Faculty Bibliography

Multi-site and multi-organizational teams are increasingly common in epidemiologic research; however, there is a lack of standards or best practices for achieving success in collaborative research networks in epidemiology. We summarize our experiences and lessons learned from the Diabetes Location, Environmental Attributes, and Disparities (LEAD) Network, a collaborative agreement between the Centers for Disease Control and Prevention and research teams at Drexel University, New York University, Johns Hopkins University and Geisinger, and the University of Alabama at Birmingham. We present a roadmap for success in collaborative epidemiologic research, with recommendations focused on the following areas to maximize efficiency and success in collaborative research agreements: 1) operational and administrative considerations; 2) data access and sharing of sensitive data; 3) aligning network research aims; 4) harmonization of methods and measures; and 5) dissemination of findings. Future collaborations can be informed by our experiences and ultimately dedicate more resources to achieving scientific aims and efficiently disseminating scientific work products.

BACKGROUND/UNASSIGNED:While there is wide evidence on concentrations of cytokines in patients attending health care facilities, evidence is scant on physiological, basal concentrations of cytokines in the general population and across sociodemographic groups, as well as on their potential stability over time. Furthermore, from a public health perspective it is remarkable that no studies have analyzed intraindividual changes in such concentrations from before the COVID-19 pandemic until its outbreak. OBJECTIVES/UNASSIGNED:To investigate: (a) prepandemic concentrations of cytokines and immunoglobulins to viral exposures in a general, non-institutionalized population, and their associated sociodemographic variables; (b) the intraindividual change in such concentrations between a prepandemic period (2016-17) and the initial pandemic period (2020-21); and (c) whether such change was similar in participants who in 2020-21 were SARS-CoV-2 seronegative and seropositive, and between participants who did and did not develop COVID-19. METHODS/UNASSIGNED:We conducted a prospective cohort study in 240 individuals from the general population of Barcelona, Spain. Thirty cytokines and 31 immunoglobulins were measured in paired serum samples collected in 2016-17 and 2020-21 in the same individuals. RESULTS/UNASSIGNED:The median value of the relative intraindividual change in cytokine concentrations between 2016 and 2020 was <15% for 29 of the 30 cytokines. A substantial number of participants had an intraindividual increase or decrease ≥15% in some cytokines. No major differences in intraindividual changes of cytokine and immunoglobulin levels between 2016 and 2020 were observed between participants who did and did not develop COVID-19. CONCLUSION/UNASSIGNED:We provide novel information on physiological, basal ex-vivo concentrations of cytokines and immunoglobulins in a general population, which should be relevant for clinical practice and public health. Intraindividual changes in cytokines and immunoglobulins during the 4 years from 2016-17 to 2020-21 were moderate, and they did not differ between participants who in 2020-21 were SARS-CoV-2 seropositive and seronegative, nor between participants who did and did not develop COVID-19 disease. These findings are also novel and relevant for medicine and public health. In particular, the stability in the biomarkers is relevant to assess the role of the immunological and inflammatory state (measured through baseline levels of cytokines and immunoglobulins) in the development of SARS-CoV-2 seropositivity and COVID-19 disease, as well as in the susceptibility to other infections and pathologies.

BACKGROUND:Despite the proven efficacy of evidence-based healthcare interventions in reducing adverse outcomes and mortality associated with Sickle Cell Disease (SCD), a vast majority of affected individuals in Africa remain deprived of such care. Hydroxyurea (HU) utilization among SCD patients in Sub-Saharan Africa (SSA) stands at less than 1%, while in Nigeria, approximately 13% of patients benefit from HU therapy. To enhance HU utilization, targeted implementation strategies addressing provider-level barriers are imperative. Existing evidence underscores the significance of addressing barriers such as inadequate healthcare worker training to improve HU adoption. The ACCELERATE study aims to evaluate the adoption of HU among providers through the Screen, Initiate, and Maintain (SIM) intervention, facilitated by healthcare worker training, clinical reminders, and task-sharing strategies, thereby enhancing patient-level SCD management in Nigeria. METHODS:This study will implement the SIM intervention, encompassing patient screening, initiation of HU treatment, and maintenance of dosage, which will be implemented via the TAsk-Strengthening Strategy for Hemoglobinopathies (TASSH TCP), derived from our team's TAsk-Strengthening Strategy for Hypertension control (TASSH) trials. Employing a sequential exploratory mixed-methods approach within the Exploration, Preparation, Implementation, and Sustainment (EPIS) framework, this study will assess SIM adoption by providers in Nigeria. The primary outcome is the rate of SIM adoption at clinical sites at 12 months, with secondary outcomes including sustainability/maintenance of SIM intervention and implementation fidelity. DISCUSSION/CONCLUSIONS:This study's findings will offer crucial insights into effective SCD management strategies, leveraging existing SCD clinical networks and resources in Nigeria to enhance HU adoption among providers in a scalable and sustainable manner. Additionally, the study will inform best practices for implementing HU therapy in resource-constrained settings, benefiting healthcare providers, policymakers, and stakeholders invested in improving SCD care delivery. TRIAL REGISTRATION/BACKGROUND:NCT06318143.

