Establishing a New Baseline of Health and Research Participation for Diverse Populations
The Project Baseline study seeks to collect health information from a diverse group of people and monitor how that information changes over time to uncover new insights about the transition from health to disease. The information gleaned from this study will help us better understand how factors such as genes, lifestyle, and the environment influence health. It is important to measure health diversity in a large number of unique individuals in order to determine what is "normal" or expected for a healthy individual. Once these measures, or reference points — referred to as biomarkers or warning signs — are established, the healthcare community may become better at predicting and possibly even preventing future onset of disease.
To make a complete map of human health, the data collected must be reflective of people of different ages, races, ethnicities, geographic locations, and health histories. However, data has shown that research studies are primarily populated by people of European descent with low representation of African American, Latino, and Asian populations. Asian Americans are the fastest growing minority group in the United States, but are among the least represented minority group in clinical research.1 Further, while African Americans and Latinos make up 30% of the U.S. population, they account for just 6% of participants in federally funded clinical trials.2 This is concerning since inherited heart diseases, such as hypertrophic cardiomyopathy (HCM), have been misdiagnosed in African Americans because the population is underrepresented in genomic studies.3
Responding to the urgent call-to-action to help eliminate these health disparities, the Project Baseline study has focused from the beginning on achieving a sample that reflects the diversity captured in U.S. census data. Study leaders have ensured that inclusion of a diverse population is a key component of the study design. Partners in the Project Baseline study, including Duke University School of Medicine and Stanford Medicine, which have deep presence and trusted relationships with minority members of their communities, immediately recognized the historic inequalities in research that might make this a challenge, and championed the approach that engagement is a bidirectional relationship resulting in mutual benefit.
These institutions and their representatives respect that research participants are embedded in dynamic histories and community frameworks, and have been committed to developing respectful relationships that create mutual value. The Baseline team believes in approaching their work with cultural humility and consistent presence. Education and information exchange are key underpinnings of their work. To create a dedicated conduit to community perspective, both institutions are working with community groups with diverse representation that includes study participants, public health officials, faith-based and civic leaders, and local physicians. These groups have had an active role in helping educate the Project Baseline study team about the needs of minority participants and underrepresented communities. Duke enrollment sites also identified local African American and Latino community representatives for the Project Baseline Study Steering Committee, who help govern the study. At Stanford Medicine, the team has been working closely with local leaders, health clinics, and community groups to get feedback and input on their processes. Additionally, they have made a concerted effort to ensure that their study staff is representative of the diversity of the Bay Area.
Meeting people where they are, having boots on the ground, and working closely with respected community leaders have proven to be successful minority engagement strategies in North Carolina, where Project Baseline has two enrollment locations with the Duke site. Learning from these successful models, all Project Baseline recruitment sites have implemented similar efforts. Project Baseline study leaders and staff regularly partner with churches, civic clubs, advocacy groups, and other community-based organizations to host educational presentations and listening sessions. They also work with healthcare teams from clinics serving low income and minority populations.
Outreach teams comprising minority community members have their fingers on the pulse of the community daily and bring valuable input to inform the project. These teams are invested in building relationships and maintaining a consistent presence at community events such as farmers’ markets, races, health fairs, and sporting events. The Project Baseline study aims to achieve a new gold standard for participant partnership and experience, reflected by its commitment to respectfully engaging minority participants. This requires a collaborative effort across the Project Baseline study partners and continuous adjustment and iteration of our collective approach as we learn from the study participants themselves. In 2018, we hope to increase the number of community engagement activities and events, and continue learning about the most effective tools for minority inclusion.
2Oh SS, et al. Diversity in clinical and biomedical research: a promise yet to be fulfilled. PLoS Med; [accepted 30 October 2015]10.1371/journal.pmed.1001918
3N Engl J Med 2016;375:655–65