Search

BackgroundHealth care inequity includes the lack of adequate representation of various populations in clinical trials. Government, academic and industry organizations have highlighted these issues and committed to actions to improve. In order to assess the current status and future success of these initiatives a quantitative objective measure to assess the state of clinical trial diversity is needed.MethodsFDA review documents for all novel drug approvals from January 2022 through February 16, 2023 were assessed using a scorecard that considers diversity across different demographic subgroups including age (>65 yo), sex (female), race (Black and Asian) and ethnicity (Hispanic/Latino). The scorecard assigns each drug a letter grade, between A and F, for each subgroup (and overall) based on 1) the percent of each sub-population included in the trials and grades relative to the percent of the US population, 2) the number of participants from each subpopulation that received the novel new drug in the trials, 3) the incidence or prevalence of the disease/condition in each of the sub-populations.ResultsThe FDA approved 43 novel new drugs for 44 indications (one drug was simultaneously approved for two indications). The three drugs with A Grades reflecting the best diversity in their registration trials were tapinarof (Vtama from Dermavant), daprodustat (Jesduvroq from GlaxoSmithKline) and eflapegrastim (Rolvedon from Spectrum Pharmaceuticals.) There was good representation of elderly and females with only two drugs receiving a D grade in either of these sub-populations. In contrast, Black and Hispanic representation was often inadequate with 4 drugs receiving F grades. There were 9 drugs (20%) where there were no Black participants receiving the novel new drug and an additional 14 approvals where there were ConclusionsThis newly developed scorecard provides an objective quantitative approach to assess the current state of diversity in clinical trials supporting new drug approvals. Substantial improvement in racial and ethnic representation is needed. Meaningful change will require actions and cooperation amongst all stakeholders to address this multifaceted issue and will take commitment, perseverance, and appropriate incentives.

The National Research Mentoring Network (NRMN) Strategic Empowerment Tailored for Health Equity Investigators (SETH) study evaluates the value of adding Developmental Network to Coaching in the career advancement of diverse Early-Stage Investigators (ESIs). Focused NIH-formatted Mock Reviewing Sessions (MRS) prior to the submission of grants can significantly enhance the scientific merits of an ESI’s grant application. We evaluated the most prevalent design, analysis-related factors, and the likelihood of grant submissions and awards associated with going through MRS, using descriptive statistics, Chi-square, and logistic regression methods. A total of 62 out of 234 applications went through the MRS. There were 69.4% that pursued R grants, 22.6% career development (K) awards, and 8.0% other grant mechanisms. Comparing applications that underwent MRS versus those that did not (N = 172), 67.7% vs. 38.4% were submitted for funding (i.e., unadjusted difference of 29.3%; OR = 4.8, 95% CI = (2.4, 9.8), p-value < 0.0001). This indicates that, relative to those who did not undergo MRS, ESIs who did, were 4.8 times as likely to submit an application for funding. Also, ESIs in earlier cohorts (1–2) (a period that coincided with the pre COVID-19 era) as compared to those who were recruited at later cohorts (3–4) (i.e., during the peak of COVID-19 period) were 3.8 times as likely to submit grants (p-value < 0.0001). The most prevalent issues that were identified included insufficient statistical design considerations and plans (75%), conceptual framework (28.3%), specific aims (11.7%), evidence of significance (3.3%), and innovation (3.3%). MRS potentially enhances grant submissions for extramural funding and offers constructive feedback allowing for modifications that enhance the scientific merits of research grants.

Background. This paper reports on the implementation and evaluation of a strategy to promote collaborations and team science among investigators at the Research Centers in Minority Institutions (RCMI). The strategy presented in this paper was a hands-on workshop that allowed the application of strategic team science through structured dialogue, asset sharing, and systematic exploration of opportunities for collaboration. Methods. The workshop was attended by more than 100 participants, including RCMI and non-RCMI investigators, practice-based research network (PBRN) supplement program directors, and an NIH Institute on Minority Health and Health Disparities Program Officer. Results. A post-workshop survey was administered to collect participant feedback, assess the relevance of the workshop to the participants’ professional development goals, and gauge the applicability of the tool as a support strategy to promote collaborative research. Most of the participants acknowledged that the session met the conference objectives (95.8%), and 93.7% noted that the workshop, to a high degree, met their personal goals and objectives. During the workshop, participants shared 35 resources they were willing and able to offer for prospective collaborative projects. Conclusion. The experience reported and evaluated in this paper paves the way to understanding methods for disseminating effective strategies for inter-institutional collaborations for the sustainable growth and operation of PBRNs.

The COVID-19 pandemic has significantly taxed scientific research and seems to have exacerbated existing inequities within the research field, particularly for early-stage investigators (ESIs). This study examines the effects of the COVID-19 pandemic on traditionally underrepresented ESIs enrolled in an NIH-supported study evaluating the effectiveness of developmental networks, grant writing coaching, and mentoring on research career advancement. The survey consisted of 24 closed-ended (quantitative) and 4 open-ended questions (qualitative) linked to a participant’s ability to meet grant submission deadlines, research and professional development disruptions, stress level, career transition level, self-efficacy and management of scholarly tasks, and familial responsibilities. Results from 32 respondents (53%) suggest that COVID-19 adversely impacted the continuity of research (81%) and grant submissions (63%). On average, grant submissions were delayed by 6.69 months (i.e., greater than one grant cycle). We also conducted additional analyses characterizing nonresponse and found that there were no significant predictors of nonresponse, indicating a limited threat to the validity of our findings. The disruption caused by COVID-19 to the careers of ESIs from underrepresented groups in the biomedical workforce has been profound in the short term. The long-term consequences to the future success of these groups are unknown but is a worthwhile area of research and potential innovation.

Arterial stiffness is a precursor for the development of hypertension and premature cardiovascular disease (CVD). Physical activity has been associated with lower arterial stiffness among largely White populations, but the types of activity required and whether these findings apply to Black adults remain unknown. We examined whether physical activity levels were associated with arterial stiffness among Black adults in two independent cohorts. In the Morehouse-Emory Cardiovascular (MECA) Center for Health Equity, 378 Black adults (age 52.8 ± 10.3, 39.7% male) without known CVD living in Atlanta, GA were recruited. Arterial stiffness was measured as pulse wave velocity (PWV). Total and domain-specific physical activity were assessed by self-report. Multiple linear regression models were used to investigate differences across physical activity levels after adjusting for age, sex, CVD risk factors, and socioeconomic status. Findings were validated in an independent cohort of Black adults ( n = 55, age 50.4 ± 9.2, 23.6% male). After adjustment for covariates, lower arterial stiffness was associated with higher self-reported levels of sport/exercise (6.92 ± 1.13 vs 7.75 ± 1.14, p < 0.001, highest vs lowest quartile) and home/life activities (7.34 ± 1.24 vs 7.73 ± 1.07, p = 0.04, highest vs lowest quartile), but not work, active living, or the overall physical activity scores. These findings were replicated in the independent cohort where higher levels of sport/exercise remained associated with lower arterial stiffness (6.66 ± 0.57 vs 8.21 ± 0.66, p < 0.001, highest vs lowest quartile). Higher levels of sport/exercise and home/life-related physical activities (in comparison to occupational physical activity) are associated with lower arterial stiffness in Black adults.

