Search

The United States witnessed a nearly 4‐fold increase in personal health care expenditures between 1980 and 2010. Despite innovations and obvious benefits to health, participants enrolled in clinical trials still do not accurately represent the racial and ethnic composition of patients nationally or globally. This lack of diversity in cohorts limits the generalizability and significance of results among all populations and has deep repercussions for patient equity. To advance diversity in clinical trials, robust evidence for the most effective strategies for recruitment of diverse participants is needed. A major limitation of previous literature on clinical trial diversity is the lack of control or comparator groups for different strategies. To date, interventions have focused primarily on (1) community‐based interventions, (2) institutional practices, and (3) digital health systems. This review article outlines prior intervention strategies across these 3 categories and considers health policy and ethical incentives for substantiation before US Food and Drug Administration approval. There are no current studies that comprehensively compare these interventions against one another. The American Heart Association Strategically Focused Research Network on the Science of Diversity in Clinical Trials represents a multicenter, collaborative network between Stanford School of Medicine and Morehouse School of Medicine created to understand the barriers to diversity in clinical trials by contemporaneous head‐to‐head interventional strategies accessing digital, institutional, and community‐based recruitment strategies to produce informed recruitment strategies targeted to improve underrepresented patient representation in clinical trials.

Abstract The World Health Organization recently defined hypertension and type 2 diabetes (T2D) as modifiable comorbidities leading to dementia and Alzheimer’s disease. In the United States (US), hypertension and T2D are health disparities, with higher prevalence seen for Black and Hispanic minority groups compared to the majority White population. We hypothesized that elevated prevalence of hypertension and T2D risk factors in Black and Hispanic groups may be associated with dementia disparities. We interrogated this hypothesis using a cross-sectional analysis of participant data from the All of Us (AoU) Research Program, a large observational cohort study of US residents. The specific objectives of our study were: (1) to compare the prevalence of dementia, hypertension, and T2D in the AoU cohort to previously reported prevalence values for the US population, (2) to investigate the association of hypertension, T2D, and race/ethnicity with dementia, and (3) to investigate whether race/ethnicity modify the association of hypertension and T2D with dementia. AoU participants were recruited from 2018 to 2019 as part of the initial project cohort (R2019Q4R3). Participants aged 40–80 with electronic health records and demographic data (age, sex, race, and ethnicity) were included for analysis, yielding a final cohort of 125,637 individuals. AoU participants show similar prevalence of hypertension (32.1%) and T2D (13.9%) compared to the US population (32.0% and 10.5%, respectively); however, the prevalence of dementia for AoU participants (0.44%) is an order of magnitude lower than seen for the US population (5%). AoU participants with dementia show a higher prevalence of hypertension (81.6% vs. 31.9%) and T2D (45.9% vs. 11.4%) compared to non-dementia participants. Dominance analysis of a multivariable logistic regression model with dementia as the outcome shows that hypertension, age, and T2D have the strongest associations with dementia. Hispanic was the only race/ethnicity group that showed a significant association with dementia, and the association of sex with dementia was non-significant. The association of T2D with dementia is likely explained by concurrent hypertension, since > 90% of participants with T2D also had hypertension. Black race and Hispanic ethnicity interact with hypertension, but not T2D, to increase the odds of dementia. This study underscores the utility of the AoU participant cohort to study disease prevalence and risk factors. We do notice a lower participation of aged minorities and participants with dementia, revealing an opportunity for targeted engagement. Our results indicate that targeting hypertension should be a priority for risk factor modifications to reduce dementia incidence.

ImportanceSARS-CoV-2 infection can result in ongoing, relapsing, or new symptoms or other health effects after the acute phase of infection; termed post-acute sequelae of SARS-CoV-2 infection (PASC), or long COVID. The characteristics, prevalence, trajectory and mechanisms of PASC are ill-defined. The objectives of the Researching COVID to Enhance Recovery (RECOVER) Multi-site Observational Study of PASC in Adults (RECOVER-Adult) are to: (1) characterize PASC prevalence; (2) characterize the symptoms, organ dysfunction, natural history, and distinct phenotypes of PASC; (3) identify demographic, social and clinical risk factors for PASC onset and recovery; and (4) define the biological mechanisms underlying PASC pathogenesis.MethodsRECOVER-Adult is a combined prospective/retrospective cohort currently planned to enroll 14,880 adults aged ≥18 years. Eligible participants either must meet WHO criteria for suspected, probable, or confirmed infection; or must have evidence of no prior infection. Recruitment occurs at 86 sites in 33 U.S. states, Washington, DC and Puerto Rico, via facility- and community-based outreach. Participants complete quarterly questionnaires about symptoms, social determinants, vaccination status, and interim SARS-CoV-2 infections. In addition, participants contribute biospecimens and undergo physical and laboratory examinations at approximately 0, 90 and 180 days from infection or negative test date, and yearly thereafter. Some participants undergo additional testing based on specific criteria or random sampling. Patient representatives provide input on all study processes. The primary study outcome is onset of PASC, measured by signs and symptoms. A paradigm for identifying PASC cases will be defined and updated using supervised and unsupervised learning approaches with cross-validation. Logistic regression and proportional hazards regression will be conducted to investigate associations between risk factors, onset, and resolution of PASC symptoms.DiscussionRECOVER-Adult is the first national, prospective, longitudinal cohort of PASC among US adults. Results of this study are intended to inform public health, spur clinical trials, and expand treatment options.RegistrationNCT05172024.

