OBJECTIVES/GOALS: Electronic cigarettes have become increasingly popular, with various combustion products generated in the process. Dihydroxyacetone (DHA), a carbohydrate made during the heating process. Exposures may reach high micromolar to low millimolar doses of DHA per day and no studies have been done to understand the effects of DHA in the heart. METHODS/STUDY POPULATION: Here, we examine if DHA contributes to these using rat cardiomyocytes, H9c2 cells, and rat cardiac tissues to DHA evaluating metabolic and mitochondrial effects. Using the cells, we will investigate metabolic and mitochondrial pathways using Seahorse, protein expression changes in nutrient sensing pathways, and understand dose-dependent effects of DHA in the heart. Metabolite pools will also be evaluated to understand the changes promoted by DHA. Oxidative stress as previously observed in other cell models will also be measured. Key findings in the cardiac cells will be investigated in the cardiac tissues exposed to DHA. RESULTS/ANTICIPATED RESULTS: We have previously shown DHA induces oxidative stress, metabolic changes, and mitochondrial dysfunction in various cell line models. Interestingly, these effects are highly cell-type dependent. E-cigarettes are known to have toxic cardiac effects, including arterial stiffness, endothelial dysfunction, vascular injury, and oxidative stress. Changes in glycolytic, fatty acid synthesis, and the citric acid cycle enzymes and metabolites were found in the H9c2 cells. We also observed increased mitochondrial ROS and fuel changes due to DHA exposure. In DHA exposed cardiac tissues, we observed oxidative stress and mitochondrial fission and fusion dynamics altered. DISCUSSION/SIGNIFICANCE: These data suggest further study at physiologically relevant doses is warranted to understand how DHA inhaled impacts the long-term health of vapers. As well as the regulation of DHA in e-cigarettes as it has been deemed as safe for topical applications and warned against inhalation.

OBJECTIVES/GOALS: To assess labels of drugs approved for Type 2 Diabetes (T2D) for the inclusion of geriatric sub-population data (ages 65-74, 75-84, ≥85) since January 1, 2013, in accordance with international guidance and US regulations in recognition of an aging populations and global demographics. METHODS/STUDY POPULATION: Utilizing FDA Guidance for Industry: Labeling for Human Prescription and Biological Products - Implementing the Physician’s Labeling Rule (PLR) Content and Format Requirements and the International Council for Harmonization of Technical Requirements (ICH) E7 guidance “Studies in Support of Special Populations: Geriatrics” as reference for assessing labels. The Center for Drug Evaluation and Research (CDER) new drugs/biologic approvals database was filtered for drugs approved between Jan. 1, 2013 and Dec. 31, 2022 with approved T2D indications. Examined original drug labels and supplements from Drugs@FDA for geriatric use efficacy and safety wording in Section 8.5 (Use in Specific Populations, Geriatric Use), for labels. Subpopulation data in labeling for ages 65-74, 75-84, and ≥85 was analyzed. RESULTS/ANTICIPATED RESULTS: Seven T2D drugs (Trulicity, Tresiba, Adlyxin, Ozempic, Steglatro, Kerendia, Mounjaro) approved within the specified time period were analyzed. In the current examination, all labels contain information regarding efficacy differences between ages 65+ and 75+, however, none contain information on efficacy for ≥85 populations. Four of the seven drugs have been updated with increased data from further efficacy trials for older adults conducted after initial approval. The remaining three drugs have only been reworded, or not changed at all, with no further efficacy trials conducted. DISCUSSION/SIGNIFICANCE: This research shows the gap in representation of older adults in clinical trial data and T2D drugs’ labeling. Despite having a higher usage of T2D drugs compared to the general population, older adults and especially the oldest-old (≥85) are underrepresented. Additional demographic requirements ensuring diversity in clinical trials is needed.

