Objectives/Goals: The aim of this study is to create a profile of Puerto Rican adults that either developed auditory or balance problems after contracting or being vaccinated against COVID-19 or whose symptoms got worse after the infection or vaccination against the coronavirus. Methods/Study Population: This research has two arms: a descriptive explorative survey designed arm and experimental profiling. Four cohorts of Puerto Rican adults between 21 and 64 years old were profiled; subjects that developed auditory or balance disorders after contracting COVID-19, subjects who’s auditory and balance conditions got worse after contracting COVID-19, subjects who developed auditory or balance disorders after being vaccinated against COVID-19 and subjects who’s auditory and balance conditions got worse after being vaccinated against COVID-19. Subjects were recruited, assessed, and interviewed at the University of Puerto Rico-Medical School Intramural Clinic after the research protocol was approved by the Office of Protection of Research Participants of the University of PR-Medical Sciences Campus. Results/Anticipated Results: Results reflected that fifty-seven percent of the subjects experienced hearing difficulty which worsen after contracting or being vaccinated against COVID-19. Seven percent of the subject’s that were vaccinated developed constant Tinnitus which was bilateral in the majority of the subjects (55%). Fourteen percent of the subjects that already had Tinnitus reported that the level of their Tinnitus increased after either contracting or being vaccinated against COVID-19. Discussion/Significance of Impact: This pilot research study adds to the evidence of the impact of COVID-19 infection and vaccination against the coronavirus on the inner ear of Hispanics of Puerto Rican ethnicity. Its significance lies in documenting the different auditory pathologies that can emerge or that can become worse by the contraction of the coronavirus.

Objectives/Goals: To present practical considerations especially important for early career investigators using large cloud-based data portals, with lessons learned from a descriptive project characterizing chronic pain among young Black adults. Our translational science goal is to improve investigators’ engagement with these types of data sources. Methods/Study Population: Lessons learned from our analytic experience conducting secondary data analyses using data from the NIH All of Us Research Program (AoU). The analytic activities are in support of Aim 1 of an NIH K01 Mentored Research Scientist award focusing on young Black adults with chronic pain. Engagement with data was a collaboration across junior and senior investigators with expertise in quantitative and qualitative methods. We assessed AoU data for usability, data completeness, accessibility, and program support. Variables of interest in the K01 project include physical and mental health, commodities, health care utilization, SDoH, and demographics. We present qualitative descriptions of our user experiences, paired with descriptive and summary statistics for the pain-related data. Results/Anticipated Results: “Controlled-tiered” data were easily accessible. Data completeness differed by variable type: variable categories (e.g., chronic pain) had fewer missing data than survey items used to calculate composite variables (e.g., GAD-7). The cohort comprised 146 Black adults aged 18–24 and 3,315 aged 25–44. We compared pain intensity, self-rated health, SDoH, and healthcare utilization by age. Limited EHR-recorded pain severity, and responses to disability and comorbidity survey items prevented comparisons by age. Program support for accessing the data met expectations. A quantitative PhD graduate student was needed to engage. Advanced coding skills required to use the cloud-based data portal challenges broad usability of the data and claims for inclusive use of this data resource. Discussion/Significance of Impact: AoU can be leveraged to examine key health indicators for large cohorts of underrepresented adults. However, the skill level and time required to fully engage with these data is beyond that of most early career investigators. We encourage CTSAs to coordinate capacity-building efforts to use these large population data and support a team science approach.

OBJECTIVES/GOALS: The development of early university technologies for commercialization is largely inefficient and exhibits a high rate of failure, often due to a lack of researcher time and commercialization experience. We have created the Translational Fellow role to address these needs and increase the throughput of university technology transfer. METHODS/STUDY POPULATION: Translational Fellows will first build their initial competencies to identify, evaluate, and develop new technologies through internships with intake organizations within the university ecosystem, including the Office of Technology Management, the LEAP gap-funding mechanism, and local venture capital firms. Following this training, Fellows will provide tailored support to validated projects by establishing development milestones, liaising with industry experts, navigating regulatory requirements, and drafting marketing materials such as executive summaries and financial projections. Lastly, Fellows will partner with a highly developed project to facilitate the commercialization of the technology, whether through a SBIR/STTR grant, direct licensing event, or startup creation. RESULTS/ANTICIPATED RESULTS: We anticipate that implementation of this mechanism will increase the proportion of university-generated inventions that undergo successful commercialization events, as well as increase the rate at which these projects develop after initial validation. Furthermore, we expect that the skills acquired through this program will allow Fellows to successfully transition to a variety of roles in the biotech space. We also expect that Fellows will be capable of training other scientific teams in the preparation of SBIR/STTR grants, further expanding opportunities for commercialization in the research space. DISCUSSION/SIGNIFICANCE OF IMPACT: Translational Fellows fill a unique interdisciplinary niche, allowing them to address common barriers faced by academic inventors. Improving commercialization throughput further capitalizes on the wealth of ideas generated in universities, thereby driving innovation in the biomedical space and directly contributing to improved human health. CONFLICT OF INTEREST DESCRIPTION: The authors have no conflicts of interest.

