OBJECTIVES/GOALS: To assess whether FDA regulations aimed at the pediatric population following the Best Pharmaceuticals for Children Act (BPCA) of 2002 are effective, this study examines the inclusion of the pediatric population in recent clinical trials for drugs used by both adult and pediatric groups. METHODS/STUDY POPULATION: From the U.S. Food and Drug Administration (FDA) a list of drugs approved between 2016 and 2018 was compiled. A search of clinicaltrials.gov provided corresponding clinical trials for the approved drugs. Study information such as eligibility criteria and demographics was gathered from each trial. From studies that included both adult and pediatric populations, the percentage of pediatric and adult subjects was calculated, resulting in values expressing exclusively pediatric subjects or the pediatric subjects as part of a category that included both populations (i.e. 18 years old). RESULTS/ANTICIPATED RESULTS: Between 2016 and 2018, 26 drugs were approved under the BPCA. From an assessment of 220 total studies, a lack of standardization is evident in terms of which ages constitute a particular pediatric sub-population even though guidelines for these sub-populations already exist under the BPCA. This lack of standardization resulted in the separate examination of each drug for pediatric inclusion. For the majority of the trials evaluated, 1% of the pediatric population was represented in trials that were open to both adult and pediatric populations. DISCUSSION/SIGNIFICANCE OF IMPACT: There is a need for more effective regulations and incentives for the pharmaceutical industry to standardize data presentation and better incorporate the pediatric population in clinical trials, especially for drugs targeted for this group.

OBJECTIVES/GOALS: Lupus lesional skin has elevated interferon expression, is highly colonized with Staphylococcus aureus (50%) and has no FDA-approved treatment options. We decided to investigate the effect of topical antibiotics on lupus lesional skin to determine whether it affects inflammatory gene expression. METHODS/STUDY POPULATION: Adult Systemic Lupus Erythematosus (SLE) patients with skin inflammation were recruited for this study from the Michigan Lupus cohort. All patients gave informed consent approved by the University of Michigan IRB. Lesions were swabbed for S. aureus colonization and then skin biopsies were collected from the affected area. Patients were then randomized for either mupirocin treatment or VaselineTM as the control. Product was applied to the lesion thrice daily for 7 days and swab samples and biopsies were collected again. Biopsies were saved at −80 °C. RNA was isolated from the biopsies, checked for quality and RNA-sequencing was performed to determine transcriptomic changes. RESULTS/ANTICIPATED RESULTS: Our preliminary results indicate that a higher number of genes are differentially expressed (DEGs) following treatment with mupirocin (184) than VaselineTM (133). Interestingly the DEGs from the two treatments were almost completely independent with only a few that were DE in both treatments when the data were fitted to a scatter plot. Functional enrichment analysis of the data showed significant downregulation of cytokine and chemokine pathways in the mupirocin but not the VaselineTM treatment group. DISCUSSION/SIGNIFICANCE OF IMPACT: Our preliminary data suggests that inflammatory signaling can be reduced in lesional skin by reducing bacterial load by topical antibiotic treatment in lupus patients. This can be particularly helpful in patients who are recalcitrant to typical treatment protocols for skin inflammation. CONFLICT OF INTEREST DESCRIPTION: J.M.K. received research funding from Celgene and serves on advisory boards for AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, and Eli Lilly and J.E.G. received research funding from AbbVie, SunPharma, Celgene, and Genentech and serves on advisory boards for Novartis, AbbVie, and MiRagen. The other authors have no financial conflicts of interest.

OBJECTIVES/GOALS:

• To describe trends in fall risk screening and referrals to community-based programs among physical therapy professionals.

• To compare fall risk screening practices to clinical practice guidelines among

• To identify gaps in fall risk screening and referrals to community-based programs among physical therapy professionals.

METHODS/STUDY POPULATION: A panel of experts between the American Physical Therapy Association (APTA) - Geriatrics, and the National Council on Aging (NCOA) developed a web-based survey to identify practices among physical therapy professionals (PTs) for fall risk screenings and community-based referrals for older adults. The web-based survey was disseminated to PTs via email, e-blasts, and social media. The survey focused on questions related to knowledge of fall risk screening tools, fall risk management for older adults, and knowledge of and referrals to community-based interventions. RESULTS/ANTICIPATED RESULTS: To date, 453 PTs representing 50 states completed the survey. The majority of PTs (50.9%) had over 20 years of experience in various settings. Eighty-three percent regularly screen older adults for fall risk. Approximately 40% conduct community-based screenings. The majority (81.3%) were somewhat to very familiar with the CDC-recommended STEADI (Stopping Elderly Accidents, Deaths, and Injuries) screening toolkit. Despite familiarity, only 32% responded to the question if they used STEADI for screening. Of those, 83.4% used the tool. The majority (73.4%) of PTs were aware that NCOA recommends evidence-based programs to address health needs of aging adults and 59.6% refer. PTs did not refer due to lack of knowledge that programs existed (21.3%) or lack of knowledge of availability (33.3%). DISCUSSION/SIGNIFICANCE OF IMPACT: Although PTs are have some familiarity with the STEADI for fall risk screening, the tool is not common in practice. PTs are lacking awareness of local evidence-based community programs to address health needs of aging adults. Educational efforts should target these knowledge gaps and provide additional resources to improve referrals.

