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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 A diverse research workforce is essential for catalyzing biomedical advancements, but this workforce goal is hindered by persistent sex and racial/ethnic disparities among investigators receiving research grants from the National Institutes of Health (NIH). In response, the NIH-funded National Research Mentoring Network implemented a Grant Writing Coaching Program (GCP) to provide diverse cohorts of early-career investigators across the United States with intensive coaching throughout the proposal development process. We evaluated the GCP’s national reach and short-term impact on participants’ proposal submissions and funding outcomes. Methods The GCP was delivered as six similar but distinct models. All models began with an in-person group session, followed by a series of coaching sessions over 4 to 12 months. Participants were surveyed at 6-, 12- and 18-months after program completion to assess proposal outcomes (submissions, awards). Self-reported data were verified and supplemented by searches of public repositories of awarded grants when available. Submission and award rates were derived from counts of participants who submitted or were awarded at least one grant proposal in a category (NIH, other federal, non-federal). Results From June 2015 through March 2019, 545 investigators (67% female, 61% under-represented racial/ethnic minority, URM) from 187 different institutions participated in the GCP. Among them, 324 (59% of participants) submitted at least one grant application and 134 (41% of submitters) received funding. A total of 164 grants were awarded, the majority being from the NIH (93, 56%). Of the 74 R01 (or similar) NIH research proposals submitted by GCP participants, 16 have been funded thus far (56% to URM, 75% to women). This 22% award rate exceeded the 2016–2018 NIH success rates for new R01s. Conclusion Inter- and intra-institutional grant writing coaching groups are a feasible and effective approach to supporting the grant acquisition efforts of early-career biomedical investigators, including women and those from URM groups.

Background: Diminished social support has shown to lead to worse cardiovascular outcomes and since cardiovascular disease (CVD) is the leading cause of death in the United States (U.S.), it is critical to non-invasively study its precursor- vascular disease (VD). Assessing the impact social support has on vascular outcomes can unveil potential CVD susceptibilities in at-risk populations. African American women exhibit the greatest burden of CVD morbidity and mortality; therefore, the purpose of this study is to examine the association between living arrangement/social support and impaired vascular function in asymptomatic African American women. Methods: Vascular function was assessed by a non-invasive screening tool, HDI/PulseWave CR-2000, during screenings at community outreach events on participants clinically free of CVD. Vascular disease was defined as abnormal/impaired vascular function. Living arrangement, a binary variable (living with someone/living alone), was determined by survey responses (N=67) and represented social support. Multivariable analyses were used to estimate adjusted odds ratios (AORs) and 95% confidence intervals (95% CIs) to determine the association between living arrangement and vascular disease after controlling for confounders. Analyses were conducted using SAS 9.2. Results: Of those who lived alone, 82% had vascular disease (p=0.03). After adjusting for family CVD, and other CVD risk factors, those who lived with a spouse/partner or relative were 78% (p=0.04) less likely to develop vascular disease (AOR=0.22; 95% CI=0.05, 0.98). Conclusions: Our study provides preliminary evidence to suggest that among African American women, clinically free of CVD, living arrangement is associated with vascular disease. While living alone may place individuals at an increased risk of CVD because of the association, living with a spouse/partner or relative may act as a protective factor against vascular disease and reduce the risk of CVD. Public health practitioners may use individuals’ living arrangement as preventive measure for CVD risk. Keywords: Living arrangement, social support, vascular disease, arterial elasticity, vascular function

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.

