Case Study Clinical Trials & Research November 1, 2022 Using genomic and survey data to understand population-level health through the Michigan Genomics Initiative (MGI) & Epidemiological Questionnaire (EPI-Q) The Michigan Genomics Initiative (MGI) and follow-up Epidemiological Questionnaire (EPI-Q) are efforts driven by the University of Michigan to create a robust database of participants’ electronic health record (EHR) data, genetic data, and participant-reported health information. These studies utilize MyDataHelps™ to recruit and consent participants, collect electronic patient-reported outcomes (ePROs), and facilitate engagement and retention. Ultimately, the database built through MGI and EPI-Q is used by international collaborations to answer novel biomedical and public health questions, including 60 publications and preprints that have used MGI data since 2017. Background The Michigan Genomics Initiative (MGI) is an effort at the University of Michigan to create an aggregate database of participants’ genetic and electronic health record (EHR) data, which can be used for research to explore answers to novel biomedical and population-level health questions. The initiative began in the Department of Anesthesiology, recruiting surgical patients who were willing to provide a biosample (e.g., blood, saliva) and grant the study team access to their EHR data. MGI has since expanded to cover the United States through the support of University of Michigan Precision Health. Starting in 2019, MGI partnered with CareEvolution, employing the MyDataHelps™ digital clinical trial and research platform for inviting and consenting participants, and collecting survey information. During consent, each MGI participant agrees to be re-contacted for follow-up studies. One such study is the MGI Epidemiological Questionnaire (EPI-Q), which aims to fill in information gaps using health-related surveys. Using MyDataHelps™, EPI-Q was able to launch as scheduled in March 2020, despite the onset of the COVID-19 pandemic. Together, MGI and EPI-Q are building a comprehensive dataset that can be used for identifying risk factors for diseases and conditions, preventing and treating complex illnesses, and more. By the numbers 5.9K+ EPI-Q participants 90% Adherence Cohort When the initiative first launched, any surgical patient over 18 who spoke English was eligible to participate in MGI. When University of Michigan Precision Health expanded the initiative, the eligible participant pool grew to include those individuals who are Michigan Medicine patients, and then further to those anywhere in the United States. As a follow-up study of MGI, individuals are eligible to participate in EPI-Q if they are an MGI participant with a biosample sequenced for genetic information. Electronic data collection MGI and EPI-Q are building a robust dataset. The EHR and genetic data gathered through MGI is complemented by electronic patient-reported outcomes (ePROs), both within the broader MGI and through EPI-Q. MGI After enrolling as a participant in MGI, participants provide the study team access to their EHR and a biosample—either blood or saliva—for DNA sequencing. Within MGI, participants also complete baseline and follow-up surveys through six months, and are able to share data from their wearable devices if they choose to do so. EPI-Q If an individual enrolled in MGI later consents to participate in EPI-Q, they are prompted to provide further health information via EPI-Q’s baseline and optional surveys. Upon enrollment in EPI-Q, 12 baseline surveys are delivered, covering topics from physical activity, smoking, and alcohol use to sexual orientation, mood, and family health. Once a participant completes all baseline surveys, they become eligible to complete 12 more optional surveys. These surveys collect information on substance use, diet, healthcare access, pain, COVID-19, and more. MyDataHelps™: the tool for a hybrid, decentralized clinical research model The MyDataHelps™ digital clinical trial and research platform has facilitated the hybrid, decentralized study model of MGI and EPI-Q. The expansion of MGI to encompass the country required decentralization from the University of Michigan Department of Anesthesiology to include new locations for participant enrollment and data collection. In addition, the combination of in-person biosampling, remote collection of ePRO data, and hybrid (i.e., both in-person and remote) informed consent processes requires digital technology to ensure a smooth participant experience. Recruit and eConsent participants from anywhere MGI started using MyDataHelps™ for enrollment in 2019, sending email invitations to potential participants. Individuals willing to participate can easily eConsent through the app, either prior to their arrival for surgery on their own device or in person using shared device mode. For the EPI-Q follow-up, eConsent is done remotely through MyDataHelps™, at the participant’s convenience. By enabling participants to consent and perform study tasks from anywhere in the United States, there is more equal opportunity for underrepresented populations to participate. Remotely collect data through electronic patient-reported outcomes (ePROs) MyDataHelps™ is the tool for collection of ePROs for both MGI and EPI-Q. Through the app, MGI participants are asked if they would like to opt-in to providing survey data. If they choose to do so, MyDataHelps™ automatically delivers the baseline surveys followed by the longitudinal surveys (up to 6 months) at the appropriate time. MyDataHelps™ also manages the streamlined delivery of 24 surveys for EPI-Q participants. After enrollment in the study, participants unlock the first of the baseline surveys: Home and Personal Details. Each subsequent survey is then unlocked after completion of every task—the Occupational Exposure survey is only delivered to participants with current employment, as determined through the first survey. Additionally, MyDataHelps™ offers a task dashboard that allows participants the opportunity to track their progress throughout the baseline surveys. After completing the baseline surveys, another set of 12 optional surveys get released to the participant, which they can complete in any order. Engage and retain participants through automated reminders, incentives, and return of results MyDataHelps™ increases participant engagement and retention for MGI and EPI-Q through automated notifications and coordinator views that facilitate incentive systems. While baseline surveys for MGI are typically completed either during or immediately following an in-clinic visit, the longitudinal surveys may require participant survey reminders to encourage completion. Thus, MGI utilizes MyDataHelps™ to automate participant reminders. Similarly, EPI-Q sends email and push notifications through MyDataHelps™ to remind participants to complete their baseline surveys. As a result, 90% of EPI-Q participants have completed all baseline surveys. Both MGI and EPI-Q have incentive systems in place to encourage participation in the studies. MGI participants who complete their longitudinal surveys can enter into a raffle—drawn each month—for a chance to win $50. Through MyDataHelps™, coordinators can easily determine which participants have completed their tasks for raffle eligibility. EPI-Q researchers first evaluated their incentive system through a study pilot. When EPI-Q first launched, participants were given the option to either receive their 16-region ancestry report or a $10 gift card after completing their baseline surveys. Through a participant engagement studio—designed to collect feedback from their participants—the EPI-Q study team learned participants found the ancestry report valuable but did not find the gift card important to their participation. Therefore, all EPI-Q participants now receive their ancestry report through a MyDataHelps™ participant-facing dashboard, following completion of the baseline surveys. Results and next steps Between 2017 and September 2022, 60 publications or preprints have used MGI data, producing impactful results in research topics from kidney function and skin cancer, to myocardial infarction and more. For example, a collaborative team spanning the globe—researchers from Norway, Canada, United Kingdom, Italy, Denmark, and the United States—recently published a study in Nature’s Communications Biology identifying 123 genetic markers associated with iron status, which can have significant implications for human health. Another team, from the University of Michigan, used MGI data to evaluate exposure and risk factors for COVID-19 in early 2020, highlighting the inequality in how the pandemic impacted minority populations. Local, national, and international use of MGI data for meaningful research studies exemplifies the need for robust databases that can contribute to improving health outcomes of individuals and their communities. Access to large datasets, like in this case study, increases the generalizability of public health research. Ultimately, the database that continues to be built through MGI and EPI-Q has the potential to help researchers develop a framework to better understand population-level health and promote a healthier future for all.