OBJECTIVES/GOALS: The purpose of this study was to investigate how suggestibility and social susceptibility relate to alcohol use in young adult non-dependent alcohol users, and the role of trait anxiety in this relationship. We hypothesized that greater trait anxiety would be associated with higher levels of alcohol misuse, and this would be mediated by suggestibility. METHODS/STUDY POPULATION: Study participants enrolled in the NIAAA screening and assessment protocol completed questionnaires on suggestibility, anxiety, and alcohol use. The Multidimensional Iowa Suggestibility Scale (MISS) is a 95-question self-report assessment of suggestibility. Trait anxiety is assessed with the State Trait Anxiety Inventory-Trait (STAI-T). Alcohol measures included the Alcohol Use Disorder Identification Test (AUDIT). Structured Clinical Interviews for DSM-IV or DSM-5 disorders were conducted, and non-dependent participants (N = 113) were considered. A median split was conducted (median age = 35.1 years), with the focus of this study on the younger individuals (N = 55). RESULTS/ANTICIPATED RESULTS: Initial analyses showed that suggestibility, alcohol misuse, and trait anxiety all had significant positive correlations with one another. To better understand the relationship of peer influence, specifically, with drinking and anxiety, MISS subscale of Peer Conformity was analyzed. MISS total score and Peer Conformity were positively correlated with AUDIT Total as well as STAI-T Score. STAI-T Score was additionally positively correlated with AUDIT Total (all p2 = 0.222). We also looked at Peer Conformity in place of MISS Total (R2 = 0.213). In both models, only suggestibility measures were significant predictors of harmful alcohol use (p<0.01). DISCUSSION/SIGNIFICANCE OF IMPACT: In young social drinkers, there were significant positive associations between suggestibility, risky alcohol use, and trait anxiety. These results suggest that suggestibility may be a modifiable risk factor for risky alcohol consumption. Future directions include using mediation models to explore the associations between suggestibility, anxiety, and alcohol misuse.

OBJECTIVES/SPECIFIC AIMS: This study aims to understand the potential immunomudualtory effect of APOL1 variants in auto-antigen activated myeloid cells by assessing lysosomal integrity in activated cells expressing APOL1. The primary stimuli were: 1. ssRNA hY3 as a proxy for the Ro immune complex; 2. in an bulk RNA seq model, interferon-response gene, Siglec 1, as a read out of interferon activity. The primary outcomes were: 1. Myeloid cell APOL1 expression both in primary macrophage cultures and ex-vivo patient derived macrophages; 2. Lysosome integrity as measured by fluorescence intensity of lysotracker dye on light microscopy. METHODS/STUDY POPULATION: All recruited subjects provided written informed consent as per the NEW YORK UNIVERSITY Division of Rheumatology-wide Specimen and Matched Phenotype Linked Examination (SAMPLE) protocol. Subjects were African American; SLE subjects met 4 American College of Rheumatology criteria for SLE. Healthy donor monocytes representing each genotype in duplicate (reference allele: G0/G0; heterozygote variant: RV/G0; and homozygote variant RV/RV) were cultured with GM-CSF to yield macrophages which were incubated in serum free media or with hY3 ssRNA (TLR 7/8 agonist) to yield inflammatory M1 macrophages. Fold increase of APOL1 in untreated vs hY3 treated macrophages was measured using qPCR. Live cells were then cultured on glass chamber slides with DNA dye, DAPI, and Lysotracker red, a fluorescent dye that stains acidic lysosomes. As a proof of concept, interferon response gene, Signlec1, and APOL1 transcriptional activity in peripheral blood monocytes (PBMCs) were measured and correlated in 17 SLE patients by RNA seq. RESULTS/ANTICIPATED RESULTS: Regardless of genotype, hY3 increased APOL1 expression by 29 (+/−18.4) fold (P = 0.007 vs no treatment). Genotyping of the qPCR product showed concordance with the chromosomal DNA with the RV heterozygotes expressing both alleles. To examine lysosomal membrane integrity, live hY3-treated macrophages were stained with lysosotracker dye and fluorescence intensity was measured. Compared to reference allele carrying macrophages, each additional variant allele corresponded with a lesser degree of lysosome compartment staining. In SLE PBMCs, we found that APOL1 was highly expressed, and significantly correlated with Siglec1 (F=10.5; P = 0.005) supporting an association between circulating interferons and APOL1 accumulation in monocytes. DISCUSSION/SIGNIFICANCE OF IMPACT: Given that the “cytokine milieu” in SLE elicits APOL1 expression, induces inflammatory cell metabolic rewiring, and stimulates autophagy thereby exposing defects in autophagic flux, this gene-environment interaction may underpin the relationship between chronic inflammation and heightened APOL1 polymorphism-attributed cardiovascular risk. These data support further inquiry into the intersection between chronic autoimmunity and APOL1’s functional role in the vascular microenvironment. The in vitro studies herein extend our prior work by demonstrating a mechanistic link between SLE-associated inflammation, APOL1 risk variant status and CVD via a lysosomal defect which converges on common autophagic and metabolic pathways in mononuclear cells.

