquillo O, Moran A | title = Changes in postmenopausal hormone replacement therapy use among women with high cardiovascular risk | journal = Am J Public Health | volume = 99 | issue = 12 | pages = 2184–7 | year = 2009 | doi = 10.2105/AJPH.2009.159889 | url = http://ajph.aphapublications.org/cgi/content/full/99/12/2184 | pmid = 19833984 | pmc=2775780}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Notable RCTs with unexpected results that contributed to changes in clinical practice include:&lt;br /&gt;
* After Food and Drug Administration approval, the antiarrhythmic agents flecainide and encainide came to market in 1986 and 1987 respectively. The non-randomized studies concerning the drugs were characterized as &amp;quot;glowing&amp;quot;, and their sales increased to a combined total of approximately 165,000 prescriptions per month in early 1989. In that year, however, a preliminary report of an RCT concluded that the two drugs increased mortality. Sales of the drugs then decreased.&lt;br /&gt;
* Prior to 2002, based on observational studies, it was routine for physicians to prescribe hormone replacement therapy for post-menopausal women to prevent myocardial infarction. In 2002 and 2004, however, published RCTs from the Women's Health Initiative claimed that women taking hormone replacement therapy with estrogen plus progestin had a higher rate of myocardial infarctions than women on a placebo, and that estrogen-only hormone replacement therapy caused no reduction in the incidence of coronary heart disease. Possible explanations for the discrepancy between the observational studies and the RCTs involved differences in methodology, in the hormone regimens used, and in the populations studied. The use of hormone replacement therapy decreased after publication of the RCTs.&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
== Disadvantages ==&lt;br /&gt;
&lt;br /&gt;
Many papers discuss the disadvantages of RCTs.&amp;lt;ref name=&amp;quot;Black-1996&amp;quot;&amp;gt;{{Cite journal | author = Black N | title = Why we need observational studies to evaluate the effectiveness of health care | journal = BMJ | volume = 312 | issue = 7040 | pages = 1215–8 | year = 1996 | pmid = 8634569 | pmc = 2350940 | doi=10.1136/bmj.312.7040.1215}}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Bell &amp;amp; Peck-2012&amp;quot;&amp;gt;{{Cite journal | author = Bell, S.H., &amp;amp; Peck, L.R. | title = Obstacles to and limitations of social experiments: 15 false alarms | journal = Abt Thought Leadership Paper Series | year = 2012 | url = http://abtassociates.com/white-papers/2012/obstacles-to-and-limitations-of-social-experiments.aspx }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Sanson-Fisher-2007&amp;quot;&amp;gt;{{Cite journal |vauthors=Sanson-Fisher RW, Bonevski B, Green LW, D'Este C | title = Limitations of the randomized controlled trial in evaluating population-based health interventions | journal = Am J Prev Med | volume = 33 | issue = 2 | pages = 155–61 | year = 2007 | doi = 10.1016/j.amepre.2007.04.007 | url = http://www.ajpm-online.net/article/S0749-3797%2807%2900225-5/abstract | pmid = 17673104 }}&amp;lt;/ref&amp;gt;   Among the most frequently cited drawbacks are:&lt;br /&gt;
&lt;br /&gt;
=== Time and costs ===&lt;br /&gt;
&lt;br /&gt;
RCTs can be expensive; one study found 28 Phase III RCTs funded by the National Institute of Neurological Disorders and Stroke prior to 2000 with a total cost of US$335 million, for a mean cost of US$12 million per RCT. Nevertheless, the return on investment of RCTs may be high, in that the same study projected that the 28 RCTs produced a &amp;quot;net benefit to society at 10-years&amp;quot; of 46 times the cost of the trials program, based on evaluating a quality-adjusted life year as equal to the prevailing mean per capita gross domestic product.&lt;br /&gt;
&lt;br /&gt;
The conduct of an RCT takes several years until being published; thus, data is restricted from the medical community for long years and may be of less relevance at time of publication.&lt;br /&gt;
&lt;br /&gt;
It is costly to maintain RCTs for the years or decades that would be ideal for evaluating some interventions.&lt;br /&gt;
&lt;br /&gt;
Interventions to prevent events that occur only infrequently (e.g., sudden infant death syndrome) and uncommon adverse outcomes (e.g., a rare side effect of a drug) would require RCTs with extremely large sample sizes and may, therefore, best be assessed by observational studies.&lt;br /&gt;
&lt;br /&gt;
Due to the costs of running RCTs, these usually only inspect one variable or very few variables, rarely reflecting the full picture of a complicated medical situation; whereas the case report, for example, can detail many aspects of the patient's medical situation (e.g. patient history, physical examination, diagnosis, psychosocial aspects, follow up).&lt;br /&gt;
&lt;br /&gt;
=== Conflict of interest dangers ===&lt;br /&gt;
&lt;br /&gt;
A 2011 study done to disclose possible conflicts of interests in underlying research studies used for medical meta-analyses reviewed 29 meta-analyses and found that conflicts of interests in the studies underlying the meta-analyses were rarely disclosed. The 29 meta-analyses included 11 from general medicine journals; 15 from specialty medicine journals, and 3 from the Cochrane Database of Systematic Reviews. The 29 meta-analyses reviewed an aggregate of 509 randomized controlled trials (RCTs). Of these, 318 RCTs reported funding sources with 219 (69%) industry funded. 132 of the 509 RCTs reported author conflict of interest disclosures, with 91 studies (69%) disclosing industry financial ties with one or more authors. The information was, however, seldom reflected in the meta-analyses. Only two (7%) reported RCT funding sources and none reported RCT author-industry ties. The authors concluded &amp;quot;without acknowledgment of COI due to industry funding or author industry financial ties from RCTs included in meta-analyses, readers' understanding and appraisal of the evidence from the meta-analysis may be compromised.&amp;quot;&lt;br /&gt;
&lt;br /&gt;
Some RCTs are fully or partly funded by the health care industry (e.g., the pharmaceutical industry) as opposed to government, nonprofit, or other sources. A systematic review published in 2003 found four 1986–2002 articles comparing industry-sponsored and nonindustry-sponsored RCTs, and in all the articles there was a correlation of industry sponsorship and positive study outcome. A 2004 study of 1999–2001 RCTs published in leading medical and surgical journals determined that industry-funded RCTs &amp;quot;are more likely to be associated with statistically significant pro-industry findings.&amp;quot; These results have been mirrored in trials in surgery, where although industry funding did not affect the rate of trial discontinuation it was however associated with a lower odds of publication for completed trials. One possible reason for the pro-industry results in industry-funded published RCTs is publication bias. Other authors have cited the differing goals of academic and industry sponsored research as contributing to the difference. Commercial sponsors may be more focused on performing trials of drugs that have already shown promise in early stage trials, and on replicating previous positive results to fulfill regulatory requirements for drug approval.&lt;br /&gt;
&lt;br /&gt;
有些 rct 完全或部分由医疗保健行业(如制药行业)资助，而不是政府、非营利组织或其他来源。2003年发表的一份系统综述研究报告发现，1986年至2002年间，有4篇文章比较了行业赞助和非行业赞助的 rct，在所有的文章中，行业赞助和正面研究结果之间存在相关性。2004年发表在主要医学和外科杂志上的一项关于1999-2001年的 rct 的研究表明，工业资助的 rct“更有可能与具有统计学意义的有利于工业的发现相关联。”这些结果已经反映在手术试验中，虽然行业资金并不影响试验中止率，但是与完成试验的发表机率较低相关。支持产业的结果在产业资助的已发表的研究报告中出现的一个可能的原因是出版偏见。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
=== Ethics ===&lt;br /&gt;
If a disruptive innovation in medical technology is developed, it may be difficult to test this ethically in an RCT if it becomes &amp;quot;obvious&amp;quot; that the control subjects have poorer outcomes—either due to other foregoing testing, or within the initial phase of the RCT itself. Ethically it may be necessary to abort the RCT prematurely, and getting ethics approval (and patient agreement) to withhold the innovation from the control group in future RCT's may not be feasible.&lt;br /&gt;
&lt;br /&gt;
Historical control trials (HCT) exploit the data of previous RCTs to reduce the sample size; however, these approaches are controversial in the scientific community and must be handled with care.&lt;br /&gt;
&lt;br /&gt;
== In social science ==&lt;br /&gt;
Due to the recent emergence of RCTs in social science, the use of RCTs in social sciences is a contested issue. Some writers from a medical or health background have argued that existing research in a range of social science disciplines lacks rigour, and should be improved by greater use of randomized control trials.&lt;br /&gt;
&lt;br /&gt;
=== Transport science ===&lt;br /&gt;
Researchers in transport science argue that public spending on programmes such as school travel plans could not be justified unless their efficacy is demonstrated by randomized controlled trials. Graham-Rowe and colleagues reviewed 77 evaluations of transport interventions found in the literature, categorising them into 5 &amp;quot;quality levels&amp;quot;. They concluded that most of the studies were of low quality and advocated the use of randomized controlled trials wherever possible in future transport research.&lt;br /&gt;
&lt;br /&gt;
Dr. Steve Melia took issue with these conclusions, arguing that claims about the advantages of RCTs, in establishing causality and avoiding bias, have been exaggerated. He proposed the following eight criteria for the use of RCTs in contexts where interventions must change human behaviour to be effective:&lt;br /&gt;
&lt;br /&gt;
The intervention:&lt;br /&gt;
&lt;br /&gt;
# Has not been applied to all members of a unique group of people (e.g. the population of a whole country, all employees of a unique organisation etc.)&lt;br /&gt;
# Is applied in a context or setting similar to that which applies to the control group&lt;br /&gt;
# Can be isolated from other activities—and the purpose of the study is to assess this isolated effect&lt;br /&gt;
# Has a short timescale between its implementation and maturity of its effects&lt;br /&gt;
&lt;br /&gt;
And the causal mechanisms:&lt;br /&gt;
&lt;br /&gt;
# Are either known to the researchers, or else all possible alternatives can be tested&lt;br /&gt;
# Do not involve significant feedback mechanisms between the intervention group and external environments&lt;br /&gt;
# Have a stable and predictable relationship to exogenous factors&lt;br /&gt;
# Would act in the same way if the control group and intervention group were reversed&lt;br /&gt;
&lt;br /&gt;
=== Criminology ===&lt;br /&gt;
A 2005 review found 83 randomized experiments in criminology published in 1982–2004, compared with only 35 published in 1957–1981. The authors classified the studies they found into five categories: &amp;quot;policing&amp;quot;, &amp;quot;prevention&amp;quot;, &amp;quot;corrections&amp;quot;, &amp;quot;court&amp;quot;, and &amp;quot;community&amp;quot;. Focusing only on offending behavior programs, Hollin (2008) argued that RCTs may be difficult to implement (e.g., if an RCT required &amp;quot;passing sentences that would randomly assign offenders to programmes&amp;quot;) and therefore that experiments with quasi-experimental design are still necessary.&lt;br /&gt;
&lt;br /&gt;
=== Education ===&lt;br /&gt;
RCTs have been used in evaluating a number of educational interventions. Between 1980 and 2016, over 1,000 reports of RCTs have been published. For example, a 2009 study randomized 260 elementary school teachers' classrooms to receive or not receive a program of behavioral screening, classroom intervention, and parent training, and then measured the behavioral and academic performance of their students. Another 2009 study randomized classrooms for 678 first-grade children to receive a classroom-centered intervention, a parent-centered intervention, or no intervention, and then followed their academic outcomes through age 19.&lt;br /&gt;
&lt;br /&gt;
== Criticism ==&lt;br /&gt;
A 2018 review of the 10 most cited randomised controlled trials noted poor distribution of background traits, difficulties with blinding, and discussed other assumptions and biases inherent in randomised controlled trials. These include the &amp;quot;unique time period assessment bias&amp;quot;, the &amp;quot;background traits remain constant assumption&amp;quot;, the &amp;quot;average treatment effects limitation&amp;quot;, the &amp;quot;simple treatment at the individual level limitation&amp;quot;, the &amp;quot;all preconditions are fully met assumption&amp;quot;, the &amp;quot;quantitative variable limitation&amp;quot; and the &amp;quot;placebo only or conventional treatment only limitation&amp;quot;.&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Category:Clinical research&lt;br /&gt;
&lt;br /&gt;
类别: 临床研究&lt;br /&gt;
&lt;br /&gt;
Category:Epidemiological study projects&lt;br /&gt;
&lt;br /&gt;
类别: 流行病学研究项目&lt;br /&gt;
&lt;br /&gt;
Category:Evidence-based practices&lt;br /&gt;
&lt;br /&gt;
类别: 循证做法&lt;br /&gt;
&lt;br /&gt;
Category:Design of experiments&lt;br /&gt;
[[Category:待整理页面]]&lt;br /&gt;
&amp;lt;references /&amp;gt;&lt;/div&gt;</summary>
		<author><name>李昊轩</name></author>
	</entry>
	<entry>
		<id>https://wiki.swarma.org/index.php?title=%E9%9A%8F%E6%9C%BA%E5%AF%B9%E7%85%A7%E8%AF%95%E9%AA%8C&amp;diff=24314</id>
		<title>随机对照试验</title>
		<link rel="alternate" type="text/html" href="https://wiki.swarma.org/index.php?title=%E9%9A%8F%E6%9C%BA%E5%AF%B9%E7%85%A7%E8%AF%95%E9%AA%8C&amp;diff=24314"/>
		<updated>2021-07-10T17:19:17Z</updated>

		<summary type="html">&lt;p&gt;李昊轩：/* Blinding */&lt;/p&gt;
&lt;hr /&gt;
&lt;div&gt;此词条暂由彩云小译翻译，翻译字数共2766，未经人工整理和审校，带来阅读不便，请见谅。&lt;br /&gt;
&lt;br /&gt;
{{Short description|Experimental method designed to reduce bias, typically accomplished by randomly allocating subjects to two or more groups, with one being a control group}}&lt;br /&gt;
&lt;br /&gt;
[[File:Flowchart of Phases of Parallel Randomized Trial - Modified from CONSORT 2010.png|thumb|upright=1.5|Flowchart of four phases (enrollment, allocation, intervention, follow-up, and data analysis) of a parallel randomized trial of two groups (in a controlled trial, one of the interventions serves as the control), modified from the CONSORT (Consolidated Standards of Reporting Trials) 2010 Statement&amp;lt;ref name=&amp;quot;Schulz-2010&amp;quot;&amp;gt;{{Cite journal | author = Schulz KF, Altman DG, ((Moher D; for the CONSORT Group)) | title = CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials | journal = [[Br Med J]] | volume = 340 | pages = c332 | year = 2010 | doi = 10.1136/bmj.c332 | pmid = 20332509 | pmc = 2844940 }}&amp;lt;/ref&amp;gt;|链接=Special:FilePath/Flowchart_of_Phases_of_Parallel_Randomized_Trial_-_Modified_from_CONSORT_2010.png]]&lt;br /&gt;
&lt;br /&gt;
[来源：图片] Flowchart of four phases (enrollment, allocation, intervention, follow-up, and data analysis) of a parallel randomized trial of two groups (in a controlled trial, one of the interventions serves as the control), modified from the CONSORT (Consolidated Standards of Reporting Trials) 2010 Statement.&lt;br /&gt;
&lt;br /&gt;
据修改的2010年CONSORT (综合报告试验标准)要求，流程图包括：两组平行随机试验分为登记、分配、干预、随访和数据分析四个阶段，在对照试验中，需要其中一项干预作为对照处理措施。 &lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
A '''randomized controlled trial''' (or '''randomized control trial''';&amp;lt;ref name=&amp;quot;Chalmers-1981&amp;quot;&amp;gt;{{Cite journal |vauthors=Chalmers TC, ((Smith H Jr)), Blackburn B, Silverman B, Schroeder B, Reitman D, Ambroz A | title = A method for assessing the quality of a randomized control trial | journal = [[Controlled Clinical Trials]] | volume = 2 | issue = 1 | pages = 31–49 | year = 1981 | doi = 10.1016/0197-2456(81)90056-8 | pmid = 7261638 }}&amp;lt;/ref&amp;gt; '''RCT''') is a type of ''[[scientific experiment]]'' (e.g. a ''[[clinical trial]]'') or ''intervention study'' (as opposed to ''[[observational study]]'') that aims to reduce certain sources of bias when testing the effectiveness of new treatments; this is accomplished by [[Random assignment|randomly allocating]] subjects to two or more groups, treating them differently, and then comparing them with respect to a measured response. One group—the experimental group—receives the intervention being assessed, while the other—usually called the control group—receives an alternative treatment, such as a [[placebo]] or no intervention. The groups are monitored under conditions of the trial design to determine the effectiveness of the experimental intervention, and efficacy is assessed in comparison to the control. &amp;lt;ref&amp;gt;{{cite web|url=https://www.nice.org.uk/glossary?letter=r|publisher=National Institute for Health and Care Excellence, London, UK|title=Randomised controlled trial|date=2019|access-date=3 June 2019}}&amp;lt;/ref&amp;gt; There may be more than one treatment group or more than one [[Treatment and control groups|control group]].&lt;br /&gt;
&lt;br /&gt;
A randomized controlled trial (or randomized control trial; RCT) is a type of scientific experiment (e.g. a clinical trial) or intervention study (as opposed to observational study) that aims to reduce certain sources of bias when testing the effectiveness of new treatments; this is accomplished by randomly allocating subjects to two or more groups, treating them differently, and then comparing them with respect to a measured response. One group—the experimental group—receives the intervention being assessed, while the other—usually called the control group—receives an alternative treatment, such as a placebo or no intervention. The groups are monitored under conditions of the trial design to determine the effectiveness of the experimental intervention, and efficacy is assessed in comparison to the control.  There may be more than one treatment group or more than one control group.&lt;br /&gt;
&lt;br /&gt;
随机对照试验(A randomized controlled trial, RCT)是一种科学实验(例如:临床试验)或干预研究(区别于观察性研究) ，其目的是在测试新治疗的有效性时减少某些偏倚来源。通过受试者随机分配到两个或两个以上的组，经过不同的处理，产生的效应再与一个有可控的处理效应相比较。即一组或多组(实验组)接受正在评估的干预措施，而另一组(通常称为对照组)接受替代治疗，如安慰剂或无干预措施。在试验设计的条件下对这些组进行监测，以确定实验干预的有效性，并与对照组进行疗效比较评估。当然这也包括一个以上的治疗组或一个以上的对照组。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
The trial may be [[blinded experiment|blinded]], meaning that information which may influence the participants is withheld until after the experiment is complete. A blind can be imposed on any participant of an experiment, including subjects, researchers, technicians, data analysts, and evaluators. Effective blinding may reduce or eliminate some sources of experimental [[bias]].&lt;br /&gt;
&lt;br /&gt;
The trial may be blinded, meaning that information which may influence the participants is withheld until after the experiment is complete. A blind can be imposed on any participant of an experiment, including subjects, researchers, technicians, data analysts, and evaluators. Effective blinding may reduce or eliminate some sources of experimental bias.&lt;br /&gt;
&lt;br /&gt;
试验可能采用了盲法，这意味着影响参与者的信息在试验完成后才会公布。试验的任何参与者，包括受试者、研究人员、技术人员、数据分析人员和评估人员，都可能被强加盲。有效的盲法可以减少或消除某些试验偏差的来源。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
The randomness in the assignment of subjects to groups reduces [[selection bias]] and allocation bias, balancing both known and unknown prognostic factors, in the assignment of treatments.&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;&amp;gt;{{Cite journal |vauthors=Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG | title = CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials | journal = [[Br Med J]] | volume = 340 | pages = c869 | year = 2010 | doi = 10.1136/bmj.c869 | pmid = 20332511 | pmc = 2844943 }}&amp;lt;/ref&amp;gt; Blinding reduces other forms of [[Observer-expectancy effect|experimenter and subject biases]].&lt;br /&gt;
&lt;br /&gt;
The randomness in the assignment of subjects to groups reduces selection bias and allocation bias, balancing both known and unknown prognostic factors, in the assignment of treatments. Blinding reduces other forms of experimenter and subject biases.&lt;br /&gt;
&lt;br /&gt;
在分配治疗方案时，受试者随机地被分配到不同组。这个随机化过程减少了选择偏差和分配偏差，平衡了已知和未知的预后因素。盲法减少了其他形式的实验者和主体偏见。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
A well-blinded RCT is often considered the [[Gold standard (test)|gold standard]] for [[clinical trial]]s. Blinded RCTs are commonly used to test the [[Efficacy#Medicine|efficacy]] of medical [[Health intervention|intervention]]s and may additionally provide information about adverse effects, such as [[adverse drug reactions|drug reactions]]. A randomized controlled trial can provide compelling evidence that the study treatment causes an effect on human health.&amp;lt;ref name=&amp;quot;hannan&amp;quot;&amp;gt;{{cite journal | vauthors = Hannan EL | title = Randomized clinical trials and observational studies: guidelines for assessing respective strengths and limitations | journal = JACC. Cardiovascular Interventions | volume = 1 | issue = 3 | pages = 211–7 | date = June 2008 | pmid = 19463302 | doi = 10.1016/j.jcin.2008.01.008 | doi-access = free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
A well-blinded RCT is often considered the gold standard for clinical trials. Blinded RCTs are commonly used to test the efficacy of medical interventions and may additionally provide information about adverse effects, such as drug reactions. A randomized controlled trial can provide compelling evidence that the study treatment causes an effect on human health.&lt;br /&gt;
&lt;br /&gt;
一个良好盲法的 RCT 通常被认为是临床试验的黄金标准。盲法随机对照试验通常用于检测医疗干预措施的效果，并且还可能提供关于药物反应等不良反应的信息。随机对照试验可以提供令人信服的证据，证明研究治疗对人类健康产生了影响。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
The terms &amp;quot;RCT&amp;quot; and &amp;quot;'''randomized trial'''&amp;quot; are sometimes used synonymously, but the latter term omits mention of controls and can therefore describe studies that compare multiple treatment groups with each other in the absence of a control group.&amp;lt;ref name=&amp;quot;Ranjith-2005&amp;quot;&amp;gt;{{Cite journal | author = Ranjith G | title = Interferon-α-induced depression: when a randomized trial is not a randomized controlled trial | journal = [[Psychother Psychosom]] | volume = 74 | issue = 6 | pages = 387; author reply 387–8 | year = 2005 | doi = 10.1159/000087787 | pmid = 16244516 | s2cid = 143644933 }}&amp;lt;/ref&amp;gt; Similarly, the [[initialism]] is sometimes expanded as &amp;quot;'''randomized clinical trial'''&amp;quot; or &amp;quot;'''randomized comparative trial'''&amp;quot;, leading to ambiguity in the [[scientific literature]].&amp;lt;ref name=&amp;quot;Peto-1976&amp;quot;&amp;gt;{{Cite journal |vauthors=Peto R, Pike MC, Armitage P, Breslow NE, Cox DR, Howard SV, Mantel N, McPherson K, Peto J, Smith PG | title = Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design | journal = [[Br J Cancer]] | volume = 34 | issue = 6 | pages = 585–612 | year = 1976 | pmc=2025229 | pmid = 795448 | doi = 10.1038/bjc.1976.220 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Peto-1977&amp;quot;&amp;gt;{{Cite journal |vauthors=Peto R, Pike MC, Armitage P, Breslow NE, Cox DR, Howard SV, Mantel N, McPherson K, Peto J, Smith PG | title = Design and analysis of randomized clinical trials requiring prolonged observation of each patient. II. Analysis and examples | journal = [[Br J Cancer]] | volume = 35 | issue = 1 | pages = 1–39 | year = 1977 | pmc=2025310 | pmid = 831755 | doi = 10.1038/bjc.1977.1 }}&amp;lt;/ref&amp;gt; Not all randomized clinical trials are randomized ''controlled'' trials (and some of them could never be, as in cases where controls would be impractical or unethical to institute). The term '''randomized controlled clinical trial''' is an alternative term used in [[clinical research]];&amp;lt;ref name=&amp;quot;Wollert-2004&amp;quot;&amp;gt;{{Cite journal |vauthors=Wollert KC, Meyer GP, Lotz J, Ringes-Lichtenberg S, Lippolt P, Breidenbach C, Fichtner S, Korte T, Hornig B, Messinger D, Arseniev L, Hertenstein B, Ganser A, Drexler H | title = Intracoronary autologous bone-marrow cell transfer after myocardial infarction: the BOOST randomised controlled clinical trial | journal = [[The Lancet|Lancet]] | volume = 364 | issue = 9429 | pages = 141–8 | year = 2004 | doi = 10.1016/S0140-6736(04)16626-9 | pmid = 15246726 | s2cid = 24361586 }}&amp;lt;/ref&amp;gt; however, RCTs are also employed in other research areas, including [[#In social science|many of the social sciences]].&lt;br /&gt;
&lt;br /&gt;
The terms &amp;quot;RCT&amp;quot; and &amp;quot;randomized trial&amp;quot; are sometimes used synonymously, but the latter term omits mention of controls and can therefore describe studies that compare multiple treatment groups with each other in the absence of a control group. Similarly, the initialism is sometimes expanded as &amp;quot;randomized clinical trial&amp;quot; or &amp;quot;randomized comparative trial&amp;quot;, leading to ambiguity in the scientific literature. Not all randomized clinical trials are randomized controlled trials (and some of them could never be, as in cases where controls would be impractical or unethical to institute). The term randomized controlled clinical trial is an alternative term used in clinical research; however, RCTs are also employed in other research areas, including many of the social sciences.&lt;br /&gt;
&lt;br /&gt;
“ RCT”和“随机试验”这两个术语有时被用作同义词，但后一个术语没有提到对照，因此可以描述在没有对照组的情况下相互比较多个治疗组的研究。科学文献中常有“随机临床试验”或“随机比较试验”这类引发歧义的术语。并非所有的随机临床试验都是随机对照试验(其中一些试验永远不可能成为随机对照试验，因为实施控制是不切实际或不道德的)。随机对照临床试验这个术语是临床研究中使用的另一个术语; 然而，随机对照临床试验也被用于其他研究领域，包括许多社会科学。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
{{toc limit}}&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
== History ==&lt;br /&gt;
&lt;br /&gt;
The first reported clinical trial was conducted by James Lind in 1747 to identify treatment for scurvy.[10] The first blind experiment was conducted by the French Royal Commission on Animal Magnetism in 1784 to investigate the claims of mesmerism. An early essay advocating the blinding of researchers came from Claude Bernard in the latter half of the 19th century. Bernard recommended that the observer of an experiment should not have knowledge of the hypothesis being tested. This suggestion contrasted starkly with the prevalent Enlightenment-era attitude that scientific observation can only be objectively valid when undertaken by a well-educated, informed scientist.[11] The first study recorded to have a blinded researcher was conducted in 1907 by W. H. R. Rivers and H. N. Webber to investigate the effects of caffeine.[12]&lt;br /&gt;
&lt;br /&gt;
据报道，1747年James Lind进行了第一个临床试验，目的是确定治疗坏血病的方法。1784年，French Royal Commission on Animal Magnetism进行了第一次盲法实验，以调查催眠术的说法。19世纪下半叶，一篇提倡研究人员失明的早期文章来自Claude Bernard。Bernard建议实验的观察者不要知道正在被测试的假设。这一建议与启蒙时代流行的态度形成鲜明对比，即科学观察只有由受过良好教育、消息灵通的科学家进行才能客观有效。1907年，W. H. R. Rivers和H. N. Webber进行了第一项有记录的盲法研究，研究咖啡因的作用。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
[[Randomized experiment]]s appeared in [[experimental psychology|psychology]], where they were introduced by [[Charles Sanders Peirce]] and [[Joseph Jastrow]] in the 1880s,&amp;lt;ref&amp;gt;{{cite journal| author=[[Charles Sanders Peirce]] and [[Joseph Jastrow]]|year=1885|title=On Small Differences in Sensation| journal=Memoirs of the National Academy of Sciences|volume=3|pages=73–83|url=http://psychclassics.yorku.ca/Peirce/small-diffs.htm}} http://psychclassics.yorku.ca/Peirce/small-diffs.htm&amp;lt;/ref&amp;gt; and in [[school of education|education]].&amp;lt;ref&amp;gt;{{cite journal|doi=10.1086/354775|first=Ian|last=Hacking|author-link=Ian Hacking | title=Telepathy: Origins of Randomization in Experimental Design|journal=[[Isis (journal)|Isis]]|series=A Special Issue on Artifact and Experiment|volume=79|issue=3|date=September 1988 |pages=427–451|jstor=234674|mr=1013489|s2cid=52201011}}&amp;lt;/ref&amp;gt;&amp;lt;ref&amp;gt;{{cite journal|doi=10.1086/444032|author=Stephen M. Stigler|title=A Historical View of Statistical Concepts in Psychology and Educational Research| journal=American Journal of Education| volume=101|issue=1|date=November 1992|pages=60–70|s2cid=143685203|author-link=Stephen M. Stigler}}&amp;lt;/ref&amp;gt;&amp;lt;ref&amp;gt;{{cite journal|doi=10.1086/383850|author=Trudy Dehue|title=Deception, Efficiency, and Random Groups: Psychology and the Gradual Origination of the Random Group Design|journal=[[Isis (journal)|Isis]]|volume=88|issue=4|date=December 1997|pages=653–673|pmid=9519574|s2cid=23526321|url=https://pure.rug.nl/ws/files/71855616/237831.pdf}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Randomized experiments appeared in psychology, where they were introduced by Charles Sanders Peirce and Joseph Jastrow in the 1880s, and in education.&lt;br /&gt;
&lt;br /&gt;
在19世纪80年代，Charles Sanders Peirce和Joseph Jastrow在心理学和教育学领域引入随机实验。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
In the early 20th century, randomized experiments appeared in agriculture, due to [[Jerzy Neyman]]&amp;lt;ref&amp;gt;Neyman, Jerzy. 1923 [1990]. &amp;quot;On the Application of Probability Theory to AgriculturalExperiments. Essay on Principles. Section 9.&amp;quot; ''Statistical Science'' 5 (4): 465–472. Trans. Dorota M. Dabrowska and Terence P. Speed.&amp;lt;/ref&amp;gt; and [[Ronald A. Fisher]]. Fisher's experimental research and his writings popularized randomized experiments.&amp;lt;ref name=&amp;quot;Conniffe&amp;quot; /&amp;gt;&lt;br /&gt;
&lt;br /&gt;
In the early 20th century, randomized experiments appeared in agriculture, due to Jerzy Neyman and Ronald A. Fisher. Fisher's experimental research and his writings popularized randomized experiments.&lt;br /&gt;
&lt;br /&gt;
在20世纪早期，Jerzy Neyman和Ronald A. Fisher将随机实验引入农业研究。Fisher的实验研究和他的著作普及了随机实验。&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;The first published RCT in medicine appeared in the 1948 paper entitled &amp;quot;[[Streptomycin]] treatment of pulmonary [[tuberculosis]]&amp;quot;, which described a [[Medical Research Council (UK)|Medical Research Council]] investigation.&amp;lt;ref name=&amp;quot;MRC-1948&amp;quot;&amp;gt;{{Cite journal | author = Streptomycin in Tuberculosis Trials Committee | title = Streptomycin treatment of pulmonary tuberculosis. A Medical Research Council investigation| journal = [[Br Med J]] | volume = 2 | issue = 4582 | pages = 769–82 | year = 1948 | doi = 10.1136/bmj.2.4582.769 | pmid = 18890300 | pmc = 2091872 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Brown-1998&amp;quot;&amp;gt;{{cite news |title= Landmark study made research resistant to bias |author= Brown D |newspaper= [[Washington Post]] |date=1998-11-02 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Shikata-2006&amp;quot;&amp;gt;{{Cite journal |vauthors=Shikata S, Nakayama T, Noguchi Y, Taji Y, Yamagishi H | title = Comparison of effects in randomized controlled trials with observational studies in digestive surgery | journal = [[Ann Surg]] | volume = 244 | issue = 5 | pages = 668–76 | year = 2006 | doi = 10.1097/01.sla.0000225356.04304.bc | pmc=1856609 | pmid = 17060757 }}&amp;lt;/ref&amp;gt; One of the authors of that paper was [[Austin Bradford Hill]], who is credited as having conceived the modern RCT.&amp;lt;ref name=&amp;quot;Stolberg-2004&amp;quot;&amp;gt;{{Cite journal |vauthors=Stolberg HO, Norman G, Trop I | title = Randomized controlled trials | journal = [[Am J Roentgenol]] | volume = 183 | issue = 6 | pages = 1539–44 | year = 2004 | pmid = 15547188 | doi=10.2214/ajr.183.6.01831539}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;The first published RCT in medicine appeared in the 1948 paper entitled &amp;quot;Streptomycin treatment of pulmonary tuberculosis&amp;quot;, which described a Medical Research Council investigation. One of the authors of that paper was Austin Bradford Hill, who is credited as having conceived the modern RCT.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;医学上首次发表的随机对照试验出现在1948年题为“Streptomycin treatment of pulmonary tuberculosis”的论文中，这篇论文描述了医学研究理事会的一项调查。这篇论文的作者之一是Austin Bradford Hill，被认为是构想出了现代 RCT理论。 &lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt; &lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;Trial design was further influenced by the large-scale [[International Studies of Infarct Survival|ISIS]] trials on [[heart attack]] treatments that were conducted in the 1980s.&amp;lt;ref&amp;gt;{{cite web| author1=Georgina Ferry |title= Peter Sleight Obituary |url=https://www.theguardian.com/society/2020/nov/02/peter-sleight-obituary |website=The Guardian |date=2 November 2020 |access-date=3 November 2020}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;Trial design was further influenced by the large-scale ISIS trials on heart attack treatments that were conducted in the 1980s.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;20世纪80年代进行的大规模 ISIS 心脏病治疗试验进一步影响了试验设计。&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;By the late 20th century, RCTs were recognized as the standard method for &amp;quot;rational therapeutics&amp;quot; in medicine.[24] As of 2004, more than 150,000 RCTs were in the Cochrane Library.[22] To improve the reporting of RCTs in the medical literature, an international group of scientists and editors published Consolidated Standards of Reporting Trials (CONSORT) Statements in 1996, 2001 and 2010, and these have become widely accepted.[1][4] Randomization is the process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce the bias.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;By the late 20th century, RCTs were recognized as the standard method for &amp;quot;rational therapeutics&amp;quot; in medicine. As of 2004, more than 150,000 RCTs were in the Cochrane Library. To improve the reporting of RCTs in the medical literature, an international group of scientists and editors published Consolidated Standards of Reporting Trials (CONSORT) Statements in 1996, 2001 and 2010, and these have become widely accepted. Randomization is the process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce the bias.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;到20世纪后期，随机对照试验被公认为医学“合理疗法”的标准方法。截至2004年，美国 Cochrane图书馆有超过15万本随机对照试验的参考资料。为了改进医学文献中对随机对照试验的报道，一个由科学家和编辑组成的国际小组在1996年、2001年和2010年发布了Consolidated Standards of Reporting Trials (CONSORT)声明，这些声明已被广泛接受。随机化是将试验受试者分配到治疗组或对照组的过程，使用机会因素来确定分配，以减少偏差。&lt;br /&gt;
&lt;br /&gt;
== Ethics ==&lt;br /&gt;
&lt;br /&gt;
Although the principle of clinical equipoise (&amp;quot;genuine uncertainty within the expert medical community... about the preferred treatment&amp;quot;) common to clinical trials[25] has been applied to RCTs, the ethics of RCTs have special considerations. For one, it has been argued that equipoise itself is insufficient to justify RCTs.[26] For another, &amp;quot;collective equipoise&amp;quot; can conflict with a lack of personal equipoise (e.g., a personal belief that an intervention is effective).[27] Finally, Zelen's design, which has been used for some RCTs, randomizes subjects before they provide informed consent, which may be ethical for RCTs of screening and selected therapies, but is likely unethical &amp;quot;for most therapeutic trials.&amp;quot;[28][29]&lt;br /&gt;
&lt;br /&gt;
Although the principle of clinical equipoise (&amp;quot;genuine uncertainty within the expert medical community... about the preferred treatment&amp;quot;) common to clinical trials has been applied to RCTs, the ethics of RCTs have special considerations. For one, it has been argued that equipoise itself is insufficient to justify RCTs. For another, &amp;quot;collective equipoise&amp;quot; can conflict with a lack of personal equipoise (e.g., a personal belief that an intervention is effective). Finally, Zelen's design, which has been used for some RCTs, randomizes subjects ''before'' they provide informed consent, which may be ethical for RCTs of screening and selected therapies, but is likely unethical &amp;quot;for most therapeutic trials.&amp;quot;&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;尽管临床平衡原则已经被广泛应用于RCT，但随机对照试验的伦理问题具有特殊性。首先，有人认为平衡本身不足以证明随机对照试验的合理性。另一方面，“集体均势”可能与缺乏个人均势相冲突(例如，个人认为干预是有效的)。最后，Zelen 的设计已经被用于一些随机试验，在受试者提供知情同意之前随机化，这对于筛选和选择性治疗的随机试验来说可能是合乎道德的，但是对于“大多数治疗试验”来说可能是不道德的。&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Although subjects almost always provide [[informed consent]] for their participation in an RCT, studies since 1982 have documented that RCT subjects may believe that they are certain to receive treatment that is best for them personally; that is, they do not understand the difference between research and treatment.&amp;lt;ref name=&amp;quot;Appelbaum-1982&amp;quot;&amp;gt;{{Cite journal |vauthors=Appelbaum PS, Roth LH, Lidz C | title = The therapeutic misconception: informed consent in psychiatric research | journal = [[Int J Law Psychiatry]] | volume = 5 | issue = 3–4 | pages = 319–29 | year = 1982 | doi = 10.1016/0160-2527(82)90026-7 | pmid = 6135666 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Henderson-2007&amp;quot;&amp;gt;{{Cite journal |vauthors=Henderson GE, Churchill LR, Davis AM, Easter MM, Grady C, Joffe S, Kass N, King NM, Lidz CW, Miller FG, Nelson DK, Peppercorn J, Rothschild BB, Sankar P, Wilfond BS, Zimmer CR | title = Clinical trials and medical care: defining the therapeutic misconception | journal = [[PLoS Med]] | volume = 4 | issue = 11 | pages = e324 | year = 2007 | doi = 10.1371/journal.pmed.0040324 | pmid = 18044980 | pmc = 2082641 }}&amp;lt;/ref&amp;gt; Further research is necessary to determine the prevalence of and ways to address this &amp;quot;[[therapeutic misconception]]&amp;quot;.&amp;lt;ref name=&amp;quot;Henderson-2007&amp;quot; /&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Although subjects almost always provide informed consent for their participation in an RCT, studies since 1982 have documented that RCT subjects may believe that they are certain to receive treatment that is best for them personally; that is, they do not understand the difference between research and treatment. Further research is necessary to determine the prevalence of and ways to address this &amp;quot;therapeutic misconception&amp;quot;. &lt;br /&gt;
&lt;br /&gt;
一般来说，受试者要为参加随机对照试验提交了知情同意书，但1982年以来的研究记录表明，随机对照试验的受试者可能认为他们肯定会接受对他们个人最好的治疗; 也就是说，他们不理解研究和治疗之间的区别。需要进一步研究，以确定这种”治疗性误解”的流行程度和解决方法。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
The RCT method variations may also create cultural effects that have not been well understood.[32] For example, patients with terminal illness may join trials in the hope of being cured, even when treatments are unlikely to be successful.&lt;br /&gt;
&lt;br /&gt;
RCT方法的变种也可能产生尚未被很好理解的文化效应。例如，患有晚期疾病的病人可能会加入临床试验以希望治愈，即使治疗不太可能成功的情况下也是如此。&lt;br /&gt;
&lt;br /&gt;
=== Trial registration ===&lt;br /&gt;
&lt;br /&gt;
In 2004, the [http://www.icmje.org/ International Committee of Medical Journal Editors] (ICMJE) announced that all trials starting enrolment after July 1, 2005 must be registered prior to consideration for publication in one of the 12 member journals of the committee.&amp;lt;ref name=&amp;quot;pmid15356289&amp;quot;&amp;gt;{{cite journal  |vauthors=De Angelis C, Drazen JM, Frizelle FA, etal |title=Clinical trial registration: a statement from the International Committee of Medical Journal Editors |journal=The New England Journal of Medicine |volume=351 |issue=12 |pages=1250–1 |date=September 2004 |pmid=15356289 |doi=10.1056/NEJMe048225 }}&amp;lt;/ref&amp;gt; However, trial registration may still occur late or not at all.&amp;lt;ref name=&amp;quot;pmid22147862&amp;quot;&amp;gt;{{cite journal|vauthors=Law MR, Kawasumi Y, Morgan SG | title=Despite law, fewer than one in eight completed studies of drugs and biologics are reported on time on ClinicalTrials.gov. | journal=Health Aff (Millwood) | year= 2011 | volume= 30 | issue= 12 | pages= 2338–45 | doi=10.1377/hlthaff.2011.0172 | pmid=22147862  | doi-access=free }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;pmid19724045&amp;quot;&amp;gt;{{cite journal|vauthors=Mathieu S, Boutron I, Moher D, Altman DG, Ravaud P | title=Comparison of registered and published primary outcomes in randomized controlled trials. | journal=JAMA | year= 2009 | volume= 302 | issue= 9 | pages= 977–84 | doi=10.1001/jama.2009.1242 | pmid=19724045  | doi-access=free }}&amp;lt;/ref&amp;gt;Medical journals have been slow in adapting policies requiring mandatory clinical trial registration as a prerequisite for publication.&amp;lt;ref&amp;gt;{{cite journal|last1=Bhaumik|first1=S|title=Editorial policies of MEDLINE indexed Indian journals on clinical trial registration.|journal=Indian Pediatr.|date=Mar 2013|volume=50|issue=3|pages=339–40|pmid=23680610|doi=10.1007/s13312-013-0092-2|s2cid=40317464}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
In 2004, the [http://www.icmje.org/ International Committee of Medical Journal Editors] (ICMJE) announced that all trials starting enrolment after July 1, 2005 must be registered prior to consideration for publication in one of the 12 member journals of the committee. However, trial registration may still occur late or not at all. Medical journals have been slow in adapting policies requiring mandatory clinical trial registration as a prerequisite for publication.&lt;br /&gt;
&lt;br /&gt;
2004年， 医学杂志编辑国际委员会(ICMJE)宣布，所有在2005年7月1日之后考虑在该委员会12种杂志上发表之前，必须对试验进行注册。尽管如此，试验登记可能仍然延迟或根本不会发生。医学期刊将强制性临床试验登记作为发表的先决条件进展缓慢。&lt;br /&gt;
== Classifications ==&lt;br /&gt;
=== By study design ===&lt;br /&gt;
&lt;br /&gt;
One way to classify RCTs is by [[study design]].  From most to least common in the healthcare literature, the major categories of RCT study designs are:&amp;lt;ref name=&amp;quot;Hopewell-2010&amp;quot;&amp;gt;{{Cite journal |vauthors=Hopewell S, Dutton S, Yu LM, Chan AW, Altman DG | title = The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed | journal = BMJ | volume = 340 | pages = c723 | year = 2010 | doi = 10.1136/bmj.c723  | pmid = 20332510 | pmc = 2844941 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
通过研究设计对 RCT 进行分类。从最常见到最不常见，RCT 研究设计的主要类别是&lt;br /&gt;
&lt;br /&gt;
* [[Parallel study|Parallel-group]] – each participant is randomly assigned to a group, and all the participants in the group receive (or do not receive) an intervention.&amp;lt;ref&amp;gt;{{cite journal |last1=Kaiser |first1=Joerg |last2=Niesen |first2=Willem |last3=Probst |first3=Pascal |last4=Bruckner |first4=Thomas |last5=Doerr-Harim |first5=Colette |last6=Strobel |first6=Oliver |last7=Knebel |first7=Phillip |last8=Diener |first8=Markus K. |last9=Mihaljevic |first9=André L. |last10=Büchler |first10=Markus W. |last11=Hackert |first11=Thilo |title=Abdominal drainage versus no drainage after distal pancreatectomy: study protocol for a randomized controlled trial |journal=Trials |date=7 June 2019 |volume=20 |issue=1 |page=332 |doi=10.1186/s13063-019-3442-0|pmid=31174583 |pmc=6555976 |doi-access=free }}&amp;lt;/ref&amp;gt;&amp;lt;ref&amp;gt;{{cite journal |last1=Farag |first1=Sara M. |last2=Mohammed |first2=Manal O. |last3=EL-Sobky |first3=Tamer A. |last4=ElKadery |first4=Nadia A. |last5=ElZohiery |first5=Abeer K. |title=Botulinum Toxin A Injection in Treatment of Upper Limb Spasticity in Children with Cerebral Palsy: A Systematic Review of Randomized Controlled Trials |journal=JBJS Reviews |date=March 2020 |volume=8 |issue=3 |pages=e0119 |doi=10.2106/JBJS.RVW.19.00119 |pmid=32224633|pmc=7161716 |doi-access=free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* 平行试验：每个参与者被随机分配到一个组，组中的所有参与者都接受(或不接受)干预。&lt;br /&gt;
&lt;br /&gt;
* [[Crossover study|Crossover]] – over time, each participant receives (or does not receive) an intervention in a random sequence.&amp;lt;ref&amp;gt;{{cite book  | last = Jones | first = Byron |author2=Kenward, Michael G.  | title = Design and Analysis of Cross-Over Trials | edition=Second| publisher = London: Chapman and Hall | year = 2003 }}&amp;lt;/ref&amp;gt;&amp;lt;ref&amp;gt;{{cite book  | last = Vonesh | first = Edward F. |author2=Chinchilli, Vernon G.  | chapter=Crossover Experiments| pages=111–202|title = Linear and Nonlinear Models for the Analysis of Repeated Measurements | publisher = London: Chapman and Hall | year = 1997 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* 交叉试验：随着时间的推移，每个参与者都会接受(或不接受)随机序列的干预。&lt;br /&gt;
&lt;br /&gt;
* [[Cluster randomised controlled trial|Cluster]] – pre-existing groups of participants (e.g., villages, schools) are randomly selected to receive (or not receive) an intervention.&amp;lt;ref&amp;gt;{{cite journal |last1=Gall |first1=Stefanie |last2=Adams |first2=Larissa |last3=Joubert |first3=Nandi |last4=Ludyga |first4=Sebastian |last5=Müller |first5=Ivan |last6=Nqweniso |first6=Siphesihle |last7=Pühse |first7=Uwe |last8=du Randt |first8=Rosa |last9=Seelig |first9=Harald |last10=Smith |first10=Danielle |last11=Steinmann |first11=Peter |last12=Utzinger |first12=Jürg |last13=Walter |first13=Cheryl |last14=Gerber |first14=Markus |last15=van Wouwe |first15=Jacobus P. |title=Effect of a 20-week physical activity intervention on selective attention and academic performance in children living in disadvantaged neighborhoods: A cluster randomized control trial |journal=PLOS ONE |date=8 November 2018 |volume=13 |issue=11 |pages=e0206908 |doi=10.1371/journal.pone.0206908 |pmid=30408073|pmc=6224098 |bibcode=2018PLoSO..1306908G |doi-access=free }}&amp;lt;/ref&amp;gt;&amp;lt;ref&amp;gt;{{cite journal |last1=Gladstone |first1=Melissa J. |last2=Chandna |first2=Jaya |last3=Kandawasvika |first3=Gwendoline |last4=Ntozini |first4=Robert |last5=Majo |first5=Florence D. |last6=Tavengwa |first6=Naume V. |last7=Mbuya |first7=Mduduzi N. N. |last8=Mangwadu |first8=Goldberg T. |last9=Chigumira |first9=Ancikaria |last10=Chasokela |first10=Cynthia M. |last11=Moulton |first11=Lawrence H. |last12=Stoltzfus |first12=Rebecca J. |last13=Humphrey |first13=Jean H. |last14=Prendergast |first14=Andrew J. |last15=Tumwine |first15=James K. |title=Independent and combined effects of improved water, sanitation, and hygiene (WASH) and improved complementary feeding on early neurodevelopment among children born to HIV-negative mothers in rural Zimbabwe: Substudy of a cluster-randomized trial |journal=PLOS Medicine |date=21 March 2019 |volume=16 |issue=3 |pages=e1002766 |doi=10.1371/journal.pmed.1002766|pmid=30897095 |pmc=6428259 |doi-access=free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* 聚类试验：预先存在的参与者组(例如，村庄、学校)被随机选择以接受(或不接受)干预。&lt;br /&gt;
&lt;br /&gt;
* [[Factorial experiment|Factorial]] – each participant is randomly assigned to a group that receives a particular combination of interventions or non-interventions (e.g., group 1 receives vitamin X and vitamin Y, group 2 receives vitamin X and placebo Y, group 3 receives placebo X and vitamin Y, and group 4 receives placebo X and placebo Y).&lt;br /&gt;
* 因子试验：每个参与者被随机分配到一个接受干预或非干预特定组合的组(例如，第1组接受维生素X和维生素Y，第2组接受维生素X和安慰剂Y，第3组接受安慰剂X和维生素Y，第4组接受安慰剂X和安慰剂Y)。&lt;br /&gt;
&lt;br /&gt;
An analysis of the 616 RCTs indexed in [[PubMed]] during December 2006 found that 78% were parallel-group trials, 16% were crossover, 2% were split-body, 2% were cluster, and 2% were factorial.&amp;lt;ref name=&amp;quot;Hopewell-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
An analysis of the 616 RCTs indexed in PubMed during December 2006 found that 78% were parallel-group trials, 16% were crossover, 2% were split-body, 2% were cluster, and 2% were factorial. &lt;br /&gt;
&lt;br /&gt;
对2006年12月在 PubMed 收录的616例随机对照试验的分析发现，78% 为平行组试验，16% 为交叉组试验，2% 为分体组试验，2% 为聚类组试验，2% 为因子组试验。&lt;br /&gt;
&lt;br /&gt;
=== By outcome of interest (efficacy vs. effectiveness) ===&lt;br /&gt;
&lt;br /&gt;
{{Main|Pragmatic clinical trial}}&lt;br /&gt;
&lt;br /&gt;
RCTs can be classified as &amp;quot;explanatory&amp;quot; or &amp;quot;pragmatic.&amp;quot;&amp;lt;ref name=&amp;quot;Zwarenstein-2008&amp;quot;&amp;gt;{{Cite journal | author = Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D; CONSORT group; Pragmatic Trials in Healthcare (Practihc) group | title = Improving the reporting of pragmatic trials: an extension of the CONSORT statement | journal = BMJ | volume = 337 | pages = a2390 | year = 2008 | doi = 10.1136/bmj.a2390 | pmid = 19001484 | pmc=3266844}}&amp;lt;/ref&amp;gt; Explanatory RCTs test [[Efficacy#Medicine|efficacy]] in a research setting with highly selected participants and under highly controlled conditions.&amp;lt;ref name=&amp;quot;Zwarenstein-2008&amp;quot;/&amp;gt; In contrast, pragmatic RCTs (pRCTs) test [[Effectiveness#Usage|effectiveness]] in everyday practice with relatively unselected participants and under flexible conditions; in this way, pragmatic RCTs can &amp;quot;inform decisions about practice.&amp;quot;&amp;lt;ref name=&amp;quot;Zwarenstein-2008&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
RCTs can be classified as &amp;quot;explanatory&amp;quot; or &amp;quot;pragmatic.&amp;quot; Explanatory RCTs test efficacy in a research setting with highly selected participants and under highly controlled conditions. In contrast, pragmatic RCTs (pRCTs) test effectiveness in everyday practice with relatively unselected participants and under flexible conditions; in this way, pragmatic RCTs can &amp;quot;inform decisions about practice.&amp;quot;&lt;br /&gt;
&lt;br /&gt;
随机对照试验可分为“解释性”或“实用性”。解释性随机对照试验在高度选定的参与者和高度受控的条件下测试有效性。相比之下，实用性随机对照测验(pragmatic RCTs, pRCT)在相对未经选择的参与者和灵活的条件下，在日常实践中检验有效性，这样，实用随机对照测验可以“为实践决策提供信息”。&lt;br /&gt;
=== By hypothesis (superiority vs. noninferiority vs. equivalence) ===&lt;br /&gt;
&lt;br /&gt;
Another classification of RCTs categorizes them as &amp;quot;superiority trials&amp;quot;, &amp;quot;noninferiority trials&amp;quot;, and &amp;quot;equivalence trials&amp;quot;, which differ in methodology and reporting.&amp;lt;ref name=&amp;quot;Piaggio-2006&amp;quot;&amp;gt;{{Cite journal | author = Piaggio G, Elbourne DR, [[Doug Altman|Altman DG]], [[Stuart Pocock|Pocock SJ]], Evans SJ; CONSORT Group | title = Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement | journal = JAMA | volume = 295 | issue = 10 | pages = 1152–60 |  year = 2006 | doi = 10.1001/jama.295.10.1152 | pmid = 16522836 | url = http://researchonline.lshtm.ac.uk/12069/1/Reporting%20of%20Noninferiority%20and%20Equivalence%20Randomized%20Trials.pdf }}&amp;lt;/ref&amp;gt; Most RCTs are superiority trials, in which one intervention is hypothesized to be superior to another in a [[Statistical significance|statistically significant]] way.&amp;lt;ref name=&amp;quot;Piaggio-2006&amp;quot;/&amp;gt; Some RCTs are noninferiority trials &amp;quot;to determine whether a new treatment is no worse than a reference treatment.&amp;quot;&amp;lt;ref name=&amp;quot;Piaggio-2006&amp;quot;/&amp;gt; Other RCTs are equivalence trials in which the hypothesis is that two interventions are indistinguishable from each other.&amp;lt;ref name=&amp;quot;Piaggio-2006&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Another classification of RCTs categorizes them as &amp;quot;superiority trials&amp;quot;, &amp;quot;noninferiority trials&amp;quot;, and &amp;quot;equivalence trials&amp;quot;, which differ in methodology and reporting. Most RCTs are superiority trials, in which one intervention is hypothesized to be superior to another in a statistically significant way. Some RCTs are noninferiority trials &amp;quot;to determine whether a new treatment is no worse than a reference treatment.&amp;quot; Other RCTs are equivalence trials in which the hypothesis is that two interventions are indistinguishable from each other.&lt;br /&gt;
&lt;br /&gt;
随机对照试验的另一种分类是“优越性试验”、“非劣性试验”和“等效性试验”，它们在方法和报告上有所不同。大多数随机对照试验都是优势试验，其中一种干预措施被假设在统计学意义上优于另一种干预措施。一些随机对照试验是非劣效性试验，“以确定一种新的治疗方法是否比一种参考治疗方法更差。”其他随机对照试验是等效试验，其中的假设是两种干预措施彼此不可区分。&lt;br /&gt;
&lt;br /&gt;
== Randomization ==&lt;br /&gt;
&lt;br /&gt;
The advantages of proper [[randomized experiment|randomization]] in RCTs include:&amp;lt;ref name=&amp;quot;SchulzGrimes2002&amp;quot;&amp;gt;{{Cite journal |vauthors=Schulz KF, Grimes DA | title = Generation of allocation sequences in randomised trials: chance, not choice | journal = Lancet | volume = 359 | issue = 9305 | pages = 515–9 | year = 2002 | doi = 10.1016/S0140-6736(02)07683-3 | url =https://www.who.int/entity/rhl/LANCET_515-519.pdf | pmid = 11853818 | s2cid = 291300 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
* &amp;quot;It eliminates bias in treatment assignment,&amp;quot; specifically [[selection bias]] and [[confounding]].&lt;br /&gt;
&lt;br /&gt;
* &amp;quot;It facilitates blinding (masking) of the identity of treatments from investigators, participants, and assessors.&amp;quot;&lt;br /&gt;
&lt;br /&gt;
* &amp;quot;It permits the use of probability theory to express the likelihood that any difference in outcome between treatment groups merely indicates chance.&amp;quot;&lt;br /&gt;
&lt;br /&gt;
There are two processes involved in randomizing patients to different interventions. First is choosing a randomization procedure to generate an unpredictable sequence of allocations; this may be a simple random assignment of patients to any of the groups at equal probabilities, may be &amp;quot;restricted&amp;quot;, or may be &amp;quot;adaptive.&amp;quot; A second and more practical issue is allocation concealment, which refers to the stringent precautions taken to ensure that the group assignment of patients are not revealed prior to definitively allocating them to their respective groups. Non-random &amp;quot;systematic&amp;quot; methods of group assignment, such as alternating subjects between one group and the other, can cause &amp;quot;limitless contamination possibilities&amp;quot; and can cause a breach of allocation concealment.&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
随机对照试验中适当随机化的优点包括：&lt;br /&gt;
* 它消除了治疗分配中的偏差，特别是选择偏差和混淆。&lt;br /&gt;
&lt;br /&gt;
* 它便于调查人员、参与者和评估人员对治疗人群的身份进行遮蔽。&lt;br /&gt;
&lt;br /&gt;
* 它允许使用概率理论来表达这样一种可能性，即治疗组之间结果的任何差异仅仅表明是偶然性的。&lt;br /&gt;
&lt;br /&gt;
有两个过程涉及到随机化的病人接受到不同的干预。首先是选择一个随机化程序来生成一个不可预测的分配序列；这可能是以相等的概率将患者随机分配到任何一组，可能是“受限的”，也可能是“适应性的”。第二个也是更实际的问题是隐藏分配，这是指在将患者明确分配到各自的组之前，采取严格的预防措施，以确保患者的组分配不被披露。非随机的“系统”组分配方法，如在一个组和另一个组之间交替患者，可能会造成“无限的污染可能性”，并可能导致分配隐藏的破坏。&lt;br /&gt;
&lt;br /&gt;
However empirical evidence that adequate randomization changes outcomes relative to inadequate randomization has been difficult to detect.&amp;lt;ref name=&amp;quot;Howick-2014&amp;quot;&amp;gt;{{Cite journal |vauthors=Howick J, Mebius A | title = In search of justification for the unpredictability paradox | journal = Trials | volume = 15 | pages = 480 | year = 2014 | doi = 10.1186/1745-6215-15-480 | pmid = 25490908 | pmc=4295227}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
然而，相对于不充分随机化，充分随机化改变结果的经验证据很难被发现。&lt;br /&gt;
&lt;br /&gt;
=== Procedures ===&lt;br /&gt;
&lt;br /&gt;
The treatment allocation is the desired proportion of patients in each treatment arm.&lt;br /&gt;
&lt;br /&gt;
治疗分配是每个治疗组中患者的期望比例。&lt;br /&gt;
&lt;br /&gt;
An ideal randomization procedure would achieve the following goals:&amp;lt;ref name=&amp;quot;Lachin-1988a&amp;quot;&amp;gt;{{Cite journal | author = Lachin JM | title = Statistical properties of randomization in clinical trials | journal = [[Controlled Clinical Trials]] | volume = 9 | issue = 4 | pages = 289–311 | year = 1988 | pmid = 3060315 |  doi = 10.1016/0197-2456(88)90045-1 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
An ideal randomization procedure would achieve the following goals:&lt;br /&gt;
&lt;br /&gt;
一个理想的随机化程序将实现以下目标:&lt;br /&gt;
&lt;br /&gt;
* '''Maximize [[statistical power]]''', especially in [[Subgroup analysis|subgroup analyses]].  Generally, equal group sizes maximize statistical power, however, unequal groups sizes may be more powerful for some analyses (e.g., multiple comparisons of placebo versus several doses using Dunnett's procedure&amp;lt;ref&amp;gt;{{cite web|last=Rosenberger|first=James|title=STAT 503 - Design of Experiments|url=https://onlinecourses.science.psu.edu/stat503/node/16|publisher=Pennsylvania State University|access-date=24 September 2012}}&amp;lt;/ref&amp;gt; ), and are sometimes desired for non-analytic reasons (e.g., patients may be more motivated to enroll if there is a higher chance of getting the test treatment, or regulatory agencies may require a minimum number of patients exposed to treatment).&amp;lt;ref name=&amp;quot;Avins-1998&amp;quot;&amp;gt;{{cite journal|last=Avins|first=A L|title=&amp;quot;Can unequal be more fair? Ethics, subject allocation, and randomized clinical trials&amp;quot;.|journal=J Med Ethics|year=1998|volume=24|pages=401–408|doi=10.1136/jme.24.6.401|issue=6|pmc=479141|pmid=9873981}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
* '''Minimize selection bias'''.  This may occur if investigators can consciously or unconsciously preferentially enroll patients between treatment arms.  A good randomization procedure will be unpredictable so that investigators cannot guess the next subject's group assignment based on prior treatment assignments. The risk of selection bias is highest when previous treatment assignments are known (as in unblinded studies) or can be guessed (perhaps if a drug has distinctive side effects).&lt;br /&gt;
&lt;br /&gt;
* '''Minimize allocation bias''' (or '''confounding''').  This may occur when [[covariate]]s that affect the outcome are not equally distributed between treatment groups, and the treatment effect is confounded with the effect of the covariates (i.e., an &amp;quot;accidental bias&amp;quot;&amp;lt;ref name=&amp;quot;SchulzGrimes2002&amp;quot;/&amp;gt;&amp;lt;ref name=&amp;quot;Buyse-1989&amp;quot;&amp;gt;{{Cite journal | author = Buyse ME | title = Analysis of clinical trial outcomes: some comments on subgroup analyses | journal = [[Controlled Clinical Trials]] | volume = 10 | issue = 4 Suppl | pages = 187S–194S | year = 1989 | pmid = 2605967 |  doi = 10.1016/0197-2456(89)90057-3 }}&amp;lt;/ref&amp;gt;).  If the randomization procedure causes an imbalance in covariates related to the outcome across groups, estimates of effect may be [[bias of an estimator|biased]] if not adjusted for the covariates (which may be unmeasured and therefore impossible to adjust for).&lt;br /&gt;
* '''最大化统计能力'''，尤其是在亚组分析中。一般来说，相等的组规模将最大化统计能力，然而，不相等的组规模对于某些分析来说可能更强大(例如，使用Dunnett程序对安慰剂与几个剂量进行多次比较)，并且有时由于非分析性原因而被采用(例如，如果有更高的机会获得试验治疗，患者可能更有动力登记，或者监管机构可能要求最少数量的患者接受治疗)。&lt;br /&gt;
&lt;br /&gt;
* '''最小化选择偏差'''。如果调查人员可以有意识或无意识地在治疗之间优先招募患者，就可能发生这种情况。一个好的随机化过程是不可预测的，因此研究人员不能根据先前的治疗分配来猜测下一个受试者的分组。当已知以前的治疗方案时(如在非盲法研究中)或可以猜到(如果一种药物有明显的副作用)，选择偏倚的风险最高。&lt;br /&gt;
&lt;br /&gt;
* '''最小化分配偏差(或混淆)'''。当影响结果的协变量在治疗组之间分布不均，并且治疗效果与协变量的效果混淆时(即“偶然偏差”)，可能会出现这种情况。如果随机化程序导致与各组结果相关的协变量失衡，如果不对协变量进行调整，效果估计可能会有偏差(这可能无法测量，因此无法调整)。&lt;br /&gt;
&lt;br /&gt;
However, no single randomization procedure meets those goals in every circumstance, so researchers must select a procedure for a given study based on its advantages and disadvantages.&lt;br /&gt;
&lt;br /&gt;
However, no single randomization procedure meets those goals in every circumstance, so researchers must select a procedure for a given study based on its advantages and disadvantages.&lt;br /&gt;
&lt;br /&gt;
然而，没有一个单一的随机化程序在每种情况下都能满足这些目标，因此研究人员必须根据其优点和缺点来选择一个给定的研究程序。&lt;br /&gt;
&lt;br /&gt;
==== Simple ====&lt;br /&gt;
&lt;br /&gt;
This is a commonly used and intuitive procedure, similar to &amp;quot;repeated fair coin-tossing.&amp;quot;&amp;lt;ref name=&amp;quot;SchulzGrimes2002&amp;quot;/&amp;gt; Also known as &amp;quot;complete&amp;quot; or &amp;quot;unrestricted&amp;quot; randomization, it is [[Robust statistics|robust]] against both selection and accidental biases. However, its main drawback is the possibility of imbalanced group sizes in small RCTs.  It is therefore recommended only for RCTs with over 200 subjects.&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;&amp;gt;{{Cite journal |vauthors=Lachin JM, Matts JP, Wei LJ | title = Randomization in clinical trials: conclusions and recommendations | journal = [[Controlled Clinical Trials]] | volume = 9 | issue = 4 | pages = 365–74 | year = 1988 | pmid = 3203526 |  doi = 10.1016/0197-2456(88)90049-9 | hdl = 2027.42/27041 | url = https://deepblue.lib.umich.edu/bitstream/2027.42/27041/1/0000029.pdf | hdl-access = free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
This is a commonly used and intuitive procedure, similar to &amp;quot;repeated fair coin-tossing.&amp;quot; Also known as &amp;quot;complete&amp;quot; or &amp;quot;unrestricted&amp;quot; randomization, it is robust against both selection and accidental biases. However, its main drawback is the possibility of imbalanced group sizes in small RCTs. It is therefore recommended only for RCTs with over 200 subjects.这是一个常用且直观的程序，类似于“反复公平抛硬币”，也被称为“完全”或“无限制”随机化，它对选择和意外偏差都是稳健的。然而，它的主要缺点是在小的随机对照试验中群体规模不平衡的可能性。因此，建议仅用于受试者超过200人时进行随机对照试验。&lt;br /&gt;
&lt;br /&gt;
==== Restricted ====&lt;br /&gt;
&lt;br /&gt;
To balance group sizes in smaller RCTs, some form of [[restricted randomization|&amp;quot;restricted&amp;quot; randomization]] is recommended.&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;/&amp;gt;  The major types of restricted randomization used in RCTs are:&lt;br /&gt;
&lt;br /&gt;
* '''[[Randomized block design|Permuted-block randomization]]''' or '''blocked randomization''': a &amp;quot;block size&amp;quot; and &amp;quot;allocation ratio&amp;quot; (number of subjects in one group versus the other group) are specified, and subjects are allocated randomly within each block.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt; For example, a block size of 6 and an allocation ratio of 2:1 would lead to random assignment of 4 subjects to one group and 2 to the other. This type of randomization can be combined with &amp;quot;[[stratified randomization]]&amp;quot;, for example by center in a [[multicenter trial]], to &amp;quot;ensure good balance of participant characteristics in each group.&amp;quot;&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt; A special case of permuted-block randomization is ''random allocation'', in which the entire sample is treated as one block.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt; The major disadvantage of permuted-block randomization is that even if the block sizes are large and randomly varied, the procedure can lead to selection bias.&amp;lt;ref name=&amp;quot;Lachin-1988a&amp;quot;/&amp;gt; Another disadvantage is that &amp;quot;proper&amp;quot; analysis of data from permuted-block-randomized RCTs requires stratification by blocks.&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
* '''Adaptive biased-coin randomization''' methods (of which '''urn randomization''' is the most widely known type): In these relatively uncommon methods, the probability of being assigned to a group decreases if the group is overrepresented and increases if the group is underrepresented.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt; The methods are thought to be less affected by selection bias than permuted-block randomization.&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
为了平衡较小随机对照试验中的组规模，建议采用某种形式的“限制性”随机化。随机对照试验中主要使用的限制随机化类型有:&lt;br /&gt;
&lt;br /&gt;
* '''置换区组随机化'''或'''区组随机化'''：规定了“区组大小”和“分配比例”(一组受试者相对于另一组受试者的数量)，受试者在每个区组内随机分配。例如，块大小为6，分配比例为2:1，将导致4个受试者随机分配到一个组，2个分配到另一个组。这种类型的随机化可以与“分层随机化”相结合，例如通过多中心试验中的中心，以“确保每个组中参与者特征的良好平衡。”置换块随机化的一个特殊情况是随机分配，其中整个样本被视为一个块。置换块随机化的主要缺点是，即使块大小很大且随机变化，该过程也会导致选择偏差。另一个缺点是，对置换区组随机对照试验数据的“适当”分析需要按区组分层。&lt;br /&gt;
&lt;br /&gt;
* '''自适应有偏-硬币随机化方法'''（其中瓮随机化是最广为人知的类型）：在这些相对不常见的方法中，如果一个组的代表人数过多，被分配到该组的概率会降低，如果该组的代表人数不足，被分配到该组的概率会增加。这些方法被认为比置换块随机化受选择偏差的影响更小。&lt;br /&gt;
==== Adaptive ====&lt;br /&gt;
&lt;br /&gt;
At least two types of &amp;quot;adaptive&amp;quot; randomization procedures have been used in RCTs, but much less frequently than simple or restricted randomization:&lt;br /&gt;
&lt;br /&gt;
* '''Covariate-adaptive randomization''', of which one type is '''[[Minimisation (clinical trials)|minimization]]''': The probability of being assigned to a group varies in order to minimize &amp;quot;covariate imbalance.&amp;quot;&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;/&amp;gt; Minimization is reported to have &amp;quot;supporters and detractors&amp;quot;&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt; because only the first subject's group assignment is truly chosen at random, the method does not necessarily eliminate bias on unknown factors.&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
* '''Response-adaptive randomization''', also known as '''outcome-adaptive randomization''': The probability of being assigned to a group increases if the responses of the prior patients in the group were favorable.&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;/&amp;gt; Although arguments have been made that this approach is more ethical than other types of randomization when the probability that a treatment is effective or ineffective increases during the course of an RCT, ethicists have not yet studied the approach in detail.&amp;lt;ref name=&amp;quot;Rosenberger-1993&amp;quot;&amp;gt;{{Cite journal |vauthors=Rosenberger WF, Lachin JM | title = The use of response-adaptive designs in clinical trials | journal = [[Controlled Clinical Trials]] | volume = 14 | issue = 6 | pages = 471–84 | year = 1993 | pmid = 8119063 |  doi = 10.1016/0197-2456(93)90028-C }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
在随机对照试验中，至少使用了两种类型的“适应性”随机化程序，但频率远低于简单或限制性随机化：&lt;br /&gt;
&lt;br /&gt;
* '''协变量自适应随机化'''，其中一种类型是最小化：被分配到一个组的概率是变化的，以便最小化“协变量不平衡”。据报道，最小化有“支持者和诋毁者”，因为只有第一个受试者的群组分配是真正随机选择的，该方法不一定能消除对未知因素的偏见。&lt;br /&gt;
&lt;br /&gt;
* '''应答自适应随机化'''，也称为'''结果自适应随机化：'''如果组中先前患者的应答是有利的，则被分配到一个组的概率增加。虽然有人认为，当治疗有效或无效的概率在RCT过程中增加时，这种方法比其他类型的随机化更符合伦理，但伦理学家尚未详细研究这种方法。&lt;br /&gt;
=== Allocation concealment ===&lt;br /&gt;
&lt;br /&gt;
{{main|Allocation concealment}}&lt;br /&gt;
&lt;br /&gt;
&amp;quot;Allocation concealment&amp;quot; (defined as &amp;quot;the procedure for protecting the randomization process so that the treatment to be allocated is not known before the patient is entered into the study&amp;quot;) is important in RCTs.&amp;lt;ref name=&amp;quot;Forder-2005&amp;quot;&amp;gt;{{Cite journal |vauthors=Forder PM, Gebski VJ, Keech AC | title = Allocation concealment and blinding: when ignorance is bliss | journal = Med J Aust | volume = 182 | issue = 2 | pages = 87–9 | year = 2005 | url = http://www.mja.com.au/public/issues/182_02_170105/for10877_fm.html | pmid = 15651970 | doi = 10.5694/j.1326-5377.2005.tb06584.x | s2cid = 202149 }}&amp;lt;/ref&amp;gt; In practice, clinical investigators in RCTs often find it difficult to maintain impartiality. Stories abound of investigators holding up sealed envelopes to lights or ransacking offices to determine group assignments in order to dictate the assignment of their next patient.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;&amp;gt;{{Cite journal | title = Allocation concealment in randomised trials: defending against deciphering | journal = Lancet | volume = 359 | issue = 9306 | pages = 614–8 | year = 2002 | doi = 10.1016/S0140-6736(02)07750-4 | url =https://www.who.int/entity/rhl/LANCET_614-618.pdf | pmid = 11867132 |vauthors=Schulz KF, Grimes DA | s2cid = 12902486 }}&amp;lt;/ref&amp;gt; Such practices introduce selection bias and [[Lurking variable|confounders]] (both of which should be minimized by randomization), possibly distorting the results of the study.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt; Adequate allocation concealment should defeat patients and investigators from discovering treatment allocation once a study is underway and after the study has concluded.  Treatment related side-effects or adverse events may be specific enough to reveal allocation to investigators or patients thereby introducing bias or influencing any subjective parameters collected by investigators or requested from subjects.&lt;br /&gt;
&lt;br /&gt;
“分配隐藏”(定义为“保护随机化过程的程序，以便在病人进入研究之前不知道要分配的治疗”)在随机对照试验中很重要。在实践中，临床研究人员在随机对照试验中常常发现难以保持公正性。关于调查人员将密封的信封举到灯光下或者搜查办公室来决定群组分配，以便指定下一个病人的分配的故事比比皆是。这种做法引入了选择偏差和混杂因素(这两者都应该通过随机化来减少) ，可能会扭曲研究结果。一旦研究开始并在研究结束后，充分的分配隐藏应该会阻止患者和研究者发现治疗分配。与治疗相关的副作用或不良事件可能足够具体，足以向研究者或患者揭示分配情况，从而引入偏差或影响研究者收集的或受试者要求的任何主观参数。&lt;br /&gt;
&lt;br /&gt;
Some standard methods of ensuring allocation concealment include sequentially numbered, opaque, sealed envelopes (SNOSE); sequentially numbered containers; pharmacy controlled randomization; and central randomization. It is recommended that allocation concealment methods be included in an RCT's protocol, and that the allocation concealment methods should be reported in detail in a publication of an RCT's results; however, a 2005 study determined that most RCTs have unclear allocation concealment in their protocols, in their publications, or both. On the other hand, a 2008 study of 146 meta-analyses concluded that the results of RCTs with inadequate or unclear allocation concealment tended to be biased toward beneficial effects only if the RCTs' outcomes were subjective as opposed to objective.&lt;br /&gt;
&lt;br /&gt;
一些确保分配隐藏的标准方法包括顺序编号、不透明、密封信封(SNOSE)；顺序编号的容器；药学控制的随机化；和中心随机化。分配隐藏方法被建议纳入RCT议定书，并在RCT结果的出版物中详细报告分配隐藏方法；然而，2005年的一项研究发现，大多数随机对照试验在其方案、出版物或两者中都有不清楚的分配隐藏。另一方面，2008年的一项对146项元分析的研究得出结论，分配隐瞒不充分或不明确的随机对照试验的结果往往只有在随机对照试验的结果是主观的而不是客观的情况下才会偏向于有益的结果。&lt;br /&gt;
=== Sample size ===&lt;br /&gt;
&lt;br /&gt;
{{Main|Sample size determination}}The number of treatment units (subjects or groups of subjects) assigned to control and treatment groups, affects an RCT's reliability. If the effect of the treatment is small, the number of treatment units in either group may be insufficient for rejecting the null hypothesis in the respective statistical test. The failure to reject the null hypothesis would imply that the treatment shows no statistically significant effect on the treated ''in a given test''. But as the sample size increases, the same RCT may be able to demonstrate a significant effect of the treatment, even if this effect is small.&lt;br /&gt;
&lt;br /&gt;
分配给控制组和治疗组的治疗单位(受试者或受试者组)的样本量影响 RCT 的可靠性。如果治疗的效果很小，任何一组的治疗单位的样本量都可能不足以在各自的统计检验中拒绝零假设。拒绝无效假设的失败意味着在给定的试验中，治疗对被治疗者没有统计学上的显著影响。但是随着样本量的增加，同样的RCT可能能够证明治疗的显著效果，即使这种效果很小。&lt;br /&gt;
&lt;br /&gt;
== Blinding ==&lt;br /&gt;
&lt;br /&gt;
{{main|Blinded experiment}}&lt;br /&gt;
&lt;br /&gt;
An RCT may be [[Blind experiment|blinded]], (also called &amp;quot;masked&amp;quot;) by &amp;quot;procedures that prevent study participants, caregivers, or outcome assessors from knowing which intervention was received.&amp;quot;&amp;lt;ref name=&amp;quot;Wood-2008&amp;quot;&amp;gt;{{Cite journal |vauthors=Wood L, Egger M, Gluud LL, Schulz KF, Jüni P, Altman DG, Gluud C, Martin RM, Wood AJ, Sterne JA | title = Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study | journal = BMJ | volume = 336 | issue = 7644 | pages = 601–5 | year = 2008 | doi = 10.1136/bmj.39465.451748.AD | pmid = 18316340 | pmc = 2267990 }}&amp;lt;/ref&amp;gt; Unlike allocation concealment, blinding is sometimes inappropriate or impossible to perform in an RCT; for example, if an RCT involves a treatment in which active participation of the patient is necessary (e.g., [[physical therapy]]), participants cannot be blinded to the intervention.&lt;br /&gt;
&lt;br /&gt;
一项RCT的盲法是指阻止研究参与者、照顾者或结果评估者知道哪些干预措施，这一程序也称“蒙面”。与分配隐藏不同，在RCT，致盲有时是不合适的或不可能的；例如，如果RCT涉及需要患者积极参与的治疗(例如物理治疗)，参与者不能对干预视而不见。&lt;br /&gt;
&lt;br /&gt;
Traditionally, blinded RCTs have been classified as &amp;quot;single-blind&amp;quot;, &amp;quot;double-blind&amp;quot;, or &amp;quot;triple-blind&amp;quot;; however, in 2001 and 2006 two studies showed that these terms have different meanings for different people.&amp;lt;ref name=&amp;quot;Devereaux-2001&amp;quot;&amp;gt;{{Cite journal |vauthors=Devereaux PJ, Manns BJ, Ghali WA, Quan H, Lacchetti C, Montori VM, Bhandari M, Guyatt GH | title = Physician interpretations and textbook definitions of blinding terminology in randomized controlled trials | journal = [[J Am Med Assoc]] | volume = 285 | issue = 15 | pages = 2000–3 | year = 2001 | doi =  10.1001/jama.285.15.2000| pmid = 11308438 | doi-access = free }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Haahr-2006&amp;quot;&amp;gt;{{Cite journal |vauthors=Haahr MT, Hróbjartsson A | title = Who is blinded in randomized clinical trials? A study of 200 trials and a survey of authors | journal = Clin Trials | volume = 3 | issue = 4 | pages = 360–5 | year = 2006 | doi = 10.1177/1740774506069153 | pmid = 17060210 | s2cid = 23818514 }}&amp;lt;/ref&amp;gt;  The 2010 [[Consolidated Standards of Reporting Trials|CONSORT Statement]] specifies that authors and editors should not use the terms &amp;quot;single-blind&amp;quot;, &amp;quot;double-blind&amp;quot;, and &amp;quot;triple-blind&amp;quot;; instead, reports of blinded RCT should discuss &amp;quot;If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how.&amp;quot;&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
传统上，盲法随机对照试验分为“单盲”、“双盲”或“三盲”；然而，2001年和2006年的两项研究表明，这些术语对不同的人有不同的含义。2010年CONSORT 声明明确指出，作者和编辑不应使用”单盲”、”双盲”和”三盲”等术语；相反，关于盲法 RCT 的报告应讨论”如果完成，干预分配后谁被“蒙面”了(例如，参与者、护理提供者、评估结果的人员)以及其原因”。&lt;br /&gt;
&lt;br /&gt;
RCTs without blinding are referred to as &amp;quot;unblinded&amp;quot;,&amp;lt;ref name=&amp;quot;Marson-2007&amp;quot;&amp;gt;{{Cite journal  |vauthors=Marson AG, Al-Kharusi AM, Alwaidh M, Appleton R, Baker GA, Chadwick DW, etal | title = The SANAD study of effectiveness of valproate, lamotrigine, or topiramate for generalised and unclassifiable epilepsy: an unblinded randomised controlled trial | journal = [[The Lancet|Lancet]] | volume = 369 | issue = 9566 | pages = 1016–26 | year = 2007 | doi = 10.1016/S0140-6736(07)60461-9 | pmid = 17382828 | pmc = 2039891 }}&amp;lt;/ref&amp;gt; &amp;quot;open&amp;quot;,&amp;lt;ref name=&amp;quot;Chan-1995&amp;quot;&amp;gt;{{Cite journal |vauthors=Chan R, Hemeryck L, O'Regan M, Clancy L, Feely J | title = Oral versus intravenous antibiotics for community acquired lower respiratory tract infection in a general hospital: open, randomised controlled trial | journal = [[BMJ]] | volume = 310 | issue = 6991 | pages = 1360–2 | year = 1995 | pmid = 7787537 | pmc = 2549744 | doi=10.1136/bmj.310.6991.1360}}&amp;lt;/ref&amp;gt; or (if the intervention is a medication) &amp;quot;[[Open-label trial|open-label]]&amp;quot;.&amp;lt;ref name=&amp;quot;Fukase-2008&amp;quot;&amp;gt;{{Cite journal | author = Fukase K, Kato M, Kikuchi S, Inoue K, Uemura N, Okamoto S, Terao S, Amagai K, Hayashi S, Asaka M; Japan Gast Study Group | title = Effect of eradication of Helicobacter pylori on incidence of metachronous gastric carcinoma after endoscopic resection of early gastric cancer: an open-label, randomised controlled trial | journal = Lancet | volume = 372 | issue = 9636 | pages = 392–7 | year = 2008 | doi = 10.1016/S0140-6736(08)61159-9 | pmid = 18675689 | hdl = 2115/34681 | s2cid = 13741892 | url = https://eprints.lib.hokudai.ac.jp/dspace/bitstream/2115/34681/1/asaka.pdf | hdl-access = free }}&amp;lt;/ref&amp;gt; In 2008 a study concluded that the results of unblinded RCTs tended to be biased toward beneficial effects only if the RCTs' outcomes were subjective as opposed to objective;&amp;lt;ref name=&amp;quot;Wood-2008&amp;quot;/&amp;gt; for example, in an RCT of treatments for [[multiple sclerosis]], unblinded neurologists (but not the blinded neurologists) felt that the treatments were beneficial.&amp;lt;ref name=&amp;quot;Noseworthy-1994&amp;quot;&amp;gt;{{Cite journal |vauthors=Noseworthy JH, Ebers GC, Vandervoort MK, Farquhar RE, Yetisir E, Roberts R | author-link1=John H. Noseworthy|title = The impact of blinding on the results of a randomized, placebo-controlled multiple sclerosis clinical trial | journal = Neurology | volume = 44 | issue = 1 | pages = 16–20 | year = 1994 | url = http://www.neurology.org/cgi/content/abstract/44/1/16 | pmid = 8290055 | doi=10.1212/wnl.44.1.16| s2cid=2663997}}&amp;lt;/ref&amp;gt; In pragmatic RCTs, although the participants and providers are often unblinded, it is &amp;quot;still desirable and often possible to blind the assessor or obtain an objective source of data for evaluation of outcomes.&amp;quot;&amp;lt;ref name=&amp;quot;Zwarenstein-2008&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
没有盲法的随机对照试验被称为“未盲法”，也称“开放”，或者(如果干预是一种药物)“开放标签”。2008年的一项研究得出结论，只有当随机对照试验的结果是主观的而不是客观的时候，非盲法随机对照试验的结果往往偏向于有益的结果；例如，在RCT多发性硬化症的治疗中，未盲的神经学家认为治疗是有益的。在实用的随机对照试验中，尽管参与者和提供者往往是非盲的，但是”仍然需要并且往往可能使评估者“蒙面”，以获得评估结果的客观数据来源”。&lt;br /&gt;
&lt;br /&gt;
== Analysis of data ==&lt;br /&gt;
&lt;br /&gt;
The types of statistical methods used in RCTs depend on the characteristics of the data and include:&lt;br /&gt;
&lt;br /&gt;
* For [[dichotomous]] (binary) outcome data, [[logistic regression]] (e.g., to predict sustained virological response after receipt of [[peginterferon alfa-2a]] for [[hepatitis C]]&amp;lt;ref name=&amp;quot;Manns-2001&amp;quot;&amp;gt;{{Cite journal |vauthors=Manns MP, McHutchison JG, Gordon SC, Rustgi VK, Shiffman M, Reindollar R, Goodman ZD, Koury K, Ling M, Albrecht JK | title = Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial | journal = [[The Lancet|Lancet]] | volume = 358 | issue = 9286 | pages = 958–65 | year = 2001 | doi = 10.1016/S0140-6736(01)06102-5 | pmid = 11583749 | s2cid = 14583372 }}&amp;lt;/ref&amp;gt;) and other methods can be used.&lt;br /&gt;
&lt;br /&gt;
* For continuous outcome data, [[analysis of covariance]] (e.g., for changes in blood lipid levels after receipt of [[atorvastatin]] after [[acute coronary syndrome]]&amp;lt;ref name=&amp;quot;Schwartz-2001&amp;quot;&amp;gt;{{Cite journal | author = Schwartz GG, Olsson AG, Ezekowitz MD, Ganz P, Oliver MF, Waters D, Zeiher A, Chaitman BR, Leslie S, Stern T; Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering (MIRACL) Study Investigators | title = Effects of atorvastatin on early recurrent ischemic events in acute coronary syndromes: the MIRACL study: a randomized controlled trial | journal = [[J Am Med Assoc]] | volume = 285 | issue = 13 | pages = 1711–8 | year = 2001 | pmid = 11277825 | doi = 10.1001/jama.285.13.1711 | doi-access = free }}&amp;lt;/ref&amp;gt;) tests the effects of predictor variables.&lt;br /&gt;
&lt;br /&gt;
* For time-to-event outcome data that may be [[Censoring (statistics)|censored]], [[survival analysis]] (e.g., [[Kaplan–Meier estimator]]s and [[Cox proportional hazards model]]s for time to [[coronary heart disease]] after receipt of [[Hormone replacement therapy (menopause)|hormone replacement therapy in menopause]]&amp;lt;ref name=&amp;quot;Rossouw-2002&amp;quot;&amp;gt;{{Cite journal | author = Rossouw JE, Anderson GL, [[Ross Prentice|Prentice RL]], LaCroix AZ, Kooperberg C, Stefanick ML, Jackson RD, Beresford SA, Howard BV, Johnson KC, Kotchen JM, Ockene J; Writing Group for the Women's Health Initiative Investigators | title = Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial | journal = [[J Am Med Assoc]] | volume = 288 | issue = 3 | pages = 321–33 | year = 2002 | pmid = 12117397 | doi = 10.1001/jama.288.3.321 | s2cid = 20149703 | url = https://escholarship.org/content/qt3mr6f93p/qt3mr6f93p.pdf?t=prll4c | doi-access = free }}&amp;lt;/ref&amp;gt;) is appropriate.&lt;br /&gt;
&lt;br /&gt;
随机对照试验中使用的统计方法类型取决于数据的特征，包括：&lt;br /&gt;
&lt;br /&gt;
* 对于二元结果数据，可以使用逻辑回归(例如，预测接受聚乙二醇干扰素α-2a治疗丙型肝炎后的持续病毒学应答)和其他方法。&lt;br /&gt;
&lt;br /&gt;
* 对于连续的结果数据，协方差分析(例如，急性冠状动脉综合征后接受阿托伐他汀后血脂水平的变化)可以用于检测预测变量效果。&lt;br /&gt;
&lt;br /&gt;
* 对于可能删失的时间到事件结果数据，生存分析(如绝经后接受激素替代治疗后冠心病发生时间的卡普兰-迈耶估计值和考克斯比例风险模型)是合适的。&lt;br /&gt;
Regardless of the statistical methods used, important considerations in the analysis of RCT data include:&lt;br /&gt;
&lt;br /&gt;
* Whether an RCT should be stopped early due to interim results.  For example, RCTs may be stopped early if an intervention produces &amp;quot;larger than expected benefit or harm&amp;quot;, or if &amp;quot;investigators find evidence of no important difference between experimental and control interventions.&amp;quot;&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
* The extent to which the groups can be analyzed exactly as they existed upon randomization (i.e., whether a so-called &amp;quot;[[intention-to-treat analysis]]&amp;quot; is used). A &amp;quot;pure&amp;quot; intention-to-treat analysis is &amp;quot;possible only when complete outcome data are available&amp;quot; for all randomized subjects;&amp;lt;ref name=&amp;quot;Hollis-1999&amp;quot;&amp;gt;{{Cite journal |vauthors=Hollis S, Campbell F | title = What is meant by intention to treat analysis? Survey of published randomised controlled trials | journal = [[Br Med J]] | volume = 319 | issue = 7211 | pages = 670–4 | year = 1999 | pmid = 10480822 | pmc = 28218 | doi=10.1136/bmj.319.7211.670}}&amp;lt;/ref&amp;gt; when some outcome data are missing, options include analyzing only cases with known outcomes and using [[Imputation (statistics)|imputed]] data.&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt; Nevertheless, the more that analyses can include all participants in the groups to which they were randomized, the less bias that an RCT will be subject to.&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
* Whether [[subgroup analysis]] should be performed.  These are &amp;quot;often discouraged&amp;quot; because [[multiple comparisons]] may produce false positive findings that cannot be confirmed by other studies.&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
无论使用何种统计方法，RCT数据分析中的重要考虑因素包括：&lt;br /&gt;
&lt;br /&gt;
* 由于中期结果，是否应该提前停止RCT。例如，如果干预产生“大于预期的益处或危害”，或者如果“研究者发现实验干预和对照干预之间没有重要区别的证据”，则可能会提前停止随机对照试验。&lt;br /&gt;
&lt;br /&gt;
* 这些组在多大程度上可以完全按照随机化时的状态进行分析(即，是否使用了所谓的“意向治疗分析”)。一项“纯”意向治疗分析“只有在获得所有随机受试者的完整结果数据时才有可能”；当一些结果数据缺失时，选项包括仅分析具有已知结果的病例和使用估算数据。然而，分析越能包括他们被随机分组的所有参与者，RCT受到的偏见就越少。&lt;br /&gt;
&lt;br /&gt;
* 是否应进行亚组分析。这些“通常是不鼓励的”，因为多次比较可能会产生假阳性结果，而其他研究无法证实。&lt;br /&gt;
== Reporting of results ==&lt;br /&gt;
&lt;br /&gt;
 Is applied in a context or setting similar to that which applies to the control group&lt;br /&gt;
&lt;br /&gt;
应用于类似于应用于控制组的上下文或设置&lt;br /&gt;
&lt;br /&gt;
The ''[[Consolidated Standards of Reporting Trials|CONSORT 2010 Statement]]'' is &amp;quot;an evidence-based, minimum set of recommendations for reporting RCTs.&amp;quot;&amp;lt;ref name=&amp;quot;CONSORT&amp;quot;&amp;gt;{{cite web |url=http://www.consort-statement.org |title=Welcome to the CONSORT statement Website |author=CONSORT Group |access-date=2010-03-29}}&amp;lt;/ref&amp;gt; The CONSORT 2010 checklist contains 25 items (many with sub-items) focusing on &amp;quot;individually randomised, two group, parallel trials&amp;quot; which are the most common type of RCT.&amp;lt;ref name=&amp;quot;Schulz-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
 Can be isolated from other activities—and the purpose of the study is to assess this isolated effect&lt;br /&gt;
&lt;br /&gt;
这项研究的目的是评估这种孤立效应&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
 Has a short timescale between its implementation and maturity of its effects&lt;br /&gt;
&lt;br /&gt;
从实施到效果成熟之间的时间跨度很短&lt;br /&gt;
&lt;br /&gt;
For other RCT study designs, &amp;quot;[[Consolidated Standards of Reporting Trials|CONSORT extensions]]&amp;quot; have been published, some examples are:&lt;br /&gt;
&lt;br /&gt;
* Consort 2010 Statement: Extension to Cluster Randomised Trials&amp;lt;ref name=&amp;quot;CONSORT2010-EXTENSION-CLUSTER&amp;quot;&amp;gt;{{Cite journal |vauthors=Campbell MK, Piaggio G, Elbourne DR, Altman DG| title = Consort 2010 statement: extension to cluster randomised trials | journal = [[BMJ]] | volume = 345| pages = e5661 | year = 2012  | pmid = 22951546 | doi = 10.1136/bmj.e5661 | doi-access = free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
And the causal mechanisms:&lt;br /&gt;
&lt;br /&gt;
以及因果机制:&lt;br /&gt;
&lt;br /&gt;
* Consort 2010 Statement: Non-Pharmacologic Treatment Interventions&amp;lt;ref name=&amp;quot;CONSORT2010-EXTENSION-NON-PHARMACOLOGIC-1&amp;quot;&amp;gt;{{Cite journal |vauthors=Boutron I, Moher D, Altman DG, Schulz K, Ravaud P| title = Extending the CONSORT Statement to randomized trials of nonpharmacologic treatment: explanation and elaboration | journal = [[Annals of Internal Medicine]] | volume = 148| issue = 4 | year = 2008 | pages=295–309  | pmid = 18283207 | doi=10.7326/0003-4819-148-4-200802190-00008| doi-access = free }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;CONSORT2010-EXTENSION-NON-PHARMACOLOGIC-2&amp;quot;&amp;gt;{{Cite journal |vauthors=Boutron I, Moher D, Altman DG, Schulz K, Ravaud P| title = Methods and Processes of the CONSORT Group: Example of an Extension for Trials Assessing Nonpharmacologic Treatments | journal = [[Annals of Internal Medicine]] | volume = 148| issue = 4 | year = 2008  | pmid = 18283201 | doi=10.7326/0003-4819-148-4-200802190-00008-w1 | pages=W60–6| doi-access = free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&amp;lt;li value=&amp;quot;5&amp;quot;&amp;gt;Are either known to the researchers, or else all possible alternatives can be tested&lt;br /&gt;
&lt;br /&gt;
&amp;lt; li value = &amp;quot; 5&amp;quot; &amp;gt; 要么被研究人员知道，要么所有可能的替代方案都可以被测试&lt;br /&gt;
&lt;br /&gt;
=== Relative importance and observational studies ===&lt;br /&gt;
&lt;br /&gt;
 Do not involve significant feedback mechanisms between the intervention group and external environments&lt;br /&gt;
&lt;br /&gt;
不涉及干预组和外部环境之间的重要反馈机制&lt;br /&gt;
&lt;br /&gt;
Two studies published in ''[[The New England Journal of Medicine]]'' in 2000 found that [[Observational study|observational studies]] and RCTs overall produced similar results.&amp;lt;ref name=&amp;quot;Benson-2000&amp;quot;&amp;gt;{{Cite journal |vauthors=Benson K, Hartz AJ | title = A comparison of observational studies and randomized, controlled trials | journal = [[N Engl J Med]] | volume = 342 | issue = 25 | pages = 1878–86 | year = 2000 | pmid = 10861324 | doi = 10.1056/NEJM200006223422506 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Concato-2000&amp;quot;&amp;gt;{{Cite journal |vauthors=Concato J, Shah N, Horwitz RI | title = Randomized, controlled trials, observational studies, and the hierarchy of research designs | journal = [[N Engl J Med]] | volume = 342 | issue = 25 | pages = 1887–92 | year = 2000 | url = http://nejm.highwire.org/cgi/content/full/342/25/1887 | pmid = 10861325 | doi = 10.1056/NEJM200006223422507 | pmc = 1557642 }}&amp;lt;/ref&amp;gt; The authors of the 2000 findings questioned the belief that &amp;quot;observational studies should not be used for defining evidence-based medical care&amp;quot; and that RCTs' results are &amp;quot;evidence of the highest grade.&amp;quot;&amp;lt;ref name=&amp;quot;Benson-2000&amp;quot;/&amp;gt;&amp;lt;ref name=&amp;quot;Concato-2000&amp;quot;/&amp;gt; However, a 2001 study published in ''[[Journal of the American Medical Association]]'' concluded that &amp;quot;discrepancies beyond chance do occur and differences in estimated magnitude of treatment effect are very common&amp;quot; between observational studies and RCTs.&amp;lt;ref name=&amp;quot;Ioannidis-2001&amp;quot;&amp;gt;{{Cite journal |vauthors=Ioannidis JP, Haidich AB, Pappa M, Pantazis N, Kokori SI, Tektonidou MG, Contopoulos-Ioannidis DG, Lau J | title = Comparison of evidence of treatment effects in randomized and nonrandomized studies | journal = [[J Am Med Assoc]] | volume = 286 | issue = 7 | pages = 821–30 | year = 2001 | pmid = 11497536 | doi = 10.1001/jama.286.7.821 | citeseerx = 10.1.1.590.2854 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Have a stable and predictable relationship to exogenous factors&lt;br /&gt;
&lt;br /&gt;
与外部因素有稳定和可预测的关系&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
 Would act in the same way if the control group and intervention group were reversed&lt;br /&gt;
&lt;br /&gt;
如果对照组和干预组的情况相反，他们也会以同样的方式行动&lt;br /&gt;
&lt;br /&gt;
Two other lines of reasoning question RCTs' contribution to scientific knowledge beyond other types of studies:&lt;br /&gt;
* If study designs are ranked by their potential for new discoveries, then [[Anecdotal evidence#Scientific context|anecdotal evidence]] would be at the top of the list, followed by observational studies, followed by RCTs.&amp;lt;ref name=&amp;quot;Vandenbroucke-2008&amp;quot;&amp;gt;{{Cite journal | author = Vandenbroucke JP | title = Observational research, randomised trials, and two views of medical science | journal = [[PLoS Med]] | volume = 5 | issue = 3 | pages = e67 | year = 2008 | doi = 10.1371/journal.pmed.0050067 | pmid = 18336067 | pmc = 2265762 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* RCTs may be unnecessary for treatments that have dramatic and rapid effects relative to the expected stable or progressively worse natural course of the condition treated.&amp;lt;ref name=&amp;quot;Black-1996&amp;quot;/&amp;gt;&amp;lt;ref name=&amp;quot;Glasziou-2007&amp;quot;&amp;gt;{{Cite journal |vauthors=Glasziou P, Chalmers I, Rawlins M, McCulloch P | title = When are randomised trials unnecessary? Picking signal from noise | journal = [[Br Med J]] | volume = 334 | issue = 7589 | pages = 349–51 | year = 2007 | doi = 10.1136/bmj.39070.527986.68 | pmc=1800999 | pmid = 17303884 }}&amp;lt;/ref&amp;gt; One example is [[History of cancer chemotherapy#Combination chemotherapy|combination chemotherapy]] including [[cisplatin]] for [[Metastasis|metastatic]] [[testicular cancer]], which increased the cure rate from 5% to 60% in a 1977 non-randomized study.&amp;lt;ref name=&amp;quot;Glasziou-2007&amp;quot;/&amp;gt;&amp;lt;ref name=&amp;quot;Einhorn-2002&amp;quot;&amp;gt;{{Cite journal | author = Einhorn LH | author-link = Lawrence Einhorn | title = Curing metastatic testicular cancer | journal = [[Proc Natl Acad Sci U S A]] | volume = 99 | issue = 7 | pages = 4592–5 | year = 2002 | doi = 10.1073/pnas.072067999 | pmid = 11904381 | pmc = 123692 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
A 2005 review found 83 randomized experiments in criminology published in 1982–2004, compared with only 35 published in 1957–1981. The authors classified the studies they found into five categories: &amp;quot;policing&amp;quot;, &amp;quot;prevention&amp;quot;, &amp;quot;corrections&amp;quot;, &amp;quot;court&amp;quot;, and &amp;quot;community&amp;quot;.&lt;br /&gt;
&lt;br /&gt;
2005年的一项研究发现，1982年至2004年发表的犯罪学随机实验有83项，而1957年至1981年发表的只有35项。作者将他们发现的研究分为五类: “警务”、“预防”、“惩戒”、“法院”和“社区”。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
=== Interpretation of statistical results ===&lt;br /&gt;
&lt;br /&gt;
Like all statistical methods, RCTs are subject to both [[type I and type II errors|type I (&amp;quot;false positive&amp;quot;) and type II (&amp;quot;false negative&amp;quot;) statistical errors]].  Regarding Type I errors, a typical RCT will use 0.05 (i.e., 1 in 20) as the probability that the RCT will falsely find two equally effective treatments significantly different.&amp;lt;ref name=&amp;quot;Wittes-2002&amp;quot;&amp;gt;{{Cite journal | author = Wittes J | title = Sample size calculations for randomized controlled trials | journal = [[Epidemiol Rev]] | volume = 24 | issue = 1 | pages = 39–53 | year = 2002 | doi = 10.1093/epirev/24.1.39 | pmid = 12119854 | doi-access = free }}&amp;lt;/ref&amp;gt; Regarding Type II errors, despite the publication of a 1978 paper noting that the [[sample size]]s of many &amp;quot;negative&amp;quot; RCTs were too small to make definitive conclusions about the negative results,&amp;lt;ref name=&amp;quot;Freiman-1978&amp;quot;&amp;gt;{{Cite journal | doi = 10.1056/NEJM197809282991304 |vauthors=Freiman JA, Chalmers TC, ((Smith H Jr)), Kuebler RR | title = The importance of beta, the type II error and sample size in the design and interpretation of the randomized control trial. Survey of 71 &amp;quot;negative&amp;quot; trials | journal = [[N Engl J Med]] | volume = 299 | issue = 13 | pages = 690–4 | year = 1978 | pmid = 355881 }}&amp;lt;/ref&amp;gt; by 2005-2006 a sizeable proportion of RCTs still had inaccurate or incompletely reported sample size calculations.&amp;lt;ref name=&amp;quot;Charles-2009&amp;quot;&amp;gt;{{Cite journal |vauthors=Charles P, Giraudeau B, Dechartres A, Baron G, Ravaud P | title = Reporting of sample size calculation in randomised controlled trials: review | journal = [[Br Med J]] | volume = 338 | pages = b1732 | date = 2009-05-12 | doi = 10.1136/bmj.b1732 | pmid = 19435763 | pmc = 2680945 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
RCTs have been used in evaluating a number of educational interventions. Between 1980 and 2016, over 1,000 reports of RCTs have been published. For example, a 2009 study randomized 260 elementary school teachers' classrooms to receive or not receive a program of behavioral screening, classroom intervention, and parent training, and then measured the behavioral and academic performance of their students. Another 2009 study randomized classrooms for 678 first-grade children to receive a classroom-centered intervention, a parent-centered intervention, or no intervention, and then followed their academic outcomes through age 19.&lt;br /&gt;
&lt;br /&gt;
随机对照试验已用于评价一些教育干预措施。从1980年到2016年，已经发表了超过1000篇关于 rct 的报告。例如，2009年的一项研究随机抽取了260名小学教师的课堂，让他们接受或不接受行为筛选、课堂干预和家长培训，然后测量他们学生的行为和学业表现。2009年的另一项研究随机化了678个一年级儿童的课堂，接受了以课堂为中心的干预，以家长为中心的干预，或没有干预，然后跟踪他们的学习成果直到19岁。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
=== Peer review ===&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
A 2017 review of the 10 most cited randomised controlled trials noted poor distribution of background traits, difficulties with blinding, and discussed other assumptions and biases inherent in randomised controlled trials. These include the &amp;quot;unique time period assessment bias&amp;quot;, the &amp;quot;background traits remain constant assumption&amp;quot;, the &amp;quot;average treatment effects limitation&amp;quot;, the &amp;quot;simple treatment at the individual level limitation&amp;quot;, the &amp;quot;all preconditions are fully met assumption&amp;quot;, the &amp;quot;quantitative variable limitation&amp;quot; and the &amp;quot;placebo only or conventional treatment only limitation&amp;quot;.&lt;br /&gt;
&lt;br /&gt;
2017年对10个最常被引用的随机对照试验的回顾指出，背景特征的分布不良，盲法存在困难，并讨论了随机对照试验中固有的其他假设和偏差。其中包括”独特的时间段评估偏差”、”背景特征保持不变的假设”、”平均治疗效果限制”、”个人层面的简单治疗限制”、”所有前提条件都得到充分满足的假设”、”定量变量限制”以及”仅安慰剂或常规治疗限制”。&lt;br /&gt;
&lt;br /&gt;
[[Peer review]] of results is an important part of the [[scientific method]]. Reviewers examine the study results for potential problems with design that could lead to unreliable results (for example by creating a [[systematic bias]]), evaluate the study in the context of related studies and other evidence, and evaluate whether the study can be reasonably considered to have proven its conclusions. To underscore the need for peer review and the danger of over-generalizing conclusions, two Boston-area medical researchers performed a randomized controlled trial in which they randomly assigned either a parachute or an empty backpack to 23 volunteers who jumped from either a biplane or a helicopter. The study was able to accurately report that parachutes fail to reduce injury compared to empty backpacks. The key context that limited the general applicability of this conclusion was that the aircraft were parked on the ground, and participants had only jumped about two feet.&amp;lt;ref&amp;gt;{{cite news |url=https://www.npr.org/sections/health-shots/2018/12/22/679083038/researchers-show-parachutes-dont-work-but-there-s-a-catch |title=Researchers Show Parachutes Don't Work, But There's A Catch |date=22 Dec 2018 |author=Richard Harris}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
== Advantages ==&lt;br /&gt;
&lt;br /&gt;
RCTs are considered to be the most reliable form of [[scientific method|scientific evidence]] in the [[hierarchy of evidence]] that influences healthcare policy and practice because RCTs reduce spurious causality and bias. Results of RCTs may be combined in [[systematic review]]s which are increasingly being used in the conduct of [[evidence-based practice]]. Some examples of scientific organizations' considering RCTs or systematic reviews of RCTs to be the highest-quality evidence available are:&lt;br /&gt;
