The influence of CONSORT on the quality of reporting of RCTs: An updated systematic review

Article type
Authors
Turner L1, Moher D1, Shamseer L1, Weeks L1, Peters J1, Plint A2, Altman D3, Schulz K4
1Ottawa Hospital Research Institute, Ottawa, Canada
2Children’s Hospital of Eastern Ontario, Canada
3University of Oxford, UK
4FHI, USA
Abstract
Background: The Consolidated Standards of Reporting Trials (CONSORT) statement was developed in response to concerns about the quality of reporting of randomized controlled trials (RCTs). It is an evidence-based minimum set of recommendations for reporting RCTs, intended to facilitate complete and transparent reporting and aid in critical appraisal and interpretation. A 2006 systematic review examining the effectiveness of CONSORT for improving the reporting of RCTs in endorsing journals (i.e. those which, at minimum, recommend that authors use CONSORT), found CONSORT endorsement to be associated with better quality of reporting, despite poor methodology of some included studies. Five years on from the publication of that review, an update is needed.

Objective: To update the systematic review of CONSORT effectiveness by Plint et al.

Methods: Conventional systematic review methods employed in the original review were followed. The search for new comparative studies evaluating the quality of reporting of RCTs spanned August 2005 to March 2010. Two reviewers independently screened studies for eligibility; data extraction and study validity assessments were conducted by a single reviewer and verified by a second reviewer.

Results: In the five year period since publication of the original review, 41 new eligible studies were identified in addition to the eight included in the original review. When comparing endorsing and non-endorsing journals, items such as sequence generation, allocation concealment and participant flow were reported better in those endorsing CONSORT. Further details of the comparison between endorsers and non-endorsers as well as between trials published before and after CONSORT publication (both 1996 and 2001) will be presented.

Conclusions: This review will provide further evidence on whether CONSORT is effective at improving the reporting of RCTs. This information will be helpful to authors, peer-reviewers and journal editors in helping to decide whether to endorse CONSORT.