Background: Enhancement of diversity within the U.S. research workforce is a recognized need and priority at a national level. Existing comprehensive programs, such as the National Research Mentoring Network (NRMN) and Research Centers in Minority Institutions (RCMI), have the dual focus of building institutional research capacity and promoting investigator self-efficacy through mentoring and training. Methods: A qualitative comparative analysis was used to identify the combination of factors that explain the success and failure to submit a grant proposal by investigators underrepresented in biomedical research from the RCMI and non-RCMI institutions. The records of 211 participants enrolled in the NRMN Strategic Empowerment Tailored for Health Equity Investigators (NRMN-SETH) program were reviewed, and data for 79 early-stage, underrepresented faculty investigators from RCMI (n = 23) and non-RCMI (n = 56) institutions were included. Results: Institutional membership (RCMI vs. non-RCMI) was used as a possible predictive factor and emerged as a contributing factor for all of the analyses. Access to local mentors was predictive of a successful grant submission for RCMI investigators, while underrepresented investigators at non-RCMI institutions who succeeded with submitting grants still lacked access to local mentors. Conclusion: Institutional contexts contribute to the grant writing experiences of investigators underrepresented in biomedical research.

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.

RATIONALE AND OBJECTIVE: The safety of intensive blood pressure (BP) targets is controversial for persons with chronic kidney disease (CKD). We studied the effects of hypertension treatment on cerebral perfusion and structure in those with and without CKD. STUDY DESIGN: Neuroimaging substudy of a randomized trial. SETTING & PARTICIPANTS: A subset of participants in the Systolic Blood Pressure Intervention Trial who underwent brain MRI studies. Presence of baseline CKD was assessed by estimated glomerular filtration rate (eGFR) and urine albumin to creatinine ratio (UACR). INTERVENTION: Participants were randomly assigned to intensive (systolic BP 30 mg/g (N=151), the effects of intensive versus standard BP treatment on change in global cerebral blood flow, WMLs and total brain volume were 1.91 ml/100g/min (95% CI −3.01, 6.82), 0.003 cm(3) (asinh transformed, 95% CI −0.13, 0.13), and −7.0 cm(3) (95% CI −13.3, −0.3), respectively. The overall treatment effects on cerebral blood flow and total brain volume were not modified by baseline eGFR or UACR; however the effect on WMLs was attenuated in participants with albuminuria (interaction p-value 0.04). LIMITATIONS: Measurement variability due to multi-site design. CONCLUSIONS: Among hypertensive adults with primarily early kidney disease, intensive versus standard blood pressure treatment did not appear to have a detrimental effect on brain perfusion or structure. The findings support the safety of intensive blood pressure treatment targets on brain health in persons with early kidney disease. FUNDING: The Systolic Blood Pressure Intervention Trial was funded by the National Institutes of Health (including the National Heart, Lung, and Blood Institute, the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute on Aging, and the National Institute of Neurological Disorders and Stroke), and this substudy was funded by the National Institutes of Diabetes and Digestive and Kidney Diseases. TRIAL REGISTRATION: SPRINT was registered at ClinicalTrials.gov with the study number NCT01206062.

Summary Background Baricitinib is an oral selective Janus kinase 1/2 inhibitor with known anti-inflammatory properties. This study evaluates the efficacy and safety of baricitinib in combination with standard of care for the treatment of hospitalised adults with COVID-19. Methods In this phase 3, double-blind, randomised, placebo-controlled trial, participants were enrolled from 101 centres across 12 countries in Asia, Europe, North America, and South America. Hospitalised adults with COVID-19 receiving standard of care were randomly assigned (1:1) to receive once-daily baricitinib (4 mg) or matched placebo for up to 14 days. Standard of care included systemic corticosteroids, such as dexamethasone, and antivirals, including remdesivir. The composite primary endpoint was the proportion who progressed to high-flow oxygen, non-invasive ventilation, invasive mechanical ventilation, or death by day 28, assessed in the intention-to-treat population. All-cause mortality by day 28 was a key secondary endpoint, and all-cause mortality by day 60 was an exploratory endpoint; both were assessed in the intention-to-treat population. Safety analyses were done in the safety population defined as all randomly allocated participants who received at least one dose of study drug and who were not lost to follow-up before the first post-baseline visit. This study is registered with ClinicalTrials.gov , NCT04421027 . Findings Between June 11, 2020, and Jan 15, 2021, 1525 participants were randomly assigned to the baricitinib group (n=764) or the placebo group (n=761). 1204 (79·3%) of 1518 participants with available data were receiving systemic corticosteroids at baseline, of whom 1099 (91·3%) were on dexamethasone; 287 (18·9%) participants were receiving remdesivir. Overall, 27·8% of participants receiving baricitinib and 30·5% receiving placebo progressed to meet the primary endpoint (odds ratio 0·85 [95% CI 0·67 to 1·08], p=0·18), with an absolute risk difference of −2·7 percentage points (95% CI −7·3 to 1·9). The 28-day all-cause mortality was 8% (n=62) for baricitinib and 13% (n=100) for placebo (hazard ratio [HR] 0·57 [95% CI 0·41–0·78]; nominal p=0·0018), a 38·2% relative reduction in mortality; one additional death was prevented per 20 baricitinib-treated participants. The 60-day all-cause mortality was 10% (n=79) for baricitinib and 15% (n=116) for placebo (HR 0·62 [95% CI 0·47–0·83]; p=0·0050). The frequencies of serious adverse events (110 [15%] of 750 in the baricitinib group vs 135 [18%] of 752 in the placebo group), serious infections (64 [9%] vs 74 [10%]), and venous thromboembolic events (20 [3%] vs 19 [3%]) were similar between the two groups. Interpretation Although there was no significant reduction in the frequency of disease progression overall, treatment with baricitinib in addition to standard of care (including dexamethasone) had a similar safety profile to that of standard of care alone, and was associated with reduced mortality in hospitalised adults with COVID-19. Funding Eli Lilly and Company. Translations For the French, Japanese, Portuguese, Russian and Spanish translations of the abstract see Supplementary Materials section.

Background:Early trauma (general, emotional, physical, and sexual abuse before age 18 years) has been associated with both cardiovascular disease risk and lifestyle-related risk factors for cardiovascular disease, including smoking, obesity, and physical inactivity. Despite higher prevalence, the association between early trauma and cardiovascular health (CVH) has been understudied in Black Americans, especially those from low-income backgrounds, who may be doubly vulnerable. Therefore, we investigated the association between early trauma and CVH, particularly among low-income Black Americans.Methods:We recruited 457 Black adults (age 53±10, 38% male) without known cardiovascular disease from the Atlanta, GA, metropolitan area using personalized, community-based recruitment methods. The Early Trauma Inventory was administered to assess overall early traumatic life experiences which include physical, sexual, emotional abuse, and general trauma. Our primary outcome was the American Heart Association Life’s Simple 7, which is a set of 7 CVH metrics, including 4 lifestyle-related factors (smoking, body mass index, physical activity, and diet) and three physiologically measured health factors (blood pressure, total blood cholesterol, and blood glucose). We used linear regression models adjusting for age, sex, socioeconomic status, and depression to test the association between early trauma and CVH and tested the early trauma by household income (Results:Higher levels of early trauma were associated with lower Life’s Simple 7 scores (β, −0.05 [95% CI, −0.09 to −0.01],P=0.02, per 1 unit increase in the Early Trauma Inventory score) among lower, but not higher, income Black participants (Pvalue for interaction=0.04). Subtypes of early trauma linked to Life’s Simple 7 were general trauma, emotional abuse, and sexual abuse. Exploratory analyses demonstrated that early trauma was only associated with the body mass index and smoking components of Life’s Simple 7.Conclusions:Early trauma, including general trauma, emotional abuse, and sexual abuse, may be associated with worse CVH among low-, but not higher-income Black adults.

