OBJECTIVES/GOALS: The overall goal is to provide tips and suggestions for designing a summer internship program for undergraduates at an institution that only offers advanced degrees. This poster seeks to highlight what worked well and items that can be improved upon from a program that ran for the first time at the University of Texas Medical Branch in Summer 2022. METHODS/STUDY POPULATION: In February 2022, we opened admissions to a summer internship program whose goals are to expose students to statistical design and analysis problems from real research, while providing them with the conceptual and technical tools to address these problems. As such, students should be able 1) to assess study designs for strengths and weaknesses in addressing specific biomedical questions, 2) to use the tools of statistical modeling, data science, and hypothesis testing along with state-of-the-art statistical software to work on problems as well as produce results and conclusions for these problems, and 3) to understand how developing these skills can lead to a wide variety of career opportunities both inside and outside of academia. We ultimately recruited 12 participants in the first summer. RESULTS/ANTICIPATED RESULTS: Based on feedback from participants, we have identified recruitment efforts that worked (and those that need improvement), teaching methods that worked (as well as those that need improving), and ideas for career development sessions (based on questions generated from current participants). Each participant was paired with another student on a research project. Each research project had both a biostatistics faculty mentor as well as a basic science/clinical faculty mentor. We will discuss what worked/what needs improvement from this sort of situation as well. The program culminated in a poster session which was very well received by participants and faculty alike. DISCUSSION/SIGNIFICANCE: This internship program is significant because developing a workforce knowledgeable in biostatistics and data science has been increasingly in demand to improve the efficiency and reliability of biomedical innovation. My providing guidance to others hoping to provide similar programs, we aim to develop such skills in the incoming workforce.

OBJECTIVES/GOALS: The Saint Georges Respiratory Questionnaire (SGRQ) is used as a patient reported outcome tool for clinical research in COPD and bronchiectasis. We established a registry and biospecimen repository of bronchiectasis patients with and without NTM and report associations between clinical phenotype and SGRQ scores. METHODS/STUDY POPULATION: Patients were recruited in a cross-sectional format from the Bronchiectasis, Cystic Fibrosis, and NTM clinics at our institution. All patients provided at least one sputum sample in the six months prior to inclusion. Clinical and epidemiologically relevant data was obtained, and blood specimens were processed and preserved. Patients were grouped based on clinical phenotype and differences in SGRQ scores were analyzed using ANOVA or Student’s t-test. Descriptive statistics are reported as means and standard deviations, p<0.05 considered significant. RESULTS/ANTICIPATED RESULTS: 72 NTM patients completed the SGRQ including 39 patients not on treatment (Colonized), 29 patients on NTM directed antibiotics, and 4 patients whose infection was cured in the past year. Among patients on treatment, 14 were treatment refractory (positive cultures beyond 12 months of therapy). The mean age of all NTM patients was 59.5±17.6 and 80.5% were female. Mean SGRQ Total scores were significantly higher among patients receiving treatment compared to patients considered colonized (35.7± 22.0 colonized group versus 48.8± 15.8 treatment group, p = 0.011). The SGRQ subdomain scores including Impacts (26.2± 26.2 colonized group versus 42.5± 17.0 treatment group, p = 0.01) and Activities (41.7± 31.8 colonized group versus 59.3± 24.5 treatment group, p = 0.018) were also significantly different between groups. DISCUSSION/SIGNIFICANCE OF IMPACT: We developed a cross sectional cohort of NTM patients and assessed associations between clinical phenotype and SGRQ score. Preliminary data suggests that female sex, treatment status, and therapeutic duration are associated with higher SGRQ scores. We intend to continue to assess the potential for specific SGRQ questions to be used for quantifying disease symptom severity for NTM patients.