* As of 1998, the [[National Health and Medical Research Council]] of Australia designated &amp;quot;Level I&amp;quot; evidence as that &amp;quot;obtained from a [[systematic review]] of all relevant randomised controlled trials&amp;quot; and &amp;quot;Level II&amp;quot; evidence as that &amp;quot;obtained from at least one properly designed randomised controlled trial.&amp;quot;&amp;lt;ref&amp;gt;{{cite book |url= http://www.nhmrc.gov.au/_files_nhmrc/file/publications/synopses/cp30.pdf |title= A guide to the development, implementation and evaluation of clinical practice guidelines |author= National Health and Medical Research Council |date=1998-11-16 |publisher= Commonwealth of Australia |location = Canberra | isbn = 978-1-86496-048-8 |page= 56|access-date=2010-03-28}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* Since at least 2001, in making [[clinical practice guideline]] recommendations the [[United States Preventive Services Task Force]] has considered both a study's design and its [[internal validity]] as indicators of its quality.&amp;lt;ref name=&amp;quot;Harris-2001&amp;quot;&amp;gt;{{Cite journal | author = Harris RP, Helfand M, Woolf SH, Lohr KN, Mulrow CD, Teutsch SM, Atkins D; Methods Work Group, Third US Preventive Services Task Force | title = Current methods of the US Preventive Services Task Force: a review of the process | journal = Am J Prev Med | volume = 20 | issue = 3 Suppl | pages = 21–35 | year = 2001 | url = http://www.ahrq.gov/clinic/ajpmsuppl/review.pdf | pmid = 11306229 | doi = 10.1016/S0749-3797(01)00261-6 }}&amp;lt;/ref&amp;gt; It has recognized &amp;quot;evidence obtained from at least one properly randomized controlled trial&amp;quot; with good [[internal validity]] (i.e., a rating of &amp;quot;I-good&amp;quot;) as the highest quality evidence available to it.&amp;lt;ref name=&amp;quot;Harris-2001&amp;quot;/&amp;gt;&lt;br /&gt;
* The [[Evidence-based medicine#Grade Working Group|GRADE Working Group]] concluded in 2008 that &amp;quot;randomised trials without important limitations constitute high quality evidence.&amp;quot;&amp;lt;ref name=&amp;quot;Guyatt-2008&amp;quot;&amp;gt;{{Cite journal | author = Guyatt GH, Oxman AD, Kunz R, Vist GE, Falck-Ytter Y, Schünemann HJ; GRADE Working Group | title = What is &amp;quot;quality of evidence&amp;quot; and why is it important to clinicians? | journal = BMJ | volume = 336 | issue = 7651 | pages = 995–8 |year = 2008 | doi = 10.1136/bmj.39490.551019.BE | pmc = 2364804 | pmid = 18456631 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* For issues involving &amp;quot;Therapy/Prevention, Aetiology/Harm&amp;quot;, the [[Oxford Centre for Evidence-based Medicine]] as of 2011 defined &amp;quot;Level 1a&amp;quot; evidence as a systematic review of RCTs that are consistent with each other, and &amp;quot;Level 1b&amp;quot; evidence as an &amp;quot;individual RCT (with narrow [[Confidence Interval]]).&amp;quot;&amp;lt;ref&amp;gt;{{cite web |url= http://www.cebm.net/index.aspx?o=1025 |title= Levels of evidence |author= Oxford Centre for Evidence-based Medicine |date=2011-09-16 |access-date=2012-02-15}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Notable RCTs with unexpected results that contributed to changes in clinical practice include:&lt;br /&gt;
* After [[Food and Drug Administration]] approval, the [[antiarrhythmic agents]] [[flecainide]] and [[encainide]] came to market in 1986 and 1987 respectively.&amp;lt;ref name=&amp;quot;Anderson-1997&amp;quot;&amp;gt;{{Cite journal |vauthors=Anderson JL, Pratt CM, Waldo AL, Karagounis LA | title = Impact of the Food and Drug Administration approval of flecainide and encainide on coronary artery disease mortality: putting &amp;quot;Deadly Medicine&amp;quot; to the test | journal = Am J Cardiol | volume = 79 | issue = 1 | pages = 43–7 | year = 1997 | url = http://www.ajconline.org/article/S0002-9149%2896%2900673-X/abstract | pmid = 9024734 | doi = 10.1016/S0002-9149(96)00673-X }}&amp;lt;/ref&amp;gt; The non-randomized studies concerning the drugs were characterized as &amp;quot;glowing&amp;quot;,&amp;lt;ref name=&amp;quot;Rubin-2006&amp;quot;&amp;gt;{{cite news |title= In medicine, evidence can be confusing - deluged with studies, doctors try to sort out what works, what doesn't |author= Rubin R |url= https://www.usatoday.com/news/health/2006-10-15-medical-evidence-cover_x.htm |newspaper= USA Today |date= 2006-10-16 |access-date=2010-03-22}}&amp;lt;/ref&amp;gt; and their sales increased to a combined total of approximately 165,000 prescriptions per month in early 1989.&amp;lt;ref name=&amp;quot;Anderson-1997&amp;quot;/&amp;gt;  In that year, however, a preliminary report of an RCT concluded that the two drugs increased mortality.&amp;lt;ref name=&amp;quot;CAST-1989&amp;quot;&amp;gt;{{Cite journal | doi = 10.1056/NEJM198908103210629 | title = Preliminary report: effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction. The Cardiac Arrhythmia Suppression Trial (CAST) Investigators | journal = N Engl J Med | volume = 321 | issue = 6 | pages = 406–12 |year = 1989 | pmid = 2473403 | author1 = Cardiac Arrhythmia Suppression Trial (CAST) Investigators }}&amp;lt;/ref&amp;gt;  Sales of the drugs then decreased.&amp;lt;ref name=&amp;quot;Anderson-1997&amp;quot;/&amp;gt;&lt;br /&gt;
* Prior to 2002, based on observational studies, it was routine for physicians to prescribe hormone replacement therapy for post-menopausal women to prevent [[myocardial infarction]].&amp;lt;ref name=&amp;quot;Rubin-2006&amp;quot;/&amp;gt; In 2002 and 2004, however, published RCTs from the [[Women's Health Initiative]] claimed that women taking hormone replacement therapy with estrogen plus progestin had a higher rate of myocardial infarctions than women on a placebo, and that estrogen-only hormone replacement therapy caused no reduction in the incidence of coronary heart disease.&amp;lt;ref name=&amp;quot;Rossouw-2002&amp;quot;/&amp;gt;&amp;lt;ref name=&amp;quot;Anderson-2004&amp;quot;&amp;gt;{{Cite journal  |vauthors=Anderson GL, Limacher M, Assaf AR, Bassford T, Beresford SA, Black H, etal | title = Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women's Health Initiative randomized controlled trial | journal = JAMA | volume = 291 | issue = 14 | pages = 1701–12 | year = 2004 | doi = 10.1001/jama.291.14.1701 | pmid = 15082697 | doi-access = free }}&amp;lt;/ref&amp;gt;  Possible explanations for the discrepancy between the observational studies and the RCTs involved differences in methodology, in the hormone regimens used, and in the populations studied.&amp;lt;ref name=&amp;quot;Grodstein-2003&amp;quot;&amp;gt;{{Cite journal |vauthors=Grodstein F, Clarkson TB, Manson JE | title = Understanding the divergent data on postmenopausal hormone therapy | journal = N Engl J Med | volume = 348 | issue = 7 | pages = 645–50 | year = 2003 | doi = 10.1056/NEJMsb022365 | pmid = 12584376 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Vandenbroucke-2009&amp;quot;&amp;gt;{{Cite journal | author = Vandenbroucke JP | title = The HRT controversy: observational studies and RCTs fall in line | journal = Lancet | volume = 373 | issue = 9671 | pages = 1233–5 | year = 2009 | doi = 10.1016/S0140-6736(09)60708-X | pmid = 19362661 | s2cid = 44991220 }}&amp;lt;/ref&amp;gt; The use of hormone replacement therapy decreased after publication of the RCTs.&amp;lt;ref name=&amp;quot;Hsu-2009&amp;quot;&amp;gt;{{Cite journal |vauthors=Hsu A, Card A, Lin SX, Mota S, Carrasquillo O, Moran A | title = Changes in postmenopausal hormone replacement therapy use among women with high cardiovascular risk | journal = Am J Public Health | volume = 99 | issue = 12 | pages = 2184–7 | year = 2009 | doi = 10.2105/AJPH.2009.159889 | url = http://ajph.aphapublications.org/cgi/content/full/99/12/2184 | pmid = 19833984 | pmc=2775780}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
== Disadvantages ==&lt;br /&gt;
&lt;br /&gt;
Many papers discuss the disadvantages of RCTs.&amp;lt;ref name=&amp;quot;Black-1996&amp;quot;&amp;gt;{{Cite journal | author = Black N | title = Why we need observational studies to evaluate the effectiveness of health care | journal = BMJ | volume = 312 | issue = 7040 | pages = 1215–8 | year = 1996 | pmid = 8634569 | pmc = 2350940 | doi=10.1136/bmj.312.7040.1215}}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Bell &amp;amp; Peck-2012&amp;quot;&amp;gt;{{Cite journal | author = Bell, S.H., &amp;amp; Peck, L.R. | title = Obstacles to and limitations of social experiments: 15 false alarms | journal = Abt Thought Leadership Paper Series | year = 2012 | url = http://abtassociates.com/white-papers/2012/obstacles-to-and-limitations-of-social-experiments.aspx }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Sanson-Fisher-2007&amp;quot;&amp;gt;{{Cite journal |vauthors=Sanson-Fisher RW, Bonevski B, Green LW, D'Este C | title = Limitations of the randomized controlled trial in evaluating population-based health interventions | journal = Am J Prev Med | volume = 33 | issue = 2 | pages = 155–61 | year = 2007 | doi = 10.1016/j.amepre.2007.04.007 | url = http://www.ajpm-online.net/article/S0749-3797%2807%2900225-5/abstract | pmid = 17673104 }}&amp;lt;/ref&amp;gt;   Among the most frequently cited drawbacks are:&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
=== Time and costs ===&lt;br /&gt;
&lt;br /&gt;
RCTs can be expensive;&amp;lt;ref name=&amp;quot;Sanson-Fisher-2007&amp;quot;/&amp;gt; one study found 28 [[Phase III clinical trials|Phase III]] RCTs funded by the [[National Institute of Neurological Disorders and Stroke]] prior to 2000 with a total cost of US$335 million,&amp;lt;ref name=&amp;quot;Johnston-2006&amp;quot;&amp;gt;{{Cite journal |vauthors=Johnston SC, Rootenberg JD, Katrak S, Smith WS, Elkins JS | title = Effect of a US National Institutes of Health programme of clinical trials on public health and costs | journal = [[The Lancet|Lancet]] | volume = 367 | issue = 9519 | pages = 1319–27 | year = 2006 | doi = 10.1016/S0140-6736(06)68578-4 | url = http://www.chrp.org/pdf/HSR20070511.pdf | pmid = 16631910 | s2cid = 41035177 }}&amp;lt;/ref&amp;gt; for a [[mean]] cost of US$12 million per RCT.  Nevertheless, the [[return on investment]] of RCTs may be high, in that the same study projected that the 28 RCTs produced a &amp;quot;net benefit to society at 10-years&amp;quot; of 46 times the cost of the trials program, based on evaluating a [[quality-adjusted life year]] as equal to the prevailing mean [[per capita]] [[gross domestic product]].&amp;lt;ref name=&amp;quot;Johnston-2006&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
The conduct of an RCT takes several years until being published; thus, data is restricted from the medical community for long years and may be of less relevance at time of publication.&amp;lt;ref name=&amp;quot;CaseReport&amp;quot;&amp;gt;{{cite journal |vauthors=Yitschaky O, Yitschaky M, Zadik Y |title=Case report on trial: Do you, Doctor, swear to tell the truth, the whole truth and nothing but the truth? |journal=J Med Case Rep |volume=5 |issue=1 |page=179 |date=May 2011 |pmid=21569508 |url=http://www.jmedicalcasereports.com/content/pdf/1752-1947-5-179.pdf|doi=10.1186/1752-1947-5-179 |pmc=3113995}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
It is costly to maintain RCTs for the years or decades that would be ideal for evaluating some interventions.&amp;lt;ref name=&amp;quot;Black-1996&amp;quot;/&amp;gt;&amp;lt;ref name=&amp;quot;Sanson-Fisher-2007&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Interventions to prevent events that occur only infrequently (e.g., [[sudden infant death syndrome]]) and uncommon adverse outcomes (e.g., a rare side effect of a drug) would require RCTs with extremely large sample sizes and may, therefore, best be assessed by observational studies.&amp;lt;ref name=&amp;quot;Black-1996&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Due to the costs of running RCTs, these usually only inspect one variable or very few variables, rarely reflecting the full picture of a complicated medical situation; whereas the [[case report]], for example, can detail many aspects of the patient's [[medicine|medical]] situation (e.g. [[patient history]], [[physical examination]], [[diagnosis]], [[psychosocial]] aspects, follow up).&amp;lt;ref name=&amp;quot;CaseReport&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
=== Conflict of interest dangers ===&lt;br /&gt;
&lt;br /&gt;
A 2011 study done to disclose possible [[conflicts of interest]]s in underlying research studies used for medical meta-analyses reviewed 29 meta-analyses and found that conflicts of interests in the studies underlying the meta-analyses were rarely disclosed.  The 29 meta-analyses included 11 from general medicine journals; 15 from specialty medicine journals, and 3 from the [[Cochrane Collaboration|Cochrane]] Database of Systematic Reviews. The 29 meta-analyses reviewed an aggregate of 509 randomized controlled trials (RCTs). Of these, 318 RCTs reported funding sources with 219 (69%) industry funded. 132 of the 509 RCTs reported author conflict of interest disclosures, with 91 studies (69%) disclosing industry financial ties with one or more authors. The information was, however, seldom reflected in the meta-analyses. Only two (7%) reported RCT funding sources and none reported RCT author-industry ties. The authors concluded &amp;quot;without acknowledgment of COI due to industry funding or author industry financial ties from RCTs included in meta-analyses, readers' understanding and appraisal of the evidence from the meta-analysis may be compromised.&amp;quot;&amp;lt;ref&amp;gt;{{cite web|url=http://www.cochrane.org/news/blog/how-well-do-meta-analyses-disclose-conflicts-interests-underlying-research-studies |title=How Well Do Meta-Analyses Disclose Conflicts of Interests in Underlying Research Studies &amp;amp;#124; The Cochrane Collaboration |publisher=Cochrane.org |access-date=2011-08-19}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
A 2011 study done to disclose possible conflicts of interests in underlying research studies used for medical meta-analyses reviewed 29 meta-analyses and found that conflicts of interests in the studies underlying the meta-analyses were rarely disclosed. The 29 meta-analyses included 11 from general medicine journals; 15 from specialty medicine journals, and 3 from the Cochrane Database of Systematic Reviews. The 29 meta-analyses reviewed an aggregate of 509 randomized controlled trials (RCTs). Of these, 318 RCTs reported funding sources with 219 (69%) industry funded. 132 of the 509 RCTs reported author conflict of interest disclosures, with 91 studies (69%) disclosing industry financial ties with one or more authors. The information was, however, seldom reflected in the meta-analyses. Only two (7%) reported RCT funding sources and none reported RCT author-industry ties. The authors concluded &amp;quot;without acknowledgment of COI due to industry funding or author industry financial ties from RCTs included in meta-analyses, readers' understanding and appraisal of the evidence from the meta-analysis may be compromised.&amp;quot;[97]&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Some RCTs are fully or partly funded by the health care industry (e.g., the [[pharmaceutical industry]]) as opposed to government, nonprofit, or other sources. A systematic review published in 2003 found four 1986–2002 articles comparing industry-sponsored and nonindustry-sponsored RCTs, and in all the articles there was a correlation of industry sponsorship and positive study outcome.&amp;lt;ref name=&amp;quot;Bekelman-2003&amp;quot;&amp;gt;{{Cite journal |vauthors=Bekelman JE, Li Y, Gross CP | title = Scope and impact of financial conflicts of interest in biomedical research: a systematic review | journal = [[J Am Med Assoc]] | volume = 289 | issue = 4 | pages = 454–65 | year = 2003 | pmid = 12533125 | doi = 10.1001/jama.289.4.454 }}&amp;lt;/ref&amp;gt; A 2004 study of 1999–2001 RCTs published in leading medical and surgical journals determined that industry-funded RCTs &amp;quot;are more likely to be associated with statistically significant pro-industry findings.&amp;quot;&amp;lt;ref name=&amp;quot;Bhandari-2004&amp;quot;&amp;gt;{{Cite journal |vauthors=Bhandari M, Busse JW, Jackowski D, Montori VM, Schünemann H, Sprague S, Mears D, Schemitsch EH, Heels-Ansdell D, Devereaux PJ | title = Association between industry funding and statistically significant pro-industry findings in medical and surgical randomized trials | journal = [[Can Med Assoc J]] | volume = 170 | issue = 4 | pages = 477–80 | year = 2004 | url = http://ecmaj.com/cgi/content/full/170/4/477 | pmid = 14970094 | pmc = 332713 }}&amp;lt;/ref&amp;gt; These results have been mirrored in trials in surgery, where although industry funding did not affect the rate of trial discontinuation it was however associated with a lower odds of publication for completed trials.&amp;lt;ref name=&amp;quot;Chapman-2014&amp;quot;&amp;gt;{{Cite journal |vauthors=Chapman SJ, Shelton B, Mahmood H, Fitzgerald JE, Harrison EM, Bhangu A | title = Discontinuation and non-publication of surgical randomised controlled trials: observational study | journal = [[BMJ]] | volume = 349 | page = g6870| year = 2014 | pmid = 25491195 | pmc = 4260649 | doi=10.1136/bmj.g6870}}&amp;lt;/ref&amp;gt; One possible reason for the pro-industry results in industry-funded published RCTs is [[publication bias]].&amp;lt;ref name=&amp;quot;Bhandari-2004&amp;quot;/&amp;gt;  Other authors have cited the differing goals of academic and industry sponsored research as contributing to the difference. Commercial sponsors may be more focused on performing trials of drugs that have already shown promise in early stage trials, and on replicating previous positive results to fulfill regulatory requirements for drug approval.&amp;lt;ref&amp;gt;{{cite journal |vauthors=Ridker PM, Torres J |title=Reported outcomes in major cardiovascular clinical trials funded by for-profit and not-for-profit organizations: 2000-2005 |journal=JAMA |volume=295 |issue=19 |pages=2270–4 |year=2006 |pmid=16705108 |doi=10.1001/jama.295.19.2270 |doi-access=free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Some RCTs are fully or partly funded by the health care industry (e.g., the pharmaceutical industry) as opposed to government, nonprofit, or other sources. A systematic review published in 2003 found four 1986–2002 articles comparing industry-sponsored and nonindustry-sponsored RCTs, and in all the articles there was a correlation of industry sponsorship and positive study outcome. A 2004 study of 1999–2001 RCTs published in leading medical and surgical journals determined that industry-funded RCTs &amp;quot;are more likely to be associated with statistically significant pro-industry findings.&amp;quot; These results have been mirrored in trials in surgery, where although industry funding did not affect the rate of trial discontinuation it was however associated with a lower odds of publication for completed trials. One possible reason for the pro-industry results in industry-funded published RCTs is publication bias.&lt;br /&gt;
&lt;br /&gt;
有些 rct 完全或部分由医疗保健行业(如制药行业)资助，而不是政府、非营利组织或其他来源。2003年发表的一份系统综述研究报告发现，1986年至2002年间，有4篇文章比较了行业赞助和非行业赞助的 rct，在所有的文章中，行业赞助和正面研究结果之间存在相关性。2004年发表在主要医学和外科杂志上的一项关于1999-2001年的 rct 的研究表明，工业资助的 rct“更有可能与具有统计学意义的有利于工业的发现相关联。”这些结果已经反映在手术试验中，虽然行业资金并不影响试验中止率，但是与完成试验的发表机率较低相关。支持产业的结果在产业资助的已发表的研究报告中出现的一个可能的原因是出版偏见。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Category:Clinical research&lt;br /&gt;
&lt;br /&gt;
类别: 临床研究&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Category:Epidemiological study projects&lt;br /&gt;
&lt;br /&gt;
类别: 流行病学研究项目&lt;br /&gt;
&lt;br /&gt;
Category:Evidence-based practices&lt;br /&gt;
&lt;br /&gt;
类别: 循证做法&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Category:Design of experiments&lt;br /&gt;
&lt;br /&gt;
类别: 实验设计&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Category:Causal inference&lt;br /&gt;
&lt;br /&gt;
类别: 因果推理&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Category:Experiments&lt;br /&gt;
&lt;br /&gt;
分类: 实验&lt;br /&gt;
Category:Research methods&lt;br /&gt;
&lt;br /&gt;
分类: 研究方法&lt;br /&gt;
&lt;br /&gt;
&amp;lt;noinclude&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&amp;lt;small&amp;gt;This page was moved from [[wikipedia:en:Randomized controlled trial]]. Its edit history can be viewed at [[随机对照试验/edithistory]]&amp;lt;/small&amp;gt;&amp;lt;/noinclude&amp;gt;&lt;br /&gt;
&lt;br /&gt;
[[Category:待整理页面]]&lt;/div&gt;</summary>
		<author><name>李昊轩</name></author>
	</entry>
	<entry>
		<id>https://wiki.swarma.org/index.php?title=%E9%9A%8F%E6%9C%BA%E5%AF%B9%E7%85%A7%E8%AF%95%E9%AA%8C&amp;diff=24313</id>
		<title>随机对照试验</title>
		<link rel="alternate" type="text/html" href="https://wiki.swarma.org/index.php?title=%E9%9A%8F%E6%9C%BA%E5%AF%B9%E7%85%A7%E8%AF%95%E9%AA%8C&amp;diff=24313"/>
		<updated>2021-07-10T16:47:27Z</updated>

		<summary type="html">&lt;p&gt;李昊轩：/* Adaptive */&lt;/p&gt;
&lt;hr /&gt;
&lt;div&gt;此词条暂由彩云小译翻译，翻译字数共2766，未经人工整理和审校，带来阅读不便，请见谅。&lt;br /&gt;
&lt;br /&gt;
{{Short description|Experimental method designed to reduce bias, typically accomplished by randomly allocating subjects to two or more groups, with one being a control group}}&lt;br /&gt;
&lt;br /&gt;
[[File:Flowchart of Phases of Parallel Randomized Trial - Modified from CONSORT 2010.png|thumb|upright=1.5|Flowchart of four phases (enrollment, allocation, intervention, follow-up, and data analysis) of a parallel randomized trial of two groups (in a controlled trial, one of the interventions serves as the control), modified from the CONSORT (Consolidated Standards of Reporting Trials) 2010 Statement&amp;lt;ref name=&amp;quot;Schulz-2010&amp;quot;&amp;gt;{{Cite journal | author = Schulz KF, Altman DG, ((Moher D; for the CONSORT Group)) | title = CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials | journal = [[Br Med J]] | volume = 340 | pages = c332 | year = 2010 | doi = 10.1136/bmj.c332 | pmid = 20332509 | pmc = 2844940 }}&amp;lt;/ref&amp;gt;|链接=Special:FilePath/Flowchart_of_Phases_of_Parallel_Randomized_Trial_-_Modified_from_CONSORT_2010.png]]&lt;br /&gt;
&lt;br /&gt;
[来源：图片] Flowchart of four phases (enrollment, allocation, intervention, follow-up, and data analysis) of a parallel randomized trial of two groups (in a controlled trial, one of the interventions serves as the control), modified from the CONSORT (Consolidated Standards of Reporting Trials) 2010 Statement.&lt;br /&gt;
&lt;br /&gt;
据修改的2010年CONSORT (综合报告试验标准)要求，流程图包括：两组平行随机试验分为登记、分配、干预、随访和数据分析四个阶段，在对照试验中，需要其中一项干预作为对照处理措施。 &lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
A '''randomized controlled trial''' (or '''randomized control trial''';&amp;lt;ref name=&amp;quot;Chalmers-1981&amp;quot;&amp;gt;{{Cite journal |vauthors=Chalmers TC, ((Smith H Jr)), Blackburn B, Silverman B, Schroeder B, Reitman D, Ambroz A | title = A method for assessing the quality of a randomized control trial | journal = [[Controlled Clinical Trials]] | volume = 2 | issue = 1 | pages = 31–49 | year = 1981 | doi = 10.1016/0197-2456(81)90056-8 | pmid = 7261638 }}&amp;lt;/ref&amp;gt; '''RCT''') is a type of ''[[scientific experiment]]'' (e.g. a ''[[clinical trial]]'') or ''intervention study'' (as opposed to ''[[observational study]]'') that aims to reduce certain sources of bias when testing the effectiveness of new treatments; this is accomplished by [[Random assignment|randomly allocating]] subjects to two or more groups, treating them differently, and then comparing them with respect to a measured response. One group—the experimental group—receives the intervention being assessed, while the other—usually called the control group—receives an alternative treatment, such as a [[placebo]] or no intervention. The groups are monitored under conditions of the trial design to determine the effectiveness of the experimental intervention, and efficacy is assessed in comparison to the control. &amp;lt;ref&amp;gt;{{cite web|url=https://www.nice.org.uk/glossary?letter=r|publisher=National Institute for Health and Care Excellence, London, UK|title=Randomised controlled trial|date=2019|access-date=3 June 2019}}&amp;lt;/ref&amp;gt; There may be more than one treatment group or more than one [[Treatment and control groups|control group]].&lt;br /&gt;
&lt;br /&gt;
A randomized controlled trial (or randomized control trial; RCT) is a type of scientific experiment (e.g. a clinical trial) or intervention study (as opposed to observational study) that aims to reduce certain sources of bias when testing the effectiveness of new treatments; this is accomplished by randomly allocating subjects to two or more groups, treating them differently, and then comparing them with respect to a measured response. One group—the experimental group—receives the intervention being assessed, while the other—usually called the control group—receives an alternative treatment, such as a placebo or no intervention. The groups are monitored under conditions of the trial design to determine the effectiveness of the experimental intervention, and efficacy is assessed in comparison to the control.  There may be more than one treatment group or more than one control group.&lt;br /&gt;
&lt;br /&gt;
随机对照试验(A randomized controlled trial, RCT)是一种科学实验(例如:临床试验)或干预研究(区别于观察性研究) ，其目的是在测试新治疗的有效性时减少某些偏倚来源。通过受试者随机分配到两个或两个以上的组，经过不同的处理，产生的效应再与一个有可控的处理效应相比较。即一组或多组(实验组)接受正在评估的干预措施，而另一组(通常称为对照组)接受替代治疗，如安慰剂或无干预措施。在试验设计的条件下对这些组进行监测，以确定实验干预的有效性，并与对照组进行疗效比较评估。当然这也包括一个以上的治疗组或一个以上的对照组。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
The trial may be [[blinded experiment|blinded]], meaning that information which may influence the participants is withheld until after the experiment is complete. A blind can be imposed on any participant of an experiment, including subjects, researchers, technicians, data analysts, and evaluators. Effective blinding may reduce or eliminate some sources of experimental [[bias]].&lt;br /&gt;
&lt;br /&gt;
The trial may be blinded, meaning that information which may influence the participants is withheld until after the experiment is complete. A blind can be imposed on any participant of an experiment, including subjects, researchers, technicians, data analysts, and evaluators. Effective blinding may reduce or eliminate some sources of experimental bias.&lt;br /&gt;
&lt;br /&gt;
试验可能采用了盲法，这意味着影响参与者的信息在试验完成后才会公布。试验的任何参与者，包括受试者、研究人员、技术人员、数据分析人员和评估人员，都可能被强加盲。有效的盲法可以减少或消除某些试验偏差的来源。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
The randomness in the assignment of subjects to groups reduces [[selection bias]] and allocation bias, balancing both known and unknown prognostic factors, in the assignment of treatments.&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;&amp;gt;{{Cite journal |vauthors=Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG | title = CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials | journal = [[Br Med J]] | volume = 340 | pages = c869 | year = 2010 | doi = 10.1136/bmj.c869 | pmid = 20332511 | pmc = 2844943 }}&amp;lt;/ref&amp;gt; Blinding reduces other forms of [[Observer-expectancy effect|experimenter and subject biases]].&lt;br /&gt;
&lt;br /&gt;
The randomness in the assignment of subjects to groups reduces selection bias and allocation bias, balancing both known and unknown prognostic factors, in the assignment of treatments. Blinding reduces other forms of experimenter and subject biases.&lt;br /&gt;
&lt;br /&gt;
在分配治疗方案时，受试者随机地被分配到不同组。这个随机化过程减少了选择偏差和分配偏差，平衡了已知和未知的预后因素。盲法减少了其他形式的实验者和主体偏见。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
A well-blinded RCT is often considered the [[Gold standard (test)|gold standard]] for [[clinical trial]]s. Blinded RCTs are commonly used to test the [[Efficacy#Medicine|efficacy]] of medical [[Health intervention|intervention]]s and may additionally provide information about adverse effects, such as [[adverse drug reactions|drug reactions]]. A randomized controlled trial can provide compelling evidence that the study treatment causes an effect on human health.&amp;lt;ref name=&amp;quot;hannan&amp;quot;&amp;gt;{{cite journal | vauthors = Hannan EL | title = Randomized clinical trials and observational studies: guidelines for assessing respective strengths and limitations | journal = JACC. Cardiovascular Interventions | volume = 1 | issue = 3 | pages = 211–7 | date = June 2008 | pmid = 19463302 | doi = 10.1016/j.jcin.2008.01.008 | doi-access = free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
A well-blinded RCT is often considered the gold standard for clinical trials. Blinded RCTs are commonly used to test the efficacy of medical interventions and may additionally provide information about adverse effects, such as drug reactions. A randomized controlled trial can provide compelling evidence that the study treatment causes an effect on human health.&lt;br /&gt;
&lt;br /&gt;
一个良好盲法的 RCT 通常被认为是临床试验的黄金标准。盲法随机对照试验通常用于检测医疗干预措施的效果，并且还可能提供关于药物反应等不良反应的信息。随机对照试验可以提供令人信服的证据，证明研究治疗对人类健康产生了影响。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
The terms &amp;quot;RCT&amp;quot; and &amp;quot;'''randomized trial'''&amp;quot; are sometimes used synonymously, but the latter term omits mention of controls and can therefore describe studies that compare multiple treatment groups with each other in the absence of a control group.&amp;lt;ref name=&amp;quot;Ranjith-2005&amp;quot;&amp;gt;{{Cite journal | author = Ranjith G | title = Interferon-α-induced depression: when a randomized trial is not a randomized controlled trial | journal = [[Psychother Psychosom]] | volume = 74 | issue = 6 | pages = 387; author reply 387–8 | year = 2005 | doi = 10.1159/000087787 | pmid = 16244516 | s2cid = 143644933 }}&amp;lt;/ref&amp;gt; Similarly, the [[initialism]] is sometimes expanded as &amp;quot;'''randomized clinical trial'''&amp;quot; or &amp;quot;'''randomized comparative trial'''&amp;quot;, leading to ambiguity in the [[scientific literature]].&amp;lt;ref name=&amp;quot;Peto-1976&amp;quot;&amp;gt;{{Cite journal |vauthors=Peto R, Pike MC, Armitage P, Breslow NE, Cox DR, Howard SV, Mantel N, McPherson K, Peto J, Smith PG | title = Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design | journal = [[Br J Cancer]] | volume = 34 | issue = 6 | pages = 585–612 | year = 1976 | pmc=2025229 | pmid = 795448 | doi = 10.1038/bjc.1976.220 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Peto-1977&amp;quot;&amp;gt;{{Cite journal |vauthors=Peto R, Pike MC, Armitage P, Breslow NE, Cox DR, Howard SV, Mantel N, McPherson K, Peto J, Smith PG | title = Design and analysis of randomized clinical trials requiring prolonged observation of each patient. II. Analysis and examples | journal = [[Br J Cancer]] | volume = 35 | issue = 1 | pages = 1–39 | year = 1977 | pmc=2025310 | pmid = 831755 | doi = 10.1038/bjc.1977.1 }}&amp;lt;/ref&amp;gt; Not all randomized clinical trials are randomized ''controlled'' trials (and some of them could never be, as in cases where controls would be impractical or unethical to institute). The term '''randomized controlled clinical trial''' is an alternative term used in [[clinical research]];&amp;lt;ref name=&amp;quot;Wollert-2004&amp;quot;&amp;gt;{{Cite journal |vauthors=Wollert KC, Meyer GP, Lotz J, Ringes-Lichtenberg S, Lippolt P, Breidenbach C, Fichtner S, Korte T, Hornig B, Messinger D, Arseniev L, Hertenstein B, Ganser A, Drexler H | title = Intracoronary autologous bone-marrow cell transfer after myocardial infarction: the BOOST randomised controlled clinical trial | journal = [[The Lancet|Lancet]] | volume = 364 | issue = 9429 | pages = 141–8 | year = 2004 | doi = 10.1016/S0140-6736(04)16626-9 | pmid = 15246726 | s2cid = 24361586 }}&amp;lt;/ref&amp;gt; however, RCTs are also employed in other research areas, including [[#In social science|many of the social sciences]].&lt;br /&gt;
&lt;br /&gt;
The terms &amp;quot;RCT&amp;quot; and &amp;quot;randomized trial&amp;quot; are sometimes used synonymously, but the latter term omits mention of controls and can therefore describe studies that compare multiple treatment groups with each other in the absence of a control group. Similarly, the initialism is sometimes expanded as &amp;quot;randomized clinical trial&amp;quot; or &amp;quot;randomized comparative trial&amp;quot;, leading to ambiguity in the scientific literature. Not all randomized clinical trials are randomized controlled trials (and some of them could never be, as in cases where controls would be impractical or unethical to institute). The term randomized controlled clinical trial is an alternative term used in clinical research; however, RCTs are also employed in other research areas, including many of the social sciences.&lt;br /&gt;
&lt;br /&gt;
“ RCT”和“随机试验”这两个术语有时被用作同义词，但后一个术语没有提到对照，因此可以描述在没有对照组的情况下相互比较多个治疗组的研究。科学文献中常有“随机临床试验”或“随机比较试验”这类引发歧义的术语。并非所有的随机临床试验都是随机对照试验(其中一些试验永远不可能成为随机对照试验，因为实施控制是不切实际或不道德的)。随机对照临床试验这个术语是临床研究中使用的另一个术语; 然而，随机对照临床试验也被用于其他研究领域，包括许多社会科学。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
{{toc limit}}&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
== History ==&lt;br /&gt;
&lt;br /&gt;
The first reported clinical trial was conducted by James Lind in 1747 to identify treatment for scurvy.[10] The first blind experiment was conducted by the French Royal Commission on Animal Magnetism in 1784 to investigate the claims of mesmerism. An early essay advocating the blinding of researchers came from Claude Bernard in the latter half of the 19th century. Bernard recommended that the observer of an experiment should not have knowledge of the hypothesis being tested. This suggestion contrasted starkly with the prevalent Enlightenment-era attitude that scientific observation can only be objectively valid when undertaken by a well-educated, informed scientist.[11] The first study recorded to have a blinded researcher was conducted in 1907 by W. H. R. Rivers and H. N. Webber to investigate the effects of caffeine.[12]&lt;br /&gt;
&lt;br /&gt;
据报道，1747年James Lind进行了第一个临床试验，目的是确定治疗坏血病的方法。1784年，French Royal Commission on Animal Magnetism进行了第一次盲法实验，以调查催眠术的说法。19世纪下半叶，一篇提倡研究人员失明的早期文章来自Claude Bernard。Bernard建议实验的观察者不要知道正在被测试的假设。这一建议与启蒙时代流行的态度形成鲜明对比，即科学观察只有由受过良好教育、消息灵通的科学家进行才能客观有效。1907年，W. H. R. Rivers和H. N. Webber进行了第一项有记录的盲法研究，研究咖啡因的作用。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
[[Randomized experiment]]s appeared in [[experimental psychology|psychology]], where they were introduced by [[Charles Sanders Peirce]] and [[Joseph Jastrow]] in the 1880s,&amp;lt;ref&amp;gt;{{cite journal| author=[[Charles Sanders Peirce]] and [[Joseph Jastrow]]|year=1885|title=On Small Differences in Sensation| journal=Memoirs of the National Academy of Sciences|volume=3|pages=73–83|url=http://psychclassics.yorku.ca/Peirce/small-diffs.htm}} http://psychclassics.yorku.ca/Peirce/small-diffs.htm&amp;lt;/ref&amp;gt; and in [[school of education|education]].&amp;lt;ref&amp;gt;{{cite journal|doi=10.1086/354775|first=Ian|last=Hacking|author-link=Ian Hacking | title=Telepathy: Origins of Randomization in Experimental Design|journal=[[Isis (journal)|Isis]]|series=A Special Issue on Artifact and Experiment|volume=79|issue=3|date=September 1988 |pages=427–451|jstor=234674|mr=1013489|s2cid=52201011}}&amp;lt;/ref&amp;gt;&amp;lt;ref&amp;gt;{{cite journal|doi=10.1086/444032|author=Stephen M. Stigler|title=A Historical View of Statistical Concepts in Psychology and Educational Research| journal=American Journal of Education| volume=101|issue=1|date=November 1992|pages=60–70|s2cid=143685203|author-link=Stephen M. Stigler}}&amp;lt;/ref&amp;gt;&amp;lt;ref&amp;gt;{{cite journal|doi=10.1086/383850|author=Trudy Dehue|title=Deception, Efficiency, and Random Groups: Psychology and the Gradual Origination of the Random Group Design|journal=[[Isis (journal)|Isis]]|volume=88|issue=4|date=December 1997|pages=653–673|pmid=9519574|s2cid=23526321|url=https://pure.rug.nl/ws/files/71855616/237831.pdf}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Randomized experiments appeared in psychology, where they were introduced by Charles Sanders Peirce and Joseph Jastrow in the 1880s, and in education.&lt;br /&gt;
&lt;br /&gt;
在19世纪80年代，Charles Sanders Peirce和Joseph Jastrow在心理学和教育学领域引入随机实验。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
In the early 20th century, randomized experiments appeared in agriculture, due to [[Jerzy Neyman]]&amp;lt;ref&amp;gt;Neyman, Jerzy. 1923 [1990]. &amp;quot;On the Application of Probability Theory to AgriculturalExperiments. Essay on Principles. Section 9.&amp;quot; ''Statistical Science'' 5 (4): 465–472. Trans. Dorota M. Dabrowska and Terence P. Speed.&amp;lt;/ref&amp;gt; and [[Ronald A. Fisher]]. Fisher's experimental research and his writings popularized randomized experiments.&amp;lt;ref name=&amp;quot;Conniffe&amp;quot; /&amp;gt;&lt;br /&gt;
&lt;br /&gt;
In the early 20th century, randomized experiments appeared in agriculture, due to Jerzy Neyman and Ronald A. Fisher. Fisher's experimental research and his writings popularized randomized experiments.&lt;br /&gt;
&lt;br /&gt;
在20世纪早期，Jerzy Neyman和Ronald A. Fisher将随机实验引入农业研究。Fisher的实验研究和他的著作普及了随机实验。&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;The first published RCT in medicine appeared in the 1948 paper entitled &amp;quot;[[Streptomycin]] treatment of pulmonary [[tuberculosis]]&amp;quot;, which described a [[Medical Research Council (UK)|Medical Research Council]] investigation.&amp;lt;ref name=&amp;quot;MRC-1948&amp;quot;&amp;gt;{{Cite journal | author = Streptomycin in Tuberculosis Trials Committee | title = Streptomycin treatment of pulmonary tuberculosis. A Medical Research Council investigation| journal = [[Br Med J]] | volume = 2 | issue = 4582 | pages = 769–82 | year = 1948 | doi = 10.1136/bmj.2.4582.769 | pmid = 18890300 | pmc = 2091872 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Brown-1998&amp;quot;&amp;gt;{{cite news |title= Landmark study made research resistant to bias |author= Brown D |newspaper= [[Washington Post]] |date=1998-11-02 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Shikata-2006&amp;quot;&amp;gt;{{Cite journal |vauthors=Shikata S, Nakayama T, Noguchi Y, Taji Y, Yamagishi H | title = Comparison of effects in randomized controlled trials with observational studies in digestive surgery | journal = [[Ann Surg]] | volume = 244 | issue = 5 | pages = 668–76 | year = 2006 | doi = 10.1097/01.sla.0000225356.04304.bc | pmc=1856609 | pmid = 17060757 }}&amp;lt;/ref&amp;gt; One of the authors of that paper was [[Austin Bradford Hill]], who is credited as having conceived the modern RCT.&amp;lt;ref name=&amp;quot;Stolberg-2004&amp;quot;&amp;gt;{{Cite journal |vauthors=Stolberg HO, Norman G, Trop I | title = Randomized controlled trials | journal = [[Am J Roentgenol]] | volume = 183 | issue = 6 | pages = 1539–44 | year = 2004 | pmid = 15547188 | doi=10.2214/ajr.183.6.01831539}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;The first published RCT in medicine appeared in the 1948 paper entitled &amp;quot;Streptomycin treatment of pulmonary tuberculosis&amp;quot;, which described a Medical Research Council investigation. One of the authors of that paper was Austin Bradford Hill, who is credited as having conceived the modern RCT.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;医学上首次发表的随机对照试验出现在1948年题为“Streptomycin treatment of pulmonary tuberculosis”的论文中，这篇论文描述了医学研究理事会的一项调查。这篇论文的作者之一是Austin Bradford Hill，被认为是构想出了现代 RCT理论。 &lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt; &lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;Trial design was further influenced by the large-scale [[International Studies of Infarct Survival|ISIS]] trials on [[heart attack]] treatments that were conducted in the 1980s.&amp;lt;ref&amp;gt;{{cite web| author1=Georgina Ferry |title= Peter Sleight Obituary |url=https://www.theguardian.com/society/2020/nov/02/peter-sleight-obituary |website=The Guardian |date=2 November 2020 |access-date=3 November 2020}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;Trial design was further influenced by the large-scale ISIS trials on heart attack treatments that were conducted in the 1980s.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;20世纪80年代进行的大规模 ISIS 心脏病治疗试验进一步影响了试验设计。&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;By the late 20th century, RCTs were recognized as the standard method for &amp;quot;rational therapeutics&amp;quot; in medicine.[24] As of 2004, more than 150,000 RCTs were in the Cochrane Library.[22] To improve the reporting of RCTs in the medical literature, an international group of scientists and editors published Consolidated Standards of Reporting Trials (CONSORT) Statements in 1996, 2001 and 2010, and these have become widely accepted.[1][4] Randomization is the process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce the bias.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;By the late 20th century, RCTs were recognized as the standard method for &amp;quot;rational therapeutics&amp;quot; in medicine. As of 2004, more than 150,000 RCTs were in the Cochrane Library. To improve the reporting of RCTs in the medical literature, an international group of scientists and editors published Consolidated Standards of Reporting Trials (CONSORT) Statements in 1996, 2001 and 2010, and these have become widely accepted. Randomization is the process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce the bias.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;到20世纪后期，随机对照试验被公认为医学“合理疗法”的标准方法。截至2004年，美国 Cochrane图书馆有超过15万本随机对照试验的参考资料。为了改进医学文献中对随机对照试验的报道，一个由科学家和编辑组成的国际小组在1996年、2001年和2010年发布了Consolidated Standards of Reporting Trials (CONSORT)声明，这些声明已被广泛接受。随机化是将试验受试者分配到治疗组或对照组的过程，使用机会因素来确定分配，以减少偏差。&lt;br /&gt;
&lt;br /&gt;
== Ethics ==&lt;br /&gt;
&lt;br /&gt;
Although the principle of clinical equipoise (&amp;quot;genuine uncertainty within the expert medical community... about the preferred treatment&amp;quot;) common to clinical trials[25] has been applied to RCTs, the ethics of RCTs have special considerations. For one, it has been argued that equipoise itself is insufficient to justify RCTs.[26] For another, &amp;quot;collective equipoise&amp;quot; can conflict with a lack of personal equipoise (e.g., a personal belief that an intervention is effective).[27] Finally, Zelen's design, which has been used for some RCTs, randomizes subjects before they provide informed consent, which may be ethical for RCTs of screening and selected therapies, but is likely unethical &amp;quot;for most therapeutic trials.&amp;quot;[28][29]&lt;br /&gt;
&lt;br /&gt;
Although the principle of clinical equipoise (&amp;quot;genuine uncertainty within the expert medical community... about the preferred treatment&amp;quot;) common to clinical trials has been applied to RCTs, the ethics of RCTs have special considerations. For one, it has been argued that equipoise itself is insufficient to justify RCTs. For another, &amp;quot;collective equipoise&amp;quot; can conflict with a lack of personal equipoise (e.g., a personal belief that an intervention is effective). Finally, Zelen's design, which has been used for some RCTs, randomizes subjects ''before'' they provide informed consent, which may be ethical for RCTs of screening and selected therapies, but is likely unethical &amp;quot;for most therapeutic trials.&amp;quot;&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;尽管临床平衡原则已经被广泛应用于RCT，但随机对照试验的伦理问题具有特殊性。首先，有人认为平衡本身不足以证明随机对照试验的合理性。另一方面，“集体均势”可能与缺乏个人均势相冲突(例如，个人认为干预是有效的)。最后，Zelen 的设计已经被用于一些随机试验，在受试者提供知情同意之前随机化，这对于筛选和选择性治疗的随机试验来说可能是合乎道德的，但是对于“大多数治疗试验”来说可能是不道德的。&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Although subjects almost always provide [[informed consent]] for their participation in an RCT, studies since 1982 have documented that RCT subjects may believe that they are certain to receive treatment that is best for them personally; that is, they do not understand the difference between research and treatment.&amp;lt;ref name=&amp;quot;Appelbaum-1982&amp;quot;&amp;gt;{{Cite journal |vauthors=Appelbaum PS, Roth LH, Lidz C | title = The therapeutic misconception: informed consent in psychiatric research | journal = [[Int J Law Psychiatry]] | volume = 5 | issue = 3–4 | pages = 319–29 | year = 1982 | doi = 10.1016/0160-2527(82)90026-7 | pmid = 6135666 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Henderson-2007&amp;quot;&amp;gt;{{Cite journal |vauthors=Henderson GE, Churchill LR, Davis AM, Easter MM, Grady C, Joffe S, Kass N, King NM, Lidz CW, Miller FG, Nelson DK, Peppercorn J, Rothschild BB, Sankar P, Wilfond BS, Zimmer CR | title = Clinical trials and medical care: defining the therapeutic misconception | journal = [[PLoS Med]] | volume = 4 | issue = 11 | pages = e324 | year = 2007 | doi = 10.1371/journal.pmed.0040324 | pmid = 18044980 | pmc = 2082641 }}&amp;lt;/ref&amp;gt; Further research is necessary to determine the prevalence of and ways to address this &amp;quot;[[therapeutic misconception]]&amp;quot;.&amp;lt;ref name=&amp;quot;Henderson-2007&amp;quot; /&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Although subjects almost always provide informed consent for their participation in an RCT, studies since 1982 have documented that RCT subjects may believe that they are certain to receive treatment that is best for them personally; that is, they do not understand the difference between research and treatment. Further research is necessary to determine the prevalence of and ways to address this &amp;quot;therapeutic misconception&amp;quot;. &lt;br /&gt;
&lt;br /&gt;
一般来说，受试者要为参加随机对照试验提交了知情同意书，但1982年以来的研究记录表明，随机对照试验的受试者可能认为他们肯定会接受对他们个人最好的治疗; 也就是说，他们不理解研究和治疗之间的区别。需要进一步研究，以确定这种”治疗性误解”的流行程度和解决方法。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
The RCT method variations may also create cultural effects that have not been well understood.[32] For example, patients with terminal illness may join trials in the hope of being cured, even when treatments are unlikely to be successful.&lt;br /&gt;
&lt;br /&gt;
RCT方法的变种也可能产生尚未被很好理解的文化效应。例如，患有晚期疾病的病人可能会加入临床试验以希望治愈，即使治疗不太可能成功的情况下也是如此。&lt;br /&gt;
&lt;br /&gt;
=== Trial registration ===&lt;br /&gt;
&lt;br /&gt;
In 2004, the [http://www.icmje.org/ International Committee of Medical Journal Editors] (ICMJE) announced that all trials starting enrolment after July 1, 2005 must be registered prior to consideration for publication in one of the 12 member journals of the committee.&amp;lt;ref name=&amp;quot;pmid15356289&amp;quot;&amp;gt;{{cite journal  |vauthors=De Angelis C, Drazen JM, Frizelle FA, etal |title=Clinical trial registration: a statement from the International Committee of Medical Journal Editors |journal=The New England Journal of Medicine |volume=351 |issue=12 |pages=1250–1 |date=September 2004 |pmid=15356289 |doi=10.1056/NEJMe048225 }}&amp;lt;/ref&amp;gt; However, trial registration may still occur late or not at all.&amp;lt;ref name=&amp;quot;pmid22147862&amp;quot;&amp;gt;{{cite journal|vauthors=Law MR, Kawasumi Y, Morgan SG | title=Despite law, fewer than one in eight completed studies of drugs and biologics are reported on time on ClinicalTrials.gov. | journal=Health Aff (Millwood) | year= 2011 | volume= 30 | issue= 12 | pages= 2338–45 | doi=10.1377/hlthaff.2011.0172 | pmid=22147862  | doi-access=free }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;pmid19724045&amp;quot;&amp;gt;{{cite journal|vauthors=Mathieu S, Boutron I, Moher D, Altman DG, Ravaud P | title=Comparison of registered and published primary outcomes in randomized controlled trials. | journal=JAMA | year= 2009 | volume= 302 | issue= 9 | pages= 977–84 | doi=10.1001/jama.2009.1242 | pmid=19724045  | doi-access=free }}&amp;lt;/ref&amp;gt;Medical journals have been slow in adapting policies requiring mandatory clinical trial registration as a prerequisite for publication.&amp;lt;ref&amp;gt;{{cite journal|last1=Bhaumik|first1=S|title=Editorial policies of MEDLINE indexed Indian journals on clinical trial registration.|journal=Indian Pediatr.|date=Mar 2013|volume=50|issue=3|pages=339–40|pmid=23680610|doi=10.1007/s13312-013-0092-2|s2cid=40317464}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
In 2004, the [http://www.icmje.org/ International Committee of Medical Journal Editors] (ICMJE) announced that all trials starting enrolment after July 1, 2005 must be registered prior to consideration for publication in one of the 12 member journals of the committee. However, trial registration may still occur late or not at all. Medical journals have been slow in adapting policies requiring mandatory clinical trial registration as a prerequisite for publication.&lt;br /&gt;
&lt;br /&gt;
2004年， 医学杂志编辑国际委员会(ICMJE)宣布，所有在2005年7月1日之后考虑在该委员会12种杂志上发表之前，必须对试验进行注册。尽管如此，试验登记可能仍然延迟或根本不会发生。医学期刊将强制性临床试验登记作为发表的先决条件进展缓慢。&lt;br /&gt;
== Classifications ==&lt;br /&gt;
=== By study design ===&lt;br /&gt;
&lt;br /&gt;
One way to classify RCTs is by [[study design]].  From most to least common in the healthcare literature, the major categories of RCT study designs are:&amp;lt;ref name=&amp;quot;Hopewell-2010&amp;quot;&amp;gt;{{Cite journal |vauthors=Hopewell S, Dutton S, Yu LM, Chan AW, Altman DG | title = The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed | journal = BMJ | volume = 340 | pages = c723 | year = 2010 | doi = 10.1136/bmj.c723  | pmid = 20332510 | pmc = 2844941 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
通过研究设计对 RCT 进行分类。从最常见到最不常见，RCT 研究设计的主要类别是&lt;br /&gt;
&lt;br /&gt;
* [[Parallel study|Parallel-group]] – each participant is randomly assigned to a group, and all the participants in the group receive (or do not receive) an intervention.&amp;lt;ref&amp;gt;{{cite journal |last1=Kaiser |first1=Joerg |last2=Niesen |first2=Willem |last3=Probst |first3=Pascal |last4=Bruckner |first4=Thomas |last5=Doerr-Harim |first5=Colette |last6=Strobel |first6=Oliver |last7=Knebel |first7=Phillip |last8=Diener |first8=Markus K. |last9=Mihaljevic |first9=André L. |last10=Büchler |first10=Markus W. |last11=Hackert |first11=Thilo |title=Abdominal drainage versus no drainage after distal pancreatectomy: study protocol for a randomized controlled trial |journal=Trials |date=7 June 2019 |volume=20 |issue=1 |page=332 |doi=10.1186/s13063-019-3442-0|pmid=31174583 |pmc=6555976 |doi-access=free }}&amp;lt;/ref&amp;gt;&amp;lt;ref&amp;gt;{{cite journal |last1=Farag |first1=Sara M. |last2=Mohammed |first2=Manal O. |last3=EL-Sobky |first3=Tamer A. |last4=ElKadery |first4=Nadia A. |last5=ElZohiery |first5=Abeer K. |title=Botulinum Toxin A Injection in Treatment of Upper Limb Spasticity in Children with Cerebral Palsy: A Systematic Review of Randomized Controlled Trials |journal=JBJS Reviews |date=March 2020 |volume=8 |issue=3 |pages=e0119 |doi=10.2106/JBJS.RVW.19.00119 |pmid=32224633|pmc=7161716 |doi-access=free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* 平行试验：每个参与者被随机分配到一个组，组中的所有参与者都接受(或不接受)干预。&lt;br /&gt;
&lt;br /&gt;
* [[Crossover study|Crossover]] – over time, each participant receives (or does not receive) an intervention in a random sequence.&amp;lt;ref&amp;gt;{{cite book  | last = Jones | first = Byron |author2=Kenward, Michael G.  | title = Design and Analysis of Cross-Over Trials | edition=Second| publisher = London: Chapman and Hall | year = 2003 }}&amp;lt;/ref&amp;gt;&amp;lt;ref&amp;gt;{{cite book  | last = Vonesh | first = Edward F. |author2=Chinchilli, Vernon G.  | chapter=Crossover Experiments| pages=111–202|title = Linear and Nonlinear Models for the Analysis of Repeated Measurements | publisher = London: Chapman and Hall | year = 1997 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* 交叉试验：随着时间的推移，每个参与者都会接受(或不接受)随机序列的干预。&lt;br /&gt;
&lt;br /&gt;
* [[Cluster randomised controlled trial|Cluster]] – pre-existing groups of participants (e.g., villages, schools) are randomly selected to receive (or not receive) an intervention.&amp;lt;ref&amp;gt;{{cite journal |last1=Gall |first1=Stefanie |last2=Adams |first2=Larissa |last3=Joubert |first3=Nandi |last4=Ludyga |first4=Sebastian |last5=Müller |first5=Ivan |last6=Nqweniso |first6=Siphesihle |last7=Pühse |first7=Uwe |last8=du Randt |first8=Rosa |last9=Seelig |first9=Harald |last10=Smith |first10=Danielle |last11=Steinmann |first11=Peter |last12=Utzinger |first12=Jürg |last13=Walter |first13=Cheryl |last14=Gerber |first14=Markus |last15=van Wouwe |first15=Jacobus P. |title=Effect of a 20-week physical activity intervention on selective attention and academic performance in children living in disadvantaged neighborhoods: A cluster randomized control trial |journal=PLOS ONE |date=8 November 2018 |volume=13 |issue=11 |pages=e0206908 |doi=10.1371/journal.pone.0206908 |pmid=30408073|pmc=6224098 |bibcode=2018PLoSO..1306908G |doi-access=free }}&amp;lt;/ref&amp;gt;&amp;lt;ref&amp;gt;{{cite journal |last1=Gladstone |first1=Melissa J. |last2=Chandna |first2=Jaya |last3=Kandawasvika |first3=Gwendoline |last4=Ntozini |first4=Robert |last5=Majo |first5=Florence D. |last6=Tavengwa |first6=Naume V. |last7=Mbuya |first7=Mduduzi N. N. |last8=Mangwadu |first8=Goldberg T. |last9=Chigumira |first9=Ancikaria |last10=Chasokela |first10=Cynthia M. |last11=Moulton |first11=Lawrence H. |last12=Stoltzfus |first12=Rebecca J. |last13=Humphrey |first13=Jean H. |last14=Prendergast |first14=Andrew J. |last15=Tumwine |first15=James K. |title=Independent and combined effects of improved water, sanitation, and hygiene (WASH) and improved complementary feeding on early neurodevelopment among children born to HIV-negative mothers in rural Zimbabwe: Substudy of a cluster-randomized trial |journal=PLOS Medicine |date=21 March 2019 |volume=16 |issue=3 |pages=e1002766 |doi=10.1371/journal.pmed.1002766|pmid=30897095 |pmc=6428259 |doi-access=free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* 聚类试验：预先存在的参与者组(例如，村庄、学校)被随机选择以接受(或不接受)干预。&lt;br /&gt;
&lt;br /&gt;
* [[Factorial experiment|Factorial]] – each participant is randomly assigned to a group that receives a particular combination of interventions or non-interventions (e.g., group 1 receives vitamin X and vitamin Y, group 2 receives vitamin X and placebo Y, group 3 receives placebo X and vitamin Y, and group 4 receives placebo X and placebo Y).&lt;br /&gt;
* 因子试验：每个参与者被随机分配到一个接受干预或非干预特定组合的组(例如，第1组接受维生素X和维生素Y，第2组接受维生素X和安慰剂Y，第3组接受安慰剂X和维生素Y，第4组接受安慰剂X和安慰剂Y)。&lt;br /&gt;
&lt;br /&gt;
An analysis of the 616 RCTs indexed in [[PubMed]] during December 2006 found that 78% were parallel-group trials, 16% were crossover, 2% were split-body, 2% were cluster, and 2% were factorial.&amp;lt;ref name=&amp;quot;Hopewell-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
An analysis of the 616 RCTs indexed in PubMed during December 2006 found that 78% were parallel-group trials, 16% were crossover, 2% were split-body, 2% were cluster, and 2% were factorial. &lt;br /&gt;
&lt;br /&gt;
对2006年12月在 PubMed 收录的616例随机对照试验的分析发现，78% 为平行组试验，16% 为交叉组试验，2% 为分体组试验，2% 为聚类组试验，2% 为因子组试验。&lt;br /&gt;
&lt;br /&gt;
=== By outcome of interest (efficacy vs. effectiveness) ===&lt;br /&gt;
&lt;br /&gt;
{{Main|Pragmatic clinical trial}}&lt;br /&gt;
&lt;br /&gt;
RCTs can be classified as &amp;quot;explanatory&amp;quot; or &amp;quot;pragmatic.&amp;quot;&amp;lt;ref name=&amp;quot;Zwarenstein-2008&amp;quot;&amp;gt;{{Cite journal | author = Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D; CONSORT group; Pragmatic Trials in Healthcare (Practihc) group | title = Improving the reporting of pragmatic trials: an extension of the CONSORT statement | journal = BMJ | volume = 337 | pages = a2390 | year = 2008 | doi = 10.1136/bmj.a2390 | pmid = 19001484 | pmc=3266844}}&amp;lt;/ref&amp;gt; Explanatory RCTs test [[Efficacy#Medicine|efficacy]] in a research setting with highly selected participants and under highly controlled conditions.&amp;lt;ref name=&amp;quot;Zwarenstein-2008&amp;quot;/&amp;gt; In contrast, pragmatic RCTs (pRCTs) test [[Effectiveness#Usage|effectiveness]] in everyday practice with relatively unselected participants and under flexible conditions; in this way, pragmatic RCTs can &amp;quot;inform decisions about practice.&amp;quot;&amp;lt;ref name=&amp;quot;Zwarenstein-2008&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
RCTs can be classified as &amp;quot;explanatory&amp;quot; or &amp;quot;pragmatic.&amp;quot; Explanatory RCTs test efficacy in a research setting with highly selected participants and under highly controlled conditions. In contrast, pragmatic RCTs (pRCTs) test effectiveness in everyday practice with relatively unselected participants and under flexible conditions; in this way, pragmatic RCTs can &amp;quot;inform decisions about practice.&amp;quot;&lt;br /&gt;
&lt;br /&gt;
随机对照试验可分为“解释性”或“实用性”。解释性随机对照试验在高度选定的参与者和高度受控的条件下测试有效性。相比之下，实用性随机对照测验(pragmatic RCTs, pRCT)在相对未经选择的参与者和灵活的条件下，在日常实践中检验有效性，这样，实用随机对照测验可以“为实践决策提供信息”。&lt;br /&gt;
=== By hypothesis (superiority vs. noninferiority vs. equivalence) ===&lt;br /&gt;
&lt;br /&gt;
Another classification of RCTs categorizes them as &amp;quot;superiority trials&amp;quot;, &amp;quot;noninferiority trials&amp;quot;, and &amp;quot;equivalence trials&amp;quot;, which differ in methodology and reporting.&amp;lt;ref name=&amp;quot;Piaggio-2006&amp;quot;&amp;gt;{{Cite journal | author = Piaggio G, Elbourne DR, [[Doug Altman|Altman DG]], [[Stuart Pocock|Pocock SJ]], Evans SJ; CONSORT Group | title = Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement | journal = JAMA | volume = 295 | issue = 10 | pages = 1152–60 |  year = 2006 | doi = 10.1001/jama.295.10.1152 | pmid = 16522836 | url = http://researchonline.lshtm.ac.uk/12069/1/Reporting%20of%20Noninferiority%20and%20Equivalence%20Randomized%20Trials.pdf }}&amp;lt;/ref&amp;gt; Most RCTs are superiority trials, in which one intervention is hypothesized to be superior to another in a [[Statistical significance|statistically significant]] way.&amp;lt;ref name=&amp;quot;Piaggio-2006&amp;quot;/&amp;gt; Some RCTs are noninferiority trials &amp;quot;to determine whether a new treatment is no worse than a reference treatment.&amp;quot;&amp;lt;ref name=&amp;quot;Piaggio-2006&amp;quot;/&amp;gt; Other RCTs are equivalence trials in which the hypothesis is that two interventions are indistinguishable from each other.&amp;lt;ref name=&amp;quot;Piaggio-2006&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Another classification of RCTs categorizes them as &amp;quot;superiority trials&amp;quot;, &amp;quot;noninferiority trials&amp;quot;, and &amp;quot;equivalence trials&amp;quot;, which differ in methodology and reporting. Most RCTs are superiority trials, in which one intervention is hypothesized to be superior to another in a statistically significant way. Some RCTs are noninferiority trials &amp;quot;to determine whether a new treatment is no worse than a reference treatment.&amp;quot; Other RCTs are equivalence trials in which the hypothesis is that two interventions are indistinguishable from each other.&lt;br /&gt;
&lt;br /&gt;
随机对照试验的另一种分类是“优越性试验”、“非劣性试验”和“等效性试验”，它们在方法和报告上有所不同。大多数随机对照试验都是优势试验，其中一种干预措施被假设在统计学意义上优于另一种干预措施。一些随机对照试验是非劣效性试验，“以确定一种新的治疗方法是否比一种参考治疗方法更差。”其他随机对照试验是等效试验，其中的假设是两种干预措施彼此不可区分。&lt;br /&gt;
&lt;br /&gt;
== Randomization ==&lt;br /&gt;
&lt;br /&gt;
The advantages of proper [[randomized experiment|randomization]] in RCTs include:&amp;lt;ref name=&amp;quot;SchulzGrimes2002&amp;quot;&amp;gt;{{Cite journal |vauthors=Schulz KF, Grimes DA | title = Generation of allocation sequences in randomised trials: chance, not choice | journal = Lancet | volume = 359 | issue = 9305 | pages = 515–9 | year = 2002 | doi = 10.1016/S0140-6736(02)07683-3 | url =https://www.who.int/entity/rhl/LANCET_515-519.pdf | pmid = 11853818 | s2cid = 291300 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
* &amp;quot;It eliminates bias in treatment assignment,&amp;quot; specifically [[selection bias]] and [[confounding]].&lt;br /&gt;
&lt;br /&gt;
* &amp;quot;It facilitates blinding (masking) of the identity of treatments from investigators, participants, and assessors.&amp;quot;&lt;br /&gt;
&lt;br /&gt;
* &amp;quot;It permits the use of probability theory to express the likelihood that any difference in outcome between treatment groups merely indicates chance.&amp;quot;&lt;br /&gt;
&lt;br /&gt;
There are two processes involved in randomizing patients to different interventions. First is choosing a randomization procedure to generate an unpredictable sequence of allocations; this may be a simple random assignment of patients to any of the groups at equal probabilities, may be &amp;quot;restricted&amp;quot;, or may be &amp;quot;adaptive.&amp;quot; A second and more practical issue is allocation concealment, which refers to the stringent precautions taken to ensure that the group assignment of patients are not revealed prior to definitively allocating them to their respective groups. Non-random &amp;quot;systematic&amp;quot; methods of group assignment, such as alternating subjects between one group and the other, can cause &amp;quot;limitless contamination possibilities&amp;quot; and can cause a breach of allocation concealment.&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
随机对照试验中适当随机化的优点包括：&lt;br /&gt;
* 它消除了治疗分配中的偏差，特别是选择偏差和混淆。&lt;br /&gt;
&lt;br /&gt;
* 它便于调查人员、参与者和评估人员对治疗人群的身份进行遮蔽。&lt;br /&gt;
&lt;br /&gt;
* 它允许使用概率理论来表达这样一种可能性，即治疗组之间结果的任何差异仅仅表明是偶然性的。&lt;br /&gt;
&lt;br /&gt;
有两个过程涉及到随机化的病人接受到不同的干预。首先是选择一个随机化程序来生成一个不可预测的分配序列；这可能是以相等的概率将患者随机分配到任何一组，可能是“受限的”，也可能是“适应性的”。第二个也是更实际的问题是隐藏分配，这是指在将患者明确分配到各自的组之前，采取严格的预防措施，以确保患者的组分配不被披露。非随机的“系统”组分配方法，如在一个组和另一个组之间交替患者，可能会造成“无限的污染可能性”，并可能导致分配隐藏的破坏。&lt;br /&gt;
&lt;br /&gt;
However empirical evidence that adequate randomization changes outcomes relative to inadequate randomization has been difficult to detect.&amp;lt;ref name=&amp;quot;Howick-2014&amp;quot;&amp;gt;{{Cite journal |vauthors=Howick J, Mebius A | title = In search of justification for the unpredictability paradox | journal = Trials | volume = 15 | pages = 480 | year = 2014 | doi = 10.1186/1745-6215-15-480 | pmid = 25490908 | pmc=4295227}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
然而，相对于不充分随机化，充分随机化改变结果的经验证据很难被发现。&lt;br /&gt;
&lt;br /&gt;
=== Procedures ===&lt;br /&gt;
&lt;br /&gt;
The treatment allocation is the desired proportion of patients in each treatment arm.&lt;br /&gt;
&lt;br /&gt;
治疗分配是每个治疗组中患者的期望比例。&lt;br /&gt;
&lt;br /&gt;
An ideal randomization procedure would achieve the following goals:&amp;lt;ref name=&amp;quot;Lachin-1988a&amp;quot;&amp;gt;{{Cite journal | author = Lachin JM | title = Statistical properties of randomization in clinical trials | journal = [[Controlled Clinical Trials]] | volume = 9 | issue = 4 | pages = 289–311 | year = 1988 | pmid = 3060315 |  doi = 10.1016/0197-2456(88)90045-1 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
An ideal randomization procedure would achieve the following goals:&lt;br /&gt;
&lt;br /&gt;
一个理想的随机化程序将实现以下目标:&lt;br /&gt;
&lt;br /&gt;
* '''Maximize [[statistical power]]''', especially in [[Subgroup analysis|subgroup analyses]].  Generally, equal group sizes maximize statistical power, however, unequal groups sizes may be more powerful for some analyses (e.g., multiple comparisons of placebo versus several doses using Dunnett's procedure&amp;lt;ref&amp;gt;{{cite web|last=Rosenberger|first=James|title=STAT 503 - Design of Experiments|url=https://onlinecourses.science.psu.edu/stat503/node/16|publisher=Pennsylvania State University|access-date=24 September 2012}}&amp;lt;/ref&amp;gt; ), and are sometimes desired for non-analytic reasons (e.g., patients may be more motivated to enroll if there is a higher chance of getting the test treatment, or regulatory agencies may require a minimum number of patients exposed to treatment).&amp;lt;ref name=&amp;quot;Avins-1998&amp;quot;&amp;gt;{{cite journal|last=Avins|first=A L|title=&amp;quot;Can unequal be more fair? Ethics, subject allocation, and randomized clinical trials&amp;quot;.|journal=J Med Ethics|year=1998|volume=24|pages=401–408|doi=10.1136/jme.24.6.401|issue=6|pmc=479141|pmid=9873981}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
* '''Minimize selection bias'''.  This may occur if investigators can consciously or unconsciously preferentially enroll patients between treatment arms.  A good randomization procedure will be unpredictable so that investigators cannot guess the next subject's group assignment based on prior treatment assignments. The risk of selection bias is highest when previous treatment assignments are known (as in unblinded studies) or can be guessed (perhaps if a drug has distinctive side effects).&lt;br /&gt;
&lt;br /&gt;
* '''Minimize allocation bias''' (or '''confounding''').  This may occur when [[covariate]]s that affect the outcome are not equally distributed between treatment groups, and the treatment effect is confounded with the effect of the covariates (i.e., an &amp;quot;accidental bias&amp;quot;&amp;lt;ref name=&amp;quot;SchulzGrimes2002&amp;quot;/&amp;gt;&amp;lt;ref name=&amp;quot;Buyse-1989&amp;quot;&amp;gt;{{Cite journal | author = Buyse ME | title = Analysis of clinical trial outcomes: some comments on subgroup analyses | journal = [[Controlled Clinical Trials]] | volume = 10 | issue = 4 Suppl | pages = 187S–194S | year = 1989 | pmid = 2605967 |  doi = 10.1016/0197-2456(89)90057-3 }}&amp;lt;/ref&amp;gt;).  If the randomization procedure causes an imbalance in covariates related to the outcome across groups, estimates of effect may be [[bias of an estimator|biased]] if not adjusted for the covariates (which may be unmeasured and therefore impossible to adjust for).&lt;br /&gt;
* '''最大化统计能力'''，尤其是在亚组分析中。一般来说，相等的组规模将最大化统计能力，然而，不相等的组规模对于某些分析来说可能更强大(例如，使用Dunnett程序对安慰剂与几个剂量进行多次比较)，并且有时由于非分析性原因而被采用(例如，如果有更高的机会获得试验治疗，患者可能更有动力登记，或者监管机构可能要求最少数量的患者接受治疗)。&lt;br /&gt;
&lt;br /&gt;
* '''最小化选择偏差'''。如果调查人员可以有意识或无意识地在治疗之间优先招募患者，就可能发生这种情况。一个好的随机化过程是不可预测的，因此研究人员不能根据先前的治疗分配来猜测下一个受试者的分组。当已知以前的治疗方案时(如在非盲法研究中)或可以猜到(如果一种药物有明显的副作用)，选择偏倚的风险最高。&lt;br /&gt;
&lt;br /&gt;
* '''最小化分配偏差(或混淆)'''。当影响结果的协变量在治疗组之间分布不均，并且治疗效果与协变量的效果混淆时(即“偶然偏差”)，可能会出现这种情况。如果随机化程序导致与各组结果相关的协变量失衡，如果不对协变量进行调整，效果估计可能会有偏差(这可能无法测量，因此无法调整)。&lt;br /&gt;
&lt;br /&gt;
However, no single randomization procedure meets those goals in every circumstance, so researchers must select a procedure for a given study based on its advantages and disadvantages.&lt;br /&gt;
&lt;br /&gt;
However, no single randomization procedure meets those goals in every circumstance, so researchers must select a procedure for a given study based on its advantages and disadvantages.&lt;br /&gt;
&lt;br /&gt;
然而，没有一个单一的随机化程序在每种情况下都能满足这些目标，因此研究人员必须根据其优点和缺点来选择一个给定的研究程序。&lt;br /&gt;
&lt;br /&gt;
==== Simple ====&lt;br /&gt;
&lt;br /&gt;
This is a commonly used and intuitive procedure, similar to &amp;quot;repeated fair coin-tossing.&amp;quot;&amp;lt;ref name=&amp;quot;SchulzGrimes2002&amp;quot;/&amp;gt; Also known as &amp;quot;complete&amp;quot; or &amp;quot;unrestricted&amp;quot; randomization, it is [[Robust statistics|robust]] against both selection and accidental biases. However, its main drawback is the possibility of imbalanced group sizes in small RCTs.  It is therefore recommended only for RCTs with over 200 subjects.&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;&amp;gt;{{Cite journal |vauthors=Lachin JM, Matts JP, Wei LJ | title = Randomization in clinical trials: conclusions and recommendations | journal = [[Controlled Clinical Trials]] | volume = 9 | issue = 4 | pages = 365–74 | year = 1988 | pmid = 3203526 |  doi = 10.1016/0197-2456(88)90049-9 | hdl = 2027.42/27041 | url = https://deepblue.lib.umich.edu/bitstream/2027.42/27041/1/0000029.pdf | hdl-access = free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
This is a commonly used and intuitive procedure, similar to &amp;quot;repeated fair coin-tossing.&amp;quot; Also known as &amp;quot;complete&amp;quot; or &amp;quot;unrestricted&amp;quot; randomization, it is robust against both selection and accidental biases. However, its main drawback is the possibility of imbalanced group sizes in small RCTs. It is therefore recommended only for RCTs with over 200 subjects.这是一个常用且直观的程序，类似于“反复公平抛硬币”，也被称为“完全”或“无限制”随机化，它对选择和意外偏差都是稳健的。然而，它的主要缺点是在小的随机对照试验中群体规模不平衡的可能性。因此，建议仅用于受试者超过200人时进行随机对照试验。&lt;br /&gt;
&lt;br /&gt;
==== Restricted ====&lt;br /&gt;
&lt;br /&gt;
To balance group sizes in smaller RCTs, some form of [[restricted randomization|&amp;quot;restricted&amp;quot; randomization]] is recommended.&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;/&amp;gt;  The major types of restricted randomization used in RCTs are:&lt;br /&gt;
&lt;br /&gt;
* '''[[Randomized block design|Permuted-block randomization]]''' or '''blocked randomization''': a &amp;quot;block size&amp;quot; and &amp;quot;allocation ratio&amp;quot; (number of subjects in one group versus the other group) are specified, and subjects are allocated randomly within each block.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt; For example, a block size of 6 and an allocation ratio of 2:1 would lead to random assignment of 4 subjects to one group and 2 to the other. This type of randomization can be combined with &amp;quot;[[stratified randomization]]&amp;quot;, for example by center in a [[multicenter trial]], to &amp;quot;ensure good balance of participant characteristics in each group.&amp;quot;&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt; A special case of permuted-block randomization is ''random allocation'', in which the entire sample is treated as one block.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt; The major disadvantage of permuted-block randomization is that even if the block sizes are large and randomly varied, the procedure can lead to selection bias.&amp;lt;ref name=&amp;quot;Lachin-1988a&amp;quot;/&amp;gt; Another disadvantage is that &amp;quot;proper&amp;quot; analysis of data from permuted-block-randomized RCTs requires stratification by blocks.&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
* '''Adaptive biased-coin randomization''' methods (of which '''urn randomization''' is the most widely known type): In these relatively uncommon methods, the probability of being assigned to a group decreases if the group is overrepresented and increases if the group is underrepresented.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt; The methods are thought to be less affected by selection bias than permuted-block randomization.&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
为了平衡较小随机对照试验中的组规模，建议采用某种形式的“限制性”随机化。随机对照试验中主要使用的限制随机化类型有:&lt;br /&gt;
&lt;br /&gt;
* '''置换区组随机化'''或'''区组随机化'''：规定了“区组大小”和“分配比例”(一组受试者相对于另一组受试者的数量)，受试者在每个区组内随机分配。例如，块大小为6，分配比例为2:1，将导致4个受试者随机分配到一个组，2个分配到另一个组。这种类型的随机化可以与“分层随机化”相结合，例如通过多中心试验中的中心，以“确保每个组中参与者特征的良好平衡。”置换块随机化的一个特殊情况是随机分配，其中整个样本被视为一个块。置换块随机化的主要缺点是，即使块大小很大且随机变化，该过程也会导致选择偏差。另一个缺点是，对置换区组随机对照试验数据的“适当”分析需要按区组分层。&lt;br /&gt;
&lt;br /&gt;
* '''自适应有偏-硬币随机化方法'''（其中瓮随机化是最广为人知的类型）：在这些相对不常见的方法中，如果一个组的代表人数过多，被分配到该组的概率会降低，如果该组的代表人数不足，被分配到该组的概率会增加。这些方法被认为比置换块随机化受选择偏差的影响更小。&lt;br /&gt;
==== Adaptive ====&lt;br /&gt;
&lt;br /&gt;
At least two types of &amp;quot;adaptive&amp;quot; randomization procedures have been used in RCTs, but much less frequently than simple or restricted randomization:&lt;br /&gt;
&lt;br /&gt;
* '''Covariate-adaptive randomization''', of which one type is '''[[Minimisation (clinical trials)|minimization]]''': The probability of being assigned to a group varies in order to minimize &amp;quot;covariate imbalance.&amp;quot;&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;/&amp;gt; Minimization is reported to have &amp;quot;supporters and detractors&amp;quot;&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt; because only the first subject's group assignment is truly chosen at random, the method does not necessarily eliminate bias on unknown factors.&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
* '''Response-adaptive randomization''', also known as '''outcome-adaptive randomization''': The probability of being assigned to a group increases if the responses of the prior patients in the group were favorable.&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;/&amp;gt; Although arguments have been made that this approach is more ethical than other types of randomization when the probability that a treatment is effective or ineffective increases during the course of an RCT, ethicists have not yet studied the approach in detail.&amp;lt;ref name=&amp;quot;Rosenberger-1993&amp;quot;&amp;gt;{{Cite journal |vauthors=Rosenberger WF, Lachin JM | title = The use of response-adaptive designs in clinical trials | journal = [[Controlled Clinical Trials]] | volume = 14 | issue = 6 | pages = 471–84 | year = 1993 | pmid = 8119063 |  doi = 10.1016/0197-2456(93)90028-C }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
在随机对照试验中，至少使用了两种类型的“适应性”随机化程序，但频率远低于简单或限制性随机化：&lt;br /&gt;
&lt;br /&gt;
* '''协变量自适应随机化'''，其中一种类型是最小化：被分配到一个组的概率是变化的，以便最小化“协变量不平衡”。据报道，最小化有“支持者和诋毁者”，因为只有第一个受试者的群组分配是真正随机选择的，该方法不一定能消除对未知因素的偏见。&lt;br /&gt;
&lt;br /&gt;
* '''应答自适应随机化'''，也称为'''结果自适应随机化：'''如果组中先前患者的应答是有利的，则被分配到一个组的概率增加。虽然有人认为，当治疗有效或无效的概率在RCT过程中增加时，这种方法比其他类型的随机化更符合伦理，但伦理学家尚未详细研究这种方法。&lt;br /&gt;
=== Allocation concealment ===&lt;br /&gt;
&lt;br /&gt;
{{main|Allocation concealment}}&lt;br /&gt;
&lt;br /&gt;
&amp;quot;Allocation concealment&amp;quot; (defined as &amp;quot;the procedure for protecting the randomization process so that the treatment to be allocated is not known before the patient is entered into the study&amp;quot;) is important in RCTs.&amp;lt;ref name=&amp;quot;Forder-2005&amp;quot;&amp;gt;{{Cite journal |vauthors=Forder PM, Gebski VJ, Keech AC | title = Allocation concealment and blinding: when ignorance is bliss | journal = Med J Aust | volume = 182 | issue = 2 | pages = 87–9 | year = 2005 | url = http://www.mja.com.au/public/issues/182_02_170105/for10877_fm.html | pmid = 15651970 | doi = 10.5694/j.1326-5377.2005.tb06584.x | s2cid = 202149 }}&amp;lt;/ref&amp;gt; In practice, clinical investigators in RCTs often find it difficult to maintain impartiality. Stories abound of investigators holding up sealed envelopes to lights or ransacking offices to determine group assignments in order to dictate the assignment of their next patient.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;&amp;gt;{{Cite journal | title = Allocation concealment in randomised trials: defending against deciphering | journal = Lancet | volume = 359 | issue = 9306 | pages = 614–8 | year = 2002 | doi = 10.1016/S0140-6736(02)07750-4 | url =https://www.who.int/entity/rhl/LANCET_614-618.pdf | pmid = 11867132 |vauthors=Schulz KF, Grimes DA | s2cid = 12902486 }}&amp;lt;/ref&amp;gt; Such practices introduce selection bias and [[Lurking variable|confounders]] (both of which should be minimized by randomization), possibly distorting the results of the study.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt; Adequate allocation concealment should defeat patients and investigators from discovering treatment allocation once a study is underway and after the study has concluded.  Treatment related side-effects or adverse events may be specific enough to reveal allocation to investigators or patients thereby introducing bias or influencing any subjective parameters collected by investigators or requested from subjects.&lt;br /&gt;
&lt;br /&gt;
“分配隐藏”(定义为“保护随机化过程的程序，以便在病人进入研究之前不知道要分配的治疗”)在随机对照试验中很重要。在实践中，临床研究人员在随机对照试验中常常发现难以保持公正性。关于调查人员将密封的信封举到灯光下或者搜查办公室来决定群组分配，以便指定下一个病人的分配的故事比比皆是。这种做法引入了选择偏差和混杂因素(这两者都应该通过随机化来减少) ，可能会扭曲研究结果。一旦研究开始并在研究结束后，充分的分配隐藏应该会阻止患者和研究者发现治疗分配。与治疗相关的副作用或不良事件可能足够具体，足以向研究者或患者揭示分配情况，从而引入偏差或影响研究者收集的或受试者要求的任何主观参数。&lt;br /&gt;
&lt;br /&gt;
Some standard methods of ensuring allocation concealment include sequentially numbered, opaque, sealed envelopes (SNOSE); sequentially numbered containers; pharmacy controlled randomization; and central randomization. It is recommended that allocation concealment methods be included in an RCT's protocol, and that the allocation concealment methods should be reported in detail in a publication of an RCT's results; however, a 2005 study determined that most RCTs have unclear allocation concealment in their protocols, in their publications, or both. On the other hand, a 2008 study of 146 meta-analyses concluded that the results of RCTs with inadequate or unclear allocation concealment tended to be biased toward beneficial effects only if the RCTs' outcomes were subjective as opposed to objective.&lt;br /&gt;
&lt;br /&gt;
一些确保分配隐藏的标准方法包括顺序编号、不透明、密封信封(SNOSE)；顺序编号的容器；药学控制的随机化；和中心随机化。分配隐藏方法被建议纳入RCT议定书，并在RCT结果的出版物中详细报告分配隐藏方法；然而，2005年的一项研究发现，大多数随机对照试验在其方案、出版物或两者中都有不清楚的分配隐藏。另一方面，2008年的一项对146项元分析的研究得出结论，分配隐瞒不充分或不明确的随机对照试验的结果往往只有在随机对照试验的结果是主观的而不是客观的情况下才会偏向于有益的结果。&lt;br /&gt;
=== Sample size ===&lt;br /&gt;
&lt;br /&gt;
{{Main|Sample size determination}}The number of treatment units (subjects or groups of subjects) assigned to control and treatment groups, affects an RCT's reliability. If the effect of the treatment is small, the number of treatment units in either group may be insufficient for rejecting the null hypothesis in the respective statistical test. The failure to reject the null hypothesis would imply that the treatment shows no statistically significant effect on the treated ''in a given test''. But as the sample size increases, the same RCT may be able to demonstrate a significant effect of the treatment, even if this effect is small.&lt;br /&gt;
&lt;br /&gt;
分配给控制组和治疗组的治疗单位(受试者或受试者组)的样本量影响 RCT 的可靠性。如果治疗的效果很小，任何一组的治疗单位的样本量都可能不足以在各自的统计检验中拒绝零假设。拒绝无效假设的失败意味着在给定的试验中，治疗对被治疗者没有统计学上的显著影响。但是随着样本量的增加，同样的RCT可能能够证明治疗的显著效果，即使这种效果很小。&lt;br /&gt;
&lt;br /&gt;
== Blinding ==&lt;br /&gt;
&lt;br /&gt;
{{main|Blinded experiment}}&lt;br /&gt;
&lt;br /&gt;
An RCT may be [[Blind experiment|blinded]], (also called &amp;quot;masked&amp;quot;) by &amp;quot;procedures that prevent study participants, caregivers, or outcome assessors from knowing which intervention was received.&amp;quot;&amp;lt;ref name=&amp;quot;Wood-2008&amp;quot;&amp;gt;{{Cite journal |vauthors=Wood L, Egger M, Gluud LL, Schulz KF, Jüni P, Altman DG, Gluud C, Martin RM, Wood AJ, Sterne JA | title = Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study | journal = BMJ | volume = 336 | issue = 7644 | pages = 601–5 | year = 2008 | doi = 10.1136/bmj.39465.451748.AD | pmid = 18316340 | pmc = 2267990 }}&amp;lt;/ref&amp;gt; Unlike allocation concealment, blinding is sometimes inappropriate or impossible to perform in an RCT; for example, if an RCT involves a treatment in which active participation of the patient is necessary (e.g., [[physical therapy]]), participants cannot be blinded to the intervention.&lt;br /&gt;
&lt;br /&gt;
If a disruptive innovation in medical technology is developed, it may be difficult to test this ethically in an RCT if it becomes &amp;quot;obvious&amp;quot; that the control subjects have poorer outcomes—either due to other foregoing testing, or within the initial phase of the RCT itself.  Ethically it may be necessary to abort the RCT prematurely, and getting ethics approval (and patient agreement) to withhold the innovation from the control group in future RCT's may not be feasible.&lt;br /&gt;
&lt;br /&gt;
如果医学技术领域出现颠覆性创新，在RCT中，对照组的结果变得“明显”—－即对照组出现明显差的结局。这要么由于其他的前述测试，要么是在 RCT 本身的初始阶段， 那么在 RCT 中很难从伦理上检验这一点。从伦理上讲，过早地中止 RCT 可能是必要的，而在未来的 RCT 中，获得伦理批准(以及患者同意)以阻止控制组的创新可能是不可行的。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Traditionally, blinded RCTs have been classified as &amp;quot;single-blind&amp;quot;, &amp;quot;double-blind&amp;quot;, or &amp;quot;triple-blind&amp;quot;; however, in 2001 and 2006 two studies showed that these terms have different meanings for different people.&amp;lt;ref name=&amp;quot;Devereaux-2001&amp;quot;&amp;gt;{{Cite journal |vauthors=Devereaux PJ, Manns BJ, Ghali WA, Quan H, Lacchetti C, Montori VM, Bhandari M, Guyatt GH | title = Physician interpretations and textbook definitions of blinding terminology in randomized controlled trials | journal = [[J Am Med Assoc]] | volume = 285 | issue = 15 | pages = 2000–3 | year = 2001 | doi =  10.1001/jama.285.15.2000| pmid = 11308438 | doi-access = free }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Haahr-2006&amp;quot;&amp;gt;{{Cite journal |vauthors=Haahr MT, Hróbjartsson A | title = Who is blinded in randomized clinical trials? A study of 200 trials and a survey of authors | journal = Clin Trials | volume = 3 | issue = 4 | pages = 360–5 | year = 2006 | doi = 10.1177/1740774506069153 | pmid = 17060210 | s2cid = 23818514 }}&amp;lt;/ref&amp;gt;  The 2010 [[Consolidated Standards of Reporting Trials|CONSORT Statement]] specifies that authors and editors should not use the terms &amp;quot;single-blind&amp;quot;, &amp;quot;double-blind&amp;quot;, and &amp;quot;triple-blind&amp;quot;; instead, reports of blinded RCT should discuss &amp;quot;If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how.&amp;quot;&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Historical control trials (HCT) exploit the data of previous RCTs to reduce the sample size; however, these approaches are controversial in the scientific community and must be handled with care.&lt;br /&gt;
&lt;br /&gt;
历史对照试验(HCT)利用以前随机对照试验的数据来减少样本量，然而，这些方法在科学界是有争议的，必须小心处理。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
RCTs without blinding are referred to as &amp;quot;unblinded&amp;quot;,&amp;lt;ref name=&amp;quot;Marson-2007&amp;quot;&amp;gt;{{Cite journal  |vauthors=Marson AG, Al-Kharusi AM, Alwaidh M, Appleton R, Baker GA, Chadwick DW, etal | title = The SANAD study of effectiveness of valproate, lamotrigine, or topiramate for generalised and unclassifiable epilepsy: an unblinded randomised controlled trial | journal = [[The Lancet|Lancet]] | volume = 369 | issue = 9566 | pages = 1016–26 | year = 2007 | doi = 10.1016/S0140-6736(07)60461-9 | pmid = 17382828 | pmc = 2039891 }}&amp;lt;/ref&amp;gt; &amp;quot;open&amp;quot;,&amp;lt;ref name=&amp;quot;Chan-1995&amp;quot;&amp;gt;{{Cite journal |vauthors=Chan R, Hemeryck L, O'Regan M, Clancy L, Feely J | title = Oral versus intravenous antibiotics for community acquired lower respiratory tract infection in a general hospital: open, randomised controlled trial | journal = [[BMJ]] | volume = 310 | issue = 6991 | pages = 1360–2 | year = 1995 | pmid = 7787537 | pmc = 2549744 | doi=10.1136/bmj.310.6991.1360}}&amp;lt;/ref&amp;gt; or (if the intervention is a medication) &amp;quot;[[Open-label trial|open-label]]&amp;quot;.&amp;lt;ref name=&amp;quot;Fukase-2008&amp;quot;&amp;gt;{{Cite journal | author = Fukase K, Kato M, Kikuchi S, Inoue K, Uemura N, Okamoto S, Terao S, Amagai K, Hayashi S, Asaka M; Japan Gast Study Group | title = Effect of eradication of Helicobacter pylori on incidence of metachronous gastric carcinoma after endoscopic resection of early gastric cancer: an open-label, randomised controlled trial | journal = Lancet | volume = 372 | issue = 9636 | pages = 392–7 | year = 2008 | doi = 10.1016/S0140-6736(08)61159-9 | pmid = 18675689 | hdl = 2115/34681 | s2cid = 13741892 | url = https://eprints.lib.hokudai.ac.jp/dspace/bitstream/2115/34681/1/asaka.pdf | hdl-access = free }}&amp;lt;/ref&amp;gt; In 2008 a study concluded that the results of unblinded RCTs tended to be biased toward beneficial effects only if the RCTs' outcomes were subjective as opposed to objective;&amp;lt;ref name=&amp;quot;Wood-2008&amp;quot;/&amp;gt; for example, in an RCT of treatments for [[multiple sclerosis]], unblinded neurologists (but not the blinded neurologists) felt that the treatments were beneficial.&amp;lt;ref name=&amp;quot;Noseworthy-1994&amp;quot;&amp;gt;{{Cite journal |vauthors=Noseworthy JH, Ebers GC, Vandervoort MK, Farquhar RE, Yetisir E, Roberts R | author-link1=John H. Noseworthy|title = The impact of blinding on the results of a randomized, placebo-controlled multiple sclerosis clinical trial | journal = Neurology | volume = 44 | issue = 1 | pages = 16–20 | year = 1994 | url = http://www.neurology.org/cgi/content/abstract/44/1/16 | pmid = 8290055 | doi=10.1212/wnl.44.1.16| s2cid=2663997}}&amp;lt;/ref&amp;gt; In pragmatic RCTs, although the participants and providers are often unblinded, it is &amp;quot;still desirable and often possible to blind the assessor or obtain an objective source of data for evaluation of outcomes.&amp;quot;&amp;lt;ref name=&amp;quot;Zwarenstein-2008&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
== Analysis of data ==&lt;br /&gt;
&lt;br /&gt;
The types of statistical methods used in RCTs depend on the characteristics of the data and include:&lt;br /&gt;
&lt;br /&gt;
* For [[dichotomous]] (binary) outcome data, [[logistic regression]] (e.g., to predict sustained virological response after receipt of [[peginterferon alfa-2a]] for [[hepatitis C]]&amp;lt;ref name=&amp;quot;Manns-2001&amp;quot;&amp;gt;{{Cite journal |vauthors=Manns MP, McHutchison JG, Gordon SC, Rustgi VK, Shiffman M, Reindollar R, Goodman ZD, Koury K, Ling M, Albrecht JK | title = Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial | journal = [[The Lancet|Lancet]] | volume = 358 | issue = 9286 | pages = 958–65 | year = 2001 | doi = 10.1016/S0140-6736(01)06102-5 | pmid = 11583749 | s2cid = 14583372 }}&amp;lt;/ref&amp;gt;) and other methods can be used.&lt;br /&gt;
&lt;br /&gt;
* For continuous outcome data, [[analysis of covariance]] (e.g., for changes in blood lipid levels after receipt of [[atorvastatin]] after [[acute coronary syndrome]]&amp;lt;ref name=&amp;quot;Schwartz-2001&amp;quot;&amp;gt;{{Cite journal | author = Schwartz GG, Olsson AG, Ezekowitz MD, Ganz P, Oliver MF, Waters D, Zeiher A, Chaitman BR, Leslie S, Stern T; Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering (MIRACL) Study Investigators | title = Effects of atorvastatin on early recurrent ischemic events in acute coronary syndromes: the MIRACL study: a randomized controlled trial | journal = [[J Am Med Assoc]] | volume = 285 | issue = 13 | pages = 1711–8 | year = 2001 | pmid = 11277825 | doi = 10.1001/jama.285.13.1711 | doi-access = free }}&amp;lt;/ref&amp;gt;) tests the effects of predictor variables.&lt;br /&gt;
&lt;br /&gt;
* For time-to-event outcome data that may be [[Censoring (statistics)|censored]], [[survival analysis]] (e.g., [[Kaplan–Meier estimator]]s and [[Cox proportional hazards model]]s for time to [[coronary heart disease]] after receipt of [[Hormone replacement therapy (menopause)|hormone replacement therapy in menopause]]&amp;lt;ref name=&amp;quot;Rossouw-2002&amp;quot;&amp;gt;{{Cite journal | author = Rossouw JE, Anderson GL, [[Ross Prentice|Prentice RL]], LaCroix AZ, Kooperberg C, Stefanick ML, Jackson RD, Beresford SA, Howard BV, Johnson KC, Kotchen JM, Ockene J; Writing Group for the Women's Health Initiative Investigators | title = Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial | journal = [[J Am Med Assoc]] | volume = 288 | issue = 3 | pages = 321–33 | year = 2002 | pmid = 12117397 | doi = 10.1001/jama.288.3.321 | s2cid = 20149703 | url = https://escholarship.org/content/qt3mr6f93p/qt3mr6f93p.pdf?t=prll4c | doi-access = free }}&amp;lt;/ref&amp;gt;) is appropriate.&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Due to the recent emergence of RCTs in social science, the use of RCTs in social sciences is a contested issue.  Some writers from a medical or health background have argued that existing research in a range of social science disciplines lacks rigour, and should be improved by greater use of randomized control trials.&lt;br /&gt;
&lt;br /&gt;
由于最近在社会科学中出现了 rct，rct 在社会科学中的应用是一个有争议的问题。一些有医学或健康背景的作家认为，一系列社会科学学科的现有研究缺乏严谨性，应该通过更多地使用随机对照试验来改进。&lt;br /&gt;
Researchers in transport science argue that public spending on programmes such as school travel plans could not be justified unless their efficacy is demonstrated by randomized controlled trials.  Graham-Rowe and colleagues  reviewed 77 evaluations of transport interventions found in the literature, categorising them into 5 &amp;quot;quality levels&amp;quot;.  They concluded that most of the studies were of low quality and advocated the use of randomized controlled trials wherever possible in future transport research.&lt;br /&gt;
&lt;br /&gt;
交通科学研究人员认为，除非随机对照试验证明其有效性，否则在学校旅行计划等项目上的公共支出是不合理的。Graham-Rowe 和他的同事回顾了文献中发现的77个运输干预评估，将它们分为5个“质量水平”。他们的结论是，大多数研究质量低下，并主张在未来的运输研究中尽可能使用随机对照试验。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Regardless of the statistical methods used, important considerations in the analysis of RCT data include:&lt;br /&gt;
&lt;br /&gt;
Dr. Steve Melia took issue with these conclusions, arguing that claims about the advantages of RCTs, in establishing causality and avoiding bias, have been exaggerated.  He proposed the following eight criteria for the use of RCTs in contexts where interventions must change human behaviour to be effective:&lt;br /&gt;
&lt;br /&gt;
Steve Melia 博士对这些结论提出异议，认为关于 rct 在确定因果关系和避免偏见方面的优势的说法被夸大了。他提出了在干预措施必须改变人的行为才能有效的情况下使用区域反应技术的八项标准:&lt;br /&gt;
&lt;br /&gt;
* Whether an RCT should be stopped early due to interim results.  For example, RCTs may be stopped early if an intervention produces &amp;quot;larger than expected benefit or harm&amp;quot;, or if &amp;quot;investigators find evidence of no important difference between experimental and control interventions.&amp;quot;&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
* The extent to which the groups can be analyzed exactly as they existed upon randomization (i.e., whether a so-called &amp;quot;[[intention-to-treat analysis]]&amp;quot; is used). A &amp;quot;pure&amp;quot; intention-to-treat analysis is &amp;quot;possible only when complete outcome data are available&amp;quot; for all randomized subjects;&amp;lt;ref name=&amp;quot;Hollis-1999&amp;quot;&amp;gt;{{Cite journal |vauthors=Hollis S, Campbell F | title = What is meant by intention to treat analysis? Survey of published randomised controlled trials | journal = [[Br Med J]] | volume = 319 | issue = 7211 | pages = 670–4 | year = 1999 | pmid = 10480822 | pmc = 28218 | doi=10.1136/bmj.319.7211.670}}&amp;lt;/ref&amp;gt; when some outcome data are missing, options include analyzing only cases with known outcomes and using [[Imputation (statistics)|imputed]] data.&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt; Nevertheless, the more that analyses can include all participants in the groups to which they were randomized, the less bias that an RCT will be subject to.&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
The intervention:&lt;br /&gt;
&lt;br /&gt;
干预措施:&lt;br /&gt;
&lt;br /&gt;
* Whether [[subgroup analysis]] should be performed.  These are &amp;quot;often discouraged&amp;quot; because [[multiple comparisons]] may produce false positive findings that cannot be confirmed by other studies.&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
 Has not been applied to all members of a unique group of people (e.g. the population of a whole country, all employees of a unique organisation etc.)&lt;br /&gt;
&lt;br /&gt;
并不适用于一个特殊群体的所有成员(例如:。整个国家的人口，一个独特组织的所有雇员等)&lt;br /&gt;
&lt;br /&gt;
== Reporting of results ==&lt;br /&gt;
&lt;br /&gt;
 Is applied in a context or setting similar to that which applies to the control group&lt;br /&gt;
&lt;br /&gt;
应用于类似于应用于控制组的上下文或设置&lt;br /&gt;
&lt;br /&gt;
The ''[[Consolidated Standards of Reporting Trials|CONSORT 2010 Statement]]'' is &amp;quot;an evidence-based, minimum set of recommendations for reporting RCTs.&amp;quot;&amp;lt;ref name=&amp;quot;CONSORT&amp;quot;&amp;gt;{{cite web |url=http://www.consort-statement.org |title=Welcome to the CONSORT statement Website |author=CONSORT Group |access-date=2010-03-29}}&amp;lt;/ref&amp;gt; The CONSORT 2010 checklist contains 25 items (many with sub-items) focusing on &amp;quot;individually randomised, two group, parallel trials&amp;quot; which are the most common type of RCT.&amp;lt;ref name=&amp;quot;Schulz-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
 Can be isolated from other activities—and the purpose of the study is to assess this isolated effect&lt;br /&gt;
&lt;br /&gt;
这项研究的目的是评估这种孤立效应&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
 Has a short timescale between its implementation and maturity of its effects&lt;br /&gt;
&lt;br /&gt;
从实施到效果成熟之间的时间跨度很短&lt;br /&gt;
&lt;br /&gt;
For other RCT study designs, &amp;quot;[[Consolidated Standards of Reporting Trials|CONSORT extensions]]&amp;quot; have been published, some examples are:&lt;br /&gt;
&lt;br /&gt;
* Consort 2010 Statement: Extension to Cluster Randomised Trials&amp;lt;ref name=&amp;quot;CONSORT2010-EXTENSION-CLUSTER&amp;quot;&amp;gt;{{Cite journal |vauthors=Campbell MK, Piaggio G, Elbourne DR, Altman DG| title = Consort 2010 statement: extension to cluster randomised trials | journal = [[BMJ]] | volume = 345| pages = e5661 | year = 2012  | pmid = 22951546 | doi = 10.1136/bmj.e5661 | doi-access = free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
And the causal mechanisms:&lt;br /&gt;
&lt;br /&gt;
以及因果机制:&lt;br /&gt;
&lt;br /&gt;
* Consort 2010 Statement: Non-Pharmacologic Treatment Interventions&amp;lt;ref name=&amp;quot;CONSORT2010-EXTENSION-NON-PHARMACOLOGIC-1&amp;quot;&amp;gt;{{Cite journal |vauthors=Boutron I, Moher D, Altman DG, Schulz K, Ravaud P| title = Extending the CONSORT Statement to randomized trials of nonpharmacologic treatment: explanation and elaboration | journal = [[Annals of Internal Medicine]] | volume = 148| issue = 4 | year = 2008 | pages=295–309  | pmid = 18283207 | doi=10.7326/0003-4819-148-4-200802190-00008| doi-access = free }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;CONSORT2010-EXTENSION-NON-PHARMACOLOGIC-2&amp;quot;&amp;gt;{{Cite journal |vauthors=Boutron I, Moher D, Altman DG, Schulz K, Ravaud P| title = Methods and Processes of the CONSORT Group: Example of an Extension for Trials Assessing Nonpharmacologic Treatments | journal = [[Annals of Internal Medicine]] | volume = 148| issue = 4 | year = 2008  | pmid = 18283201 | doi=10.7326/0003-4819-148-4-200802190-00008-w1 | pages=W60–6| doi-access = free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&amp;lt;li value=&amp;quot;5&amp;quot;&amp;gt;Are either known to the researchers, or else all possible alternatives can be tested&lt;br /&gt;
&lt;br /&gt;
&amp;lt; li value = &amp;quot; 5&amp;quot; &amp;gt; 要么被研究人员知道，要么所有可能的替代方案都可以被测试&lt;br /&gt;
&lt;br /&gt;
=== Relative importance and observational studies ===&lt;br /&gt;
&lt;br /&gt;
 Do not involve significant feedback mechanisms between the intervention group and external environments&lt;br /&gt;
&lt;br /&gt;
不涉及干预组和外部环境之间的重要反馈机制&lt;br /&gt;
&lt;br /&gt;
Two studies published in ''[[The New England Journal of Medicine]]'' in 2000 found that [[Observational study|observational studies]] and RCTs overall produced similar results.&amp;lt;ref name=&amp;quot;Benson-2000&amp;quot;&amp;gt;{{Cite journal |vauthors=Benson K, Hartz AJ | title = A comparison of observational studies and randomized, controlled trials | journal = [[N Engl J Med]] | volume = 342 | issue = 25 | pages = 1878–86 | year = 2000 | pmid = 10861324 | doi = 10.1056/NEJM200006223422506 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Concato-2000&amp;quot;&amp;gt;{{Cite journal |vauthors=Concato J, Shah N, Horwitz RI | title = Randomized, controlled trials, observational studies, and the hierarchy of research designs | journal = [[N Engl J Med]] | volume = 342 | issue = 25 | pages = 1887–92 | year = 2000 | url = http://nejm.highwire.org/cgi/content/full/342/25/1887 | pmid = 10861325 | doi = 10.1056/NEJM200006223422507 | pmc = 1557642 }}&amp;lt;/ref&amp;gt; The authors of the 2000 findings questioned the belief that &amp;quot;observational studies should not be used for defining evidence-based medical care&amp;quot; and that RCTs' results are &amp;quot;evidence of the highest grade.&amp;quot;&amp;lt;ref name=&amp;quot;Benson-2000&amp;quot;/&amp;gt;&amp;lt;ref name=&amp;quot;Concato-2000&amp;quot;/&amp;gt; However, a 2001 study published in ''[[Journal of the American Medical Association]]'' concluded that &amp;quot;discrepancies beyond chance do occur and differences in estimated magnitude of treatment effect are very common&amp;quot; between observational studies and RCTs.&amp;lt;ref name=&amp;quot;Ioannidis-2001&amp;quot;&amp;gt;{{Cite journal |vauthors=Ioannidis JP, Haidich AB, Pappa M, Pantazis N, Kokori SI, Tektonidou MG, Contopoulos-Ioannidis DG, Lau J | title = Comparison of evidence of treatment effects in randomized and nonrandomized studies | journal = [[J Am Med Assoc]] | volume = 286 | issue = 7 | pages = 821–30 | year = 2001 | pmid = 11497536 | doi = 10.1001/jama.286.7.821 | citeseerx = 10.1.1.590.2854 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Have a stable and predictable relationship to exogenous factors&lt;br /&gt;
