Precision medicine is a phrase often used in healthcare but not well understood, especially by the general public. What type of precision are we talking about? Precision medicine is an emerging approach to disease treatment and prevention that considers differences in people’s lifestyles, environments and biological makeup, including genes. When the Precision Medicine Initiative launched in 2015 it was promoted as a great leap forward in understanding the various factors that contribute to human health and disease in the United States (U.S.).
The project has since been branded the All of Us Research Program and that title could not be more fitting. The goal of the program is to recruit 1 million individuals who will volunteer to provide their biological and health information in the form of medical records, genetic samples, and lifestyle data both self-reported and from wearables. These participants are to reflect the diversity of individuals living in the U.S. and are seen as partners in the study. This concept of partnership speaks to the idea of participant engagement, an area Consuelo H. Wilkins, MD, MSCI, Executive Director of the Meharry-Vanderbilt Alliance and leader of the All of Us Research Program Engagement Core, knows quite a bit about. Engagement differs from recruitment in that its goal is to involve participants in the design, implementation, and oversight of the research, not just to enroll them in a study. Engagement is also a 2-way line of communication where research plans are transformed based on the perspectives of all those involved in it: participants and researchers.
An important role of the Engagement Core headed by Wilkins is educating both participants and researchers on how to be engaged with one another. This means emphasizing to both groups the value that participants can bring to the project. This is a newer approach to involving participants in research with some instructional materials already in place and many needing to be modified or created for the project. A critical goal of this Engagement Core is to carefully document and chart the processes they employ so that best practices can be used in future research work that seeks to be more inclusive and transparent. In addition, new metrics of engagement are being created and program leaders are developing effective ways to receive evaluations from participants. These include allowing for emoticons, audio, and even video feedback to be submitted. Every effort is being made to lower the potential for written communication barriers to impede an individual’s ability to provide feedback. In addition, every bit of material provided to participants in All of Us is available in both English and Spanish, making the program more accessible to >50 million Spanish-speakers in the U.S.
All of Us has made participant engagement central to its governance and operation with 7 participants serving as partner members on a wide range of the research program’s oversight committees including the executive committee, steering committee, and the advisory panel. Importantly, 2 of the 12 executive committee members are All of Us participants and have equal voting rights to NIH staff and researchers involved in All of Us. So, the participants on the committee have the power to influence the operation of the program.
The backstory of how these 7 participants were chosen speaks to the desire All of Us participants have to contribute to the success of the program. In the All of Us participant newsletter, an advertisement sought individuals interested in serving as participant partners in the governance and oversight of the All of Us Research Program. More than 100 individuals had expressed interest from this call of Participant Partners. The nomination process consisted of a 50-word personal statement on why they wanted to be involved in the governance and oversight of All of Us. Participant Partners were selected to represent the diversity of age, ethnicity, and geography that the All of Us program is seeking to enroll in the program.
Other activities to engage participants and community partners in the All of Us Research Program include Participant Ambassadors. These individuals are nominated by Engagement Leads from the Health Provider Organizations, Regional Medical Centers, Direct Volunteer, and Veteran’s Administration system that make up the All of Us research network. Twenty four ambassadors will be providing feedback on the design, implementation, and dissemination processes of the All of Us Research Program.
Another aspect of how the community provides useful feedback on the All of Us program is in the form of community engagement studios, modeled on a similar program at Vanderbilt (PDF toolkit available here). These groups are held across the country and allow individuals from the community to voice concerns or share their thoughts on various practices the program is planning to implement to recruit and interact with potential study participants. More than 70 studios were held in preparation for the nationwide rollout of All of Us on May 6, 2018. The Engagement Core works closely with community partners across the U.S. to help host these studios in a manner that makes community members feel welcome. For example, the community organizations are asked for guidance on everything from the time of day the studio should be held to the location and what type of food should be ordered. There was one particularly memorable instance in Chicago where the Engagement Core staff had to bring cash to purchase food at a restaurant recommended by an Asian community group. While a seemingly small thing, acts such as this engender trust between All of Us and its community partners because the partners can see that their opinions are being used to guide not just food but research and policy choices made by the national program. Changes coming out of these community engagement studio sessions have included making the language in participant materials easier to understand (less jargon and complex terms) as well as providing a small amount of monetary compensation to All of Us participants. Many potential participants saw the compensation, even if it was small, as evidence they and their time was being valued. Such changes emerging out of these studios can have a major impact on study participation (see, for example) and the Engagement Core expects it to be the case for the All of Us program as well.
