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Health and Quality of Life Outcomes
Published in: Health and Quality of Life Outcomes 1/2021

Open Access 01-12-2021 | Affective Disorder | Research

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

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

Published in: Health and Quality of Life Outcomes | Issue 1/2021

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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
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Metadata
Title
Responsiveness of PROMIS and Patient Health Questionnaire (PHQ) Depression Scales in three clinical trials
Authors
Kurt Kroenke
Timothy E. Stump
Chen X. Chen
Jacob Kean
Teresa M. Damush
Matthew J. Bair
Erin E. Krebs
Patrick O. Monahan
Publication date
01-12-2021
Publisher
BioMed Central
Published in
Health and Quality of Life Outcomes / Issue 1/2021
Electronic ISSN: 1477-7525
DOI
https://doi.org/10.1186/s12955-021-01674-3

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