Journal Article

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

Bair, Matthew J., Kean, Jacob, Kroenke, Kurt, Stump, Timothy E., Chen, Chen X., Krebs, Erin E., Damush, Teresa M., Monahan, Patrick O.

2021

Overview

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

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Adult / Aged / Back pain / Chronic pain / Chronic Pain - diagnosis / Chronic Pain - psychology / Clinical medicine / Clinical trials / Clinical Trials as Topic / Depression / Depression - diagnosis / Depression, Mental / Diagnosis / Evaluation / Female / Humans / Longitudinal studies / Male / Medicine / Medicine & Public Health / Mental depression / Mental disorders / Mental Health / Methods / Middle Aged / Narcotics / Outcome and process assessment (Health Care) / Pain Measurement - standards / Patient Health Questionnaire / Patient Outcome Assessment / Patient outcomes / Patient Reported Outcome Measures / Patients / PHQ-9 / Primary care / PROMIS / Psychometrics / Public domain / Quality of Life / Quality of Life Research / Quantitative psychology / Questionnaires / Responsiveness / Retrospective Studies / Risk factors / Sensitivity to change / Severity of Illness Index / Statistical analysis / Statistical methods / Statistical tests / Surveys and Questionnaires - standards