OBJECTIVES/SPECIFIC AIMS: Oculopharyngeal muscular dystrophy (OPMD) is a rare, late-onset muscular dystrophy that causes severe swallowing impairment (dysphagia). Although promising therapies are in the pipeline, validated dysphagia outcome measures for use in OPMD trials have not been established. Videofluoroscopic swallow studies (VFSS) are considered the clinical gold standard for dysphagia assessment, yet the optimal objective measure of VFSS in OPMD is not known. Our aim was to investigate the utility of the Modified Barium Swallow Impairment Profile (MBSImP) as an objective measure of VFSS in OPMD patients. METHODS/STUDY POPULATION: This was a single-center, prospective, cross-sectional study. In total, 26 individuals with OPMD underwent VFSS and other measures of dysphagia including 50-mL water swallow time (ST). Validity was assessed by examining correlations with an OPMD Global Severity Score (GSS) and with dysphagia duration. RESULTS/ANTICIPATED RESULTS: The MBSImP demonstrated moderate correlations with GSS (Pearson r=0.52, p=0.006) and ST (r=0.39, p=0.049). The relationship between MBSImP and dysphagia duration appeared nonlinear, and levelled off with long dysphagia duration. In contrast, ST did not correlate significantly with GSS (r=0.27, p=0.18), nor with disease duration (r=0.05, p=0.83). DISCUSSION/SIGNIFICANCE OF IMPACT: Objective measurement of VFSS is a promising outcome measure in OPMD. With long disease duration, the MBSImP may not be sufficiently sensitive to detect disease progression. More sensitive measures for scoring dysphagia severity on VFSS should be explored for application to future s of OPMD.

OBJECTIVES/SPECIFIC AIMS: Low cancer clinical trial (CCTs) enrollment may contribute to the poor survival improvement for adolescents and young adults (AYAs, aged 15–39 years) with cancer. Treatment site is thought to exacerbate this problem. This study evaluated whether differences in CCT availability explain lower CCT enrollment depending on treatment site for AYAs. METHODS/STUDY POPULATION: This prospective, observational cohort study was conducted at an academic children’s hospital and an adult cancer hospital, 2 affiliated sites within a NCI-designated Comprehensive Cancer Center over 13 months. In consecutive AYA patients newly diagnosed with cancer at both site, it was determined whether an appropriate CCT existed nationally, was available locally, and if enrollment occurred. The proportions of AYAs in these categories were compared by site using the χ2 test. RESULTS/ANTICIPATED RESULTS: Among 152 consecutive AYA patients, 68 and 84 were treated at the children’s hospital and adult cancer hospital, respectively. AYAs treated at the children’s hospital had similar CCT existence nationally compared with AYAs treated at the adult hospital [36/68 (52.9%) vs. 45/84 (53.6%), p=0.938]. However, a significantly higher percentage of children’s hospital treated AYAs than adult hospital treated AYAs had an available CCT [30/68 (44.1%) vs. 14/84 (16.7%), p<0.001]. Enrollment percentages were similarly low in both groups [8/68 (11.8%) vs. 6/84 (7.1%), p=0.327]. DISCUSSION/SIGNIFICANCE OF IMPACT: Significantly fewer AYAs treated at the adult hospital had a CCT available, but national existence was similar at both sites. This suggests that institutional barriers to opening CCT have more importance at adult centers.

