Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.
BMJ Open. 2020 Mar 19;10(3):e035114. doi: 10.1136/bmjopen-2019-035114.
INTRODUCTION: Transparent and accurate reporting is essential for readers to adequately interpret the results of a study. Journals can play a vital role in improving the reporting of published randomised controlled trials (RCTs). We describe an RCT to evaluate our hypothesis that asking peer reviewers to check whether the most important and poorly reported CONsolidated Standards of Reporting Trials (CONSORT) items are adequately reported will result in higher adherence to CONSORT guidelines in published RCTs. METHODS AND ANALYSIS: Manuscripts presenting the primary results of RCTs submitted to participating journals will be randomised to either the intervention group (peer reviewers will receive a reminder and short explanation of the 10 most important and poorly reported CONSORT items; they will be asked to check if these items are reported in the submitted manuscript) or a control group (usual journal practice). The primary outcome will be the mean proportion of the 10 items that are adequately reported in the published articles. Peer reviewers and manuscript authors will not be informed of the study hypothesis, design or intervention. Outcomes will be assessed in duplicate from published articles by two data extractors (at least one blinded to the intervention). We will enrol eligible manuscripts until a minimum of 83 articles per group (166 in total) are published. ETHICS AND DISSEMINATION: This pragmatic RCT was approved by the Medical Sciences Interdivisional Research Ethics Committee of the University of Oxford (R62779/RE001). If this intervention is effective, it could be implemented by all medical journals without requiring large additional resources at journal level. Findings will be disseminated through presentations in relevant conferences and peer-reviewed publications. This trial is registered on the Open Science Framework (https://osf.io/c4hn8).
简介:透明和准确的报告对于读者充分解释研究结果至关重要。期刊在提高已发表随机对照试验(RCT)的报告质量方面可以发挥重要作用。我们描述了一项 RCT,以评估我们的假设,即要求同行评审员检查最重要和报告最差的 CONSolidated Standards of Reporting Trials(CONSORT)项目是否得到充分报告,是否会导致已发表 RCT 更符合 CONSORT 指南。
方法和分析:将提交给参与期刊的主要结果为 RCT 的手稿随机分配到干预组(同行评审员将收到关于 10 个最重要和报告最差的 CONSORT 项目的提醒和简短说明;他们将被要求检查这些项目是否在提交的手稿中报告)或对照组(通常的期刊实践)。主要结果将是已发表文章中充分报告的 10 个项目的平均比例。同行评审员和手稿作者不会被告知研究假设、设计或干预措施。结果将由两名数据提取员(至少有一名对干预措施不知情)从已发表的文章中重复评估。我们将招募符合条件的手稿,直到每组至少有 83 篇文章(共 166 篇)发表。
伦理和传播:这项实用的 RCT 已获得牛津大学医学科学跨部门研究伦理委员会的批准(R62779/RE001)。如果这种干预措施有效,它可以在不要求期刊层面增加大量额外资源的情况下,由所有医学期刊实施。研究结果将通过在相关会议上的介绍和同行评议出版物进行传播。该试验在开放科学框架(https://osf.io/c4hn8)上注册。
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