&lt;br /&gt;
与外部因素有稳定和可预测的关系&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
 Would act in the same way if the control group and intervention group were reversed&lt;br /&gt;
&lt;br /&gt;
如果对照组和干预组的情况相反，他们也会以同样的方式行动&lt;br /&gt;
&lt;br /&gt;
Two other lines of reasoning question RCTs' contribution to scientific knowledge beyond other types of studies:&lt;br /&gt;
* If study designs are ranked by their potential for new discoveries, then [[Anecdotal evidence#Scientific context|anecdotal evidence]] would be at the top of the list, followed by observational studies, followed by RCTs.&amp;lt;ref name=&amp;quot;Vandenbroucke-2008&amp;quot;&amp;gt;{{Cite journal | author = Vandenbroucke JP | title = Observational research, randomised trials, and two views of medical science | journal = [[PLoS Med]] | volume = 5 | issue = 3 | pages = e67 | year = 2008 | doi = 10.1371/journal.pmed.0050067 | pmid = 18336067 | pmc = 2265762 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* RCTs may be unnecessary for treatments that have dramatic and rapid effects relative to the expected stable or progressively worse natural course of the condition treated.&amp;lt;ref name=&amp;quot;Black-1996&amp;quot;/&amp;gt;&amp;lt;ref name=&amp;quot;Glasziou-2007&amp;quot;&amp;gt;{{Cite journal |vauthors=Glasziou P, Chalmers I, Rawlins M, McCulloch P | title = When are randomised trials unnecessary? Picking signal from noise | journal = [[Br Med J]] | volume = 334 | issue = 7589 | pages = 349–51 | year = 2007 | doi = 10.1136/bmj.39070.527986.68 | pmc=1800999 | pmid = 17303884 }}&amp;lt;/ref&amp;gt; One example is [[History of cancer chemotherapy#Combination chemotherapy|combination chemotherapy]] including [[cisplatin]] for [[Metastasis|metastatic]] [[testicular cancer]], which increased the cure rate from 5% to 60% in a 1977 non-randomized study.&amp;lt;ref name=&amp;quot;Glasziou-2007&amp;quot;/&amp;gt;&amp;lt;ref name=&amp;quot;Einhorn-2002&amp;quot;&amp;gt;{{Cite journal | author = Einhorn LH | author-link = Lawrence Einhorn | title = Curing metastatic testicular cancer | journal = [[Proc Natl Acad Sci U S A]] | volume = 99 | issue = 7 | pages = 4592–5 | year = 2002 | doi = 10.1073/pnas.072067999 | pmid = 11904381 | pmc = 123692 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
A 2005 review found 83 randomized experiments in criminology published in 1982–2004, compared with only 35 published in 1957–1981. The authors classified the studies they found into five categories: &amp;quot;policing&amp;quot;, &amp;quot;prevention&amp;quot;, &amp;quot;corrections&amp;quot;, &amp;quot;court&amp;quot;, and &amp;quot;community&amp;quot;.&lt;br /&gt;
&lt;br /&gt;
2005年的一项研究发现，1982年至2004年发表的犯罪学随机实验有83项，而1957年至1981年发表的只有35项。作者将他们发现的研究分为五类: “警务”、“预防”、“惩戒”、“法院”和“社区”。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
=== Interpretation of statistical results ===&lt;br /&gt;
&lt;br /&gt;
Like all statistical methods, RCTs are subject to both [[type I and type II errors|type I (&amp;quot;false positive&amp;quot;) and type II (&amp;quot;false negative&amp;quot;) statistical errors]].  Regarding Type I errors, a typical RCT will use 0.05 (i.e., 1 in 20) as the probability that the RCT will falsely find two equally effective treatments significantly different.&amp;lt;ref name=&amp;quot;Wittes-2002&amp;quot;&amp;gt;{{Cite journal | author = Wittes J | title = Sample size calculations for randomized controlled trials | journal = [[Epidemiol Rev]] | volume = 24 | issue = 1 | pages = 39–53 | year = 2002 | doi = 10.1093/epirev/24.1.39 | pmid = 12119854 | doi-access = free }}&amp;lt;/ref&amp;gt; Regarding Type II errors, despite the publication of a 1978 paper noting that the [[sample size]]s of many &amp;quot;negative&amp;quot; RCTs were too small to make definitive conclusions about the negative results,&amp;lt;ref name=&amp;quot;Freiman-1978&amp;quot;&amp;gt;{{Cite journal | doi = 10.1056/NEJM197809282991304 |vauthors=Freiman JA, Chalmers TC, ((Smith H Jr)), Kuebler RR | title = The importance of beta, the type II error and sample size in the design and interpretation of the randomized control trial. Survey of 71 &amp;quot;negative&amp;quot; trials | journal = [[N Engl J Med]] | volume = 299 | issue = 13 | pages = 690–4 | year = 1978 | pmid = 355881 }}&amp;lt;/ref&amp;gt; by 2005-2006 a sizeable proportion of RCTs still had inaccurate or incompletely reported sample size calculations.&amp;lt;ref name=&amp;quot;Charles-2009&amp;quot;&amp;gt;{{Cite journal |vauthors=Charles P, Giraudeau B, Dechartres A, Baron G, Ravaud P | title = Reporting of sample size calculation in randomised controlled trials: review | journal = [[Br Med J]] | volume = 338 | pages = b1732 | date = 2009-05-12 | doi = 10.1136/bmj.b1732 | pmid = 19435763 | pmc = 2680945 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
RCTs have been used in evaluating a number of educational interventions. Between 1980 and 2016, over 1,000 reports of RCTs have been published. For example, a 2009 study randomized 260 elementary school teachers' classrooms to receive or not receive a program of behavioral screening, classroom intervention, and parent training, and then measured the behavioral and academic performance of their students. Another 2009 study randomized classrooms for 678 first-grade children to receive a classroom-centered intervention, a parent-centered intervention, or no intervention, and then followed their academic outcomes through age 19.&lt;br /&gt;
&lt;br /&gt;
随机对照试验已用于评价一些教育干预措施。从1980年到2016年，已经发表了超过1000篇关于 rct 的报告。例如，2009年的一项研究随机抽取了260名小学教师的课堂，让他们接受或不接受行为筛选、课堂干预和家长培训，然后测量他们学生的行为和学业表现。2009年的另一项研究随机化了678个一年级儿童的课堂，接受了以课堂为中心的干预，以家长为中心的干预，或没有干预，然后跟踪他们的学习成果直到19岁。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
=== Peer review ===&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
A 2017 review of the 10 most cited randomised controlled trials noted poor distribution of background traits, difficulties with blinding, and discussed other assumptions and biases inherent in randomised controlled trials. These include the &amp;quot;unique time period assessment bias&amp;quot;, the &amp;quot;background traits remain constant assumption&amp;quot;, the &amp;quot;average treatment effects limitation&amp;quot;, the &amp;quot;simple treatment at the individual level limitation&amp;quot;, the &amp;quot;all preconditions are fully met assumption&amp;quot;, the &amp;quot;quantitative variable limitation&amp;quot; and the &amp;quot;placebo only or conventional treatment only limitation&amp;quot;.&lt;br /&gt;
&lt;br /&gt;
2017年对10个最常被引用的随机对照试验的回顾指出，背景特征的分布不良，盲法存在困难，并讨论了随机对照试验中固有的其他假设和偏差。其中包括”独特的时间段评估偏差”、”背景特征保持不变的假设”、”平均治疗效果限制”、”个人层面的简单治疗限制”、”所有前提条件都得到充分满足的假设”、”定量变量限制”以及”仅安慰剂或常规治疗限制”。&lt;br /&gt;
&lt;br /&gt;
[[Peer review]] of results is an important part of the [[scientific method]]. Reviewers examine the study results for potential problems with design that could lead to unreliable results (for example by creating a [[systematic bias]]), evaluate the study in the context of related studies and other evidence, and evaluate whether the study can be reasonably considered to have proven its conclusions. To underscore the need for peer review and the danger of over-generalizing conclusions, two Boston-area medical researchers performed a randomized controlled trial in which they randomly assigned either a parachute or an empty backpack to 23 volunteers who jumped from either a biplane or a helicopter. The study was able to accurately report that parachutes fail to reduce injury compared to empty backpacks. The key context that limited the general applicability of this conclusion was that the aircraft were parked on the ground, and participants had only jumped about two feet.&amp;lt;ref&amp;gt;{{cite news |url=https://www.npr.org/sections/health-shots/2018/12/22/679083038/researchers-show-parachutes-dont-work-but-there-s-a-catch |title=Researchers Show Parachutes Don't Work, But There's A Catch |date=22 Dec 2018 |author=Richard Harris}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
== Advantages ==&lt;br /&gt;
&lt;br /&gt;
RCTs are considered to be the most reliable form of [[scientific method|scientific evidence]] in the [[hierarchy of evidence]] that influences healthcare policy and practice because RCTs reduce spurious causality and bias. Results of RCTs may be combined in [[systematic review]]s which are increasingly being used in the conduct of [[evidence-based practice]]. Some examples of scientific organizations' considering RCTs or systematic reviews of RCTs to be the highest-quality evidence available are:&lt;br /&gt;
* As of 1998, the [[National Health and Medical Research Council]] of Australia designated &amp;quot;Level I&amp;quot; evidence as that &amp;quot;obtained from a [[systematic review]] of all relevant randomised controlled trials&amp;quot; and &amp;quot;Level II&amp;quot; evidence as that &amp;quot;obtained from at least one properly designed randomised controlled trial.&amp;quot;&amp;lt;ref&amp;gt;{{cite book |url= http://www.nhmrc.gov.au/_files_nhmrc/file/publications/synopses/cp30.pdf |title= A guide to the development, implementation and evaluation of clinical practice guidelines |author= National Health and Medical Research Council |date=1998-11-16 |publisher= Commonwealth of Australia |location = Canberra | isbn = 978-1-86496-048-8 |page= 56|access-date=2010-03-28}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* Since at least 2001, in making [[clinical practice guideline]] recommendations the [[United States Preventive Services Task Force]] has considered both a study's design and its [[internal validity]] as indicators of its quality.&amp;lt;ref name=&amp;quot;Harris-2001&amp;quot;&amp;gt;{{Cite journal | author = Harris RP, Helfand M, Woolf SH, Lohr KN, Mulrow CD, Teutsch SM, Atkins D; Methods Work Group, Third US Preventive Services Task Force | title = Current methods of the US Preventive Services Task Force: a review of the process | journal = Am J Prev Med | volume = 20 | issue = 3 Suppl | pages = 21–35 | year = 2001 | url = http://www.ahrq.gov/clinic/ajpmsuppl/review.pdf | pmid = 11306229 | doi = 10.1016/S0749-3797(01)00261-6 }}&amp;lt;/ref&amp;gt; It has recognized &amp;quot;evidence obtained from at least one properly randomized controlled trial&amp;quot; with good [[internal validity]] (i.e., a rating of &amp;quot;I-good&amp;quot;) as the highest quality evidence available to it.&amp;lt;ref name=&amp;quot;Harris-2001&amp;quot;/&amp;gt;&lt;br /&gt;
* The [[Evidence-based medicine#Grade Working Group|GRADE Working Group]] concluded in 2008 that &amp;quot;randomised trials without important limitations constitute high quality evidence.&amp;quot;&amp;lt;ref name=&amp;quot;Guyatt-2008&amp;quot;&amp;gt;{{Cite journal | author = Guyatt GH, Oxman AD, Kunz R, Vist GE, Falck-Ytter Y, Schünemann HJ; GRADE Working Group | title = What is &amp;quot;quality of evidence&amp;quot; and why is it important to clinicians? | journal = BMJ | volume = 336 | issue = 7651 | pages = 995–8 |year = 2008 | doi = 10.1136/bmj.39490.551019.BE | pmc = 2364804 | pmid = 18456631 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* For issues involving &amp;quot;Therapy/Prevention, Aetiology/Harm&amp;quot;, the [[Oxford Centre for Evidence-based Medicine]] as of 2011 defined &amp;quot;Level 1a&amp;quot; evidence as a systematic review of RCTs that are consistent with each other, and &amp;quot;Level 1b&amp;quot; evidence as an &amp;quot;individual RCT (with narrow [[Confidence Interval]]).&amp;quot;&amp;lt;ref&amp;gt;{{cite web |url= http://www.cebm.net/index.aspx?o=1025 |title= Levels of evidence |author= Oxford Centre for Evidence-based Medicine |date=2011-09-16 |access-date=2012-02-15}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Notable RCTs with unexpected results that contributed to changes in clinical practice include:&lt;br /&gt;
* After [[Food and Drug Administration]] approval, the [[antiarrhythmic agents]] [[flecainide]] and [[encainide]] came to market in 1986 and 1987 respectively.&amp;lt;ref name=&amp;quot;Anderson-1997&amp;quot;&amp;gt;{{Cite journal |vauthors=Anderson JL, Pratt CM, Waldo AL, Karagounis LA | title = Impact of the Food and Drug Administration approval of flecainide and encainide on coronary artery disease mortality: putting &amp;quot;Deadly Medicine&amp;quot; to the test | journal = Am J Cardiol | volume = 79 | issue = 1 | pages = 43–7 | year = 1997 | url = http://www.ajconline.org/article/S0002-9149%2896%2900673-X/abstract | pmid = 9024734 | doi = 10.1016/S0002-9149(96)00673-X }}&amp;lt;/ref&amp;gt; The non-randomized studies concerning the drugs were characterized as &amp;quot;glowing&amp;quot;,&amp;lt;ref name=&amp;quot;Rubin-2006&amp;quot;&amp;gt;{{cite news |title= In medicine, evidence can be confusing - deluged with studies, doctors try to sort out what works, what doesn't |author= Rubin R |url= https://www.usatoday.com/news/health/2006-10-15-medical-evidence-cover_x.htm |newspaper= USA Today |date= 2006-10-16 |access-date=2010-03-22}}&amp;lt;/ref&amp;gt; and their sales increased to a combined total of approximately 165,000 prescriptions per month in early 1989.&amp;lt;ref name=&amp;quot;Anderson-1997&amp;quot;/&amp;gt;  In that year, however, a preliminary report of an RCT concluded that the two drugs increased mortality.&amp;lt;ref name=&amp;quot;CAST-1989&amp;quot;&amp;gt;{{Cite journal | doi = 10.1056/NEJM198908103210629 | title = Preliminary report: effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction. The Cardiac Arrhythmia Suppression Trial (CAST) Investigators | journal = N Engl J Med | volume = 321 | issue = 6 | pages = 406–12 |year = 1989 | pmid = 2473403 | author1 = Cardiac Arrhythmia Suppression Trial (CAST) Investigators }}&amp;lt;/ref&amp;gt;  Sales of the drugs then decreased.&amp;lt;ref name=&amp;quot;Anderson-1997&amp;quot;/&amp;gt;&lt;br /&gt;
* Prior to 2002, based on observational studies, it was routine for physicians to prescribe hormone replacement therapy for post-menopausal women to prevent [[myocardial infarction]].&amp;lt;ref name=&amp;quot;Rubin-2006&amp;quot;/&amp;gt; In 2002 and 2004, however, published RCTs from the [[Women's Health Initiative]] claimed that women taking hormone replacement therapy with estrogen plus progestin had a higher rate of myocardial infarctions than women on a placebo, and that estrogen-only hormone replacement therapy caused no reduction in the incidence of coronary heart disease.&amp;lt;ref name=&amp;quot;Rossouw-2002&amp;quot;/&amp;gt;&amp;lt;ref name=&amp;quot;Anderson-2004&amp;quot;&amp;gt;{{Cite journal  |vauthors=Anderson GL, Limacher M, Assaf AR, Bassford T, Beresford SA, Black H, etal | title = Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women's Health Initiative randomized controlled trial | journal = JAMA | volume = 291 | issue = 14 | pages = 1701–12 | year = 2004 | doi = 10.1001/jama.291.14.1701 | pmid = 15082697 | doi-access = free }}&amp;lt;/ref&amp;gt;  Possible explanations for the discrepancy between the observational studies and the RCTs involved differences in methodology, in the hormone regimens used, and in the populations studied.&amp;lt;ref name=&amp;quot;Grodstein-2003&amp;quot;&amp;gt;{{Cite journal |vauthors=Grodstein F, Clarkson TB, Manson JE | title = Understanding the divergent data on postmenopausal hormone therapy | journal = N Engl J Med | volume = 348 | issue = 7 | pages = 645–50 | year = 2003 | doi = 10.1056/NEJMsb022365 | pmid = 12584376 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Vandenbroucke-2009&amp;quot;&amp;gt;{{Cite journal | author = Vandenbroucke JP | title = The HRT controversy: observational studies and RCTs fall in line | journal = Lancet | volume = 373 | issue = 9671 | pages = 1233–5 | year = 2009 | doi = 10.1016/S0140-6736(09)60708-X | pmid = 19362661 | s2cid = 44991220 }}&amp;lt;/ref&amp;gt; The use of hormone replacement therapy decreased after publication of the RCTs.&amp;lt;ref name=&amp;quot;Hsu-2009&amp;quot;&amp;gt;{{Cite journal |vauthors=Hsu A, Card A, Lin SX, Mota S, Carrasquillo O, Moran A | title = Changes in postmenopausal hormone replacement therapy use among women with high cardiovascular risk | journal = Am J Public Health | volume = 99 | issue = 12 | pages = 2184–7 | year = 2009 | doi = 10.2105/AJPH.2009.159889 | url = http://ajph.aphapublications.org/cgi/content/full/99/12/2184 | pmid = 19833984 | pmc=2775780}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
== Disadvantages ==&lt;br /&gt;
&lt;br /&gt;
Many papers discuss the disadvantages of RCTs.&amp;lt;ref name=&amp;quot;Black-1996&amp;quot;&amp;gt;{{Cite journal | author = Black N | title = Why we need observational studies to evaluate the effectiveness of health care | journal = BMJ | volume = 312 | issue = 7040 | pages = 1215–8 | year = 1996 | pmid = 8634569 | pmc = 2350940 | doi=10.1136/bmj.312.7040.1215}}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Bell &amp;amp; Peck-2012&amp;quot;&amp;gt;{{Cite journal | author = Bell, S.H., &amp;amp; Peck, L.R. | title = Obstacles to and limitations of social experiments: 15 false alarms | journal = Abt Thought Leadership Paper Series | year = 2012 | url = http://abtassociates.com/white-papers/2012/obstacles-to-and-limitations-of-social-experiments.aspx }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Sanson-Fisher-2007&amp;quot;&amp;gt;{{Cite journal |vauthors=Sanson-Fisher RW, Bonevski B, Green LW, D'Este C | title = Limitations of the randomized controlled trial in evaluating population-based health interventions | journal = Am J Prev Med | volume = 33 | issue = 2 | pages = 155–61 | year = 2007 | doi = 10.1016/j.amepre.2007.04.007 | url = http://www.ajpm-online.net/article/S0749-3797%2807%2900225-5/abstract | pmid = 17673104 }}&amp;lt;/ref&amp;gt;   Among the most frequently cited drawbacks are:&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
=== Time and costs ===&lt;br /&gt;
&lt;br /&gt;
RCTs can be expensive;&amp;lt;ref name=&amp;quot;Sanson-Fisher-2007&amp;quot;/&amp;gt; one study found 28 [[Phase III clinical trials|Phase III]] RCTs funded by the [[National Institute of Neurological Disorders and Stroke]] prior to 2000 with a total cost of US$335 million,&amp;lt;ref name=&amp;quot;Johnston-2006&amp;quot;&amp;gt;{{Cite journal |vauthors=Johnston SC, Rootenberg JD, Katrak S, Smith WS, Elkins JS | title = Effect of a US National Institutes of Health programme of clinical trials on public health and costs | journal = [[The Lancet|Lancet]] | volume = 367 | issue = 9519 | pages = 1319–27 | year = 2006 | doi = 10.1016/S0140-6736(06)68578-4 | url = http://www.chrp.org/pdf/HSR20070511.pdf | pmid = 16631910 | s2cid = 41035177 }}&amp;lt;/ref&amp;gt; for a [[mean]] cost of US$12 million per RCT.  Nevertheless, the [[return on investment]] of RCTs may be high, in that the same study projected that the 28 RCTs produced a &amp;quot;net benefit to society at 10-years&amp;quot; of 46 times the cost of the trials program, based on evaluating a [[quality-adjusted life year]] as equal to the prevailing mean [[per capita]] [[gross domestic product]].&amp;lt;ref name=&amp;quot;Johnston-2006&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
The conduct of an RCT takes several years until being published; thus, data is restricted from the medical community for long years and may be of less relevance at time of publication.&amp;lt;ref name=&amp;quot;CaseReport&amp;quot;&amp;gt;{{cite journal |vauthors=Yitschaky O, Yitschaky M, Zadik Y |title=Case report on trial: Do you, Doctor, swear to tell the truth, the whole truth and nothing but the truth? |journal=J Med Case Rep |volume=5 |issue=1 |page=179 |date=May 2011 |pmid=21569508 |url=http://www.jmedicalcasereports.com/content/pdf/1752-1947-5-179.pdf|doi=10.1186/1752-1947-5-179 |pmc=3113995}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
It is costly to maintain RCTs for the years or decades that would be ideal for evaluating some interventions.&amp;lt;ref name=&amp;quot;Black-1996&amp;quot;/&amp;gt;&amp;lt;ref name=&amp;quot;Sanson-Fisher-2007&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Interventions to prevent events that occur only infrequently (e.g., [[sudden infant death syndrome]]) and uncommon adverse outcomes (e.g., a rare side effect of a drug) would require RCTs with extremely large sample sizes and may, therefore, best be assessed by observational studies.&amp;lt;ref name=&amp;quot;Black-1996&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Due to the costs of running RCTs, these usually only inspect one variable or very few variables, rarely reflecting the full picture of a complicated medical situation; whereas the [[case report]], for example, can detail many aspects of the patient's [[medicine|medical]] situation (e.g. [[patient history]], [[physical examination]], [[diagnosis]], [[psychosocial]] aspects, follow up).&amp;lt;ref name=&amp;quot;CaseReport&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
=== Conflict of interest dangers ===&lt;br /&gt;
&lt;br /&gt;
A 2011 study done to disclose possible [[conflicts of interest]]s in underlying research studies used for medical meta-analyses reviewed 29 meta-analyses and found that conflicts of interests in the studies underlying the meta-analyses were rarely disclosed.  The 29 meta-analyses included 11 from general medicine journals; 15 from specialty medicine journals, and 3 from the [[Cochrane Collaboration|Cochrane]] Database of Systematic Reviews. The 29 meta-analyses reviewed an aggregate of 509 randomized controlled trials (RCTs). Of these, 318 RCTs reported funding sources with 219 (69%) industry funded. 132 of the 509 RCTs reported author conflict of interest disclosures, with 91 studies (69%) disclosing industry financial ties with one or more authors. The information was, however, seldom reflected in the meta-analyses. Only two (7%) reported RCT funding sources and none reported RCT author-industry ties. The authors concluded &amp;quot;without acknowledgment of COI due to industry funding or author industry financial ties from RCTs included in meta-analyses, readers' understanding and appraisal of the evidence from the meta-analysis may be compromised.&amp;quot;&amp;lt;ref&amp;gt;{{cite web|url=http://www.cochrane.org/news/blog/how-well-do-meta-analyses-disclose-conflicts-interests-underlying-research-studies |title=How Well Do Meta-Analyses Disclose Conflicts of Interests in Underlying Research Studies &amp;amp;#124; The Cochrane Collaboration |publisher=Cochrane.org |access-date=2011-08-19}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
A 2011 study done to disclose possible conflicts of interests in underlying research studies used for medical meta-analyses reviewed 29 meta-analyses and found that conflicts of interests in the studies underlying the meta-analyses were rarely disclosed. The 29 meta-analyses included 11 from general medicine journals; 15 from specialty medicine journals, and 3 from the Cochrane Database of Systematic Reviews. The 29 meta-analyses reviewed an aggregate of 509 randomized controlled trials (RCTs). Of these, 318 RCTs reported funding sources with 219 (69%) industry funded. 132 of the 509 RCTs reported author conflict of interest disclosures, with 91 studies (69%) disclosing industry financial ties with one or more authors. The information was, however, seldom reflected in the meta-analyses. Only two (7%) reported RCT funding sources and none reported RCT author-industry ties. The authors concluded &amp;quot;without acknowledgment of COI due to industry funding or author industry financial ties from RCTs included in meta-analyses, readers' understanding and appraisal of the evidence from the meta-analysis may be compromised.&amp;quot;[97]&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Some RCTs are fully or partly funded by the health care industry (e.g., the [[pharmaceutical industry]]) as opposed to government, nonprofit, or other sources. A systematic review published in 2003 found four 1986–2002 articles comparing industry-sponsored and nonindustry-sponsored RCTs, and in all the articles there was a correlation of industry sponsorship and positive study outcome.&amp;lt;ref name=&amp;quot;Bekelman-2003&amp;quot;&amp;gt;{{Cite journal |vauthors=Bekelman JE, Li Y, Gross CP | title = Scope and impact of financial conflicts of interest in biomedical research: a systematic review | journal = [[J Am Med Assoc]] | volume = 289 | issue = 4 | pages = 454–65 | year = 2003 | pmid = 12533125 | doi = 10.1001/jama.289.4.454 }}&amp;lt;/ref&amp;gt; A 2004 study of 1999–2001 RCTs published in leading medical and surgical journals determined that industry-funded RCTs &amp;quot;are more likely to be associated with statistically significant pro-industry findings.&amp;quot;&amp;lt;ref name=&amp;quot;Bhandari-2004&amp;quot;&amp;gt;{{Cite journal |vauthors=Bhandari M, Busse JW, Jackowski D, Montori VM, Schünemann H, Sprague S, Mears D, Schemitsch EH, Heels-Ansdell D, Devereaux PJ | title = Association between industry funding and statistically significant pro-industry findings in medical and surgical randomized trials | journal = [[Can Med Assoc J]] | volume = 170 | issue = 4 | pages = 477–80 | year = 2004 | url = http://ecmaj.com/cgi/content/full/170/4/477 | pmid = 14970094 | pmc = 332713 }}&amp;lt;/ref&amp;gt; These results have been mirrored in trials in surgery, where although industry funding did not affect the rate of trial discontinuation it was however associated with a lower odds of publication for completed trials.&amp;lt;ref name=&amp;quot;Chapman-2014&amp;quot;&amp;gt;{{Cite journal |vauthors=Chapman SJ, Shelton B, Mahmood H, Fitzgerald JE, Harrison EM, Bhangu A | title = Discontinuation and non-publication of surgical randomised controlled trials: observational study | journal = [[BMJ]] | volume = 349 | page = g6870| year = 2014 | pmid = 25491195 | pmc = 4260649 | doi=10.1136/bmj.g6870}}&amp;lt;/ref&amp;gt; One possible reason for the pro-industry results in industry-funded published RCTs is [[publication bias]].&amp;lt;ref name=&amp;quot;Bhandari-2004&amp;quot;/&amp;gt;  Other authors have cited the differing goals of academic and industry sponsored research as contributing to the difference. Commercial sponsors may be more focused on performing trials of drugs that have already shown promise in early stage trials, and on replicating previous positive results to fulfill regulatory requirements for drug approval.&amp;lt;ref&amp;gt;{{cite journal |vauthors=Ridker PM, Torres J |title=Reported outcomes in major cardiovascular clinical trials funded by for-profit and not-for-profit organizations: 2000-2005 |journal=JAMA |volume=295 |issue=19 |pages=2270–4 |year=2006 |pmid=16705108 |doi=10.1001/jama.295.19.2270 |doi-access=free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Some RCTs are fully or partly funded by the health care industry (e.g., the pharmaceutical industry) as opposed to government, nonprofit, or other sources. A systematic review published in 2003 found four 1986–2002 articles comparing industry-sponsored and nonindustry-sponsored RCTs, and in all the articles there was a correlation of industry sponsorship and positive study outcome. A 2004 study of 1999–2001 RCTs published in leading medical and surgical journals determined that industry-funded RCTs &amp;quot;are more likely to be associated with statistically significant pro-industry findings.&amp;quot; These results have been mirrored in trials in surgery, where although industry funding did not affect the rate of trial discontinuation it was however associated with a lower odds of publication for completed trials. One possible reason for the pro-industry results in industry-funded published RCTs is publication bias.&lt;br /&gt;
&lt;br /&gt;
有些 rct 完全或部分由医疗保健行业(如制药行业)资助，而不是政府、非营利组织或其他来源。2003年发表的一份系统综述研究报告发现，1986年至2002年间，有4篇文章比较了行业赞助和非行业赞助的 rct，在所有的文章中，行业赞助和正面研究结果之间存在相关性。2004年发表在主要医学和外科杂志上的一项关于1999-2001年的 rct 的研究表明，工业资助的 rct“更有可能与具有统计学意义的有利于工业的发现相关联。”这些结果已经反映在手术试验中，虽然行业资金并不影响试验中止率，但是与完成试验的发表机率较低相关。支持产业的结果在产业资助的已发表的研究报告中出现的一个可能的原因是出版偏见。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Category:Clinical research&lt;br /&gt;
&lt;br /&gt;
类别: 临床研究&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Category:Epidemiological study projects&lt;br /&gt;
&lt;br /&gt;
类别: 流行病学研究项目&lt;br /&gt;
&lt;br /&gt;
Category:Evidence-based practices&lt;br /&gt;
&lt;br /&gt;
类别: 循证做法&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Category:Design of experiments&lt;br /&gt;
&lt;br /&gt;
类别: 实验设计&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Category:Causal inference&lt;br /&gt;
&lt;br /&gt;
类别: 因果推理&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Category:Experiments&lt;br /&gt;
&lt;br /&gt;
分类: 实验&lt;br /&gt;
Category:Research methods&lt;br /&gt;
&lt;br /&gt;
分类: 研究方法&lt;br /&gt;
&lt;br /&gt;
&amp;lt;noinclude&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&amp;lt;small&amp;gt;This page was moved from [[wikipedia:en:Randomized controlled trial]]. Its edit history can be viewed at [[随机对照试验/edithistory]]&amp;lt;/small&amp;gt;&amp;lt;/noinclude&amp;gt;&lt;br /&gt;
&lt;br /&gt;
[[Category:待整理页面]]&lt;/div&gt;</summary>
		<author><name>李昊轩</name></author>
	</entry>
	<entry>
		<id>https://wiki.swarma.org/index.php?title=%E9%9A%8F%E6%9C%BA%E5%AF%B9%E7%85%A7%E8%AF%95%E9%AA%8C&amp;diff=24312</id>
		<title>随机对照试验</title>
		<link rel="alternate" type="text/html" href="https://wiki.swarma.org/index.php?title=%E9%9A%8F%E6%9C%BA%E5%AF%B9%E7%85%A7%E8%AF%95%E9%AA%8C&amp;diff=24312"/>
		<updated>2021-07-10T07:43:52Z</updated>

		<summary type="html">&lt;p&gt;李昊轩：Procedures&lt;/p&gt;
&lt;hr /&gt;
&lt;div&gt;此词条暂由彩云小译翻译，翻译字数共2766，未经人工整理和审校，带来阅读不便，请见谅。&lt;br /&gt;
&lt;br /&gt;
{{Short description|Experimental method designed to reduce bias, typically accomplished by randomly allocating subjects to two or more groups, with one being a control group}}&lt;br /&gt;
&lt;br /&gt;
[[File:Flowchart of Phases of Parallel Randomized Trial - Modified from CONSORT 2010.png|thumb|upright=1.5|Flowchart of four phases (enrollment, allocation, intervention, follow-up, and data analysis) of a parallel randomized trial of two groups (in a controlled trial, one of the interventions serves as the control), modified from the CONSORT (Consolidated Standards of Reporting Trials) 2010 Statement&amp;lt;ref name=&amp;quot;Schulz-2010&amp;quot;&amp;gt;{{Cite journal | author = Schulz KF, Altman DG, ((Moher D; for the CONSORT Group)) | title = CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials | journal = [[Br Med J]] | volume = 340 | pages = c332 | year = 2010 | doi = 10.1136/bmj.c332 | pmid = 20332509 | pmc = 2844940 }}&amp;lt;/ref&amp;gt;|链接=Special:FilePath/Flowchart_of_Phases_of_Parallel_Randomized_Trial_-_Modified_from_CONSORT_2010.png]]&lt;br /&gt;
&lt;br /&gt;
[来源：图片] Flowchart of four phases (enrollment, allocation, intervention, follow-up, and data analysis) of a parallel randomized trial of two groups (in a controlled trial, one of the interventions serves as the control), modified from the CONSORT (Consolidated Standards of Reporting Trials) 2010 Statement.&lt;br /&gt;
&lt;br /&gt;
据修改的2010年CONSORT (综合报告试验标准)要求，流程图包括：两组平行随机试验分为登记、分配、干预、随访和数据分析四个阶段，在对照试验中，需要其中一项干预作为对照处理措施。 &lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
A '''randomized controlled trial''' (or '''randomized control trial''';&amp;lt;ref name=&amp;quot;Chalmers-1981&amp;quot;&amp;gt;{{Cite journal |vauthors=Chalmers TC, ((Smith H Jr)), Blackburn B, Silverman B, Schroeder B, Reitman D, Ambroz A | title = A method for assessing the quality of a randomized control trial | journal = [[Controlled Clinical Trials]] | volume = 2 | issue = 1 | pages = 31–49 | year = 1981 | doi = 10.1016/0197-2456(81)90056-8 | pmid = 7261638 }}&amp;lt;/ref&amp;gt; '''RCT''') is a type of ''[[scientific experiment]]'' (e.g. a ''[[clinical trial]]'') or ''intervention study'' (as opposed to ''[[observational study]]'') that aims to reduce certain sources of bias when testing the effectiveness of new treatments; this is accomplished by [[Random assignment|randomly allocating]] subjects to two or more groups, treating them differently, and then comparing them with respect to a measured response. One group—the experimental group—receives the intervention being assessed, while the other—usually called the control group—receives an alternative treatment, such as a [[placebo]] or no intervention. The groups are monitored under conditions of the trial design to determine the effectiveness of the experimental intervention, and efficacy is assessed in comparison to the control. &amp;lt;ref&amp;gt;{{cite web|url=https://www.nice.org.uk/glossary?letter=r|publisher=National Institute for Health and Care Excellence, London, UK|title=Randomised controlled trial|date=2019|access-date=3 June 2019}}&amp;lt;/ref&amp;gt; There may be more than one treatment group or more than one [[Treatment and control groups|control group]].&lt;br /&gt;
&lt;br /&gt;
A randomized controlled trial (or randomized control trial; RCT) is a type of scientific experiment (e.g. a clinical trial) or intervention study (as opposed to observational study) that aims to reduce certain sources of bias when testing the effectiveness of new treatments; this is accomplished by randomly allocating subjects to two or more groups, treating them differently, and then comparing them with respect to a measured response. One group—the experimental group—receives the intervention being assessed, while the other—usually called the control group—receives an alternative treatment, such as a placebo or no intervention. The groups are monitored under conditions of the trial design to determine the effectiveness of the experimental intervention, and efficacy is assessed in comparison to the control.  There may be more than one treatment group or more than one control group.&lt;br /&gt;
&lt;br /&gt;
随机对照试验(A randomized controlled trial, RCT)是一种科学实验(例如:临床试验)或干预研究(区别于观察性研究) ，其目的是在测试新治疗的有效性时减少某些偏倚来源。通过受试者随机分配到两个或两个以上的组，经过不同的处理，产生的效应再与一个有可控的处理效应相比较。即一组或多组(实验组)接受正在评估的干预措施，而另一组(通常称为对照组)接受替代治疗，如安慰剂或无干预措施。在试验设计的条件下对这些组进行监测，以确定实验干预的有效性，并与对照组进行疗效比较评估。当然这也包括一个以上的治疗组或一个以上的对照组。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
The trial may be [[blinded experiment|blinded]], meaning that information which may influence the participants is withheld until after the experiment is complete. A blind can be imposed on any participant of an experiment, including subjects, researchers, technicians, data analysts, and evaluators. Effective blinding may reduce or eliminate some sources of experimental [[bias]].&lt;br /&gt;
&lt;br /&gt;
The trial may be blinded, meaning that information which may influence the participants is withheld until after the experiment is complete. A blind can be imposed on any participant of an experiment, including subjects, researchers, technicians, data analysts, and evaluators. Effective blinding may reduce or eliminate some sources of experimental bias.&lt;br /&gt;
&lt;br /&gt;
试验可能采用了盲法，这意味着影响参与者的信息在试验完成后才会公布。试验的任何参与者，包括受试者、研究人员、技术人员、数据分析人员和评估人员，都可能被强加盲。有效的盲法可以减少或消除某些试验偏差的来源。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
The randomness in the assignment of subjects to groups reduces [[selection bias]] and allocation bias, balancing both known and unknown prognostic factors, in the assignment of treatments.&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;&amp;gt;{{Cite journal |vauthors=Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG | title = CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials | journal = [[Br Med J]] | volume = 340 | pages = c869 | year = 2010 | doi = 10.1136/bmj.c869 | pmid = 20332511 | pmc = 2844943 }}&amp;lt;/ref&amp;gt; Blinding reduces other forms of [[Observer-expectancy effect|experimenter and subject biases]].&lt;br /&gt;
&lt;br /&gt;
The randomness in the assignment of subjects to groups reduces selection bias and allocation bias, balancing both known and unknown prognostic factors, in the assignment of treatments. Blinding reduces other forms of experimenter and subject biases.&lt;br /&gt;
&lt;br /&gt;
在分配治疗方案时，受试者随机地被分配到不同组。这个随机化过程减少了选择偏差和分配偏差，平衡了已知和未知的预后因素。盲法减少了其他形式的实验者和主体偏见。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
A well-blinded RCT is often considered the [[Gold standard (test)|gold standard]] for [[clinical trial]]s. Blinded RCTs are commonly used to test the [[Efficacy#Medicine|efficacy]] of medical [[Health intervention|intervention]]s and may additionally provide information about adverse effects, such as [[adverse drug reactions|drug reactions]]. A randomized controlled trial can provide compelling evidence that the study treatment causes an effect on human health.&amp;lt;ref name=&amp;quot;hannan&amp;quot;&amp;gt;{{cite journal | vauthors = Hannan EL | title = Randomized clinical trials and observational studies: guidelines for assessing respective strengths and limitations | journal = JACC. Cardiovascular Interventions | volume = 1 | issue = 3 | pages = 211–7 | date = June 2008 | pmid = 19463302 | doi = 10.1016/j.jcin.2008.01.008 | doi-access = free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
A well-blinded RCT is often considered the gold standard for clinical trials. Blinded RCTs are commonly used to test the efficacy of medical interventions and may additionally provide information about adverse effects, such as drug reactions. A randomized controlled trial can provide compelling evidence that the study treatment causes an effect on human health.&lt;br /&gt;
&lt;br /&gt;
一个良好盲法的 RCT 通常被认为是临床试验的黄金标准。盲法随机对照试验通常用于检测医疗干预措施的效果，并且还可能提供关于药物反应等不良反应的信息。随机对照试验可以提供令人信服的证据，证明研究治疗对人类健康产生了影响。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
The terms &amp;quot;RCT&amp;quot; and &amp;quot;'''randomized trial'''&amp;quot; are sometimes used synonymously, but the latter term omits mention of controls and can therefore describe studies that compare multiple treatment groups with each other in the absence of a control group.&amp;lt;ref name=&amp;quot;Ranjith-2005&amp;quot;&amp;gt;{{Cite journal | author = Ranjith G | title = Interferon-α-induced depression: when a randomized trial is not a randomized controlled trial | journal = [[Psychother Psychosom]] | volume = 74 | issue = 6 | pages = 387; author reply 387–8 | year = 2005 | doi = 10.1159/000087787 | pmid = 16244516 | s2cid = 143644933 }}&amp;lt;/ref&amp;gt; Similarly, the [[initialism]] is sometimes expanded as &amp;quot;'''randomized clinical trial'''&amp;quot; or &amp;quot;'''randomized comparative trial'''&amp;quot;, leading to ambiguity in the [[scientific literature]].&amp;lt;ref name=&amp;quot;Peto-1976&amp;quot;&amp;gt;{{Cite journal |vauthors=Peto R, Pike MC, Armitage P, Breslow NE, Cox DR, Howard SV, Mantel N, McPherson K, Peto J, Smith PG | title = Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design | journal = [[Br J Cancer]] | volume = 34 | issue = 6 | pages = 585–612 | year = 1976 | pmc=2025229 | pmid = 795448 | doi = 10.1038/bjc.1976.220 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Peto-1977&amp;quot;&amp;gt;{{Cite journal |vauthors=Peto R, Pike MC, Armitage P, Breslow NE, Cox DR, Howard SV, Mantel N, McPherson K, Peto J, Smith PG | title = Design and analysis of randomized clinical trials requiring prolonged observation of each patient. II. Analysis and examples | journal = [[Br J Cancer]] | volume = 35 | issue = 1 | pages = 1–39 | year = 1977 | pmc=2025310 | pmid = 831755 | doi = 10.1038/bjc.1977.1 }}&amp;lt;/ref&amp;gt; Not all randomized clinical trials are randomized ''controlled'' trials (and some of them could never be, as in cases where controls would be impractical or unethical to institute). The term '''randomized controlled clinical trial''' is an alternative term used in [[clinical research]];&amp;lt;ref name=&amp;quot;Wollert-2004&amp;quot;&amp;gt;{{Cite journal |vauthors=Wollert KC, Meyer GP, Lotz J, Ringes-Lichtenberg S, Lippolt P, Breidenbach C, Fichtner S, Korte T, Hornig B, Messinger D, Arseniev L, Hertenstein B, Ganser A, Drexler H | title = Intracoronary autologous bone-marrow cell transfer after myocardial infarction: the BOOST randomised controlled clinical trial | journal = [[The Lancet|Lancet]] | volume = 364 | issue = 9429 | pages = 141–8 | year = 2004 | doi = 10.1016/S0140-6736(04)16626-9 | pmid = 15246726 | s2cid = 24361586 }}&amp;lt;/ref&amp;gt; however, RCTs are also employed in other research areas, including [[#In social science|many of the social sciences]].&lt;br /&gt;
&lt;br /&gt;
The terms &amp;quot;RCT&amp;quot; and &amp;quot;randomized trial&amp;quot; are sometimes used synonymously, but the latter term omits mention of controls and can therefore describe studies that compare multiple treatment groups with each other in the absence of a control group. Similarly, the initialism is sometimes expanded as &amp;quot;randomized clinical trial&amp;quot; or &amp;quot;randomized comparative trial&amp;quot;, leading to ambiguity in the scientific literature. Not all randomized clinical trials are randomized controlled trials (and some of them could never be, as in cases where controls would be impractical or unethical to institute). The term randomized controlled clinical trial is an alternative term used in clinical research; however, RCTs are also employed in other research areas, including many of the social sciences.&lt;br /&gt;
&lt;br /&gt;
“ RCT”和“随机试验”这两个术语有时被用作同义词，但后一个术语没有提到对照，因此可以描述在没有对照组的情况下相互比较多个治疗组的研究。科学文献中常有“随机临床试验”或“随机比较试验”这类引发歧义的术语。并非所有的随机临床试验都是随机对照试验(其中一些试验永远不可能成为随机对照试验，因为实施控制是不切实际或不道德的)。随机对照临床试验这个术语是临床研究中使用的另一个术语; 然而，随机对照临床试验也被用于其他研究领域，包括许多社会科学。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
{{toc limit}}&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
== History ==&lt;br /&gt;
&lt;br /&gt;
The first reported clinical trial was conducted by James Lind in 1747 to identify treatment for scurvy.[10] The first blind experiment was conducted by the French Royal Commission on Animal Magnetism in 1784 to investigate the claims of mesmerism. An early essay advocating the blinding of researchers came from Claude Bernard in the latter half of the 19th century. Bernard recommended that the observer of an experiment should not have knowledge of the hypothesis being tested. This suggestion contrasted starkly with the prevalent Enlightenment-era attitude that scientific observation can only be objectively valid when undertaken by a well-educated, informed scientist.[11] The first study recorded to have a blinded researcher was conducted in 1907 by W. H. R. Rivers and H. N. Webber to investigate the effects of caffeine.[12]&lt;br /&gt;
&lt;br /&gt;
据报道，1747年James Lind进行了第一个临床试验，目的是确定治疗坏血病的方法。1784年，French Royal Commission on Animal Magnetism进行了第一次盲法实验，以调查催眠术的说法。19世纪下半叶，一篇提倡研究人员失明的早期文章来自Claude Bernard。Bernard建议实验的观察者不要知道正在被测试的假设。这一建议与启蒙时代流行的态度形成鲜明对比，即科学观察只有由受过良好教育、消息灵通的科学家进行才能客观有效。1907年，W. H. R. Rivers和H. N. Webber进行了第一项有记录的盲法研究，研究咖啡因的作用。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
[[Randomized experiment]]s appeared in [[experimental psychology|psychology]], where they were introduced by [[Charles Sanders Peirce]] and [[Joseph Jastrow]] in the 1880s,&amp;lt;ref&amp;gt;{{cite journal| author=[[Charles Sanders Peirce]] and [[Joseph Jastrow]]|year=1885|title=On Small Differences in Sensation| journal=Memoirs of the National Academy of Sciences|volume=3|pages=73–83|url=http://psychclassics.yorku.ca/Peirce/small-diffs.htm}} http://psychclassics.yorku.ca/Peirce/small-diffs.htm&amp;lt;/ref&amp;gt; and in [[school of education|education]].&amp;lt;ref&amp;gt;{{cite journal|doi=10.1086/354775|first=Ian|last=Hacking|author-link=Ian Hacking | title=Telepathy: Origins of Randomization in Experimental Design|journal=[[Isis (journal)|Isis]]|series=A Special Issue on Artifact and Experiment|volume=79|issue=3|date=September 1988 |pages=427–451|jstor=234674|mr=1013489|s2cid=52201011}}&amp;lt;/ref&amp;gt;&amp;lt;ref&amp;gt;{{cite journal|doi=10.1086/444032|author=Stephen M. Stigler|title=A Historical View of Statistical Concepts in Psychology and Educational Research| journal=American Journal of Education| volume=101|issue=1|date=November 1992|pages=60–70|s2cid=143685203|author-link=Stephen M. Stigler}}&amp;lt;/ref&amp;gt;&amp;lt;ref&amp;gt;{{cite journal|doi=10.1086/383850|author=Trudy Dehue|title=Deception, Efficiency, and Random Groups: Psychology and the Gradual Origination of the Random Group Design|journal=[[Isis (journal)|Isis]]|volume=88|issue=4|date=December 1997|pages=653–673|pmid=9519574|s2cid=23526321|url=https://pure.rug.nl/ws/files/71855616/237831.pdf}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Randomized experiments appeared in psychology, where they were introduced by Charles Sanders Peirce and Joseph Jastrow in the 1880s, and in education.&lt;br /&gt;
&lt;br /&gt;
在19世纪80年代，Charles Sanders Peirce和Joseph Jastrow在心理学和教育学领域引入随机实验。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
In the early 20th century, randomized experiments appeared in agriculture, due to [[Jerzy Neyman]]&amp;lt;ref&amp;gt;Neyman, Jerzy. 1923 [1990]. &amp;quot;On the Application of Probability Theory to AgriculturalExperiments. Essay on Principles. Section 9.&amp;quot; ''Statistical Science'' 5 (4): 465–472. Trans. Dorota M. Dabrowska and Terence P. Speed.&amp;lt;/ref&amp;gt; and [[Ronald A. Fisher]]. Fisher's experimental research and his writings popularized randomized experiments.&amp;lt;ref name=&amp;quot;Conniffe&amp;quot; /&amp;gt;&lt;br /&gt;
&lt;br /&gt;
In the early 20th century, randomized experiments appeared in agriculture, due to Jerzy Neyman and Ronald A. Fisher. Fisher's experimental research and his writings popularized randomized experiments.&lt;br /&gt;
&lt;br /&gt;
在20世纪早期，Jerzy Neyman和Ronald A. Fisher将随机实验引入农业研究。Fisher的实验研究和他的著作普及了随机实验。&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;The first published RCT in medicine appeared in the 1948 paper entitled &amp;quot;[[Streptomycin]] treatment of pulmonary [[tuberculosis]]&amp;quot;, which described a [[Medical Research Council (UK)|Medical Research Council]] investigation.&amp;lt;ref name=&amp;quot;MRC-1948&amp;quot;&amp;gt;{{Cite journal | author = Streptomycin in Tuberculosis Trials Committee | title = Streptomycin treatment of pulmonary tuberculosis. A Medical Research Council investigation| journal = [[Br Med J]] | volume = 2 | issue = 4582 | pages = 769–82 | year = 1948 | doi = 10.1136/bmj.2.4582.769 | pmid = 18890300 | pmc = 2091872 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Brown-1998&amp;quot;&amp;gt;{{cite news |title= Landmark study made research resistant to bias |author= Brown D |newspaper= [[Washington Post]] |date=1998-11-02 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Shikata-2006&amp;quot;&amp;gt;{{Cite journal |vauthors=Shikata S, Nakayama T, Noguchi Y, Taji Y, Yamagishi H | title = Comparison of effects in randomized controlled trials with observational studies in digestive surgery | journal = [[Ann Surg]] | volume = 244 | issue = 5 | pages = 668–76 | year = 2006 | doi = 10.1097/01.sla.0000225356.04304.bc | pmc=1856609 | pmid = 17060757 }}&amp;lt;/ref&amp;gt; One of the authors of that paper was [[Austin Bradford Hill]], who is credited as having conceived the modern RCT.&amp;lt;ref name=&amp;quot;Stolberg-2004&amp;quot;&amp;gt;{{Cite journal |vauthors=Stolberg HO, Norman G, Trop I | title = Randomized controlled trials | journal = [[Am J Roentgenol]] | volume = 183 | issue = 6 | pages = 1539–44 | year = 2004 | pmid = 15547188 | doi=10.2214/ajr.183.6.01831539}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;The first published RCT in medicine appeared in the 1948 paper entitled &amp;quot;Streptomycin treatment of pulmonary tuberculosis&amp;quot;, which described a Medical Research Council investigation. One of the authors of that paper was Austin Bradford Hill, who is credited as having conceived the modern RCT.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;医学上首次发表的随机对照试验出现在1948年题为“Streptomycin treatment of pulmonary tuberculosis”的论文中，这篇论文描述了医学研究理事会的一项调查。这篇论文的作者之一是Austin Bradford Hill，被认为是构想出了现代 RCT理论。 &lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt; &lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;Trial design was further influenced by the large-scale [[International Studies of Infarct Survival|ISIS]] trials on [[heart attack]] treatments that were conducted in the 1980s.&amp;lt;ref&amp;gt;{{cite web| author1=Georgina Ferry |title= Peter Sleight Obituary |url=https://www.theguardian.com/society/2020/nov/02/peter-sleight-obituary |website=The Guardian |date=2 November 2020 |access-date=3 November 2020}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;Trial design was further influenced by the large-scale ISIS trials on heart attack treatments that were conducted in the 1980s.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;20世纪80年代进行的大规模 ISIS 心脏病治疗试验进一步影响了试验设计。&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;By the late 20th century, RCTs were recognized as the standard method for &amp;quot;rational therapeutics&amp;quot; in medicine.[24] As of 2004, more than 150,000 RCTs were in the Cochrane Library.[22] To improve the reporting of RCTs in the medical literature, an international group of scientists and editors published Consolidated Standards of Reporting Trials (CONSORT) Statements in 1996, 2001 and 2010, and these have become widely accepted.[1][4] Randomization is the process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce the bias.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;By the late 20th century, RCTs were recognized as the standard method for &amp;quot;rational therapeutics&amp;quot; in medicine. As of 2004, more than 150,000 RCTs were in the Cochrane Library. To improve the reporting of RCTs in the medical literature, an international group of scientists and editors published Consolidated Standards of Reporting Trials (CONSORT) Statements in 1996, 2001 and 2010, and these have become widely accepted. Randomization is the process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce the bias.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;到20世纪后期，随机对照试验被公认为医学“合理疗法”的标准方法。截至2004年，美国 Cochrane图书馆有超过15万本随机对照试验的参考资料。为了改进医学文献中对随机对照试验的报道，一个由科学家和编辑组成的国际小组在1996年、2001年和2010年发布了Consolidated Standards of Reporting Trials (CONSORT)声明，这些声明已被广泛接受。随机化是将试验受试者分配到治疗组或对照组的过程，使用机会因素来确定分配，以减少偏差。&lt;br /&gt;
&lt;br /&gt;
== Ethics ==&lt;br /&gt;
&lt;br /&gt;
Although the principle of clinical equipoise (&amp;quot;genuine uncertainty within the expert medical community... about the preferred treatment&amp;quot;) common to clinical trials[25] has been applied to RCTs, the ethics of RCTs have special considerations. For one, it has been argued that equipoise itself is insufficient to justify RCTs.[26] For another, &amp;quot;collective equipoise&amp;quot; can conflict with a lack of personal equipoise (e.g., a personal belief that an intervention is effective).[27] Finally, Zelen's design, which has been used for some RCTs, randomizes subjects before they provide informed consent, which may be ethical for RCTs of screening and selected therapies, but is likely unethical &amp;quot;for most therapeutic trials.&amp;quot;[28][29]&lt;br /&gt;
&lt;br /&gt;
Although the principle of clinical equipoise (&amp;quot;genuine uncertainty within the expert medical community... about the preferred treatment&amp;quot;) common to clinical trials has been applied to RCTs, the ethics of RCTs have special considerations. For one, it has been argued that equipoise itself is insufficient to justify RCTs. For another, &amp;quot;collective equipoise&amp;quot; can conflict with a lack of personal equipoise (e.g., a personal belief that an intervention is effective). Finally, Zelen's design, which has been used for some RCTs, randomizes subjects ''before'' they provide informed consent, which may be ethical for RCTs of screening and selected therapies, but is likely unethical &amp;quot;for most therapeutic trials.&amp;quot;&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;尽管临床平衡原则已经被广泛应用于RCT，但随机对照试验的伦理问题具有特殊性。首先，有人认为平衡本身不足以证明随机对照试验的合理性。另一方面，“集体均势”可能与缺乏个人均势相冲突(例如，个人认为干预是有效的)。最后，Zelen 的设计已经被用于一些随机试验，在受试者提供知情同意之前随机化，这对于筛选和选择性治疗的随机试验来说可能是合乎道德的，但是对于“大多数治疗试验”来说可能是不道德的。&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Although subjects almost always provide [[informed consent]] for their participation in an RCT, studies since 1982 have documented that RCT subjects may believe that they are certain to receive treatment that is best for them personally; that is, they do not understand the difference between research and treatment.&amp;lt;ref name=&amp;quot;Appelbaum-1982&amp;quot;&amp;gt;{{Cite journal |vauthors=Appelbaum PS, Roth LH, Lidz C | title = The therapeutic misconception: informed consent in psychiatric research | journal = [[Int J Law Psychiatry]] | volume = 5 | issue = 3–4 | pages = 319–29 | year = 1982 | doi = 10.1016/0160-2527(82)90026-7 | pmid = 6135666 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Henderson-2007&amp;quot;&amp;gt;{{Cite journal |vauthors=Henderson GE, Churchill LR, Davis AM, Easter MM, Grady C, Joffe S, Kass N, King NM, Lidz CW, Miller FG, Nelson DK, Peppercorn J, Rothschild BB, Sankar P, Wilfond BS, Zimmer CR | title = Clinical trials and medical care: defining the therapeutic misconception | journal = [[PLoS Med]] | volume = 4 | issue = 11 | pages = e324 | year = 2007 | doi = 10.1371/journal.pmed.0040324 | pmid = 18044980 | pmc = 2082641 }}&amp;lt;/ref&amp;gt; Further research is necessary to determine the prevalence of and ways to address this &amp;quot;[[therapeutic misconception]]&amp;quot;.&amp;lt;ref name=&amp;quot;Henderson-2007&amp;quot; /&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Although subjects almost always provide informed consent for their participation in an RCT, studies since 1982 have documented that RCT subjects may believe that they are certain to receive treatment that is best for them personally; that is, they do not understand the difference between research and treatment. Further research is necessary to determine the prevalence of and ways to address this &amp;quot;therapeutic misconception&amp;quot;. &lt;br /&gt;
&lt;br /&gt;
一般来说，受试者要为参加随机对照试验提交了知情同意书，但1982年以来的研究记录表明，随机对照试验的受试者可能认为他们肯定会接受对他们个人最好的治疗; 也就是说，他们不理解研究和治疗之间的区别。需要进一步研究，以确定这种”治疗性误解”的流行程度和解决方法。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
The RCT method variations may also create cultural effects that have not been well understood.[32] For example, patients with terminal illness may join trials in the hope of being cured, even when treatments are unlikely to be successful.&lt;br /&gt;
&lt;br /&gt;
RCT方法的变种也可能产生尚未被很好理解的文化效应。例如，患有晚期疾病的病人可能会加入临床试验以希望治愈，即使治疗不太可能成功的情况下也是如此。&lt;br /&gt;
&lt;br /&gt;
=== Trial registration ===&lt;br /&gt;
&lt;br /&gt;
In 2004, the [http://www.icmje.org/ International Committee of Medical Journal Editors] (ICMJE) announced that all trials starting enrolment after July 1, 2005 must be registered prior to consideration for publication in one of the 12 member journals of the committee.&amp;lt;ref name=&amp;quot;pmid15356289&amp;quot;&amp;gt;{{cite journal  |vauthors=De Angelis C, Drazen JM, Frizelle FA, etal |title=Clinical trial registration: a statement from the International Committee of Medical Journal Editors |journal=The New England Journal of Medicine |volume=351 |issue=12 |pages=1250–1 |date=September 2004 |pmid=15356289 |doi=10.1056/NEJMe048225 }}&amp;lt;/ref&amp;gt; However, trial registration may still occur late or not at all.&amp;lt;ref name=&amp;quot;pmid22147862&amp;quot;&amp;gt;{{cite journal|vauthors=Law MR, Kawasumi Y, Morgan SG | title=Despite law, fewer than one in eight completed studies of drugs and biologics are reported on time on ClinicalTrials.gov. | journal=Health Aff (Millwood) | year= 2011 | volume= 30 | issue= 12 | pages= 2338–45 | doi=10.1377/hlthaff.2011.0172 | pmid=22147862  | doi-access=free }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;pmid19724045&amp;quot;&amp;gt;{{cite journal|vauthors=Mathieu S, Boutron I, Moher D, Altman DG, Ravaud P | title=Comparison of registered and published primary outcomes in randomized controlled trials. | journal=JAMA | year= 2009 | volume= 302 | issue= 9 | pages= 977–84 | doi=10.1001/jama.2009.1242 | pmid=19724045  | doi-access=free }}&amp;lt;/ref&amp;gt;Medical journals have been slow in adapting policies requiring mandatory clinical trial registration as a prerequisite for publication.&amp;lt;ref&amp;gt;{{cite journal|last1=Bhaumik|first1=S|title=Editorial policies of MEDLINE indexed Indian journals on clinical trial registration.|journal=Indian Pediatr.|date=Mar 2013|volume=50|issue=3|pages=339–40|pmid=23680610|doi=10.1007/s13312-013-0092-2|s2cid=40317464}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
In 2004, the [http://www.icmje.org/ International Committee of Medical Journal Editors] (ICMJE) announced that all trials starting enrolment after July 1, 2005 must be registered prior to consideration for publication in one of the 12 member journals of the committee. However, trial registration may still occur late or not at all. Medical journals have been slow in adapting policies requiring mandatory clinical trial registration as a prerequisite for publication.&lt;br /&gt;
&lt;br /&gt;
2004年， 医学杂志编辑国际委员会(ICMJE)宣布，所有在2005年7月1日之后考虑在该委员会12种杂志上发表之前，必须对试验进行注册。尽管如此，试验登记可能仍然延迟或根本不会发生。医学期刊将强制性临床试验登记作为发表的先决条件进展缓慢。&lt;br /&gt;
== Classifications ==&lt;br /&gt;
=== By study design ===&lt;br /&gt;
&lt;br /&gt;
One way to classify RCTs is by [[study design]].  From most to least common in the healthcare literature, the major categories of RCT study designs are:&amp;lt;ref name=&amp;quot;Hopewell-2010&amp;quot;&amp;gt;{{Cite journal |vauthors=Hopewell S, Dutton S, Yu LM, Chan AW, Altman DG | title = The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed | journal = BMJ | volume = 340 | pages = c723 | year = 2010 | doi = 10.1136/bmj.c723  | pmid = 20332510 | pmc = 2844941 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
通过研究设计对 RCT 进行分类。从最常见到最不常见，RCT 研究设计的主要类别是&lt;br /&gt;
&lt;br /&gt;
* [[Parallel study|Parallel-group]] – each participant is randomly assigned to a group, and all the participants in the group receive (or do not receive) an intervention.&amp;lt;ref&amp;gt;{{cite journal |last1=Kaiser |first1=Joerg |last2=Niesen |first2=Willem |last3=Probst |first3=Pascal |last4=Bruckner |first4=Thomas |last5=Doerr-Harim |first5=Colette |last6=Strobel |first6=Oliver |last7=Knebel |first7=Phillip |last8=Diener |first8=Markus K. |last9=Mihaljevic |first9=André L. |last10=Büchler |first10=Markus W. |last11=Hackert |first11=Thilo |title=Abdominal drainage versus no drainage after distal pancreatectomy: study protocol for a randomized controlled trial |journal=Trials |date=7 June 2019 |volume=20 |issue=1 |page=332 |doi=10.1186/s13063-019-3442-0|pmid=31174583 |pmc=6555976 |doi-access=free }}&amp;lt;/ref&amp;gt;&amp;lt;ref&amp;gt;{{cite journal |last1=Farag |first1=Sara M. |last2=Mohammed |first2=Manal O. |last3=EL-Sobky |first3=Tamer A. |last4=ElKadery |first4=Nadia A. |last5=ElZohiery |first5=Abeer K. |title=Botulinum Toxin A Injection in Treatment of Upper Limb Spasticity in Children with Cerebral Palsy: A Systematic Review of Randomized Controlled Trials |journal=JBJS Reviews |date=March 2020 |volume=8 |issue=3 |pages=e0119 |doi=10.2106/JBJS.RVW.19.00119 |pmid=32224633|pmc=7161716 |doi-access=free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* 平行试验：每个参与者被随机分配到一个组，组中的所有参与者都接受(或不接受)干预。&lt;br /&gt;
&lt;br /&gt;
* [[Crossover study|Crossover]] – over time, each participant receives (or does not receive) an intervention in a random sequence.&amp;lt;ref&amp;gt;{{cite book  | last = Jones | first = Byron |author2=Kenward, Michael G.  | title = Design and Analysis of Cross-Over Trials | edition=Second| publisher = London: Chapman and Hall | year = 2003 }}&amp;lt;/ref&amp;gt;&amp;lt;ref&amp;gt;{{cite book  | last = Vonesh | first = Edward F. |author2=Chinchilli, Vernon G.  | chapter=Crossover Experiments| pages=111–202|title = Linear and Nonlinear Models for the Analysis of Repeated Measurements | publisher = London: Chapman and Hall | year = 1997 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* 交叉试验：随着时间的推移，每个参与者都会接受(或不接受)随机序列的干预。&lt;br /&gt;
&lt;br /&gt;
* [[Cluster randomised controlled trial|Cluster]] – pre-existing groups of participants (e.g., villages, schools) are randomly selected to receive (or not receive) an intervention.&amp;lt;ref&amp;gt;{{cite journal |last1=Gall |first1=Stefanie |last2=Adams |first2=Larissa |last3=Joubert |first3=Nandi |last4=Ludyga |first4=Sebastian |last5=Müller |first5=Ivan |last6=Nqweniso |first6=Siphesihle |last7=Pühse |first7=Uwe |last8=du Randt |first8=Rosa |last9=Seelig |first9=Harald |last10=Smith |first10=Danielle |last11=Steinmann |first11=Peter |last12=Utzinger |first12=Jürg |last13=Walter |first13=Cheryl |last14=Gerber |first14=Markus |last15=van Wouwe |first15=Jacobus P. |title=Effect of a 20-week physical activity intervention on selective attention and academic performance in children living in disadvantaged neighborhoods: A cluster randomized control trial |journal=PLOS ONE |date=8 November 2018 |volume=13 |issue=11 |pages=e0206908 |doi=10.1371/journal.pone.0206908 |pmid=30408073|pmc=6224098 |bibcode=2018PLoSO..1306908G |doi-access=free }}&amp;lt;/ref&amp;gt;&amp;lt;ref&amp;gt;{{cite journal |last1=Gladstone |first1=Melissa J. |last2=Chandna |first2=Jaya |last3=Kandawasvika |first3=Gwendoline |last4=Ntozini |first4=Robert |last5=Majo |first5=Florence D. |last6=Tavengwa |first6=Naume V. |last7=Mbuya |first7=Mduduzi N. N. |last8=Mangwadu |first8=Goldberg T. |last9=Chigumira |first9=Ancikaria |last10=Chasokela |first10=Cynthia M. |last11=Moulton |first11=Lawrence H. |last12=Stoltzfus |first12=Rebecca J. |last13=Humphrey |first13=Jean H. |last14=Prendergast |first14=Andrew J. |last15=Tumwine |first15=James K. |title=Independent and combined effects of improved water, sanitation, and hygiene (WASH) and improved complementary feeding on early neurodevelopment among children born to HIV-negative mothers in rural Zimbabwe: Substudy of a cluster-randomized trial |journal=PLOS Medicine |date=21 March 2019 |volume=16 |issue=3 |pages=e1002766 |doi=10.1371/journal.pmed.1002766|pmid=30897095 |pmc=6428259 |doi-access=free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* 聚类试验：预先存在的参与者组(例如，村庄、学校)被随机选择以接受(或不接受)干预。&lt;br /&gt;
&lt;br /&gt;
* [[Factorial experiment|Factorial]] – each participant is randomly assigned to a group that receives a particular combination of interventions or non-interventions (e.g., group 1 receives vitamin X and vitamin Y, group 2 receives vitamin X and placebo Y, group 3 receives placebo X and vitamin Y, and group 4 receives placebo X and placebo Y).&lt;br /&gt;
* 因子试验：每个参与者被随机分配到一个接受干预或非干预特定组合的组(例如，第1组接受维生素X和维生素Y，第2组接受维生素X和安慰剂Y，第3组接受安慰剂X和维生素Y，第4组接受安慰剂X和安慰剂Y)。&lt;br /&gt;
&lt;br /&gt;
An analysis of the 616 RCTs indexed in [[PubMed]] during December 2006 found that 78% were parallel-group trials, 16% were crossover, 2% were split-body, 2% were cluster, and 2% were factorial.&amp;lt;ref name=&amp;quot;Hopewell-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
An analysis of the 616 RCTs indexed in PubMed during December 2006 found that 78% were parallel-group trials, 16% were crossover, 2% were split-body, 2% were cluster, and 2% were factorial. &lt;br /&gt;
&lt;br /&gt;
对2006年12月在 PubMed 收录的616例随机对照试验的分析发现，78% 为平行组试验，16% 为交叉组试验，2% 为分体组试验，2% 为聚类组试验，2% 为因子组试验。&lt;br /&gt;
&lt;br /&gt;
=== By outcome of interest (efficacy vs. effectiveness) ===&lt;br /&gt;
&lt;br /&gt;
{{Main|Pragmatic clinical trial}}&lt;br /&gt;
&lt;br /&gt;
RCTs can be classified as &amp;quot;explanatory&amp;quot; or &amp;quot;pragmatic.&amp;quot;&amp;lt;ref name=&amp;quot;Zwarenstein-2008&amp;quot;&amp;gt;{{Cite journal | author = Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D; CONSORT group; Pragmatic Trials in Healthcare (Practihc) group | title = Improving the reporting of pragmatic trials: an extension of the CONSORT statement | journal = BMJ | volume = 337 | pages = a2390 | year = 2008 | doi = 10.1136/bmj.a2390 | pmid = 19001484 | pmc=3266844}}&amp;lt;/ref&amp;gt; Explanatory RCTs test [[Efficacy#Medicine|efficacy]] in a research setting with highly selected participants and under highly controlled conditions.&amp;lt;ref name=&amp;quot;Zwarenstein-2008&amp;quot;/&amp;gt; In contrast, pragmatic RCTs (pRCTs) test [[Effectiveness#Usage|effectiveness]] in everyday practice with relatively unselected participants and under flexible conditions; in this way, pragmatic RCTs can &amp;quot;inform decisions about practice.&amp;quot;&amp;lt;ref name=&amp;quot;Zwarenstein-2008&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
RCTs can be classified as &amp;quot;explanatory&amp;quot; or &amp;quot;pragmatic.&amp;quot; Explanatory RCTs test efficacy in a research setting with highly selected participants and under highly controlled conditions. In contrast, pragmatic RCTs (pRCTs) test effectiveness in everyday practice with relatively unselected participants and under flexible conditions; in this way, pragmatic RCTs can &amp;quot;inform decisions about practice.&amp;quot;&lt;br /&gt;
&lt;br /&gt;
随机对照试验可分为“解释性”或“实用性”。解释性随机对照试验在高度选定的参与者和高度受控的条件下测试有效性。相比之下，实用性随机对照测验(pragmatic RCTs, pRCT)在相对未经选择的参与者和灵活的条件下，在日常实践中检验有效性，这样，实用随机对照测验可以“为实践决策提供信息”。&lt;br /&gt;
=== By hypothesis (superiority vs. noninferiority vs. equivalence) ===&lt;br /&gt;
&lt;br /&gt;
Another classification of RCTs categorizes them as &amp;quot;superiority trials&amp;quot;, &amp;quot;noninferiority trials&amp;quot;, and &amp;quot;equivalence trials&amp;quot;, which differ in methodology and reporting.&amp;lt;ref name=&amp;quot;Piaggio-2006&amp;quot;&amp;gt;{{Cite journal | author = Piaggio G, Elbourne DR, [[Doug Altman|Altman DG]], [[Stuart Pocock|Pocock SJ]], Evans SJ; CONSORT Group | title = Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement | journal = JAMA | volume = 295 | issue = 10 | pages = 1152–60 |  year = 2006 | doi = 10.1001/jama.295.10.1152 | pmid = 16522836 | url = http://researchonline.lshtm.ac.uk/12069/1/Reporting%20of%20Noninferiority%20and%20Equivalence%20Randomized%20Trials.pdf }}&amp;lt;/ref&amp;gt; Most RCTs are superiority trials, in which one intervention is hypothesized to be superior to another in a [[Statistical significance|statistically significant]] way.&amp;lt;ref name=&amp;quot;Piaggio-2006&amp;quot;/&amp;gt; Some RCTs are noninferiority trials &amp;quot;to determine whether a new treatment is no worse than a reference treatment.&amp;quot;&amp;lt;ref name=&amp;quot;Piaggio-2006&amp;quot;/&amp;gt; Other RCTs are equivalence trials in which the hypothesis is that two interventions are indistinguishable from each other.&amp;lt;ref name=&amp;quot;Piaggio-2006&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Another classification of RCTs categorizes them as &amp;quot;superiority trials&amp;quot;, &amp;quot;noninferiority trials&amp;quot;, and &amp;quot;equivalence trials&amp;quot;, which differ in methodology and reporting. Most RCTs are superiority trials, in which one intervention is hypothesized to be superior to another in a statistically significant way. Some RCTs are noninferiority trials &amp;quot;to determine whether a new treatment is no worse than a reference treatment.&amp;quot; Other RCTs are equivalence trials in which the hypothesis is that two interventions are indistinguishable from each other.&lt;br /&gt;
&lt;br /&gt;
随机对照试验的另一种分类是“优越性试验”、“非劣性试验”和“等效性试验”，它们在方法和报告上有所不同。大多数随机对照试验都是优势试验，其中一种干预措施被假设在统计学意义上优于另一种干预措施。一些随机对照试验是非劣效性试验，“以确定一种新的治疗方法是否比一种参考治疗方法更差。”其他随机对照试验是等效试验，其中的假设是两种干预措施彼此不可区分。&lt;br /&gt;
&lt;br /&gt;
== Randomization ==&lt;br /&gt;
&lt;br /&gt;
The advantages of proper [[randomized experiment|randomization]] in RCTs include:&amp;lt;ref name=&amp;quot;SchulzGrimes2002&amp;quot;&amp;gt;{{Cite journal |vauthors=Schulz KF, Grimes DA | title = Generation of allocation sequences in randomised trials: chance, not choice | journal = Lancet | volume = 359 | issue = 9305 | pages = 515–9 | year = 2002 | doi = 10.1016/S0140-6736(02)07683-3 | url =https://www.who.int/entity/rhl/LANCET_515-519.pdf | pmid = 11853818 | s2cid = 291300 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
* &amp;quot;It eliminates bias in treatment assignment,&amp;quot; specifically [[selection bias]] and [[confounding]].&lt;br /&gt;
&lt;br /&gt;
* &amp;quot;It facilitates blinding (masking) of the identity of treatments from investigators, participants, and assessors.&amp;quot;&lt;br /&gt;
&lt;br /&gt;
* &amp;quot;It permits the use of probability theory to express the likelihood that any difference in outcome between treatment groups merely indicates chance.&amp;quot;&lt;br /&gt;
&lt;br /&gt;
There are two processes involved in randomizing patients to different interventions. First is choosing a randomization procedure to generate an unpredictable sequence of allocations; this may be a simple random assignment of patients to any of the groups at equal probabilities, may be &amp;quot;restricted&amp;quot;, or may be &amp;quot;adaptive.&amp;quot; A second and more practical issue is allocation concealment, which refers to the stringent precautions taken to ensure that the group assignment of patients are not revealed prior to definitively allocating them to their respective groups. Non-random &amp;quot;systematic&amp;quot; methods of group assignment, such as alternating subjects between one group and the other, can cause &amp;quot;limitless contamination possibilities&amp;quot; and can cause a breach of allocation concealment.&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
随机对照试验中适当随机化的优点包括：&lt;br /&gt;
* 它消除了治疗分配中的偏差，特别是选择偏差和混淆。&lt;br /&gt;
&lt;br /&gt;
* 它便于调查人员、参与者和评估人员对治疗人群的身份进行遮蔽。&lt;br /&gt;
&lt;br /&gt;
* 它允许使用概率理论来表达这样一种可能性，即治疗组之间结果的任何差异仅仅表明是偶然性的。&lt;br /&gt;
&lt;br /&gt;
有两个过程涉及到随机化的病人接受到不同的干预。首先是选择一个随机化程序来生成一个不可预测的分配序列；这可能是以相等的概率将患者随机分配到任何一组，可能是“受限的”，也可能是“适应性的”。第二个也是更实际的问题是隐藏分配，这是指在将患者明确分配到各自的组之前，采取严格的预防措施，以确保患者的组分配不被披露。非随机的“系统”组分配方法，如在一个组和另一个组之间交替患者，可能会造成“无限的污染可能性”，并可能导致分配隐藏的破坏。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
However empirical evidence that adequate randomization changes outcomes relative to inadequate randomization has been difficult to detect.&amp;lt;ref name=&amp;quot;Howick-2014&amp;quot;&amp;gt;{{Cite journal |vauthors=Howick J, Mebius A | title = In search of justification for the unpredictability paradox | journal = Trials | volume = 15 | pages = 480 | year = 2014 | doi = 10.1186/1745-6215-15-480 | pmid = 25490908 | pmc=4295227}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
然而，相对于不充分随机化，充分随机化改变结果的经验证据很难被发现。&lt;br /&gt;
&lt;br /&gt;
=== Procedures ===&lt;br /&gt;
&lt;br /&gt;
The treatment allocation is the desired proportion of patients in each treatment arm.&lt;br /&gt;
&lt;br /&gt;
治疗分配是每个治疗组中患者的期望比例。&lt;br /&gt;
&lt;br /&gt;
An ideal randomization procedure would achieve the following goals:&amp;lt;ref name=&amp;quot;Lachin-1988a&amp;quot;&amp;gt;{{Cite journal | author = Lachin JM | title = Statistical properties of randomization in clinical trials | journal = [[Controlled Clinical Trials]] | volume = 9 | issue = 4 | pages = 289–311 | year = 1988 | pmid = 3060315 |  doi = 10.1016/0197-2456(88)90045-1 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
An ideal randomization procedure would achieve the following goals:&lt;br /&gt;
&lt;br /&gt;
一个理想的随机化程序将实现以下目标:&lt;br /&gt;
&lt;br /&gt;
* '''Maximize [[statistical power]]''', especially in [[Subgroup analysis|subgroup analyses]].  Generally, equal group sizes maximize statistical power, however, unequal groups sizes may be more powerful for some analyses (e.g., multiple comparisons of placebo versus several doses using Dunnett's procedure&amp;lt;ref&amp;gt;{{cite web|last=Rosenberger|first=James|title=STAT 503 - Design of Experiments|url=https://onlinecourses.science.psu.edu/stat503/node/16|publisher=Pennsylvania State University|access-date=24 September 2012}}&amp;lt;/ref&amp;gt; ), and are sometimes desired for non-analytic reasons (e.g., patients may be more motivated to enroll if there is a higher chance of getting the test treatment, or regulatory agencies may require a minimum number of patients exposed to treatment).&amp;lt;ref name=&amp;quot;Avins-1998&amp;quot;&amp;gt;{{cite journal|last=Avins|first=A L|title=&amp;quot;Can unequal be more fair? Ethics, subject allocation, and randomized clinical trials&amp;quot;.|journal=J Med Ethics|year=1998|volume=24|pages=401–408|doi=10.1136/jme.24.6.401|issue=6|pmc=479141|pmid=9873981}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
* '''Minimize selection bias'''.  This may occur if investigators can consciously or unconsciously preferentially enroll patients between treatment arms.  A good randomization procedure will be unpredictable so that investigators cannot guess the next subject's group assignment based on prior treatment assignments. The risk of selection bias is highest when previous treatment assignments are known (as in unblinded studies) or can be guessed (perhaps if a drug has distinctive side effects).&lt;br /&gt;
&lt;br /&gt;
* '''Minimize allocation bias''' (or '''confounding''').  This may occur when [[covariate]]s that affect the outcome are not equally distributed between treatment groups, and the treatment effect is confounded with the effect of the covariates (i.e., an &amp;quot;accidental bias&amp;quot;&amp;lt;ref name=&amp;quot;SchulzGrimes2002&amp;quot;/&amp;gt;&amp;lt;ref name=&amp;quot;Buyse-1989&amp;quot;&amp;gt;{{Cite journal | author = Buyse ME | title = Analysis of clinical trial outcomes: some comments on subgroup analyses | journal = [[Controlled Clinical Trials]] | volume = 10 | issue = 4 Suppl | pages = 187S–194S | year = 1989 | pmid = 2605967 |  doi = 10.1016/0197-2456(89)90057-3 }}&amp;lt;/ref&amp;gt;).  If the randomization procedure causes an imbalance in covariates related to the outcome across groups, estimates of effect may be [[bias of an estimator|biased]] if not adjusted for the covariates (which may be unmeasured and therefore impossible to adjust for).&lt;br /&gt;
&lt;br /&gt;
However, no single randomization procedure meets those goals in every circumstance, so researchers must select a procedure for a given study based on its advantages and disadvantages.&lt;br /&gt;
&lt;br /&gt;
However, no single randomization procedure meets those goals in every circumstance, so researchers must select a procedure for a given study based on its advantages and disadvantages.&lt;br /&gt;
&lt;br /&gt;
然而，没有一个单一的随机化程序在每种情况下都能满足这些目标，因此研究人员必须根据其优点和缺点来选择一个给定的研究程序。&lt;br /&gt;
&lt;br /&gt;
==== Simple ====&lt;br /&gt;
&lt;br /&gt;
This is a commonly used and intuitive procedure, similar to &amp;quot;repeated fair coin-tossing.&amp;quot;&amp;lt;ref name=&amp;quot;SchulzGrimes2002&amp;quot;/&amp;gt; Also known as &amp;quot;complete&amp;quot; or &amp;quot;unrestricted&amp;quot; randomization, it is [[Robust statistics|robust]] against both selection and accidental biases. However, its main drawback is the possibility of imbalanced group sizes in small RCTs.  It is therefore recommended only for RCTs with over 200 subjects.&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;&amp;gt;{{Cite journal |vauthors=Lachin JM, Matts JP, Wei LJ | title = Randomization in clinical trials: conclusions and recommendations | journal = [[Controlled Clinical Trials]] | volume = 9 | issue = 4 | pages = 365–74 | year = 1988 | pmid = 3203526 |  doi = 10.1016/0197-2456(88)90049-9 | hdl = 2027.42/27041 | url = https://deepblue.lib.umich.edu/bitstream/2027.42/27041/1/0000029.pdf | hdl-access = free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
==== Restricted ====&lt;br /&gt;
&lt;br /&gt;
To balance group sizes in smaller RCTs, some form of [[restricted randomization|&amp;quot;restricted&amp;quot; randomization]] is recommended.&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;/&amp;gt;  The major types of restricted randomization used in RCTs are:&lt;br /&gt;
&lt;br /&gt;
Peer review of results is an important part of the scientific method. Reviewers examine the study results for potential problems with design that could lead to unreliable results (for example by creating a systematic bias), evaluate the study in the context of related studies and other evidence, and evaluate whether the study can be reasonably considered to have proven its conclusions. To underscore the need for peer review and the danger of over-generalizing conclusions, two Boston-area medical researchers performed a randomized controlled trial in which they randomly assigned either a parachute or an empty backpack to 23 volunteers who jumped from either a biplane or a helicopter. The study was able to accurately report that parachutes fail to reduce injury compared to empty backpacks. The key context that limited the general applicability of this conclusion was that the aircraft were parked on the ground, and participants had only jumped about two feet.&lt;br /&gt;
&lt;br /&gt;
同行评议是科学方法的重要组成部分。审查人员检查研究结果是否存在设计方面的潜在问题，这些问题可能导致不可靠的结果(例如产生系统性偏差) ，在相关研究和其他证据的背景下评估研究，并评估是否可以合理地认为该研究已经证明了其结论。为了强调同行评议的必要性和过于笼统结论的危险性，波士顿地区的两名医学研究人员进行了一次随机对照试验测试，他们随机给23名从双翼飞机或直升机上跳下的志愿者分配一个降落伞或一个空背包。这项研究能够准确地报告，与空背包相比，降落伞无法减少伤害。限制这一结论普遍适用性的关键背景是飞机停在地面上，参与者只跳了大约两英尺。&lt;br /&gt;
&lt;br /&gt;
* '''[[Randomized block design|Permuted-block randomization]]''' or '''blocked randomization''': a &amp;quot;block size&amp;quot; and &amp;quot;allocation ratio&amp;quot; (number of subjects in one group versus the other group) are specified, and subjects are allocated randomly within each block.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt; For example, a block size of 6 and an allocation ratio of 2:1 would lead to random assignment of 4 subjects to one group and 2 to the other. This type of randomization can be combined with &amp;quot;[[stratified randomization]]&amp;quot;, for example by center in a [[multicenter trial]], to &amp;quot;ensure good balance of participant characteristics in each group.&amp;quot;&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt; A special case of permuted-block randomization is ''random allocation'', in which the entire sample is treated as one block.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt; The major disadvantage of permuted-block randomization is that even if the block sizes are large and randomly varied, the procedure can lead to selection bias.&amp;lt;ref name=&amp;quot;Lachin-1988a&amp;quot;/&amp;gt; Another disadvantage is that &amp;quot;proper&amp;quot; analysis of data from permuted-block-randomized RCTs requires stratification by blocks.&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
* '''Adaptive biased-coin randomization''' methods (of which '''urn randomization''' is the most widely known type): In these relatively uncommon methods, the probability of being assigned to a group decreases if the group is overrepresented and increases if the group is underrepresented.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt; The methods are thought to be less affected by selection bias than permuted-block randomization.&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
RCTs are considered to be the most reliable form of scientific evidence in the hierarchy of evidence that influences healthcare policy and practice because RCTs reduce spurious causality and bias. Results of RCTs may be combined in systematic reviews which are increasingly being used in the conduct of evidence-based practice. Some examples of scientific organizations' considering RCTs or systematic reviews of RCTs to be the highest-quality evidence available are:&lt;br /&gt;
&lt;br /&gt;
在影响医疗政策和实践的证据层次中，随机对照试验被认为是最可靠的科学证据形式，因为它减少了虚假的因果关系和偏差。随机对照试验的结果可以结合进行系统评价，这种评价正越来越多地用于循证实践的操作。一些科学组织认为区域研究报告或对区域研究报告的系统审查是现有的最高质量证据的例子如下:&lt;br /&gt;
&lt;br /&gt;
==== Adaptive ====&lt;br /&gt;
&lt;br /&gt;
At least two types of &amp;quot;adaptive&amp;quot; randomization procedures have been used in RCTs, but much less frequently than simple or restricted randomization:&lt;br /&gt;
&lt;br /&gt;
* '''Covariate-adaptive randomization''', of which one type is '''[[Minimisation (clinical trials)|minimization]]''': The probability of being assigned to a group varies in order to minimize &amp;quot;covariate imbalance.&amp;quot;&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;/&amp;gt; Minimization is reported to have &amp;quot;supporters and detractors&amp;quot;&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt; because only the first subject's group assignment is truly chosen at random, the method does not necessarily eliminate bias on unknown factors.&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
* '''Response-adaptive randomization''', also known as '''outcome-adaptive randomization''': The probability of being assigned to a group increases if the responses of the prior patients in the group were favorable.&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;/&amp;gt; Although arguments have been made that this approach is more ethical than other types of randomization when the probability that a treatment is effective or ineffective increases during the course of an RCT, ethicists have not yet studied the approach in detail.&amp;lt;ref name=&amp;quot;Rosenberger-1993&amp;quot;&amp;gt;{{Cite journal |vauthors=Rosenberger WF, Lachin JM | title = The use of response-adaptive designs in clinical trials | journal = [[Controlled Clinical Trials]] | volume = 14 | issue = 6 | pages = 471–84 | year = 1993 | pmid = 8119063 |  doi = 10.1016/0197-2456(93)90028-C }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Notable RCTs with unexpected results that contributed to changes in clinical practice include:&lt;br /&gt;
&lt;br /&gt;
值得注意的随机对照试验，其意想不到的结果促成了临床实践的改变，包括:&lt;br /&gt;
&lt;br /&gt;
=== Allocation concealment ===&lt;br /&gt;
&lt;br /&gt;
{{main|Allocation concealment}}&lt;br /&gt;
&lt;br /&gt;
&amp;quot;Allocation concealment&amp;quot; (defined as &amp;quot;the procedure for protecting the randomization process so that the treatment to be allocated is not known before the patient is entered into the study&amp;quot;) is important in RCTs.&amp;lt;ref name=&amp;quot;Forder-2005&amp;quot;&amp;gt;{{Cite journal |vauthors=Forder PM, Gebski VJ, Keech AC | title = Allocation concealment and blinding: when ignorance is bliss | journal = Med J Aust | volume = 182 | issue = 2 | pages = 87–9 | year = 2005 | url = http://www.mja.com.au/public/issues/182_02_170105/for10877_fm.html | pmid = 15651970 | doi = 10.5694/j.1326-5377.2005.tb06584.x | s2cid = 202149 }}&amp;lt;/ref&amp;gt; In practice, clinical investigators in RCTs often find it difficult to maintain impartiality. Stories abound of investigators holding up sealed envelopes to lights or ransacking offices to determine group assignments in order to dictate the assignment of their next patient.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;&amp;gt;{{Cite journal | title = Allocation concealment in randomised trials: defending against deciphering | journal = Lancet | volume = 359 | issue = 9306 | pages = 614–8 | year = 2002 | doi = 10.1016/S0140-6736(02)07750-4 | url =https://www.who.int/entity/rhl/LANCET_614-618.pdf | pmid = 11867132 |vauthors=Schulz KF, Grimes DA | s2cid = 12902486 }}&amp;lt;/ref&amp;gt; Such practices introduce selection bias and [[Lurking variable|confounders]] (both of which should be minimized by randomization), possibly distorting the results of the study.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt; Adequate allocation concealment should defeat patients and investigators from discovering treatment allocation once a study is underway and after the study has concluded.  Treatment related side-effects or adverse events may be specific enough to reveal allocation to investigators or patients thereby introducing bias or influencing any subjective parameters collected by investigators or requested from subjects.&lt;br /&gt;
&lt;br /&gt;
&amp;quot;Allocation concealment&amp;quot; (defined as &amp;quot;the procedure for protecting the randomization process so that the treatment to be allocated is not known before the patient is entered into the study&amp;quot;) is important in RCTs. In practice, clinical investigators in RCTs often find it difficult to maintain impartiality. Stories abound of investigators holding up sealed envelopes to lights or ransacking offices to determine group assignments in order to dictate the assignment of their next patient. Such practices introduce selection bias and confounders (both of which should be minimized by randomization), possibly distorting the results of the study. On the other hand, a 2008 study of 146 meta-analyses concluded that the results of RCTs with inadequate or unclear allocation concealment tended to be biased toward beneficial effects only if the RCTs' outcomes were subjective as opposed to objective.&lt;br /&gt;
&lt;br /&gt;
“分配隐藏”(定义为“保护随机化过程的程序，以便在病人进入研究之前不知道要分配的治疗”)在随机对照试验中很重要。在实践中，临床研究人员在随机对照试验中常常发现难以保持公正性。关于调查人员将密封的信封举到灯光下或者搜查办公室来决定团队任务，以便指定下一个病人的任务的故事比比皆是。这种做法引入了选择偏差和混杂因素(这两者都应该通过随机化来减少) ，可能会扭曲研究结果。另一方面，2008年的一项对146项元分析的研究得出结论，分配隐瞒不充分或不明确的随机对照试验的结果往往只有在随机对照试验的结果是主观的而不是客观的情况下才会偏向于有益的结果。&lt;br /&gt;
&lt;br /&gt;
Many papers discuss the disadvantages of RCTs.   Among the most frequently cited drawbacks are:&lt;br /&gt;
&lt;br /&gt;
许多论文讨论了 rct 的缺点。最常被提到的缺点是:&lt;br /&gt;
&lt;br /&gt;
Some standard methods of ensuring allocation concealment include sequentially numbered, opaque, sealed envelopes (SNOSE); sequentially numbered containers; pharmacy controlled randomization; and central randomization.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt; It is recommended that allocation concealment methods be included in an RCT's [[Clinical trial protocol|protocol]], and that the allocation concealment methods should be reported in detail in a publication of an RCT's results; however, a 2005 study determined that most RCTs have unclear allocation concealment in their protocols, in their publications, or both.&amp;lt;ref name=&amp;quot;Pildal-2005&amp;quot;&amp;gt;{{Cite journal |vauthors=Pildal J, Chan AW, Hróbjartsson A, Forfang E, Altman DG, Gøtzsche PC | title = Comparison of descriptions of allocation concealment in trial protocols and the published reports: cohort study | journal = BMJ | volume = 330 | issue = 7499 | page = 1049 | year = 2005 | doi = 10.1136/bmj.38414.422650.8F | pmid = 15817527 | pmc = 557221 }}&amp;lt;/ref&amp;gt; On the other hand, a 2008 study of 146 [[meta-analysis|meta-analyses]] concluded that the results of RCTs with inadequate or unclear allocation concealment tended to be biased toward beneficial effects only if the RCTs' outcomes were [[Subjectivity|subjective]] as opposed to [[Objectivity (philosophy)|objective]].&amp;lt;ref name=&amp;quot;Wood-2008&amp;quot;&amp;gt;{{Cite journal |vauthors=Wood L, Egger M, Gluud LL, Schulz KF, Jüni P, Altman DG, Gluud C, Martin RM, Wood AJ, Sterne JA | title = Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study | journal = BMJ | volume = 336 | issue = 7644 | pages = 601–5 | year = 2008 | doi = 10.1136/bmj.39465.451748.AD | pmid = 18316340 | pmc = 2267990 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Some standard methods of ensuring allocation concealment include sequentially numbered, opaque, sealed envelopes (SNOSE); sequentially numbered containers; pharmacy controlled randomization; and central randomization. It is recommended that allocation concealment methods be included in an RCT's protocol, and that the allocation concealment methods should be reported in detail in a publication of an RCT's results; however, a 2005 study determined that most RCTs have unclear allocation concealment in their protocols, in their publications, or both. On the other hand, a 2008 study of 146 meta-analyses concluded that the results of RCTs with inadequate or unclear allocation concealment tended to be biased toward beneficial effects only if the RCTs' outcomes were subjective as opposed to objective.&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
=== Sample size ===&lt;br /&gt;
&lt;br /&gt;
RCTs can be expensive; for a mean cost of US$12 million per RCT.  Nevertheless, the return on investment of RCTs may be high, in that the same study projected that the 28 RCTs produced a &amp;quot;net benefit to society at 10-years&amp;quot; of 46 times the cost of the trials program, based on evaluating a quality-adjusted life year as equal to the prevailing mean per capita gross domestic product.&lt;br /&gt;
&lt;br /&gt;
随机对照试验可能很昂贵，每次随机对照试验的平均成本为1200万美元。然而，随机对照试验的投资回报率可能很高，因为同一项研究预测，28个 随机对照试验 产生的“10年社会净效益”是试验项目成本的46倍，其基础是评估一个质量调整寿命年等于当前人均国内生产总值的平均值。&lt;br /&gt;
&lt;br /&gt;
{{Main|Sample size determination}}&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
It is costly to maintain RCTs for the years or decades that would be ideal for evaluating some interventions.&lt;br /&gt;
&lt;br /&gt;
有些随机对照试验需要持续几年或几十年，花费巨大，但这些试验对于评价某些干预措施是理想的。&lt;br /&gt;
The number of treatment units (subjects or groups of subjects) assigned to control and treatment groups, affects an RCT's reliability. If the effect of the treatment is small, the number of treatment units in either group may be insufficient for rejecting the null hypothesis in the respective [[statistical hypothesis testing|statistical test]]. The failure to reject the [[null hypothesis]] would imply that the treatment shows no statistically significant effect on the treated ''in a given test''. But as the sample size increases, the same RCT may be able to demonstrate a significant effect of the treatment, even if this effect is small.&amp;lt;ref name=&amp;quot;Glennerster-2013&amp;quot;&amp;gt;{{Cite book | publisher = Princeton University Press | isbn = 9780691159249 | last = Glennerster | first = Rachel |author2=Kudzai Takavarasha  | title = Running randomized evaluations: a practical guide | location = Princeton | date = 2013 |url=https://www.jstor.org/stable/j.ctt4cgd52 |chapter=&amp;quot;Chapter 6&amp;quot; }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
The number of treatment units (subjects or groups of subjects) assigned to control and treatment groups, affects an RCT's reliability. If the effect of the treatment is small, the number of treatment units in either group may be insufficient for rejecting the null hypothesis in the respective statistical test. The failure to reject the null hypothesis would imply that the treatment shows no statistically significant effect on the treated in a given test. But as the sample size increases, the same RCT may be able to demonstrate a significant effect of the treatment, even if this effect is small.&lt;br /&gt;
&lt;br /&gt;
分配给控制组和治疗组的治疗单位(受试者或受试者组)的样本量影响 RCT 的可靠性。如果治疗的效果很小，任何一组的治疗单位的样本量都可能不足以在各自的统计检验中拒绝无效假设（零假设）。拒绝零假设的失败将意味着治疗在给定的测试中对治疗没有统计学意义上的显著影响。但是随着样本量的增加，相同的随机对照试验也许能够证明治疗的显著效果，即使这种效果很小。&lt;br /&gt;
&lt;br /&gt;
== Blinding ==&lt;br /&gt;
&lt;br /&gt;
{{main|Blinded experiment}}&lt;br /&gt;
&lt;br /&gt;
An RCT may be [[Blind experiment|blinded]], (also called &amp;quot;masked&amp;quot;) by &amp;quot;procedures that prevent study participants, caregivers, or outcome assessors from knowing which intervention was received.&amp;quot;&amp;lt;ref name=&amp;quot;Wood-2008&amp;quot;/&amp;gt; Unlike allocation concealment, blinding is sometimes inappropriate or impossible to perform in an RCT; for example, if an RCT involves a treatment in which active participation of the patient is necessary (e.g., [[physical therapy]]), participants cannot be blinded to the intervention.&lt;br /&gt;
&lt;br /&gt;
If a disruptive innovation in medical technology is developed, it may be difficult to test this ethically in an RCT if it becomes &amp;quot;obvious&amp;quot; that the control subjects have poorer outcomes—either due to other foregoing testing, or within the initial phase of the RCT itself.  Ethically it may be necessary to abort the RCT prematurely, and getting ethics approval (and patient agreement) to withhold the innovation from the control group in future RCT's may not be feasible.&lt;br /&gt;
&lt;br /&gt;
如果医学技术领域出现颠覆性创新，在RCT中，对照组的结果变得“明显”—－即对照组出现明显差的结局。这要么由于其他的前述测试，要么是在 RCT 本身的初始阶段， 那么在 RCT 中很难从伦理上检验这一点。从伦理上讲，过早地中止 RCT 可能是必要的，而在未来的 RCT 中，获得伦理批准(以及患者同意)以阻止控制组的创新可能是不可行的。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Traditionally, blinded RCTs have been classified as &amp;quot;single-blind&amp;quot;, &amp;quot;double-blind&amp;quot;, or &amp;quot;triple-blind&amp;quot;; however, in 2001 and 2006 two studies showed that these terms have different meanings for different people.&amp;lt;ref name=&amp;quot;Devereaux-2001&amp;quot;&amp;gt;{{Cite journal |vauthors=Devereaux PJ, Manns BJ, Ghali WA, Quan H, Lacchetti C, Montori VM, Bhandari M, Guyatt GH | title = Physician interpretations and textbook definitions of blinding terminology in randomized controlled trials | journal = [[J Am Med Assoc]] | volume = 285 | issue = 15 | pages = 2000–3 | year = 2001 | doi =  10.1001/jama.285.15.2000| pmid = 11308438 | doi-access = free }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Haahr-2006&amp;quot;&amp;gt;{{Cite journal |vauthors=Haahr MT, Hróbjartsson A | title = Who is blinded in randomized clinical trials? A study of 200 trials and a survey of authors | journal = Clin Trials | volume = 3 | issue = 4 | pages = 360–5 | year = 2006 | doi = 10.1177/1740774506069153 | pmid = 17060210 | s2cid = 23818514 }}&amp;lt;/ref&amp;gt;  The 2010 [[Consolidated Standards of Reporting Trials|CONSORT Statement]] specifies that authors and editors should not use the terms &amp;quot;single-blind&amp;quot;, &amp;quot;double-blind&amp;quot;, and &amp;quot;triple-blind&amp;quot;; instead, reports of blinded RCT should discuss &amp;quot;If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how.&amp;quot;&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Historical control trials (HCT) exploit the data of previous RCTs to reduce the sample size; however, these approaches are controversial in the scientific community and must be handled with care.&lt;br /&gt;
&lt;br /&gt;
历史对照试验(HCT)利用以前随机对照试验的数据来减少样本量，然而，这些方法在科学界是有争议的，必须小心处理。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
RCTs without blinding are referred to as &amp;quot;unblinded&amp;quot;,&amp;lt;ref name=&amp;quot;Marson-2007&amp;quot;&amp;gt;{{Cite journal  |vauthors=Marson AG, Al-Kharusi AM, Alwaidh M, Appleton R, Baker GA, Chadwick DW, etal | title = The SANAD study of effectiveness of valproate, lamotrigine, or topiramate for generalised and unclassifiable epilepsy: an unblinded randomised controlled trial | journal = [[The Lancet|Lancet]] | volume = 369 | issue = 9566 | pages = 1016–26 | year = 2007 | doi = 10.1016/S0140-6736(07)60461-9 | pmid = 17382828 | pmc = 2039891 }}&amp;lt;/ref&amp;gt; &amp;quot;open&amp;quot;,&amp;lt;ref name=&amp;quot;Chan-1995&amp;quot;&amp;gt;{{Cite journal |vauthors=Chan R, Hemeryck L, O'Regan M, Clancy L, Feely J | title = Oral versus intravenous antibiotics for community acquired lower respiratory tract infection in a general hospital: open, randomised controlled trial | journal = [[BMJ]] | volume = 310 | issue = 6991 | pages = 1360–2 | year = 1995 | pmid = 7787537 | pmc = 2549744 | doi=10.1136/bmj.310.6991.1360}}&amp;lt;/ref&amp;gt; or (if the intervention is a medication) &amp;quot;[[Open-label trial|open-label]]&amp;quot;.&amp;lt;ref name=&amp;quot;Fukase-2008&amp;quot;&amp;gt;{{Cite journal | author = Fukase K, Kato M, Kikuchi S, Inoue K, Uemura N, Okamoto S, Terao S, Amagai K, Hayashi S, Asaka M; Japan Gast Study Group | title = Effect of eradication of Helicobacter pylori on incidence of metachronous gastric carcinoma after endoscopic resection of early gastric cancer: an open-label, randomised controlled trial | journal = Lancet | volume = 372 | issue = 9636 | pages = 392–7 | year = 2008 | doi = 10.1016/S0140-6736(08)61159-9 | pmid = 18675689 | hdl = 2115/34681 | s2cid = 13741892 | url = https://eprints.lib.hokudai.ac.jp/dspace/bitstream/2115/34681/1/asaka.pdf | hdl-access = free }}&amp;lt;/ref&amp;gt; In 2008 a study concluded that the results of unblinded RCTs tended to be biased toward beneficial effects only if the RCTs' outcomes were subjective as opposed to objective;&amp;lt;ref name=&amp;quot;Wood-2008&amp;quot;/&amp;gt; for example, in an RCT of treatments for [[multiple sclerosis]], unblinded neurologists (but not the blinded neurologists) felt that the treatments were beneficial.&amp;lt;ref name=&amp;quot;Noseworthy-1994&amp;quot;&amp;gt;{{Cite journal |vauthors=Noseworthy JH, Ebers GC, Vandervoort MK, Farquhar RE, Yetisir E, Roberts R | author-link1=John H. Noseworthy|title = The impact of blinding on the results of a randomized, placebo-controlled multiple sclerosis clinical trial | journal = Neurology | volume = 44 | issue = 1 | pages = 16–20 | year = 1994 | url = http://www.neurology.org/cgi/content/abstract/44/1/16 | pmid = 8290055 | doi=10.1212/wnl.44.1.16| s2cid=2663997}}&amp;lt;/ref&amp;gt; In pragmatic RCTs, although the participants and providers are often unblinded, it is &amp;quot;still desirable and often possible to blind the assessor or obtain an objective source of data for evaluation of outcomes.&amp;quot;&amp;lt;ref name=&amp;quot;Zwarenstein-2008&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
