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

Daniela R Junqueira; Liliane Zorzela; Susan Golder; Yoon Loke; Joel J Gagnier; Steven A Julious; Tianjing Li; Evan Mayo-Wilson; Ba Pham; Rachel Phillips; Pasqualina Santaguida; Roberta W Scherer; Peter C Gøtzsche; David Moher; John P A Ioannidis; Sunita Vohra; CONSORT Harms Group

doi:10.1016/j.jclinepi.2023.04.005

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

J Clin Epidemiol. 2023 Jun:158:149-165. doi: 10.1016/j.jclinepi.2023.04.005. Epub 2023 Apr 24.

Authors

Daniela R Junqueira¹, Liliane Zorzela¹, Susan Golder², Yoon Loke³, Joel J Gagnier⁴, Steven A Julious⁵, Tianjing Li⁶, Evan Mayo-Wilson⁷, Ba Pham⁸, Rachel Phillips⁹, Pasqualina Santaguida¹⁰, Roberta W Scherer¹¹, Peter C Gøtzsche¹², David Moher¹³, John P A Ioannidis¹⁴, Sunita Vohra¹⁵; CONSORT Harms Group

Collaborators

CONSORT Harms Group:
Stephen Evans, Ann Fonfa, Thomas A Lang, Elizabeth Loder, Laura Weeks

Affiliations

¹ Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada.
² Department of Health Sciences, University of York, York, UK.
³ Norwich Medical School, University of East Anglia, Norwich, UK.
⁴ Department of Epidemiology and Biostatistics, Department of Surgery, Western University, London, Ontario, Canada.
⁵ Design, Trials and Statistics, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK.
⁶ Department of Ophthalmology, School of Medicine, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO, USA; Department of Epidemiology, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
⁷ Department of Epidemiology, UNC Gillings School of Global Public Health, Chapel Hill, NC, USA.
⁸ Knowledge Translation Programme, Unity Health Toronto, Toronto, Ontario, Canada.
⁹ Faculty of Medicine, School of Public Health, Imperial College London, London, UK.
¹⁰ Department of Health Research Methods, Evidence and Impact (HEI), McMaster University, Hamilton, Ontario, Canada.
¹¹ Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.
¹² Institute for Scientific Freedom, Hørsholm, Denmark.
¹³ Centre for Journalology, Clinical Epidemiology Programme, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada; School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada.
¹⁴ Departments of Medicine, of Epidemiology and Population Health, of Biomedical Data Science, and of Statistics, Stanford University, Stanford, CA, USA.
¹⁵ Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada. Electronic address: svohra@ualberta.ca.

PMID: 37100738
DOI: 10.1016/j.jclinepi.2023.04.005

Abstract

Randomized controlled trials remain the reference standard for healthcare research on effects of interventions, and the need to report both benefits and harms is essential. The Consolidated Standards of Reporting Trials (the main CONSORT) statement includes one item on reporting harms (i.e., all important harms or unintended effects in each group). In 2004, the CONSORT group developed the CONSORT Harms extension; however, it has not been consistently applied and needs to be updated. Here, we describe CONSORT Harms 2022, which replaces the CONSORT Harms 2004 checklist, and shows how CONSORT Harms 2022 items could be incorporated into the main CONSORT checklist. Thirteen items from the main CONSORT were modified to improve harms reporting. Three new items were added. 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 randomized controlled trials. Until future work from the CONSORT group produces an updated checklist, authors, journal reviewers, and editors of randomized controlled trials should use the integrated checklist presented in this paper.

Keywords: Adverse Drug Reaction; Adverse Effects; Adverse Events; Checklist; Harms; Randomized clinical trials; Reporting guideline; Reproducibility; Side Effects; Transparency.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Checklist*
Humans
Publishing*
Randomized Controlled Trials as Topic
Reference Standards
Research Design
Research Report

Associated data

figshare/10.6084/m9.figshare.5375026.v1