Individual and Institutional Factors Contribute to Research Capacity Building for Early-Stage Investigators from Groups Underrepresented in Biomedical Research: A Qualitative Comparative Analysis.

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.

Impact of COVID-19 on the Research Career Advancement of Health Equity Scholars from Diverse Backgrounds.

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.

Strategic Team Science Promotes Collaboration and Practice-Based Research at the Research Centers in Minority Institutions.

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.

Nurturing Diverse Generations of the Medical Workforce for Success With Authenticity: An Association of Black Cardiologists' Roundtable.

The COVID-19 pandemic exposed the consequences of systemic racism in the United States with Black, Hispanic, and other racial and ethnic diverse populations dying at disproportionately higher rates than White Americans. Addressing the social and health disparities amplified by COVID-19 requires in part restructuring of the healthcare system, particularly the diversity of the healthcare workforce to better reflect that of the US population. In January 2021, the Association of Black Cardiologists hosted a virtual roundtable designed to discuss key issues pertaining to medical workforce diversity and to identify strategies aimed at improving racial and ethnic diversity in medical school, graduate medical education, faculty, and leadership positions. The Nurturing Diverse Generations of the Medical Workforce for Success with Authenticity roundtable brought together diverse stakeholders and champions of diversity and inclusion to discuss innovative ideas, solutions, and opportunities to address workforce diversification.

Research Infrastructure Core Facilities at Research Centers in Minority Institutions: Part I-Research Resources Management, Operation, and Best Practices.

Funded by the National Institutes of Health (NIH), the Research Centers in Minority Institutions (RCMI) Program fosters the development and implementation of innovative research aimed at improving minority health and reducing or eliminating health disparities. Currently, there are 21 RCMI Specialized (U54) Centers that share the same framework, comprising four required core components, namely the Administrative, Research Infrastructure, Investigator Development, and Community Engagement Cores. The Research Infrastructure Core (RIC) is fundamentally important for biomedical and health disparities research as a critical function domain. This paper aims to assess the research resources and services provided and evaluate the best practices in research resources management and networking across the RCMI Consortium. We conducted a REDCap-based survey and collected responses from 57 RIC Directors and Co-Directors from 98 core leaders. Our findings indicated that the RIC facilities across the 21 RCMI Centers provide access to major research equipment and are managed by experienced faculty and staff who provide expert consultative and technical services. However, several impediments to RIC facilities operation and management have been identified, and these are currently being addressed through implementation of cost-effective strategies and best practices of laboratory management and operation.

Disparities in Cardiovascular Mortality Between Black and White Adults in the United States, 1999 to 2019.

BACKGROUND: Black adults experience a disproportionately higher burden of cardiovascular risk factors and disease in comparison with White adults in the United States. Less is known about how sex-based disparities in cardiovascular mortality between these groups have changed on a national scale over the past 20 years, particularly across geographic determinants of health and residential racial segregation. METHODS: We used CDC WONDER (Centers for Disease Control and Prevention's Wide-Ranging Online Data for Epidemiologic Research) to identify Black and White adults age ≥25 years in the United States from 1999 to 2019. We calculated annual age-adjusted cardiovascular mortality rates (per 100 000) for Black and White women and men, as well as absolute rate differences and rate ratios to compare the mortality gap between these groups. We also examined patterns by US census region, rural versus urban residence, and degree of neighborhood segregation. RESULTS: From 1999 to 2019, age-adjusted mortality rates declined overall for both Black and White adults. There was a decline in age-adjusted cardiovascular mortality among Black (602.1 to 351.8 per 100 000 population) and White women (447.0 to 267.5), and the absolute rate difference (ARD) between these groups decreased over time (1999: ARD, 155.1 [95% CI, 149.9-160.3]; 2019: ARD, 84.3 [95% CI, 81.2-87.4]). These patterns were similar for Black (824.1 to 526.3 per 100 000) and White men (637.5 to 396.0; 1999: ARD, 186.6 [95% CI, 178.6-194.6]; 2019: ARD, 130.3 [95% CI, 125.6-135.0]). Despite this progress, cardiovascular mortality in 2019 was higher for Black women (rate ratio, 1.32 [95% CI, 1.30-1.33])- especially in the younger (age <65 years) subgroup (rate ratio, 2.28 [95% CI, 2.23-2.32])-as well as for Black men (rate ratio, 1.33 [95% CI, 1.32-1.34]), compared with their respective White counterparts. There was regional variation in cardiovascular mortality patterns, and the Black-White gap differed across rural and urban areas. Cardiovascular mortality rates among Black women and men were consistently higher in communities with high levels of racial segregation compared with those with low to moderate levels. CONCLUSIONS: During the past 2 decades, age-adjusted cardiovascular mortality declined significantly for Black and White adults in the United States, as did the absolute difference in death rates between these groups. Despite this progress, Black women and men continue to experience higher cardiovascular mortality rates than their White counterparts.

