Objectives/Goals: Lack of comparative data limits research operations quality improvement (QI). The Northwest Participant and Clinical Interactions (NW PCI) Network, a group of 17 unaffiliated university and health system-based research centers, built an operations dashboard to track efficiency and enable multisite QI projects. Methods/Study Population: A Data Governance Working Group was assembled to establish shared data governance, draft nondisclosure (NDA), and data transfer and use agreements (DTUA) suitable across organizations and standardize research operations metric definitions. Sites in the NW PCI Network were recruited to participate in a pilot program to assess data sharing and governance infrastructure, data collection, upload procedures, and data visualization tools. The NW PCI Coordinating Center developed an analytical data dashboard of research operations metrics and conducted semi-structured interviews with participating sites to understand barriers and facilitators of program success. Results/Anticipated Results: Four sites (2 health systems, 2 universities) were recruited for the pilot and reviewed and executed NDAs and DTUAs. Three of the sites have submitted data for a total of 1,405 studies. Of the 24 requested data operations metrics (e.g., study startup, recruitment, implementation, and basic study information), 71% of the metrics were submitted by all three sites (n = 17), 25% were submitted by at least one site (n = 6), and 4% were not submitted by any site (n = 1). Interviews with sites after data submission found areas for improvements (clarification of data definitions, efficiency of data upload process) and positive effects for sites (e.g., process improved insight into own data operations). Discussion/Significance of Impact: Unaffiliated research centers created data governance procedures to enable sharing of operations data. Pilot sites successfully loaded most but not all operations data to the dashboard. Interviews identified process limitations and opportunities for improvement to inform expansion to all NW PCI sites.

Objectives/Goals: Now in its 10th year, Research Jam, Indiana CTSI’s Patient Engagement Core, has proven to be an effective approach to patient engagement, foregoing generalized CABs for study-specific groups, personally invested in the research. Here we share our methods to benefit CTSAs seeking deeper engagement. Methods/Study Population: Research Jam is unique from patient engagement efforts in other CTSAs in almost every aspect. The composition and background of our team, the methodology to our practice and often our outcomes. This poster will use 10 years of projects, publications, and participant evaluations to explore our approach both quantitatively and qualitatively to see how it has contributed to the Indiana CTSI’s commitment to community engagement. Results/Anticipated Results: We will present quantitative data from 10 years of participant evaluations illustrating that Research Jams are received positively by those that attend, and qualitative analysis of the evaluations around themes of feeling heard, valued, and integral in research. By finding themes in evaluations across 10 years of studies, with different topics, different population types, and different investigators, we can speculate on what aspects of our approach appeal to the community, contribute to their positivity toward research and researchers, and could be reproducible in other CTSAs. Discussion/Significance of Impact: We use “blueprint” instead of “toolkit” when describing our process, as we hope others can see this not as a tool to fix a problem, but a plan to be iterated on in agreement with the community that will benefit from it. The relationships researchers need to build with communities are not cookie cutter neighborhoods, but rich, colorful and vibrant ones.

Objectives/Goals: * Examination of the acute glucose-lowering response to physical activity within a comprehensive behavioral weight loss intervention in adults without T2DM. * Explore whether the acute response to yogadiffers from the acute response to brisk walking and to examine whether these responses vary across the intervention period. Methods/Study Population: Participants in the behavioral weight loss and aerobic exercise group will start with 100 minutes per week of moderate-intensity aerobic activity, increasing every four weeks to 250–300 minutes, spread over five days. Activities will be self-selected, such as walking. Participants in the combined aerobic exercise and yoga group will do aerobic exercise three days a week and yoga two days a week, also progressing from 100 to 250–300 minutes weekly. All participants will follow an energy-restricted diet (1200–1800 kcal/day) and participate in weekly education sessions to learn lifestyle modification skills for successful weight loss. The study will explore differences in acute responses to yoga versus walking and how these vary during the intervention, controlling for initial and changing weight status. Results/Anticipated Results: Primary and secondary outcomes from the parent study will include body weight, BMI, body composition (via DXA), cardiorespiratory fitness, energy intake, and physical activity. Glucose and insulin levels will be measured pre- and post-exercise, with HOMA-IR computed. Continuous glucose monitoring (CGM) will be used to track glucose responses during each session, with the area under the curve (AUC) as the primary metric. The study will also explore advanced CGM analytics in collaboration with the KUMC Diabetes Institute that will include in-depth analyzation of peak and trough change velocity as well as novel correlations betwen glucose dynamics and physical activity patterns with an aim to uncover insights that transcend conventional CGM analyses. Discussion/Significance of Impact: This study uses advanced CGM analytics to examine glucose control during physical activity, collaborating with experts to create comprehensive models for glucose fluctuations. It compares acute responses to walking and yoga, addressing a key gap in research, with potential clinical insights for managing glucose in obesity.

