Lack of adherence to guidelines for RCT reporting

First published in 1996, the CONSORT statement and subsequent extensions aim to improve transparent and complete reporting of trials

Endorsement of CONSORT and requirement to include the CONSORT checklist at the time of submission by journals are associated with enhanced quality of trial reporting and peer reviews

Levels of adherence to CONSORT guidelines remain suboptimal, unsatisfactory, inadequate, or poor across various biomedical research fields

Suggestions for improvements: (i) Training of researchers and reviewers on CONSORT principles and the importance of using guidelines in the study design and writing process; (ii) endorsement of CONSORT by journals; (iii) journal requirements for authors to include the CONSORT checklist during manuscript submission; (iv) journal instructions for reviewers to review CONSORT checklist as part of the peer-review process; and (v) educators, healthcare providers, and other research consumers need to be vigilant about the problem of inadequate reporting

Inconsistency between protocols or registrations and full reports of RCTs

Trial registration requirement and trial protocol publication aim to reduce publication bias

Major inconsistencies exist between trial protocols or registrations and corresponding full trial reports across various fields, including outcome measures, subgroup analyses, statistical analyses, and other trial aspects

Results not statistically significant for primary outcomes are significantly associated with more inconsistencies

Suggestions for improvement: (i) Authors need to explain the protocol modifications that occur during trial conduct that may be seen as major discrepancies between full reports and the protocols or registrations; (ii) journal requirements for submission of trial reports should include a list of trial modifications; (iii) journal peer-review process of full trial reports needs to include a careful check of protocols or registrations for discrepancies; and (iv) educators, healthcare providers, and other research consumers need be cautious about the potential for discrepancies

Inconsistency between abstracts and full reports of RCTs

Abstracts usually prepared with the least care; reporting quality of abstracts remains unsatisfactory

Comparison of abstracts with full-text reports show: (i) high levels of abstract inaccuracy across various fields and (ii) a major “spin problem” (defined as an overinterpretation of trial findings in an attempt to show significant results or draw strong conclusions, despite findings for the primary outcome in full reports being clearly not significant)

Suggestions for improvement: (i) Authors need to follow the CONSORT extension for reporting of trial abstracts; (ii) authors need to carefully check the abstract to ensure its accuracy and consistency with findings in the full report; (iii) journal requirements should include instruction for authors to confirm that information in the abstract has been verified against what is reported in the full report; (iv) editorial staff and reviewers need to be cautious about the “spin problem”; and (v) educators, healthcare providers, and other research consumers need to pay particular attention to the wording of conclusions or interpretations of findings

CONSORT, Consolidated Standards of Reporting Trials; RCT, randomized controlled trial.