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

被引:20
作者
Speich, Benjamin [1 ,2 ]
Schroter, Sara [3 ]
Briel, Matthias [2 ,4 ]
Moher, David [5 ,6 ]
Puebla, Iratxe [7 ]
Clark, Alejandra [7 ]
Schlussel, Michael Maia [1 ,8 ]
Ravaud, Philippe [9 ,10 ]
Boutron, Isabelle [9 ,10 ]
Hopewell, Sally [1 ]
机构
[1] Univ Oxford, Nuffield Dept Orthopaed Rheumatol & Musculoskelet, Ctr Stat Med, Oxford, England
[2] Univ Basel, Univ Hosp Basel, Dept Clin Res, Basel Inst Clin Epidemiol & Biostat, Basel, Switzerland
[3] BMJ, London, England
[4] McMaster Univ, Dept Hlth Res Methods Evidence & Impact, Hamilton, ON, Canada
[5] Ottawa Hosp, Res Inst, Clin Epidemiol Program, Ctr Journalol, Ottawa, ON, Canada
[6] Univ Ottawa, Fac Med, Sch Epidemiol & Publ Hlth, Ottawa, ON, Canada
[7] PLOS ONE, Publ Lib Sci, Cambridge, England
[8] EQUATOR Network, Oxford, England
[9] Univ Paris, CRESS, Inserm, INRA, F-75004 Paris, France
[10] Hop Hotel Dieu, AP HP, Ctr Epidemiol Clin, Paris, France
基金
瑞士国家科学基金会;
关键词
GUIDELINES; EQUATOR;
D O I
10.1136/bmjopen-2019-035114
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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).
引用
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页数:10
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共 32 条
[1]   EQUATOR: reporting guidelines for health research [J].
Altman, Douglas G. ;
Simera, Iveta ;
Hoey, John ;
Moher, David ;
Schutz, Ken .
LANCET, 2008, 371 (9619) :1149-1150
[2]   A history of the evolution of guidelines for reporting medical research: the long road to the EQUATOR Network [J].
Altman, Douglas G. ;
Simera, Iveta .
JOURNAL OF THE ROYAL SOCIETY OF MEDICINE, 2016, 109 (02) :67-77
[3]  
[Anonymous], 2010, BMJ BRIT MED J, DOI DOI 10.1136/BMJ.C723
[4]   Impact of an online writing aid tool for writing a randomized trial report: the COBWEB (Consort-based WEB tool) randomized controlled trial [J].
Barnes, Caroline ;
Boutron, Isabelle ;
Giraudeau, Bruno ;
Porcher, Raphael ;
Altman, Douglas G. ;
Ravaud, Philippe .
BMC MEDICINE, 2015, 13
[5]   Scoping review on interventions to improve adherence to reporting guidelines in health research [J].
Blanco, David ;
Altman, Doug ;
Moher, David ;
Boutron, Isabelle ;
Kirkham, Jamie J. ;
Cobo, Erik .
BMJ OPEN, 2019, 9 (05)
[6]   Reporting and Interpretation of Randomized Controlled Trials With Statistically Nonsignificant Results for Primary Outcomes [J].
Boutron, Isabelle ;
Dutton, Susan ;
Ravaud, Philippe ;
Altman, Douglas G. .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2010, 303 (20) :2058-2064
[7]   Unbiased, relevant, and reliable assessments in health care - Important progress during the past century, but plenty of scope for doing better [J].
Chalmers, I .
BMJ-BRITISH MEDICAL JOURNAL, 1998, 317 (7167) :1167-1168
[8]   Avoidable waste in the production and reporting of research evidence [J].
Chalmers, Iain ;
Glasziou, Paul .
LANCET, 2009, 374 (9683) :86-89
[9]   SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials [J].
Chan, An-Wen ;
Tetzlaff, Jennifer M. ;
Gotzsche, Peter C. ;
Altman, Douglas G. ;
Mann, Howard ;
Berlin, Jesse A. ;
Dickersin, Kay ;
Hrobjartsson, Asbjorn ;
Schulz, Kenneth F. ;
Parulekar, Wendy R. ;
Krleza-Jeric, Karmela ;
Laupacis, Andreas ;
Moher, David .
BMJ-BRITISH MEDICAL JOURNAL, 2013, 346
[10]   Empirical evidence for selective reporting of outcomes in randomized trials -: Comparison of Protocols to published articles [J].
Chan, AW ;
Hróbjartsson, A ;
Haahr, MT ;
Gotzsche, PC ;
Altman, DG .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2004, 291 (20) :2457-2465