Access to an academic clinical research center (CRC) in health professional shortage areas (HPSA) can help address healthcare disparities and increase research accessibility and enrollment. Here we describe the development of a community-centered CRC in the underserved area of Sunset Park, Brooklyn, New York, centered within a larger academic health network and the evaluation of its outcomes within the first two years. In addition to resources and space, establishment of the CRC required a culturally competent and multilingual team of healthcare professionals and researchers and buy-in from the community. Between 1/2022 and 12/2023, the CRC opened 21 new trials (10 interventional and 11 noninterventional) with greater than 500 participant visits that reflect the racial and ethnic diversity of the community. These participants represent 110 distinct zip codes; 76% of these zip codes are underserved and designated HPSA. 60% self-identified as non-White and 20% identified as Hispanic, with 12 other distinct ethnicities represented. 28% of participants speak 11 languages other than English. Community-based CRCs can be created with sustainable growth to align with the mission of the National Institutes of Health and U.S. Food and Drug Administration to meet the ever-growing clinical, social, and research needs of the communities they serve.

INTRODUCTION/BACKGROUND:Family history of cardiovascular disease (CVD) is an independent risk factor for coronary heart disease, and the risk increases with number of family members affected. It offers insights into shared genetic, environmental and lifestyle factors that influence heart disease risk. In this study, we aimed to estimate the association of family history of CVD and its risk factors, as well as the number of affected parents or siblings, with the prevalence of major cardiometabolic risk factors (CRFs) such as hypertension, dysglycemia, dyslipidemia and obesity in a sample of young adults. METHODS:The study utilized a cross-sectional analysis of baseline data from the UAE Healthy Future Study (UAEHFS), involving 5,058 respondents below the age of 40 years. Information on parental and sibling health regarding heart disease and stroke, hypertension, type 2 diabetes (T2D), high cholesterol and obesity, was gathered through a self-completed questionnaire. CRFs were estimated based on body measurements, biochemical markers and self-reported conditions. Multivariate regression analyses were used to examine the associations between categories of family history and the estimated CRFs. RESULTS:More than half (58%) of the sample reported having a positive family history of CVD or its risk factors. The most common family history reported was T2D and hypertension, which accounted for 39.8% and 35% of the sample, respectively. The prevalence of all CRFs was significantly higher among those with a positive family history compared to those without family-history (P < 0.001). The prevalence and likelihood of having a CRF increased as the number of parents and/or siblings affected increased, indicating a potential dose-response trend. The odds were highest among individuals with both parental-and-sibling family history of disease, where they increased to 2.36 (95% CI 1.68-3.32) for hypertension, 2.59 (95% CI 1.86-3.60) for dysglycemia, 1.9 (95% CI 1.29-2.91) for dyslipidemia and 3.79 (95% CI 2.83-5.06) for obesity. CONCLUSION/CONCLUSIONS:In this study, we addressed the effect of family history as an independent risk factor on the major CRFs for the first time in the region. We observed that the majority of young Emirati adults had a positive family history of CVD-related diseases. Family history showed a strong association with the increased prevalence of CRFs. Additionally, having more relatives with specific diseases was associated with a higher risk of developing CRFs. Identifying people with a history of these conditions can help in early intervention and personalized risk assessments.