Objectives/Goals: The objective of the Clinical and Translational Science Awards (CTSA) Program Collaborative and Innovative Acceleration (CCIA) Award Initiative is to support synergistic collaborations to develop, demonstrate, and sustainably implement innovative solutions across and beyond the CTSA Consortium. Methods/Study Population: All CCIA awards between 2016 and 2022 were reviewed and analyzed by Fiscal year, activity code, and research area using NIH analytical tools and platforms. Subject matter experts categorized each award by research topics, study populations, stage of translational science, and innovation type. The number and type of collaborating organizations were noted and major accomplishments and expected outcomes were summarized. Results/Anticipated Results: Between FY2016 and FY2022, NCATS funded 37 U01 and 18 R21 CCIA awards including >90 different public and private partnering organizations. CCIA awards spanned all stages of translation including preclinical (26%), clinical (36%), implementation (31%), and public health research (7%). Of the 55 CCIA awards, 31% focused on urgent public health needs and 25% were designed to address health disparities. Broadly, types of innovations included: Data science-related projects (18%), clinical care innovations (15%), biomarker or clinical outcome assessments (13%), digital health solutions (11%), therapeutic development (11%), therapeutic discovery (9%), education and training (7%), diagnostic tools (5%), software tools (5%), or tools for clinical research (5%). In total, >735 publications cited CCIA awards. Discussion/Significance of Impact: For >8 years, the CCIAs have brought together researchers from diverse scientific disciplines across the nation to speed the development of new health solutions with broad impact. Advancements in genomic screening, for example, have led to policy changes while new delivery approaches have improved the quality of care for underserved populations.

Objectives/Goals: The objective of this study is to explore strategies for AI-physician collaboration in diagnosing acute respiratory distress syndrome (ARDS) using chest X-rays. By comparing the diagnostic accuracy of different AI deployment methods, the study aims to identify optimal strategies that leverage both AI and physician expertise to improve outcomes. Methods/Study Population: The study analyzed 414 frontal chest X-rays from 115 patients hospitalized between August 15 and October 2, 2017, at the University of Michigan. Each X-ray was reviewed by six physicians for ARDS presence and diagnostic confidence. We developed a deep learning AI model for detecting ARDS and explored the strengths, weaknesses, and blind spots of both physicians and AI systems to inform optimal system deployment. We then investigated several AI-physician collaboration strategies, including: 1) AI-aided physician: physicians interpret chest X-rays first and defer to the AI model if uncertain, 2) physician-aided AI: the AI model interprets chest X-rays first and defers to a physician if uncertain, and 3) AI model and physician interpreting chest X-rays separately and then averaging their interpretations. Results/Anticipated Results: While the AI model (84.7% accuracy) had higher accuracy than physicians (80.8%), we found evidence that AI and physician expertise are complementary. When physicians lacked confidence in a chest X-ray’s interpretation, the AI model had higher accuracy. Conversely, in cases of AI uncertainty, physicians were more accurate. The AI excelled with easier cases, while physicians were better with difficult cases, defined as those where at least two physicians disagreed with the majority label. Collaboration strategies tested include AI-aided physician (82.4%), physician-aided AI (86.9%), and averaging interpretations (86%). The physician-aided AI approach had the highest accuracy, could off-load the human expert workload on the reading of up to 79% chest X-rays, allowing physicians to focus on challenging cases. Discussion/Significance of Impact: This study shows AI and physicians complement each other in ARDS diagnosis, improving accuracy when combined. A physician-aided AI strategy, where the AI defers to physicians when uncertain, proved most effective. Implementing AI-physician collaborations in clinical settings could enhance ARDS care, especially in low-resource environments.