OBJECTIVES/GOALS: Using the covariate-rich Veteran Health Administration data, estimate the association between Proton Pump Inhibitor (PPI) use and severe COVID-19, rigorously adjusting for confounding using propensity score (PS)-weighting. METHODS/STUDY POPULATION: We assembled a national retrospective cohort of United States veterans who tested positive for SARS-CoV-2, with information on 33 covariates including comorbidity diagnoses, lab values, and medications. Current outpatient PPI use was compared to non-use (two or more fills and pills on hand at admission vs no PPI prescription fill in prior year). The primary composite outcome was mechanical ventilation use or death within 60 days; the secondary composite outcome included ICU admission. PS-weighting mimicked a 1:1 matching cohort, allowing inclusion of all patients while achieving good covariate balance. The weighted cohort was analyzed using logistic regression. RESULTS/ANTICIPATED RESULTS: Our analytic cohort included 97,674 veterans with SARS-CoV-2 testing, of whom 14,958 (15.3%) tested positive (6,262 [41.9%] current PPI-users, 8,696 [58.1%] non-users). After weighting, all covariates were well-balanced with standardized mean differences less than a threshold of 0.1. Prior to PS-weighting (no covariate adjustment), we observed higher odds of the primary (9.3% vs 7.5%; OR 1.27, 95% CI 1.13-1.43) and secondary (25.8% vs 21.4%; OR 1.27, 95% CI 1.18-1.37) outcomes among PPI users vs non-users. After PS-weighting, PPI use vs non-use was not associated with the primary (8.2% vs 8.0%; OR 1.03, 95% CI 0.91-1.16) or secondary (23.4% vs 22.9%;OR 1.03, 95% CI 0.95-1.12) outcomes. DISCUSSION/SIGNIFICANCE: The associations between PPI use and severe COVID-19 outcomes that have been previously reported may be due to limitations in the covariates available for adjustment. With respect to COVID-19, our robust PS-weighted analysis provides patients and providers with further evidence for PPI safety.

OBJECTIVES/SPECIFIC AIMS: Alcohol use disorder (AUD) has been associated with greater discounting of delayed rewards relative to healthy controls. The relationship, however, has been inconsistent, likely because previous studies had relatively small sample sizes and inadequately controlled for comorbid psychopathology and substance use. In the present study, we analyzed one of the largest clinical research samples to date to assess the influence of alcohol use on delay discounting, and examine the influence of confounding variables including substance use disorder. METHODS/STUDY POPULATION: In total, 801 participants completed a delay discounting task where they chose between smaller, immediately available monetary amounts ($0–$90) and $100 available after a delay of 7–30 days. Delay discounting behavior was summarized as the natural log of k, a constant derived from a hyperbolic discounting equation. Participants also completed Structured Clinical Interviews for DSM-IV disorders, 90-day Timeline Followback interviews, and the Fagerström Test for Nicotine Dependence. Participants were divided into 4 groups: healthy controls (n=298), past AUD (n=69), and current AUD with (n=224) and without (n=210) comorbid psychopathology or substance use disorder. Kruskal-Wallis test was used to examine the effect of group on delay discounting. RESULTS/ANTICIPATED RESULTS: There were significant differences in the distribution of delay discounting scores by group (H=80.195, p<0.001). Healthy controls and past AUD showed lower levels of delay discounting than current AUD and current AUD+comorbidity groups with medium effect sizes (Cohen’s d=−0.635 and Cohen’s d=−0.614, respectively). There were nearly no differences between current AUD with and without comorbid psychopathology groups (Cohen’s d=−0.024). The past AUD group showed almost no difference relative to the healthy control group (Cohen’s d=0.007). DISCUSSION/SIGNIFICANCE OF IMPACT: Individuals with current AUD were shown to discount rewards greater than those without current AUD, although comorbid psychopathology did not significantly affect discounting. Surprisingly, individuals with past AUD were more similar to controls than to those with current AUD. Our findings suggest that current problematic alcohol use is related to greater discounting of delayed rewards, but comorbid diagnoses do not significantly impact this relationship. However, once problematic patterns of alcohol use cease, delay discounting appears to return to levels comparable to healthy controls.

