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Author Notes:

Dr Christopher W Jones, jones-christopher@cooperhealth.edu

Concept and design: CJ, AA, SS, MAW, DLS, BSM, BM, TFP-M. Acquisition, analysis or interpretation of data: all authors. Drafting of the manuscript: CJ, MAW, TFP-M. Critical revision of the manuscript for important intellectual content: all authors. Statistical analysis: MAW. Obtained funding: CJ, TFP-M. Administrative, technical or material support: CJ, AA, SS, BSM, BM, TFP-M. Supervision: CJ, TFP-M. CJ is guarantor.

All authors have completed the ICMJE uniform disclosure form at http://www.icmje.org/disclosure-of-interest/ and declare: no support from any commercial organisation for the submitted work; CJ has received research grants from AstraZeneca, Vapotherm, Abbott, and Ophirex outside the submitted work. SS is a full time employee at BMJ but is not involved in editorial decision-making on manuscripts. BM is an employee of the Department of Health and Human Services in the Office of Research Integrity. DLS is an associate editor at JAMA and a deputy editor at Annals of Emergency Medicine. TFP-M is an employee of Ophirex; no other relationships or activities that could appear to have influenced the submitted work.

Subjects:

Research Funding:

This work was supported by the US Department of Health and Human Services Office of Research Integrity, grant number ORIIR180039. The sponsor has no role in the design and conduct of the study; collection, management, analysis and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. The contents of this manuscript are those of the authors and do not represent the official views of, nor an endorsement, by OASH, HHS or the U.S. Government. All authors, external and internal, had full access to all of the data (including statistical reports and tables) in the study and can take responsibility for the integrity of the data and the accuracy of the data analysis.

Keywords:

  • Science & Technology
  • Life Sciences & Biomedicine
  • Medicine, General & Internal
  • General & Internal Medicine
  • PUBLISHED PRIMARY OUTCOMES
  • QUALITY
  • REGISTRATION

Peer Reviewed Evaluation of Registered End-Points of Randomised Trials (the PRE-REPORT study): a stepped wedge, cluster-randomised trial

Journal Title:

BMJ OPEN

Volume:

Volume 12, Number 9

Publisher:

, Pages e066624-e066624

Type of Work:

Article | Final Publisher PDF

Abstract:

Objective To test whether providing relevant clinical trial registry information to peer reviewers evaluating trial manuscripts decreases discrepancies between registered and published trial outcomes. Design Stepped wedge, cluster-randomised trial, with clusters comprised of eligible manuscripts submitted to each participating journal between 1 November 2018 and 31 October 2019. Setting Thirteen medical journals. Participants Manuscripts were eligible for inclusion if they were submitted to a participating journal during the study period, presented results from the primary analysis of a clinical trial, and were peer reviewed. Interventions During the control phase, there were no changes to pre-existing peer review practices. After journals crossed over into the intervention phase, peer reviewers received a data sheet describing whether trials were registered, the initial registration and enrolment dates, and the registered primary outcome(s) when enrolment began. Main outcome measure The presence of a clearly defined, prospectively registered primary outcome consistent with the primary outcome in the published trial manuscript, as determined by two independent outcome assessors. Results We included 419 manuscripts (243 control and 176 intervention). Participating journals published 43% of control-phase manuscripts and 39% of intervention-phase manuscripts (model-estimated percentage difference between intervention and control trials = -10%, 95% CI -25% to 4%). Among the 173 accepted trials, published primary outcomes were consistent with clearly defined, prospectively registered primary outcomes in 40 of 105 (38%) control-phase trials and 27 of 68 (40%) intervention-phase trials. A linear mixed model did not show evidence of a statistically significant primary outcome effect from the intervention (estimated difference between intervention and control=-6% (90% CI -27% to 15%); one-sided p value=0.68). Conclusions These results do not support use of the tested intervention as implemented here to increase agreement between prospectively registered and published trial outcomes. Other approaches are needed to improve the quality of outcome reporting of clinical trials. Trial registration number ISRCTN41225307.

Copyright information:

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

This is an Open Access work distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (https://creativecommons.org/licenses/by-nc/4.0/).
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