7,129
个编辑
更改
跳到导航
跳到搜索
第19行：
第19行： − + + 第25行：
第26行： − − 第41行：
第40行： − <p>By the late 20th century, RCTs were recognized as the standard method for "rational therapeutics" 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.+ − − − 第54行：
第50行： − 第82行：
第77行： − +
无编辑摘要
“ 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。.<ref name="Ranjith-2005">{{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 }}</ref>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。<ref name="Peto-1976">{{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 }}</ref><ref name="Peto-1977">{{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 }}</ref>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；<ref name="Wollert-2004">{{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 | volume = 364 | issue = 9429 | pages = 141–8 | year = 2004 | doi = 10.1016/S0140-6736(04)16626-9 | pmid = 15246726 | s2cid = 24361586 }}</ref>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。
“ 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。<ref name="Ranjith-2005">{{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 }}</ref>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。<ref name="Peto-1976">{{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 }}</ref><ref name="Peto-1977">{{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 }}</ref>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；<ref name="Wollert-2004">{{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 | volume = 364 | issue = 9429 | pages = 141–8 | year = 2004 | doi = 10.1016/S0140-6736(04)16626-9 | pmid = 15246726 | s2cid = 24361586 }}</ref>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。
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>
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 | name-list-style = vanc |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>
{{cite journal|last=Daston|first=Lorraine | name-list-style = vanc |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|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)|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>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|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|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)|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>领域引入随机实验。
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。<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>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。<ref name="Stolberg-2004" /> 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。<ref name="Schulz-2010" /><ref name="Moher-2010" />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。
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。<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>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。<ref name="Stolberg-2004"/> 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。<ref name="Schulz-2010"/><ref name="Moher-2010"/>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。
== 伦理 ==
== 伦理 ==
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。
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。
=== 试验注册 ===
=== 试验注册 ===
=== 结果（效力 vs 效果） ===
=== 结果（效力 vs 效果） ===
随机对照试验可分为“解释性”或“实用性”。<ref name="Zwarenstein-2008">{{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}}</ref> Explanatory RCTs test Efficacy in a research setting with highly selected participants and under highly controlled conditions.<ref name="Zwarenstein-2008"/>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”。<ref name="Zwarenstein-2008"/>
随机对照试验可分为“解释性”或“实用性”。<ref name="Zwarenstein-2008">{{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}}</ref> 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”。<ref name="Zwarenstein-2008"/>