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1. A scoping review on the roles and tasks of peer reviewers in the manuscript review process in biomedical journals

Author

Isabelle Boutron, Ketevan Glonti, David Moher, Erik Cobo, Darko Hren, Daniel Cauchi, Department of Psychology [Split, Croatie], Faculty of Humanities and Social Sciences [Split, Croatie], University of Split-University of Split, Equipe 5 : METHODS - Méthodes de l’évaluation thérapeutique des maladies chroniques (CRESS - U1153), Université Paris Descartes - Paris 5 (UPD5)-Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Université Paris Descartes - Paris 5 (UPD5), Department of Public Health [Msida, Malte], Faculty of Medicine and Surgery [Msida, Malte], University of Malta [Malta]-University of Malta [Malta], Statistics and Operations Research Department [Barcelone, Espagne], Universitat Politècnica de Catalunya [Barcelona] (UPC), Center for Journalology [Ottawa, Canada], Clinical Epidemiology Program [Ottawa, Canada], Ottawa Hospital Research Institute [Ottawa] (OHRI)-Ottawa Hospital Research Institute [Ottawa] (OHRI), This project was supported by the European Union’s Horizon 2020 research and innovation programme under the Marie Sklodowska-Curie grant agreement no. 676207., European Project: 676207,H2020,H2020-MSCA-ITN-2015,MIROR(2016), Universitat Politècnica de Catalunya. Departament d'Estadística i Investigació Operativa, Universitat Politècnica de Catalunya. GRBIO - Grup de Recerca en Bioestadística i Bioinformàtica, Bodescot, Myriam, and Methods in Research on Research - MIROR - - H20202016-03-01 - 2020-02-29 - 676207 - VALID

Subjects
Scoping review, Journal, Biomatemàtica, Biomedical, education, Scopus, MEDLINE, Matemàtiques i estadística::Matemàtica aplicada a les ciències [Àrees temàtiques de la UPC], lcsh:Medicine, PsycINFO, Competencies, Roles, Tasks, law.invention, 03 medical and health sciences, 0302 clinical medicine, law, Humans, Medicine, 030212 general & internal medicine, Biomathematics, Protocol (science), Medical education, business.industry, lcsh:R, 92 Biology and other natural sciences::92B Mathematical biology in general [Classificació AMS], General Medicine, Grey literature, 3. Good health, Index (publishing), [SDV.SPEE] Life Sciences [q-bio]/Santé publique et épidémiologie, CLARITY, [SDV.SPEE]Life Sciences [q-bio]/Santé publique et épidémiologie, Periodicals as Topic, business, 030217 neurology & neurosurgery, Research Article
Abstract

Background Although peer reviewers play a key role in the manuscript review process, their roles and tasks are poorly defined. Clarity around this issue is important as it may influence the quality of peer reviewer reports. This scoping review explored the roles and tasks of peer reviewers of biomedical journals. Methods Comprehensive literature searches were conducted in Cochrane Library, Cumulative Index to Nursing and Allied Health Literature, Educational Resources Information Center, EMBASE, MEDLINE, PsycINFO, Scopus and Web of Science from inception up to May 2017. There were no date and language restrictions. We also searched for grey literature. Studies with statements mentioning roles, tasks and competencies pertaining to the role of peer reviewers in biomedical journals were eligible for inclusion. Two reviewers independently performed study screening and selection. Relevant statements were extracted, collated and classified into themes. Results After screening 2763 citations and 600 full-text papers, 209 articles and 13 grey literature sources were included. A total of 1426 statements related to roles were extracted, resulting in 76 unique statements. These were grouped into 13 emergent themes: proficient experts in their field (3 items), dutiful/altruistic towards scientific community (7 items), familiar with journal (2 items), unbiased and ethical professionals (18 items), self-critical professionals (4 items), reliable professionals (7 items), skilled critics (15 items), respectful communicators (6 items), gatekeepers (2 items), educators (2 items), advocates for author/editor/reader (3 items) and advisors to editors (2 items). Roles that do not fall within the remit of peer reviewers were also identified (5 items). We also extracted 2026 statements related to peer reviewers’ tasks, resulting in 73 unique statements. These were grouped under six themes: organisation and approach to reviewing (10 items), make general comments (10 items), assess and address content for each section of the manuscript (36 items), address ethical aspects (5 items), assess manuscript presentation (8 items) and provide recommendations (4 items). Conclusions Peer reviewers are expected to perform a large number of roles and tasks for biomedical journals. These warrant further discussion and clarification in order not to overburden these key actors. Electronic supplementary material The online version of this article (10.1186/s12916-019-1347-0) contains supplementary material, which is available to authorized users.

