CONSORT Harms 2022 statement, explanation, and elaboration: updated guideline for the reporting of harms in randomized trials.
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Published version
Author(s)
Type
Journal Article
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.
Date Issued
2023-06
Date Acceptance
2023-03-21
Citation
Journal of Clinical Epidemiology, 2023, 158, pp.149-165
ISSN
0895-4356
Publisher
Elsevier
Start Page
149
End Page
165
Journal / Book Title
Journal of Clinical Epidemiology
Volume
158
Copyright Statement
© 2023 Published by Elsevier Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/
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Identifier
https://www.ncbi.nlm.nih.gov/pubmed/37100738
PII: S0895-4356(23)00090-2
Subjects
Adverse Drug Reaction
Adverse Effects
Adverse Events
Checklist
Harms
Randomized clinical trials
Reporting guideline
Reproducibility
Side Effects
Transparency
Publication Status
Published
Coverage Spatial
United States
Date Publish Online
2023-04-24