Maternal health and nutrition in early pregnancy play a vital role in the growth and development of the foetus. During this time, macro and micronutrients contribute to nutritional programming, which helps form the foundations of the foetus's life course health outcomes. This study aimed to investigate dietary habits, macro and micronutrient intake, micronutrient status, and folic acid supplement adherence among Emirati pregnant women in their first trimester. Data were collected according to the UAE-BCS study protocol, which was set up to investigate maternal nutrition, health, child growth, and developmental outcomes within the first 1000 days. Pregnant Emirati women with singleton pregnancies within their first trimester of pregnancy (between 8 and 12 weeks of gestation) were enrolled. The 24-hour food recall method was administered to collect dietary intake. The maternal mean average age was 29 years. Participants had high adherence to supplementation during pregnancy compared to preconception. The mean energy intake was 1345kcal, and 56% of participants consumed saturated fats above the acceptable macronutrient distribution ranges (AMDR), while 94% consumed below AMDR for total fibre. The consumption of micronutrients was below the recommended dietary allowance (RDA). Biochemical results show a high prevalence of low haemoglobin (74%) and deficiencies in vitamin D (39%) and vitamin E (96%). There is a need for research into dietary patterns and influences in pregnant women in the UAE. Furthermore, investigations of knowledge practices and attitudes towards supplementation and the factors contributing to folic acid supplement use are needed to inform government strategies and interventions.

BACKGROUND/UNASSIGNED:Evidence-based interventions (EBI) for cardiovascular disease (CVD) in low- and middle-income countries (LMIC) may face feasibility challenges due to the inadequacy of existing instruments. To address this, researchers developed the Contextual Index of Feasibility on Early-Stage Implementation in LMIC (CATALYTIC) tool, which integrates contextual factors into the assessment of feasibility. METHODS/UNASSIGNED:The tool's items were developed through a systematic review and key informant interviews, and were later assessed for relevance and importance by 13 LMIC researchers and implementers employing a Delphi technique. The survey was then tested for usability by five individuals with CVD experience in LMIC. The CATALYTIC tool consists of 17 items that measure contextual factors that directly influence early-stage LMIC implementation. Descriptive analysis, logistic regression, item reliability using Cronbach's alpha, and exploratory factor analysis (EFA) were performed on survey data. RESULTS/UNASSIGNED:In a survey of 216 respondents from 46 countries, 63.4 to 81.5% of respondents noted a significant impact of contextual factors on implementation feasibility, with high reliability (Cronbach's alpha 0.88) for 12 items. The majority of interventions focused on patient-level care in rural settings. The survey items align primarily with constructs related to implementation climate and readiness for implementation, as well as inductive themes addressing existing needs and barriers to inform intervention design. The survey found diversity in geographic and experiential backgrounds, with significant representation from South Africa, Mexico, and India. Over a third identified as researchers, and 15% held multiple roles. The survey identified three distinct factors influencing how researchers and implementers assess CVD intervention feasibility in LMIC. A 6% increase in odds for moderately feasible interventions was linked to each point increase in the composite score of perceived contextual influence. CONCLUSION/UNASSIGNED:Overall, the CATALYTIC tool with 12 reliable survey items can help researchers and implementers elucidate perceptions of contextual factors influencing the feasibility of CVD-related EBI in LMIC. The survey items reflect respondents' practical focus in resource-limited settings and can inform intervention design by addressing existing needs and barriers. The tool's integration of contextual factors into the assessment of feasibility can help overcome the inadequacy of existing instruments by providing more tailored and conceptually clear assessments of feasibility.

PURPOSE/OBJECTIVE:To determine the robustness of randomized controlled trials (RCTs) supporting the current rhinosinusitis guideline; International Consensus Statement on Allergy and Rhinology: rhinosinusitis (ICAR-RS). MATERIALS & METHODS/METHODS:RCTs referenced by ICAR-RS with primary dichotomous outcomes were analyzed. The Fragility Index (FI) was calculated for trials with statistically significant findings. Trial characteristics, the FI, and FI minus number lost to follow-up (LTF) were assessed for associations. RESULTS:A total of 317 RCTs were identified, with 38 trials possessing a primary dichotomous outcome. Thirty-one percent evaluated surgical interventions and 24 % were industry-sponsored. The mean sample size was 116 with 9 patients, on average, LTF. Sixty-three percent were eligible for FI calculation and had a median FI of 2.5 (IQR 1, 4.25). Sixty-seven percent of trials had an FI ≤ 3, indicating low robustness. No difference in FI was observed between trials with and without industry support (p = 0.577). The FI was less than or equal to the number of patients LTF in 33 % of trials (n = 8). Higher FI was strongly correlated with higher sample size, total number of events, p-value, and grade of recommendation (p < 0.001). After adjusting for covariates, higher sample size and total number of events were associated with higher FI. CONCLUSION/CONCLUSIONS:The RCTs used to support the ICAR-RS have an overall low robustness and future rhinosinusitis trials should report FI measures to provide improved context of their results.