OBJECTIVES/GOALS: Specific aims are to: (Qualitative aim) Develop a new measure of cancer-related self-efficacy in partners (BCSES-P) and obtain feedback on the items (Quantitative) Evaluate the psychometric properties of the BCSES-P including: dimensionality, factor analysis, and construct validity assessing the relationships posited METHODS/STUDY POPULATION: 2-Phase Approach: 1) Item development and 1) Item testing Phase 1 Stage 1: Literature review to identify additional covariates Stage 2: Focus groups and individual interviews to determine partners’ needs Sample size: 20 partners (18 years of age or older, identifying as being in a committed relationship with a BCS) Design: cross-sectional, qualitative interviews Stage 3: Develop candidate items Stage 4: Cognitive interviews Stage 5: Finalize items with research team Phase 2 Preliminary psychometric testing Dimensionality Internal consistency reliability Construct validity Sample size: 150 partners Design: cross-sectional, online survey RESULTS/ANTICIPATED RESULTS: The BCSES-P will be unidimensional as assessed by exploratory factor analysis. The BCSES-P will demonstrate an internal consistency coefficient of 0.70 or above. Construct validity of the BCSES-P will be demonstrated by support of the following theoretical relationships: Cancer-related self-efficacy will be positively related to marital satisfaction and sexual functioning (social well-being) and the distal outcome, overall QoL. Cancer-related self-efficacy will be negatively related to fatigue (physical well-being), fear of recurrence, depression, and anxiety (psychological well-being). DISCUSSION/SIGNIFICANCE OF IMPACT: Findings will guide intervention development to improve partners’ quality of life The BCSES-P will be the first scale to measure partners’ cancer-related self-efficacy. This study will highlight a holistic approach to studying the long-term effects of breast cancer on partners.

OBJECTIVES/GOALS: Socioeconomic status (SES) affects risk of disease and access to therapies. The expanded access (EA) pathway allows for the clinical use of investigational products for patients who have serious illness but no Food and Drug Administration (FDA)-approved therapeutic options. The SES of patients who receive EA is unknown. METHODS/STUDY POPULATION: We reviewed the patients who were approved for treatment through a single-patient EA pathway between 2018 and 2023. Using Michigan Medicine (MM) DataDirect software linked to the MM electronic medical record system, we linked the EA pathway patients to neighborhood data from the National Neighborhood Data Archive (NaNDA) to compare neighborhood related markers of affluence among EA patients and others treated at MM. We used descriptive statistics to compare variables between EA pathway patients and residents of the state of Michigan or the local county surrounding MM (Washtenaw County), using US Census tract data to provide context for these findings. RESULTS/ANTICIPATED RESULTS: MM patients who received EA treatments were more likely to come from neighborhoods that showed markers of high SES compared to residents of the state of Michigan but not Washtenaw County. This includes the proportion of persons living in poverty (12.5% EA / 13.4% Michigan / 12.4% Washtenaw) and education in the form of a bachelor’s degree or higher (32.2% / 30.6% / 57.2%). This varied by the disease being treated. Oncology patients were more likely to be from areas with less poverty and more education (12.4% / 76.8%) than the EA average. EA patients being treated for infectious diseases were from areas with more poverty and less education (13.5% / 26.7%). DISCUSSION/SIGNIFICANCE: Patients treated at Michigan Medicine using treatments obtained through the EA pathway came from areas that were, on average, more affluent than residents of the state of Michigan as a whole. This finding warrants more research to ensure equitable access to these therapies for patients in disadvantaged neighborhoods.