OBJECTIVES/SPECIFIC AIMS: Effective HIV therapeutic options for persons with advanced HIV disease whose regimens have failed multiple times are limited. Current clinical practice utilizes regimens comprised of combinations of anti-retroviral (ARV) drugs. Despite the widespread use of ARV medications, optimization of initial treatment composition and subsequent management remains challenging. The goals of this study are (a) to better understand the ARV treatment structuring using prior clinical and patient information including virtual phenotype data and measures of viral load and CD4 cell count. We evaluated the potential impact of ARV strategies on AIDS-defining events and mortality; (b) to assess and understand differences of treatment composition and management when comparing standard ARV strategy (<5 ARVs) with an intensive ARV strategy (at least 5 ARVs). METHODS/STUDY POPULATION: OPTIMA was a tri-national (United States, Canada, and United Kingdom) randomized open label of alternative ARV treatment strategies for patients with advanced HIV disease (CD4≤300 cells/mm3) and evidence of resistance to 3 classes of ARV medications. OPTIMA used a 2×2 factorial design where the 2 factors were an ARV-free period Versus not; and standard Versus intensive ARV regimen. In this study, we focus on participants enrolled in OPTIMA at US participating sites and utilize demographic and clinical data including baseline virtual phenotype, ARV-related data (initial assignments and changes with drugs and dosages), follow-up lab data, AIDS-defining events, and vital status. RESULTS/ANTICIPATED RESULTS: Among 278 US-OPTIMA participants, 146 were randomly assigned to the standard ARV strategy and the rest were assigned to the intensive ARV strategy. Although not the sole factor, baseline virtual phenotype was used in selecting ARV medications within each assigned strategy. Participants in the standard arm exhibited better agreement between virtual phenotype results and the individual drugs selected for their regimen compared with participants in the intensive arm. This agreement had an almost statistically significant impact on survival time. No significant difference was detected in the frequency of ARV changes between standard and intensive ARV groups. DISCUSSION/SIGNIFICANCE OF IMPACT: Even though per design, OPTIMA assigned participants to an ARV strategy using a binary factor (standard vs. intensive ARV) and assessed its effect on HIV-related disease at a coarse level, the trial’s design and rich database allowed for a closer examination of the ARV drug initial selection and subsequent management. Our findings summarize the patterns and discuss the effects of ARV and their management, on AIDS-defining events and survival. Such findings could provide preliminary, yet important insight, in understanding ARV use practice and could inform the conduct of future HIV treatment trials. Since the trial’s randomization was at the ARV strategy level and not the individual ARV drugs, findings cannot be described in terms of causal pathways for specific ARVs.

OBJECTIVES/GOALS: Diabetes is a prevalent chronic illness that imposes health-related burdens including nephropathy, retinopathy and sleep disorders. The goal of this study was to examine the relation between both sleep disorders and sleep duration and diabetic chronic kidney disease (CKD) and retinopathy. METHODS/STUDY POPULATION: We analyzed data from the National Health and Nutrition Examination Survey 2005-2016 related to diabetic nephropathy and retinopathy, sleep disorders and duration, demographics, and risk factors among diabetics. The subjects were adults with diabetes type 2. Multiple logistic regression analysis was performed to look at the relationship between diabetic complications (CKD and retinopathy) and sleep disorders and sleep duration adjusting for demographics and risk factors. RESULTS/ANTICIPATED RESULTS: Of the 4087 diabetics, 45% had CKD, 19% had retinopathy, and 15% had sleep disorders. CKD and retinopathy were not associated with sleep disorders (p>0.05) but CKD was associated with sleep duration (Adjusted odds ration = 1.014, 95% confidence interval = 1.001-1.027, p<0.05). Cardiovascular disease was a predictor of both CKD and nephropathy (P<0.05). Other predictors of CKD and nephropathy were age >60 years, Non-Hispanic Black, hypertension, low education level, and living under 200% of the Federal Poverty Level (P<0.05). DISCUSSION/SIGNIFICANCE OF IMPACT : Among diabetics, CKD and retinopathy were not associated with sleep disorders, and only CKD was associated with sleep duration. These findings may impact the management of diabetes in the future, since it has effects on a range of other health conditions.