Objective: We describe the implementa­tion, clinical outcomes and participant perspectives for e-Healthystrides©. Setting: Three independent ambulatory clinics and an historic African American (AA) church. Participants: Adults with diagnosed diabe­tes mellitus type 2. Interventions: e-Healthystrides© health coach facilitated intervention Primary outcome: Acquisition of three new self-management behaviors. Secondary outcomes: Blood pressure, blood glucose, A1c, attrition rate and par­ticipant perspectives of e-Healthystrides© Methods: A convergent parallel mixed method design was used in both pilot stud­ies. Results: Two hundred and sixty-four par­ticipants, aged ~62±16 years, enrolled. At­trition at 52 weeks varied 50%-90% by site. Low engagement users were defined mainly by anxiety with putting health information online. The primary outcome was achieved in 36% of our participants, with the top 3 self-management behaviors acquired be­ing: reducing risk (24.5%); healthy eating (23.7%); and monitoring (16.4%). Problem solving had the lowest rate of achievement (.91%). Blood pressure improved signifi­cantly at all sites at 12 weeks and at clinics A,B,C at 52 weeks. Blood glucose im­proved at 12 weeks: clinic A (P=.0001), B (P=.003), C (P=.001) and D (P=.03); but, at 52 weeks, only clinics A (P=

Cardiovascular disease (CVD) is the number one killer of adults in the U.S., with marked ethnic/racial disparities in prevalence, risk factors, associated health behaviors, and death rates. In this study, we recruited and randomized Blacks with poor cardiovascular health in the Atlanta Metro area to receive an intervention comparing two approaches to engagement with a behavioral intervention technology for CVD. Generalized Linear Mixed Models results from a 6-month intervention indicate that 53% of all participants experienced a statistical improvement in Life’s Simple 7 (LS7), 54% in BMI, 61% in blood glucose, and 53% in systolic blood pressure. Females demonstrated a statistically significant improvement in BMI and diastolic blood pressure and a reduction in self-reported physical activity. We found no significant differences in changes in LS7 or their constituent parts but found strong evidence that health coaches can help improve overall LS7 in participants living in at-risk neighborhoods. In terms of clinical significance, our result indicates that improvements in LS7 correspond to a 7% lifetime reduction of incident CVD. Our findings suggest that technology-enabled self-management can be effective for managing selected CVD risk factors among Blacks.

Introduction: Clinical trials often have low enrollment of minorities, particularly African-Americans (AAs), which may limit the generalizability of research findings. Previously identified barriers to AAs recruitment include historical abuses leading to mistrust, communication issues with providers, socio-economic factors, and a lack of access to clinical trials. In a Historically Black College and University (HBCU) serving a primarily AA population at a large safe-net hospital, we evaluated the enrollment of eligible AA patients for a colorectal cancer (CRC) screening clinical trial. This was compared to the enrollment rates across other study sites. Methods: A large, prospective, multi-centered clinical trial to validate a blood-based test for early detection of CRC (PREEMPT-CRC) was initiated at a HBCU, where 84% of patients are AAs. To maximize study recruitment, culturally sensitive methods were employed including racially congruent recruitment staff as well as synchronized timing of consent/study procedures with preendoscopy COVID testing/clinic visits. Detailed information for all eligible subjects was recorded. Demographic and socio-economic data including census information for enrolled and not enrolled subjects were compared. The enrollment rate (defined as enrolled/eligible patients) over the first 6 weeks at the HBCU and that of the other study sites providing screening logs was analyzed. Results: The enrollment rate at the HBCU was 55% (44 out of 80 eligible patients;95% CI 43.5- 66.2%), compared to 49.8% (258 out of 518 eligible patients;95% CI 45.4- 54.2%) at the other 26 study sites. While age and gender of enrolled patients at the HBCU were comparable to other sites, the main difference was race: at the HBCU the study participants were 79.5% AAs and 9.1% whites, while at the other sites the participants were 11.5% AAs and 82.8% whites (p< 0.001). At the HBCU, the demographic characteristics and socio-demographic data including income, marital status insurance status/type, and census tract median household income of the 44 enrolled and 36 notenrolled subjects were similar (Table 1). Conclusion: Contrary to conventional belief that AAs do not want to be involved in clinical trials, we find their enrollment is similar to a predominant white study population when offered the opportunity in a culturally sensitive setting. Future trials should consider including HBCU sites in order to attain adequate AA enrollment to improve the generalizability of research findings. (Table Presented).

Background: Despite well-documented cardiovascular disparities between racial groups, within-race determinants of cardiovascular health among Black adults remain understudied. Factors promoting cardiovascular resilience among Black adults in particular warrant further investigation. Our objective was to examine whether individual psychosocial resilience and neighborhood-level cardiovascular resilience were associated with better cardiovascular health in Black adults, measured utilizing Life’s Simple 7 (LS7) scores. Methods: We assessed LS7 scores in 389 Black adults (mean age, 53±10 years; 39% men) living in Atlanta, Georgia. A composite score of individual psychosocial resilience was created by assessing environmental mastery, purpose in life, optimism, resilient coping, and depressive symptoms. Neighborhood-level cardiovascular resilience was separately determined by the census tract-level rates of cardiovascular mortality/morbidity events. Generalized linear mixed regression models were used to examine the association between individual psychosocial resilience, neighborhood cardiovascular resilience, and LS7 scores. Results: Higher individual psychosocial resilience was significantly associated with higher LS7 (β=0.38 [0.16–0.59] per 1 SD) after adjustment for sociodemographic factors. Similarly, higher neighborhood-level cardiovascular resilience was significantly associated with higher LS7 (β=0.23 [0.02–0.45] per 1 SD). When jointly examined, high individual psychosocial resilience (>median) was independently associated with higher LS7 (β=0.73 [0.31–1.17]), whereas living in high-resilience neighborhoods (>median) was not. The largest difference in LS7 score was between those with high and low psychosocial resilience living in low-resilience neighborhoods (8.38 [7.90–8.86] versus 7.42 [7.04–7.79]). Conclusions: Individual psychosocial resilience in Black adults is associated with better cardiovascular health.

BACKGROUND A 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. OBJECTIVE This 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. METHODS We 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. RESULTS Transcripts 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; PβCoach=.02; PβCoach=.01; PβCoach=.01; P=.04), diabetes knowledge (βCoach=.02; PβCoach=.03; P001), and using Health360x (βCoach=.003; P=.03) were dominated by coaches. CONCLUSIONS Coach-facilitated, technology-based diabetes self-management education can help underserved patients with diabetes. Our use of topic modeling in this application sheds light on the actual dynamics in conversations between patients and coaches. Knowledge of the key elements for successful coach–patient interactions based on the analysis of transcripts could be applied to understanding everyday patient–provider encounters, given the recent paradigm shift around the use of telehealth.

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 micro RNA 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: NCT 03308812.

