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  • David Moher
Does use of the CONSORT Statement impact the completeness of reporting of randomised controlled trials published in medical journals? A Cochrane review
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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.

Subject:
Health, Medicine and Nursing
Material Type:
Reading
Provider:
Systematic Reviews
Author:
David Moher
Douglas G. Altman
Kenneth F. Schulz
Larissa Shamseer
Lucy Turner
Date Added:
08/07/2020
Does use of the CONSORT Statement impact the completeness of reporting of randomised controlled trials published in medical journals? A Cochrane reviewa
Unrestricted Use
CC BY
Rating

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.

Subject:
Health, Medicine and Nursing
Material Type:
Reading
Provider:
Systematic Reviews
Author:
David Moher
Douglas G Altman
Kenneth F Schulz
Larissa Shamseer
Lucy Turner
Date Added:
08/07/2020
Update on the endorsement of CONSORT by high impact factor journals: a survey of journal “Instructions to Authors” in 2014
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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 research aims to provide an update on the endorsement of CONSORT by high impact medical journals. Methods We 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. Results Sixty-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. Conclusions The 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.

Subject:
Health, Medicine and Nursing
Material Type:
Reading
Provider:
Trials
Author:
David Moher
Douglas G. Altman
Kenneth F. Schulz
Larissa Shamseer
Sally Hopewell
Date Added:
08/07/2020