OBJECTIVES/GOALS: The UCLA Clinical and Translational Science Institute’s Population Health Program is creating versatile scientists who can solve population health problems. This means building learning capability in health care and public health agencies, and fostering a cross-sector, outcomes-based, regional ecosystem for implementation and improvement. METHODS/STUDY POPULATION: A synthesis of achievements and lessons learned reveals the Program’s trajectory. It maps progress in science leading to sustainable interventions for target populations. PHP goals are predicated on networked team science, rather than disorganized assortment of individual studies and interventions, and emphasize design, modeling and iteration. Evolving metrics include network analysis to document collaborative impact; extent of integrating real-world application into systems science and learning system curriculum; legislative and institutional policies developed and adopted; evidence of system orientation, cross-sector focus, and implementation research in scientists’ portfolios; and demonstration of population health impact. Barriers offer the opportunity for iteration and improvement. RESULTS/ANTICIPATED RESULTS: The PHP has progressed in its envisioned shared university-public health stewardship of translation and transformation. Milestones included galvanizing activities such as annual regional dissemination, implementation, and improvement (DII) symposia and Public Health Science Summits; pre- and post-doctoral experiential learning of system science and learning system methods based in Los Angeles County Health Agency initiatives; development of a regional CTSA network for implementation science training; strengthened public health policy practice (e.g., establishing a new Office of Youth Diversion and Development); learning healthcare system capability; and prototypes of population learning systems focused on hypertension, food insecurity, tobacco/vaping, and complex care management. DISCUSSION/SIGNIFICANCE OF IMPACT: PHP is committed to advancing science for population health. Prototypes were an essential initial phase. New areas include use of methodological advances (e.g., artificial intelligence, rapid assessments) in health and public health systems; an academic home for full-time, population-focused clinicians; and social policy innovations.

OBJECTIVES/GOALS: To explore the patterns, sequence, quantity, frequency and duration of poly substance use among adults for back translation of information to rodent models. METHODS/STUDY POPULATION: From May –December 2019, we conducted 13 focus group discussions with adults 19 to 63 years of age who reported concurrent use of cocaine with alcohol and/or marijuana in the past 30 days. All participants were recruited from the community through community outreach activities. Written informed consent was obtained and all focus group discussions were audio recorded, transcribed and analyzed using the qualitative data analysis software Atlas Ti™. RESULTS/ANTICIPATED RESULTS: A total of 34 cocaine users, (68% male, and 59% minority) participated. The majority reported cocaine as the drug of preference, while marijuana and alcohol were used to extend or control the ‘highs’, or ‘to take the edge off’ after cocaine use. All participants reported when they used alcohol with cocaine, they could keep drinking a large amount of alcohol without feeling its effect. Participants also reported using marijuana throughout the day while driving, at work, or in class. Frequent patterns noted for the study included using two drugs at the same time or right before or after each other with alcohol used throughout the day. Participants also gave feedback on our Poly Substance Use (PSU) assessment that captures exact patterns so that the most common can be translated for the rodent models. DISCUSSION/SIGNIFICANCE OF IMPACT: Our focus group discussions provided detailed information on patterns, sequence, quantity, and types of poly substance use that could be useful for developing a poly substance use assessment in the collection of data for rodent models to understand effects of poly substance use.