Introduction: Sleep is hypothesized to be a contributing factor towards disparities in cardiovascular disease (CVD). It has been demonstrated that Black Americans have worse sleep quality compared to other ethnic groups, but within group differences have not been studied. Whether overall sleep quality and patterns affect cardiovascular health (CVH) among Blacks has yet to be elucidated. Hypothesis: Black individuals reporting worse sleep quality and patterns will have poor CVH as measured by the American Heart Association’s Life’s Simple 7 (LS7) scores. Methods: We recruited 499 Black adults (age 53 ± 10, 38% male) without known CVD from the Atlanta, GA metropolitan area. Sleep quality and patterns were assessed by the Pittsburgh Sleep Quality Index (PSQI) which includes sleep quality, nighttime disturbance, efficiency (amount of time slept while in bed), daytime dysfunction, duration, need of medications and latency (time required to fall asleep). CVH was determined by LS7 scores calculated from measured blood pressure, glucose, cholesterol, body mass index (BMI), and self-reported exercise, diet, and smoking, and categorized into poor (0-8), intermediate (9-10), and ideal (11-14). Multinomial logistic regression was used to examine the relationship between sleep and the odds of intermediate (vs. poor) and ideal (vs. poor) CVH categories after adjusting for age, gender, household income, education, marital status, and employment status. Results: A total of 55 (11%), 107 (21%), and 337 (67%) participants had ideal, intermediate, and poor LS7 scores, respectively. Those reporting PSQI-assessed poor sleep quality (OR 0.50, 95% CI [0.33 - 0.78]), longer latency (OR 0.50, 95% CI [0.36 - 0.70]), disturbance (OR 0.45, 95% CI [0.26 - 0.77]) and daytime dysfunction (OR 0.52, 95% CI [0.31 - 0.89]) had significantly lower adjusted odds of having ideal CVH. Daytime dysfunction was significantly associated with lower adjusted odds of having ideal blood pressure (OR 0.57, 95% CI [0.38 - 0.87]), glucose (OR 0.71, 95% CI [0.51 - 0.98]), and physical activity (OR 0.58, 95% CI [0.36 - 0.93]). Similarly, longer latency was significantly associated with lower adjusted odds of having ideal BMI (OR 0.72, 95% CI [0.54 - 0.95]), blood pressure (OR 0.71, 95% CI [0.55 - 0.92]), and cholesterol (OR 0.73, 95% CI [0.55 - 0.98]). PSQI-assessed shorter sleep duration was not associated with poor overall CVH, but was associated with significantly lower adjusted odds of having ideal blood pressure (OR 0.77, 95% CI [0.61 - 0.99]). Conclusion: Among Black Americans, poor sleep in terms of quality, nighttime disturbance, daytime dysfunction and longer latency, was associated with worse overall CVH or its components. Whether addressing sleep quality in Blacks will improve CVH and outcomes needs to be studied.

Introduction: Early trauma (e.g. general, emotional, physical, and sexual abuse before age 18) has been associated with both cardiovascular disease (CVD) risk and lifestyle-related risk factors for CVD including smoking, obesity, and physical inactivity. However, previous studies have primarily focused on White participants, despite the fact that early trauma is more common in Blacks. In particular, the role played by low socioeconomic status (SES) in this population has been relatively understudied. Hypothesis: Black individuals reporting early trauma will have worse cardiovascular health (CVH) as measured by the American Heart Association’s Life’s Simple 7 (LS7) scores and these associations will vary by SES. Methods: We recruited 499 Black adults (age 53 ± 10, 38% male) without CVD from the Atlanta, GA metropolitan area. The Early Trauma Inventory (ETI) was administered to assess physical, sexual, emotional abuse and general trauma. CVH was determined by LS7 scores calculated from measured blood pressure, blood glucose, cholesterol, body mass index (BMI), and self-reported exercise, diet, and smoking and was categorized as poor (0-8), intermediate (9-10), and ideal (11-14). Multinomial logistic regression was used to examine the relationship between early trauma and the odds of intermediate (vs. poor) and ideal (vs. poor) CVH categories after adjusting for age, gender, household income, education, marital status, employment status, and depression. After testing for interaction between ETI and SES, stratified analysis was conducted separately on individuals with low and high SES (defined as household income less or greater than $50,000 per year, respectively). Results: A total of 55 (11%), 107 (21%), and 337 (67%) participants had ideal, intermediate, and poor LS7 scores, respectively. In the full cohort, higher levels of early trauma were associated with lower adjusted odds of ideal LS7 scores (OR 0.94, 95% CI [0.88 - 1.00] per 1 SD increase in the ETI score). In SES-stratified analyses, higher levels of early trauma (OR 0.91, 95% CI [0.84 - 0.98]), in particular emotional (OR 0.74, 95% CI [0.59 - 0.94]) and sexual abuse (OR 0.69, 95% CI [0.49 - 0.96]), were significantly associated with lower adjusted odds of ideal LS7 scores among lower, but not higher, SES Black participants (p value for interaction =0.03). Among the CVH components, emotional and sexual abuse were both associated with significantly lower adjusted odds of ideal BMI (OR 0.81, 95% CI [0.68-0.97] and OR 0.72, 95% CI [0.56-0.93], respectively) in low SES participants. Conclusion: Early trauma, particularly emotional and sexual abuse, was associated with worse CVH among Black individuals with lower SES. Further research is needed to investigate the mechanisms through which economic disadvantage potentiates the adverse influence of early trauma on CVH in Black individuals.

Background A 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. Objective This 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. Methods We 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. Results Transcripts 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 Conclusions Coach-facilitated, technology-based diabetes self-management education can help underserved patients with diabetes. Our use of topic modeling in this application sheds light on the actual dynamics in conversations between patients and coaches. Knowledge of the key elements for successful coach–patient interactions based on the analysis of transcripts could be applied to understanding everyday patient–provider encounters, given the recent paradigm shift around the use of telehealth.

Background Neighborhood environment is increasingly recognized as an important determinant of CVH among Black adults. Most research to date has focused on negative aspects of the neighborhood environment, with little attention being paid to the specific positive features, in particular the social environment, that promote cardiovascular resilience among Black adults. Objective We examined whether better neighborhood physical and social characteristics are associated with ideal CVH among Black adults, as measured by Life's Simple 7 (LS7) scores. Methods We recruited 392 Black adults (age 53 ± 10, 39% male) without known CV disease living in Atlanta, GA. Seven neighborhood domains were assessed via questionnaire: aesthetic quality, walking environment, safety, food access, social cohesion, activity with neighbors, and violence. CVH was determined by LS7 scores calculated from measured blood pressure, glucose, cholesterol, body mass index (BMI), and self-reported exercise, diet, and smoking, and categorized into poor (0-8), intermediate (9-10), and ideal (11-14). Multinomial logistic regression was used to examine the association between neighborhood characteristics and the odds of intermediate/ideal CVH categories compared to poor CVH after adjustment for age, gender, household income, education, marital status, and employment status. Results Better scores in the neighborhood domains of social cohesion and activity with neighbors were significantly associated with higher adjusted odds of ideal LS7 scores (OR 2.02, 95% CI [1.36 - 3.01] and 1.71 [1.20 - 2.45] per 1 standard deviation [SD] increase in respective scores). These associations were stronger for both social cohesion (OR 2.61, 95% CI [1.48 - 4.61] versus 1.40 [0.82 - 2.40]) and activity with neighbors (OR 1.82, 95% CI [1.15 - 2.86] versus 1.53 [0.84 - 2.78]) in Black women compared to men. Specifically, better scores in social cohesion were associated with higher odds of ideal CVH in exercise (OR 1.73 [1.16 - 2.59]), diet (OR 1.90 [1.11 - 3.26]), and BMI (OR 1.52 [1.09 - 2.09]); better scores in activity with neighbors were also similarly associated with higher odds of ideal CVH in exercise (OR 1.48 [1.00 - 2.19]), diet (OR 2.15 [1.23 - 3.77]), and BMI (OR 1.45 [1.07 - 1.98]; per 1 SD in respective scores). Conclusion More desirable neighborhood characteristics, particularly social cohesion and activity with neighbors, were associated with better CVH among Black adults.

