Adverse event assessment, analysis, and reporting in recent published analgesic clinical trials: ACTTION systematic review and recommendations
Abstract
The development of valid and informative treatment risk-benefit profiles requires consistent and thorough information about adverse event (AE) assessment and participants' AEs during randomized controlled trials (RCTs). Despite a 2004 extension of the Consolidated Standards of Reporting Trials (CONSORT) statement recommending the specific AE information that investigators should report, there is little evidence that analgesic RCTs adequately adhere to these recommendations. This systematic review builds on prior recommendations by describing a comprehensive checklist for AE reporting developed to capture clinically important AE information. Using this checklist, we coded AE assessment methods and reporting in all 80 double-blind RCTs of noninvasive pharmacologic treatments published in the European Journal of Pain, Journal of Pain, and PAIN® from 2006 to 2011. Across all trials, reports of AEs were frequently incomplete, inconsistent across trials, and, in some cases, missing. For example, >40% of trials failed to report any information on serious adverse events. Trials of participants with acute or chronic pain conditions and industry-sponsored trials typically provided more and better-quality AE data than trials involving pain-free volunteers or trials that were not industry sponsored. The results of this review suggest that improved AE reporting is needed in analgesic RCTs. We developed an ACTTION (Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks) AE reporting checklist that is intended to assist investigators in thoroughly and consistently capturing and reporting these critically important data in publications.
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Missing or insufficient reporting of harm-related data is not specific to the probiotic field; similar issues have been reported regarding other interventions.
“Missing or insufficient reporting of harm-related data is not specific to the probiotic field. Similar issues have been reported regarding other interventions.139–142”
From Emerging issues in probiotic safety: 2023 perspectives (2023) · cites this paper as [139]
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References 44 · Cited by 58
- Authors
- Smith, S. M., Wang, A. T., Katz, N. P., McDermott, M. P., Burke, L. B., Coplan, P., Gilron, I., Hertz, S. H., Lin, A. H., Rappaport, B. A., Rowbotham, M. C., Sampaio, C., Sweeney, M., Turk, D. C., & Dworkin, R. H.
- Affiliations
- University of Rochester Medicine (US)
- Case Western Reserve University (US)
- Tufts University (US)
- United States Food and Drug Administration (US)
- Purdue Pharma (United States) (US)
- Queen's University (CA)
- California Pacific Medical Center (US)
- CHDI Foundation (US)
- University of Washington (US)
- Corresponding author
- Smith, Shannon M.
- ORCID
- Venue
- Pain
- Published
- 2013-07
- Volume
- 154
- Issue
- 7
- Pages
- 997-1008
- ISSN
- 0304-3959 (ISSN-L)
- OpenAlex
- W1966141303
- Cited by
- 58
- References
- 44
- Citations by year
- 2026: 1 · 2025: 4 · 2024: 1 · 2023: 3 · 2022: 4 · 2021: 4 · 2020: 6 · 2019: 5 · 2018: 3 · 2017: 5 · 2016: 6 · 2015: 10 · 2014: 5 · 2013: 1
- FWCI
- 1.52
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Pain (publishedVersion)
- PubMed (publishedVersion)
- 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
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Keywords
- adverse event reporting, adverse event assessment, reporting checklist, CONSORT extension, serious adverse events, pain management, industry-sponsored trials, trial quality
- MeSH terms
- Analgesics, Europe, Pain, Prevalence, Randomized Controlled Trials as Topic, Treatment Outcome, Adverse Drug Reaction Reporting Systems, Practice Guidelines as Topic, Drug Utilization Review, Mandatory Reporting, Guideline Adherence, Drug-Related Side Effects and Adverse Reactions
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