Digital health innovations, such as telehealth and remote monitoring, have shown promise in addressing patient barriers to accessing evidence-based programs and providing a scalable path for tailored behavioral interventions that support self-management skills, knowledge acquisition and promotion of relevant behavioral change. However, significant attrition continues to plague internet-based studies, a result we believe can be attributed to characteristics of the intervention, or individual user characteristics. In this paper, we provide the first analysis of determinants of non usage attrition in a randomized control trial of a technology-based intervention for improving self-management behaviors among Black adults who face increased cardiovascular risk factors. We introduce a different way to measure nonusage attrition that considers usage over a specific period of time and estimate a cox proportional hazards model of the impact of intervention factors and participant demographics on the risk of a nonusage event. Our results indicated that not having a coach (compared to having a coach) decreases the risk of becoming an inactive user by 36% (HR = .63, P = 0.04). We also found that several demographic factors can influence Non-usage attrition: The risk of nonusage attrition amongst those who completed some college or technical school (HR = 2.91, P = 0.04) or graduated college (HR = 2.98, P = 0.047) is significantly higher when compared to participants who did not graduate high school. Finally, we found that the risk of nonsage attrition among participants with poor cardiovascular from “at-risk” neighborhoods with higher morbidity and mortality rates related to CVD is significantly higher when compared to participants from “resilient” neighborhoods (HR = 1.99, P = 0.03). Our results underscore the importance of understanding challenges to the use of mhealth technologies for cardiovascular health in underserved communities. Addressing these unique barriers is essential, because a lack of diffusion of digital health innovations exacerbates health disparities. Author summary Mobile-health (mHealth) technologies continue to serve immensely valuable roles in current healthcare systems by bridging several accessibility gaps and facilitating patient-provider interactions. However, and ironically, they also present several accessibility gaps due to design features and/or individual characteristics. In this study, we explore the effects of having an adjunct health coach with a behavior-modification mHealth app, Health360x (H360x) in promoting user-interface interaction in a population of African American patients with significant cardiovascular (CV) risk factors. While we saw an improvement in CV risk factors, we also identified an interesting attrition in app usage in patients assigned a health coach; and observed similar effects in those with higher socioeconomic status. These findings may be due to a higher (baseline or acquired) self-efficacy in these patients, and suggests that longitudinal assessments of app engagement in this population should be approached with careful consideration of attrition.

Digital health innovations, such as telehealth and remote monitoring, have shown promise in addressing patient barriers to accessing evidence-based programs and providing a scalable path for tailored behavioral interventions that support self-management skills, knowledge acquisition and promotion of relevant behavioral change. However, significant attrition continues to plague internet-based studies, a result we believe can be attributed to characteristics of the intervention, or individual user characteristics. In this paper, we provide the first analysis of determinants of non usage attrition in a randomized control trial of a technology-based intervention for improving self-management behaviors among Black adults who face increased cardiovascular risk factors. We introduce a different way to measure nonusage attrition that considers usage over a specific period of time and estimate a cox proportional hazards model of the impact of intervention factors and participant demographics on the risk of a nonusage event. Our results indicated that not having a coach (compared to having a coach) decreases the risk of becoming an inactive user by 36% (HR = .63, P = 0.04). We also found that several demographic factors can influence Non-usage attrition: The risk of nonusage attrition amongst those who completed some college or technical school (HR = 2.91, P = 0.04) or graduated college (HR = 2.98, P = 0.047) is significantly higher when compared to participants who did not graduate high school. Finally, we found that the risk of nonsage attrition among participants with poor cardiovascular from "at-risk" neighborhoods with higher morbidity and mortality rates related to CVD is significantly higher when compared to participants from "resilient" neighborhoods (HR = 1.99, P = 0.03). Our results underscore the importance of understanding challenges to the use of mhealth technologies for cardiovascular health in underserved communities. Addressing these unique barriers is essential, because a lack of diffusion of digital health innovations exacerbates health disparities.

