随机对照试验 - 版本历史

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随机对照试验

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历史

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历史

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历史

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2021-07-17T04:08:05Z

历史

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 *[https://mp.weixin.qq.com/s/7MEyMWedztyweoiYOxRh7w 设计变化、质量控制和伦理问题]
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 本条目由[[用户:Songgang77|Songgang77]]参与贡献，[[用户:李昊轩|李昊轩]]审校，[[用户:薄荷|薄荷]]编辑，如有问题，欢迎在讨论页面进行讨论。

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 ==编者推荐==
 [[File:随机对照试验.jpg|400px|thumb|随机对照试验]]
-====随机对照试验====
+====随机对照试验相关文章====
 *[https://mp.weixin.qq.com/s/W_D9L39Nol9-k5lRdY1T3w 概述]
 *[https://mp.weixin.qq.com/s/gDiTv0_RqRuCBQaLH4o_mQ 随机对照试验设计的原理]

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−	~~本条目由Dorr用户参与贡献，~~[[用户:李昊轩\|李昊轩]]审校，[[用户:薄荷\|薄荷]]编辑，如有问题，欢迎在讨论页面进行讨论。	+	本条目由[[用户:Songgang77\|Songgang77]]参与贡献，[[用户:李昊轩\|李昊轩]]审校，[[用户:薄荷\|薄荷]]编辑，如有问题，欢迎在讨论页面进行讨论。

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 ==编者推荐==
-===集智读书会===
+[[File:随机对照试验.jpg|400px|thumb|随机对照试验]]
 [[Category:临床研究]]
 [[Category:流行病学研究项目]]
 [[Category:循证做法]]
 [[Category:实验设计]]

←上一版本		2021年7月17日 (六) 04:11的版本
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−	在19世纪80年代，Charles Sanders Peirce和Joseph Jastrow在心理学<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>和教育学<ref>~~{{cite journal\|doi=10~~.~~1086/354775\|first=Ian\|last=Hacking\|mr=1013489}}~~</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}}</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)\|volume=88\|issue=4\|date=December 1997\|pages=653–673\|pmid=9519574\|url=https://pure.rug.nl/ws/files/71855616/237831.pdf}}</ref>领域引入随机实验。	+	在19世纪80年代，Charles Sanders Peirce和Joseph Jastrow在心理学<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>和教育学<ref>Hacking, Ian (September 1988). "Telepathy: Origins of Randomization in Experimental Design". Isis. A Special Issue on Artifact and Experiment. 79 (3): 427–451. </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}}</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)\|volume=88\|issue=4\|date=December 1997\|pages=653–673\|pmid=9519574\|url=https://pure.rug.nl/ws/files/71855616/237831.pdf}}</ref>领域引入随机实验。

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−	在19世纪80年代，Charles Sanders Peirce和Joseph Jastrow在心理学<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>和教育学<ref>{{cite journal\|doi=10.1086/354775\|first=Ian\|last=Hacking~~\|34674~~\|mr=1013489}}</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}}</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)\|volume=88\|issue=4\|date=December 1997\|pages=653–673\|pmid=9519574\|url=https://pure.rug.nl/ws/files/71855616/237831.pdf}}</ref>领域引入随机实验。	+	在19世纪80年代，Charles Sanders Peirce和Joseph Jastrow在心理学<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>和教育学<ref>{{cite journal\|doi=10.1086/354775\|first=Ian\|last=Hacking\|mr=1013489}}</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}}</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)\|volume=88\|issue=4\|date=December 1997\|pages=653–673\|pmid=9519574\|url=https://pure.rug.nl/ws/files/71855616/237831.pdf}}</ref>领域引入随机实验。