== Analysis of data ==&lt;br /&gt;
&lt;br /&gt;
The types of statistical methods used in RCTs depend on the characteristics of the data and include:&lt;br /&gt;
&lt;br /&gt;
* For [[dichotomous]] (binary) outcome data, [[logistic regression]] (e.g., to predict sustained virological response after receipt of [[peginterferon alfa-2a]] for [[hepatitis C]]&amp;lt;ref name=&amp;quot;Manns-2001&amp;quot;&amp;gt;{{Cite journal |vauthors=Manns MP, McHutchison JG, Gordon SC, Rustgi VK, Shiffman M, Reindollar R, Goodman ZD, Koury K, Ling M, Albrecht JK | title = Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial | journal = [[The Lancet|Lancet]] | volume = 358 | issue = 9286 | pages = 958–65 | year = 2001 | doi = 10.1016/S0140-6736(01)06102-5 | pmid = 11583749 | s2cid = 14583372 }}&amp;lt;/ref&amp;gt;) and other methods can be used.&lt;br /&gt;
&lt;br /&gt;
* For continuous outcome data, [[analysis of covariance]] (e.g., for changes in blood lipid levels after receipt of [[atorvastatin]] after [[acute coronary syndrome]]&amp;lt;ref name=&amp;quot;Schwartz-2001&amp;quot;&amp;gt;{{Cite journal | author = Schwartz GG, Olsson AG, Ezekowitz MD, Ganz P, Oliver MF, Waters D, Zeiher A, Chaitman BR, Leslie S, Stern T; Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering (MIRACL) Study Investigators | title = Effects of atorvastatin on early recurrent ischemic events in acute coronary syndromes: the MIRACL study: a randomized controlled trial | journal = [[J Am Med Assoc]] | volume = 285 | issue = 13 | pages = 1711–8 | year = 2001 | pmid = 11277825 | doi = 10.1001/jama.285.13.1711 | doi-access = free }}&amp;lt;/ref&amp;gt;) tests the effects of predictor variables.&lt;br /&gt;
&lt;br /&gt;
* For time-to-event outcome data that may be [[Censoring (statistics)|censored]], [[survival analysis]] (e.g., [[Kaplan–Meier estimator]]s and [[Cox proportional hazards model]]s for time to [[coronary heart disease]] after receipt of [[Hormone replacement therapy (menopause)|hormone replacement therapy in menopause]]&amp;lt;ref name=&amp;quot;Rossouw-2002&amp;quot;&amp;gt;{{Cite journal | author = Rossouw JE, Anderson GL, [[Ross Prentice|Prentice RL]], LaCroix AZ, Kooperberg C, Stefanick ML, Jackson RD, Beresford SA, Howard BV, Johnson KC, Kotchen JM, Ockene J; Writing Group for the Women's Health Initiative Investigators | title = Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial | journal = [[J Am Med Assoc]] | volume = 288 | issue = 3 | pages = 321–33 | year = 2002 | pmid = 12117397 | doi = 10.1001/jama.288.3.321 | s2cid = 20149703 | url = https://escholarship.org/content/qt3mr6f93p/qt3mr6f93p.pdf?t=prll4c | doi-access = free }}&amp;lt;/ref&amp;gt;) is appropriate.&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Due to the recent emergence of RCTs in social science, the use of RCTs in social sciences is a contested issue.  Some writers from a medical or health background have argued that existing research in a range of social science disciplines lacks rigour, and should be improved by greater use of randomized control trials.&lt;br /&gt;
&lt;br /&gt;
由于最近在社会科学中出现了 rct，rct 在社会科学中的应用是一个有争议的问题。一些有医学或健康背景的作家认为，一系列社会科学学科的现有研究缺乏严谨性，应该通过更多地使用随机对照试验来改进。&lt;br /&gt;
Researchers in transport science argue that public spending on programmes such as school travel plans could not be justified unless their efficacy is demonstrated by randomized controlled trials.  Graham-Rowe and colleagues  reviewed 77 evaluations of transport interventions found in the literature, categorising them into 5 &amp;quot;quality levels&amp;quot;.  They concluded that most of the studies were of low quality and advocated the use of randomized controlled trials wherever possible in future transport research.&lt;br /&gt;
&lt;br /&gt;
交通科学研究人员认为，除非随机对照试验证明其有效性，否则在学校旅行计划等项目上的公共支出是不合理的。Graham-Rowe 和他的同事回顾了文献中发现的77个运输干预评估，将它们分为5个“质量水平”。他们的结论是，大多数研究质量低下，并主张在未来的运输研究中尽可能使用随机对照试验。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Regardless of the statistical methods used, important considerations in the analysis of RCT data include:&lt;br /&gt;
&lt;br /&gt;
Dr. Steve Melia took issue with these conclusions, arguing that claims about the advantages of RCTs, in establishing causality and avoiding bias, have been exaggerated.  He proposed the following eight criteria for the use of RCTs in contexts where interventions must change human behaviour to be effective:&lt;br /&gt;
&lt;br /&gt;
Steve Melia 博士对这些结论提出异议，认为关于 rct 在确定因果关系和避免偏见方面的优势的说法被夸大了。他提出了在干预措施必须改变人的行为才能有效的情况下使用区域反应技术的八项标准:&lt;br /&gt;
&lt;br /&gt;
* Whether an RCT should be stopped early due to interim results.  For example, RCTs may be stopped early if an intervention produces &amp;quot;larger than expected benefit or harm&amp;quot;, or if &amp;quot;investigators find evidence of no important difference between experimental and control interventions.&amp;quot;&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
* The extent to which the groups can be analyzed exactly as they existed upon randomization (i.e., whether a so-called &amp;quot;[[intention-to-treat analysis]]&amp;quot; is used). A &amp;quot;pure&amp;quot; intention-to-treat analysis is &amp;quot;possible only when complete outcome data are available&amp;quot; for all randomized subjects;&amp;lt;ref name=&amp;quot;Hollis-1999&amp;quot;&amp;gt;{{Cite journal |vauthors=Hollis S, Campbell F | title = What is meant by intention to treat analysis? Survey of published randomised controlled trials | journal = [[Br Med J]] | volume = 319 | issue = 7211 | pages = 670–4 | year = 1999 | pmid = 10480822 | pmc = 28218 | doi=10.1136/bmj.319.7211.670}}&amp;lt;/ref&amp;gt; when some outcome data are missing, options include analyzing only cases with known outcomes and using [[Imputation (statistics)|imputed]] data.&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt; Nevertheless, the more that analyses can include all participants in the groups to which they were randomized, the less bias that an RCT will be subject to.&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
The intervention:&lt;br /&gt;
&lt;br /&gt;
干预措施:&lt;br /&gt;
&lt;br /&gt;
* Whether [[subgroup analysis]] should be performed.  These are &amp;quot;often discouraged&amp;quot; because [[multiple comparisons]] may produce false positive findings that cannot be confirmed by other studies.&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
 Has not been applied to all members of a unique group of people (e.g. the population of a whole country, all employees of a unique organisation etc.)&lt;br /&gt;
&lt;br /&gt;
并不适用于一个特殊群体的所有成员(例如:。整个国家的人口，一个独特组织的所有雇员等)&lt;br /&gt;
&lt;br /&gt;
== Reporting of results ==&lt;br /&gt;
&lt;br /&gt;
 Is applied in a context or setting similar to that which applies to the control group&lt;br /&gt;
&lt;br /&gt;
应用于类似于应用于控制组的上下文或设置&lt;br /&gt;
&lt;br /&gt;
The ''[[Consolidated Standards of Reporting Trials|CONSORT 2010 Statement]]'' is &amp;quot;an evidence-based, minimum set of recommendations for reporting RCTs.&amp;quot;&amp;lt;ref name=&amp;quot;CONSORT&amp;quot;&amp;gt;{{cite web |url=http://www.consort-statement.org |title=Welcome to the CONSORT statement Website |author=CONSORT Group |access-date=2010-03-29}}&amp;lt;/ref&amp;gt; The CONSORT 2010 checklist contains 25 items (many with sub-items) focusing on &amp;quot;individually randomised, two group, parallel trials&amp;quot; which are the most common type of RCT.&amp;lt;ref name=&amp;quot;Schulz-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
 Can be isolated from other activities—and the purpose of the study is to assess this isolated effect&lt;br /&gt;
&lt;br /&gt;
这项研究的目的是评估这种孤立效应&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
 Has a short timescale between its implementation and maturity of its effects&lt;br /&gt;
&lt;br /&gt;
从实施到效果成熟之间的时间跨度很短&lt;br /&gt;
&lt;br /&gt;
For other RCT study designs, &amp;quot;[[Consolidated Standards of Reporting Trials|CONSORT extensions]]&amp;quot; have been published, some examples are:&lt;br /&gt;
&lt;br /&gt;
* Consort 2010 Statement: Extension to Cluster Randomised Trials&amp;lt;ref name=&amp;quot;CONSORT2010-EXTENSION-CLUSTER&amp;quot;&amp;gt;{{Cite journal |vauthors=Campbell MK, Piaggio G, Elbourne DR, Altman DG| title = Consort 2010 statement: extension to cluster randomised trials | journal = [[BMJ]] | volume = 345| pages = e5661 | year = 2012  | pmid = 22951546 | doi = 10.1136/bmj.e5661 | doi-access = free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
And the causal mechanisms:&lt;br /&gt;
&lt;br /&gt;
以及因果机制:&lt;br /&gt;
&lt;br /&gt;
* Consort 2010 Statement: Non-Pharmacologic Treatment Interventions&amp;lt;ref name=&amp;quot;CONSORT2010-EXTENSION-NON-PHARMACOLOGIC-1&amp;quot;&amp;gt;{{Cite journal |vauthors=Boutron I, Moher D, Altman DG, Schulz K, Ravaud P| title = Extending the CONSORT Statement to randomized trials of nonpharmacologic treatment: explanation and elaboration | journal = [[Annals of Internal Medicine]] | volume = 148| issue = 4 | year = 2008 | pages=295–309  | pmid = 18283207 | doi=10.7326/0003-4819-148-4-200802190-00008| doi-access = free }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;CONSORT2010-EXTENSION-NON-PHARMACOLOGIC-2&amp;quot;&amp;gt;{{Cite journal |vauthors=Boutron I, Moher D, Altman DG, Schulz K, Ravaud P| title = Methods and Processes of the CONSORT Group: Example of an Extension for Trials Assessing Nonpharmacologic Treatments | journal = [[Annals of Internal Medicine]] | volume = 148| issue = 4 | year = 2008  | pmid = 18283201 | doi=10.7326/0003-4819-148-4-200802190-00008-w1 | pages=W60–6| doi-access = free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&amp;lt;li value=&amp;quot;5&amp;quot;&amp;gt;Are either known to the researchers, or else all possible alternatives can be tested&lt;br /&gt;
&lt;br /&gt;
&amp;lt; li value = &amp;quot; 5&amp;quot; &amp;gt; 要么被研究人员知道，要么所有可能的替代方案都可以被测试&lt;br /&gt;
&lt;br /&gt;
=== Relative importance and observational studies ===&lt;br /&gt;
&lt;br /&gt;
 Do not involve significant feedback mechanisms between the intervention group and external environments&lt;br /&gt;
&lt;br /&gt;
不涉及干预组和外部环境之间的重要反馈机制&lt;br /&gt;
&lt;br /&gt;
Two studies published in ''[[The New England Journal of Medicine]]'' in 2000 found that [[Observational study|observational studies]] and RCTs overall produced similar results.&amp;lt;ref name=&amp;quot;Benson-2000&amp;quot;&amp;gt;{{Cite journal |vauthors=Benson K, Hartz AJ | title = A comparison of observational studies and randomized, controlled trials | journal = [[N Engl J Med]] | volume = 342 | issue = 25 | pages = 1878–86 | year = 2000 | pmid = 10861324 | doi = 10.1056/NEJM200006223422506 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Concato-2000&amp;quot;&amp;gt;{{Cite journal |vauthors=Concato J, Shah N, Horwitz RI | title = Randomized, controlled trials, observational studies, and the hierarchy of research designs | journal = [[N Engl J Med]] | volume = 342 | issue = 25 | pages = 1887–92 | year = 2000 | url = http://nejm.highwire.org/cgi/content/full/342/25/1887 | pmid = 10861325 | doi = 10.1056/NEJM200006223422507 | pmc = 1557642 }}&amp;lt;/ref&amp;gt; The authors of the 2000 findings questioned the belief that &amp;quot;observational studies should not be used for defining evidence-based medical care&amp;quot; and that RCTs' results are &amp;quot;evidence of the highest grade.&amp;quot;&amp;lt;ref name=&amp;quot;Benson-2000&amp;quot;/&amp;gt;&amp;lt;ref name=&amp;quot;Concato-2000&amp;quot;/&amp;gt; However, a 2001 study published in ''[[Journal of the American Medical Association]]'' concluded that &amp;quot;discrepancies beyond chance do occur and differences in estimated magnitude of treatment effect are very common&amp;quot; between observational studies and RCTs.&amp;lt;ref name=&amp;quot;Ioannidis-2001&amp;quot;&amp;gt;{{Cite journal |vauthors=Ioannidis JP, Haidich AB, Pappa M, Pantazis N, Kokori SI, Tektonidou MG, Contopoulos-Ioannidis DG, Lau J | title = Comparison of evidence of treatment effects in randomized and nonrandomized studies | journal = [[J Am Med Assoc]] | volume = 286 | issue = 7 | pages = 821–30 | year = 2001 | pmid = 11497536 | doi = 10.1001/jama.286.7.821 | citeseerx = 10.1.1.590.2854 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Have a stable and predictable relationship to exogenous factors&lt;br /&gt;
&lt;br /&gt;
与外部因素有稳定和可预测的关系&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
 Would act in the same way if the control group and intervention group were reversed&lt;br /&gt;
&lt;br /&gt;
如果对照组和干预组的情况相反，他们也会以同样的方式行动&lt;br /&gt;
&lt;br /&gt;
Two other lines of reasoning question RCTs' contribution to scientific knowledge beyond other types of studies:&lt;br /&gt;
* If study designs are ranked by their potential for new discoveries, then [[Anecdotal evidence#Scientific context|anecdotal evidence]] would be at the top of the list, followed by observational studies, followed by RCTs.&amp;lt;ref name=&amp;quot;Vandenbroucke-2008&amp;quot;&amp;gt;{{Cite journal | author = Vandenbroucke JP | title = Observational research, randomised trials, and two views of medical science | journal = [[PLoS Med]] | volume = 5 | issue = 3 | pages = e67 | year = 2008 | doi = 10.1371/journal.pmed.0050067 | pmid = 18336067 | pmc = 2265762 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* RCTs may be unnecessary for treatments that have dramatic and rapid effects relative to the expected stable or progressively worse natural course of the condition treated.&amp;lt;ref name=&amp;quot;Black-1996&amp;quot;/&amp;gt;&amp;lt;ref name=&amp;quot;Glasziou-2007&amp;quot;&amp;gt;{{Cite journal |vauthors=Glasziou P, Chalmers I, Rawlins M, McCulloch P | title = When are randomised trials unnecessary? Picking signal from noise | journal = [[Br Med J]] | volume = 334 | issue = 7589 | pages = 349–51 | year = 2007 | doi = 10.1136/bmj.39070.527986.68 | pmc=1800999 | pmid = 17303884 }}&amp;lt;/ref&amp;gt; One example is [[History of cancer chemotherapy#Combination chemotherapy|combination chemotherapy]] including [[cisplatin]] for [[Metastasis|metastatic]] [[testicular cancer]], which increased the cure rate from 5% to 60% in a 1977 non-randomized study.&amp;lt;ref name=&amp;quot;Glasziou-2007&amp;quot;/&amp;gt;&amp;lt;ref name=&amp;quot;Einhorn-2002&amp;quot;&amp;gt;{{Cite journal | author = Einhorn LH | author-link = Lawrence Einhorn | title = Curing metastatic testicular cancer | journal = [[Proc Natl Acad Sci U S A]] | volume = 99 | issue = 7 | pages = 4592–5 | year = 2002 | doi = 10.1073/pnas.072067999 | pmid = 11904381 | pmc = 123692 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
A 2005 review found 83 randomized experiments in criminology published in 1982–2004, compared with only 35 published in 1957–1981. The authors classified the studies they found into five categories: &amp;quot;policing&amp;quot;, &amp;quot;prevention&amp;quot;, &amp;quot;corrections&amp;quot;, &amp;quot;court&amp;quot;, and &amp;quot;community&amp;quot;.&lt;br /&gt;
&lt;br /&gt;
2005年的一项研究发现，1982年至2004年发表的犯罪学随机实验有83项，而1957年至1981年发表的只有35项。作者将他们发现的研究分为五类: “警务”、“预防”、“惩戒”、“法院”和“社区”。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
=== Interpretation of statistical results ===&lt;br /&gt;
&lt;br /&gt;
Like all statistical methods, RCTs are subject to both [[type I and type II errors|type I (&amp;quot;false positive&amp;quot;) and type II (&amp;quot;false negative&amp;quot;) statistical errors]].  Regarding Type I errors, a typical RCT will use 0.05 (i.e., 1 in 20) as the probability that the RCT will falsely find two equally effective treatments significantly different.&amp;lt;ref name=&amp;quot;Wittes-2002&amp;quot;&amp;gt;{{Cite journal | author = Wittes J | title = Sample size calculations for randomized controlled trials | journal = [[Epidemiol Rev]] | volume = 24 | issue = 1 | pages = 39–53 | year = 2002 | doi = 10.1093/epirev/24.1.39 | pmid = 12119854 | doi-access = free }}&amp;lt;/ref&amp;gt; Regarding Type II errors, despite the publication of a 1978 paper noting that the [[sample size]]s of many &amp;quot;negative&amp;quot; RCTs were too small to make definitive conclusions about the negative results,&amp;lt;ref name=&amp;quot;Freiman-1978&amp;quot;&amp;gt;{{Cite journal | doi = 10.1056/NEJM197809282991304 |vauthors=Freiman JA, Chalmers TC, ((Smith H Jr)), Kuebler RR | title = The importance of beta, the type II error and sample size in the design and interpretation of the randomized control trial. Survey of 71 &amp;quot;negative&amp;quot; trials | journal = [[N Engl J Med]] | volume = 299 | issue = 13 | pages = 690–4 | year = 1978 | pmid = 355881 }}&amp;lt;/ref&amp;gt; by 2005-2006 a sizeable proportion of RCTs still had inaccurate or incompletely reported sample size calculations.&amp;lt;ref name=&amp;quot;Charles-2009&amp;quot;&amp;gt;{{Cite journal |vauthors=Charles P, Giraudeau B, Dechartres A, Baron G, Ravaud P | title = Reporting of sample size calculation in randomised controlled trials: review | journal = [[Br Med J]] | volume = 338 | pages = b1732 | date = 2009-05-12 | doi = 10.1136/bmj.b1732 | pmid = 19435763 | pmc = 2680945 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
RCTs have been used in evaluating a number of educational interventions. Between 1980 and 2016, over 1,000 reports of RCTs have been published. For example, a 2009 study randomized 260 elementary school teachers' classrooms to receive or not receive a program of behavioral screening, classroom intervention, and parent training, and then measured the behavioral and academic performance of their students. Another 2009 study randomized classrooms for 678 first-grade children to receive a classroom-centered intervention, a parent-centered intervention, or no intervention, and then followed their academic outcomes through age 19.&lt;br /&gt;
&lt;br /&gt;
随机对照试验已用于评价一些教育干预措施。从1980年到2016年，已经发表了超过1000篇关于 rct 的报告。例如，2009年的一项研究随机抽取了260名小学教师的课堂，让他们接受或不接受行为筛选、课堂干预和家长培训，然后测量他们学生的行为和学业表现。2009年的另一项研究随机化了678个一年级儿童的课堂，接受了以课堂为中心的干预，以家长为中心的干预，或没有干预，然后跟踪他们的学习成果直到19岁。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
=== Peer review ===&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
A 2017 review of the 10 most cited randomised controlled trials noted poor distribution of background traits, difficulties with blinding, and discussed other assumptions and biases inherent in randomised controlled trials. These include the &amp;quot;unique time period assessment bias&amp;quot;, the &amp;quot;background traits remain constant assumption&amp;quot;, the &amp;quot;average treatment effects limitation&amp;quot;, the &amp;quot;simple treatment at the individual level limitation&amp;quot;, the &amp;quot;all preconditions are fully met assumption&amp;quot;, the &amp;quot;quantitative variable limitation&amp;quot; and the &amp;quot;placebo only or conventional treatment only limitation&amp;quot;.&lt;br /&gt;
&lt;br /&gt;
2017年对10个最常被引用的随机对照试验的回顾指出，背景特征的分布不良，盲法存在困难，并讨论了随机对照试验中固有的其他假设和偏差。其中包括”独特的时间段评估偏差”、”背景特征保持不变的假设”、”平均治疗效果限制”、”个人层面的简单治疗限制”、”所有前提条件都得到充分满足的假设”、”定量变量限制”以及”仅安慰剂或常规治疗限制”。&lt;br /&gt;
&lt;br /&gt;
[[Peer review]] of results is an important part of the [[scientific method]]. Reviewers examine the study results for potential problems with design that could lead to unreliable results (for example by creating a [[systematic bias]]), evaluate the study in the context of related studies and other evidence, and evaluate whether the study can be reasonably considered to have proven its conclusions. To underscore the need for peer review and the danger of over-generalizing conclusions, two Boston-area medical researchers performed a randomized controlled trial in which they randomly assigned either a parachute or an empty backpack to 23 volunteers who jumped from either a biplane or a helicopter. The study was able to accurately report that parachutes fail to reduce injury compared to empty backpacks. The key context that limited the general applicability of this conclusion was that the aircraft were parked on the ground, and participants had only jumped about two feet.&amp;lt;ref&amp;gt;{{cite news |url=https://www.npr.org/sections/health-shots/2018/12/22/679083038/researchers-show-parachutes-dont-work-but-there-s-a-catch |title=Researchers Show Parachutes Don't Work, But There's A Catch |date=22 Dec 2018 |author=Richard Harris}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
== Advantages ==&lt;br /&gt;
&lt;br /&gt;
RCTs are considered to be the most reliable form of [[scientific method|scientific evidence]] in the [[hierarchy of evidence]] that influences healthcare policy and practice because RCTs reduce spurious causality and bias. Results of RCTs may be combined in [[systematic review]]s which are increasingly being used in the conduct of [[evidence-based practice]]. Some examples of scientific organizations' considering RCTs or systematic reviews of RCTs to be the highest-quality evidence available are:&lt;br /&gt;
* As of 1998, the [[National Health and Medical Research Council]] of Australia designated &amp;quot;Level I&amp;quot; evidence as that &amp;quot;obtained from a [[systematic review]] of all relevant randomised controlled trials&amp;quot; and &amp;quot;Level II&amp;quot; evidence as that &amp;quot;obtained from at least one properly designed randomised controlled trial.&amp;quot;&amp;lt;ref&amp;gt;{{cite book |url= http://www.nhmrc.gov.au/_files_nhmrc/file/publications/synopses/cp30.pdf |title= A guide to the development, implementation and evaluation of clinical practice guidelines |author= National Health and Medical Research Council |date=1998-11-16 |publisher= Commonwealth of Australia |location = Canberra | isbn = 978-1-86496-048-8 |page= 56|access-date=2010-03-28}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* Since at least 2001, in making [[clinical practice guideline]] recommendations the [[United States Preventive Services Task Force]] has considered both a study's design and its [[internal validity]] as indicators of its quality.&amp;lt;ref name=&amp;quot;Harris-2001&amp;quot;&amp;gt;{{Cite journal | author = Harris RP, Helfand M, Woolf SH, Lohr KN, Mulrow CD, Teutsch SM, Atkins D; Methods Work Group, Third US Preventive Services Task Force | title = Current methods of the US Preventive Services Task Force: a review of the process | journal = Am J Prev Med | volume = 20 | issue = 3 Suppl | pages = 21–35 | year = 2001 | url = http://www.ahrq.gov/clinic/ajpmsuppl/review.pdf | pmid = 11306229 | doi = 10.1016/S0749-3797(01)00261-6 }}&amp;lt;/ref&amp;gt; It has recognized &amp;quot;evidence obtained from at least one properly randomized controlled trial&amp;quot; with good [[internal validity]] (i.e., a rating of &amp;quot;I-good&amp;quot;) as the highest quality evidence available to it.&amp;lt;ref name=&amp;quot;Harris-2001&amp;quot;/&amp;gt;&lt;br /&gt;
* The [[Evidence-based medicine#Grade Working Group|GRADE Working Group]] concluded in 2008 that &amp;quot;randomised trials without important limitations constitute high quality evidence.&amp;quot;&amp;lt;ref name=&amp;quot;Guyatt-2008&amp;quot;&amp;gt;{{Cite journal | author = Guyatt GH, Oxman AD, Kunz R, Vist GE, Falck-Ytter Y, Schünemann HJ; GRADE Working Group | title = What is &amp;quot;quality of evidence&amp;quot; and why is it important to clinicians? | journal = BMJ | volume = 336 | issue = 7651 | pages = 995–8 |year = 2008 | doi = 10.1136/bmj.39490.551019.BE | pmc = 2364804 | pmid = 18456631 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* For issues involving &amp;quot;Therapy/Prevention, Aetiology/Harm&amp;quot;, the [[Oxford Centre for Evidence-based Medicine]] as of 2011 defined &amp;quot;Level 1a&amp;quot; evidence as a systematic review of RCTs that are consistent with each other, and &amp;quot;Level 1b&amp;quot; evidence as an &amp;quot;individual RCT (with narrow [[Confidence Interval]]).&amp;quot;&amp;lt;ref&amp;gt;{{cite web |url= http://www.cebm.net/index.aspx?o=1025 |title= Levels of evidence |author= Oxford Centre for Evidence-based Medicine |date=2011-09-16 |access-date=2012-02-15}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Notable RCTs with unexpected results that contributed to changes in clinical practice include:&lt;br /&gt;
* After [[Food and Drug Administration]] approval, the [[antiarrhythmic agents]] [[flecainide]] and [[encainide]] came to market in 1986 and 1987 respectively.&amp;lt;ref name=&amp;quot;Anderson-1997&amp;quot;&amp;gt;{{Cite journal |vauthors=Anderson JL, Pratt CM, Waldo AL, Karagounis LA | title = Impact of the Food and Drug Administration approval of flecainide and encainide on coronary artery disease mortality: putting &amp;quot;Deadly Medicine&amp;quot; to the test | journal = Am J Cardiol | volume = 79 | issue = 1 | pages = 43–7 | year = 1997 | url = http://www.ajconline.org/article/S0002-9149%2896%2900673-X/abstract | pmid = 9024734 | doi = 10.1016/S0002-9149(96)00673-X }}&amp;lt;/ref&amp;gt; The non-randomized studies concerning the drugs were characterized as &amp;quot;glowing&amp;quot;,&amp;lt;ref name=&amp;quot;Rubin-2006&amp;quot;&amp;gt;{{cite news |title= In medicine, evidence can be confusing - deluged with studies, doctors try to sort out what works, what doesn't |author= Rubin R |url= https://www.usatoday.com/news/health/2006-10-15-medical-evidence-cover_x.htm |newspaper= USA Today |date= 2006-10-16 |access-date=2010-03-22}}&amp;lt;/ref&amp;gt; and their sales increased to a combined total of approximately 165,000 prescriptions per month in early 1989.&amp;lt;ref name=&amp;quot;Anderson-1997&amp;quot;/&amp;gt;  In that year, however, a preliminary report of an RCT concluded that the two drugs increased mortality.&amp;lt;ref name=&amp;quot;CAST-1989&amp;quot;&amp;gt;{{Cite journal | doi = 10.1056/NEJM198908103210629 | title = Preliminary report: effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction. The Cardiac Arrhythmia Suppression Trial (CAST) Investigators | journal = N Engl J Med | volume = 321 | issue = 6 | pages = 406–12 |year = 1989 | pmid = 2473403 | author1 = Cardiac Arrhythmia Suppression Trial (CAST) Investigators }}&amp;lt;/ref&amp;gt;  Sales of the drugs then decreased.&amp;lt;ref name=&amp;quot;Anderson-1997&amp;quot;/&amp;gt;&lt;br /&gt;
* Prior to 2002, based on observational studies, it was routine for physicians to prescribe hormone replacement therapy for post-menopausal women to prevent [[myocardial infarction]].&amp;lt;ref name=&amp;quot;Rubin-2006&amp;quot;/&amp;gt; In 2002 and 2004, however, published RCTs from the [[Women's Health Initiative]] claimed that women taking hormone replacement therapy with estrogen plus progestin had a higher rate of myocardial infarctions than women on a placebo, and that estrogen-only hormone replacement therapy caused no reduction in the incidence of coronary heart disease.&amp;lt;ref name=&amp;quot;Rossouw-2002&amp;quot;/&amp;gt;&amp;lt;ref name=&amp;quot;Anderson-2004&amp;quot;&amp;gt;{{Cite journal  |vauthors=Anderson GL, Limacher M, Assaf AR, Bassford T, Beresford SA, Black H, etal | title = Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women's Health Initiative randomized controlled trial | journal = JAMA | volume = 291 | issue = 14 | pages = 1701–12 | year = 2004 | doi = 10.1001/jama.291.14.1701 | pmid = 15082697 | doi-access = free }}&amp;lt;/ref&amp;gt;  Possible explanations for the discrepancy between the observational studies and the RCTs involved differences in methodology, in the hormone regimens used, and in the populations studied.&amp;lt;ref name=&amp;quot;Grodstein-2003&amp;quot;&amp;gt;{{Cite journal |vauthors=Grodstein F, Clarkson TB, Manson JE | title = Understanding the divergent data on postmenopausal hormone therapy | journal = N Engl J Med | volume = 348 | issue = 7 | pages = 645–50 | year = 2003 | doi = 10.1056/NEJMsb022365 | pmid = 12584376 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Vandenbroucke-2009&amp;quot;&amp;gt;{{Cite journal | author = Vandenbroucke JP | title = The HRT controversy: observational studies and RCTs fall in line | journal = Lancet | volume = 373 | issue = 9671 | pages = 1233–5 | year = 2009 | doi = 10.1016/S0140-6736(09)60708-X | pmid = 19362661 | s2cid = 44991220 }}&amp;lt;/ref&amp;gt; The use of hormone replacement therapy decreased after publication of the RCTs.&amp;lt;ref name=&amp;quot;Hsu-2009&amp;quot;&amp;gt;{{Cite journal |vauthors=Hsu A, Card A, Lin SX, Mota S, Carrasquillo O, Moran A | title = Changes in postmenopausal hormone replacement therapy use among women with high cardiovascular risk | journal = Am J Public Health | volume = 99 | issue = 12 | pages = 2184–7 | year = 2009 | doi = 10.2105/AJPH.2009.159889 | url = http://ajph.aphapublications.org/cgi/content/full/99/12/2184 | pmid = 19833984 | pmc=2775780}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
== Disadvantages ==&lt;br /&gt;
&lt;br /&gt;
Many papers discuss the disadvantages of RCTs.&amp;lt;ref name=&amp;quot;Black-1996&amp;quot;&amp;gt;{{Cite journal | author = Black N | title = Why we need observational studies to evaluate the effectiveness of health care | journal = BMJ | volume = 312 | issue = 7040 | pages = 1215–8 | year = 1996 | pmid = 8634569 | pmc = 2350940 | doi=10.1136/bmj.312.7040.1215}}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Bell &amp;amp; Peck-2012&amp;quot;&amp;gt;{{Cite journal | author = Bell, S.H., &amp;amp; Peck, L.R. | title = Obstacles to and limitations of social experiments: 15 false alarms | journal = Abt Thought Leadership Paper Series | year = 2012 | url = http://abtassociates.com/white-papers/2012/obstacles-to-and-limitations-of-social-experiments.aspx }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Sanson-Fisher-2007&amp;quot;&amp;gt;{{Cite journal |vauthors=Sanson-Fisher RW, Bonevski B, Green LW, D'Este C | title = Limitations of the randomized controlled trial in evaluating population-based health interventions | journal = Am J Prev Med | volume = 33 | issue = 2 | pages = 155–61 | year = 2007 | doi = 10.1016/j.amepre.2007.04.007 | url = http://www.ajpm-online.net/article/S0749-3797%2807%2900225-5/abstract | pmid = 17673104 }}&amp;lt;/ref&amp;gt;   Among the most frequently cited drawbacks are:&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
=== Time and costs ===&lt;br /&gt;
&lt;br /&gt;
RCTs can be expensive;&amp;lt;ref name=&amp;quot;Sanson-Fisher-2007&amp;quot;/&amp;gt; one study found 28 [[Phase III clinical trials|Phase III]] RCTs funded by the [[National Institute of Neurological Disorders and Stroke]] prior to 2000 with a total cost of US$335 million,&amp;lt;ref name=&amp;quot;Johnston-2006&amp;quot;&amp;gt;{{Cite journal |vauthors=Johnston SC, Rootenberg JD, Katrak S, Smith WS, Elkins JS | title = Effect of a US National Institutes of Health programme of clinical trials on public health and costs | journal = [[The Lancet|Lancet]] | volume = 367 | issue = 9519 | pages = 1319–27 | year = 2006 | doi = 10.1016/S0140-6736(06)68578-4 | url = http://www.chrp.org/pdf/HSR20070511.pdf | pmid = 16631910 | s2cid = 41035177 }}&amp;lt;/ref&amp;gt; for a [[mean]] cost of US$12 million per RCT.  Nevertheless, the [[return on investment]] of RCTs may be high, in that the same study projected that the 28 RCTs produced a &amp;quot;net benefit to society at 10-years&amp;quot; of 46 times the cost of the trials program, based on evaluating a [[quality-adjusted life year]] as equal to the prevailing mean [[per capita]] [[gross domestic product]].&amp;lt;ref name=&amp;quot;Johnston-2006&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
The conduct of an RCT takes several years until being published; thus, data is restricted from the medical community for long years and may be of less relevance at time of publication.&amp;lt;ref name=&amp;quot;CaseReport&amp;quot;&amp;gt;{{cite journal |vauthors=Yitschaky O, Yitschaky M, Zadik Y |title=Case report on trial: Do you, Doctor, swear to tell the truth, the whole truth and nothing but the truth? |journal=J Med Case Rep |volume=5 |issue=1 |page=179 |date=May 2011 |pmid=21569508 |url=http://www.jmedicalcasereports.com/content/pdf/1752-1947-5-179.pdf|doi=10.1186/1752-1947-5-179 |pmc=3113995}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
It is costly to maintain RCTs for the years or decades that would be ideal for evaluating some interventions.&amp;lt;ref name=&amp;quot;Black-1996&amp;quot;/&amp;gt;&amp;lt;ref name=&amp;quot;Sanson-Fisher-2007&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Interventions to prevent events that occur only infrequently (e.g., [[sudden infant death syndrome]]) and uncommon adverse outcomes (e.g., a rare side effect of a drug) would require RCTs with extremely large sample sizes and may, therefore, best be assessed by observational studies.&amp;lt;ref name=&amp;quot;Black-1996&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Due to the costs of running RCTs, these usually only inspect one variable or very few variables, rarely reflecting the full picture of a complicated medical situation; whereas the [[case report]], for example, can detail many aspects of the patient's [[medicine|medical]] situation (e.g. [[patient history]], [[physical examination]], [[diagnosis]], [[psychosocial]] aspects, follow up).&amp;lt;ref name=&amp;quot;CaseReport&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
=== Conflict of interest dangers ===&lt;br /&gt;
&lt;br /&gt;
A 2011 study done to disclose possible [[conflicts of interest]]s in underlying research studies used for medical meta-analyses reviewed 29 meta-analyses and found that conflicts of interests in the studies underlying the meta-analyses were rarely disclosed.  The 29 meta-analyses included 11 from general medicine journals; 15 from specialty medicine journals, and 3 from the [[Cochrane Collaboration|Cochrane]] Database of Systematic Reviews. The 29 meta-analyses reviewed an aggregate of 509 randomized controlled trials (RCTs). Of these, 318 RCTs reported funding sources with 219 (69%) industry funded. 132 of the 509 RCTs reported author conflict of interest disclosures, with 91 studies (69%) disclosing industry financial ties with one or more authors. The information was, however, seldom reflected in the meta-analyses. Only two (7%) reported RCT funding sources and none reported RCT author-industry ties. The authors concluded &amp;quot;without acknowledgment of COI due to industry funding or author industry financial ties from RCTs included in meta-analyses, readers' understanding and appraisal of the evidence from the meta-analysis may be compromised.&amp;quot;&amp;lt;ref&amp;gt;{{cite web|url=http://www.cochrane.org/news/blog/how-well-do-meta-analyses-disclose-conflicts-interests-underlying-research-studies |title=How Well Do Meta-Analyses Disclose Conflicts of Interests in Underlying Research Studies &amp;amp;#124; The Cochrane Collaboration |publisher=Cochrane.org |access-date=2011-08-19}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
A 2011 study done to disclose possible conflicts of interests in underlying research studies used for medical meta-analyses reviewed 29 meta-analyses and found that conflicts of interests in the studies underlying the meta-analyses were rarely disclosed. The 29 meta-analyses included 11 from general medicine journals; 15 from specialty medicine journals, and 3 from the Cochrane Database of Systematic Reviews. The 29 meta-analyses reviewed an aggregate of 509 randomized controlled trials (RCTs). Of these, 318 RCTs reported funding sources with 219 (69%) industry funded. 132 of the 509 RCTs reported author conflict of interest disclosures, with 91 studies (69%) disclosing industry financial ties with one or more authors. The information was, however, seldom reflected in the meta-analyses. Only two (7%) reported RCT funding sources and none reported RCT author-industry ties. The authors concluded &amp;quot;without acknowledgment of COI due to industry funding or author industry financial ties from RCTs included in meta-analyses, readers' understanding and appraisal of the evidence from the meta-analysis may be compromised.&amp;quot;[97]&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Some RCTs are fully or partly funded by the health care industry (e.g., the [[pharmaceutical industry]]) as opposed to government, nonprofit, or other sources. A systematic review published in 2003 found four 1986–2002 articles comparing industry-sponsored and nonindustry-sponsored RCTs, and in all the articles there was a correlation of industry sponsorship and positive study outcome.&amp;lt;ref name=&amp;quot;Bekelman-2003&amp;quot;&amp;gt;{{Cite journal |vauthors=Bekelman JE, Li Y, Gross CP | title = Scope and impact of financial conflicts of interest in biomedical research: a systematic review | journal = [[J Am Med Assoc]] | volume = 289 | issue = 4 | pages = 454–65 | year = 2003 | pmid = 12533125 | doi = 10.1001/jama.289.4.454 }}&amp;lt;/ref&amp;gt; A 2004 study of 1999–2001 RCTs published in leading medical and surgical journals determined that industry-funded RCTs &amp;quot;are more likely to be associated with statistically significant pro-industry findings.&amp;quot;&amp;lt;ref name=&amp;quot;Bhandari-2004&amp;quot;&amp;gt;{{Cite journal |vauthors=Bhandari M, Busse JW, Jackowski D, Montori VM, Schünemann H, Sprague S, Mears D, Schemitsch EH, Heels-Ansdell D, Devereaux PJ | title = Association between industry funding and statistically significant pro-industry findings in medical and surgical randomized trials | journal = [[Can Med Assoc J]] | volume = 170 | issue = 4 | pages = 477–80 | year = 2004 | url = http://ecmaj.com/cgi/content/full/170/4/477 | pmid = 14970094 | pmc = 332713 }}&amp;lt;/ref&amp;gt; These results have been mirrored in trials in surgery, where although industry funding did not affect the rate of trial discontinuation it was however associated with a lower odds of publication for completed trials.&amp;lt;ref name=&amp;quot;Chapman-2014&amp;quot;&amp;gt;{{Cite journal |vauthors=Chapman SJ, Shelton B, Mahmood H, Fitzgerald JE, Harrison EM, Bhangu A | title = Discontinuation and non-publication of surgical randomised controlled trials: observational study | journal = [[BMJ]] | volume = 349 | page = g6870| year = 2014 | pmid = 25491195 | pmc = 4260649 | doi=10.1136/bmj.g6870}}&amp;lt;/ref&amp;gt; One possible reason for the pro-industry results in industry-funded published RCTs is [[publication bias]].&amp;lt;ref name=&amp;quot;Bhandari-2004&amp;quot;/&amp;gt;  Other authors have cited the differing goals of academic and industry sponsored research as contributing to the difference. Commercial sponsors may be more focused on performing trials of drugs that have already shown promise in early stage trials, and on replicating previous positive results to fulfill regulatory requirements for drug approval.&amp;lt;ref&amp;gt;{{cite journal |vauthors=Ridker PM, Torres J |title=Reported outcomes in major cardiovascular clinical trials funded by for-profit and not-for-profit organizations: 2000-2005 |journal=JAMA |volume=295 |issue=19 |pages=2270–4 |year=2006 |pmid=16705108 |doi=10.1001/jama.295.19.2270 |doi-access=free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Some RCTs are fully or partly funded by the health care industry (e.g., the pharmaceutical industry) as opposed to government, nonprofit, or other sources. A systematic review published in 2003 found four 1986–2002 articles comparing industry-sponsored and nonindustry-sponsored RCTs, and in all the articles there was a correlation of industry sponsorship and positive study outcome. A 2004 study of 1999–2001 RCTs published in leading medical and surgical journals determined that industry-funded RCTs &amp;quot;are more likely to be associated with statistically significant pro-industry findings.&amp;quot; These results have been mirrored in trials in surgery, where although industry funding did not affect the rate of trial discontinuation it was however associated with a lower odds of publication for completed trials. One possible reason for the pro-industry results in industry-funded published RCTs is publication bias.&lt;br /&gt;
&lt;br /&gt;
有些 rct 完全或部分由医疗保健行业(如制药行业)资助，而不是政府、非营利组织或其他来源。2003年发表的一份系统综述研究报告发现，1986年至2002年间，有4篇文章比较了行业赞助和非行业赞助的 rct，在所有的文章中，行业赞助和正面研究结果之间存在相关性。2004年发表在主要医学和外科杂志上的一项关于1999-2001年的 rct 的研究表明，工业资助的 rct“更有可能与具有统计学意义的有利于工业的发现相关联。”这些结果已经反映在手术试验中，虽然行业资金并不影响试验中止率，但是与完成试验的发表机率较低相关。支持产业的结果在产业资助的已发表的研究报告中出现的一个可能的原因是出版偏见。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Category:Clinical research&lt;br /&gt;
&lt;br /&gt;
类别: 临床研究&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Category:Epidemiological study projects&lt;br /&gt;
&lt;br /&gt;
类别: 流行病学研究项目&lt;br /&gt;
&lt;br /&gt;
Category:Evidence-based practices&lt;br /&gt;
&lt;br /&gt;
类别: 循证做法&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Category:Design of experiments&lt;br /&gt;
&lt;br /&gt;
类别: 实验设计&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Category:Causal inference&lt;br /&gt;
&lt;br /&gt;
类别: 因果推理&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Category:Experiments&lt;br /&gt;
&lt;br /&gt;
分类: 实验&lt;br /&gt;
Category:Research methods&lt;br /&gt;
&lt;br /&gt;
分类: 研究方法&lt;br /&gt;
&lt;br /&gt;
&amp;lt;noinclude&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&amp;lt;small&amp;gt;This page was moved from [[wikipedia:en:Randomized controlled trial]]. Its edit history can be viewed at [[随机对照试验/edithistory]]&amp;lt;/small&amp;gt;&amp;lt;/noinclude&amp;gt;&lt;br /&gt;
&lt;br /&gt;
[[Category:待整理页面]]&lt;/div&gt;</summary>
		<author><name>李昊轩</name></author>
	</entry>
	<entry>
		<id>https://wiki.swarma.org/index.php?title=%E9%9A%8F%E6%9C%BA%E5%AF%B9%E7%85%A7%E8%AF%95%E9%AA%8C&amp;diff=24311</id>
		<title>随机对照试验</title>
		<link rel="alternate" type="text/html" href="https://wiki.swarma.org/index.php?title=%E9%9A%8F%E6%9C%BA%E5%AF%B9%E7%85%A7%E8%AF%95%E9%AA%8C&amp;diff=24311"/>
		<updated>2021-07-10T06:57:00Z</updated>

		<summary type="html">&lt;p&gt;李昊轩：/* Randomization */&lt;/p&gt;
&lt;hr /&gt;
&lt;div&gt;此词条暂由彩云小译翻译，翻译字数共2766，未经人工整理和审校，带来阅读不便，请见谅。&lt;br /&gt;
&lt;br /&gt;
{{Short description|Experimental method designed to reduce bias, typically accomplished by randomly allocating subjects to two or more groups, with one being a control group}}&lt;br /&gt;
&lt;br /&gt;
[[File:Flowchart of Phases of Parallel Randomized Trial - Modified from CONSORT 2010.png|thumb|upright=1.5|Flowchart of four phases (enrollment, allocation, intervention, follow-up, and data analysis) of a parallel randomized trial of two groups (in a controlled trial, one of the interventions serves as the control), modified from the CONSORT (Consolidated Standards of Reporting Trials) 2010 Statement&amp;lt;ref name=&amp;quot;Schulz-2010&amp;quot;&amp;gt;{{Cite journal | author = Schulz KF, Altman DG, ((Moher D; for the CONSORT Group)) | title = CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials | journal = [[Br Med J]] | volume = 340 | pages = c332 | year = 2010 | doi = 10.1136/bmj.c332 | pmid = 20332509 | pmc = 2844940 }}&amp;lt;/ref&amp;gt;|链接=Special:FilePath/Flowchart_of_Phases_of_Parallel_Randomized_Trial_-_Modified_from_CONSORT_2010.png]]&lt;br /&gt;
&lt;br /&gt;
[来源：图片] Flowchart of four phases (enrollment, allocation, intervention, follow-up, and data analysis) of a parallel randomized trial of two groups (in a controlled trial, one of the interventions serves as the control), modified from the CONSORT (Consolidated Standards of Reporting Trials) 2010 Statement.&lt;br /&gt;
&lt;br /&gt;
据修改的2010年CONSORT (综合报告试验标准)要求，流程图包括：两组平行随机试验分为登记、分配、干预、随访和数据分析四个阶段，在对照试验中，需要其中一项干预作为对照处理措施。 &lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
A '''randomized controlled trial''' (or '''randomized control trial''';&amp;lt;ref name=&amp;quot;Chalmers-1981&amp;quot;&amp;gt;{{Cite journal |vauthors=Chalmers TC, ((Smith H Jr)), Blackburn B, Silverman B, Schroeder B, Reitman D, Ambroz A | title = A method for assessing the quality of a randomized control trial | journal = [[Controlled Clinical Trials]] | volume = 2 | issue = 1 | pages = 31–49 | year = 1981 | doi = 10.1016/0197-2456(81)90056-8 | pmid = 7261638 }}&amp;lt;/ref&amp;gt; '''RCT''') is a type of ''[[scientific experiment]]'' (e.g. a ''[[clinical trial]]'') or ''intervention study'' (as opposed to ''[[observational study]]'') that aims to reduce certain sources of bias when testing the effectiveness of new treatments; this is accomplished by [[Random assignment|randomly allocating]] subjects to two or more groups, treating them differently, and then comparing them with respect to a measured response. One group—the experimental group—receives the intervention being assessed, while the other—usually called the control group—receives an alternative treatment, such as a [[placebo]] or no intervention. The groups are monitored under conditions of the trial design to determine the effectiveness of the experimental intervention, and efficacy is assessed in comparison to the control. &amp;lt;ref&amp;gt;{{cite web|url=https://www.nice.org.uk/glossary?letter=r|publisher=National Institute for Health and Care Excellence, London, UK|title=Randomised controlled trial|date=2019|access-date=3 June 2019}}&amp;lt;/ref&amp;gt; There may be more than one treatment group or more than one [[Treatment and control groups|control group]].&lt;br /&gt;
&lt;br /&gt;
A randomized controlled trial (or randomized control trial; RCT) is a type of scientific experiment (e.g. a clinical trial) or intervention study (as opposed to observational study) that aims to reduce certain sources of bias when testing the effectiveness of new treatments; this is accomplished by randomly allocating subjects to two or more groups, treating them differently, and then comparing them with respect to a measured response. One group—the experimental group—receives the intervention being assessed, while the other—usually called the control group—receives an alternative treatment, such as a placebo or no intervention. The groups are monitored under conditions of the trial design to determine the effectiveness of the experimental intervention, and efficacy is assessed in comparison to the control.  There may be more than one treatment group or more than one control group.&lt;br /&gt;
&lt;br /&gt;
随机对照试验(A randomized controlled trial, RCT)是一种科学实验(例如:临床试验)或干预研究(区别于观察性研究) ，其目的是在测试新治疗的有效性时减少某些偏倚来源。通过受试者随机分配到两个或两个以上的组，经过不同的处理，产生的效应再与一个有可控的处理效应相比较。即一组或多组(实验组)接受正在评估的干预措施，而另一组(通常称为对照组)接受替代治疗，如安慰剂或无干预措施。在试验设计的条件下对这些组进行监测，以确定实验干预的有效性，并与对照组进行疗效比较评估。当然这也包括一个以上的治疗组或一个以上的对照组。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
The trial may be [[blinded experiment|blinded]], meaning that information which may influence the participants is withheld until after the experiment is complete. A blind can be imposed on any participant of an experiment, including subjects, researchers, technicians, data analysts, and evaluators. Effective blinding may reduce or eliminate some sources of experimental [[bias]].&lt;br /&gt;
&lt;br /&gt;
The trial may be blinded, meaning that information which may influence the participants is withheld until after the experiment is complete. A blind can be imposed on any participant of an experiment, including subjects, researchers, technicians, data analysts, and evaluators. Effective blinding may reduce or eliminate some sources of experimental bias.&lt;br /&gt;
&lt;br /&gt;
试验可能采用了盲法，这意味着影响参与者的信息在试验完成后才会公布。试验的任何参与者，包括受试者、研究人员、技术人员、数据分析人员和评估人员，都可能被强加盲。有效的盲法可以减少或消除某些试验偏差的来源。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
The randomness in the assignment of subjects to groups reduces [[selection bias]] and allocation bias, balancing both known and unknown prognostic factors, in the assignment of treatments.&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;&amp;gt;{{Cite journal |vauthors=Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG | title = CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials | journal = [[Br Med J]] | volume = 340 | pages = c869 | year = 2010 | doi = 10.1136/bmj.c869 | pmid = 20332511 | pmc = 2844943 }}&amp;lt;/ref&amp;gt; Blinding reduces other forms of [[Observer-expectancy effect|experimenter and subject biases]].&lt;br /&gt;
&lt;br /&gt;
The randomness in the assignment of subjects to groups reduces selection bias and allocation bias, balancing both known and unknown prognostic factors, in the assignment of treatments. Blinding reduces other forms of experimenter and subject biases.&lt;br /&gt;
&lt;br /&gt;
在分配治疗方案时，受试者随机地被分配到不同组。这个随机化过程减少了选择偏差和分配偏差，平衡了已知和未知的预后因素。盲法减少了其他形式的实验者和主体偏见。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
A well-blinded RCT is often considered the [[Gold standard (test)|gold standard]] for [[clinical trial]]s. Blinded RCTs are commonly used to test the [[Efficacy#Medicine|efficacy]] of medical [[Health intervention|intervention]]s and may additionally provide information about adverse effects, such as [[adverse drug reactions|drug reactions]]. A randomized controlled trial can provide compelling evidence that the study treatment causes an effect on human health.&amp;lt;ref name=&amp;quot;hannan&amp;quot;&amp;gt;{{cite journal | vauthors = Hannan EL | title = Randomized clinical trials and observational studies: guidelines for assessing respective strengths and limitations | journal = JACC. Cardiovascular Interventions | volume = 1 | issue = 3 | pages = 211–7 | date = June 2008 | pmid = 19463302 | doi = 10.1016/j.jcin.2008.01.008 | doi-access = free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
A well-blinded RCT is often considered the gold standard for clinical trials. Blinded RCTs are commonly used to test the efficacy of medical interventions and may additionally provide information about adverse effects, such as drug reactions. A randomized controlled trial can provide compelling evidence that the study treatment causes an effect on human health.&lt;br /&gt;
&lt;br /&gt;
一个良好盲法的 RCT 通常被认为是临床试验的黄金标准。盲法随机对照试验通常用于检测医疗干预措施的效果，并且还可能提供关于药物反应等不良反应的信息。随机对照试验可以提供令人信服的证据，证明研究治疗对人类健康产生了影响。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
The terms &amp;quot;RCT&amp;quot; and &amp;quot;'''randomized trial'''&amp;quot; are sometimes used synonymously, but the latter term omits mention of controls and can therefore describe studies that compare multiple treatment groups with each other in the absence of a control group.&amp;lt;ref name=&amp;quot;Ranjith-2005&amp;quot;&amp;gt;{{Cite journal | author = Ranjith G | title = Interferon-α-induced depression: when a randomized trial is not a randomized controlled trial | journal = [[Psychother Psychosom]] | volume = 74 | issue = 6 | pages = 387; author reply 387–8 | year = 2005 | doi = 10.1159/000087787 | pmid = 16244516 | s2cid = 143644933 }}&amp;lt;/ref&amp;gt; Similarly, the [[initialism]] is sometimes expanded as &amp;quot;'''randomized clinical trial'''&amp;quot; or &amp;quot;'''randomized comparative trial'''&amp;quot;, leading to ambiguity in the [[scientific literature]].&amp;lt;ref name=&amp;quot;Peto-1976&amp;quot;&amp;gt;{{Cite journal |vauthors=Peto R, Pike MC, Armitage P, Breslow NE, Cox DR, Howard SV, Mantel N, McPherson K, Peto J, Smith PG | title = Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design | journal = [[Br J Cancer]] | volume = 34 | issue = 6 | pages = 585–612 | year = 1976 | pmc=2025229 | pmid = 795448 | doi = 10.1038/bjc.1976.220 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Peto-1977&amp;quot;&amp;gt;{{Cite journal |vauthors=Peto R, Pike MC, Armitage P, Breslow NE, Cox DR, Howard SV, Mantel N, McPherson K, Peto J, Smith PG | title = Design and analysis of randomized clinical trials requiring prolonged observation of each patient. II. Analysis and examples | journal = [[Br J Cancer]] | volume = 35 | issue = 1 | pages = 1–39 | year = 1977 | pmc=2025310 | pmid = 831755 | doi = 10.1038/bjc.1977.1 }}&amp;lt;/ref&amp;gt; Not all randomized clinical trials are randomized ''controlled'' trials (and some of them could never be, as in cases where controls would be impractical or unethical to institute). The term '''randomized controlled clinical trial''' is an alternative term used in [[clinical research]];&amp;lt;ref name=&amp;quot;Wollert-2004&amp;quot;&amp;gt;{{Cite journal |vauthors=Wollert KC, Meyer GP, Lotz J, Ringes-Lichtenberg S, Lippolt P, Breidenbach C, Fichtner S, Korte T, Hornig B, Messinger D, Arseniev L, Hertenstein B, Ganser A, Drexler H | title = Intracoronary autologous bone-marrow cell transfer after myocardial infarction: the BOOST randomised controlled clinical trial | journal = [[The Lancet|Lancet]] | volume = 364 | issue = 9429 | pages = 141–8 | year = 2004 | doi = 10.1016/S0140-6736(04)16626-9 | pmid = 15246726 | s2cid = 24361586 }}&amp;lt;/ref&amp;gt; however, RCTs are also employed in other research areas, including [[#In social science|many of the social sciences]].&lt;br /&gt;
&lt;br /&gt;
The terms &amp;quot;RCT&amp;quot; and &amp;quot;randomized trial&amp;quot; are sometimes used synonymously, but the latter term omits mention of controls and can therefore describe studies that compare multiple treatment groups with each other in the absence of a control group. Similarly, the initialism is sometimes expanded as &amp;quot;randomized clinical trial&amp;quot; or &amp;quot;randomized comparative trial&amp;quot;, leading to ambiguity in the scientific literature. Not all randomized clinical trials are randomized controlled trials (and some of them could never be, as in cases where controls would be impractical or unethical to institute). The term randomized controlled clinical trial is an alternative term used in clinical research; however, RCTs are also employed in other research areas, including many of the social sciences.&lt;br /&gt;
&lt;br /&gt;
“ RCT”和“随机试验”这两个术语有时被用作同义词，但后一个术语没有提到对照，因此可以描述在没有对照组的情况下相互比较多个治疗组的研究。科学文献中常有“随机临床试验”或“随机比较试验”这类引发歧义的术语。并非所有的随机临床试验都是随机对照试验(其中一些试验永远不可能成为随机对照试验，因为实施控制是不切实际或不道德的)。随机对照临床试验这个术语是临床研究中使用的另一个术语; 然而，随机对照临床试验也被用于其他研究领域，包括许多社会科学。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
{{toc limit}}&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
== History ==&lt;br /&gt;
&lt;br /&gt;
The first reported [[clinical trial]] was conducted by [[James Lind]] in 1747 to identify treatment for [[scurvy]].&amp;lt;ref&amp;gt;{{cite journal | pmc=1720613 | pmid=9059193 | volume=76 |issue = 1| title=James Lind (1716-94) of Edinburgh and the treatment of scurvy | date=January 1997 | author=Dunn PM | journal=Arch. Dis. Child. Fetal Neonatal Ed. | pages=F64–5 | doi=10.1136/fn.76.1.f64}}&amp;lt;/ref&amp;gt; [[Randomized experiment]]s appeared in [[experimental psychology|psychology]], where they were introduced by [[Charles Sanders Peirce]] and [[Joseph Jastrow]] in the 1880s,&amp;lt;ref&amp;gt;{{cite journal| author=[[Charles Sanders Peirce]] and [[Joseph Jastrow]]|year=1885|title=On Small Differences in Sensation| journal=Memoirs of the National Academy of Sciences|volume=3|pages=73–83|url=http://psychclassics.yorku.ca/Peirce/small-diffs.htm}} http://psychclassics.yorku.ca/Peirce/small-diffs.htm&amp;lt;/ref&amp;gt; and in [[school of education|education]].&amp;lt;ref&amp;gt;{{cite journal|doi=10.1086/354775|first=Ian|last=Hacking|author-link=Ian Hacking | title=Telepathy: Origins of Randomization in Experimental Design|journal=[[Isis (journal)|Isis]]|series=A Special Issue on Artifact and Experiment|volume=79|issue=3|date=September 1988 |pages=427–451|jstor=234674|mr=1013489|s2cid=52201011}}&amp;lt;/ref&amp;gt;&amp;lt;ref&amp;gt;{{cite journal|doi=10.1086/444032|author=Stephen M. Stigler|title=A Historical View of Statistical Concepts in Psychology and Educational Research| journal=American Journal of Education| volume=101|issue=1|date=November 1992|pages=60–70|s2cid=143685203|author-link=Stephen M. Stigler}}&amp;lt;/ref&amp;gt;&amp;lt;ref&amp;gt;{{cite journal|doi=10.1086/383850|author=Trudy Dehue|title=Deception, Efficiency, and Random Groups: Psychology and the Gradual Origination of the Random Group Design|journal=[[Isis (journal)|Isis]]|volume=88|issue=4|date=December 1997|pages=653–673|pmid=9519574|s2cid=23526321|url=https://pure.rug.nl/ws/files/71855616/237831.pdf}}&amp;lt;/ref&amp;gt; Later, in the early 20th century, randomized experiments appeared in agriculture, due to [[Jerzy Neyman]]&amp;lt;ref&amp;gt;Neyman, Jerzy. 1923 [1990]. &amp;quot;On the Application of Probability Theory to AgriculturalExperiments. Essay on Principles. Section 9.&amp;quot; ''Statistical Science'' 5 (4): 465–472. Trans. Dorota M. Dabrowska and Terence P. Speed.&amp;lt;/ref&amp;gt; and [[Ronald A. Fisher]]. Fisher's experimental research and his writings popularized randomized experiments.&amp;lt;ref name=&amp;quot;Conniffe&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
The first reported clinical trial was conducted by James Lind in 1747 to identify treatment for scurvy. Randomized experiments appeared in psychology, where they were introduced by Charles Sanders Peirce and Joseph Jastrow in the 1880s, and in education. Later, in the early 20th century, randomized experiments appeared in agriculture, due to Jerzy Neyman and Ronald A. Fisher. Fisher's experimental research and his writings popularized randomized experiments.&lt;br /&gt;
&lt;br /&gt;
据报道，1747年詹姆斯•林德进行了第一个临床试验，目的是确定治疗坏血病的方法。在19世纪80年代，查尔斯•桑德斯•皮尔士和约瑟夫 • 杰斯特罗在心理学和教育学领域引入随机实验。后来，在20世纪早期，奈曼和罗纳德•费希尔将随机实验引入农业研究。费希尔的实验研究和他的著作普及了随机实验。&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;The first published RCT in medicine appeared in the 1948 paper entitled &amp;quot;[[Streptomycin]] treatment of pulmonary [[tuberculosis]]&amp;quot;, which described a [[Medical Research Council (UK)|Medical Research Council]] investigation.&amp;lt;ref name=&amp;quot;MRC-1948&amp;quot;&amp;gt;{{Cite journal | author = Streptomycin in Tuberculosis Trials Committee | title = Streptomycin treatment of pulmonary tuberculosis. A Medical Research Council investigation| journal = [[Br Med J]] | volume = 2 | issue = 4582 | pages = 769–82 | year = 1948 | doi = 10.1136/bmj.2.4582.769 | pmid = 18890300 | pmc = 2091872 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Brown-1998&amp;quot;&amp;gt;{{cite news |title= Landmark study made research resistant to bias |author= Brown D |newspaper= [[Washington Post]] |date=1998-11-02 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Shikata-2006&amp;quot;&amp;gt;{{Cite journal |vauthors=Shikata S, Nakayama T, Noguchi Y, Taji Y, Yamagishi H | title = Comparison of effects in randomized controlled trials with observational studies in digestive surgery | journal = [[Ann Surg]] | volume = 244 | issue = 5 | pages = 668–76 | year = 2006 | doi = 10.1097/01.sla.0000225356.04304.bc | pmc=1856609 | pmid = 17060757 }}&amp;lt;/ref&amp;gt; One of the authors of that paper was [[Austin Bradford Hill]], who is credited as having conceived the modern RCT.&amp;lt;ref name=&amp;quot;Stolberg-2004&amp;quot;&amp;gt;{{Cite journal |vauthors=Stolberg HO, Norman G, Trop I | title = Randomized controlled trials | journal = [[Am J Roentgenol]] | volume = 183 | issue = 6 | pages = 1539–44 | year = 2004 | pmid = 15547188 | doi=10.2214/ajr.183.6.01831539}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;The first published RCT in medicine appeared in the 1948 paper entitled &amp;quot;Streptomycin treatment of pulmonary tuberculosis&amp;quot;, which described a Medical Research Council investigation. One of the authors of that paper was Austin Bradford Hill, who is credited as having conceived the modern RCT.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;医学上首次发表的随机对照试验出现在1948年题为“链霉素治疗肺结核”的论文中，这篇论文描述了医学研究理事会的一项调查。这篇论文的作者之一是奥斯汀•布拉德福德•希尔，他被认为是构想出现代 RCT 的人。 &lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;Trial design was further influenced by the large-scale [[International Studies of Infarct Survival|ISIS]] trials on [[heart attack]] treatments that were conducted in the 1980s.&amp;lt;ref&amp;gt;{{cite web| author1=Georgina Ferry |title= Peter Sleight Obituary |url=https://www.theguardian.com/society/2020/nov/02/peter-sleight-obituary |website=The Guardian |date=2 November 2020 |access-date=3 November 2020}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;Trial design was further influenced by the large-scale ISIS trials on heart attack treatments that were conducted in the 1980s.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;20世纪80年代进行的大规模 ISIS 心脏病治疗试验进一步影响了试验设计。&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;By the late 20th century, RCTs were recognized as the standard method for &amp;quot;rational therapeutics&amp;quot; in medicine.&amp;lt;ref name=&amp;quot;Meldrum-2000&amp;quot;&amp;gt;{{Cite journal | author = Meldrum ML | title = A brief history of the randomized controlled trial. From oranges and lemons to the gold standard | journal = [[Hematol Oncol Clin North Am]] | volume = 14 | issue = 4 | pages = 745–60, vii | year = 2000 | doi = 10.1016/S0889-8588(05)70309-9  | pmid = 10949771 | url = https://zenodo.org/record/1260107 }}&amp;lt;/ref&amp;gt;  As of 2004, more than 150,000 RCTs were in the [[Cochrane Library]].&amp;lt;ref name=&amp;quot;Stolberg-2004&amp;quot; /&amp;gt;  To improve the reporting of RCTs in the medical literature, an international group of scientists and editors published [[Consolidated Standards of Reporting Trials]] (CONSORT) Statements in 1996, 2001 and 2010, and these have become widely accepted.&amp;lt;ref name=&amp;quot;Schulz-2010&amp;quot; /&amp;gt;&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot; /&amp;gt; Randomization is the process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce the bias.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;By the late 20th century, RCTs were recognized as the standard method for &amp;quot;rational therapeutics&amp;quot; in medicine.  As of 2004, more than 150,000 RCTs were in the Cochrane Library. has been applied to RCTs, the ethics of RCTs have special considerations.  For one, it has been argued that equipoise itself is insufficient to justify RCTs.  For another, &amp;quot;collective equipoise&amp;quot; can conflict with a lack of personal equipoise (e.g., a personal belief that an intervention is effective).  Finally, Zelen's design, which has been used for some RCTs, randomizes subjects before they provide informed consent, which may be ethical for RCTs of screening and selected therapies, but is likely unethical &amp;quot;for most therapeutic trials.&amp;quot;&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;到20世纪后期，随机对照试验被公认为医学“合理疗法”的标准方法。截至2004年，美国 Cochrane图书馆有超过15万本随机对照试验。但是，随机对照试验的伦理问题具有特殊性。首先，有人认为平衡本身不足以证明随机对照试验的合理性。另一方面，“集体均势”可能与缺乏个人均势相冲突(例如，个人认为干预是有效的)。最后，Zelen 的设计，已经被用于一些随机试验，在受试者提供知情同意之前随机化，这对于筛选和选择性治疗的随机试验来说可能是合乎道德的，但是对于“大多数治疗试验”来说可能是不道德的。&lt;br /&gt;
&lt;br /&gt;
== Ethics ==&lt;br /&gt;
&lt;br /&gt;
Although subjects almost always provide [[informed consent]] for their participation in an RCT, studies since 1982 have documented that RCT subjects may believe that they are certain to receive treatment that is best for them personally; that is, they do not understand the difference between research and treatment.&amp;lt;ref name=&amp;quot;Appelbaum-1982&amp;quot;&amp;gt;{{Cite journal |vauthors=Appelbaum PS, Roth LH, Lidz C | title = The therapeutic misconception: informed consent in psychiatric research | journal = [[Int J Law Psychiatry]] | volume = 5 | issue = 3–4 | pages = 319–29 | year = 1982 | doi = 10.1016/0160-2527(82)90026-7 | pmid = 6135666 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Henderson-2007&amp;quot;&amp;gt;{{Cite journal |vauthors=Henderson GE, Churchill LR, Davis AM, Easter MM, Grady C, Joffe S, Kass N, King NM, Lidz CW, Miller FG, Nelson DK, Peppercorn J, Rothschild BB, Sankar P, Wilfond BS, Zimmer CR | title = Clinical trials and medical care: defining the therapeutic misconception | journal = [[PLoS Med]] | volume = 4 | issue = 11 | pages = e324 | year = 2007 | doi = 10.1371/journal.pmed.0040324 | pmid = 18044980 | pmc = 2082641 }}&amp;lt;/ref&amp;gt; Further research is necessary to determine the prevalence of and ways to address this &amp;quot;[[therapeutic misconception]]&amp;quot;.&amp;lt;ref name=&amp;quot;Henderson-2007&amp;quot; /&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Although subjects almost always provide informed consent for their participation in an RCT, studies since 1982 have documented that RCT subjects may believe that they are certain to receive treatment that is best for them personally; that is, they do not understand the difference between research and treatment. Further research is necessary to determine the prevalence of and ways to address this &amp;quot;therapeutic misconception&amp;quot;. For example, patients with terminal illness may join trials in the hope of being cured, even when treatments are unlikely to be successful.&lt;br /&gt;
&lt;br /&gt;
一般来说，受试者要为参加随机对照试验提交了知情同意书，但1982年以来的研究记录表明，随机对照试验的受试者可能认为他们肯定会接受对他们个人最好的治疗; 也就是说，他们不理解研究和治疗之间的区别。需要进一步研究，以确定这种”治疗性误解”的流行程度和解决方法。例如，患有晚期疾病的病人可能会加入临床试验，希望治愈，即使治疗不太可能成功的情况下也是如此。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
There are two processes involved in randomizing patients to different interventions. First is choosing a randomization procedure to generate an unpredictable sequence of allocations; this may be a simple random assignment of patients to any of the groups at equal probabilities, may be &amp;quot;restricted&amp;quot;, or may be &amp;quot;adaptive.&amp;quot; A second and more practical issue is allocation concealment, which refers to the stringent precautions taken to ensure that the group assignment of patients are not revealed prior to definitively allocating them to their respective groups. Non-random &amp;quot;systematic&amp;quot; methods of group assignment, such as alternating subjects between one group and the other, can cause &amp;quot;limitless contamination possibilities&amp;quot; and can cause a breach of allocation concealment.&lt;br /&gt;
&lt;br /&gt;
有两个过程涉及到随机化的病人接受到不同的干预。首先是选择一个随机化程序来生成一个不可预测的分配方式; 这可能是一个将病人简单的随机等概率分配到任何一个组，这一过程可能是“受限制的”，或者可能是“适应性的”。第二个更实际的问题是分配隐瞒，即采取严格的预防措施，以确保在将病人到各自的群体之前，不会透露病人的群体分配。非随机的“系统的”分配方法，例如在一组和另一组之间交换主题，可以造成“无限的污染概率”，并可能造成分配隐蔽性被破坏。&lt;br /&gt;
&lt;br /&gt;
=== Trial registration ===&lt;br /&gt;
&lt;br /&gt;
The treatment allocation is the desired proportion of patients in each treatment arm.&lt;br /&gt;
&lt;br /&gt;
治疗分配是指每个治疗机构中患者的期望比例。&lt;br /&gt;
&lt;br /&gt;
In 2004, the [http://www.icmje.org/ International Committee of Medical Journal Editors] (ICMJE) announced that all trials starting enrolment after July 1, 2005 must be registered prior to consideration for publication in one of the 12 member journals of the committee.&amp;lt;ref name=&amp;quot;pmid15356289&amp;quot;&amp;gt;{{cite journal  |vauthors=De Angelis C, Drazen JM, Frizelle FA, etal |title=Clinical trial registration: a statement from the International Committee of Medical Journal Editors |journal=The New England Journal of Medicine |volume=351 |issue=12 |pages=1250–1 |date=September 2004 |pmid=15356289 |doi=10.1056/NEJMe048225 }}&amp;lt;/ref&amp;gt; However, trial registration may still occur late or not at all.&amp;lt;ref name=&amp;quot;pmid22147862&amp;quot;&amp;gt;{{cite journal|vauthors=Law MR, Kawasumi Y, Morgan SG | title=Despite law, fewer than one in eight completed studies of drugs and biologics are reported on time on ClinicalTrials.gov. | journal=Health Aff (Millwood) | year= 2011 | volume= 30 | issue= 12 | pages= 2338–45 | doi=10.1377/hlthaff.2011.0172 | pmid=22147862  | doi-access=free }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;pmid19724045&amp;quot;&amp;gt;{{cite journal|vauthors=Mathieu S, Boutron I, Moher D, Altman DG, Ravaud P | title=Comparison of registered and published primary outcomes in randomized controlled trials. | journal=JAMA | year= 2009 | volume= 302 | issue= 9 | pages= 977–84 | doi=10.1001/jama.2009.1242 | pmid=19724045  | doi-access=free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
In 2004, the [http://www.icmje.org/ International Committee of Medical Journal Editors] (ICMJE) announced that all trials starting enrolment after July 1, 2005 must be registered prior to consideration for publication in one of the 12 member journals of the committee. However, trial registration may still occur late or not at all.&lt;br /&gt;
&lt;br /&gt;
2004年， 医学杂志编辑国际委员会(ICMJE)宣布，所有在2005年7月1日之后考虑在该委员会12种杂志上发表之前，必须对试验进行注册。尽管如此，试验登记可能仍然延迟或根本不会发生。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Medical journals have been slow in adapting policies requiring mandatory clinical trial registration as a prerequisite for publication.&amp;lt;ref&amp;gt;{{cite journal|last1=Bhaumik|first1=S|title=Editorial policies of MEDLINE indexed Indian journals on clinical trial registration.|journal=Indian Pediatr.|date=Mar 2013|volume=50|issue=3|pages=339–40|pmid=23680610|doi=10.1007/s13312-013-0092-2|s2cid=40317464}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Medical journals have been slow in adapting policies requiring mandatory clinical trial registration as a prerequisite for publication.&lt;br /&gt;
&lt;br /&gt;
医学期刊将强制性临床试验登记作为发表的先决条件进展缓慢。&lt;br /&gt;
&lt;br /&gt;
== Classifications ==&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
=== By study design ===&lt;br /&gt;
&lt;br /&gt;
One way to classify RCTs is by [[study design]].  From most to least common in the healthcare literature, the major categories of RCT study designs are:&amp;lt;ref name=&amp;quot;Hopewell-2010&amp;quot;&amp;gt;{{Cite journal |vauthors=Hopewell S, Dutton S, Yu LM, Chan AW, Altman DG | title = The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed | journal = BMJ | volume = 340 | pages = c723 | year = 2010 | doi = 10.1136/bmj.c723  | pmid = 20332510 | pmc = 2844941 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
通过研究设计对 RCT 进行分类。从最常见到最不常见，RCT 研究设计的主要类别是&lt;br /&gt;
&lt;br /&gt;
* [[Parallel study|Parallel-group]] – each participant is randomly assigned to a group, and all the participants in the group receive (or do not receive) an intervention.&amp;lt;ref&amp;gt;{{cite journal |last1=Kaiser |first1=Joerg |last2=Niesen |first2=Willem |last3=Probst |first3=Pascal |last4=Bruckner |first4=Thomas |last5=Doerr-Harim |first5=Colette |last6=Strobel |first6=Oliver |last7=Knebel |first7=Phillip |last8=Diener |first8=Markus K. |last9=Mihaljevic |first9=André L. |last10=Büchler |first10=Markus W. |last11=Hackert |first11=Thilo |title=Abdominal drainage versus no drainage after distal pancreatectomy: study protocol for a randomized controlled trial |journal=Trials |date=7 June 2019 |volume=20 |issue=1 |page=332 |doi=10.1186/s13063-019-3442-0|pmid=31174583 |pmc=6555976 |doi-access=free }}&amp;lt;/ref&amp;gt;&amp;lt;ref&amp;gt;{{cite journal |last1=Farag |first1=Sara M. |last2=Mohammed |first2=Manal O. |last3=EL-Sobky |first3=Tamer A. |last4=ElKadery |first4=Nadia A. |last5=ElZohiery |first5=Abeer K. |title=Botulinum Toxin A Injection in Treatment of Upper Limb Spasticity in Children with Cerebral Palsy: A Systematic Review of Randomized Controlled Trials |journal=JBJS Reviews |date=March 2020 |volume=8 |issue=3 |pages=e0119 |doi=10.2106/JBJS.RVW.19.00119 |pmid=32224633|pmc=7161716 |doi-access=free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* 平行试验：每个参与者被随机分配到一个组，组中的所有参与者都接受(或不接受)干预。&lt;br /&gt;
&lt;br /&gt;
* [[Crossover study|Crossover]] – over time, each participant receives (or does not receive) an intervention in a random sequence.&amp;lt;ref&amp;gt;{{cite book  | last = Jones | first = Byron |author2=Kenward, Michael G.  | title = Design and Analysis of Cross-Over Trials | edition=Second| publisher = London: Chapman and Hall | year = 2003 }}&amp;lt;/ref&amp;gt;&amp;lt;ref&amp;gt;{{cite book  | last = Vonesh | first = Edward F. |author2=Chinchilli, Vernon G.  | chapter=Crossover Experiments| pages=111–202|title = Linear and Nonlinear Models for the Analysis of Repeated Measurements | publisher = London: Chapman and Hall | year = 1997 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* 交叉试验：随着时间的推移，每个参与者都会接受(或不接受)随机序列的干预。&lt;br /&gt;
&lt;br /&gt;
* [[Cluster randomised controlled trial|Cluster]] – pre-existing groups of participants (e.g., villages, schools) are randomly selected to receive (or not receive) an intervention.&amp;lt;ref&amp;gt;{{cite journal |last1=Gall |first1=Stefanie |last2=Adams |first2=Larissa |last3=Joubert |first3=Nandi |last4=Ludyga |first4=Sebastian |last5=Müller |first5=Ivan |last6=Nqweniso |first6=Siphesihle |last7=Pühse |first7=Uwe |last8=du Randt |first8=Rosa |last9=Seelig |first9=Harald |last10=Smith |first10=Danielle |last11=Steinmann |first11=Peter |last12=Utzinger |first12=Jürg |last13=Walter |first13=Cheryl |last14=Gerber |first14=Markus |last15=van Wouwe |first15=Jacobus P. |title=Effect of a 20-week physical activity intervention on selective attention and academic performance in children living in disadvantaged neighborhoods: A cluster randomized control trial |journal=PLOS ONE |date=8 November 2018 |volume=13 |issue=11 |pages=e0206908 |doi=10.1371/journal.pone.0206908 |pmid=30408073|pmc=6224098 |bibcode=2018PLoSO..1306908G |doi-access=free }}&amp;lt;/ref&amp;gt;&amp;lt;ref&amp;gt;{{cite journal |last1=Gladstone |first1=Melissa J. |last2=Chandna |first2=Jaya |last3=Kandawasvika |first3=Gwendoline |last4=Ntozini |first4=Robert |last5=Majo |first5=Florence D. |last6=Tavengwa |first6=Naume V. |last7=Mbuya |first7=Mduduzi N. N. |last8=Mangwadu |first8=Goldberg T. |last9=Chigumira |first9=Ancikaria |last10=Chasokela |first10=Cynthia M. |last11=Moulton |first11=Lawrence H. |last12=Stoltzfus |first12=Rebecca J. |last13=Humphrey |first13=Jean H. |last14=Prendergast |first14=Andrew J. |last15=Tumwine |first15=James K. |title=Independent and combined effects of improved water, sanitation, and hygiene (WASH) and improved complementary feeding on early neurodevelopment among children born to HIV-negative mothers in rural Zimbabwe: Substudy of a cluster-randomized trial |journal=PLOS Medicine |date=21 March 2019 |volume=16 |issue=3 |pages=e1002766 |doi=10.1371/journal.pmed.1002766|pmid=30897095 |pmc=6428259 |doi-access=free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* 聚类试验：预先存在的参与者组(例如，村庄、学校)被随机选择以接受(或不接受)干预。&lt;br /&gt;
&lt;br /&gt;
* [[Factorial experiment|Factorial]] – each participant is randomly assigned to a group that receives a particular combination of interventions or non-interventions (e.g., group 1 receives vitamin X and vitamin Y, group 2 receives vitamin X and placebo Y, group 3 receives placebo X and vitamin Y, and group 4 receives placebo X and placebo Y).&lt;br /&gt;
* 因子试验：每个参与者被随机分配到一个接受干预或非干预特定组合的组(例如，第1组接受维生素X和维生素Y，第2组接受维生素X和安慰剂Y，第3组接受安慰剂X和维生素Y，第4组接受安慰剂X和安慰剂Y)。&lt;br /&gt;
&lt;br /&gt;
An analysis of the 616 RCTs indexed in [[PubMed]] during December 2006 found that 78% were parallel-group trials, 16% were crossover, 2% were split-body, 2% were cluster, and 2% were factorial.&amp;lt;ref name=&amp;quot;Hopewell-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
An analysis of the 616 RCTs indexed in PubMed during December 2006 found that 78% were parallel-group trials, 16% were crossover, 2% were split-body, 2% were cluster, and 2% were factorial. &lt;br /&gt;
&lt;br /&gt;
对2006年12月在 PubMed 收录的616例随机对照试验的分析发现，78% 为平行组试验，16% 为交叉组试验，2% 为分体组试验，2% 为聚类组试验，2% 为因子组试验。&lt;br /&gt;
&lt;br /&gt;
To balance group sizes in smaller RCTs, some form of &amp;quot;restricted&amp;quot; randomization is recommended.&lt;br /&gt;
&lt;br /&gt;
为了在较小的随机对照试验中平衡组的大小，建议采用某种形式的“受限”随机化。&lt;br /&gt;
&lt;br /&gt;
=== By outcome of interest (efficacy vs. effectiveness) ===&lt;br /&gt;
&lt;br /&gt;
{{Main|Pragmatic clinical trial}}&lt;br /&gt;
&lt;br /&gt;
RCTs can be classified as &amp;quot;explanatory&amp;quot; or &amp;quot;pragmatic.&amp;quot;&amp;lt;ref name=&amp;quot;Zwarenstein-2008&amp;quot;&amp;gt;{{Cite journal | author = Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D; CONSORT group; Pragmatic Trials in Healthcare (Practihc) group | title = Improving the reporting of pragmatic trials: an extension of the CONSORT statement | journal = BMJ | volume = 337 | pages = a2390 | year = 2008 | doi = 10.1136/bmj.a2390 | pmid = 19001484 | pmc=3266844}}&amp;lt;/ref&amp;gt; Explanatory RCTs test [[Efficacy#Medicine|efficacy]] in a research setting with highly selected participants and under highly controlled conditions.&amp;lt;ref name=&amp;quot;Zwarenstein-2008&amp;quot;/&amp;gt; In contrast, pragmatic RCTs (pRCTs) test [[Effectiveness#Usage|effectiveness]] in everyday practice with relatively unselected participants and under flexible conditions; in this way, pragmatic RCTs can &amp;quot;inform decisions about practice.&amp;quot;&amp;lt;ref name=&amp;quot;Zwarenstein-2008&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
RCTs can be classified as &amp;quot;explanatory&amp;quot; or &amp;quot;pragmatic.&amp;quot; Explanatory RCTs test efficacy in a research setting with highly selected participants and under highly controlled conditions. In contrast, pragmatic RCTs (pRCTs) test effectiveness in everyday practice with relatively unselected participants and under flexible conditions; in this way, pragmatic RCTs can &amp;quot;inform decisions about practice.&amp;quot;&lt;br /&gt;
&lt;br /&gt;
随机对照试验可分为“解释性”或“实用性”。解释性随机对照试验在高度选定的参与者和高度受控的条件下测试有效性。相比之下，实用性随机对照测验(pragmatic RCTs, pRCT)在相对未经选择的参与者和灵活的条件下，在日常实践中检验有效性，这样，实用随机对照测验可以“为实践决策提供信息”。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
=== By hypothesis (superiority vs. noninferiority vs. equivalence) ===&lt;br /&gt;
&lt;br /&gt;
Another classification of RCTs categorizes them as &amp;quot;superiority trials&amp;quot;, &amp;quot;noninferiority trials&amp;quot;, and &amp;quot;equivalence trials&amp;quot;, which differ in methodology and reporting.&amp;lt;ref name=&amp;quot;Piaggio-2006&amp;quot;&amp;gt;{{Cite journal | author = Piaggio G, Elbourne DR, [[Doug Altman|Altman DG]], [[Stuart Pocock|Pocock SJ]], Evans SJ; CONSORT Group | title = Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement | journal = JAMA | volume = 295 | issue = 10 | pages = 1152–60 |  year = 2006 | doi = 10.1001/jama.295.10.1152 | pmid = 16522836 | url = http://researchonline.lshtm.ac.uk/12069/1/Reporting%20of%20Noninferiority%20and%20Equivalence%20Randomized%20Trials.pdf }}&amp;lt;/ref&amp;gt; Most RCTs are superiority trials, in which one intervention is hypothesized to be superior to another in a [[Statistical significance|statistically significant]] way.&amp;lt;ref name=&amp;quot;Piaggio-2006&amp;quot;/&amp;gt; Some RCTs are noninferiority trials &amp;quot;to determine whether a new treatment is no worse than a reference treatment.&amp;quot;&amp;lt;ref name=&amp;quot;Piaggio-2006&amp;quot;/&amp;gt; Other RCTs are equivalence trials in which the hypothesis is that two interventions are indistinguishable from each other.&amp;lt;ref name=&amp;quot;Piaggio-2006&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Another classification of RCTs categorizes them as &amp;quot;superiority trials&amp;quot;, &amp;quot;noninferiority trials&amp;quot;, and &amp;quot;equivalence trials&amp;quot;, which differ in methodology and reporting. Most RCTs are superiority trials, in which one intervention is hypothesized to be superior to another in a statistically significant way. Some RCTs are noninferiority trials &amp;quot;to determine whether a new treatment is no worse than a reference treatment.&amp;quot; Other RCTs are equivalence trials in which the hypothesis is that two interventions are indistinguishable from each other.&lt;br /&gt;
&lt;br /&gt;
随机对照试验的另一种分类是“优越性试验”、“非劣性试验”和“等效性试验”，它们在方法和报告上有所不同。大多数随机对照试验都是优势试验，其中一种干预措施被假设在统计学意义上优于另一种干预措施。一些随机对照试验是非劣效性试验，“以确定一种新的治疗方法是否比一种参考治疗方法更差。”其他随机对照试验是等效试验，其中的假设是两种干预措施彼此不可区分。&lt;br /&gt;
&lt;br /&gt;
== Randomization ==&lt;br /&gt;
&lt;br /&gt;
The advantages of proper [[randomized experiment|randomization]] in RCTs include:&amp;lt;ref name=&amp;quot;SchulzGrimes2002&amp;quot;&amp;gt;{{Cite journal |vauthors=Schulz KF, Grimes DA | title = Generation of allocation sequences in randomised trials: chance, not choice | journal = Lancet | volume = 359 | issue = 9305 | pages = 515–9 | year = 2002 | doi = 10.1016/S0140-6736(02)07683-3 | url =https://www.who.int/entity/rhl/LANCET_515-519.pdf | pmid = 11853818 | s2cid = 291300 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
* &amp;quot;It eliminates bias in treatment assignment,&amp;quot; specifically [[selection bias]] and [[confounding]].&lt;br /&gt;
&lt;br /&gt;
* &amp;quot;It facilitates blinding (masking) of the identity of treatments from investigators, participants, and assessors.&amp;quot;&lt;br /&gt;
&lt;br /&gt;
* &amp;quot;It permits the use of probability theory to express the likelihood that any difference in outcome between treatment groups merely indicates chance.&amp;quot;&lt;br /&gt;
&lt;br /&gt;
An RCT may be blinded, (also called &amp;quot;masked&amp;quot;) by &amp;quot;procedures that prevent study participants, caregivers, or outcome assessors from knowing which intervention was received.&amp;quot;  The 2010 CONSORT Statement specifies that authors and editors should not use the terms &amp;quot;single-blind&amp;quot;, &amp;quot;double-blind&amp;quot;, and &amp;quot;triple-blind&amp;quot;; instead, reports of blinded RCT should discuss &amp;quot;If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how.&amp;quot; &amp;quot;open&amp;quot;, or (if the intervention is a medication) &amp;quot;open-label&amp;quot;. In 2008 a study concluded that the results of unblinded RCTs tended to be biased toward beneficial effects only if the RCTs' outcomes were subjective as opposed to objective; In pragmatic RCTs, although the participants and providers are often unblinded, it is &amp;quot;still desirable and often possible to blind the assessor or obtain an objective source of data for evaluation of outcomes.&amp;quot;) and other methods can be used.&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
随机对照试验中适当随机化的优点包括：&lt;br /&gt;
* 它消除了治疗分配中的偏差，特别是选择偏差和混淆。&lt;br /&gt;
&lt;br /&gt;
* 它便于调查人员、参与者和评估人员对治疗人群的身份进行遮蔽。&lt;br /&gt;
&lt;br /&gt;
* 它允许使用概率理论来表达这样一种可能性，即治疗组之间结果的任何差异仅仅表明是偶然性的。&lt;br /&gt;
&lt;br /&gt;
一项RCT的盲法是指阻止研究参与者、照顾者或结果评估者知道哪些干预措施，这一程序也称“蒙面”。2010年CONSORT 声明明确指出，作者和编辑不应使用”单盲”、”双盲”和”三盲”等术语；相反，关于盲法 RCT 的报告应讨论”如果完成了，干预分配后谁被“蒙面”了(例如，参与者、护理提供者、评估结果的人员)以及如何完成”“开放”，或者(如果干预是一种药物)“开放标签”。2008年的一项研究得出结论认为，只有当随机对照试验的结果是主观的而不是客观的时候，非盲法随机对照试验的结果往往偏向于有益的结果；在实用的随机对照试验中，尽管参与者和提供者往往是非盲的，但是”仍然需要并且往往可能使评估者“蒙面”，以获得评估结果的客观数据来源”以及其他方法。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
There are two processes involved in randomizing patients to different interventions. First is choosing a ''randomization procedure'' to generate an unpredictable sequence of allocations; this may be a simple random assignment of patients to any of the groups at equal probabilities, may be &amp;quot;restricted&amp;quot;, or may be &amp;quot;adaptive.&amp;quot; A second and more practical issue is ''allocation concealment'', which refers to the stringent precautions taken to ensure that the group assignment of patients are not revealed prior to definitively allocating them to their respective groups. Non-random &amp;quot;systematic&amp;quot; methods of group assignment, such as alternating subjects between one group and the other, can cause &amp;quot;limitless contamination possibilities&amp;quot; and can cause a breach of allocation concealment.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
将患者随机分配到不同的干预措施中涉及两个过程。首先是选择一个随机化程序来生成一个不可预测的分配序列；这可能是以相等的概率将患者随机分配到任何一组，可能是“受限的”，也可能是“适应性的”。第二个也是更实际的问题是隐藏分配，这是指在将患者明确分配到各自的组之前，采取严格的预防措施，以确保患者的组分配不被披露。非随机的“系统”组分配方法，如在一个组和另一个组之间交替患者，可能会造成“无限的污染可能性”，并可能导致分配隐藏的破坏。&lt;br /&gt;
&lt;br /&gt;
However empirical evidence that adequate randomization changes outcomes relative to inadequate randomization has been difficult to detect.&amp;lt;ref name=&amp;quot;Howick-2014&amp;quot;&amp;gt;{{Cite journal |vauthors=Howick J, Mebius A | title = In search of justification for the unpredictability paradox | journal = Trials | volume = 15 | pages = 480 | year = 2014 | doi = 10.1186/1745-6215-15-480 | pmid = 25490908 | pmc=4295227}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
然而，相对于不充分随机化，充分随机化改变结果的经验证据很难被发现。&lt;br /&gt;
&lt;br /&gt;
Regardless of the statistical methods used, important considerations in the analysis of RCT data include:&lt;br /&gt;
&lt;br /&gt;
无论使用何种统计方法，RCT 数据分析中的重要考虑因素包括:&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
=== Procedures ===&lt;br /&gt;
&lt;br /&gt;
The treatment allocation is the desired proportion of patients in each treatment arm.&lt;br /&gt;
&lt;br /&gt;
治疗分配是每个治疗组中患者的期望比例。&lt;br /&gt;
&lt;br /&gt;
An ideal randomization procedure would achieve the following goals:&amp;lt;ref name=&amp;quot;Lachin-1988a&amp;quot;&amp;gt;{{Cite journal | author = Lachin JM | title = Statistical properties of randomization in clinical trials | journal = [[Controlled Clinical Trials]] | volume = 9 | issue = 4 | pages = 289–311 | year = 1988 | pmid = 3060315 |  doi = 10.1016/0197-2456(88)90045-1 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
An ideal randomization procedure would achieve the following goals:&lt;br /&gt;
&lt;br /&gt;
一个理想的随机化程序将实现以下目标:&lt;br /&gt;
&lt;br /&gt;
Two studies published in The New England Journal of Medicine in 2000 found that observational studies and RCTs overall produced similar results. The authors of the 2000 findings questioned the belief that &amp;quot;observational studies should not be used for defining evidence-based medical care&amp;quot; and that RCTs' results are &amp;quot;evidence of the highest grade.&amp;quot;&lt;br /&gt;
&lt;br /&gt;
2000年发表在《新英格兰医学杂志》上的两项研究发现，观察性研究和随机对照试验总体产生了类似的结果。2000年研究结果的作者质疑“观察性研究不应该被用来定义循证医疗保健”的信念，以及随机对照试验的结果是“最高等级的证据”的观点。&lt;br /&gt;
&lt;br /&gt;
* '''Maximize [[statistical power]]''', especially in [[Subgroup analysis|subgroup analyses]].  Generally, equal group sizes maximize statistical power, however, unequal groups sizes may be more powerful for some analyses (e.g., multiple comparisons of placebo versus several doses using Dunnett's procedure&amp;lt;ref&amp;gt;{{cite web|last=Rosenberger|first=James|title=STAT 503 - Design of Experiments|url=https://onlinecourses.science.psu.edu/stat503/node/16|publisher=Pennsylvania State University|access-date=24 September 2012}}&amp;lt;/ref&amp;gt; ), and are sometimes desired for non-analytic reasons (e.g., patients may be more motivated to enroll if there is a higher chance of getting the test treatment, or regulatory agencies may require a minimum number of patients exposed to treatment).&amp;lt;ref name=&amp;quot;Avins-1998&amp;quot;&amp;gt;{{cite journal|last=Avins|first=A L|title=&amp;quot;Can unequal be more fair? Ethics, subject allocation, and randomized clinical trials&amp;quot;.|journal=J Med Ethics|year=1998|volume=24|pages=401–408|doi=10.1136/jme.24.6.401|issue=6|pmc=479141|pmid=9873981}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
* '''Minimize selection bias'''.  This may occur if investigators can consciously or unconsciously preferentially enroll patients between treatment arms.  A good randomization procedure will be unpredictable so that investigators cannot guess the next subject's group assignment based on prior treatment assignments. The risk of selection bias is highest when previous treatment assignments are known (as in unblinded studies) or can be guessed (perhaps if a drug has distinctive side effects).&lt;br /&gt;
&lt;br /&gt;
Two other lines of reasoning question RCTs' contribution to scientific knowledge beyond other types of studies:&lt;br /&gt;
&lt;br /&gt;
另外两条推理线索质疑 rct 对科学知识的贡献超越了其他类型的研究:&lt;br /&gt;
&lt;br /&gt;
* '''Minimize allocation bias''' (or '''confounding''').  This may occur when [[covariate]]s that affect the outcome are not equally distributed between treatment groups, and the treatment effect is confounded with the effect of the covariates (i.e., an &amp;quot;accidental bias&amp;quot;&amp;lt;ref name=&amp;quot;SchulzGrimes2002&amp;quot;/&amp;gt;&amp;lt;ref name=&amp;quot;Buyse-1989&amp;quot;&amp;gt;{{Cite journal | author = Buyse ME | title = Analysis of clinical trial outcomes: some comments on subgroup analyses | journal = [[Controlled Clinical Trials]] | volume = 10 | issue = 4 Suppl | pages = 187S–194S | year = 1989 | pmid = 2605967 |  doi = 10.1016/0197-2456(89)90057-3 }}&amp;lt;/ref&amp;gt;).  If the randomization procedure causes an imbalance in covariates related to the outcome across groups, estimates of effect may be [[bias of an estimator|biased]] if not adjusted for the covariates (which may be unmeasured and therefore impossible to adjust for).&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
However, no single randomization procedure meets those goals in every circumstance, so researchers must select a procedure for a given study based on its advantages and disadvantages.&lt;br /&gt;
&lt;br /&gt;
However, no single randomization procedure meets those goals in every circumstance, so researchers must select a procedure for a given study based on its advantages and disadvantages.&lt;br /&gt;
&lt;br /&gt;
然而，没有一个单一的随机化程序在每种情况下都能满足这些目标，因此研究人员必须根据其优点和缺点来选择一个给定的研究程序。&lt;br /&gt;
&lt;br /&gt;
==== Simple ====&lt;br /&gt;
&lt;br /&gt;
Like all statistical methods, RCTs are subject to both type I (&amp;quot;false positive&amp;quot;) and type II (&amp;quot;false negative&amp;quot;) statistical errors.  Regarding Type I errors, a typical RCT will use 0.05 (i.e., 1 in 20) as the probability that the RCT will falsely find two equally effective treatments significantly different. Regarding Type II errors, despite the publication of a 1978 paper noting that the sample sizes of many &amp;quot;negative&amp;quot; RCTs were too small to make definitive conclusions about the negative results, by 2005-2006 a sizeable proportion of RCTs still had inaccurate or incompletely reported sample size calculations.&lt;br /&gt;
&lt;br /&gt;
像所有的统计方法一样，rct 同时受到Ⅰ型(“假阳性”)和 II 型(“假阴性”)统计错误的影响。关于Ⅰ型错误，一个典型的 RCT 将使用0.05(即，1/20)作为 RCT 错误地发现两个同样有效的治疗方法显著不同的概率。关于第二类错误，尽管1978年发表的一篇论文指出，许多”负面”随机对照试验的样本量太小，无法对负面结果作出明确的结论，但到2005-2006年，相当大一部分随机对照试验的样本量计算仍然不准确或不完全。&lt;br /&gt;
&lt;br /&gt;
This is a commonly used and intuitive procedure, similar to &amp;quot;repeated fair coin-tossing.&amp;quot;&amp;lt;ref name=&amp;quot;SchulzGrimes2002&amp;quot;/&amp;gt; Also known as &amp;quot;complete&amp;quot; or &amp;quot;unrestricted&amp;quot; randomization, it is [[Robust statistics|robust]] against both selection and accidental biases. However, its main drawback is the possibility of imbalanced group sizes in small RCTs.  It is therefore recommended only for RCTs with over 200 subjects.&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;&amp;gt;{{Cite journal |vauthors=Lachin JM, Matts JP, Wei LJ | title = Randomization in clinical trials: conclusions and recommendations | journal = [[Controlled Clinical Trials]] | volume = 9 | issue = 4 | pages = 365–74 | year = 1988 | pmid = 3203526 |  doi = 10.1016/0197-2456(88)90049-9 | hdl = 2027.42/27041 | url = https://deepblue.lib.umich.edu/bitstream/2027.42/27041/1/0000029.pdf | hdl-access = free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
This is a commonly used and intuitive procedure, similar to &amp;quot;repeated fair coin-tossing.&amp;quot;&lt;br /&gt;
&lt;br /&gt;
这是一个常用且直观的过程，类似于“反复公平地掷硬币”&lt;br /&gt;
&lt;br /&gt;
==== Restricted ====&lt;br /&gt;
&lt;br /&gt;
To balance group sizes in smaller RCTs, some form of [[restricted randomization|&amp;quot;restricted&amp;quot; randomization]] is recommended.&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;/&amp;gt;  The major types of restricted randomization used in RCTs are:&lt;br /&gt;
&lt;br /&gt;
Peer review of results is an important part of the scientific method. Reviewers examine the study results for potential problems with design that could lead to unreliable results (for example by creating a systematic bias), evaluate the study in the context of related studies and other evidence, and evaluate whether the study can be reasonably considered to have proven its conclusions. To underscore the need for peer review and the danger of over-generalizing conclusions, two Boston-area medical researchers performed a randomized controlled trial in which they randomly assigned either a parachute or an empty backpack to 23 volunteers who jumped from either a biplane or a helicopter. The study was able to accurately report that parachutes fail to reduce injury compared to empty backpacks. The key context that limited the general applicability of this conclusion was that the aircraft were parked on the ground, and participants had only jumped about two feet.&lt;br /&gt;
&lt;br /&gt;
同行评议是科学方法的重要组成部分。审查人员检查研究结果是否存在设计方面的潜在问题，这些问题可能导致不可靠的结果(例如产生系统性偏差) ，在相关研究和其他证据的背景下评估研究，并评估是否可以合理地认为该研究已经证明了其结论。为了强调同行评议的必要性和过于笼统结论的危险性，波士顿地区的两名医学研究人员进行了一次随机对照试验测试，他们随机给23名从双翼飞机或直升机上跳下的志愿者分配一个降落伞或一个空背包。这项研究能够准确地报告，与空背包相比，降落伞无法减少伤害。限制这一结论普遍适用性的关键背景是飞机停在地面上，参与者只跳了大约两英尺。&lt;br /&gt;
&lt;br /&gt;
* '''[[Randomized block design|Permuted-block randomization]]''' or '''blocked randomization''': a &amp;quot;block size&amp;quot; and &amp;quot;allocation ratio&amp;quot; (number of subjects in one group versus the other group) are specified, and subjects are allocated randomly within each block.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt; For example, a block size of 6 and an allocation ratio of 2:1 would lead to random assignment of 4 subjects to one group and 2 to the other. This type of randomization can be combined with &amp;quot;[[stratified randomization]]&amp;quot;, for example by center in a [[multicenter trial]], to &amp;quot;ensure good balance of participant characteristics in each group.&amp;quot;&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt; A special case of permuted-block randomization is ''random allocation'', in which the entire sample is treated as one block.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt; The major disadvantage of permuted-block randomization is that even if the block sizes are large and randomly varied, the procedure can lead to selection bias.&amp;lt;ref name=&amp;quot;Lachin-1988a&amp;quot;/&amp;gt; Another disadvantage is that &amp;quot;proper&amp;quot; analysis of data from permuted-block-randomized RCTs requires stratification by blocks.&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
* '''Adaptive biased-coin randomization''' methods (of which '''urn randomization''' is the most widely known type): In these relatively uncommon methods, the probability of being assigned to a group decreases if the group is overrepresented and increases if the group is underrepresented.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt; The methods are thought to be less affected by selection bias than permuted-block randomization.&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