OBJECTIVES/GOALS: Using multi-state discharge data, to identify predictors of frequent emergency department (ED) use among the homeless patients seen in emergent care, and to compare frequent versus less frequent homeless ED users for their risk of serious health services utilization outcomes. METHODS/STUDY POPULATION: Based on the State Emergency Department Database and the State Inpatient Database, homeless individuals (n = 88,541) who made at least one ED visit in four states (Florida, Maryland, Massachusetts, and New York) in 2014. In this retrospective cross-sectional analysis, patient-level demographic and clinical factors were assessed as predictors for increased ED use. Risks of opioid overdose, opioid-related hospital admission/ED visit, in-hospital mortality, mechanical ventilation, and number of hospitalizations were compared between individuals with 4 or more vs. 2-3 vs. 1 ED visit(s), adjusting for potential confounders including hospital fixed effects (allowing for within hospital comparisons). RESULTS/ANTICIPATED RESULTS: Higher rates of ED use were associated with Medicare coverage <65; primary diagnosis of alcohol abuse, asthma, or abdominal pain; and co-morbidity of alcohol abuse, psychoses, or chronic pulmonary disease. Individuals with ≥4 visits had significantly higher adjusted risk of opioid overdose (3.7% vs. 1.2% vs. 1.0%), opioid-related hospitalizations/ED visits (17.9% vs. 8.5% vs. 6.6%), mechanical ventilation (9.8% vs. 7.0% vs. 4.7%), and greater # of hospitalizations (3.2 vs. 1.3 vs. 0.8) compared to individuals with 2-3 or 1 ED visit. Individuals with ≥4 and 2-3 ED visits had similar but increased risks of in-hospital mortality compared to individuals with 1 ED visit (2.8% vs. 2.8% vs. 2.3%). DISCUSSION/SIGNIFICANCE OF IMPACT: Homeless patients who were high ED users were more likely to be hospitalized and have other adverse outcomes. These findings encourage targeted interventions (i.e. housing) for the high-utilizer homeless population to reduce the burden of serious outcomes and costs for the patient and society.

OBJECTIVES/GOALS: Highly Active Antiretroviral Therapy (HAART) is beneficial for managing HIV infection, however the long-term use of HAART may be problematic for healthy weight maintenance. The aim of the study was to investigate the association of race, weight status, and co-morbidities among individuals with HIV. METHODS/STUDY POPULATION: Self-reported data from 283 participants who completed the Symptom Checklist, the Co-Morbidity Questionnaire, and the Sociodemographic Questionnaire were included in the data analyses. Data were analyzed using Latent Class Analysis on JMP 13. Approximately 50% of participants self-identified as Black, 69% as male, and 35% as having AIDS. Participants’ age ranged from 25 to 66 years (mean age = 43.70 years, SD = 8.14). Participants were grouped by race (self- reported Black or non-Black), and then each group was clustered based on the top three most prevalent symptoms. The clusters identified were least symptomatic, weight gain, and weight loss. RESULTS/ANTICIPATED RESULTS: The non-Black weight gain cluster reported a higher incidence of AIDS (70.6% vs 38.2%), nausea (70.6% vs 17.6%), diarrhea (70.6% vs 26.5%), and shortness of breath (58.8% vs 20.6%) compared to the Black weight gain cluster. The Black weight loss cluster reported a higher incidence of cardiovascular symptoms including chest palpitations (42.2% vs 2.7%), chest pain (44.4% vs 8.1%), and shortness of breath (73.3% vs 35.1%) and a higher incidence of all GI symptoms with the most prominent being diarrhea (71.1% vs 48.6%) compared to the non-Black weight loss cluster. DISCUSSION/SIGNIFICANCE OF IMPACT: Future studies supporting these results will assist practitioners to target treatments that may prevent adverse health outcomes for individuals with HIV on HAART. Further studies will also assist with setting standards that allow practitioners to provide personalized care for individuals with HIV on HAART.

OBJECTIVES/GOALS: We sought to examine: 1) variability in center acceptance patterns for heart allografts offered to the highest-priority candidates, 2) impact of this acceptance behavior on candidate survival, and 3) post-transplantation outcomes in candidates who accepted first rank offer vs. previously declined offer. METHODS/STUDY POPULATION: In this retrospective cohort study, the US national transplant registry was queried for all match runs of adult candidates listed for isolated heart transplantation between 2007-2017. We examined center acceptance rates for heart allografts offered to the highest-priority candidates and accounted for covariates in multivariable logistic regression. Competing risks analysis was performed to assess the relationship between center acceptance rate and waitlist mortality. Post-transplantation outcomes (patient survival and graft failure) between candidates who accepted their first-rank offers vs those who accepted previously declined offers were compared using Fine-Gray subdistribution hazards model. RESULTS/ANTICIPATED RESULTS: Among 19,703 unique organ offers, 6,302 (32%) were accepted for first-ranked candidates. After adjustment for donor, recipient, and geographic covariates, transplant centers varied markedly in acceptance rates (12%-62%) of offers made to first-ranked candidates. Lowest acceptance rate centers (<25%) associated with highest cumulative incidence of waitlist mortality. For every 10% increase in adjusted center acceptance rate, waitlist mortality risk decreased by 27% (SHR 0.73, 95% CI 0.67-0.80). No significant difference was observed in 5-year adjusted post-Tx survival and graft failure between hearts accepted at the first-rank vs lower-rank positions. DISCUSSION/SIGNIFICANCE OF IMPACT: Wide variability in heart acceptance rates exists among centers, with candidates listed at low acceptance rate centers more likely to die waiting. Similar post-Tx survival suggests previously declined allografts function as well as those accepted at first offer. Center-level decision is a modifiable behavior associated with waitlist mortality.