Objectives/Goals: NIH requires researchers submit Data Management and Sharing (DMS) Plans with their grant applications. Librarians developed an assessment tool for the plans and completed a pilot assessment in order to leverage the plans and understand current institutional research data management and sharing. Methods/Study Population: The assessment tool includes questions related to evaluations of DMS Plans as well as questions related to the content of the plans. Evaluation questions were adapted from the Federation of American Societies for Experimental Biology evaluation rubric developed for the DataWorks! Data Management Plan (DMP) Challenge. Fields were added to collect information on the content of DMS Plans, including data type, institutional resources, data repositories, data standards, and data dissemination timelines. The assessment tool was tested in a pilot implementation. Seven library workers were trained and completed paired review samples of 27 DMS Plans (54 evaluations total) in order to test for tool reliability. Results/Anticipated Results: Results include findings on the reliability of the tool as well as preliminary results from an assessment of DMS Plans. Findings on the reliability of the tool include assessments of the paired reviewers for each question included in the tool. Paired reviewers generally agreed, but tended to differ on specific questions, including questions pertaining to the data types generated or used in a research project. Questions with high levels of agreement included subjects of study and code sharing practices. Results on the content of the DMS Plans include information such as data repositories used, data oversight responsibilities, and data and metadata standards employed. Discussion/Significance of Impact: DMS Plans present an opportunity to better understand data management and sharing practices, and good data management supports high-quality, reproducible research. Developing and testing assessment tools for these plans is a key step toward understanding and improving current research data management practices.

Objectives/Goals: People with insulin-treated diabetes face hypoglycemia risk due to imperfect insulin replacement and impaired counterregulation. We identified the dopamine antagonist, metoclopramide, as a potential treatment. Hypothesis: Treatment with metoclopramide will prevent the development of impaired counterregulatory response to hypoglycemia. Methods/Study Population: In a pre-clinical model, diabetes was induced in 10-week-old Sprague-Dawley rats with streptozotocin (STZ, 65 mg/kg IP). Rats were divided into three groups: 1) diabetic controls (STZ+RS, n = 6), 2) recurrent hypoglycemia (STZ+RH, n = 7), and 3) recurrent hypoglycemia + metoclopramide (STZ+RH+MET, 3 mg/kg IP, n = 7). After 3 days, all rats underwent a hyperinsulinemic (50 mU/kg/min) and hypoglycemic (~45 mg/dl) clamp. In the clinical trial, adults with Type 1 diabetes (age 20–60, ≥5 years duration) were enrolled in a phase II, double-blinded, placebo-controlled trial. Awareness status was assessed via Gold score, and subjects maintained drug regimens and underwent two hyperinsulinemic-hypoglycemic clamps (where blood glucose was lowered to 100, 65, 55, and 45 mg/dl) to assess counterregulation. Results/Anticipated Results: In the pre-clinical model, glucose infusion rates (GIR) to maintain hypoglycemia were higher in STZ+RH (27±0.9 mg/kg/min) than STZ+RS (19±0.8 mg/kg/min, p Discussion/Significance of Impact: Metoclopramide improves glucoregulatory, sympathoadrenal, and counterregulatory responses to hypoglycemia in pre-clinical models, suggesting dopaminergic regulation. While clinical data are still blinded, increased epinephrine and growth hormone responses suggest treatment may preserve or restore counterregulation.