Published
2019
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3. Accuracy in detecting inadequate research reporting by early career peer reviewers using an online CONSORT-based peer-review tool (COBPeer) versus the usual peer-review process: a cross-sectional diagnostic study

Author

Alessandro Recchioni, Gabriel Baron, Perrine Crequit, Douglas G. Altman, Daniel Shanahan, Philippe Ravaud, Anthony Chauvin, David L. Schriger, Isabelle Boutron, David Moher, Sally Hopewell, Valeria Martinez, Carolina Riveros, Sabina Alam, Jean-Philippe Regnaux, L. Le Cleach, Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Université Paris Descartes - Paris 5 (UPD5)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA), Centre d'épidémiologie Clinique [Hôtel-Dieu], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital Hôtel Dieu, Emergency department, Service d'Accueil des Urgences, Hôpital Lariboisière, Assistance Publique des Hôpitaux de Paris, Université Paris Diderot - Paris 7 (UPD7)-Université Paris Diderot - Paris 7 (UPD7)-Assistance Publique des Hôpitaux de Paris, Université Paris Diderot - Paris 7 (UPD7)-Université Paris Diderot - Paris 7 (UPD7)-Hôpital Lariboisière, Université Paris Diderot - Paris 7 (UPD7)-Université Paris Diderot - Paris 7 (UPD7), Centre for Journalology, Ottawa Hospital Research Institute, School of Epidemiology and Public Health, University of Ottawa [Ottawa]-University of Ottawa [Ottawa]-School of Epidemiology and Public Health, University of Ottawa [Ottawa]-University of Ottawa [Ottawa], Department of Emergency Medicine, School of Medicine, University of California [Los Angeles] (UCLA), University of California-University of California-University of California [Los Angeles] (UCLA), University of California-University of California, Centre for Statistics in Medicine, University of Oxford [Oxford], Cochrane Central Executive, Taylor and Francis group, Department of Anesthesiology, Assistance Publique Hôpitaux de Paris, Hôpital Raymond Poincaré [AP-HP]-Hôpital Raymond Poincaré [AP-HP], Service de Dermatologie, Hopital Mondor, Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12)-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12)-Assistance Publique des Hôpitaux de Paris, Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12)-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), BMC Medicine, Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), University of California (UC)-University of California (UC)-University of California [Los Angeles] (UCLA), and University of California (UC)-University of California (UC)

Subjects
Research Report, medicine.medical_specialty, MEDLINE, lcsh:Medicine, 01 natural sciences, Mean difference, law.invention, 03 medical and health sciences, 0302 clinical medicine, Primary outcome, Randomized controlled trial, law, 0103 physical sciences, CONSORT statement, medicine, Humans, 030212 general & internal medicine, Early career, 010301 acoustics, Publishing, business.industry, lcsh:R, Consolidated Standards of Reporting Trials, General Medicine, Research reporting, Cross-Sectional Studies, Reporting, Family medicine, Randomized controlled trials, Periodicals as Topic, business, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Research Article
Abstract

