Abstract
BackgroundThe CONSORT Statement provides recommendations for reporting randomized controlled trials. We assessed the extent to which leading medical journals that publish reports of randomized trials incorporate the CONSORT recommendations into their journal and editorial processes.MethodsThis article reports on two observational studies. Study 1: We examined the online version of 'Instructions to Authors' for 165 high impact factor medical journals and extracted all text mentioning the CONSORT Statement or CONSORT extension papers. Any mention of the International Committee of Medical Journal Editors (ICMJE) or clinical trial registration were also sought and extracted. Study 2: We surveyed the editor-in-chief, or editorial office, for each of the 165 journals about their journal's endorsement of CONSORT recommendations and its incorporation into their editorial and peer-review processes.ResultsStudy 1: Thirty-eight percent (62/165) of journals mentioned the CONSORT Statement in their online 'Instructions to Authors'; of these 37% (23/62) stated this was a requirement, 63% (39/62) were less clear in their recommendations. Very few journals mentioned the CONSORT extension papers. Journals that referred to CONSORT were more likely to refer to ICMJE guidelines (RR 2.16; 95% CI 1.51 to 3.08) and clinical trial registration (RR 3.67; 95% CI 2.36 to 5.71) than those journals which did not.Study 2: Thirty-nine percent (64/165) of journals responded to the on-line survey, the majority were journal editors. Eighty-eight percent (50/57) of journals recommended authors comply with the CONSORT Statement; 62% (35/56) said they would require this. Forty-one percent (22/53) reported incorporating CONSORT into their peer-review process and 47% (25/53) into their editorial process. Eighty-one percent (47/58) reported including CONSORT in their 'Instructions to Authors' although there was some inconsistency when cross checking information on the journal's website. Sixty-nine percent (31/45) of journals recommended authors comply with the CONSORT extension for cluster trials, 60% (27/45) for harms and 42% (19/45) for non-inferiority and equivalence trials. Few journals mentioned these extensions in their 'Instructions to Authors'.ConclusionJournals should be more explicit in their recommendations and expectations of authors regarding the CONSORT Statement and related CONSORT extensions papers.
Highlights
The CONSORT Statement provides recommendations for reporting randomized controlled trials
Journals should be more explicit in their recommendations and expectations of authors regarding the CONSORT Statement and related CONSORT extensions papers
It is over ten years since the CONSORT (Consolidated Standards of Reporting Trials) Statement was first published in 1996 [1] providing recommendations for reporting parallel group randomized controlled trials (RCTs)
Summary
The CONSORT Statement provides recommendations for reporting randomized controlled trials. We assessed the extent to which leading medical journals that publish reports of randomized trials incorporate the CONSORT recommendations into their journal and editorial processes It is over ten years since the CONSORT (Consolidated Standards of Reporting Trials) Statement was first published in 1996 [1] providing recommendations for reporting parallel group randomized controlled trials (RCTs). CONSORT provides recommendations for authors regarding how to prepare reports of trial findings, facilitating their complete and transparent reporting, and aiding their critical appraisal and interpretation. It has been endorsed by the World Association of Medical Editors (WAME), the International Committee of Medical Journal Editors (ICMJE), the Council of Science Editors (CSE), and well over 200 journals worldwide [2]. These included the CONSORT extensions for cluster trials [4], non-inferiority and equivalence trials [5], herbal interventions [6], non-pharmacological interventions [7], abstracts [8] and harms [9]
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