The Research Centers in Minority Institutions (RCMI) Consortium: A Blueprint for Inclusive Excellence.

The Research Centers in Minority Institutions, (RCMI) Program was established by Congress to address the health research and training needs of minority populations, by preparing future generations of scientists at these institutions, with a track record of producing minority scholars in medicine, science, and technology. The RCMI Consortium consists of the RCMI Specialized Centers and a Coordinating Center (CC). The RCMI-CC leverages the scientific expertise, technologies, and innovations of RCMI Centers to accelerate the delivery of solutions to address health disparities in communities that are most impacted. There is increasing recognition that the gap in representation of racial/ethnic groups and women is perpetuated by institutional cultures lacking inclusion and equity. The objective of this work is to provide a framework for inclusive excellence by developing a systematic evaluation process with common data elements that can track the inter-linked goals of workforce diversity and health equity. At its core, the RCMI Program embodies the trinity of diversity, equity, and inclusion. We propose a realist evaluation framework and a logic model that integrates the institutional context to develop common data metrics for inclusive excellence. The RCMI-CC will collaborate with NIH-funded institutions and research consortia to disseminate and scale this model.

Strengthening and Sustaining Inter-Institutional Research Collaborations and Partnerships.

Inter-institutional collaborations and partnerships play fundamental roles in developing and diversifying the basic biomedical, behavioral, and clinical research enterprise at resource-limited, minority-serving institutions. In conjunction with the Research Centers in Minority Institutions (RCMI) Program National Conference in Bethesda, Maryland, in December 2019, a special workshop was convened to summarize current practices and to explore future strategies to strengthen and sustain inter-institutional collaborations and partnerships with research-intensive majority-serving institutions. Representative examples of current inter-institutional collaborations at RCMI grantee institutions are presented. Practical approaches used to leverage institutional resources through collaborations and partnerships within regional and national network programs are summarized. Challenges and opportunities related to such collaborations are provided.

Morehouse Choice Accountable Care Organization and Education System (MCACO-ES): Integrated Model Delivering Equitable Quality Care.

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'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'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 "dual eligibles"). 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.

The Association of Black Cardiologists (ABC) Cardiovascular Implementation Study (CVIS): A Research Registry Integrating Social Determinants to Support Care for Underserved Patients.

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.

A federated EHR network data completeness tracking system.