Objectives/Goals: This study aims to evaluate diversity of participants in GLP-1 T2DKM clinical research with regard to sex, race, and ethnicity by using results data available through the ClinicalTrials.gov database. Sample population estimates for studies were calculated using the 2020 Census and compared within groups with respect to sex, race, and ethnicity. Methods/Study Population: The public ClinicalTrials.gov database was searched for interventional studies with GLP1 inclusion as treatment (n = 2,397). This search was then filtered to studies where results were reported (n = 772). From these studies, 466 studies focused on type 2 diabetes as a condition and thus became the analysis dataset. Participant and protocol information for these 466 studies were obtained from the clinical trials transformation initiative (CTTI) as an AACT data download. Observed to expected ratios were calculated for each subgroup-based population estimates from the 2020 Census and using the baseline counts of participants for studies where sex, race, and ethnicity were provided. In addition to within group comparisons, study characteristics (e.g. phase) were included in models to assess influence of covariates. Results/Anticipated Results: Of the 466 studies, 430 (92%) reported sex, 171 (37%) reported race, and 145 (31%) reported Hispanic ethnicity. Among those found to be underrepresented in studies (defined as a ratio < 1): females (mean  =  0.89, median  =  0.92); Black/African Americans (mean  =  0.88, median  =  0.39). Hispanic or Latinos mean ratio was 1.16 (95% CL: 0.97, 1.35) but had the least available data. When including covariates in the models, there were statistically significant differences in ratios with respect to sex as females had significantly lower odds compared to males (ratio > =  1), with the odds being about 21% of those for males. With respect to race, Black or African American individuals had significantly lower odds (about 32% of those of White individuals) (ratio > =  1). Discussion/Significance of Impact: This study reveals significant underrepresentation of females (mean ratio 0.89) and Black/African Americans (mean ratio 0.88) in clinical trials for GLP-1 drugs in type 2 diabetes. These disparities highlight the need for more inclusive research to ensure diverse populations benefit equally from medical advancements.

Objectives/Goals: Community-based practices have limited research opportunities for providers. As a rural community-based health system, Mayo Clinic Health System (MCHS) sought to create intramural funding mechanisms to help early-stage researchers conduct pilot research so they are more competitive to compete for more robust extramural funding opportunities. Methods/Study Population: We created a Research Seed Grant Program infrastructure across our four MCHS regions (Southwest and Southeast Minnesota, Northwest and Southwest Wisconsin). This model program featured an initial research funding announcement call based on 6 prioritized programs (AI Validation & Stewardship, Cancer, Health Equity, Population Health, Rural Health, Learning Healthcare System [LHS]), with submissions uploaded to a central electronic repository. Proposal review and ranking was organized on a regional basis, with ranking of all proposals by at least 2 clinical scientist reviewers according to the NIH domain-specific framework (i.e., 1.0 best > 9.0 worst). Awards were competitively selected by conformity to prioritized research areas and through ranking of most competitive overall application scores. Results/Anticipated Results: For our inaugural RFA, we received 55 grant application submissions across the MCHS regions. Fifteen of the most highly ranked applications were selected for awards on a per region basis, providing direct funding as well as protected investigator research time of 10% for up to six months. The selected projects address several research priorities including improving access, reducing health disparities, improving behavioral health in our communities, increasing cancer screening and prevention, and community-based pragmatic trials and interventions. Outcomes from these now completed pilot projects remain pending at this time. Funding for this seed grant program was supported by philanthropy, Mayo Clinic Research Administration, Mayo Clinic Comprehensive Cancer Center, and the Mayo Clinic CCaTS Rural Core. Discussion/Significance of Impact: We present this framework for a LHS-focused Seed Grant program model for consideration of adoption by other national/international LHS. Future plans include tracking of outcome metrics (e.g., published peer review articles, extramural grant applications) of this initial cycle and future expansion of this program to support the goals of our LHS.

Objectives/Goals: Highlight the importance of community engagement: Showcase how the involvement of Promotoras de Salud is critical for fostering trust and encouraging participation in clinical trials. Cultural relevance and adaptation: Underline the importance of cultural and contextual relevance in developing and refining clinical research tools. Methods/Study Population: The theater test, an interactive evaluation approach akin to a dress rehearsal in theater, was conducted with approximately 60 Promotoras de Salud at a community center near the US-Mexico border. The Promotoras were divided into four groups, each focusing on one domain of the toolkit and facilitated discussions provided critical feedback on the materials and methods. A community engagement liaison with the University of New Mexico Health Sciences Center played a key role in introducing the EXPLORE team to these community leaders, leveraging long-standing relationships that predate this project. Results/Anticipated Results: Post-testing evaluations showed that 97% of the Promotoras were likely to encourage clinical trials in their communities, and 86% saw significant benefits for their community members. The Promotoras provided key insights and recommendations to enhance the toolkit’s cultural and contextual relevance. The community engagement liaison created a bilingual infographic to share these insights, which was presented at a Promotoras meeting, fostering meaningful discussion about clinical trials. Discussion/Significance of Impact: This project underscores the importance of community voices in research, transforming feedback into actionable insights for public health. Engaging Promotoras through theater testing validated the EXPLORE Toolkit and strengthened ties between clinical research and communities impacted by the opioid crisis.