Purpose: While the intellectual and scientific rationale for research collaboration has been articulated, a paucity of information is available on a strategic approach to facilitate the collaboration within a research network designed to reduce health disparities. This study aimed to (1) develop a conceptual model to facilitate collaboration among biostatisticians in a research network, (2) describe collaborative engagement performed by the Network&rsquo, s Data Coordinating Center (DCC), and (3) discuss potential challenges and opportunities in engaging the collaboration. Methods: Key components of the strategic approach will be developed through a systematic literature review. The Network&rsquo, s initiatives for the biostatistical collaboration will be described in the areas of infrastructure, expertise and knowledge management and experiential lessons will be discussed. Results: Components of the strategic approach model included three Ps (people, processes and programs) which were integrated into expert management, infrastructure management and knowledge management, respectively. Ongoing initiatives for collaboration with non-DCC biostatisticians included both web-based and face-to-face interaction approaches: Network&rsquo, s biostatistical capacities and needs assessment, webinar statistical seminars, mobile statistical workshop and clinics, adjunct appointment program, one-on-one consulting, and on-site workshop. The outreach program, as a face-to-face interaction approach, especially resulted in a useful tool for expertise management and needs assessment as well as knowledge exchange. Conclusions: Although fostering a partnered research culture, sustaining senior management commitment and ongoing monitoring are a challenge for this collaborative engagement, the proposed strategies centrally performed by the DCC may be useful in accelerating the pace and enhancing the quality of the scientific outcomes within a multidisciplinary clinical and translational research network.

The Learning and Action in Community Health project was implemented to gather preliminary data needed to inform community-engaged educational approaches to increase clinical research participation among racial minorities. The Health Belief Model was the theoretical framework utilized to develop the intervention and assessment tools. An educational session about clinical research and biorepository participation was designed using clinicaltrials.gov information and administered to adult, African American community residents (n = 60) in Atlanta, Georgia. Pre- and post-tests were collected and analyzed to assess changes in participants&rsquo, knowledge, perceptions, and willingness to participate in clinical studies and biorepositories. There were statistically significant changes in knowledge about joining a clinical study (p &lt, 0.001) and registry or biorepository (p &lt, 0.001). There was no statistically significant change in willingness to participate in clinical research or biorepositories after the educational session. Focus groups were conducted to gather feedback on the educational session and perceived barriers and benefits to participating in clinical research. Perceived benefits were improving health, receiving incentives, early detection of health issues, and access to care. Perceived barriers included fear, lack of knowledge, historical mistrust of research, and time constraints. Results have implications for subsequent community-engaged approaches to increasing minority participation in clinical research.

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

The opportunity created by the NIH Clinical and Translational Science Awards (CTSAs) prompted the leadership of Emory University (Emory) and its two closest academic partners, Morehouse School of Medicine (MSM) and Georgia Institute of Technology (GT), to develop an innovative model for transforming clinical and translational science. These academic institutions along with other Atlanta and Georgia partners established the Atlanta Clinical & Translational Science Institute (ACTSI) to create and accelerate clinical and translational science discovery, training and community engagement in Atlanta and the state of Georgia. The ACTSI partnership creates compelling, unique and synergistic advantages. Emory is a national leader in education, healthcare, biomedical research and product developmenti. MSM is a leading historically black institution focused on social missionii that brings ethnic diversity to the biomedical research community, addresses health disparities through translational and clinical research and successful community engagement, and serves as a pipeline for training minority investigators. GT is a national leader in biomedical engineeringiii, nanomedicine, computation and application of innovative systems engineering to healthcare solutions. These institutions, historic partners in healthcare, education, and cutting-edge, interdisciplinary research, are now catalyzed by the ACTSI partnership. The creation of the ACTSI led to many accomplishments: establishment of a city-wide, multi-tiered (hospital, clinic, office) integrated network conducting clinical and translational research; establishment of an inter-institutional and innovative collaborative education and training program in clinical and translational research with enhanced curricula (highlighted in this communication); development of a city-wide infrastructure for pediatric-focused clinical and translational research; dissemination of new clinical and translational infrastructure and technologies through the ACTSI web portal - www.ACTSI.org; the creation and/or support of new cutting-edge cores and centers - the GRA (Georgia Research Alliance) Genomics Core; Center for System Imaging (CSI); a Heath Innovation Program, Center for Health Discovery and Well Being; and development of new interdisciplinary, innovative clinical and translational science through pilot projects, new inter-institutional collaborations, seminars, and direct support. A key theme of the endeavor is ACTSI’s leveraging of multiple diverse assets to enhance clinical and translational research in Atlanta and Georgia. ACTSI is a catalyst exceeding the sum of the parts.

