Identifying outcome reporting bias in randomised trials on PubMed: review of publications and survey of authors
Identifying outcome reporting bias in randomised trials on PubMed: review of publications and survey of authors
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DOI：
10.1136/bmj.38356.424606.8f
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发表时间：
2005-04-02
影响因子：
105.7
通讯作者：
Altman, DG
中科院分区：
文献类型：
--
作者：
Chan, AW;Altman, DG
目的探讨结果报告偏倚的程度和性质，在一个广泛的队列发表的randomizedtrials.Design回顾性审查的出版物和后续调查的作者。队列PubMed中收录的所有随机试验的期刊文章，其主要出版物出现在2000年12月。主要结果测量每个试验不完全报告结果的患病率;未报告结果的原因;报告的完整性与统计学显著性之间的关联。调查应答者（应答率69%）提供了未报告结果的信息，但往往是不可靠的，对于32%否认存在此类结果的人来说，在他们的出版物中有相反的证据。平均而言，在平行组试验中，超过20%的结果被不完全报告。在一项试验中，与完全报告的结局相比，此类结局具有更高的统计学不显著性几率（有效性结局的比值比为2.0（95%置信区间1.6至2.7）;伤害结局的比值比为1.9（1.1至3.5））。最常报告的原因省略疗效结果包括空间限制，缺乏临床意义，缺乏统计significance.Conclusions不完整的报告结果内发表的文章的随机试验是常见的，并与统计学非显着性。因此，医学文献代表了一个有选择性和有偏见的研究结果子集，试验方案应公开。
Objective To examine the extent and nature of outcome reporting bias in a broad cohort of published randomised trials.Design Retrospective review of publications and follow up survey of authors. Cohort All journal articles of randomised trials indexed in PubMed whose primary publication appeared in December 2000.Main outcome measures Prevalence of incompletely reported outcomes per trial; reasons for not reporting outcomes; association between completeness of reporting and statistical significance.Results 519 trials with 553 publications and 10 557 outcomes were identified. Survey responders (response rate 69%) provided information on unreported outcomes but were often unreliable-for 32% of those who denied the existence of such outcomes there was evidence to the contrary in their publications. On average, over 20% of the outcomes measured in a parallel group trial were incompletely reported. Within a trial, such outcomes had a higher odds of being statistically non-significant compared with fully reported outcomes (odds ratio 2.0 (95% confidence interval 1.6 to 2.7) for efficacy outcomes; 1.9 (1.1 to 3.5) for harm outcomes). The most commonly reported reasons for omitting efficacy outcomes included space constraints, lack of clinical importance, and lack of statistical significance.Conclusions Incomplete reporting of outcomes Within published articles of randomised trials is common and is associated with statistical non-significance. The medical literature therefore represents a selective and biased subset of study outcomes, and trial protocols should be made publicly available.