RCTs are considered to be the most reliable form of scientific evidence in the hierarchy of evidence that influences healthcare policy and practice because RCTs reduce spurious causality and bias. Results of RCTs may be combined in systematic reviews which are increasingly being used in the conduct of evidence-based practice. Some examples of scientific organizations' considering RCTs or systematic reviews of RCTs to be the highest-quality evidence available are:&lt;br /&gt;
&lt;br /&gt;
在影响医疗政策和实践的证据层次中，随机对照试验被认为是最可靠的科学证据形式，因为它减少了虚假的因果关系和偏差。随机对照试验的结果可以结合进行系统评价，这种评价正越来越多地用于循证实践的操作。一些科学组织认为区域研究报告或对区域研究报告的系统审查是现有的最高质量证据的例子如下:&lt;br /&gt;
&lt;br /&gt;
==== Adaptive ====&lt;br /&gt;
&lt;br /&gt;
At least two types of &amp;quot;adaptive&amp;quot; randomization procedures have been used in RCTs, but much less frequently than simple or restricted randomization:&lt;br /&gt;
&lt;br /&gt;
* '''Covariate-adaptive randomization''', of which one type is '''[[Minimisation (clinical trials)|minimization]]''': The probability of being assigned to a group varies in order to minimize &amp;quot;covariate imbalance.&amp;quot;&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;/&amp;gt; Minimization is reported to have &amp;quot;supporters and detractors&amp;quot;&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt; because only the first subject's group assignment is truly chosen at random, the method does not necessarily eliminate bias on unknown factors.&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
* '''Response-adaptive randomization''', also known as '''outcome-adaptive randomization''': The probability of being assigned to a group increases if the responses of the prior patients in the group were favorable.&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;/&amp;gt; Although arguments have been made that this approach is more ethical than other types of randomization when the probability that a treatment is effective or ineffective increases during the course of an RCT, ethicists have not yet studied the approach in detail.&amp;lt;ref name=&amp;quot;Rosenberger-1993&amp;quot;&amp;gt;{{Cite journal |vauthors=Rosenberger WF, Lachin JM | title = The use of response-adaptive designs in clinical trials | journal = [[Controlled Clinical Trials]] | volume = 14 | issue = 6 | pages = 471–84 | year = 1993 | pmid = 8119063 |  doi = 10.1016/0197-2456(93)90028-C }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Notable RCTs with unexpected results that contributed to changes in clinical practice include:&lt;br /&gt;
&lt;br /&gt;
值得注意的随机对照试验，其意想不到的结果促成了临床实践的改变，包括:&lt;br /&gt;
&lt;br /&gt;
=== Allocation concealment ===&lt;br /&gt;
&lt;br /&gt;
{{main|Allocation concealment}}&lt;br /&gt;
&lt;br /&gt;
&amp;quot;Allocation concealment&amp;quot; (defined as &amp;quot;the procedure for protecting the randomization process so that the treatment to be allocated is not known before the patient is entered into the study&amp;quot;) is important in RCTs.&amp;lt;ref name=&amp;quot;Forder-2005&amp;quot;&amp;gt;{{Cite journal |vauthors=Forder PM, Gebski VJ, Keech AC | title = Allocation concealment and blinding: when ignorance is bliss | journal = Med J Aust | volume = 182 | issue = 2 | pages = 87–9 | year = 2005 | url = http://www.mja.com.au/public/issues/182_02_170105/for10877_fm.html | pmid = 15651970 | doi = 10.5694/j.1326-5377.2005.tb06584.x | s2cid = 202149 }}&amp;lt;/ref&amp;gt; In practice, clinical investigators in RCTs often find it difficult to maintain impartiality. Stories abound of investigators holding up sealed envelopes to lights or ransacking offices to determine group assignments in order to dictate the assignment of their next patient.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;&amp;gt;{{Cite journal | title = Allocation concealment in randomised trials: defending against deciphering | journal = Lancet | volume = 359 | issue = 9306 | pages = 614–8 | year = 2002 | doi = 10.1016/S0140-6736(02)07750-4 | url =https://www.who.int/entity/rhl/LANCET_614-618.pdf | pmid = 11867132 |vauthors=Schulz KF, Grimes DA | s2cid = 12902486 }}&amp;lt;/ref&amp;gt; Such practices introduce selection bias and [[Lurking variable|confounders]] (both of which should be minimized by randomization), possibly distorting the results of the study.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt; Adequate allocation concealment should defeat patients and investigators from discovering treatment allocation once a study is underway and after the study has concluded.  Treatment related side-effects or adverse events may be specific enough to reveal allocation to investigators or patients thereby introducing bias or influencing any subjective parameters collected by investigators or requested from subjects.&lt;br /&gt;
&lt;br /&gt;
&amp;quot;Allocation concealment&amp;quot; (defined as &amp;quot;the procedure for protecting the randomization process so that the treatment to be allocated is not known before the patient is entered into the study&amp;quot;) is important in RCTs. In practice, clinical investigators in RCTs often find it difficult to maintain impartiality. Stories abound of investigators holding up sealed envelopes to lights or ransacking offices to determine group assignments in order to dictate the assignment of their next patient. Such practices introduce selection bias and confounders (both of which should be minimized by randomization), possibly distorting the results of the study. On the other hand, a 2008 study of 146 meta-analyses concluded that the results of RCTs with inadequate or unclear allocation concealment tended to be biased toward beneficial effects only if the RCTs' outcomes were subjective as opposed to objective.&lt;br /&gt;
&lt;br /&gt;
“分配隐藏”(定义为“保护随机化过程的程序，以便在病人进入研究之前不知道要分配的治疗”)在随机对照试验中很重要。在实践中，临床研究人员在随机对照试验中常常发现难以保持公正性。关于调查人员将密封的信封举到灯光下或者搜查办公室来决定团队任务，以便指定下一个病人的任务的故事比比皆是。这种做法引入了选择偏差和混杂因素(这两者都应该通过随机化来减少) ，可能会扭曲研究结果。另一方面，2008年的一项对146项元分析的研究得出结论，分配隐瞒不充分或不明确的随机对照试验的结果往往只有在随机对照试验的结果是主观的而不是客观的情况下才会偏向于有益的结果。&lt;br /&gt;
&lt;br /&gt;
Many papers discuss the disadvantages of RCTs.   Among the most frequently cited drawbacks are:&lt;br /&gt;
&lt;br /&gt;
许多论文讨论了 rct 的缺点。最常被提到的缺点是:&lt;br /&gt;
&lt;br /&gt;
Some standard methods of ensuring allocation concealment include sequentially numbered, opaque, sealed envelopes (SNOSE); sequentially numbered containers; pharmacy controlled randomization; and central randomization.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt; It is recommended that allocation concealment methods be included in an RCT's [[Clinical trial protocol|protocol]], and that the allocation concealment methods should be reported in detail in a publication of an RCT's results; however, a 2005 study determined that most RCTs have unclear allocation concealment in their protocols, in their publications, or both.&amp;lt;ref name=&amp;quot;Pildal-2005&amp;quot;&amp;gt;{{Cite journal |vauthors=Pildal J, Chan AW, Hróbjartsson A, Forfang E, Altman DG, Gøtzsche PC | title = Comparison of descriptions of allocation concealment in trial protocols and the published reports: cohort study | journal = BMJ | volume = 330 | issue = 7499 | page = 1049 | year = 2005 | doi = 10.1136/bmj.38414.422650.8F | pmid = 15817527 | pmc = 557221 }}&amp;lt;/ref&amp;gt; On the other hand, a 2008 study of 146 [[meta-analysis|meta-analyses]] concluded that the results of RCTs with inadequate or unclear allocation concealment tended to be biased toward beneficial effects only if the RCTs' outcomes were [[Subjectivity|subjective]] as opposed to [[Objectivity (philosophy)|objective]].&amp;lt;ref name=&amp;quot;Wood-2008&amp;quot;&amp;gt;{{Cite journal |vauthors=Wood L, Egger M, Gluud LL, Schulz KF, Jüni P, Altman DG, Gluud C, Martin RM, Wood AJ, Sterne JA | title = Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study | journal = BMJ | volume = 336 | issue = 7644 | pages = 601–5 | year = 2008 | doi = 10.1136/bmj.39465.451748.AD | pmid = 18316340 | pmc = 2267990 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Some standard methods of ensuring allocation concealment include sequentially numbered, opaque, sealed envelopes (SNOSE); sequentially numbered containers; pharmacy controlled randomization; and central randomization. It is recommended that allocation concealment methods be included in an RCT's protocol, and that the allocation concealment methods should be reported in detail in a publication of an RCT's results; however, a 2005 study determined that most RCTs have unclear allocation concealment in their protocols, in their publications, or both. On the other hand, a 2008 study of 146 meta-analyses concluded that the results of RCTs with inadequate or unclear allocation concealment tended to be biased toward beneficial effects only if the RCTs' outcomes were subjective as opposed to objective.&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
=== Sample size ===&lt;br /&gt;
&lt;br /&gt;
RCTs can be expensive; for a mean cost of US$12 million per RCT.  Nevertheless, the return on investment of RCTs may be high, in that the same study projected that the 28 RCTs produced a &amp;quot;net benefit to society at 10-years&amp;quot; of 46 times the cost of the trials program, based on evaluating a quality-adjusted life year as equal to the prevailing mean per capita gross domestic product.&lt;br /&gt;
&lt;br /&gt;
随机对照试验可能很昂贵，每次随机对照试验的平均成本为1200万美元。然而，随机对照试验的投资回报率可能很高，因为同一项研究预测，28个 随机对照试验 产生的“10年社会净效益”是试验项目成本的46倍，其基础是评估一个质量调整寿命年等于当前人均国内生产总值的平均值。&lt;br /&gt;
&lt;br /&gt;
{{Main|Sample size determination}}&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
It is costly to maintain RCTs for the years or decades that would be ideal for evaluating some interventions.&lt;br /&gt;
&lt;br /&gt;
有些随机对照试验需要持续几年或几十年，花费巨大，但这些试验对于评价某些干预措施是理想的。&lt;br /&gt;
The number of treatment units (subjects or groups of subjects) assigned to control and treatment groups, affects an RCT's reliability. If the effect of the treatment is small, the number of treatment units in either group may be insufficient for rejecting the null hypothesis in the respective [[statistical hypothesis testing|statistical test]]. The failure to reject the [[null hypothesis]] would imply that the treatment shows no statistically significant effect on the treated ''in a given test''. But as the sample size increases, the same RCT may be able to demonstrate a significant effect of the treatment, even if this effect is small.&amp;lt;ref name=&amp;quot;Glennerster-2013&amp;quot;&amp;gt;{{Cite book | publisher = Princeton University Press | isbn = 9780691159249 | last = Glennerster | first = Rachel |author2=Kudzai Takavarasha  | title = Running randomized evaluations: a practical guide | location = Princeton | date = 2013 |url=https://www.jstor.org/stable/j.ctt4cgd52 |chapter=&amp;quot;Chapter 6&amp;quot; }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
The number of treatment units (subjects or groups of subjects) assigned to control and treatment groups, affects an RCT's reliability. If the effect of the treatment is small, the number of treatment units in either group may be insufficient for rejecting the null hypothesis in the respective statistical test. The failure to reject the null hypothesis would imply that the treatment shows no statistically significant effect on the treated in a given test. But as the sample size increases, the same RCT may be able to demonstrate a significant effect of the treatment, even if this effect is small.&lt;br /&gt;
&lt;br /&gt;
分配给控制组和治疗组的治疗单位(受试者或受试者组)的样本量影响 RCT 的可靠性。如果治疗的效果很小，任何一组的治疗单位的样本量都可能不足以在各自的统计检验中拒绝无效假设（零假设）。拒绝零假设的失败将意味着治疗在给定的测试中对治疗没有统计学意义上的显著影响。但是随着样本量的增加，相同的随机对照试验也许能够证明治疗的显著效果，即使这种效果很小。&lt;br /&gt;
&lt;br /&gt;
== Blinding ==&lt;br /&gt;
&lt;br /&gt;
{{main|Blinded experiment}}&lt;br /&gt;
&lt;br /&gt;
An RCT may be [[Blind experiment|blinded]], (also called &amp;quot;masked&amp;quot;) by &amp;quot;procedures that prevent study participants, caregivers, or outcome assessors from knowing which intervention was received.&amp;quot;&amp;lt;ref name=&amp;quot;Wood-2008&amp;quot;/&amp;gt; Unlike allocation concealment, blinding is sometimes inappropriate or impossible to perform in an RCT; for example, if an RCT involves a treatment in which active participation of the patient is necessary (e.g., [[physical therapy]]), participants cannot be blinded to the intervention.&lt;br /&gt;
&lt;br /&gt;
If a disruptive innovation in medical technology is developed, it may be difficult to test this ethically in an RCT if it becomes &amp;quot;obvious&amp;quot; that the control subjects have poorer outcomes—either due to other foregoing testing, or within the initial phase of the RCT itself.  Ethically it may be necessary to abort the RCT prematurely, and getting ethics approval (and patient agreement) to withhold the innovation from the control group in future RCT's may not be feasible.&lt;br /&gt;
&lt;br /&gt;
如果医学技术领域出现颠覆性创新，在RCT中，对照组的结果变得“明显”—－即对照组出现明显差的结局。这要么由于其他的前述测试，要么是在 RCT 本身的初始阶段， 那么在 RCT 中很难从伦理上检验这一点。从伦理上讲，过早地中止 RCT 可能是必要的，而在未来的 RCT 中，获得伦理批准(以及患者同意)以阻止控制组的创新可能是不可行的。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Traditionally, blinded RCTs have been classified as &amp;quot;single-blind&amp;quot;, &amp;quot;double-blind&amp;quot;, or &amp;quot;triple-blind&amp;quot;; however, in 2001 and 2006 two studies showed that these terms have different meanings for different people.&amp;lt;ref name=&amp;quot;Devereaux-2001&amp;quot;&amp;gt;{{Cite journal |vauthors=Devereaux PJ, Manns BJ, Ghali WA, Quan H, Lacchetti C, Montori VM, Bhandari M, Guyatt GH | title = Physician interpretations and textbook definitions of blinding terminology in randomized controlled trials | journal = [[J Am Med Assoc]] | volume = 285 | issue = 15 | pages = 2000–3 | year = 2001 | doi =  10.1001/jama.285.15.2000| pmid = 11308438 | doi-access = free }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Haahr-2006&amp;quot;&amp;gt;{{Cite journal |vauthors=Haahr MT, Hróbjartsson A | title = Who is blinded in randomized clinical trials? A study of 200 trials and a survey of authors | journal = Clin Trials | volume = 3 | issue = 4 | pages = 360–5 | year = 2006 | doi = 10.1177/1740774506069153 | pmid = 17060210 | s2cid = 23818514 }}&amp;lt;/ref&amp;gt;  The 2010 [[Consolidated Standards of Reporting Trials|CONSORT Statement]] specifies that authors and editors should not use the terms &amp;quot;single-blind&amp;quot;, &amp;quot;double-blind&amp;quot;, and &amp;quot;triple-blind&amp;quot;; instead, reports of blinded RCT should discuss &amp;quot;If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how.&amp;quot;&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Historical control trials (HCT) exploit the data of previous RCTs to reduce the sample size; however, these approaches are controversial in the scientific community and must be handled with care.&lt;br /&gt;
&lt;br /&gt;
历史对照试验(HCT)利用以前随机对照试验的数据来减少样本量，然而，这些方法在科学界是有争议的，必须小心处理。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
RCTs without blinding are referred to as &amp;quot;unblinded&amp;quot;,&amp;lt;ref name=&amp;quot;Marson-2007&amp;quot;&amp;gt;{{Cite journal  |vauthors=Marson AG, Al-Kharusi AM, Alwaidh M, Appleton R, Baker GA, Chadwick DW, etal | title = The SANAD study of effectiveness of valproate, lamotrigine, or topiramate for generalised and unclassifiable epilepsy: an unblinded randomised controlled trial | journal = [[The Lancet|Lancet]] | volume = 369 | issue = 9566 | pages = 1016–26 | year = 2007 | doi = 10.1016/S0140-6736(07)60461-9 | pmid = 17382828 | pmc = 2039891 }}&amp;lt;/ref&amp;gt; &amp;quot;open&amp;quot;,&amp;lt;ref name=&amp;quot;Chan-1995&amp;quot;&amp;gt;{{Cite journal |vauthors=Chan R, Hemeryck L, O'Regan M, Clancy L, Feely J | title = Oral versus intravenous antibiotics for community acquired lower respiratory tract infection in a general hospital: open, randomised controlled trial | journal = [[BMJ]] | volume = 310 | issue = 6991 | pages = 1360–2 | year = 1995 | pmid = 7787537 | pmc = 2549744 | doi=10.1136/bmj.310.6991.1360}}&amp;lt;/ref&amp;gt; or (if the intervention is a medication) &amp;quot;[[Open-label trial|open-label]]&amp;quot;.&amp;lt;ref name=&amp;quot;Fukase-2008&amp;quot;&amp;gt;{{Cite journal | author = Fukase K, Kato M, Kikuchi S, Inoue K, Uemura N, Okamoto S, Terao S, Amagai K, Hayashi S, Asaka M; Japan Gast Study Group | title = Effect of eradication of Helicobacter pylori on incidence of metachronous gastric carcinoma after endoscopic resection of early gastric cancer: an open-label, randomised controlled trial | journal = Lancet | volume = 372 | issue = 9636 | pages = 392–7 | year = 2008 | doi = 10.1016/S0140-6736(08)61159-9 | pmid = 18675689 | hdl = 2115/34681 | s2cid = 13741892 | url = https://eprints.lib.hokudai.ac.jp/dspace/bitstream/2115/34681/1/asaka.pdf | hdl-access = free }}&amp;lt;/ref&amp;gt; In 2008 a study concluded that the results of unblinded RCTs tended to be biased toward beneficial effects only if the RCTs' outcomes were subjective as opposed to objective;&amp;lt;ref name=&amp;quot;Wood-2008&amp;quot;/&amp;gt; for example, in an RCT of treatments for [[multiple sclerosis]], unblinded neurologists (but not the blinded neurologists) felt that the treatments were beneficial.&amp;lt;ref name=&amp;quot;Noseworthy-1994&amp;quot;&amp;gt;{{Cite journal |vauthors=Noseworthy JH, Ebers GC, Vandervoort MK, Farquhar RE, Yetisir E, Roberts R | author-link1=John H. Noseworthy|title = The impact of blinding on the results of a randomized, placebo-controlled multiple sclerosis clinical trial | journal = Neurology | volume = 44 | issue = 1 | pages = 16–20 | year = 1994 | url = http://www.neurology.org/cgi/content/abstract/44/1/16 | pmid = 8290055 | doi=10.1212/wnl.44.1.16| s2cid=2663997}}&amp;lt;/ref&amp;gt; In pragmatic RCTs, although the participants and providers are often unblinded, it is &amp;quot;still desirable and often possible to blind the assessor or obtain an objective source of data for evaluation of outcomes.&amp;quot;&amp;lt;ref name=&amp;quot;Zwarenstein-2008&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
== Analysis of data ==&lt;br /&gt;
&lt;br /&gt;
The types of statistical methods used in RCTs depend on the characteristics of the data and include:&lt;br /&gt;
&lt;br /&gt;
* For [[dichotomous]] (binary) outcome data, [[logistic regression]] (e.g., to predict sustained virological response after receipt of [[peginterferon alfa-2a]] for [[hepatitis C]]&amp;lt;ref name=&amp;quot;Manns-2001&amp;quot;&amp;gt;{{Cite journal |vauthors=Manns MP, McHutchison JG, Gordon SC, Rustgi VK, Shiffman M, Reindollar R, Goodman ZD, Koury K, Ling M, Albrecht JK | title = Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial | journal = [[The Lancet|Lancet]] | volume = 358 | issue = 9286 | pages = 958–65 | year = 2001 | doi = 10.1016/S0140-6736(01)06102-5 | pmid = 11583749 | s2cid = 14583372 }}&amp;lt;/ref&amp;gt;) and other methods can be used.&lt;br /&gt;
&lt;br /&gt;
* For continuous outcome data, [[analysis of covariance]] (e.g., for changes in blood lipid levels after receipt of [[atorvastatin]] after [[acute coronary syndrome]]&amp;lt;ref name=&amp;quot;Schwartz-2001&amp;quot;&amp;gt;{{Cite journal | author = Schwartz GG, Olsson AG, Ezekowitz MD, Ganz P, Oliver MF, Waters D, Zeiher A, Chaitman BR, Leslie S, Stern T; Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering (MIRACL) Study Investigators | title = Effects of atorvastatin on early recurrent ischemic events in acute coronary syndromes: the MIRACL study: a randomized controlled trial | journal = [[J Am Med Assoc]] | volume = 285 | issue = 13 | pages = 1711–8 | year = 2001 | pmid = 11277825 | doi = 10.1001/jama.285.13.1711 | doi-access = free }}&amp;lt;/ref&amp;gt;) tests the effects of predictor variables.&lt;br /&gt;
&lt;br /&gt;
* For time-to-event outcome data that may be [[Censoring (statistics)|censored]], [[survival analysis]] (e.g., [[Kaplan–Meier estimator]]s and [[Cox proportional hazards model]]s for time to [[coronary heart disease]] after receipt of [[Hormone replacement therapy (menopause)|hormone replacement therapy in menopause]]&amp;lt;ref name=&amp;quot;Rossouw-2002&amp;quot;&amp;gt;{{Cite journal | author = Rossouw JE, Anderson GL, [[Ross Prentice|Prentice RL]], LaCroix AZ, Kooperberg C, Stefanick ML, Jackson RD, Beresford SA, Howard BV, Johnson KC, Kotchen JM, Ockene J; Writing Group for the Women's Health Initiative Investigators | title = Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial | journal = [[J Am Med Assoc]] | volume = 288 | issue = 3 | pages = 321–33 | year = 2002 | pmid = 12117397 | doi = 10.1001/jama.288.3.321 | s2cid = 20149703 | url = https://escholarship.org/content/qt3mr6f93p/qt3mr6f93p.pdf?t=prll4c | doi-access = free }}&amp;lt;/ref&amp;gt;) is appropriate.&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Due to the recent emergence of RCTs in social science, the use of RCTs in social sciences is a contested issue.  Some writers from a medical or health background have argued that existing research in a range of social science disciplines lacks rigour, and should be improved by greater use of randomized control trials.&lt;br /&gt;
&lt;br /&gt;
由于最近在社会科学中出现了 rct，rct 在社会科学中的应用是一个有争议的问题。一些有医学或健康背景的作家认为，一系列社会科学学科的现有研究缺乏严谨性，应该通过更多地使用随机对照试验来改进。&lt;br /&gt;
Researchers in transport science argue that public spending on programmes such as school travel plans could not be justified unless their efficacy is demonstrated by randomized controlled trials.  Graham-Rowe and colleagues  reviewed 77 evaluations of transport interventions found in the literature, categorising them into 5 &amp;quot;quality levels&amp;quot;.  They concluded that most of the studies were of low quality and advocated the use of randomized controlled trials wherever possible in future transport research.&lt;br /&gt;
&lt;br /&gt;
交通科学研究人员认为，除非随机对照试验证明其有效性，否则在学校旅行计划等项目上的公共支出是不合理的。Graham-Rowe 和他的同事回顾了文献中发现的77个运输干预评估，将它们分为5个“质量水平”。他们的结论是，大多数研究质量低下，并主张在未来的运输研究中尽可能使用随机对照试验。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Regardless of the statistical methods used, important considerations in the analysis of RCT data include:&lt;br /&gt;
&lt;br /&gt;
Dr. Steve Melia took issue with these conclusions, arguing that claims about the advantages of RCTs, in establishing causality and avoiding bias, have been exaggerated.  He proposed the following eight criteria for the use of RCTs in contexts where interventions must change human behaviour to be effective:&lt;br /&gt;
&lt;br /&gt;
Steve Melia 博士对这些结论提出异议，认为关于 rct 在确定因果关系和避免偏见方面的优势的说法被夸大了。他提出了在干预措施必须改变人的行为才能有效的情况下使用区域反应技术的八项标准:&lt;br /&gt;
&lt;br /&gt;
* Whether an RCT should be stopped early due to interim results.  For example, RCTs may be stopped early if an intervention produces &amp;quot;larger than expected benefit or harm&amp;quot;, or if &amp;quot;investigators find evidence of no important difference between experimental and control interventions.&amp;quot;&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
* The extent to which the groups can be analyzed exactly as they existed upon randomization (i.e., whether a so-called &amp;quot;[[intention-to-treat analysis]]&amp;quot; is used). A &amp;quot;pure&amp;quot; intention-to-treat analysis is &amp;quot;possible only when complete outcome data are available&amp;quot; for all randomized subjects;&amp;lt;ref name=&amp;quot;Hollis-1999&amp;quot;&amp;gt;{{Cite journal |vauthors=Hollis S, Campbell F | title = What is meant by intention to treat analysis? Survey of published randomised controlled trials | journal = [[Br Med J]] | volume = 319 | issue = 7211 | pages = 670–4 | year = 1999 | pmid = 10480822 | pmc = 28218 | doi=10.1136/bmj.319.7211.670}}&amp;lt;/ref&amp;gt; when some outcome data are missing, options include analyzing only cases with known outcomes and using [[Imputation (statistics)|imputed]] data.&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt; Nevertheless, the more that analyses can include all participants in the groups to which they were randomized, the less bias that an RCT will be subject to.&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
The intervention:&lt;br /&gt;
&lt;br /&gt;
干预措施:&lt;br /&gt;
&lt;br /&gt;
* Whether [[subgroup analysis]] should be performed.  These are &amp;quot;often discouraged&amp;quot; because [[multiple comparisons]] may produce false positive findings that cannot be confirmed by other studies.&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
 Has not been applied to all members of a unique group of people (e.g. the population of a whole country, all employees of a unique organisation etc.)&lt;br /&gt;
&lt;br /&gt;
并不适用于一个特殊群体的所有成员(例如:。整个国家的人口，一个独特组织的所有雇员等)&lt;br /&gt;
&lt;br /&gt;
== Reporting of results ==&lt;br /&gt;
&lt;br /&gt;
 Is applied in a context or setting similar to that which applies to the control group&lt;br /&gt;
&lt;br /&gt;
应用于类似于应用于控制组的上下文或设置&lt;br /&gt;
&lt;br /&gt;
The ''[[Consolidated Standards of Reporting Trials|CONSORT 2010 Statement]]'' is &amp;quot;an evidence-based, minimum set of recommendations for reporting RCTs.&amp;quot;&amp;lt;ref name=&amp;quot;CONSORT&amp;quot;&amp;gt;{{cite web |url=http://www.consort-statement.org |title=Welcome to the CONSORT statement Website |author=CONSORT Group |access-date=2010-03-29}}&amp;lt;/ref&amp;gt; The CONSORT 2010 checklist contains 25 items (many with sub-items) focusing on &amp;quot;individually randomised, two group, parallel trials&amp;quot; which are the most common type of RCT.&amp;lt;ref name=&amp;quot;Schulz-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
 Can be isolated from other activities—and the purpose of the study is to assess this isolated effect&lt;br /&gt;
&lt;br /&gt;
这项研究的目的是评估这种孤立效应&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
 Has a short timescale between its implementation and maturity of its effects&lt;br /&gt;
&lt;br /&gt;
从实施到效果成熟之间的时间跨度很短&lt;br /&gt;
&lt;br /&gt;
For other RCT study designs, &amp;quot;[[Consolidated Standards of Reporting Trials|CONSORT extensions]]&amp;quot; have been published, some examples are:&lt;br /&gt;
&lt;br /&gt;
* Consort 2010 Statement: Extension to Cluster Randomised Trials&amp;lt;ref name=&amp;quot;CONSORT2010-EXTENSION-CLUSTER&amp;quot;&amp;gt;{{Cite journal |vauthors=Campbell MK, Piaggio G, Elbourne DR, Altman DG| title = Consort 2010 statement: extension to cluster randomised trials | journal = [[BMJ]] | volume = 345| pages = e5661 | year = 2012  | pmid = 22951546 | doi = 10.1136/bmj.e5661 | doi-access = free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
And the causal mechanisms:&lt;br /&gt;
&lt;br /&gt;
以及因果机制:&lt;br /&gt;
&lt;br /&gt;
* Consort 2010 Statement: Non-Pharmacologic Treatment Interventions&amp;lt;ref name=&amp;quot;CONSORT2010-EXTENSION-NON-PHARMACOLOGIC-1&amp;quot;&amp;gt;{{Cite journal |vauthors=Boutron I, Moher D, Altman DG, Schulz K, Ravaud P| title = Extending the CONSORT Statement to randomized trials of nonpharmacologic treatment: explanation and elaboration | journal = [[Annals of Internal Medicine]] | volume = 148| issue = 4 | year = 2008 | pages=295–309  | pmid = 18283207 | doi=10.7326/0003-4819-148-4-200802190-00008| doi-access = free }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;CONSORT2010-EXTENSION-NON-PHARMACOLOGIC-2&amp;quot;&amp;gt;{{Cite journal |vauthors=Boutron I, Moher D, Altman DG, Schulz K, Ravaud P| title = Methods and Processes of the CONSORT Group: Example of an Extension for Trials Assessing Nonpharmacologic Treatments | journal = [[Annals of Internal Medicine]] | volume = 148| issue = 4 | year = 2008  | pmid = 18283201 | doi=10.7326/0003-4819-148-4-200802190-00008-w1 | pages=W60–6| doi-access = free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&amp;lt;li value=&amp;quot;5&amp;quot;&amp;gt;Are either known to the researchers, or else all possible alternatives can be tested&lt;br /&gt;
&lt;br /&gt;
&amp;lt; li value = &amp;quot; 5&amp;quot; &amp;gt; 要么被研究人员知道，要么所有可能的替代方案都可以被测试&lt;br /&gt;
&lt;br /&gt;
=== Relative importance and observational studies ===&lt;br /&gt;
&lt;br /&gt;
 Do not involve significant feedback mechanisms between the intervention group and external environments&lt;br /&gt;
&lt;br /&gt;
不涉及干预组和外部环境之间的重要反馈机制&lt;br /&gt;
&lt;br /&gt;
Two studies published in ''[[The New England Journal of Medicine]]'' in 2000 found that [[Observational study|observational studies]] and RCTs overall produced similar results.&amp;lt;ref name=&amp;quot;Benson-2000&amp;quot;&amp;gt;{{Cite journal |vauthors=Benson K, Hartz AJ | title = A comparison of observational studies and randomized, controlled trials | journal = [[N Engl J Med]] | volume = 342 | issue = 25 | pages = 1878–86 | year = 2000 | pmid = 10861324 | doi = 10.1056/NEJM200006223422506 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Concato-2000&amp;quot;&amp;gt;{{Cite journal |vauthors=Concato J, Shah N, Horwitz RI | title = Randomized, controlled trials, observational studies, and the hierarchy of research designs | journal = [[N Engl J Med]] | volume = 342 | issue = 25 | pages = 1887–92 | year = 2000 | url = http://nejm.highwire.org/cgi/content/full/342/25/1887 | pmid = 10861325 | doi = 10.1056/NEJM200006223422507 | pmc = 1557642 }}&amp;lt;/ref&amp;gt; The authors of the 2000 findings questioned the belief that &amp;quot;observational studies should not be used for defining evidence-based medical care&amp;quot; and that RCTs' results are &amp;quot;evidence of the highest grade.&amp;quot;&amp;lt;ref name=&amp;quot;Benson-2000&amp;quot;/&amp;gt;&amp;lt;ref name=&amp;quot;Concato-2000&amp;quot;/&amp;gt; However, a 2001 study published in ''[[Journal of the American Medical Association]]'' concluded that &amp;quot;discrepancies beyond chance do occur and differences in estimated magnitude of treatment effect are very common&amp;quot; between observational studies and RCTs.&amp;lt;ref name=&amp;quot;Ioannidis-2001&amp;quot;&amp;gt;{{Cite journal |vauthors=Ioannidis JP, Haidich AB, Pappa M, Pantazis N, Kokori SI, Tektonidou MG, Contopoulos-Ioannidis DG, Lau J | title = Comparison of evidence of treatment effects in randomized and nonrandomized studies | journal = [[J Am Med Assoc]] | volume = 286 | issue = 7 | pages = 821–30 | year = 2001 | pmid = 11497536 | doi = 10.1001/jama.286.7.821 | citeseerx = 10.1.1.590.2854 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Have a stable and predictable relationship to exogenous factors&lt;br /&gt;
&lt;br /&gt;
与外部因素有稳定和可预测的关系&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
 Would act in the same way if the control group and intervention group were reversed&lt;br /&gt;
&lt;br /&gt;
如果对照组和干预组的情况相反，他们也会以同样的方式行动&lt;br /&gt;
&lt;br /&gt;
Two other lines of reasoning question RCTs' contribution to scientific knowledge beyond other types of studies:&lt;br /&gt;
* If study designs are ranked by their potential for new discoveries, then [[Anecdotal evidence#Scientific context|anecdotal evidence]] would be at the top of the list, followed by observational studies, followed by RCTs.&amp;lt;ref name=&amp;quot;Vandenbroucke-2008&amp;quot;&amp;gt;{{Cite journal | author = Vandenbroucke JP | title = Observational research, randomised trials, and two views of medical science | journal = [[PLoS Med]] | volume = 5 | issue = 3 | pages = e67 | year = 2008 | doi = 10.1371/journal.pmed.0050067 | pmid = 18336067 | pmc = 2265762 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* RCTs may be unnecessary for treatments that have dramatic and rapid effects relative to the expected stable or progressively worse natural course of the condition treated.&amp;lt;ref name=&amp;quot;Black-1996&amp;quot;/&amp;gt;&amp;lt;ref name=&amp;quot;Glasziou-2007&amp;quot;&amp;gt;{{Cite journal |vauthors=Glasziou P, Chalmers I, Rawlins M, McCulloch P | title = When are randomised trials unnecessary? Picking signal from noise | journal = [[Br Med J]] | volume = 334 | issue = 7589 | pages = 349–51 | year = 2007 | doi = 10.1136/bmj.39070.527986.68 | pmc=1800999 | pmid = 17303884 }}&amp;lt;/ref&amp;gt; One example is [[History of cancer chemotherapy#Combination chemotherapy|combination chemotherapy]] including [[cisplatin]] for [[Metastasis|metastatic]] [[testicular cancer]], which increased the cure rate from 5% to 60% in a 1977 non-randomized study.&amp;lt;ref name=&amp;quot;Glasziou-2007&amp;quot;/&amp;gt;&amp;lt;ref name=&amp;quot;Einhorn-2002&amp;quot;&amp;gt;{{Cite journal | author = Einhorn LH | author-link = Lawrence Einhorn | title = Curing metastatic testicular cancer | journal = [[Proc Natl Acad Sci U S A]] | volume = 99 | issue = 7 | pages = 4592–5 | year = 2002 | doi = 10.1073/pnas.072067999 | pmid = 11904381 | pmc = 123692 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
A 2005 review found 83 randomized experiments in criminology published in 1982–2004, compared with only 35 published in 1957–1981. The authors classified the studies they found into five categories: &amp;quot;policing&amp;quot;, &amp;quot;prevention&amp;quot;, &amp;quot;corrections&amp;quot;, &amp;quot;court&amp;quot;, and &amp;quot;community&amp;quot;.&lt;br /&gt;
&lt;br /&gt;
2005年的一项研究发现，1982年至2004年发表的犯罪学随机实验有83项，而1957年至1981年发表的只有35项。作者将他们发现的研究分为五类: “警务”、“预防”、“惩戒”、“法院”和“社区”。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
=== Interpretation of statistical results ===&lt;br /&gt;
&lt;br /&gt;
Like all statistical methods, RCTs are subject to both [[type I and type II errors|type I (&amp;quot;false positive&amp;quot;) and type II (&amp;quot;false negative&amp;quot;) statistical errors]].  Regarding Type I errors, a typical RCT will use 0.05 (i.e., 1 in 20) as the probability that the RCT will falsely find two equally effective treatments significantly different.&amp;lt;ref name=&amp;quot;Wittes-2002&amp;quot;&amp;gt;{{Cite journal | author = Wittes J | title = Sample size calculations for randomized controlled trials | journal = [[Epidemiol Rev]] | volume = 24 | issue = 1 | pages = 39–53 | year = 2002 | doi = 10.1093/epirev/24.1.39 | pmid = 12119854 | doi-access = free }}&amp;lt;/ref&amp;gt; Regarding Type II errors, despite the publication of a 1978 paper noting that the [[sample size]]s of many &amp;quot;negative&amp;quot; RCTs were too small to make definitive conclusions about the negative results,&amp;lt;ref name=&amp;quot;Freiman-1978&amp;quot;&amp;gt;{{Cite journal | doi = 10.1056/NEJM197809282991304 |vauthors=Freiman JA, Chalmers TC, ((Smith H Jr)), Kuebler RR | title = The importance of beta, the type II error and sample size in the design and interpretation of the randomized control trial. Survey of 71 &amp;quot;negative&amp;quot; trials | journal = [[N Engl J Med]] | volume = 299 | issue = 13 | pages = 690–4 | year = 1978 | pmid = 355881 }}&amp;lt;/ref&amp;gt; by 2005-2006 a sizeable proportion of RCTs still had inaccurate or incompletely reported sample size calculations.&amp;lt;ref name=&amp;quot;Charles-2009&amp;quot;&amp;gt;{{Cite journal |vauthors=Charles P, Giraudeau B, Dechartres A, Baron G, Ravaud P | title = Reporting of sample size calculation in randomised controlled trials: review | journal = [[Br Med J]] | volume = 338 | pages = b1732 | date = 2009-05-12 | doi = 10.1136/bmj.b1732 | pmid = 19435763 | pmc = 2680945 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
RCTs have been used in evaluating a number of educational interventions. Between 1980 and 2016, over 1,000 reports of RCTs have been published. For example, a 2009 study randomized 260 elementary school teachers' classrooms to receive or not receive a program of behavioral screening, classroom intervention, and parent training, and then measured the behavioral and academic performance of their students. Another 2009 study randomized classrooms for 678 first-grade children to receive a classroom-centered intervention, a parent-centered intervention, or no intervention, and then followed their academic outcomes through age 19.&lt;br /&gt;
&lt;br /&gt;
随机对照试验已用于评价一些教育干预措施。从1980年到2016年，已经发表了超过1000篇关于 rct 的报告。例如，2009年的一项研究随机抽取了260名小学教师的课堂，让他们接受或不接受行为筛选、课堂干预和家长培训，然后测量他们学生的行为和学业表现。2009年的另一项研究随机化了678个一年级儿童的课堂，接受了以课堂为中心的干预，以家长为中心的干预，或没有干预，然后跟踪他们的学习成果直到19岁。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
=== Peer review ===&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
A 2017 review of the 10 most cited randomised controlled trials noted poor distribution of background traits, difficulties with blinding, and discussed other assumptions and biases inherent in randomised controlled trials. These include the &amp;quot;unique time period assessment bias&amp;quot;, the &amp;quot;background traits remain constant assumption&amp;quot;, the &amp;quot;average treatment effects limitation&amp;quot;, the &amp;quot;simple treatment at the individual level limitation&amp;quot;, the &amp;quot;all preconditions are fully met assumption&amp;quot;, the &amp;quot;quantitative variable limitation&amp;quot; and the &amp;quot;placebo only or conventional treatment only limitation&amp;quot;.&lt;br /&gt;
&lt;br /&gt;
2017年对10个最常被引用的随机对照试验的回顾指出，背景特征的分布不良，盲法存在困难，并讨论了随机对照试验中固有的其他假设和偏差。其中包括”独特的时间段评估偏差”、”背景特征保持不变的假设”、”平均治疗效果限制”、”个人层面的简单治疗限制”、”所有前提条件都得到充分满足的假设”、”定量变量限制”以及”仅安慰剂或常规治疗限制”。&lt;br /&gt;
&lt;br /&gt;
[[Peer review]] of results is an important part of the [[scientific method]]. Reviewers examine the study results for potential problems with design that could lead to unreliable results (for example by creating a [[systematic bias]]), evaluate the study in the context of related studies and other evidence, and evaluate whether the study can be reasonably considered to have proven its conclusions. To underscore the need for peer review and the danger of over-generalizing conclusions, two Boston-area medical researchers performed a randomized controlled trial in which they randomly assigned either a parachute or an empty backpack to 23 volunteers who jumped from either a biplane or a helicopter. The study was able to accurately report that parachutes fail to reduce injury compared to empty backpacks. The key context that limited the general applicability of this conclusion was that the aircraft were parked on the ground, and participants had only jumped about two feet.&amp;lt;ref&amp;gt;{{cite news |url=https://www.npr.org/sections/health-shots/2018/12/22/679083038/researchers-show-parachutes-dont-work-but-there-s-a-catch |title=Researchers Show Parachutes Don't Work, But There's A Catch |date=22 Dec 2018 |author=Richard Harris}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
== Advantages ==&lt;br /&gt;
&lt;br /&gt;
RCTs are considered to be the most reliable form of [[scientific method|scientific evidence]] in the [[hierarchy of evidence]] that influences healthcare policy and practice because RCTs reduce spurious causality and bias. Results of RCTs may be combined in [[systematic review]]s which are increasingly being used in the conduct of [[evidence-based practice]]. Some examples of scientific organizations' considering RCTs or systematic reviews of RCTs to be the highest-quality evidence available are:&lt;br /&gt;
* As of 1998, the [[National Health and Medical Research Council]] of Australia designated &amp;quot;Level I&amp;quot; evidence as that &amp;quot;obtained from a [[systematic review]] of all relevant randomised controlled trials&amp;quot; and &amp;quot;Level II&amp;quot; evidence as that &amp;quot;obtained from at least one properly designed randomised controlled trial.&amp;quot;&amp;lt;ref&amp;gt;{{cite book |url= http://www.nhmrc.gov.au/_files_nhmrc/file/publications/synopses/cp30.pdf |title= A guide to the development, implementation and evaluation of clinical practice guidelines |author= National Health and Medical Research Council |date=1998-11-16 |publisher= Commonwealth of Australia |location = Canberra | isbn = 978-1-86496-048-8 |page= 56|access-date=2010-03-28}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* Since at least 2001, in making [[clinical practice guideline]] recommendations the [[United States Preventive Services Task Force]] has considered both a study's design and its [[internal validity]] as indicators of its quality.&amp;lt;ref name=&amp;quot;Harris-2001&amp;quot;&amp;gt;{{Cite journal | author = Harris RP, Helfand M, Woolf SH, Lohr KN, Mulrow CD, Teutsch SM, Atkins D; Methods Work Group, Third US Preventive Services Task Force | title = Current methods of the US Preventive Services Task Force: a review of the process | journal = Am J Prev Med | volume = 20 | issue = 3 Suppl | pages = 21–35 | year = 2001 | url = http://www.ahrq.gov/clinic/ajpmsuppl/review.pdf | pmid = 11306229 | doi = 10.1016/S0749-3797(01)00261-6 }}&amp;lt;/ref&amp;gt; It has recognized &amp;quot;evidence obtained from at least one properly randomized controlled trial&amp;quot; with good [[internal validity]] (i.e., a rating of &amp;quot;I-good&amp;quot;) as the highest quality evidence available to it.&amp;lt;ref name=&amp;quot;Harris-2001&amp;quot;/&amp;gt;&lt;br /&gt;
* The [[Evidence-based medicine#Grade Working Group|GRADE Working Group]] concluded in 2008 that &amp;quot;randomised trials without important limitations constitute high quality evidence.&amp;quot;&amp;lt;ref name=&amp;quot;Guyatt-2008&amp;quot;&amp;gt;{{Cite journal | author = Guyatt GH, Oxman AD, Kunz R, Vist GE, Falck-Ytter Y, Schünemann HJ; GRADE Working Group | title = What is &amp;quot;quality of evidence&amp;quot; and why is it important to clinicians? | journal = BMJ | volume = 336 | issue = 7651 | pages = 995–8 |year = 2008 | doi = 10.1136/bmj.39490.551019.BE | pmc = 2364804 | pmid = 18456631 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* For issues involving &amp;quot;Therapy/Prevention, Aetiology/Harm&amp;quot;, the [[Oxford Centre for Evidence-based Medicine]] as of 2011 defined &amp;quot;Level 1a&amp;quot; evidence as a systematic review of RCTs that are consistent with each other, and &amp;quot;Level 1b&amp;quot; evidence as an &amp;quot;individual RCT (with narrow [[Confidence Interval]]).&amp;quot;&amp;lt;ref&amp;gt;{{cite web |url= http://www.cebm.net/index.aspx?o=1025 |title= Levels of evidence |author= Oxford Centre for Evidence-based Medicine |date=2011-09-16 |access-date=2012-02-15}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Notable RCTs with unexpected results that contributed to changes in clinical practice include:&lt;br /&gt;
* After [[Food and Drug Administration]] approval, the [[antiarrhythmic agents]] [[flecainide]] and [[encainide]] came to market in 1986 and 1987 respectively.&amp;lt;ref name=&amp;quot;Anderson-1997&amp;quot;&amp;gt;{{Cite journal |vauthors=Anderson JL, Pratt CM, Waldo AL, Karagounis LA | title = Impact of the Food and Drug Administration approval of flecainide and encainide on coronary artery disease mortality: putting &amp;quot;Deadly Medicine&amp;quot; to the test | journal = Am J Cardiol | volume = 79 | issue = 1 | pages = 43–7 | year = 1997 | url = http://www.ajconline.org/article/S0002-9149%2896%2900673-X/abstract | pmid = 9024734 | doi = 10.1016/S0002-9149(96)00673-X }}&amp;lt;/ref&amp;gt; The non-randomized studies concerning the drugs were characterized as &amp;quot;glowing&amp;quot;,&amp;lt;ref name=&amp;quot;Rubin-2006&amp;quot;&amp;gt;{{cite news |title= In medicine, evidence can be confusing - deluged with studies, doctors try to sort out what works, what doesn't |author= Rubin R |url= https://www.usatoday.com/news/health/2006-10-15-medical-evidence-cover_x.htm |newspaper= USA Today |date= 2006-10-16 |access-date=2010-03-22}}&amp;lt;/ref&amp;gt; and their sales increased to a combined total of approximately 165,000 prescriptions per month in early 1989.&amp;lt;ref name=&amp;quot;Anderson-1997&amp;quot;/&amp;gt;  In that year, however, a preliminary report of an RCT concluded that the two drugs increased mortality.&amp;lt;ref name=&amp;quot;CAST-1989&amp;quot;&amp;gt;{{Cite journal | doi = 10.1056/NEJM198908103210629 | title = Preliminary report: effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction. The Cardiac Arrhythmia Suppression Trial (CAST) Investigators | journal = N Engl J Med | volume = 321 | issue = 6 | pages = 406–12 |year = 1989 | pmid = 2473403 | author1 = Cardiac Arrhythmia Suppression Trial (CAST) Investigators }}&amp;lt;/ref&amp;gt;  Sales of the drugs then decreased.&amp;lt;ref name=&amp;quot;Anderson-1997&amp;quot;/&amp;gt;&lt;br /&gt;
* Prior to 2002, based on observational studies, it was routine for physicians to prescribe hormone replacement therapy for post-menopausal women to prevent [[myocardial infarction]].&amp;lt;ref name=&amp;quot;Rubin-2006&amp;quot;/&amp;gt; In 2002 and 2004, however, published RCTs from the [[Women's Health Initiative]] claimed that women taking hormone replacement therapy with estrogen plus progestin had a higher rate of myocardial infarctions than women on a placebo, and that estrogen-only hormone replacement therapy caused no reduction in the incidence of coronary heart disease.&amp;lt;ref name=&amp;quot;Rossouw-2002&amp;quot;/&amp;gt;&amp;lt;ref name=&amp;quot;Anderson-2004&amp;quot;&amp;gt;{{Cite journal  |vauthors=Anderson GL, Limacher M, Assaf AR, Bassford T, Beresford SA, Black H, etal | title = Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women's Health Initiative randomized controlled trial | journal = JAMA | volume = 291 | issue = 14 | pages = 1701–12 | year = 2004 | doi = 10.1001/jama.291.14.1701 | pmid = 15082697 | doi-access = free }}&amp;lt;/ref&amp;gt;  Possible explanations for the discrepancy between the observational studies and the RCTs involved differences in methodology, in the hormone regimens used, and in the populations studied.&amp;lt;ref name=&amp;quot;Grodstein-2003&amp;quot;&amp;gt;{{Cite journal |vauthors=Grodstein F, Clarkson TB, Manson JE | title = Understanding the divergent data on postmenopausal hormone therapy | journal = N Engl J Med | volume = 348 | issue = 7 | pages = 645–50 | year = 2003 | doi = 10.1056/NEJMsb022365 | pmid = 12584376 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Vandenbroucke-2009&amp;quot;&amp;gt;{{Cite journal | author = Vandenbroucke JP | title = The HRT controversy: observational studies and RCTs fall in line | journal = Lancet | volume = 373 | issue = 9671 | pages = 1233–5 | year = 2009 | doi = 10.1016/S0140-6736(09)60708-X | pmid = 19362661 | s2cid = 44991220 }}&amp;lt;/ref&amp;gt; The use of hormone replacement therapy decreased after publication of the RCTs.&amp;lt;ref name=&amp;quot;Hsu-2009&amp;quot;&amp;gt;{{Cite journal |vauthors=Hsu A, Card A, Lin SX, Mota S, Carrasquillo O, Moran A | title = Changes in postmenopausal hormone replacement therapy use among women with high cardiovascular risk | journal = Am J Public Health | volume = 99 | issue = 12 | pages = 2184–7 | year = 2009 | doi = 10.2105/AJPH.2009.159889 | url = http://ajph.aphapublications.org/cgi/content/full/99/12/2184 | pmid = 19833984 | pmc=2775780}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
== Disadvantages ==&lt;br /&gt;
&lt;br /&gt;
Many papers discuss the disadvantages of RCTs.&amp;lt;ref name=&amp;quot;Black-1996&amp;quot;&amp;gt;{{Cite journal | author = Black N | title = Why we need observational studies to evaluate the effectiveness of health care | journal = BMJ | volume = 312 | issue = 7040 | pages = 1215–8 | year = 1996 | pmid = 8634569 | pmc = 2350940 | doi=10.1136/bmj.312.7040.1215}}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Bell &amp;amp; Peck-2012&amp;quot;&amp;gt;{{Cite journal | author = Bell, S.H., &amp;amp; Peck, L.R. | title = Obstacles to and limitations of social experiments: 15 false alarms | journal = Abt Thought Leadership Paper Series | year = 2012 | url = http://abtassociates.com/white-papers/2012/obstacles-to-and-limitations-of-social-experiments.aspx }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Sanson-Fisher-2007&amp;quot;&amp;gt;{{Cite journal |vauthors=Sanson-Fisher RW, Bonevski B, Green LW, D'Este C | title = Limitations of the randomized controlled trial in evaluating population-based health interventions | journal = Am J Prev Med | volume = 33 | issue = 2 | pages = 155–61 | year = 2007 | doi = 10.1016/j.amepre.2007.04.007 | url = http://www.ajpm-online.net/article/S0749-3797%2807%2900225-5/abstract | pmid = 17673104 }}&amp;lt;/ref&amp;gt;   Among the most frequently cited drawbacks are:&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
=== Time and costs ===&lt;br /&gt;
&lt;br /&gt;
RCTs can be expensive;&amp;lt;ref name=&amp;quot;Sanson-Fisher-2007&amp;quot;/&amp;gt; one study found 28 [[Phase III clinical trials|Phase III]] RCTs funded by the [[National Institute of Neurological Disorders and Stroke]] prior to 2000 with a total cost of US$335 million,&amp;lt;ref name=&amp;quot;Johnston-2006&amp;quot;&amp;gt;{{Cite journal |vauthors=Johnston SC, Rootenberg JD, Katrak S, Smith WS, Elkins JS | title = Effect of a US National Institutes of Health programme of clinical trials on public health and costs | journal = [[The Lancet|Lancet]] | volume = 367 | issue = 9519 | pages = 1319–27 | year = 2006 | doi = 10.1016/S0140-6736(06)68578-4 | url = http://www.chrp.org/pdf/HSR20070511.pdf | pmid = 16631910 | s2cid = 41035177 }}&amp;lt;/ref&amp;gt; for a [[mean]] cost of US$12 million per RCT.  Nevertheless, the [[return on investment]] of RCTs may be high, in that the same study projected that the 28 RCTs produced a &amp;quot;net benefit to society at 10-years&amp;quot; of 46 times the cost of the trials program, based on evaluating a [[quality-adjusted life year]] as equal to the prevailing mean [[per capita]] [[gross domestic product]].&amp;lt;ref name=&amp;quot;Johnston-2006&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
The conduct of an RCT takes several years until being published; thus, data is restricted from the medical community for long years and may be of less relevance at time of publication.&amp;lt;ref name=&amp;quot;CaseReport&amp;quot;&amp;gt;{{cite journal |vauthors=Yitschaky O, Yitschaky M, Zadik Y |title=Case report on trial: Do you, Doctor, swear to tell the truth, the whole truth and nothing but the truth? |journal=J Med Case Rep |volume=5 |issue=1 |page=179 |date=May 2011 |pmid=21569508 |url=http://www.jmedicalcasereports.com/content/pdf/1752-1947-5-179.pdf|doi=10.1186/1752-1947-5-179 |pmc=3113995}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
It is costly to maintain RCTs for the years or decades that would be ideal for evaluating some interventions.&amp;lt;ref name=&amp;quot;Black-1996&amp;quot;/&amp;gt;&amp;lt;ref name=&amp;quot;Sanson-Fisher-2007&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Interventions to prevent events that occur only infrequently (e.g., [[sudden infant death syndrome]]) and uncommon adverse outcomes (e.g., a rare side effect of a drug) would require RCTs with extremely large sample sizes and may, therefore, best be assessed by observational studies.&amp;lt;ref name=&amp;quot;Black-1996&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Due to the costs of running RCTs, these usually only inspect one variable or very few variables, rarely reflecting the full picture of a complicated medical situation; whereas the [[case report]], for example, can detail many aspects of the patient's [[medicine|medical]] situation (e.g. [[patient history]], [[physical examination]], [[diagnosis]], [[psychosocial]] aspects, follow up).&amp;lt;ref name=&amp;quot;CaseReport&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
=== Conflict of interest dangers ===&lt;br /&gt;
&lt;br /&gt;
A 2011 study done to disclose possible [[conflicts of interest]]s in underlying research studies used for medical meta-analyses reviewed 29 meta-analyses and found that conflicts of interests in the studies underlying the meta-analyses were rarely disclosed.  The 29 meta-analyses included 11 from general medicine journals; 15 from specialty medicine journals, and 3 from the [[Cochrane Collaboration|Cochrane]] Database of Systematic Reviews. The 29 meta-analyses reviewed an aggregate of 509 randomized controlled trials (RCTs). Of these, 318 RCTs reported funding sources with 219 (69%) industry funded. 132 of the 509 RCTs reported author conflict of interest disclosures, with 91 studies (69%) disclosing industry financial ties with one or more authors. The information was, however, seldom reflected in the meta-analyses. Only two (7%) reported RCT funding sources and none reported RCT author-industry ties. The authors concluded &amp;quot;without acknowledgment of COI due to industry funding or author industry financial ties from RCTs included in meta-analyses, readers' understanding and appraisal of the evidence from the meta-analysis may be compromised.&amp;quot;&amp;lt;ref&amp;gt;{{cite web|url=http://www.cochrane.org/news/blog/how-well-do-meta-analyses-disclose-conflicts-interests-underlying-research-studies |title=How Well Do Meta-Analyses Disclose Conflicts of Interests in Underlying Research Studies &amp;amp;#124; The Cochrane Collaboration |publisher=Cochrane.org |access-date=2011-08-19}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
A 2011 study done to disclose possible conflicts of interests in underlying research studies used for medical meta-analyses reviewed 29 meta-analyses and found that conflicts of interests in the studies underlying the meta-analyses were rarely disclosed. The 29 meta-analyses included 11 from general medicine journals; 15 from specialty medicine journals, and 3 from the Cochrane Database of Systematic Reviews. The 29 meta-analyses reviewed an aggregate of 509 randomized controlled trials (RCTs). Of these, 318 RCTs reported funding sources with 219 (69%) industry funded. 132 of the 509 RCTs reported author conflict of interest disclosures, with 91 studies (69%) disclosing industry financial ties with one or more authors. The information was, however, seldom reflected in the meta-analyses. Only two (7%) reported RCT funding sources and none reported RCT author-industry ties. The authors concluded &amp;quot;without acknowledgment of COI due to industry funding or author industry financial ties from RCTs included in meta-analyses, readers' understanding and appraisal of the evidence from the meta-analysis may be compromised.&amp;quot;[97]&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Some RCTs are fully or partly funded by the health care industry (e.g., the [[pharmaceutical industry]]) as opposed to government, nonprofit, or other sources. A systematic review published in 2003 found four 1986–2002 articles comparing industry-sponsored and nonindustry-sponsored RCTs, and in all the articles there was a correlation of industry sponsorship and positive study outcome.&amp;lt;ref name=&amp;quot;Bekelman-2003&amp;quot;&amp;gt;{{Cite journal |vauthors=Bekelman JE, Li Y, Gross CP | title = Scope and impact of financial conflicts of interest in biomedical research: a systematic review | journal = [[J Am Med Assoc]] | volume = 289 | issue = 4 | pages = 454–65 | year = 2003 | pmid = 12533125 | doi = 10.1001/jama.289.4.454 }}&amp;lt;/ref&amp;gt; A 2004 study of 1999–2001 RCTs published in leading medical and surgical journals determined that industry-funded RCTs &amp;quot;are more likely to be associated with statistically significant pro-industry findings.&amp;quot;&amp;lt;ref name=&amp;quot;Bhandari-2004&amp;quot;&amp;gt;{{Cite journal |vauthors=Bhandari M, Busse JW, Jackowski D, Montori VM, Schünemann H, Sprague S, Mears D, Schemitsch EH, Heels-Ansdell D, Devereaux PJ | title = Association between industry funding and statistically significant pro-industry findings in medical and surgical randomized trials | journal = [[Can Med Assoc J]] | volume = 170 | issue = 4 | pages = 477–80 | year = 2004 | url = http://ecmaj.com/cgi/content/full/170/4/477 | pmid = 14970094 | pmc = 332713 }}&amp;lt;/ref&amp;gt; These results have been mirrored in trials in surgery, where although industry funding did not affect the rate of trial discontinuation it was however associated with a lower odds of publication for completed trials.&amp;lt;ref name=&amp;quot;Chapman-2014&amp;quot;&amp;gt;{{Cite journal |vauthors=Chapman SJ, Shelton B, Mahmood H, Fitzgerald JE, Harrison EM, Bhangu A | title = Discontinuation and non-publication of surgical randomised controlled trials: observational study | journal = [[BMJ]] | volume = 349 | page = g6870| year = 2014 | pmid = 25491195 | pmc = 4260649 | doi=10.1136/bmj.g6870}}&amp;lt;/ref&amp;gt; One possible reason for the pro-industry results in industry-funded published RCTs is [[publication bias]].&amp;lt;ref name=&amp;quot;Bhandari-2004&amp;quot;/&amp;gt;  Other authors have cited the differing goals of academic and industry sponsored research as contributing to the difference. Commercial sponsors may be more focused on performing trials of drugs that have already shown promise in early stage trials, and on replicating previous positive results to fulfill regulatory requirements for drug approval.&amp;lt;ref&amp;gt;{{cite journal |vauthors=Ridker PM, Torres J |title=Reported outcomes in major cardiovascular clinical trials funded by for-profit and not-for-profit organizations: 2000-2005 |journal=JAMA |volume=295 |issue=19 |pages=2270–4 |year=2006 |pmid=16705108 |doi=10.1001/jama.295.19.2270 |doi-access=free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Some RCTs are fully or partly funded by the health care industry (e.g., the pharmaceutical industry) as opposed to government, nonprofit, or other sources. A systematic review published in 2003 found four 1986–2002 articles comparing industry-sponsored and nonindustry-sponsored RCTs, and in all the articles there was a correlation of industry sponsorship and positive study outcome. A 2004 study of 1999–2001 RCTs published in leading medical and surgical journals determined that industry-funded RCTs &amp;quot;are more likely to be associated with statistically significant pro-industry findings.&amp;quot; These results have been mirrored in trials in surgery, where although industry funding did not affect the rate of trial discontinuation it was however associated with a lower odds of publication for completed trials. One possible reason for the pro-industry results in industry-funded published RCTs is publication bias.&lt;br /&gt;
&lt;br /&gt;
有些 rct 完全或部分由医疗保健行业(如制药行业)资助，而不是政府、非营利组织或其他来源。2003年发表的一份系统综述研究报告发现，1986年至2002年间，有4篇文章比较了行业赞助和非行业赞助的 rct，在所有的文章中，行业赞助和正面研究结果之间存在相关性。2004年发表在主要医学和外科杂志上的一项关于1999-2001年的 rct 的研究表明，工业资助的 rct“更有可能与具有统计学意义的有利于工业的发现相关联。”这些结果已经反映在手术试验中，虽然行业资金并不影响试验中止率，但是与完成试验的发表机率较低相关。支持产业的结果在产业资助的已发表的研究报告中出现的一个可能的原因是出版偏见。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Category:Clinical research&lt;br /&gt;
&lt;br /&gt;
类别: 临床研究&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Category:Epidemiological study projects&lt;br /&gt;
&lt;br /&gt;
类别: 流行病学研究项目&lt;br /&gt;
&lt;br /&gt;
Category:Evidence-based practices&lt;br /&gt;
&lt;br /&gt;
类别: 循证做法&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Category:Design of experiments&lt;br /&gt;
&lt;br /&gt;
类别: 实验设计&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Category:Causal inference&lt;br /&gt;
&lt;br /&gt;
类别: 因果推理&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Category:Experiments&lt;br /&gt;
&lt;br /&gt;
分类: 实验&lt;br /&gt;
Category:Research methods&lt;br /&gt;
&lt;br /&gt;
分类: 研究方法&lt;br /&gt;
&lt;br /&gt;
&amp;lt;noinclude&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&amp;lt;small&amp;gt;This page was moved from [[wikipedia:en:Randomized controlled trial]]. Its edit history can be viewed at [[随机对照试验/edithistory]]&amp;lt;/small&amp;gt;&amp;lt;/noinclude&amp;gt;&lt;br /&gt;
&lt;br /&gt;
[[Category:待整理页面]]&lt;/div&gt;</summary>
		<author><name>李昊轩</name></author>
	</entry>
	<entry>
		<id>https://wiki.swarma.org/index.php?title=%E9%9A%8F%E6%9C%BA%E5%AF%B9%E7%85%A7%E8%AF%95%E9%AA%8C&amp;diff=24251</id>
		<title>随机对照试验</title>
		<link rel="alternate" type="text/html" href="https://wiki.swarma.org/index.php?title=%E9%9A%8F%E6%9C%BA%E5%AF%B9%E7%85%A7%E8%AF%95%E9%AA%8C&amp;diff=24251"/>
		<updated>2021-07-05T05:29:10Z</updated>

		<summary type="html">&lt;p&gt;李昊轩：&lt;/p&gt;
&lt;hr /&gt;
&lt;div&gt;此词条暂由彩云小译翻译，翻译字数共2766，未经人工整理和审校，带来阅读不便，请见谅。&lt;br /&gt;
&lt;br /&gt;
{{Short description|Experimental method designed to reduce bias, typically accomplished by randomly allocating subjects to two or more groups, with one being a control group}}&lt;br /&gt;
&lt;br /&gt;
[[File:Flowchart of Phases of Parallel Randomized Trial - Modified from CONSORT 2010.png|thumb|upright=1.5|Flowchart of four phases (enrollment, allocation, intervention, follow-up, and data analysis) of a parallel randomized trial of two groups (in a controlled trial, one of the interventions serves as the control), modified from the CONSORT (Consolidated Standards of Reporting Trials) 2010 Statement&amp;lt;ref name=&amp;quot;Schulz-2010&amp;quot;&amp;gt;{{Cite journal | author = Schulz KF, Altman DG, ((Moher D; for the CONSORT Group)) | title = CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials | journal = [[Br Med J]] | volume = 340 | pages = c332 | year = 2010 | doi = 10.1136/bmj.c332 | pmid = 20332509 | pmc = 2844940 }}&amp;lt;/ref&amp;gt;|链接=Special:FilePath/Flowchart_of_Phases_of_Parallel_Randomized_Trial_-_Modified_from_CONSORT_2010.png]]&lt;br /&gt;
&lt;br /&gt;
Flowchart of four phases (enrollment, allocation, intervention, follow-up, and data analysis) of a parallel randomized trial of two groups (in a controlled trial, one of the interventions serves as the control), modified from the CONSORT (Consolidated Standards of Reporting Trials) 2010 Statement.&lt;br /&gt;
&lt;br /&gt;
据修改的2010年CONSORT (综合报告试验标准)要求，流程图包括：两组平行随机试验分为登记、分配、干预、随访和数据分析四个阶段，在对照试验中，需要其中一项干预作为对照处理措施。 &lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
A '''randomized controlled trial''' (or '''randomized control trial''';&amp;lt;ref name=&amp;quot;Chalmers-1981&amp;quot;&amp;gt;{{Cite journal |vauthors=Chalmers TC, ((Smith H Jr)), Blackburn B, Silverman B, Schroeder B, Reitman D, Ambroz A | title = A method for assessing the quality of a randomized control trial | journal = [[Controlled Clinical Trials]] | volume = 2 | issue = 1 | pages = 31–49 | year = 1981 | doi = 10.1016/0197-2456(81)90056-8 | pmid = 7261638 }}&amp;lt;/ref&amp;gt; '''RCT''') is a type of ''[[scientific experiment]]'' (e.g. a ''[[clinical trial]]'') or ''intervention study'' (as opposed to ''[[observational study]]'') that aims to reduce certain sources of bias when testing the effectiveness of new treatments; this is accomplished by [[Random assignment|randomly allocating]] subjects to two or more groups, treating them differently, and then comparing them with respect to a measured response. One group—the experimental group—receives the intervention being assessed, while the other—usually called the control group—receives an alternative treatment, such as a [[placebo]] or no intervention. The groups are monitored under conditions of the trial design to determine the effectiveness of the experimental intervention, and efficacy is assessed in comparison to the control. &amp;lt;ref&amp;gt;{{cite web|url=https://www.nice.org.uk/glossary?letter=r|publisher=National Institute for Health and Care Excellence, London, UK|title=Randomised controlled trial|date=2019|access-date=3 June 2019}}&amp;lt;/ref&amp;gt; There may be more than one treatment group or more than one [[Treatment and control groups|control group]].&lt;br /&gt;
&lt;br /&gt;
A randomized controlled trial (or randomized control trial; RCT) is a type of scientific experiment (e.g. a clinical trial) or intervention study (as opposed to observational study) that aims to reduce certain sources of bias when testing the effectiveness of new treatments; this is accomplished by randomly allocating subjects to two or more groups, treating them differently, and then comparing them with respect to a measured response. One group—the experimental group—receives the intervention being assessed, while the other—usually called the control group—receives an alternative treatment, such as a placebo or no intervention. The groups are monitored under conditions of the trial design to determine the effectiveness of the experimental intervention, and efficacy is assessed in comparison to the control.  There may be more than one treatment group or more than one control group.&lt;br /&gt;
&lt;br /&gt;
随机对照试验(A randomized controlled trial, RCT)是一种科学实验(例如:临床试验)或干预研究(区别于观察性研究) ，其目的是在测试新治疗的有效性时减少某些偏倚来源。通过受试者随机分配到两个或两个以上的组，经过不同的处理，产生的效应再与一个有可控的处理效应相比较。即一组或多组(实验组)接受正在评估的干预措施，而另一组(通常称为对照组)接受替代治疗，如安慰剂或无干预措施。在试验设计的条件下对这些组进行监测，以确定实验干预的有效性，并与对照组进行疗效比较评估。当然这也包括一个以上的治疗组或一个以上的对照组。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
The trial may be [[blinded experiment|blinded]], meaning that information which may influence the participants is withheld until after the experiment is complete. A blind can be imposed on any participant of an experiment, including subjects, researchers, technicians, data analysts, and evaluators. Effective blinding may reduce or eliminate some sources of experimental [[bias]].&lt;br /&gt;
&lt;br /&gt;
The trial may be blinded, meaning that information which may influence the participants is withheld until after the experiment is complete. A blind can be imposed on any participant of an experiment, including subjects, researchers, technicians, data analysts, and evaluators. Effective blinding may reduce or eliminate some sources of experimental bias.&lt;br /&gt;
&lt;br /&gt;
试验可能采用了盲法，这意味着影响参与者的信息在试验完成后才会公布。试验的任何参与者，包括受试者、研究人员、技术人员、数据分析人员和评估人员，都可能被强加盲。有效的盲法可以减少或消除某些试验偏差的来源。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
The randomness in the assignment of subjects to groups reduces [[selection bias]] and allocation bias, balancing both known and unknown prognostic factors, in the assignment of treatments.&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;&amp;gt;{{Cite journal |vauthors=Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG | title = CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials | journal = [[Br Med J]] | volume = 340 | pages = c869 | year = 2010 | doi = 10.1136/bmj.c869 | pmid = 20332511 | pmc = 2844943 }}&amp;lt;/ref&amp;gt; Blinding reduces other forms of [[Observer-expectancy effect|experimenter and subject biases]].&lt;br /&gt;
&lt;br /&gt;
The randomness in the assignment of subjects to groups reduces selection bias and allocation bias, balancing both known and unknown prognostic factors, in the assignment of treatments. Blinding reduces other forms of experimenter and subject biases.&lt;br /&gt;
&lt;br /&gt;
在分配治疗方案时，受试者随机地被分配到不同组。这个随机化过程减少了选择偏差和分配偏差，平衡了已知和未知的预后因素。盲法减少了其他形式的实验者和主体偏见。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
A well-blinded RCT is often considered the [[Gold standard (test)|gold standard]] for [[clinical trial]]s. Blinded RCTs are commonly used to test the [[Efficacy#Medicine|efficacy]] of medical [[Health intervention|intervention]]s and may additionally provide information about adverse effects, such as [[adverse drug reactions|drug reactions]]. A randomized controlled trial can provide compelling evidence that the study treatment causes an effect on human health.&amp;lt;ref name=&amp;quot;hannan&amp;quot;&amp;gt;{{cite journal | vauthors = Hannan EL | title = Randomized clinical trials and observational studies: guidelines for assessing respective strengths and limitations | journal = JACC. Cardiovascular Interventions | volume = 1 | issue = 3 | pages = 211–7 | date = June 2008 | pmid = 19463302 | doi = 10.1016/j.jcin.2008.01.008 | doi-access = free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
A well-blinded RCT is often considered the gold standard for clinical trials. Blinded RCTs are commonly used to test the efficacy of medical interventions and may additionally provide information about adverse effects, such as drug reactions. A randomized controlled trial can provide compelling evidence that the study treatment causes an effect on human health.&lt;br /&gt;
&lt;br /&gt;
一个良好盲法的 RCT 通常被认为是临床试验的黄金标准。盲法随机对照试验通常用于检测医疗干预措施的效果，并且还可能提供关于药物反应等不良反应的信息。随机对照试验可以提供令人信服的证据，证明研究治疗对人类健康产生了影响。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
The terms &amp;quot;RCT&amp;quot; and &amp;quot;'''randomized trial'''&amp;quot; are sometimes used synonymously, but the latter term omits mention of controls and can therefore describe studies that compare multiple treatment groups with each other in the absence of a control group.&amp;lt;ref name=&amp;quot;Ranjith-2005&amp;quot;&amp;gt;{{Cite journal | author = Ranjith G | title = Interferon-α-induced depression: when a randomized trial is not a randomized controlled trial | journal = [[Psychother Psychosom]] | volume = 74 | issue = 6 | pages = 387; author reply 387–8 | year = 2005 | doi = 10.1159/000087787 | pmid = 16244516 | s2cid = 143644933 }}&amp;lt;/ref&amp;gt; Similarly, the [[initialism]] is sometimes expanded as &amp;quot;'''randomized clinical trial'''&amp;quot; or &amp;quot;'''randomized comparative trial'''&amp;quot;, leading to ambiguity in the [[scientific literature]].&amp;lt;ref name=&amp;quot;Peto-1976&amp;quot;&amp;gt;{{Cite journal |vauthors=Peto R, Pike MC, Armitage P, Breslow NE, Cox DR, Howard SV, Mantel N, McPherson K, Peto J, Smith PG | title = Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design | journal = [[Br J Cancer]] | volume = 34 | issue = 6 | pages = 585–612 | year = 1976 | pmc=2025229 | pmid = 795448 | doi = 10.1038/bjc.1976.220 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Peto-1977&amp;quot;&amp;gt;{{Cite journal |vauthors=Peto R, Pike MC, Armitage P, Breslow NE, Cox DR, Howard SV, Mantel N, McPherson K, Peto J, Smith PG | title = Design and analysis of randomized clinical trials requiring prolonged observation of each patient. II. Analysis and examples | journal = [[Br J Cancer]] | volume = 35 | issue = 1 | pages = 1–39 | year = 1977 | pmc=2025310 | pmid = 831755 | doi = 10.1038/bjc.1977.1 }}&amp;lt;/ref&amp;gt; Not all randomized clinical trials are randomized ''controlled'' trials (and some of them could never be, as in cases where controls would be impractical or unethical to institute). The term '''randomized controlled clinical trial''' is an alternative term used in [[clinical research]];&amp;lt;ref name=&amp;quot;Wollert-2004&amp;quot;&amp;gt;{{Cite journal |vauthors=Wollert KC, Meyer GP, Lotz J, Ringes-Lichtenberg S, Lippolt P, Breidenbach C, Fichtner S, Korte T, Hornig B, Messinger D, Arseniev L, Hertenstein B, Ganser A, Drexler H | title = Intracoronary autologous bone-marrow cell transfer after myocardial infarction: the BOOST randomised controlled clinical trial | journal = [[The Lancet|Lancet]] | volume = 364 | issue = 9429 | pages = 141–8 | year = 2004 | doi = 10.1016/S0140-6736(04)16626-9 | pmid = 15246726 | s2cid = 24361586 }}&amp;lt;/ref&amp;gt; however, RCTs are also employed in other research areas, including [[#In social science|many of the social sciences]].&lt;br /&gt;
&lt;br /&gt;
The terms &amp;quot;RCT&amp;quot; and &amp;quot;randomized trial&amp;quot; are sometimes used synonymously, but the latter term omits mention of controls and can therefore describe studies that compare multiple treatment groups with each other in the absence of a control group. Similarly, the initialism is sometimes expanded as &amp;quot;randomized clinical trial&amp;quot; or &amp;quot;randomized comparative trial&amp;quot;, leading to ambiguity in the scientific literature. Not all randomized clinical trials are randomized controlled trials (and some of them could never be, as in cases where controls would be impractical or unethical to institute). The term randomized controlled clinical trial is an alternative term used in clinical research; however, RCTs are also employed in other research areas, including many of the social sciences.&lt;br /&gt;
&lt;br /&gt;
“ RCT”和“随机试验”这两个术语有时被用作同义词，但后一个术语没有提到对照，因此可以描述在没有对照组的情况下相互比较多个治疗组的研究。科学文献中常有“随机临床试验”或“随机比较试验”这类引发歧义的术语。并非所有的随机临床试验都是随机对照试验(其中一些试验永远不可能成为随机对照试验，因为实施控制是不切实际或不道德的)。随机对照临床试验这个术语是临床研究中使用的另一个术语; 然而，随机对照临床试验也被用于其他研究领域，包括许多社会科学。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
{{toc limit}}&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
== History ==&lt;br /&gt;
&lt;br /&gt;
The first reported [[clinical trial]] was conducted by [[James Lind]] in 1747 to identify treatment for [[scurvy]].&amp;lt;ref&amp;gt;{{cite journal | pmc=1720613 | pmid=9059193 | volume=76 |issue = 1| title=James Lind (1716-94) of Edinburgh and the treatment of scurvy | date=January 1997 | author=Dunn PM | journal=Arch. Dis. Child. Fetal Neonatal Ed. | pages=F64–5 | doi=10.1136/fn.76.1.f64}}&amp;lt;/ref&amp;gt; [[Randomized experiment]]s appeared in [[experimental psychology|psychology]], where they were introduced by [[Charles Sanders Peirce]] and [[Joseph Jastrow]] in the 1880s,&amp;lt;ref&amp;gt;{{cite journal| author=[[Charles Sanders Peirce]] and [[Joseph Jastrow]]|year=1885|title=On Small Differences in Sensation| journal=Memoirs of the National Academy of Sciences|volume=3|pages=73–83|url=http://psychclassics.yorku.ca/Peirce/small-diffs.htm}} http://psychclassics.yorku.ca/Peirce/small-diffs.htm&amp;lt;/ref&amp;gt; and in [[school of education|education]].&amp;lt;ref&amp;gt;{{cite journal|doi=10.1086/354775|first=Ian|last=Hacking|author-link=Ian Hacking | title=Telepathy: Origins of Randomization in Experimental Design|journal=[[Isis (journal)|Isis]]|series=A Special Issue on Artifact and Experiment|volume=79|issue=3|date=September 1988 |pages=427–451|jstor=234674|mr=1013489|s2cid=52201011}}&amp;lt;/ref&amp;gt;&amp;lt;ref&amp;gt;{{cite journal|doi=10.1086/444032|author=Stephen M. Stigler|title=A Historical View of Statistical Concepts in Psychology and Educational Research| journal=American Journal of Education| volume=101|issue=1|date=November 1992|pages=60–70|s2cid=143685203|author-link=Stephen M. Stigler}}&amp;lt;/ref&amp;gt;&amp;lt;ref&amp;gt;{{cite journal|doi=10.1086/383850|author=Trudy Dehue|title=Deception, Efficiency, and Random Groups: Psychology and the Gradual Origination of the Random Group Design|journal=[[Isis (journal)|Isis]]|volume=88|issue=4|date=December 1997|pages=653–673|pmid=9519574|s2cid=23526321|url=https://pure.rug.nl/ws/files/71855616/237831.pdf}}&amp;lt;/ref&amp;gt; Later, in the early 20th century, randomized experiments appeared in agriculture, due to [[Jerzy Neyman]]&amp;lt;ref&amp;gt;Neyman, Jerzy. 1923 [1990]. &amp;quot;On the Application of Probability Theory to AgriculturalExperiments. Essay on Principles. Section 9.&amp;quot; ''Statistical Science'' 5 (4): 465–472. Trans. Dorota M. Dabrowska and Terence P. Speed.&amp;lt;/ref&amp;gt; and [[Ronald A. Fisher]]. Fisher's experimental research and his writings popularized randomized experiments.&amp;lt;ref name=&amp;quot;Conniffe&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
The first reported clinical trial was conducted by James Lind in 1747 to identify treatment for scurvy. Randomized experiments appeared in psychology, where they were introduced by Charles Sanders Peirce and Joseph Jastrow in the 1880s, and in education. Later, in the early 20th century, randomized experiments appeared in agriculture, due to Jerzy Neyman and Ronald A. Fisher. Fisher's experimental research and his writings popularized randomized experiments.&lt;br /&gt;
&lt;br /&gt;
据报道，1747年詹姆斯•林德进行了第一个临床试验，目的是确定治疗坏血病的方法。在19世纪80年代，查尔斯•桑德斯•皮尔士和约瑟夫 • 杰斯特罗在心理学和教育学领域引入随机实验。后来，在20世纪早期，奈曼和罗纳德•费希尔将随机实验引入农业研究。费希尔的实验研究和他的著作普及了随机实验。&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;The first published RCT in medicine appeared in the 1948 paper entitled &amp;quot;[[Streptomycin]] treatment of pulmonary [[tuberculosis]]&amp;quot;, which described a [[Medical Research Council (UK)|Medical Research Council]] investigation.&amp;lt;ref name=&amp;quot;MRC-1948&amp;quot;&amp;gt;{{Cite journal | author = Streptomycin in Tuberculosis Trials Committee | title = Streptomycin treatment of pulmonary tuberculosis. A Medical Research Council investigation| journal = [[Br Med J]] | volume = 2 | issue = 4582 | pages = 769–82 | year = 1948 | doi = 10.1136/bmj.2.4582.769 | pmid = 18890300 | pmc = 2091872 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Brown-1998&amp;quot;&amp;gt;{{cite news |title= Landmark study made research resistant to bias |author= Brown D |newspaper= [[Washington Post]] |date=1998-11-02 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Shikata-2006&amp;quot;&amp;gt;{{Cite journal |vauthors=Shikata S, Nakayama T, Noguchi Y, Taji Y, Yamagishi H | title = Comparison of effects in randomized controlled trials with observational studies in digestive surgery | journal = [[Ann Surg]] | volume = 244 | issue = 5 | pages = 668–76 | year = 2006 | doi = 10.1097/01.sla.0000225356.04304.bc | pmc=1856609 | pmid = 17060757 }}&amp;lt;/ref&amp;gt; One of the authors of that paper was [[Austin Bradford Hill]], who is credited as having conceived the modern RCT.&amp;lt;ref name=&amp;quot;Stolberg-2004&amp;quot;&amp;gt;{{Cite journal |vauthors=Stolberg HO, Norman G, Trop I | title = Randomized controlled trials | journal = [[Am J Roentgenol]] | volume = 183 | issue = 6 | pages = 1539–44 | year = 2004 | pmid = 15547188 | doi=10.2214/ajr.183.6.01831539}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;The first published RCT in medicine appeared in the 1948 paper entitled &amp;quot;Streptomycin treatment of pulmonary tuberculosis&amp;quot;, which described a Medical Research Council investigation. One of the authors of that paper was Austin Bradford Hill, who is credited as having conceived the modern RCT.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;医学上首次发表的随机对照试验出现在1948年题为“链霉素治疗肺结核”的论文中，这篇论文描述了医学研究理事会的一项调查。这篇论文的作者之一是奥斯汀•布拉德福德•希尔，他被认为是构想出现代 RCT 的人。 &lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;Trial design was further influenced by the large-scale [[International Studies of Infarct Survival|ISIS]] trials on [[heart attack]] treatments that were conducted in the 1980s.&amp;lt;ref&amp;gt;{{cite web| author1=Georgina Ferry |title= Peter Sleight Obituary |url=https://www.theguardian.com/society/2020/nov/02/peter-sleight-obituary |website=The Guardian |date=2 November 2020 |access-date=3 November 2020}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;Trial design was further influenced by the large-scale ISIS trials on heart attack treatments that were conducted in the 1980s.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;20世纪80年代进行的大规模 ISIS 心脏病治疗试验进一步影响了试验设计。&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;By the late 20th century, RCTs were recognized as the standard method for &amp;quot;rational therapeutics&amp;quot; in medicine.&amp;lt;ref name=&amp;quot;Meldrum-2000&amp;quot;&amp;gt;{{Cite journal | author = Meldrum ML | title = A brief history of the randomized controlled trial. From oranges and lemons to the gold standard | journal = [[Hematol Oncol Clin North Am]] | volume = 14 | issue = 4 | pages = 745–60, vii | year = 2000 | doi = 10.1016/S0889-8588(05)70309-9  | pmid = 10949771 | url = https://zenodo.org/record/1260107 }}&amp;lt;/ref&amp;gt;  As of 2004, more than 150,000 RCTs were in the [[Cochrane Library]].&amp;lt;ref name=&amp;quot;Stolberg-2004&amp;quot; /&amp;gt;  To improve the reporting of RCTs in the medical literature, an international group of scientists and editors published [[Consolidated Standards of Reporting Trials]] (CONSORT) Statements in 1996, 2001 and 2010, and these have become widely accepted.&amp;lt;ref name=&amp;quot;Schulz-2010&amp;quot; /&amp;gt;&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot; /&amp;gt; Randomization is the process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce the bias.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;By the late 20th century, RCTs were recognized as the standard method for &amp;quot;rational therapeutics&amp;quot; in medicine.  As of 2004, more than 150,000 RCTs were in the Cochrane Library. has been applied to RCTs, the ethics of RCTs have special considerations.  For one, it has been argued that equipoise itself is insufficient to justify RCTs.  For another, &amp;quot;collective equipoise&amp;quot; can conflict with a lack of personal equipoise (e.g., a personal belief that an intervention is effective).  Finally, Zelen's design, which has been used for some RCTs, randomizes subjects before they provide informed consent, which may be ethical for RCTs of screening and selected therapies, but is likely unethical &amp;quot;for most therapeutic trials.&amp;quot;&lt;br /&gt;
&lt;br /&gt;
&amp;lt;p&amp;gt;到20世纪后期，随机对照试验被公认为医学“合理疗法”的标准方法。截至2004年，美国 Cochrane图书馆有超过15万本随机对照试验。但是，随机对照试验的伦理问题具有特殊性。首先，有人认为平衡本身不足以证明随机对照试验的合理性。另一方面，“集体均势”可能与缺乏个人均势相冲突(例如，个人认为干预是有效的)。最后，Zelen 的设计，已经被用于一些随机试验，在受试者提供知情同意之前随机化，这对于筛选和选择性治疗的随机试验来说可能是合乎道德的，但是对于“大多数治疗试验”来说可能是不道德的。&lt;br /&gt;
&lt;br /&gt;
== Ethics ==&lt;br /&gt;
&lt;br /&gt;
Although subjects almost always provide [[informed consent]] for their participation in an RCT, studies since 1982 have documented that RCT subjects may believe that they are certain to receive treatment that is best for them personally; that is, they do not understand the difference between research and treatment.&amp;lt;ref name=&amp;quot;Appelbaum-1982&amp;quot;&amp;gt;{{Cite journal |vauthors=Appelbaum PS, Roth LH, Lidz C | title = The therapeutic misconception: informed consent in psychiatric research | journal = [[Int J Law Psychiatry]] | volume = 5 | issue = 3–4 | pages = 319–29 | year = 1982 | doi = 10.1016/0160-2527(82)90026-7 | pmid = 6135666 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Henderson-2007&amp;quot;&amp;gt;{{Cite journal |vauthors=Henderson GE, Churchill LR, Davis AM, Easter MM, Grady C, Joffe S, Kass N, King NM, Lidz CW, Miller FG, Nelson DK, Peppercorn J, Rothschild BB, Sankar P, Wilfond BS, Zimmer CR | title = Clinical trials and medical care: defining the therapeutic misconception | journal = [[PLoS Med]] | volume = 4 | issue = 11 | pages = e324 | year = 2007 | doi = 10.1371/journal.pmed.0040324 | pmid = 18044980 | pmc = 2082641 }}&amp;lt;/ref&amp;gt; Further research is necessary to determine the prevalence of and ways to address this &amp;quot;[[therapeutic misconception]]&amp;quot;.&amp;lt;ref name=&amp;quot;Henderson-2007&amp;quot; /&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Although subjects almost always provide informed consent for their participation in an RCT, studies since 1982 have documented that RCT subjects may believe that they are certain to receive treatment that is best for them personally; that is, they do not understand the difference between research and treatment. Further research is necessary to determine the prevalence of and ways to address this &amp;quot;therapeutic misconception&amp;quot;. For example, patients with terminal illness may join trials in the hope of being cured, even when treatments are unlikely to be successful.&lt;br /&gt;
&lt;br /&gt;
一般来说，受试者要为参加随机对照试验提交了知情同意书，但1982年以来的研究记录表明，随机对照试验的受试者可能认为他们肯定会接受对他们个人最好的治疗; 也就是说，他们不理解研究和治疗之间的区别。需要进一步研究，以确定这种”治疗性误解”的流行程度和解决方法。例如，患有晚期疾病的病人可能会加入临床试验，希望治愈，即使治疗不太可能成功的情况下也是如此。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
There are two processes involved in randomizing patients to different interventions. First is choosing a randomization procedure to generate an unpredictable sequence of allocations; this may be a simple random assignment of patients to any of the groups at equal probabilities, may be &amp;quot;restricted&amp;quot;, or may be &amp;quot;adaptive.&amp;quot; A second and more practical issue is allocation concealment, which refers to the stringent precautions taken to ensure that the group assignment of patients are not revealed prior to definitively allocating them to their respective groups. Non-random &amp;quot;systematic&amp;quot; methods of group assignment, such as alternating subjects between one group and the other, can cause &amp;quot;limitless contamination possibilities&amp;quot; and can cause a breach of allocation concealment.&lt;br /&gt;
&lt;br /&gt;
有两个过程涉及到随机化的病人接受到不同的干预。首先是选择一个随机化程序来生成一个不可预测的分配方式; 这可能是一个将病人简单的随机等概率分配到任何一个组，这一过程可能是“受限制的”，或者可能是“适应性的”。第二个更实际的问题是分配隐瞒，即采取严格的预防措施，以确保在将病人到各自的群体之前，不会透露病人的群体分配。非随机的“系统的”分配方法，例如在一组和另一组之间交换主题，可以造成“无限的污染概率”，并可能造成分配隐蔽性被破坏。&lt;br /&gt;
&lt;br /&gt;
=== Trial registration ===&lt;br /&gt;
&lt;br /&gt;
The treatment allocation is the desired proportion of patients in each treatment arm.&lt;br /&gt;
&lt;br /&gt;
治疗分配是指每个治疗机构中患者的期望比例。&lt;br /&gt;
&lt;br /&gt;
In 2004, the [http://www.icmje.org/ International Committee of Medical Journal Editors] (ICMJE) announced that all trials starting enrolment after July 1, 2005 must be registered prior to consideration for publication in one of the 12 member journals of the committee.&amp;lt;ref name=&amp;quot;pmid15356289&amp;quot;&amp;gt;{{cite journal  |vauthors=De Angelis C, Drazen JM, Frizelle FA, etal |title=Clinical trial registration: a statement from the International Committee of Medical Journal Editors |journal=The New England Journal of Medicine |volume=351 |issue=12 |pages=1250–1 |date=September 2004 |pmid=15356289 |doi=10.1056/NEJMe048225 }}&amp;lt;/ref&amp;gt; However, trial registration may still occur late or not at all.&amp;lt;ref name=&amp;quot;pmid22147862&amp;quot;&amp;gt;{{cite journal|vauthors=Law MR, Kawasumi Y, Morgan SG | title=Despite law, fewer than one in eight completed studies of drugs and biologics are reported on time on ClinicalTrials.gov. | journal=Health Aff (Millwood) | year= 2011 | volume= 30 | issue= 12 | pages= 2338–45 | doi=10.1377/hlthaff.2011.0172 | pmid=22147862  | doi-access=free }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;pmid19724045&amp;quot;&amp;gt;{{cite journal|vauthors=Mathieu S, Boutron I, Moher D, Altman DG, Ravaud P | title=Comparison of registered and published primary outcomes in randomized controlled trials. | journal=JAMA | year= 2009 | volume= 302 | issue= 9 | pages= 977–84 | doi=10.1001/jama.2009.1242 | pmid=19724045  | doi-access=free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
In 2004, the [http://www.icmje.org/ International Committee of Medical Journal Editors] (ICMJE) announced that all trials starting enrolment after July 1, 2005 must be registered prior to consideration for publication in one of the 12 member journals of the committee. However, trial registration may still occur late or not at all.&lt;br /&gt;
&lt;br /&gt;
2004年， 医学杂志编辑国际委员会(ICMJE)宣布，所有在2005年7月1日之后考虑在该委员会12种杂志上发表之前，必须对试验进行注册。尽管如此，试验登记可能仍然延迟或根本不会发生。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Medical journals have been slow in adapting policies requiring mandatory clinical trial registration as a prerequisite for publication.&amp;lt;ref&amp;gt;{{cite journal|last1=Bhaumik|first1=S|title=Editorial policies of MEDLINE indexed Indian journals on clinical trial registration.|journal=Indian Pediatr.|date=Mar 2013|volume=50|issue=3|pages=339–40|pmid=23680610|doi=10.1007/s13312-013-0092-2|s2cid=40317464}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Medical journals have been slow in adapting policies requiring mandatory clinical trial registration as a prerequisite for publication.&lt;br /&gt;
&lt;br /&gt;
医学期刊将强制性临床试验登记作为发表的先决条件进展缓慢。&lt;br /&gt;
&lt;br /&gt;
== Classifications ==&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
=== By study design ===&lt;br /&gt;
&lt;br /&gt;
One way to classify RCTs is by [[study design]].  From most to least common in the healthcare literature, the major categories of RCT study designs are:&amp;lt;ref name=&amp;quot;Hopewell-2010&amp;quot;&amp;gt;{{Cite journal |vauthors=Hopewell S, Dutton S, Yu LM, Chan AW, Altman DG | title = The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed | journal = BMJ | volume = 340 | pages = c723 | year = 2010 | doi = 10.1136/bmj.c723  | pmid = 20332510 | pmc = 2844941 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
通过研究设计对 RCT 进行分类。从最常见到最不常见，RCT 研究设计的主要类别是&lt;br /&gt;
&lt;br /&gt;
* [[Parallel study|Parallel-group]] – each participant is randomly assigned to a group, and all the participants in the group receive (or do not receive) an intervention.&amp;lt;ref&amp;gt;{{cite journal |last1=Kaiser |first1=Joerg |last2=Niesen |first2=Willem |last3=Probst |first3=Pascal |last4=Bruckner |first4=Thomas |last5=Doerr-Harim |first5=Colette |last6=Strobel |first6=Oliver |last7=Knebel |first7=Phillip |last8=Diener |first8=Markus K. |last9=Mihaljevic |first9=André L. |last10=Büchler |first10=Markus W. |last11=Hackert |first11=Thilo |title=Abdominal drainage versus no drainage after distal pancreatectomy: study protocol for a randomized controlled trial |journal=Trials |date=7 June 2019 |volume=20 |issue=1 |page=332 |doi=10.1186/s13063-019-3442-0|pmid=31174583 |pmc=6555976 |doi-access=free }}&amp;lt;/ref&amp;gt;&amp;lt;ref&amp;gt;{{cite journal |last1=Farag |first1=Sara M. |last2=Mohammed |first2=Manal O. |last3=EL-Sobky |first3=Tamer A. |last4=ElKadery |first4=Nadia A. |last5=ElZohiery |first5=Abeer K. |title=Botulinum Toxin A Injection in Treatment of Upper Limb Spasticity in Children with Cerebral Palsy: A Systematic Review of Randomized Controlled Trials |journal=JBJS Reviews |date=March 2020 |volume=8 |issue=3 |pages=e0119 |doi=10.2106/JBJS.RVW.19.00119 |pmid=32224633|pmc=7161716 |doi-access=free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* 平行试验：每个参与者被随机分配到一个组，组中的所有参与者都接受(或不接受)干预。&lt;br /&gt;
&lt;br /&gt;
* [[Crossover study|Crossover]] – over time, each participant receives (or does not receive) an intervention in a random sequence.&amp;lt;ref&amp;gt;{{cite book  | last = Jones | first = Byron |author2=Kenward, Michael G.  | title = Design and Analysis of Cross-Over Trials | edition=Second| publisher = London: Chapman and Hall | year = 2003 }}&amp;lt;/ref&amp;gt;&amp;lt;ref&amp;gt;{{cite book  | last = Vonesh | first = Edward F. |author2=Chinchilli, Vernon G.  | chapter=Crossover Experiments| pages=111–202|title = Linear and Nonlinear Models for the Analysis of Repeated Measurements | publisher = London: Chapman and Hall | year = 1997 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* 交叉试验：随着时间的推移，每个参与者都会接受(或不接受)随机序列的干预。&lt;br /&gt;
&lt;br /&gt;
* [[Cluster randomised controlled trial|Cluster]] – pre-existing groups of participants (e.g., villages, schools) are randomly selected to receive (or not receive) an intervention.&amp;lt;ref&amp;gt;{{cite journal |last1=Gall |first1=Stefanie |last2=Adams |first2=Larissa |last3=Joubert |first3=Nandi |last4=Ludyga |first4=Sebastian |last5=Müller |first5=Ivan |last6=Nqweniso |first6=Siphesihle |last7=Pühse |first7=Uwe |last8=du Randt |first8=Rosa |last9=Seelig |first9=Harald |last10=Smith |first10=Danielle |last11=Steinmann |first11=Peter |last12=Utzinger |first12=Jürg |last13=Walter |first13=Cheryl |last14=Gerber |first14=Markus |last15=van Wouwe |first15=Jacobus P. |title=Effect of a 20-week physical activity intervention on selective attention and academic performance in children living in disadvantaged neighborhoods: A cluster randomized control trial |journal=PLOS ONE |date=8 November 2018 |volume=13 |issue=11 |pages=e0206908 |doi=10.1371/journal.pone.0206908 |pmid=30408073|pmc=6224098 |bibcode=2018PLoSO..1306908G |doi-access=free }}&amp;lt;/ref&amp;gt;&amp;lt;ref&amp;gt;{{cite journal |last1=Gladstone |first1=Melissa J. |last2=Chandna |first2=Jaya |last3=Kandawasvika |first3=Gwendoline |last4=Ntozini |first4=Robert |last5=Majo |first5=Florence D. |last6=Tavengwa |first6=Naume V. |last7=Mbuya |first7=Mduduzi N. N. |last8=Mangwadu |first8=Goldberg T. |last9=Chigumira |first9=Ancikaria |last10=Chasokela |first10=Cynthia M. |last11=Moulton |first11=Lawrence H. |last12=Stoltzfus |first12=Rebecca J. |last13=Humphrey |first13=Jean H. |last14=Prendergast |first14=Andrew J. |last15=Tumwine |first15=James K. |title=Independent and combined effects of improved water, sanitation, and hygiene (WASH) and improved complementary feeding on early neurodevelopment among children born to HIV-negative mothers in rural Zimbabwe: Substudy of a cluster-randomized trial |journal=PLOS Medicine |date=21 March 2019 |volume=16 |issue=3 |pages=e1002766 |doi=10.1371/journal.pmed.1002766|pmid=30897095 |pmc=6428259 |doi-access=free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* 聚类试验：预先存在的参与者组(例如，村庄、学校)被随机选择以接受(或不接受)干预。&lt;br /&gt;
&lt;br /&gt;
* [[Factorial experiment|Factorial]] – each participant is randomly assigned to a group that receives a particular combination of interventions or non-interventions (e.g., group 1 receives vitamin X and vitamin Y, group 2 receives vitamin X and placebo Y, group 3 receives placebo X and vitamin Y, and group 4 receives placebo X and placebo Y).&lt;br /&gt;
* 因子试验：每个参与者被随机分配到一个接受干预或非干预特定组合的组(例如，第1组接受维生素X和维生素Y，第2组接受维生素X和安慰剂Y，第3组接受安慰剂X和维生素Y，第4组接受安慰剂X和安慰剂Y)。&lt;br /&gt;
&lt;br /&gt;
An analysis of the 616 RCTs indexed in [[PubMed]] during December 2006 found that 78% were parallel-group trials, 16% were crossover, 2% were split-body, 2% were cluster, and 2% were factorial.&amp;lt;ref name=&amp;quot;Hopewell-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
An analysis of the 616 RCTs indexed in PubMed during December 2006 found that 78% were parallel-group trials, 16% were crossover, 2% were split-body, 2% were cluster, and 2% were factorial. &lt;br /&gt;
&lt;br /&gt;
对2006年12月在 PubMed 收录的616例随机对照试验的分析发现，78% 为平行组试验，16% 为交叉组试验，2% 为分体组试验，2% 为聚类组试验，2% 为因子组试验。&lt;br /&gt;
&lt;br /&gt;
To balance group sizes in smaller RCTs, some form of &amp;quot;restricted&amp;quot; randomization is recommended.&lt;br /&gt;
&lt;br /&gt;
为了在较小的随机对照试验中平衡组的大小，建议采用某种形式的“受限”随机化。&lt;br /&gt;
&lt;br /&gt;
=== By outcome of interest (efficacy vs. effectiveness) ===&lt;br /&gt;
&lt;br /&gt;
{{Main|Pragmatic clinical trial}}&lt;br /&gt;
&lt;br /&gt;
RCTs can be classified as &amp;quot;explanatory&amp;quot; or &amp;quot;pragmatic.&amp;quot;&amp;lt;ref name=&amp;quot;Zwarenstein-2008&amp;quot;&amp;gt;{{Cite journal | author = Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D; CONSORT group; Pragmatic Trials in Healthcare (Practihc) group | title = Improving the reporting of pragmatic trials: an extension of the CONSORT statement | journal = BMJ | volume = 337 | pages = a2390 | year = 2008 | doi = 10.1136/bmj.a2390 | pmid = 19001484 | pmc=3266844}}&amp;lt;/ref&amp;gt; Explanatory RCTs test [[Efficacy#Medicine|efficacy]] in a research setting with highly selected participants and under highly controlled conditions.&amp;lt;ref name=&amp;quot;Zwarenstein-2008&amp;quot;/&amp;gt; In contrast, pragmatic RCTs (pRCTs) test [[Effectiveness#Usage|effectiveness]] in everyday practice with relatively unselected participants and under flexible conditions; in this way, pragmatic RCTs can &amp;quot;inform decisions about practice.&amp;quot;&amp;lt;ref name=&amp;quot;Zwarenstein-2008&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
RCTs can be classified as &amp;quot;explanatory&amp;quot; or &amp;quot;pragmatic.&amp;quot; Explanatory RCTs test efficacy in a research setting with highly selected participants and under highly controlled conditions. In contrast, pragmatic RCTs (pRCTs) test effectiveness in everyday practice with relatively unselected participants and under flexible conditions; in this way, pragmatic RCTs can &amp;quot;inform decisions about practice.&amp;quot;&lt;br /&gt;
&lt;br /&gt;
随机对照试验可分为“解释性”或“实用性”。解释性随机对照试验在高度选定的参与者和高度受控的条件下测试有效性。相比之下，实用性随机对照测验(pragmatic RCTs, pRCT)在相对未经选择的参与者和灵活的条件下，在日常实践中检验有效性，这样，实用随机对照测验可以“为实践决策提供信息”。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
=== By hypothesis (superiority vs. noninferiority vs. equivalence) ===&lt;br /&gt;
&lt;br /&gt;
