Better Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement

TLDR

The CONSORT statement, endorsed by many journals, improves trial reporting but originally addressed only efficacy, leaving safety reporting inadequately covered, and evidence shows harms data remain poorly reported. This extension aims to enhance authors’ reporting of harms in RCTs, thereby enabling readers to better appraise and interpret trial outcomes. The CONSORT Group convened in 2003 to develop the extension, and journals can promote it by updating their Instructions to Authors to reference the new guidance. The resulting document adds ten new recommendations, explanations, and examples to the standard checklist to guide proper harms reporting. Appendix 1 lists the CONSORT Group members.

Abstract

In response to overwhelming evidence and the consequences of poor-quality reporting of randomized, controlled trials (RCTs), many medical journals and editorial groups have now endorsed the CONSORT (Consolidated Standards of Reporting Trials) statement, a 22-item checklist and flow diagram. Because CONSORT primarily aimed at improving the quality of reporting of efficacy, only 1 checklist item specifically addressed the reporting of safety. Considerable evidence suggests that reporting of harms-related data from RCTs also needs improvement. Members of the CONSORT Group, including journal editors and scientists, met in Montebello, Quebec, Canada, in May 2003 to address this problem. The result is the following document: the standard CONSORT checklist with 10 new recommendations about reporting harms-related issues, accompanying explanation, and examples to highlight specific aspects of proper reporting. We hope that this document, in conjunction with other CONSORT-related materials (www.consort-statement.org), will help authors improve their reporting of harms-related data from RCTs. Better reporting will help readers critically appraise and interpret trial results. Journals can support this goal by revising Instructions to Authors so that they refer authors to this document. *For a list of members of the CONSORT Group, see Appendix 1.