Cardiovascular disease (CVD) and dementia are leading causes of death in women, with dementia disproportionately affecting females. Both share risk factors such as type 2 and gestational diabetes. While diabetes and CVD risk factors are well studied, gaps remain in understanding dementia’s lifespan influences, sex-specific effects, and social determinants. This report advocates a convergence science approach, integrating basic, behavioral, and implementation sciences, to address these gaps. We propose a novel framework to examine shared cardiometabolic risks across the lifespan, enabling targeted early interventions to reduce dementia burden and improve heart-brain health outcomes in women.

Objectives/Goals: The growing burden of hypertension in the USA disproportionately impacts individuals with lower socioeconomic status and those in rural communities. This study aims to investigate specific social determinants of health associated with uncontrolled hypertension among rural, underserved patients residing in Alabama. Methods/Study Population: A retrospective review of electronic health records data from the UAB Selma Family Medicine clinic was conducted. The deidentified data were entered into the Population Health Assessment Engine (PHATE) to render social characteristics and community vital sign (CVS) scores, a social deprivation index, by census tracts. We provide descriptive statistics and compare the stated factors between patients with controlled and uncontrolled hypertension using logistic regression models. We are conducting phone surveys to gather individualized data on social determinants of health to assess the perceived social needs of patients with hypertension. The Protocol for Responding to & Assessing Patients’ Assets, Risks & Experience tool was used to develop the survey, and survey responses will be compared with the PHATE results. Results/Anticipated Results: Among 2129 patients, 375 (17.6%) had uncontrolled hypertension with a mean age of 58.7 ± 14.4 years. Women comprised 66.7% (250) and 65.1% (1142) of the uncontrolled and controlled hypertension populations, respectively. The prevalence of uncontrolled hypertension was 19.1% among Black patients and 8.2% in White patients. Patients with uncontrolled hypertension had a CVS of 82.37 ± 7.31 and 81.81 ± 8.40 patients with controlled hypertension. Patients with uncontrolled hypertension lived in areas where an average of 46 ± 11% were not employed, 36 ± 9% rented, and 28 ± 1% lived below the federal poverty line (FPL). Adjusting for age, race, and sex, a unit increase in the proportion of people below the FPL was associated with 43% higher odds of uncontrolled versus controlled hypertension (OR  =  1.43, 95% CI 0.44, 4.64). Discussion/Significance of Impact: Rural, underserved patients with hypertension experience multiple adverse social determinants, such as nonemployment rates, low income, and rental housing. Survey results will allow us to compare assessed and individualized social determinants that may be important to address when caring for this population.

ASReview is a software that can potentially reduce the workload of literature screening in systematic reviews by ranking the retrieved records. We assessed the tool’s feasibility, advantages, and limitations, to populate a database of cancer immunotherapy trials. ASReview is easy to use, and it efficiently identified relevant records. It may save resources compared to traditional systematic reviews using two human reviewers. Predefined procedures are necessary to maintain a transparent and reproducible workflow. Limitations include that adding references to existing projects is difficult and that the algorithm learns from every decision, even when this may not be appropriate.

