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Interpretation of chronic pain clinical trial outcomes: IMMPACT recommended considerations
Open accessAbstract
Interpreting randomized clinical trials (RCTs) is crucial to making decisions regarding the use of analgesic treatments in clinical practice. In this article, we report on an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) consensus meeting organized by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks, the purpose of which was to recommend approaches that facilitate interpretation of analgesic RCTs. We review issues to consider when drawing conclusions from RCTs, as well as common methods for reporting RCT results and the limitations of each method. These issues include the type of trial, study design, statistical analysis methods, magnitude of the estimated beneficial and harmful effects and associated precision, availability of alternative treatments and their benefit-risk profile, clinical importance of the change from baseline both within and between groups, presentation of the outcome data, and the limitations of the approaches used.
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The percentage of participants reporting improvements of ≥30% and ≥50% was reported based on IMMPACT recommendations.
“Based on the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials recommendations, 48 the percentage of participants reporting improvements in symptoms of ≥30% and ≥50% from pre-to posttreatment for both groups and pre-treatment to follow-up for the treatment group are reported.”
From Internet-Delivered Psychological Pain-Management for Young Adults With Chronic Pain: An Investigation of Clinical Trial Data (2024) · cites this paper as [48]
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Metadata
- Authors
- Smith, S. M., Dworkin, R. H., Turk, D. C., McDermott, M. P., Eccleston, C., Farrar, J. T., Rowbotham, M. C., Bhagwagar, Z., Burke, L. B., Cowan, P., Ellenberg, S. S., Evans, S. R., Freeman, R. L., Garrison, L. P., Iyengar, S., Jadad, A., Jensen, M. P., Junor, R., Kamp, C., Katz, N. P., Kesslak, J. P., Kopecky, E. A., Lissin, D., Markman, J. D., Mease, P. J., O'Connor, A. B., Patel, K. V., Raja, S. N., Sampaio, C., Schoenfeld, D., Singh, J., Steigerwald, I., Strand, V., Tive, L. A., Tobias, J., Wasan, A. D., & Wilson, H. D.
- Affiliations
- University of Rochester Medicine (US)
- University of Washington (US)
- University of Bath (GB)
- University of Pennsylvania (US)
- Sutter Health (US)
- Yale University (US)
- University of Maryland, Baltimore (US)
- American Chronic Pain Association (US)
- George Washington University (US)
- Harvard University (US)
- Eli Lilly (United States) (US)
- University of Toronto (CA)
- Eisai (United Kingdom) (GB)
- Tufts University (US)
- Johns Hopkins University (US)
- University of Lisbon (PT)
- University of Alabama at Birmingham (US)
- Neumentum, Inc, Palo Alto, CA, United States
- Stanford University (US)
- Pfizer (United States) (US)
- University of Pittsburgh (US)
- Corresponding author
- Smith, Shannon M.
- ORCID
- Smith, Shannon M.
- Dworkin, Robert H.
- McDermott, Michael P.
- Eccleston, Christopher
- Farrar, John T.
- Bhagwagar, Zubin
- Burke, Laurie B.
- Ellenberg, Susan S.
- Evans, Scott R.
- Freeman, Roy L.
- Garrison, Louis P.
- Jadad, Alejandro
- Jensen, Mark P.
- Kamp, Cornelia
- Katz, Nathaniel P.
- Kopecky, Ernest A.
- Lissin, Dmitri
- Markman, John D.
- Mease, Philip J.
- O'Connor, Alec B.
- Patel, Kushang V.
- Raja, Srinivasa N.
- Sampaio, Cristina
- Schoenfeld, David
- Singh, Jasvinder
- Strand, Vibeke
- Tive, Leslie A.
- Tobias, Jeffrey
- Wasan, Ajay D.
- Wilson, Hilary D.
- Venue
- Pain
- Published
- 2020-06-08
- Volume
- 161
- Issue
- 11
- Pages
- 2446-2461
- ISSN
- 0304-3959 (ISSN-L)
- 1872-6623
- PMC
- PMC7572524
- OpenAlex
- W3033940508
- Cited by
- 194
- References
- 112
- Citations by year
- 2026: 48 · 2025: 41 · 2024: 39 · 2023: 23 · 2022: 16 · 2021: 21 · 2020: 3
- FWCI
- 11.28
- Type
- journal article
- Language
- en
- Open access
- green
- europepmc.org
- Locations
- Pain (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Pure (University of Bath) (submittedVersion, cc-by-nc)
- Portuguese National Funding Agency for Science, Research and Technology (RCAAP Project by FCT) (submittedVersion)
- Funders
- Amgen
- Eli Lilly and Company
- Pfizer
- AstraZeneca
- GlaxoSmithKline
- Biogen
- Alexion Pharmaceuticals
- Alnylam Pharmaceuticals
- Celgene
- Depomed
- Washington State University
- University of Washington
- Novartis Pharmaceuticals Corporation
- New York State Stem Cell Science
- PTC Therapeutics
- ACADIA Pharmaceuticals
- aTyr
- Voyager Therapeutics
- Multiple Sclerosis Society
- Astellas Pharma
- National Institutes of Health
- U.S. Food and Drug Administration (U01-FD005936)
- Administration for Community Living
- Allergan
- National Institute on Aging
- National Institute of Allergy and Infectious Diseases
- Daiichi Sankyo Europe
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Health Sciences › Medicine › Anesthesiology and Pain Medicine › Pain Management and Opioid Use
- Keywords
- chronic pain, randomized controlled trials, analgesic treatment, IMMPACT, risk-benefit assessment, statistical analysis methods, study design limitations, consensus recommendations
- MeSH terms
- Analgesics, Humans, Pain Measurement, Research Design, Translations, Randomized Controlled Trials as Topic, Chronic Pain
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
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