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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。
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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。
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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"/>
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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 |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>
 
* 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>
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* 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>
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* 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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