The DOI matches its Crossref record; 15 of the 15 references it cites were found in a registry or an index.
Reporting of Harm in Randomized, Controlled Trials of Nonpharmacologic Treatment for Rheumatic Disease
Abstract
BACKGROUND: Reports of clinical trials usually emphasize benefits and give less attention to harms. PURPOSE: To compare the reporting of harm in trials of pharmacologic and nonpharmacologic treatment. DATA SOURCES: MEDLINE and the Cochrane Central Register of Controlled Trials. STUDY SELECTION: Reports of randomized, controlled trials assessing treatment of rheumatic disease that were published between January 1999 and January 2005. DATA EXTRACTION: A standardized abstraction form was used to extract data. DATA SYNTHESIS: 193 articles were analyzed. After adjustment for medical area, sample size, funding source, and multicenter trials, data on harm were more often described in pharmacologic treatment reports than in nonpharmacologic treatment reports in reporting adverse events (odds ratio, 5.2 [95% CI, 2.1 to 12.9]), reporting withdrawals due to adverse events (odds ratio, 4.6 [CI, 2.0 to 10.9]), reporting severity (odds ratio, 3.7 [CI, 1.5 to 9.1]), and allocating space for describing harm (odds ratio, 1.6 [CI, 1.2 to 2.3]). LIMITATIONS: Extrapolating results to trials in areas other than rheumatic disease is questionable. CONCLUSIONS: The lack of reporting harm in trials assessing nonpharmacologic treatment in rheumatic disease is an important barrier to evaluating the benefit-harm balance of nonpharmacologic treatments.
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“Despite these injunctions, there remain inadequacies of adverse event reporting in non-pharmacological interventions in general and particularly in mental health trials.”
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 [19]
In the citing paper
“Ethgen et al. [19] showed that in the reporting of harms, withdrawals due to adverse events and severity were more frequent in pharmacological compared with non-pharmacological treatments in rheumatoid arthritis and osteoarthritis.”
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 [19]
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Cites
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The Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration
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Better Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement
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Association of Journal Quality Indicators With Methodological Quality of Clinical Research Articles
Lee, K. P. (2002) · JAMA · doi:10.1001/jama.287.21.2805 · Cited by 284
Neurologic complications following chiropractic manipulation
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Reporting of Adverse Effects in Clinical Trials Should Be Improved
Edwards, J. E., McQuay, H. J., Moore, R. A., & Collins, S. (1999) · Journal of Pain and Symptom Management · doi:10.1016/s0885-3924(99)00093-7 · Cited by 165
Reporting of adverse drug reactions in randomised controlled trials – a systematic survey
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Reporting methods of blinding in randomized trials assessing nonpharmacological treatments
Boutron, I., Guittet, L., Estellat, C., Moher, D., Hróbjartsson, A., & Ravaud, P. (2007) · PLoS Medicine · doi:10.1371/journal.pmed.0040061 · Cited by 389
Self-citationAquatic exercise for the treatment of knee and hip osteoarthritis
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Bent, S., Padula, A., & Avins, A. L. (2006) · Annals of Internal Medicine · doi:10.7326/0003-4819-144-4-200602210-00007 · Cited by 177
Metadata
- Authors
- Ethgen, M., Boutron, I., Baron, G., Giraudeau, B., Sibilia, J., & Ravaud, P.
- Affiliations
- Inserm (FR)
- Venue
- Annals of Internal Medicine
- Publisher
- American College of Physicians
- Published
- 2005-07-05
- Volume
- 143
- Issue
- 1
- Pages
- 20-25
- ISSN
- 0003-4819 (ISSN-L)
- 1539-3704
- OpenAlex
- W2089258837
- Cited by
- 49
- References
- 15
- Citations by year
- 2026: 2 · 2024: 1 · 2023: 1 · 2022: 2 · 2021: 1 · 2019: 1 · 2018: 1 · 2017: 3 · 2016: 1 · 2014: 3 · 2013: 6 · 2012: 3
- FWCI
- 6.17
- 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
- harms reporting, adverse events, non-pharmacological treatment, rheumatic diseases, benefit-harm balance, trial reporting quality, adverse event severity, pharmacotherapy, randomized controlled trials
- MeSH terms
- Arthritis, Rheumatoid, Humans, Product Surveillance, Postmarketing, Osteoarthritis, Hip, Randomized Controlled Trials as Topic, Antirheumatic Agents, Osteoarthritis, Knee
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Cite CoChat for the checks on this page, and the paper for its own findings.
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- CoChat. (2026). Citation check: Reporting of Harm in Randomized, Controlled Trials of Nonpharmacologic Treatment for Rheumatic Disease. https://app.cochat.ai/papers/10.7326/0003-4819-143-1-200507050-00006
- The paper
- Ethgen, M., Boutron, I., Baron, G., Giraudeau, B., Sibilia, J., & Ravaud, P. (2005). Reporting of Harm in Randomized, Controlled Trials of Nonpharmacologic Treatment for Rheumatic Disease. Annals of Internal Medicine. https://doi.org/10.7326/0003-4819-143-1-200507050-00006