OBJECTIVES/GOALS: We conducted interviews with investigators, clinicians, and health system and health agency leaders to assess regional educational needs in implementation and improvement science, including content (knowledge and skill), format, experiential learning, and mentoring, to identify barriers and guide planning. METHODS/STUDY POPULATION: Five CTSAs in the University of California Biomedical Research Acceleration, Integration, & Development consortium (UC BRAID) plus a fifth affiliated CTSA developed a common protocol and interviewed 31 California-based learners (current fellows, early and mid-career investigators, clinicians, and health agency personnel) and system leaders from health care and health agencies. Interviews focused on impact goals, educational needs in dissemination, implementation, and improvement (DII) science, challenges in DII research, preferred learning formats, desired proficiencies and skills, and barriers such as cost, time, awareness, terminology, and suitability and availability of training. A rapid review of literature identified potential domains of knowledge and skills for a proposed curriculum. RESULTS/ANTICIPATED RESULTS: Areas of emphasis varied among interviewees; identified learning needs differed between traditional research perspectives (emphasizing areas such as partner engagement, grant writing, frameworks, study design) and applied perspectives (emphasizing areas such as managing change, complex systems, learning system capacity). Learners had a range of preferences; most interviewees desired formats that are longitudinal, experiential, applied, cooperative, and affordable. Variation in knowledge of, and interpretations of, DII terms and goals limited the ability of some interviewees to specify educational needs. A synthesis reveals areas for potential future co-development and networked approaches to regional training and capacity enhancement. DISCUSSION/SIGNIFICANCE OF IMPACT: In response to a rapidly changing health landscape, our academic health systems are developing capabilities to improve care for their populations. Our work informs the training and education needs that are critical to translation at a system-wide level. Regional convenings can raise awareness while translational programs fill educational gaps.

OBJECTIVES/GOALS: The purpose of this study is to identify and quantitatively describe environmental barriers to community engagement and activity participation for adults with stroke and low income. Repeated electronic surveys collected in real time will reduce recall bias and improve characterization of barriers. METHODS/STUDY POPULATION: 20-30 community-dwelling adults with stroke and low income will be recruited for this pilot study. Inclusion criteria: > 1 month post stroke and evidence that they have the vision, literacy, and cognitive capacities to answer survey questions on a smart device. Exclusion criteria: severe aphasia, severe mental illness or substance abuse within 3 months, and ataxia. Participants will complete standardized assessments of daily activities, engagement in and perceptions about community activities, social support, and perceived environmental barriers. Participants then complete four surveys per day for 14 days using an app on an iPod Touch, reporting activities attempted and barriers encountered. RESULTS/ANTICIPATED RESULTS: This is the first study of this kind and is a work in progress. We anticipate that the environmental barriers reported will include physical (e.g. built structures, climate, and natural terrain), social (e.g. support or lack thereof; stigma), political (e.g. access to transportation; healthcare services), and technological barriers (e.g. difficulties with personal equipment and/or technologies such as elevators, ticket kiosks, etc.). DISCUSSION/SIGNIFICANCE OF IMPACT: An increased understanding of the barriers facing community-dwelling adults with stroke and low income will facilitate the development of culturally-appropriate and more accessible self-management programs to help this population re-engage in their communities and return to pre-stroke activities.

