Commentary: Time to improve the reporting of harms in randomized controlled trials

Junqueira DR, Phillips R, Zorzela L, Golder S, Loke Y, Moher D, Ioannidis JPA, Vohra S

This article describes an overview of reviews to analyse changes in the reporting of harms in RCTs, in relation to the milestone of the publication of the CONSORT Harms guidance in 2004. Results showed that, overall, there has been only a slight improvement in the reporting of harms in clinical trials post publication of CONSORT Harms, and the reporting of harms in RCTs re- mains suboptimal as most trials report less than half of the CONSORT Harms items. We call for an update of CONSORT Harms to better align the reporting of harm outcomes with those of efficacy outcomes.