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Leavy MB, Cooke D, Hajjar S, et al. Outcome Measure Harmonization and Data Infrastructure for Patient-Centered Outcomes Research in Depression: Report on Registry Configuration [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2020 Nov.

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

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

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Introduction

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. Connecting data across registries and other data collection efforts would yield a robust national data infrastructure to help address these questions, but a lack of harmonization in the outcome measures currently collected in research programs and clinical practice hinders the ability to connect these data sources. The Agency for Healthcare Research and Quality recently funded a stakeholder-driven effort to use the Outcome Measures Framework (OMF) to develop a minimum set of harmonized outcome measures for use in depression registries and clinical practice. The minimum measure set was finalized in 2018.

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.

OM1, in collaboration with the American Board of Family Medicine’s PRIME Registry and the American Psychiatric Association’s Psychiatric Patient Registry Online (PsychPRO), seeks to demonstrate that data can be captured within the clinician workflow and directly from patients, exchanged seamlessly with multiple registries, and provided back to clinicians in a usable format to inform decision making. The project team will accomplish this by calculating six harmonized measures developed for depression (response, remission, recurrence, adverse events, suicide ideation and behavior, and mortality) within the registries, developing Fast Healthcare Interoperability Resources (FHIR) resources to extract and send the relevant data from electronic health records (EHRs) and any ancillary patient-reported outcome (PRO) systems to the registries, and building and implementing a Substitutable Medical Applications, Reusable Technologies (SMART) on FHIR app to provide information back to the clinician.

The purpose of this document is to describe the approach and actions taken to enable calculation of six harmonized outcome measures within the PRIME Registry and PsychPRO. Key findings from this practical implementation of the measures are presented here, along with a summary of the next steps.

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