CONSORT Harms update

In September of 2019, members of the Adverse Effects Methods Group, along with other experts, met in Edmonton, Canada, for the consensus meeting of the update of CONSORT Harms.

CONSORT Harms is an extension to CONSORT published in 2004. In 2017, a review of the literature was performed and found that the reporting of harms in randomised controlled trials (RCTs) remains inadequate. This prompted the formation of an initiative to update CONSORT Harms by deploying a modified Delphi survey comprising two electronic rounds and one in-person meeting.

The project, which started in 2017, is coordinated by Daniela Junqueira and is supported by a steering committee formed by Liliane Zorzela, Yoon Loke, Su Golder, David Moher, Stephen Evans, Peter Gotzsche, John Ioannidis, Sunita Vohra. The results of the review of the reporting on harms in clinical trials and the CONSORT Harms update are being prepared for submission and will hopefully be publicly available in 2021.

The participants in the consensus meeting.