BackgroundA critical unmet need for underserved patients with diabetes is regular access to sufficient support for diabetes self-management. Although advances in digital technologies have made way for eHealth applications that provide a scalable path for tailored interventions for self-management of chronic conditions, health and digital literacy has remained an obstacle to leveraging these technologies for effective diabetes self-management education. Studies have shown that the availability of coaches helps to maintain engagement in internet-based studies and improves self-efficacy for behavior change. However, little is known about the substances involved in these interactions. ObjectiveThis study aims to compare the content of conversations between patient–coach pairs that achieved their self-management goals and those that did not. The context is a clinical implementation study of diabetes self-management behavior change using Health360x within the practices of the Morehouse Choice Accountable Care Organization in the Atlanta metro area. Health360x is a coach-assisted consumer health information technology designed to support self-management skills acquisition and behavior among underserved, high-risk patients with diabetes. MethodsWe provide a novel analysis of the discursive emphasis on patients and coaches. We examined transcripts of visits using a structural topic model to estimate topic content and prevalence as a function of patient and coach characteristics. We compared topics between patient–coach pairs that achieved diabetes-related self-management goals and those who did not. We also estimated a regression in which utterances are the units, the dependent variable is the proportion of an utterance that is about a given topic, and the independent variables are speaker types and explored other themes. ResultsTranscripts from 50 patients who were recruited and consented, starting in February 2015, were analyzed. A total of 44 topics were estimated for patient–coach pairs that achieved their intended health goals and 50 topics for those who did not. Analysis of the structural topic model results indicated that coaches in patient–coach pairs that were able to achieve self-management goals provided more contextual feedback and probed into patients’ experience with technology and trust in consumer information technologies. We also found that discussions around problem areas and stress, support (βCoach=.015; P

Background Cardiovascular disease incidence, prevalence, morbidity, and mortality have declined in the past several decades; however, disparities persist among subsets of the population. Notably, blacks have not experienced the same improvements on the whole as whites. Furthermore, frequent reports of relatively poorer health statistics among the black population have led to a broad assumption that black race reliably predicts relatively poorer health outcomes. However, substantial intraethnic and intraracial heterogeneity exists; moreover, individuals with similar risk factors and environmental exposures are often known to experience vastly different cardiovascular health outcomes. Thus, some individuals have good outcomes even in the presence of cardiovascular risk factors, a concept known as resilience. Methods and Results The MECA (Morehouse‐Emory Center for Health Equity) Study was designed to investigate the multilevel exposures that contribute to “resilience” in the face of risk for poor cardiovascular health among blacks in the greater Atlanta, GA, metropolitan area. We used census tract data to determine “at‐risk” and “resilient” neighborhoods with high or low prevalence of cardiovascular morbidity and mortality, based on cardiovascular death, hospitalization, and emergency department visits for blacks. More than 1400 individuals from these census tracts assented to demographic, health, and psychosocial questionnaires administered through telephone surveys. Afterwards, ≈500 individuals were recruited to enroll in a clinical study, where risk biomarkers, such as oxidative stress, and inflammatory markers, endothelial progenitor cells, metabolomic and microRNA profiles, and subclinical vascular dysfunction were measured. In addition, comprehensive behavioral questionnaires were collected and ideal cardiovascular health metrics were assessed using the American Heart Association's Life Simple 7 measure. Last, 150 individuals with low Life Simple 7 were recruited and randomized to a behavioral mobile health (eHealth) plus health coach or eHealth only intervention and followed up for improvement. Conclusions The MECA Study is investigating socioenvironmental and individual behavioral measures that promote resilience to cardiovascular disease in blacks by assessing biological, functional, and molecular mechanisms. REGISTRATION URL: https://www.clini​caltr​ials.gov. Unique identifier: NCT03308812.

Abstract Background and purpose Effective mentorship is critical to the success of early stage investigators, and has been linked to enhanced mentee productivity, self-efficacy, and career satisfaction. The mission of the National Research Mentoring Network (NRMN) is to provide all trainees across the biomedical, behavioral, clinical, and social sciences with evidence-based mentorship and professional development programming that emphasizes the benefits and challenges of diversity, inclusivity, and culture within mentoring relationships, and more broadly the research workforce. The purpose of this paper is to describe the structure and activities of NRMN. Key highlights NRMN serves as a national training hub for mentors and mentees striving to improve their relationships by better aligning expectations, promoting professional development, maintaining effective communication, addressing equity and inclusion, assessing understanding, fostering independence, and cultivating ethical behavior. Training is offered in-person at institutions, regional training, or national meetings, as well as via synchronous and asynchronous platforms; the growing training demand is being met by a cadre of NRMN Master Facilitators. NRMN offers career stage-focused coaching models for grant writing, and other professional development programs. NRMN partners with diverse stakeholders from the NIH-sponsored Diversity Program Consortium (DPC), as well as organizations outside the DPC to work synergistically towards common diversity goals. NRMN offers a virtual portal to the Network and all NRMN program offerings for mentees and mentors across career development stages. NRMNet provides access to a wide array of mentoring experiences and resources including MyNRMN, Guided Virtual Mentorship Program, news, training calendar, videos, and workshops. National scale and sustainability are being addressed by NRMN “Coaches-in-Training” offerings for more senior researchers to implement coaching models across the nation. “Shark Tanks” provide intensive review and coaching for early career health disparities investigators, focusing on grant writing for graduate students, postdoctoral trainees, and junior faculty. Implications Partners from diverse perspectives are building the national capacity and sparking the institutional changes necessary to truly diversify and transform the biomedical research workforce. NRMN works to leverage resources towards the goals of sustainability, scalability, and expanded reach.