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第345行： − + − + − Like all statistical methods, RCTs are subject to both type I ("false positive") and type II ("false negative") 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 "negative" 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.+ − 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.+ 第364行：
第364行： − 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:+ − + − + − + − + 第376行：
第376行： − Notable RCTs with unexpected results that contributed to changes in clinical practice include:+ − + − + − − + + 第396行：
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第413行： − 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。+ − − + + + + + + 第430行：
第444行： + + + + + + + + + + + + + + + + + + + − + − Category:Clinical research
无编辑摘要
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:
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:
* 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.
* 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。
* 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.
* 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%。
=== Interpretation of statistical results ===
=== Interpretation of statistical results ===
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。
=== Peer review ===
=== Peer review ===
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。
== Advantages ==
== Advantages ==
* For issues involving "Therapy/Prevention, Aetiology/Harm", the [[Oxford Centre for Evidence-based Medicine]] as of 2011 defined "Level 1a" evidence as a systematic review of RCTs that are consistent with each other, and "Level 1b" evidence as an "individual RCT (with narrow [[Confidence Interval]])."<ref>{{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}}</ref>
* For issues involving "Therapy/Prevention, Aetiology/Harm", the [[Oxford Centre for Evidence-based Medicine]] as of 2011 defined "Level 1a" evidence as a systematic review of RCTs that are consistent with each other, and "Level 1b" evidence as an "individual RCT (with narrow [[Confidence Interval]])."<ref>{{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}}</ref>
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:
* As of 1998, the National Health and Medical Research Council of Australia designated "Level I" evidence as that "obtained from a systematic review of all relevant randomised controlled trials" and "Level II" evidence as that "obtained from at least one properly designed randomised controlled trial."
* 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”
* 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 "evidence obtained from at least one properly randomized controlled trial" with good internal validity (i.e., a rating of "I-good") as the highest quality evidence available to it.
* 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。
* The GRADE Working Group concluded in 2008 that "randomised trials without important limitations constitute high quality evidence."
* 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。”
* For issues involving "Therapy/Prevention, Aetiology/Harm", the Oxford Centre for Evidence-based Medicine as of 2011 defined "Level 1a" evidence as a systematic review of RCTs that are consistent with each other, and "Level 1b" evidence as an "individual RCT (with narrow Confidence Interval)."
* 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)。”
* 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]].<ref name="Rubin-2006"/> 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.<ref name="Rossouw-2002"/><ref name="Anderson-2004">{{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 }}</ref> 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.<ref name="Grodstein-2003">{{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 }}</ref><ref name="Vandenbroucke-2009">{{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 }}</ref> The use of hormone replacement therapy decreased after publication of the RCTs.<ref name="Hsu-2009">{{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}}</ref>
* 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]].<ref name="Rubin-2006"/> 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.<ref name="Rossouw-2002"/><ref name="Anderson-2004">{{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 }}</ref> 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.<ref name="Grodstein-2003">{{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 }}</ref><ref name="Vandenbroucke-2009">{{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 }}</ref> The use of hormone replacement therapy decreased after publication of the RCTs.<ref name="Hsu-2009">{{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}}</ref>
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:
* 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 "glowing", 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.
* 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。
* 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.
* 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。
== Disadvantages ==
== Disadvantages ==
Many papers discuss the disadvantages of RCTs.<ref name="Black-1996">{{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}}</ref><ref name="Bell & Peck-2012">{{Cite journal | author = Bell, S.H., & 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 }}</ref><ref name="Sanson-Fisher-2007">{{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 }}</ref> Among the most frequently cited drawbacks are:
Many papers discuss the disadvantages of RCTs.<ref name="Black-1996">{{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}}</ref><ref name="Bell & Peck-2012">{{Cite journal | author = Bell, S.H., & 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 }}</ref><ref name="Sanson-Fisher-2007">{{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 }}</ref> Among the most frequently cited drawbacks are:
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:
=== Time and costs ===
=== Time and costs ===
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).
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).
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。
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。
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。
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。
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)。
=== Conflict of interest dangers ===
=== Conflict of interest dangers ===
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 "are more likely to be associated with statistically significant pro-industry findings." 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.
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 "are more likely to be associated with statistically significant pro-industry findings." 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.
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。"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。
=== Ethics ===
=== Ethics ===
If a disruptive innovation in medical technology is developed, it may be difficult to test this ethically in an RCT if it becomes "obvious" 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.
If a disruptive innovation in medical technology is developed, it may be difficult to test this ethically in an RCT if it becomes "obvious" 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.
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.
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.
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。
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。
== In social science ==
== In social science ==
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.
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.
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。
=== Transport science ===
=== Transport science ===
# Have a stable and predictable relationship to exogenous factors
# Have a stable and predictable relationship to exogenous factors
# Would act in the same way if the control group and intervention group were reversed
# Would act in the same way if the control group and intervention group were reversed
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。
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:
干预措施:
# 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)
# 应用于类似于应用于控制组的上下文或设置中
# 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
# 从实施到效果成熟的时间很短
以及因果机制:
# 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
# 不要涉及干预组和外部环境之间的重要反馈机制
# 与外部因素有稳定且可预测的关系
# 如果对照组和干预组颠倒过来，会以同样的方式起作用
=== Criminology ===
=== Criminology ===
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: "policing", "prevention", "corrections", "court", and "community". Focusing only on offending behavior programs, Hollin (2008) argued that RCTs may be difficult to implement (e.g., if an RCT required "passing sentences that would randomly assign offenders to programmes") and therefore that experiments with quasi-experimental design are still necessary.
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: "policing", "prevention", "corrections", "court", and "community". Focusing only on offending behavior programs, Hollin (2008) argued that RCTs may be difficult to implement (e.g., if an RCT required "passing sentences that would randomly assign offenders to programmes") and therefore that experiments with quasi-experimental design are still necessary.
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。
=== Education ===
=== Education ===
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.
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.
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。
== Criticism ==
== Criticism ==
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 "unique time period assessment bias", the "background traits remain constant assumption", the "average treatment effects limitation", the "simple treatment at the individual level limitation", the "all preconditions are fully met assumption", the "quantitative variable limitation" and the "placebo only or conventional treatment only limitation".
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 "unique time period assessment bias", the "background traits remain constant assumption", the "average treatment effects limitation", the "simple treatment at the individual level limitation", the "all preconditions are fully met assumption", the "quantitative variable limitation" and the "placebo only or conventional treatment only limitation".
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
类别: 临床研究
类别: 临床研究