Among patients with acute decompensated heart failure, there were no significant differences in patients’ global assessment of symptoms or in the change in renal function when diuretic therapy was administered by bolus as compared with continuous infusion or at a high dose as compared with a low dose. (Funded by the National Heart, Lung, and Blood Institute; ClinicalTrials.gov number, NCT00577135.)

The Morehouse School of Medicine (MSM) Research Centers in Minority Institutions (RCMI) Center of Excellence in Clinical and Translational Research has developed a research web-portal to foster research development and collaborations. We describe the role of focus groups (FG). Research faculty and staff were organized into three groups by research interest. Each FG discussion had five steps: Brainstorming, Reporting, Card-sorting, Priority-setting, and Discussions. Integration of top priorities across each FG culminated in a final priority-setting step. Each FG generated 45 to 50 unique ideas during brainstorming that were categorized into 10 to 12 unique categories. Final priority-setting captured six top items for the initial design of the portal: ability to identify researchers working on similar research; common data management tools; access to clinical trials information; participant recruitment tools; secure access to research databases; and financial support. Focus groups allowed for a discovery period that generated common themes for the design and customization of the web-portal.

OBJECTIVES Previous trials testing isosorbide dinitrate/hydralazine (I/H) were performed in all-male study cohorts, and thus the efficacy of I/H in women was unknown; 40% of the A-HeFT (African-American Heart Failure Trial) cohort were women. We therefore compared outcomes by gender and treatment. BACKGROUND Fixed-dose combined I/H significantly reduced mortality and heart failure hospitalizations and improved quality of life in 1,050 black patients with heart failure treated with background neurohormonal blockade. Previous trials testing I/H were done in all-male study cohorts, and thus the efficacy of I/H in women was unknown. METHODS Baseline characteristics and medications were compared between men and women by I/H and placebo treatment. Survival, time to first heart failure hospitalization, change in quality of life, and event-free survival were compared by gender and treatment. RESULTS At baseline, women had lower hemoglobin and creatinine levels; less renal insufficiency; and higher body mass indexes, diabetes prevalence, and systolic blood pressures; but worse quality of life scores. All-cause mortality was lower in women than in men treated with I/H but without significant treatment interaction by gender. The primary composite score, which weighted mortality, first heart failure hospitalization, and change in quality of life at 6 months, was similarly improved by I/H in men and women. First heart failure hospitalization and event-free survival (time to death or first heart failure hospitalization) were similarly improved in both genders. CONCLUSIONS Fixed-dose I/H improved heart failure outcomes in both men and women in A-HeFT. The I/H significantly improved the primary composite score and event-free survival as well as reduced the risk of first heart failure hospitalizations similarly in both genders. The I/H had a slightly greater mortality benefit in women, but without a significant treatment interaction by gender.

Human participant research is a crucial element in the development and approval of new drugs, biologics, devices, and procedures that seek to improve patient care. Participation in clinical research is an important professional obligation for cardiovascular practitioners. This involvement ranges from study design and implementation as investigators to the critical role of subject enrollment for all cardiovascular practitioners. The conduct of such research is one of the highest callings of the clinical researcher/practitioner and must be conducted according to the highest standards of science and ethics. All human subjects research should be conducted according to such standards. Difficult issues continue to require awareness and careful management. Some of these issues are examined in this report; conflict of interest is the first of these. A conflict of interest may exist when a secondary interest has the potential to distort, or appear to distort, the integrity of judgment relative to the primary interest. The Hippocratic tradition and the principle of beneficence require that the physician always act in the patient's best interest. However, when the physician profits both professionally and financially from the patient's participation in a clinical trial, the situation may become ethically tenuous for the involved physician. Conversely, information derived from clinical trials improves patient care. Thus, patients may also benefit from participation in clinical trials. This might mitigate, in part, the ethical dilemma just described. Non-financial conflicts of interest. Physician-investigators obtain a number of non-financial benefits from participation in clinical research trials (1). Career advancement, fulfillment of a desire to do good, an opportunity to publish in a peer-reviewed journal, fame, invitations to present at national and international meetings, future success in obtaining grant funding for research, prestigious research prizes, professional accolades for obtaining a positive outcome from a particular clinical trial, and a personal sense of worth—all potentially …