title: Better reporting of harms in randomized trials: an extension of the CONSORT statement.
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 (http://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.
authors.affiliation: University of Ioannina School of Medicine and Biomedical Research Institute, Foundation for Research and Technology-Hellas, Ioannina, Greece.
authors.forename: John P A
authors.initials: JP
authors.lastname: Ioannidis
authors.forename: Stephen J W
authors.initials: SJ
authors.lastname: Evans
authors.forename: Peter C
authors.initials: PC
authors.lastname: Gøtzsche
authors.forename: Robert T
authors.initials: RT
authors.lastname: O'Neill
authors.forename: Douglas G
authors.initials: DG
authors.lastname: Altman
authors.forename: Kenneth
authors.initials: K
authors.lastname: Schulz
authors.forename: David
authors.initials: D
authors.lastname: Moher
mesh_terms: D019317:Evidence-Based Medicine; D011643:Publishing / Q000592:standards*; D011786:Quality Control; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D012449:Safety