OBJECTIVES/GOALS: Data were collected or abstracted from a wide variety of sources related to health and health care needs to determine the current health status of the Galveston community including:

• Demographics

• Social Determinants of Health

• Health Care Access and Insurance Status

• Poverty and Socio-Economic Indicators Impacting Health

• Health Behaviors

• Chronic Disease

• Communicable Disease

• Birth Outcomes

• Mortality

• Cancer

• Data on Services Provided at UTMB

• Data on Services Provided through the Galveston County Health District

• Data on Services Provided through the St. Vincent’s House Clinics, student-led clinics operated at a local non-profit organization

• Previous Galveston County Community Health Needs Assessment

• Identifying Gaps in Services

• Prevention Quality Indicator Data

METHODS/STUDY POPULATION: In addition to collection and analysis of secondary data, we also interviewed key stakeholders to solicit their input and recommendations. We met with leadership from St. Vincent’s House regarding current services provided, perceived issues and concerns, and needs for improvements. We met with leaders from UTMB’s academic enterprise to discuss the operation of our current student-led clinics as well as ways in which clinical practice experiences might be expanded and included more formally in the student curricula should the clinical capacity of St. Vincent’s House also be significantly expanded. This would increase the number of services that could be offered at St. Vincent’s and greatly increase the capacity for enrolling patients without relying on faculty volunteers to staff the clinics. We also met with UTMB leaders in a position to provide insight to issues that bridge the UTMB practice arena and public health and with Community Health leaders from the Galveston County Health District and Teen Health Clinics. Information Services leadership and Institute for Translational Science informatics faculty and staff were instrumental in determining what data could be abstracted from the Electronic Medical Record (without patient identifiers) to determine the specific need for services at St. Vincent’s. RESULTS/ANTICIPATED RESULTS: The City of Galveston has a population just under 50,000. Since 2010, the proportion of elderly has increased, and the proportion of families with younger children has decreased. Poverty is high at 22.3% for all people, and especially high for children at 32.1%. Poverty disproportionately affects racial and ethnic minorities, with 36.5% of the Black population living below the poverty level, compared to 25.5% Hispanic, 30.5% Asian, and 14.7% White. Home ownership is decreasing, and median rent costs have sharply increased. The percentage without health insurance is considerable, driven by educational attainment, age, and race. In 2017, >40% of renters spent more than 35% of their income on housing. Upwards of 2,650 reported not having access to a vehicle for transportation. While residents of Galveston County as a whole are less impoverished, those that are impoverished share marked similarities. Lower educational attainment, in particular failure to complete high school or obtain a college degree, are correlated with race. Lower educational attainment then is highly predictive of poverty and low income. The income inequality ratio, i.e., the greater division between the top and bottom ends of the income spectrum in Galveston County is higher than in Texas or the nation and has increased every year but one since 2010. Issues of concern for Galveston County include obesity, Type II diabetes, and disability. These are exacerbated by built and social environment issues such as food insecurity, limited access to healthy foods, and food deserts in some neighborhoods. Pre-term birth rates are higher in Galveston than in the state or nation, and approximately 40% of women do not receive prenatal care until the 2nd or 3rd trimester or receive no prenatal care at all. 8.4% of births are low-birth weight. Marked disparities by race and ethnicity exist for each of these indicators. Age-adjusted death rates for all-cause mortality are higher in Galveston County than they are in Texas or the United States. Perhaps of most concern are the rates of death from septicemia, which are nearly triple that of the U.S. and nearly double that of the state, and cancer. Cancer incidence is not particularly remarkable, however, cancer age-adjusted mortality rates for many specific cancers well exceed state rates. DISCUSSION/SIGNIFICANCE OF IMPACT: With a clearer picture of the medical and other needs impacting health or health care access for our community, all stakeholders and experts can provide more detailed recommendations about prioritizing care and especially, preventive care—much of which could conceivably be provided in St. Vincent’s House clinics. Opportunities exist for enhanced practice and education opportunities for UTMB students from all schools. Preventive Care and Population Health practices can be brought to bear in novel practice settings that could serve as models for provision of integrated services. Social and other services provided by non-profit organizations can be coordinated and streamlined. It is our hope that the considerable data presented herein will enable stakeholders to begin to prioritize issues and to make some evidence-based decisions about the next steps in this process. Throughout the interview and data collection process, all stakeholders have expressed both enthusiasm and hope at the prospect of re-visioning how they can contribute to a process that will improve how we as a community care for our most vulnerable members. CONFLICT OF INTEREST DESCRIPTION: The authors have no conflicts of interest to disclose.

OBJECTIVES/SPECIFIC AIMS: Dissemination of research findings through the published literature is a complex but critical part of the scholarly communication process. Additionally, this time point on the translational spectrum is a key objective of the National Clinical Association for Advancing Translational Sciences (NCATS). Tracking the dissemination of research outputs can be difficult to identify and evaluate. The purpose of this case study was 2-fold: (1) identify tools and resources available freely to the public and through university subscriptions used to assess research output; and (2) compare the effectiveness of these tools oat tracking output at different levels of granularity. METHODS/STUDY POPULATION: The authors, Spectrum staff (D.A.) and School of Medicine librarian (M.B.), attended webinars hosted by other Academic Medical Center libraries conducting work on impact tracking and learned from vendor product managers about available tools and resources during on-site campus visits. Publications from Stanford’s Clinical and Translational Science Award (CTSA) were used to track the diffusion of research outputs (e.g., number of citations, document types, research areas, relative citation ratio, CTSAs collaboration) via library subscription services (e.g., Web of Science and Scopus) and freely available tools (e.g., iCite and PubMed). RESULTS/ANTICIPATED RESULTS: The authors found certain tools were more inclusive in retrieving grant funded research outputs. For example, in the case of UL1 grant (UL1TR001085, UL1TR000093, UL1RR025744), on a grant-level output, there were discrepancies in the number of publications retrieved: (1) PubMed found 644 outputs; (2) Web of Science found 497 outputs; and (3) Scopus found 190 outputs. After de-duplication, the search across Web of Science (WoS), Scopus, and PubMed yielded 899 publications. In total, 389 outputs were unique to PubMed; 165 were unique to WoS; and 90 were unique to Scopus. Future analysis will be conducted to identify the source of unique outputs from each database (e.g., conference proceeding, specific journals). Additional analysis based on other units of research outputs (e.g., author-level outputs and article-level outputs) are expected to yield similar discrepancies. DISCUSSION/SIGNIFICANCE OF IMPACT: Citation analysis is a valuable method of assessing research output and, to a larger extent, research impact in a given field. It can help investigators illustrate qualifications for undertaking new projects, highlight collaborations across schools and departments, justify a grant renewal, and/or highlight accomplishments for promotion. However, systematic and comprehensive evaluations are needed in tandem with citation analysis/bibliometric analysis to assess the translation and uptake of research outputs and activities that result in research impact. Furthermore, both investigators and staff need adequate time and training to process research outputs/activities and to effectively organize them in easily understood visualizations.

