The end users of patient-centered research data are primarily analysts, researchers, research networks, and research programs that study patient-centered questions. These groups are not mutually exclusive and are often interconnected with one another by statute, regulation, mission, professional interests, funding, or in other ways. Given the OS-PCORTF statutory charge to “coordinate federal programs to build data capacity…including the development and use of clinical registries and health outcomes research networks”, the OS-PCORTF focuses on the needs of research networks which use federal data to conduct health outcomes studies that address HHS priorities related to patient-centered questions or concerns. Together, these groups represent key partners for identifying and carrying out projects that are supported by OS-PCORTF funding.
The OS-PCORTF portfolio recognizes that certain types of infrastructure components or “building blocks” would enable the desired research functionalities, support interoperability, and help to ensure sustainability of data infrastructure for research over time. The basic types of building blocks for data infrastructure to support research consist of the following:
Standards represent information and meaning to patient-centered data to ensure that health specific information can be accurately (and securely) exchanged and used. In most cases standards should be nationally accepted, widely approved, or broadly adopted either through market forces, community approval or regulatory requirements. These include such items as data standards for capturing, storing, representing, and exchanging data in a secure manner such that accurate information is conveyed to the recipient of the data.
Policies are standards of behavior that participants can rely on consistently to build patient-centered data for research. Policies may include federal policies, as well as models for standardized state and local policies, that will lead to a trusted framework within the PCOR data infrastructure that ensures productivity, protects the patient and the patient’s data, ensures that evidence generations remains in the center of PCOR, and ensures the use of agreed upon standards and services.
Services refer to resources that entities can employ on demand to capture, store, or exchange either PCOR data or evidence through a centrally hosted model provided remotely (such as through the internet) rather that provided locally or on-site. Services make it easy for the research data to interoperate among different systems without having to start from scratch for every connection.
Governance structures refer to entities that are needed to develop and apply the rules and policies needed for building an interoperable and sustainable research network. Governance structures support the efficient use of the data infrastructure for research across individual and organizations’ boundaries of control and ownership. Governance structures are distinguished from “governance” which is what a governing body or governance structure does.
To provide a framework for PCOR data and show how it would be used to conduct PCOR, a Strategic Framework was developed in collaboration with HHS agencies. The Strategic Framework for OS-PCORTF identifies five functional goals that are essential as the basis for PCOR data infrastructures. These goals and functions are:
- Standardized Collection of Standardized Clinical Data: Researchers will be able to use standardized clinical data based on common data element standards across research projects and networks, thereby facilitating linkage and aggregation of data across data sources.
- Collection of Participant-Provided Information: Participants, including those in safety net organizations, will be able to participate more fully in clinical research by directly providing information (i.e., data points provided by the participant such as Patient-Reported Outcomes (PROs)).
- Linking of Clinical and Other Data for Research: Researchers will be able to follow patients across the care continuum over time, including those enrolled in clinical trials. Researchers will be able to capture the range of variables influencing health outcomes, and link clinical and other types of data (e.g., other clinical data, claims data, participant-provided information, and environmental data) required for research regardless of where the participant goes.
- Use of Clinical Data for Research: Researchers will be able to utilize and analyze routinely collected clinical data for implementation of clinical studies (observational and interventional) including data relevant to assessing safety, efficacy and adherence, as well as genetic data and PROs.
- Use of Enhanced Publicly-Funded Data Systems for Research: Researchers will be able to readily use, retrieve, link and aggregate publicly-funded data for research due to enhancements in publicly-funded data systems.
Here are featured reports, assessments and evaluations about data capabilities for PCOR as well as the performance of the OS-PCORTF program itself.
Reports on Data Capabilities for PCOR
- Considerations for Building Federal Data Capacity for Patient-Centered Outcomes Research Related to Intellectual and Developmental Disabilities - This report describes the current state of Patient-Centered Outcomes Research (PCOR) data infrastructure resources related to Intellectual and Developmental Disabilities (ID/DD), highlights data issues in the ID/DD research landscape that require more research, and identifies opportunities to enhance data infrastructure to improve PCOR for ID/DD.
- Building Data Capacity for Patient-Centered Outcomes Research (PCOR) for COVID-19: Highlights of Seven OS-PCORTF Funded Multiagency Data Initiatives - This report describes seven new multiagency projects to strengthen the data infrastructure for conducting patient-centered outcomes research on COVID-19, during and after the pandemic. In general, these projects either expand the use of existing data or link datasets across Federal and State sources. Some projects advance modeling using artificial intelligence (AI) and machine learning (ML) to identify subpopulations at risk for poorer outcomes, sequelae, and the impacts of care settings and community characteristics. Other projects gather critical data on the effectiveness of repurposed treatments and vaccines for COVID-19.
- Social Determinants of Health Data Sharing at the Community Level - This report represents a landscape review of community-level efforts to address SDOH, followed by interviews with participants in three community-level initiatives that have built networks to coordinate clinical and social services. This report presents a cross-site analysis of the three initiatives, highlighting factors they identified as facilitating their efforts, the challenges they have faced thus far, their plans for continued expansion, and opportunities for federal and state entities, among other actors, to contribute to their efforts.
- State Data for Conducting Patient-Centered Outcomes Research to Improve Maternal Health: Stakeholder Discussions Summary Report - This report presents a summary of discussions with stakeholders conducted to identify key components of successful state-based maternal health data linkage initiatives, to recognize the gaps in implementing such initiatives including data use for research and finally to understand the current status of existing linkages of state-level data with other data sources and with electronic health records.
