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Peer reviewed evaluation of registered end-points of randomised trials (the PRE-REPORT study): protocol for a stepped-wedge, cluster-randomised trial
  1. Christopher W Jones1,
  2. Amanda Adams2,
  3. Mark A Weaver3,
  4. Sara Schroter4,
  5. Benjamin S Misemer5,
  6. David Schriger6,
  7. Timothy F Platts-Mills7
  1. 1 Emergency Medicine, Cooper Medical School of Rowan University, Camden, New Jersey, USA
  2. 2 Medical Library, Cooper Medical School of Rowan University, Camden, New Jersey, USA
  3. 3 Mathematics and Statistics, Elon University, Elon, North Carolina, USA
  4. 4 BMJ Editorial, London, UK
  5. 5 Emergency Medicine, University of Michigan, Ann Arbor, Michigan, USA
  6. 6 Emergency Medicine, University of California Los Angeles, Los Angeles, California, USA
  7. 7 University of North Carolina, Chapel Hill, Chapel Hill, North Carolina, USA
  1. Correspondence to Dr Christopher W Jones; jones-christopher{at}cooperhealth.edu

Abstract

Introduction 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.

Methods and analysis 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.

Ethics and dissemination 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.

Trial registration number ISRCTN41225307; Pre-results.

  • clinical trial
  • peer review
  • trial registration
  • Clinicaltrials.gov

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Footnotes

  • Contributors CWJ and TPM conceived of the study and secured funding. CWJ, ACA, SS, MAW, DLS, BSM and TPM all contributed to the study design. Statistical planning and analyses were performed by MAW. CWJ initially drafted this manuscript and CWJ, ACA, SS, MAW, DLS, BSM and TPM all contributed to critical revision of the manuscript. All authors have read and approved the final manuscript.

  • Funding This work was supported by the US Department of Health and Human Services Office of Research Integrity, grant number ORIIR180039.

  • Competing interests CWJ in an investigator on studies sponsored by AstraZeneca, Roche Diagnostics, Hologic Inc, and Janssen for which his department received research grants. SS is a full-time employee at BMJ, but is not involved in editorial decision making on manuscripts.

  • Ethics approval The trial protocol was reviewed by the Cooper University Hospital Institutional Review Board and was determined to not meet the regulatory definition for human subjects’ research and is therefore exempt from further Institutional Review Board review.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Patient consent for publication Not required.

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