Background The peer review process has been questioned as it may fail to allow the publication of high-quality articles. This study aimed to evaluate the accuracy in identifying inadequate reporting in RCT reports by early career researchers (ECRs) using an online CONSORT-based peer-review tool (COBPeer) versus the usual peer-review process. Methods We performed a cross-sectional diagnostic study of 119 manuscripts, from BMC series medical journals, BMJ, BMJ Open, and Annals of Emergency Medicine reporting the results of two-arm parallel-group RCTs. One hundred and nineteen ECRs who had never reviewed an RCT manuscript were recruited from December 2017 to January 2018. Each ECR assessed one manuscript. To assess accuracy in identifying inadequate reporting, we used two tests: (1) ECRs assessing a manuscript using the COBPeer tool (after completing an online training module) and (2) the usual peer-review process. The reference standard was the assessment of the manuscript by two systematic reviewers. Inadequate reporting was defined as incomplete reporting or a switch in primary outcome and considered nine domains: the eight most important CONSORT domains and a switch in primary outcome(s). The primary outcome was the mean number of domains accurately classified (scale from 0 to 9). Results The mean (SD) number of domains (0 to 9) accurately classified per manuscript was 6.39 (1.49) for ECRs using COBPeer versus 5.03 (1.84) for the journal’s usual peer-review process, with a mean difference [95% CI] of 1.36 [0.88–1.84] (p Conclusions Trained ECRs using the COBPeer tool were more likely to detect inadequate reporting in RCTs than the usual peer review processes used by journals. Implementing a two-step peer-review process could help improve the quality of reporting. Trial registration Clinical.Trials.govNCT03119376 (Registered April, 18, 2017).

Published
2019
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4. The PRISMA 2020 statement:An updated guideline for reporting systematic reviews

Author

Matthew J. Page, Elizabeth Loder, Cynthia D. Mulrow, Julie Glanville, Vivian Welch, James Thomas, Patrick M.M. Bossuyt, Larissa Shamseer, Jennifer Tetzlaff, Tammy Hoffmann, Jeremy M. Grimshaw, Isabelle Boutron, David Moher, Asbjørn Hróbjartsson, Manoj M. Lalu, Andrea C. Tricco, Evan Mayo-Wilson, Luke A McGuinness, Joanne E. McKenzie, Penny Whiting, Tianjing Li, Roger Chou, Steve McDonald, Sue E. Brennan, Elie A. Akl, Lesley A. Stewart, Université Paris Cité, Equipe HAL, Monash University [Melbourne], VU University Medical Center [Amsterdam], Equipe 5 : METHODS - Méthodes de l’évaluation thérapeutique des maladies chroniques (CRESS - U1153), Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Conservatoire National des Arts et Métiers [CNAM] (CNAM), HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Conservatoire National des Arts et Métiers [CNAM] (CNAM), HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-HESAM Université - Communauté d'universités et d'établissements Hautes écoles Sorbonne Arts et métiers université (HESAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Bond University [Gold Coast], The University of Texas Health Science Center at Houston (UTHealth), University of Ottawa [Ottawa], Auteur indépendant, McMaster University [Hamilton, Ontario], Oregon Health and Science University [Portland] (OHSU), York Health Economics Consortium, University of York, Centre for Evidence-Based Medicine Odense (CEBMO), Odense University Hospital (OUH), Ottawa Hospital Research Institute [Ottawa] (OHRI), Johns Hopkins Bloomberg School of Public Health [Baltimore], Johns Hopkins University (JHU), Harvard Medical School [Boston] (HMS), Indiana University [Bloomington], Indiana University System, University of Bristol [Bristol], University of York [York, UK], University College of London [London] (UCL), University of Toronto, Epidemiology and Data Science, APH - Methodology, APH - Personalized Medicine, and Conservatoire National des Arts et Métiers [CNAM] (CNAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Conservatoire National des Arts et Métiers [CNAM] (CNAM)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)

