Responsiveness of PROMIS and Patient Health Questionnaire (PHQ) Depression Scales in three clinical trials.

Affiliation

Kroenke K(1)(2), Stump TE(3), Chen CX(4), Kean J(5), Damush TM(6)(7)(8), Bair MJ(6)(7)(8), Krebs EE(9)(10), Monahan PO(3).
Author information:
(1)Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA. [Email]
(2)Regenstrief Institute, Inc, 1101 West 10th St., Indianapolis, IN, 46202, USA. [Email]
(3)Department of Biostatistics, Indiana University Fairbanks School of Public Health and School of Medicine, Indianapolis, IN, USA.
(4)Indiana University School of Nursing, Indianapolis, IN, USA.
(5)Department of Population Health Sciences, University of Utah School of Medicine, Salt Lake City, Utah, USA.
(6)Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, USA.
(7)Regenstrief Institute, Inc, 1101 West 10th St., Indianapolis, IN, 46202, USA.
(8)VA Health Services Research and Development Center for Health Information and Communication, Indianapolis, IN, USA.
(9)Center for Chronic Disease Outcomes Research, Minneapolis VA Health Care System, Minneapolis, MN, USA.
(10)University of Minnesota Medical School, Minneapolis, MN, USA.

Abstract

BACKGROUND: The PROMIS depression scales are reliable and valid measures that have extensive normative data in general population samples. However, less is known about how responsive they are to detect change in clinical settings and how their responsiveness compares to legacy measures. The purpose of this study was to assess and compare the responsiveness of the PROMIS and Patient Health Questionnaire (PHQ) depression scales in three separate samples. METHODS: We used data from three clinical trials (two in patients with chronic pain and one in stroke survivors) totaling 651 participants. At both baseline and follow-up, participants completed four PROMIS depression fixed-length scales as well as legacy measures: Patient Health Questionnaire 9-item and 2-item scales (PHQ-9 and PHQ-2) and the SF-36 Mental Health scale. We measured global ratings of depression change, both prospectively and retrospectively, as anchors to classify patients as improved, unchanged, or worsened. Responsiveness was assessed with standardized response means, statistical tests comparing change groups, and area-under-curve analysis. RESULTS: The PROMIS depression and legacy scales had generally comparable responsiveness. Moreover, the four PROMIS depression scales of varying lengths were similarly responsive. In general, measures performed better in detecting depression improvement than depression worsening. For all measures, responsiveness varied based on the study sample and on whether depression improved or worsened. CONCLUSIONS: Both PROMIS and PHQ depression scales are brief public domain measures that are responsive (i.e., sensitive to change) and thus appropriate as outcome measures in research as well as for monitoring treatment in clinical practice. Trial registration ClinicalTrials.gov ID: NCT01236521, NCT01583985, NCT01507688.