CONSORT Harms 2022 statement, explanation, and elaboration: updated guideline for the reporting of harms in randomized trials

Junqueira DR, Zorzela L, Golder S, Loke Y, Gagnier JJ, Julious SA, Li T, Mayo-Wilson E, Pham B, Phillips R, Santaguida P, Scherer RW, Gøtzsche PC, Moher D, Ioannidis JPA, Vohra S

In this article, we describe CONSORT Harms 2022 and how it was integrated into the main CONSORT checklist, and elaborate on each item relevant to complete reporting of harms in randomised controlled trials. Until future work from the CONSORT group produces an updated checklist, authors, journal reviewers, and editors of randomised controlled trials should use the integrated checklist presented in this paper.