Minimally important differences and severity thresholds are estimated for the PROMIS depression scales from three randomized clinical trials
Open accessAbstract
Background Patient Reported Outcomes Measurement Information Systems (PROMIS) scales are increasingly being used to measure symptoms in research and practice. The purpose of this study was to determine the minimally important difference (MID) and severity thresholds (cut-points) for the four fixed-length PROMIS depression scales. Methods The study sample was adult participants in three randomized clinical trials (N=651). MID was estimated using multiple distribution- and anchor-based approaches including assessing correspondence between Patient Health Questionnaire (PHQ-9) and PROMIS depression scores. Results The best MID estimate was a PROMIS depression T-score of 3.5 points with most methods producing an MID in the 3 to 4 point range across all three samples. MID estimates were similar for all four PROMIS scales. A PHQ-9 1-point change equated to a PROMIS 1.25-point T-score change. PROMIS T-scores of 55, 60, 65, and 70 appeared to be reasonable thresholds for mild, moderate, moderately severe, and severe depression, respectively. Limitations The study sample was predominantly male veterans with either chronic pain (2 trials) or previous stroke (1 trial). The severity of depression was mild to moderate. Conclusion A T-score of 3 to 4 points is a reasonable MID for PROMIS depression scales and can be used to assess treatment effects in both practice and research as well to calculate sample sizes for clinical trials. Severity cut-points can help interpret the meaning of scores and action thresholds for treatment decisions.
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T-scores of 60 or more on PROMIS indicate moderate depression/anxiety in need for further psychological evaluation.
“T-scores of 60 or more indicate moderate depression/anxiety in need for further psychological evaluation.31, 32, 33”
From Multisite Randomized Controlled Trial of CareSTEPS: A Supportive Care Intervention for the Family Caregivers of Patients With Advanced Lung Cancer (2024) · cites this paper as [32]
The Results section (page not available in our copy) identifies a PROMIS depression T-score of 60 as an approximate threshold for moderate depression, with 65 and 70 marking higher severity levels. The paper does not establish the same threshold for anxiety or say that a score of 60 or more requires further psychological evaluation; it discusses cut-points as aids to treatment decisions. (LLM, conf=0.88)
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“Four additional metrics were calculated for each FSI measure [43, 45].”
MethodSelf-citationRangel, M. L., Milbury, K., Kayser, K., Ripley, R. T., Kvale, E., & Badr, H. (2024) · JTO Clinical and Research Reports · doi:10.1016/j.jtocrr.2024.100736 · Cited by 5 · see citing works
- Authors
- Kroenke, K., Stump, T. E., Chen, C. X., Kean, J., Bair, M. J., Damush, T. M., Krebs, E. E., & Monahan, P. O.
- Affiliations
- Regenstrief Institute (US)
- Indiana University Indianapolis (US)
- University of Utah (US)
- University of Minnesota (US)
- Corresponding author
- Kroenke, Kurt
- ORCID
- Venue
- Journal of Affective Disorders
- Publisher
- Elsevier BV
- Published
- 2020-04
- Volume
- 266
- Pages
- 100-108
- ISSN
- 0165-0327 (ISSN-L)
- PMC
- PMC7103541
- OpenAlex
- W3000904406
- Cited by
- 131
- References
- 17
- Citations by year
- 2026: 26 · 2025: 26 · 2024: 27 · 2023: 13 · 2022: 22 · 2021: 13 · 2020: 3 · 2019: 1
- FWCI
- 8.11
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Journal of Affective Disorders (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- IUScholarWorks (Indiana University) (submittedVersion)
- Purdue University Indianapolis (Indiana University) (submittedVersion)
- Funders
- National Institutes of Health
- Topics
- Social Sciences › Decision Sciences › Management Science and Operations Research › Psychometric Methodologies and Testing
- Social Sciences › Economics, Econometrics and Finance › Economics and Econometrics › Health Systems, Economic Evaluations, Quality of Life
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
- Keywords
- minimally important difference, severity thresholds, patient-reported outcomes, depression severity, PHQ-9, anchor-based estimation, distribution-based estimation, veterans, chronic pain, stroke, sample size determination
- MeSH terms
- Patient Reported Outcome Measures, Adult, Depression, Depressive Disorder, Humans, Male, Randomized Controlled Trials as Topic, Chronic Pain
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