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).
- protocols & guidelines
- quality in healthcare
- medical education & training
- statistics & research methods
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Contributors SH, BS, IB, MB, DM and PR had the study idea and designed the study. SS, IP and AC provided expertise to ensure implementation at the journal level was possible. MMS was responsible for statistical aspects, including the sample size calculation and the data analysis plan. BS and SH wrote the first draft of the study protocol. All authors critically revised the protocol and approved the final version.
Funding BS is supported by an Advanced Postdoc.Mobility grant from the Swiss National Science Foundation (P300PB_177933). DM is supported by a University Research Chair, University of Ottawa. MMS is funded by Cancer Research UK. The funders had no role in designing the study and will also have no role in conducting the study, or analysing and reporting study results.
Competing interests, and roles of the steering committee SS is employed by the British Medical Journal (BMJ). IP and AC are employed by the Public Library of Science. DM, SH and IB are members of the CONsolidated Standards for Reporting Trials (CONSORT) executive and authors of the CONSORT 2010 statement. DM and PR are members of the EQUATOR (Enhancing the Quality and Transparency of Research) network steering group. MMS is a meta-researcher and reporting guideline developer, enthusiast and disseminator; he may therefore overestimate the importance of this project. All authors have declared that no other competing interests exist: the principal investigator (BS) is responsible for the preparation and the revisions of the study protocol, organising meetings of the steering committee, recruiting and randomising eligible manuscripts as well as the publication of study reports. The steering committee (IB, MB, SH, DM, PR, BS, MMS and SS) is responsible for revising the protocol, defining and validating the additional short explanation for each CONSORT item, advising on study implementation and for publishing the results of this study. MMS is responsible for the sample size calculation and the statistical analyses.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting or dissemination plans of this research.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
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