OBJECTIVE: The study sought to design, pilot, and evaluate a federated data completeness tracking system (CTX) for assessing completeness in research data extracted from electronic health record data across the Accessible Research Commons for Health (ARCH) Clinical Data Research Network. MATERIALS AND METHODS: The CTX applies a systems-based approach to design workflow and technology for assessing completeness across distributed electronic health record data repositories participating in a queryable, federated network. The CTX invokes 2 positive feedback loops that utilize open source tools (DQe-c and Vue) to integrate technology and human actors in a system geared for increasing capacity and taking action. A pilot implementation of the system involved 6 ARCH partner sites between January 2017 and May 2018. RESULTS: The ARCH CTX has enabled the network to monitor and, if needed, adjust its data management processes to maintain complete datasets for secondary use. The system allows the network and its partner sites to profile data completeness both at the network and partner site levels. Interactive visualizations presenting the current state of completeness in the context of the entire network as well as changes in completeness across time were valued among the CTX user base. DISCUSSION: Distributed clinical data networks are complex systems. Top-down approaches that solely rely on technology to report data completeness may be necessary but not sufficient for improving completeness (and quality) of data in large-scale clinical data networks. Improving and maintaining complete (high-quality) data in such complex environments entails sociotechnical systems that exploit technology and empower human actors to engage in the process of high-quality data curating. CONCLUSIONS: The CTX has increased the network's capacity to rapidly identify data completeness issues and empowered ARCH partner sites to get involved in improving the completeness of respective data in their repositories.

The Research Centers in Minority Institutions (RCMI) Translational Research Network: Building and Sustaining Capacity for Multi-Site Basic Biomedical, Clinical and Behavioral Research.

The Research Centers in Minority Institutions (RCMI) program was established by the US Congress to support the development of biomedical research infrastructure at minority-serving institutions granting doctoral degrees in the health professions or in a health-related science. RCMI institutions also conduct research on diseases that disproportionately affect racial and ethnic minorities (ie, African Americans/Blacks, American Indians and Alaska Natives, Hispanics, Native Hawaiians and Other Pacific Islanders), those of low socioeconomic status, and rural persons. Quantitative metrics, including the numbers of doctoral science degrees granted to underrepresented students, NIH peer-reviewed research funding, peer-reviewed publications, and numbers of racial and ethnic minorities participating in sponsored research, demonstrate that RCMI grantee institutions have made substantial progress toward the intent of the Congressional legislation, as well as the NIH/NIMHD-linked goals of addressing workforce diversity and health disparities. Despite this progress, nationally, many challenges remain, including persistent disparities in research and career development awards to minority investigators. The continuing underrepresentation of minority investigators in NIH-sponsored research across multiple disease areas is of concern, in the face of unrelenting national health inequities. With the collaborative network support by the RCMI Translational Research Network (RTRN), the RCMI community is uniquely positioned to address these challenges through its community engagement and strategic partnerships with non-RCMI institutions. Funding agencies can play an important role by incentivizing such collaborations, and incorporating metrics for research funding that address underrepresented populations, workforce diversity and health equity.

Statins and Cardiovascular Disease Outcomes in Chronic Kidney Disease: Reaffirmation vs. Repudiation.

Cardiovascular disease (CVD) burden is several-fold higher in patients with chronic kidney disease (CKD). Although statins have been shown to provide significant CVD benefits in both the general population and patients with CKD, this has not translated into survival advantage in patients with advanced CKD or on dialysis. It has been reported that CVD risk continues to escalate as CKD progresses to end-stage kidney disease (ESKD); however, the CVD risk reduction by statins appears to decline as patients' progress from the early to later stages of CKD. Statins have also been associated with a higher incidence of stroke in ESKD patients. Thus, the CVD benefits of statins in ESKD remain questionable.

DEMOCRATIZING DISCOVERY HEALTH WITH N=Me.

Health 360x is a mobile health application and social platform that integrates self-monitoring and decision support for preventive health. We studied 240 diabetic patients in primary care practices and a church community in metropolitan Atlanta. Health coaches were trained on the Health 360x curriculum, which was adapted from the American Association of Diabetes Educators. Participants worked with the health coaches to set goals for diabetes self-management. The intervention included weekly coaching for 12 weeks and online peer networking. Outcome variables included blood pressure, physical activity, and blood glucose that showed significant improvement at 12 weeks and 12 months compared to baseline. Focus group testing revealed that references for empowerment and engagement were associated with positive clinical outcomes. Barriers to adoption and use of the technology were inability to use the internet and concern about privacy and security of health data. Future efforts will integrate a multidisciplinary training dashboard with considerable attention to education on security features including data encryption and sign-on verification.