Subjects
Research Report, Epidemiology, Computer science, Statement (logic), [SDV]Life Sciences [q-bio], Statistics as Topic, lcsh:Medicine, Medicine (miscellaneous), 030204 cardiovascular system & hematology, Terminology, Guidelines and Guidance, Database and Informatics Methods, Mathematical and Statistical Techniques, 0302 clinical medicine, Medicine and Health Sciences, Medicine, 030212 general & internal medicine, Meta-Analysis as Topic, ComputingMilieux_MISCELLANEOUS, Research reporting guidelines, Evidence-Based Medicine, 030503 health policy & services, Statistics, Reporting guideline, bepress|Medicine and Health Sciences, General Medicine, Research Assessment, Metaanalysis, MetaArXiv|Medicine and Health Sciences, Reproducibility, Checklist, 3. Good health, [SDV] Life Sciences [q-bio], Systematic review, Research Design, Meta-analysis, 030220 oncology & carcinogenesis, Physical Sciences, Practice Guidelines as Topic, 030211 gastroenterology & hepatology, 0305 other medical science, Quality Control, medicine.medical_specialty, MEDLINE, Systematic review methodology, Guidelines as Topic, Health care policy reports, Research and Analysis Methods, Transparency, 03 medical and health sciences, Terminology as Topic, Humans, Medical physics, Statistical Methods, Health care providers, Publishing, Statement (computer science), Medical education, Health Care Policy, business.industry, Research, lcsh:R, Systematic reviews, Guideline, Medical Writing, Database searching, Health Care, Medical risk factors, Surgery, Research Report/standards, business, Mathematics, 030217 neurology & neurosurgery, Systematic Reviews as Topic
Abstract

Background: The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) Statement, published in 2009, was designed to help systematic reviewers transparently report why the review was done, what the authors did and what they found. Over the last decade, there have been many advances in systematic review methodology and terminology, which have necessitated an update to the guideline.Objectives: To develop the PRISMA 2020 statement for reporting systematic reviews.Methods: We reviewed 60 documents with reporting guidance for systematic reviews to generate suggested modifications to the PRISMA 2009 statement. We sought feedback on the suggested modifications through an online survey of 110 systematic review methodologists and journal editors. The results of the review and survey were discussed at a 21-member in-person meeting. Following the meeting, drafts of the PRISMA 2020 checklist, abstract checklist, explanation and elaboration and flow diagram were generated and refined iteratively based on feedback from co-authors and a convenience sample of 15 systematic reviewers.Results: In this statement paper, we present the PRISMA 2020 27-item checklist, an expanded checklist that details reporting recommendations for each item, the PRISMA 2020 abstract checklist, and the revised flow diagrams for original and updated reviews. The checklist includes new reporting guidance that reflects advances in methods to identify, select, appraise and synthesise studies. The structure and presentation of the items have been modified to facilitate implementation. The PRISMA 2020 statement replaces the 2009 statement.Conclusions: The PRISMA 2020 statement is intended to facilitate transparent, complete and accurate reporting of systematic reviews. Improved reporting should benefit users of reviews, including guideline developers, policy makers, health care providers, patients and other stakeholders. In order to achieve this, we encourage authors, editors and peer-reviewers to adopt the guideline.

Published
2021
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6. Journal editors’ perspectives on the roles and tasks of peer reviewers in biomedical journals: a qualitative study

Author

Darko Hren, Ketevan Glonti, Isabelle Boutron, David Moher, Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), University of Split, Ottawa Hospital Research Institute [Ottawa] (OHRI), European Project: 676207,H2020,H2020-MSCA-ITN-2015,MIROR(2016), Lallemant, Christopher, and Methods in Research on Research - MIROR - - H20202016-03-01 - 2020-02-29 - 676207 - VALID

Subjects
Biomedical Research, Process (engineering), biomedical publishing, qualitative research, scientific journal publishing, stakeholder consultation, media_common.quotation_subject, Psychological intervention, Specialty, Context (language use), Guidelines as Topic, 03 medical and health sciences, Interviews, 0302 clinical medicine, Professional Competence, Decline, Medicine, Humans, 030212 general & internal medicine, Human resources, GeneralLiterature_REFERENCE(e.g.,dictionaries,encyclopedias,glossaries), media_common, Original Research, Medical education, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, business.industry, Social nature, General Medicine, Periodicals as Topic, business, 030217 neurology & neurosurgery, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Editorial Policies, Reputation, Qualitative research
Abstract