OBJECTIVES/GOALS: To test if a machine learning algorithm could predict a person’s capacity to binge drink and explore what measures might be important for identifying individuals at risk for high-intensity binge drinking behaviors. METHODS/STUDY POPULATION: The sample included 1177 (474 female) non-treatment-seeking drinkers (age: 18-91 years), that were assigned to a group based on their heaviest drinking day reported in a 90-Day Alcohol Timeline Followback questionnaire. The groups were Non-Bingers (female: 12 drinks, male:>15 drinks). The sample was divided into a training sample (N = 884) and a testing sample (N = 293). A machine learning algorithm called random forest was then used to generate a predictive model based on measures of substance use, personality traits, and trauma. The model was applied to the testing sample to determine accuracy. RESULTS/ANTICIPATED RESULTS: The first model correctly assigned 190 out of 293 subjects, giving it a total error rate of 0.35, with lowest rates for non-binge (0.19) and high-intensity (0.18), while medium-intensity had the highest error rate (0.86). The most important variables for the accuracy of the model included: total score on the Alcohol Use Disorder Identification Test, first five sub-score of the Self-Reported Effects of Alcohol, Compulsive Drinking subscale, and presence of a current psychiatric diagnosis. As a follow-up analysis, we built and tested another random forest model without the use of drinking dependence measures. This model had a total error rate of 0.39, and introduced other important variables such as smoking behaviors, perceived stress, IQ, and number of negative life events. DISCUSSION/SIGNIFICANCE OF IMPACT: Our study showed that it was possible for a machine learning algorithm to predict binge drinking intensity better than chance. Drinking patterns were the most robust predictors, and stress, IQ, and psychiatric diagnoses were also useful in predicting binge drinking intensity.

OBJECTIVES/GOALS: This work-in-progress aims to: 1) identify and differentiate symptom pattern trajectories in a sample of older adult heart failure (HF) patients over 24 weeks, and 2) examine associations between sociodemographic/clinical/physiological characteristics, dyadic health, and symptom trajectories. METHODS/STUDY POPULATION: ENABLE CHF-PC, a palliative care RCT (NCT02505425), was conducted at a Southeastern US medical center. Between 2016-2018, 415 older adult HF patients and 159 family caregivers were randomized to receive a psychoeducational intervention or usual care. Baseline sociodemographic information (age, gender, rurality, etc.) were collected. Outcome variables of interest include symptoms (Kansas City Cardiomyopathy Questionnaire (KCCQ), Functional Assessment of Chronic Illness Therapy-Palliative 14, Hospital Anxiety and Depression Scale (HADS)) and dyadic health (PROMIS-SF Global Health). We have calculated baseline descriptive statistics. Future work includes latent growth mixture modeling to identify distinct symptom trajectories and univariate associations with patient level factors. RESULTS/ANTICIPATED RESULTS: Of 415 patient participants, mean age was 64, 53% were male; 55% were African American; 26% were rural dwellers; 46% had +15.8) and low anxiety (6.7+3.6) and depressive symptoms (5.7+4.3) on the HADS. Of 159 family caregivers participants, the mean age was 57.9, 85.4% were female, 51.9% were African-American, and 65.2% were the patient’s spouse/partner. DISCUSSION/SIGNIFICANCE OF IMPACT: Limited data describes HF symptom pattern trajectories.How co-occurring symptoms affect quality of life or are affected by personal or situational factors are not well-understood. This study will help to identify factors and symptom phenotypes that may serve as targets for future interventions.

OBJECTIVES/GOALS: The goal of this mixed methods project is to develop a comprehensive framework of the personal and care-related needs of informal caregivers of people with dementia. This model can be used to enhance targeted delivery of evidence-based services to caregivers in need. METHODS/STUDY POPULATION: To create a model of the personal and care-related needs of family caregivers of people with dementia, we conducted semi-structured in-depth interviews with current caregivers (N = 12) and conducted a content analysis of materials related to government reports and evidence-based interventions (N = 28) and existing measures of dementia caregiver needs (N = 54). Content analysis is a systematic qualitative methodology that is used to distill complex source material into content-related categories and is well-suited for both interview data and document data (Elo & Kyngäs, 2008). We identified themes related to caregiver needs through examination of materials within and across source categories. RESULTS/ANTICIPATED RESULTS: We propose a framework of five inter-related need categories: Environmental needs (e.g., transportation, health-care access, financial resources, time), psychological needs (e.g., emotional wellbeing, identity/autonomy, perceived preparedness), social needs (e.g., social support, family dynamics), health-related needs (e.g., health behaviors, sleep), and needs related to the care and functioning of the person with dementia. We also consider how needs and background characteristics transact to influence which services may be of greatest use. In the future, we plan to test this model empirically with a nationally representative sample of caregivers. DISCUSSION/SIGNIFICANCE OF IMPACT: Evidence-based services exist to meet the needs of dementia caregivers. A dearth of models clearly defining caregiver needs limits empirically-based plans for dissemination of services. We have identified a framework of the needs of family caregivers from which to create targeted dissemination plans.