Another classification of RCTs categorizes them as &amp;quot;superiority trials&amp;quot;, &amp;quot;noninferiority trials&amp;quot;, and &amp;quot;equivalence trials&amp;quot;, which differ in methodology and reporting.&amp;lt;ref name=&amp;quot;Piaggio-2006&amp;quot;&amp;gt;{{Cite journal | author = Piaggio G, Elbourne DR, [[Doug Altman|Altman DG]], [[Stuart Pocock|Pocock SJ]], Evans SJ; CONSORT Group | title = Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement | journal = JAMA | volume = 295 | issue = 10 | pages = 1152–60 |  year = 2006 | doi = 10.1001/jama.295.10.1152 | pmid = 16522836 | url = http://researchonline.lshtm.ac.uk/12069/1/Reporting%20of%20Noninferiority%20and%20Equivalence%20Randomized%20Trials.pdf }}&amp;lt;/ref&amp;gt; Most RCTs are superiority trials, in which one intervention is hypothesized to be superior to another in a [[Statistical significance|statistically significant]] way.&amp;lt;ref name=&amp;quot;Piaggio-2006&amp;quot;/&amp;gt; Some RCTs are noninferiority trials &amp;quot;to determine whether a new treatment is no worse than a reference treatment.&amp;quot;&amp;lt;ref name=&amp;quot;Piaggio-2006&amp;quot;/&amp;gt; Other RCTs are equivalence trials in which the hypothesis is that two interventions are indistinguishable from each other.&amp;lt;ref name=&amp;quot;Piaggio-2006&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Another classification of RCTs categorizes them as &amp;quot;superiority trials&amp;quot;, &amp;quot;noninferiority trials&amp;quot;, and &amp;quot;equivalence trials&amp;quot;, which differ in methodology and reporting. Most RCTs are superiority trials, in which one intervention is hypothesized to be superior to another in a statistically significant way. Some RCTs are noninferiority trials &amp;quot;to determine whether a new treatment is no worse than a reference treatment.&amp;quot; Other RCTs are equivalence trials in which the hypothesis is that two interventions are indistinguishable from each other.&lt;br /&gt;
&lt;br /&gt;
随机对照试验的另一种分类是“优越性试验”、“非劣性试验”和“等效性试验”，它们在方法和报告上有所不同。大多数随机对照试验都是优势试验，其中一种干预措施被假设在统计学意义上优于另一种干预措施。一些随机对照试验是非劣效性试验，“以确定一种新的治疗方法是否比一种参考治疗方法更差。”其他随机对照试验是等效试验，其中的假设是两种干预措施彼此不可区分。&lt;br /&gt;
&lt;br /&gt;
== Randomization ==&lt;br /&gt;
&lt;br /&gt;
The advantages of proper [[randomized experiment|randomization]] in RCTs include:&amp;lt;ref name=&amp;quot;SchulzGrimes2002&amp;quot;&amp;gt;{{Cite journal |vauthors=Schulz KF, Grimes DA | title = Generation of allocation sequences in randomised trials: chance, not choice | journal = Lancet | volume = 359 | issue = 9305 | pages = 515–9 | year = 2002 | doi = 10.1016/S0140-6736(02)07683-3 | url =https://www.who.int/entity/rhl/LANCET_515-519.pdf | pmid = 11853818 | s2cid = 291300 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
* &amp;quot;It eliminates bias in treatment assignment,&amp;quot; specifically [[selection bias]] and [[confounding]].&lt;br /&gt;
&lt;br /&gt;
* &amp;quot;It facilitates blinding (masking) of the identity of treatments from investigators, participants, and assessors.&amp;quot;&lt;br /&gt;
&lt;br /&gt;
* &amp;quot;It permits the use of probability theory to express the likelihood that any difference in outcome between treatment groups merely indicates chance.&amp;quot;&lt;br /&gt;
&lt;br /&gt;
An RCT may be blinded, (also called &amp;quot;masked&amp;quot;) by &amp;quot;procedures that prevent study participants, caregivers, or outcome assessors from knowing which intervention was received.&amp;quot;  The 2010 CONSORT Statement specifies that authors and editors should not use the terms &amp;quot;single-blind&amp;quot;, &amp;quot;double-blind&amp;quot;, and &amp;quot;triple-blind&amp;quot;; instead, reports of blinded RCT should discuss &amp;quot;If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how.&amp;quot; &amp;quot;open&amp;quot;, or (if the intervention is a medication) &amp;quot;open-label&amp;quot;. In 2008 a study concluded that the results of unblinded RCTs tended to be biased toward beneficial effects only if the RCTs' outcomes were subjective as opposed to objective; In pragmatic RCTs, although the participants and providers are often unblinded, it is &amp;quot;still desirable and often possible to blind the assessor or obtain an objective source of data for evaluation of outcomes.&amp;quot;) and other methods can be used.&lt;br /&gt;
&lt;br /&gt;
一项RCT的盲法是指阻止研究参与者、照顾者或结果评估者知道哪些干预措施，这一程序也称“蒙面”。2010年 CONSORT 声明明确指出，作者和编辑不应使用”单盲”、”双盲”和”三盲”等术语; 相反，关于盲法 RCT 的报告应讨论”如果完成了，干预分配后谁被“蒙面”了(例如，参与者、护理提供者、评估结果的人员)以及如何完成”“开放”，或者(如果干预是一种药物)“开放标签”。2008年的一项研究得出结论认为，只有当随机对照试验的结果是主观的而不是客观的时候，非盲法随机对照试验的结果往往偏向于有益的结果; 在实用的随机对照试验中，尽管参与者和提供者往往是非盲的，但是”仍然需要并且往往可能使评估者“蒙面”，以获得评估结果的客观数据来源”以及其他方法。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
There are two processes involved in randomizing patients to different interventions. First is choosing a ''randomization procedure'' to generate an unpredictable sequence of allocations; this may be a simple random assignment of patients to any of the groups at equal probabilities, may be &amp;quot;restricted&amp;quot;, or may be &amp;quot;adaptive.&amp;quot; A second and more practical issue is ''allocation concealment'', which refers to the stringent precautions taken to ensure that the group assignment of patients are not revealed prior to definitively allocating them to their respective groups. Non-random &amp;quot;systematic&amp;quot; methods of group assignment, such as alternating subjects between one group and the other, can cause &amp;quot;limitless contamination possibilities&amp;quot; and can cause a breach of allocation concealment.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
However empirical evidence that adequate randomization changes outcomes relative to inadequate randomization has been difficult to detect.&amp;lt;ref name=&amp;quot;Howick-2014&amp;quot;&amp;gt;{{Cite journal |vauthors=Howick J, Mebius A | title = In search of justification for the unpredictability paradox | journal = Trials | volume = 15 | pages = 480 | year = 2014 | doi = 10.1186/1745-6215-15-480 | pmid = 25490908 | pmc=4295227}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Regardless of the statistical methods used, important considerations in the analysis of RCT data include:&lt;br /&gt;
&lt;br /&gt;
无论使用何种统计方法，RCT 数据分析中的重要考虑因素包括:&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
=== Procedures ===&lt;br /&gt;
&lt;br /&gt;
The treatment allocation is the desired proportion of patients in each treatment arm.&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
An ideal randomization procedure would achieve the following goals:&amp;lt;ref name=&amp;quot;Lachin-1988a&amp;quot;&amp;gt;{{Cite journal | author = Lachin JM | title = Statistical properties of randomization in clinical trials | journal = [[Controlled Clinical Trials]] | volume = 9 | issue = 4 | pages = 289–311 | year = 1988 | pmid = 3060315 |  doi = 10.1016/0197-2456(88)90045-1 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
An ideal randomization procedure would achieve the following goals:&lt;br /&gt;
&lt;br /&gt;
一个理想的随机化程序将实现以下目标:&lt;br /&gt;
&lt;br /&gt;
Two studies published in The New England Journal of Medicine in 2000 found that observational studies and RCTs overall produced similar results. The authors of the 2000 findings questioned the belief that &amp;quot;observational studies should not be used for defining evidence-based medical care&amp;quot; and that RCTs' results are &amp;quot;evidence of the highest grade.&amp;quot;&lt;br /&gt;
&lt;br /&gt;
2000年发表在《新英格兰医学杂志》上的两项研究发现，观察性研究和随机对照试验总体产生了类似的结果。2000年研究结果的作者质疑“观察性研究不应该被用来定义循证医疗保健”的信念，以及随机对照试验的结果是“最高等级的证据”&lt;br /&gt;
&lt;br /&gt;
* '''Maximize [[statistical power]]''', especially in [[Subgroup analysis|subgroup analyses]].  Generally, equal group sizes maximize statistical power, however, unequal groups sizes may be more powerful for some analyses (e.g., multiple comparisons of placebo versus several doses using Dunnett's procedure&amp;lt;ref&amp;gt;{{cite web|last=Rosenberger|first=James|title=STAT 503 - Design of Experiments|url=https://onlinecourses.science.psu.edu/stat503/node/16|publisher=Pennsylvania State University|access-date=24 September 2012}}&amp;lt;/ref&amp;gt; ), and are sometimes desired for non-analytic reasons (e.g., patients may be more motivated to enroll if there is a higher chance of getting the test treatment, or regulatory agencies may require a minimum number of patients exposed to treatment).&amp;lt;ref name=&amp;quot;Avins-1998&amp;quot;&amp;gt;{{cite journal|last=Avins|first=A L|title=&amp;quot;Can unequal be more fair? Ethics, subject allocation, and randomized clinical trials&amp;quot;.|journal=J Med Ethics|year=1998|volume=24|pages=401–408|doi=10.1136/jme.24.6.401|issue=6|pmc=479141|pmid=9873981}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
* '''Minimize selection bias'''.  This may occur if investigators can consciously or unconsciously preferentially enroll patients between treatment arms.  A good randomization procedure will be unpredictable so that investigators cannot guess the next subject's group assignment based on prior treatment assignments. The risk of selection bias is highest when previous treatment assignments are known (as in unblinded studies) or can be guessed (perhaps if a drug has distinctive side effects).&lt;br /&gt;
&lt;br /&gt;
Two other lines of reasoning question RCTs' contribution to scientific knowledge beyond other types of studies:&lt;br /&gt;
&lt;br /&gt;
另外两条推理线索质疑 rct 对科学知识的贡献超越了其他类型的研究:&lt;br /&gt;
&lt;br /&gt;
* '''Minimize allocation bias''' (or '''confounding''').  This may occur when [[covariate]]s that affect the outcome are not equally distributed between treatment groups, and the treatment effect is confounded with the effect of the covariates (i.e., an &amp;quot;accidental bias&amp;quot;&amp;lt;ref name=&amp;quot;SchulzGrimes2002&amp;quot;/&amp;gt;&amp;lt;ref name=&amp;quot;Buyse-1989&amp;quot;&amp;gt;{{Cite journal | author = Buyse ME | title = Analysis of clinical trial outcomes: some comments on subgroup analyses | journal = [[Controlled Clinical Trials]] | volume = 10 | issue = 4 Suppl | pages = 187S–194S | year = 1989 | pmid = 2605967 |  doi = 10.1016/0197-2456(89)90057-3 }}&amp;lt;/ref&amp;gt;).  If the randomization procedure causes an imbalance in covariates related to the outcome across groups, estimates of effect may be [[bias of an estimator|biased]] if not adjusted for the covariates (which may be unmeasured and therefore impossible to adjust for).&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
However, no single randomization procedure meets those goals in every circumstance, so researchers must select a procedure for a given study based on its advantages and disadvantages.&lt;br /&gt;
&lt;br /&gt;
However, no single randomization procedure meets those goals in every circumstance, so researchers must select a procedure for a given study based on its advantages and disadvantages.&lt;br /&gt;
&lt;br /&gt;
然而，没有一个单一的随机化程序在每种情况下都能满足这些目标，因此研究人员必须根据其优点和缺点来选择一个给定的研究程序。&lt;br /&gt;
&lt;br /&gt;
==== Simple ====&lt;br /&gt;
&lt;br /&gt;
Like all statistical methods, RCTs are subject to both type I (&amp;quot;false positive&amp;quot;) and type II (&amp;quot;false negative&amp;quot;) statistical errors.  Regarding Type I errors, a typical RCT will use 0.05 (i.e., 1 in 20) as the probability that the RCT will falsely find two equally effective treatments significantly different. Regarding Type II errors, despite the publication of a 1978 paper noting that the sample sizes of many &amp;quot;negative&amp;quot; RCTs were too small to make definitive conclusions about the negative results, by 2005-2006 a sizeable proportion of RCTs still had inaccurate or incompletely reported sample size calculations.&lt;br /&gt;
&lt;br /&gt;
像所有的统计方法一样，rct 同时受到Ⅰ型(“假阳性”)和 II 型(“假阴性”)统计错误的影响。关于Ⅰ型错误，一个典型的 RCT 将使用0.05(即，1/20)作为 RCT 错误地发现两个同样有效的治疗方法显著不同的概率。关于第二类错误，尽管1978年发表的一篇论文指出，许多”负面”随机对照试验的样本量太小，无法对负面结果作出明确的结论，但到2005-2006年，相当大一部分随机对照试验的样本量计算仍然不准确或不完全。&lt;br /&gt;
&lt;br /&gt;
This is a commonly used and intuitive procedure, similar to &amp;quot;repeated fair coin-tossing.&amp;quot;&amp;lt;ref name=&amp;quot;SchulzGrimes2002&amp;quot;/&amp;gt; Also known as &amp;quot;complete&amp;quot; or &amp;quot;unrestricted&amp;quot; randomization, it is [[Robust statistics|robust]] against both selection and accidental biases. However, its main drawback is the possibility of imbalanced group sizes in small RCTs.  It is therefore recommended only for RCTs with over 200 subjects.&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;&amp;gt;{{Cite journal |vauthors=Lachin JM, Matts JP, Wei LJ | title = Randomization in clinical trials: conclusions and recommendations | journal = [[Controlled Clinical Trials]] | volume = 9 | issue = 4 | pages = 365–74 | year = 1988 | pmid = 3203526 |  doi = 10.1016/0197-2456(88)90049-9 | hdl = 2027.42/27041 | url = https://deepblue.lib.umich.edu/bitstream/2027.42/27041/1/0000029.pdf | hdl-access = free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
This is a commonly used and intuitive procedure, similar to &amp;quot;repeated fair coin-tossing.&amp;quot;&lt;br /&gt;
&lt;br /&gt;
这是一个常用且直观的过程，类似于“反复公平地掷硬币”&lt;br /&gt;
&lt;br /&gt;
==== Restricted ====&lt;br /&gt;
&lt;br /&gt;
To balance group sizes in smaller RCTs, some form of [[restricted randomization|&amp;quot;restricted&amp;quot; randomization]] is recommended.&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;/&amp;gt;  The major types of restricted randomization used in RCTs are:&lt;br /&gt;
&lt;br /&gt;
Peer review of results is an important part of the scientific method. Reviewers examine the study results for potential problems with design that could lead to unreliable results (for example by creating a systematic bias), evaluate the study in the context of related studies and other evidence, and evaluate whether the study can be reasonably considered to have proven its conclusions. To underscore the need for peer review and the danger of over-generalizing conclusions, two Boston-area medical researchers performed a randomized controlled trial in which they randomly assigned either a parachute or an empty backpack to 23 volunteers who jumped from either a biplane or a helicopter. The study was able to accurately report that parachutes fail to reduce injury compared to empty backpacks. The key context that limited the general applicability of this conclusion was that the aircraft were parked on the ground, and participants had only jumped about two feet.&lt;br /&gt;
&lt;br /&gt;
同行评议是科学方法的重要组成部分。审查人员检查研究结果是否存在设计方面的潜在问题，这些问题可能导致不可靠的结果(例如产生系统性偏差) ，在相关研究和其他证据的背景下评估研究，并评估是否可以合理地认为该研究已经证明了其结论。为了强调同行评议的必要性和过于笼统结论的危险性，波士顿地区的两名医学研究人员进行了一次随机对照试验测试，他们随机给23名从双翼飞机或直升机上跳下的志愿者分配一个降落伞或一个空背包。这项研究能够准确地报告，与空背包相比，降落伞无法减少伤害。限制这一结论普遍适用性的关键背景是飞机停在地面上，参与者只跳了大约两英尺。&lt;br /&gt;
&lt;br /&gt;
* '''[[Randomized block design|Permuted-block randomization]]''' or '''blocked randomization''': a &amp;quot;block size&amp;quot; and &amp;quot;allocation ratio&amp;quot; (number of subjects in one group versus the other group) are specified, and subjects are allocated randomly within each block.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt; For example, a block size of 6 and an allocation ratio of 2:1 would lead to random assignment of 4 subjects to one group and 2 to the other. This type of randomization can be combined with &amp;quot;[[stratified randomization]]&amp;quot;, for example by center in a [[multicenter trial]], to &amp;quot;ensure good balance of participant characteristics in each group.&amp;quot;&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt; A special case of permuted-block randomization is ''random allocation'', in which the entire sample is treated as one block.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt; The major disadvantage of permuted-block randomization is that even if the block sizes are large and randomly varied, the procedure can lead to selection bias.&amp;lt;ref name=&amp;quot;Lachin-1988a&amp;quot;/&amp;gt; Another disadvantage is that &amp;quot;proper&amp;quot; analysis of data from permuted-block-randomized RCTs requires stratification by blocks.&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
* '''Adaptive biased-coin randomization''' methods (of which '''urn randomization''' is the most widely known type): In these relatively uncommon methods, the probability of being assigned to a group decreases if the group is overrepresented and increases if the group is underrepresented.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt; The methods are thought to be less affected by selection bias than permuted-block randomization.&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
RCTs are considered to be the most reliable form of scientific evidence in the hierarchy of evidence that influences healthcare policy and practice because RCTs reduce spurious causality and bias. Results of RCTs may be combined in systematic reviews which are increasingly being used in the conduct of evidence-based practice. Some examples of scientific organizations' considering RCTs or systematic reviews of RCTs to be the highest-quality evidence available are:&lt;br /&gt;
&lt;br /&gt;
在影响医疗政策和实践的证据层次中，随机对照试验被认为是最可靠的科学证据形式，因为它减少了虚假的因果关系和偏差。随机对照试验的结果可以结合进行系统评价，这种评价正越来越多地用于循证实践的操作。一些科学组织认为区域研究报告或对区域研究报告的系统审查是现有的最高质量证据的例子如下:&lt;br /&gt;
&lt;br /&gt;
==== Adaptive ====&lt;br /&gt;
&lt;br /&gt;
At least two types of &amp;quot;adaptive&amp;quot; randomization procedures have been used in RCTs, but much less frequently than simple or restricted randomization:&lt;br /&gt;
&lt;br /&gt;
* '''Covariate-adaptive randomization''', of which one type is '''[[Minimisation (clinical trials)|minimization]]''': The probability of being assigned to a group varies in order to minimize &amp;quot;covariate imbalance.&amp;quot;&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;/&amp;gt; Minimization is reported to have &amp;quot;supporters and detractors&amp;quot;&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt; because only the first subject's group assignment is truly chosen at random, the method does not necessarily eliminate bias on unknown factors.&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
* '''Response-adaptive randomization''', also known as '''outcome-adaptive randomization''': The probability of being assigned to a group increases if the responses of the prior patients in the group were favorable.&amp;lt;ref name=&amp;quot;Lachin-1988b&amp;quot;/&amp;gt; Although arguments have been made that this approach is more ethical than other types of randomization when the probability that a treatment is effective or ineffective increases during the course of an RCT, ethicists have not yet studied the approach in detail.&amp;lt;ref name=&amp;quot;Rosenberger-1993&amp;quot;&amp;gt;{{Cite journal |vauthors=Rosenberger WF, Lachin JM | title = The use of response-adaptive designs in clinical trials | journal = [[Controlled Clinical Trials]] | volume = 14 | issue = 6 | pages = 471–84 | year = 1993 | pmid = 8119063 |  doi = 10.1016/0197-2456(93)90028-C }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Notable RCTs with unexpected results that contributed to changes in clinical practice include:&lt;br /&gt;
&lt;br /&gt;
值得注意的随机对照试验，其意想不到的结果促成了临床实践的改变，包括:&lt;br /&gt;
&lt;br /&gt;
=== Allocation concealment ===&lt;br /&gt;
&lt;br /&gt;
{{main|Allocation concealment}}&lt;br /&gt;
&lt;br /&gt;
&amp;quot;Allocation concealment&amp;quot; (defined as &amp;quot;the procedure for protecting the randomization process so that the treatment to be allocated is not known before the patient is entered into the study&amp;quot;) is important in RCTs.&amp;lt;ref name=&amp;quot;Forder-2005&amp;quot;&amp;gt;{{Cite journal |vauthors=Forder PM, Gebski VJ, Keech AC | title = Allocation concealment and blinding: when ignorance is bliss | journal = Med J Aust | volume = 182 | issue = 2 | pages = 87–9 | year = 2005 | url = http://www.mja.com.au/public/issues/182_02_170105/for10877_fm.html | pmid = 15651970 | doi = 10.5694/j.1326-5377.2005.tb06584.x | s2cid = 202149 }}&amp;lt;/ref&amp;gt; In practice, clinical investigators in RCTs often find it difficult to maintain impartiality. Stories abound of investigators holding up sealed envelopes to lights or ransacking offices to determine group assignments in order to dictate the assignment of their next patient.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;&amp;gt;{{Cite journal | title = Allocation concealment in randomised trials: defending against deciphering | journal = Lancet | volume = 359 | issue = 9306 | pages = 614–8 | year = 2002 | doi = 10.1016/S0140-6736(02)07750-4 | url =https://www.who.int/entity/rhl/LANCET_614-618.pdf | pmid = 11867132 |vauthors=Schulz KF, Grimes DA | s2cid = 12902486 }}&amp;lt;/ref&amp;gt; Such practices introduce selection bias and [[Lurking variable|confounders]] (both of which should be minimized by randomization), possibly distorting the results of the study.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt; Adequate allocation concealment should defeat patients and investigators from discovering treatment allocation once a study is underway and after the study has concluded.  Treatment related side-effects or adverse events may be specific enough to reveal allocation to investigators or patients thereby introducing bias or influencing any subjective parameters collected by investigators or requested from subjects.&lt;br /&gt;
&lt;br /&gt;
&amp;quot;Allocation concealment&amp;quot; (defined as &amp;quot;the procedure for protecting the randomization process so that the treatment to be allocated is not known before the patient is entered into the study&amp;quot;) is important in RCTs. In practice, clinical investigators in RCTs often find it difficult to maintain impartiality. Stories abound of investigators holding up sealed envelopes to lights or ransacking offices to determine group assignments in order to dictate the assignment of their next patient. Such practices introduce selection bias and confounders (both of which should be minimized by randomization), possibly distorting the results of the study. On the other hand, a 2008 study of 146 meta-analyses concluded that the results of RCTs with inadequate or unclear allocation concealment tended to be biased toward beneficial effects only if the RCTs' outcomes were subjective as opposed to objective.&lt;br /&gt;
&lt;br /&gt;
“分配隐藏”(定义为“保护随机化过程的程序，以便在病人进入研究之前不知道要分配的治疗”)在随机对照试验中很重要。在实践中，临床研究人员在随机对照试验中常常发现难以保持公正性。关于调查人员将密封的信封举到灯光下或者搜查办公室来决定团队任务，以便指定下一个病人的任务的故事比比皆是。这种做法引入了选择偏差和混杂因素(这两者都应该通过随机化来减少) ，可能会扭曲研究结果。另一方面，2008年的一项对146项元分析的研究得出结论，分配隐瞒不充分或不明确的随机对照试验的结果往往只有在随机对照试验的结果是主观的而不是客观的情况下才会偏向于有益的结果。&lt;br /&gt;
&lt;br /&gt;
Many papers discuss the disadvantages of RCTs.   Among the most frequently cited drawbacks are:&lt;br /&gt;
&lt;br /&gt;
许多论文讨论了 rct 的缺点。最常被提到的缺点是:&lt;br /&gt;
&lt;br /&gt;
Some standard methods of ensuring allocation concealment include sequentially numbered, opaque, sealed envelopes (SNOSE); sequentially numbered containers; pharmacy controlled randomization; and central randomization.&amp;lt;ref name=&amp;quot;Schulz-2002&amp;quot;/&amp;gt; It is recommended that allocation concealment methods be included in an RCT's [[Clinical trial protocol|protocol]], and that the allocation concealment methods should be reported in detail in a publication of an RCT's results; however, a 2005 study determined that most RCTs have unclear allocation concealment in their protocols, in their publications, or both.&amp;lt;ref name=&amp;quot;Pildal-2005&amp;quot;&amp;gt;{{Cite journal |vauthors=Pildal J, Chan AW, Hróbjartsson A, Forfang E, Altman DG, Gøtzsche PC | title = Comparison of descriptions of allocation concealment in trial protocols and the published reports: cohort study | journal = BMJ | volume = 330 | issue = 7499 | page = 1049 | year = 2005 | doi = 10.1136/bmj.38414.422650.8F | pmid = 15817527 | pmc = 557221 }}&amp;lt;/ref&amp;gt; On the other hand, a 2008 study of 146 [[meta-analysis|meta-analyses]] concluded that the results of RCTs with inadequate or unclear allocation concealment tended to be biased toward beneficial effects only if the RCTs' outcomes were [[Subjectivity|subjective]] as opposed to [[Objectivity (philosophy)|objective]].&amp;lt;ref name=&amp;quot;Wood-2008&amp;quot;&amp;gt;{{Cite journal |vauthors=Wood L, Egger M, Gluud LL, Schulz KF, Jüni P, Altman DG, Gluud C, Martin RM, Wood AJ, Sterne JA | title = Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study | journal = BMJ | volume = 336 | issue = 7644 | pages = 601–5 | year = 2008 | doi = 10.1136/bmj.39465.451748.AD | pmid = 18316340 | pmc = 2267990 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Some standard methods of ensuring allocation concealment include sequentially numbered, opaque, sealed envelopes (SNOSE); sequentially numbered containers; pharmacy controlled randomization; and central randomization. It is recommended that allocation concealment methods be included in an RCT's protocol, and that the allocation concealment methods should be reported in detail in a publication of an RCT's results; however, a 2005 study determined that most RCTs have unclear allocation concealment in their protocols, in their publications, or both. On the other hand, a 2008 study of 146 meta-analyses concluded that the results of RCTs with inadequate or unclear allocation concealment tended to be biased toward beneficial effects only if the RCTs' outcomes were subjective as opposed to objective.&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
=== Sample size ===&lt;br /&gt;
&lt;br /&gt;
RCTs can be expensive; for a mean cost of US$12 million per RCT.  Nevertheless, the return on investment of RCTs may be high, in that the same study projected that the 28 RCTs produced a &amp;quot;net benefit to society at 10-years&amp;quot; of 46 times the cost of the trials program, based on evaluating a quality-adjusted life year as equal to the prevailing mean per capita gross domestic product.&lt;br /&gt;
&lt;br /&gt;
随机对照试验可能很昂贵，每次随机对照试验的平均成本为1200万美元。然而，随机对照试验的投资回报率可能很高，因为同一项研究预测，28个 随机对照试验 产生的“10年社会净效益”是试验项目成本的46倍，其基础是评估一个质量调整寿命年等于当前人均国内生产总值的平均值。&lt;br /&gt;
&lt;br /&gt;
{{Main|Sample size determination}}&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
It is costly to maintain RCTs for the years or decades that would be ideal for evaluating some interventions.&lt;br /&gt;
&lt;br /&gt;
有些随机对照试验需要持续几年或几十年，花费巨大，但这些试验对于评价某些干预措施是理想的。&lt;br /&gt;
The number of treatment units (subjects or groups of subjects) assigned to control and treatment groups, affects an RCT's reliability. If the effect of the treatment is small, the number of treatment units in either group may be insufficient for rejecting the null hypothesis in the respective [[statistical hypothesis testing|statistical test]]. The failure to reject the [[null hypothesis]] would imply that the treatment shows no statistically significant effect on the treated ''in a given test''. But as the sample size increases, the same RCT may be able to demonstrate a significant effect of the treatment, even if this effect is small.&amp;lt;ref name=&amp;quot;Glennerster-2013&amp;quot;&amp;gt;{{Cite book | publisher = Princeton University Press | isbn = 9780691159249 | last = Glennerster | first = Rachel |author2=Kudzai Takavarasha  | title = Running randomized evaluations: a practical guide | location = Princeton | date = 2013 |url=https://www.jstor.org/stable/j.ctt4cgd52 |chapter=&amp;quot;Chapter 6&amp;quot; }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
The number of treatment units (subjects or groups of subjects) assigned to control and treatment groups, affects an RCT's reliability. If the effect of the treatment is small, the number of treatment units in either group may be insufficient for rejecting the null hypothesis in the respective statistical test. The failure to reject the null hypothesis would imply that the treatment shows no statistically significant effect on the treated in a given test. But as the sample size increases, the same RCT may be able to demonstrate a significant effect of the treatment, even if this effect is small.&lt;br /&gt;
&lt;br /&gt;
分配给控制组和治疗组的治疗单位(受试者或受试者组)的样本量影响 RCT 的可靠性。如果治疗的效果很小，任何一组的治疗单位的样本量都可能不足以在各自的统计检验中拒绝无效假设（零假设）。拒绝零假设的失败将意味着治疗在给定的测试中对治疗没有统计学意义上的显著影响。但是随着样本量的增加，相同的随机对照试验也许能够证明治疗的显著效果，即使这种效果很小。&lt;br /&gt;
&lt;br /&gt;
== Blinding ==&lt;br /&gt;
&lt;br /&gt;
{{main|Blinded experiment}}&lt;br /&gt;
&lt;br /&gt;
An RCT may be [[Blind experiment|blinded]], (also called &amp;quot;masked&amp;quot;) by &amp;quot;procedures that prevent study participants, caregivers, or outcome assessors from knowing which intervention was received.&amp;quot;&amp;lt;ref name=&amp;quot;Wood-2008&amp;quot;/&amp;gt; Unlike allocation concealment, blinding is sometimes inappropriate or impossible to perform in an RCT; for example, if an RCT involves a treatment in which active participation of the patient is necessary (e.g., [[physical therapy]]), participants cannot be blinded to the intervention.&lt;br /&gt;
&lt;br /&gt;
If a disruptive innovation in medical technology is developed, it may be difficult to test this ethically in an RCT if it becomes &amp;quot;obvious&amp;quot; that the control subjects have poorer outcomes—either due to other foregoing testing, or within the initial phase of the RCT itself.  Ethically it may be necessary to abort the RCT prematurely, and getting ethics approval (and patient agreement) to withhold the innovation from the control group in future RCT's may not be feasible.&lt;br /&gt;
&lt;br /&gt;
如果医学技术领域出现颠覆性创新，在RCT中，对照组的结果变得“明显”—－即对照组出现明显差的结局。这要么由于其他的前述测试，要么是在 RCT 本身的初始阶段， 那么在 RCT 中很难从伦理上检验这一点。从伦理上讲，过早地中止 RCT 可能是必要的，而在未来的 RCT 中，获得伦理批准(以及患者同意)以阻止控制组的创新可能是不可行的。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Traditionally, blinded RCTs have been classified as &amp;quot;single-blind&amp;quot;, &amp;quot;double-blind&amp;quot;, or &amp;quot;triple-blind&amp;quot;; however, in 2001 and 2006 two studies showed that these terms have different meanings for different people.&amp;lt;ref name=&amp;quot;Devereaux-2001&amp;quot;&amp;gt;{{Cite journal |vauthors=Devereaux PJ, Manns BJ, Ghali WA, Quan H, Lacchetti C, Montori VM, Bhandari M, Guyatt GH | title = Physician interpretations and textbook definitions of blinding terminology in randomized controlled trials | journal = [[J Am Med Assoc]] | volume = 285 | issue = 15 | pages = 2000–3 | year = 2001 | doi =  10.1001/jama.285.15.2000| pmid = 11308438 | doi-access = free }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Haahr-2006&amp;quot;&amp;gt;{{Cite journal |vauthors=Haahr MT, Hróbjartsson A | title = Who is blinded in randomized clinical trials? A study of 200 trials and a survey of authors | journal = Clin Trials | volume = 3 | issue = 4 | pages = 360–5 | year = 2006 | doi = 10.1177/1740774506069153 | pmid = 17060210 | s2cid = 23818514 }}&amp;lt;/ref&amp;gt;  The 2010 [[Consolidated Standards of Reporting Trials|CONSORT Statement]] specifies that authors and editors should not use the terms &amp;quot;single-blind&amp;quot;, &amp;quot;double-blind&amp;quot;, and &amp;quot;triple-blind&amp;quot;; instead, reports of blinded RCT should discuss &amp;quot;If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how.&amp;quot;&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Historical control trials (HCT) exploit the data of previous RCTs to reduce the sample size; however, these approaches are controversial in the scientific community and must be handled with care.&lt;br /&gt;
&lt;br /&gt;
历史对照试验(HCT)利用以前随机对照试验的数据来减少样本量，然而，这些方法在科学界是有争议的，必须小心处理。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
RCTs without blinding are referred to as &amp;quot;unblinded&amp;quot;,&amp;lt;ref name=&amp;quot;Marson-2007&amp;quot;&amp;gt;{{Cite journal  |vauthors=Marson AG, Al-Kharusi AM, Alwaidh M, Appleton R, Baker GA, Chadwick DW, etal | title = The SANAD study of effectiveness of valproate, lamotrigine, or topiramate for generalised and unclassifiable epilepsy: an unblinded randomised controlled trial | journal = [[The Lancet|Lancet]] | volume = 369 | issue = 9566 | pages = 1016–26 | year = 2007 | doi = 10.1016/S0140-6736(07)60461-9 | pmid = 17382828 | pmc = 2039891 }}&amp;lt;/ref&amp;gt; &amp;quot;open&amp;quot;,&amp;lt;ref name=&amp;quot;Chan-1995&amp;quot;&amp;gt;{{Cite journal |vauthors=Chan R, Hemeryck L, O'Regan M, Clancy L, Feely J | title = Oral versus intravenous antibiotics for community acquired lower respiratory tract infection in a general hospital: open, randomised controlled trial | journal = [[BMJ]] | volume = 310 | issue = 6991 | pages = 1360–2 | year = 1995 | pmid = 7787537 | pmc = 2549744 | doi=10.1136/bmj.310.6991.1360}}&amp;lt;/ref&amp;gt; or (if the intervention is a medication) &amp;quot;[[Open-label trial|open-label]]&amp;quot;.&amp;lt;ref name=&amp;quot;Fukase-2008&amp;quot;&amp;gt;{{Cite journal | author = Fukase K, Kato M, Kikuchi S, Inoue K, Uemura N, Okamoto S, Terao S, Amagai K, Hayashi S, Asaka M; Japan Gast Study Group | title = Effect of eradication of Helicobacter pylori on incidence of metachronous gastric carcinoma after endoscopic resection of early gastric cancer: an open-label, randomised controlled trial | journal = Lancet | volume = 372 | issue = 9636 | pages = 392–7 | year = 2008 | doi = 10.1016/S0140-6736(08)61159-9 | pmid = 18675689 | hdl = 2115/34681 | s2cid = 13741892 | url = https://eprints.lib.hokudai.ac.jp/dspace/bitstream/2115/34681/1/asaka.pdf | hdl-access = free }}&amp;lt;/ref&amp;gt; In 2008 a study concluded that the results of unblinded RCTs tended to be biased toward beneficial effects only if the RCTs' outcomes were subjective as opposed to objective;&amp;lt;ref name=&amp;quot;Wood-2008&amp;quot;/&amp;gt; for example, in an RCT of treatments for [[multiple sclerosis]], unblinded neurologists (but not the blinded neurologists) felt that the treatments were beneficial.&amp;lt;ref name=&amp;quot;Noseworthy-1994&amp;quot;&amp;gt;{{Cite journal |vauthors=Noseworthy JH, Ebers GC, Vandervoort MK, Farquhar RE, Yetisir E, Roberts R | author-link1=John H. Noseworthy|title = The impact of blinding on the results of a randomized, placebo-controlled multiple sclerosis clinical trial | journal = Neurology | volume = 44 | issue = 1 | pages = 16–20 | year = 1994 | url = http://www.neurology.org/cgi/content/abstract/44/1/16 | pmid = 8290055 | doi=10.1212/wnl.44.1.16| s2cid=2663997}}&amp;lt;/ref&amp;gt; In pragmatic RCTs, although the participants and providers are often unblinded, it is &amp;quot;still desirable and often possible to blind the assessor or obtain an objective source of data for evaluation of outcomes.&amp;quot;&amp;lt;ref name=&amp;quot;Zwarenstein-2008&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
== Analysis of data ==&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
The types of statistical methods used in RCTs depend on the characteristics of the data and include:&lt;br /&gt;
&lt;br /&gt;
* For [[dichotomous]] (binary) outcome data, [[logistic regression]] (e.g., to predict sustained virological response after receipt of [[peginterferon alfa-2a]] for [[hepatitis C]]&amp;lt;ref name=&amp;quot;Manns-2001&amp;quot;&amp;gt;{{Cite journal |vauthors=Manns MP, McHutchison JG, Gordon SC, Rustgi VK, Shiffman M, Reindollar R, Goodman ZD, Koury K, Ling M, Albrecht JK | title = Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial | journal = [[The Lancet|Lancet]] | volume = 358 | issue = 9286 | pages = 958–65 | year = 2001 | doi = 10.1016/S0140-6736(01)06102-5 | pmid = 11583749 | s2cid = 14583372 }}&amp;lt;/ref&amp;gt;) and other methods can be used.&lt;br /&gt;
&lt;br /&gt;
* For continuous outcome data, [[analysis of covariance]] (e.g., for changes in blood lipid levels after receipt of [[atorvastatin]] after [[acute coronary syndrome]]&amp;lt;ref name=&amp;quot;Schwartz-2001&amp;quot;&amp;gt;{{Cite journal | author = Schwartz GG, Olsson AG, Ezekowitz MD, Ganz P, Oliver MF, Waters D, Zeiher A, Chaitman BR, Leslie S, Stern T; Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering (MIRACL) Study Investigators | title = Effects of atorvastatin on early recurrent ischemic events in acute coronary syndromes: the MIRACL study: a randomized controlled trial | journal = [[J Am Med Assoc]] | volume = 285 | issue = 13 | pages = 1711–8 | year = 2001 | pmid = 11277825 | doi = 10.1001/jama.285.13.1711 | doi-access = free }}&amp;lt;/ref&amp;gt;) tests the effects of predictor variables.&lt;br /&gt;
&lt;br /&gt;
* For time-to-event outcome data that may be [[Censoring (statistics)|censored]], [[survival analysis]] (e.g., [[Kaplan–Meier estimator]]s and [[Cox proportional hazards model]]s for time to [[coronary heart disease]] after receipt of [[Hormone replacement therapy (menopause)|hormone replacement therapy in menopause]]&amp;lt;ref name=&amp;quot;Rossouw-2002&amp;quot;&amp;gt;{{Cite journal | author = Rossouw JE, Anderson GL, [[Ross Prentice|Prentice RL]], LaCroix AZ, Kooperberg C, Stefanick ML, Jackson RD, Beresford SA, Howard BV, Johnson KC, Kotchen JM, Ockene J; Writing Group for the Women's Health Initiative Investigators | title = Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial | journal = [[J Am Med Assoc]] | volume = 288 | issue = 3 | pages = 321–33 | year = 2002 | pmid = 12117397 | doi = 10.1001/jama.288.3.321 | s2cid = 20149703 | url = https://escholarship.org/content/qt3mr6f93p/qt3mr6f93p.pdf?t=prll4c | doi-access = free }}&amp;lt;/ref&amp;gt;) is appropriate.&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Due to the recent emergence of RCTs in social science, the use of RCTs in social sciences is a contested issue.  Some writers from a medical or health background have argued that existing research in a range of social science disciplines lacks rigour, and should be improved by greater use of randomized control trials.&lt;br /&gt;
&lt;br /&gt;
由于最近在社会科学中出现了 rct，rct 在社会科学中的应用是一个有争议的问题。一些有医学或健康背景的作家认为，一系列社会科学学科的现有研究缺乏严谨性，应该通过更多地使用随机对照试验来改进。&lt;br /&gt;
Researchers in transport science argue that public spending on programmes such as school travel plans could not be justified unless their efficacy is demonstrated by randomized controlled trials.  Graham-Rowe and colleagues  reviewed 77 evaluations of transport interventions found in the literature, categorising them into 5 &amp;quot;quality levels&amp;quot;.  They concluded that most of the studies were of low quality and advocated the use of randomized controlled trials wherever possible in future transport research.&lt;br /&gt;
&lt;br /&gt;
交通科学研究人员认为，除非随机对照试验证明其有效性，否则在学校旅行计划等项目上的公共支出是不合理的。Graham-Rowe 和他的同事回顾了文献中发现的77个运输干预评估，将它们分为5个“质量水平”。他们的结论是，大多数研究质量低下，并主张在未来的运输研究中尽可能使用随机对照试验。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Regardless of the statistical methods used, important considerations in the analysis of RCT data include:&lt;br /&gt;
&lt;br /&gt;
Dr. Steve Melia took issue with these conclusions, arguing that claims about the advantages of RCTs, in establishing causality and avoiding bias, have been exaggerated.  He proposed the following eight criteria for the use of RCTs in contexts where interventions must change human behaviour to be effective:&lt;br /&gt;
&lt;br /&gt;
Steve Melia 博士对这些结论提出异议，认为关于 rct 在确定因果关系和避免偏见方面的优势的说法被夸大了。他提出了在干预措施必须改变人的行为才能有效的情况下使用区域反应技术的八项标准:&lt;br /&gt;
&lt;br /&gt;
* Whether an RCT should be stopped early due to interim results.  For example, RCTs may be stopped early if an intervention produces &amp;quot;larger than expected benefit or harm&amp;quot;, or if &amp;quot;investigators find evidence of no important difference between experimental and control interventions.&amp;quot;&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
* The extent to which the groups can be analyzed exactly as they existed upon randomization (i.e., whether a so-called &amp;quot;[[intention-to-treat analysis]]&amp;quot; is used). A &amp;quot;pure&amp;quot; intention-to-treat analysis is &amp;quot;possible only when complete outcome data are available&amp;quot; for all randomized subjects;&amp;lt;ref name=&amp;quot;Hollis-1999&amp;quot;&amp;gt;{{Cite journal |vauthors=Hollis S, Campbell F | title = What is meant by intention to treat analysis? Survey of published randomised controlled trials | journal = [[Br Med J]] | volume = 319 | issue = 7211 | pages = 670–4 | year = 1999 | pmid = 10480822 | pmc = 28218 | doi=10.1136/bmj.319.7211.670}}&amp;lt;/ref&amp;gt; when some outcome data are missing, options include analyzing only cases with known outcomes and using [[Imputation (statistics)|imputed]] data.&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt; Nevertheless, the more that analyses can include all participants in the groups to which they were randomized, the less bias that an RCT will be subject to.&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
The intervention:&lt;br /&gt;
&lt;br /&gt;
干预措施:&lt;br /&gt;
&lt;br /&gt;
* Whether [[subgroup analysis]] should be performed.  These are &amp;quot;often discouraged&amp;quot; because [[multiple comparisons]] may produce false positive findings that cannot be confirmed by other studies.&amp;lt;ref name=&amp;quot;Moher-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
 Has not been applied to all members of a unique group of people (e.g. the population of a whole country, all employees of a unique organisation etc.)&lt;br /&gt;
&lt;br /&gt;
并不适用于一个特殊群体的所有成员(例如:。整个国家的人口，一个独特组织的所有雇员等)&lt;br /&gt;
&lt;br /&gt;
== Reporting of results ==&lt;br /&gt;
&lt;br /&gt;
 Is applied in a context or setting similar to that which applies to the control group&lt;br /&gt;
&lt;br /&gt;
应用于类似于应用于控制组的上下文或设置&lt;br /&gt;
&lt;br /&gt;
The ''[[Consolidated Standards of Reporting Trials|CONSORT 2010 Statement]]'' is &amp;quot;an evidence-based, minimum set of recommendations for reporting RCTs.&amp;quot;&amp;lt;ref name=&amp;quot;CONSORT&amp;quot;&amp;gt;{{cite web |url=http://www.consort-statement.org |title=Welcome to the CONSORT statement Website |author=CONSORT Group |access-date=2010-03-29}}&amp;lt;/ref&amp;gt; The CONSORT 2010 checklist contains 25 items (many with sub-items) focusing on &amp;quot;individually randomised, two group, parallel trials&amp;quot; which are the most common type of RCT.&amp;lt;ref name=&amp;quot;Schulz-2010&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
 Can be isolated from other activities—and the purpose of the study is to assess this isolated effect&lt;br /&gt;
&lt;br /&gt;
这项研究的目的是评估这种孤立效应&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
 Has a short timescale between its implementation and maturity of its effects&lt;br /&gt;
&lt;br /&gt;
从实施到效果成熟之间的时间跨度很短&lt;br /&gt;
&lt;br /&gt;
For other RCT study designs, &amp;quot;[[Consolidated Standards of Reporting Trials|CONSORT extensions]]&amp;quot; have been published, some examples are:&lt;br /&gt;
&lt;br /&gt;
* Consort 2010 Statement: Extension to Cluster Randomised Trials&amp;lt;ref name=&amp;quot;CONSORT2010-EXTENSION-CLUSTER&amp;quot;&amp;gt;{{Cite journal |vauthors=Campbell MK, Piaggio G, Elbourne DR, Altman DG| title = Consort 2010 statement: extension to cluster randomised trials | journal = [[BMJ]] | volume = 345| pages = e5661 | year = 2012  | pmid = 22951546 | doi = 10.1136/bmj.e5661 | doi-access = free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
And the causal mechanisms:&lt;br /&gt;
&lt;br /&gt;
以及因果机制:&lt;br /&gt;
&lt;br /&gt;
* Consort 2010 Statement: Non-Pharmacologic Treatment Interventions&amp;lt;ref name=&amp;quot;CONSORT2010-EXTENSION-NON-PHARMACOLOGIC-1&amp;quot;&amp;gt;{{Cite journal |vauthors=Boutron I, Moher D, Altman DG, Schulz K, Ravaud P| title = Extending the CONSORT Statement to randomized trials of nonpharmacologic treatment: explanation and elaboration | journal = [[Annals of Internal Medicine]] | volume = 148| issue = 4 | year = 2008 | pages=295–309  | pmid = 18283207 | doi=10.7326/0003-4819-148-4-200802190-00008| doi-access = free }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;CONSORT2010-EXTENSION-NON-PHARMACOLOGIC-2&amp;quot;&amp;gt;{{Cite journal |vauthors=Boutron I, Moher D, Altman DG, Schulz K, Ravaud P| title = Methods and Processes of the CONSORT Group: Example of an Extension for Trials Assessing Nonpharmacologic Treatments | journal = [[Annals of Internal Medicine]] | volume = 148| issue = 4 | year = 2008  | pmid = 18283201 | doi=10.7326/0003-4819-148-4-200802190-00008-w1 | pages=W60–6| doi-access = free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&amp;lt;li value=&amp;quot;5&amp;quot;&amp;gt;Are either known to the researchers, or else all possible alternatives can be tested&lt;br /&gt;
&lt;br /&gt;
&amp;lt; li value = &amp;quot; 5&amp;quot; &amp;gt; 要么被研究人员知道，要么所有可能的替代方案都可以被测试&lt;br /&gt;
&lt;br /&gt;
=== Relative importance and observational studies ===&lt;br /&gt;
&lt;br /&gt;
 Do not involve significant feedback mechanisms between the intervention group and external environments&lt;br /&gt;
&lt;br /&gt;
不涉及干预组和外部环境之间的重要反馈机制&lt;br /&gt;
&lt;br /&gt;
Two studies published in ''[[The New England Journal of Medicine]]'' in 2000 found that [[Observational study|observational studies]] and RCTs overall produced similar results.&amp;lt;ref name=&amp;quot;Benson-2000&amp;quot;&amp;gt;{{Cite journal |vauthors=Benson K, Hartz AJ | title = A comparison of observational studies and randomized, controlled trials | journal = [[N Engl J Med]] | volume = 342 | issue = 25 | pages = 1878–86 | year = 2000 | pmid = 10861324 | doi = 10.1056/NEJM200006223422506 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Concato-2000&amp;quot;&amp;gt;{{Cite journal |vauthors=Concato J, Shah N, Horwitz RI | title = Randomized, controlled trials, observational studies, and the hierarchy of research designs | journal = [[N Engl J Med]] | volume = 342 | issue = 25 | pages = 1887–92 | year = 2000 | url = http://nejm.highwire.org/cgi/content/full/342/25/1887 | pmid = 10861325 | doi = 10.1056/NEJM200006223422507 | pmc = 1557642 }}&amp;lt;/ref&amp;gt; The authors of the 2000 findings questioned the belief that &amp;quot;observational studies should not be used for defining evidence-based medical care&amp;quot; and that RCTs' results are &amp;quot;evidence of the highest grade.&amp;quot;&amp;lt;ref name=&amp;quot;Benson-2000&amp;quot;/&amp;gt;&amp;lt;ref name=&amp;quot;Concato-2000&amp;quot;/&amp;gt; However, a 2001 study published in ''[[Journal of the American Medical Association]]'' concluded that &amp;quot;discrepancies beyond chance do occur and differences in estimated magnitude of treatment effect are very common&amp;quot; between observational studies and RCTs.&amp;lt;ref name=&amp;quot;Ioannidis-2001&amp;quot;&amp;gt;{{Cite journal |vauthors=Ioannidis JP, Haidich AB, Pappa M, Pantazis N, Kokori SI, Tektonidou MG, Contopoulos-Ioannidis DG, Lau J | title = Comparison of evidence of treatment effects in randomized and nonrandomized studies | journal = [[J Am Med Assoc]] | volume = 286 | issue = 7 | pages = 821–30 | year = 2001 | pmid = 11497536 | doi = 10.1001/jama.286.7.821 | citeseerx = 10.1.1.590.2854 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Have a stable and predictable relationship to exogenous factors&lt;br /&gt;
&lt;br /&gt;
与外部因素有稳定和可预测的关系&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
 Would act in the same way if the control group and intervention group were reversed&lt;br /&gt;
&lt;br /&gt;
如果对照组和干预组的情况相反，他们也会以同样的方式行动&lt;br /&gt;
&lt;br /&gt;
Two other lines of reasoning question RCTs' contribution to scientific knowledge beyond other types of studies:&lt;br /&gt;
* If study designs are ranked by their potential for new discoveries, then [[Anecdotal evidence#Scientific context|anecdotal evidence]] would be at the top of the list, followed by observational studies, followed by RCTs.&amp;lt;ref name=&amp;quot;Vandenbroucke-2008&amp;quot;&amp;gt;{{Cite journal | author = Vandenbroucke JP | title = Observational research, randomised trials, and two views of medical science | journal = [[PLoS Med]] | volume = 5 | issue = 3 | pages = e67 | year = 2008 | doi = 10.1371/journal.pmed.0050067 | pmid = 18336067 | pmc = 2265762 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* RCTs may be unnecessary for treatments that have dramatic and rapid effects relative to the expected stable or progressively worse natural course of the condition treated.&amp;lt;ref name=&amp;quot;Black-1996&amp;quot;/&amp;gt;&amp;lt;ref name=&amp;quot;Glasziou-2007&amp;quot;&amp;gt;{{Cite journal |vauthors=Glasziou P, Chalmers I, Rawlins M, McCulloch P | title = When are randomised trials unnecessary? Picking signal from noise | journal = [[Br Med J]] | volume = 334 | issue = 7589 | pages = 349–51 | year = 2007 | doi = 10.1136/bmj.39070.527986.68 | pmc=1800999 | pmid = 17303884 }}&amp;lt;/ref&amp;gt; One example is [[History of cancer chemotherapy#Combination chemotherapy|combination chemotherapy]] including [[cisplatin]] for [[Metastasis|metastatic]] [[testicular cancer]], which increased the cure rate from 5% to 60% in a 1977 non-randomized study.&amp;lt;ref name=&amp;quot;Glasziou-2007&amp;quot;/&amp;gt;&amp;lt;ref name=&amp;quot;Einhorn-2002&amp;quot;&amp;gt;{{Cite journal | author = Einhorn LH | author-link = Lawrence Einhorn | title = Curing metastatic testicular cancer | journal = [[Proc Natl Acad Sci U S A]] | volume = 99 | issue = 7 | pages = 4592–5 | year = 2002 | doi = 10.1073/pnas.072067999 | pmid = 11904381 | pmc = 123692 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
A 2005 review found 83 randomized experiments in criminology published in 1982–2004, compared with only 35 published in 1957–1981. The authors classified the studies they found into five categories: &amp;quot;policing&amp;quot;, &amp;quot;prevention&amp;quot;, &amp;quot;corrections&amp;quot;, &amp;quot;court&amp;quot;, and &amp;quot;community&amp;quot;.&lt;br /&gt;
&lt;br /&gt;
2005年的一项研究发现，1982年至2004年发表的犯罪学随机实验有83项，而1957年至1981年发表的只有35项。作者将他们发现的研究分为五类: “警务”、“预防”、“惩戒”、“法院”和“社区”。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
=== Interpretation of statistical results ===&lt;br /&gt;
&lt;br /&gt;
Like all statistical methods, RCTs are subject to both [[type I and type II errors|type I (&amp;quot;false positive&amp;quot;) and type II (&amp;quot;false negative&amp;quot;) statistical errors]].  Regarding Type I errors, a typical RCT will use 0.05 (i.e., 1 in 20) as the probability that the RCT will falsely find two equally effective treatments significantly different.&amp;lt;ref name=&amp;quot;Wittes-2002&amp;quot;&amp;gt;{{Cite journal | author = Wittes J | title = Sample size calculations for randomized controlled trials | journal = [[Epidemiol Rev]] | volume = 24 | issue = 1 | pages = 39–53 | year = 2002 | doi = 10.1093/epirev/24.1.39 | pmid = 12119854 | doi-access = free }}&amp;lt;/ref&amp;gt; Regarding Type II errors, despite the publication of a 1978 paper noting that the [[sample size]]s of many &amp;quot;negative&amp;quot; RCTs were too small to make definitive conclusions about the negative results,&amp;lt;ref name=&amp;quot;Freiman-1978&amp;quot;&amp;gt;{{Cite journal | doi = 10.1056/NEJM197809282991304 |vauthors=Freiman JA, Chalmers TC, ((Smith H Jr)), Kuebler RR | title = The importance of beta, the type II error and sample size in the design and interpretation of the randomized control trial. Survey of 71 &amp;quot;negative&amp;quot; trials | journal = [[N Engl J Med]] | volume = 299 | issue = 13 | pages = 690–4 | year = 1978 | pmid = 355881 }}&amp;lt;/ref&amp;gt; by 2005-2006 a sizeable proportion of RCTs still had inaccurate or incompletely reported sample size calculations.&amp;lt;ref name=&amp;quot;Charles-2009&amp;quot;&amp;gt;{{Cite journal |vauthors=Charles P, Giraudeau B, Dechartres A, Baron G, Ravaud P | title = Reporting of sample size calculation in randomised controlled trials: review | journal = [[Br Med J]] | volume = 338 | pages = b1732 | date = 2009-05-12 | doi = 10.1136/bmj.b1732 | pmid = 19435763 | pmc = 2680945 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
RCTs have been used in evaluating a number of educational interventions. Between 1980 and 2016, over 1,000 reports of RCTs have been published. For example, a 2009 study randomized 260 elementary school teachers' classrooms to receive or not receive a program of behavioral screening, classroom intervention, and parent training, and then measured the behavioral and academic performance of their students. Another 2009 study randomized classrooms for 678 first-grade children to receive a classroom-centered intervention, a parent-centered intervention, or no intervention, and then followed their academic outcomes through age 19.&lt;br /&gt;
&lt;br /&gt;
随机对照试验已用于评价一些教育干预措施。从1980年到2016年，已经发表了超过1000篇关于 rct 的报告。例如，2009年的一项研究随机抽取了260名小学教师的课堂，让他们接受或不接受行为筛选、课堂干预和家长培训，然后测量他们学生的行为和学业表现。2009年的另一项研究随机化了678个一年级儿童的课堂，接受了以课堂为中心的干预，以家长为中心的干预，或没有干预，然后跟踪他们的学习成果直到19岁。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
=== Peer review ===&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
A 2017 review of the 10 most cited randomised controlled trials noted poor distribution of background traits, difficulties with blinding, and discussed other assumptions and biases inherent in randomised controlled trials. These include the &amp;quot;unique time period assessment bias&amp;quot;, the &amp;quot;background traits remain constant assumption&amp;quot;, the &amp;quot;average treatment effects limitation&amp;quot;, the &amp;quot;simple treatment at the individual level limitation&amp;quot;, the &amp;quot;all preconditions are fully met assumption&amp;quot;, the &amp;quot;quantitative variable limitation&amp;quot; and the &amp;quot;placebo only or conventional treatment only limitation&amp;quot;.&lt;br /&gt;
&lt;br /&gt;
2017年对10个最常被引用的随机对照试验的回顾指出，背景特征的分布不良，盲法存在困难，并讨论了随机对照试验中固有的其他假设和偏差。其中包括”独特的时间段评估偏差”、”背景特征保持不变的假设”、”平均治疗效果限制”、”个人层面的简单治疗限制”、”所有前提条件都得到充分满足的假设”、”定量变量限制”以及”仅安慰剂或常规治疗限制”。&lt;br /&gt;
&lt;br /&gt;
[[Peer review]] of results is an important part of the [[scientific method]]. Reviewers examine the study results for potential problems with design that could lead to unreliable results (for example by creating a [[systematic bias]]), evaluate the study in the context of related studies and other evidence, and evaluate whether the study can be reasonably considered to have proven its conclusions. To underscore the need for peer review and the danger of over-generalizing conclusions, two Boston-area medical researchers performed a randomized controlled trial in which they randomly assigned either a parachute or an empty backpack to 23 volunteers who jumped from either a biplane or a helicopter. The study was able to accurately report that parachutes fail to reduce injury compared to empty backpacks. The key context that limited the general applicability of this conclusion was that the aircraft were parked on the ground, and participants had only jumped about two feet.&amp;lt;ref&amp;gt;{{cite news |url=https://www.npr.org/sections/health-shots/2018/12/22/679083038/researchers-show-parachutes-dont-work-but-there-s-a-catch |title=Researchers Show Parachutes Don't Work, But There's A Catch |date=22 Dec 2018 |author=Richard Harris}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
== Advantages ==&lt;br /&gt;
&lt;br /&gt;
RCTs are considered to be the most reliable form of [[scientific method|scientific evidence]] in the [[hierarchy of evidence]] that influences healthcare policy and practice because RCTs reduce spurious causality and bias. Results of RCTs may be combined in [[systematic review]]s which are increasingly being used in the conduct of [[evidence-based practice]]. Some examples of scientific organizations' considering RCTs or systematic reviews of RCTs to be the highest-quality evidence available are:&lt;br /&gt;
* As of 1998, the [[National Health and Medical Research Council]] of Australia designated &amp;quot;Level I&amp;quot; evidence as that &amp;quot;obtained from a [[systematic review]] of all relevant randomised controlled trials&amp;quot; and &amp;quot;Level II&amp;quot; evidence as that &amp;quot;obtained from at least one properly designed randomised controlled trial.&amp;quot;&amp;lt;ref&amp;gt;{{cite book |url= http://www.nhmrc.gov.au/_files_nhmrc/file/publications/synopses/cp30.pdf |title= A guide to the development, implementation and evaluation of clinical practice guidelines |author= National Health and Medical Research Council |date=1998-11-16 |publisher= Commonwealth of Australia |location = Canberra | isbn = 978-1-86496-048-8 |page= 56|access-date=2010-03-28}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* Since at least 2001, in making [[clinical practice guideline]] recommendations the [[United States Preventive Services Task Force]] has considered both a study's design and its [[internal validity]] as indicators of its quality.&amp;lt;ref name=&amp;quot;Harris-2001&amp;quot;&amp;gt;{{Cite journal | author = Harris RP, Helfand M, Woolf SH, Lohr KN, Mulrow CD, Teutsch SM, Atkins D; Methods Work Group, Third US Preventive Services Task Force | title = Current methods of the US Preventive Services Task Force: a review of the process | journal = Am J Prev Med | volume = 20 | issue = 3 Suppl | pages = 21–35 | year = 2001 | url = http://www.ahrq.gov/clinic/ajpmsuppl/review.pdf | pmid = 11306229 | doi = 10.1016/S0749-3797(01)00261-6 }}&amp;lt;/ref&amp;gt; It has recognized &amp;quot;evidence obtained from at least one properly randomized controlled trial&amp;quot; with good [[internal validity]] (i.e., a rating of &amp;quot;I-good&amp;quot;) as the highest quality evidence available to it.&amp;lt;ref name=&amp;quot;Harris-2001&amp;quot;/&amp;gt;&lt;br /&gt;
* The [[Evidence-based medicine#Grade Working Group|GRADE Working Group]] concluded in 2008 that &amp;quot;randomised trials without important limitations constitute high quality evidence.&amp;quot;&amp;lt;ref name=&amp;quot;Guyatt-2008&amp;quot;&amp;gt;{{Cite journal | author = Guyatt GH, Oxman AD, Kunz R, Vist GE, Falck-Ytter Y, Schünemann HJ; GRADE Working Group | title = What is &amp;quot;quality of evidence&amp;quot; and why is it important to clinicians? | journal = BMJ | volume = 336 | issue = 7651 | pages = 995–8 |year = 2008 | doi = 10.1136/bmj.39490.551019.BE | pmc = 2364804 | pmid = 18456631 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
* For issues involving &amp;quot;Therapy/Prevention, Aetiology/Harm&amp;quot;, the [[Oxford Centre for Evidence-based Medicine]] as of 2011 defined &amp;quot;Level 1a&amp;quot; evidence as a systematic review of RCTs that are consistent with each other, and &amp;quot;Level 1b&amp;quot; evidence as an &amp;quot;individual RCT (with narrow [[Confidence Interval]]).&amp;quot;&amp;lt;ref&amp;gt;{{cite web |url= http://www.cebm.net/index.aspx?o=1025 |title= Levels of evidence |author= Oxford Centre for Evidence-based Medicine |date=2011-09-16 |access-date=2012-02-15}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Notable RCTs with unexpected results that contributed to changes in clinical practice include:&lt;br /&gt;
* After [[Food and Drug Administration]] approval, the [[antiarrhythmic agents]] [[flecainide]] and [[encainide]] came to market in 1986 and 1987 respectively.&amp;lt;ref name=&amp;quot;Anderson-1997&amp;quot;&amp;gt;{{Cite journal |vauthors=Anderson JL, Pratt CM, Waldo AL, Karagounis LA | title = Impact of the Food and Drug Administration approval of flecainide and encainide on coronary artery disease mortality: putting &amp;quot;Deadly Medicine&amp;quot; to the test | journal = Am J Cardiol | volume = 79 | issue = 1 | pages = 43–7 | year = 1997 | url = http://www.ajconline.org/article/S0002-9149%2896%2900673-X/abstract | pmid = 9024734 | doi = 10.1016/S0002-9149(96)00673-X }}&amp;lt;/ref&amp;gt; The non-randomized studies concerning the drugs were characterized as &amp;quot;glowing&amp;quot;,&amp;lt;ref name=&amp;quot;Rubin-2006&amp;quot;&amp;gt;{{cite news |title= In medicine, evidence can be confusing - deluged with studies, doctors try to sort out what works, what doesn't |author= Rubin R |url= https://www.usatoday.com/news/health/2006-10-15-medical-evidence-cover_x.htm |newspaper= USA Today |date= 2006-10-16 |access-date=2010-03-22}}&amp;lt;/ref&amp;gt; and their sales increased to a combined total of approximately 165,000 prescriptions per month in early 1989.&amp;lt;ref name=&amp;quot;Anderson-1997&amp;quot;/&amp;gt;  In that year, however, a preliminary report of an RCT concluded that the two drugs increased mortality.&amp;lt;ref name=&amp;quot;CAST-1989&amp;quot;&amp;gt;{{Cite journal | doi = 10.1056/NEJM198908103210629 | title = Preliminary report: effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction. The Cardiac Arrhythmia Suppression Trial (CAST) Investigators | journal = N Engl J Med | volume = 321 | issue = 6 | pages = 406–12 |year = 1989 | pmid = 2473403 | author1 = Cardiac Arrhythmia Suppression Trial (CAST) Investigators }}&amp;lt;/ref&amp;gt;  Sales of the drugs then decreased.&amp;lt;ref name=&amp;quot;Anderson-1997&amp;quot;/&amp;gt;&lt;br /&gt;
* Prior to 2002, based on observational studies, it was routine for physicians to prescribe hormone replacement therapy for post-menopausal women to prevent [[myocardial infarction]].&amp;lt;ref name=&amp;quot;Rubin-2006&amp;quot;/&amp;gt; In 2002 and 2004, however, published RCTs from the [[Women's Health Initiative]] claimed that women taking hormone replacement therapy with estrogen plus progestin had a higher rate of myocardial infarctions than women on a placebo, and that estrogen-only hormone replacement therapy caused no reduction in the incidence of coronary heart disease.&amp;lt;ref name=&amp;quot;Rossouw-2002&amp;quot;/&amp;gt;&amp;lt;ref name=&amp;quot;Anderson-2004&amp;quot;&amp;gt;{{Cite journal  |vauthors=Anderson GL, Limacher M, Assaf AR, Bassford T, Beresford SA, Black H, etal | title = Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: the Women's Health Initiative randomized controlled trial | journal = JAMA | volume = 291 | issue = 14 | pages = 1701–12 | year = 2004 | doi = 10.1001/jama.291.14.1701 | pmid = 15082697 | doi-access = free }}&amp;lt;/ref&amp;gt;  Possible explanations for the discrepancy between the observational studies and the RCTs involved differences in methodology, in the hormone regimens used, and in the populations studied.&amp;lt;ref name=&amp;quot;Grodstein-2003&amp;quot;&amp;gt;{{Cite journal |vauthors=Grodstein F, Clarkson TB, Manson JE | title = Understanding the divergent data on postmenopausal hormone therapy | journal = N Engl J Med | volume = 348 | issue = 7 | pages = 645–50 | year = 2003 | doi = 10.1056/NEJMsb022365 | pmid = 12584376 }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Vandenbroucke-2009&amp;quot;&amp;gt;{{Cite journal | author = Vandenbroucke JP | title = The HRT controversy: observational studies and RCTs fall in line | journal = Lancet | volume = 373 | issue = 9671 | pages = 1233–5 | year = 2009 | doi = 10.1016/S0140-6736(09)60708-X | pmid = 19362661 | s2cid = 44991220 }}&amp;lt;/ref&amp;gt; The use of hormone replacement therapy decreased after publication of the RCTs.&amp;lt;ref name=&amp;quot;Hsu-2009&amp;quot;&amp;gt;{{Cite journal |vauthors=Hsu A, Card A, Lin SX, Mota S, Carrasquillo O, Moran A | title = Changes in postmenopausal hormone replacement therapy use among women with high cardiovascular risk | journal = Am J Public Health | volume = 99 | issue = 12 | pages = 2184–7 | year = 2009 | doi = 10.2105/AJPH.2009.159889 | url = http://ajph.aphapublications.org/cgi/content/full/99/12/2184 | pmid = 19833984 | pmc=2775780}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
== Disadvantages ==&lt;br /&gt;
&lt;br /&gt;
Many papers discuss the disadvantages of RCTs.&amp;lt;ref name=&amp;quot;Black-1996&amp;quot;&amp;gt;{{Cite journal | author = Black N | title = Why we need observational studies to evaluate the effectiveness of health care | journal = BMJ | volume = 312 | issue = 7040 | pages = 1215–8 | year = 1996 | pmid = 8634569 | pmc = 2350940 | doi=10.1136/bmj.312.7040.1215}}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Bell &amp;amp; Peck-2012&amp;quot;&amp;gt;{{Cite journal | author = Bell, S.H., &amp;amp; Peck, L.R. | title = Obstacles to and limitations of social experiments: 15 false alarms | journal = Abt Thought Leadership Paper Series | year = 2012 | url = http://abtassociates.com/white-papers/2012/obstacles-to-and-limitations-of-social-experiments.aspx }}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;Sanson-Fisher-2007&amp;quot;&amp;gt;{{Cite journal |vauthors=Sanson-Fisher RW, Bonevski B, Green LW, D'Este C | title = Limitations of the randomized controlled trial in evaluating population-based health interventions | journal = Am J Prev Med | volume = 33 | issue = 2 | pages = 155–61 | year = 2007 | doi = 10.1016/j.amepre.2007.04.007 | url = http://www.ajpm-online.net/article/S0749-3797%2807%2900225-5/abstract | pmid = 17673104 }}&amp;lt;/ref&amp;gt;   Among the most frequently cited drawbacks are:&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
=== Time and costs ===&lt;br /&gt;
&lt;br /&gt;
RCTs can be expensive;&amp;lt;ref name=&amp;quot;Sanson-Fisher-2007&amp;quot;/&amp;gt; one study found 28 [[Phase III clinical trials|Phase III]] RCTs funded by the [[National Institute of Neurological Disorders and Stroke]] prior to 2000 with a total cost of US$335 million,&amp;lt;ref name=&amp;quot;Johnston-2006&amp;quot;&amp;gt;{{Cite journal |vauthors=Johnston SC, Rootenberg JD, Katrak S, Smith WS, Elkins JS | title = Effect of a US National Institutes of Health programme of clinical trials on public health and costs | journal = [[The Lancet|Lancet]] | volume = 367 | issue = 9519 | pages = 1319–27 | year = 2006 | doi = 10.1016/S0140-6736(06)68578-4 | url = http://www.chrp.org/pdf/HSR20070511.pdf | pmid = 16631910 | s2cid = 41035177 }}&amp;lt;/ref&amp;gt; for a [[mean]] cost of US$12 million per RCT.  Nevertheless, the [[return on investment]] of RCTs may be high, in that the same study projected that the 28 RCTs produced a &amp;quot;net benefit to society at 10-years&amp;quot; of 46 times the cost of the trials program, based on evaluating a [[quality-adjusted life year]] as equal to the prevailing mean [[per capita]] [[gross domestic product]].&amp;lt;ref name=&amp;quot;Johnston-2006&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
The conduct of an RCT takes several years until being published; thus, data is restricted from the medical community for long years and may be of less relevance at time of publication.&amp;lt;ref name=&amp;quot;CaseReport&amp;quot;&amp;gt;{{cite journal |vauthors=Yitschaky O, Yitschaky M, Zadik Y |title=Case report on trial: Do you, Doctor, swear to tell the truth, the whole truth and nothing but the truth? |journal=J Med Case Rep |volume=5 |issue=1 |page=179 |date=May 2011 |pmid=21569508 |url=http://www.jmedicalcasereports.com/content/pdf/1752-1947-5-179.pdf|doi=10.1186/1752-1947-5-179 |pmc=3113995}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
It is costly to maintain RCTs for the years or decades that would be ideal for evaluating some interventions.&amp;lt;ref name=&amp;quot;Black-1996&amp;quot;/&amp;gt;&amp;lt;ref name=&amp;quot;Sanson-Fisher-2007&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Interventions to prevent events that occur only infrequently (e.g., [[sudden infant death syndrome]]) and uncommon adverse outcomes (e.g., a rare side effect of a drug) would require RCTs with extremely large sample sizes and may, therefore, best be assessed by observational studies.&amp;lt;ref name=&amp;quot;Black-1996&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Due to the costs of running RCTs, these usually only inspect one variable or very few variables, rarely reflecting the full picture of a complicated medical situation; whereas the [[case report]], for example, can detail many aspects of the patient's [[medicine|medical]] situation (e.g. [[patient history]], [[physical examination]], [[diagnosis]], [[psychosocial]] aspects, follow up).&amp;lt;ref name=&amp;quot;CaseReport&amp;quot;/&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
=== Conflict of interest dangers ===&lt;br /&gt;
&lt;br /&gt;
A 2011 study done to disclose possible [[conflicts of interest]]s in underlying research studies used for medical meta-analyses reviewed 29 meta-analyses and found that conflicts of interests in the studies underlying the meta-analyses were rarely disclosed.  The 29 meta-analyses included 11 from general medicine journals; 15 from specialty medicine journals, and 3 from the [[Cochrane Collaboration|Cochrane]] Database of Systematic Reviews. The 29 meta-analyses reviewed an aggregate of 509 randomized controlled trials (RCTs). Of these, 318 RCTs reported funding sources with 219 (69%) industry funded. 132 of the 509 RCTs reported author conflict of interest disclosures, with 91 studies (69%) disclosing industry financial ties with one or more authors. The information was, however, seldom reflected in the meta-analyses. Only two (7%) reported RCT funding sources and none reported RCT author-industry ties. The authors concluded &amp;quot;without acknowledgment of COI due to industry funding or author industry financial ties from RCTs included in meta-analyses, readers' understanding and appraisal of the evidence from the meta-analysis may be compromised.&amp;quot;&amp;lt;ref&amp;gt;{{cite web|url=http://www.cochrane.org/news/blog/how-well-do-meta-analyses-disclose-conflicts-interests-underlying-research-studies |title=How Well Do Meta-Analyses Disclose Conflicts of Interests in Underlying Research Studies &amp;amp;#124; The Cochrane Collaboration |publisher=Cochrane.org |access-date=2011-08-19}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
A 2011 study done to disclose possible conflicts of interests in underlying research studies used for medical meta-analyses reviewed 29 meta-analyses and found that conflicts of interests in the studies underlying the meta-analyses were rarely disclosed. The 29 meta-analyses included 11 from general medicine journals; 15 from specialty medicine journals, and 3 from the Cochrane Database of Systematic Reviews. The 29 meta-analyses reviewed an aggregate of 509 randomized controlled trials (RCTs). Of these, 318 RCTs reported funding sources with 219 (69%) industry funded. 132 of the 509 RCTs reported author conflict of interest disclosures, with 91 studies (69%) disclosing industry financial ties with one or more authors. The information was, however, seldom reflected in the meta-analyses. Only two (7%) reported RCT funding sources and none reported RCT author-industry ties. The authors concluded &amp;quot;without acknowledgment of COI due to industry funding or author industry financial ties from RCTs included in meta-analyses, readers' understanding and appraisal of the evidence from the meta-analysis may be compromised.&amp;quot;[97]&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Some RCTs are fully or partly funded by the health care industry (e.g., the [[pharmaceutical industry]]) as opposed to government, nonprofit, or other sources. A systematic review published in 2003 found four 1986–2002 articles comparing industry-sponsored and nonindustry-sponsored RCTs, and in all the articles there was a correlation of industry sponsorship and positive study outcome.&amp;lt;ref name=&amp;quot;Bekelman-2003&amp;quot;&amp;gt;{{Cite journal |vauthors=Bekelman JE, Li Y, Gross CP | title = Scope and impact of financial conflicts of interest in biomedical research: a systematic review | journal = [[J Am Med Assoc]] | volume = 289 | issue = 4 | pages = 454–65 | year = 2003 | pmid = 12533125 | doi = 10.1001/jama.289.4.454 }}&amp;lt;/ref&amp;gt; A 2004 study of 1999–2001 RCTs published in leading medical and surgical journals determined that industry-funded RCTs &amp;quot;are more likely to be associated with statistically significant pro-industry findings.&amp;quot;&amp;lt;ref name=&amp;quot;Bhandari-2004&amp;quot;&amp;gt;{{Cite journal |vauthors=Bhandari M, Busse JW, Jackowski D, Montori VM, Schünemann H, Sprague S, Mears D, Schemitsch EH, Heels-Ansdell D, Devereaux PJ | title = Association between industry funding and statistically significant pro-industry findings in medical and surgical randomized trials | journal = [[Can Med Assoc J]] | volume = 170 | issue = 4 | pages = 477–80 | year = 2004 | url = http://ecmaj.com/cgi/content/full/170/4/477 | pmid = 14970094 | pmc = 332713 }}&amp;lt;/ref&amp;gt; These results have been mirrored in trials in surgery, where although industry funding did not affect the rate of trial discontinuation it was however associated with a lower odds of publication for completed trials.&amp;lt;ref name=&amp;quot;Chapman-2014&amp;quot;&amp;gt;{{Cite journal |vauthors=Chapman SJ, Shelton B, Mahmood H, Fitzgerald JE, Harrison EM, Bhangu A | title = Discontinuation and non-publication of surgical randomised controlled trials: observational study | journal = [[BMJ]] | volume = 349 | page = g6870| year = 2014 | pmid = 25491195 | pmc = 4260649 | doi=10.1136/bmj.g6870}}&amp;lt;/ref&amp;gt; One possible reason for the pro-industry results in industry-funded published RCTs is [[publication bias]].&amp;lt;ref name=&amp;quot;Bhandari-2004&amp;quot;/&amp;gt;  Other authors have cited the differing goals of academic and industry sponsored research as contributing to the difference. Commercial sponsors may be more focused on performing trials of drugs that have already shown promise in early stage trials, and on replicating previous positive results to fulfill regulatory requirements for drug approval.&amp;lt;ref&amp;gt;{{cite journal |vauthors=Ridker PM, Torres J |title=Reported outcomes in major cardiovascular clinical trials funded by for-profit and not-for-profit organizations: 2000-2005 |journal=JAMA |volume=295 |issue=19 |pages=2270–4 |year=2006 |pmid=16705108 |doi=10.1001/jama.295.19.2270 |doi-access=free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Some RCTs are fully or partly funded by the health care industry (e.g., the pharmaceutical industry) as opposed to government, nonprofit, or other sources. A systematic review published in 2003 found four 1986–2002 articles comparing industry-sponsored and nonindustry-sponsored RCTs, and in all the articles there was a correlation of industry sponsorship and positive study outcome. A 2004 study of 1999–2001 RCTs published in leading medical and surgical journals determined that industry-funded RCTs &amp;quot;are more likely to be associated with statistically significant pro-industry findings.&amp;quot; These results have been mirrored in trials in surgery, where although industry funding did not affect the rate of trial discontinuation it was however associated with a lower odds of publication for completed trials. One possible reason for the pro-industry results in industry-funded published RCTs is publication bias.&lt;br /&gt;
&lt;br /&gt;
有些 rct 完全或部分由医疗保健行业(如制药行业)资助，而不是政府、非营利组织或其他来源。2003年发表的一份系统综述研究报告发现，1986年至2002年间，有4篇文章比较了行业赞助和非行业赞助的 rct，在所有的文章中，行业赞助和正面研究结果之间存在相关性。2004年发表在主要医学和外科杂志上的一项关于1999-2001年的 rct 的研究表明，工业资助的 rct“更有可能与具有统计学意义的有利于工业的发现相关联。”这些结果已经反映在手术试验中，虽然行业资金并不影响试验中止率，但是与完成试验的发表机率较低相关。支持产业的结果在产业资助的已发表的研究报告中出现的一个可能的原因是出版偏见。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Category:Clinical research&lt;br /&gt;
&lt;br /&gt;
类别: 临床研究&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Category:Epidemiological study projects&lt;br /&gt;
&lt;br /&gt;
类别: 流行病学研究项目&lt;br /&gt;
&lt;br /&gt;
Category:Evidence-based practices&lt;br /&gt;
&lt;br /&gt;
类别: 循证做法&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Category:Design of experiments&lt;br /&gt;
&lt;br /&gt;
类别: 实验设计&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Category:Causal inference&lt;br /&gt;
&lt;br /&gt;
类别: 因果推理&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Category:Experiments&lt;br /&gt;
&lt;br /&gt;
分类: 实验&lt;br /&gt;
Category:Research methods&lt;br /&gt;
&lt;br /&gt;
分类: 研究方法&lt;br /&gt;
&lt;br /&gt;
&amp;lt;noinclude&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&amp;lt;small&amp;gt;This page was moved from [[wikipedia:en:Randomized controlled trial]]. Its edit history can be viewed at [[随机对照试验/edithistory]]&amp;lt;/small&amp;gt;&amp;lt;/noinclude&amp;gt;&lt;br /&gt;
&lt;br /&gt;
[[Category:待整理页面]]&lt;/div&gt;</summary>
		<author><name>李昊轩</name></author>
	</entry>
	<entry>
		<id>https://wiki.swarma.org/index.php?title=%E5%88%86%E5%B1%82%E9%9A%8F%E6%9C%BA%E8%AF%95%E9%AA%8C&amp;diff=23577</id>
		<title>分层随机试验</title>
		<link rel="alternate" type="text/html" href="https://wiki.swarma.org/index.php?title=%E5%88%86%E5%B1%82%E9%9A%8F%E6%9C%BA%E8%AF%95%E9%AA%8C&amp;diff=23577"/>
		<updated>2021-06-13T03:18:12Z</updated>

		<summary type="html">&lt;p&gt;李昊轩：&lt;/p&gt;
&lt;hr /&gt;
&lt;div&gt;&lt;br /&gt;
[[File:Graphic_breakdown_of_stratified_random_sampling.jpeg|thumb|220x220px|分层随机抽样的图形分解 Graphic breakdown of stratified random sampling]]&lt;br /&gt;
&lt;br /&gt;
在统计学中，&amp;lt;font color=&amp;quot;#ff8000&amp;quot;&amp;gt; '''分层随机试验 Stratified randomization''' &amp;lt;/font&amp;gt;是一种抽样方法，首先将整个研究&amp;lt;font color=&amp;quot;#ff8000&amp;quot;&amp;gt; '''总体 Population''' &amp;lt;/font&amp;gt;层为具有相同属性或特征的子群，称为&amp;lt;font color=&amp;quot;#ff8000&amp;quot;&amp;gt; '''分层 Attributes'''  &amp;lt;/font&amp;gt;，然后从分层组中进行简单随机抽样，在抽样过程的任何阶段，随机、完全偶然地无偏抽取同一子群中的元素。&amp;lt;ref name=&amp;quot;:3&amp;quot; /&amp;gt;&amp;lt;ref&amp;gt;{{Citation|title=Simple random sample|date=2020-03-18|url=https://en.wikipedia.org/w/index.php?title=Simple_random_sample&amp;amp;oldid=946144051|work=Wikipedia|language=en|access-date=2020-04-07}}&amp;lt;/ref&amp;gt;分层随机试验被认为是&amp;lt;font color=&amp;quot;#ff8000&amp;quot;&amp;gt; '''分层抽样 Stratified sampling''' &amp;lt;/font&amp;gt;的一个细分。当共享属性部分存在，并且在被调查总体的不同亚群之间有很大差异时，应该采用分层随机试验。因此，在取样过程中需要特别考虑或明确区分。&amp;lt;ref&amp;gt;{{Citation|title=Stratified sampling|date=2020-02-09|url=https://en.wikipedia.org/w/index.php?title=Stratified_sampling&amp;amp;oldid=939938944|work=Wikipedia|language=en|access-date=2020-04-07}}&amp;lt;/ref&amp;gt;这种抽样方法应区别于&amp;lt;font color=&amp;quot;#ff8000&amp;quot;&amp;gt; '''整群抽样方法 Cluster sampling''' &amp;lt;/font&amp;gt;，整群抽样方法是在整个群体中选择一个简单的随机抽样来代表整个总体，或分层系统抽样方法，在分层过程之后进行&amp;lt;font color=&amp;quot;#ff8000&amp;quot;&amp;gt; '''系统抽样 Systematic sampling''' &amp;lt;/font&amp;gt;。分层随机抽样有时也称为&amp;lt;font color=&amp;quot;#ff8000&amp;quot;&amp;gt; '''定额随机抽样 Quota random sampling''' &amp;lt;/font&amp;gt;。&amp;lt;ref name=&amp;quot;:3&amp;quot;&amp;gt;{{Cite web|url=https://www.investopedia.com/ask/answers/032615/what-are-some-examples-stratified-random-sampling.asp|title=How Stratified Random Sampling Works|last=Nickolas|first=Steven|date=July 14, 2019|website=Investopedia|language=en|access-date=2020-04-07}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
== 分层随机试验的步骤 Steps for stratified randomization==&lt;br /&gt;
&lt;br /&gt;
分层随机试验在目标总体异&amp;lt;font color=&amp;quot;#ff8000&amp;quot;&amp;gt; '''质性 Heterogeneous'''&amp;lt;/font&amp;gt;的情况下非常有用， 它能有效地显示研究中的趋势或特征在不同阶层之间的差异。&amp;lt;ref name=&amp;quot;:3&amp;quot; /&amp;gt;当进行分层随机试验时，应采取以下8个步骤：&amp;lt;ref name=&amp;quot;:4&amp;quot;&amp;gt;{{Cite web|url=https://www.statisticshowto.com/stratified-random-sample/|title=Stratified Random Sample: Definition, Examples|last=Stephanie|date=Dec 11, 2013|website=Statistics How To|language=en-US|access-date=2020-04-07}}&amp;lt;/ref&amp;gt;&amp;lt;ref name=&amp;quot;:5&amp;quot;&amp;gt;{{Cite web|url=https://www.questionpro.com/blog/stratified-random-sampling/|title=Stratified Random Sampling: Definition, Method and Examples|date=2018-03-13|website=QuestionPro|language=en|access-date=2020-04-07}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
#定义目标总体&lt;br /&gt;
#定义分层&amp;lt;font color=&amp;quot;#ff8000&amp;quot;&amp;gt; '''变量 Variables''' &amp;lt;/font&amp;gt;并决定要创建的分层数量。确定分层变量的标准,包括年龄、社会经济地位、国籍、种族、教育程度等，并应与研究目标相一致。理想情况下，应该使用4-6个阶层，因为任何分层变量的增加将提高其中一些变量抵消其他变量的影响的概率。&amp;lt;ref name=&amp;quot;:5&amp;quot; /&amp;gt;&lt;br /&gt;
#使用&amp;lt;font color=&amp;quot;#ff8000&amp;quot;&amp;gt; '''抽样框架 Sampling frame''' &amp;lt;/font&amp;gt;评估目标总体中的所有元素。之后根据&amp;lt;font color=&amp;quot;#ff8000&amp;quot;&amp;gt; '''覆盖率 Coverage''' &amp;lt;/font&amp;gt; 和分组进行更改。&lt;br /&gt;
#列出所有的元素并考虑抽样结果。每个阶层应该相互排斥 Mutually exclusive，加起来涵盖总体的所有成员，而总体的每一个成员应该属于唯一的阶层，和其他差异最小的成员一起。&amp;lt;ref name=&amp;quot;:4&amp;quot; /&amp;gt;&lt;br /&gt;
#决定随机抽样的选择标准。这可以手动完成，也可以用设计好的计算机程序完成。&lt;br /&gt;
#为所有元素分配一个随机且唯一的编号，然后根据分配的编号对这些元素进行排序。&lt;br /&gt;
#回顾每一层的大小（Size）和每一层中所有元素的&amp;lt;font color=&amp;quot;#ff8000&amp;quot;&amp;gt; '''数值分布 Numerical distribution''' &amp;lt;/font&amp;gt;。确定抽样类型，按比例或不按比例分层抽样。&lt;br /&gt;
#按照第5步中的规定进行所选的随机抽样。至少，必须从每个阶层中选择一种元素，以便最终样品包括每个阶层的代表。如果从每个阶层中选择两个或两个以上的元素，则可以计算所收集数据的&amp;lt;font color=&amp;quot;#ff8000&amp;quot;&amp;gt; '''误差范围 Error margins''' &amp;lt;/font&amp;gt;。&amp;lt;ref name=&amp;quot;:5&amp;quot; /&amp;gt;&lt;br /&gt;
&lt;br /&gt;
== 技术 Techniques ==&lt;br /&gt;
[[File:Simple_random_sampling_after_stratification_step.png|thumb|分层后简单随机抽样]]&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#32cd32&amp;quot;&amp;gt;分层随机试验决定一个或多个预后因素，在平均意义下，每个亚组具有相似的进入特征。Stratified randomization decides one or multiple prognostic factors to make subgroups, on average, have similar entry characteristics.&amp;lt;/font&amp;gt; 通过检查先前研究的结果，可以准确地确定患者因素。&amp;lt;ref&amp;gt;{{Cite journal|last=Sylvester|first=Richard|date=December 1982|title=Fundamentals of clinical trials|journal=Controlled Clinical Trials|volume=3|issue=4|pages=385–386|doi=10.1016/0197-2456(82)90029-0|issn=0197-2456}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
子群的数量可以通过乘以每个因素的层数来计算。在随机化前或随机化时测量因素，并根据测量结果将实验对象分为若干亚组或层。&lt;br /&gt;
&lt;br /&gt;
在每一层中，可以应用几种随机试验策略，包括&amp;lt;font color=&amp;quot;#ff8000&amp;quot;&amp;gt; '''简单随机试验 Simple randomization''' &amp;lt;/font&amp;gt;、&amp;lt;font color=&amp;quot;#ff8000&amp;quot;&amp;gt; '''分块随机试验 Blocked randomization''' &amp;lt;/font&amp;gt;和&amp;lt;font color=&amp;quot;#ff8000&amp;quot;&amp;gt; '''最小化试验 Minimization''' &amp;lt;/font&amp;gt;。&lt;br /&gt;
=== 分层内简单随机抽样 Simple randomization within strata ===&lt;br /&gt;
&lt;br /&gt;
简单随机试验被认为是在每个阶层中分配受试者的最简单方法。对于每个任务，受试者被完全随机地分配到每个组中。尽管简单的随机化很容易进行，但由于取样量小，分配不均，因此在含有100多个样本的地层中，通常采用简单的随机化方法。尽管很容易进行，但简单随机试验通常应用于包含 100 个以上样本的层，因为小样本量会使分配不均等。&amp;lt;ref name=&amp;quot;:0&amp;quot; /&amp;gt;&lt;br /&gt;
&lt;br /&gt;
===分层内的区块随机试验 Block randomization within strata===&lt;br /&gt;
&lt;br /&gt;
'''&amp;lt;font color=&amp;quot;#ff8000&amp;quot;&amp;gt; 区块随机试验 Block randomization &amp;lt;/font&amp;gt;'''，有时称为置换区块随机试验，应用区块将来自同一阶层的受试者平均分配到研究中的每个组。 在区块随机试验中，指定了分配比率（一个特定组与其他组的数量之比）和组大小。 块大小必须是处理次数的倍数，以便每个层中的样本可以按预期比例分配到处理组。&amp;lt;ref name=&amp;quot;:0&amp;quot;&amp;gt;{{Cite book|last=Pocock, Stuart J.|title=Clinical trials : a practical approach|publisher=John Wiley &amp;amp; Sons Ltd|date=Jul 1, 2013|isbn=978-1-118-79391-6|location=Chichester|oclc=894581169}}&amp;lt;/ref&amp;gt;例如，在一项关于乳腺癌的临床试验中，应该有 4 或 8 个层次，其中年龄和淋巴结状态是两个预后因素（prognostic factors），每个因素分为两个水平。 可以通过多种方式将不同的区块分配给样本，包括随机列表（random list）和计算机编程。&amp;lt;ref&amp;gt;{{Cite web|url=https://www.sealedenvelope.com/help/redpill/latest/block/|title=Sealed Envelope {{!}} Random permuted blocks|date=Feb 25, 2020|website=www.sealedenvelope.com|access-date=2020-04-07}}&amp;lt;/ref&amp;gt;&amp;lt;ref&amp;gt;{{Citation|last1=Friedman|first1=Lawrence M.|title=Introduction to Clinical Trials|date=2010|work=Fundamentals of Clinical Trials|pages=1–18|publisher=Springer New York|isbn=978-1-4419-1585-6|last2=Furberg|first2=Curt D.|last3=DeMets|first3=David L.|doi=10.1007/978-1-4419-1586-3_1}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
区块随机试验通常用于样本量较大的实验，以避免具有重要特征的样本分配不平衡。 在某些对随机试验有严格要求的领域，如临床试验，当没有对导体（conductors）进行盲法处理且区块块大小有限时，分配是可预测的。 分层中的块置换随机试验可能会随着分层数量的增加和样本量的限制而导致分层之间的样本不平衡，例如，有可能找不到符合某些分层特征的样本&amp;lt;ref&amp;gt;{{Cite book|title=Fundamentals of clinical trials|others=Friedman, Lawrence M., 1942-, Furberg, Curt,, DeMets, David L., 1944-, Reboussin, David,, Granger, Christopher B.|date=27 August 2015|isbn=978-3-319-18539-2|edition=Fifth|location=New York|oclc=919463985}}&amp;lt;/ref&amp;gt;。&lt;br /&gt;
&lt;br /&gt;
==最小化方法 Minimization method==&lt;br /&gt;
&lt;br /&gt;
为了保证每个处理组的相似性，尝试了“最小化”方法，这比分层内的随机排列块更直接。在最小化方法中，根据每个处理组中的样本总和将每个层中的样本分配到处理组中，这使得受试者数量在组间保持平衡。&amp;lt;ref name=&amp;quot;:0&amp;quot; /&amp;gt; 如果多个治疗组的总和相同，则将进行简单的随机化以分配治疗。在实践中，最小化方法需要根据预后因素（prognostic factors）跟踪治疗分配的每日记录，这可以通过使用一组索引卡进行记录来有效完成。最小化方法有效地避免了组间不平衡，但比块随机化涉及的随机过程更少，因为随机过程仅在治疗的总人数相同时进行。一个可行的解决方案是应用额外的随机列表，这使得具有较小边际总数的总和的治疗组具有更高的机会（例如 ¾），而其他治疗具有较低的机会（例如 ¼）。&amp;lt;ref name=&amp;quot;:1&amp;quot;&amp;gt;{{Cite journal|last=Pocock|first=S. J.|date=March 1979|title=Allocation of Patients to Treatment in Clinical Trials|journal=Biometrics|volume=35|issue=1|pages=183–197|doi=10.2307/2529944|jstor=2529944|pmid=497334|issn=0006-341X}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
==应用 Application==&lt;br /&gt;
&lt;br /&gt;
[[File:Confounding_factors_are_important_to_consider_in_clinical_trials.png|thumb|219x219px|混杂因素在临床试验中很重要]]&lt;br /&gt;
&lt;br /&gt;
分层随机试验在需要对特定层进行不同权重的情况下非常有用且富有成效。 通过这种方式，研究人员可以操纵每个层次的选择机制，以放大或最小化调查结果中所需的特征。&amp;lt;ref&amp;gt;{{Cite web|url=https://www.thoughtco.com/stratified-sampling-3026731|title=Understanding Stratified Samples and How to Make Them|last=Crossman|first=Ashley|date=Jan 27, 2020|website=ThoughtCo|language=en|access-date=2020-04-07}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
当研究人员打算寻找两个或多个层次之间的关联时，分层随机化很有帮助，因为简单的随机抽样会导致更大的可能出现目标群体的不平等代表性。当研究人员希望消除观察性研究中的'''&amp;lt;font color=&amp;quot;#ff8000&amp;quot;&amp;gt; 混杂因素 Confounder &amp;lt;/font&amp;gt;'''时，它也很有用，因为分层随机试验允许调整'''&amp;lt;font color=&amp;quot;#ff8000&amp;quot;&amp;gt; 协方差 Covariances &amp;lt;/font&amp;gt;'''和 '''&amp;lt;font color=&amp;quot;#ff8000&amp;quot;&amp;gt; p 值 p-values &amp;lt;/font&amp;gt;'''以获得更准确的结果。 &amp;lt;ref&amp;gt;{{Cite book|last=Hennekens, Charles H.|title=Epidemiology in medicine|date=1987|publisher=Little, Brown|others=Buring, Julie E., Mayrent, Sherry L.|isbn=0-316-35636-0|edition=1st|location=Boston, Massachusetts|oclc=16890223}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
与简单随机抽样相比，分层随机抽样的统计准确度也更高，因为选择代表总体的元素具有高度相关性。&amp;lt;ref name=&amp;quot;:5&amp;quot; /&amp;gt;与分层之间的差异相比，分层内的差异要小得多。因此，随着样本间差异的最小化，'''&amp;lt;font color=&amp;quot;#ff8000&amp;quot;&amp;gt; 标准差 Standard deviation &amp;lt;/font&amp;gt;'''也会随之收紧，从而导致最终结果的准确性更高，误差更小。当研究资金紧张时，这有效地减少了所需的样本量并提高了抽样的'''&amp;lt;font color=&amp;quot;#ff8000&amp;quot;&amp;gt; 成本效益 Cost-effectiveness &amp;lt;/font&amp;gt;'''。&lt;br /&gt;
&lt;br /&gt;
在现实生活中，分层随机试验可应用于选举投票结果、社会群体收入差距调查或各国教育机会的衡量。 &amp;lt;ref name=&amp;quot;:3&amp;quot; /&amp;gt;&lt;br /&gt;
&lt;br /&gt;
==临床试验中的分层随机试验 Stratified randomization in clinical trials==&lt;br /&gt;
&lt;br /&gt;
在'''&amp;lt;font color=&amp;quot;#ff8000&amp;quot;&amp;gt; 临床试验 Clinical trials &amp;lt;/font&amp;gt;'''中，根据患者的社会和个人背景或与研究相关的任何因素对患者进行分层，以匹配整个患者群体中的每个组。 这样做的目的是建立临床/预后因素（prognostic factor）的平衡，因为如果研究设计不平衡，试验将不会产生有效的结果。&amp;lt;ref&amp;gt;{{Cite book|last1=Polit|first1=DF|title=Nursing Research: Generating and Assessing Evidence for Nursing Practice, 9th ed.|last2=Beck|first2=CT|publisher=Lippincott Williams &amp;amp; Wilkins.|year=2012|location=Philadelphia, USA: Wolters Klower Health}}&amp;lt;/ref&amp;gt;  分层随机化的步骤非常重要，因为它试图确保没有偏见、有意或无意地影响所研究患者样本的代表性。 &amp;lt;ref&amp;gt;{{Cite web|url=https://www.omixon.com/patient-stratification-in-clinical-trials/|title=Patient Stratification in Clinical Trials|date=2014-12-01|website=Omixon {{!}} NGS for HLA|language=en-US|access-date=2020-04-26}}&amp;lt;/ref&amp;gt;  它增加了研究能力，尤其是在小型临床试验中（n&amp;lt;400），因为这些已知的临床特征分层被认为会影响干预的结果。&amp;lt;ref&amp;gt;{{Cite web|url=https://www.statisticshowto.com/stratified-randomization/|title=Stratified Randomization in Clinical Trials|last=Stephanie|date=2016-05-20|website=Statistics How To|language=en-US|access-date=2020-04-26}}&amp;lt;/ref&amp;gt;它有助于防止在临床研究中受到高度重视的 '''&amp;lt;font color=&amp;quot;#ff8000&amp;quot;&amp;gt; I 型错误 Type I error &amp;lt;/font&amp;gt;'''的发生。 &amp;lt;ref name=&amp;quot;:6&amp;quot;&amp;gt;{{Cite journal|last=Kernan|first=W|date=Jan 1999|title=Stratified Randomization for Clinical Trials|journal=Journal of Clinical Epidemiology|volume=52|issue=1|pages=19–26|doi=10.1016/S0895-4356(98)00138-3|pmid=9973070}}&amp;lt;/ref&amp;gt;它还对主动对照等效试验的样本量产生重要影响，并且在理论上有助于'''&amp;lt;font color=&amp;quot;#ff8000&amp;quot;&amp;gt; 亚组分析 Subgroup analysis &amp;lt;/font&amp;gt;'''和'''&amp;lt;font color=&amp;quot;#ff8000&amp;quot;&amp;gt; 中期分析 Interim analysis &amp;lt;/font&amp;gt;'''。 &amp;lt;ref name=&amp;quot;:6&amp;quot; /&amp;gt;&lt;br /&gt;
&lt;br /&gt;
==优势 Advantage==&lt;br /&gt;
分层随机试验的优点包括：&lt;br /&gt;
&lt;br /&gt;
#分层随机试验可以准确反映一般人群的结果，因为应用影响因素对整个样本进行分层并平衡样本在治疗组之间的重要特征。例如，采用分层随机化从人群中抽取 100 名样本可以保证每个治疗组的男女平衡，而使用简单随机化可能会导致一组只有 20 名男性，而另一组有 80 名男性。&amp;lt;ref name=&amp;quot;:0&amp;quot; /&amp;gt;&lt;br /&gt;
#分层随机试验比其他抽样方法（例如'''&amp;lt;font color=&amp;quot;#ff8000&amp;quot;&amp;gt; 整群抽样 Cluster sampling &amp;lt;/font&amp;gt;'''、简单随机抽样 和'''&amp;lt;font color=&amp;quot;#ff8000&amp;quot;&amp;gt; 系统抽样 Systematic sampling &amp;lt;/font&amp;gt;'''或'''&amp;lt;font color=&amp;quot;#ff8000&amp;quot;&amp;gt; 非概率方法 Non-probability methods &amp;lt;/font&amp;gt;'''）的误差更小，因为可以使分层内的测量具有较低的标准差。在某些情况下，将分割的分层随机试验比简单地随机试验一般样本更易于管理且成本更低。&amp;lt;ref name=&amp;quot;:1&amp;quot; /&amp;gt;&lt;br /&gt;
#由于分层随机试验本质的精确性，团队更容易接受分层样本的训练。&lt;br /&gt;
#由于这种方法的统计准确性，研究人员可以通过分析小样本得到非常有用的结果。&lt;br /&gt;
#'''&amp;lt;font color=&amp;quot;#32cd32&amp;quot;&amp;gt;这种抽样技术涵盖了广泛的总体，因为已经对分层划分进行了完整的控制。 This sampling technique covers a wide range of population since complete charge over the strata division has been made.&amp;lt;/font&amp;gt;'''&lt;br /&gt;
# 有时需要分层随机试验来估计总体中各组的总体参数。&amp;lt;ref name=&amp;quot;:1&amp;quot; /&amp;gt;&lt;br /&gt;
&lt;br /&gt;
==缺点 Disadvantage ==&lt;br /&gt;
&lt;br /&gt;
分层随机试验的限制包括：&lt;br /&gt;
&lt;br /&gt;
#分层随机试验首先参考预后因素将样本分成若干层，但有可能无法划分样本。在应用中，在某些情况下，预后因素的重要性缺乏严格的认可，这可能进一步导致偏差。这就是为什么在将因素纳入分层之前应该检查因素产生影响的潜力的原因。在某些因素对结果的影响无法得到批准（approved）的情况下，建议进行无分层随机试验。 &amp;lt;ref&amp;gt;{{Cite web|url=https://www.investopedia.com/ask/answers/041615/what-are-advantages-and-disadvantages-stratified-random-sampling.asp|title=Pros and Cons of Stratified Random Sampling|last=Murphy|first=Chris B.|date=Apr 13, 2019|website=Investopedia|language=en|access-date=2020-04-07}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
#如果可用数据不能代表整个亚组总体，则认为亚组大小具有相同的重要性。在某些应用中，子组大小是根据可用数据量来决定的，而不是将样本大小缩放到子组大小，这会在因子效应中引入偏差。在某些需要对数据进行方差分层的情况下，子组方差差异显着，使得每个子组的抽样规模无法保证与整个子组总体成正比。&amp;lt;ref name=&amp;quot;:2&amp;quot;&amp;gt;{{Citation|last1=Glass|first1=Aenne|title=Potential Advantages and Disadvantages of Stratification in Methods of Randomization|date=2014|work=Springer Proceedings in Mathematics &amp;amp; Statistics|pages=239–246|publisher=Springer New York|isbn=978-1-4939-2103-4|last2=Kundt|first2=Guenther|doi=10.1007/978-1-4939-2104-1_23}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
#如果人口不能完全分配到层中，则不能应用分层抽样，这将导致样本大小与可用样本成正比，而不是与总体子组人口成正比。&amp;lt;ref name=&amp;quot;:0&amp;quot; /&amp;gt;&lt;br /&gt;
#如果受试者符合多层次的纳入标准，则将样本分配到亚组的过程可能涉及重叠，这可能导致总体的错误陈述。&amp;lt;ref name=&amp;quot;:2&amp;quot;&amp;gt;{{Citation|last1=Glass|first1=Aenne|title=Potential Advantages and Disadvantages of Stratification in Methods of Randomization|date=2014|work=Springer Proceedings in Mathematics &amp;amp; Statistics|pages=239–246|publisher=Springer New York|isbn=978-1-4939-2103-4|last2=Kundt|first2=Guenther|doi=10.1007/978-1-4939-2104-1_23}}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
==参考文献==&lt;br /&gt;
{{Citation|last1=Glass|first1=Aenne|title=Potential Advantages and Disadvantages of Stratification in Methods of Randomization|date=2014|work=Springer Proceedings in Mathematics &amp;amp; Statistics|pages=239–246|publisher=Springer New York|isbn=978-1-4939-2103-4|last2=Kundt|first2=Guenther|doi=10.1007/978-1-4939-2104-1_23}}&amp;lt;/ref&amp;gt;&lt;/div&gt;</summary>
		<author><name>李昊轩</name></author>
	</entry>
	<entry>
		<id>https://wiki.swarma.org/index.php?title=%E5%80%BE%E5%90%91%E5%BE%97%E5%88%86%E5%8C%B9%E9%85%8D&amp;diff=23568</id>
		<title>倾向得分匹配</title>
		<link rel="alternate" type="text/html" href="https://wiki.swarma.org/index.php?title=%E5%80%BE%E5%90%91%E5%BE%97%E5%88%86%E5%8C%B9%E9%85%8D&amp;diff=23568"/>
		<updated>2021-06-12T16:19:51Z</updated>

		<summary type="html">&lt;p&gt;李昊轩：/* 缺点 */&lt;/p&gt;
&lt;hr /&gt;
&lt;div&gt;此词条暂由彩云小译翻译，翻译字数共893，未经人工整理和审校，带来阅读不便，请见谅。&lt;br /&gt;
&lt;br /&gt;
{{Short description|Statistical matching technique}}&lt;br /&gt;
&lt;br /&gt;
In the [[statistics|statistical]] analysis of [[observational study|observational data]], '''propensity score matching''' ('''PSM''') is a [[Matching (statistics)|statistical matching]] technique that attempts to [[Estimation theory|estimate]] the effect of a treatment, policy, or other intervention by accounting for the [[covariate]]s that predict receiving the treatment. PSM attempts to reduce the [[Bias (statistics)|bias]] due to [[confounding]] variables that could be found in an estimate of the treatment effect obtained from simply comparing outcomes among [[Statistical unit|units]] that [[Treatment and control groups|received the treatment versus those that did not]]. [[Paul R. Rosenbaum]] and [[Donald Rubin]] introduced the technique in 1983.&amp;lt;ref name=&amp;quot;Rosenbaum 1983 41–55&amp;quot;&amp;gt;{{cite journal |last=Rosenbaum |first=Paul R. |last2=Rubin |first2=Donald B. |title=The Central Role of the Propensity Score in Observational Studies for Causal Effects |journal=[[Biometrika]] |year=1983 |volume=70 |issue=1 |pages=41–55 |doi=10.1093/biomet/70.1.41 |doi-access=free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
In the statistical analysis of observational data, propensity score matching (PSM) is a statistical matching technique that attempts to estimate the effect of a treatment, policy, or other intervention by accounting for the covariates that predict receiving the treatment. PSM attempts to reduce the bias due to confounding variables that could be found in an estimate of the treatment effect obtained from simply comparing outcomes among units that received the treatment versus those that did not. Paul R. Rosenbaum and Donald Rubin introduced the technique in 1983.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】在观察数据的统计分析中，倾向性评分匹配是一种统计匹配技术，它试图通过计算预测接受治疗的协变量来估计治疗、政策或其他干预的效果。PSM 试图减少由于混杂变量造成的偏倚，这些变量可以通过简单地比较接受治疗的单位和没有接受治疗的单位之间的结果来估计治疗效果。保罗 · 罗森鲍姆和唐纳德 · 鲁宾在1983年介绍了这项技术。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
在观察数据的统计分析中，倾向性评分匹配Propensity Score Matching (PSM)是一种用于估计治疗、政策或其他干预的效果统计匹配技术，方法是将协变量对样本“是否接受处理”的影响考虑在内。PSM试图减少由于混杂变量造成的偏倚。这些偏倚一般会在那些只对处理单元和对照单元的结果做简单对比的评估中出现。保罗·罗森鲍姆Paul R. Rosenbaum和唐纳德·鲁宾Donald Rubin在1983年介绍了这项技术。&lt;br /&gt;
&lt;br /&gt;
The possibility of bias arises because a difference in the treatment outcome (such as the [[average treatment effect]]) between treated and untreated groups may be caused by a factor that predicts treatment rather than the treatment itself. In [[randomized experiment]]s, the randomization enables unbiased estimation of treatment effects; for each covariate, randomization implies that treatment-groups will be balanced on average, by the [[law of large numbers]]. Unfortunately, for observational studies, the assignment of treatments to research subjects is typically not random. [[Matching (statistics)|Matching]] attempts to reduce the treatment assignment bias, and mimic randomization, by creating a sample of units that received the treatment that is comparable on all observed covariates to a sample of units that did not receive the treatment.&lt;br /&gt;
&lt;br /&gt;
The possibility of bias arises because a difference in the treatment outcome (such as the average treatment effect) between treated and untreated groups may be caused by a factor that predicts treatment rather than the treatment itself. In randomized experiments, the randomization enables unbiased estimation of treatment effects; for each covariate, randomization implies that treatment-groups will be balanced on average, by the law of large numbers. Unfortunately, for observational studies, the assignment of treatments to research subjects is typically not random. Matching attempts to reduce the treatment assignment bias, and mimic randomization, by creating a sample of units that received the treatment that is comparable on all observed covariates to a sample of units that did not receive the treatment.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】出现偏倚的可能性是因为治疗组和未治疗组之间治疗结果(如平均治疗效果)的差异可能是由预测治疗的因素而不是治疗本身造成的。在随机实验中，随机化可以对治疗效果进行无偏估计; 对于每个协变量，随机化意味着治疗组将按照大数定律在平均水平上达到平衡。不幸的是，对于观察性研究来说，对研究对象的治疗分配通常不是随机的。匹配试图减少处理分配偏差，并模拟随机化，通过创建一个样本单位接受的处理是可比的所有观察到的协变量的一个样本单位没有接受处理。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
出现偏倚的原因可能是某个因素通过决定样本是否接受处理而导致了处理组和对照组的效果（如平均处理效果）差异，而不是处理本身导致了差异。在随机实验中，随机化选择样本可以做到对处理效果的无偏估计，根据大数定律，随机化分配机制意味着每个协变量将在处理组和对照组中呈现类似的分布。不幸的是，对于观察性研究来说，研究对象通常不是随机接受处理的。匹配就是要减少对象非随机接受处理产生的偏倚，并模拟随机试验，方法是从处理组和对照组中分别取样，让两组样本的全部协变量都比较接近。&lt;br /&gt;
&lt;br /&gt;
