Building data capacity for patient-centered outcomes research in HHS

Abstract

The purpose of this report is to present the findings of a formative evaluation to assess the progress of the OS PCORTF portfolio at a point in time and how the findings inform future efforts to build data capacity to support clinical comparative effectiveness research (CER) and patient-centered outcomes research (PCOR). This report describes a formative evaluation of OS-PCORTF projects that were active or completed between 2012 to 2016.
The projects were supported by the Patient-Centered Outcomes Research Trust Fund (PCORTF) and administered by the Office of the Assistant Secretary for Planning and Evaluation (ASPE) for the United States Department of Health and Human Services (HHS).
HHS has identified 4 components necessary to build data capacity to support PCOR:
1. Standards, or accepted specifications that ensure that the data used for PCOR are consistent and usable across different sources and for different uses,
2. Services, such as programming protocols and interfaces, that allow for the capture,storage, linkage, analysis, and exchange of clinical data or evidence,
3. Policies that address how data are used and to ensure that data are protected and secure, and
4. Governance structures to support data sharing among organizations.
The evaluation assessed the progress made by the OS PCORTF portfolio towards implementation of these 4 components and 5 specific research functionalities identified in the HHS Strategic Framework for Building Data Capacity. The evaluation also examined the perspectives of federal and nonfederal stakeholders to better understand the current status of the universe of data capacity-building projects, identify strengths and limitations of the current work, and to determine areas where further work is needed.
The evaluation found that:
• Efforts to improve standards, services, policies, and governance have moved from planning to implementation. The most significant progress has been made in standards,particularly standards for common data elements, and in services, which encompass the resources to capture, store, and exchange data. Further work is most needed to implement policies that oversee data use, security and privacy, and to create governance structures that support the efficient use of data.
• Significant progress has been made toward the core functionalities identified in the HHS Strategic Framework, especially the use of clinical data for research and the standardized collection of standardized clinical data.
• Modest progress has been made on standards, services, policies and governance aimed at improving data quality.

Future projects are needed to explore how to enhance data privacy and security, ensure data quality, address data governance, and operationalize related standards.
Potential specific areas for future research include:
• Developing technical services and standards for services that allow patient data to be securely linked to other data sources.
• Developing standards, services, and policies to assure data quality for research.
• Creating a policy framework that preserves security and privacy while improving the ability to access and query clinical data by researchers.
• Developing a better understanding and methods to address the socio-legal challenges that arise with using patient data for research.
• Dissemination efforts to promote greater awareness of OS-PCORTF initiatives and products among members of the research community.