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Better Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement
Abstract
In response to overwhelming evidence and the consequences of poor-quality reporting of randomized, controlled trials (RCTs), many medical journals and editorial groups have now endorsed the CONSORT (Consolidated Standards of Reporting Trials) statement, a 22-item checklist and flow diagram. Because CONSORT primarily aimed at improving the quality of reporting of efficacy, only 1 checklist item specifically addressed the reporting of safety. Considerable evidence suggests that reporting of harms-related data from RCTs also needs improvement. Members of the CONSORT Group, including journal editors and scientists, met in Montebello, Quebec, Canada, in May 2003 to address this problem. The result is the following document: the standard CONSORT checklist with 10 new recommendations about reporting harms-related issues, accompanying explanation, and examples to highlight specific aspects of proper reporting. We hope that this document, in conjunction with other CONSORT-related materials (http://www.consort-statement.org), will help authors improve their reporting of harms-related data from RCTs. Better reporting will help readers critically appraise and interpret trial results. Journals can support this goal by revising Instructions to Authors so that they refer authors to this document.
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“Most MBI studies use data only from the treatment completers and lack data from long-term follow-ups and dropouts—the groups most likely to have negative effects [56,60].”
From Can mindfulness be too much of a good thing? The value of a middle way (2019) · cites this paper as [60]
In the citing paper
“In addition, very few MBI trials actively measure adverse effects [58], relying instead on passive monitoring, which can underestimate the actual frequency by more than 20-fold [59,60].”
From Can mindfulness be too much of a good thing? The value of a middle way (2019) · cites this paper as [60]
In the citing paper
“the use of means and effect sizes typically obscures individual differences and extreme scores [60].”
From Can mindfulness be too much of a good thing? The value of a middle way (2019) · cites this paper as [60]
In the citing paper
“The recognition that the reporting of harms in randomized controlled trials is unsatisfactory led to the CONSORT group suggesting 10 new recommendations in the reporting of harms [16].”
From The recording of adverse events from psychological treatments in clinical trials: evidence from a review of NIHR-funded trials (2014) · cites this paper as [16]
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Metadata
- Authors
- Ioannidis, J. P. A., Evans, S. J. W., Gøtzsche, P. C., O'Neill, R. T., Altman, D. G., Schulz, K., Moher, D., & for the CONSORT Group*
- Affiliations
- National Health Service (GB)
- Corresponding author
- Ioannidis, John P.A.
- Venue
- Annals of Internal Medicine
- Publisher
- American College of Physicians
- Published
- 2004-11-16
- Volume
- 141
- Issue
- 10
- Pages
- 781-788
- ISSN
- 0003-4819 (ISSN-L)
- 1539-3704
- OpenAlex
- W1986360186
- Cited by
- 1,593
- References
- 73
- Citations by year
- 2026: 55 · 2025: 64 · 2024: 90 · 2023: 76 · 2022: 99 · 2021: 89 · 2020: 111 · 2019: 88 · 2018: 72 · 2017: 73 · 2016: 89 · 2015: 76 · 2014: 87 · 2013: 69 · 2012: 50
- FWCI
- 62.04
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Annals of Internal Medicine (publishedVersion)
- PubMed (publishedVersion)
- DigitalGeorgetown (Georgetown University Library) (submittedVersion)
- 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
- Health Sciences › Nursing › Issues, ethics and legal aspects › Pharmaceutical industry and healthcare
- Keywords
- CONSORT statement, harms reporting, safety reporting, randomized controlled trials, reporting quality, trial reporting checklist, adverse events, author guidelines, critical appraisal
- MeSH terms
- Publishing, Quality Control, Safety, Randomized Controlled Trials as Topic, Evidence-Based Medicine
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