Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2020 Mar 19;10(3):e035114.
doi: 10.1136/bmjopen-2019-035114.

Impact of a short version of the CONSORT checklist for peer reviewers to improve the reporting of randomised controlled trials published in biomedical journals: study protocol for a randomised controlled trial

Benjamin Speich  1   2 , Sara Schroter  3 , Matthias Briel  2   4 , David Moher  5   6 , Iratxe Puebla  7 , Alejandra Clark  7 , Michael Maia Schlüssel  8   9 , Philippe Ravaud  10   11 , Isabelle Boutron  10   11 , Sally Hopewell  8
Affiliations

Impact of a short version of the CONSORT checklist for peer reviewers to improve the reporting of randomised controlled trials published in biomedical journals: study protocol for a randomised controlled trial

Benjamin Speich et al. BMJ Open. .

Abstract

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).

Keywords: medical education & training; protocols & guidelines; quality in healthcare; statistics & research methods.

PubMed Disclaimer

Conflict of interest statement

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.

Figures

Figure 1
Figure 1
Study flow chart. CONSORT, CONsolidated Standards of Reporting Trials; SPIRIT: Standard Protocol Items: Recommendations for Interventional Trials.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Duley L, Antman K, Arena J, et al. . Specific barriers to the conduct of randomized trials. Clin Trials 2008;5:40–8. 10.1177/1740774507087704 - DOI - PubMed
    1. Collins R, MacMahon S. Reliable assessment of the effects of treatment on mortality and major morbidity, I: clinical trials. Lancet 2001;357:373–80. 10.1016/S0140-6736(00)03651-5 - DOI - PubMed
    1. Chalmers I. Unbiased, relevant, and reliable assessments in health care: important progress during the past century, but plenty of scope for doing better. BMJ 1998;317:1167–8. 10.1136/bmj.317.7167.1167 - DOI - PMC - PubMed
    1. Altman DG, Simera I, Hoey J, et al. . EQUATOR: reporting guidelines for health research. Lancet 2008;371:1149–50. 10.1016/S0140-6736(08)60505-X - DOI - PubMed
    1. Simera I. EQUATOR network collates resources for good research. BMJ 2008;337:a2471 10.1136/bmj.a2471 - DOI - PubMed

Publication types

MeSH terms

LinkOut - more resources