OBJECTIVES/SPECIFIC AIMS: Our goals were to understand the pattern, location, and extent of cardiac replacement fibrosis seen as late gadolinium enhancement on cardiovascular magnetic resonance imaging in a large cohort of cancer patients treated with anthracyclines and/or trastuzumab. METHODS/STUDY POPULATION: We performed a retrospective cohort study of consecutive adult cancer patients treated with anthracyclines and/or trastuzumab from 2004 through 2017. CMRs were analyzed for the presence, location, and pattern of LGE. RESULTS/ANTICIPATED RESULTS: Of 238 patients, 220/(92.4%) had no LGE. Among the 18/(7.6%) patients with LGE, 13/(72.2%) were ischemic in pattern (myocardial infarctions); 10 of these had known coronary artery disease (CAD). Of 5/(27.8%) patients with non-ischemic LGE, the etiologies were known for 4 – myocarditis, cardiac sarcoidosis, eosinophilic myocarditis, and acute myocardial calcification. Only 4/(1.7%) patients had unexpected LGE, of which 3 were unrecognized myocardial infarctions. DISCUSSION/SIGNIFICANCE OF IMPACT: The assessment of fibrosis helps to diagnose the cause of LVSD in cancer patients treated with potentially cardiotoxic medications. This is necessary because currently, the cause of LVSD in cancer patients cannot be established conclusively even though the cause is closely linked to patient outcomes. Our results demonstrate that cancer treatment-related LVSD is not associated with fibrosis. A minority of cancer patients with LVSD have fibrosis related to other reasons, most commonly CAD. Identification of the correct cause of LVSD in cancer patients treated with cardiotoxic medications allows for appropriate treatment. This, in turn, could improve patient outcomes.

OBJECTIVES/GOALS: In vitro models that mimic the human respiratory system are needed to assess the toxicity of inhaled contaminants. Therefore, our goal is to establish a Dosimetric Aerosol in-Vitro Inhalation Device (DAVID) that delivers aerosols in different patterns to human lung cells cultured at an air-liquid interface (ALI). METHODS/STUDY POPULATION: The collection unit of DAVID was modified in this study to accommodate different deposition patterns (spots, annular ring, rectangle & circle). CuO aerosols of varying concentrations were generated using a 6-jet Collison nebulizer for varying time periods to achieve different doses. To quantify the doses that were delivered to cells, the samples were digested with nitric acid & analyzed by Inductively Coupled Plasma-Optical Emission Spectrometry. Following the exposure of A549 cells to CuO aerosols, cytotoxicity and mRNA expression (i.e., HMOX1 & IL-8) will be assessed via LDH and RT-qPCR to determine the effect of regional (mass deposited/area of the pattern) and global (mass deposited/area of the cell culture insert) doses in cells. RESULTS/ANTICIPATED RESULTS: The deposition areas covered by rectangular, spot, annular ring, and circular patterns are estimated to be 6, 17, 27 and 85% of the insert’s surface area, onto which cells are cultured. Results for the patterns tested (spots and annular ring) show that both the regional and global doses were greater for spots than annular ring. Also, the regional doses were higher than global doses. Irrespective of the patterns, the global doses were the same for nebulizer suspensions of 0.1-1 mg/mL. Statistical analysis by ANOVA revealed there was no significant difference in doses between replicate inserts used in the same trial. We anticipate that regional doses with aerosol deposition to a larger surface area of the cell culture insert will correspond with higher cytotoxicity and mRNA expression of HMOX1 and IL-8 in cells. DISCUSSION/SIGNIFICANCE: There are limited in vitro exposure systems that can efficiently deliver aerosols to lung cells, while also mimicking inhalation by humans. In addition to addressing this knowledge gap, we will show the role of regional & global doses in studying cellular response & the ability of DAVID to deliver aerosols in different deposition patterns.