Objectives/Goals: Identify risks in the regulatory reliance ecosystem, specifically for generic reliance pathways, using system theoretic process analysis (STPA), a proactive hazard analysis method, and create sustainable solutions to ensure global accessibility to the highest attainable standard of health. Methods/Study Population: A systematic literature review will assess the regulatory reliance ecosystem and interactions among National Regulatory Agencies (NRAs). This will involve using a hierarchical control structure (HCS) to identify operational loop failures, decision-making, and information flow. The HCS will inform an STPA to prevent adverse outcomes like patient harm or regulatory non-compliance. With IRB approval, 10 regulatory experts will also be interviewed to gather insights on risk scenarios. Their input will be used to integrate regulatory pathways into the HCS for adaptability, and a second round of interviews will be conducted to validate the scenarios and assess the effectiveness of recommendations. Results/Anticipated Results: A preliminary literature review on regulatory reliance pathways from PubMed, WHO guidelines, and the DIA global forum, revealed potential risks in NRA interactions, such as overly redacted reports obscuring critical details and discrepancies in product versions or incomplete reviews affecting evaluations. Diverging guidelines and failure to adapt to country-specific needs are potential risks that also impact patient access to essential medicines. The STPA framework, along with expert feedback, will uncover unknown risks like “secondary-reliance” and soft risks, leading to sustainable recommendations to improve and optimize the safety of regulatory reliance. Discussion/Significance of Impact: Safe regulatory reliance is crucial for global health equity and patient access to essential and innovative medicines. STPA will identify and address different layers of risk in the system, improving safety, efficiency, and innovation for timely patient access to therapeutics.

Objectives/Goals: Planning research studies can be daunting for early-career investigators. The UW Madison Institute for Clinical and Translational Research (ICTR) has many services to assist, but navigating them can be convoluted. Therefore, we developed a method to streamline services for investigators. Methods/Study Population: Investigators were reaching out to ICTR research support services for assistance in the wrong order, delaying their study progress. To streamline ICTR services and improve investigator support, we developed the ICTR COllaborative Network (ICON) that meets weekly to discuss investigator needs and how best ICTR services can assist them. This group consists of members from ICTR’s Research and Protocol Development Program, the Recruitment and Retention Resource Center, and the Collaborative Center for Health Equity. After discussion and decision-making, a member of the group schedules a studio, bringing key services together at one time to help investigators more efficiently. Results/Anticipated Results: The group has worked with 22 investigators, decreasing the time to study implementation. One investigator indicated ICON saved her team over four months of work. Other investigators indicated the assistance with finding community partners and collaborators was essential to their success. We expect ICON, with its goal to streamline regulatory submissions and study planning, will continue to help investigators improve organization during study start up and execution, while enhancing recruitment strategies. This will result in quicker study completion and the capability to move forward with future projects and grant submissions. Discussion/Significance of Impact: ICON streamlined the consult process, improved efficiency of study planning, and brought together various experts for studio meetings with investigators. This efficient method can improve study function and execution for early-career investigators resulting in improved study success.

Objectives/Goals: Evaluate the impact of intrauterine growth restriction (IUGR) on neonatal brain development using magnetoencephalography (MEG) and correlate findings with NICU Network Neurobehavioral scale (NNNS) scores at 1 month Methods/Study Population: In this prospective cohort study, we will enroll 30 participants, consisting of 15 neonates diagnosed with IUGR and 15 healthy controls, matched by gestational age, from the University of Arkansas for Medical Sciences. We will perform MEG scans at three key developmental stages: during fetal life, at 1 month, and at 3 months of age and a Bayley IV exam at 12 months of age. The NNNS assessments will be conducted at the 1-month visit to evaluate neurobehavioral outcomes. All MEG data will be synchronized with clinical evaluations and maternal health records to ensure comprehensive analysis. Results/Anticipated Results: We anticipate that the study will reveal significant differences in brain maturation and neural activity patterns between IUGR-affected infants and healthy controls. Specifically, we expect to find altered neural connectivity and delayed maturation in the delta and theta frequency bands during the early neonatal period in the IUGR group. These anticipated neuroimaging findings will be correlated with NNNS scores to assess functional implications of the observed brain activity differences. If our hypotheses are confirmed, the study will provide robust biomarkers for early identification of neurodevelopmental delays in IUGR-affected infants, paving the way for targeted early interventions. Discussion/Significance of Impact: This study could significantly enhance early detection and intervention strategies for IUGR, potentially reducing long-term neurodevelopmental challenges and improving clinical outcomes

