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Does use of the CONSORT Statement impact the completeness of reporting of randomised controlled trials published in medical journals? A Cochrane reviewa

Lucy Turner1, Larissa Shamseer1, Douglas G Altman2, Kenneth F Schulz3 and David Moher14*

Author Affiliations

1 Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada

2 Centre for Statistics in Medicine, University of Oxford, Oxford, UK

3 FHI 360 and UNC School of Medicine, Quantitative Sciences, Research Triangle Park, NC, USA

4 Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Canada

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Systematic Reviews 2012, 1:60  doi:10.1186/2046-4053-1-60

Published: 29 November 2012

Abstract

Background

The Consolidated Standards of Reporting Trials (CONSORT) Statement is intended to facilitate better reporting of randomised clinical trials (RCTs). A systematic review recently published in the Cochrane Library assesses whether journal endorsement of CONSORT impacts the completeness of reporting of RCTs; those findings are summarised here.

Methods

Evaluations assessing the completeness of reporting of RCTs based on any of 27 outcomes formulated based on the 1996 or 2001 CONSORT checklists were included; two primary comparisons were evaluated. The 27 outcomes were: the 22 items of the 2001 CONSORT checklist, four sub-items describing blinding and a ‘total summary score’ of aggregate items, as reported. Relative risks (RR) and 99% confidence intervals were calculated to determine effect estimates for each outcome across evaluations.

Results

Fifty-three reports describing 50 evaluations of 16,604 RCTs were assessed for adherence to at least one of 27 outcomes. Sixty-nine of 81 meta-analyses show relative benefit from CONSORT endorsement on completeness of reporting. Between endorsing and non-endorsing journals, 25 outcomes are improved with CONSORT endorsement, five of these significantly (α = 0.01). The number of evaluations per meta-analysis was often low with substantial heterogeneity; validity was assessed as low or unclear for many evaluations.

Conclusions

The results of this review suggest that journal endorsement of CONSORT may benefit the completeness of reporting of RCTs they publish. No evidence suggests that endorsement hinders the completeness of RCT reporting. However, despite relative improvements when CONSORT is endorsed by journals, the completeness of reporting of trials remains sub-optimal. Journals are not sending a clear message about endorsement to authors submitting manuscripts for publication. As such, fidelity of endorsement as an ‘intervention’ has been weak to date. Journals need to take further action regarding their endorsement and implementation of CONSORT to facilitate accurate, transparent and complete reporting of trials.

Keywords:
CONSORT; Endorsement; Reporting guideline; Completeness of reporting