An observational study found that authors of randomized controlled trials frequently use concealment of randomization and blinding, despite the failure to report these methods
An observational study found that authors of randomized controlled trials frequently use concealment of randomization and blinding, despite the failure to report these methods
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DOI：
10.1016/j.jclinepi.2004.03.017
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发表时间：
2004-12-01
影响因子：
7.2
通讯作者：
Guyatt, GH
中科院分区：
文献类型：
--
作者：
Devereaux, PJ;Choi, PTL;Guyatt, GH
背景和目的：随机对照试验(RCT)的读者通常认为没有报道的事情没有发生。我们进行了一项观察性研究，以确定在未报告这些偏见减少策略的随机对照试验中是否使用了隐藏随机和盲化策略。方法：我们记录了105篇随机对照试验中关于隐藏随机和盲化的报告。我们随后联系了作者，并确定他们是否使用了这些方法保障。结果：我们成功地获得了98名作者的数据。在这98篇随机对照研究的全文出版物中，作者没有报告55%的随机抽样存在或没有隐藏，26%的参与者失明，的医疗保健提供者，84%的数据收集者，83%的结果评估者，96%的数据分析师。在直接接触中，作者经常报告隐藏随机(96%；95%可信区间=87-100%)、致盲参与者(20%；95%可信区间=7-41%)、致盲医疗保健提供者(65%；95%可信区间=52-77%)、致盲数据收集者(65%；95%可信区间=53-75%)、致盲结果评估者(79%；95%可信区间=69-87%)和致盲数据分析师(50%；95%CI=40%-60%)，尽管在他们的出版物中没有报告这些方法保障措施的使用。结论：读者不应该认为随机对照试验中没有报告的减少偏见的程序没有发生。(C)2004 Elsevier Inc.保留所有权利。
Background and objective: Readers of randomized controlled trials (RCTs) commonly assume that what was not reported did not occur. We undertook an observational study to determine whether concealment of randomization or blinding was used in RCTs that failed to report these bias-reducing strategies.Methods: We recorded the reporting of concealment of randomization and blinding in 105 RCTs. We Subsequently contacted the authors and determined if they had used these methodological safeguards.Results: We successfully obtained data from 98 authors. The authors in the full-text publications of these 98 RCTs failed to report the presence or absence of concealment of randomization in 55%, and the blinding status of participants in 26%, health care providers in 64%, data collectors in 84%, outcome assessors in 83%, and data analysts in 96%. In direct contact, authors frequently reported concealing randomization (96%; 95% confidence interval CI = 87-100%), blinding participants (20%; 95% CI = 7-41%), blinding healthcare providers (65%; 95% CI = 52-77%), blinding data collectors (65%; 95% CI = 53-75%), blinding outcome assessors (79%; 95% CI = 69-87%), and blinding data analysts (50%; 95% CI = 40-60%), despite not reporting the use of these methodological safeguards in their publications.Conclusions: Readers should not assume that bias-reducing procedures not reported in an RCT did not occur. (C) 2004 Elsevier Inc. All rights reserved.