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-在19世纪80年代，Charles Sanders Peirce和Joseph Jastrow在心理学<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>和教育学<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)|series=A Special Issue on Artifact and Experiment|volume=79|issue=3|date=September 1988 |pages=427–451|jstor=234674|mr=1013489}}</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|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)|volume=88|issue=4|date=December 1997|pages=653–673|pmid=9519574|url=https://pure.rug.nl/ws/files/71855616/237831.pdf}}</ref>领域引入随机实验。
+在19世纪80年代，Charles Sanders Peirce和Joseph Jastrow在心理学<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>和教育学<ref>{{cite journal|doi=10.1086/354775|first=Ian|last=Hacking|34674|mr=1013489}}</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}}</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)|volume=88|issue=4|date=December 1997|pages=653–673|pmid=9519574|url=https://pure.rug.nl/ws/files/71855616/237831.pdf}}</ref>领域引入随机实验。
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-没有盲法的随机对照试验被称为“未盲法”，<ref name="Marson-2007">{{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|| volume = 369 | issue = 9566 | pages = 1016–26 | year = 2007 | doi = 10.1016/S0140-6736(07)60461-9 | pmid = 17382828 | pmc = 2039891 }}</ref>也称“开放”，<ref name="Chan-1995">{{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}}</ref>或者（如果干预是一种药物）“开放标签”。<ref name="Fukase-2008">{{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 | url = https://eprints.lib.hokudai.ac.jp/dspace/bitstream/2115/34681/1/asaka.pdf | hdl-access = free }}</ref>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；<ref name="Wood-2008"/>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。<ref name="Noseworthy-1994">{{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}}</ref>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”。<ref name="Zwarenstein-2008"/>
+没有盲法的随机对照试验被称为“未盲法”，<ref name="Marson-2007">{{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|| volume = 369 | issue = 9566 | pages = 1016–26 | year = 2007 | doi = 10.1016/S0140-6736(07)60461-9 | pmid = 17382828 | pmc = 2039891 }}</ref>也称“开放”，<ref name="Chan-1995">{{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}}</ref>或者（如果干预是一种药物）“开放标签”。<ref name="Fukase-2008">{{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 | url = https://eprints.lib.hokudai.ac.jp/dspace/bitstream/2115/34681/1/asaka.pdf | hdl-access = free }}</ref>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；<ref name="Wood-2008"/>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。<ref name="Noseworthy-1994">{{Cite journal |vauthors=Noseworthy JH, Ebers GC, Vandervoort MK, Farquhar RE, Yetisir E, Roberts R |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}}</ref>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”。<ref name="Zwarenstein-2008"/>
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 * 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。<ref name="Vandenbroucke-2008">{{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 }}</ref>
-* 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。<ref name="Black-1996"/><ref name="Glasziou-2007">{{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 }}</ref>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%。<ref name="Glasziou-2007"/><ref name="Einhorn-2002">{{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 }}</ref>
+* 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。<ref name="Black-1996"/><ref name="Glasziou-2007">{{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 }}</ref>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%。<ref name="Glasziou-2007"/><ref name="Einhorn-2002">{{Cite journal | author = Einhorn LH | 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 }}</ref>

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 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。<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>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。<ref>
 {{cite journal|last=Daston|first=Lorraine|title=Scientific Error and the Ethos of Belief|journal=Social Research|volume=72|number=1|year=2005|page=18}}</ref>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。<ref name="pmid16992882">{{cite journal | vauthors = Rivers WH, Webber HN | title = The action of caffeine on the capacity for muscular work | journal = The Journal of Physiology | volume = 36 | issue = 1 | pages = 33–47 | date = August 1907 | pmid = 16992882 | pmc = 1533733 | doi = 10.1113/jphysiol.1907.sp001215 }}</ref>
 在19世纪80年代，Charles Sanders Peirce和Joseph Jastrow在心理学<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>和教育学<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)|series=A Special Issue on Artifact and Experiment|volume=79|issue=3|date=September 1988 |pages=427–451|jstor=234674|mr=1013489}}</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|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)|volume=88|issue=4|date=December 1997|pages=653–673|pmid=9519574|url=https://pure.rug.nl/ws/files/71855616/237831.pdf}}</ref>领域引入随机实验。
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 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。<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>

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−	在20世纪早期，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>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。<ref ~~name=~~"~~Conniffe~~" />	+	在20世纪早期，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>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。<ref>Conniffe, Denis (1990–1991). "R. A. Fisher and the development of statistics—a view in his centenary year". Journal of the Statistical and Social Inquiry Society of Ireland. XXVI (3). Dublin: Statistical and Social Inquiry Society of Ireland. p. 87.</ref>