Responsiveness and Minimally Important Differences for 4 Patient-Reported Outcomes Measurement Information System Short Forms: Physical Function, Pain Interference, Depression, and Anxiety in Knee Osteoarthritis
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Patient-Reported Outcomes Measurement Information System (PROMIS) instruments can provide valid, interpretable measures of health status among adults with osteoarthritis (OA). However, their ability to detect meaningful change over time is unknown. We evaluated the responsiveness and minimally important differences (MIDs) for 4 PROMIS Short Forms: Physical Function, Pain Interference, Depression, and Anxiety. We analyzed adults with symptomatic knee OA from our randomized trial comparing Tai Chi and physical therapy. Using baseline and 12-week scores, responsiveness was evaluated according to consensus standards by testing 6 a priori hypotheses of the correlations between PROMIS and legacy change scores. Responsiveness was considered high if ≥5 hypotheses were confirmed, and moderate if 3 or 4 were confirmed. MIDs were evaluated according to prospective change for people achieving previously-established MID on legacy comparators. The lowest and highest MIDs meeting a priori quality criteria formed a MID range for each PROMIS Short Form. Among 165 predominantly female (70%) and white (57%) participants, mean age was 61 years and body mass index was 33. PROMIS Physical Function had 5 confirmed hypotheses and Pain Interference, Depression, and Anxiety had 3 or 4. MID ranges were: Depression = 3.0 to 3.1; Anxiety = 2.3 to 3.4; Physical Function = 1.9 to 2.2; and Pain Interference = 2.35 to 2.4. PROMIS Physical Function has high responsiveness, and Depression, Anxiety, and Pain Interference have moderate responsiveness among adults with knee OA. We established the first MIDs for PROMIS in this population, and provided an important standard of reference to better apply or interpret PROMIS in future trials or clinical practice.Perspective This study examined whether PROMIS Short Form instruments (Physical Function, Pain Interference, Depression, and Anxiety) were able to detect change over time among adults with knee OA, and provided minimally important change estimates for each measure. This standard of reference can help apply or interpret these instruments in the future.
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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.
“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 [40]
Split into 2 atoms — 0 confirmed, 2 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measuredClinically 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.
“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 [45]
The Results (MIDs; page not supplied) give ranges for adults with symptomatic knee osteoarthritis: Anxiety 2.3–3.4 and Physical Function 1.9–2.2, which include the cited values. They give Depression as 3.0–3.1 and Pain Interference as 2.35–2.4, not the claimed 3.2 and 2.0. The study does not establish those values for conservatively managed chronic musculoskeletal pain generally. (LLM, conf=0.90)
Experimental — accuracy not yet measuredClinically 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.
“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 [34]
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.
“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 [34]
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- [60]Spector PE Method Variance in Organizational Research Organ Res Methods [Internet] 9 221 32 2006 Available from: http://resolver.scholarsportal.info/resolve/10944281/v09i0002/221_mvior%5Cnhttp://orm.sagepub.com/content/9/2/221.abstract
- [68]de Vet HCW Terwee CB Mokkink LB Knol DL Chapter 6: Validity Meas Med A Pract Guid 1 Cambridge Cambridge University Press 150 201 2011
- [69]de Vet HCW Terwee CB Mokkink LB Knol DL Chapter 7: Responsiveness Meas Med A Pract Guid 1 Cambridge Cambridge University Press 202 26 2011
- [70]de Vet HCW Terwee CB Mokkink LB Knol DL Chapter 8: Interpretability Meas Med A Pract Guid 1 Cambridge Cambridge University Press 227 74 2011
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Leo, A. J., Schuelke, M. J., Hunt, D. M., Metzler, J. P., Miller, J. P., Areán, P. A., Armbrecht, M. A., & Cheng, A. L. (2022) · JMIR Formative Research · doi:10.2196/34889 · Cited by 70 · see citing works
Leo, A. J., Schuelke, M. J., Hunt, D. M., Miller, J. P., Areán, P. A., & Cheng, A. L. (2022) · JMIR Formative Research · doi:10.2196/36203 · Cited by 41 · see citing works
“Improvements in PROMIS Physical Function were also meaningfully greater than longitudinal changes shown by patients who received in-person psychological counseling (mean between-group difference 2.4 points; P=.04).”
InfluentialBarreveld, A. M., Rosén Klement, M. L., Cheung, S., Axelsson, U., Basem, J. I., Reddy, A. S., Borrebaeck, C. A. K., & Mehta, N. (2023) · Pain Medicine · doi:10.1093/pm/pnad049 · Cited by 22 · see citing works
Cheng, A. L., Agarwal, M., Armbrecht, M. A., Abraham, J., Calfee, R. P., & Goss, C. W. (2023) · JMIR Formative Research · doi:10.2196/51422 · Cited by 10 · see citing works
“For reference, 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].”
BackgroundInfluential
- Authors
- Lee, A. C., Driban, J. B., Price, L. L., Harvey, W. F., Rodday, A. M., & Wang, C.
- Affiliations
- Tufts Medical Center (US)
- Tufts University (US)
- Corresponding author
- Wang, Chenchen
- Venue
- The Journal of Pain
- Publisher
- Elsevier BV
- Published
- 2017-09
- Volume
- 18
- Issue
- 9
- Pages
- 1096-1110
- ISSN
- 1526-5900 (ISSN-L)
- PMC
- PMC5581239
- OpenAlex
- W2613037581
- Cited by
- 197
- References
- 81
- Citations by year
- 2026: 13 · 2025: 14 · 2024: 19 · 2023: 22 · 2022: 34 · 2021: 29 · 2020: 35 · 2019: 18 · 2018: 11 · 2017: 2
- FWCI
- 12.59
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Journal of Pain (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institutes of Health (UL1TR001064, 5u01ar057940-04)
- 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)
- National Center for Advancing Translational Sciences
- National Center for Complementary and Integrative Health (K24AT007323, R01AT005521)
- Topics
- Health Sciences › Medicine › Pharmacology › Musculoskeletal pain and rehabilitation
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Health Systems, Economic Evaluations, Quality of Life
- Social Sciences › Decision Sciences › Management Science and Operations Research › Psychometric Methodologies and Testing
- Keywords
- knee osteoarthritis, responsiveness, minimally important difference, physical function, pain interference, depression, anxiety, patient-reported outcomes, Tai Chi, physiotherapy
- MeSH terms
- Patient Reported Outcome Measures, Anxiety, Depression, Female, Humans, Male, Middle Aged, Osteoarthritis, Knee, Tai Ji, Physical Therapy Modalities
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