Comparison of Registered and Published Primary Outcomes in Randomized Controlled Trials
Comparison of Registered and Published Primary Outcomes in Randomized Controlled Trials
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DOI：
10.1001/jama.2009.1242
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发表时间：
2009-09-02
影响因子：
120.7
通讯作者：
Ravaud, Philippe
中科院分区：
文献类型：
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作者：
Mathieu, Sylvain;Boutron, Isabelle;Ravaud, Philippe
背景 自 2005 年起，国际医学期刊编辑委员会要求研究者在受试者入组之前注册其试验，作为在会员期刊上发表试验结果的先决条件。 目的 评估最近在高影响因子期刊上发表结果的注册试验的比例；将试验登记处指定的主要结果与已发表文章中报告的结果进行比较；数据来源和研究选择 通过 PubMed 在 MEDLINE 中搜索 3 个医学领域（心脏病学、风湿病学和胃肠病学）的随机对照试验 (RCT) 报告，该研究于 2008 年被收录在影响因子最高的 10 种普通医学期刊和专业期刊中。数据提取 对于每篇纳入的文章，我们使用标准化数据提取表格获得了试验注册信息。 323 项纳入试验，147 项（45.5%）进行了充分注册（即在试验结束前注册，并明确规定了主要结局）。 89 项已发表的报告（27.6%）缺乏试验注册，45 项试验（13.9%）在研究完成后注册，35 项试验（10.8%）在注册时没有对主要结局描述或描述不清楚，39 项试验（12%）在注册时没有对主要结局描述或描述不清楚，3 项试验（0.9%）在研究完成后注册，对主要结局描述不清楚。在充分注册试验的文章中，31%（147 篇中的 6 篇）显示了注册结果与发布结果之间存在差异的一些证据。只有一半的研究可以评估这些差异的影响，并且在这些具有统计学意义的结果中，82.6% 的人（23 人中的 19 人）赞成使用这些差异的影响。 结论 对随后发表的随机对照试验的主要结果进行比较表明，选择性结果报告很普遍。贾马。 2009;302(9):977-984 www.jama.com
Context As of 2005, the International Committee of Medical Journal Editors required investigators to register their trials prior to participant enrollment as a precondition for publishing the trial's findings in member journals.Objective To assess the proportion of registered trials with results recently published in journals with high impact factors; to compare the primary outcomes specified in trial registries with those reported in the published articles; and to determine whether primary outcome reporting bias favored significant outcomes.Data Sources and Study Selection MEDLINE via PubMed was searched for reports of randomized controlled trials (RCTs) in 3 medical areas (cardiology, rheumatology, and gastroenterology) indexed in 2008 in the 10 general medical journals and specialty journals with the highest impact factors.Data Extraction For each included article, we obtained the trial registration information using a standardized data extraction form.Results Of the 323 included trials, 147 (45.5%) were adequately registered (ie, registered before the end of the trial, with the primary outcome clearly specified). Trial registration was lacking for 89 published reports (27.6%), 45 trials (13.9%) were registered after the completion of the study, 35 (10.8%) were registered with no or an unclear description of the primary outcome, 39 (12%) were registered with no or an unclear description of the primary outcome, and 3 (0.9%) were registered after the completion of the study and had an unclear description of the primary outcome. Among articles with trials adequately registered, 31% ( 6 of 147) showed some evidence of discrepancies between the outcomes registered and the outcomes published. The influence of these discrepancies could be assessed in only half of them and in these statistically significant results were favored in 82.6% (19 of 23).Conclusion Comparison of the primary outcomes of RCTs registered with their subsequent publication indicated that selective outcome reporting is prevalent. JAMA. 2009;302(9):977-984 www.jama.com