OBJECTIVES/GOALS: Development of interventions that improve social functioning (SF) in first episode psychosis (FEP) is hindered by a poor understanding of the neural mechanisms underlying SF deficits. This research aims to identify neural correlates of social functioning in FEP, and to evaluate whether this substrate is malleable in response to cognitive training. METHODS/STUDY POPULATION: This is a secondary data-analysis of participants in an ongoing randomized clinical trial investigating whether 12 weeks of targeted cognitive training is neuroprotective in FEP, versus treatment as usual. Baseline and post-training assessments include a brain MRI, three measures of SF, and a neurocognitive battery. Healthy controls complete MRI only. Differences in cortical thickness (CTh) and gray matter volume (GMV) in regions of interest between FEP and controls will be determined with ANCOVA. Multiple linear regression will be used to determine the relationship between neural substrate and SF in FEP. Linear mixed models will be used to examine the relationship between change in CTh and GMV and change in SF. Data collection is ongoing for this study. RESULTS/ANTICIPATED RESULTS: In preliminary data including 12 FEP and 9 healthy controls, FEP demonstrated cortical loss in the right superior frontal cortex and the right isthmus-posterior cingulate. Greater cortical thickness in the posterior cingulate cortex was associated with better social functioning across multiple measures when controlling for global cognition. Gray matter volume in the parahippocampal gyrus was also associated with better social functioning. Preliminary results evaluating whether targeted cognitive training is neuroprotective in these regions of interest in a manner that is associated with improved social functioning will also be presented. DISCUSSION/SIGNIFICANCE OF IMPACT: Preliminary results link the posterior cingulate and parahippocampal gyrus to SF in FEP. Further research will investigate the contribution of changes in these brain regions to improved SF. The identification of biological treatment targets for SF may lead to development and optimization of novel interventions to alleviate SF deficits in FEP.

OBJECTIVES/SPECIFIC AIMS: Cocaine use is a significant health problem in the United States and associated with increased risk of adverse cardiovascular outcomes. Our goal was to evaluate the effects of rapid cocaine infusions on cardiovascular hemodynamics among patients with cocaine abuse disorder. METHODS/STUDY POPULATION: Patients with a history of cocaine abuse but no overt cardiovascular disease received 4 consecutive intravenous infusions of cocaine (0, 10, 20, 40 mg) given in randomized, double-blinded order. The infusion procedure was repeated on 2 consecutive days (4 infusions each day). Following each dose, patients underwent continuous monitoring via fingertip plethysmography for 30 minutes, followed by an additional 30 minutes washout procedure. Patients were surveyed throughout this timeline to record symptoms of cocaine response. Finger tracings were then used to calculate arterial pressure curves and parameters of heart rate, blood pressure, cardiac output, stroke volume, and systemic vascular resistance according to device-specific algorithms. Mean values were calculated over the entire 30 minutes follow-up and peak values were defined as the maximum value sustained over any 60-second interval during the follow-up period. RESULTS/ANTICIPATED RESULTS: Seven patients were enrolled and received cocaine infusions of 2 consecutive days. Cocaine dose was positively associated with mean cardiac output (R=0.489, p<0.001), peak diastolic blood pressure (R=0.435, p=0.001), mean heart rate (R=0.401, p=0.003), peak systolic blood pressure (R=0.399, p=0.003), peak mean arterial pressure (R=0.362, p=0.008), mean systolic blood pressure (R=0.399, p=0.003), +dP/dt (R=0.346, p=0.012), and peak heart rate (R=0.334, p=0.015). Hemodynamic parameters were also predictive of patient-reported symptoms of cocaine response. DISCUSSION/SIGNIFICANCE OF IMPACT: These data confirm the known pharmacologic effect of cocaine to prevent reuptake of neurotransmitters and demonstrate the feasibility of conducting a noninvasive assessment of cardiovascular hemodynamics as a measure of responsiveness to cocaine infusions. This procedure also provides a benchmark to evaluate the potential impact of pharmacologic treatments on cocaine-induced hemodynamic changes and patient perceptions of cocaine response.