Objectives/Goals: Using k-means clustering, we aimed to identify whether clusters characterized by greater exposure to minority stressors (e.g., experienced/anticipated discrimination) were associated with lower moderate-vigorous physical activity (MVPA) and higher sedentary behavior among sexual and gender minority (SGM; e.g., lesbian/gay, bisexual, transgender) adults. Methods/Study Population: SGM adults face higher risks of inadequate PA due to exposure to minority stressors, which may influence their willingness and ability to engage in PA. An online sample of SGM adults completed daily surveys about experienced and anticipated discrimination and wore wrist accelerometers for 28 days to objectively measure PA. We used k-means clustering to identify clusters based on reports of experienced and anticipated discrimination. We determined the optimal number of clusters using established partition criteria and ran linear regression models (adjusted for demographic factors) to examine the associations of minority stress clusters with MVPA and sedentary time. Results/Anticipated Results: Among 42 SGM adults (mean age 27.0±7.7 years) with 1133 person-days of accelerometry data, we identified four minority stress clusters: low anticipated/low experienced (LALE; reference group), low anticipated/high experienced (LAHE); high anticipated/low experienced (HALE), and high anticipated/high experienced discrimination (HAHE). Participants in the HALE cluster (n = 12) engaged in 202 fewer minutes of MVPA than those in the LALE cluster (n = 7). Participants in the LAHE cluster (n = 10) had 123 fewer minutes of vigorous PA than those in the LALE cluster. No differences were identified for sedentary time. Discussion/Significance of Impact: This is the first study to examine the association of minority stressors with objective PA among SGM adults. Participants in the HALE/LAHE clusters had lower PA than those with low levels of experienced and anticipated discrimination. Interventions to improve PA among SGM adults must target reduction of minority stressors.

OBJECTIVES/SPECIFIC AIMS: Stress urinary incontinence (SUI) significantly affects quality of life and occurs in 60% of men after radical prostatectomy, with 5% requiring surgical treatment. The artificial urinary sphincter (AUS) offers these patients excellent control of their post-prostatectomy SUI. The device contains 3 parts: the pump, urethral cuff, and pressure regulating balloon. Despite the effectiveness of AUS, up to 50% of patients require surgical revision after initial placement due to recurring SUI. Thus far, literature is heterogeneous regarding the causes of mechanical AUS failure and appropriate surgical management. Our study aims to characterize the most common reasons of AUS failure requiring surgical revision and the survival of each AUS component. METHODS/STUDY POPULATION: We report a series of 48 patients who received AUS placement and/or revision by 1 surgeon from 2010 to 2013. Upon presenting for revision, intraoperatively, the surgeon systematically evaluated the device for failure of the balloon, cuff and pump as well as urethral erosion and atrophy. In patients not requiring revision all device components were presumed functional. We conducted retrospective chart review to collect baseline characteristics, intraoperative findings, and postoperative outcomes. Using Kaplan-Meier estimates, we calculated incidence rates of component failure for the cuff, pump, and balloon. To identify risk factors for AUS failure, Cox regression was performed for univariate and multivariable testing. Multivariable modeling included those variables considered biologically plausible and significant in univariate testing. RESULTS/ANTICIPATED RESULTS: In total, 48 patients were studied with median follow up of 4.25 years. All patients received an AMS 800 device with a 61–70 mL balloon filled with 27 cc of isotonic contrast. Cuff sizes ranged from 3.5 to 5.5 cm, with 4.5 cm selected in 33/48 cases (68.8%); 19 of the patients required AUS correction (41.7%). Balloon leak constituted 57.9% (11/19) of failures, followed by cuff failure/urethral atrophy (21.1%), urethral erosion (10.5%), and individual cases of infection and pump failure. Median time to mechanical failure due to balloon leak was 3.67 years (IQR 2.17, 5.33); median time to failure for nonballoon causes was 0.54 years (IQR 0.25, 1.83). Survival of the balloon, cuff, and pump was 100%, 95.7%, and 97.9% at 1 year and 76.9%, 91.0%, and 97.9% at 5 years, respectively. DISCUSSION/SIGNIFICANCE OF IMPACT: Our study identifies fluid leakage from the balloon as the most common cause of AUS failure, particularly in patients presenting between 1 and 5 years after initial placement. For such patients, interrogating the balloon first can decrease infection risk and surgical morbidity as it can avoid manipulation of the urethral cuff. Furthermore, simply replacing lost fluid saves cost and allows for immediate reactivation of the AUS device.

