Interpreting the clinical importance of group differences in chronic pain clinical trials: IMMPACT recommendations
Abstract
An essential component of the interpretation of results of randomized clinical trials of treatments for chronic pain involves the determination of their clinical importance or meaningfulness. This involves two distinct processes--interpreting the clinical importance of individual patient improvements and the clinical importance of group differences--which are frequently misunderstood. In this article, we first describe the essential differences between the interpretation of the clinical importance of patient improvements and of group differences. We then discuss the factors to consider when evaluating the clinical importance of group differences, which include the results of responder analyses of the primary outcome measure, the treatment effect size compared to available therapies, analyses of secondary efficacy endpoints, the safety and tolerability of treatment, the rapidity of onset and durability of the treatment benefit, convenience, cost, limitations of existing treatments, and other factors. The clinical importance of individual patient improvements can be determined by assessing what patients themselves consider meaningful improvement using well-described methods. In contrast, the clinical meaningfulness of group differences must be determined by a multi-factorial evaluation of the benefits and risks of the treatment and of other available treatments for the condition in light of the primary goals of therapy. Such determinations must be conducted on a case-by-case ba…
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There are no specific recommendations for clinically important group differences for commonly used pain measures.
“However, there also are no specific recommendations for clinically important group differences for commonly used pain measures.17”
From Telehealth Versus In-Person Acceptance and Commitment Therapy for Chronic Pain: A Randomized Noninferiority Trial. (2017) · cites this paper as Dworkin et al., 2009
The IMMPACT recommendations state that mean differences for efficacious treatments at the group level are generally smaller than what is considered clinically meaningful at the individual level.
“The IMMPACT recommendations for the interpretation of group differences in chronic pain clinical trials state that mean differences for efficacious treatments at the group level are generally smaller than what is considered clinically meaningful at the individual level.17”
From Telehealth Versus In-Person Acceptance and Commitment Therapy for Chronic Pain: A Randomized Noninferiority Trial. (2017) · cites this paper as Dworkin et al., 2009
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- Authors
- Dworkin, R. H., Turk, D. C., McDermott, M. P., Peirce-Sandner, S., Burke, L. B., Cowan, P., Farrar, J. T., Hertz, S., Raja, S. N., Rappaport, B. A., Rauschkolb, C., & Sampaio, C.
- Affiliations
- United States Food and Drug Administration (US)
- University of Washington (US)
- University of Rochester Medicine (US)
- American Chronic Pain Association (US)
- University of Pennsylvania (US)
- Johns Hopkins University (US)
- Janssen Research & Development (United States) (US)
- University of Lisbon (PT)
- Corresponding author
- Dworkin, Robert H.
- ORCID
- Venue
- Pain
- Published
- 2009-12
- Volume
- 146
- Issue
- 3
- Pages
- 238-244
- ISSN
- 0304-3959 (ISSN-L)
- OpenAlex
- W1966892791
- Cited by
- 654
- References
- 5
- Citations by year
- 2026: 26 · 2025: 33 · 2024: 38 · 2023: 37 · 2022: 47 · 2021: 54 · 2020: 55 · 2019: 36 · 2018: 48 · 2017: 40 · 2016: 43 · 2015: 48 · 2014: 42 · 2013: 40 · 2012: 24
- FWCI
- 2.42
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Pain (publishedVersion)
- PubMed (publishedVersion)
- Funders
- University of Rochester
- U.S. Food and Drug Administration
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Health Sciences › Medicine › Pharmacology › Musculoskeletal pain and rehabilitation
- Health Sciences › Medicine › Anesthesiology and Pain Medicine › Pain Management and Opioid Use
- Keywords
- chronic pain, clinical significance, clinical meaningfulness, group differences, responder analysis, treatment effect size, safety and tolerability, risk-benefit assessment, patient-reported outcomes, randomized controlled trials
- MeSH terms
- Analgesics, Chronic Disease, Clinical Trials as Topic, Humans, Pain, Research Design, Randomized Controlled Trials as Topic, Treatment Outcome, Guidelines as Topic, Patient Selection, Pain Management
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