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A protocol of a cross-sectional study evaluating an online tool for early career peer reviewers assessing reports of randomised controlled trials
  1. Anthony Chauvin1,2,3,
  2. David Moher4,5,
  3. Doug Altman6,
  4. David L Schriger7,
  5. Sabina Alam8,
  6. Sally Hopewell9,
  7. Daniel R Shanahan10,
  8. Alessandro Recchioni10,
  9. Philippe Ravaud1,2,
  10. Isabelle Boutron1,2,11
  1. 1 METHODS team, Centre of Research in Epidemiology and Statistics Sorbonne Paris Cité (CRESS), Paris, France
  2. 2 Paris Descartes University, Paris, France
  3. 3 Department of Emergency, Hôpital Lariboisière, Assistance Publique des Hôpitaux de Paris, University Diderot, Paris, France
  4. 4 Centre for Journalology, Ottawa Hospital Research Institute, Ottawa, Canada
  5. 5 School of Epidemiology and Public Health, University of Ottawa, Ottawa, Canada
  6. 6 Centre for Statistics in Medicine, University of Oxford, Oxford, UK
  7. 7 Department of Emergency Medicine, School of Medicine, University of California, Los Angeles, California, USA
  8. 8 Faculty of 1000, London, UK
  9. 9 Oxford Clinical Trials Research Unit, University of Oxford, Oxford, UK
  10. 10 BioMed Central Ltd, London, UK
  11. 11 METHODS team, Centre d'Épidémiologie Clinique, Hôpital Hôtel Dieu, Assistance Publique des Hôpitaux de Paris, Paris, France
  1. Correspondence to Dr Anthony Chauvin; anthony.chauvin{at}


Introduction Systematic reviews evaluating the impact of interventions to improve the quality of peer review for biomedical publications highlighted that interventions were limited and have little impact. This study aims to compare the accuracy of early career peer reviewers who use an innovative online tool to the usual peer reviewer process in evaluating the completeness of reporting and switched primary outcomes in completed reports.

Methods and analysis This is a cross-sectional study of individual two-arm parallel-group randomised controlled trials (RCTs) published in the BioMed Central series medical journals, BMJ, BMJ Open and Annals of Emergency Medicine and indexed with the publication type ‘Randomised Controlled Trial’. First, we will develop an online tool and training module based (a) on the Consolidated Standards of Reporting Trials (CONSORT) 2010 checklist and the Explanation and Elaboration document that would be dedicated to junior peer reviewers for assessing the completeness of reporting of key items and (b) the Centre for Evidence-Based Medicine Outcome Monitoring Project process used to identify switched outcomes in completed reports of the primary results of RCTs when initially submitted. Then, we will compare the performance of early career peer reviewers who use the online tool to the usual peer review process in identifying inadequate reporting and switched outcomes in completed reports of RCTs at initial journal submission. The primary outcome will be the mean number of items accurately classified per manuscript. The secondary outcomes will be the mean number of items accurately classified per manuscript for the CONSORT items and the sensitivity, specificity and likelihood ratio to detect the item as adequately reported and to identify a switch in outcomes. We aim to include 120 RCTs and 120 early career peer reviewers.

Ethics and dissemination The research protocol was approved by the ethics committee of the INSERM Institutional Review Board (21 January 2016). The study is based on voluntary participation and informed written consent.

Trial registration number NCT03119376.

  • peer reviewers
  • randomized controlled trials
  • reporting

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 and the use is non-commercial. See:

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  • Contributors AC and IB were responsible for the concept of the study and conceived and designed the study. DM, DGA, DS, SA, SH, DRS and PR helped to write the draft protocol and made a critical contribution to the content. All authors read and approved the final protocol.

  • Competing interests None declared.

  • Patient consent Obtained.

  • Ethics approval The Institutional Review Board of INSERM ethics committee (IRB 17-335).

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

  • Data sharing statement All data will be published.

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