Kurt Kroenke1, Timothy E Stump2, Chen X Chen3, Jacob Kean4, Matthew J Bair5, Teresa M Damush5, Erin E Krebs6, Patrick O Monahan2. 1. Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA; Regenstrief Institute, Inc., 1101 West 10th St., Indianapolis, 46202 IN, USA. Electronic address: kkroenke@regenstrief.org. 2. Department of Biostatistics, Indiana University Fairbanks School of Public Health and School of Medicine, Indianapolis, IN, USA. 3. Indiana University School of Nursing, Indianapolis, IN, USA. 4. Department of Population Health Sciences, University of Utah School of Medicine, Salt Lake City, Utah, USA. 5. Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA; Regenstrief Institute, Inc., 1101 West 10th St., Indianapolis, 46202 IN, USA; VA Health Services Research and Development Center for Health Information and Communication, Indianapolis, IN, USA. 6. Center for Chronic Disease Outcomes Research, Minneapolis VA Health Care System, Minnesota, USA; University of Minnesota Medical School, Minneapolis, Minnesota, USA.
Abstract
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.
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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