Introduction: Adding developmental networks (DN) to grant-writing coaching can significantly enhance ESIs’ research careers. Herein, we present study design, ESIs’ characteristics and encountered challenges/lessons learned and their resolutions when deploying/implementing (a) NCR algorithm(s), (b) recruitment/retention and (c) implementing DN intervention. Methods: Nested Cluster Randomization (NCR) design governs this study implementation. The sample size is 220 ESIs intending to submit an NIH K, R, U, and/or Minority Supplement application(s). Primary outcome: intensity/sustainability of grant submission(s)/funding(s), measured by time to/between application(s). Outcome(s) analyses modes: summaries, Kaplan Meir and Cox proportional hazard models as a function of randomization groups and other predictors of outcomes. Results: In the present study, we recruited two cohorts of ESIs (N = 85): 39% African Americans, 18% Latinx, 18% Whites, 20% Asians and 6% Hawaiian/Pacific Islander/other ethnicities, 65% are women, 73% are assistant professors, 4% are Associate Professors and 23% are instructors/scientists/post-doctoral. Participants’ disciplines: 32% basic/biomedical, 36% clinical/translational and 32% social/behavioral. Proposal(s) mechanisms: 61% research grants (R series), 31% career development (K series), 7% support of competitive research (SCORE) and 1% National Science Foundation applications. NCR did produce balance in the distribution of ESIs’ demographics, sex at birth, ethnicity, professional appointments, background disciplines, and mechanism of sought funding. Lessons learned/challenges: NCR implementation was methodologically challenged during implementation by added constraints (e.g., assigning coaches to the same randomization arm of their participants as well as blinding them to ESIs’ randomization group). Recruitment and retention were hampered by the COVID-19 pandemic and more progressive and innovative strategies were needed to heighten the visibility and outreach of this program. DN delivery was also affected by the pandemic and monitoring of ESIs’ engagement and facilitation of communications interventions were needed. Resolution of these challenges effectively reconfigured NCR algorithms, recruitment/retention plans, and DN intervention delivery. We intend to recruit an additional 135 ESIs focusing on underrepresented scholars from RCMIs, CTSAs, and other programs. COVID-19 rendered this program 100% virtual, with recruitment/retention challenges and substantial disruption of ESIs’ research. We may extend the grant writing period, coaching, and Mock Study Section support.

Objectives We examined the association between socioeconomic status (SES) discrimination and C-reactive protein (CRP) in a biracial cohort of middle-aged adults using an intersectionality framework. Methods Participants were 401 African-American and White adults from a population-based cohort in the Southeastern United States. SES discrimination was self-reported with a modified Experiences of Discrimination Scale, and CRP levels were assayed from blood samples. Linear regression analyses were used to examine the associations among SES discrimination, race, education, and CRP after controlling for age, gender, racial and gender discrimination, financial and general stress, body mass index, smoking, sleep quality, and depressive symptoms. Intersectional effects were tested using race × SES discrimination, education × SES discrimination and race × education × SES discrimination interactions. Results Adjusting for sociodemographics, racial discrimination, gender discrimination, and all relevant two-way interaction terms, we observed a significant race × education × SES discrimination interaction (p = 0.019). In adjusted models stratified by race and education, SES discrimination was associated with elevated CRP among higher educated African-Americans (β = 0.29, p = 0.018), but not lower educated African-Americans (β= −0.13, p = 0.32); or lower educated (β= −0.02, p = 0.92) or higher educated (β= −0.01, p = 0.90) Whites. Conclusions Findings support the relevance of SES discrimination as an important discriminatory stressor for CRP specifically among higher educated African-Americans.

Accountable Care Organizations (ACOs) seek sustainable innovation through the testing of new care delivery methods that promote shared goals among value-based health care collaborators. The Morehouse Choice Accountable Care Organization and Education System (MCACO-ES), or (M-ACO) is a physician led integrated delivery model participating in the Medicare Shared Savings Program (MSSP) offered through the Centers for Medicare and Medicaid Services (CMS) Innovation Center. The MSSP establishes incentivized, performance-based payment models for qualifying health care organizations serving traditional Medicare beneficiaries that promote collaborative efficiency models designed to mitigate fragmented and insufficient access to health care, reduce unnecessary cost, and improve clinical outcomes. The M-ACO integration model is administered through participant organizations that include a multi-site community based academic practice, independent physician practices, and federally qualified health center systems (FQHCs). This manuscript aims to present a descriptive and exploratory assessment of health care programs and related innovation methods that validate M-ACO as a reliable simulator to implement, evaluate, and refine M-ACO&rsquo, s integration model to render value-based performance outcomes over time. A part of the research approach also includes early outcomes and lessons learned advancing the framework for ongoing testing of M-ACO&rsquo, s integration model across independently owned, rural, and urban health care locations that predominantly serve low-income, traditional Medicare beneficiaries, (including those who also qualify for Medicaid benefits (also referred to as &ldquo, dual eligibles&rdquo, ). M-ACO seeks to determine how integration potentially impacts targeted performance results. As a simulator to test value-based innovation and related clinical and business practices, M-ACO uses enterprise-level data and advanced analytics to measure certain areas, including: 1) health program insight and effectiveness, 2) optimal implementation process and workflows that align primary care with specialists to expand access to care, 3) chronic care management/coordination deployment as an effective extender service to physicians and patients risk stratified based on defined clinical and social determinant criteria, 4) adoption of technology tools for patient outreach and engagement, including a mobile application for remote biometric monitoring and telemedicine, and 5) use of structured communication platforms that enable practitioner engagement and ongoing training regarding the shift from volume to value-based care delivery.

African Americans, other minorities and underserved populations are consistently under- represented in clinical trials. Such underrepresentation results in a gap in the evidence base, and health disparities. The ABC Cardiovascular Implementation Study (CVIS) is a comprehensive prospective cohort registry that integrates social determinants of health. ABC CVIS uses real world clinical practice data to address critical gaps in care by facilitating robust participation of African Americans and other minorities in clinical trials. ABC CVIS will include diverse patients from collaborating ABC member private practices, as well as patients from academic health centers and Federally Qualified Health Centers (FQHCs). This paper describes the rationale and design of the ABC CVIS Registry. The registry will: (1) prospectively collect socio-demographic, clinical and biospecimen data from enrolled adults, adolescents and children with prioritized cardiovascular diseases, (2) Evaluate the safety and clinical outcomes of new therapeutic agents, including post marketing surveillance and pharmacovigilance, (3) Support National Institutes of Health (NIH) and industry sponsored research, (4) Support Quality Measures standards from the Center for Medicare and Medicaid Services (CMS) and Commercial Health Plans. The registry will utilize novel data and technology tools to facilitate mobile health technology application programming interface (API) to health system or practice electronic health records (EHR). Long term, CVIS will become the most comprehensive patient registry for underserved diverse patients with cardiovascular disease (CVD) and co morbid conditions, providing real world data to address health disparities. At least 10,000 patients will be enrolled from 50 sites across the United States.

