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

被引：464

作者：

Lucy Turner

Larissa Shamseer

Douglas G Altman

Kenneth F Schulz

David Moher

机构：

[1] Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa

[2] Centre for Statistics in Medicine, University of Oxford, Oxford

[3] FHI 360, UNC School of Medicine, Quantitative Sciences, Research Triangle Park, NC

[4] Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa

来源：

Systematic Reviews | / 1卷 / 1期

基金：

英国医学研究理事会;

关键词：

Completeness of reporting; CONSORT; Endorsement; Reporting guideline;

D O I：

10.1186/2046-4053-1-60

中图分类号：

学科分类号：

摘要：

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. © 2012 Turner et al.; licensee BioMed Central Ltd.

引用

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