Reducing Cardiovascular Disparities Through Community-Engaged Implementation Research: A National Heart, Lung, and Blood Institute Workshop Report.

Cardiovascular disparities remain pervasive in the United States. Unequal disease burden is evident among population groups based on sex, race, ethnicity, socioeconomic status, educational attainment, nativity, or geography. Despite the significant declines in cardiovascular disease mortality rates in all demographic groups during the last 50 years, large disparities remain by sex, race, ethnicity, and geography. Recent data from modeling studies, linked micromap plots, and small-area analyses also demonstrate prominent variation in cardiovascular disease mortality rates across states and counties, with an especially high disease burden in the southeastern United States and Appalachia. Despite these continued disparities, few large-scale intervention studies have been conducted in these high-burden populations to examine the feasibility of reducing or eliminating cardiovascular disparities. To address this challenge, on June 22 and 23, 2017, the National Heart, Lung, and Blood Institute convened experts from a broad range of biomedical, behavioral, environmental, implementation, and social science backgrounds to summarize the current state of knowledge of cardiovascular disease disparities and propose intervention strategies aligned with the National Heart, Lung, and Blood Institute mission. This report presents the themes, challenges, opportunities, available resources, and recommended actions discussed at the workshop.

A new approach to mentoring for research careers: the National Research Mentoring Network.

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.

Effects of Xanthine Oxidase Inhibition in Hyperuricemic Heart Failure Patients: The Xanthine Oxidase Inhibition for Hyperuricemic Heart Failure Patients (EXACT-HF) Study.

BACKGROUND: Oxidative stress may contribute to heart failure (HF) progression. Inhibiting xanthine oxidase in hyperuricemic HF patients may improve outcomes. METHODS AND RESULTS: We randomly assigned 253 patients with symptomatic HF, left ventricular ejection fraction ≤40%, and serum uric acid levels ≥9.5 mg/dL to receive allopurinol (target dose, 600 mg daily) or placebo in a double-blind, multicenter trial. The primary composite end point at 24 weeks was based on survival, worsening HF, and patient global assessment. Secondary end points included change in quality of life, submaximal exercise capacity, and left ventricular ejection fraction. Uric acid levels were significantly reduced with allopurinol in comparison with placebo (treatment difference, -4.2 [-4.9, -3.5] mg/dL and -3.5 [-4.2, -2.7] mg/dL at 12 and 24 weeks, respectively, both P<0.0001). At 24 weeks, there was no significant difference in clinical status between the allopurinol- and placebo-treated patients (worsened 45% versus 46%, unchanged 42% versus 34%, improved 13% versus 19%, respectively; P=0.68). At 12 and 24 weeks, there was no significant difference in change in Kansas City Cardiomyopathy Questionnaire scores or 6-minute walk distances between the 2 groups. At 24 weeks, left ventricular ejection fraction did not change in either group or between groups. Rash occurred more frequently with allopurinol (10% versus 2%, P=0.01), but there was no difference in serious adverse event rates between the groups (20% versus 15%, P=0.36). CONCLUSIONS: In high-risk HF patients with reduced ejection fraction and elevated uric acid levels, xanthine oxidase inhibition with allopurinol failed to improve clinical status, exercise capacity, quality of life, or left ventricular ejection fraction at 24 weeks. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00987415.

Cardiorenal metabolic syndrome and cardiometabolic risks in minority populations.

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.

Low-dose dopamine or low-dose nesiritide in acute heart failure with renal dysfunction: the ROSE acute heart failure randomized trial.