OBJECTIVES/GOALS: We aim to identify and characterize anti-Sox2-specific CD8+ T cell responses in stable MUGS patients expressing HLA class I alleles-A*02:01 and /or -B*07:02. METHODS/STUDY POPULATION: Cross sectional study of patients with stable MGUS defined as stable serum paraprotein for ≥ 12 months from the MM Research Clinic at the Abramson Cancer Institute. Sox2 T cell reactivity will be assessed by IFN-γ ELISPOT assays. Rested PBMC will be pulsed with candidate Sox2-derived peptides predicted to display high affinity to HLA class I alleles and known to be processed and presented as determined by “targeted MS/MS” (mass spectrometry). The presence of anti-Sox2-specific CD8+ T cells will be confirmed in peptide/HLA multimer assays using flow cytometry. Anti-Sox2-specific CD8+ T cells will be characterized for HLA restriction and TCR αβ composition. RESULTS/ANTICIPATED RESULTS: Our work is still in progress. From Aug to Dec 2019, 22 MGUS subjects have been analyzed, 11 of which were found to have the HLA of interest. Positive Sox-2 reactivity by ELISpot was found in 3 subjects. DISCUSSION/SIGNIFICANCE OF IMPACT: Anti-Sox2 immune responses may maintain MGUS in a clinical indolent state by eliminating Sox2-expressing clonogenic MM cells. A detailed characterization of anti-Sox2 T cells followed by in-vivo assessment of their anti-myeloma activity could provide the foundation for a Sox2 based immunotherapy approach in MM.

OBJECTIVES/GOALS: Neuroblastoma (NB) is the most common extra-cranial solid tumor with outcomes varying from spontaneous regression to metastatic with high mortality rates. The tumor immune microenvironment (TIME) may play a significant role in this disease. In this study we analyze the TIME comparing high-risk (HR) and low-risk (LR) NBs using multiplex platforms. METHODS/STUDY POPULATION: Two tissue microarrays (TMAs) with 2mm cores were created from 41 patients treated at Columbia University Irving Medical Center. Five micron TMA slides were stained for Digital Spatial Profiling (DSP, nanoString) and multiplex immunofluorescence (mIF). For DSP, a 24-patient subset including 11 HR, 8 LR and 4 intermediate risk patients was analyzed for 34 proteins. Protein expression among risk groups was compared using Mann-Whitney t-test. For mIF, TMA FFPE slides were stained for DAPI, CD3, CD8, CD68, HLA-DR, PDL1 and Chromogranin A. Whole TMA cores were captured as 9 -20X multispectral images (MSIs) stitched into a 3x3 MSI using Vectra (Akoya). MSIs were processed with inForm and qualitative analysis performed comparing HR and LR tumors. RESULTS/ANTICIPATED RESULTS: With DSP, we find significantly more HLA-DR in HR compared to LR tumors (p = 0.016). When controlling for immune cells with CD45 we find HLA-DR/CD45 to be higher in HR than LR tumors (p = 0.026). We found increased PD1 and PDL1 expression in all groups without significant difference between LR and HR (p = 0.778 and p = 0.310, respectively). Preliminary analysis of mIF on 9 patients (4 HR and 5 LR) finds HR tumors appear to have more immune cells than LR tumors, specifically more CD3+CD8- T cells while total CD8+ cells may be similar. There may be less macrophages in the HR compared to LR tumors. Completion of image processing and quantitative analysis of mIF data is underway. DISCUSSION/SIGNIFICANCE OF IMPACT: Increased expression of immune markers in NB TIME correlates with higher risk, which is unlike many other tumors. We compared TIME in HR and LR NB using multiplex platforms, DSP and mIF. We find that HLA-DR is more expressed in HR NB while PD1 and PDL1 expression is consistently high and not different between risk groups. Further analysis is underway. CONFLICT OF INTEREST DESCRIPTION: Robyn D. Gartrell-Corrado received grant support from nanoString for Digital Spatial Profiling and received honoraria and travel support from Northwest Biotherapeutics and PerkinElmer, respectively.

