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第57行： − + 第65行：
第65行： − − The first published RCT in medicine appeared in the 1948 paper entitled "Streptomycin treatment of pulmonary tuberculosis", 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. − − 1948年发表的题为“链霉素治疗肺结核”的论文首次发表了医学研究委员会的调查报告。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。 − + − − Trial design was further influenced by the large-scale ISIS trials on heart attack treatments that were conducted in the 1980s. − − 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。 − − − − − − By the late 20th century, RCTs were recognized as the standard method for "rational therapeutics" 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, "collective equipoise" 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 "for most therapeutic trials." − − 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15万个随机对照试验。但是，随机对照试验的伦理问题有着特殊的考虑。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 − − − − − − 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 "therapeutic misconception". For example, patients with terminal illness may join trials in the hope of being cured, even when treatments are unlikely to be successful. − − 尽管受试者几乎总是在知情的情况下同意参加随机对照试验，但自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。 − − − − − − 第120行：
第90行： − 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: − 研究设计是区分随机对照试验的一种方法。在医疗文献中，从最常见到最不常见，RCT 研究设计的主要类别有:+ + + + + + + +
→History
== History ==
== History ==
The first reported [[clinical trial]] was conducted by [[James Lind]] in 1747 to identify treatment for [[scurvy]].<ref>{{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}}</ref> [[Randomized experiment]]s appeared in [[experimental psychology|psychology]], where they were introduced by [[Charles Sanders Peirce]] and [[Joseph Jastrow]] in the 1880s,<ref>{{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</ref> and in [[school of education|education]].<ref>{{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}}</ref><ref>{{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}}</ref><ref>{{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}}</ref> Later, in the early 20th century, randomized experiments appeared in agriculture, due to [[Jerzy Neyman]]<ref>Neyman, Jerzy. 1923 [1990]. "On the Application of Probability Theory to AgriculturalExperiments. Essay on Principles. Section 9." ''Statistical Science'' 5 (4): 465–472. Trans. Dorota M. Dabrowska and Terence P. Speed.</ref> and [[Ronald A. Fisher]]. Fisher's experimental research and his writings popularized randomized experiments.<ref name="Conniffe" >
The first reported [[clinical trial]] was conducted by [[James Lind]] in 1747 to identify treatment for [[scurvy]].<ref>{{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}}</ref> [[Randomized experiment]]s appeared in [[experimental psychology|psychology]], where they were introduced by [[Charles Sanders Peirce]] and [[Joseph Jastrow]] in the 1880s,<ref>{{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</ref> and in [[school of education|education]].<ref>{{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}}</ref><ref>{{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}}</ref><ref>{{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}}</ref> Later, in the early 20th century, randomized experiments appeared in agriculture, due to [[Jerzy Neyman]]<ref>Neyman, Jerzy. 1923 [1990]. "On the Application of Probability Theory to AgriculturalExperiments. Essay on Principles. Section 9." ''Statistical Science'' 5 (4): 465–472. Trans. Dorota M. Dabrowska and Terence P. Speed.</ref> and [[Ronald A. Fisher]]. Fisher's experimental research and his writings popularized randomized experiments.<ref name="Conniffe"/>
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.
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.
According to Denis Conniffe:
According to Denis Conniffe:
<blockquote>
<blockquote>
Ronald A. Fisher was "interested in application and in the popularization
Ronald A. Fisher was "interested in application and in the popularization of statistical methods and his early book ''[[Statistical Methods for Research Workers]]'', published in 1925, went through many editions and motivated and influenced the practical use of statistics in many fields of study. His ''Design of Experiments'' (1935) <!-- was also crucially fundamental in the promotion of--> [promoted] statistical technique and application. In that book he emphasized examples and how to design experiments systematically from a statistical point of view. The mathematical justification of the methods described was not stressed and, indeed, proofs were often barely sketched
of statistical methods and his early book ''[[Statistical Methods for Research Workers]]'', published in 1925, went through many editions and
motivated and influenced the practical use of statistics in many fields of
study. His ''Design of Experiments'' (1935) <!-- was also crucially fundamental
in the promotion of--> [promoted] statistical technique and application. In that book he
emphasized examples and how to design experiments systematically from
a statistical point of view. The mathematical justification of the methods
described was not stressed and, indeed, proofs were often barely sketched
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.
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.
The first published RCT in medicine appeared in the 1948 paper entitled "[[Streptomycin]] treatment of pulmonary [[tuberculosis]]", which described a [[Medical Research Council (UK)|Medical Research Council]] investigation.<ref name="MRC-1948">{{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 }}</ref><ref name="Brown-1998">{{cite news |title= Landmark study made research resistant to bias |author= Brown D |newspaper= [[Washington Post]] |date=1998-11-02 }}</ref><ref name="Shikata-2006">{{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 }}</ref> One of the authors of that paper was [[Austin Bradford Hill]], who is credited as having conceived the modern RCT.<ref name="Stolberg-2004">{{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}}</ref>
The first published RCT in medicine appeared in the 1948 paper entitled "[[Streptomycin]] treatment of pulmonary [[tuberculosis]]", which described a [[Medical Research Council (UK)|Medical Research Council]] investigation.<ref name="MRC-1948">{{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 }}</ref><ref name="Brown-1998">{{cite news |title= Landmark study made research resistant to bias |author= Brown D |newspaper= [[Washington Post]] |date=1998-11-02 }}</ref><ref name="Shikata-2006">{{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 }}</ref> One of the authors of that paper was [[Austin Bradford Hill]], who is credited as having conceived the modern RCT.<ref name="Stolberg-2004">{{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}}</ref>
The first published RCT in medicine appeared in the 1948 paper entitled "Streptomycin treatment of pulmonary tuberculosis", 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.
1948年发表的题为“链霉素治疗肺结核”的论文首次发表了医学研究委员会的调查报告。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。
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.<ref>{{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}}</ref>
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.<ref>{{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}}</ref>
Trial design was further influenced by the large-scale ISIS trials on heart attack treatments that were conducted in the 1980s.
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。
By the late 20th century, RCTs were recognized as the standard method for "rational therapeutics" in medicine.<ref name="Meldrum-2000">{{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 }}</ref> As of 2004, more than 150,000 RCTs were in the [[Cochrane Library]].<ref name="Stolberg-2004"/> 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.<ref name="Schulz-2010"/><ref name="Moher-2010"/> 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.
By the late 20th century, RCTs were recognized as the standard method for "rational therapeutics" in medicine.<ref name="Meldrum-2000">{{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 }}</ref> As of 2004, more than 150,000 RCTs were in the [[Cochrane Library]].<ref name="Stolberg-2004"/> 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.<ref name="Schulz-2010"/><ref name="Moher-2010"/> 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.
By the late 20th century, RCTs were recognized as the standard method for "rational therapeutics" 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, "collective equipoise" 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 "for most therapeutic trials."
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15万个随机对照试验。但是，随机对照试验的伦理问题有着特殊的考虑。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