Objectives/Goals: REDCap is a popular electronic data capture tool. However, training users in how to best utilize REDCap can be a challenge for many institutions. The Clinical and Translational Science Institute (CTSI) strives to setup a self-service training program that takes the day to day roles of users into account. Methods/Study Population: Our new training curriculum is a collaboration with our Workforce Development team and our REDCap Support Team. The REDCap team functions as the subject matter experts and generate a training outline based on a certain feature or topic. The Workforce Development team transform that outline into an LMS style course that’s available online. In order to organize the courses for maximum relevance to user, we engaged with various REDCap training and regulatory experts around the globe. Based on their input, we organized the various training courses into a role-based schema. The training courses are freely available online and contain an optional test and completion certification in order to comply with regulatory standards like 21 CRF part 11 or GDPR. Results/Anticipated Results: We released the first 17 training courses in July 2024 with another 20 courses planned in the near future. Responses to the courses have been overwhelmingly positive from users and the greater REDCap community. Our collection of training courses won the best website award at the yearly REDCap conference in 2024. To date we have had 137 people go through a training course with the optional test and completion certificate. While the majority have been from the USA, a significant portion hails from other countries. We believed these people only represent a small subset of users due to the optional nature of the test and accreditation section. Discussion/Significance of Impact: Our new role-based training curriculum is crucial in giving REDCap users the training tools they need for their particular role. The certification option fills a niche for professionals to demonstrate their REDCap proficiency to further their careers. Overall, this user training should increase the utilization of REDCap in all research endeavors.

Objectives/Goals: Objectives/Goals (300 characters): Sarcopenia is a progressive skeletal muscle disorder associated with adverse outcomes. There is a gab of having objective measures upon performing interventions in patients with muscular dystrophies. The object of the present study is to describe the severity of sarcopenia in DMD patients in Puerto Rico. Methods/Study Population: Methods/Study Population (700 characters): Forty to 30 patients with DMD who are followed in MDA Care Center in the “Instituto De Rehabilitacion del Caribe.” Diagnosis will be confirmed with genetic testing and/or muscle biopsy. Lean muscle mass will be measured with a Whole Body Dexa (WBD) in a Nuclear Medicine Lab. Hand grip, elbow flexor, and knee extensor muscles strength will be measures with an isometric dynamometer. Patients’ functionality will done using the North Star Ambulatory Assessment scale and Brook and Vignos scales, which have been validated for patients with DMD and neuromuscular disease respectively. Correlations will be made with lean body mass (independent variable) and muscle strength and functionality (dependent variable). Results/Anticipated Results: Results/Anticipated Results (700 characters): We expect to find severe sarcopenia in patients with DMD in PR and that it will be more severe with older age. There will be a direct correlation between lean muscle mass and muscle strength, and functionality in DMD patients. Discussion/Significance of Impact: Discussion/Significance of Impact (300 characters): The findings of our study can help us to explore the possibility that Whole Body DEXA can serve as a potential biomarker for future studies since there is a need to develop noninvasive biomarkers that correlate with disease progression and interventions in DMD patients.

