Consent for Use of Genetic Data among US Hispanics/Latinos: Results from the Hispanic Community Health Study/ Study of Latinos

Inclusion of historically underrepresented populations in biomedical research is critical for large precision medicine research initia­tives. Among 13,721 Hispanic Community Health Study/Study of Latinos (HCHS/SOL) enrollees, we used multivariable-adjusted prevalence ratios to describe characteristics associated with participants’ willingness to consent to different levels of biospecimen and genetic data analysis and sharing. At baseline (2008-2011), HCHS/SOL par­ticipants almost universally consented to the use of biospecimens and genetic data by study investigators and their collabora­tors (97.6%; 95%CI: 97.1, 98.0). Fewer consented to biospecimen and genetic data sharing with investigators not affiliated with the HCHS/SOL research team (81%, 95%CI: 80, 82) or any data sharing with commer­cial/for-profit entities (75%, 95%CI: 74, 76). Those refusing to share their data beyond the study investigators group were more often females, Spanish language-speakers and non-US born individuals. As expected, participants who were retained and recon­sented at the six-year follow up visit tended to embrace broader data sharing, although this varied by group. Over time, Puerto Ricans and Dominicans were more likely to convert to broader data sharing than individuals of a Mexican background. Our analysis suggests that acculturation and im­migration status of specific Hispanic/Latino communities may influence decisions about participation in genomic research projects and biobanks. Ethn Dis. 2021;31(4):547- 558; doi:10.18865/ed.31.4.547

Optimizing Coaching During Online Relationship Education for Low-Income Couples: A Precision Medicine Research Protocol (Preprint)

BACKGROUND In-person relationship education classes funded by the federal government tend to experience relatively high attrition rates and have only limited effects on relationships. In contrast, low-income couples tend to report meaningful gains from online relationship education when provided with individualized coach contact. However, little is known about the method and intensity of practitioner contact that a couple requires to complete the online program and receive the intended benefit. OBJECTIVE The current protocol seeks to: a) use the within-group models to create an algorithm to assign future couples to different programs and level of coach contact, b) identify the most powerful predictors of treatment adherence and gains in relationship satisfaction within three different levels of coaching, and c) examine the most powerful predictors of treatment adherence and gains in relationship satisfaction between three levels of coach contact. METHODS To accomplish these goals, this project intends to use data from an online Sequential Multiple Assignment Randomized Trial of the OurRelationship and ePREP programs where the method and type of coach contact were randomly varied across 1,248 couples (2,496 individuals) with the hope of advancing theory in this area and generating accurate predictions. RESULTS The current protocol was funded by the U.S. Department of Health and Human Services, Administration for Children and Families, Grant Number 90PD0309. CONCLUSIONS Some of the direct benefits from this protocol include benefits to social services programs administrators, tailoring of more effective relationship education, and the effective delivery of evidence- and web-based relationship health interventions. CLINICALTRIAL The current protocol was pre-registered with ClinicalTrials.gov (NCT02806635).

The Impact of Communicating Uncertainty on Public Responses to Precision Medicine Research

Background Precision medicine research depends upon recruiting large and diverse participant cohorts to provide genetic, environmental, and lifestyle data. How prospective participants react to information about this research, including depictions of uncertainty, is not well understood. Purpose The current study examined public responses to precision medicine research, focusing on reactions toward (a) uncertainty about the scientific impact of sharing data for research, and (b) uncertainty about the privacy, security, or intended uses of participant data. Methods U.S. adults (N = 674; 51.9% male; 50% non-Hispanic white; Mage = 42.23) participated in an online experimental survey. Participants read a manipulated news article about precision medicine research that conveyed either certainty or uncertainty of each type (scientific, data). Participants then rated their attitudes toward the research, trust in the researchers, and willingness to join a cohort. We tested direct and mediated paths between message condition and outcomes and examined individual characteristics as moderators. Results Overall attitudes were positive and a majority of participants (65%) reported being somewhat or very likely to participate in precision medicine research if invited. Conveying uncertainty of either type had no overall main effect on outcomes. Instead, those who reported perceiving greater uncertainty had lower attitudes, trust, and willingness to join, while those with more tolerance for uncertainty, support for science, and scientific understanding responded favorably to the scientific uncertainty disclosure. Conclusions Findings suggest responses to precision medicine research uncertainty are nuanced and that successful cohort enrollment may be well-supported by a transparent approach to communicating with prospective participants.

Care and Precision Medicine Research in the Time of COVID-19

Purpose: Enhancing the bidirectional benefit of precision medicine research in­frastructure may advance equity in research participation for diverse groups. This study explores the use of research infrastructure to provide human-centered COVID-19 resources to participants as a part of their research participation.Design: The All of Us New England (AoUNE) consortium research team devel­oped standardized check-in telephone calls to ask participants about their well-being and share COVID-19 resources.Participants: A total of 20,559 partici­pants in the AoUNE consortium received a COVID-19 check-in call.Methods: Research assistants called partici­pants during March-April 2020, distributed COVID-19 resources to interested partici­pants, and subsequently rated call tone.Results: Of the total cohort participants called, 8,512 (41%) spoke with a research team member. The majority of calls were rated as positive or neutral; only 3% rated as negative. African American and Black as well as Hispanic populations requested COVID-19 resources at higher rates than other groups.Conclusion: Calls made to AoUNE participants were received positively by diverse groups. These findings may have implications for participant-centered en­gagement strategies in precision medicine research.Ethn Dis. 2021;31(3):407-410; doi:10.18865/ed.31.3.407

Hypertension prevalence in the All of Us Research Program among groups traditionally underrepresented in medical research

The All of Us Research Program was designed to enable broad-based precision medicine research in a cohort of unprecedented scale and diversity. Hypertension (HTN) is a major public health concern. The validity of HTN data and definition of hypertension cases in the All of Us (AoU) Research Program for use in rule-based algorithms is unknown. In this cross-sectional, population-based study, we compare HTN prevalence in the AoU Research Program to HTN prevalence in the 2015–2016 National Health and Nutrition Examination Survey (NHANES). We used AoU baseline data from patient (age ≥ 18) measurements (PM), surveys, and electronic health record (EHR) blood pressure measurements. We retrospectively examined the prevalence of HTN in the EHR cohort using Systemized Nomenclature of Medicine (SNOMED) codes and blood pressure medications recorded in the EHR. We defined HTN as the participant having at least 2 HTN diagnosis/billing codes on separate dates in the EHR data AND at least one HTN medication. We calculated an age-standardized HTN prevalence according to the age distribution of the U.S. Census, using 3 groups (18–39, 40–59, and ≥ 60). Among the 185,770 participants enrolled in the AoU Cohort (mean age at enrollment = 51.2 years) available in a Researcher Workbench as of October 2019, EHR data was available for at least one SNOMED code from 112,805 participants, medications for 104,230 participants, and 103,490 participants had both medication and SNOMED data. The total number of persons with SNOMED codes on at least two distinct dates and at least one antihypertensive medication was 33,310 for a crude prevalence of HTN of 32.2%. AoU age-adjusted HTN prevalence was 27.9% using 3 groups compared to 29.6% in NHANES. The AoU cohort is a growing source of diverse longitudinal data to study hypertension nationwide and develop precision rule-based algorithms for use in hypertension treatment and prevention research. The prevalence of hypertension in this cohort is similar to that in prior population-based surveys.