OBJECTIVES/GOALS: Insertable devices (IDs) for obstetric fistula (OF) management are feasible, acceptable, but not accessible; implementation determinants in low and middle-income countries (LMICs) are unknown. Thus, the purpose of this study was to understand pre-adoption facilitators and barriers among global stakeholders for a therapeutic ID for OF in LMICs. METHODS/STUDY POPULATION: Stakeholders, including researchers (n = 11), clinicians (n = 4), government officials (n = 2), and administrators (n = 4), were purposefully identified from various sectors involved in understanding and addressing the needs of women with OF: clinical care, academia, international health, civil society, and government. Twenty-one individuals were interviewed about their perceptions of IDs for OF self-management and their implementation. Interviews were audio-recorded and transcribed. The Consolidated Framework for Implementation Research (CFIR) guided data collection and analysis. Thematic analyses were carried out within Nvivo v.12. RESULTS/ANTICIPATED RESULTS: Determinants of implementation of an ID for OF self-management (by CFIR domain) include: (1) intervention characteristics—relative advantage and cost; (2) individual characteristics—knowledge and beliefs about the innovation; (3) inner setting-- organizational culture, implementation climate, tension for change, and compatibility; (4) outer setting-- patient needs and resources and external policy and incentives; (5) process—opinion leaders and collaboration. Facilitators include: tension for change for low-cost, accessible IDs; relative advantage over existing tools; development of partnerships; and identification of implementation champions. Barriers include: need for educational strategies to encourage clinical provider acceptability; lack of evidence of the optimal beneficiary. DISCUSSION/SIGNIFICANCE OF IMPACT: Tools for therapeutic OF self-management could be integrated into comprehensive OF programming. Employing the CFIR as an overarching typology allows for comparison across contexts and settings where OF care occurs and may be useful for clinicians, researchers, and policy-makers interested in implementing IDs for OF self-management in LMICs. CONFLICT OF INTEREST DESCRIPTION: I am working with colleagues at the non-profit Restore Health on developing an insertable cup for therapeutic self-management of obstetric fistula in LMICs

OBJECTIVES/SPECIFIC AIMS: Anxiety is prevalent in early childhood and, when left untreated, increases children’s risk for chronic anxiety and depression later in life. Maternal risk factors (e.g. income and marital status) have also been shown to heighten their children’s risk for the development of the aforementioned psychopathology. Sleep plays a critical role in behavior regulation, is affected in depression, and is influenced by a wide range of demographic and psychological variables. The purpose of this study was to examine the relationship between maternal sleep and the presence in their children of reported symptoms relating to anxiety, depression, and behavior regulation. METHODS/STUDY POPULATION: Children (n=59, aged: 4-9 years (M = 6.069, SD = 1.006, 59.3% female) and their mothers were sampled from clinic and community settings and were administered questionnaires. Maternal sleep quality was assessed by the Pittsburgh Sleep Quality Index, which captures both numeric and self-reported categories relating to an individual’s perception of their sleep. Child anxiety and depression were assessed via parent-reported Child Behavioral Checklist (CBCL). Maternal depression symptoms were assessed with the Beck Depression Inventory (BDI). Associations between these measures were analyzed by ANOVA with post-hoc analysis and linear regression as appropriate. RESULTS/ANTICIPATED RESULTS: A statistically significant difference was observed in the mean child CBCL scores when children were sub-set into maternal categories of self-reported days of dysfunction due to sleepiness over the past month. Mean child CBCL T-score domains with statistically significant differences were: attention problems (F = 4.935, p = 0.004), depression problems (F = 3.073, p = 0.035), ADHD (F = 4.422, p = 0.007), oppositional defiant (F = 2.865, p = 0.045), and total t-score (F = 3.073, p = 0.035). Maternal mean DBI scores were also statistically significantly different when grouped by days of maternal dysfunction due to sleepiness (F = 9.791, p < 0.001). There was no relation between these CBCL categories and maternal DBI scores. DISCUSSION/SIGNIFICANCE OF IMPACT: Maternal self-reported days of dysfunction due to sleepiness may potentially increase risk for their children to develop further psychopathology independent of mothers’ depression symptomatology. These findings highlight the need for broader assessment clinically of children’s environments with additional focus on maternal function given the potential impact on their children’s functional outcomes.