Objectives/Goals: To guide UCSF in adopting a justice-based, patient-informed model of health data sharing that moves beyond traditional regulatory frameworks that focus on individual privacy and do not address public good and health equity; to create a roadmap for UCSF to implement transparent, community-engaged data governance that is both responsible and effective. Methods/Study Population: We conducted 24 hours of observation at outpatient clinics and 75 in-depth interviews with multiple stakeholder groups: patients, community advisors, and UCSF faculty and staff involved in managing and governing health and research-generated data. We used an ethnographic approach to investigate health data sharing policies and practices and explore perspectives on data governance. We were particularly interested in how data sharing is explained to patients, and what patients and community members know and think about how patient data may be used other than for clinical care. We explored faculty, staff, patient, and community member perspectives about the potential involvement of patients/communities in data governance. We also reviewed UCSF websites with information about data use and sharing policies. Results/Anticipated Results: Policy Awareness: Clear communication and improved guidelines for data use policies will enhance awareness among patients, the public, and researchers, boosting UCSF’s credibility as a data steward. Risks/Benefits: Data sharing drives scientific and clinical progress but raises concerns about privacy, profiteering, and unequal benefit distribution. Improving the Data Ecosystem: Safe data sharing and public benefit can be strengthened through centralized governance and better communication. Key growth areas include deidentification, external sharing criteria, and leakage prevention. Shared Governance: Patients and community advisors favor shared governance with public involvement, while UCSF informants were equivocal. All are concerned about equitable representation and technical training challenges. Discussion/Significance of Impact: Our recommendations to University leadership: Improve communication of data sharing policies to patients and the public. Involve patients and the public in data governance. Support investigators to ensure understanding and compliance with data use policies. Hold UCSF and collaborators accountable for transparency, equity, and public benefit.

Objectives/Goals: • To examine current barriers to research translation that collide with funder imperatives to share research results broadly. • To create community-driven guidance on broadening dissemination of research findings to communities to enhance health literacy and trustworthiness in the research process. Methods/Study Population: The Penn State Community Health Equity & Engagement in Research team, part of our Clinical and Translational Science Institute, completed six semi-structured focus groups in the Fall of 2023 (N = 46, including geographically diverse communities with and without research experience). Focus groups included presentation of evidence-based and novel approaches to lay results dissemination, including lay briefs and data walks, to elucidate experiences with and preferences for receiving research study results. Qualitative data were analyzed using MAXQDA software, with successful (>0.70) kappa coefficient achieved for interrater reliability. Codes and themes were developed inductively. Results/Anticipated Results: Focus group characteristics included N = 39 identifying as women, with a mean age of 56 years old and 10% identifying as Black/African American. Geographic breakdown included 49% rural, 44% suburban, and 7% urban. Thematic analyses demonstrated a perceived lack of trustworthiness and representation in the research process, with several cultural and geographic barriers to research accessibility and results dissemination. The majority of participants did not receive research results from prior studies and identified the importance of trusted community messengers to share findings broadly. Participants prefer receiving lay briefs, with health literate infographics, over published study manuscripts. Data walks featuring key findings presented by researchers within communities were highly desired. Discussion/Significance of Impact: Improving translation of study results in underrepresented communities is a catalyst for increasing engagement, demonstrating trustworthiness, and improving health literacy. The development of evidence-based lay dissemination methodologies can increase translation and bolster efforts to support informed, research-ready communities.

Clinical data science, like the broader discipline of all data science, has quickly grown from obscurity only a few decades ago to one of the fastest growing specialties in biomedical research today. Yet, the education and training of the workforce has not kept pace with the growth of the field, the complexity of science, or the needs of the profession. The purpose of this paper is to provide a template for an intensive short course on fundamentals of clinical data science that meets the needs of working professionals in academic, industry, and government research settings. Care will be taken to introduce students to essential roles, responsibilities, and practice patterns within the field, the foundational components from which they come, and many of the soft skills needed for professional practice and advancement in the field today. The course is designed as an evidence-based, immersive learning experience taught over a 5-day period on a university campus, taught using principles of best educational practice and multiple modalities, to assure optimal interaction and engagement throughout the week. This template may be reproduced by any institution interested in and capable of offering such a program.