OBJECTIVES/GOALS: In this study, the ability of a pathologist to detect malignancy on digital pseudo-H&E slides obtained via structured illumination microscopy (SIM) imaging of fresh diagnostic breast biopsies was assessed. The speed of imaging and processing was also assessed for potential clinical implementation. METHODS/STUDY POPULATION: This study was conducted in accordance with an Ochsner Medical Center of New Orleans IRB. 200 patients undergoing either stereotactic or ultrasound-guided diagnostic breast biopsies were consented and an additional core from the suspicious lesion was collected for research use. Research biopsies were transported to the lab and stained with DRAQ5 and Eosin-Y and imaged with SIM before being submitted for histology processing. Imaging and digital processing times were recorded. The resulting SIM images and histology slides were given to a pathologist for blind review to assess accuracy. RESULTS/ANTICIPATED RESULTS: The ex-vivo structured illumination microscopy images and subsequent histology slides from 79 research cores have been assessed to date. Some samples were excluded from the total data set and not included in the final assessment due to technical failures of the imaging protocol. Of the current set, the pathologist has a specificity of 88% and a sensitivity of 65%, as well as an NPV of 88% and a PPV of 65%. Staining time for each biopsy was completed within 3 and a half minutes and imaging at 20x magnification took between 4 and 12 minutes, depending on size and implementation of autofocus to the imaging system. Image processing took approximately 5 minutes per biopsy and is a direct function of biopsy size. DISCUSSION/SIGNIFICANCE: Decreased time between cancer suspicion and treatment will improve the prognosis of breast cancer patients. SIM imaging of fresh breast biopsies could ultimately allow primary and secondary histology to be performed simultaneously and minimize histopathology time, thus allowing clinicians and patients to implement treatment course more quickly.

OBJECTIVES/SPECIFIC AIMS: To identify factors associated with urban youth and parent perceptions of the preventability (PoP) of the youth’s medically attended assault injuries in order to guide future violence prevention strategies. METHODS/STUDY POPULATION: Assault-injured youth (n=180; ages 10–15; 60% male; 96% African-American) and their parents were recruited from 2 pediatric emergency departments (EDs) in Baltimore and Philadelphia between June 2014 and June 2016. Data on demographics, circumstances of injury, injury severity, and perceptions of the injury were collected from chart review and in-person interviews with youth and parents using previously validated instruments. Within youth and parent groups, we compared those who reported “definitely true” when asked if the event that brought them to the ED could have been prevented to those who reported “maybe true” or “unlikely” using χ2 testing. RESULTS/ANTICIPATED RESULTS: In total, 68 (37.8%) youth and 123 parents (68.3%) reported that the injury was definitely preventable. Youth who were injured indoors [OR 2.13 (95% CI 1.17, 3.88), p=0.013] or considered their injury not serious [OR 4.82 (95% CI 1.78, 13.11), p=0.002] were more likely to perceive injury preventability and those who reported being the victim were less likely to perceive injury preventability [OR 0.26 (95% CI 0.01, 0.67), p=0.005]. Bullying and use of weapons were not associated with youth PoP. Parents were significantly more likely to perceive preventability when the person/people involved were known by the youth [OR 1.94 (95% CI 1.04, 3.62), p=0.037] and when the injury occurred indoors [OR 1.96 (95% CI 1.04, 3.69), p=0.038]. Similar to youth, parental report of bullying was not associated with parent PoP. Injury severity, and victim role of their child were also not associated with parent PoP. DISCUSSION/SIGNIFICANCE OF IMPACT: A prior violent injury is a major risk factor for future injuries and homicides. Through our work we were able to identify factors associated with youth and parent perception of preventability of injuries in a high risk population. Youth who felt victimized were less likely to perceive their injury as preventable. In addition, parents were more likely to perceive the injury as preventable when their injured child knew those involved in the incident. This work can inform violence prevention strategies and potentially identify opportunities to reduce intentional injuries in urban youth.

OBJECTIVES/GOALS: The Community Engagement and Advisory Board (CEAB) has been an active and sustainable source of expert recruitment, retention, and community engagement advice. Our goal is to describe the strategies offered by the CEAB to university researchers and discuss which are most and least likely to be implemented. METHODS/STUDY POPULATION: The University of Illinois at Chicago’s (UIC) Center for Clinical and Translational Science’s (CCTS) CEAB was established in 2009 and is one of the longest-standing boards across the CTSA network. Our CEAB consists of 28 members, each representing a community-based organization or underrepresented community, which has provided 16 consultations since 2021. Our analysis consisted of: 1) reviewing and coding consultation notes (n= 16) to extract common recruitment and retention strategies provided to researchers; 2) reviewing feedback forms (n = 10) completed by the research team to code the strategies most likely to be implemented by researchers; 3) analyzing the codes to identify the strategies least likely to be implemented. RESULTS/ANTICIPATED RESULTS: Our preliminary analysis indicated that the majority of researchers reported they are most likely to implement strategies to reduce burden for research participants (make study participation more convenient, e.g., allowing participant accompaniment, avoiding commuting to study site, providing transportation provide them with resources to their healthcare) and enhance recruitment from trusted community sources (e.g., Aldermen, local agencies, libraries). Researchers are least able to follow recommendations to alter their budget (e.g., increase participant stipends, hire community staff). DISCUSSION/SIGNIFICANCE: In a previous paper focused on this CEAB, Matthews etal. (2018) found researchers indicated that they plan to implement at least one recommended strategy. In this follow-up examination, we describe the recommended strategies to guide CEABs to align recommendations with researcher priorities to best assist with their translational science goal.