OBJECTIVES/GOALS: Patients who require a hematopoietic cell transplant (HCT) and dont have an HLA-matched related or unrelated donor may rely on a haploidentical donor. The optimal haploidentical donor and guidance for selection is limited. We aim to determine how donor characteristics affect outcomes following haploidentical-HCT for pediatric patients. METHODS/STUDY POPULATION: This is a retrospective cohort study evaluating the effect of donor age and relationship on post-HCT outcomes in children (0-18y) from 2008-2018. Multivariable logistic regression analysis will identify if donor age or donor relationship affect the development of graft-versus-host-disease (GVHD), while adjusting for other patient, donor, and transplant related variables. Two-year overall survival & event-free survival will be determined using Kaplan-Meier curves, stratified by donor age group and donor relationship, and compared by log-rank testing. Sub-analyses will be performed for myeloablative transplants and reduced intensity conditioning, as well as for malignant and non-malignant diseases. RESULTS/ANTICIPATED RESULTS: Our primary aim to is determine the effect of donor age and the effect of donor relationship to patient on the development of GVHD. We hypothesize that utilization of a younger donor will decrease the incidence of GVHD. Further, we hypothesize that utilizing a sibling haploidentical donor will result in less GVHD than a parental donor. Secondary aims include evaluating the effect of donor age and donor relationship on overall survival, event-free survival, non-relapse mortality, relapse, graft failure and time to engraftment. The results of this study will help us to develop criteria for optimal haploidentical donor selection. If donor selection is optimized, this could result in improved outcomes following haploidentical transplants. DISCUSSION/SIGNIFICANCE: Haploidentical donors are increasingly used as many patients, especially ethnic minorities, do not have an HLA-matched donor. This will be the largest study of haploidentical HCT in children. The data gathered will allow us to identify important donor characteristics to help guide physician decision-making when choosing a haploidentical donor.

OBJECTIVES/GOALS: Scholarly activity is a key component of most residency programs. To establish fundamental research skills and fill gaps within training curricula, we developed an online, asynchronous set of modules to introduce trainees to various topics that are germane to the conduct of research and evaluated its effectiveness in resident research education. METHODS/STUDY POPULATION: Research 101 was utilized by residents at the Brookdale Hospital Medical Center in Brooklyn, NY. Resident knowledge, confidence, and satisfaction were assessed using pre- and post-module surveys with 5-point Likert scaled questions, open-ended text responses, and a final quiz. RESULTS/ANTICIPATED RESULTS: Pre-module survey results indicated that residents were most confident with the Aligning expectations, Introduction to research, and Study design and data analysis basics modules and least confident with the Submitting an Institutional Review Board (IRB) protocol at UC and Presenting your summer research modules. Post-module survey responses increased significantly compared to pre-module results for all modules and learning objectives (p<0.0001). “This module met my needs” was endorsed 91.4% of the time. A final quiz of 25 multiple choice questions resulted in a median score of 23. Content analysis of open-ended post-module survey responses identified multiple strengths and opportunities for improvement in course content and instructional methods. DISCUSSION/SIGNIFICANCE: These data demonstratethat residents can benefit from completion of Research 101, as post-module survey scores were significantly higher than pre-module survey scores for all modules and questions, and final quiz scores were high and highlighted opportunities for additional resident learning.