Introduction: Intra-racial heterogeneity in cardiovascular health (CVH) among Blacks is understudied, and more research is needed to identify factors promoting CVH among Blacks. Neighborhood environment is increasingly recognized as an important determinant of CV risk and health, Yet whether specific features of neighborhood physical and social environments may promote CV resilience among Blacks has been underexplored. Hypothesis: Better neighborhood characteristics are associated with ideal CVH among Black adults, measured as Life’s Simple 7 (LS7) scores. Methods: We recruited 392 Black adults (age 53 ± 10, 39% male) without known CV disease in Atlanta, GA, who resided in 199 residential neighborhood (defined as census tracts). Seven neighborhood domains were assessed via questionnaire: aesthetic quality, walking environment, safety, food access, social cohesion, activity with neighbors, and violence. CVH was determined by LS7 scores calculated from measured blood pressure, glucose, cholesterol, body mass index (BMI), and self-reported exercise, diet, and smoking, and categorized into poor (0-8), intermediate (9-10), and ideal (11-14). Multinomial logistic regression was used to examine the association between neighborhood characteristics and the odds of intermediate/ideal CVH categories compared to poor CVH after adjustment for age, gender, household income, education, marital status, and employment status. Results: A total of 53 (14%), 110 (28%), and 229 (58%) participants had ideal, intermediate, and poor LS7 scores, respectively. Better scores in the neighborhood domains of social cohesion and activity with neighbors were significantly associated with higher adjusted odds of ideal LS7 scores (OR 1.95, 95% CI [1.32 - 2.90] and 1.65 [1.16 - 2.35] per 1 standard deviation [SD] increase in respective scores). Specifically, better scores in social cohesion were associated with higher odds of ideal CVH in exercise (OR 1.73 [1.16 - 2.59]), diet (OR 1.99 [1.14 - 3.48]), and BMI (OR 1.51 [1.09 - 2.09]); better scores in activity with neighbors were also similarly associated with higher odds of ideal CVH in exercise (OR 1.47 [0.99 - 2.19]), diet (OR 2.37 [1.32 - 4.26]), and BMI (OR 1.44 [1.05 - 1.96]; per 1 SD in respective scores). Aesthetic quality, walking environment, safety, food access, and violence were not significantly associated with overall CVH categories in the adjusted models. Conclusion: More desirable neighborhood characteristics, particularly social cohesion and activity with neighbors, were associated with better CVH among Black adults. Further research is needed to investigate whether interventions to improve neighborhood qualities lead to better CVH in Blacks.

Introduction: Arterial stiffness is associated with cardiovascular (CV) risk factors and adverse cardiovascular events. While inter-racial differences in arterial stiffness have been reported, factors contributing to intra-racial differences within Blacks are less known. We examined whether neighborhood characteristics and personal resilience factors were associated with arterial stiffness among Blacks. Hypothesis: More desirable neighborhood characteristics and greater personal resilience are associated with reduced arterial stiffness. Methods: We examined 385 Black adults (age 53 ± 10, 40% male) without known CV disease living in Atlanta, GA. Arterial stiffness was measured as augmentation index (AIX) and pulse wave velocity (PWV) using applanation tonometry (Sphygmocor Inc). Perceived residential neighborhood characteristics in 7 domains: aesthetic quality, walking environment, safety, food access, social cohesion, activity with neighbors, and violence were determined. Personal resilience was also assessed using standard questionnaires on experience of discrimination, environmental mastery, purpose in life, optimism, resilient coping, and depressive symptoms. Multiple linear regression models were used to examine the differences of arterial stiffness between the highest and the lowest tertiles of neighborhood characteristics and personal resilience factors after adjustment for age, gender, systolic blood pressure, body mass index, household income, education, marital status, and employment status. Results: Higher composite scores of neighborhood characteristics were associated with lower AIX (β=-3.42, 95% CI [-6.42 to -0.41], P=0.026; highest vs lowest tertiles). Specifically, higher scores of safety (β=-4.26, 95% CI [-7.34 to -1.17], P=0.007) and social cohesion (β=-4.62 [-7.64 to -1.61], P=0.003) were associated with lower AIX (highest vs lowest tertiles for both). For factors of personal resilience, higher scores in purpose in life (β=-4.89 [-7.88 to -1.90], P=0.001) and resilient coping (β=-3.26 [-6.36 to -0.15], P=0.040) were significantly associated with lower AIX (highest vs lowest tertiles for both). There were no significant associations between PWV and scores of neighborhood characteristics or personal resilience factors. Conclusion: In a study examining the impact of neighborhood and markers of resilience on arterial stiffness in an exclusively Black cohort, we found that better neighborhood characteristics and personal resilience factors were associated with lower pulse wave reflections (AIX).

Importance There are concerns with translating results from the Systolic Blood Pressure Intervention Trial (SPRINT) into clinical practice because the standardized protocol used to measure blood pressure (BP) may not be consistently applied in routine clinical practice. Objectives To evaluate the concordance between BPs obtained in routine clinical practice and those obtained using the SPRINT protocol and whether concordance varied by target trial BP. Design, setting, and participants This observational prognostic study linking outpatient vital sign information from electronic health records (EHRs) with data from 49 of the 102 SPRINT sites was conducted from November 8, 2010, to August 20, 2015, among 3074 adults 50 years or older with hypertension without diabetes or a history of stroke. Statistical analysis was performed from May 21, 2019, to March 20, 2020. Main outcomes and measures Blood pressures measured in routine clinical practice and SPRINT. Results Participant-level EHR data was obtained for 3074 participants (2482 men [80.7%]; mean [SD] age, 68.5 [9.1] years) with 3 or more outpatient and trial BP measurements. In the period from the 6-month study visit to the end of the study intervention, the mean systolic BP (SBP) in the intensive treatment group from outpatient BP recorded in the EHR was 7.3 mm Hg higher (95% CI, 7.0-7.6 mm Hg) than BP measured at trial visits; the mean difference between BP recorded in the outpatient EHR and trial SBP was smaller for participants in the standard treatment group (4.6 mm Hg [95% CI, 4.4-4.9 mm Hg]). Bland-Altman analyses demonstrated low agreement between outpatient BP recorded in the EHR and trial BP, with wide agreement intervals ranging from approximately -30 mm Hg to 45 mm Hg in both treatment groups. In addition, the difference between BP recorded in the EHR and trial BP varied widely by site. Conclusions and relevance Outpatient BPs measured in routine clinical practice were generally higher than BP measurements taken in SPRINT, with greater mean SBP differences apparent in the intensive treatment group. There was a consistent high degree of heterogeneity between the BPs recorded in the EHR and trial BPs, with significant variability over time, between and within the participants, and across clinic sites. These results highlight the importance of proper BP measurement technique and an inability to apply 1 common correction factor (ie, approximately 10 mm Hg) to approximate research-quality BP estimates when BP is not measured appropriately in routine clinical practice. Trial registration SPRINT ClinicalTrials.gov Identifier: NCT01206062.