The shift in learning environments due to the COVID-19 pandemic necessitates a closer look at course design, faculty approaches to teaching, and student interaction, all of which may predict learner achievement and satisfaction. Transitioning to an online environment requires the reinvention, reimagining, and applying of “e-flavors” of general learning theory. With this shift to online learning comes the opportunity for misunderstandings and “myths” to occur, which may stand in the way of faculty embracing online learning and fully realizing its potential. This article seeks to address several myths and misconceptions that have arisen in higher education during the rapid shift to online teaching and learning. While not comprehensive, these myths represent a snapshot of common challenges. These are we can transfer our in-person course design to online; adult learners do not need an empathetic approach; and online teaching and learning is socially isolating. Through an appreciative inquiry framework, we present each myth in the context of relevant literature and invite faculty with varied online teaching experience to share their own case studies that illustrate how they have “busted” these myths with the goal to identify existing examples of locally effective practices for the express purpose of replication that leads to positive change.

Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) was an extraordinary example of a public-private partnership (PPP) that brought together over thirty organizations and hundreds of individuals to address one of the most pressing global health needs in recent decades. In particular, ACTIV provided a key avenue for testing numerous therapeutics for their potential benefit in treating the SARS-CoV-2 virus or the resulting symptoms of acute COVID-19 infection. Given the speed and scale at which ACTIV designed and implemented master protocols across global networks that it was simultaneously working to create, the PPP can provide valuable lessons for best practices and avoiding pitfalls the next time the world is faced with a global pandemic of a novel pathogen. This report provides a general overview of the ACTIV partnership to set the stage and context for the subsequent articles in this issue that will relay these lessons learned.

OBJECTIVES/GOALS: To compare the herbal medicine (HM) programs of the U.S. to those of different countries–including the European Union, South Korea, China, and India–and to examine each regulatory body’s process for obtaining market approval for HM drugs. METHODS/STUDY POPULATION: The European Union, South Korea, China, and India’s respective HM regulatory programs were examined and compared to the U.S. FDA’s HM process. These specific regulatory bodies were chosen based on the country’s long history with HM and/or the robustness of their existing HM review processes. International HM programs were researched using official government websites and journals published by independent, external research institutions that were accessed via USC’s library services. Data regarding the efficacy of HM policies such as HM IND approval rates, number of marketed HM drugs, and establishment of unique HM sectors will be collected. RESULTS/ANTICIPATED RESULTS: Investigational New Drug (INDs) applications regarding HM from each country will be categorized and displayed according to their approval status in order to provide insight on a HM program’s efficiency. Results also included a table displaying common challenges for approval for HM drugs across federal regulatory bodies. If applicable, effective solutions implemented to address some of these obstacles that proved to be effective will also be displayed in the form of a table. DISCUSSION/SIGNIFICANCE: Tables displaying the collective flaws of international HM programs and the resulting regulatory solutions can provide clearer guidance for companies seeking to submit HM INDs and for the U.S. FDA seeking to develop improved HM regulations.

OBJECTIVES/GOALS: This study seeks to comprehensively evaluate the extent to which participants in clinical trials (CT) for Atopic Dermatitis (AD) accurately mirror the demographics and characteristics of the broader AD-affected populations. We will achieve this objective by analyzing data from AD CTs spanning the years 2011 to 2022. METHODS/STUDY POPULATION: We examined completed trials for 10 FDA approved treatments for AD, utilizing data sourced fromclinicaltrials.gov [http://clinicaltrials.gov]. In light of the increased number of AD clinical trials over the past decade, we tailored our search parameters to encampass all trials related to approved treatments from 2011-2022. To assess the characteristics of the participant population in these trials, information including inclusion and exclusion criteria, age, location, sex, and disease severity were collected for each trial. Furthermore, race and ethnicity data were also extracted and analyzed. Additionally, comparisons were drawn between trials completed before and after April 2017, when the FDA began requiring that researchers publish race and ethnicity data toclinicaltrials.gov [http://clinicaltrials.gov]. RESULTS/ANTICIPATED RESULTS: Across 67 CTs examined, 45% of trials were restricted to adult patients, 28% were restricted to pediatric patients, and 27% included both. 77% of CTs occurred in urban settings and 23% occurred in rural settings according to the The Economic Research Service definition. 36% of CTs included mild-to-moderate AD patients, and 64% of CTs included moderate-to-severe AD patients. Race distribution of CTs revealed 67% White, 14% Black/African American, 16% Asian, and 3% others. 13% of participants identified as Hispanic or Latino. With further analysis, we will determine whether there is a difference in ethnic distribution between trials completed before and after April 2017, when the FDA started requiring race/ethnicity data to be submitted. DISCUSSION/SIGNIFICANCE: The findings highlight a significant concern in AD CTs: the insufficient representation of Black and Asian populations. The findings emphasize the need for a more inclusive selection process that accurately reflects the diversity of patients. Failing to do so could undermine the assessment of treatment effectiveness in such populations.