OBJECTIVES/GOALS: IgA1 nephropathy, which can lead to kidney failure, is caused by complexes formed between aberrant galactose-deficient IgA1 and antibodies directed against it. Our goals are to characterize shifting glycosylation patterns at the level of single IgA1 molecules and to apply this to patient samples for early detection and understanding of the disease. METHODS/STUDY POPULATION: To characterize glycosylation patterns on single IgA1 molecules, labelled IgA1 in low concentration was physisorbed to borosilicate glass in a fluidic cell and labelled Jacalin was flowed in to bind with Glycans on IgA1. The samples were observed with a Nikon TiE epi-fluorescence microscope. FRET images were created by exciting the Jacalin dye with a blue laser and recording the red emission of the IgA1 dye with an EMCCD camera. FRET emission intensities of individual IgA1 molecules over time were analyzed to determine how frequent and how long Jacalin binds to each of them. The rate of binding is roughly inversely proportional to the amount of abnormal glycans on a given IgA1 molecule. After the method is perfected, we intend to compare the glycosylation patterns of healthy and diseased patient samples. RESULTS/ANTICIPATED RESULTS: Addition of the competitive binder Galactose to the solution led to an increase in the off times of Jacalin and IgA1 and a decrease in the on times in a concentration-dependent manner, yielding an increase in the dissociation constant. Dissociation constants of individual molecules within a single experiment vary by 3 orders of magnitude, which cannot be attributed to stochastic fluctuations but rather reflects differences in the adsorption geometry. Nevertheless, the unaffected dissociation constant can be identified. We expect that when this method is applied to samples from healthy and IgA1 Nephropathy patients, specific IgA1 molecules from patients will have higher dissociation constants for Jacalin compared to those from healthy patients. DISCUSSION/SIGNIFICANCE: The binding rates of Jacalin to single IgA1 vary by 3 orders of magnitude. The observed heterogeneity shows the Jacalin probe can differentiate between different IgA1 populations. An understanding of which IgA1 molecules in patient samples are problematic and what their distribution of Glycans is can lead to discovering biomarkers and treatments.

ABSTRACT IMPACT: Understanding the women community leaders’ sense of relational and financial empowerment in the social entrepreneurship context will be key to developing a sustainable pathway to scale-up community-based HPV self-sampling programs in low resource settings. OBJECTIVES/GOALS: The Hope Project, a social entrepreneurship (SE) near Lima, Peru, trains women leaders (Hope Ladies) to promote human papillomavirus (HPV) self-sampling in their communities. This study aims to evaluate the Hope Ladies’ own relational/financial empowerment after participating in the program. METHODS/STUDY POPULATION: The Hope Ladies participated in semi-structured in-depth interviews (n= 9) and 8-question 5-point Likert-scale survey (n=16) that evaluated their relational/financial empowerment after participating in the social entrepreneurship. The interview and the survey questions were developed using validated empowerment frameworks, indicators, and theory, respectively: 1) Kabeer’s conceptual framework, 2) International Center for Research on Women (ICRW), and 3) Relational Leadership Theory (RLT). Direct content analysis was used to deductively evaluate the interviews with predetermined codes and categories of empowerment. Descriptive statistics were used to analyze the survey results. RESULTS/ANTICIPATED RESULTS: All reported experiencing empowerment in the SE. Interviews: The codes were mapped onto 3 categories/9 sub-categories: 1) voicing confidence (willingness to challenge social/gender norms); 2) social resources (new skills, knowledge, self-efficacy, access to networks, role models); 3) financial gains (helpful but not the primary motivation to continue as Hope Ladies, and not enough to override traditional household roles/priorities). Survey: 75% indicated an increase in social contacts, confidence in discussing reproductive topics (75%), comfort with medical facilities (44%), ability to help the community (62.5%), and ability to make household purchasing decisions (36%) since joining the program. DISCUSSION/SIGNIFICANCE OF FINDINGS: The Hope Ladies’ experience in this SE demonstrated the complex relationship between various domains of empowerment (e.g., relational/financial). More studies are needed to elucidate the relationship between empowerment and worker retention/performance to inform scale-up of HPV self-sampling SE’s.

ABSTRACT IMPACT: This work will contribute to the understanding of challenges and best practices for navigating the research review process for collaborative community-engaged research. OBJECTIVES/GOALS: The aim of this scoping review is to comprehensively identify the challenges that researchers, community partners, and the Institutional Review Board (IRB) face, in order to develop best practices to guide future community-engaged research (CEnR). METHODS/STUDY POPULATION: Community-engaged research (CEnR) encompasses all research practices in which traditional researchers collaborate with community partners to identify health disparities that affect the community. CEnR aims to empower communities and prevent exploitative research practices on vulnerable populations. Though many goals of CEnR align with that of the Institutional Review Board (IRB) to protect human research subjects from unethical harm, researchers and community members conducting CEnR are often met with challenges when getting research approval. The search strategy included all publications pertaining to challenges in IRB approval and process for studies in the spectrum in community-engaged research. Systematic searches in PubMed Central and PsycINFO were conducted. RESULTS/ANTICIPATED RESULTS: The search strategy produced 748 publications from peer-reviewed journals. We included 118 publications that met our initial inclusion/exclusion criteria from the search strategy in our analysis. Preliminary results show that common challenges include lack understanding of the duo role of community members as researchers and participants, informed consent language barriers, and lack of understanding community-based participatory research. Best practices when working with the IRB include fostering an environment for open communication with the IRB early in the research process, understanding timeline constraints from both researcher and community agencies and supporting the role of community members as research staff. DISCUSSION/SIGNIFICANCE OF FINDINGS: Community-engaged research efforts are advantageous in empowering and providing agency for community members to address important health concerns within their communities. To prevent the exploitation of vulnerable and underserved populations, more research should engage in collaborative community-based partnerships.

