Operating Characteristics of PROMIS Four-Item Depression and Anxiety Scales in Primary Care Patients with Chronic Pain
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OBJECTIVE: Depression and anxiety are prevalent in patients with chronic pain and adversely affect pain, quality of life, and treatment response. The purpose of this psychometric study was to determine the reliability and validity of the four-item Patient Reported Outcomes Measurement Information System (PROMIS) depression and anxiety scales in patients with chronic pain. DESIGN: Secondary analysis of data from the Stepped Care to Optimize Pain care Effectiveness study, a randomized clinical trial of optimized analgesic therapy. SETTING: Five primary care clinics at the Roudebush VA Medical Center (RVAMC) in Indianapolis, Indiana. SUBJECTS: Two hundred forty-four primary care patients with chronic musculoskeletal pain. METHODS: All patients completed the four-item depression and anxiety scales from the PROMIS 29-item profile, as well as several other validated psychological measures. The minimally important difference (MID) using the standard error of measurement (SEM) was calculated for each scale, and convergent validity was assessed by interscale correlations at baseline and 3 months. Operating characteristics of the PROMIS measures for detecting patients who had probable major depression or were anxiety-disorder screen-positive were calculated. RESULTS: The PROMIS scales had good internal reliability, and the MID (as represented by two SEMs) was 2 points for the depression scale and 2.5 points for the anxiety scale. Convergent validity was supported by strong interscale correlations. The optimal screening cutpoint on the 4- to 20-point PROMIS scales appeared to be 8 for both the depression and anxiety scales. CONCLUSIONS: The PROMIS four-item depression and anxiety scales are reasonable options as ultra-brief measures for screening in patients with chronic pain.
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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 [41]
The Abstract and Discussion (page unavailable) report minimally important differences of 2 and 2.5 points for PROMIS depression and anxiety scales in primary-care patients with chronic musculoskeletal pain. They do not say these were a priori thresholds matched to a pilot feasibility study or derived from literature on conservatively managed orthopedic patients. (LLM, conf=0.78)
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 [46]
The Results and Discussion report minimally important differences for four-item PROMIS depression and anxiety scales in primary care patients with chronic pain, and describe three points as a conservative estimate. They do not define the claimed 3.0-point Anxiety and 3.2-point Depression thresholds, or report thresholds for Pain Interference and Physical Function. No page numbers are available in our copy. (LLM, conf=0.87)
Experimental — accuracy not yet measuredThe PROMIS-29 Profile v2.1 has good internal reliability and convergent validity in chronic pain samples.
“Good internal reliability and convergent validity have been found in chronic pain samples (19).”
From Internet Cognitive-Behavioral Therapy for Painful Chronic Pancreatitis: A Pilot Feasibility Randomized Controlled Trial (2021) · cites this paper as [19]
The Results and Discussion report good internal reliability and strong convergent validity for the four-item PROMIS depression and anxiety scales in primary care patients with chronic pain. Those scales came from the PROMIS 29-item profile, but the paper does not establish these properties for the PROMIS-29 Profile v2.1 as a whole. Page numbers were not provided in the supplied passages. (LLM, conf=0.88)
Experimental — accuracy not yet measuredMinimum 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 [35]
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.
“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 [35]
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Bhatia, A., Kara, J., Janmohamed, T., Prabhu, A., Lebovic, G., Katz, J., & Clarke, H. (2021) · JMIR mHealth and uHealth · doi:10.2196/26528 · Cited by 73 · see citing works
Palermo, T. M., Law, E. F., Topazian, M. D., Slack, K., Dear, B. F., Ko, Y. J., Vege, S. S., Fogel, E., Trikudanathan, G., Andersen, D. K., et al. (2021) · Clinical and Translational Gastroenterology · doi:10.14309/ctg.0000000000000373 · Cited by 45 · see citing works
“Good internal reliability and convergent validity have been found in chronic pain samples (19).”
BackgroundLeo, 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
Behavioral inhibition, maladaptive pain cognitions, and function in patients with chronic pain
Jensen, M. P., Solé, E., Castarlenas, E., Racine, M., Roy, R., Miró, J., & Cane, D. (2017) · Scandinavian Journal of Pain · doi:10.1016/j.sjpain.2017.07.002 · Cited by 19 · see citing works
Dash, G. F., Feldstein Ewing, S. W., Murphy, C., Hudson, K. A., & Wilson, A. C. (2020) · Addictive Behaviors · doi:10.1016/j.addbeh.2020.106314 · Cited by 17 · 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
- Authors
- Kroenke, K., Yu, Z., Wu, J., Kean, J., & Monahan, P. O.
- Affiliations
- Regenstrief Institute (US)
- Indiana University Indianapolis (US)
- Richard L. Roudebush VA Medical Center (US)
- Corresponding author
- Kroenke, Kurt
- Venue
- Pain Medicine
- Publisher
- Oxford University Press (OUP)
- Published
- 2014-11
- Volume
- 15
- Issue
- 11
- Pages
- 1892-1901
- ISSN
- 1526-2375 (ISSN-L)
- 1526-4637
- PMC
- PMC6283354
- OpenAlex
- W1489618335
- Cited by
- 187
- References
- 72
- Citations by year
- 2026: 13 · 2025: 14 · 2024: 23 · 2023: 14 · 2022: 26 · 2021: 28 · 2020: 20 · 2019: 14 · 2018: 18 · 2017: 5 · 2016: 7 · 2015: 4 · 2013: 1
- FWCI
- 6.74
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- public-domain
- doi.wiley.com/10.1002/tdm_license_1 (tdm, 304 d)
- Locations
- Pain Medicine (publishedVersion, public-domain)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- IUScholarWorks (Indiana University) (submittedVersion)
- PMC
- Funders
- U.S. Department of Veterans Affairs (NCT00926588, IIR 07-119, IK2 RX000879)
- Health Services Research and Development
- National Institute of Mental Health (R03MH078785, P30MH062512)
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (R01AR064081)
- Topics
- Social Sciences › Decision Sciences › Management Science and Operations Research › Psychometric Methodologies and Testing
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
- Health Sciences › Medicine › Pharmacology › Musculoskeletal pain and rehabilitation
- Keywords
- PROMIS, depression screening, anxiety screening, chronic pain, primary care, musculoskeletal pain, minimally important difference, convergent validity, patient-reported outcomes, veterans
- MeSH terms
- Adult, Aged, Analgesics, Anxiety, Depression, Female, Humans, Male, Middle Aged, Psychiatric Status Rating Scales, Psychometrics, ROC Curve, Reproducibility of Results, Area Under Curve, Chronic Pain
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