Objectives/Goals: Discovery Day aims to bring diverse and underrepresented groups of potential biomedical research participants into research spaces to increase transparency, knowledge of the research process, trust in research, and interest in STEM fields. Methods/Study Population: Discovery Days are one-day events held on Saturdays at a large hospital in the Midwest. Attendees are recruited through flyers, social media, and other media. Recruitment targets communities that are predominantly underrepresented in research, such as Black/African American and Hispanic/Latino. Events included lunch, presentations, interactive lab demonstrations, Q&A sessions, and a tour of the BioBank research facility. Families completed surveys assessing demographics, trust in research, understanding of research, and interest in STEM careers. Descriptive statistics were used to summarize findings. Results/Anticipated Results: At a Discovery Day held in May 2024, 58 individuals attended. Each family (N  =  30) completed a 15-item survey. Most (70%) participants identified with diverse racial and ethnic backgrounds, with the largest group identifying as Black/African American. Five diverse neighborhoods were represented, as expected for our recruitment strategy. Following Discovery Day, 73.3% of participants reported their trust in research increased, and 93.1% of participants indicated their understanding of research increased. 37.5% reported interest in learning about STEM jobs or internships, and 100% of participants would recommend Discovery Day to friends and family. Discussion/Significance of Impact: We hope that by increasing transparency and trust around the research process, community members that may benefit from research (e.g., genetic research on chronic diseases) may be more likely to participate. Additional findings and future goals for Discovery Day will be discussed.

Objectives/Goals: Despite the acknowledgment of post-Ebola syndrome (PES), young EVD survivors have received little attention. The mechanistic drivers and long-term consequences of PES and EVD early in life are unknown. We aim to define PES presentations in pediatric EVD survivors and propose potential mechanistic factors contributing to PES in young people. Methods/Study Population: Here we focus on physical health outcomes in an ongoing cohort study assessing mental and physical health in pediatric EVD survivors (age Results/Anticipated Results: 671 participants were enrolled between 2021 and 2022 (Infected: n = 226, Affected: n = 207, and Control: n = 238). Groups were similar in sex distribution (52.7%, 54.0%, and 53.8% female, respectively) and mean age, although the Infected group was slightly older (14.6 y) than the Affected (13.5 y) and Control groups (14.1 y), a difference unlikely to be clinically significant. Notably, the EVD Infected group exhibited a higher burden of symptoms, with significant findings in cardiac, MSK, ophthalmologic, and “ear, nose, and throat” systems. Principal component analysis showed differential patterns of sequelae across the groups, primarily defined by MSK. Discussion/Significance of Impact: PES is heterogeneous in pediatric EVD survivors. EVD Affected children exhibit a similar yet distinct pattern of clinical sequelae indicating ecological factors impact sequelae and raising questions about the mechanistic drivers of PES in children. Potential mechanisms include inflammation or accelerated aging and immune dysfunction.

Advancing community engagement and participatory research approaches necessitates shifting cultural norms. The paper describes a program designed to explicitly embed and reinforce a culture of engagement through resource allocation, modeling, and recognition that was initiated by a Clinical and Translational Science Institute Community Engagement Program CE Program. Resources were allocated to the relationship development process between researchers and community partners. Funded partnerships were provided with guidance to support the equitable distribution of resources. Partnerships received additional reinforcement through participation in a learning collaborative, intended to support community partnership development, model best practices in community engagement and to build a network of community engaged, and participatory researchers at the institution. Investigators reported the learning collaborative “gave them permission” to focus on the process. Overall, lessons learned indicate embedding and reinforcing practices that center relationship and reward time spent building partnerships is a promising strategy to buffer against cultural norms that favor outcomes and over process.

Objectives/Goals: The NIH Common Fund launched Community Partnerships to Advance Science for Society (ComPASS) to study ways to reduce health disparities by addressing underlying structural factors within communities. ComPASS was designed for community organizations to lead research that addresses community needs. Methods/Study Population: ComPASS awarded five health equity research hubs (Hubs) to provide specialized technical support to ComPASS research projects led by community organizations. Expertise provided by the Hubs to the community-led projects will focus on specific facets of community health, including nutrition access, health care access, and built environment. The Hubs support community-led piloting and testing of structural interventions within community settings by providing subject matter expertise in areas including structural and multilevel intervention study design and methods, implementation science, and community engagement. Results/Anticipated Results: The Hubs will provide expertise and support to the community-led research projects around one or more social determinants of health domains: health care access and quality, education access and quality, economic stability, social and community context, and neighborhood and built environment. The Hubs will help identify strategies for measuring health outcomes and assessing the effects of structural and contextual factors on intervention outcomes. We anticipate the ComPASS program will lead to a better understanding of how structural interventions that leverage multi-sectoral partnerships can advance health equity. Discussion/Significance of Impact: Through community-led research, ComPASS projects are implementing structural interventions to address social determinants and advance health equity. The technical scientific support rooted in health equity provided by the Hubs is essential to the success of these research projects.

