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Â PREPUBLICATIONÂ COPY,Â UncorrectedÂ ProofsÂ Â Summary 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 patients face when making health care choices. The data infrastructure includes data sources and functionalities that support the research. Major building blocks are the services, standards, policies, and governance that enable the use of the data. ASPE asked the National Academies to appoint a consensus study committee to identify issues critical to the continued development of the data infrastructure for PCOR. The committeeâs work will contribute to ASPEâs development of a strategic plan that will guide their work related to PCOR data capacity over the next decade. As part of its information gathering activities, the committee organized three workshops to collect input from stakeholders on the PCOR data infrastructure, which includes a variety of types of data, such as clinical data, research data, administrative data from payer records, and patient-provided data. This report, the second in a series of three interim reports, summarizes the discussion and committee conclusions from the second workshop, which focused on data standards, methods, and policies that could make the PCOR data infrastructure more useful in the years ahead. Participants in the workshop included researchers and policy experts working in these areas. The first report in the series centered on emerging data needs.1 The third report will discuss research and data collaborations. The committee will also issue a final report. The high-level conclusions included in this interim report are based primarily on the input collected as part of the workshop, background documentation received from ASPE and other public sources, and the committee membersâ synthesis and expert judgment regarding the input received. As an interim report based on one in a series of information-gathering activities, the scope of this report is narrowly focused on a subset of key topics relevant to the committeeâs charge. The conclusions reached by the committee are, at this stage, fairly high-level. After completing all of its information gathering activities, which include but are not limited to the three workshops, the committee will also issue a final report, containing the studyâs overall findings and conclusions. DATA STANDARDS Part of the workshop discussed in this report focused on standards for PCOR. Standards are increasingly widely used for a variety of purposes, including collecting, storing, analyzing, and exchanging data. One theme that emerged from the workshop was that these standards are most useful when they are focused on addressing a specific problem or are driven by the specific Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â 1 https://www.nap.edu/catalog/26297/building-data-capacity-for-patient-centered-outcomes-research-interim- report. 1 Â
Â PREPUBLICATIONÂ COPY,Â UncorrectedÂ ProofsÂ Â value they can contribute. The needs and norms evolve over time, and because of this, standards need to evolve too. The workshop also identified some key areas where ASPEâs role is particularly important. CONCLUSION 2-1: Standards are most useful when their development is driven by their potential uses and a clear concept of the value they can contribute. CONCLUSION 2-2: ASPE could add significant value in the area of standards for patient-centered outcomes research by - Continuing to promote the development of a data infrastructure and an implementation strategy that facilitates the use of standards and access to the data; - Convening stakeholder meetings to enhance communication and work towards developing a common language for standards; - Facilitating accessibility to the data and collaborations with existing organizations working in this area; and - Leading efforts to catalogue and exemplify data standards and analytic standards. CONCLUSION 2-3: While data standards are important to conducting patient- centered outcomes research, applying standards to the analytic methods as well is important to facilitate the reliability and reproducibility of study results. Learning from the work on standards happening across the globe would further advance patient-centered outcomes research. CONCLUSION 2-4: An international perspective is an important consideration for the patient-centered outcomes research data infrastructure, and the infrastructure focused on standards specifically would benefit from building on work that happens internationally. METHODS A promising area of research focuses on better understanding the longitudinal, holistic experiences of people across time and different settings, which requires matching records across databases. To balance these opportunities and concerns, it would be useful to develop a carefully thought out strategy for linking data from a variety of sources, and to focus on strengthening the data infrastructure in additional ways that would enable longitudinal research that provides a comprehensive understanding of peopleâs experiences over their life course. CONCLUSION 3-1: The ability to adopt a longitudinal, comprehensive perspective of an individualâs journey could open new opportunities for patient- centered outcomes research. The shift could be facilitated by focusing on efforts to - simplify integration of data across the research data ecosystem; 2 Â
Â PREPUBLICATIONÂ COPY,Â UncorrectedÂ ProofsÂ Â - address challenges posed by the limitations associated with health identifiers; - incorporate person-generated data into health data systems; and - leverage real-world data to expand the timeline view of a personâs health-related experiences. There is also a need for transparency and the continued refinement of best practices related to how data and methods are used. This is especially important for emerging data sources and methods that capture more lifestyle and behavioral information than traditional clinical measurements, as well as the application of artificial intelligence methods, which could have biases confounded by patterns associated with new technologies. These considerations are also important for the use of observational data. CONCLUSION 3-2: Observing scientific best practices, including those of transparency and ethical use of data, is essential to generate trust in patient- centered-outcomes research among all stakeholders, including the public and researchers. This is important both for observational data and for emerging data sources and methods. The workshop highlighted the importance of interpreting best practices in the dissemination of research broadly, to include not only sharing results but also making available other resources and components associated with the research process, such as the software developed for the analyses. CONCLUSION 3-3: The results of patient-centered outcomes research (and research in general) are only replicable and are most useful when the underlying data and comprehensive research documentation (such as analytic code) are made available for use by others. DATA POLICY AND OTHER DATA INFRASTRUCTURE CONSIDERATIONS A theme that emerged from the workshop was the need to involve the people and communities whose data are being used in decisions about the data collection and data use throughout the entire research lifecycle. This is essential for building trust, which increases willingness to participate and, in turn, the likelihood that the data that are obtained will be complete, reliable, representative, and relevant to diverse stakeholders. This is particularly important for data on social determinants of health. CONCLUSION 4-1: Building and maintaining trust among the people and communities whose data are being sought for research is essential for high-quality data. Including representatives of consumers and patients in the research process to understand how to measure health impacts that matter to individuals is an important component in building trust. The existing laws and regulations that govern the use of data for research, including the Health Insurance Portability and Accountability Act of 1996 (HIPAA), are outdated and would 3 Â
Â PREPUBLICATIONÂ COPY,Â UncorrectedÂ ProofsÂ Â benefit from a critical review and updating to facilitate patient-centered outcomes research while preventing misuses of the data. CONCLUSION 4-2: This is an opportune time to revisit and update the legislation and rules governing data privacy and the sharing of data for research. 4 Â