OBJECTIVES/GOALS: Prior work has established subtypes of OSA and linked them to risks of future adverse events but rarely with the longitudinality and richness of data available in the EMR. Our goal is to leverage EMR data identify clinically meaningful sub-phenotypes of OSA and better study how they affect risks of adverse outcomes. METHODS/STUDY POPULATION: Vanderbilt’s EMR database has over 61,000 adult patients with a literature-validated EMR definition of OSA with a median EMR follow-up period of 4 years after OSA diagnosis. Of these patients, 12,516 have fully recorded sleep study data in addition to EMR variables such as age at study and most recent BMI. We applied several clustering methods including to identify natural sub-phenotypes of OSA and assessed cluster quality. We also applied techniques which allow a single patient to belong to multiple clusters in various degrees. After selecting final clusters, we plan to analyze the associations between OSA sub-phenotypes and risks using statistical tools like logistic regression and Cox proportional hazards regression, with and without adjusting for factors such as age, gender, and certain medications. RESULTS/ANTICIPATED RESULTS: Preliminary clustering with primarily sleep study data has shown overlap with literature-described patient clusters, including a severe, high non-REM stage 1 sleep, high BMI cluster and a high nocturnal limb movement cluster. As we incorporate more EMR variables, we will select a final set of OSA sub-types. We anticipate patients in different clusters to have different risks of various adverse OSA-associated outcomes that are tracked in our EMR data. Notable outcomes with sufficient incidence rates (>3%) after OSA diagnosis include essential hypertension (43.4%), hyperlipidemia (28.8%), type 2 diabetes (21.9%), anxiety disorder (19.2%), coronary atherosclerosis (14.9%), cerebrovascular disease (7.7%), and pulmonary heart disease (5.9%). DISCUSSION/SIGNIFICANCE: If our results match anticipations, we will show how EMR data can be used to define OSA sub-phenotypes and predict patient risks of various OSA-associated outcomes. This analysis enables work in personalized risk and treatment predictions for OSA patients. By better understanding these risks, providers can better tailor treatments to patients.

OBJECTIVES/GOALS: Improving physical activity of African American women experiencing disproportionate health risks from sedentarism, educational and socio-environmental barriers. BeFit: Building Empowerment through Fitness is based on “What I Learned At Home” project, run by Women Under Construction Network, for residents of the Birmingham Housing Authority. METHODS/STUDY POPULATION: A qualitative study design to understand unique cultural context and challenges faced by African American women residing in the Birmingham Housing Authority, regarding physical activity engagement, including sedentarism. A needs assessment approach will help determine barriers, support systems, and social networks. Semi-structured, pre, mid, and post program focus groups will identify challenges and opportunities for health, such as diet and exercise, and will be analyzed by hand with a thematic analysis. The project framework uses exercise and home repair tools with a life-building/life repair curriculum to influence health, self-efficacy, and program engagement. The Study enrollment will include 50 women over two cohorts in a 12-week project. RESULTS/ANTICIPATED RESULTS: This research addresses the urgent health needs of African American women in low-income communities. These women face heightened health risks due to sedentary lifestyles, educational gaps, and socio-environmental barriers. This project targets the pronounced prevalence of allostatic burden in this population by applying a culturally sensitive, bottom-up approach. Our goal of incorporating healthy lifestyles to improve health in at-risk women and their families requires multiple projects. This project is a necessary first step in engaging with a community to identify local environmental circumstances and barriers to increasing the relevance of physical activity within the home. These barriers can then be addressed by adapting an exercise promotion program to the needs of this community. DISCUSSION/SIGNIFICANCE: Black women in under-resourced communities are more likely to be sedentary and have poor health. Exercise programs can be a powerful tool to address disparities and help prioritize health. The circumstances of women in public housing in Birmingham, AL, need community partners to adapt exercise engagement programs to meet environmental challenges.