Objectives/Goals: Effective research relies on a well-trained study coordinator workforce, but mentorship programs are lacking. Retaining and empowering career development for skilled research staff is challenging. To address this, the Michigan Institute for Clinical and Health Research launched the STEP.up program. Methods/Study Population: The Staff Enrichment Program for Research Professionals (STEP.up) was created in 2018. To increase knowledge and awareness of our program, we developed an implementation guide to share best practices and open access to our program structure and content. We identified seven critical elements integral to program success. The implementation guide provides a description and rationale for these elements. We partnered with an instructional designer to build a descriptive and easy-to-use guide that describes insights into the successful implementation of the program, practical strategies for program management, and adaptable resources for institutions to use and tailor to their unique needs. Results/Anticipated Results: In the STEP.up program, early career, new-to-role, or new-to-organization research staff members are paired with senior research professionals in a 9-month structured mentorship and career development experience to promote professional development, job satisfaction, and retention for individuals currently working as research professionals. Of the 82 participants from 2018 to 2024, 76 (93%) have remained in their roles as study coordinators. The STEP.up program implementation guide provides the tools, resources, and insights senior research professionals need to implement this program successfully at their sites. Discussion/Significance of Impact: STEP.up program materials are available as an open-source resource on the DIAMOND portal. This resource can encourage others to invest in structured mentorship for research professionals to help establish a culture of growth and cultivate a resilient, skilled, and committed research workforce.

Objectives/Goals: The gut microbiome and its metabolites, such as short-chain fatty acids (SCFA), are dysregulated in rheumatoid arthritis (RA); however, the significance of this observation and its implications in pathogenesis and therapeutics is unclear. Here, we explore the role of the SCFA, butyrate, in treatment efficacy in new-onset rheumatoid arthritis. Methods/Study Population: We designed a proof-of-principle study to determine the effects of butyrate supplementation in new-onset RA (NORA) patients that fulfilled 2010 ACR/EULAR RA criteria. We evaluated the effects of methotrexate (MTX) plus butyrate in NORA (n = 17; 1 gm butyrate, 3 times daily) compared to MTX alone (n = 19) over 4 months. MTX responders were defined by a change in disease activity score (DAS)-28 ESR of > 1.8 at 4 months. Fecal samples were collected at baseline and followed up for 16s rRNA sequencing and metabolite quantification by 1H NMR spectroscopy. Unpaired-t, paired-t, Wilcox and Fisher’s exact test were performed as appropriate. Results/Anticipated Results: MTX responders in the MTX-only group had a higher concentration of fecal butyrate than nonresponders at baseline (p = 0.045). Fecal butyrate concentration decreased over time in treatment responders in MTX group (p = 0.05), whereas butyrate concentration remained similar in MTX/butyrate group. Prior to treatment, both MTX and MTX/butyrate groups demonstrated similar levels of gut bacterial alpha diversity (Shannon index), yet only the MTX/butyrate group demonstrated a significant increase in alpha diversity by 4 months (p = 0.022). LefSe analysis demonstrated increased abundances of Bacteroides, Clostridium, and Phascolarctobacterium in responders in the MTX/butyrate group by 4 months. Ten (52.6%) patients in MTX and 11 (64.7%) in MTX/butyrate group were considered MTX responders by 4 months (p = 0.516). Discussion/Significance of Impact: Butyrate supplementation increased gut microbial diversity in patients and led to increased abundance of Bacteroides, which has been implicated in efficacy of methotrexate, a first line medication in rheumatoid arthritis. Butyrate may have implications for the maximization of therapeutic effectiveness in rheumatoid arthritis.

Objectives/Goals: To fully understand the scientific objectives, overall financial commitment, and outcome of the pilot projects. Methods/Study Population: We evaluated pilots reported in the in the annual, interim, and final Research Performance Progress Reports (RPPRs) for Clinical and Translational Science Awards (CTSA) Program UM1 and UL1 grants from FYs 2021–2023 to assess research categories across the translational science spectrum. We analyzed the number of pilots involving human subjects, vertebrate animals, both, or neither; financial allocations; publication outputs; and other characteristics. Pilots reported across multiple years were deduplicated and assigned to the latest reporting year. Each pilot was classified into broad (Category 1) and specific (Category 2) areas. Descriptive statistics, including means and frequency distributions, were generated. Multi-year pilots with NA or 0 values used the most recent prior value. Results/Anticipated Results: In the period from FY 2021 to 2023, 61 hubs reported 1,811 unique pilot projects in their RPPRs, receiving a total of approximately $62 million, of which two-thirds were expended. On average, each hub conducted 30 pilots with an award size of about $35K. Just over half of the pilots involved human subjects research (HSR), while about one-third were neither HSR nor vertebrate animal studies (VAS), with the remaining focused primarily on VAS. Notably, only 13% of pilots resulted in peer-reviewed publications. Collaborative efforts were observed in one-third of the projects. The majority of pilots fell into Preclinical Research (46%), followed by Clinical Research (33%) and Public Health (20%). Limitations in data quality were identified, and ten pilots reported $0 awarded funds, which may be captured in future RPPRs. Discussion/Significance of Impact: Analysis of pilots reported in RPPRs from FYs 2021–2023 across 61 hubs shows a strong focus on HSR, highlighting collaborative efforts that enhance translational science and align with CTSA goals. Future analysis will help assess the pilots’ impact and their alignment with NCATS’ mission to expedite research translation into health solutions.

