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

The CONSORT Harm is an extension of CONSORT guidelines providing specific guidance for the complete reporting of harms in randomised controlled trials. CONSORT Harms 2022 replaces the CONSORT Harms 2004 checklist: 13 items were modified to improve harms reporting and 3 new items were added. This paper presents the final integrated list that should be used as checklist by authors of RCTs.

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Recommended on behalf of EASE by Silvia Maina, Italy

Written by: Junqueira DR, Zorzela L, Golder S, et al; CONSORT Harms Group.

BMJ. 2023 Apr 24;381:e073725. doi: 10.1136/bmj-2022-073725. PMID: 37094878.