OBJECTIVES/GOALS: Intravenous immunoglobulin (IVIG) is used for infection prevention in pediatric B-cell acute lymphoblastic leukemia (B-ALL), but evidence for this is lacking. We describe the prevalence of hypogammaglobulinemia in pediatric B-ALL, predictors of IVIG use and its efficacy for infection prevention. METHODS/STUDY POPULATION: We will conduct a retrospective review of children age 1-21 years with B-ALL treated at Aflac Cancer and Blood Disorders Center from 2010 to 2017. The cohort was identified through the cancer registry. Demographics, disease factors, laboratory values, medications and infection outcomes were linked between the electronic medical record and an institutional database. Outcomes of interest include emergency department (ED) visits, hospitalization days, and episodes of infection. Descriptive statistics will be performed. Outcomes will be compared between IVIG recipients and non-recipients. Univariate and multivariate logistic regression models will assess predictors of IVIG administration. RESULTS/ANTICIPATED RESULTS: We identified 443 patients with B-ALL during the study period who met inclusion criteria. Exclusion criteria included receipt of IVIG or hematopoietic stem cell transplant prior to diagnosis. The average age at diagnosis is 6.5 years (standard deviation 4.8 years); 52.6% are male; 61.6% are white; 61.0% are standard risk per National Cancer Institute criteria. Among eligible patients, 137 (31.1%) received IVIG. We hypothesize that IVIG initiation is associated with hypogammaglobulinemia and history of severe infection. We also anticipate that frequency of emergency department visits, hospitalization days, and episodes of infection will decrease after IVIG initiation. DISCUSSION/SIGNIFICANCE OF IMPACT: The immunological profile of children with B-ALL and factors influencing their susceptibility to infection are still incompletely understood. The benefits of IVIG are unknown. This study will provide evidence for IVIG prophylaxis recommendations in pediatric leukemia patients.

OBJECTIVES/GOALS: Lung cancer is the leading cause of cancer-related mortality in the United States for both men and women. African Americans are disproportionately affected with lung cancer, having higher incidence and mortality rates compared to Caucasian men and women. African American smokers are diagnosed with lung cancer at a lower age with lower cumulative smoking history. Differences in socioeconomic and environmental factors likely contribute to lung cancer disparities, but less is known about acquired biologic alterations that can promote initiation and progression of lung cancer, particularly in African Americans. This is of interest because there may be other biological, genetic, or environmental factors contributing to lung cancer outcomes as it relates to differences in gender and race. One potential biologic variable may be in the DNA repair capacity (DRC), which describes a cell’s ability to repair damage to DNA caused by carcinogens, oxidants, and radiation. Altered DNA repair is a hallmark of cancer, leading to mutations and malignant transformation. We hypothesize that DRC is decreased in African Americans with lung cancer compared to Caucasian Americans with lung cancer, contributing to the disparity that exists in this racial group. We will 1) perform a retrospective chart review to determine demographic differences between African Americans and Caucasians at three central Indiana hospitals and 2) determine the impact of race and lung cancer on DRC amongst African Americans and Caucasians with and without lung cancer. METHODS/STUDY POPULATION: Lung cancer patients are identified in 3 central Indiana hospitals with different payer source and patient populations using ICD codes. Collected demographics include age, gender, pack-years, lung cancer histology, treatment, and mortality. DRC is measured by host-cell reactivation (non-homologous end-joining and nucleotide excision repair pathways) by flow-cytometry. Measurement of DRC is performed on PBMCs obtained from 120 patients (male and female, African Americans and Caucasians with and without lung cancer). Correlation of DRC and lung cancer will be determined by comparing lung cancer diagnosis to quartile DRC, and adjusted for confounders (measured demographics). Correlative measures will include measures of DNA damage and genomic instability. RESULTS/ANTICIPATED RESULTS: 3450 lung cancer patients were diagnosed with lung cancer at Indiana University Hospital between 1/1/2000 – 5/31/2015. Of these, 48.2% were female and 92.7% smokers. African Americans, Caucasians and Other ethnicities represented 12%, 86% and 2%, respectively. Of smokers, 11.4% were African American. The primary payer source was Federal/Medicare. Retrospective review of lung cancer patients from two additional health systems (county and VA hospitals) will be performed as above with outcomes measured. DRC and additional correlative measures will be performed as in Methods. DISCUSSION/SIGNIFICANCE OF IMPACT: If present, altered DRC in African Americans compared to Caucasians may contribute to the disproportional impact of lung cancer on African Americans. If DRC is decreased in African Americans with lung cancer, future studies will focus on identifying potential genetic, epigenetic and environmental causes for this decrease.

OBJECTIVES/GOALS: The objective of this study is to examine the relationship between gastro-intestinal (GI) patients’ health literacy levels and patients’ health outcomes (length of stay, readmission, complication). METHODS/STUDY POPULATION: A research team at the University of Alabama at Birmingham (UAB) ‘s Gastro-Intestinal (GI) surgical department collected inpatient GI patients’ health literacy data by distributing the Brief Health Literacy Screen (BRIEF) survey to patients are about to be discharged. Patients’ health outcomes data were gathered through Business Objects, an online platform that allows physicians and researchers to access and gather patients’ medical information with an IRB approval. After accounting for necessary control variables, logistic regression and multiple linear regression models will be run to assess whether there is a significant relationship between patients’ health literacy levels and patients’ health outcomes. RESULTS/ANTICIPATED RESULTS: Three specific hypotheses are proposed in this study. H1: GI patients’ health literacy levels will be negatively associated with their lengths of stay H2: GI patients’ health literacy levels will be negatively associated with their readmission status to the hospital H3: GI patients’ health literacy levels will be negatively associated with their complication status to the hospital DISCUSSION/SIGNIFICANCE OF IMPACT: This study allows us to further our understanding of patients’ health literacy level and its’ relationship with important health outcomes. By looking at a variety of diverse health outcomes, the impact of a patients’ health literacy level on that patients’ health outcomes will be observed more clearly.

