What Health Care Professionals Should Know About the NIH All of Us Program
Learn how the nation’s big-data health research program will enable you to provide more targeted care to your patients.
In the coming years, you may be able to tailor more precisely the care you provide to patients with prediabetes or diabetes, compared to how you practice today. The specific guidance you give to a patient—regarding diet, exercise, glucose monitoring, and medication—could be shaped by that person’s genotype, lifestyle, environment, and a wealth of other data points to which you will have access.
This ability to apply “precision medicine” in diabetes care is one of the many outcomes promised by the National Institute of Health’s All of Us Research Program. Targeted management of many diseases, including diabetes, is the ultimate goal of the All of Us Research Program.
All of Us aims to improve health care through big-data science. It is designed to do for all diseases what the Framingham Heart Study has done for prevention and treatment of heart disease. Framingham, an ongoing observational study of around 5,200 people begun in 1948, was instrumental in uncovering the cardiovascular risks to heart disease. The study findings have helped contribute to a major decline in the disease’s occurrence over the past decades.
All of Us is similar but will be 40 times bigger, with a much more diverse participant community, and with more investigative tools available to researchers. The plan is to recruit 1 million or more people from all walks of life across the United States who will complete surveys, agree to share their electronic health records (EHRs) with the program, and provide physical measurements and biosamples. Some participants also may be asked to complete diet diaries or wear digital electronic devices to provide continuous health data, such as data on physical activity, heart rate, sleep patterns, and more. The information provided by each participating individual in All of Us will become part of the database, with obvious personal identifiers removed to protect privacy, and could potentially contribute to thousands of medical studies and thousands of medical advances.
Already, more than 253,000 people have joined the program, of which 193,000 have completed the first research protocol. Participants will be followed for 10 or more years to provide a longitudinal perspective on health and disease.
Below are answers to questions you may have about All of Us.
What does have to do with diabetes prevention and treatment?
In a May 6 mini-symposium marking the first anniversary of All of Us, NIH Director Francis Collins envisioned the specific, diabetes-related impact of this national research project:
According to the Centers for Disease Control and Prevention, more than 30 million Americans, or almost 10 percent of our population, have type 2 diabetes, and another 84 million have prediabetes…. With the All of Us dataset of 1 million participants, we may expect about 90,000 of those participants to have diabetes and as many as 300,000 to have evidence of prediabetes….
With access to their electronic health records, researchers may be able to explore early signs and symptoms and compare the effectiveness of various prevention strategies. Since All of Us will also pull in environmental data linking to national databases, researchers can look into the environmental risk factors for diabetes. And with the genomic data available, a better understanding of the genomic factors that confer risk should also emerge.
Given the depth and breadth of data that will emerge through All of Us, researchers may uncover all sorts of valuable information that could be applied to diabetes prevention and treatment. In fact, says Dr. Collins, “I’m willing to predict that we will be able to demonstrate that what we currently call type 2 diabetes will actually turn out to be made up of several subtypes, each with different factors for vulnerability and resilience, and with different responses to treatment.”
How will All of Us benefit participants who have prediabetes and diabetes?
Everyone who participates will have access to their own data. All of Us will make available counselors to help participants make sense of the genomic data. Participants also will be able to see aggregated results from across the program in the newly released Data Browser, such as the collated results of surveys, so they can compare their own status to others like themselves or to the whole population.
All of Us is designed as a learning health system, where research knowledge is put into practice, and vice versa. This means that participants can make use of their own and comparative research data to become more proactive in their own care. For example, they can choose to share this information with their health care professionals to devise a more individualized plan to prevent or manage their diabetes.
Furthermore, participants may be invited into follow-up studies through which clinical researchers test interventions to prevent, detect, and treat diabetes, for example, clinical trials on the artificial pancreas. In this way, participants will obtain the benefits of participating in clinical trials while also advancing scientific knowledge about diabetes.
Will All of Us address disparities in diabetes occurrence and outcomes?
Like most diseases, diabetes disproportionately affects people from racial and ethnic minority groups and people with lower educational status. Furthermore, these same groups historically have not been as involved in clinical research for a number of reasons, including lack of access to the health care system, logistical difficulties in accessing study sites, cultural dissonance between prospective participants and researchers, and distrust stemming from the past abuse of participants in research studies, such as the Tuskegee experiment. Disparities in research involvement mean that results and treatment protocols are skewed toward the groups of people, for example male, white, middle-aged, higher income, higher education, who have received more study.
All of Us has been specifically designed to overcome barriers to clinical trials participation. Through partnerships with more than 100 health provider organizations, pharmacies, and other entities, we’ve been actively engaging people from historically underrepresented populations. And we’ve had success. Of the people already enrolled, more than 80 percent are from communities underrepresented in clinical research and more than 50 percent belong to a racial or ethnic minority group.
We’re deliberately building a geographically dispersed consortium of partners so that everyone who chooses to participate can be within reasonable traveling distance to a partner center where measurements and samples can be taken. In-home visits, mobile clinics, and other means are also being engaged to make it possible for every willing person to participate.
But one of the most important ways that All of Us is designed to be more inclusive is through the program’s transparency. Since the inception, participants have been partners in planning and governance to ensure that everyone’s involvement is respected and ethically protected. Too often, people participate in studies and never learn what the point was, what was learned, or even what was discovered about their own particular health or disease condition. That’s not the case with All of Us. This isn’t research done to participants, it’s research shaped by participants and fully shared with them.
How will All of Us change diabetes research?
We can’t yet predict all the ways in which this project will affect diabetes research. However, it seems certain that the number and variety of projects will increase exponentially, and that more research will emerge from clinicians in the field, like you. For example, through the program’s Research Hub, it will be relatively simple for health care professionals to obtain data to apply to research questions that arise in their clinical practice. This is how a learning health system should work—the research will influence your practice, but your practice will also influence the research.
Data will be available in two ways, with multiple protections in place to ensure the privacy and security of individual-level data. The Public Data Browser provides snapshot summaries of participant population characteristics and aggregate data on measurements, medications, and procedures. You can use this overview information to think about a research question you’d like to explore. And in a few months, All of Us will launch its Researcher Workbench, which will provide access to actual data sets plus tools that allow for filtering, segmenting, and analyzing this information. That’s when researchers at all levels—academic scientists, clinicians like yourself, and even the nonprofessional scientists among your patients—can begin to make use of this data to find new ways to prevent and treat diabetes.
An FAQ page provides more information on how you’ll be able to conduct research using All of Us data. You can also subscribe to get updates.
How can health care professionals support diabetes research through All of Us?
We hope that every health care professional, including those of you in diabetes practice, will encourage your patients to join All of Us as participants and as citizen scientists, and that you yourselves engage as both participant and researcher in this amazing national project.