For example, one may be interested to know the [[Health_effects_of_tobacco#Early_observational_studies|consequences of smoking]]. An observational study is required since it is unethical to randomly assign people to the treatment 'smoking.' The treatment effect estimated by simply comparing those who smoked to those who did not smoke would be biased by any factors that predict smoking (e.g.: gender and age). PSM attempts to control for these biases by making the groups receiving treatment and not-treatment comparable with respect to the control variables.&lt;br /&gt;
&lt;br /&gt;
For example, one may be interested to know the consequences of smoking. An observational study is required since it is unethical to randomly assign people to the treatment 'smoking.' The treatment effect estimated by simply comparing those who smoked to those who did not smoke would be biased by any factors that predict smoking (e.g.: gender and age). PSM attempts to control for these biases by making the groups receiving treatment and not-treatment comparable with respect to the control variables.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】例如，人们可能有兴趣知道吸烟的后果。因为随机分配患者接受‘吸烟’治疗是不道德的，所以需要一个观察性研究简单地比较吸烟者和不吸烟者的治疗效果会受到任何预测吸烟的因素的影响(例如:。: 性别及年龄)。PSM 试图通过使接受治疗和不接受治疗的组与控制变量相比较来控制这些偏差。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
例如，人们想知道吸烟的后果。但是随机分配让患者“吸烟”是不道德的，所以需要做一个观察性研究。简单地通过对比评估吸烟者和不吸烟者来估计平均处理效果将产生偏差，它会受到能影响吸烟行为的因素的影响（例如：性别及年龄）。PSM要做的是通过让处理组和对照组的控制变量尽量相似来达到控制这些偏差的目的。&lt;br /&gt;
&lt;br /&gt;
==Overview ==&lt;br /&gt;
&lt;br /&gt;
==综述==&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
PSM is for cases of [[Inductive reasoning#Causal inference|causal inference]] and simple selection bias in [[non-experimental]] settings in which: (i) few units in the non-treatment comparison group are comparable to the treatment units; and (ii) selecting a subset of comparison units similar to the treatment unit is difficult because units must be compared across a high-dimensional set of pretreatment characteristics.&lt;br /&gt;
&lt;br /&gt;
PSM is for cases of causal inference and simple selection bias in non-experimental settings in which: (i) few units in the non-treatment comparison group are comparable to the treatment units; and (ii) selecting a subset of comparison units similar to the treatment unit is difficult because units must be compared across a high-dimensional set of pretreatment characteristics.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】PSM 适用于非实验环境中因果推断和简单选择偏差的情况，其中: (i)非处理对照组中与处理单元可比的单元很少; (ii)选择与处理单元类似的比较单元子集很困难，因为必须跨一组高维预处理特征进行比较。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
PSM适用于非实验环境中因果推断和简单选择偏差的情况，其中: (i)对照组与处理组中的类似单元很少; (ii)选择与处理单元类似的对照单元集合很困难，因为必须对一组高维的协变量特征进行比较。&lt;br /&gt;
&lt;br /&gt;
In normal matching, single characteristics that distinguish treatment and control groups are matched in an attempt to make the groups more alike. But if the two groups do not have substantial overlap, then substantial [[Errors and residuals|error]] may be introduced. For example, if only the worst cases from the [[control group|untreated &amp;quot;comparison&amp;quot; group]] are compared to only the best cases from the [[treatment group]], the result may be [[regression toward the mean]], which may make the comparison group look better or worse than reality.&lt;br /&gt;
&lt;br /&gt;
In normal matching, single characteristics that distinguish treatment and control groups are matched in an attempt to make the groups more alike. But if the two groups do not have substantial overlap, then substantial error may be introduced. For example, if only the worst cases from the untreated &amp;quot;comparison&amp;quot; group are compared to only the best cases from the treatment group, the result may be regression toward the mean, which may make the comparison group look better or worse than reality.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】在正常的匹配中，区分治疗组和对照组的单一特征被匹配，试图使这些组更加相似。但是，如果这两个组没有实质性的重叠，那么可能会引入实质性的错误。例如，如果只将来自未经治疗的对照组的最差病例与来自治疗组的最好病例进行比较，结果可能是趋中回归，这可能使对照组看起来比实际情况更好或更糟。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
在常规的匹配机制中，对一组能够区分处理组和对照组的特征做匹配，以使两组的特征更加相似。但如果这两个组的特征没有显著的重叠，那么可能会引入实质性的错误。例如，拿对照组最糟的病例和处理组最好的病例进行比较，结果可能倾向于回归均值，这会让对照组看起来比实际情况更好或更糟。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
PSM employs a predicted probability of group membership—e.g., treatment versus control group—based on observed predictors, usually obtained from [[logistic regression]] to create a [[Impact evaluation#Counterfactual evaluation designs|counterfactual group]]. Propensity scores may be used for matching or as [[covariance|covariate]]s, alone or with other matching variables or covariates.&lt;br /&gt;
&lt;br /&gt;
PSM employs a predicted probability of group membership—e.g., treatment versus control group—based on observed predictors, usually obtained from logistic regression to create a counterfactual group. Propensity scores may be used for matching or as covariates, alone or with other matching variables or covariates.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】PSM 使用了一种预测的群体成员概率---- 例如，治疗组与控制组---- 基于观察预测，通常从 Logit模型获得来创造一个反事实的群体。倾向得分可用于匹配或作为协变量，单独或与其他匹配变量或协变量。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
PSM利用观察数据预测样本落入不同分组（例如，处理组与控制组）的概率，通常用Logistic回归方法，然后利用此概率创造一个反事实的群体。倾向性评分可用于匹配，也可作为协变量，可以单独使用，也可以与其他匹配变量或协变量一同使用。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
==General procedure==&lt;br /&gt;
&lt;br /&gt;
==一般步骤==&lt;br /&gt;
&lt;br /&gt;
1. Run [[logistic regression]]:&lt;br /&gt;
&lt;br /&gt;
1. Run logistic regression:&lt;br /&gt;
&lt;br /&gt;
1. 做Logistic回归：&lt;br /&gt;
&lt;br /&gt;
*Dependent variable: ''Z'' = 1, if unit participated (i.e. is member of the treatment group); ''Z'' = 0, if unit did not participate (i.e. is member of the control group).&lt;br /&gt;
&lt;br /&gt;
*因变量：参与处理（属于处理组），则''Z'' = 1；未参与处理（属于对照组），则''Z'' = 0。&lt;br /&gt;
&lt;br /&gt;
*Choose appropriate confounders (variables hypothesized to be associated with both treatment and outcome)&lt;br /&gt;
&lt;br /&gt;
*选择合适的混杂因素（既影响处理方式又影响处理结果的变量）&lt;br /&gt;
&lt;br /&gt;
*Obtain an [[Estimator|estimation]] for the propensity score: predicted probability (''p'') or log[''p''/(1&amp;amp;nbsp;−&amp;amp;nbsp;''p'')].&lt;br /&gt;
&lt;br /&gt;
*计算倾向性评分的[[Estimator|估计量]]：预测概率(''p'')或log[''p''/(1&amp;amp;nbsp;−&amp;amp;nbsp;''p'')]。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
2. Check that covariates are balanced across treatment and comparison groups within strata of the propensity score.&lt;br /&gt;
&lt;br /&gt;
2. Check that covariates are balanced across treatment and comparison groups within strata of the propensity score.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;2. 【机器翻译】检查协变量是平衡的治疗和比较组内的倾向分层。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
2. 依照倾向性评分的估计量进行分层，&amp;lt;font color=&amp;quot;#32cd32&amp;quot;&amp;gt;检查协变量的倾向性评分的估计量在每层处理组和对照组是否均衡&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
*Use standardized differences or graphs to examine distributions&lt;br /&gt;
&lt;br /&gt;
*使用标准化差异指标或者图形来检验分布情况&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
3. Match each participant to one or more nonparticipants on propensity score, using one of these methods:&lt;br /&gt;
&lt;br /&gt;
3. Match each participant to one or more nonparticipants on propensity score, using one of these methods:&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;3. 【机器翻译】根据倾向得分，将每个参与者与一个或多个非参与者进行匹配，使用以下方法之一:&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
3. 根据倾向性评分的估计量，将每个处理组个体与一个或多个对照组个体进行匹配，使用以下方法之一：&lt;br /&gt;
&lt;br /&gt;
*[[Nearest neighbor search|Nearest neighbor matching]]&lt;br /&gt;
&lt;br /&gt;
*[[Nearest neighbor search|最近邻匹配]]&lt;br /&gt;
&lt;br /&gt;
*Caliper matching: comparison units within a certain width of the propensity score of the treated units get matched, where the width is generally a fraction of the standard deviation of the propensity score&lt;br /&gt;
&lt;br /&gt;
*卡钳匹配：在处理单元倾向性评分的一个范围内选取对照单元，范围的宽度通常用倾向性评分的标准差乘上一个比例值&lt;br /&gt;
&lt;br /&gt;
*[[Mahalanobis distance|Mahalanobis metric]] matching in conjunction with PSM&lt;br /&gt;
&lt;br /&gt;
*[[Mahalanobis distance|马氏度量]] 与PSM配合使用&lt;br /&gt;
&lt;br /&gt;
*[[Stratified sampling|Stratification matching]]&lt;br /&gt;
&lt;br /&gt;
*[[Stratified sampling|分层匹配]]&lt;br /&gt;
&lt;br /&gt;
*Difference-in-differences matching (kernel and local linear weights)&lt;br /&gt;
&lt;br /&gt;
*&amp;lt;font color=&amp;quot;#32cd32&amp;quot;&amp;gt;双重差分匹配（核和局部线性加权）&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
*Exact matching&lt;br /&gt;
&lt;br /&gt;
*精确匹配&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
4. Verify that covariates are balanced across treatment and comparison groups in the matched or weighted sample&lt;br /&gt;
&lt;br /&gt;
4. Verify that covariates are balanced across treatment and comparison groups in the matched or weighted sample&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;4.【机器翻译】验证协变量是平衡的处理和对照组在匹配或加权样本&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
4. &amp;lt;font color=&amp;quot;#32cd32&amp;quot;&amp;gt;对比处理组和对照组的匹配样本或加权样本，验证协变量是否均衡&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
5. Multivariate analysis based on new sample&lt;br /&gt;
&lt;br /&gt;
5. Multivariate analysis based on new sample&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;5.【机器翻译】基于新样本的多变量分析&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
5. 基于新样本的多变量分析&lt;br /&gt;
&lt;br /&gt;
*Use analyses appropriate for non-independent matched samples if more than one nonparticipant is matched to each participant&lt;br /&gt;
&lt;br /&gt;
* 如果每个参与者都匹配了多个非参与者，则适当应用非独立匹配样本分析&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Note: When you have multiple matches for a single treated observation, it is essential to use Weighted Least Squares rather than Ordinary Least Squares.&lt;br /&gt;
&lt;br /&gt;
Note: When you have multiple matches for a single treated observation, it is essential to use Weighted Least Squares rather than Ordinary Least Squares.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】注意: 当你有多个匹配的单一处理的观察，它是必不可少的使用加权最小二乘而不是一般最小平方法。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
注意：当一个处理样本有多个匹配时，则必须用加权最小二乘法，而不能用普通最小二乘法。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
==Formal definitions==&lt;br /&gt;
&lt;br /&gt;
==形式定义 ==&lt;br /&gt;
&lt;br /&gt;
===Basic settings ===&lt;br /&gt;
&lt;br /&gt;
===基本设置===&lt;br /&gt;
&lt;br /&gt;
The basic case&amp;lt;ref name=&amp;quot;Rosenbaum 1983 41–55&amp;quot; /&amp;gt; is of two treatments (numbered 1 and 0), with ''N'' [Independent and identically distributed random variables|i.i.d] subjects. Each subject ''i'' would respond to the treatment with &amp;lt;math&amp;gt;r_{1i}&amp;lt;/math&amp;gt; and to the control with &amp;lt;math&amp;gt;r_{0i}&amp;lt;/math&amp;gt;. The quantity to be estimated is the [[average treatment effect]]: &amp;lt;math&amp;gt;E[r_1]-E[r_0]&amp;lt;/math&amp;gt;. The variable &amp;lt;math&amp;gt;Z_i&amp;lt;/math&amp;gt; indicates if subject ''i'' got treatment (''Z''&amp;amp;nbsp;=&amp;amp;nbsp;1) or control (''Z''&amp;amp;nbsp;=&amp;amp;nbsp;0). Let &amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt; be a vector of observed pretreatment measurement (or covariate) for the ''i''th subject. The observations of &amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt; are made prior to treatment assignment, but the features in &amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt; may not include all (or any) of the ones used to decide on the treatment assignment. The numbering of the units (i.e.: ''i''&amp;amp;nbsp;=&amp;amp;nbsp;1,&amp;amp;nbsp;...,&amp;amp;nbsp;''i''&amp;amp;nbsp;=&amp;amp;nbsp;''N'') are assumed to not contain any information beyond what is contained in &amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt;. The following sections will omit the ''i'' index while still discussing about the stochastic behavior of some subject.&lt;br /&gt;
&lt;br /&gt;
基本场景&amp;lt;ref name=&amp;quot;Rosenbaum 1983 41–55&amp;quot; /&amp;gt;是，有两种处理方式（分别记为1和0），''N''个[[Independent and identically distributed random variables|独立同分布]]个体。每个个体''i''如果接受了处理则响应为&amp;lt;math&amp;gt;r_{1i}&amp;lt;/math&amp;gt;，接受控制则响应为&amp;lt;math&amp;gt;r_{0i}&amp;lt;/math&amp;gt;。被估计量是[[average treatment effect|平均处理效应]]：&amp;lt;math&amp;gt;E[r_1]-E[r_0]&amp;lt;/math&amp;gt;。变量&amp;lt;math&amp;gt;Z_i&amp;lt;/math&amp;gt;指示个体''i''接受处理(''Z''&amp;amp;nbsp;=&amp;amp;nbsp;1)还是接受控制(''Z''&amp;amp;nbsp;=&amp;amp;nbsp;0)。让&amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt;代表第''i''个个体处理前观测值（或者协变量）的向量。对&amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt;的测量发生于处理前，但是&amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt;中也可以不包括那些决定是否接受处理的特征。个体编号（即：''i''&amp;amp;nbsp;=&amp;amp;nbsp;1,&amp;amp;nbsp;...,&amp;amp;nbsp;''i''&amp;amp;nbsp;=&amp;amp;nbsp;''N''）不包含任何&amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt;所包含信息之外的的信息。以下部分在讨论某些个体的随机行为的时候将省略索引''i''。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
===Strongly ignorable treatment assignment===&lt;br /&gt;
&lt;br /&gt;
===强可忽略处理分配===&lt;br /&gt;
&lt;br /&gt;
{{See also|Ignorability}}&lt;br /&gt;
&lt;br /&gt;
{{See also|可忽略性}}&lt;br /&gt;
&lt;br /&gt;
Let some subject have a vector of covariates ''X'' (i.e.: conditionally unconfounded), and some '''potential outcomes''' ''r''&amp;lt;sub&amp;gt;0&amp;lt;/sub&amp;gt; and ''r''&amp;lt;sub&amp;gt;1&amp;lt;/sub&amp;gt; under control and treatment, respectively. Treatment assignment is said to be '''strongly ignorable''' if the potential outcomes are [[statistical independence|independent]] of treatment (''Z'') conditional on background variables ''X''.  This can be written compactly as&lt;br /&gt;
&lt;br /&gt;
设某个物体有协变量''X''（即：条件非混杂变量）向量，以及对应着控制和处理两种情况的'''潜在结果'''''r''&amp;lt;sub&amp;gt;0&amp;lt;/sub&amp;gt;和''r''&amp;lt;sub&amp;gt;1&amp;lt;/sub&amp;gt;。如果潜在结果在给定背景变量''X''的条件下独立于处理举动（''Z''），则可以说样本是否接受处理分配是'''强可忽略'''的。可简洁表述为&lt;br /&gt;
&lt;br /&gt;
:&amp;lt;math&amp;gt; r_0, r_1 \perp Z \mid X &amp;lt;/math&amp;gt;&lt;br /&gt;
&lt;br /&gt;
这里&amp;lt;math&amp;gt;\perp&amp;lt;/math&amp;gt;代表[[statistical independence|统计独立]].&amp;lt;ref name=&amp;quot;Rosenbaum 1983 41–55&amp;quot; /&amp;gt;&lt;br /&gt;
&lt;br /&gt;
=== Balancing score===&lt;br /&gt;
&lt;br /&gt;
=== 平衡得分===&lt;br /&gt;
&lt;br /&gt;
A '''balancing score''' ''b''(''X'') is a function of the observed covariates ''X'' such that the [[conditional probability|conditional distribution]] of ''X'' given ''b''(''X'') is the same for treated (''Z''&amp;amp;nbsp;=&amp;amp;nbsp;1) and control (''Z''&amp;amp;nbsp;=&amp;amp;nbsp;0) units:&lt;br /&gt;
&lt;br /&gt;
A balancing score b(X) is a function of the observed covariates X such that the conditional distribution of X given b(X) is the same for treated (Z = 1) and control (Z = 0) units:&lt;br /&gt;
&lt;br /&gt;
平衡得分b(X)是观测协变量X的函数。在给定b(X)时，处理单元和控制单元的X有相同的条件分布：&lt;br /&gt;
&lt;br /&gt;
:&amp;lt;math&amp;gt; Z \perp X \mid b(X).&amp;lt;/math&amp;gt;&lt;br /&gt;
&lt;br /&gt;
最一般的平衡得分函数是&amp;lt;math&amp;gt; b(X) = X&amp;lt;/math&amp;gt;.&lt;br /&gt;
&lt;br /&gt;
===Propensity score===&lt;br /&gt;
&lt;br /&gt;
===倾向性评分 ===&lt;br /&gt;
&lt;br /&gt;
A '''propensity score''' is the [[probability]] of a unit (e.g., person, classroom, school) being assigned to a particular treatment given a set of observed covariates.  Propensity scores are used to reduce [[selection bias]] by equating groups based on these covariates.&lt;br /&gt;
&lt;br /&gt;
Suppose that we have a binary treatment [[Indicator function|indicator]] ''Z'', a response variable ''r'', and background observed covariates ''X''.  The propensity score is defined as the [[conditional probability]] of treatment given background variables:&lt;br /&gt;
&lt;br /&gt;
A propensity score is the probability of a unit (e.g., person, classroom, school) being assigned to a particular treatment given a set of observed covariates. Propensity scores are used to reduce selection bias by equating groups based on these covariates.&lt;br /&gt;
&lt;br /&gt;
Suppose that we have a binary treatment indicator Z, a response variable r, and background observed covariates X. The propensity score is defined as the conditional probability of treatment given background variables:&lt;br /&gt;
&lt;br /&gt;
倾向性评分是根据协变量观测值计算得出的一个单元（例如：个人，教室，学校）被指配接受特定处理的概率。倾向性评分匹配将使得处理组和对照组的协变量分布趋同，从而减少选择偏差。&lt;br /&gt;
&lt;br /&gt;
假设有一个二值处理标识Z，一个响应变量r，以及被观测的背景协变量X。倾向性评分定义为，在给定背景变量条件下单元接受处理的条件概率：&lt;br /&gt;
&lt;br /&gt;
:&amp;lt;math&amp;gt;e(x) \ \stackrel{\mathrm{def}}{=}\  \Pr(Z=1 \mid X=x).&amp;lt;/math&amp;gt;&lt;br /&gt;
&lt;br /&gt;
In the context of [[causal inference]] and [[survey methodology]], propensity scores are estimated (via methods such as [[logistic regression]], [[random forests]], or others), using some set of covariates. These propensity scores are then used as estimators for weights to be used with [[Inverse probability weighting]] methods.&lt;br /&gt;
&lt;br /&gt;
In the context of causal inference and survey methodology, propensity scores are estimated (via methods such as logistic regression, random forests, or others), using some set of covariates. These propensity scores are then used as estimators for weights to be used with Inverse probability weighting methods.&lt;br /&gt;
&lt;br /&gt;
在因果推断和调查方法的范围内，通过Logistic回归、随机森林或其他方法，利用一组协变量估计倾向性评分。然后这些倾向性评分即可作为用于逆概率加权方法的权重估计量。&lt;br /&gt;
&lt;br /&gt;
===Main theorems===&lt;br /&gt;
&lt;br /&gt;
===主要定理===&lt;br /&gt;
&lt;br /&gt;
The following were first presented, and proven, by Rosenbaum and Rubin in 1983:&amp;lt;ref name=&amp;quot;Rosenbaum 1983 41–55&amp;quot; /&amp;gt;&lt;br /&gt;
&lt;br /&gt;
The following were first presented, and proven, by Rosenbaum and Rubin in 1983:[1]&lt;br /&gt;
&lt;br /&gt;
以下是Rosenbaum和Rubin于1983年首次提出并证明的：&amp;lt;ref name=&amp;quot;Rosenbaum 1983 41–55&amp;quot; /&amp;gt;&lt;br /&gt;
&lt;br /&gt;
*The propensity score &amp;lt;math&amp;gt;e(x)&amp;lt;/math&amp;gt; is a balancing score.&lt;br /&gt;
*倾向性评分&amp;lt;math&amp;gt;e(x)&amp;lt;/math&amp;gt;是平衡得分。&lt;br /&gt;
&lt;br /&gt;
*Any score that is 'finer' than the propensity score is a balancing score (i.e.: &amp;lt;math&amp;gt;e(X)=f(b(X))&amp;lt;/math&amp;gt; for some function ''f''). The propensity score is the coarsest balancing score function, as it takes a (possibly) multidimensional object (''X''&amp;lt;sub&amp;gt;''i''&amp;lt;/sub&amp;gt;) and transforms it into one dimension (although others, obviously, also exist), while &amp;lt;math&amp;gt;b(X)=X&amp;lt;/math&amp;gt; is the finest one.&lt;br /&gt;
*任何比倾向性评分更“精细”的得分都是平衡得分（即：对于函数''f''，&amp;lt;math&amp;gt;e(X)=f(b(X))&amp;lt;/math&amp;gt;）。倾向性评分是最粗粒度的平衡得分函数，因为它把一个（可能是）多维的对象（''X''&amp;lt;sub&amp;gt;''i''&amp;lt;/sub&amp;gt;）转换成只有一维（尽管其他维度显然也存在），而&amp;lt;math&amp;gt;b(X)=X&amp;lt;/math&amp;gt;则是最细粒度的平衡得分函数（保留全部维度）。&lt;br /&gt;
&lt;br /&gt;
*If treatment assignment is strongly ignorable given ''X'' then:&lt;br /&gt;
*如果对于给定的''X''，处理分配满足强可忽略条件，则：&lt;br /&gt;
&lt;br /&gt;
:*It is also strongly ignorable given any balancing function. Specifically, given the propensity score:&lt;br /&gt;
:* 给定任何的平衡函数，具体来说，给定倾向性评分，处理分配也是强可忽略的：&lt;br /&gt;
&lt;br /&gt;
:::&amp;lt;math&amp;gt; (r_0, r_1) \perp Z \mid e(X).&amp;lt;/math&amp;gt;&lt;br /&gt;
回归&lt;br /&gt;
:*For any value of a balancing score, the difference between the treatment and control means of the samples at hand (i.e.: &amp;lt;math&amp;gt;\bar{r}_1-\bar{r}_0&amp;lt;/math&amp;gt;), based on subjects that have the same value of the balancing score, can serve as an [[Bias of an estimator|unbiased estimator]] of the [[average treatment effect]]: &amp;lt;math&amp;gt;E[r_1]-E[r_0]&amp;lt;/math&amp;gt;.&lt;br /&gt;
:*对于有相同平衡得分值的处理样本和对照样本，它们响应变量均值之差（即：&amp;lt;math&amp;gt;\bar{r}_1-\bar{r}_0&amp;lt;/math&amp;gt;），可以作为[[average treatment effect|平均处理效应]]的[[Bias of an estimator|无偏估计量]]：&amp;lt;math&amp;gt;E[r_1]-E[r_0]&amp;lt;/math&amp;gt;。&lt;br /&gt;
&lt;br /&gt;
*Using sample estimates of balancing scores can produce sample balance on&amp;amp;nbsp;''X''&lt;br /&gt;
*利用平衡得分的样本估计可产生在X上均衡的样本&lt;br /&gt;
&lt;br /&gt;
===Relationship to sufficiency===&lt;br /&gt;
===与充分性的关系 ===&lt;br /&gt;
&lt;br /&gt;
If we think of the value of ''Z'' as a [[Statistical parameter|parameter]] of the population that impacts the distribution of ''X'' then the balancing score serves as a [[Sufficient_statistic#Mathematical_definition|sufficient statistic]] for ''Z''. Furthermore, the above theorems indicate that the propensity score is a [[Sufficient_statistic#Minimal_sufficiency|minimal sufficient statistic]] if thinking of ''Z'' as a parameter of ''X''. Lastly, if treatment assignment ''Z'' is strongly ignorable given ''X'' then the propensity score is a [[Sufficient_statistic#Minimal_sufficiency|minimal sufficient statistic]] for the joint distribution of &amp;lt;math&amp;gt;(r_0, r_1)&amp;lt;/math&amp;gt;.&lt;br /&gt;
&lt;br /&gt;
If we think of the value of Z as a parameter of the population that impacts the distribution of X then the balancing score serves as a sufficient statistic for Z. Furthermore, the above theorems indicate that the propensity score is a minimal sufficient statistic if thinking of Z as a parameter of X. Lastly, if treatment assignment Z is strongly ignorable given X then the propensity score is a minimal sufficient statistic for the joint distribution of {\displaystyle (r_{0},r_{1})}{\displaystyle (r_{0},r_{1})}.&lt;br /&gt;
&lt;br /&gt;
如果我们把''Z''的值想成影响''X''分布的群体参数，则平衡得分充当了''Z''的充分统计量。进一步，上述定理指出，如果把''Z''视为''X''的参数，则倾向性评分就是最小充分统计量。最后，给定''X''，如果''Z''是强可忽略的，则倾向性评分是&amp;lt;math&amp;gt;(r_0, r_1)&amp;lt;/math&amp;gt;联合分布的最小充分统计量。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
===Graphical test for detecting the presence of confounding variables===&lt;br /&gt;
===混杂变量的图检测方法===&lt;br /&gt;
&lt;br /&gt;
[[Judea Pearl]] has shown that there exists a simple graphical test, called the back-door criterion, which detects the presence of confounding variables. To estimate the effect of treatment, the background variables X must block all back-door paths in the graph. This blocking can be done either by adding the confounding variable as a control in regression, or by matching on the confounding variable.&amp;lt;ref name=&amp;quot;pearl&amp;quot;&amp;gt;{{cite book |last=Pearl |first=J. |year=2000 |title=Causality: Models, Reasoning, and Inference |url=https://archive.org/details/causalitymodelsr0000pear |url-access=registration |location=New York |publisher=Cambridge University Press |isbn=978-0-521-77362-1 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Judea Pearl has shown that there exists a simple graphical test, called the back-door criterion, which detects the presence of confounding variables. To estimate the effect of treatment, the background variables X must block all back-door paths in the graph. This blocking can be done either by adding the confounding variable as a control in regression, or by matching on the confounding variable.[2]&lt;br /&gt;
&lt;br /&gt;
朱迪亚·珀尔Judea Pearl已经表明存在一个简单的图检测方法，称为后门准则，它可以检测到混杂变量的存在。为了估计处理效果，背景变量X必须阻断图中的所有后门路径。通过把混杂变量加入回归的控制变量，或者在混杂变量上进行匹配可以实现后门路径的阻断。&lt;br /&gt;
&lt;br /&gt;
== Disadvantages==&lt;br /&gt;
== 缺点 ==&lt;br /&gt;
&lt;br /&gt;
PSM has been shown to increase model &amp;quot;imbalance, inefficiency, model dependence, and bias,&amp;quot; which is not the case with most other matching methods. The insights behind the use of matching still hold but should be applied with other matching methods; propensity scores also have other productive uses in weighting and doubly robust estimation.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】PSM 已经被证明会增加模型的“不平衡性、低效率、模型依赖性和偏差”，这与大多数其他匹配方法不同。使用匹配的见解仍然有效，但应该与其他匹配方法一起应用; 倾向得分在加权和双重稳健估计方面也有其他有益的用途。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
PSM已经被证明会加剧模型的“不平衡性、低效率、模型依赖性和偏差”，这与大多数其他匹配方法不同。匹配方法背后的直观仍然成立，但应该与其他匹配方法一起应用；倾向得分在加权和双重稳健估计方面也有其他有益的用途。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Like other matching procedures, PSM estimates an average treatment effect from observational data. The key advantages of PSM were, at the time of its introduction, that by using a linear combination of covariates for a single score, it balances treatment and control groups on a large number of covariates without losing a large number of observations. If units in the treatment and control were balanced on a large number of covariates one at a time, large numbers of observations would be needed to overcome the &amp;quot;dimensionality problem&amp;quot; whereby the introduction of a new balancing covariate increases the minimum necessary number of observations in the sample geometrically.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】与其他匹配程序一样，PSM 从观测数据中估计平均处理效果。在引入 PSM 的时候，它的主要优点是，通过使用一个线性组合的协变量作为一个单一的评分，它平衡了治疗组和对照组在大量的协变量上，而不会失去大量的观察数据。如果处理和控制中的单元在大量的协变量上一次平衡，就需要大量的观测数据来克服“维数问题”，即引入新的平衡协变量几何地增加样本中必要的最小观测数据。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
与其他匹配过程一样，PSM也是从观测数据中估计平均处理效应。在引入PSM之时，它的主要优点是，通过使用协变量的线性组合得到一个单一评分，以大量的协变量为基础平衡了处理组和对照组，却不大量损失观测数据。如果在有众多协变量的情况下，对每一个些变量都分别做处理单元和对照单元平衡的话，就需要大量的观测数据来克服”维数问题“，即每引入一个新的平衡协变量都会在几何上增加最小所需的观测样本数量。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
One disadvantage of PSM is that it only accounts for observed (and observable) covariates and not latent characteristics. Factors that affect assignment to treatment and outcome but that cannot be observed cannot be accounted for in the matching procedure. As the procedure only controls for observed variables, any hidden bias due to latent variables may remain after matching. Another issue is that PSM requires large samples, with substantial overlap between treatment and control groups.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】PSM 的一个缺点是它只能解释观察到的(和可观察到的)协变量，而不能解释潜在的特征。影响治疗分配和结果但无法观察的因素不能在匹配程序中说明。由于程序只控制观察变量，任何隐藏的偏见由于潜在变量可能仍然匹配后。另一个问题是 PSM 需要大量的样本，治疗组和对照组之间有大量的重叠。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
PSM的一个缺点是它只能涵盖已观测的（和可观测的）协变量，而无法涵盖潜在变量。那些能影响处理分配却不可观测的因素无法被纳入匹配过程的考量范围。由于匹配过程只控制可观测变量，那些隐藏的偏差在匹配后依然可能存在。另一个问题是PSM还要求在大量样本中，在处理组和对照组之间有大量的重叠。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
General concerns with matching have also been raised by Judea Pearl, who has argued that hidden bias may actually increase because matching on observed variables may unleash bias due to dormant unobserved confounders. Similarly, Pearl has argued that bias reduction can only be assured (asymptotically) by modelling the qualitative causal relationships between treatment, outcome, observed and unobserved covariates. Confounding occurs when the experimenter is unable to control for alternative, non-causal explanations for an observed relationship between independent and dependent variables. Such control should satisfy the &amp;quot;backdoor criterion&amp;quot; of Pearl. It can also easily be implemented manually.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】朱迪亚 · 珀尔也提出了关于配对的普遍担忧，他认为隐性偏见实际上可能会增加，因为观察变量的配对可能会由于潜在的未观察混杂因素而释放出偏见。同样，珀尔认为，只有通过建立治疗、结果、观察和未观察协变量之间的定性因果关系模型，才能确保(渐近地)减少偏见。当实验者无法控制对独立变量和因变量之间观察到的关系的替代性、非因果性解释时，混淆就发生了。这种控制应满足珍珠的“后门规范”。它也可以很容易地手动实现。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Judea Pearl也提出了关于匹配方法的普遍担忧，他认为对可观测变量进行匹配可能会让那些原本处于休眠状态的混杂因素被释放，从而实际上可能加剧隐藏的偏差。同样，Pearl认为，只有通过对处理、结果、可观测和不可观测的协变量之间的定性因果关系进行建模，才能确保（渐进地）减少偏差。当试验者无法控制&amp;lt;font color=&amp;quot;#32cd32&amp;quot;&amp;gt;对独立变量和因变量之间观察到的关系的替代性、非因果性解释时&amp;lt;/font&amp;gt;，混杂就会发生。这样的控制应该满足Pearl的“后门准则”。它也很容易地手动实现。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&amp;lt;noinclude&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&amp;lt;small&amp;gt;This page was moved from [[wikipedia:en:Propensity score matching]]. Its edit history can be viewed at [[倾向性评分/edithistory]]&amp;lt;/small&amp;gt;&amp;lt;/noinclude&amp;gt;&lt;br /&gt;
&lt;br /&gt;
[[Category:待整理页面]]&lt;br /&gt;
&lt;br /&gt;
&amp;lt;references /&amp;gt;&lt;/div&gt;</summary>
		<author><name>李昊轩</name></author>
	</entry>
	<entry>
		<id>https://wiki.swarma.org/index.php?title=%E5%80%BE%E5%90%91%E5%BE%97%E5%88%86%E5%8C%B9%E9%85%8D&amp;diff=23567</id>
		<title>倾向得分匹配</title>
		<link rel="alternate" type="text/html" href="https://wiki.swarma.org/index.php?title=%E5%80%BE%E5%90%91%E5%BE%97%E5%88%86%E5%8C%B9%E9%85%8D&amp;diff=23567"/>
		<updated>2021-06-12T16:03:46Z</updated>

		<summary type="html">&lt;p&gt;李昊轩：/* 倾向性评分 */&lt;/p&gt;
&lt;hr /&gt;
&lt;div&gt;此词条暂由彩云小译翻译，翻译字数共893，未经人工整理和审校，带来阅读不便，请见谅。&lt;br /&gt;
&lt;br /&gt;
{{Short description|Statistical matching technique}}&lt;br /&gt;
&lt;br /&gt;
In the [[statistics|statistical]] analysis of [[observational study|observational data]], '''propensity score matching''' ('''PSM''') is a [[Matching (statistics)|statistical matching]] technique that attempts to [[Estimation theory|estimate]] the effect of a treatment, policy, or other intervention by accounting for the [[covariate]]s that predict receiving the treatment. PSM attempts to reduce the [[Bias (statistics)|bias]] due to [[confounding]] variables that could be found in an estimate of the treatment effect obtained from simply comparing outcomes among [[Statistical unit|units]] that [[Treatment and control groups|received the treatment versus those that did not]]. [[Paul R. Rosenbaum]] and [[Donald Rubin]] introduced the technique in 1983.&amp;lt;ref name=&amp;quot;Rosenbaum 1983 41–55&amp;quot;&amp;gt;{{cite journal |last=Rosenbaum |first=Paul R. |last2=Rubin |first2=Donald B. |title=The Central Role of the Propensity Score in Observational Studies for Causal Effects |journal=[[Biometrika]] |year=1983 |volume=70 |issue=1 |pages=41–55 |doi=10.1093/biomet/70.1.41 |doi-access=free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
In the statistical analysis of observational data, propensity score matching (PSM) is a statistical matching technique that attempts to estimate the effect of a treatment, policy, or other intervention by accounting for the covariates that predict receiving the treatment. PSM attempts to reduce the bias due to confounding variables that could be found in an estimate of the treatment effect obtained from simply comparing outcomes among units that received the treatment versus those that did not. Paul R. Rosenbaum and Donald Rubin introduced the technique in 1983.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】在观察数据的统计分析中，倾向性评分匹配是一种统计匹配技术，它试图通过计算预测接受治疗的协变量来估计治疗、政策或其他干预的效果。PSM 试图减少由于混杂变量造成的偏倚，这些变量可以通过简单地比较接受治疗的单位和没有接受治疗的单位之间的结果来估计治疗效果。保罗 · 罗森鲍姆和唐纳德 · 鲁宾在1983年介绍了这项技术。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
在观察数据的统计分析中，倾向性评分匹配Propensity Score Matching (PSM)是一种用于估计治疗、政策或其他干预的效果统计匹配技术，方法是将协变量对样本“是否接受处理”的影响考虑在内。PSM试图减少由于混杂变量造成的偏倚。这些偏倚一般会在那些只对处理单元和对照单元的结果做简单对比的评估中出现。保罗·罗森鲍姆Paul R. Rosenbaum和唐纳德·鲁宾Donald Rubin在1983年介绍了这项技术。&lt;br /&gt;
&lt;br /&gt;
The possibility of bias arises because a difference in the treatment outcome (such as the [[average treatment effect]]) between treated and untreated groups may be caused by a factor that predicts treatment rather than the treatment itself. In [[randomized experiment]]s, the randomization enables unbiased estimation of treatment effects; for each covariate, randomization implies that treatment-groups will be balanced on average, by the [[law of large numbers]]. Unfortunately, for observational studies, the assignment of treatments to research subjects is typically not random. [[Matching (statistics)|Matching]] attempts to reduce the treatment assignment bias, and mimic randomization, by creating a sample of units that received the treatment that is comparable on all observed covariates to a sample of units that did not receive the treatment.&lt;br /&gt;
&lt;br /&gt;
The possibility of bias arises because a difference in the treatment outcome (such as the average treatment effect) between treated and untreated groups may be caused by a factor that predicts treatment rather than the treatment itself. In randomized experiments, the randomization enables unbiased estimation of treatment effects; for each covariate, randomization implies that treatment-groups will be balanced on average, by the law of large numbers. Unfortunately, for observational studies, the assignment of treatments to research subjects is typically not random. Matching attempts to reduce the treatment assignment bias, and mimic randomization, by creating a sample of units that received the treatment that is comparable on all observed covariates to a sample of units that did not receive the treatment.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】出现偏倚的可能性是因为治疗组和未治疗组之间治疗结果(如平均治疗效果)的差异可能是由预测治疗的因素而不是治疗本身造成的。在随机实验中，随机化可以对治疗效果进行无偏估计; 对于每个协变量，随机化意味着治疗组将按照大数定律在平均水平上达到平衡。不幸的是，对于观察性研究来说，对研究对象的治疗分配通常不是随机的。匹配试图减少处理分配偏差，并模拟随机化，通过创建一个样本单位接受的处理是可比的所有观察到的协变量的一个样本单位没有接受处理。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
出现偏倚的原因可能是某个因素通过决定样本是否接受处理而导致了处理组和对照组的效果（如平均处理效果）差异，而不是处理本身导致了差异。在随机实验中，随机化选择样本可以做到对处理效果的无偏估计，根据大数定律，随机化分配机制意味着每个协变量将在处理组和对照组中呈现类似的分布。不幸的是，对于观察性研究来说，研究对象通常不是随机接受处理的。匹配就是要减少对象非随机接受处理产生的偏倚，并模拟随机试验，方法是从处理组和对照组中分别取样，让两组样本的全部协变量都比较接近。&lt;br /&gt;
&lt;br /&gt;
For example, one may be interested to know the [[Health_effects_of_tobacco#Early_observational_studies|consequences of smoking]]. An observational study is required since it is unethical to randomly assign people to the treatment 'smoking.' The treatment effect estimated by simply comparing those who smoked to those who did not smoke would be biased by any factors that predict smoking (e.g.: gender and age). PSM attempts to control for these biases by making the groups receiving treatment and not-treatment comparable with respect to the control variables.&lt;br /&gt;
&lt;br /&gt;
For example, one may be interested to know the consequences of smoking. An observational study is required since it is unethical to randomly assign people to the treatment 'smoking.' The treatment effect estimated by simply comparing those who smoked to those who did not smoke would be biased by any factors that predict smoking (e.g.: gender and age). PSM attempts to control for these biases by making the groups receiving treatment and not-treatment comparable with respect to the control variables.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】例如，人们可能有兴趣知道吸烟的后果。因为随机分配患者接受‘吸烟’治疗是不道德的，所以需要一个观察性研究简单地比较吸烟者和不吸烟者的治疗效果会受到任何预测吸烟的因素的影响(例如:。: 性别及年龄)。PSM 试图通过使接受治疗和不接受治疗的组与控制变量相比较来控制这些偏差。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
例如，人们想知道吸烟的后果。但是随机分配让患者“吸烟”是不道德的，所以需要做一个观察性研究。简单地通过对比评估吸烟者和不吸烟者来估计平均处理效果将产生偏差，它会受到能影响吸烟行为的因素的影响（例如：性别及年龄）。PSM要做的是通过让处理组和对照组的控制变量尽量相似来达到控制这些偏差的目的。&lt;br /&gt;
&lt;br /&gt;
==Overview ==&lt;br /&gt;
&lt;br /&gt;
==综述==&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
PSM is for cases of [[Inductive reasoning#Causal inference|causal inference]] and simple selection bias in [[non-experimental]] settings in which: (i) few units in the non-treatment comparison group are comparable to the treatment units; and (ii) selecting a subset of comparison units similar to the treatment unit is difficult because units must be compared across a high-dimensional set of pretreatment characteristics.&lt;br /&gt;
&lt;br /&gt;
PSM is for cases of causal inference and simple selection bias in non-experimental settings in which: (i) few units in the non-treatment comparison group are comparable to the treatment units; and (ii) selecting a subset of comparison units similar to the treatment unit is difficult because units must be compared across a high-dimensional set of pretreatment characteristics.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】PSM 适用于非实验环境中因果推断和简单选择偏差的情况，其中: (i)非处理对照组中与处理单元可比的单元很少; (ii)选择与处理单元类似的比较单元子集很困难，因为必须跨一组高维预处理特征进行比较。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
PSM适用于非实验环境中因果推断和简单选择偏差的情况，其中: (i)对照组与处理组中的类似单元很少; (ii)选择与处理单元类似的对照单元集合很困难，因为必须对一组高维的协变量特征进行比较。&lt;br /&gt;
&lt;br /&gt;
In normal matching, single characteristics that distinguish treatment and control groups are matched in an attempt to make the groups more alike. But if the two groups do not have substantial overlap, then substantial [[Errors and residuals|error]] may be introduced. For example, if only the worst cases from the [[control group|untreated &amp;quot;comparison&amp;quot; group]] are compared to only the best cases from the [[treatment group]], the result may be [[regression toward the mean]], which may make the comparison group look better or worse than reality.&lt;br /&gt;
&lt;br /&gt;
In normal matching, single characteristics that distinguish treatment and control groups are matched in an attempt to make the groups more alike. But if the two groups do not have substantial overlap, then substantial error may be introduced. For example, if only the worst cases from the untreated &amp;quot;comparison&amp;quot; group are compared to only the best cases from the treatment group, the result may be regression toward the mean, which may make the comparison group look better or worse than reality.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】在正常的匹配中，区分治疗组和对照组的单一特征被匹配，试图使这些组更加相似。但是，如果这两个组没有实质性的重叠，那么可能会引入实质性的错误。例如，如果只将来自未经治疗的对照组的最差病例与来自治疗组的最好病例进行比较，结果可能是趋中回归，这可能使对照组看起来比实际情况更好或更糟。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
在常规的匹配机制中，对一组能够区分处理组和对照组的特征做匹配，以使两组的特征更加相似。但如果这两个组的特征没有显著的重叠，那么可能会引入实质性的错误。例如，拿对照组最糟的病例和处理组最好的病例进行比较，结果可能倾向于回归均值，这会让对照组看起来比实际情况更好或更糟。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
PSM employs a predicted probability of group membership—e.g., treatment versus control group—based on observed predictors, usually obtained from [[logistic regression]] to create a [[Impact evaluation#Counterfactual evaluation designs|counterfactual group]]. Propensity scores may be used for matching or as [[covariance|covariate]]s, alone or with other matching variables or covariates.&lt;br /&gt;
&lt;br /&gt;
PSM employs a predicted probability of group membership—e.g., treatment versus control group—based on observed predictors, usually obtained from logistic regression to create a counterfactual group. Propensity scores may be used for matching or as covariates, alone or with other matching variables or covariates.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】PSM 使用了一种预测的群体成员概率---- 例如，治疗组与控制组---- 基于观察预测，通常从 Logit模型获得来创造一个反事实的群体。倾向得分可用于匹配或作为协变量，单独或与其他匹配变量或协变量。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
PSM利用观察数据预测样本落入不同分组（例如，处理组与控制组）的概率，通常用Logistic回归方法，然后利用此概率创造一个反事实的群体。倾向性评分可用于匹配，也可作为协变量，可以单独使用，也可以与其他匹配变量或协变量一同使用。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
==General procedure==&lt;br /&gt;
&lt;br /&gt;
==一般步骤==&lt;br /&gt;
&lt;br /&gt;
1. Run [[logistic regression]]:&lt;br /&gt;
&lt;br /&gt;
1. Run logistic regression:&lt;br /&gt;
&lt;br /&gt;
1. 做Logistic回归：&lt;br /&gt;
&lt;br /&gt;
*Dependent variable: ''Z'' = 1, if unit participated (i.e. is member of the treatment group); ''Z'' = 0, if unit did not participate (i.e. is member of the control group).&lt;br /&gt;
&lt;br /&gt;
*因变量：参与处理（属于处理组），则''Z'' = 1；未参与处理（属于对照组），则''Z'' = 0。&lt;br /&gt;
&lt;br /&gt;
*Choose appropriate confounders (variables hypothesized to be associated with both treatment and outcome)&lt;br /&gt;
&lt;br /&gt;
*选择合适的混杂因素（既影响处理方式又影响处理结果的变量）&lt;br /&gt;
&lt;br /&gt;
*Obtain an [[Estimator|estimation]] for the propensity score: predicted probability (''p'') or log[''p''/(1&amp;amp;nbsp;−&amp;amp;nbsp;''p'')].&lt;br /&gt;
&lt;br /&gt;
*计算倾向性评分的[[Estimator|估计量]]：预测概率(''p'')或log[''p''/(1&amp;amp;nbsp;−&amp;amp;nbsp;''p'')]。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
2. Check that covariates are balanced across treatment and comparison groups within strata of the propensity score.&lt;br /&gt;
&lt;br /&gt;
2. Check that covariates are balanced across treatment and comparison groups within strata of the propensity score.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;2. 【机器翻译】检查协变量是平衡的治疗和比较组内的倾向分层。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
2. 依照倾向性评分的估计量进行分层，&amp;lt;font color=&amp;quot;#32cd32&amp;quot;&amp;gt;检查协变量的倾向性评分的估计量在每层处理组和对照组是否均衡&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
*Use standardized differences or graphs to examine distributions&lt;br /&gt;
&lt;br /&gt;
*使用标准化差异指标或者图形来检验分布情况&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
3. Match each participant to one or more nonparticipants on propensity score, using one of these methods:&lt;br /&gt;
&lt;br /&gt;
3. Match each participant to one or more nonparticipants on propensity score, using one of these methods:&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;3. 【机器翻译】根据倾向得分，将每个参与者与一个或多个非参与者进行匹配，使用以下方法之一:&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
3. 根据倾向性评分的估计量，将每个处理组个体与一个或多个对照组个体进行匹配，使用以下方法之一：&lt;br /&gt;
&lt;br /&gt;
*[[Nearest neighbor search|Nearest neighbor matching]]&lt;br /&gt;
&lt;br /&gt;
*[[Nearest neighbor search|最近邻匹配]]&lt;br /&gt;
&lt;br /&gt;
*Caliper matching: comparison units within a certain width of the propensity score of the treated units get matched, where the width is generally a fraction of the standard deviation of the propensity score&lt;br /&gt;
&lt;br /&gt;
*卡钳匹配：在处理单元倾向性评分的一个范围内选取对照单元，范围的宽度通常用倾向性评分的标准差乘上一个比例值&lt;br /&gt;
&lt;br /&gt;
*[[Mahalanobis distance|Mahalanobis metric]] matching in conjunction with PSM&lt;br /&gt;
&lt;br /&gt;
*[[Mahalanobis distance|马氏度量]] 与PSM配合使用&lt;br /&gt;
&lt;br /&gt;
*[[Stratified sampling|Stratification matching]]&lt;br /&gt;
&lt;br /&gt;
*[[Stratified sampling|分层匹配]]&lt;br /&gt;
&lt;br /&gt;
*Difference-in-differences matching (kernel and local linear weights)&lt;br /&gt;
&lt;br /&gt;
*&amp;lt;font color=&amp;quot;#32cd32&amp;quot;&amp;gt;双重差分匹配（核和局部线性加权）&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
*Exact matching&lt;br /&gt;
&lt;br /&gt;
*精确匹配&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
4. Verify that covariates are balanced across treatment and comparison groups in the matched or weighted sample&lt;br /&gt;
&lt;br /&gt;
4. Verify that covariates are balanced across treatment and comparison groups in the matched or weighted sample&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;4.【机器翻译】验证协变量是平衡的处理和对照组在匹配或加权样本&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
4. &amp;lt;font color=&amp;quot;#32cd32&amp;quot;&amp;gt;对比处理组和对照组的匹配样本或加权样本，验证协变量是否均衡&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
5. Multivariate analysis based on new sample&lt;br /&gt;
&lt;br /&gt;
5. Multivariate analysis based on new sample&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;5.【机器翻译】基于新样本的多变量分析&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
5. 基于新样本的多变量分析&lt;br /&gt;
&lt;br /&gt;
*Use analyses appropriate for non-independent matched samples if more than one nonparticipant is matched to each participant&lt;br /&gt;
&lt;br /&gt;
* 如果每个参与者都匹配了多个非参与者，则适当应用非独立匹配样本分析&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Note: When you have multiple matches for a single treated observation, it is essential to use Weighted Least Squares rather than Ordinary Least Squares.&lt;br /&gt;
&lt;br /&gt;
Note: When you have multiple matches for a single treated observation, it is essential to use Weighted Least Squares rather than Ordinary Least Squares.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】注意: 当你有多个匹配的单一处理的观察，它是必不可少的使用加权最小二乘而不是一般最小平方法。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
注意：当一个处理样本有多个匹配时，则必须用加权最小二乘法，而不能用普通最小二乘法。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
==Formal definitions==&lt;br /&gt;
&lt;br /&gt;
==形式定义 ==&lt;br /&gt;
&lt;br /&gt;
===Basic settings ===&lt;br /&gt;
&lt;br /&gt;
===基本设置===&lt;br /&gt;
&lt;br /&gt;
The basic case&amp;lt;ref name=&amp;quot;Rosenbaum 1983 41–55&amp;quot; /&amp;gt; is of two treatments (numbered 1 and 0), with ''N'' [Independent and identically distributed random variables|i.i.d] subjects. Each subject ''i'' would respond to the treatment with &amp;lt;math&amp;gt;r_{1i}&amp;lt;/math&amp;gt; and to the control with &amp;lt;math&amp;gt;r_{0i}&amp;lt;/math&amp;gt;. The quantity to be estimated is the [[average treatment effect]]: &amp;lt;math&amp;gt;E[r_1]-E[r_0]&amp;lt;/math&amp;gt;. The variable &amp;lt;math&amp;gt;Z_i&amp;lt;/math&amp;gt; indicates if subject ''i'' got treatment (''Z''&amp;amp;nbsp;=&amp;amp;nbsp;1) or control (''Z''&amp;amp;nbsp;=&amp;amp;nbsp;0). Let &amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt; be a vector of observed pretreatment measurement (or covariate) for the ''i''th subject. The observations of &amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt; are made prior to treatment assignment, but the features in &amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt; may not include all (or any) of the ones used to decide on the treatment assignment. The numbering of the units (i.e.: ''i''&amp;amp;nbsp;=&amp;amp;nbsp;1,&amp;amp;nbsp;...,&amp;amp;nbsp;''i''&amp;amp;nbsp;=&amp;amp;nbsp;''N'') are assumed to not contain any information beyond what is contained in &amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt;. The following sections will omit the ''i'' index while still discussing about the stochastic behavior of some subject.&lt;br /&gt;
&lt;br /&gt;
基本场景&amp;lt;ref name=&amp;quot;Rosenbaum 1983 41–55&amp;quot; /&amp;gt;是，有两种处理方式（分别记为1和0），''N''个[[Independent and identically distributed random variables|独立同分布]]个体。每个个体''i''如果接受了处理则响应为&amp;lt;math&amp;gt;r_{1i}&amp;lt;/math&amp;gt;，接受控制则响应为&amp;lt;math&amp;gt;r_{0i}&amp;lt;/math&amp;gt;。被估计量是[[average treatment effect|平均处理效应]]：&amp;lt;math&amp;gt;E[r_1]-E[r_0]&amp;lt;/math&amp;gt;。变量&amp;lt;math&amp;gt;Z_i&amp;lt;/math&amp;gt;指示个体''i''接受处理(''Z''&amp;amp;nbsp;=&amp;amp;nbsp;1)还是接受控制(''Z''&amp;amp;nbsp;=&amp;amp;nbsp;0)。让&amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt;代表第''i''个个体处理前观测值（或者协变量）的向量。对&amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt;的测量发生于处理前，但是&amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt;中也可以不包括那些决定是否接受处理的特征。个体编号（即：''i''&amp;amp;nbsp;=&amp;amp;nbsp;1,&amp;amp;nbsp;...,&amp;amp;nbsp;''i''&amp;amp;nbsp;=&amp;amp;nbsp;''N''）不包含任何&amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt;所包含信息之外的的信息。以下部分在讨论某些个体的随机行为的时候将省略索引''i''。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
===Strongly ignorable treatment assignment===&lt;br /&gt;
&lt;br /&gt;
===强可忽略处理分配===&lt;br /&gt;
&lt;br /&gt;
{{See also|Ignorability}}&lt;br /&gt;
&lt;br /&gt;
{{See also|可忽略性}}&lt;br /&gt;
&lt;br /&gt;
Let some subject have a vector of covariates ''X'' (i.e.: conditionally unconfounded), and some '''potential outcomes''' ''r''&amp;lt;sub&amp;gt;0&amp;lt;/sub&amp;gt; and ''r''&amp;lt;sub&amp;gt;1&amp;lt;/sub&amp;gt; under control and treatment, respectively. Treatment assignment is said to be '''strongly ignorable''' if the potential outcomes are [[statistical independence|independent]] of treatment (''Z'') conditional on background variables ''X''.  This can be written compactly as&lt;br /&gt;
&lt;br /&gt;
设某个物体有协变量''X''（即：条件非混杂变量）向量，以及对应着控制和处理两种情况的'''潜在结果'''''r''&amp;lt;sub&amp;gt;0&amp;lt;/sub&amp;gt;和''r''&amp;lt;sub&amp;gt;1&amp;lt;/sub&amp;gt;。如果潜在结果在给定背景变量''X''的条件下独立于处理举动（''Z''），则可以说样本是否接受处理分配是'''强可忽略'''的。可简洁表述为&lt;br /&gt;
&lt;br /&gt;
:&amp;lt;math&amp;gt; r_0, r_1 \perp Z \mid X &amp;lt;/math&amp;gt;&lt;br /&gt;
&lt;br /&gt;
这里&amp;lt;math&amp;gt;\perp&amp;lt;/math&amp;gt;代表[[statistical independence|统计独立]].&amp;lt;ref name=&amp;quot;Rosenbaum 1983 41–55&amp;quot; /&amp;gt;&lt;br /&gt;
&lt;br /&gt;
=== Balancing score===&lt;br /&gt;
&lt;br /&gt;
=== 平衡得分===&lt;br /&gt;
&lt;br /&gt;
A '''balancing score''' ''b''(''X'') is a function of the observed covariates ''X'' such that the [[conditional probability|conditional distribution]] of ''X'' given ''b''(''X'') is the same for treated (''Z''&amp;amp;nbsp;=&amp;amp;nbsp;1) and control (''Z''&amp;amp;nbsp;=&amp;amp;nbsp;0) units:&lt;br /&gt;
&lt;br /&gt;
A balancing score b(X) is a function of the observed covariates X such that the conditional distribution of X given b(X) is the same for treated (Z = 1) and control (Z = 0) units:&lt;br /&gt;
&lt;br /&gt;
平衡得分b(X)是观测协变量X的函数。在给定b(X)时，处理单元和控制单元的X有相同的条件分布：&lt;br /&gt;
&lt;br /&gt;
:&amp;lt;math&amp;gt; Z \perp X \mid b(X).&amp;lt;/math&amp;gt;&lt;br /&gt;
&lt;br /&gt;
最一般的平衡得分函数是&amp;lt;math&amp;gt; b(X) = X&amp;lt;/math&amp;gt;.&lt;br /&gt;
&lt;br /&gt;
===Propensity score===&lt;br /&gt;
&lt;br /&gt;
===倾向性评分 ===&lt;br /&gt;
&lt;br /&gt;
A '''propensity score''' is the [[probability]] of a unit (e.g., person, classroom, school) being assigned to a particular treatment given a set of observed covariates.  Propensity scores are used to reduce [[selection bias]] by equating groups based on these covariates.&lt;br /&gt;
&lt;br /&gt;
Suppose that we have a binary treatment [[Indicator function|indicator]] ''Z'', a response variable ''r'', and background observed covariates ''X''.  The propensity score is defined as the [[conditional probability]] of treatment given background variables:&lt;br /&gt;
&lt;br /&gt;
A propensity score is the probability of a unit (e.g., person, classroom, school) being assigned to a particular treatment given a set of observed covariates. Propensity scores are used to reduce selection bias by equating groups based on these covariates.&lt;br /&gt;
&lt;br /&gt;
Suppose that we have a binary treatment indicator Z, a response variable r, and background observed covariates X. The propensity score is defined as the conditional probability of treatment given background variables:&lt;br /&gt;
&lt;br /&gt;
倾向性评分是根据协变量观测值计算得出的一个单元（例如：个人，教室，学校）被指配接受特定处理的概率。倾向性评分匹配将使得处理组和对照组的协变量分布趋同，从而减少选择偏差。&lt;br /&gt;
&lt;br /&gt;
假设有一个二值处理标识Z，一个响应变量r，以及被观测的背景协变量X。倾向性评分定义为，在给定背景变量条件下单元接受处理的条件概率：&lt;br /&gt;
&lt;br /&gt;
:&amp;lt;math&amp;gt;e(x) \ \stackrel{\mathrm{def}}{=}\  \Pr(Z=1 \mid X=x).&amp;lt;/math&amp;gt;&lt;br /&gt;
&lt;br /&gt;
In the context of [[causal inference]] and [[survey methodology]], propensity scores are estimated (via methods such as [[logistic regression]], [[random forests]], or others), using some set of covariates. These propensity scores are then used as estimators for weights to be used with [[Inverse probability weighting]] methods.&lt;br /&gt;
&lt;br /&gt;
In the context of causal inference and survey methodology, propensity scores are estimated (via methods such as logistic regression, random forests, or others), using some set of covariates. These propensity scores are then used as estimators for weights to be used with Inverse probability weighting methods.&lt;br /&gt;
&lt;br /&gt;
在因果推断和调查方法的范围内，通过Logistic回归、随机森林或其他方法，利用一组协变量估计倾向性评分。然后这些倾向性评分即可作为用于逆概率加权方法的权重估计量。&lt;br /&gt;
&lt;br /&gt;
===Main theorems===&lt;br /&gt;
&lt;br /&gt;
===主要定理===&lt;br /&gt;
&lt;br /&gt;
The following were first presented, and proven, by Rosenbaum and Rubin in 1983:&amp;lt;ref name=&amp;quot;Rosenbaum 1983 41–55&amp;quot; /&amp;gt;&lt;br /&gt;
&lt;br /&gt;
The following were first presented, and proven, by Rosenbaum and Rubin in 1983:[1]&lt;br /&gt;
&lt;br /&gt;
以下是Rosenbaum和Rubin于1983年首次提出并证明的：&amp;lt;ref name=&amp;quot;Rosenbaum 1983 41–55&amp;quot; /&amp;gt;&lt;br /&gt;
&lt;br /&gt;
*The propensity score &amp;lt;math&amp;gt;e(x)&amp;lt;/math&amp;gt; is a balancing score.&lt;br /&gt;
*倾向性评分&amp;lt;math&amp;gt;e(x)&amp;lt;/math&amp;gt;是平衡得分。&lt;br /&gt;
&lt;br /&gt;
*Any score that is 'finer' than the propensity score is a balancing score (i.e.: &amp;lt;math&amp;gt;e(X)=f(b(X))&amp;lt;/math&amp;gt; for some function ''f''). The propensity score is the coarsest balancing score function, as it takes a (possibly) multidimensional object (''X''&amp;lt;sub&amp;gt;''i''&amp;lt;/sub&amp;gt;) and transforms it into one dimension (although others, obviously, also exist), while &amp;lt;math&amp;gt;b(X)=X&amp;lt;/math&amp;gt; is the finest one.&lt;br /&gt;
*任何比倾向性评分更“精细”的得分都是平衡得分（即：对于函数''f''，&amp;lt;math&amp;gt;e(X)=f(b(X))&amp;lt;/math&amp;gt;）。倾向性评分是最粗粒度的平衡得分函数，因为它把一个（可能是）多维的对象（''X''&amp;lt;sub&amp;gt;''i''&amp;lt;/sub&amp;gt;）转换成只有一维（尽管其他维度显然也存在），而&amp;lt;math&amp;gt;b(X)=X&amp;lt;/math&amp;gt;则是最细粒度的平衡得分函数（保留全部维度）。&lt;br /&gt;
&lt;br /&gt;
*If treatment assignment is strongly ignorable given ''X'' then:&lt;br /&gt;
*如果对于给定的''X''，处理分配满足强可忽略条件，则：&lt;br /&gt;
&lt;br /&gt;
:*It is also strongly ignorable given any balancing function. Specifically, given the propensity score:&lt;br /&gt;
:* 给定任何的平衡函数，具体来说，给定倾向性评分，处理分配也是强可忽略的：&lt;br /&gt;
&lt;br /&gt;
:::&amp;lt;math&amp;gt; (r_0, r_1) \perp Z \mid e(X).&amp;lt;/math&amp;gt;&lt;br /&gt;
回归&lt;br /&gt;
:*For any value of a balancing score, the difference between the treatment and control means of the samples at hand (i.e.: &amp;lt;math&amp;gt;\bar{r}_1-\bar{r}_0&amp;lt;/math&amp;gt;), based on subjects that have the same value of the balancing score, can serve as an [[Bias of an estimator|unbiased estimator]] of the [[average treatment effect]]: &amp;lt;math&amp;gt;E[r_1]-E[r_0]&amp;lt;/math&amp;gt;.&lt;br /&gt;
:*对于有相同平衡得分值的处理样本和对照样本，它们响应变量均值之差（即：&amp;lt;math&amp;gt;\bar{r}_1-\bar{r}_0&amp;lt;/math&amp;gt;），可以作为[[average treatment effect|平均处理效应]]的[[Bias of an estimator|无偏估计量]]：&amp;lt;math&amp;gt;E[r_1]-E[r_0]&amp;lt;/math&amp;gt;。&lt;br /&gt;
&lt;br /&gt;
*Using sample estimates of balancing scores can produce sample balance on&amp;amp;nbsp;''X''&lt;br /&gt;
*利用平衡得分的样本估计可产生在X上均衡的样本&lt;br /&gt;
&lt;br /&gt;
===Relationship to sufficiency===&lt;br /&gt;
===与充分性的关系 ===&lt;br /&gt;
&lt;br /&gt;
If we think of the value of ''Z'' as a [[Statistical parameter|parameter]] of the population that impacts the distribution of ''X'' then the balancing score serves as a [[Sufficient_statistic#Mathematical_definition|sufficient statistic]] for ''Z''. Furthermore, the above theorems indicate that the propensity score is a [[Sufficient_statistic#Minimal_sufficiency|minimal sufficient statistic]] if thinking of ''Z'' as a parameter of ''X''. Lastly, if treatment assignment ''Z'' is strongly ignorable given ''X'' then the propensity score is a [[Sufficient_statistic#Minimal_sufficiency|minimal sufficient statistic]] for the joint distribution of &amp;lt;math&amp;gt;(r_0, r_1)&amp;lt;/math&amp;gt;.&lt;br /&gt;
&lt;br /&gt;
If we think of the value of Z as a parameter of the population that impacts the distribution of X then the balancing score serves as a sufficient statistic for Z. Furthermore, the above theorems indicate that the propensity score is a minimal sufficient statistic if thinking of Z as a parameter of X. Lastly, if treatment assignment Z is strongly ignorable given X then the propensity score is a minimal sufficient statistic for the joint distribution of {\displaystyle (r_{0},r_{1})}{\displaystyle (r_{0},r_{1})}.&lt;br /&gt;
&lt;br /&gt;
如果我们把''Z''的值想成影响''X''分布的群体参数，则平衡得分充当了''Z''的充分统计量。进一步，上述定理指出，如果把''Z''视为''X''的参数，则倾向性评分就是最小充分统计量。最后，给定''X''，如果''Z''是强可忽略的，则倾向性评分是&amp;lt;math&amp;gt;(r_0, r_1)&amp;lt;/math&amp;gt;联合分布的最小充分统计量。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
===Graphical test for detecting the presence of confounding variables===&lt;br /&gt;
===混杂变量的图检测方法===&lt;br /&gt;
&lt;br /&gt;
[[Judea Pearl]] has shown that there exists a simple graphical test, called the back-door criterion, which detects the presence of confounding variables. To estimate the effect of treatment, the background variables X must block all back-door paths in the graph. This blocking can be done either by adding the confounding variable as a control in regression, or by matching on the confounding variable.&amp;lt;ref name=&amp;quot;pearl&amp;quot;&amp;gt;{{cite book |last=Pearl |first=J. |year=2000 |title=Causality: Models, Reasoning, and Inference |url=https://archive.org/details/causalitymodelsr0000pear |url-access=registration |location=New York |publisher=Cambridge University Press |isbn=978-0-521-77362-1 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Judea Pearl has shown that there exists a simple graphical test, called the back-door criterion, which detects the presence of confounding variables. To estimate the effect of treatment, the background variables X must block all back-door paths in the graph. This blocking can be done either by adding the confounding variable as a control in regression, or by matching on the confounding variable.[2]&lt;br /&gt;
&lt;br /&gt;
朱迪亚·珀尔Judea Pearl已经表明存在一个简单的图检测方法，称为后门准则，它可以检测到混杂变量的存在。为了估计处理效果，背景变量X必须阻断图中的所有后门路径。通过把混杂变量加入回归的控制变量，或者在混杂变量上进行匹配可以实现后门路径的阻断。&lt;br /&gt;
&lt;br /&gt;
== Disadvantages==&lt;br /&gt;
== 缺点 ==&lt;br /&gt;
&lt;br /&gt;
PSM has been shown to increase model &amp;quot;imbalance, inefficiency, model dependence, and bias,&amp;quot; which is not the case with most other matching methods. The insights behind the use of matching still hold but should be applied with other matching methods; propensity scores also have other productive uses in weighting and doubly robust estimation.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】PSM 已经被证明会增加模型的“不平衡性、低效率、模型依赖性和偏差”，这与大多数其他匹配方法不同。使用匹配的见解仍然有效，但应该与其他匹配方法一起应用; 倾向得分在加权和双重稳健估计方面也有其他有益的用途。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
PSM已经被证明会加剧模型的“不平衡性、低效率、模型依赖性和偏差”，这与大多数其他匹配方法不同。匹配方法背后的见解仍然成立，但应该与其他匹配方法一起应用；倾向得分在加权和双重稳健估计方面也有其他有益的用途。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Like other matching procedures, PSM estimates an average treatment effect from observational data. The key advantages of PSM were, at the time of its introduction, that by using a linear combination of covariates for a single score, it balances treatment and control groups on a large number of covariates without losing a large number of observations. If units in the treatment and control were balanced on a large number of covariates one at a time, large numbers of observations would be needed to overcome the &amp;quot;dimensionality problem&amp;quot; whereby the introduction of a new balancing covariate increases the minimum necessary number of observations in the sample geometrically.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】与其他匹配程序一样，PSM 从观测数据中估计平均处理效果。在引入 PSM 的时候，它的主要优点是，通过使用一个线性组合的协变量作为一个单一的评分，它平衡了治疗组和对照组在大量的协变量上，而不会失去大量的观察数据。如果处理和控制中的单元在大量的协变量上一次平衡，就需要大量的观测数据来克服“维数问题”，即引入新的平衡协变量几何地增加样本中必要的最小观测数据。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
与其他匹配过程一样，PSM也是从观测数据中估计平均处理效应。在引入PSM之时，它的主要优点是，通过使用协变量的线性组合得到一个单一评分，以大量的协变量为基础平衡了处理组和对照组，却不大量损失观测数据。如果在有众多协变量的情况下，对每一个些变量都分别做处理单元和对照单元平衡的话，就需要大量的观测数据来克服”维度问题“，即，每引入一个新的平衡协变量都会在几何上增加最小所需的观测样本数量。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
One disadvantage of PSM is that it only accounts for observed (and observable) covariates and not latent characteristics. Factors that affect assignment to treatment and outcome but that cannot be observed cannot be accounted for in the matching procedure. As the procedure only controls for observed variables, any hidden bias due to latent variables may remain after matching. Another issue is that PSM requires large samples, with substantial overlap between treatment and control groups.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】PSM 的一个缺点是它只能解释观察到的(和可观察到的)协变量，而不能解释潜在的特征。影响治疗分配和结果但无法观察的因素不能在匹配程序中说明。由于程序只控制观察变量，任何隐藏的偏见由于潜在变量可能仍然匹配后。另一个问题是 PSM 需要大量的样本，治疗组和对照组之间有大量的重叠。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
PSM的一个缺点是它只能涵盖已观测的（和可观测的）协变量，而无法涵盖潜在变量。那些能影响处理分配却不可观测的因素无法被纳入匹配过程的考量范围。由于匹配过程只控制可观测变量，那些隐藏的偏差在匹配后依然可能存在。另一个问题是PSM还要求在大量样本中，在处理组和对照组之间有大量的重叠。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
General concerns with matching have also been raised by Judea Pearl, who has argued that hidden bias may actually increase because matching on observed variables may unleash bias due to dormant unobserved confounders. Similarly, Pearl has argued that bias reduction can only be assured (asymptotically) by modelling the qualitative causal relationships between treatment, outcome, observed and unobserved covariates. Confounding occurs when the experimenter is unable to control for alternative, non-causal explanations for an observed relationship between independent and dependent variables. Such control should satisfy the &amp;quot;backdoor criterion&amp;quot; of Pearl. It can also easily be implemented manually.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】朱迪亚 · 珀尔也提出了关于配对的普遍担忧，他认为隐性偏见实际上可能会增加，因为观察变量的配对可能会由于潜在的未观察混杂因素而释放出偏见。同样，珀尔认为，只有通过建立治疗、结果、观察和未观察协变量之间的定性因果关系模型，才能确保(渐近地)减少偏见。当实验者无法控制对独立变量和因变量之间观察到的关系的替代性、非因果性解释时，混淆就发生了。这种控制应满足珍珠的“后门规范”。它也可以很容易地手动实现。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Judea Pearl也提出了关于匹配方法的一般性担忧，他认为对可观测变量进行匹配可能会让那些原本处于休眠状态的混杂因素被释放，从而实际上可能加剧隐藏的偏差。同样，Pearl认为，只有通过对处理、结果、可观测和不可观测的协变量之间的定性因果关系进行建模，才能确保（渐进地）减少偏差。当试验者无法控制&amp;lt;font color=&amp;quot;#32cd32&amp;quot;&amp;gt;对独立变量和因变量之间观察到的关系的替代性、非因果性解释时&amp;lt;/font&amp;gt;，混杂就会发生。这样的控制应该满足Pearl的“后门准则”。它很容易手工实现。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&amp;lt;noinclude&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&amp;lt;small&amp;gt;This page was moved from [[wikipedia:en:Propensity score matching]]. Its edit history can be viewed at [[倾向性评分/edithistory]]&amp;lt;/small&amp;gt;&amp;lt;/noinclude&amp;gt;&lt;br /&gt;
&lt;br /&gt;
[[Category:待整理页面]]&lt;br /&gt;
&lt;br /&gt;
&amp;lt;references /&amp;gt;&lt;/div&gt;</summary>
		<author><name>李昊轩</name></author>
	</entry>
	<entry>
		<id>https://wiki.swarma.org/index.php?title=%E5%80%BE%E5%90%91%E5%BE%97%E5%88%86%E5%8C%B9%E9%85%8D&amp;diff=23566</id>
		<title>倾向得分匹配</title>
		<link rel="alternate" type="text/html" href="https://wiki.swarma.org/index.php?title=%E5%80%BE%E5%90%91%E5%BE%97%E5%88%86%E5%8C%B9%E9%85%8D&amp;diff=23566"/>
		<updated>2021-06-12T16:01:52Z</updated>

		<summary type="html">&lt;p&gt;李昊轩：/* 倾向性评分 */&lt;/p&gt;
&lt;hr /&gt;
&lt;div&gt;此词条暂由彩云小译翻译，翻译字数共893，未经人工整理和审校，带来阅读不便，请见谅。&lt;br /&gt;
&lt;br /&gt;
{{Short description|Statistical matching technique}}&lt;br /&gt;
&lt;br /&gt;
In the [[statistics|statistical]] analysis of [[observational study|observational data]], '''propensity score matching''' ('''PSM''') is a [[Matching (statistics)|statistical matching]] technique that attempts to [[Estimation theory|estimate]] the effect of a treatment, policy, or other intervention by accounting for the [[covariate]]s that predict receiving the treatment. PSM attempts to reduce the [[Bias (statistics)|bias]] due to [[confounding]] variables that could be found in an estimate of the treatment effect obtained from simply comparing outcomes among [[Statistical unit|units]] that [[Treatment and control groups|received the treatment versus those that did not]]. [[Paul R. Rosenbaum]] and [[Donald Rubin]] introduced the technique in 1983.&amp;lt;ref name=&amp;quot;Rosenbaum 1983 41–55&amp;quot;&amp;gt;{{cite journal |last=Rosenbaum |first=Paul R. |last2=Rubin |first2=Donald B. |title=The Central Role of the Propensity Score in Observational Studies for Causal Effects |journal=[[Biometrika]] |year=1983 |volume=70 |issue=1 |pages=41–55 |doi=10.1093/biomet/70.1.41 |doi-access=free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
In the statistical analysis of observational data, propensity score matching (PSM) is a statistical matching technique that attempts to estimate the effect of a treatment, policy, or other intervention by accounting for the covariates that predict receiving the treatment. PSM attempts to reduce the bias due to confounding variables that could be found in an estimate of the treatment effect obtained from simply comparing outcomes among units that received the treatment versus those that did not. Paul R. Rosenbaum and Donald Rubin introduced the technique in 1983.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】在观察数据的统计分析中，倾向性评分匹配是一种统计匹配技术，它试图通过计算预测接受治疗的协变量来估计治疗、政策或其他干预的效果。PSM 试图减少由于混杂变量造成的偏倚，这些变量可以通过简单地比较接受治疗的单位和没有接受治疗的单位之间的结果来估计治疗效果。保罗 · 罗森鲍姆和唐纳德 · 鲁宾在1983年介绍了这项技术。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
在观察数据的统计分析中，倾向性评分匹配Propensity Score Matching (PSM)是一种用于估计治疗、政策或其他干预的效果统计匹配技术，方法是将协变量对样本“是否接受处理”的影响考虑在内。PSM试图减少由于混杂变量造成的偏倚。这些偏倚一般会在那些只对处理单元和对照单元的结果做简单对比的评估中出现。保罗·罗森鲍姆Paul R. Rosenbaum和唐纳德·鲁宾Donald Rubin在1983年介绍了这项技术。&lt;br /&gt;
&lt;br /&gt;
The possibility of bias arises because a difference in the treatment outcome (such as the [[average treatment effect]]) between treated and untreated groups may be caused by a factor that predicts treatment rather than the treatment itself. In [[randomized experiment]]s, the randomization enables unbiased estimation of treatment effects; for each covariate, randomization implies that treatment-groups will be balanced on average, by the [[law of large numbers]]. Unfortunately, for observational studies, the assignment of treatments to research subjects is typically not random. [[Matching (statistics)|Matching]] attempts to reduce the treatment assignment bias, and mimic randomization, by creating a sample of units that received the treatment that is comparable on all observed covariates to a sample of units that did not receive the treatment.&lt;br /&gt;
&lt;br /&gt;
The possibility of bias arises because a difference in the treatment outcome (such as the average treatment effect) between treated and untreated groups may be caused by a factor that predicts treatment rather than the treatment itself. In randomized experiments, the randomization enables unbiased estimation of treatment effects; for each covariate, randomization implies that treatment-groups will be balanced on average, by the law of large numbers. Unfortunately, for observational studies, the assignment of treatments to research subjects is typically not random. Matching attempts to reduce the treatment assignment bias, and mimic randomization, by creating a sample of units that received the treatment that is comparable on all observed covariates to a sample of units that did not receive the treatment.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】出现偏倚的可能性是因为治疗组和未治疗组之间治疗结果(如平均治疗效果)的差异可能是由预测治疗的因素而不是治疗本身造成的。在随机实验中，随机化可以对治疗效果进行无偏估计; 对于每个协变量，随机化意味着治疗组将按照大数定律在平均水平上达到平衡。不幸的是，对于观察性研究来说，对研究对象的治疗分配通常不是随机的。匹配试图减少处理分配偏差，并模拟随机化，通过创建一个样本单位接受的处理是可比的所有观察到的协变量的一个样本单位没有接受处理。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
出现偏倚的原因可能是某个因素通过决定样本是否接受处理而导致了处理组和对照组的效果（如平均处理效果）差异，而不是处理本身导致了差异。在随机实验中，随机化选择样本可以做到对处理效果的无偏估计，根据大数定律，随机化分配机制意味着每个协变量将在处理组和对照组中呈现类似的分布。不幸的是，对于观察性研究来说，研究对象通常不是随机接受处理的。匹配就是要减少对象非随机接受处理产生的偏倚，并模拟随机试验，方法是从处理组和对照组中分别取样，让两组样本的全部协变量都比较接近。&lt;br /&gt;
&lt;br /&gt;
For example, one may be interested to know the [[Health_effects_of_tobacco#Early_observational_studies|consequences of smoking]]. An observational study is required since it is unethical to randomly assign people to the treatment 'smoking.' The treatment effect estimated by simply comparing those who smoked to those who did not smoke would be biased by any factors that predict smoking (e.g.: gender and age). PSM attempts to control for these biases by making the groups receiving treatment and not-treatment comparable with respect to the control variables.&lt;br /&gt;
&lt;br /&gt;
For example, one may be interested to know the consequences of smoking. An observational study is required since it is unethical to randomly assign people to the treatment 'smoking.' The treatment effect estimated by simply comparing those who smoked to those who did not smoke would be biased by any factors that predict smoking (e.g.: gender and age). PSM attempts to control for these biases by making the groups receiving treatment and not-treatment comparable with respect to the control variables.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】例如，人们可能有兴趣知道吸烟的后果。因为随机分配患者接受‘吸烟’治疗是不道德的，所以需要一个观察性研究简单地比较吸烟者和不吸烟者的治疗效果会受到任何预测吸烟的因素的影响(例如:。: 性别及年龄)。PSM 试图通过使接受治疗和不接受治疗的组与控制变量相比较来控制这些偏差。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
例如，人们想知道吸烟的后果。但是随机分配让患者“吸烟”是不道德的，所以需要做一个观察性研究。简单地通过对比评估吸烟者和不吸烟者来估计平均处理效果将产生偏差，它会受到能影响吸烟行为的因素的影响（例如：性别及年龄）。PSM要做的是通过让处理组和对照组的控制变量尽量相似来达到控制这些偏差的目的。&lt;br /&gt;
&lt;br /&gt;
==Overview ==&lt;br /&gt;
&lt;br /&gt;
==综述==&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
PSM is for cases of [[Inductive reasoning#Causal inference|causal inference]] and simple selection bias in [[non-experimental]] settings in which: (i) few units in the non-treatment comparison group are comparable to the treatment units; and (ii) selecting a subset of comparison units similar to the treatment unit is difficult because units must be compared across a high-dimensional set of pretreatment characteristics.&lt;br /&gt;
&lt;br /&gt;
PSM is for cases of causal inference and simple selection bias in non-experimental settings in which: (i) few units in the non-treatment comparison group are comparable to the treatment units; and (ii) selecting a subset of comparison units similar to the treatment unit is difficult because units must be compared across a high-dimensional set of pretreatment characteristics.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】PSM 适用于非实验环境中因果推断和简单选择偏差的情况，其中: (i)非处理对照组中与处理单元可比的单元很少; (ii)选择与处理单元类似的比较单元子集很困难，因为必须跨一组高维预处理特征进行比较。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
PSM适用于非实验环境中因果推断和简单选择偏差的情况，其中: (i)对照组与处理组中的类似单元很少; (ii)选择与处理单元类似的对照单元集合很困难，因为必须对一组高维的协变量特征进行比较。&lt;br /&gt;
&lt;br /&gt;
In normal matching, single characteristics that distinguish treatment and control groups are matched in an attempt to make the groups more alike. But if the two groups do not have substantial overlap, then substantial [[Errors and residuals|error]] may be introduced. For example, if only the worst cases from the [[control group|untreated &amp;quot;comparison&amp;quot; group]] are compared to only the best cases from the [[treatment group]], the result may be [[regression toward the mean]], which may make the comparison group look better or worse than reality.&lt;br /&gt;
&lt;br /&gt;
In normal matching, single characteristics that distinguish treatment and control groups are matched in an attempt to make the groups more alike. But if the two groups do not have substantial overlap, then substantial error may be introduced. For example, if only the worst cases from the untreated &amp;quot;comparison&amp;quot; group are compared to only the best cases from the treatment group, the result may be regression toward the mean, which may make the comparison group look better or worse than reality.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】在正常的匹配中，区分治疗组和对照组的单一特征被匹配，试图使这些组更加相似。但是，如果这两个组没有实质性的重叠，那么可能会引入实质性的错误。例如，如果只将来自未经治疗的对照组的最差病例与来自治疗组的最好病例进行比较，结果可能是趋中回归，这可能使对照组看起来比实际情况更好或更糟。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
在常规的匹配机制中，对一组能够区分处理组和对照组的特征做匹配，以使两组的特征更加相似。但如果这两个组的特征没有显著的重叠，那么可能会引入实质性的错误。例如，拿对照组最糟的病例和处理组最好的病例进行比较，结果可能倾向于回归均值，这会让对照组看起来比实际情况更好或更糟。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
PSM employs a predicted probability of group membership—e.g., treatment versus control group—based on observed predictors, usually obtained from [[logistic regression]] to create a [[Impact evaluation#Counterfactual evaluation designs|counterfactual group]]. Propensity scores may be used for matching or as [[covariance|covariate]]s, alone or with other matching variables or covariates.&lt;br /&gt;
&lt;br /&gt;
PSM employs a predicted probability of group membership—e.g., treatment versus control group—based on observed predictors, usually obtained from logistic regression to create a counterfactual group. Propensity scores may be used for matching or as covariates, alone or with other matching variables or covariates.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】PSM 使用了一种预测的群体成员概率---- 例如，治疗组与控制组---- 基于观察预测，通常从 Logit模型获得来创造一个反事实的群体。倾向得分可用于匹配或作为协变量，单独或与其他匹配变量或协变量。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
PSM利用观察数据预测样本落入不同分组（例如，处理组与控制组）的概率，通常用Logistic回归方法，然后利用此概率创造一个反事实的群体。倾向性评分可用于匹配，也可作为协变量，可以单独使用，也可以与其他匹配变量或协变量一同使用。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
==General procedure==&lt;br /&gt;
&lt;br /&gt;
==一般步骤==&lt;br /&gt;
&lt;br /&gt;
1. Run [[logistic regression]]:&lt;br /&gt;
&lt;br /&gt;
1. Run logistic regression:&lt;br /&gt;
&lt;br /&gt;
1. 做Logistic回归：&lt;br /&gt;
&lt;br /&gt;
*Dependent variable: ''Z'' = 1, if unit participated (i.e. is member of the treatment group); ''Z'' = 0, if unit did not participate (i.e. is member of the control group).&lt;br /&gt;
&lt;br /&gt;
*因变量：参与处理（属于处理组），则''Z'' = 1；未参与处理（属于对照组），则''Z'' = 0。&lt;br /&gt;
&lt;br /&gt;
*Choose appropriate confounders (variables hypothesized to be associated with both treatment and outcome)&lt;br /&gt;
&lt;br /&gt;
*选择合适的混杂因素（既影响处理方式又影响处理结果的变量）&lt;br /&gt;
&lt;br /&gt;
*Obtain an [[Estimator|estimation]] for the propensity score: predicted probability (''p'') or log[''p''/(1&amp;amp;nbsp;−&amp;amp;nbsp;''p'')].&lt;br /&gt;
&lt;br /&gt;
*计算倾向性评分的[[Estimator|估计量]]：预测概率(''p'')或log[''p''/(1&amp;amp;nbsp;−&amp;amp;nbsp;''p'')]。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
2. Check that covariates are balanced across treatment and comparison groups within strata of the propensity score.&lt;br /&gt;
&lt;br /&gt;
2. Check that covariates are balanced across treatment and comparison groups within strata of the propensity score.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;2. 【机器翻译】检查协变量是平衡的治疗和比较组内的倾向分层。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
2. 依照倾向性评分的估计量进行分层，&amp;lt;font color=&amp;quot;#32cd32&amp;quot;&amp;gt;检查协变量的倾向性评分的估计量在每层处理组和对照组是否均衡&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
*Use standardized differences or graphs to examine distributions&lt;br /&gt;
&lt;br /&gt;
*使用标准化差异指标或者图形来检验分布情况&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
3. Match each participant to one or more nonparticipants on propensity score, using one of these methods:&lt;br /&gt;
&lt;br /&gt;
3. Match each participant to one or more nonparticipants on propensity score, using one of these methods:&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;3. 【机器翻译】根据倾向得分，将每个参与者与一个或多个非参与者进行匹配，使用以下方法之一:&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
3. 根据倾向性评分的估计量，将每个处理组个体与一个或多个对照组个体进行匹配，使用以下方法之一：&lt;br /&gt;
&lt;br /&gt;
*[[Nearest neighbor search|Nearest neighbor matching]]&lt;br /&gt;
&lt;br /&gt;
*[[Nearest neighbor search|最近邻匹配]]&lt;br /&gt;
&lt;br /&gt;
*Caliper matching: comparison units within a certain width of the propensity score of the treated units get matched, where the width is generally a fraction of the standard deviation of the propensity score&lt;br /&gt;
&lt;br /&gt;
*卡钳匹配：在处理单元倾向性评分的一个范围内选取对照单元，范围的宽度通常用倾向性评分的标准差乘上一个比例值&lt;br /&gt;
&lt;br /&gt;
*[[Mahalanobis distance|Mahalanobis metric]] matching in conjunction with PSM&lt;br /&gt;
&lt;br /&gt;
*[[Mahalanobis distance|马氏度量]] 与PSM配合使用&lt;br /&gt;
&lt;br /&gt;
*[[Stratified sampling|Stratification matching]]&lt;br /&gt;
&lt;br /&gt;
*[[Stratified sampling|分层匹配]]&lt;br /&gt;
&lt;br /&gt;
*Difference-in-differences matching (kernel and local linear weights)&lt;br /&gt;
&lt;br /&gt;
*&amp;lt;font color=&amp;quot;#32cd32&amp;quot;&amp;gt;双重差分匹配（核和局部线性加权）&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
*Exact matching&lt;br /&gt;
&lt;br /&gt;
*精确匹配&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
4. Verify that covariates are balanced across treatment and comparison groups in the matched or weighted sample&lt;br /&gt;
&lt;br /&gt;
4. Verify that covariates are balanced across treatment and comparison groups in the matched or weighted sample&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;4.【机器翻译】验证协变量是平衡的处理和对照组在匹配或加权样本&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
4. &amp;lt;font color=&amp;quot;#32cd32&amp;quot;&amp;gt;对比处理组和对照组的匹配样本或加权样本，验证协变量是否均衡&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
5. Multivariate analysis based on new sample&lt;br /&gt;
&lt;br /&gt;
5. Multivariate analysis based on new sample&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;5.【机器翻译】基于新样本的多变量分析&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
5. 基于新样本的多变量分析&lt;br /&gt;
&lt;br /&gt;
*Use analyses appropriate for non-independent matched samples if more than one nonparticipant is matched to each participant&lt;br /&gt;
&lt;br /&gt;
* 如果每个参与者都匹配了多个非参与者，则适当应用非独立匹配样本分析&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Note: When you have multiple matches for a single treated observation, it is essential to use Weighted Least Squares rather than Ordinary Least Squares.&lt;br /&gt;
&lt;br /&gt;
Note: When you have multiple matches for a single treated observation, it is essential to use Weighted Least Squares rather than Ordinary Least Squares.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】注意: 当你有多个匹配的单一处理的观察，它是必不可少的使用加权最小二乘而不是一般最小平方法。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
注意：当一个处理样本有多个匹配时，则必须用加权最小二乘法，而不能用普通最小二乘法。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
==Formal definitions==&lt;br /&gt;
&lt;br /&gt;
==形式定义 ==&lt;br /&gt;
&lt;br /&gt;
===Basic settings ===&lt;br /&gt;
&lt;br /&gt;
===基本设置===&lt;br /&gt;
&lt;br /&gt;
The basic case&amp;lt;ref name=&amp;quot;Rosenbaum 1983 41–55&amp;quot; /&amp;gt; is of two treatments (numbered 1 and 0), with ''N'' [Independent and identically distributed random variables|i.i.d] subjects. Each subject ''i'' would respond to the treatment with &amp;lt;math&amp;gt;r_{1i}&amp;lt;/math&amp;gt; and to the control with &amp;lt;math&amp;gt;r_{0i}&amp;lt;/math&amp;gt;. The quantity to be estimated is the [[average treatment effect]]: &amp;lt;math&amp;gt;E[r_1]-E[r_0]&amp;lt;/math&amp;gt;. The variable &amp;lt;math&amp;gt;Z_i&amp;lt;/math&amp;gt; indicates if subject ''i'' got treatment (''Z''&amp;amp;nbsp;=&amp;amp;nbsp;1) or control (''Z''&amp;amp;nbsp;=&amp;amp;nbsp;0). Let &amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt; be a vector of observed pretreatment measurement (or covariate) for the ''i''th subject. The observations of &amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt; are made prior to treatment assignment, but the features in &amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt; may not include all (or any) of the ones used to decide on the treatment assignment. The numbering of the units (i.e.: ''i''&amp;amp;nbsp;=&amp;amp;nbsp;1,&amp;amp;nbsp;...,&amp;amp;nbsp;''i''&amp;amp;nbsp;=&amp;amp;nbsp;''N'') are assumed to not contain any information beyond what is contained in &amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt;. The following sections will omit the ''i'' index while still discussing about the stochastic behavior of some subject.&lt;br /&gt;
&lt;br /&gt;
基本场景&amp;lt;ref name=&amp;quot;Rosenbaum 1983 41–55&amp;quot; /&amp;gt;是，有两种处理方式（分别记为1和0），''N''个[[Independent and identically distributed random variables|独立同分布]]个体。每个个体''i''如果接受了处理则响应为&amp;lt;math&amp;gt;r_{1i}&amp;lt;/math&amp;gt;，接受控制则响应为&amp;lt;math&amp;gt;r_{0i}&amp;lt;/math&amp;gt;。被估计量是[[average treatment effect|平均处理效应]]：&amp;lt;math&amp;gt;E[r_1]-E[r_0]&amp;lt;/math&amp;gt;。变量&amp;lt;math&amp;gt;Z_i&amp;lt;/math&amp;gt;指示个体''i''接受处理(''Z''&amp;amp;nbsp;=&amp;amp;nbsp;1)还是接受控制(''Z''&amp;amp;nbsp;=&amp;amp;nbsp;0)。让&amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt;代表第''i''个个体处理前观测值（或者协变量）的向量。对&amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt;的测量发生于处理前，但是&amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt;中也可以不包括那些决定是否接受处理的特征。个体编号（即：''i''&amp;amp;nbsp;=&amp;amp;nbsp;1,&amp;amp;nbsp;...,&amp;amp;nbsp;''i''&amp;amp;nbsp;=&amp;amp;nbsp;''N''）不包含任何&amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt;所包含信息之外的的信息。以下部分在讨论某些个体的随机行为的时候将省略索引''i''。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
===Strongly ignorable treatment assignment===&lt;br /&gt;
&lt;br /&gt;
===强可忽略处理分配===&lt;br /&gt;
&lt;br /&gt;
{{See also|Ignorability}}&lt;br /&gt;
&lt;br /&gt;
{{See also|可忽略性}}&lt;br /&gt;
&lt;br /&gt;
Let some subject have a vector of covariates ''X'' (i.e.: conditionally unconfounded), and some '''potential outcomes''' ''r''&amp;lt;sub&amp;gt;0&amp;lt;/sub&amp;gt; and ''r''&amp;lt;sub&amp;gt;1&amp;lt;/sub&amp;gt; under control and treatment, respectively. Treatment assignment is said to be '''strongly ignorable''' if the potential outcomes are [[statistical independence|independent]] of treatment (''Z'') conditional on background variables ''X''.  This can be written compactly as&lt;br /&gt;
&lt;br /&gt;
设某个物体有协变量''X''（即：条件非混杂变量）向量，以及对应着控制和处理两种情况的'''潜在结果'''''r''&amp;lt;sub&amp;gt;0&amp;lt;/sub&amp;gt;和''r''&amp;lt;sub&amp;gt;1&amp;lt;/sub&amp;gt;。如果潜在结果在给定背景变量''X''的条件下独立于处理举动（''Z''），则可以说样本是否接受处理分配是'''强可忽略'''的。可简洁表述为&lt;br /&gt;
&lt;br /&gt;
:&amp;lt;math&amp;gt; r_0, r_1 \perp Z \mid X &amp;lt;/math&amp;gt;&lt;br /&gt;
&lt;br /&gt;
这里&amp;lt;math&amp;gt;\perp&amp;lt;/math&amp;gt;代表[[statistical independence|统计独立]].&amp;lt;ref name=&amp;quot;Rosenbaum 1983 41–55&amp;quot; /&amp;gt;&lt;br /&gt;
&lt;br /&gt;
=== Balancing score===&lt;br /&gt;
&lt;br /&gt;
=== 平衡得分===&lt;br /&gt;
&lt;br /&gt;
A '''balancing score''' ''b''(''X'') is a function of the observed covariates ''X'' such that the [[conditional probability|conditional distribution]] of ''X'' given ''b''(''X'') is the same for treated (''Z''&amp;amp;nbsp;=&amp;amp;nbsp;1) and control (''Z''&amp;amp;nbsp;=&amp;amp;nbsp;0) units:&lt;br /&gt;
&lt;br /&gt;
A balancing score b(X) is a function of the observed covariates X such that the conditional distribution of X given b(X) is the same for treated (Z = 1) and control (Z = 0) units:&lt;br /&gt;
&lt;br /&gt;
平衡得分b(X)是观测协变量X的函数。在给定b(X)时，处理单元和控制单元的X有相同的条件分布：&lt;br /&gt;
&lt;br /&gt;
:&amp;lt;math&amp;gt; Z \perp X \mid b(X).&amp;lt;/math&amp;gt;&lt;br /&gt;
&lt;br /&gt;
最一般的平衡得分函数是&amp;lt;math&amp;gt; b(X) = X&amp;lt;/math&amp;gt;.&lt;br /&gt;
&lt;br /&gt;
===Propensity score===&lt;br /&gt;
&lt;br /&gt;
===倾向性评分 ===&lt;br /&gt;
&lt;br /&gt;
A '''propensity score''' is the [[probability]] of a unit (e.g., person, classroom, school) being assigned to a particular treatment given a set of observed covariates.  Propensity scores are used to reduce [[selection bias]] by equating groups based on these covariates.&lt;br /&gt;
&lt;br /&gt;
Suppose that we have a binary treatment [[Indicator function|indicator]] ''Z'', a response variable ''r'', and background observed covariates ''X''.  The propensity score is defined as the [[conditional probability]] of treatment given background variables:&lt;br /&gt;
&lt;br /&gt;
A propensity score is the probability of a unit (e.g., person, classroom, school) being assigned to a particular treatment given a set of observed covariates. Propensity scores are used to reduce selection bias by equating groups based on these covariates.&lt;br /&gt;
&lt;br /&gt;
Suppose that we have a binary treatment indicator Z, a response variable r, and background observed covariates X. The propensity score is defined as the conditional probability of treatment given background variables:&lt;br /&gt;
&lt;br /&gt;
倾向性评分是根据协变量观测值计算得出的一个单元（例如：个人，教室，学校）被指配接受特定处理的概率。倾向性评分匹配将使得处理组和对照组的协变量分布趋同，从而减少选择偏差。&lt;br /&gt;
&lt;br /&gt;
假设有一个二值处理标识Z，一个响应变量r，以及被观测的背景协变量X。倾向性评分定义为，在给定背景变量条件下单元接受处理的条件概率：&lt;br /&gt;
&lt;br /&gt;
:&amp;lt;math&amp;gt;e(x) \ \stackrel{\mathrm{def}}{=}\  \Pr(Z=1 \mid X=x).&amp;lt;/math&amp;gt;&lt;br /&gt;
&lt;br /&gt;
In the context of [[causal inference]] and [[survey methodology]], propensity scores are estimated (via methods such as [[logistic regression]], [[random forests]], or others), using some set of covariates. These propensity scores are then used as estimators for weights to be used with [[Inverse probability weighting]] methods.&lt;br /&gt;
&lt;br /&gt;
In the context of causal inference and survey methodology, propensity scores are estimated (via methods such as logistic regression, random forests, or others), using some set of covariates. These propensity scores are then used as estimators for weights to be used with Inverse probability weighting methods.&lt;br /&gt;
&lt;br /&gt;
在因果推断和调查方法的范围内，通过Logistic回归、随机森林或其他方法，利用一组协变量估计倾向性评分。然后将这些倾向性评分即可作为权重估计量用于逆概率加权方法。&lt;br /&gt;
&lt;br /&gt;
===Main theorems===&lt;br /&gt;
&lt;br /&gt;
===主要定理===&lt;br /&gt;
&lt;br /&gt;
The following were first presented, and proven, by Rosenbaum and Rubin in 1983:&amp;lt;ref name=&amp;quot;Rosenbaum 1983 41–55&amp;quot; /&amp;gt;&lt;br /&gt;
&lt;br /&gt;
The following were first presented, and proven, by Rosenbaum and Rubin in 1983:[1]&lt;br /&gt;
&lt;br /&gt;
以下是Rosenbaum和Rubin于1983年首次提出并证明的：&amp;lt;ref name=&amp;quot;Rosenbaum 1983 41–55&amp;quot; /&amp;gt;&lt;br /&gt;
&lt;br /&gt;
*The propensity score &amp;lt;math&amp;gt;e(x)&amp;lt;/math&amp;gt; is a balancing score.&lt;br /&gt;
*倾向性评分&amp;lt;math&amp;gt;e(x)&amp;lt;/math&amp;gt;是平衡得分。&lt;br /&gt;
&lt;br /&gt;
*Any score that is 'finer' than the propensity score is a balancing score (i.e.: &amp;lt;math&amp;gt;e(X)=f(b(X))&amp;lt;/math&amp;gt; for some function ''f''). The propensity score is the coarsest balancing score function, as it takes a (possibly) multidimensional object (''X''&amp;lt;sub&amp;gt;''i''&amp;lt;/sub&amp;gt;) and transforms it into one dimension (although others, obviously, also exist), while &amp;lt;math&amp;gt;b(X)=X&amp;lt;/math&amp;gt; is the finest one.&lt;br /&gt;
*任何比倾向性评分更“精细”的得分都是平衡得分（即：对于函数''f''，&amp;lt;math&amp;gt;e(X)=f(b(X))&amp;lt;/math&amp;gt;）。倾向性评分是最粗粒度的平衡得分函数，因为它把一个（可能是）多维的对象（''X''&amp;lt;sub&amp;gt;''i''&amp;lt;/sub&amp;gt;）转换成只有一维（尽管其他维度显然也存在），而&amp;lt;math&amp;gt;b(X)=X&amp;lt;/math&amp;gt;则是最细粒度的平衡得分函数（保留全部维度）。&lt;br /&gt;
&lt;br /&gt;
*If treatment assignment is strongly ignorable given ''X'' then:&lt;br /&gt;
*如果对于给定的''X''，处理分配满足强可忽略条件，则：&lt;br /&gt;
&lt;br /&gt;
:*It is also strongly ignorable given any balancing function. Specifically, given the propensity score:&lt;br /&gt;
:* 给定任何的平衡函数，具体来说，给定倾向性评分，处理分配也是强可忽略的：&lt;br /&gt;
&lt;br /&gt;
:::&amp;lt;math&amp;gt; (r_0, r_1) \perp Z \mid e(X).&amp;lt;/math&amp;gt;&lt;br /&gt;
回归&lt;br /&gt;
:*For any value of a balancing score, the difference between the treatment and control means of the samples at hand (i.e.: &amp;lt;math&amp;gt;\bar{r}_1-\bar{r}_0&amp;lt;/math&amp;gt;), based on subjects that have the same value of the balancing score, can serve as an [[Bias of an estimator|unbiased estimator]] of the [[average treatment effect]]: &amp;lt;math&amp;gt;E[r_1]-E[r_0]&amp;lt;/math&amp;gt;.&lt;br /&gt;
:*对于有相同平衡得分值的处理样本和对照样本，它们响应变量均值之差（即：&amp;lt;math&amp;gt;\bar{r}_1-\bar{r}_0&amp;lt;/math&amp;gt;），可以作为[[average treatment effect|平均处理效应]]的[[Bias of an estimator|无偏估计量]]：&amp;lt;math&amp;gt;E[r_1]-E[r_0]&amp;lt;/math&amp;gt;。&lt;br /&gt;
&lt;br /&gt;
*Using sample estimates of balancing scores can produce sample balance on&amp;amp;nbsp;''X''&lt;br /&gt;
*利用平衡得分的样本估计可产生在X上均衡的样本&lt;br /&gt;
&lt;br /&gt;
===Relationship to sufficiency===&lt;br /&gt;
===与充分性的关系 ===&lt;br /&gt;
&lt;br /&gt;
If we think of the value of ''Z'' as a [[Statistical parameter|parameter]] of the population that impacts the distribution of ''X'' then the balancing score serves as a [[Sufficient_statistic#Mathematical_definition|sufficient statistic]] for ''Z''. Furthermore, the above theorems indicate that the propensity score is a [[Sufficient_statistic#Minimal_sufficiency|minimal sufficient statistic]] if thinking of ''Z'' as a parameter of ''X''. Lastly, if treatment assignment ''Z'' is strongly ignorable given ''X'' then the propensity score is a [[Sufficient_statistic#Minimal_sufficiency|minimal sufficient statistic]] for the joint distribution of &amp;lt;math&amp;gt;(r_0, r_1)&amp;lt;/math&amp;gt;.&lt;br /&gt;
&lt;br /&gt;
If we think of the value of Z as a parameter of the population that impacts the distribution of X then the balancing score serves as a sufficient statistic for Z. Furthermore, the above theorems indicate that the propensity score is a minimal sufficient statistic if thinking of Z as a parameter of X. Lastly, if treatment assignment Z is strongly ignorable given X then the propensity score is a minimal sufficient statistic for the joint distribution of {\displaystyle (r_{0},r_{1})}{\displaystyle (r_{0},r_{1})}.&lt;br /&gt;
&lt;br /&gt;
如果我们把''Z''的值想成影响''X''分布的群体参数，则平衡得分充当了''Z''的充分统计量。进一步，上述定理指出，如果把''Z''视为''X''的参数，则倾向性评分就是最小充分统计量。最后，给定''X''，如果''Z''是强可忽略的，则倾向性评分是&amp;lt;math&amp;gt;(r_0, r_1)&amp;lt;/math&amp;gt;联合分布的最小充分统计量。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
===Graphical test for detecting the presence of confounding variables===&lt;br /&gt;
===混杂变量的图检测方法===&lt;br /&gt;
&lt;br /&gt;
[[Judea Pearl]] has shown that there exists a simple graphical test, called the back-door criterion, which detects the presence of confounding variables. To estimate the effect of treatment, the background variables X must block all back-door paths in the graph. This blocking can be done either by adding the confounding variable as a control in regression, or by matching on the confounding variable.&amp;lt;ref name=&amp;quot;pearl&amp;quot;&amp;gt;{{cite book |last=Pearl |first=J. |year=2000 |title=Causality: Models, Reasoning, and Inference |url=https://archive.org/details/causalitymodelsr0000pear |url-access=registration |location=New York |publisher=Cambridge University Press |isbn=978-0-521-77362-1 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Judea Pearl has shown that there exists a simple graphical test, called the back-door criterion, which detects the presence of confounding variables. To estimate the effect of treatment, the background variables X must block all back-door paths in the graph. This blocking can be done either by adding the confounding variable as a control in regression, or by matching on the confounding variable.[2]&lt;br /&gt;
&lt;br /&gt;
朱迪亚·珀尔Judea Pearl已经表明存在一个简单的图检测方法，称为后门准则，它可以检测到混杂变量的存在。为了估计处理效果，背景变量X必须阻断图中的所有后门路径。通过把混杂变量加入回归的控制变量，或者在混杂变量上进行匹配可以实现后门路径的阻断。&lt;br /&gt;
&lt;br /&gt;
== Disadvantages==&lt;br /&gt;
== 缺点 ==&lt;br /&gt;
&lt;br /&gt;
PSM has been shown to increase model &amp;quot;imbalance, inefficiency, model dependence, and bias,&amp;quot; which is not the case with most other matching methods. The insights behind the use of matching still hold but should be applied with other matching methods; propensity scores also have other productive uses in weighting and doubly robust estimation.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】PSM 已经被证明会增加模型的“不平衡性、低效率、模型依赖性和偏差”，这与大多数其他匹配方法不同。使用匹配的见解仍然有效，但应该与其他匹配方法一起应用; 倾向得分在加权和双重稳健估计方面也有其他有益的用途。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
PSM已经被证明会加剧模型的“不平衡性、低效率、模型依赖性和偏差”，这与大多数其他匹配方法不同。匹配方法背后的见解仍然成立，但应该与其他匹配方法一起应用；倾向得分在加权和双重稳健估计方面也有其他有益的用途。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Like other matching procedures, PSM estimates an average treatment effect from observational data. The key advantages of PSM were, at the time of its introduction, that by using a linear combination of covariates for a single score, it balances treatment and control groups on a large number of covariates without losing a large number of observations. If units in the treatment and control were balanced on a large number of covariates one at a time, large numbers of observations would be needed to overcome the &amp;quot;dimensionality problem&amp;quot; whereby the introduction of a new balancing covariate increases the minimum necessary number of observations in the sample geometrically.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】与其他匹配程序一样，PSM 从观测数据中估计平均处理效果。在引入 PSM 的时候，它的主要优点是，通过使用一个线性组合的协变量作为一个单一的评分，它平衡了治疗组和对照组在大量的协变量上，而不会失去大量的观察数据。如果处理和控制中的单元在大量的协变量上一次平衡，就需要大量的观测数据来克服“维数问题”，即引入新的平衡协变量几何地增加样本中必要的最小观测数据。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
与其他匹配过程一样，PSM也是从观测数据中估计平均处理效应。在引入PSM之时，它的主要优点是，通过使用协变量的线性组合得到一个单一评分，以大量的协变量为基础平衡了处理组和对照组，却不大量损失观测数据。如果在有众多协变量的情况下，对每一个些变量都分别做处理单元和对照单元平衡的话，就需要大量的观测数据来克服”维度问题“，即，每引入一个新的平衡协变量都会在几何上增加最小所需的观测样本数量。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
One disadvantage of PSM is that it only accounts for observed (and observable) covariates and not latent characteristics. Factors that affect assignment to treatment and outcome but that cannot be observed cannot be accounted for in the matching procedure. As the procedure only controls for observed variables, any hidden bias due to latent variables may remain after matching. Another issue is that PSM requires large samples, with substantial overlap between treatment and control groups.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】PSM 的一个缺点是它只能解释观察到的(和可观察到的)协变量，而不能解释潜在的特征。影响治疗分配和结果但无法观察的因素不能在匹配程序中说明。由于程序只控制观察变量，任何隐藏的偏见由于潜在变量可能仍然匹配后。另一个问题是 PSM 需要大量的样本，治疗组和对照组之间有大量的重叠。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
PSM的一个缺点是它只能涵盖已观测的（和可观测的）协变量，而无法涵盖潜在变量。那些能影响处理分配却不可观测的因素无法被纳入匹配过程的考量范围。由于匹配过程只控制可观测变量，那些隐藏的偏差在匹配后依然可能存在。另一个问题是PSM还要求在大量样本中，在处理组和对照组之间有大量的重叠。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
General concerns with matching have also been raised by Judea Pearl, who has argued that hidden bias may actually increase because matching on observed variables may unleash bias due to dormant unobserved confounders. Similarly, Pearl has argued that bias reduction can only be assured (asymptotically) by modelling the qualitative causal relationships between treatment, outcome, observed and unobserved covariates. Confounding occurs when the experimenter is unable to control for alternative, non-causal explanations for an observed relationship between independent and dependent variables. Such control should satisfy the &amp;quot;backdoor criterion&amp;quot; of Pearl. It can also easily be implemented manually.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】朱迪亚 · 珀尔也提出了关于配对的普遍担忧，他认为隐性偏见实际上可能会增加，因为观察变量的配对可能会由于潜在的未观察混杂因素而释放出偏见。同样，珀尔认为，只有通过建立治疗、结果、观察和未观察协变量之间的定性因果关系模型，才能确保(渐近地)减少偏见。当实验者无法控制对独立变量和因变量之间观察到的关系的替代性、非因果性解释时，混淆就发生了。这种控制应满足珍珠的“后门规范”。它也可以很容易地手动实现。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Judea Pearl也提出了关于匹配方法的一般性担忧，他认为对可观测变量进行匹配可能会让那些原本处于休眠状态的混杂因素被释放，从而实际上可能加剧隐藏的偏差。同样，Pearl认为，只有通过对处理、结果、可观测和不可观测的协变量之间的定性因果关系进行建模，才能确保（渐进地）减少偏差。当试验者无法控制&amp;lt;font color=&amp;quot;#32cd32&amp;quot;&amp;gt;对独立变量和因变量之间观察到的关系的替代性、非因果性解释时&amp;lt;/font&amp;gt;，混杂就会发生。这样的控制应该满足Pearl的“后门准则”。它很容易手工实现。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&amp;lt;noinclude&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&amp;lt;small&amp;gt;This page was moved from [[wikipedia:en:Propensity score matching]]. Its edit history can be viewed at [[倾向性评分/edithistory]]&amp;lt;/small&amp;gt;&amp;lt;/noinclude&amp;gt;&lt;br /&gt;
&lt;br /&gt;
[[Category:待整理页面]]&lt;br /&gt;
&lt;br /&gt;
&amp;lt;references /&amp;gt;&lt;/div&gt;</summary>
		<author><name>李昊轩</name></author>
	</entry>
	<entry>
		<id>https://wiki.swarma.org/index.php?title=%E5%80%BE%E5%90%91%E5%BE%97%E5%88%86%E5%8C%B9%E9%85%8D&amp;diff=23565</id>
		<title>倾向得分匹配</title>
		<link rel="alternate" type="text/html" href="https://wiki.swarma.org/index.php?title=%E5%80%BE%E5%90%91%E5%BE%97%E5%88%86%E5%8C%B9%E9%85%8D&amp;diff=23565"/>
		<updated>2021-06-12T16:00:30Z</updated>

		<summary type="html">&lt;p&gt;李昊轩：/* 基本设置 */&lt;/p&gt;
&lt;hr /&gt;
&lt;div&gt;此词条暂由彩云小译翻译，翻译字数共893，未经人工整理和审校，带来阅读不便，请见谅。&lt;br /&gt;
&lt;br /&gt;
{{Short description|Statistical matching technique}}&lt;br /&gt;
&lt;br /&gt;
In the [[statistics|statistical]] analysis of [[observational study|observational data]], '''propensity score matching''' ('''PSM''') is a [[Matching (statistics)|statistical matching]] technique that attempts to [[Estimation theory|estimate]] the effect of a treatment, policy, or other intervention by accounting for the [[covariate]]s that predict receiving the treatment. PSM attempts to reduce the [[Bias (statistics)|bias]] due to [[confounding]] variables that could be found in an estimate of the treatment effect obtained from simply comparing outcomes among [[Statistical unit|units]] that [[Treatment and control groups|received the treatment versus those that did not]]. [[Paul R. Rosenbaum]] and [[Donald Rubin]] introduced the technique in 1983.&amp;lt;ref name=&amp;quot;Rosenbaum 1983 41–55&amp;quot;&amp;gt;{{cite journal |last=Rosenbaum |first=Paul R. |last2=Rubin |first2=Donald B. |title=The Central Role of the Propensity Score in Observational Studies for Causal Effects |journal=[[Biometrika]] |year=1983 |volume=70 |issue=1 |pages=41–55 |doi=10.1093/biomet/70.1.41 |doi-access=free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
In the statistical analysis of observational data, propensity score matching (PSM) is a statistical matching technique that attempts to estimate the effect of a treatment, policy, or other intervention by accounting for the covariates that predict receiving the treatment. PSM attempts to reduce the bias due to confounding variables that could be found in an estimate of the treatment effect obtained from simply comparing outcomes among units that received the treatment versus those that did not. Paul R. Rosenbaum and Donald Rubin introduced the technique in 1983.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】在观察数据的统计分析中，倾向性评分匹配是一种统计匹配技术，它试图通过计算预测接受治疗的协变量来估计治疗、政策或其他干预的效果。PSM 试图减少由于混杂变量造成的偏倚，这些变量可以通过简单地比较接受治疗的单位和没有接受治疗的单位之间的结果来估计治疗效果。保罗 · 罗森鲍姆和唐纳德 · 鲁宾在1983年介绍了这项技术。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