Introduction Social cohesion is a positive neighborhood characteristic defined by feelings of connectedness and solidarity within a community. Studies have found significant associations between social cohesion and cardiovascular disease (CVD) risk factors and outcomes. Inflammation is one potential physiological pathway linking social cohesion to CVD development, but few studies have evaluated the relationship between social cohesion and inflammatory biomarkers. Prior research has also established that race and gender can modify the effects of neighborhood features, including social cohesion, on CVD risk factors and outcomes. This study aimed to examine the association between social cohesion and the inflammatory biomarkers interleukin-6 (IL-6) and C-reactive protein (CRP) in a cohort of African American and White women and men. Materials and methods Data from the Morehouse and Emory Team Up to Eliminate Health Disparities (META-Health) Study were used to assess the association between social cohesion and inflammation among African American (n = 203) and White (n = 176) adults from the Atlanta metropolitan area. Social cohesion was measured using the social cohesion subscale from the Neighborhood Health Questionnaire. Inflammatory biomarkers were measured from plasma frozen at −70 °C. Multivariable linear regression analyses were conducted, controlling for demographic, clinical, behavioral, and psychosocial factors sequentially. Interaction by race and gender was also examined. Results In models adjusted for age, race, gender, and education, social cohesion was significantly associated with lower levels of IL-6 (β = −0.06, p = 0.03). There was a significant race × social cohesion interaction (p = 0.04), and a marginally significant gender × race × social cohesion interaction (p = 0.09). In race-stratified models controlling for age, gender, and education, social cohesion was associated with lower IL-6 levels in African Americans (β = −0.11, p = 0.01), but not Whites (β = 0.01, p = 0.91). In fully adjusted race- and gender-stratified models, social cohesion was associated with lower levels of IL-6 in African American women only (β = −0.15, p = 0.003). CRP was not associated with social cohesion in fully adjusted models. Conclusion The association between social cohesion and lower levels of IL-6 is modified by gender and race, with the strongest association emerging for African American women. Although the pathways through which social cohesion impacts inflammation remain unclear, it is possible that for African American women social cohesion manifests through neighborhood networks.

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.

The positive impact of diversity in increasing the effectiveness of the research workforce has been undeniably demonstrated to be an essential element for achieving health equity. Diversity is also instrumental for the research workforce to advance discovery, eliminate health disparities, improve minority health and achieve effective patient-centered outcomes in the quest for better health. One of the sustainable ways to achieve diversity in the work force is through training, education and career development of all interested individuals including minority, underserved, underrepresented and populations with special needs. A Hispanic public, academic health center, and a historically black private medical school, have joined efforts in this article to share their experiences in addressing diversity in the clinical and translational research workforce with grant support from the National Institutes of Health. The purpose of this paper is to describe how diversity has been achieved through a concerted effort to recruit and develop underrepresented junior faculty and doctoral candidates for successful careers in clinical and translational research focused on health disparities and minority health. We describe Initiatives designed to achieve diversity in recruitment and development of research teams, together with an evaluation of outcomes to determine the success of the program and its participants.

Background— Food deserts (FD), neighborhoods defined as low-income areas with low access to healthy food, are a public health concern. We evaluated the impact of living in FD on cardiovascular risk factors and subclinical cardiovascular disease (CVD) with the hypothesis that people living in FD will have an unfavorable CVD risk profile. We further assessed whether the impact of FD on these measures is driven by area income, individual household income, or area access to healthy food. Methods and Results— We studied 1421 subjects residing in the Atlanta metropolitan area who participated in the META-Health study (Morehouse and Emory Team up to Eliminate Health Disparities; n=712) and the Predictive Health study (n=709). Participants’ zip codes were entered into the United States Food Access Research Atlas for FD status. Demographic data, metabolic profiles, hs-CRP (high-sensitivity C-reactive protein) levels, oxidative stress markers (glutathione and cystine), and arterial stiffness were evaluated. Mean age was 49.4 years, 38.5% male and 36.6% black. Compared with those not living in FD, subjects living in FD (n=187, 13.2%) had a higher prevalence of hypertension and smoking, higher body mass index, fasting glucose, and 10-year risk for CVD. They also had higher hs-CRP ( P =0.014), higher central augmentation index ( P =0.015), and lower glutathione level ( P =0.003), indicative of increased oxidative stress. Area income and individual income, rather than food access, were associated with CVD risk measures. In a multivariate analysis that included food access, area income and individual income, both low-income area and low individual household income, were independent predictors of a higher 10-year risk for CVD. Only low individual income was an independent predictor of higher hs-CRP and augmentation index. Conclusions— Although living in FD is associated with a higher burden of cardiovascular risk factors and preclinical indices of CVD, these associations are mainly driven by area income and individual income rather than access to healthy food.

Objective: To identify predictors that allow for early detection of cardiovascular disease in African American women Background: Cardiovascular (CV) mortality is high in African Americans in the United States. Cardiovascular disease (CVD) remains the leading cause of death in African American females. We hypothesize that certain cardiovascular risk factors are predictors of abnormal peripheral vascular compliance. We aim to identify determinants of abnormal vascular compliance by assessing the association between known CVD risk factors and the extent of vascular compliance Methods: This cross-sectional study utilized survey responses and results from a noninvasive screening tool. The study included only African American women. Traditional CV risk factors were independent variables (history of hypertension, high serum lipids, family or personal history of CVD). The instrument employed biomarkers that detect blood vessel elasticity. Outcome measures included small and large vessel compliance. Both survey responses and screening results were obtained from 70 consecutive participants. We conducted a univariate and bivariate descriptive analysis. A Chi-square or Fishers exact test was used to determine the significance as appropriate. We adjusted for potential confounders in our multivariable analysis. SAS 9.4 software was used for all the data analyses Results: Our study indicates that personal history of cardiovascular disease is strongly associated with abnormal small vessel compliance (Pvalue - 0.01). Family history of cardiovascular disease is strongly associated with abnormal large artery compliance (Pvalue - 0.02). History of cardiovascular disease in both parents is associated with abnormal large artery compliance (Pvalue - 0.04). Interestingly, Living Situation (Living alone) was associated with abnormal large artery compliance (Pvalue - 0.03) Conclusion: Family and personal history of CVD, and living alone have strong associations with abnormal vascular compliance. Cardiovascular mortality is high in Black and African American females. Identifying predictors of abnormal vascular compliance can allow for early disease detection and intervention.

Cardiovascular disease (CVD), including heart disease and stroke, is the leading cause of death in the USA, regardless of self-determined race/ethnicity, and largely driven by cardiometabolic risk (CMR) and cardiorenal metabolic syndrome (CRS). The primary drivers of increased CMR include obesity, hypertension, insulin resistance, hyperglycemia, dyslipidemia, chronic kidney disease as well as associated adverse behaviors of physical inactivity, smoking, and unhealthy eating habits. Given the importance of CRS for public health, multiple stakeholders, including the National Minority Quality Forum (the Forum), the American Association of Clinical Endocrinologists (AACE), the American College of Cardiology (ACC), and the Association of Black Cardiologists (ABC), have developed this review to inform clinicians and other health professionals of the unique aspects of CMR in racial/ethnic minorities and of potential means to improve CMR factor control, to reduce CRS and CVD in diverse populations, and to provide more effective, coordinated care. This paper highlights CRS and CMR as sources of significant morbidity and mortality (particularly in racial/ethnic minorities), associated health-care costs, and an evolving index tool for cardiometabolic disease to determine geographical and environmental factors. Finally, this work provides a few examples of interventions potentially successful at reducing disparities in cardiometabolic health.

Cost-effective strategies to maintain healthy active lifestyle in aging populations are required to address the global burden of age-related diseases. ASPREE will examine whether the potential primary prevention benefits of low dose aspirin outweigh the risks in older healthy individuals. Our primary hypothesis is that daily oral 100. mg enteric-coated aspirin will extend a composite primary endpoint termed 'disability-free life' including onset of dementia, total mortality, or persistent disability in at least one of the Katz Activities of Daily Living in 19,000 healthy participants aged 65. years and above ('US minorities') and 70. years and above (non-'US minorities'). ASPREE is a double-blind, randomized, placebo-controlled trial of oral 100. mg enteric-coated acetyl salicylic acid (ASA) or matching placebo being conducted in Australian and US community settings on individuals free of dementia, disability and cardiovascular disease (CVD) events. Secondary endpoints are all-cause and cause specific mortality, fatal and non-fatal cardiovascular events, fatal and non-fatal cancer (excluding non-melanoma skin cancer), dementia, mild cognitive impairment, depression, physical disability, and clinically significant bleeding. To 20 September 2013 14,383 participants have been recruited. Recruitment and study completion are anticipated in July 2014 and December 2018 respectively. In contrast to other aspirin trials that have largely focused on cardiovascular endpoints, ASPREE has a unique composite primary endpoint to better capture the overall risk and benefit of aspirin to extend healthy independent lifespan in older adults in the US and Australia.

