INSERM U738, Centre d'épidémiologie Clinique, French Cochrane Center, University Paris Descartes et Hotel Dieu, Paris, France.
PLoS One. 2013 Apr 10;8(4):e59910. doi: 10.1371/journal.pone.0059910. Print 2013.
Evidence in the medical literature suggests that trial registration may not be preventing selective reporting of results. We wondered about the place of such information in the peer-review process.
We asked 1,503 corresponding authors of clinical trials and 1,733 reviewers to complete an online survey soliciting their views on the use of trial registry information during the peer-review process.
1,136 authors (n = 713) and reviewers (n = 423) responded (37.5%); 676 (59.5%) had reviewed an article reporting a clinical trial in the past 2 years. Among these, 232 (34.3%) examined information registered on a trial registry. If one or more items (primary outcome, eligibility criteria, etc.) differed between the registry record and the manuscript, 206 (88.8%) mentioned the discrepancy in their review comments, 46 (19.8%) advised editors not to accept the manuscript, and 8 did nothing. The reviewers' reasons for not using the trial registry information included a lack of registration number in the manuscript (n = 132; 34.2%), lack of time (n = 128; 33.2%), lack of usefulness of registered information for peer review (n = 100; 25.9%), lack of awareness about registries (n = 54; 14%), and excessive complexity of the process (n = 39; 10.1%).
This survey revealed that only one-third of the peer reviewers surveyed examined registered trial information and reported any discrepancies to journal editors.
医学文献中的证据表明,试验注册可能并未防止结果的选择性报告。我们想了解此类信息在同行评审过程中的地位。
我们向 1503 名临床试验的通讯作者和 1733 名评审员提出在线调查,征求他们对在同行评审过程中使用试验注册信息的看法。
共有 1136 名作者(n=713)和评审员(n=423)做出回应(37.5%);其中 676 名(59.5%)在过去 2 年中评审过一篇报告临床试验的文章。在这些评审员中,有 232 名(34.3%)检查了试验注册处的注册信息。如果注册记录和手稿之间有一个或多个项目(主要结局、纳入标准等)存在差异,206 名(88.8%)会在评审意见中提及差异,46 名(19.8%)建议编辑不接受手稿,8 名则什么都不做。评审员不使用试验注册信息的原因包括手稿中没有注册号码(n=132;34.2%)、缺乏时间(n=128;33.2%)、注册信息对同行评审没有用(n=100;25.9%)、对注册处缺乏了解(n=54;14%)以及程序过于复杂(n=39;10.1%)。
这项调查显示,只有三分之一的被调查评审员检查了注册试验信息,并向期刊编辑报告了任何差异。