OBJECTIVES/SPECIFIC AIMS: (1) Evaluate the relative incremental cost-effectiveness [cost per quality-adjusted life year (QALY) gained] of antibiotics, laparotomy, and laparascopy for the initial treatment of uncomplicated appendicitis. (2) Detect if the relative incremental cost-effectiveness of each treatment differs by age, namely in pediatric patients, adult patients, and geriatric patients. (3) Use deterministic and probabilistic sensitivity analyses to assess the robustness of our findings when varying multiple model parameters. METHODS/STUDY POPULATION: Study Population and Analytic Approach: The population under analysis is a simulated population of those aged 1–90 diagnosed with uncomplicated appendicitis with computed tomography (CT) in the emergency department. Pregnant women and those younger than 1 year old were excluded from our analysis. We simulated our population through a Markov state-transition simulation model. Using this model, we estimated the lifelong costs and effects on QALYs from the use of antibiotics, laparoscopy, and laparotomy for a given hypothetical individual with uncomplicated appendicitis. This model allowed for the incorporation of both the short-term and long-term effects of each respective treatment option. The primary outcome of the model was the cost per additional QALY gained. The analysis was conducted using a healthcare perspective. A 100 age-year time horizon was used. A 3% discount rate was applied to both the costs and effects in the model. Transition states are depicted. Surgical state rates were derived from HCUP. Treatment failure of antibiotics was defined as recurrent appendicitis within one year of antibiotic treatment. This was determined using results from prior RCTs and a Cochrane review of antibiotic management for uncomplicated appendicitis. Recurrent appendicitis was defined as recurrent appendicitis after 1 year of antibiotic treatment, using rates of appendicitis applied to the general population by age group. National age-adjusted mortality rates were applied to account for death due to causes unrelated to appendicitis. To assess differential results by age, different acute and long-term outcome, cost, and state transition rates were applied to 3 age groups: a pediatric group (1–17 years old), an adult group (18–64 years old), and a geriatric group (65+ years old). As an individual progressed through the model until age 100, the respective parameters would change to adjust for the transitions between the 3 life stages. Outcomes After Appendicitis: Lifetime QALYs were incorporated throughout the study for short-term and long-term health states. There is limited availability of QALY data in the literature pertaining to the health states specific to appendicitis. Due to this limitation, however, calculated quality of life (QoL) indices for 2015 created by Wu et al. were utilized for this study. QALYs were subsequently derived by multiplying QoL by the appropriate duration of time spent in a respective health status. Transition rates between health states were abstracted from the existing literature. Costs: Direct medical costs were obtained from HCUP statistics from the 2014 fiscal year for all age groups in the nationwide network. This database contains all costs of care related to surgical appendicitis intervention, however it lacks costs associated with antibiotic-only management. To account for these costs, data was extracted from current available literature, and the resulting average was applied to our model. Sensitivity Analysis: One-way analyses by cost of procedure and effectiveness of antibiotic protocol were undertaken to account for regional variation in costs and improvements in antibiotic therapy, respectively. For cost of procedure sensitivity analysis, costs were varied by 1 standard deviation below and above the mean cost per treatment group per age. These costs were then compared to a designated reference group. Antibiotic sensitivity analysis was conducted by reducing the effectiveness of antibiotics from the maximum reported effectiveness down to 0, with the goal of obtaining a level of effectiveness at which antibiotics were no longer cost-effective. A probabilistic Monte-Carlo sensitivity analysis was then employed to determine the percent likelihood of each treatment arm being cost-effective at a level of $100,000 per additional QALY. The probabilistic sensitivity analysis was then repeated to determine the percent likelihood of each treatment arm being the dominant option, in that it lowers costs and adds QALYs. RESULTS/ANTICIPATED RESULTS: Our model examined the cost-effectiveness of 3 different treatment options for patients with acute uncomplicated appendicitis: laparoscopic appendectomy, laparotomy appendectomy, and an antibiotic regimen. We first examined the cost-effectiveness of each of these strategies in comparison to laparotomy. Laparoscopic appendectomy was shown to be superior to laparotomy in regards to costs and QALYs for patients ages 18 to 65+, while there was very little difference for patients ages 1–17. For those aged 1–17, laparoscopy had an additional cost of $90.00 with an associated gain of 0.1 QALYs compared with laparotomy. For those aged 18–64, laparoscopy had a net cost-savings of $3437.03 with an associated gain of 0.13 QALYs compared with laparotomy. For those aged 65+, laparoscopy had a net cost-savings of $5713.55 with an associated gain of 0.13 QALYs compared to laparotomy. Antibiotic management was superior to laparotomy as it relates to both costs and QALYs for all 3 age cohorts. For those aged 1–17, antibiotic management had a net cost-savings of $5972.55, with an associated gain of 0.6 QALYs compared with laparotomy. For those aged 18–64, antibiotic management had a net cost-savings of $6621.00 with an associated gain of 0.5 QALYs compared with laparotomy. For those aged 65+, antibiotic management had a net cost-savings of $11,953.00 with an associated gain of 0.21 QALYs compared with laparotomy. We then assessed the cost-effectiveness of antibiotics relative to laparoscopy. In all 3 age groups, antibiotics added QALYs and were cost-saving. For those aged 1–17, antibiotic management had a net cost-savings of $6062.55, with an associated gain of 0.6 QALYs compared with laparotomy. For those aged 18–64, antibiotic management had a net cost-savings of $3183.97 with an associated gain of 0.5 QALYs compared with laparotomy. For those aged 65+, antibiotic management had a net cost-savings of $6239.45 with an associated gain of 0.21 QALYs compared with laparotomy. Sensitivity Analysis: We first examined the effect of varying costs on our results. Costs for all interventions were varied by 1 standard deviation above and below the average costs used in our original model, yielding 3 cost estimate levels: high cost (1 standard deviation above), middle cost (average cost reported in model), low cost (1 standard deviation below). For all 3 cost estimate levels of antibiotics, antibiotics persistently dominated laparotomy for all 3 age groups. Laparoscopy dominated at all cost levels in age groups 18–64 and 65+ but had a positive ICER for both high and medium cost levels in the 1–17 age group. We then varied effectiveness (one minus the failure rate) of antibiotic treatment in each age group to assess at what level of effectiveness to antibiotics become dominant relative to laparotomy. In ages 1–17, antibiotic treatment became dominant at 43.8%; in ages 18–64, antibiotic treatment became dominant at 33%; and in ages 65+, there was no level of antibiotic effectiveness that did not result in this therapy being dominant over laparotomy. Probabilistic Monte-Carlo sensitivity analysis is pending, but we anticipate antibiotics having a high likelihood of being both cost-effective and dominant relative to the other 2 treatment options. DISCUSSION/SIGNIFICANCE OF IMPACT: We performed a cost-effective analysis comparing surgery versus antibiotic management for uncomplicated appendicitis. Our study found that antibiotic therapy was the dominant strategy in all age groups as it yielded lower costs and additional QALYs gained compared with laparotomy and laparoscopy. Appendicitis is the most common surgical emergencies worldwide, with a lifetime risk of 6.9% in females and 8.6% in males (Körner 1997). For over 100 years, open appendectomy had been the established treatment for appendicitis, but current management has evolved with the advent of laparoscopy and now growing use of antibiotics for treatment of appendicitis. There is growing interest in nonoperative management of uncomplicated appendicitis, given both an aging population that is increasingly frail and vulnerable to surgical complications and concerns over skyrocketing medical costs. Our model showed that antibiotic-only management was cost-effective in all age groups. This has important implications for management of appendicitis, where current management is to offer antibiotic-only management only in the “rare cases” where the patient is unfit for surgery or refuses surgery. Our data show that medical management of appendicitis not only is cheaper, but also provides more QALYs in all age groups. Our study has several limitations. First, we conducted our analysis under the assumption that all patients will be cured of appendicitis following surgical intervention. Some patients following appendectomy will develop symptoms of appendicitis and be diagnosed with “stump appendicitis,” which can occur in stumps as short as 0.5cm and can present as late as 50 years following initial surgery (Kanona, 2012). Additionally, any intraperitoneal surgery can lead to late complications such as small bowel obstruction from adhesions following surgery. Thus, our assumption that patients following appendectomy will return to the general population’s QALYs and mortality rate is not necessarily an accurate reflection of all clinical courses. However, the overwhelming majority of appendectomy patients recover fully post-surgery and we do not believe the above complications would significantly change our analysis. We also assumed that all patients with recurrent appendicitis following medical management would undergo surgery. However, patients who underwent nonoperative management at initial appendicitis may be more likely to be ineligible for surgery or refuse surgery during this second case of appendicitis. In addition, data were sparse for QALYs for the complications of open and laparoscopic surgery. We estimated these numbers from the EQ-5D, which while perhaps not accurate, we believe to be the best approximation given the available data. The next steps in evaluating the use of nonoperative management in uncomplicated appendicitis would be to validate the use of nonoperative management in elderly populations and to develop more accurate diagnostic criteria for uncomplicated Versus complicated appendicitis. Additionally, with increasing attention on antibiotic-resistant micro-organisms, policy decisions on the use of nonoperative management must also consider antibiotic stewardship. While one dose of perioperative antibiotics is indicated for appendectomy, treatment strategies from trial protocols for antibiotic-only management require significantly more antibiotics—some protocols require 1–3 days of IV antibiotics followed by up to 10 days of oral antibiotics. This study provides a cost-effectiveness analysis of treatment options for acute uncomplicated appendicitis among varying age groups. Our analysis demonstrates the benefit of antibiotics for initial therapy in the management of acute uncomplicated appendicitis. While the historic gold standard of laparotomy still is present as the first line treatment option in many physicians’ minds, new evidence indicates that the advancement of other methods, whether surgical via laparoscopic removal of the appendix or medical via improved antibiotic regimens, suggests better alternatives exist. Our study builds upon a growing body of literature supporting initial treatment of acute uncomplicated appendicitis with antibiotics, before surgical intervention.

