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Introduction1
On January 20, 2015, President Obama announced the Precision Medicine Initiative (PMI) in his State of the Union address. The PMI, by developing new approaches for detecting, measuring, and analyzing a wide range of biomedical information including molecular, genomic, cellular, clinical, behavioral, physiological, and environmental parameters, is intended to enable a new era of medicine in which researchers, providers, and patients work together to develop individualized care. The President called for $215 million in fiscal year 2016 to support the initiative, which was to include efforts at several agencies within the federal government. Of this total proposed budget, $130 million was allocated to the National Institutes of Health (NIH) to build a national, large-scale research participant group, or cohort. The PMI Cohort Program is aimed at extending precision medicine to many diseases, including both rare and common diseases such as diabetes, heart disease, Alzheimer’s disease, obesity, and mental illnesses such as depression, bipolar disorder, and schizophrenia, by building a national research cohort of 1 million or more U.S. participants.
Many factors have converged to make now the right time to begin a program of this scale and scope, noted Bernard Rosof, chief executive officer at
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1 The planning committee’s role was limited to planning the workshop, and the proceedings has been prepared by the workshop rapporteur as a factual summary of what occurred at the workshop. Statements, recommendations, and opinions expressed are those of individual presenters and participants and have not been endorsed or verified by the National Academies of Sciences, Engineering, and Medicine, and they should not be construed as reflecting any group consensus.
the Quality in Healthcare Advisory Group, in his introduction to the workshop Relevance of Health Literacy to Precision Medicine, which was convened by the National Academies of Sciences, Engineering, and Medicine’s Roundtable on Health Literacy. Americans are engaging in improving their health and participating in health research more than ever before, electronic health records have been widely adopted, genomic sequencing costs have dropped significantly, data science has become increasingly sophisticated, and health technologies have become mobile. The PMI Cohort Program will be a participant-engaged, data-driven enterprise supporting research at the intersection of human biology, behavior, genetics, environment, data science and computation, and other disciplines to produce new knowledge with the goal of developing more effective ways to prolong health and treat disease. The cohort will broadly reflect the diversity of the U.S. population by including participants from diverse social, racial/ethnic, and ancestral populations living in a variety of geographies, social environments, and economic circumstances and from all age groups and health statuses. Information from the cohort will provide a broad, powerful resource for researchers working on a variety of important health questions. Importantly, the cohort will focus not just on disease, but also on ways to increase an individual’s chances of remaining healthy throughout life. The goal of the PMI Cohort Program is to set the foundation for a new way of doing research that will foster open, responsible data sharing with the highest regard to participant privacy and that puts engaged participants at the center of research efforts.
An important challenge to assembling the PMI Cohort will be to reach individuals who are socioeconomically disadvantaged. Individuals who are socioeconomically disadvantaged have lower health literacy; often belong to racial, ethnic, and minority communities; and are often less likely to participate in research studies and biorepositories, said Rosof, and they are also less likely to understand the institutional review board (IRB) process and informed consent, “Health literacy communication strategies and messaging designs are key factors to address these challenges and overcome the barriers to participation in the PMI Cohort,” Rosof said.
To explore possible strategies and messaging designs, the Roundtable on Health Literacy formed an ad hoc committee charged with planning and conducting a 1-day public workshop on the intersection of health literacy and precision medicine. According to the statement of task, the workshop was to feature invited presentations and discussions on topics that could include an overview of precision medicine and its potential; the relevance of health literacy to the success of precision medicine efforts; and perspectives and understanding of different groups, such as health care providers, consumers, and insurers. The planning committee was charged with defining the specific topics to be addressed, developing the agenda, selecting and inviting speakers and other participants, and moderating the discussions.
The planning committee was also charged with designating a rapporteur to prepare a summary of the presentations and discussions at the workshop in accordance with institutional guidelines.
ORGANIZATION OF THE PROCEEDINGS
The workshop (see Appendix A for the agenda) was organized by an independent planning committee in accordance with the procedures of the National Academies of Sciences, Engineering, and Medicine. The planning committee’s members were Suzanne Bakken, Ellen Clayton, W. Gregory Feero, Spero Manson, Ruth Parker, and Catherine Wicklund. This publication summarizes the workshop’s presentations and discussions, and it recounts what workshop participants identified as key lessons, practical strategies, and the needs and opportunities for applying the principles of health literacy to the precision medicine. Chapter 2 provides an overview of the communication challenges that have arisen in the genomic era, and Chapter 3 presents a picture of the intersection of health literacy and precision medicine. Chapter 4 discusses the role of health literacy in precision medicine research, Chapter 5 reviews the challenges of communicating risk and uncertainty in the clinical setting, and Chapter 6 addresses the role that health associations and social media can play in communicating with the public. Chapter 7 summarizes an open discussion during which Roundtable on Health Literacy members and workshop participants provided their reflections on the day’s presentations and deliberations.
In accordance with the policies of the National Academies of Sciences, Engineering, and Medicine, the workshop did not attempt to establish any conclusions or recommendations about needs and future directions, focusing instead on issues identified by the speakers and workshop participants. Furthermore, the organizing committee’s role was limited to planning the workshop. This Proceedings of a Workshop has been prepared by workshop rapporteur Joe Alper as a factual summary of what occurred at the workshop.
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