Does use of the CONSORT Statement impact the completeness of reporting of randomised controlled trials published in medical journals? A Cochrane review<sup>a</sup>

<p>Abstract</p> <p>Background</p> <p>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 journ...

Full description

Bibliographic Details
Main Authors: Turner Lucy, Shamseer Larissa, Altman Douglas G, Schulz Kenneth F, Moher David
Format: Article
Language:English
Published: BMC 2012-11-01
Series:Systematic Reviews
Subjects:
Online Access:http://www.systematicreviewsjournal.com/content/1/1/60
_version_ 1819175302780157952
author Turner Lucy
Shamseer Larissa
Altman Douglas G
Schulz Kenneth F
Moher David
author_facet Turner Lucy
Shamseer Larissa
Altman Douglas G
Schulz Kenneth F
Moher David
author_sort Turner Lucy
collection DOAJ
description <p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods</p> <p>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.</p> <p>Results</p> <p>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.</p> <p>Conclusions</p> <p>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.</p>
first_indexed 2024-12-22T20:52:43Z
format Article
id doaj.art-d5c88f14ff014bf4a1ae23928bd66cd3
institution Directory Open Access Journal
issn 2046-4053
language English
last_indexed 2024-12-22T20:52:43Z
publishDate 2012-11-01
publisher BMC
record_format Article
series Systematic Reviews
spelling doaj.art-d5c88f14ff014bf4a1ae23928bd66cd32022-12-21T18:13:03ZengBMCSystematic Reviews2046-40532012-11-01116010.1186/2046-4053-1-60Does use of the CONSORT Statement impact the completeness of reporting of randomised controlled trials published in medical journals? A Cochrane review<sup>a</sup>Turner LucyShamseer LarissaAltman Douglas GSchulz Kenneth FMoher David<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods</p> <p>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.</p> <p>Results</p> <p>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.</p> <p>Conclusions</p> <p>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.</p>http://www.systematicreviewsjournal.com/content/1/1/60CONSORTEndorsementReporting guidelineCompleteness of reporting
spellingShingle Turner Lucy
Shamseer Larissa
Altman Douglas G
Schulz Kenneth F
Moher David
Does use of the CONSORT Statement impact the completeness of reporting of randomised controlled trials published in medical journals? A Cochrane review<sup>a</sup>
Systematic Reviews
CONSORT
Endorsement
Reporting guideline
Completeness of reporting
title Does use of the CONSORT Statement impact the completeness of reporting of randomised controlled trials published in medical journals? A Cochrane review<sup>a</sup>
title_full Does use of the CONSORT Statement impact the completeness of reporting of randomised controlled trials published in medical journals? A Cochrane review<sup>a</sup>
title_fullStr Does use of the CONSORT Statement impact the completeness of reporting of randomised controlled trials published in medical journals? A Cochrane review<sup>a</sup>
title_full_unstemmed Does use of the CONSORT Statement impact the completeness of reporting of randomised controlled trials published in medical journals? A Cochrane review<sup>a</sup>
title_short Does use of the CONSORT Statement impact the completeness of reporting of randomised controlled trials published in medical journals? A Cochrane review<sup>a</sup>
title_sort does use of the consort statement impact the completeness of reporting of randomised controlled trials published in medical journals a cochrane review sup a sup
topic CONSORT
Endorsement
Reporting guideline
Completeness of reporting
url http://www.systematicreviewsjournal.com/content/1/1/60
work_keys_str_mv AT turnerlucy doesuseoftheconsortstatementimpactthecompletenessofreportingofrandomisedcontrolledtrialspublishedinmedicaljournalsacochranereviewsupasup
AT shamseerlarissa doesuseoftheconsortstatementimpactthecompletenessofreportingofrandomisedcontrolledtrialspublishedinmedicaljournalsacochranereviewsupasup
AT altmandouglasg doesuseoftheconsortstatementimpactthecompletenessofreportingofrandomisedcontrolledtrialspublishedinmedicaljournalsacochranereviewsupasup
AT schulzkennethf doesuseoftheconsortstatementimpactthecompletenessofreportingofrandomisedcontrolledtrialspublishedinmedicaljournalsacochranereviewsupasup
AT moherdavid doesuseoftheconsortstatementimpactthecompletenessofreportingofrandomisedcontrolledtrialspublishedinmedicaljournalsacochranereviewsupasup