ObjectivePeer reviewers of biomedical journals are expected to perform a large number of roles and tasks, some of which are seemingly contradictory or demonstrate incongruities between the respective positions of peer reviewers and journal editors. Our aim was to explore the perspectives, expectations and understanding of the roles and tasks of peer reviewers of journal editors from general and specialty biomedical journals.DesignQualitative study.SettingWorldwide.Participants56 journal editors from biomedical journals, most of whom were editors-in-chief (n=39), male (n=40) and worked part-time (n=50) at journals from 22 different publishers.MethodsSemistructured interviews with journal editors were conducted. Recruitment was based on purposive maximum variation sampling. Data were analysed thematically following the methodology by Braun and Clarke.ResultsJournal editors’ understanding of the roles and partly of tasks of peer reviewers are profoundly shaped by each journal’s unique context and characteristics, including financial and human resources and journal reputation or prestige. There was a broad agreement among journal editors on expected technical tasks of peer reviewers related to scientific aspects, but there were different expectations in the level of depth. We also found that most journal editors support the perspective that authorship experience is key to high-quality reviews, while formal training in peer reviewing is not.ConclusionThese journal editors’ accounts reveal issues of a social nature within the peer-review process related to missed opportunities for journal editors to engage with peer reviewers to clarify the expected roles and tasks.Further research is needed on actual performance of peer reviewers looking into the content of peer-reviewer reports to inform meaningful training interventions, journal policies and guidelines.

Published
2019
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7. A protocol of a cross-sectional study evaluating an online tool for early career peer reviewers assessing reports of randomised controlled trials

Author

Chauvin, Anthony, Moher, David, Altman, Doug, Schriger, David L, Alam, Sabina, Hopewell, Sally, Shanahan, Daniel R, Recchioni, Alessandro, Ravaud, Philippe, Boutron, Isabelle, Université Paris Descartes - Faculté de Médecine (UPD5 Médecine), Université Paris Descartes - Paris 5 (UPD5), Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC), Equipe 5 : METHODS - Méthodes de l’évaluation thérapeutique des maladies chroniques (CRESS - U1153), Université Paris Descartes - Paris 5 (UPD5)-Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A_1125 / UMR_S_1153)), Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Université Paris Diderot - Paris 7 (UPD7)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Sorbonne Paris Cité (USPC), Clinical Epidemiology Program, Ottawa Hospital Research Institute [Ottawa] (OHRI), Centre for Statistics in Medicine, University of Oxford [Oxford], University of California [Los Angeles] (UCLA), University of California, Faculty of 1000, London, Biomed Central Ltd, London, Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A 1125)), Institut National de la Recherche Agronomique (INRA) - Université Sorbonne Paris Cité (USPC) - Institut National de la Santé et de la Recherche Médicale (INSERM), Université Paris Descartes - Paris 5 (UPD5) - Centre de Recherche Épidémiologie et Statistique Sorbonne Paris Cité (CRESS (U1153 / UMR_A 1125)), Institut National de la Recherche Agronomique (INRA) - Université Sorbonne Paris Cité (USPC) - Institut National de la Santé et de la Recherche Médicale (INSERM) - Institut National de la Recherche Agronomique (INRA) - Université Sorbonne Paris Cité (USPC) - Institut National de la Santé et de la Recherche Médicale (INSERM), University of California at Los Angeles [Los Angeles] (UCLA), Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Paris Descartes - Paris 5 (UPD5)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de la Recherche Agronomique (INRA)-Université Paris Diderot - Paris 7 (UPD7)-Université Sorbonne Paris Cité (USPC)-Institut National de la Santé et de la Recherche Médicale (INSERM), HAL-UPMC, Gestionnaire, University of Oxford, and University of California (UC)

Subjects
Research Report, reporting, Evidence-Based Medicine, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, [SHS.INFO]Humanities and Social Sciences/Library and information sciences, Publications, education, Medical Writing, biomedical, [SHS.INFO] Humanities and Social Sciences/Library and information sciences, Checklist, Cross-Sectional Studies, Research Design, randomized controlled trials, Humans, protocol, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Randomized Controlled Trials as Topic
Abstract

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.

Published
2017
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