Emergency Medicine, Cooper Medical School of Rowan University, Camden, New Jersey, USA.
Medical Library, Cooper Medical School of Rowan University, Camden, New Jersey, USA.
BMJ Open. 2019 Jun 1;9(5):e028694. doi: 10.1136/bmjopen-2018-028694.
Clinical trials are critical to the advancement of medical knowledge. However, the reliability of trial conclusions depends in part on consistency between pre-planned and reported study outcomes. Unfortunately, selective outcome reporting, in which outcomes reported in published manuscripts differ from pre-specified study outcomes, is common. Trial registries such as ClinicalTrials.gov have the potential to help identify and stop selective outcome reporting during peer review by allowing peer reviewers to compare outcomes between registry entries and submitted manuscripts. However, the persistently high rate of selective outcome reporting among published clinical trials indicates that the current peer review process at most journals does not effectively address the problem of selective outcome reporting.
PRE-REPORT is a stepped-wedge cluster-randomised trial that will test whether providing peer reviewers with a summary of registered, pre-specified primary trial outcomes decreases inconsistencies between prospectively registered and published primary outcomes. Peer reviewed manuscripts describing clinical trial results will be included. Eligible manuscripts submitted to each participating journal during the study period will comprise each cluster. After an initial control phase, journals will transition to the intervention phase in random order, after which peer reviewers will be emailed registry information consisting of the date of registration and any prospectively defined primary outcomes. Blinded outcome assessors will compare registered and published primary outcomes for all included trials. The primary PRE-REPORT outcome is the presence of a published primary outcome that is consistent with a prospectively defined primary outcome in the study's trial registry. The primary outcome will be analysed using a mixed effect logistical regression model to compare results between the intervention and control phases.
The Cooper Health System Institutional Review Board determined that this study does not meet criteria for human subject research. Findings will be published in peer-reviewed journals.
ISRCTN41225307; Pre-results.
临床试验对于医学知识的进步至关重要。然而，试验结论的可靠性部分取决于预先计划和报告的研究结果之间的一致性。不幸的是，选择性结果报告（即发表的手稿中报告的结果与预先指定的研究结果不同）很常见。临床试验注册如 ClinicalTrials.gov 有可能通过允许同行评审员在同行评审中比较注册条目和提交的手稿之间的结果来帮助识别和阻止选择性结果报告。然而，发表的临床试验中选择性结果报告的持续高发生率表明，大多数期刊目前的同行评审过程并没有有效地解决选择性结果报告的问题。
PRE-REPORT 是一项阶梯式楔形集群随机试验，旨在测试为同行评审员提供注册的预先指定的主要试验结果摘要是否会减少前瞻性注册和发表的主要结果之间的不一致。将包括描述临床试验结果的同行评审手稿。在研究期间提交给每个参与期刊的合格手稿将构成每个集群。在初始对照阶段之后，期刊将随机顺序过渡到干预阶段，之后同行评审员将收到包含注册日期和任何预先定义的主要结果的注册表信息的电子邮件。盲法结局评估员将比较所有纳入试验的注册和发表的主要结局。主要的 PRE-REPORT 结局是存在与研究试验注册中预先定义的主要结局一致的已发表的主要结局。主要结局将使用混合效应逻辑回归模型进行分析，以比较干预和对照阶段的结果。
库珀健康系统机构审查委员会确定这项研究不符合人体研究的标准。研究结果将发表在同行评议的期刊上。
ISRCTN41225307；预结果。
