Dataset Information

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

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.

SUBMITTER: Kroenke K

PROVIDER: S-EPMC7860196 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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Publications

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

Kroenke Kurt K Stump Timothy E TE Chen Chen X CX Kean Jacob J Damush Teresa M TM Bair Matthew J MJ Krebs Erin E EE Monahan Patrick O PO

Health and quality of life outcomes 20210204 1

<h4>Background</h4>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.<h4>Methods</h4>We used data from thr ...[more]

PMID: 33541362

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Project description:ObjectiveTo determine the accuracy of the Patient Health Questionnaire-9 (PHQ-9) for screening to detect major depression.DesignIndividual participant data meta-analysis.Data sourcesMedline, Medline In-Process and Other Non-Indexed Citations, PsycINFO, and Web of Science (January 2000-February 2015).Inclusion criteriaEligible studies compared PHQ-9 scores with major depression diagnoses from validated diagnostic interviews. Primary study data and study level data extracted from primary reports were synthesized. For PHQ-9 cut-off scores 5-15, bivariate random effects meta-analysis was used to estimate pooled sensitivity and specificity, separately, among studies that used semistructured diagnostic interviews, which are designed for administration by clinicians; fully structured interviews, which are designed for lay administration; and the Mini International Neuropsychiatric (MINI) diagnostic interviews, a brief fully structured interview. Sensitivity and specificity were examined among participant subgroups and, separately, using meta-regression, considering all subgroup variables in a single model.ResultsData were obtained for 58 of 72 eligible studies (total n=17 357; major depression cases n=2312). Combined sensitivity and specificity was maximized at a cut-off score of 10 or above among studies using a semistructured interview (29 studies, 6725 participants; sensitivity 0.88, 95% confidence interval 0.83 to 0.92; specificity 0.85, 0.82 to 0.88). Across cut-off scores 5-15, sensitivity with semistructured interviews was 5-22% higher than for fully structured interviews (MINI excluded; 14 studies, 7680 participants) and 2-15% higher than for the MINI (15 studies, 2952 participants). Specificity was similar across diagnostic interviews. The PHQ-9 seems to be similarly sensitive but may be less specific for younger patients than for older patients; a cut-off score of 10 or above can be used regardless of age..ConclusionsPHQ-9 sensitivity compared with semistructured diagnostic interviews was greater than in previous conventional meta-analyses that combined reference standards. A cut-off score of 10 or above maximized combined sensitivity and specificity overall and for subgroups.RegistrationPROSPERO CRD42014010673.

Project description:In Uganda, depression is a major public health issue because of its direct disease burden and as a risk factor and co-morbidity for other pervasive health issues. Psychometric assessment of translated depression measures is critical to public health planning to ensure proper screening, surveillance, and treatment of depression and related outcomes. We examined aspects of the validity and reliability of the Patient Health Questionnaire-9 (PHQ-9) translated into Luganda and Runyoro in a large population-based cohort of Ugandan adolescents and adults. Data from the ongoing open cohort AMBSO Population Health Surveillance study were analyzed from the Wakiso and Hoima districts in Uganda. Descriptive statistics were calculated for the overall sample and stratified by translated language. Construct validity was assessed for each translated scale using confirmatory factor analysis for ordinal data. The internal consistency of each translated scale was assessed using Cronbach's alpha, McDonald's omega total and omega hierarchical. Compared to the Runyoro-speaking subsample from Hoima (n=2297), participants in the Luganda-speaking subsample from Wakiso (n=672) were older (27 vs 21 years, p < 0.01) and a greater proportion were female (62% vs. 55%, p < 0.01). The Luganda-translated PHQ-9 had a sample mean of 3.46 (SD=3.26), supported a single-factor structure (RMSEA=0.05, CFI=0.96, TLI=0.94), and demonstrated satisfactory internal consistency (Cronbach's alpha=0.73, McDonald's omega total=0.76, McDonald's omega hierarchical=0.53). The Runyoro-translated PHQ-9 had a comparable sample mean of 3.58 (SD=3.00), also supported a one-factor structure (RMSEA=0.08, CFI=0.92, TLI=0.90), and demonstrated satisfactory internal consistency (Cronbach's alpha=0.72, McDonald's omega total=0.76, McDonald's omega hierarchical=0.57). Our preliminary findings indicate that the Luganda and Runyoro translations of the PHQ-9 had satisfactory construct validity and internal consistency in our sample of Ugandan adolescents and adults. Future studies should expand on this promising work by assessing additional psychometric characteristics of these translated measures in other communities in Uganda.

Dataset Information

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

Background

Methods

Results

Conclusions

Publications

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

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