在观察数据的统计分析中，倾向性评分匹配Propensity Score Matching (PSM)是一种用于估计治疗、政策或其他干预的效果统计匹配技术，方法是将协变量对样本“是否接受处理”的影响考虑在内。PSM试图减少由于混杂变量造成的偏倚。这些偏倚一般会在那些只对处理单元和对照单元的结果做简单对比的评估中出现。保罗·罗森鲍姆Paul R. Rosenbaum和唐纳德·鲁宾Donald Rubin在1983年介绍了这项技术。&lt;br /&gt;
&lt;br /&gt;
The possibility of bias arises because a difference in the treatment outcome (such as the [[average treatment effect]]) between treated and untreated groups may be caused by a factor that predicts treatment rather than the treatment itself. In [[randomized experiment]]s, the randomization enables unbiased estimation of treatment effects; for each covariate, randomization implies that treatment-groups will be balanced on average, by the [[law of large numbers]]. Unfortunately, for observational studies, the assignment of treatments to research subjects is typically not random. [[Matching (statistics)|Matching]] attempts to reduce the treatment assignment bias, and mimic randomization, by creating a sample of units that received the treatment that is comparable on all observed covariates to a sample of units that did not receive the treatment.&lt;br /&gt;
&lt;br /&gt;
The possibility of bias arises because a difference in the treatment outcome (such as the average treatment effect) between treated and untreated groups may be caused by a factor that predicts treatment rather than the treatment itself. In randomized experiments, the randomization enables unbiased estimation of treatment effects; for each covariate, randomization implies that treatment-groups will be balanced on average, by the law of large numbers. Unfortunately, for observational studies, the assignment of treatments to research subjects is typically not random. Matching attempts to reduce the treatment assignment bias, and mimic randomization, by creating a sample of units that received the treatment that is comparable on all observed covariates to a sample of units that did not receive the treatment.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】出现偏倚的可能性是因为治疗组和未治疗组之间治疗结果(如平均治疗效果)的差异可能是由预测治疗的因素而不是治疗本身造成的。在随机实验中，随机化可以对治疗效果进行无偏估计; 对于每个协变量，随机化意味着治疗组将按照大数定律在平均水平上达到平衡。不幸的是，对于观察性研究来说，对研究对象的治疗分配通常不是随机的。匹配试图减少处理分配偏差，并模拟随机化，通过创建一个样本单位接受的处理是可比的所有观察到的协变量的一个样本单位没有接受处理。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
出现偏倚的原因可能是某个因素通过决定样本是否接受处理而导致了处理组和对照组的效果（如平均处理效果）差异，而不是处理本身导致了差异。在随机实验中，随机化选择样本可以做到对处理效果的无偏估计，根据大数定律，随机化分配机制意味着每个协变量将在处理组和对照组中呈现类似的分布。不幸的是，对于观察性研究来说，研究对象通常不是随机接受处理的。匹配就是要减少对象非随机接受处理产生的偏倚，并模拟随机试验，方法是从处理组和对照组中分别取样，让两组样本的全部协变量都比较接近。&lt;br /&gt;
&lt;br /&gt;
For example, one may be interested to know the [[Health_effects_of_tobacco#Early_observational_studies|consequences of smoking]]. An observational study is required since it is unethical to randomly assign people to the treatment 'smoking.' The treatment effect estimated by simply comparing those who smoked to those who did not smoke would be biased by any factors that predict smoking (e.g.: gender and age). PSM attempts to control for these biases by making the groups receiving treatment and not-treatment comparable with respect to the control variables.&lt;br /&gt;
&lt;br /&gt;
For example, one may be interested to know the consequences of smoking. An observational study is required since it is unethical to randomly assign people to the treatment 'smoking.' The treatment effect estimated by simply comparing those who smoked to those who did not smoke would be biased by any factors that predict smoking (e.g.: gender and age). PSM attempts to control for these biases by making the groups receiving treatment and not-treatment comparable with respect to the control variables.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】例如，人们可能有兴趣知道吸烟的后果。因为随机分配患者接受‘吸烟’治疗是不道德的，所以需要一个观察性研究简单地比较吸烟者和不吸烟者的治疗效果会受到任何预测吸烟的因素的影响(例如:。: 性别及年龄)。PSM 试图通过使接受治疗和不接受治疗的组与控制变量相比较来控制这些偏差。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
例如，人们想知道吸烟的后果。但是随机分配让患者“吸烟”是不道德的，所以需要做一个观察性研究。简单地通过对比评估吸烟者和不吸烟者来估计平均处理效果将产生偏差，它会受到能影响吸烟行为的因素的影响（例如：性别及年龄）。PSM要做的是通过让处理组和对照组的控制变量尽量相似来达到控制这些偏差的目的。&lt;br /&gt;
&lt;br /&gt;
==Overview ==&lt;br /&gt;
&lt;br /&gt;
==综述==&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
PSM is for cases of [[Inductive reasoning#Causal inference|causal inference]] and simple selection bias in [[non-experimental]] settings in which: (i) few units in the non-treatment comparison group are comparable to the treatment units; and (ii) selecting a subset of comparison units similar to the treatment unit is difficult because units must be compared across a high-dimensional set of pretreatment characteristics.&lt;br /&gt;
&lt;br /&gt;
PSM is for cases of causal inference and simple selection bias in non-experimental settings in which: (i) few units in the non-treatment comparison group are comparable to the treatment units; and (ii) selecting a subset of comparison units similar to the treatment unit is difficult because units must be compared across a high-dimensional set of pretreatment characteristics.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】PSM 适用于非实验环境中因果推断和简单选择偏差的情况，其中: (i)非处理对照组中与处理单元可比的单元很少; (ii)选择与处理单元类似的比较单元子集很困难，因为必须跨一组高维预处理特征进行比较。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
PSM适用于非实验环境中因果推断和简单选择偏差的情况，其中: (i)对照组与处理组中的类似单元很少; (ii)选择与处理单元类似的对照单元集合很困难，因为必须对一组高维的协变量特征进行比较。&lt;br /&gt;
&lt;br /&gt;
In normal matching, single characteristics that distinguish treatment and control groups are matched in an attempt to make the groups more alike. But if the two groups do not have substantial overlap, then substantial [[Errors and residuals|error]] may be introduced. For example, if only the worst cases from the [[control group|untreated &amp;quot;comparison&amp;quot; group]] are compared to only the best cases from the [[treatment group]], the result may be [[regression toward the mean]], which may make the comparison group look better or worse than reality.&lt;br /&gt;
&lt;br /&gt;
In normal matching, single characteristics that distinguish treatment and control groups are matched in an attempt to make the groups more alike. But if the two groups do not have substantial overlap, then substantial error may be introduced. For example, if only the worst cases from the untreated &amp;quot;comparison&amp;quot; group are compared to only the best cases from the treatment group, the result may be regression toward the mean, which may make the comparison group look better or worse than reality.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】在正常的匹配中，区分治疗组和对照组的单一特征被匹配，试图使这些组更加相似。但是，如果这两个组没有实质性的重叠，那么可能会引入实质性的错误。例如，如果只将来自未经治疗的对照组的最差病例与来自治疗组的最好病例进行比较，结果可能是趋中回归，这可能使对照组看起来比实际情况更好或更糟。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
在常规的匹配机制中，对一组能够区分处理组和对照组的特征做匹配，以使两组的特征更加相似。但如果这两个组的特征没有显著的重叠，那么可能会引入实质性的错误。例如，拿对照组最糟的病例和处理组最好的病例进行比较，结果可能倾向于回归均值，这会让对照组看起来比实际情况更好或更糟。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
PSM employs a predicted probability of group membership—e.g., treatment versus control group—based on observed predictors, usually obtained from [[logistic regression]] to create a [[Impact evaluation#Counterfactual evaluation designs|counterfactual group]]. Propensity scores may be used for matching or as [[covariance|covariate]]s, alone or with other matching variables or covariates.&lt;br /&gt;
&lt;br /&gt;
PSM employs a predicted probability of group membership—e.g., treatment versus control group—based on observed predictors, usually obtained from logistic regression to create a counterfactual group. Propensity scores may be used for matching or as covariates, alone or with other matching variables or covariates.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】PSM 使用了一种预测的群体成员概率---- 例如，治疗组与控制组---- 基于观察预测，通常从 Logit模型获得来创造一个反事实的群体。倾向得分可用于匹配或作为协变量，单独或与其他匹配变量或协变量。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
PSM利用观察数据预测样本落入不同分组（例如，处理组与控制组）的概率，通常用Logistic回归方法，然后利用此概率创造一个反事实的群体。倾向性评分可用于匹配，也可作为协变量，可以单独使用，也可以与其他匹配变量或协变量一同使用。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
==General procedure==&lt;br /&gt;
&lt;br /&gt;
==一般步骤==&lt;br /&gt;
&lt;br /&gt;
1. Run [[logistic regression]]:&lt;br /&gt;
&lt;br /&gt;
1. Run logistic regression:&lt;br /&gt;
&lt;br /&gt;
1. 做Logistic回归：&lt;br /&gt;
&lt;br /&gt;
*Dependent variable: ''Z'' = 1, if unit participated (i.e. is member of the treatment group); ''Z'' = 0, if unit did not participate (i.e. is member of the control group).&lt;br /&gt;
&lt;br /&gt;
*因变量：参与处理（属于处理组），则''Z'' = 1；未参与处理（属于对照组），则''Z'' = 0。&lt;br /&gt;
&lt;br /&gt;
*Choose appropriate confounders (variables hypothesized to be associated with both treatment and outcome)&lt;br /&gt;
&lt;br /&gt;
*选择合适的混杂因素（既影响处理方式又影响处理结果的变量）&lt;br /&gt;
&lt;br /&gt;
*Obtain an [[Estimator|estimation]] for the propensity score: predicted probability (''p'') or log[''p''/(1&amp;amp;nbsp;−&amp;amp;nbsp;''p'')].&lt;br /&gt;
&lt;br /&gt;
*计算倾向性评分的[[Estimator|估计量]]：预测概率(''p'')或log[''p''/(1&amp;amp;nbsp;−&amp;amp;nbsp;''p'')]。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
2. Check that covariates are balanced across treatment and comparison groups within strata of the propensity score.&lt;br /&gt;
&lt;br /&gt;
2. Check that covariates are balanced across treatment and comparison groups within strata of the propensity score.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;2. 【机器翻译】检查协变量是平衡的治疗和比较组内的倾向分层。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
2. 依照倾向性评分的估计量进行分层，&amp;lt;font color=&amp;quot;#32cd32&amp;quot;&amp;gt;检查协变量的倾向性评分的估计量在每层处理组和对照组是否均衡&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
*Use standardized differences or graphs to examine distributions&lt;br /&gt;
&lt;br /&gt;
*使用标准化差异指标或者图形来检验分布情况&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
3. Match each participant to one or more nonparticipants on propensity score, using one of these methods:&lt;br /&gt;
&lt;br /&gt;
3. Match each participant to one or more nonparticipants on propensity score, using one of these methods:&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;3. 【机器翻译】根据倾向得分，将每个参与者与一个或多个非参与者进行匹配，使用以下方法之一:&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
3. 根据倾向性评分的估计量，将每个处理组个体与一个或多个对照组个体进行匹配，使用以下方法之一：&lt;br /&gt;
&lt;br /&gt;
*[[Nearest neighbor search|Nearest neighbor matching]]&lt;br /&gt;
&lt;br /&gt;
*[[Nearest neighbor search|最近邻匹配]]&lt;br /&gt;
&lt;br /&gt;
*Caliper matching: comparison units within a certain width of the propensity score of the treated units get matched, where the width is generally a fraction of the standard deviation of the propensity score&lt;br /&gt;
&lt;br /&gt;
*卡钳匹配：在处理单元倾向性评分的一个范围内选取对照单元，范围的宽度通常用倾向性评分的标准差乘上一个比例值&lt;br /&gt;
&lt;br /&gt;
*[[Mahalanobis distance|Mahalanobis metric]] matching in conjunction with PSM&lt;br /&gt;
&lt;br /&gt;
*[[Mahalanobis distance|马氏度量]] 与PSM配合使用&lt;br /&gt;
&lt;br /&gt;
*[[Stratified sampling|Stratification matching]]&lt;br /&gt;
&lt;br /&gt;
*[[Stratified sampling|分层匹配]]&lt;br /&gt;
&lt;br /&gt;
*Difference-in-differences matching (kernel and local linear weights)&lt;br /&gt;
&lt;br /&gt;
*&amp;lt;font color=&amp;quot;#32cd32&amp;quot;&amp;gt;双重差分匹配（核和局部线性加权）&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
*Exact matching&lt;br /&gt;
&lt;br /&gt;
*精确匹配&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
4. Verify that covariates are balanced across treatment and comparison groups in the matched or weighted sample&lt;br /&gt;
&lt;br /&gt;
4. Verify that covariates are balanced across treatment and comparison groups in the matched or weighted sample&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;4.【机器翻译】验证协变量是平衡的处理和对照组在匹配或加权样本&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
4. &amp;lt;font color=&amp;quot;#32cd32&amp;quot;&amp;gt;对比处理组和对照组的匹配样本或加权样本，验证协变量是否均衡&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
5. Multivariate analysis based on new sample&lt;br /&gt;
&lt;br /&gt;
5. Multivariate analysis based on new sample&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;5.【机器翻译】基于新样本的多变量分析&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
5. 基于新样本的多变量分析&lt;br /&gt;
&lt;br /&gt;
*Use analyses appropriate for non-independent matched samples if more than one nonparticipant is matched to each participant&lt;br /&gt;
&lt;br /&gt;
* 如果每个参与者都匹配了多个非参与者，则适当应用非独立匹配样本分析&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Note: When you have multiple matches for a single treated observation, it is essential to use Weighted Least Squares rather than Ordinary Least Squares.&lt;br /&gt;
&lt;br /&gt;
Note: When you have multiple matches for a single treated observation, it is essential to use Weighted Least Squares rather than Ordinary Least Squares.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】注意: 当你有多个匹配的单一处理的观察，它是必不可少的使用加权最小二乘而不是一般最小平方法。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
注意：当一个处理样本有多个匹配时，则必须用加权最小二乘法，而不能用普通最小二乘法。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
==Formal definitions==&lt;br /&gt;
&lt;br /&gt;
==形式定义 ==&lt;br /&gt;
&lt;br /&gt;
===Basic settings ===&lt;br /&gt;
&lt;br /&gt;
===基本设置===&lt;br /&gt;
&lt;br /&gt;
The basic case&amp;lt;ref name=&amp;quot;Rosenbaum 1983 41–55&amp;quot; /&amp;gt; is of two treatments (numbered 1 and 0), with ''N'' [Independent and identically distributed random variables|i.i.d] subjects. Each subject ''i'' would respond to the treatment with &amp;lt;math&amp;gt;r_{1i}&amp;lt;/math&amp;gt; and to the control with &amp;lt;math&amp;gt;r_{0i}&amp;lt;/math&amp;gt;. The quantity to be estimated is the [[average treatment effect]]: &amp;lt;math&amp;gt;E[r_1]-E[r_0]&amp;lt;/math&amp;gt;. The variable &amp;lt;math&amp;gt;Z_i&amp;lt;/math&amp;gt; indicates if subject ''i'' got treatment (''Z''&amp;amp;nbsp;=&amp;amp;nbsp;1) or control (''Z''&amp;amp;nbsp;=&amp;amp;nbsp;0). Let &amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt; be a vector of observed pretreatment measurement (or covariate) for the ''i''th subject. The observations of &amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt; are made prior to treatment assignment, but the features in &amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt; may not include all (or any) of the ones used to decide on the treatment assignment. The numbering of the units (i.e.: ''i''&amp;amp;nbsp;=&amp;amp;nbsp;1,&amp;amp;nbsp;...,&amp;amp;nbsp;''i''&amp;amp;nbsp;=&amp;amp;nbsp;''N'') are assumed to not contain any information beyond what is contained in &amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt;. The following sections will omit the ''i'' index while still discussing about the stochastic behavior of some subject.&lt;br /&gt;
&lt;br /&gt;
基本场景&amp;lt;ref name=&amp;quot;Rosenbaum 1983 41–55&amp;quot; /&amp;gt;是，有两种处理方式（分别记为1和0），''N''个[[Independent and identically distributed random variables|独立同分布]]个体。每个个体''i''如果接受了处理则响应为&amp;lt;math&amp;gt;r_{1i}&amp;lt;/math&amp;gt;，接受控制则响应为&amp;lt;math&amp;gt;r_{0i}&amp;lt;/math&amp;gt;。被估计量是[[average treatment effect|平均处理效应]]：&amp;lt;math&amp;gt;E[r_1]-E[r_0]&amp;lt;/math&amp;gt;。变量&amp;lt;math&amp;gt;Z_i&amp;lt;/math&amp;gt;指示个体''i''接受处理(''Z''&amp;amp;nbsp;=&amp;amp;nbsp;1)还是接受控制(''Z''&amp;amp;nbsp;=&amp;amp;nbsp;0)。让&amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt;代表第''i''个个体处理前观测值（或者协变量）的向量。对&amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt;的测量发生于处理前，但是&amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt;中也可以不包括那些决定是否接受处理的特征。个体编号（即：''i''&amp;amp;nbsp;=&amp;amp;nbsp;1,&amp;amp;nbsp;...,&amp;amp;nbsp;''i''&amp;amp;nbsp;=&amp;amp;nbsp;''N''）不包含任何&amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt;所包含信息之外的的信息。以下部分在讨论某些个体的随机行为的时候将省略索引''i''。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
===Strongly ignorable treatment assignment===&lt;br /&gt;
&lt;br /&gt;
===强可忽略处理分配===&lt;br /&gt;
&lt;br /&gt;
{{See also|Ignorability}}&lt;br /&gt;
&lt;br /&gt;
{{See also|可忽略性}}&lt;br /&gt;
&lt;br /&gt;
Let some subject have a vector of covariates ''X'' (i.e.: conditionally unconfounded), and some '''potential outcomes''' ''r''&amp;lt;sub&amp;gt;0&amp;lt;/sub&amp;gt; and ''r''&amp;lt;sub&amp;gt;1&amp;lt;/sub&amp;gt; under control and treatment, respectively. Treatment assignment is said to be '''strongly ignorable''' if the potential outcomes are [[statistical independence|independent]] of treatment (''Z'') conditional on background variables ''X''.  This can be written compactly as&lt;br /&gt;
&lt;br /&gt;
设某个物体有协变量''X''（即：条件非混杂变量）向量，以及对应着控制和处理两种情况的'''潜在结果'''''r''&amp;lt;sub&amp;gt;0&amp;lt;/sub&amp;gt;和''r''&amp;lt;sub&amp;gt;1&amp;lt;/sub&amp;gt;。如果潜在结果在给定背景变量''X''的条件下独立于处理举动（''Z''），则可以说样本是否接受处理分配是'''强可忽略'''的。可简洁表述为&lt;br /&gt;
&lt;br /&gt;
:&amp;lt;math&amp;gt; r_0, r_1 \perp Z \mid X &amp;lt;/math&amp;gt;&lt;br /&gt;
&lt;br /&gt;
这里&amp;lt;math&amp;gt;\perp&amp;lt;/math&amp;gt;代表[[statistical independence|统计独立]].&amp;lt;ref name=&amp;quot;Rosenbaum 1983 41–55&amp;quot; /&amp;gt;&lt;br /&gt;
&lt;br /&gt;
=== Balancing score===&lt;br /&gt;
&lt;br /&gt;
=== 平衡得分===&lt;br /&gt;
&lt;br /&gt;
A '''balancing score''' ''b''(''X'') is a function of the observed covariates ''X'' such that the [[conditional probability|conditional distribution]] of ''X'' given ''b''(''X'') is the same for treated (''Z''&amp;amp;nbsp;=&amp;amp;nbsp;1) and control (''Z''&amp;amp;nbsp;=&amp;amp;nbsp;0) units:&lt;br /&gt;
&lt;br /&gt;
A balancing score b(X) is a function of the observed covariates X such that the conditional distribution of X given b(X) is the same for treated (Z = 1) and control (Z = 0) units:&lt;br /&gt;
&lt;br /&gt;
平衡得分b(X)是观测协变量X的函数。在给定b(X)时，处理单元和控制单元的X有相同的条件分布：&lt;br /&gt;
&lt;br /&gt;
:&amp;lt;math&amp;gt; Z \perp X \mid b(X).&amp;lt;/math&amp;gt;&lt;br /&gt;
&lt;br /&gt;
最一般的平衡得分函数是&amp;lt;math&amp;gt; b(X) = X&amp;lt;/math&amp;gt;.&lt;br /&gt;
&lt;br /&gt;
===Propensity score===&lt;br /&gt;
&lt;br /&gt;
===倾向性评分 ===&lt;br /&gt;
&lt;br /&gt;
A '''propensity score''' is the [[probability]] of a unit (e.g., person, classroom, school) being assigned to a particular treatment given a set of observed covariates.  Propensity scores are used to reduce [[selection bias]] by equating groups based on these covariates.&lt;br /&gt;
&lt;br /&gt;
Suppose that we have a binary treatment [[Indicator function|indicator]] ''Z'', a response variable ''r'', and background observed covariates ''X''.  The propensity score is defined as the [[conditional probability]] of treatment given background variables:&lt;br /&gt;
&lt;br /&gt;
A propensity score is the probability of a unit (e.g., person, classroom, school) being assigned to a particular treatment given a set of observed covariates. Propensity scores are used to reduce selection bias by equating groups based on these covariates.&lt;br /&gt;
&lt;br /&gt;
Suppose that we have a binary treatment indicator Z, a response variable r, and background observed covariates X. The propensity score is defined as the conditional probability of treatment given background variables:&lt;br /&gt;
&lt;br /&gt;
倾向性评分是根据协变量观测值计算得出的一个单元（例如：个人，教室，学校）被指配接受特定处理的概率。通倾向性评分可用于让处理组和对照组的协变量趋同，从而减少选择偏差。&lt;br /&gt;
&lt;br /&gt;
假设有一个二值处理标识Z，一个响应变量r，以及被观测的背景协变量X。倾向性评分定义为，在给定背景变量条件下单元接受处理的条件概率：&lt;br /&gt;
&lt;br /&gt;
:&amp;lt;math&amp;gt;e(x) \ \stackrel{\mathrm{def}}{=}\  \Pr(Z=1 \mid X=x).&amp;lt;/math&amp;gt;&lt;br /&gt;
&lt;br /&gt;
In the context of [[causal inference]] and [[survey methodology]], propensity scores are estimated (via methods such as [[logistic regression]], [[random forests]], or others), using some set of covariates. These propensity scores are then used as estimators for weights to be used with [[Inverse probability weighting]] methods.&lt;br /&gt;
&lt;br /&gt;
In the context of causal inference and survey methodology, propensity scores are estimated (via methods such as logistic regression, random forests, or others), using some set of covariates. These propensity scores are then used as estimators for weights to be used with Inverse probability weighting methods.&lt;br /&gt;
&lt;br /&gt;
在因果推断和调查方法的范围内，通过Logistic回归、随机森林或其他方法，利用一组协变量估计倾向性评分。然后将这些倾向性评分即可作为权重估计量用于逆概率加权方法。&lt;br /&gt;
&lt;br /&gt;
===Main theorems===&lt;br /&gt;
&lt;br /&gt;
===主要定理===&lt;br /&gt;
&lt;br /&gt;
The following were first presented, and proven, by Rosenbaum and Rubin in 1983:&amp;lt;ref name=&amp;quot;Rosenbaum 1983 41–55&amp;quot; /&amp;gt;&lt;br /&gt;
&lt;br /&gt;
The following were first presented, and proven, by Rosenbaum and Rubin in 1983:[1]&lt;br /&gt;
&lt;br /&gt;
以下是Rosenbaum和Rubin于1983年首次提出并证明的：&amp;lt;ref name=&amp;quot;Rosenbaum 1983 41–55&amp;quot; /&amp;gt;&lt;br /&gt;
&lt;br /&gt;
*The propensity score &amp;lt;math&amp;gt;e(x)&amp;lt;/math&amp;gt; is a balancing score.&lt;br /&gt;
*倾向性评分&amp;lt;math&amp;gt;e(x)&amp;lt;/math&amp;gt;是平衡得分。&lt;br /&gt;
&lt;br /&gt;
*Any score that is 'finer' than the propensity score is a balancing score (i.e.: &amp;lt;math&amp;gt;e(X)=f(b(X))&amp;lt;/math&amp;gt; for some function ''f''). The propensity score is the coarsest balancing score function, as it takes a (possibly) multidimensional object (''X''&amp;lt;sub&amp;gt;''i''&amp;lt;/sub&amp;gt;) and transforms it into one dimension (although others, obviously, also exist), while &amp;lt;math&amp;gt;b(X)=X&amp;lt;/math&amp;gt; is the finest one.&lt;br /&gt;
*任何比倾向性评分更“精细”的得分都是平衡得分（即：对于函数''f''，&amp;lt;math&amp;gt;e(X)=f(b(X))&amp;lt;/math&amp;gt;）。倾向性评分是最粗粒度的平衡得分函数，因为它把一个（可能是）多维的对象（''X''&amp;lt;sub&amp;gt;''i''&amp;lt;/sub&amp;gt;）转换成只有一维（尽管其他维度显然也存在），而&amp;lt;math&amp;gt;b(X)=X&amp;lt;/math&amp;gt;则是最细粒度的平衡得分函数（保留全部维度）。&lt;br /&gt;
&lt;br /&gt;
*If treatment assignment is strongly ignorable given ''X'' then:&lt;br /&gt;
*如果对于给定的''X''，处理分配满足强可忽略条件，则：&lt;br /&gt;
&lt;br /&gt;
:*It is also strongly ignorable given any balancing function. Specifically, given the propensity score:&lt;br /&gt;
:* 给定任何的平衡函数，具体来说，给定倾向性评分，处理分配也是强可忽略的：&lt;br /&gt;
&lt;br /&gt;
:::&amp;lt;math&amp;gt; (r_0, r_1) \perp Z \mid e(X).&amp;lt;/math&amp;gt;&lt;br /&gt;
回归&lt;br /&gt;
:*For any value of a balancing score, the difference between the treatment and control means of the samples at hand (i.e.: &amp;lt;math&amp;gt;\bar{r}_1-\bar{r}_0&amp;lt;/math&amp;gt;), based on subjects that have the same value of the balancing score, can serve as an [[Bias of an estimator|unbiased estimator]] of the [[average treatment effect]]: &amp;lt;math&amp;gt;E[r_1]-E[r_0]&amp;lt;/math&amp;gt;.&lt;br /&gt;
:*对于有相同平衡得分值的处理样本和对照样本，它们响应变量均值之差（即：&amp;lt;math&amp;gt;\bar{r}_1-\bar{r}_0&amp;lt;/math&amp;gt;），可以作为[[average treatment effect|平均处理效应]]的[[Bias of an estimator|无偏估计量]]：&amp;lt;math&amp;gt;E[r_1]-E[r_0]&amp;lt;/math&amp;gt;。&lt;br /&gt;
&lt;br /&gt;
*Using sample estimates of balancing scores can produce sample balance on&amp;amp;nbsp;''X''&lt;br /&gt;
*利用平衡得分的样本估计可产生在X上均衡的样本&lt;br /&gt;
&lt;br /&gt;
===Relationship to sufficiency===&lt;br /&gt;
===与充分性的关系 ===&lt;br /&gt;
&lt;br /&gt;
If we think of the value of ''Z'' as a [[Statistical parameter|parameter]] of the population that impacts the distribution of ''X'' then the balancing score serves as a [[Sufficient_statistic#Mathematical_definition|sufficient statistic]] for ''Z''. Furthermore, the above theorems indicate that the propensity score is a [[Sufficient_statistic#Minimal_sufficiency|minimal sufficient statistic]] if thinking of ''Z'' as a parameter of ''X''. Lastly, if treatment assignment ''Z'' is strongly ignorable given ''X'' then the propensity score is a [[Sufficient_statistic#Minimal_sufficiency|minimal sufficient statistic]] for the joint distribution of &amp;lt;math&amp;gt;(r_0, r_1)&amp;lt;/math&amp;gt;.&lt;br /&gt;
&lt;br /&gt;
If we think of the value of Z as a parameter of the population that impacts the distribution of X then the balancing score serves as a sufficient statistic for Z. Furthermore, the above theorems indicate that the propensity score is a minimal sufficient statistic if thinking of Z as a parameter of X. Lastly, if treatment assignment Z is strongly ignorable given X then the propensity score is a minimal sufficient statistic for the joint distribution of {\displaystyle (r_{0},r_{1})}{\displaystyle (r_{0},r_{1})}.&lt;br /&gt;
&lt;br /&gt;
如果我们把''Z''的值想成影响''X''分布的群体参数，则平衡得分充当了''Z''的充分统计量。进一步，上述定理指出，如果把''Z''视为''X''的参数，则倾向性评分就是最小充分统计量。最后，给定''X''，如果''Z''是强可忽略的，则倾向性评分是&amp;lt;math&amp;gt;(r_0, r_1)&amp;lt;/math&amp;gt;联合分布的最小充分统计量。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
===Graphical test for detecting the presence of confounding variables===&lt;br /&gt;
===混杂变量的图检测方法===&lt;br /&gt;
&lt;br /&gt;
[[Judea Pearl]] has shown that there exists a simple graphical test, called the back-door criterion, which detects the presence of confounding variables. To estimate the effect of treatment, the background variables X must block all back-door paths in the graph. This blocking can be done either by adding the confounding variable as a control in regression, or by matching on the confounding variable.&amp;lt;ref name=&amp;quot;pearl&amp;quot;&amp;gt;{{cite book |last=Pearl |first=J. |year=2000 |title=Causality: Models, Reasoning, and Inference |url=https://archive.org/details/causalitymodelsr0000pear |url-access=registration |location=New York |publisher=Cambridge University Press |isbn=978-0-521-77362-1 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Judea Pearl has shown that there exists a simple graphical test, called the back-door criterion, which detects the presence of confounding variables. To estimate the effect of treatment, the background variables X must block all back-door paths in the graph. This blocking can be done either by adding the confounding variable as a control in regression, or by matching on the confounding variable.[2]&lt;br /&gt;
&lt;br /&gt;
朱迪亚·珀尔Judea Pearl已经表明存在一个简单的图检测方法，称为后门准则，它可以检测到混杂变量的存在。为了估计处理效果，背景变量X必须阻断图中的所有后门路径。通过把混杂变量加入回归的控制变量，或者在混杂变量上进行匹配可以实现后门路径的阻断。&lt;br /&gt;
&lt;br /&gt;
== Disadvantages==&lt;br /&gt;
== 缺点 ==&lt;br /&gt;
&lt;br /&gt;
PSM has been shown to increase model &amp;quot;imbalance, inefficiency, model dependence, and bias,&amp;quot; which is not the case with most other matching methods. The insights behind the use of matching still hold but should be applied with other matching methods; propensity scores also have other productive uses in weighting and doubly robust estimation.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】PSM 已经被证明会增加模型的“不平衡性、低效率、模型依赖性和偏差”，这与大多数其他匹配方法不同。使用匹配的见解仍然有效，但应该与其他匹配方法一起应用; 倾向得分在加权和双重稳健估计方面也有其他有益的用途。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
PSM已经被证明会加剧模型的“不平衡性、低效率、模型依赖性和偏差”，这与大多数其他匹配方法不同。匹配方法背后的见解仍然成立，但应该与其他匹配方法一起应用；倾向得分在加权和双重稳健估计方面也有其他有益的用途。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Like other matching procedures, PSM estimates an average treatment effect from observational data. The key advantages of PSM were, at the time of its introduction, that by using a linear combination of covariates for a single score, it balances treatment and control groups on a large number of covariates without losing a large number of observations. If units in the treatment and control were balanced on a large number of covariates one at a time, large numbers of observations would be needed to overcome the &amp;quot;dimensionality problem&amp;quot; whereby the introduction of a new balancing covariate increases the minimum necessary number of observations in the sample geometrically.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】与其他匹配程序一样，PSM 从观测数据中估计平均处理效果。在引入 PSM 的时候，它的主要优点是，通过使用一个线性组合的协变量作为一个单一的评分，它平衡了治疗组和对照组在大量的协变量上，而不会失去大量的观察数据。如果处理和控制中的单元在大量的协变量上一次平衡，就需要大量的观测数据来克服“维数问题”，即引入新的平衡协变量几何地增加样本中必要的最小观测数据。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
与其他匹配过程一样，PSM也是从观测数据中估计平均处理效应。在引入PSM之时，它的主要优点是，通过使用协变量的线性组合得到一个单一评分，以大量的协变量为基础平衡了处理组和对照组，却不大量损失观测数据。如果在有众多协变量的情况下，对每一个些变量都分别做处理单元和对照单元平衡的话，就需要大量的观测数据来克服”维度问题“，即，每引入一个新的平衡协变量都会在几何上增加最小所需的观测样本数量。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
One disadvantage of PSM is that it only accounts for observed (and observable) covariates and not latent characteristics. Factors that affect assignment to treatment and outcome but that cannot be observed cannot be accounted for in the matching procedure. As the procedure only controls for observed variables, any hidden bias due to latent variables may remain after matching. Another issue is that PSM requires large samples, with substantial overlap between treatment and control groups.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】PSM 的一个缺点是它只能解释观察到的(和可观察到的)协变量，而不能解释潜在的特征。影响治疗分配和结果但无法观察的因素不能在匹配程序中说明。由于程序只控制观察变量，任何隐藏的偏见由于潜在变量可能仍然匹配后。另一个问题是 PSM 需要大量的样本，治疗组和对照组之间有大量的重叠。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
PSM的一个缺点是它只能涵盖已观测的（和可观测的）协变量，而无法涵盖潜在变量。那些能影响处理分配却不可观测的因素无法被纳入匹配过程的考量范围。由于匹配过程只控制可观测变量，那些隐藏的偏差在匹配后依然可能存在。另一个问题是PSM还要求在大量样本中，在处理组和对照组之间有大量的重叠。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
General concerns with matching have also been raised by Judea Pearl, who has argued that hidden bias may actually increase because matching on observed variables may unleash bias due to dormant unobserved confounders. Similarly, Pearl has argued that bias reduction can only be assured (asymptotically) by modelling the qualitative causal relationships between treatment, outcome, observed and unobserved covariates. Confounding occurs when the experimenter is unable to control for alternative, non-causal explanations for an observed relationship between independent and dependent variables. Such control should satisfy the &amp;quot;backdoor criterion&amp;quot; of Pearl. It can also easily be implemented manually.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】朱迪亚 · 珀尔也提出了关于配对的普遍担忧，他认为隐性偏见实际上可能会增加，因为观察变量的配对可能会由于潜在的未观察混杂因素而释放出偏见。同样，珀尔认为，只有通过建立治疗、结果、观察和未观察协变量之间的定性因果关系模型，才能确保(渐近地)减少偏见。当实验者无法控制对独立变量和因变量之间观察到的关系的替代性、非因果性解释时，混淆就发生了。这种控制应满足珍珠的“后门规范”。它也可以很容易地手动实现。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Judea Pearl也提出了关于匹配方法的一般性担忧，他认为对可观测变量进行匹配可能会让那些原本处于休眠状态的混杂因素被释放，从而实际上可能加剧隐藏的偏差。同样，Pearl认为，只有通过对处理、结果、可观测和不可观测的协变量之间的定性因果关系进行建模，才能确保（渐进地）减少偏差。当试验者无法控制&amp;lt;font color=&amp;quot;#32cd32&amp;quot;&amp;gt;对独立变量和因变量之间观察到的关系的替代性、非因果性解释时&amp;lt;/font&amp;gt;，混杂就会发生。这样的控制应该满足Pearl的“后门准则”。它很容易手工实现。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&amp;lt;noinclude&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&amp;lt;small&amp;gt;This page was moved from [[wikipedia:en:Propensity score matching]]. Its edit history can be viewed at [[倾向性评分/edithistory]]&amp;lt;/small&amp;gt;&amp;lt;/noinclude&amp;gt;&lt;br /&gt;
&lt;br /&gt;
[[Category:待整理页面]]&lt;br /&gt;
&lt;br /&gt;
&amp;lt;references /&amp;gt;&lt;/div&gt;</summary>
		<author><name>李昊轩</name></author>
	</entry>
	<entry>
		<id>https://wiki.swarma.org/index.php?title=%E5%80%BE%E5%90%91%E5%BE%97%E5%88%86%E5%8C%B9%E9%85%8D&amp;diff=23564</id>
		<title>倾向得分匹配</title>
		<link rel="alternate" type="text/html" href="https://wiki.swarma.org/index.php?title=%E5%80%BE%E5%90%91%E5%BE%97%E5%88%86%E5%8C%B9%E9%85%8D&amp;diff=23564"/>
		<updated>2021-06-12T15:58:57Z</updated>

		<summary type="html">&lt;p&gt;李昊轩：/* 基本设置 */&lt;/p&gt;
&lt;hr /&gt;
&lt;div&gt;此词条暂由彩云小译翻译，翻译字数共893，未经人工整理和审校，带来阅读不便，请见谅。&lt;br /&gt;
&lt;br /&gt;
{{Short description|Statistical matching technique}}&lt;br /&gt;
&lt;br /&gt;
In the [[statistics|statistical]] analysis of [[observational study|observational data]], '''propensity score matching''' ('''PSM''') is a [[Matching (statistics)|statistical matching]] technique that attempts to [[Estimation theory|estimate]] the effect of a treatment, policy, or other intervention by accounting for the [[covariate]]s that predict receiving the treatment. PSM attempts to reduce the [[Bias (statistics)|bias]] due to [[confounding]] variables that could be found in an estimate of the treatment effect obtained from simply comparing outcomes among [[Statistical unit|units]] that [[Treatment and control groups|received the treatment versus those that did not]]. [[Paul R. Rosenbaum]] and [[Donald Rubin]] introduced the technique in 1983.&amp;lt;ref name=&amp;quot;Rosenbaum 1983 41–55&amp;quot;&amp;gt;{{cite journal |last=Rosenbaum |first=Paul R. |last2=Rubin |first2=Donald B. |title=The Central Role of the Propensity Score in Observational Studies for Causal Effects |journal=[[Biometrika]] |year=1983 |volume=70 |issue=1 |pages=41–55 |doi=10.1093/biomet/70.1.41 |doi-access=free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
In the statistical analysis of observational data, propensity score matching (PSM) is a statistical matching technique that attempts to estimate the effect of a treatment, policy, or other intervention by accounting for the covariates that predict receiving the treatment. PSM attempts to reduce the bias due to confounding variables that could be found in an estimate of the treatment effect obtained from simply comparing outcomes among units that received the treatment versus those that did not. Paul R. Rosenbaum and Donald Rubin introduced the technique in 1983.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】在观察数据的统计分析中，倾向性评分匹配是一种统计匹配技术，它试图通过计算预测接受治疗的协变量来估计治疗、政策或其他干预的效果。PSM 试图减少由于混杂变量造成的偏倚，这些变量可以通过简单地比较接受治疗的单位和没有接受治疗的单位之间的结果来估计治疗效果。保罗 · 罗森鲍姆和唐纳德 · 鲁宾在1983年介绍了这项技术。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
在观察数据的统计分析中，倾向性评分匹配Propensity Score Matching (PSM)是一种用于估计治疗、政策或其他干预的效果统计匹配技术，方法是将协变量对样本“是否接受处理”的影响考虑在内。PSM试图减少由于混杂变量造成的偏倚。这些偏倚一般会在那些只对处理单元和对照单元的结果做简单对比的评估中出现。保罗·罗森鲍姆Paul R. Rosenbaum和唐纳德·鲁宾Donald Rubin在1983年介绍了这项技术。&lt;br /&gt;
&lt;br /&gt;
The possibility of bias arises because a difference in the treatment outcome (such as the [[average treatment effect]]) between treated and untreated groups may be caused by a factor that predicts treatment rather than the treatment itself. In [[randomized experiment]]s, the randomization enables unbiased estimation of treatment effects; for each covariate, randomization implies that treatment-groups will be balanced on average, by the [[law of large numbers]]. Unfortunately, for observational studies, the assignment of treatments to research subjects is typically not random. [[Matching (statistics)|Matching]] attempts to reduce the treatment assignment bias, and mimic randomization, by creating a sample of units that received the treatment that is comparable on all observed covariates to a sample of units that did not receive the treatment.&lt;br /&gt;
&lt;br /&gt;
The possibility of bias arises because a difference in the treatment outcome (such as the average treatment effect) between treated and untreated groups may be caused by a factor that predicts treatment rather than the treatment itself. In randomized experiments, the randomization enables unbiased estimation of treatment effects; for each covariate, randomization implies that treatment-groups will be balanced on average, by the law of large numbers. Unfortunately, for observational studies, the assignment of treatments to research subjects is typically not random. Matching attempts to reduce the treatment assignment bias, and mimic randomization, by creating a sample of units that received the treatment that is comparable on all observed covariates to a sample of units that did not receive the treatment.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】出现偏倚的可能性是因为治疗组和未治疗组之间治疗结果(如平均治疗效果)的差异可能是由预测治疗的因素而不是治疗本身造成的。在随机实验中，随机化可以对治疗效果进行无偏估计; 对于每个协变量，随机化意味着治疗组将按照大数定律在平均水平上达到平衡。不幸的是，对于观察性研究来说，对研究对象的治疗分配通常不是随机的。匹配试图减少处理分配偏差，并模拟随机化，通过创建一个样本单位接受的处理是可比的所有观察到的协变量的一个样本单位没有接受处理。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
出现偏倚的原因可能是某个因素通过决定样本是否接受处理而导致了处理组和对照组的效果（如平均处理效果）差异，而不是处理本身导致了差异。在随机实验中，随机化选择样本可以做到对处理效果的无偏估计，根据大数定律，随机化分配机制意味着每个协变量将在处理组和对照组中呈现类似的分布。不幸的是，对于观察性研究来说，研究对象通常不是随机接受处理的。匹配就是要减少对象非随机接受处理产生的偏倚，并模拟随机试验，方法是从处理组和对照组中分别取样，让两组样本的全部协变量都比较接近。&lt;br /&gt;
&lt;br /&gt;
For example, one may be interested to know the [[Health_effects_of_tobacco#Early_observational_studies|consequences of smoking]]. An observational study is required since it is unethical to randomly assign people to the treatment 'smoking.' The treatment effect estimated by simply comparing those who smoked to those who did not smoke would be biased by any factors that predict smoking (e.g.: gender and age). PSM attempts to control for these biases by making the groups receiving treatment and not-treatment comparable with respect to the control variables.&lt;br /&gt;
&lt;br /&gt;
For example, one may be interested to know the consequences of smoking. An observational study is required since it is unethical to randomly assign people to the treatment 'smoking.' The treatment effect estimated by simply comparing those who smoked to those who did not smoke would be biased by any factors that predict smoking (e.g.: gender and age). PSM attempts to control for these biases by making the groups receiving treatment and not-treatment comparable with respect to the control variables.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】例如，人们可能有兴趣知道吸烟的后果。因为随机分配患者接受‘吸烟’治疗是不道德的，所以需要一个观察性研究简单地比较吸烟者和不吸烟者的治疗效果会受到任何预测吸烟的因素的影响(例如:。: 性别及年龄)。PSM 试图通过使接受治疗和不接受治疗的组与控制变量相比较来控制这些偏差。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
例如，人们想知道吸烟的后果。但是随机分配让患者“吸烟”是不道德的，所以需要做一个观察性研究。简单地通过对比评估吸烟者和不吸烟者来估计平均处理效果将产生偏差，它会受到能影响吸烟行为的因素的影响（例如：性别及年龄）。PSM要做的是通过让处理组和对照组的控制变量尽量相似来达到控制这些偏差的目的。&lt;br /&gt;
&lt;br /&gt;
==Overview ==&lt;br /&gt;
&lt;br /&gt;
==综述==&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
PSM is for cases of [[Inductive reasoning#Causal inference|causal inference]] and simple selection bias in [[non-experimental]] settings in which: (i) few units in the non-treatment comparison group are comparable to the treatment units; and (ii) selecting a subset of comparison units similar to the treatment unit is difficult because units must be compared across a high-dimensional set of pretreatment characteristics.&lt;br /&gt;
&lt;br /&gt;
PSM is for cases of causal inference and simple selection bias in non-experimental settings in which: (i) few units in the non-treatment comparison group are comparable to the treatment units; and (ii) selecting a subset of comparison units similar to the treatment unit is difficult because units must be compared across a high-dimensional set of pretreatment characteristics.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】PSM 适用于非实验环境中因果推断和简单选择偏差的情况，其中: (i)非处理对照组中与处理单元可比的单元很少; (ii)选择与处理单元类似的比较单元子集很困难，因为必须跨一组高维预处理特征进行比较。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
PSM适用于非实验环境中因果推断和简单选择偏差的情况，其中: (i)对照组与处理组中的类似单元很少; (ii)选择与处理单元类似的对照单元集合很困难，因为必须对一组高维的协变量特征进行比较。&lt;br /&gt;
&lt;br /&gt;
In normal matching, single characteristics that distinguish treatment and control groups are matched in an attempt to make the groups more alike. But if the two groups do not have substantial overlap, then substantial [[Errors and residuals|error]] may be introduced. For example, if only the worst cases from the [[control group|untreated &amp;quot;comparison&amp;quot; group]] are compared to only the best cases from the [[treatment group]], the result may be [[regression toward the mean]], which may make the comparison group look better or worse than reality.&lt;br /&gt;
&lt;br /&gt;
In normal matching, single characteristics that distinguish treatment and control groups are matched in an attempt to make the groups more alike. But if the two groups do not have substantial overlap, then substantial error may be introduced. For example, if only the worst cases from the untreated &amp;quot;comparison&amp;quot; group are compared to only the best cases from the treatment group, the result may be regression toward the mean, which may make the comparison group look better or worse than reality.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】在正常的匹配中，区分治疗组和对照组的单一特征被匹配，试图使这些组更加相似。但是，如果这两个组没有实质性的重叠，那么可能会引入实质性的错误。例如，如果只将来自未经治疗的对照组的最差病例与来自治疗组的最好病例进行比较，结果可能是趋中回归，这可能使对照组看起来比实际情况更好或更糟。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
在常规的匹配机制中，对一组能够区分处理组和对照组的特征做匹配，以使两组的特征更加相似。但如果这两个组的特征没有显著的重叠，那么可能会引入实质性的错误。例如，拿对照组最糟的病例和处理组最好的病例进行比较，结果可能倾向于回归均值，这会让对照组看起来比实际情况更好或更糟。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
PSM employs a predicted probability of group membership—e.g., treatment versus control group—based on observed predictors, usually obtained from [[logistic regression]] to create a [[Impact evaluation#Counterfactual evaluation designs|counterfactual group]]. Propensity scores may be used for matching or as [[covariance|covariate]]s, alone or with other matching variables or covariates.&lt;br /&gt;
&lt;br /&gt;
PSM employs a predicted probability of group membership—e.g., treatment versus control group—based on observed predictors, usually obtained from logistic regression to create a counterfactual group. Propensity scores may be used for matching or as covariates, alone or with other matching variables or covariates.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】PSM 使用了一种预测的群体成员概率---- 例如，治疗组与控制组---- 基于观察预测，通常从 Logit模型获得来创造一个反事实的群体。倾向得分可用于匹配或作为协变量，单独或与其他匹配变量或协变量。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
PSM利用观察数据预测样本落入不同分组（例如，处理组与控制组）的概率，通常用Logistic回归方法，然后利用此概率创造一个反事实的群体。倾向性评分可用于匹配，也可作为协变量，可以单独使用，也可以与其他匹配变量或协变量一同使用。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
==General procedure==&lt;br /&gt;
&lt;br /&gt;
==一般步骤==&lt;br /&gt;
&lt;br /&gt;
1. Run [[logistic regression]]:&lt;br /&gt;
&lt;br /&gt;
1. Run logistic regression:&lt;br /&gt;
&lt;br /&gt;
1. 做Logistic回归：&lt;br /&gt;
&lt;br /&gt;
*Dependent variable: ''Z'' = 1, if unit participated (i.e. is member of the treatment group); ''Z'' = 0, if unit did not participate (i.e. is member of the control group).&lt;br /&gt;
&lt;br /&gt;
*因变量：参与处理（属于处理组），则''Z'' = 1；未参与处理（属于对照组），则''Z'' = 0。&lt;br /&gt;
&lt;br /&gt;
*Choose appropriate confounders (variables hypothesized to be associated with both treatment and outcome)&lt;br /&gt;
&lt;br /&gt;
*选择合适的混杂因素（既影响处理方式又影响处理结果的变量）&lt;br /&gt;
&lt;br /&gt;
*Obtain an [[Estimator|estimation]] for the propensity score: predicted probability (''p'') or log[''p''/(1&amp;amp;nbsp;−&amp;amp;nbsp;''p'')].&lt;br /&gt;
&lt;br /&gt;
*计算倾向性评分的[[Estimator|估计量]]：预测概率(''p'')或log[''p''/(1&amp;amp;nbsp;−&amp;amp;nbsp;''p'')]。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
2. Check that covariates are balanced across treatment and comparison groups within strata of the propensity score.&lt;br /&gt;
&lt;br /&gt;
2. Check that covariates are balanced across treatment and comparison groups within strata of the propensity score.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;2. 【机器翻译】检查协变量是平衡的治疗和比较组内的倾向分层。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
2. 依照倾向性评分的估计量进行分层，&amp;lt;font color=&amp;quot;#32cd32&amp;quot;&amp;gt;检查协变量的倾向性评分的估计量在每层处理组和对照组是否均衡&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
*Use standardized differences or graphs to examine distributions&lt;br /&gt;
&lt;br /&gt;
*使用标准化差异指标或者图形来检验分布情况&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
3. Match each participant to one or more nonparticipants on propensity score, using one of these methods:&lt;br /&gt;
&lt;br /&gt;
3. Match each participant to one or more nonparticipants on propensity score, using one of these methods:&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;3. 【机器翻译】根据倾向得分，将每个参与者与一个或多个非参与者进行匹配，使用以下方法之一:&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
3. 根据倾向性评分的估计量，将每个处理组个体与一个或多个对照组个体进行匹配，使用以下方法之一：&lt;br /&gt;
&lt;br /&gt;
*[[Nearest neighbor search|Nearest neighbor matching]]&lt;br /&gt;
&lt;br /&gt;
*[[Nearest neighbor search|最近邻匹配]]&lt;br /&gt;
&lt;br /&gt;
*Caliper matching: comparison units within a certain width of the propensity score of the treated units get matched, where the width is generally a fraction of the standard deviation of the propensity score&lt;br /&gt;
&lt;br /&gt;
*卡钳匹配：在处理单元倾向性评分的一个范围内选取对照单元，范围的宽度通常用倾向性评分的标准差乘上一个比例值&lt;br /&gt;
&lt;br /&gt;
*[[Mahalanobis distance|Mahalanobis metric]] matching in conjunction with PSM&lt;br /&gt;
&lt;br /&gt;
*[[Mahalanobis distance|马氏度量]] 与PSM配合使用&lt;br /&gt;
&lt;br /&gt;
*[[Stratified sampling|Stratification matching]]&lt;br /&gt;
&lt;br /&gt;
*[[Stratified sampling|分层匹配]]&lt;br /&gt;
&lt;br /&gt;
*Difference-in-differences matching (kernel and local linear weights)&lt;br /&gt;
&lt;br /&gt;
*&amp;lt;font color=&amp;quot;#32cd32&amp;quot;&amp;gt;双重差分匹配（核和局部线性加权）&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
*Exact matching&lt;br /&gt;
&lt;br /&gt;
*精确匹配&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
4. Verify that covariates are balanced across treatment and comparison groups in the matched or weighted sample&lt;br /&gt;
&lt;br /&gt;
4. Verify that covariates are balanced across treatment and comparison groups in the matched or weighted sample&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;4.【机器翻译】验证协变量是平衡的处理和对照组在匹配或加权样本&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
4. &amp;lt;font color=&amp;quot;#32cd32&amp;quot;&amp;gt;对比处理组和对照组的匹配样本或加权样本，验证协变量是否均衡&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
5. Multivariate analysis based on new sample&lt;br /&gt;
&lt;br /&gt;
5. Multivariate analysis based on new sample&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;5.【机器翻译】基于新样本的多变量分析&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
5. 基于新样本的多变量分析&lt;br /&gt;
&lt;br /&gt;
*Use analyses appropriate for non-independent matched samples if more than one nonparticipant is matched to each participant&lt;br /&gt;
&lt;br /&gt;
* 如果每个参与者都匹配了多个非参与者，则适当应用非独立匹配样本分析&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Note: When you have multiple matches for a single treated observation, it is essential to use Weighted Least Squares rather than Ordinary Least Squares.&lt;br /&gt;
&lt;br /&gt;
Note: When you have multiple matches for a single treated observation, it is essential to use Weighted Least Squares rather than Ordinary Least Squares.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】注意: 当你有多个匹配的单一处理的观察，它是必不可少的使用加权最小二乘而不是一般最小平方法。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
注意：当一个处理样本有多个匹配时，则必须用加权最小二乘法，而不能用普通最小二乘法。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
==Formal definitions==&lt;br /&gt;
&lt;br /&gt;
==形式定义 ==&lt;br /&gt;
&lt;br /&gt;
===Basic settings ===&lt;br /&gt;
&lt;br /&gt;
===基本设置===&lt;br /&gt;
&lt;br /&gt;
The basic case&amp;lt;ref name=&amp;quot;Rosenbaum 1983 41–55&amp;quot; /&amp;gt; is of two treatments (numbered 1 and 0), with ''N'' [Independent and identically distributed random variables|i.i.d] subjects. Each subject ''i'' would respond to the treatment with &amp;lt;math&amp;gt;r_{1i}&amp;lt;/math&amp;gt; and to the control with &amp;lt;math&amp;gt;r_{0i}&amp;lt;/math&amp;gt;. The quantity to be estimated is the [[average treatment effect]]: &amp;lt;math&amp;gt;E[r_1]-E[r_0]&amp;lt;/math&amp;gt;. The variable &amp;lt;math&amp;gt;Z_i&amp;lt;/math&amp;gt; indicates if subject ''i'' got treatment (''Z''&amp;amp;nbsp;=&amp;amp;nbsp;1) or control (''Z''&amp;amp;nbsp;=&amp;amp;nbsp;0). Let &amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt; be a vector of observed pretreatment measurement (or covariate) for the ''i''th subject. The observations of &amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt; are made prior to treatment assignment, but the features in &amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt; may not include all (or any) of the ones used to decide on the treatment assignment. The numbering of the units (i.e.: ''i''&amp;amp;nbsp;=&amp;amp;nbsp;1,&amp;amp;nbsp;...,&amp;amp;nbsp;''i''&amp;amp;nbsp;=&amp;amp;nbsp;''N'') are assumed to not contain any information beyond what is contained in &amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt;. The following sections will omit the ''i'' index while still discussing about the stochastic behavior of some subject.&lt;br /&gt;
&lt;br /&gt;
基本场景&amp;lt;ref name=&amp;quot;Rosenbaum 1983 41–55&amp;quot; /&amp;gt;是，有两种处理方式（分别记为1和0），''N''个[[Independent and identically distributed random variables|独立同分布]]个体。每个个体''i''如果接受了处理则响应为&amp;lt;math&amp;gt;r_{1i}&amp;lt;/math&amp;gt;，接受控制则响应为&amp;lt;math&amp;gt;r_{0i}&amp;lt;/math&amp;gt;。被估计量是[[average treatment effect|平均处理效应]]：&amp;lt;math&amp;gt;E[r_1]-E[r_0]&amp;lt;/math&amp;gt;。变量&amp;lt;math&amp;gt;Z_i&amp;lt;/math&amp;gt;指示个体''i''接受处理(''Z''&amp;amp;nbsp;=&amp;amp;nbsp;1)还是接受控制(''Z''&amp;amp;nbsp;=&amp;amp;nbsp;0)。让&amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt;代表第''i''个个体处理前观测值（或者协变量）的向量。对&amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt;的测量发生于处理前，但是&amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt;中也可以不包括那些决定是否接受处理的特征。单元编号（即：''i''&amp;amp;nbsp;=&amp;amp;nbsp;1,&amp;amp;nbsp;...,&amp;amp;nbsp;''i''&amp;amp;nbsp;=&amp;amp;nbsp;''N''）不包含任何&amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt;所包含信息之外的的信息。以下部分在讨论某些物体的随机行为的时候将省略索引''i''。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
===Strongly ignorable treatment assignment===&lt;br /&gt;
&lt;br /&gt;
===强可忽略处理分配===&lt;br /&gt;
&lt;br /&gt;
{{See also|Ignorability}}&lt;br /&gt;
&lt;br /&gt;
{{See also|可忽略性}}&lt;br /&gt;
&lt;br /&gt;
Let some subject have a vector of covariates ''X'' (i.e.: conditionally unconfounded), and some '''potential outcomes''' ''r''&amp;lt;sub&amp;gt;0&amp;lt;/sub&amp;gt; and ''r''&amp;lt;sub&amp;gt;1&amp;lt;/sub&amp;gt; under control and treatment, respectively. Treatment assignment is said to be '''strongly ignorable''' if the potential outcomes are [[statistical independence|independent]] of treatment (''Z'') conditional on background variables ''X''.  This can be written compactly as&lt;br /&gt;
&lt;br /&gt;
设某个物体有协变量''X''（即：条件非混杂变量）向量，以及对应着控制和处理两种情况的'''潜在结果'''''r''&amp;lt;sub&amp;gt;0&amp;lt;/sub&amp;gt;和''r''&amp;lt;sub&amp;gt;1&amp;lt;/sub&amp;gt;。如果潜在结果在给定背景变量''X''的条件下独立于处理举动（''Z''），则可以说样本是否接受处理分配是'''强可忽略'''的。可简洁表述为&lt;br /&gt;
&lt;br /&gt;
:&amp;lt;math&amp;gt; r_0, r_1 \perp Z \mid X &amp;lt;/math&amp;gt;&lt;br /&gt;
&lt;br /&gt;
这里&amp;lt;math&amp;gt;\perp&amp;lt;/math&amp;gt;代表[[statistical independence|统计独立]].&amp;lt;ref name=&amp;quot;Rosenbaum 1983 41–55&amp;quot; /&amp;gt;&lt;br /&gt;
&lt;br /&gt;
=== Balancing score===&lt;br /&gt;
&lt;br /&gt;
=== 平衡得分===&lt;br /&gt;
&lt;br /&gt;
A '''balancing score''' ''b''(''X'') is a function of the observed covariates ''X'' such that the [[conditional probability|conditional distribution]] of ''X'' given ''b''(''X'') is the same for treated (''Z''&amp;amp;nbsp;=&amp;amp;nbsp;1) and control (''Z''&amp;amp;nbsp;=&amp;amp;nbsp;0) units:&lt;br /&gt;
&lt;br /&gt;
A balancing score b(X) is a function of the observed covariates X such that the conditional distribution of X given b(X) is the same for treated (Z = 1) and control (Z = 0) units:&lt;br /&gt;
&lt;br /&gt;
平衡得分b(X)是观测协变量X的函数。在给定b(X)时，处理单元和控制单元的X有相同的条件分布：&lt;br /&gt;
&lt;br /&gt;
:&amp;lt;math&amp;gt; Z \perp X \mid b(X).&amp;lt;/math&amp;gt;&lt;br /&gt;
&lt;br /&gt;
最一般的平衡得分函数是&amp;lt;math&amp;gt; b(X) = X&amp;lt;/math&amp;gt;.&lt;br /&gt;
&lt;br /&gt;
===Propensity score===&lt;br /&gt;
&lt;br /&gt;
===倾向性评分 ===&lt;br /&gt;
&lt;br /&gt;
A '''propensity score''' is the [[probability]] of a unit (e.g., person, classroom, school) being assigned to a particular treatment given a set of observed covariates.  Propensity scores are used to reduce [[selection bias]] by equating groups based on these covariates.&lt;br /&gt;
&lt;br /&gt;
Suppose that we have a binary treatment [[Indicator function|indicator]] ''Z'', a response variable ''r'', and background observed covariates ''X''.  The propensity score is defined as the [[conditional probability]] of treatment given background variables:&lt;br /&gt;
&lt;br /&gt;
A propensity score is the probability of a unit (e.g., person, classroom, school) being assigned to a particular treatment given a set of observed covariates. Propensity scores are used to reduce selection bias by equating groups based on these covariates.&lt;br /&gt;
&lt;br /&gt;
Suppose that we have a binary treatment indicator Z, a response variable r, and background observed covariates X. The propensity score is defined as the conditional probability of treatment given background variables:&lt;br /&gt;
&lt;br /&gt;
倾向性评分是根据协变量观测值计算得出的一个单元（例如：个人，教室，学校）被指配接受特定处理的概率。通倾向性评分可用于让处理组和对照组的协变量趋同，从而减少选择偏差。&lt;br /&gt;
&lt;br /&gt;
假设有一个二值处理标识Z，一个响应变量r，以及被观测的背景协变量X。倾向性评分定义为，在给定背景变量条件下单元接受处理的条件概率：&lt;br /&gt;
&lt;br /&gt;
:&amp;lt;math&amp;gt;e(x) \ \stackrel{\mathrm{def}}{=}\  \Pr(Z=1 \mid X=x).&amp;lt;/math&amp;gt;&lt;br /&gt;
&lt;br /&gt;
In the context of [[causal inference]] and [[survey methodology]], propensity scores are estimated (via methods such as [[logistic regression]], [[random forests]], or others), using some set of covariates. These propensity scores are then used as estimators for weights to be used with [[Inverse probability weighting]] methods.&lt;br /&gt;
&lt;br /&gt;
In the context of causal inference and survey methodology, propensity scores are estimated (via methods such as logistic regression, random forests, or others), using some set of covariates. These propensity scores are then used as estimators for weights to be used with Inverse probability weighting methods.&lt;br /&gt;
&lt;br /&gt;
在因果推断和调查方法的范围内，通过Logistic回归、随机森林或其他方法，利用一组协变量估计倾向性评分。然后将这些倾向性评分即可作为权重估计量用于逆概率加权方法。&lt;br /&gt;
&lt;br /&gt;
===Main theorems===&lt;br /&gt;
&lt;br /&gt;
===主要定理===&lt;br /&gt;
&lt;br /&gt;
The following were first presented, and proven, by Rosenbaum and Rubin in 1983:&amp;lt;ref name=&amp;quot;Rosenbaum 1983 41–55&amp;quot; /&amp;gt;&lt;br /&gt;
&lt;br /&gt;
The following were first presented, and proven, by Rosenbaum and Rubin in 1983:[1]&lt;br /&gt;
&lt;br /&gt;
以下是Rosenbaum和Rubin于1983年首次提出并证明的：&amp;lt;ref name=&amp;quot;Rosenbaum 1983 41–55&amp;quot; /&amp;gt;&lt;br /&gt;
&lt;br /&gt;
*The propensity score &amp;lt;math&amp;gt;e(x)&amp;lt;/math&amp;gt; is a balancing score.&lt;br /&gt;
*倾向性评分&amp;lt;math&amp;gt;e(x)&amp;lt;/math&amp;gt;是平衡得分。&lt;br /&gt;
&lt;br /&gt;
*Any score that is 'finer' than the propensity score is a balancing score (i.e.: &amp;lt;math&amp;gt;e(X)=f(b(X))&amp;lt;/math&amp;gt; for some function ''f''). The propensity score is the coarsest balancing score function, as it takes a (possibly) multidimensional object (''X''&amp;lt;sub&amp;gt;''i''&amp;lt;/sub&amp;gt;) and transforms it into one dimension (although others, obviously, also exist), while &amp;lt;math&amp;gt;b(X)=X&amp;lt;/math&amp;gt; is the finest one.&lt;br /&gt;
*任何比倾向性评分更“精细”的得分都是平衡得分（即：对于函数''f''，&amp;lt;math&amp;gt;e(X)=f(b(X))&amp;lt;/math&amp;gt;）。倾向性评分是最粗粒度的平衡得分函数，因为它把一个（可能是）多维的对象（''X''&amp;lt;sub&amp;gt;''i''&amp;lt;/sub&amp;gt;）转换成只有一维（尽管其他维度显然也存在），而&amp;lt;math&amp;gt;b(X)=X&amp;lt;/math&amp;gt;则是最细粒度的平衡得分函数（保留全部维度）。&lt;br /&gt;
&lt;br /&gt;
*If treatment assignment is strongly ignorable given ''X'' then:&lt;br /&gt;
*如果对于给定的''X''，处理分配满足强可忽略条件，则：&lt;br /&gt;
&lt;br /&gt;
:*It is also strongly ignorable given any balancing function. Specifically, given the propensity score:&lt;br /&gt;
:* 给定任何的平衡函数，具体来说，给定倾向性评分，处理分配也是强可忽略的：&lt;br /&gt;
&lt;br /&gt;
:::&amp;lt;math&amp;gt; (r_0, r_1) \perp Z \mid e(X).&amp;lt;/math&amp;gt;&lt;br /&gt;
回归&lt;br /&gt;
:*For any value of a balancing score, the difference between the treatment and control means of the samples at hand (i.e.: &amp;lt;math&amp;gt;\bar{r}_1-\bar{r}_0&amp;lt;/math&amp;gt;), based on subjects that have the same value of the balancing score, can serve as an [[Bias of an estimator|unbiased estimator]] of the [[average treatment effect]]: &amp;lt;math&amp;gt;E[r_1]-E[r_0]&amp;lt;/math&amp;gt;.&lt;br /&gt;
:*对于有相同平衡得分值的处理样本和对照样本，它们响应变量均值之差（即：&amp;lt;math&amp;gt;\bar{r}_1-\bar{r}_0&amp;lt;/math&amp;gt;），可以作为[[average treatment effect|平均处理效应]]的[[Bias of an estimator|无偏估计量]]：&amp;lt;math&amp;gt;E[r_1]-E[r_0]&amp;lt;/math&amp;gt;。&lt;br /&gt;
&lt;br /&gt;
*Using sample estimates of balancing scores can produce sample balance on&amp;amp;nbsp;''X''&lt;br /&gt;
*利用平衡得分的样本估计可产生在X上均衡的样本&lt;br /&gt;
&lt;br /&gt;
===Relationship to sufficiency===&lt;br /&gt;
===与充分性的关系 ===&lt;br /&gt;
&lt;br /&gt;
If we think of the value of ''Z'' as a [[Statistical parameter|parameter]] of the population that impacts the distribution of ''X'' then the balancing score serves as a [[Sufficient_statistic#Mathematical_definition|sufficient statistic]] for ''Z''. Furthermore, the above theorems indicate that the propensity score is a [[Sufficient_statistic#Minimal_sufficiency|minimal sufficient statistic]] if thinking of ''Z'' as a parameter of ''X''. Lastly, if treatment assignment ''Z'' is strongly ignorable given ''X'' then the propensity score is a [[Sufficient_statistic#Minimal_sufficiency|minimal sufficient statistic]] for the joint distribution of &amp;lt;math&amp;gt;(r_0, r_1)&amp;lt;/math&amp;gt;.&lt;br /&gt;
&lt;br /&gt;
If we think of the value of Z as a parameter of the population that impacts the distribution of X then the balancing score serves as a sufficient statistic for Z. Furthermore, the above theorems indicate that the propensity score is a minimal sufficient statistic if thinking of Z as a parameter of X. Lastly, if treatment assignment Z is strongly ignorable given X then the propensity score is a minimal sufficient statistic for the joint distribution of {\displaystyle (r_{0},r_{1})}{\displaystyle (r_{0},r_{1})}.&lt;br /&gt;
&lt;br /&gt;
如果我们把''Z''的值想成影响''X''分布的群体参数，则平衡得分充当了''Z''的充分统计量。进一步，上述定理指出，如果把''Z''视为''X''的参数，则倾向性评分就是最小充分统计量。最后，给定''X''，如果''Z''是强可忽略的，则倾向性评分是&amp;lt;math&amp;gt;(r_0, r_1)&amp;lt;/math&amp;gt;联合分布的最小充分统计量。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
===Graphical test for detecting the presence of confounding variables===&lt;br /&gt;
===混杂变量的图检测方法===&lt;br /&gt;
&lt;br /&gt;
[[Judea Pearl]] has shown that there exists a simple graphical test, called the back-door criterion, which detects the presence of confounding variables. To estimate the effect of treatment, the background variables X must block all back-door paths in the graph. This blocking can be done either by adding the confounding variable as a control in regression, or by matching on the confounding variable.&amp;lt;ref name=&amp;quot;pearl&amp;quot;&amp;gt;{{cite book |last=Pearl |first=J. |year=2000 |title=Causality: Models, Reasoning, and Inference |url=https://archive.org/details/causalitymodelsr0000pear |url-access=registration |location=New York |publisher=Cambridge University Press |isbn=978-0-521-77362-1 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Judea Pearl has shown that there exists a simple graphical test, called the back-door criterion, which detects the presence of confounding variables. To estimate the effect of treatment, the background variables X must block all back-door paths in the graph. This blocking can be done either by adding the confounding variable as a control in regression, or by matching on the confounding variable.[2]&lt;br /&gt;
&lt;br /&gt;
朱迪亚·珀尔Judea Pearl已经表明存在一个简单的图检测方法，称为后门准则，它可以检测到混杂变量的存在。为了估计处理效果，背景变量X必须阻断图中的所有后门路径。通过把混杂变量加入回归的控制变量，或者在混杂变量上进行匹配可以实现后门路径的阻断。&lt;br /&gt;
&lt;br /&gt;
== Disadvantages==&lt;br /&gt;
== 缺点 ==&lt;br /&gt;
&lt;br /&gt;
PSM has been shown to increase model &amp;quot;imbalance, inefficiency, model dependence, and bias,&amp;quot; which is not the case with most other matching methods. The insights behind the use of matching still hold but should be applied with other matching methods; propensity scores also have other productive uses in weighting and doubly robust estimation.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】PSM 已经被证明会增加模型的“不平衡性、低效率、模型依赖性和偏差”，这与大多数其他匹配方法不同。使用匹配的见解仍然有效，但应该与其他匹配方法一起应用; 倾向得分在加权和双重稳健估计方面也有其他有益的用途。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
PSM已经被证明会加剧模型的“不平衡性、低效率、模型依赖性和偏差”，这与大多数其他匹配方法不同。匹配方法背后的见解仍然成立，但应该与其他匹配方法一起应用；倾向得分在加权和双重稳健估计方面也有其他有益的用途。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Like other matching procedures, PSM estimates an average treatment effect from observational data. The key advantages of PSM were, at the time of its introduction, that by using a linear combination of covariates for a single score, it balances treatment and control groups on a large number of covariates without losing a large number of observations. If units in the treatment and control were balanced on a large number of covariates one at a time, large numbers of observations would be needed to overcome the &amp;quot;dimensionality problem&amp;quot; whereby the introduction of a new balancing covariate increases the minimum necessary number of observations in the sample geometrically.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】与其他匹配程序一样，PSM 从观测数据中估计平均处理效果。在引入 PSM 的时候，它的主要优点是，通过使用一个线性组合的协变量作为一个单一的评分，它平衡了治疗组和对照组在大量的协变量上，而不会失去大量的观察数据。如果处理和控制中的单元在大量的协变量上一次平衡，就需要大量的观测数据来克服“维数问题”，即引入新的平衡协变量几何地增加样本中必要的最小观测数据。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
与其他匹配过程一样，PSM也是从观测数据中估计平均处理效应。在引入PSM之时，它的主要优点是，通过使用协变量的线性组合得到一个单一评分，以大量的协变量为基础平衡了处理组和对照组，却不大量损失观测数据。如果在有众多协变量的情况下，对每一个些变量都分别做处理单元和对照单元平衡的话，就需要大量的观测数据来克服”维度问题“，即，每引入一个新的平衡协变量都会在几何上增加最小所需的观测样本数量。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
One disadvantage of PSM is that it only accounts for observed (and observable) covariates and not latent characteristics. Factors that affect assignment to treatment and outcome but that cannot be observed cannot be accounted for in the matching procedure. As the procedure only controls for observed variables, any hidden bias due to latent variables may remain after matching. Another issue is that PSM requires large samples, with substantial overlap between treatment and control groups.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】PSM 的一个缺点是它只能解释观察到的(和可观察到的)协变量，而不能解释潜在的特征。影响治疗分配和结果但无法观察的因素不能在匹配程序中说明。由于程序只控制观察变量，任何隐藏的偏见由于潜在变量可能仍然匹配后。另一个问题是 PSM 需要大量的样本，治疗组和对照组之间有大量的重叠。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
PSM的一个缺点是它只能涵盖已观测的（和可观测的）协变量，而无法涵盖潜在变量。那些能影响处理分配却不可观测的因素无法被纳入匹配过程的考量范围。由于匹配过程只控制可观测变量，那些隐藏的偏差在匹配后依然可能存在。另一个问题是PSM还要求在大量样本中，在处理组和对照组之间有大量的重叠。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
General concerns with matching have also been raised by Judea Pearl, who has argued that hidden bias may actually increase because matching on observed variables may unleash bias due to dormant unobserved confounders. Similarly, Pearl has argued that bias reduction can only be assured (asymptotically) by modelling the qualitative causal relationships between treatment, outcome, observed and unobserved covariates. Confounding occurs when the experimenter is unable to control for alternative, non-causal explanations for an observed relationship between independent and dependent variables. Such control should satisfy the &amp;quot;backdoor criterion&amp;quot; of Pearl. It can also easily be implemented manually.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】朱迪亚 · 珀尔也提出了关于配对的普遍担忧，他认为隐性偏见实际上可能会增加，因为观察变量的配对可能会由于潜在的未观察混杂因素而释放出偏见。同样，珀尔认为，只有通过建立治疗、结果、观察和未观察协变量之间的定性因果关系模型，才能确保(渐近地)减少偏见。当实验者无法控制对独立变量和因变量之间观察到的关系的替代性、非因果性解释时，混淆就发生了。这种控制应满足珍珠的“后门规范”。它也可以很容易地手动实现。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Judea Pearl也提出了关于匹配方法的一般性担忧，他认为对可观测变量进行匹配可能会让那些原本处于休眠状态的混杂因素被释放，从而实际上可能加剧隐藏的偏差。同样，Pearl认为，只有通过对处理、结果、可观测和不可观测的协变量之间的定性因果关系进行建模，才能确保（渐进地）减少偏差。当试验者无法控制&amp;lt;font color=&amp;quot;#32cd32&amp;quot;&amp;gt;对独立变量和因变量之间观察到的关系的替代性、非因果性解释时&amp;lt;/font&amp;gt;，混杂就会发生。这样的控制应该满足Pearl的“后门准则”。它很容易手工实现。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&amp;lt;noinclude&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&amp;lt;small&amp;gt;This page was moved from [[wikipedia:en:Propensity score matching]]. Its edit history can be viewed at [[倾向性评分/edithistory]]&amp;lt;/small&amp;gt;&amp;lt;/noinclude&amp;gt;&lt;br /&gt;
&lt;br /&gt;
[[Category:待整理页面]]&lt;br /&gt;
&lt;br /&gt;
&amp;lt;references /&amp;gt;&lt;/div&gt;</summary>
		<author><name>李昊轩</name></author>
	</entry>
	<entry>
		<id>https://wiki.swarma.org/index.php?title=%E5%80%BE%E5%90%91%E5%BE%97%E5%88%86%E5%8C%B9%E9%85%8D&amp;diff=23563</id>
		<title>倾向得分匹配</title>
		<link rel="alternate" type="text/html" href="https://wiki.swarma.org/index.php?title=%E5%80%BE%E5%90%91%E5%BE%97%E5%88%86%E5%8C%B9%E9%85%8D&amp;diff=23563"/>
		<updated>2021-06-12T15:52:22Z</updated>

		<summary type="html">&lt;p&gt;李昊轩：校对至Formal definitions之前&lt;/p&gt;
&lt;hr /&gt;
&lt;div&gt;此词条暂由彩云小译翻译，翻译字数共893，未经人工整理和审校，带来阅读不便，请见谅。&lt;br /&gt;
&lt;br /&gt;
{{Short description|Statistical matching technique}}&lt;br /&gt;
&lt;br /&gt;
In the [[statistics|statistical]] analysis of [[observational study|observational data]], '''propensity score matching''' ('''PSM''') is a [[Matching (statistics)|statistical matching]] technique that attempts to [[Estimation theory|estimate]] the effect of a treatment, policy, or other intervention by accounting for the [[covariate]]s that predict receiving the treatment. PSM attempts to reduce the [[Bias (statistics)|bias]] due to [[confounding]] variables that could be found in an estimate of the treatment effect obtained from simply comparing outcomes among [[Statistical unit|units]] that [[Treatment and control groups|received the treatment versus those that did not]]. [[Paul R. Rosenbaum]] and [[Donald Rubin]] introduced the technique in 1983.&amp;lt;ref name=&amp;quot;Rosenbaum 1983 41–55&amp;quot;&amp;gt;{{cite journal |last=Rosenbaum |first=Paul R. |last2=Rubin |first2=Donald B. |title=The Central Role of the Propensity Score in Observational Studies for Causal Effects |journal=[[Biometrika]] |year=1983 |volume=70 |issue=1 |pages=41–55 |doi=10.1093/biomet/70.1.41 |doi-access=free }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
In the statistical analysis of observational data, propensity score matching (PSM) is a statistical matching technique that attempts to estimate the effect of a treatment, policy, or other intervention by accounting for the covariates that predict receiving the treatment. PSM attempts to reduce the bias due to confounding variables that could be found in an estimate of the treatment effect obtained from simply comparing outcomes among units that received the treatment versus those that did not. Paul R. Rosenbaum and Donald Rubin introduced the technique in 1983.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】在观察数据的统计分析中，倾向性评分匹配是一种统计匹配技术，它试图通过计算预测接受治疗的协变量来估计治疗、政策或其他干预的效果。PSM 试图减少由于混杂变量造成的偏倚，这些变量可以通过简单地比较接受治疗的单位和没有接受治疗的单位之间的结果来估计治疗效果。保罗 · 罗森鲍姆和唐纳德 · 鲁宾在1983年介绍了这项技术。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
在观察数据的统计分析中，倾向性评分匹配Propensity Score Matching (PSM)是一种用于估计治疗、政策或其他干预的效果统计匹配技术，方法是将协变量对样本“是否接受处理”的影响考虑在内。PSM试图减少由于混杂变量造成的偏倚。这些偏倚一般会在那些只对处理单元和对照单元的结果做简单对比的评估中出现。保罗·罗森鲍姆Paul R. Rosenbaum和唐纳德·鲁宾Donald Rubin在1983年介绍了这项技术。&lt;br /&gt;
&lt;br /&gt;
The possibility of bias arises because a difference in the treatment outcome (such as the [[average treatment effect]]) between treated and untreated groups may be caused by a factor that predicts treatment rather than the treatment itself. In [[randomized experiment]]s, the randomization enables unbiased estimation of treatment effects; for each covariate, randomization implies that treatment-groups will be balanced on average, by the [[law of large numbers]]. Unfortunately, for observational studies, the assignment of treatments to research subjects is typically not random. [[Matching (statistics)|Matching]] attempts to reduce the treatment assignment bias, and mimic randomization, by creating a sample of units that received the treatment that is comparable on all observed covariates to a sample of units that did not receive the treatment.&lt;br /&gt;
&lt;br /&gt;
The possibility of bias arises because a difference in the treatment outcome (such as the average treatment effect) between treated and untreated groups may be caused by a factor that predicts treatment rather than the treatment itself. In randomized experiments, the randomization enables unbiased estimation of treatment effects; for each covariate, randomization implies that treatment-groups will be balanced on average, by the law of large numbers. Unfortunately, for observational studies, the assignment of treatments to research subjects is typically not random. Matching attempts to reduce the treatment assignment bias, and mimic randomization, by creating a sample of units that received the treatment that is comparable on all observed covariates to a sample of units that did not receive the treatment.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】出现偏倚的可能性是因为治疗组和未治疗组之间治疗结果(如平均治疗效果)的差异可能是由预测治疗的因素而不是治疗本身造成的。在随机实验中，随机化可以对治疗效果进行无偏估计; 对于每个协变量，随机化意味着治疗组将按照大数定律在平均水平上达到平衡。不幸的是，对于观察性研究来说，对研究对象的治疗分配通常不是随机的。匹配试图减少处理分配偏差，并模拟随机化，通过创建一个样本单位接受的处理是可比的所有观察到的协变量的一个样本单位没有接受处理。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
出现偏倚的原因可能是某个因素通过决定样本是否接受处理而导致了处理组和对照组的效果（如平均处理效果）差异，而不是处理本身导致了差异。在随机实验中，随机化选择样本可以做到对处理效果的无偏估计，根据大数定律，随机化分配机制意味着每个协变量将在处理组和对照组中呈现类似的分布。不幸的是，对于观察性研究来说，研究对象通常不是随机接受处理的。匹配就是要减少对象非随机接受处理产生的偏倚，并模拟随机试验，方法是从处理组和对照组中分别取样，让两组样本的全部协变量都比较接近。&lt;br /&gt;
&lt;br /&gt;
For example, one may be interested to know the [[Health_effects_of_tobacco#Early_observational_studies|consequences of smoking]]. An observational study is required since it is unethical to randomly assign people to the treatment 'smoking.' The treatment effect estimated by simply comparing those who smoked to those who did not smoke would be biased by any factors that predict smoking (e.g.: gender and age). PSM attempts to control for these biases by making the groups receiving treatment and not-treatment comparable with respect to the control variables.&lt;br /&gt;
&lt;br /&gt;
For example, one may be interested to know the consequences of smoking. An observational study is required since it is unethical to randomly assign people to the treatment 'smoking.' The treatment effect estimated by simply comparing those who smoked to those who did not smoke would be biased by any factors that predict smoking (e.g.: gender and age). PSM attempts to control for these biases by making the groups receiving treatment and not-treatment comparable with respect to the control variables.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】例如，人们可能有兴趣知道吸烟的后果。因为随机分配患者接受‘吸烟’治疗是不道德的，所以需要一个观察性研究简单地比较吸烟者和不吸烟者的治疗效果会受到任何预测吸烟的因素的影响(例如:。: 性别及年龄)。PSM 试图通过使接受治疗和不接受治疗的组与控制变量相比较来控制这些偏差。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
例如，人们想知道吸烟的后果。但是随机分配让患者“吸烟”是不道德的，所以需要做一个观察性研究。简单地通过对比评估吸烟者和不吸烟者来估计平均处理效果将产生偏差，它会受到能影响吸烟行为的因素的影响（例如：性别及年龄）。PSM要做的是通过让处理组和对照组的控制变量尽量相似来达到控制这些偏差的目的。&lt;br /&gt;
&lt;br /&gt;
==Overview ==&lt;br /&gt;
&lt;br /&gt;
==综述==&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
PSM is for cases of [[Inductive reasoning#Causal inference|causal inference]] and simple selection bias in [[non-experimental]] settings in which: (i) few units in the non-treatment comparison group are comparable to the treatment units; and (ii) selecting a subset of comparison units similar to the treatment unit is difficult because units must be compared across a high-dimensional set of pretreatment characteristics.&lt;br /&gt;
&lt;br /&gt;
PSM is for cases of causal inference and simple selection bias in non-experimental settings in which: (i) few units in the non-treatment comparison group are comparable to the treatment units; and (ii) selecting a subset of comparison units similar to the treatment unit is difficult because units must be compared across a high-dimensional set of pretreatment characteristics.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】PSM 适用于非实验环境中因果推断和简单选择偏差的情况，其中: (i)非处理对照组中与处理单元可比的单元很少; (ii)选择与处理单元类似的比较单元子集很困难，因为必须跨一组高维预处理特征进行比较。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
PSM适用于非实验环境中因果推断和简单选择偏差的情况，其中: (i)对照组与处理组中的类似单元很少; (ii)选择与处理单元类似的对照单元集合很困难，因为必须对一组高维的协变量特征进行比较。&lt;br /&gt;
&lt;br /&gt;
In normal matching, single characteristics that distinguish treatment and control groups are matched in an attempt to make the groups more alike. But if the two groups do not have substantial overlap, then substantial [[Errors and residuals|error]] may be introduced. For example, if only the worst cases from the [[control group|untreated &amp;quot;comparison&amp;quot; group]] are compared to only the best cases from the [[treatment group]], the result may be [[regression toward the mean]], which may make the comparison group look better or worse than reality.&lt;br /&gt;
&lt;br /&gt;
In normal matching, single characteristics that distinguish treatment and control groups are matched in an attempt to make the groups more alike. But if the two groups do not have substantial overlap, then substantial error may be introduced. For example, if only the worst cases from the untreated &amp;quot;comparison&amp;quot; group are compared to only the best cases from the treatment group, the result may be regression toward the mean, which may make the comparison group look better or worse than reality.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】在正常的匹配中，区分治疗组和对照组的单一特征被匹配，试图使这些组更加相似。但是，如果这两个组没有实质性的重叠，那么可能会引入实质性的错误。例如，如果只将来自未经治疗的对照组的最差病例与来自治疗组的最好病例进行比较，结果可能是趋中回归，这可能使对照组看起来比实际情况更好或更糟。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
在常规的匹配机制中，对一组能够区分处理组和对照组的特征做匹配，以使两组的特征更加相似。但如果这两个组的特征没有显著的重叠，那么可能会引入实质性的错误。例如，拿对照组最糟的病例和处理组最好的病例进行比较，结果可能倾向于回归均值，这会让对照组看起来比实际情况更好或更糟。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
PSM employs a predicted probability of group membership—e.g., treatment versus control group—based on observed predictors, usually obtained from [[logistic regression]] to create a [[Impact evaluation#Counterfactual evaluation designs|counterfactual group]]. Propensity scores may be used for matching or as [[covariance|covariate]]s, alone or with other matching variables or covariates.&lt;br /&gt;
&lt;br /&gt;
PSM employs a predicted probability of group membership—e.g., treatment versus control group—based on observed predictors, usually obtained from logistic regression to create a counterfactual group. Propensity scores may be used for matching or as covariates, alone or with other matching variables or covariates.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】PSM 使用了一种预测的群体成员概率---- 例如，治疗组与控制组---- 基于观察预测，通常从 Logit模型获得来创造一个反事实的群体。倾向得分可用于匹配或作为协变量，单独或与其他匹配变量或协变量。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
PSM利用观察数据预测样本落入不同分组（例如，处理组与控制组）的概率，通常用Logistic回归方法，然后利用此概率创造一个反事实的群体。倾向性评分可用于匹配，也可作为协变量，可以单独使用，也可以与其他匹配变量或协变量一同使用。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
==General procedure==&lt;br /&gt;
&lt;br /&gt;
==一般步骤==&lt;br /&gt;
&lt;br /&gt;
1. Run [[logistic regression]]:&lt;br /&gt;
&lt;br /&gt;
1. Run logistic regression:&lt;br /&gt;
&lt;br /&gt;
1. 做Logistic回归：&lt;br /&gt;
&lt;br /&gt;
*Dependent variable: ''Z'' = 1, if unit participated (i.e. is member of the treatment group); ''Z'' = 0, if unit did not participate (i.e. is member of the control group).&lt;br /&gt;
&lt;br /&gt;
*因变量：参与处理（属于处理组），则''Z'' = 1；未参与处理（属于对照组），则''Z'' = 0。&lt;br /&gt;
&lt;br /&gt;
*Choose appropriate confounders (variables hypothesized to be associated with both treatment and outcome)&lt;br /&gt;
&lt;br /&gt;
*选择合适的混杂因素（既影响处理方式又影响处理结果的变量）&lt;br /&gt;
&lt;br /&gt;
*Obtain an [[Estimator|estimation]] for the propensity score: predicted probability (''p'') or log[''p''/(1&amp;amp;nbsp;−&amp;amp;nbsp;''p'')].&lt;br /&gt;
&lt;br /&gt;
*计算倾向性评分的[[Estimator|估计量]]：预测概率(''p'')或log[''p''/(1&amp;amp;nbsp;−&amp;amp;nbsp;''p'')]。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
2. Check that covariates are balanced across treatment and comparison groups within strata of the propensity score.&lt;br /&gt;
&lt;br /&gt;
2. Check that covariates are balanced across treatment and comparison groups within strata of the propensity score.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;2. 【机器翻译】检查协变量是平衡的治疗和比较组内的倾向分层。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
2. 依照倾向性评分的估计量进行分层，&amp;lt;font color=&amp;quot;#32cd32&amp;quot;&amp;gt;检查协变量的倾向性评分的估计量在每层处理组和对照组是否均衡&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
*Use standardized differences or graphs to examine distributions&lt;br /&gt;
&lt;br /&gt;
*使用标准化差异指标或者图形来检验分布情况&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
3. Match each participant to one or more nonparticipants on propensity score, using one of these methods:&lt;br /&gt;
&lt;br /&gt;
3. Match each participant to one or more nonparticipants on propensity score, using one of these methods:&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;3. 【机器翻译】根据倾向得分，将每个参与者与一个或多个非参与者进行匹配，使用以下方法之一:&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
3. 根据倾向性评分的估计量，将每个处理组个体与一个或多个对照组个体进行匹配，使用以下方法之一：&lt;br /&gt;
&lt;br /&gt;
*[[Nearest neighbor search|Nearest neighbor matching]]&lt;br /&gt;
&lt;br /&gt;
*[[Nearest neighbor search|最近邻匹配]]&lt;br /&gt;
&lt;br /&gt;
*Caliper matching: comparison units within a certain width of the propensity score of the treated units get matched, where the width is generally a fraction of the standard deviation of the propensity score&lt;br /&gt;
&lt;br /&gt;
*卡钳匹配：在处理单元倾向性评分的一个范围内选取对照单元，范围的宽度通常用倾向性评分的标准差乘上一个比例值&lt;br /&gt;
&lt;br /&gt;
*[[Mahalanobis distance|Mahalanobis metric]] matching in conjunction with PSM&lt;br /&gt;
&lt;br /&gt;
*[[Mahalanobis distance|马氏度量]] 与PSM配合使用&lt;br /&gt;
&lt;br /&gt;
*[[Stratified sampling|Stratification matching]]&lt;br /&gt;
&lt;br /&gt;
*[[Stratified sampling|分层匹配]]&lt;br /&gt;
&lt;br /&gt;
*Difference-in-differences matching (kernel and local linear weights)&lt;br /&gt;
&lt;br /&gt;
*&amp;lt;font color=&amp;quot;#32cd32&amp;quot;&amp;gt;双重差分匹配（核和局部线性加权）&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
*Exact matching&lt;br /&gt;
&lt;br /&gt;
*精确匹配&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
4. Verify that covariates are balanced across treatment and comparison groups in the matched or weighted sample&lt;br /&gt;
&lt;br /&gt;
4. Verify that covariates are balanced across treatment and comparison groups in the matched or weighted sample&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;4.【机器翻译】验证协变量是平衡的处理和对照组在匹配或加权样本&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
4. &amp;lt;font color=&amp;quot;#32cd32&amp;quot;&amp;gt;对比处理组和对照组的匹配样本或加权样本，验证协变量是否均衡&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
5. Multivariate analysis based on new sample&lt;br /&gt;
&lt;br /&gt;
5. Multivariate analysis based on new sample&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;5.【机器翻译】基于新样本的多变量分析&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
5. 基于新样本的多变量分析&lt;br /&gt;
&lt;br /&gt;
*Use analyses appropriate for non-independent matched samples if more than one nonparticipant is matched to each participant&lt;br /&gt;
&lt;br /&gt;
* 如果每个参与者都匹配了多个非参与者，则适当应用非独立匹配样本分析&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Note: When you have multiple matches for a single treated observation, it is essential to use Weighted Least Squares rather than Ordinary Least Squares.&lt;br /&gt;
&lt;br /&gt;
Note: When you have multiple matches for a single treated observation, it is essential to use Weighted Least Squares rather than Ordinary Least Squares.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】注意: 当你有多个匹配的单一处理的观察，它是必不可少的使用加权最小二乘而不是一般最小平方法。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
注意：当一个处理样本有多个匹配时，则必须用加权最小二乘法，而不能用普通最小二乘法。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
==Formal definitions==&lt;br /&gt;
&lt;br /&gt;
==形式定义 ==&lt;br /&gt;
&lt;br /&gt;
===Basic settings ===&lt;br /&gt;
&lt;br /&gt;
===基本设置===&lt;br /&gt;
&lt;br /&gt;
The basic case&amp;lt;ref name=&amp;quot;Rosenbaum 1983 41–55&amp;quot; /&amp;gt; is of two treatments (numbered 1 and 0), with ''N'' [Independent and identically distributed random variables|i.i.d] subjects. Each subject ''i'' would respond to the treatment with &amp;lt;math&amp;gt;r_{1i}&amp;lt;/math&amp;gt; and to the control with &amp;lt;math&amp;gt;r_{0i}&amp;lt;/math&amp;gt;. The quantity to be estimated is the [[average treatment effect]]: &amp;lt;math&amp;gt;E[r_1]-E[r_0]&amp;lt;/math&amp;gt;. The variable &amp;lt;math&amp;gt;Z_i&amp;lt;/math&amp;gt; indicates if subject ''i'' got treatment (''Z''&amp;amp;nbsp;=&amp;amp;nbsp;1) or control (''Z''&amp;amp;nbsp;=&amp;amp;nbsp;0). Let &amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt; be a vector of observed pretreatment measurement (or covariate) for the ''i''th subject. The observations of &amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt; are made prior to treatment assignment, but the features in &amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt; may not include all (or any) of the ones used to decide on the treatment assignment. The numbering of the units (i.e.: ''i''&amp;amp;nbsp;=&amp;amp;nbsp;1,&amp;amp;nbsp;...,&amp;amp;nbsp;''i''&amp;amp;nbsp;=&amp;amp;nbsp;''N'') are assumed to not contain any information beyond what is contained in &amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt;. The following sections will omit the ''i'' index while still discussing about the stochastic behavior of some subject.&lt;br /&gt;
&lt;br /&gt;
基本场景&amp;lt;ref name=&amp;quot;Rosenbaum 1983 41–55&amp;quot; /&amp;gt;是，有两种处理方式（分别记为1和0），''N''个[[Independent and identically distributed random variables|独立同分布]]物体。每个物体''i''如果接受了处理则响应为&amp;lt;math&amp;gt;r_{1i}&amp;lt;/math&amp;gt;，接受控制则响应为&amp;lt;math&amp;gt;r_{0i}&amp;lt;/math&amp;gt;。被估计量是[[average treatment effect|平均处理效应]]：&amp;lt;math&amp;gt;E[r_1]-E[r_0]&amp;lt;/math&amp;gt;。变量&amp;lt;math&amp;gt;Z_i&amp;lt;/math&amp;gt;指示物体''i''接受处理(''Z''&amp;amp;nbsp;=&amp;amp;nbsp;1)还是接受控制(''Z''&amp;amp;nbsp;=&amp;amp;nbsp;0)。让&amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt;代表第''i''个物体处理前观测值（或者协变量）的向量。对&amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt;的测量发生于处理前，但是&amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt;中也可以不包括那些决定是否接受处理的特征。单元编号（即：''i''&amp;amp;nbsp;=&amp;amp;nbsp;1,&amp;amp;nbsp;...,&amp;amp;nbsp;''i''&amp;amp;nbsp;=&amp;amp;nbsp;''N''）不包含任何&amp;lt;math&amp;gt;X_i&amp;lt;/math&amp;gt;所包含信息之外的的信息。以下部分在讨论某些物体的随机行为的时候将省略索引''i''。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
===Strongly ignorable treatment assignment===&lt;br /&gt;
&lt;br /&gt;
===强可忽略处理分配===&lt;br /&gt;
&lt;br /&gt;
{{See also|Ignorability}}&lt;br /&gt;
&lt;br /&gt;
{{See also|可忽略性}}&lt;br /&gt;
&lt;br /&gt;
Let some subject have a vector of covariates ''X'' (i.e.: conditionally unconfounded), and some '''potential outcomes''' ''r''&amp;lt;sub&amp;gt;0&amp;lt;/sub&amp;gt; and ''r''&amp;lt;sub&amp;gt;1&amp;lt;/sub&amp;gt; under control and treatment, respectively. Treatment assignment is said to be '''strongly ignorable''' if the potential outcomes are [[statistical independence|independent]] of treatment (''Z'') conditional on background variables ''X''.  This can be written compactly as&lt;br /&gt;
&lt;br /&gt;
设某个物体有协变量''X''（即：条件非混杂变量）向量，以及对应着控制和处理两种情况的'''潜在结果'''''r''&amp;lt;sub&amp;gt;0&amp;lt;/sub&amp;gt;和''r''&amp;lt;sub&amp;gt;1&amp;lt;/sub&amp;gt;。如果潜在结果在给定背景变量''X''的条件下独立于处理举动（''Z''），则可以说样本是否接受处理分配是'''强可忽略'''的。可简洁表述为&lt;br /&gt;
&lt;br /&gt;
:&amp;lt;math&amp;gt; r_0, r_1 \perp Z \mid X &amp;lt;/math&amp;gt;&lt;br /&gt;
&lt;br /&gt;
这里&amp;lt;math&amp;gt;\perp&amp;lt;/math&amp;gt;代表[[statistical independence|统计独立]].&amp;lt;ref name=&amp;quot;Rosenbaum 1983 41–55&amp;quot; /&amp;gt;&lt;br /&gt;
&lt;br /&gt;
=== Balancing score===&lt;br /&gt;
&lt;br /&gt;
=== 平衡得分===&lt;br /&gt;
&lt;br /&gt;
A '''balancing score''' ''b''(''X'') is a function of the observed covariates ''X'' such that the [[conditional probability|conditional distribution]] of ''X'' given ''b''(''X'') is the same for treated (''Z''&amp;amp;nbsp;=&amp;amp;nbsp;1) and control (''Z''&amp;amp;nbsp;=&amp;amp;nbsp;0) units:&lt;br /&gt;
&lt;br /&gt;
A balancing score b(X) is a function of the observed covariates X such that the conditional distribution of X given b(X) is the same for treated (Z = 1) and control (Z = 0) units:&lt;br /&gt;
&lt;br /&gt;
平衡得分b(X)是观测协变量X的函数。在给定b(X)时，处理单元和控制单元的X有相同的条件分布：&lt;br /&gt;
&lt;br /&gt;
:&amp;lt;math&amp;gt; Z \perp X \mid b(X).&amp;lt;/math&amp;gt;&lt;br /&gt;
&lt;br /&gt;
最一般的平衡得分函数是&amp;lt;math&amp;gt; b(X) = X&amp;lt;/math&amp;gt;.&lt;br /&gt;
&lt;br /&gt;
===Propensity score===&lt;br /&gt;
&lt;br /&gt;
===倾向性评分 ===&lt;br /&gt;
&lt;br /&gt;
A '''propensity score''' is the [[probability]] of a unit (e.g., person, classroom, school) being assigned to a particular treatment given a set of observed covariates.  Propensity scores are used to reduce [[selection bias]] by equating groups based on these covariates.&lt;br /&gt;
&lt;br /&gt;
Suppose that we have a binary treatment [[Indicator function|indicator]] ''Z'', a response variable ''r'', and background observed covariates ''X''.  The propensity score is defined as the [[conditional probability]] of treatment given background variables:&lt;br /&gt;
&lt;br /&gt;
A propensity score is the probability of a unit (e.g., person, classroom, school) being assigned to a particular treatment given a set of observed covariates. Propensity scores are used to reduce selection bias by equating groups based on these covariates.&lt;br /&gt;
&lt;br /&gt;
Suppose that we have a binary treatment indicator Z, a response variable r, and background observed covariates X. The propensity score is defined as the conditional probability of treatment given background variables:&lt;br /&gt;
&lt;br /&gt;
倾向性评分是根据协变量观测值计算得出的一个单元（例如：个人，教室，学校）被指配接受特定处理的概率。通倾向性评分可用于让处理组和对照组的协变量趋同，从而减少选择偏差。&lt;br /&gt;
&lt;br /&gt;
假设有一个二值处理标识Z，一个响应变量r，以及被观测的背景协变量X。倾向性评分定义为，在给定背景变量条件下单元接受处理的条件概率：&lt;br /&gt;
&lt;br /&gt;
:&amp;lt;math&amp;gt;e(x) \ \stackrel{\mathrm{def}}{=}\  \Pr(Z=1 \mid X=x).&amp;lt;/math&amp;gt;&lt;br /&gt;
&lt;br /&gt;
In the context of [[causal inference]] and [[survey methodology]], propensity scores are estimated (via methods such as [[logistic regression]], [[random forests]], or others), using some set of covariates. These propensity scores are then used as estimators for weights to be used with [[Inverse probability weighting]] methods.&lt;br /&gt;
&lt;br /&gt;
In the context of causal inference and survey methodology, propensity scores are estimated (via methods such as logistic regression, random forests, or others), using some set of covariates. These propensity scores are then used as estimators for weights to be used with Inverse probability weighting methods.&lt;br /&gt;
&lt;br /&gt;
在因果推断和调查方法的范围内，通过Logistic回归、随机森林或其他方法，利用一组协变量估计倾向性评分。然后将这些倾向性评分即可作为权重估计量用于逆概率加权方法。&lt;br /&gt;
&lt;br /&gt;
===Main theorems===&lt;br /&gt;
&lt;br /&gt;
===主要定理===&lt;br /&gt;
&lt;br /&gt;
The following were first presented, and proven, by Rosenbaum and Rubin in 1983:&amp;lt;ref name=&amp;quot;Rosenbaum 1983 41–55&amp;quot; /&amp;gt;&lt;br /&gt;
&lt;br /&gt;
The following were first presented, and proven, by Rosenbaum and Rubin in 1983:[1]&lt;br /&gt;
&lt;br /&gt;
以下是Rosenbaum和Rubin于1983年首次提出并证明的：&amp;lt;ref name=&amp;quot;Rosenbaum 1983 41–55&amp;quot; /&amp;gt;&lt;br /&gt;
&lt;br /&gt;
*The propensity score &amp;lt;math&amp;gt;e(x)&amp;lt;/math&amp;gt; is a balancing score.&lt;br /&gt;
*倾向性评分&amp;lt;math&amp;gt;e(x)&amp;lt;/math&amp;gt;是平衡得分。&lt;br /&gt;
&lt;br /&gt;
*Any score that is 'finer' than the propensity score is a balancing score (i.e.: &amp;lt;math&amp;gt;e(X)=f(b(X))&amp;lt;/math&amp;gt; for some function ''f''). The propensity score is the coarsest balancing score function, as it takes a (possibly) multidimensional object (''X''&amp;lt;sub&amp;gt;''i''&amp;lt;/sub&amp;gt;) and transforms it into one dimension (although others, obviously, also exist), while &amp;lt;math&amp;gt;b(X)=X&amp;lt;/math&amp;gt; is the finest one.&lt;br /&gt;
*任何比倾向性评分更“精细”的得分都是平衡得分（即：对于函数''f''，&amp;lt;math&amp;gt;e(X)=f(b(X))&amp;lt;/math&amp;gt;）。倾向性评分是最粗粒度的平衡得分函数，因为它把一个（可能是）多维的对象（''X''&amp;lt;sub&amp;gt;''i''&amp;lt;/sub&amp;gt;）转换成只有一维（尽管其他维度显然也存在），而&amp;lt;math&amp;gt;b(X)=X&amp;lt;/math&amp;gt;则是最细粒度的平衡得分函数（保留全部维度）。&lt;br /&gt;
&lt;br /&gt;
*If treatment assignment is strongly ignorable given ''X'' then:&lt;br /&gt;
*如果对于给定的''X''，处理分配满足强可忽略条件，则：&lt;br /&gt;
&lt;br /&gt;
:*It is also strongly ignorable given any balancing function. Specifically, given the propensity score:&lt;br /&gt;
:* 给定任何的平衡函数，具体来说，给定倾向性评分，处理分配也是强可忽略的：&lt;br /&gt;
&lt;br /&gt;
:::&amp;lt;math&amp;gt; (r_0, r_1) \perp Z \mid e(X).&amp;lt;/math&amp;gt;&lt;br /&gt;
回归&lt;br /&gt;
:*For any value of a balancing score, the difference between the treatment and control means of the samples at hand (i.e.: &amp;lt;math&amp;gt;\bar{r}_1-\bar{r}_0&amp;lt;/math&amp;gt;), based on subjects that have the same value of the balancing score, can serve as an [[Bias of an estimator|unbiased estimator]] of the [[average treatment effect]]: &amp;lt;math&amp;gt;E[r_1]-E[r_0]&amp;lt;/math&amp;gt;.&lt;br /&gt;
:*对于有相同平衡得分值的处理样本和对照样本，它们响应变量均值之差（即：&amp;lt;math&amp;gt;\bar{r}_1-\bar{r}_0&amp;lt;/math&amp;gt;），可以作为[[average treatment effect|平均处理效应]]的[[Bias of an estimator|无偏估计量]]：&amp;lt;math&amp;gt;E[r_1]-E[r_0]&amp;lt;/math&amp;gt;。&lt;br /&gt;
&lt;br /&gt;
*Using sample estimates of balancing scores can produce sample balance on&amp;amp;nbsp;''X''&lt;br /&gt;
*利用平衡得分的样本估计可产生在X上均衡的样本&lt;br /&gt;
&lt;br /&gt;
===Relationship to sufficiency===&lt;br /&gt;
===与充分性的关系 ===&lt;br /&gt;
&lt;br /&gt;
If we think of the value of ''Z'' as a [[Statistical parameter|parameter]] of the population that impacts the distribution of ''X'' then the balancing score serves as a [[Sufficient_statistic#Mathematical_definition|sufficient statistic]] for ''Z''. Furthermore, the above theorems indicate that the propensity score is a [[Sufficient_statistic#Minimal_sufficiency|minimal sufficient statistic]] if thinking of ''Z'' as a parameter of ''X''. Lastly, if treatment assignment ''Z'' is strongly ignorable given ''X'' then the propensity score is a [[Sufficient_statistic#Minimal_sufficiency|minimal sufficient statistic]] for the joint distribution of &amp;lt;math&amp;gt;(r_0, r_1)&amp;lt;/math&amp;gt;.&lt;br /&gt;
&lt;br /&gt;
If we think of the value of Z as a parameter of the population that impacts the distribution of X then the balancing score serves as a sufficient statistic for Z. Furthermore, the above theorems indicate that the propensity score is a minimal sufficient statistic if thinking of Z as a parameter of X. Lastly, if treatment assignment Z is strongly ignorable given X then the propensity score is a minimal sufficient statistic for the joint distribution of {\displaystyle (r_{0},r_{1})}{\displaystyle (r_{0},r_{1})}.&lt;br /&gt;
&lt;br /&gt;
如果我们把''Z''的值想成影响''X''分布的群体参数，则平衡得分充当了''Z''的充分统计量。进一步，上述定理指出，如果把''Z''视为''X''的参数，则倾向性评分就是最小充分统计量。最后，给定''X''，如果''Z''是强可忽略的，则倾向性评分是&amp;lt;math&amp;gt;(r_0, r_1)&amp;lt;/math&amp;gt;联合分布的最小充分统计量。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
===Graphical test for detecting the presence of confounding variables===&lt;br /&gt;
===混杂变量的图检测方法===&lt;br /&gt;
&lt;br /&gt;
[[Judea Pearl]] has shown that there exists a simple graphical test, called the back-door criterion, which detects the presence of confounding variables. To estimate the effect of treatment, the background variables X must block all back-door paths in the graph. This blocking can be done either by adding the confounding variable as a control in regression, or by matching on the confounding variable.&amp;lt;ref name=&amp;quot;pearl&amp;quot;&amp;gt;{{cite book |last=Pearl |first=J. |year=2000 |title=Causality: Models, Reasoning, and Inference |url=https://archive.org/details/causalitymodelsr0000pear |url-access=registration |location=New York |publisher=Cambridge University Press |isbn=978-0-521-77362-1 }}&amp;lt;/ref&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Judea Pearl has shown that there exists a simple graphical test, called the back-door criterion, which detects the presence of confounding variables. To estimate the effect of treatment, the background variables X must block all back-door paths in the graph. This blocking can be done either by adding the confounding variable as a control in regression, or by matching on the confounding variable.[2]&lt;br /&gt;
&lt;br /&gt;
朱迪亚·珀尔Judea Pearl已经表明存在一个简单的图检测方法，称为后门准则，它可以检测到混杂变量的存在。为了估计处理效果，背景变量X必须阻断图中的所有后门路径。通过把混杂变量加入回归的控制变量，或者在混杂变量上进行匹配可以实现后门路径的阻断。&lt;br /&gt;
&lt;br /&gt;
== Disadvantages==&lt;br /&gt;
== 缺点 ==&lt;br /&gt;
&lt;br /&gt;
PSM has been shown to increase model &amp;quot;imbalance, inefficiency, model dependence, and bias,&amp;quot; which is not the case with most other matching methods. The insights behind the use of matching still hold but should be applied with other matching methods; propensity scores also have other productive uses in weighting and doubly robust estimation.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】PSM 已经被证明会增加模型的“不平衡性、低效率、模型依赖性和偏差”，这与大多数其他匹配方法不同。使用匹配的见解仍然有效，但应该与其他匹配方法一起应用; 倾向得分在加权和双重稳健估计方面也有其他有益的用途。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
PSM已经被证明会加剧模型的“不平衡性、低效率、模型依赖性和偏差”，这与大多数其他匹配方法不同。匹配方法背后的见解仍然成立，但应该与其他匹配方法一起应用；倾向得分在加权和双重稳健估计方面也有其他有益的用途。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
Like other matching procedures, PSM estimates an average treatment effect from observational data. The key advantages of PSM were, at the time of its introduction, that by using a linear combination of covariates for a single score, it balances treatment and control groups on a large number of covariates without losing a large number of observations. If units in the treatment and control were balanced on a large number of covariates one at a time, large numbers of observations would be needed to overcome the &amp;quot;dimensionality problem&amp;quot; whereby the introduction of a new balancing covariate increases the minimum necessary number of observations in the sample geometrically.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】与其他匹配程序一样，PSM 从观测数据中估计平均处理效果。在引入 PSM 的时候，它的主要优点是，通过使用一个线性组合的协变量作为一个单一的评分，它平衡了治疗组和对照组在大量的协变量上，而不会失去大量的观察数据。如果处理和控制中的单元在大量的协变量上一次平衡，就需要大量的观测数据来克服“维数问题”，即引入新的平衡协变量几何地增加样本中必要的最小观测数据。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
与其他匹配过程一样，PSM也是从观测数据中估计平均处理效应。在引入PSM之时，它的主要优点是，通过使用协变量的线性组合得到一个单一评分，以大量的协变量为基础平衡了处理组和对照组，却不大量损失观测数据。如果在有众多协变量的情况下，对每一个些变量都分别做处理单元和对照单元平衡的话，就需要大量的观测数据来克服”维度问题“，即，每引入一个新的平衡协变量都会在几何上增加最小所需的观测样本数量。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
One disadvantage of PSM is that it only accounts for observed (and observable) covariates and not latent characteristics. Factors that affect assignment to treatment and outcome but that cannot be observed cannot be accounted for in the matching procedure. As the procedure only controls for observed variables, any hidden bias due to latent variables may remain after matching. Another issue is that PSM requires large samples, with substantial overlap between treatment and control groups.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】PSM 的一个缺点是它只能解释观察到的(和可观察到的)协变量，而不能解释潜在的特征。影响治疗分配和结果但无法观察的因素不能在匹配程序中说明。由于程序只控制观察变量，任何隐藏的偏见由于潜在变量可能仍然匹配后。另一个问题是 PSM 需要大量的样本，治疗组和对照组之间有大量的重叠。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
PSM的一个缺点是它只能涵盖已观测的（和可观测的）协变量，而无法涵盖潜在变量。那些能影响处理分配却不可观测的因素无法被纳入匹配过程的考量范围。由于匹配过程只控制可观测变量，那些隐藏的偏差在匹配后依然可能存在。另一个问题是PSM还要求在大量样本中，在处理组和对照组之间有大量的重叠。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
General concerns with matching have also been raised by Judea Pearl, who has argued that hidden bias may actually increase because matching on observed variables may unleash bias due to dormant unobserved confounders. Similarly, Pearl has argued that bias reduction can only be assured (asymptotically) by modelling the qualitative causal relationships between treatment, outcome, observed and unobserved covariates. Confounding occurs when the experimenter is unable to control for alternative, non-causal explanations for an observed relationship between independent and dependent variables. Such control should satisfy the &amp;quot;backdoor criterion&amp;quot; of Pearl. It can also easily be implemented manually.&lt;br /&gt;
&lt;br /&gt;
&amp;lt;font color=&amp;quot;#aaaaaaa&amp;quot;&amp;gt;【机器翻译】朱迪亚 · 珀尔也提出了关于配对的普遍担忧，他认为隐性偏见实际上可能会增加，因为观察变量的配对可能会由于潜在的未观察混杂因素而释放出偏见。同样，珀尔认为，只有通过建立治疗、结果、观察和未观察协变量之间的定性因果关系模型，才能确保(渐近地)减少偏见。当实验者无法控制对独立变量和因变量之间观察到的关系的替代性、非因果性解释时，混淆就发生了。这种控制应满足珍珠的“后门规范”。它也可以很容易地手动实现。&amp;lt;/font&amp;gt;&lt;br /&gt;
&lt;br /&gt;
Judea Pearl也提出了关于匹配方法的一般性担忧，他认为对可观测变量进行匹配可能会让那些原本处于休眠状态的混杂因素被释放，从而实际上可能加剧隐藏的偏差。同样，Pearl认为，只有通过对处理、结果、可观测和不可观测的协变量之间的定性因果关系进行建模，才能确保（渐进地）减少偏差。当试验者无法控制&amp;lt;font color=&amp;quot;#32cd32&amp;quot;&amp;gt;对独立变量和因变量之间观察到的关系的替代性、非因果性解释时&amp;lt;/font&amp;gt;，混杂就会发生。这样的控制应该满足Pearl的“后门准则”。它很容易手工实现。&lt;br /&gt;
&lt;br /&gt;
&lt;br /&gt;
&amp;lt;noinclude&amp;gt;&lt;br /&gt;
&lt;br /&gt;
&amp;lt;small&amp;gt;This page was moved from [[wikipedia:en:Propensity score matching]]. Its edit history can be viewed at [[倾向性评分/edithistory]]&amp;lt;/small&amp;gt;&amp;lt;/noinclude&amp;gt;&lt;br /&gt;
&lt;br /&gt;
[[Category:待整理页面]]&lt;br /&gt;
&lt;br /&gt;
&amp;lt;references /&amp;gt;&lt;/div&gt;</summary>
		<author><name>李昊轩</name></author>
	</entry>
</feed>