OBJECTIVES/SPECIFIC AIMS: In this study, we propose to investigate effectiveness of 2 core services provided by the Center for Clinical and Translational Science (CCTS), home for CTSA program in the School of Medicine at the University of Utah. METHODS/STUDY POPULATION: We will apply a longitudinal database of research and tenure track faculty (n>600) in the School of Medicine at the University of Utah from 2006 to 2016 to estimate the effect of initial usage of the biostatistics and clinical services cores of the University of Utah CCTS on the probability of (a) ≥1 peer reviewed publication, (b) external grant funding, and (c) academic promotion within 1, 2, and 3 years after the initial contact. We will apply a “new users” design (Hernan et al., Epidemiology, 2008; 19: 766–779) to compare the outcomes of faculty initiating use of the 2 CCTS cores Versus faculty without prior use of these cores in a series of cohorts defined by the calendar year of initial contract with the 2 cores, with covariate adjustment performed within each cohort to account for measured confounders. Separate outcome models will be specified for each cohort, but the statistical models will be fit to stacked augmented data sets which include the data from each cohort. Using the stacked data set, results will be pooled across each of the cohorts to increase statistical power. Robust sandwich estimates of standard errors will be used to account for the inclusion of multiple assessments for each faculty member. RESULTS/ANTICIPATED RESULTS: Estimates of the effect of initiation of new CTSA usage on academic productivity outcomes will be obtained, and provided in conjunction with sensitivity analyses to address the potential impact of uncontrolled confounding. DISCUSSION/SIGNIFICANCE OF IMPACT: The proposed evaluation strategy should overcome some of the biases inherent in typical metrics for effectiveness of CTSA programs, and will be applied to evaluate success of future initiatives.

ABSTRACT IMPACT: This work will standardize necessary image pre-processing for diagnostic and prognostic clinical workflows dependent on quantitative analysis of conventional magnetic resonance imaging. OBJECTIVES/GOALS: Conventional magnetic resonance imaging (MRI) poses challenges for quantitative analysis due to a lack of uniform inter-scanner voxel intensity values. Head and neck cancer (HNC) applications in particular have not been well investigated. This project aims to systematically evaluate voxel intensity standardization (VIS) methods for HNC MRI. METHODS/STUDY POPULATION: We utilize two separate cohorts of HNC patients, where T2-weighted (T2-w) MRI sequences were acquired before beginning radiotherapy for five patients in each cohort. The first cohort corresponds to patients with images taken at various institutions with a variety of non-uniform acquisition scanners and parameters. The second cohort corresponds to patients from a prospective clinical trial with uniformity in both scanner and acquisition parameters. Regions of interest from a variety of healthy tissues assumed to have minimal interpatient variation were manually contoured for each image and used to compare differences between a variety of VIS methods for each cohort. Towards this end, we implement a new metric for cohort intensity distributional overlap to compare region of interest similarity in a given cohort. RESULTS/ANTICIPATED RESULTS: Using a simple and interpretable metric, we have systematically investigated the effects of various commonly implementable VIS methods on T2-w sequences for two independent cohorts of HNC patients based on region of interest intensity similarity. We demonstrate VIS has a substantial effect on T2-w images where non-uniform acquisition parameters and scanners are utilized. Oppositely, it has a modest to minimal impact on T2-w images generated from the same scanner with the same acquisition parameters. Moreover, with a few notable exceptions, there does not seem to be a clear advantage or disadvantage to using one VIS method over another for T2-w images with non-uniform acquisition parameters. DISCUSSION/SIGNIFICANCE OF FINDINGS: Our results inform which VIS methods should be favored in HNC MRI and may indicate VIS is not a critical factor to consider in circumstances where similar acquisition parameters can be utilized. Moreover, our results can help guide downstream quantitative imaging tasks that may one day be implemented in clinical workflows.