IMPORTANCE: Small studies suggest that low-dose dopamine or low-dose nesiritide may enhance decongestion and preserve renal function in patients with acute heart failure and renal dysfunction; however, neither strategy has been rigorously tested. OBJECTIVE: To test the 2 independent hypotheses that, compared with placebo, addition of low-dose dopamine (2 µg/kg/min) or low-dose nesiritide (0.005 µg/kg/min without bolus) to diuretic therapy will enhance decongestion and preserve renal function in patients with acute heart failure and renal dysfunction. DESIGN, SETTING, AND PARTICIPANTS: Multicenter, double-blind, placebo-controlled clinical trial (Renal Optimization Strategies Evaluation [ROSE]) of 360 hospitalized patients with acute heart failure and renal dysfunction (estimated glomerular filtration rate of 15-60 mL/min/1.73 m2), randomized within 24 hours of admission. Enrollment occurred from September 2010 to March 2013 across 26 sites in North America. INTERVENTIONS: Participants were randomized in an open, 1:1 allocation ratio to the dopamine or nesiritide strategy. Within each strategy, participants were randomized in a double-blind, 2:1 ratio to active treatment or placebo. The dopamine (n = 122) and nesiritide (n = 119) groups were independently compared with the pooled placebo group (n = 119). MAIN OUTCOMES AND MEASURES: Coprimary end points included 72-hour cumulative urine volume (decongestion end point) and the change in serum cystatin C from enrollment to 72 hours (renal function end point). RESULTS: Compared with placebo, low-dose dopamine had no significant effect on 72-hour cumulative urine volume (dopamine, 8524 mL; 95% CI, 7917-9131 vs placebo, 8296 mL; 95% CI, 7762-8830 ; difference, 229 mL; 95% CI, -714 to 1171 mL; P = .59) or on the change in cystatin C level (dopamine, 0.12 mg/L; 95% CI, 0.06-0.18 vs placebo, 0.11 mg/L; 95% CI, 0.06-0.16; difference, 0.01; 95% CI, -0.08 to 0.10; P = .72). Similarly, low-dose nesiritide had no significant effect on 72-hour cumulative urine volume (nesiritide, 8574 mL; 95% CI, 8014-9134 vs placebo, 8296 mL; 95% CI, 7762-8830; difference, 279 mL; 95% CI, -618 to 1176 mL; P = .49) or on the change in cystatin C level (nesiritide, 0.07 mg/L; 95% CI, 0.01-0.13 vs placebo, 0.11 mg/L; 95% CI, 0.06-0.16; difference, -0.04; 95% CI, -0.13 to 0.05; P = .36). Compared with placebo, there was no effect of low-dose dopamine or nesiritide on secondary end points reflective of decongestion, renal function, or clinical outcomes. CONCLUSION AND RELEVANCE: In participants with acute heart failure and renal dysfunction, neither low-dose dopamine nor low-dose nesiritide enhanced decongestion or improved renal function when added to diuretic therapy. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01132846.

Models of interinstitutional partnerships between research intensive universities and minority serving institutions (MSI) across the Clinical Translational Science Award (CTSA) consortium.

Health disparities are an immense challenge to American society. Clinical and Translational Science Awards (CTSAs) housed within the National Center for Advancing Translational Science (NCATS) are designed to accelerate the translation of experimental findings into clinically meaningful practices and bring new therapies to the doorsteps of all patients. Research Centers at Minority Institutions (RCMI) program at the National Institute on Minority Health and Health Disparities (NIMHD) are designed to build capacity for biomedical research and training at minority serving institutions. The CTSA created a mechanism fostering formal collaborations between research intensive universities and minority serving institutions (MSI) supported by the RCMI program. These consortium-level collaborations activate unique translational research approaches to reduce health disparities with credence to each academic institutions history and unique characteristics. Five formal partnerships between research intensive universities and MSI have formed as a result of the CTSA and RCMI programs. These partnerships present a multifocal approach; shifting cultural change and consciousness toward addressing health disparities, and training the next generation of minority scientists. This collaborative model is based on the respective strengths and contributions of the partnering institutions, allowing bidirectional interchange and leveraging NIH and institutional investments providing measurable benchmarks toward the elimination of health disparities.