OBJECTIVES/SPECIFIC AIMS: The Rockefeller University Center for Clinical and Translational Science (RU-CCTS), Clinical Directors Network (CDN), and Carter Burden Network (CBN), a multi-site senior services organization serving East Harlem, NY, formed a community-academic research partnership to characterize the health of the CBN seniors (many who are racial/ethnic minorities, low-income, and suffering from multiple chronic conditions) and to explore the use and associations of a measure of overall health status and frailty in this population. A simple validated measure of health status could standardize and streamline community-based translational research to study the impact of CBN’s services on health outcomes. The CCTS-funded Pilot Project aims to: 1) Engage CBN seniors and stakeholders in priority-setting, joint protocol development, research conduct, analysis and dissemination; 2) Characterize the health status of the CBN seniors using validated measures; 3) Establish an electronic database infrastructure for current and future research; 4) Understand how health and senior activities information can be used to implement programs to improve senior health and well-being. METHODS/STUDY POPULATION: 1) We used Community Engaged Research Navigation (CEnR-Nav) methods to facilitate partnership development, and to engage CBN seniors and stakeholders in each step of the research; 2) Research staff conducted recruitment, informed consent, and physical assessments (e.g., pulse, blood pressure, BMI); and administered validated surveys to collect health status information. 3) Data were captured on a REDCap-based platform. The primary outcome, frailty, was measured by the validated Short Physical Performance Battery (SPPB). 4) Secondary outcomes include the association of use of services/activities with the primary outcome. Research participants consented to sharing of their health, demographic and services utilization data compiled by CBN staff and the NYC Department for the Aging (DFTA). DFTA provided comparison datasets of de-identified health and demographic data for clients attending other NYC DFTA-funded senior centers. RESULTS/ANTICIPATED RESULTS: 1) 43 residents and stakeholders engaged in partnership-building, study design and implementation. 2) 218 participants from two senior centers were enrolled. Mean age, 68 ± 11 years; 58% Hispanic; 33% African American, 23% White, 1% Asian, 18% Unknown, 17% Other; 69% reported <$20000 annual income; 40% had not completed high school; 30% scored as moderately or severely frail; 83% were overweight or obese; and 33% reported a history of diabetes. 84% had uncontrolled high blood pressure; many participants were previously aware of their hypertension diagnosis. 3) A REDcap database was developed to store historical and prospective data. 4) Across frailty categories, there was a significant difference in utilization of non-meal (p = 0.0237) and meal services (p = 0.0127) and there was an inverse proportional relationship between the number of meal and non-meal visits, and frailty. Additional associations among health status measures (e.g., SPPB, demographics, biological measures: pulse, blood pressure, BMI; psychosocial and nutritional scales) and CBN service utilization (i.e., meals vs. non-meals activities) will be presented. DISCUSSION/SIGNIFICANCE OF IMPACT: We developed a community-academic research partnership, infrastructure and capacity, built through our Community-Engaged (CEnR-Nav) model, to conduct a pilot study characterizing the health status and services utilization of low-income minority seniors. Our pilot study identified an urgent health priority, uncontrolled hypertension in 84% of CBN’s seniors. We then leveraged the team’s expertise and CBN’s meal services program to develop a research proposal for external funding to conduct a community-based multi-component intervention study. Replacement of a typical Western diet with the Dietary Approaches to Stop Hypertension (DASH) diet has been proven to reduce blood pressure in hypertensive and normotensive individuals in as little as 14 days, yet effective implementation has been lacking, and it is relatively untested in community-living seniors who receive their meals in settings such as CBN. We are also exploring mechanistic questions that relate to blood pressure control, such as the impact of the DASH diet on inflammation, which may lead to a better understanding of the underlying mechanism of action of the DASH diet. Our community partner, CBN, was awarded the DHHS-ACL nutrition innovation grant to conduct this 2-year study with CDN and RU-CCTS. The resulting study developed out of the community engaged pilot study represents a unique combination of community-centered care, within an implementation science framework (with embedded mechanistic measures under development). This is an example of the novel, full-spectrum approach to translational research that the RU-CCTS/CDN Community Engaged Research Core has been developing over the last decade. The research to characterize CBN clients’ health status is now being extended to address cardiovascular health by way of intervening on diet quality and food insecurity, a key component of the social determinants of health, in partnership with agencies outside of the healthcare delivery system. The outcomes of the DASH Diet implementation study will also serve to inform the broader aging service provider network and the healthcare community about the impact of senior center congregate meal composition and services on health outcomes.