Objectives/Goals: The primary objectives of this project were to create a user-friendly website that • Shares details of ongoing studies in an easily searchable and filterable format. • Provides lay summaries of study results. • Highlights our volunteer registry. • Offers a platform for community engagement and feedback on research interests. Methods/Study Population: The website, developed using DRUPAL 10 and launched in June 2024, was created with input from faculty, staff, research participants, and community partners. It targets potential participants, community members, providers, and other Academic Medical Centers. The development process included focus groups to identify design and feature needs, design iterations and usability testing, and an external accessibility review. Study information is automatically updated from the Study Information Portal (SIP) in OnCore and a custom REDCap survey. Features include a research volunteer registry, study results in lay terms, educational content about research, and multiple ways for community engagement. The site supports English and Spanish and follows best practices for accessibility. Results/Anticipated Results: Community feedback on the site has been very positive, with positive comments about ease of navigation and the improved appearance of the website. It is still early, but we have seen a notable increase in enrollment in the Volunteer Registry since the launch of the website. We track referral sources for the registry, and to date, we have seen 98 individuals enrolled who were directed to us through the website since it launched. This equates to an average of 5 people a week, more than any other referral source. This rate increases to almost 7 per week if we look solely at the period since we started the promotion of the website in early August. As the site awareness expands, we will also be getting feedback from individual studies and are tracking email communication generated from the site as well. Discussion/Significance of Impact: The development of this website represents a significant step toward improving community engagement in clinical research at Duke. By providing a centralized platform for study information, results, and community feedback, we aim to foster a more informed and involved participant base, ultimately enhancing the impact and reach of our research.

ABSTRACT IMPACT: This work aims to identify best practices for university-based asset development programs to improve commercialization throughput, which in turn will drive innovation in the biomedical space and directly contribute to improved human health. OBJECTIVES/GOALS: University technology transfer exhibits a high rate of failure, often due to a lack of researcher experience or early-stage financial capital. The LEAP program at Washington University (WUSTL) was created to address these needs. The goal of this study is to assess the performance of LEAP against similar gap funds and further improve program operations. METHODS/STUDY POPULATION: The goals of LEAP are achieved by providing university inventors with individualized consulting and feedback from industry experts, as well as awarding funding to the most promising projects. To determine whether these activities are impactful, we distributed an awardee report form to collect data on all funded LEAP projects, and then combined the results with project registration information. We also collected records Office of Technology Management, including invention disclosures, licenses, and startup creations. The resulting dataset was used to calculate program metrics and then evaluated against comparable gap funds. Sentiment data from participant surveys were also analyzed to assess perceived program value and knowledge transfer. RESULTS/ANTICIPATED RESULTS: As of the Sp2020 cycle, LEAP has funded 76 projects. Resubmitted projects had a funding rate of 52%, vs. 34% for new projects. Of the startups founded off of WUSTL intellectual property since 2016, nearly two-thirds had previously participated in LEAP. Funded LEAP projects also had a 29% licensing rate, which is comparable to similar gap funds. Lastly, participants self-reported an increase in knowledge across a range of commercialization areas. DISCUSSION/SIGNIFICANCE OF FINDINGS: The increased repeat funding rate and self-reported knowledge suggest that LEAP is impactful in building commercialization proficiency. The licensing rate and prevalence of LEAP projects in WUSTL startups also indicate that LEAP is indeed promoting tech transfer. Together, these results suggest that LEAP could be a model for other institutions.

OBJECTIVES/GOALS: (1) Assess challenges with our current continuous improvement processes via stakeholders. (2) Implement a revised continuous improvement process. (3) Evaluate the revised processes to assess implementation and use for strategic improvement. (4) Implement analysis mechanisms for new process to assess trends across the CTSI. METHODS/STUDY POPULATION: We used a mixed-methods, multi-phased, stakeholder-engaged approach with different processes per objective. Obj. 1: We implemented focus groups, surveys, and listening sessions incorporating two populations: both teams required to participate in reporting process, and CTSI leadership. Obj. 2: We utilized data from Obj. 1 processes to develop a revised continuous improvement process. Obj. 3: We integrated qualitative feedback processes onto the structure of continuous improvement processes, and we implemented a survey to assess use and value for the new process. Obj. 4: We developed a qualitative coding schema to assess key trends across teams and over time. RESULTS/ANTICIPATED RESULTS: Obj. 1: Numerous challenges in metrics format and process, including significant limitations in data use to inform decision-making and appropriately assess impact. Obj. 2: Resultant changes to continuous improvement processes, including a restructured reporting format and use-oriented approach that enhanced organizational integration; changes included added focus on facilitators of success, challenge, and key opportunities to better inform decision-making. Obj. 3: The majority of teams experienced the new quarterly process as a better tool for program monitoring and communicating program needs to leadership, but that fuller integration into vertical communication is needed. Obj. 4: Implementation of new analysis process enabling examination of trends and themes across diverse teams within the CTSI. DISCUSSION/SIGNIFICANCE: This work has particular relevance within ACTS given our focus on a clinical and translational research enterprise, the complexity in evaluating the diverse work of translation research entities, and limitations in a commonly-used metrics-monitoring approach. Our focus on improving translational processes advances translational science.