So far, All of Us research participants have been “all in” to contribute to the program. Alecia Fair, DrPH, Research Assistant Professor with the Meharry-Vanderbilt Alliance, has been in the public health and health promotion/education field since 1992 and has never seen the degree of investment participants in the All of Us pilot program have displayed since it began in 2016. Individuals have strong motivations for volunteering as participants. Many have loved ones who are sick or died prematurely from disease and hope their contribution to the program as a participant, and also as a voice of participants, will make a difference in the health of others. Generating a high level of individual involvement, investment, and trust in participants is critical as they can volunteer as much or as little information as they want to the program. In order for deeper insights and knowledge to be gleaned from the program, though, having access to participants’ electronic medical record, genetics, data from wearable devices, and self-reported daily lifestyle choices will be essential.
The data collected in All of Us is not just for researchers. One important goal of the program is that all data collected from any participant will be provided back to the participant through useful insights. The Participant Technology Systems Center (PTSC) for All of Us is being administered by Vibrent Health, a digital health technology company headquartered in Fairfax, Virginia. The PTSC is responsible for innovating, developing and monitoring all participant-facing apps and technology systems (available across a variety of platforms: PC, iOS, Android) of All of Us that enables study enrollment and data collection and, on the back end, data storage, organization, analysis, and curation—the full lifecycle of the participant’s involvement with the study. Vibrent Health provides a large-scale, cost-effective, mission-critical system to the program that needs around-the-clock support, a service they can provide that would be difficult for an academic institution to match.
The All of Us system has been designed by Vibrent to provide an overview of the study to potential participants as well as offer an interactive, informed consent process that allows for the opt-in or out of a variety of data collection processes. Importantly, the information is provided in the form of videos and text to make participant engagement and comprehension of the various data types the program seeks to collect clear. Knowledge of participants’ understanding of how their data will be collected, secured, and used is assessed via comprehension quizzes they must pass before being allowed to sign the consent forms. Vibrent Health CEO Praduman Jain (PJ), spoke to the importance of returning value back to All of Us participants, a value that is above and beyond their own health data. Using the company’s Research Platform, Vibrent will develop useful insights from the large and diverse sets of data provided by the All of Us participants, ultimately enabling researchers and clinicians to more precisely predict, prevent, and treat a variety of health conditions.
Vibrent Health’s technology will make it possible to understand the complex relationships of cause and effect in human health, including how behavior, genomics, environment, and lifestyle impact human health.
Currently, as the research initiative gears up, Vibrent is in the data collection phase but hopes to soon amass the breadth and depth of data needed to develop meaningful insights through machine learning and other predictive analytics. The security and privacy of the participant information collected by Vibrent Health’s platform is of the utmost importance and various layers of encryption and de-identification of data are in place. In the end, Vibrent expects to develop novel and powerful predictive tools from this work that can be applied to the broader healthcare system in the U.S.
Only through the critical buy-in of participants will a program as ambitious as All of Us succeed. In the end, the program hopes to set a
precedent for how long-term, longitudinal, health and lifestyle research can take place in the 21st Century. No longer will participants in this type of research be passive subjects (often distrusting what is being done with their data) who provide (or don’t, or not truthfully) information and samples from which they never learn the insights obtained. Rather, participants will be partners in the research process, knowing their opinions and ideas matter and that their data is leading to new insights in which they are being informed. In doing all this, All of Us leadership expects participants will feel more engaged and empowered: willing to provide an unprecedented amount of health data with the knowledge that it will lead to discoveries that truly benefit All of Us.
Read more about Engagement and the All of Us Program Here: https://catalyst.nejm.org/precision-medicine-initiative-everyone/
Vibrent Health’s Role in All of Us: https://www.vibrenthealth.com/knowledge-center/2018/05/vibrent-health-power-technology-history-making-us-research-program/