OBJECTIVES/GOALS: Heart failure and depression are important public health problems. Depression has been identified as an independent risk factor for increased cardiovascular morbidities. It is estimated that 1 out of every 5 patients living with heart failure suffer from depression. (Kop, W. J.) Studies have found that Hispanic patients have a higher rate of heart failure than non-Hispanic whites. Current guidelines recommend that proper screening tools must be used to identify and manage major depression disorder in HF patients, however many of these patients go unrecognized in the medical setting. The prevalence, management, and outcomes of depression among PuertoRican Hispanics living with heart failure is unknown. Objective: The purpose of this study is to evaluate the relationship between heart failure and depression in Hispanics with heart failure METHODS/STUDY POPULATION: To this end, we will perform a secondary analysis of data from the PR CardiovascularSurveillance Study (PRCSS). We will extract personal data from 4,461 medical records of patients admitted with heart failure (ICD-9 Codes 428) at 21 hospitals in Puerto Rico, during the years 2007, 2009 and 2011. For statistical methods, we will implement chi-square and t-tests at a significance level of 0.05 RESULTS/ANTICIPATED RESULTS: We expect to see older aged women with higher NYHA and pro-BNP levels to be associatedwith diagnosis of major depression disorder and worse in-hospital outcomes DISCUSSION/SIGNIFICANCE OF IMPACT: With this study, we would like to raise awareness about depression in patients with heart failure, and its role in improving patient outcomes. Moreover, we would like to determine if there are gender-specific health disparities among Puerto Rican Hispanics with heart failure

OBJECTIVES/GOALS: The MEF2 family of transcription factors regulate gene expression controlling cell differentiation and synapse development. Mutations or deletions in the MEF2C gene cause a neurodevelopmental disorder that includes symptoms of autism spectrum disorder. In this study, we aim to study the role of MEF2C in GABAergic populations using an animal model. METHODS/STUDY POPULATION: MEF2C Haploinsufficiency Syndrome (MCHS) occurs when there is one functional allele and one disrupted allele of MEF2C. To study the role of MEF2C in GABAergic populations during mouse development, we bred Vgat (vesicular GABA transporter)-Cre mice, which express cre recombinase broadly in early developing GABAergic neurons, with a floxed Mef2c loss-of-function mouse to create offspring that are GABAergic cell-specific Mef2c heterozygous mutants (Mef2c cHetVgat-cre). We then subjected these mutants and littermate controls to a battery of tests measuring MCHS-relevant phenotypes, including spatial working memory, anxiety-like behavior, social preference, sensory sensitivity, and Pavlovian learning and memory. RESULTS/ANTICIPATED RESULTS: Mef2c cHetVgat-cre mice showed significant deficits in spatial working memory, social preference, and contextual fear memory, all of which are prefrontal cortex (PFC)-dependent behaviors. Interestingly, we noted that conditional Mef2c knockout mice (Mef2c cKOVgat-cre) showed embryonic and early postnatal lethality, probable seizures, and severe motor coordination problems, highlighting the importance of MEF2C function in GABAergic populations. DISCUSSION/SIGNIFICANCE: We hypothesize that MEF2C plays a cell-autonomous role in GABAergic cells to control the balance of excitatory and inhibitory synaptic transmission in the developing and mature brain, which in the Mef2c cHet mice might be critical for PFC-dependent learning and memory and sociability.

This article presents a landscape assessment of the findings from the 2021 Clinical and Translational Science Award (CTSA) Evaluators Survey. This survey was the most recent iteration of a well established, national, peer-led systematic snapshot of the CTSA evaluators, their skillsets, listed evaluation resources, preferred methods, and identified best practices. Three questions guided our study: who are the CTSA evaluators, what competencies do they share and how is their work used within hubs. We describe our survey process (logistics of development, deployment, and differences in historical context with prior instruments); and present its main findings. We provide specific recommendations for evaluation practice in two main categories (National vs Group-level) including, among others, the need for a national, strategic plan for evaluation as well as enhanced mentoring and training of the next generation of evaluators. Although based on the challenges and opportunities currently within the CTSA Consortium, takeaways from this study constitute important lessons with potential for application in other large evaluation consortia. To our knowledge, this is the first time 2021 survey findings are disseminated widely, to increase transparency of the CTSA evaluators' work and to motivate conversations within hub and beyond, as to how best to leverage existent evaluative capacity.

The success rate for translation of newly engineered medical technologies into clinical practice is low. Traversing the “translational valleys of death” requires a high level of knowledge of the complex landscape of technical, ethical, regulatory, and commercialization challenges along a multi-agency path of approvals. The Indiana Clinical and Translational Sciences Institute developed a program targeted at increasing that success rate through comprehensive training, education, and resourcing. The Medical Technology Advance Program (MTAP) provides technical, educational, and consultative assistance to investigators that leverages partnerships with experts in the health products industry to speed progress toward clinical implementation. The training, resourcing, and guidance are integrated through the entire journey of medical technology translation. Investigators are supported through a set of courses that cover bioethics, ethical engineering, preclinical and clinical study design, regulatory submissions, entrepreneurship, and commercialization. In addition to the integrated technical and educational resources, program experts provide direct consultation for planning each phase along the life cycle of translation. Since 2008, nearly 200 investigators have gained assistance from MTAP resulting in over 100 publications and patents. This support via medicine–engineering–industry partnership provides a unique and novel opportunity to expedite new medical technologies into clinical and product implementation.