Objectives/Goals: Research participants are not representative of our communities. To determine research perceptions, we are recruiting individuals who have and have not participated in studies. We aim to identify trends, capturing motivating factors, access barriers, and participants’ concerns to inform best practices to engage participants. Methods/Study Population: We developed a 25-item survey with a goal of engaging 500 individuals. Survey questions were developed based on published literature of research motivations and barriers, as well as focus groups conducted in our central Pennsylvania community. Survey questions consist of Likert-scale, multiple choice, and free text, with administration through REDCap. Potential survey participants will be recruited from the Penn State Volunteer Repository and through partnering clinical networks, including federally qualified health centers. We will also recruit individuals who have never participated in research to engage underrepresented groups via the Penn State Clinical and Translational Science Institute’s community partner network. Analyses will include Chi-squared tests and binomial logistic regression. Results/Anticipated Results: The primary dependent variable will be past participation in research, while the primary independent variables will be binary responses to questions relating to motivators and barriers to participation in research. Secondary analysis will stratify these comparisons by race or rurality with a subgroup analysis using the same methods as the primary analysis. Based on these analyses, we anticipate that those who have never participated in research will face greater and different barriers than those who have participated in research. We also anticipate that motivators will be similar between to the two groups. We anticipate finding differences in motivators and barriers among different races as well as differences when examining rurality versus non-rurality. Survey results will be available in January. Discussion/Significance of Impact: This will be one of the few studies in the literature focused on uncovering motivators and barriers to research participation. Understanding what motivates and prevents individuals from participating in research is one of the first steps to enhancing the research process so that people want, and are able, to participate in studies.

Medication errors in clinical care and in clinical research are preventable situations requiring quality improvement approaches to mitigate negative safety trends. The “Rights of Medication Administration” framework has existed in hospital and clinic settings for decades to aid clinicians with ensuring medication administration safety for patients. These quality measures such as expanded rights of medication administration, bar coding, and “time outs” have been employed to improve clinical patient safety. In clinical trials, drug accountability standard operating procedures are established standards; however, policies for direct administration of the investigational medical product to the study participant in a trial are lacking. Current administration rights were examined through the lens of clinical research practices, regulations, and case studies leading to proposed revisions for local adaptation. The authors suggest a standard operating procedure for investigational product that includes a “time out” checklist to ensure improved quality study performance and safety for clinical trial participants. This new standard operating procedure considers evolved quality practices suggested in the new “Good Clinical Practice” guidelines, ICH E6 (R3). With safety and quality at the forefront, this newly proposed SOP has been developed for implementation at the local site. Future research is encouraged.

