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Committee Charge and Process

ISSUES FOR THE COMMITTEE

The Office of the Assistant Secretary for Planning and Evaluation (ASPE), in partnership with other agencies and divisions of the U.S. Department of Health and Human Services (HHS), coordinates a portfolio of projects that build data capacity for conducting patient-centered outcomes research (PCOR). PCOR focuses on producing scientific evidence on the effectiveness of prevention and treatment options to inform the health care decisions of patients, families, and health care providers, taking into consideration the preferences, values, and questions people face when making health care choices. The data infrastructure includes data sources and functionalities that support the research.

ASPE asked the National Academies of Sciences, Engineering, and Medicine to appoint a consensus study committee and identify issues critical to building data capacity for PCOR and for generating new evidence to inform health care decisions. The input provided by the committee will contribute to ASPE’s strategic planning for its work related to the data infrastructure over the next decade. The study is part of a broader initiative by ASPE intended to update the strategic plan in light of the reauthorization of the PCOR Trust Fund and the recent advances achieved in health information technology and interoperability tools. Box 1-1 shows the committee’s Statement of Task.

The study is a collaboration of three units of the National Academies: the Committee on National Statistics, the Board on Health Care Services, and the Computer Science and Telecommunications Board. The consensus

study committee had a diverse membership, its 15 members including experts with decades of experience as well as emerging leaders in the broad fields of (1) PCOR; (2) research methods, statistics, and demography; (3) computer science and data infrastructure; and (4) patient engagement and patient perspectives. Appendix A contains the biographical sketches of the committee members.

WORKSHOPS AND OTHER INFORMATION-GATHERING ACTIVITIES

To obtain a thorough understanding of the PCOR data infrastructure, the committee met with ASPE and other HHS staff and reviewed background documentation, such as the Office of the Secretary PCOR Trust Fund (OS-PCORTF) project portfolio, annual reports, and reviews completed by other entities. As part of its information-gathering activities, the committee also organized three workshops to collect input from stakeholders on aspects of the charge developed in consultation with ASPE. The workshops focused on key topics that the committee believed would be particularly useful for the strategic planning and would benefit from broad input from a variety of data users and other stakeholders. The three topics were (1) data user needs; (2) data standards, methods, and policies; and (3) collaborations, data linkages, and interoperability of electronic databases.

The first workshop, focused on looking ahead at data user needs over the next decade, was held on May 3, 2021. The committee’s goal for this event was to bring together researchers and representatives of patient organizations to understand the needs of these two important data user groups. Specifically, the goals of the workshop were:

• Provide a high-level overview of the types of data included in the data infrastructure for PCOR.
• Identify key questions that stakeholders are most likely to want answered going forward, including general themes that cut across health conditions and circumstances.
• Discuss the implications of the broadened statutory scope for PCOR.
• Identify gaps in what stakeholders need and what the infrastructure allows. Consider both limitations in the existing data and improvements that could be made to new data collections.
• Discuss what questions cannot be answered and who is not served by the current PCOR data infrastructure.
• Discuss what matters HHS is best positioned to address and how the agency could maximize resources available for the PCOR data infrastructure (representing four percent of the PCOR Trust Fund) in the context of HHS’s public mission, authorities, programs, and data resources.

The second workshop, held on May 24, 2021, focused on developments in the areas of data standards, methods, and policies relevant to PCOR. The committee’s goal for this event was to bring together researchers and policy experts to

• Identify data standards and methods that can make the PCOR data infrastructure more useful for research and other data needs;
• Identify data policies that are needed to facilitate the continued development and operation of the PCOR data infrastructure; and
• Discuss what HHS is best positioned to address and support, and how the agency could maximize resources available for the PCOR data infrastructure (representing four percent of the PCOR Trust Fund), in the context of the HHS public mission, authorities, programs, and data resources.

The third workshop, held on June 14, 2021, focused on ways of enhancing collaborations, data linkages, and the interoperability of electronic databases to make the PCOR data infrastructure more useful in the years ahead. The goals of the workshop were to

• Discuss how research and data collaborations can evolve to meet PCOR and data capacity challenges, and how HHS can support effective research and data collaborations;
• Identify barriers and potential solutions to the access and use of linked public data, and to the access and use of linked public and private/proprietary data; and
• Discuss the feasibility and utility of developing a phased-in approach to building the interoperable data capacity for PCOR with existing databases in HHS, in other federal departments, and in the private sector.

Prior to each workshop, information about the event was disseminated through National Academies mailing lists and on the project website. To collect additional stakeholder input, members of the public were invited to provide comments on topics related to the workshop (or any other topic related to the committee’s charge), using a public input form available on the National Academies website.

The discussions and committee conclusions from the workshops were summarized in a series of interim reports. The interim reports have been published as stand-alone reports and are also included as appendixes to this report (see Appendixes B, C, and D). The appendixes contain additional details about the presenters, the input received, and the committee’s interim conclusions. Recordings of the workshops and the presentation slides are available on the National Academies website at www.nationalacademies.org/PCORData.

OVERVIEW OF THE REPORT

This report contains the committee’s overall findings and conclusions from the study. The findings and conclusions are based on the committee’s deliberations and integrated judgment on the materials reviewed and input received from all sources, including the workshops. The report’s conclusions reflect the conclusions of the interim reports, but they are further integrated here as part of a more holistic and streamlined discussion. In other words, some of the conclusions from the interim reports are included without substantive changes, while others have been combined and reworded primarily to present them in a more concise way. The final report also includes a few overarching findings and conclusions that do not appear as specific conclusions in any of the three interim reports, resulting instead from the committee’s subsequent deliberations that reflected on everything that was learned. Throughout the report, we included references to specific sections of the interim reports (Appendixes B, C, and D) that provide a more in-depth discussion of the topics covered in the final report.

Chapter 2 describes the PCOR data infrastructure and the OS-PCORTF. Chapter 3 discusses the committee’s conclusions concerning those aspects of the PCOR data infrastructure that emerged as areas that could particularly benefit from being prioritized as part of ASPE’s work over the next decade. The topics covered in the final report reflect the topics covered in the three interim reports, with an effort to offer integrated conclusions on the themes that overlapped across the workshops. Chapter 3 also offers additional conclusions on strengthening the overall framework for building the data infrastructure based on the committee’s collective judgment and deliberations on the input received. Appendix A contains biographical sketches of the committee members. Appendixes B, C, and D include the previously published interim reports. Appendix E contains a list and details on the data infrastructure projects funded through the OS-PCORTF.

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