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

By Lucy Turner, Larissa Shamseer, Douglas G. Altman, K. F. Schulz, David Moher. Systematic Reviews, 2012

595 citations recorded by the source corpus.

BackgroundThe 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.MethodsEvaluations 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.ResultsFifty-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.ConclusionsThe 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.

Subfields: General Health Professions, Pharmacology, Statistics and Probability

View Paper: https://www.semanticscholar.org/paper/4d85ee5cb8d93f3b7e86ca3b175176e65ba51950

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Citations in the corpus

The CARE Guidelines: Consensus‐Based Clinical Case Reporting Guideline Development (2013, unknown): “trials and found that CONSORT-endorsing journals consistently have better overall reporting.(13) However, the potential impact of the CONSORT statement and related reporting guidelines has not been fully real-”
A taxonomy of behaviour change methods: an Intervention Mapping approach (2015, unknown): “…most recently updated in 2010 by Schultz, Altman, and Moher for the CONSORT Group) have had substantial impact on the completeness of reporting of study reports, that is, randomised controlled trials (Turner, Shamseer, Altman, Schulz, & Moher, 2012; Turner, Shamseer, Altman, Weeks, et al., 2012).”
CONSORT 2025 statement: updated guideline for reporting randomised trials (2025, unknown): “However, extensive evidence displays that the completeness of reporting of randomised trials is inadequate 2,3 and that incomplete reporting may be associated with biased estimates of intervention effects.”
CARE guidelines for case reports: explanation and elaboration document. (2017, background): “Referencing the guidelines informs the reader of the standards for reporting and facilitates the evaluation of the adherence to the guidelines [28].”
Consolidated Health Economic Evaluation Reporting Standards (CHEERS) Statement (2013, unknown): “Endorsement of guidelines by journals for randomised controlled trials has been shown to improve reporting [6].”
Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement (2013, unknown): “Endorsement of guidelines by journals for randomised controlled trials has been shown to improve reporting [6].”
Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement (2015, methodology): “As has been done for previous reporting guidelines [18,32] we plan to evaluate whether and to what degree”
The CARE guidelines: consensus-based clinical case reporting guideline development (2013, unknown): “Empirical evidence suggests that a journal’s adoption of the CONSORT statement as a guide to authors is associated with an increase in the completeness of published randomized trials [13].”
Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide (2014, unknown): “Properly endorsed and implemented reporting guidelines offer a way for publishers, editors, peer reviewers, and authors to do a better job of completely and transparently describing what was done and found.(28) Doing so will help reduce wasteful research 29,30 and increase the potential”
Consolidated Health Economic Evaluation Reporting Standards (CHEERS)--explanation and elaboration: a report of the ISPOR Health Economic Evaluation Publication Guidelines Good Reporting Practices Task Force. (2013, background): “Endorsement of guidelines by journals has been shown to improve reporting [10].”