Objectives/Goals: Youth-onset diabetes and its risk factors are increasing in ethnic and racial minority communities. Our mixed-methods study aimed to explore the associations between participation in a community youth sports program and key diabetes risk factors in youth, including mental health, physical activity, nutrition, and weight status. Methods/Study Population: We used a single cohort, mixed-methods design focused on the Community Leadership Revolution (CLR) Academy, a local youth sports program. Participants, ethnic and racial minority youth ages 5–14, were recruited to assess their mental health, physical activity, and nutrition using validated and reliable questionnaires. Weight status was measured via bioelectrical impedance. Group interviews with youth and individual interviews with staff provided context for the quantitative results. A thematic analysis of the qualitative data will further explore how CLR Academy may impact diabetes risk factors. Results/Anticipated Results: We recruited 24 CLR participants (16 boys/8 girls) and 4 CLR staff (3 males/1 female). Sixteen youth identified as African-American, while the rest identified as multiracial. Correlations revealed that higher attendance at CLR Academy was negatively associated with mental health scores, specifically total, externalizing, and hyperactive scores (all p < 0.01). Higher CLR attendance was negatively associated with physical activity during spare time (p < 0.05), waist circumference (p< 0.05), and waist-to-height ratio (p < 0.01). Being a girl was associated with lower diet quality and physical activity (both p < 0.05). Qualitative data highlighted life skills and supportive relationships in CLR as key factors in improving health outcomes. Thematic analysis is ongoing to clarify these relationships. Discussion/Significance of Impact: This study highlights how participation in programs like CLR Academy may improve ethnic and racial minority youth diabetes risk factors. Staff and participant insights on mechanisms driving these health improvements may offer strategies that can be applied to similar programs focused on reducing marginalized youth’s diabetes risk.

Objectives/Goals: The prevalence of type 2 diabetes (T2D) in adolescents is rising, presenting unique challenges for recruitment in clinical research – particularly among adolescents who belong to minoritized race/ethnic backgrounds. The primary aims of our study are to identify and address barriers to recruiting adolescents, particularly around community trust. Methods/Study Population: This study employed a two-phase approach to evaluate recruitment strategies for underrepresented adolescent populations in genomics studies of T2D. After IRB approval, in Phase 1, we utilized the electronic medical record (EMR) system at Children’s of Alabama to prescreen based on inclusion criteria (adolescents aged 12–18 years with T2D). Recruitment efforts were tailored to address barriers unique to underrepresented populations, such as flexibility in scheduling contact times to accommodate family availability. In Phase 2, we are implementing and assessing the effectiveness of a peer recruitment model, wherein adolescents from underrepresented groups are trained to engage peers within their community. Focus groups (6–8 participants per group) will explore facilitators and barriers to recruitment. Results/Anticipated Results: Phase 1 revealed that EMR prescreening effectively identified eligible participants, and direct outreach (phone calls, face-to-face contact during clinical visits) significantly improved recruitment success, especially among underrepresented adolescents. Flexible scheduling and consolidating study appointments enhanced participation, addressing logistical challenges like geographic distance. However, frequent changes in contact information (phone and email information) created barriers. In Phase 2, early focus group results suggest that peer recruitment is promising, with trust and community engagement being key factors. Adolescents recruited by peers were more likely to participate, though logistical hurdles such as transportation and family concerns remain. Discussion/Significance of Impact: Our study demonstrates the value of personalized outreach and prescreening in improving recruitment among adolescents. These strategies can engage communities that include Black, Indigenous, and People of Colored. These findings underscore the need for flexible recruitment strategies to ensure their participation in T2D adolescent research.

Objectives/Goals: This study explores strategies to engage minority and vulnerable populations, including individuals with disabilities, in genomics research. It addresses the ethical, legal, and social implications (ELSI) of human research, with emphasis on data management and culturally sensitive return of actionable results. Methods/Study Population: This study will utilize a mixed-methods approach, combining quantitative surveys with qualitative interviews and focus groups to gather data from minority populations and individuals with disabilities in genomics research. Key stakeholders, including community leaders and healthcare providers, will be engaged to ensure the study’s design reflects community needs and values. Data management practices will be evaluated to align with ethical standards and community expectations. Additionally, the study will examine how actionable results can be effectively communicated to participants, considering cultural and individual differences. Results/Anticipated Results: Preliminary findings suggest that a one-size-fits-all approach to community engagement in genomic research is ineffective. This research emphasizes the importance of engaging diverse populations from the very beginning of the study to ensure that their voices are heard, and their concerns are adequately addressed. Preliminary data reveal significant variations in how communities perceive genetic research, highlighting the need for culturally tailored communication strategies. The proposed study also identifies key barriers to participation, such as mistrust of the research process and concerns about data privacy, which must be addressed to enhance community engagement. Discussion/Significance of Impact: Successful community engagement in genomic research requires understanding the cultural and social dynamics of the populations involved. Researchers must adopt flexible, community-centered approaches that address the unique needs of minority and vulnerable groups, improving inclusivity and leading to more equitable health outcomes.