OBJECTIVES/GOALS: - Illuminate processes and findings of a translational science case study of impactful research with incarcerated pregnant women and mothers; - Improve our understanding of the translational mechanisms by sharing translational challenges, facilitators, an METHODS/STUDY POPULATION: Utilized the following evaluation methods and tools: - The Retrospective Translational Science Case Study protocol to examine translational path from innovation to policy and practice, barriers and facilitators for that translational movement. - Translational Science Benefits Model (TSBM) Checklist for translational/research impact analysis Triangulated diverse data sources: - Primary data: semi-structured interviews with research partners - Secondary data: researchers’ grant applications, reports, and publications; public stories/news related to their research; scientific publications; organizational/policy documents; and over 50 interviews with 30 stakeholders featured in published sources. RESULTS/ANTICIPATED RESULTS: The research contributed to community and public health, policy/legislative, clinical/medical, and economic benefits, social/institutional change, health equity advocacy, catalyzing research (consequent research studies) and public awareness. Translational research challenges: cultural differences between research and prison system; politics of translating research to policy change; issues of capacity, power, privilege, and opportunity when doing community-engaged research; and science vs. social justice criticism. Facilitators of translation: CTSA support; stakeholder engagement; authentic collaboration; researchers as translation catalysts; and engagement in legislative activities. DISCUSSION/SIGNIFICANCE: The evaluation case study provides useful knowledge about translational impact, challenges, and facilitators of community-based research that moved along the translational continuum and contributed to transformational, systemic changes on the legal, clinical, organizational, and interpersonal levels.

OBJECTIVES/GOALS:

1. 1. Examine the associations among BMI and markers of cardiometabolic risk, including blood pressure, lipids and blood glucose.

2. 2. Assess prevalence of kidney function deterioration, identified as hyperfiltration and moderately increased albuminuria (MIA), in obese compared to normal weight adolescents.

METHODS/STUDY POPULATION: De-identified electronic health records (EHR) data were extracted for female adolescents, aged 12-21 years, and their offspring through 24 months, who received health care services (Jan 2012 to Dec 2016) in NYC from 12 academic health centers and community health centers that are part of PCORnet NYC Clinical Data Research Network (NYC-CDRN). Data were analyzed using SAS (version 3.2.5). Patient characteristics overall and for study subgroups were examined using standard summary statistics. Trends in cardio-renal variables were examined by BMI groups coded according to NHANES as underweight, normal weight, overweight or obese. Multiple linear regression analyses will control for covariates. RESULTS/ANTICIPATED RESULTS: Data from 651,066 adolescent females ages 12-21 were retrieved. Analysis was performed on a subset of 202,214 unique patients (26% white, 15% black, 12.9% Latina) for whom there was complete data for BMI and blood pressure. Distribution of BMI was 6% underweight, 59% normal weight, 19% overweight, and 17% obese. There were significant differences in mean systolic (SBP, mean±SD mmHg: 102±12, 108±11, 112±12, 116±12) and diastolic blood pressure (DBP, mean±SD mmHg: 62±10, 66±8, 68±8.9, 70±9) across the four BMI groups with an increasing trend (p-values<0.0001). We will examine renal function trends, and whether these cardio-renal differences persist when controlling for age, race and ethnicity. DISCUSSION/SIGNIFICANCE OF IMPACT: Although SBP/DBP means were within normal limits across BMI groups, significant increasing trends suggest that women in higher BMI groups may be at increased risk for hypertension and potentially for renal dysfunction. We will examine contributions of race/ ethnicity and age to these associations.

