The National Institutes of Health (NIH) launched an observational cohort study known as the All of Us Research Program to build one of the largest, most diverse health databases in history, ultimately aiming to facilitate precision medicine research. CareEvolution’s MyDataHelps™ digital clinical trial and research platform is used by the program for recruiting and electronic consent (eConsent), kitting fulfillment, collecting electronic clinical outcome assessments (eCOA) including electronic patient-reported outcomes (ePROs) and performance outcomes (PerfOs), and integrating electronic health or medical records (EHR/EMR).
In March 2015, the NIH formed the Precision Medicine Initiative Working Group of the Advisory Committee to the Director, creating the framework for the All of Us Research Program. The program launched nationwide in 2018, first enrolling participants through health centers. Then, in 2019, All of Us began leveraging CareEvolution’s digital health platform MyDataHelps™ to add a “direct volunteer” participant experience for people recruited outside of a provider’s office. By using digital health platforms, the program is able to reach underrepresented populations and capture an unprecedented amount of granular, 360-degree data to advance precision health and bridge the healthcare divide.
Unlike many other research studies, All of Us is disease agnostic. Rather, the program aims to facilitate precision medicine research in a wide variety of disciplines by creating a diverse, longitudinal, comprehensive database. By employing digital health platforms like MyDataHelps™, All of Us capitalizes on the high prevalence of mobile phones and wearable devices to collect a complete digital phenotype of its participants, including ePROs, EHR/EMR, digital endpoints, and biosample data through kitting fulfillment. Thus, researchers can now gain an even deeper understanding of health and wellness for different demographics.
By the numbers: on the CareEvolution platform
All of Us aims to enroll one million or more people from all fifty states, the District of Columbia, and the five inhabited territories of the United States. Through targeted community outreach, the program focuses on enrolling participants from populations that are traditionally underrepresented in biomedical research (UBR). These UBR populations include race or ethnic minorities, people over 65 years of age, LGBTQ+ people, those with low income, females, people in rural areas, those with less than a high school education, and those with little or no access to healthcare. To date, 50%+ of enrolled participants identify as a race/ethnic minority and 80%+ belong to at least one of these UBR populations. The All of Us Research Program also completed an extensive consultation with Tribal Nations to ensure respectful engagement and inclusion of American Indian and Alaska Native (AI/AN) populations in the study.
Data collection/assessment measures & methods
The program was designed to collect a rich array of biologic, behavioral, social, and environmental data from participants, including:
- Digital endpoints (sleep data, steps, activity tracking) through Fitbit direct API and direct connection to Apple Health and Google Fit
- EHR data imported from various providers through industry standard FHIR endpoints
- Baseline physical measurements (height, weight, hip and waist circumference, heart rate, blood pressure)
- Biosamples (blood, urine, saliva)
- eCOA collecting social determinants of health, overall health information, lifestyle, personal and family medical history, health care access and utilization, and the COVID-19 participant experience
To promote the geographic expansion of the program and to reach more participants in UBR populations through the MyDataHelps™ platform, All of Us has initiated a wearables sub-study that provides Fitbits to participants across the United States. This adds to the wearable data already collected through the Bring Your Own Device (BYOD) program, which includes Fitbit and devices compatible with Apple Health and Google Fit (e.g., Apple Watch, glucometer, blood pressure cuff). In addition, for participants that are not enrolled through a health center or don’t have easy access to a clinic, All of Us is still able to collect biosamples through various mechanisms: saliva through an at-home kit, and blood either through a visit to a blood donation center or a kit delivered to the home and brought to a Quest lab.
All of Us uses the MyDataHelps™ digital clinical trial and research platform to reach participants that enroll in the study without targeted recruitment from health centers, also known as direct volunteer participants. After downloading the All of Us app—a white label version of the MyDataHelps™ app—participants are able to easily enroll in the program through eConsent. Implementing eConsent allows All of Us to ensure that direct volunteer participants and those that are enrolled through a health center have a consistent experience. The All of Us eConsent also includes comprehension screening using the MyDataHelps™ robust survey logic tool to ensure that participants understand what they are agreeing to do as part of the study.
Upon enrollment, participants can use the app to provide ePROs, connect to their EHR and wearable device, request an at-home saliva collection kit, or schedule a Quest lab appointment for blood collection. Participants can also view their results and gain access to educational and support resources through the app.
Results and next steps
A dataset including information from over 330 thousand participants (those enrolled through a health center and direct volunteers) has been released to the All of Us Researcher Workbench. With over 1,400 active projects on the workbench spanning a wide spectrum of disciplines, All of Us participant data has already contributed to significant scientific findings. For example, researchers at the University of California San Diego identified novel risk factors for retinal vein occlusion, which is a major cause of vision loss, and a team of scientists at Vanderbilt University Medical Center utilized the gene expression and clinical data available to develop a method to identify high priority candidates for drug repurposing, or a way to find new uses for existing drugs to reduce the cost and time associated with the drug development process.
To date, All of Us has enrolled a little less than half of their total goal of at least one million participants. Thus, the program will continue enrollment, with a sustained focus on UBR populations. In addition, All of Us is a longitudinal study, so much of the program’s future efforts will be designed to increase engagement and retention of participants.