OBJECTIVES/SPECIFIC AIMS: The study aims to measure the associations between nonclinical factors and the likelihood of electing contralateral prophylactic mastectomy [(CPM) i.e. bilateral mastectomy for unilateral cancer] among women with breast cancer, with a focus on the roles of race, relationship status, and geographic location. The outcome of interest is a dichotomized surgery type variable (i.e. CPM versus other surgery). METHODS/STUDY POPULATION:. The Surveillance, Epidemiology, and End Results registry was queried to identify female breast cancer patients diagnosed at stage IA through IIIC from 2010 through 2015 and received surgery as part of their primary treatment (n=174,776). A multilevel logistic regression was used to model likelihood of CPM versus less aggressive surgical treatment (i.e. breast conserving surgery or unilateral mastectomy). Fixed-effects included age at diagnosis, race, relationship status, insurance type, county-level median income, county-level population density, stage at diagnosis (low-stage, IA-IIB; advanced-stage, IIIA-IIIC), an interaction term between race and stage at diagnosis, and breast tumor subtype. County of residence was used as a random-effect. RESULTS/ANTICIPATED RESULTS: Among women with low-stage cancer, compared to the reference class of white women, black women had 0.57 times lower odds of CPM (p<0.0001), Hispanic women had 0.69 times lower odds of CPM (p<0.0001), and Asian women had 0.60 times lower odds of CPM (p<0.0001). Among women with advanced-stage cancer, compared to white women, black women had 0.42 times lower odds of CPM (p<0.0001), Hispanic women had 0.51 times lower odds of CPM (p<0.0001), and Asian women had 0.45 times lower odds of CPM (p<0.0001). Compared to the reference class of single, never-married women, divorced/separated women had 1.25 times greater odds of CPM (p<0.0001), widowed women had 1.11 times greater odds of CPM (p=0.009), and married/partnered women had 1.18 times greater odds of CPM (p<0.0001). County-level variation from the random-effect (MOR, 1.49; p<0.001) had a greater influence on CPM election than fixed-effects for insurance class, breast tumor subtype, county median income, county population density, and year of surgery. DISCUSSION/SIGNIFICANCE OF IMPACT: The nonclinical factors associated with variation in breast cancer surgical decision-making suggest patients and providers both may benefit from further education about surgical treatment options. Providers may also benefit from educational materials that highlight treatment selection disparities within specific contexts, such as surgery for primary unilateral breast cancer. To more narrowly tailor future policy interventions, an additional mixed-methods exploration is recommended to clarify how relationship status and location serve as mechanisms for breast cancer decision-making.

OBJECTIVES/GOALS: In 2017, new guidelines recommended multi-step algorithms for CDI diagnosis, and clinical centers rapidly implemented changes despite limited pediatric data. We assessed a multi-step algorithm using NAAT followed by EIA for ability to differentiate symptomatic CDI from colonization in children. METHODS/STUDY POPULATION: We prospectively enrolled pediatric patients with cancer, cystic fibrosis, or inflammatory bowel disease who were not being tested or treated for CDI and obtained a stool sample for NAAT. If positive by NAAT (colonized), EIA was performed. Children with symptomatic CDI who tested positive by NAAT via the clinical laboratory were also enrolled and EIA performed on residual stool. A functional cell cytotoxicity neutralization assay (CCNA) was performed in addition. RESULTS/ANTICIPATED RESULTS: Of the 138 asymptomatic children enrolled, 24 (17%) were colonized. An additional 37 children with symptomatic CDI were enrolled. Neither EIA positivity (41% versus 21%, P = 0.11) or CCNA positivity (49% versus 46%, P = 0.84) were significantly different between symptomatic versus colonized children. When both EIA and CCNA were positive, children were more commonly symptomatic than colonized (33% versus 13%, P = 0.04). DISCUSSION/SIGNIFICANCE OF IMPACT: A multi-step testing algorithm with NAAT and EIA failed to differentiate symptomatic CDI from colonization in our pediatric cohort. As multi-step algorithms are moved into clinical care, pediatric providers will need to be aware of the continued limitations in diagnostic testing.