Objectives/Goals: Posttraumatic stress disorder (PTSD) is common during pregnancy and postpartum, leading to adverse birth outcomes. Despite effective interventions like narrative exposure therapy, PTSD often goes untreated due limited training opportunities and lack of community support. Expanding training for PTSD is crucial to improving access to care. Methods/Study Population: Six 3-day PNET trainings were delivered to 57 participants over a 23-month period. Workshop attendees represented a variety of professions (19% Social Workers, 19% Mental Health Graduate Trainees, 18% Psychologists, 18% Counselors, 12% Doulas, 11% Physicians, and 5% Home Visitor/Parent Educators) with varying levels of specialty experience from diverse locations (2 countries and 13 states). Key workshop outcomes included participant one-week post-workshop satisfaction, perceptions of acceptability, appropriateness, and feasibility of the intervention, and pre- to one-week post-workshop perceptions of connectedness to trauma treatment and perinatal healthcare communities. Data will be explored at 6 months post-workshop to evaluate longer-term effects on connectedness. Results/Anticipated Results: The majority of workshop attendees (84%, M =  4.76, range 1–5) reported being “extremely satisfied” with the training and 98% indicated they would “recommend it to others.” Most attendees found NET to be acceptable (M  =  4.64, range  =  1–5), appropriate (M  =  4.37, range  =  1–5), and feasible (M  =  4.49, range  =  1–5) to use within their practice. Paired t-tests revealed a significant increase in a sense of connectedness to both the trauma treatment and perinatal healthcare communities from pre- to post-workshop. Discussion/Significance of Impact: Findings indicate that the PNET workshop is feasible and effective in training interdisciplinary providers on perinatal PTSD evidence-based interventions. By training a range of professionals and fostering a sense of connectedness, the PNET workshop has the potential to make effective trauma treatments accessible to underserved populations.

Objectives/Goals: MyCTSC harmonizes data from many sources into one database for evaluation, marketing, and CTSC member management to address current disparate collection and siloed use of data. It simplifies report creation with real-time dashboards so administrators and leadership can view progress quickly and plan for improvements based on real-time data. Methods/Study Population: MyCTSC is built using open-source software like Python, Django, MariaDB, Bootstrap, and Chart.js, and integrates data from sources such as systems for consult requests, pilot/voucher applications, and REDCap surveys. Each data source is imported into the warehouse either automatically via API, if available, or via manual file upload. De-duplication and other data cleaning are performed as well. Customized, real-time dashboards are developed based on the needs of administrators and leadership. While MyCTSC does not have a study population, it does have the stakeholders mentioned above as well as leadership. The development timeline spans three years: initial development and data warehouse population in Year 1, data cleaning and dashboard creation in Year 2, and full rollout to all CTSC members in Year 3. Results/Anticipated Results: MyCTSC aims to create a seamless data and member management system to resolve issues stemming from multiple data sources. Demographic challenges are addressed by implementing data cleaning and consolidating duplicate identities into a single profile. The initiative will enhance stakeholder buy-in by presenting evaluation use cases that show the impacts of CTSC resources. For example, workforce development needs will be met through surveys and integration of a course catalog. MyCTSC will also facilitate targeted resource and event advertising, and support investigator outreach and collaboration by utilizing dashboards and reports. Furthermore, it will serve as the consolidated data source for all CTSC modules, promoting greater interaction and collaboration across administration and modules. Discussion/Significance of Impact: MyCTSC integrates multiple sources, consolidates identities, and simplifies reporting for outreach and collaboration. It enhances interaction with researchers and community members, advancing translational science by linking projects and publications. MyCTSC, built with open-source software, can be made available to other CTSA hubs.