CONSORT Extension for Better Reporting of Harms

The extension of the Consolidated Standards of Reporting Trials (CONSORT) statement for better reporting of harms in randomized trials is a guidance document for authors reporting randomized trials, with emphasis on how to best report aspects of harm-related data. The extension can be used by authors who wish to improve the quality of information that they include in a trial report, by peer reviewers and editors reviewing a submitted report of a randomized trial, and by readers who want to understand the completeness and validity of harm-related information in a randomized trial report. The extension for better reporting of harms is aimed at those reporting randomized controlled trials. This chapter discusses how best to use the guideline. Peer reviewers often pay limited attention to harms when appraising a randomized trial for publication. Authors should present results separately for each arm of the trial, otherwise the comparative information is lost.