Objectives/Goals: This study looks to better understand and call attention to the inequalities found within medical treatment options for individuals suffering from preeclampsia during pregnancy in the USA. The goal is to map the terrain of clinical trials and evaluating existing medicare/medicaid covered services on a both national and state levels. Methods/Study Population: The study population for this research was limited to: pregnant women, ages 18–45, both pregnant and postpartum suffering from preeclampsia. We began looking at clinical trials targeting preeclampsia treatment conducted within the United States between 2019 and 2024. Using our study population parameters, we searched clinicaltrials.gov. These trials’ inclusionary and exclusionary factors were noted, along with participant race. The drug intervention medication used during these clinical trials was compared to those prescribed by doctors via the current national standard of care. We then looked at Medicaid coverage provided to expecting mothers on a state-to-state basis and nationally regulated level. These factors included coverage on ultrasounds, low-dose aspirin, blood pressure monitors, and more. Results/Anticipated Results: Preliminary findings demonstrate the need for more federally regulated policies and programs set in place to help combat the lack of resources faced by expecting mothers across the nation. This research will expose factors contributing to a lack of successful and completed clinical trials and lack of drug intervention innovations taking place to combat the rise in maternal deaths. This study will also focus on the importance of more education and awareness for communities such as African American mothers and those facing multiple gestational pregnancies who are at much higher risk of complications during their pregnancies. We also anticipate a large correlation between a lack of proper childbirth education and mothers who experience complications during birth. Discussion/Significance of Impact: Within the past two decades, rates of preeclampsia have grown 25% within the USA. It affects 5–8% of all pregnancies, and with maternal death rates rising, it is crucial to highlight the alarming lack of government regulation. It is imperative to provide awareness to mothers from disadvantaged backgrounds to treat this preventable condition.

Objectives/Goals: To present an asset-based approach to advance minoritized patients’ participation in clinical research by elevating experienced Black research participants’ motivations and decision-making processes, favorable sociocultural research contexts, and impactful research questions to reduce chronic disease burden and improve quality of life. Methods/Study Population: Data will be extracted from a pilot study to develop an asset-based approach to clinical research with young Black adults living with chronic pain. Participants will be Black patients at an academic medical institution on the West Coast, ages 21 to 44, currently or formerly have chronic pain, and current or previous electronic health record-captured enrollment in a clinical research study. Approximately 25 Black patients will participate in semi-structured focus groups with topics including: motivations for research participation, access to research, preferred research activities, perceived research benefits, favorable structural and cultural contexts, considerations of past ethical and trust violations, and alignment of research questions and patient needs. Data will be collected Fall ‘24 and analyzed in Winter ‘25. Results/Anticipated Results: We will examine experienced Black clinical research participants’ decision-making processes for participating in research, including access to studies, perceived value of research, community support, and alignment of study goals with their personal interests and needs. Results will illuminate the sociocultural, structural, and historical contexts under which Black patients have successfully participated in clinical research, and types of studies they have participated in, and recruitment procedures that have been effective. Also, we will examine the conditions for successful study completion. Investigators will also learn about the types of clinical research questions that minoritized patients believe will have an immediate and long term impact on their lived experienced with chronic illness. Discussion/Significance of Impact: The results will challenge deficit models of minority research participation that focus solely on barriers to participation, previous ethical harms, and violations of trust/trustworthiness by elevating the motivations, favorable contexts, and empirical priorities of experienced Black clinical research participants.