OBJECTIVES/SPECIFIC AIMS: The primary objective of this study is to determine the prevalence of maternal GBS colonization and demographic risk factors associated with maternal GBS colonization in Latin America. Secondary objectives include: To determine if there is an association between maternal colonization with GBS and stillbirth or preterm birth in Latin America. To determine the effect of cesarean section (CS) on the incidence of neonatal sepsis with GBS in mothers colonized with GBS. METHODS/STUDY POPULATION: Study Population: Pregnant women who received prenatal care at sites that utilize the Perinatal Information System (SIP) from 1989 through 2015, and were screened for GBS between 35 and 37 weeks of gestation. Maternal exclusion criteria included spontaneous abortion, stillbirth before 35 weeks, and lack of screening for GBS. Methods: Estimated prevalence (and 95% confidence interval) of maternal GBS colonization for the entire data set, by region, and by country. The prevalence data for each country further stratified by maternal age, ethnicity, education, civil status and habitation. Descriptive statistics calculated for each clinical prenatal and clinical perinatal health indicator as well as for each clinical history variable for GBS colonized and non-GBS colonized women. Odds ratios will be calculated for each demographic and clinical risk factor. Fisher’s exact tests will be used to test hypotheses about the relationship between maternal GBS colonization and specific perinatal outcomes such as stillbirth or preterm birth. We will use multiple logistic regression models to test the hypotheses about the relationships between demographic variables, maternal GBS colonization and perinatal outcomes. RESULTS/ANTICIPATED RESULTS: Preliminary results: 712,061 records included in database. 98,852 records with data for GBS screening. o90.6% White, 7.4% Mixed, 0.6% Black, 0.3% Native Indian, 0.1% Other. GBS prevalence among screened women, 17.5% There was a significant association between maternal GBS colonization and ethnicity (X2 (4, N=97006)=569.901, p<0.01) o Prevalence rates by ethnicity: 20.5% Black, 18.4% White, 15.2% Native Indian, 8.8% Mixed, 3.3% Other. There was a significant association between maternal GBS colonization and age (X2 (4, N=98655)=119.901, p<0.01) o Prevalence rates by age group:. Age ≤ 20 - 15.2%. Age 21-34 – 17.8%. Age ≥ 35 – 19.6% Anticipated results:. GBS positive mothers will have an increased burden of stillbirth and preterm birth compared to GBS negative mothers. Neonates born to GBS colonized mothers who deliver via cesarean section will have a decreased incidence of sepsis compared to neonates born to GBS colonized mothers who deliver vaginally DISCUSSION/SIGNIFICANCE OF IMPACT: There have been no comprehensive studies to date that use the CLAP data to characterize the epidemiology of maternal GBS colonization and GBS disease and the burden of neonatal GBS disease in Latin America. Taking advantage of this unique database, this is the first region-wide study using systematically collected data. Our preliminary analysis indicates that GBS colonization status among pregnant women in Latin America is 17.5%, which is greater than previously reported. While there is evidence that maternal carriage of GBS is associated with stillbirth, this will be the first study to quantify the burden of GBS-associated stillbirth in Latin America. Additionally, previous work has been inconclusive in regards to maternal colonization with GBS and its association with preterm birth. This will be the largest study to evaluate the association of maternal GBS carriage with preterm birth. Findings from this study have the potential to inform public health policy and interventions by identifying the prevalence and risk factors.

OBJECTIVES/SPECIFIC AIMS: Missing data is a common problem in research studies that may lead to inconclusive or inaccurate results. It may even lead to harm secondary to wrong research conclusions. The purpose of this ancillary study is to measure the differences in missing data following implementation of a variety of mechanisms to improve data quality and documentation in a global quality improvement study. Many of the sites involved in the study were in low-income or middle-income countries with minimal research infrastructure. Missing data is defined as “values that are not available that would be meaningful for analysis if they were observed” (The prevention and treatment of missing data, New Engl J Med 367; 14, nejm.org, October 4, 2012). METHODS/STUDY POPULATION: All study sites used REDCap software to enter various data points including hospital and ICU admission and discharge dates as well as whether items on a Checklist relevant to processes of care in the ICU were reviewed. After initial general data collection phase, we categorized data as “must have” and “good to have.” “Must have” variables were defined as data variables that were essential for the study outcomes. “Good to have” variables would not affect the main outcomes of the study if missing. We measured completeness of data using the in-built REDCap data quality check feature. We used several strategies to encourage reduction of missing data. We initially did random data checks but noted that the amount of missing data was substantial and could not be adequately addressed this way. Second, we created excel sheets highlighting missing data for each site and notified sites. This proved onerous to create and made it burdensome for sites to identify easily where data was missing. Third, we built a custom report form in REDCap specifically able to identify which “must have” data points were missing. This could be easily accessed by the principal investigator at each site and made completing the data forms more straightforward. We encouraged all sites to complete their data collection by sending weekly data reports to each site highlighting the patients with missing data. An instructional YouTube tutorial was also created and the link was shared with all sites to demonstrate how to use the custom built report form in REDCap and how to appropriately fill in the missing data. Since this was a global study, we communicated with sites using a variety of locally favored mechanisms including Zoom, FaceTime, WeChat, WhatsApp as well as email. By harnessing the buy-in of local champions our approach was successful. RESULTS/ANTICIPATED RESULTS: The total number of patients recruited for the CERTAIN study is 4843. The rate of all missing variables improved with the efforts described above. Hospital admission dates were missing in 8.4% pre efforts and 4.2% post efforts (p<0.01). ICU admission dates were missing in 5.5% pre and 2.0% post (p<0.01). Documentation of completion of processes of care (including central line review, urinary catheter review, consideration for blood transfusion) improved significantly from pre to post (p<0.01). DISCUSSION/SIGNIFICANCE OF IMPACT: Missing data can be a problem in all types of research studies. This study provides some preliminary evidence for effective approaches that can reduce the problem of missing data when conducting a global study at sites with limited research infrastructure in place. By addressing the concern about missing data, we can be more confident that our results can be accurately analyzed and interpreted, improving the quality of the research.