OBJECTIVES/SPECIFIC AIMS: To describe the epidemiology of patients with carbapenem-resistant Enterobacteriaceae (CRE) bacteriuria in metropolitan Atlanta, GA and to identify risk factors associated with progression to an invasive CRE infection. We hypothesize that having an indwelling urinary catheter increases the risk of progression. METHODS/STUDY POPULATION: The Georgia Emerging Infections Program (EIP) performs active population- and laboratory-based surveillance to identify CRE isolated from a sterile site (e.g. blood) or urine among patients who reside in the 8-county metropolitan Atlanta area (population ~4 million). The Georgia EIP performs a chart review of each case to extract data on demographics, culture location, resistance patterns, healthcare exposures, and other underlying risk factors. We used a retrospective cohort study design to include all Georgia EIP cases with Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae, or Klebsiella (formerly Enterobacter) aerogenes, adapting the current EIP definition of resistance to only include isolates resistant to meropenem, imipenem or doripenem (minimum inhibitory concentration ≥ 4) first identified in a urine culture from 8/1/2011 to 7/31/2017. Patients with CRE identified in a sterile site culture prior to a urine culture will be excluded. Within this cohort, we will identify which patients had a subsequent similar CRE isolate identified from a sterile site between one day and one year after the original urine culture was identified (termed “progression”). CRE isolates will be defined as similar if they are the same species and have the same carbapenem susceptibility pattern. Univariable analyses using T-tests or other nonparametric tests for continuous variables, and Chi-square tests (or Fisher’s exact tests as appropriate) for categorical variables will compare patient demographics, comorbidities and presence of invasive devices including urinary catheters between patients who had progression to an invasive infection and those who did not have progression. Covariates with a p-value of < 0.2 will be eligible for inclusion in the multivariable logistic regression model with progression to invasive infection as the primary outcome. All statistical analyses will be done in SAS 9.4. RESULTS/ANTICIPATED RESULTS: From 8/1/2011 to 7/31/2017 we have preliminarily identified 546 patients with CRE first identified in urine, representing an annual incidence rate of 1.1 cases per 100,000 population. Most cases were K. pneumoniae (352, 64%), followed by E. coli (117, 21%), E. cloacae (48, 9%), K. aerogenes (18, 3%), and K. oxytoca (11, 2%). The mean patient age was 64 +/− 18 years and the majority (308, 56%) were female. Clinical characterization through chart review was available for 507 patients. The majority of the patients were black (301, 59%), followed by white (166, 33%), Asian (12, 2%), and other or unknown race (28, 6%). 466 (92%) patients had at least one underlying comorbid condition with a median Charlson Comorbidity Index of 3 (IQR 1-5). 460 (91%) infections were considered healthcare-associated (366 community-onset and 94 hospital-onset), while 44 (9%) were community-associated. 279 (55%) patients had a urinary catheter within the two days prior to the CRE culture. The analysis of patients who progress to an invasive CRE infection, including the results of the univariable and multivariable analyses assessing risk factors for progression is in progress and will be reported in the future. DISCUSSION/SIGNIFICANCE OF IMPACT: In metropolitan Atlanta, the annual incidence of CRE first isolated in urine was estimated to be 1.1 cases per 100,000 population between 2011 and 2017, with the majority of the cases being K. pneumoniae. Most patients had prior healthcare exposure and more than 50% of the patients had a urinary catheter. Our anticipated results will identify risk factors associated with progression from CRE bacteriuria to an invasive infection with a specific focus on having a urinary catheter, as this is a potentially modifiable characteristic that could be a target of future interventions.

Objectives/Goals: Given previously demonstrated relationships between decline in proteinuria to thresholds below 0.3-1.5 g/g and kidney failure, we sought to assess if this relationship was maintained when proteinuria change was measured on a continuous scale and to compare the difference in association between changes measured at 12- and 24-months post-index. Methods/Study Population: PARASOL is a consortium of academic scientists, patient advocacy organizations, and industry partners who came together to identify candidate surrogate endpoints for clinical trials in focal segmental glomerulosclerosis (FSGS). Data were harmonized among international cohorts and registries of adults and children with clinically adjudicated FSGS without other causes. Index was identified as the first observed urine protein-creatinine ratio (UPCR)≥1.5 g/g with associated eGFR≥30 ml/min/1.73m2. Change in UPCR from index to 12 and 24 months was evaluated using the difference in log(UPCR) from baseline and follow-up and transformed to percent change. Time-updated landmark Cox regression models were fitted, and the interaction between UPCR change and the 24-month timepoint indicator was assessed. Results/Anticipated Results: 1366 participants with at least 12 months of follow-up post-index and UPCR measurements 6-12 and/or 18-24 post-index were included. Mean age was 27 years (SD=21); 46% were pediatric at index. Median (IQR) eGFR and UPCR at index were 83 (57, 110) ml/min/1.73m2 and 3.7 (2.3, 7.0) g/g, respectively. A 50% decrease in UPCR from index was associated with a 28% and 32% reduction in the probability of kidney failure at 12 and 24 months, respectively, with no difference detected based on timing of UPCR (HR [95% CI] = 0.72 [0.65-0.80] at 12m, 0.68 [0.63-0.74] at 24m, interaction p-value = 0.46). In subgroups based on age, UPCR, and eGFR at index, results were consistent (HR range 0.66-0.72 at 12m and 0.58-0.78 at 24m), with only the eGFR≥60 ml/min/a.73m2 subgroup showing patterns of larger effects at 24m (HR = 0.62 vs. 0.72, p=0.08). Discussion/Significance of Impact: Continuous measures of proteinuria demonstrated consistent associations with kidney failure at 12- and 24-months post-index and across patient subgroups. If validated, these relationships support potential variation in timing of endpoint evaluation in clinical trials where there is mechanistic justification for earlier assessment.

