CONSORT Harms 2022 statement, explanation, and elaboration: updated guideline for the reporting of harms in randomized trials
Open accessAbstract
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.
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Items related to reporting of how harms were assessed and analysed (items 7, 15, 21a, 23a, 27), how outcomes were measured and analysed (items 14, 26), and how the intervention and comparator were actually administered and by whom (item 24) were integrated from key CONSORT extensions.
“- Addition of items related to reporting of how harms [24] were assessed and analysed (items 7, 15, 21a, 23a, 27), how outcomes [25] were measured and analysed (items 14, 26), and how the intervention [27,28] and comparator were actually administered and by whom (item 24).”
From CONSORT 2025 statement: Updated guideline for reporting randomised trials (2025) · cites this paper as [24]
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Experimental — accuracy not yet measuredThe update process led to the addition of two new protocol items, revision to five items, deletion of three items, merger of two items, and integration of key items from other relevant reporting guidelines.
“The process led to the addition of two new protocol items, revision to five items, deletion/merger of five items, and integration of key items from other relevant reporting guidelines.”
From SPIRIT 2025 statement: updated guideline for protocols of randomised trials (2025) · cites this paper as [24]
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References 83 · Cited by 67
Research works printed but not linked: 2
- Zarin DA, Tse T, Williams RJ, Califf RM, Ide NC. The Clinical- Trials.gov results databasedupdate and key issues. N Engl J Med 2011;364:852e60.
- McGauran N, Wieseler B, Kreis J, Sch€ uler YB, K€ olsch H, Kaiser T. Reporting bias in medical researchda narrative review. Trials 2010; 11:37.
- Authors
- Junqueira, D. R., Zorzela, L., Golder, S., Loke, Y., Gagnier, J. J., Julious, S. A., Li, T., Mayo-Wilson, E., Pham, B., Phillips, R., Santaguida, P., Scherer, R. W., Gøtzsche, P. C., Moher, D., Ioannidis, J. P. A., Vohra, S., Evans, S., Fonfa, A., Lang, T. A., Loder, E., & Weeks, L.
- Affiliations
- University of Alberta (CA)
- University of East Anglia (GB)
- Western University (CA)
- University of Sheffield (GB)
- Colorado School of Public Health (US)
- Unity Health Toronto (CA)
- Imperial College London (GB)
- McMaster University (CA)
- Johns Hopkins University (US)
- University of Ottawa (CA)
- Stanford University (US)
- Corresponding author
- Vohra, Sunita
- ORCID
- Venue
- Journal of Clinical Epidemiology
- Publisher
- Elsevier BV
- Published
- 2023-06
- Volume
- 158
- Pages
- 149-165
- ISSN
- 0895-4356 (ISSN-L)
- OpenAlex
- W4366817706
- Cited by
- 67
- References
- 83
- Citations by year
- 2026: 20 · 2025: 34 · 2024: 9 · 2023: 4
- FWCI
- 12.43
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Journal of Clinical Epidemiology (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- White Rose Research Online (University of Leeds, The University of Sheffield, University of York) (acceptedVersion, other-oa)
- Spiral (Imperial College London) (submittedVersion, cc-by-nc-nd)
- Funders
- Northern Alberta Clinical Trials and Research Centre
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Social Sciences › Sociology and Political Science › Delphi Technique in Research
- Keywords
- harms reporting, randomized controlled trials, reporting guidelines, CONSORT checklist, adverse events, unintended consequences, trial reporting quality
- MeSH terms
- Humans, Publishing, Reference Standards, Research Design, Randomized Controlled Trials as Topic, Guidelines as Topic, Checklist, Research Report
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