Published methodological quality of randomized controlled trials does not reflect the actual quality assessed in protocols.
Published methodological quality of randomized controlled trials does not reflect the actual quality assessed in protocols.
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DOI：
10.1016/j.jclinepi.2011.10.016
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发表时间：
2012-06
影响因子：
7.2
通讯作者：
Kumar, Ambuj
中科院分区：
文献类型：
--
作者：
Mhaskar, Rahul;Djulbegovic, Benjamin;Magazin, Anja;Soares, Heloisa P.;Kumar, Ambuj
评价随机对照试验（RCT）报告的方法学质量是否反映了实际的方法学质量，并评价效应量（ES）和样本量与方法学质量的关系。系统性回顾性分析了8个国家癌症研究所合作组截至2006年发表的所有连续III期RCT。从每项研究的方案（实际质量）和出版物（报告质量）中提取数据。429项RCT符合纳入标准。方法学质量的总体报告较差，没有反映RCT的实际高方法学质量。结果表明，样本量和试验的实际方法学质量之间没有关联。分配隐藏和设盲的不良报告分别将ES夸大了6%（风险比[RHR]：0.94，95%CI：0.88，0.99）和24%（RHR：1.24，95%CI：1.05，1.43）。然而，实际的质量评估显示ES和方法学质量之间没有关联。迄今为止规模最大的一项研究表明，报告质量差并不反映实际的高方法质量。根据报告的质量评估质量对环境质量的影响可能会产生误导性的结果。
To assess whether reported methodological quality of randomized controlled trials (RCTs) reflect the actual methodological quality, and to evaluate the association of effect size (ES) and sample size with methodological quality. Systematic review Retrospective analysis of all consecutive phase III RCTs published by 8 National Cancer Institute Cooperative Groups until year 2006. Data were extracted from protocols (actual quality) and publications (reported quality) for each study. 429 RCTs met the inclusion criteria. Overall reporting of methodological quality was poor and did not reflect the actual high methodological quality of RCTs. The results showed no association between sample size and actual methodological quality of a trial. Poor reporting of allocation concealment and blinding exaggerated the ES by 6% (ratio of hazard ratio [RHR]: 0.94, 95%CI: 0.88, 0.99) and 24% (RHR: 1.24, 95%CI: 1.05, 1.43), respectively. However, actual quality assessment showed no association between ES and methodological quality. The largest study to-date shows poor quality of reporting does not reflect the actual high methodological quality. Assessment of the impact of quality on the ES based on reported quality can produce misleading results.
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影响因子：
7.2
作者：
Devereaux, PJ;Choi, PTL;Guyatt, GH
通讯作者：
Guyatt, GH
影响因子：
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通讯作者：
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影响因子：
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作者：
Soares, HP;Daniels, S;Djulbegovic, B
通讯作者：
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