Diabetes self-management (DSM) training helps prevent diabetic complications. eHealth approaches may improve its optimal use. The aims were to determine a) acceptability of e-HealthyStrides© (an interactive, Internet-based, patient-driven, diabetes self-management support and social networking program) among Morehouse Community Physicians’ Network diabetics; b) efficacy for DSM behavior change c) success factors for use of e-HealthyStrides©. Baseline characteristics of pilot study participants are reported. Of those approached, 13.8% agreed to participate. Among participants, 96% were Black, 77% female; age 56±9.2 years; education: 44% college or higher and 15% less than 12th grade; 92.5% with home computers. Over half (51%) failed the Diabetes Knowledge Test. Nearly half (47%) were at goal A1C; 24% at goal blood pressure; 3% at goal LDL cholesterol level. Median (SD) Diabetes Empowerment Scale score = 3.93 (0.72) but managing psychosocial aspects = 3.89 (0.89) scored lower than other domains. There was low overall confidence for DSM behaviors. Assistance with healthy eating was the most frequently requested service. Requestors were more obese with worse A1C than others. Chronic care delivery scored average with high scores for counseling and problem solving but low scores for care coordination and follow up.

Junior investigators often have limited access to networks of scientific experts and resources that facilitate competitive grant submissions. Since environments in which scientists are trained are critically important for long-term success, we built and tested a virtual environment for early-stage investigators (ESIs) working on grant proposals. The aim of this study was to evaluate the virtual community&rsquo, s influence on grant submission patterns among participants from underrepresented groups. As part of a grant writing coaching model, junior investigators were recruited into a professional development program designed to develop competitive grantsmanship skills. Designed by the Research Resources and Outreach Core (RROC) of the National Research Mentoring Network (NRMN), the Health Equity Learning Collaboratory (EQ-Collaboratory) provided a virtual community for social support, accountability, constructive feedback, and access to peer networks to help investigators overcome barriers to grant submission. This study assessed differences in outcomes for participants who completed the training within the EQ-Collaboratory compared to those who did not. The analyzed data revealed a statistically significant difference in the average time to submission for participants enrolled in the EQ-Collaboratory. EQ-Collaboratory ESIs submitted proposals 148.6 days earlier, (p &lt, 0.0001). The results suggest that a supportive virtual environment can help investigators more quickly overcome barriers to grant submission.

Unparalleled technological advances have fueled an explosive growth in the scope and scale of biological data and have propelled life sciences into the realm of "Big Data" that cannot be managed or analyzed by conventional approaches. Big Data in the life sciences are driven primarily via a diverse collection of 'omics'-based technologies, including genomics, proteomics, metabolomics, transcriptomics, metagenomics, and lipidomics. Gene-set enrichment analysis is a powerful approach for interrogating large 'omics' datasets, leading to the identification of biological mechanisms associated with observed outcomes. While several factors influence the results from such analysis, the impact from the contents of pathway databases is often under-appreciated. Pathway databases often contain variously named pathways that overlap with one another to varying degrees. Ignoring such redundancies during pathway analysis can lead to the designation of several pathways as being significant due to high content-similarity, rather than truly independent biological mechanisms. Statistically, such dependencies also result in correlated p values and overdispersion, leading to biased results. We investigated the level of redundancies in multiple pathway databases and observed large discrepancies in the nature and extent of pathway overlap. This prompted us to develop the application, ReCiPa (Redundancy Control in Pathway Databases), to control redundancies in pathway databases based on user-defined thresholds. Analysis of genomic and genetic datasets, using ReCiPa-generated overlap-controlled versions of KEGG and Reactome pathways, led to a reduction in redundancy among the top-scoring gene-sets and allowed for the inclusion of additional gene-sets representing possibly novel biological mechanisms. Using obesity as an example, bioinformatic analysis further demonstrated that gene-sets identified from overlap-controlled pathway databases show stronger evidence of prior association to obesity compared to pathways identified from the original databases.

Progenitor cells (PCs) are key components of vasculogenic remodeling and hematopoietic development. Decreases in the number and function of angiogenic progenitors have been observed in coronary artery disease, hypertension, and diabetic vasculopathy. Several recent studies have also demonstrated a close relationship between increased visceral fat and cardiovascular disease, implying an association between obesity and vascular dysfunction. However, very little is known about the role of PCs in obesity. We generated whole genome expression profiles of cultured PCs from 18 obese and 6 lean African-American women on Agilent microarrays and analyzed the data through bioinformatic pathway analysis using multiple databases and analytic tools. False-discovery rates (FDR) were calculated to assess statistical significance while controlling for multiple testing. We identified 1,145 upregulated and 2,257 downregulated genes associated with obesity (1.5-fold or greater absolute fold-change). Pathway analysis further identified a statistically significant downregulation of immune-response pathways in the obese subjects, including T-cell receptor signaling, natural killer cell signaling, and chemokine-signaling pathways (FDR

99 Background: Breast cancer patients taking tamoxifen (TAM) or an aromatase inhibitor (AI) often develop severe vasomotor symptoms (VMS) yet the only FDA approved non-hormonal treatment for VMS, 7.5 mg paroxetine, has a warning against concomitant use with TAM. Q-122, an orally-available small molecule, is being developed to address this unmet medical need. Results from the Phase 1b study, Q-1001, are presented. Methods: Q-1001 was a Phase 1 open-label, two-dose, dose-escalation study of the safety and preliminary effectiveness of Q-122 in females with breast cancer currently taking TAM or an AI and experiencing an average of at least 7-8 moderate to severe hot flashes per day. Key exclusion criteria included significant renal or hepatic disease, untreated hyperthyroidism and clinically significant abnormal laboratory findings. The study period included a 2 week drug-free screening phase, 28 day treatment phase, and 2 week drug-free follow-up period. Subjects were initially enrolled into Group 1 (100 mg Q-122) followed by Group 2 (200 mg Q-122). Safety was assessed by review of adverse events (AEs), physical findings and laboratory values. The primary efficacy endpoints were mean changes in frequency and severity (hot flash severity score, HFSS) of moderate and severe hot flashes from baseline to Week 4. Menopausal symptoms were assessed using the Greene Climacteric Scale (GCS). Results: 10 and 11 subjects received 100 and 200 mg Q-122 respectively; 8 subjects in each group completed the study. At the end of treatment for groups 1 and 2 respectively, the daily average frequency of hot flashes was reduced from 9.9 to 4.1 and from 8.6 to 3.2, and the mean HFSS was reduced by 62% and 68% from baseline values. Menopausal symptoms assessed using the GCS were significantly reduced from baseline (psychological: -82%; somatic: -65%; vasomotor: -65%). All AEs (n = 29) were either mild (79%) or moderate (21%) in severity and only 3 (all in one subject) were considered possibly related to study drug. Conclusions: Treatment with Q-122 resulted in significant reduction in the frequency and severity of VMS and improvement in menopausal symptoms as assessed by the GCS. No safety issues associated with the use of Q-122 were identified in this study.