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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.

Executive Summary Patient registries are important tools for advancing research, improving healthcare quality, and supporting health policy. Registries contain vast amounts of data that could be used for new purposes when linked with other sources or shared with researchers. This toolkit was developed to summarize current best practices and provide information to assist registries interested in sharing data. The contents of this toolkit were developed based on review of the literature, existing registry practices, interviews with registries, and input from key stakeholders involved in the sharing of registry data. While some information in this toolkit may be relevant in other countries, this toolkit focuses on best practices for sharing data within the United States. Considerations related to data sharing differ across registries depending on the type of registry, registry purpose, funding source(s), and other factors; as such, this toolkit describes general best practices and considerations rather than providing specific recommendations. Finally, data sharing raises complex legal, regulatory, operational, and technical questions, and none of the information contained herein should be substituted for legal advice. The toolkit is organized into three sections: “Preparing to Share Data,” “Governance,” and “Procedures for Reviewing and Responding to Data Requests.” The section on “Preparing to Share Data” discusses the role of appropriate legal rights to further share the data and the need to follow all applicable ethical regulations. Registries should also prepare for data sharing activities by ensuring data are maintained appropriately and developing policies and procedures for governance and data sharing. The “Governance” section describes the role of governance in data sharing and outlines key governance tasks, including defining and staffing relevant oversight bodies; developing a data request process; reviewing data requests; and overseeing access to data by the requesting party. Governance structures vary based on the scope of data shared and registry resources. Lastly, the section on “Procedures for Reviewing and Responding to Data Requests” discusses the operational steps involved in sharing data. Policies and procedures for sharing data may depend on what types of data are available for sharing and with whom the data can be shared. Many registries develop a data request form for external researchers interested in using registry data. When reviewing requests, registries may consider whether the request aligns with the registry’s mission/purpose, the feasibility and merit of the proposed research, the qualifications of the requestor, and the necessary ethical and regulatory approvals, as well as administrative factors such as costs and timelines. Registries may require researchers to sign a data use agreement or other such contract to clearly define the terms and conditions of data use before providing access to the data in a secure manner. The toolkit concludes with a list of resources and appendices with supporting materials that registries may find helpful.