ABSTRACT IMPACT: This work will impact participants of clinical trials by better informing them of their trial’s results and their important role within the clinical research process. OBJECTIVES/GOALS: This project aims to equip researchers with an online tool for the development, dissemination, and collection of participant feedback for plain language clinical trial (CT) result summaries (PLCTRS). PLCTRS ensure that participants fully understand their trial’s results and their role in the CT process. METHODS/STUDY POPULATION: This online development platform is a web application made with CSS, HTML, and JavaScript. First, general trial identification information including study aims and eligibility will be input by researchers. Then, they will be prompted with tips and suggestions for composing in plain language and to ensure inclusion of all essential trial information. Next, the platform will disseminate this writing electronically to participants. Participants then provide meaningful feedback on the platform about their comprehension for the researcher, which the platform will aggregate and summarize for revisions. This process of drafting and feedback is repeated until a satisfactory PLCTRS is finalized. RESULTS/ANTICIPATED RESULTS: The anticipated results of this project are overall improved comprehension of clinical trial results by participants. This comprehension will be measured by participants ability to answer certain questions not only regarding trial outcomes, but also about the trial in general. For instance, before and after interacting with the PLCTRS, trial participants will be asked if they can identify which investigational drug was being studied and its possible side effects. This project could anticipate identification of trial elements and results deemed difficult to comprehend by participants; thus they would be better informed after interacting with the platform. DISCUSSION/SIGNIFICANCE OF FINDINGS: This project will ensure that participants better comprehend the trials they participated in beyond the required informed consent process - which only covers their comprehension prospectively. This project seeks to address the gap of ensuring participant comprehension retrospectively.

Mini-sabbaticals are formal short-term training and educational experiences away from an investigator’s home research unit. These may include rotations with other research units and externships at government research or regulatory agencies, industry and non-profit programs, and training and/or intensive educational programs. The National Institutes of Health have been encouraging training institutions to consider offering mini-sabbaticals, but given the newness of the concept, limited data are available to guide the implementation of mini-sabbatical programs. In this paper, we review the history of sabbaticals and mini-sabbaticals, report the results of surveys we performed to ascertain the use of mini-sabbaticals at Clinical and Translational Science Award hubs, and consider best practice recommendations for institutions seeking to establish formal mini-sabbatical programs.

Well-designed, accessible short-term research training programs are needed to recruit and retain underrepresented persons into clinical and translational research training programs and diversify the workforce. The Michigan Institute for Clinical and Health Research developed a summer research program, training over 270 students in 15 years. In response to the 2020 COVID-19 pandemic, we pivoted swiftly from an in-person format to a fully remote format. We describe this process, focusing on factors of diversity, equity, and inclusion including enabling student participation in remote research activities. We collected data about students’ learning experiences since the program’s inception; therefore, we could evaluate the impact of remote vs. in-person formats. We examined data from five cohorts: three in-person (2017–2019; n = 57) and two remote (2020–2021; n = 45). While there was some concern about the value of participating in a remote format, overall students in both formats viewed the program favorably, with students in the remote cohorts rating some aspects of the program significantly more favorably. In addition, more students who identified as Black or African American participated in the remote format than in the in-person format. We describe lessons learned from this unprecedented challenge and future program directions.