Abstract
BackgroundThe CONsolidated Standards Of Reporting Trials (CONSORT) Statement provides a minimum standard set of items to be reported in published clinical trials; it has received widespread recognition within the biomedical publishing community. This research aims to provide an update on the endorsement of CONSORT by high impact medical journals.MethodsWe performed a cross-sectional examination of the online “Instructions to Authors” of 168 high impact factor (2012) biomedical journals between July and December 2014. We assessed whether the text of the “Instructions to Authors” mentioned the CONSORT Statement and any CONSORT extensions, and we quantified the extent and nature of the journals’ endorsements of these. These data were described by frequencies. We also determined whether journals mentioned trial registration and the International Committee of Medical Journal Editors (ICMJE; other than in regards to trial registration) and whether either of these was associated with CONSORT endorsement (relative risk and 95 % confidence interval). We compared our findings to the two previous iterations of this survey (in 2003 and 2007). We also identified the publishers of the included journals.ResultsSixty-three percent (106/168) of the included journals mentioned CONSORT in their “Instructions to Authors.” Forty-four endorsers (42 %) explicitly stated that authors “must” use CONSORT to prepare their trial manuscript, 38 % required an accompanying completed CONSORT checklist as a condition of submission, and 39 % explicitly requested the inclusion of a flow diagram with the submission. CONSORT extensions were endorsed by very few journals. One hundred and thirty journals (77 %) mentioned ICMJE, and 106 (63 %) mentioned trial registration.ConclusionsThe endorsement of CONSORT by high impact journals has increased over time; however, specific instructions on how CONSORT should be used by authors are inconsistent across journals and publishers. Publishers and journals should encourage authors to use CONSORT and set clear expectations for authors about compliance with CONSORT.
Highlights
The CONsolidated Standards Of Reporting Trials (CONSORT) Statement provides a minimum standard set of items to be reported in published clinical trials; it has received widespread recognition within the biomedical publishing community
This study provides an up-to-date assessment of the extent and nature of CONSORT endorsement in high impact factor journals in 2014 and describes changes in endorsement over time
While we aimed to examine endorsement of any official CONSORT extensions, we recognize that some types of trials for which CONSORT extensions exist may be published in niche journals not included in our sample [19]
Summary
The CONsolidated Standards Of Reporting Trials (CONSORT) Statement provides a minimum standard set of items to be reported in published clinical trials; it has received widespread recognition within the biomedical publishing community. The CONsolidated Standards Of Reporting Trials (CONSORT) guideline was first published 20 years ago. Since that time, it has received widespread attention, including being lauded as a twentieth century milestone in health research methodology [1]. Perhaps a more reflective measure of CONSORT uptake, is the Shamseer et al Trials (2016) 17:301 support from a number of major editorial organizations (i.e., the International Committee of Medical Journal Editors, Committee on Publication Ethics, and World Association of Medical Editors) and its endorsement by more than 600 biomedical journals. Endorsement of CONSORT is typically demonstrated by a statement in a journal’s “Instructions to Authors” indicating support for CONSORT or a recommendation or requirement for authors to adhere to CONSORT when submitting a manuscript of a randomized trial for publication consideration
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