Evidence from diverse clinical populations supported clinical validity of PROMIS pain interference and pain behavior
Open accessAbstract
Objective To evaluate clinical validity, including responsiveness, of Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference (PROMIS-PI) and pain behavior (PROMIS-PB) T-scores.Study design and setting Data were aggregated from longitudinal studies of cancer, chronic low back pain (cLBP), rheumatoid arthritis, chronic obstructive pulmonary disease (COPD), and major depressive disorder (MDD). Linear mixed-effects models were used to compare baseline score differences and score changes over time. We calculated standardized response means (SRMs) for subgroups defined by self-reported change in general health and pain.Results A total of 1,357 individuals participated at baseline and 1,225 at follow-up. Hypotheses of significant change in PROMIS-PI and PROMIS-PB scores were supported in the intervention groups (cLBP and MDD). Differences in baseline scores for COPD exacerbators compared to stable COPD patients were in the hypothesized direction but were not statistically significant. Subgroups reporting better health showed corresponding negative SRM values supporting responsiveness of T-scores to improvement. Responsiveness to decrements was supported in some but not all clinical groups and varied by anchor. More congruent values were obtained when using a pain-specific anchor.Conclusion This study provides evidence that PROMIS-PI and PROMIS-PB scores are sensitive to changes in pain in studies of interventions expected to impact pain. The results inform estimation of meaningful change and support power analyses for comparative effectiveness research.
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The PROMIS pain intensity, pain interference and physical function scales have been shown to detect intervention-related change in heterogeneous pain groups.
“These measures have been shown to detect intervention-related change in heterogeneous pain groups [39].”
From A randomized controlled trial of yoga vs nonaerobic exercise for veterans with PTSD: Understanding efficacy, mechanisms of change, and mode of delivery (2021) · cites this paper as [39]
The Measures section says the study used PROMIS pain interference and pain behavior, not pain intensity or physical function. The Results (Longitudinal Change) report significant intervention-related changes in pain interference scores in the chronic low back pain and depression groups. The cited paper therefore supports the claim for pain interference, but not for the other two named scales. (LLM, conf=0.90)
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- Authors
- Askew, R. L., Cook, K. F., Revicki, D. A., Cella, D., & Amtmann, D.
- Affiliations
- University of Washington (US)
- Northwestern University (US)
- Corresponding author
- Amtmann, Dagmar
- Venue
- Journal of Clinical Epidemiology
- Publisher
- Elsevier BV
- Published
- 2016-05
- Volume
- 73
- Pages
- 103-111
- ISSN
- 0895-4356 (ISSN-L)
- PMC
- PMC4957699
- OpenAlex
- W2297767387
- Cited by
- 212
- References
- 51
- Citations by year
- 2026: 12 · 2025: 36 · 2024: 22 · 2023: 26 · 2022: 24 · 2021: 28 · 2020: 24 · 2019: 13 · 2018: 15 · 2017: 8 · 2016: 3
- FWCI
- 14.25
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Journal of Clinical Epidemiology (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institutes of Health (5u01ar057940-04)
- National Cancer Institute (R01CA060068, P30CA060553)
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (U01AR052171, U01AR057956, U01AR057967, U01AR052186, U01-AR-057940, U01AR057936, U54AR057943, U01AR057929, U01AR052170, U01AR052158, U01AR052155, U01AR052177, U01AR052181, U01AR057971, U01AR057954, U01AR057948, U54AR057926, U54AR057951)
- Topics
- Social Sciences › Decision Sciences › Management Science and Operations Research › Psychometric Methodologies and Testing
- Health Sciences › Medicine › Pharmacology › Musculoskeletal pain and rehabilitation
- Health Sciences › Medicine › Anesthesiology and Pain Medicine › Pain Management and Opioid Use
- Keywords
- PROMIS, pain interference, pain behavior, clinical validity, responsiveness, standardized response mean, patient-reported outcomes, chronic low back pain, cancer, rheumatoid arthritis, chronic obstructive pulmonary disease, major depressive disorder, meaningful change, power analysis, comparative effectiveness research
- MeSH terms
- Activities of Daily Living, Adolescent, Adult, Aged, Chronic Disease, Female, Follow-Up Studies, Humans, Longitudinal Studies, Male, Middle Aged, National Institutes of Health (U.S.), Pain Measurement, Psychometrics, Surveys and Questionnaires, Social Behavior, United States, Reproducibility of Results, Comorbidity, Young Adult, Comparative Effectiveness Research, Self Report, Chronic Pain
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