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Outcome Measure Harmonization and Data Infrastructure for Patient-Centered Outcomes Research in Depression

Report on Registry Configuration

White Paper

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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.


Leavy MB, Cooke D, Hajjar S, Bickelman E, Egan B, Clarke D, Gibson D, Casanova B, Gliklich R. Outcome Measure Harmonization and Data Infrastructure for Patient-Centered Outcomes Research in Depression. Research White Paper. (Prepared by OM1, Inc., with subcontractors American Board of Family Medicine and American Psychiatric Association under Contract No. 75Q80119C00005.) AHRQ Publication No. 21-EHC003. Rockville, MD: Agency for Healthcare Research and Quality; November 2020. Posted final reports are located on the Effective Health Care Program search page. DOI: 10.23970/AHRQEPCREGISTRYOUTCOME.