OBJECTIVES/GOALS: Transportation may be a barrier for individuals with Autism Spectrum Disorder (ASD). More individuals with ASD utilize public transportation compared to typically developing (TD) individuals. This study seeks to elucidate the transportation needs of individuals with ASD in the Southeast. METHODS/STUDY POPULATION: Sixty-one licensed drivers with a diagnosis of ASD (n = 21), Attention-Deficit/Hyperactivity Disorder (ADHD; n = 19), or no diagnosis (TD; n = 21) were recruited and were matched across diagnosis groups by age (16-30 years old), gender, and IQ. Participants completed an adapted version of the Barriers to Care Scale and a survey assessing transportation preferences and quality of life. Means and frequencies were obtained. Chi-square analyses were conducted to estimate associations between diagnosis and transportation preferences. RESULTS/ANTICIPATED RESULTS: Nearly all of the sample had access to a car (98.4%). Yet, only 71.4% of drivers ASD preferred to use their own car compared to 89.5% and 90.5% of the ADHD and TD groups respectively. The use of public transportation (6.6%) and ride-hailing services (18%) for general transportation needs was very low across the groups. There was a significant association between group type and the reliance on others for transportation (χ2(2,61) = 9.9, p < .01). Only 21.1% of those with ADHD relying on others for transportation needs, compared to 61.9% of TD and 66.7% of individuals with ASD. 23.8% of ASD drivers, 10.5% of ADHD drivers, and 9.5% of TD drivers believe transportation proved as an obstacle. DISCUSSION/SIGNIFICANCE OF IMPACT: The proportion of ASD drivers who believed transportation to be a barrier appeared slightly higher than other groups. Public transportation use may be low due to lower accessibility to such services in the Southeast. The travel patterns of individuals with ASD and ADHD merits further exploration.

OBJECTIVES/SPECIFIC AIMS: Examine data from PNID patients to evaluation the strength of associations between pre-operative and post-operative levels of pain, quality of life, and emotional reactions to pain to determine if one or more can serve as better predictors of surgical success than pain. METHODS/STUDY POPULATION: In our preliminary study, we gathered data from a pre-existing database of 464 PNID patients that contains self-reported visual analog scale scores (VAS) of pain intensity, QoL, and depression. We measured these variables at three time points: pre-operatively, post-operatively, and at the final visit. We used the Wilcoxon signed rank test to determine if each of these three variables differed significantly between the pre-operative visit and the post-operative visit period and from the pre-operative visit to the final visit. RESULTS/ANTICIPATED RESULTS: Median time from the pre-operative visit to surgery was 9 weeks; median time from surgery to the post-operative visit was 4 weeks; and median time from the post-operative visit to the final visit was 23.5 weeks. There was a clinically meaningful difference in pain scores between the pre-operative and post-operative visits (median difference 1.15; 95% CI 0.75-1.55). In the period between the post-operative visit and the final visit there was also a decrease in pain (0.90; 95% CI 0.55-1.30). The magnitude of change in median difference of 1.85 (95% CI 1.50-2.20) between the pre-operative visit and the final visit was larger than the change in median difference of 0.90 (95% CI 0.55-1.30) between the post-operative visit and the final visit. The pre-operative visit median QoL score was higher than the median score at the post-operative visit (1.65; 95% CI 1.25-2.10). The smallest median difference in QoL of occurred between the post-operative and the final visit (1.10; 95% CI 0.60-1.45). As seen with the pain scores, the magnitude of change in median difference of 2.50 (95% CI 2.20-2.85) for QoL was greatest between the pre-operative and the final visit. Depression scores showed the least amount of change amongst all the variables, between the pre-operative and the post-operative visit (1.00; 95% CI (0.70-1.40), and similarly between the post-operative visit and the final visit (0.15; 95% CI (0-.40). The median differences between the pre-operative and final visit were greatest in QoL (2.50; 95% CI 2.20-2.85), followed by pain scores (1.85; 95% CI 1.50-2.20), and finally, depression (1.05; 95% CI 0.70-1.40). DISCUSSION/SIGNIFICANCE OF IMPACT: Our results show that all three variables measured improve with surgery and continue to improve over the post-operative course to the final visit. This suggest that the relationships between pain, QoL, and depression should be further investigated. We are hopeful that elucidating how these variables interact in the PNID patient population, will encourage peripheral nerve surgeons to use these parameters in conjunction with pain intensity to measure outcomes. A follow-up study expanding on these results and including measures of anger and frustration in a larger sample is underway.

