Harmonized Outcome Measures for Use in Depression Patient Registries and Clinical Practice

Gliklich, Richard E.; Leavy, Michelle B; Cosgrove, Lisa; Simon, Gregory E.; Peterson, Lars E.; Olin, Bryan; Cole, Collette; DePaulo, J. Raymond; Wang, Philip; Crowe, Chris M.; Cusin, Cristina; Nix, Mary; Berliner, Elise; Trivedi, Madhukar H.

doi:10.7326/m19-3818

Cited by 21 publications

(20 citation statements)

References 11 publications

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“…The interest in dimensional approaches to depression has led investigators to develop measures of depression severity. Among these measures, the PHQ-9 has become an instrument of reference in research as well as an international legacy measure in detecting and monitoring depression in clinical settings (Gliklich et al, 2020; Kroenke, 2021; Martin-Subero et al, 2017).…”

mentioning

confidence: 99%

Is the PHQ-9 a unidimensional measure of depression? A 58,272-participant study.

Bianchi¹,

Verkuilen²,

Toker³

et al. 2022

Psychological Assessment

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The PHQ-9 has become a measure of reference in depression research and clinical practice. However, the issue of the PHQ-9's unidimensionality has not been fully elucidated, and the usability of the PHQ-9's total score requires clarification. In this study, we examined the dimensionality, scalability, and monotonicity properties of the PHQ-9 as well as the scale's total-score reliability. We did so based on exploratory structural equation modeling (ESEM) bifactor analysis and Mokken scale analysis (MSA). We relied on a total of 58,272 participants (63% female; M age = 43, SD age = 13) from 29 samples involving seven different countries (e.g., Germany, the U.S.) and five different languages (e.g., German, English). We found no concerning deviations from measurement invariance for our ESEM bifactor model, neither across samples nor across sexes, age groups, and languages. The PHQ-9 met the requirements for essential unidimensionality in the pooled sample and across sex-, age-, and language-based subsamples. In each case, the general factor was strong (e.g., factor loadings ranged from 0.725 to 0.893 in the pooled sample) and Omega Hierarchical values exceeded 0.900. The correlations between the general factor and the observed total scores were large (≥0.952). Our MSA, including multilevel MSA, revealed that the PHQ-9's scalability is satisfactory. No monotonicity violation was detected, suggesting that the scale's total score accurately orders respondents on the latent Depression variable. Total-score reliability was good. This study provides robust evidence that the PHQ-9 can be used as a unidimensional measure of depressive symptoms by researchers and practitioners. Public Significance StatementBecause depression is a widespread condition with potentially lethal consequences, assessing depressive symptoms reliably and validly is of critical importance. This study indicates, with an unprecedented level of confidence, that researchers and practitioners are justified in employing the PHQ-9 as a unidimensional measure of depressive symptoms based on the scale's total score.

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mentioning

confidence: 99%

Is the PHQ-9 a unidimensional measure of depression? A 58,272-participant study.

Bianchi¹,

Verkuilen²,

Toker³

et al. 2022

Psychological Assessment

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“…The harmonized outcome measures for depression were developed through a multistakeholder, consensus-based process in the prior project. 1 This pilot project is the first practical implementation of the measures. The six measures selected for this project are presented in Table 1.…”

Section: Harmonized Outcome Measures For Depressionmentioning

confidence: 99%

Outcome Measure Harmonization and Data Infrastructure for Patient-Centered Outcomes Research in Depression: Report on Registry Configuration

Leavy¹,

Cooke²,

Hajjar³

et al. 2020

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Background: Major depressive disorder is a common mental disorder. Many pressing questions regarding depression treatment and outcomes exist, and new, efficient research approaches are necessary to address them. The primary objective of this project is to demonstrate the feasibility and value of capturing the harmonized depression outcome measures in the clinical workflow and submitting these data to different registries. Secondary objectives include demonstrating the feasibility of using these data for patient-centered outcomes research and developing a toolkit to support registries interested in sharing data with external researchers. Methods: The harmonized outcome measures for depression were developed through a multi-stakeholder, consensus-based process supported by AHRQ. For this implementation effort, the PRIME Registry, sponsored by the American Board of Family Medicine, and PsychPRO, sponsored by the American Psychiatric Association, each recruited 10 pilot sites from existing registry sites, added the harmonized measures to the registry platform, and submitted the project for institutional review board review Results: The process of preparing each registry to calculate the harmonized measures produced three major findings. First, some clarifications were necessary to make the harmonized definitions operational. Second, some data necessary for the measures are not routinely captured in structured form (e.g., PHQ-9 item 9, adverse events, suicide ideation and behavior, and mortality data). Finally, capture of the PHQ-9 requires operational and technical modifications. The next phase of this project will focus collection of the baseline and follow-up PHQ-9s, as well as other supporting clinical documentation. In parallel to the data collection process, the project team will examine the feasibility of using natural language processing to extract information on PHQ-9 scores, adverse events, and suicidal behaviors from unstructured data. Conclusion: This pilot project represents the first practical implementation of the harmonized outcome measures for depression. Initial results indicate that it is feasible to calculate the measures within the two patient registries, although some challenges were encountered related to the harmonized definition specifications, the availability of the necessary data, and the clinical workflow for collecting the PHQ-9. The ongoing data collection period, combined with an evaluation of the utility of natural language processing for these measures, will produce more information about the practical challenges, value, and burden of using the harmonized measures in the primary care and mental health setting. These findings will be useful to inform future implementations of the harmonized depression outcome measures.

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“…Major depressive disorder (MDD) is a debilitating condition characterized by depressed mood, diminished interest, impaired cognitive function, and vegetative symptoms [2]. The incidence and prevalence of these two diseases has increased in recent years,becoming a global health concern [3][4][5][6].…”

Section: Introductionmentioning

confidence: 99%

Association between depression and sleep apnoea: a Mendelian randomisation study

et al. 2021

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BackgroundStudies have reported a close relationship between depression and sleep apnoea, yet it is unknown whether these are causally related. Thus, we aimed to determine whether depression is associated with the aetiology of sleep apnoea.MethodsWe used publicly available genetic summary data from two large consortia, the Psychiatric Genomics Consortium, with data from 36 single-nucleotide polymorphisms (SNPs) closely associated with major depressive disorder (MDD) and UK Biobank, including 456 736 patients with sleep apnoea and 766 964 controls. For Mendelian randomisation (MR) analysis, we used the inverse-variance weighted method, weighted median method, MR-Egger regression, MR pleiotropy residual sum, and outlier test to retrieve summary data. Analyses were performed using the “TwoSampleMR” package in R.ResultsOf the 36 SNPs associated with MDD, we found statistically significant evidence of a potential causal effect of MDD on the risk of sleep apnoea (odds ratio 1.004, 95% confidence interval: 1.001–1.006, p=0.001). Similar results were obtained using the MR-Egger and weighted median methods. Additionally, we found no heterogeneity or pleiotropy.ConclusionsOur findings suggest that depression slightly increases the risk of sleep apnoea. Further investigation of the potential biological mechanisms is necessary.

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Harmonized Outcome Measures for Use in Depression Patient Registries and Clinical Practice

Cited by 21 publications

References 11 publications

Is the PHQ-9 a unidimensional measure of depression? A 58,272-participant study.

Is the PHQ-9 a unidimensional measure of depression? A 58,272-participant study.

Outcome Measure Harmonization and Data Infrastructure for Patient-Centered Outcomes Research in Depression: Report on Registry Configuration

Association between depression and sleep apnoea: a Mendelian randomisation study

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