- Challenges and Improvements for PCOR Data Infrastructure: Results from a Stakeholder Prioritization Activity - ASPE sought to gather perspectives on challenges and improvements for PCOR data infrastructure from a diverse group of stakeholders—with a wide range of occupational backgrounds including policy, health care delivery, research and informatics—through an online prioritization activity. Participants first generated challenges and improvements for the five functionalities. Participants then voted on challenges and improvements within each functionality, generating a ranked list of the participant-generated ideas.
- Addressing the Opioid Epidemic with Better Data: An Overview of HHS Priorities and Projects to Expand Data Capacity for Patient-Centered Outcomes Research on Opioids - This report builds on a workshop sponsored by ASPE, titled Addressing the Opioid Epidemic: Harnessing the Power of Data for Patient-Centered Research in December 2018, which showcased projects working to build the data infrastructure for patient-centered outcomes research around opioids.
Portfolio Over Time – Overviews, Annual Reports, Infographics
- Building the Data Capacity for Patient-Centered Outcomes Research: 2019 Vignettes - This report presents brief vignettes that describe highlights of projects that are funded through the OS-PCOR trust fund. The report gives illustrative examples of the value of the work that has been done in partnership with HHS agencies to build data capacity for patient-centered outcomes research. The vignette document showcases accomplishments of the portfolio and explains the usefulness of the products that project teams are producing.
- Building Data Capacity for Patient-Centered Outcomes Research: Portfolio Highlights (2016-2019): Impact, Opportunities and Case Studies [Executive Summary] [Full Report] - The purpose of this report is to summarize the impact of the OS-PCORTF portfolio in terms of products, tools and lessons learned for future work. The report is based on an assessment of portfolio awards funded from Fiscal Year (FY) 2016 through FY 2019.
- Building Data Capacity for Patient-Centered Outcomes Research in HHS: Highlights - This vignette describes select OS-PCORTF projects in progress or recently completed in FY 2018.
- Building Data Capacity for Patient-Centered Outcomes Research in HHS: A Formative Evaluation of 2012-2016 Projects - This report is a formative evaluation of the OS-PCORTF portfolio of projects from 2012 to 2016. It summarizes achievements as well as considerations for future work to build data capacity for clinical comparative effectiveness research and patient-centered outcomes research.
- The OS-PCORTF Strategic Framework - This statement summarizes the initial vision of the strategic framework to guide OS-PCORTF investments, as endorsed by the OS-PCORTF Leadership Council.
- Meeting the ACA Mandate to Build Data Capacity - This vignette, describing projects from 2010 to 2013 describes a two-prong approach to building data capacity under the ACA’s mandate: “development and use of clinical registries and health outcomes research data networks,” and “enable interoperable data flows, linkage and analysis with the plethora of existing electronic clinical data resources.”
Annual Reports of the OS-PCORTF Portfolio
- Building the Data Capacity for Patient-Centered Outcomes Research: The 2020 Annual Report
- The OS PCORTF Annual Report provides project descriptions for each of the OS-PCORTF portfolio’s 27 projects that were active in calendar year 2020, as well as the major accomplishments.
Executive Summary | Infographic
- Building the Data Capacity for Patient-Centered Outcomes Research: The 2019 Annual Report - The OS-PCORTF Annual Report provides project descriptions for each of the OS-PCORTF portfolio’s 27 projects that were active in calendar year 2019, as well as the major accomplishments. The 2019 Portfolio Report executive summary and infographic are also available for viewing.
Executive Summary | Infographic
- Building the Data Capacity for Patient-Centered Outcomes Research: The 2018 Annual Report
- The OS-PCORTF Annual Report provides project descriptions for each of the OS-PCORTF portfolio’s 25 projects that were active in calendar 2018.
- 2017 Annual Report of HHS Projects to Build Data Capacity for Patient-Centered Outcomes Research - The OS-PCORTF Annual Report provides project descriptions for each of the OS-PCORTF portfolio’s 21 projects that were active in calendar year 2017.
- 2016 Annual Report of HHS Projects to Build Data Capacity for Patient-Centered Outcomes Research - The OS-PCORTF Annual Report provides project descriptions for each of the OS-PCORTF portfolio’s 18 projects that were active in calendar year 2016.
- HHS Projects to Build Data Capacity for Patient-Centered Outcomes Research: Completed Projects FY 2010 through FY 2015 - The purpose of this document is to provide a summary of projects that were funded through the Office of the Secretary Patient-Centered Outcomes Research Trust Fund (OS-PCORTF) and completed between fiscal years (FY) 2010 and 2015.
- United States Government Accountability Office, Report to Congressional Committees, November 2020 Comparative Effectiveness Research - In this report, GAO reviewed the CER activities that PCORI and HHS have carried out to meet legislative requirements, described how PCORI and HHS allocated funding to CER activities, and described PCORI and HHS efforts to evaluate the effectiveness of their CER dissemination and implementation activities. The report can also be viewed by visiting: https://www.gao.gov/products/GAO-21-61
- United States Government Accountability Office, Report to Congressional Committees, March 2018 Comparative Effectiveness Research: Activities Funded by the Patient-Centered Outcomes Research Trust Fund - In this report, GAO reviewed the CER activities that PCORI and HHS have carried out to meet legislative requirements, described how PCORI and HHS allocated funding to CER activities, and described PCORI and HHS efforts to evaluate the effectiveness of their CER dissemination and implementation activities. The report can also be viewed by visiting: https://www.gao.gov/products/gao-18-311