Patient-Centered Outcomes Research Trust Fund FAQs

What is the Office of the Secretary’s Patient-Centered Outcomes Research Trust Fund (OS-PCORTF)?

The Office of the Secretary (OS) of HHS receives 4% annually (2011-2019) of the Patient-Centered Outcomes Research Trust Fund (PCORTF) to build data capacity for PCOR.  Under a delegation of authority by the Secretary, ASPE manages the OS-PCORTF funds on behalf of the Department.  Section 937(f) of the PHS Act charges the Secretary of HHS, through PCORTF funding, to:

 … provide for the coordination of relevant Federal health programs to build data capacity for comparative clinical effectiveness research, including the development and use of clinical registries and health outcomes research networks, in order to develop and maintain a comprehensive, interoperable data network to collect, link, and analyze data on outcomes and effectiveness from multiple sources including electronic health records.

In coordination with the HHS Leadership Council for OS-PCORTF, the portfolio has made coordinated funding investments over time to build data capacity for research.   

Who are members of the HHS Leadership Council for the OS-PCORTF?

The Leadership Council is composed of relevant HHS agency heads or their designees.  The Council assists ASPE in identifying priorities, reviews and approves annual projects for further consideration of OS-PCORTF annual awards.  To fulfill its responsibilities, OS-PCORTF staff works closely with its Leadership Council, HHS agency representatives, and project leads.  The current Leadership Council members are:

  1. Administration for Children and Families (ACF)

  2. Assistant Secretary for Planning and Evaluation (ASPE) Coordinator

  3. Agency for Healthcare Research and Quality (AHRQ)

  4. Assistant Secretary for Preparedness and Response (ASPR)

  5. Centers for Disease Control and Prevention (CDC)

  6. Centers for Medicare & Medicaid Services (CMS)

  7. HHS Chief Technology Officer (CTO)

  8. Food and Drug Administration (FDA)

  9. Health Resources and Services Administration (HRSA)

  10. National Institutes of Health (NIH)

  11. Office of the National Coordinator for Health Information Technology (ONC)

  12. Substance Abuse and Mental Health Services Administration (SAMHSA)

What is meant by building data capacity for research?

To provide a framework for PCOR data and how it would be used, 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:

  1. 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.

  2. 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)).

  3. 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.

  4. 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. 

  5. Use of Enhanced Publically-Funded Data Systems for Research: Researchers will be able to readily use, retrieve, link and aggregate publically-funded data for research due to enhancements in publicly-funded data systems.

What are the main components of an interoperable data network?

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:

  1. 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. 

  2. 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.

  3. 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. 

  4. 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. 

How are existing data used as part of the OS-PCORTF portfolio?

The growing volume of health data generated by patients and providers across the continuum of health care offers expanding opportunities for secondary use of existing health data for a wide spectrum of research questions.  These data can represent important clinical, environmental, and socio-behavioral factors that influence patient health outcomes such as death, disease, and disability.  Analyzing data derived from the delivery of health care can enhance many HHS research efforts including:

  • Biomedical research programs and clinical trials networks at the National Institutes of Health (NIH);

  • Medical product safety surveillance programs at the Food and Drug Administration (FDA);

  • Quality and health services research programs at the Agency for Healthcare Research and Quality (AHRQ);

  • National and state statistical reporting programs on disease burden by the Centers for Disease Control and Prevention (CDC);

  • Planning and emergency response programs by the Assistant Secretary for Preparedness and Response (ASPR); and

  • Demonstration projects which examine the effects of alternative policies of health care coverage and delivery at the Centers for Medicare & Medicaid Services (CMS).

 How does ASPE work with other HHS agencies?

ASPE regularly convenes HHS agency leaders to identify priorities for projects that build data capacity for PCOR.  Through this coordination, ASPE and agency leaders support HHS research programs and generate new scientific evidence that help to inform decisions about patient health outcomes. 

In addition, ASPE fosters interagency working groups that bring together Federal researchers and research networks, program officials, and data experts to conduct collaborative projects which are designed to build data capacity for patient-centered research.  ASPE regularly convenes project teams comprised of Federal researchers for administrative and educational meetings to discuss progress towards building data capacity, share outputs from projects, stimulate collaboration, disseminate information tools, and maintain a strategic plan. 

Who are the end users of OS-PCORTF projects outputs?

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.