OBJECTIVES/GOALS: To describe the creation, use and outcome of a successful multi-session case study for team science education and training. Creating a case study that spans multiple sessions can aid in emphasizing many team science concepts using one ongoing scenario. METHODS/STUDY POPULATION: We will describe the creation and use of a multi-session case study used in a team science graduate course. This case study incorporates the interpretation and use of assessments that coincide with concepts presented in each session. Participants engage with the case study as a team. The use of this case study allows participants to draw conclusions and make decisions about team interventions using concepts they’ve just learned. The multi-session case study also allows participants to see the outcome of their decisions in the next session. Further, the continuous nature of this case study allows participants to build on their knowledge from session to session and make connections between concepts. RESULTS/ANTICIPATED RESULTS: Incorporating a multi-session case study should help participants better understand team science concepts and practice incorporating the use of those concepts into teams in a more realistic way over time. The case study framework has been used in a team science graduate course for the last two years. The teaching team has incorporated continuous improvement into optimizing the case study over time. We’ll share preliminary results collected over the use of the case study so far along with the improvements made over time. DISCUSSION/SIGNIFICANCE: This education framework is very versatile and can be incorporated into a team science course or series of workshops and provides a real-world situation that allows participants to practice incorporating team science concepts and interventions in a team.

Objectives/Goals: This qualitative study evaluated facilitators and barriers to clinical research participation among lower-income, predominately racial/ethnic minority communities to inform a Co-Learning series. The Co-Learning series of community members, stakeholders, and researchers developed strategies to improve diversity in research. Methods/Study Population: Community focus group (FG) participants were recruited from urban communities experiencing poverty, whereas stakeholder FGs included diverse community leaders and researchers. The Social Ecological Model was used as the guiding theoretical framework throughout the qualitative design. Directed content analysis using three independent coders reaching 100% consensus identified prominent factors for increasing diversity in research. The co-learning series was comprised of community members, stakeholders, and researchers who discussed the prominent FG factors over seven in-person meetings to develop a toolkit to increase diversity in research. Results/Anticipated Results: Community (n = 51) and stakeholder (n = 50) FG participants were 54.0±16.0 years of age, 81.2% female, 39.6% Black/African American, 51.5% Hispanic, and 60% had Discussion/Significance of Impact: Due to the lack of inclusivity in clinical research, findings are typically not applicable to health disparity populations limiting the benefit of research to all. This study provides practical community-driven strategies to increase diversity in clinical research, highlighting the role of trust, relationships, and cultural relevancy.

OBJECTIVES/GOALS: Empowering the Participant Voice (EPV) is a Rockefeller-led 6-CTSA consortium that aims to collect research participant feedback through new Research Participant Perception Survey (RPPS)/REDCap infrastructure and data aggregation to a national database. Here we describe diverse Use Cases and launch dissemination to other hubs. METHODS/STUDY POPULATION: The EPV team refined the RPPS-S and developed fielding and data standards, a multi-lingual RPPS/REDCap project XML, At-a-Glance Dashboard, EPV Consortium Database, and Use Cases to align with local initiatives and stakeholder input. Sites ran full thread tests of the infrastructure before launch. To demonstrate RPPS/REDCap, 5 sites implemented Use Cases, surveyed diverse populations via email, patient portal or SMS, and analyzed results using the At-a-Glance Dashboard External module (which provides visual analytics and enables filtering by participant/study characteristics). Sites continue to collect, synthesize and respond to actionable data. To disseminate infrastructure, we will invite early adopters to implement the RPPS/REDCap infrastructure locally, joining the EPV learning collective. RESULTS/ANTICIPATED RESULTS: To date, 5 sites surveyed 10,199 research participants, at post-consent or end of study. 2833 (26%) research participants responded, from diverse demographic groups. More than 90% gave the Top Box score response regarding courtesy, respect for cultural background, privacy, and lack of pressure to join a study. Disparities were apparent in the informed consent experience, with a Top Box score range of 38-78% in different demographics. Dissatisfaction with out-of-pocket research costs was a recurring theme. Top Box scores varied for feeling like a valued partner in research (69-93%), would recommend research participation to friends or family (56%-81%), and Overall Experience (64%-90%) questions. Sites identified actionable findings in areas of consent, communication, partnership, and study conduct. DISCUSSION/SIGNIFICANCE: The EPV RPPS/REDCap infrastructure enabled sites to broadly collect participant feedback, identify actionable findings and make inter-institutional comparisons. Collaborators are designing local initiatives to increase response rate and diversity, address disparities in research participation experiences, and discover better practices.

