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Estimating minimally important differences for the PROMIS pain interference scales: results from 3 randomized clinical trials
Open accessAbstract
Minimally important difference (MID) refers to the smallest meaningful difference that carries implications for patient care. Minimally important differences are necessary to help interpret patient-reported pain outcomes in research and clinical practice. The PROMIS pain interference scales were validated across diverse samples; however, more information about their MIDs could improve their interpretability. The purpose of this study was to estimate MIDs for 4 fixed-length PROMIS pain interference scales, including the 6-item Pain Short Form and the 4-, 6-, and 8-item pain interference scales used in the PROMIS profile instruments. Data were analyzed from 3 randomized controlled trials (N = 759). The 3 samples, respectively, consisted of patients with chronic low back pain (n = 261), chronic back pain or hip/knee osteoarthritis pain (n = 240), and a history of stroke (n = 258). For each sample, anchor- and distribution-based approaches were used to estimate MIDs. Standard error of measurement and effect sizes were used as distribution-based MID estimates. Anchor-based MID estimates were established by mapping PROMIS pain interference scores onto established anchor measures, including the Brief Pain Inventory, and retrospective and prospective global ratings of change. The distribution- and anchor-based MID estimates showed convergence. For the pain samples, MID estimates ranged from 2 to 3 T-score points. For the nonpain sample, MID estimates ranged from 3.5 to 4.5 T-score points. The MID estimates were comparable across the 4 fixed-length scales. These MIDs can be used to evaluate treatment effects in research and clinical care and to calculate estimates for powering clinical trials.
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“Minimum clinically meaningful effect sizes were a priori set to match thresholds used in the pilot feasibility study, which were determined from previously published literature in conservatively managed orthopedic patients with chronic musculoskeletal pain.”
From Digital Mental Health Intervention Plus Usual Care Compared With Usual Care Only and Usual Care Plus In-Person Psychological Counseling for Orthopedic Patients With Symptoms of Depression or Anxiety: Cohort Study (2022) · cites this paper as [42]
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“clinically meaningful PROMIS score changes in patients with conservatively managed chronic musculoskeletal pain have previously been defined as 3.0 points for Anxiety, 3.2 points for Depression, 2.0 points for Pain Interference, and 2.2 points for Physical Function [45-47].”
From Behavioral Mechanisms That Mediate Mental and Physical Health Improvements in People With Chronic Pain Who Receive a Digital Health Intervention: Prospective Cohort Pilot Study (2023) · cites this paper as [47]
Experimental — accuracy not yet measuredIn the citing paper
“Therefore, clinically meaningful effect sizes were defined as at least 3.2 points for PROMIS Depression, 3.0 points for Anxiety, 2.0 points for Pain Interference, and 2.2 points for Physical Function [34-36].”
From A Digital Mental Health Intervention in an Orthopedic Setting for Patients With Symptoms of Depression and/or Anxiety: Feasibility Prospective Cohort Study (2022) · cites this paper as [36]
In the citing paper
“Minimum clinically meaningful effect sizes were a priori chosen in accordance with previously published literature involving patients with chronic musculoskeletal pain who were managed nonoperatively.”
From A Digital Mental Health Intervention in an Orthopedic Setting for Patients With Symptoms of Depression and/or Anxiety: Feasibility Prospective Cohort Study (2022) · cites this paper as [36]
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Metadata
- Authors
- Chen, C. X., Kroenke, K., Stump, T. E., Kean, J., Carpenter, J. S., Krebs, E. E., Bair, M. J., Damush, T. M., & Monahan, P. O.
- Affiliations
- Indiana University Indianapolis (US)
- Regenstrief Institute (US)
- University of Utah (US)
- University of Minnesota (US)
- Corresponding author
- Chen, Chen X.
- ORCID
- Venue
- Pain
- Published
- 2017-12-01
- Volume
- 159
- Issue
- 4
- Pages
- 775-782
- ISSN
- 0304-3959 (ISSN-L)
- 1872-6623
- PMC
- PMC5860950
- OpenAlex
- W2773505783
- Cited by
- 199
- References
- 28
- Citations by year
- 2026: 21 · 2025: 22 · 2024: 12 · 2023: 32 · 2022: 42 · 2021: 21 · 2020: 27 · 2019: 13 · 2018: 9
- FWCI
- 11.84
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Pain (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- IUScholarWorks (Indiana University) (submittedVersion)
- Purdue University Indianapolis (Indiana University) (submittedVersion)
- Funders
- U.S. Department of Veterans Affairs (I01 HX000587, I01 HX000495, IK2 RX000879, I01 HX000671)
- National Institute of Nursing Research (T32NR007066)
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (R01AR064081)
- Topics
- Social Sciences › Decision Sciences › Management Science and Operations Research › Psychometric Methodologies and Testing
- Health Sciences › Health Professions › Physical Therapy, Sports Therapy and Rehabilitation › Musculoskeletal pain and rehabilitation
- Health Sciences › Medicine › Anesthesiology and Pain Medicine › Pain Management and Opioid Use
- Keywords
- minimally important difference, PROMIS, pain interference, patient-reported outcomes, anchor-based estimation, distribution-based estimation, chronic low back pain, osteoarthritis pain, stroke, Brief Pain Inventory, global rating of change
- MeSH terms
- Patient Reported Outcome Measures, Aged, Cross-Sectional Studies, Disability Evaluation, Female, Humans, Male, Middle Aged, Pain Measurement, Psychometrics, Randomized Controlled Trials as Topic, Treatment Outcome, Self Report, Chronic Pain
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