OBJECTIVES/GOALS: Designed sampling from databases (DSD) methods have been used to cross-check electronic medical records for errors, structure study design, and, we hypothesize, can be used to make data collection for surgical quality metrics more efficient, particularly within national databases. We plan to apply statistical and DSD methods to accomplish the following aims:

1. 1. Identify the most important elements in managing post-operative pain

2. 2. Identify the most informative procedure or population-based targets to focus collection of additional, labor-intense detail surrounding adequacy of pain control (i.e., Patient Reported Outcome Measures (PROMs)).

METHODS/STUDY POPULATION: Our study population includes all children, ages 1-18 years, captured in the National Surgical Quality Improvement Project-Pediatric (NSQIP-P) from 2019 to 2021. We plan to apply statistical (regression modeling) and DSD methods to accomplish the aims listed above. RESULTS/ANTICIPATED RESULTS: For Aim 1, we expect to identify patient, procedure, and perioperative pain management practices that influence postoperative pain. For Aim 2, we will focus on outcomes such as PROMs that are challenging to obtain. By applying DSD methods, we will identify specific procedure and/or population-based cohorts to capture PROMs and decrease data collection burdens, while maintaining power, as the project is scaled nationally to all of NSQIP-P. DISCUSSION/SIGNIFICANCE OF IMPACT: Data from this study will inform expansion of NSQIP-P to collect novel outcomes of clinical and societal importance without prohibitively increasing data collection burden.

OBJECTIVES/GOALS: The aim was to examine whether nicotine patch was more effective in encouraging abstinence from cigarettes smoking compared to placebo. METHODS/STUDY POPULATION: Randomized controlled trials involving the general teenage age group smokers who were current smokers-“smoked less than 100 cigarettes over their lifetime and smoked at the time of the interview. Databases were searched for relevant studies reported in English that employed a randomized design published since 2000. Two authors extracted data and assessed quality. The primary outcomes and prioritization were continuous abstinence at 3, 6 and 12-month follow-up or more for the number of patients who responded to treatment, defined as a reduction/abstinence. Heterogeneity between studies did not preclude combined analyses of the data. RESULTS/ANTICIPATED RESULTS: 4 of 266 publications were included. Four studies reported positive effects on smoking cessation at end of treatment: (1) nicotine patches improved continuous abstinence at 6 weeks – 9 weeks months; (2) nicotine patch improved continuous abstinence at 3 to 6 months; (3) nicotine patches improved continuous abstinence 6 and 12 months; (4) nicotine patches improved continuous abstinence at 6 months – 12 and 24 months (5). All studies showed, continuous abstinence at follow up differed in percentage between groups both at 6 weeks through 24 months, with NRT (Nicotine patch) intervention groups achieving higher rates in most of the studies compared to placebo intervention group. Conclusions: NRT intervention methods seem to increase smoking abstinence in those treated for smoking cessation. Further and larger sample size studies are required to make stronger the base of evidence. DISCUSSION/SIGNIFICANCE OF IMPACT: Four randomized controlled trials investigating the effectiveness of smoking cessation interventions, for teenagers who smoke cigarettes were identified for inclusion in this review. Four of the studies reported significant effects on smoking cessation, providing evidence of effectiveness of NRT (nicotine patch), behavioral support and combinations of the two, although not all trials intervention treatments found an effect. The four studies reported important intervention effects at both the short and long follow-ups required: 6 weeks up to the 24 months, thereby, providing stronger evidence to support the effectiveness of NRT intervention on smoking cessation. All studies showed some evidence of improved smoking abstinence outcomes. The four studies had in common that the smoking cessation interventions provided a combination of intent to treat prevention, and of all the clinical trials none of them suggested a negative effect of smoking cessation treatment on substance use outcomes using NRT. However, the studies used reliable methods and reported their cases properly, but the small number of studies reviewed for the systematic review makes the conclusion about the effectiveness of these interventions uncertain. The papers visibly stated how the trials protected against bias, as indicated by the Yes (low risk). No (high risk) and U as “unclear risk.” All four studies conducted a random sequence generation of participants enrolled into the study sample.