OBJECTIVES/GOALS: Physicians can request the clinical use of investigational products for their patients through an FDA pathway called Expanded Access (EA). Most evaluations of EA focus on the FDA submission only. We sought to evaluate these requests through the full academic medical center process. METHODS/STUDY POPULATION: Through the Transforming Expanded Access to Maximize Support and Study grant, we reviewed regulatory records for single-patient EA requests at four institutions (Duke University, University of Rochester, University of Michigan, and University of Texas Southwestern) which occurred between June 1, 2021 and February 28, 2023. Key data was collected, including the investigational product requested, submission and approval dates, urgency of request, and indication for treatment. Descriptive statistics were performed with Microsoft Excel. RESULTS/ANTICIPATED RESULTS: A total of 405 EA requests were identified, of which 319 (78.8%) were for drugs, 59 (14.6%) for biologics, and 27 (6.7%) for medical devices. The majority were characterized as non-emergency (60.7%), but the proportion of emergency to non-emergency cases varied considerably when stratified by year, with a peak in emergency cases in 2020. The most common products included therapies for COVID-19 and Mpox. Median time to obtain all approvals for treatment was 7 days for emergency cases and 28 days for non-emergency. The FDA review took the least time, with a median of 1 day in non-emergency cases. Full board approval from an institutional review board in non-emergency cases was 7 days. DISCUSSION/SIGNIFICANCE: These results generally align with previous reports on EA submissions received by the FDA. The timelines for the EA process represent an important benchmark both for treatment planning and institutional improvement.

OBJECTIVES/GOALS: There are two objectives: 1) To identify healthcare providers’ (HCP) barriers and potential solutions towards rural adolescents’ access to mental healthcare. Healthcare providers include pharmacists, physicians, and mental healthcare providers (MHPs). 2) To identify rural high schoolers’ barriers and potential solutions towards access to mental healthcare. METHODS/STUDY POPULATION: Fifteen HCPs will be recruited via email listserv and the snowball method. Perceived barriers of rural adolescents, personal barriers, current practices to address mental health in adolescents, and preferred solutions will be discussed. Twenty student and parent dyads will be recruited using fliers in school systems and will be interviewed individually outside of class time on school grounds or over the phone. Barriers to care and preferred solutions will be discussed. All interviews will be semi-structured, recorded, conducted in person or over the phone, and last for 30 minutes to an hour. Compensation will be $25 for students and parents each, $50 for pharmacists and mental health providers and $100 for physicians. Thematic qualitative data analysis will be performed using Atlas.ti software. RESULTS/ANTICIPATED RESULTS: Data collection is ongoing. Anticipated results for barriers include absence of mental healthcare providers in rural areas, inability to access mental healthcare providers further away, stigma towards mental healthcare, and lack of knowledge of mental health conditions and treatment. Anticipated results for potential solutions may include promoting mobile applications to assist with telehealth and self-care. Other solutions may be collaboration among rural healthcare providers for adolescents with mental health conditions. Preferred solutions may also include pharmacists disseminating knowledge to rural adolescents and their parents or referrals to mental healthcare providers. DISCUSSION/SIGNIFICANCE OF IMPACT: This project will identify barriers and solutions to access to mental healthcare among rural adolescents. These solutions can then be applied towards the creation of programs that address salient issues within rural communities with a greater chance of uptake and use so that rates of depression and suicide will decrease. CONFLICT OF INTEREST DESCRIPTION: Funding through UAB TL1 award.