OBJECTIVES/SPECIFIC AIMS: Clinical research in the 21st century will require a well-trained workforce to insure that research protocols yield valid and reliable results. Several organizations have developed lists of core competencies for clinical trial coordinators, administrators, monitors, data management/informaticians, regulatory affairs personnel, and others. While the Clinical Research Appraisal Inventory assesses the self-confidence of physician scientists to be clinical investigators, no such index exists to assess the competence of clinical research professionals who coordinate, monitor, and administer clinical trials. We developed the Competency Index for Clinical Research Professionals (CICRP) as a general index of competency (ie, GCPs) as well as sub-scales to assess competency in the specific domains of Medicines Development; Ethics and Participant Safety; Data Management; and Research Methods. METHODS/STUDY POPULATION: We analyzed data collected by the Joint Task Force on the Harmonization of Core Competencies from a survey of research professionals working in the United States and Canada. Respondents reported how competent they believed themselves to be on 51 clinical research core competencies. Factor analyzes identified 20 core competencies that defined a Competency Index for Clinical Research Professionals—General (CICRP-General, ie, GCPs) and 4 subindices that define specialized research functions: Medicines Development; Ethics and Participant Safety; Data Management; and Research Concepts. RESULTS/ANTICIPATED RESULTS: Factor analysis identified 20 core competencies that defined a Competency Index for Clinical Research Professionals—General (CICRP-General, ie, GCPs) and 4 subindices that define specialized research functions: Medicines Development; Ethics and Participant Safety; Data Management; and Research Concepts. DISCUSSION/SIGNIFICANCE OF IMPACT: These indices can be used to gage an individual’s readiness to perform general as well as more advanced research functions; to assess the education and training needs of research workers; and to evaluate the impact of education and training programs on the competency of research coordinators, monitors, and other clinical research team members.

OBJECTIVES/SPECIFIC AIMS: Morphea (localized scleroderma) is an autoimmune disease characterized that is widely thought to have a monophasic course, in which an initial period of inflammation (activity) ultimately results in scarring, atrophy, and functional impairment (damage). Understanding the long-term clinical course of morphea is important for the planning of future interventional studies, and as a tool for clinicians in determining risk for poor disease outcomes. METHODS/STUDY POPULATION: We conducted a prospective cohort study of 130 participants enrolled in the Morphea in Children and Adults Cohort over a median follow-up time of 4.3 years, to determine the rates of response to treatment and disease recurrence as measured by the Localized Scleroderma Cutaneous Assessment Tool (LoSCAT). To determine risk factors for recurrence of disease activity, survival analysis using the log-rank test was used to compare subgroups by morphea type, therapy, and age at disease onset. RESULTS/ANTICIPATED RESULTS: Within a 1-year follow-up period, 66% of patients treated with methotrexate and 46% of patients with UVA1 phototherapy had achieved complete response to treatment. In patients who had achieved response to treatment, 29% experienced disease recurrence at an average of 1.7 years after documented disease inactivity. Patients with generalized morphea experiencedhigher recurrence rates than those with linear morphea (HR: 3.03, 95% CI: 1.48–6.22), and those treated with UVA1 phototherapy had higher recurrence over those treated with methotrexate (HR: 2.33, 95% CI: 1.03–5.31). In patients with follow-up periods longer than 5 years (n=50), disease recurrence was observed in 44% of patients and the majority of recurrence represented new activity in an area of pre-existing morphea (82%). DISCUSSION/SIGNIFICANCE OF IMPACT: This study highlights the previously under-studied dynamic long-term course of morphea, and identifies the clinical characteristics that predispose patients to having a relapsing-remitting course. We conclude that patients with morphea should be followed closely over time even in the absence of disease activity due to the potential for disease recurrence.