Achieving the clinical, public health, economic, and policy benefits of translational science requires the integration and application of findings across biomedical, clinical, and behavioral science and health policy, and thus, collaboration across experts in these areas. To do so, translational teams need the skills, knowledge, and attitudes to mitigate challenges and build on strengths of cross-disciplinary collaboration. Though these competencies are not innate to teams, they can be built through the implementation of effective strategies and interventions. The Science of Team Science (SciTS) has contributed robust theories and evidence of empirically-informed strategies and best practices to enhance collaboration. Yet the field lacks methodological approaches to rigorously translate those strategies into evidence-based interventions to improve collaborative translational research. Here, we apply lessons from Implementation Science and Human-Centered Design & Engineering to describe the Wisconsin Interventions in Team Science (WITS) framework, a process for translating established team science strategies into evidence-based interventions to bolster translational team effectiveness. To illustrate our use of WITS, we describe how University of Wisconsin’s Institute for Clinical and Translational Research translated the existing Collaboration Planning framework into a robust, scalable, replicable intervention. We conclude with recommendations for future SciTS research to refine and test the framework.

OBJECTIVES/GOALS: NCATS requires that CTSA-funded pilot projects focus on translational science (TS) and evaluate the translational process. However, a consistent understanding of TS remains elusive. This gap is being addressed by a consortium of 12 CTSA hubs aimed at identifying distinctive features of TS and translational research (TR) proposals. METHODS/STUDY POPULATION: CTSA External Review Exchange Consortium (CEREC) is a reciprocal review collaboration among CTSA hubs. Reviewers were CEREC members from hubs that submitted CTSA applications (PAR-21-293); read the Notice of Funding Opportunity (NOFO) Clinical and Translations Science Pilot Module; and discussed TS with their hubs “a fair amount” or “quite a bit” and then they independently categorized proposals. Proposals were labeled TS or TR if reviewers reached a consensus on category assignment; without consensus, proposals were labeled unclassified. In addition to category assignment, reviewers commented about their classifications. R was used to evaluate the comments and create word clouds with phrases/themes that distinguished between the categories of proposals. RESULTS/ANTICIPATED RESULTS: Twelve CEREC participating hubs submitted 26 proposals, which were funded prior to the new NCATS TS requirements. Eight reviewers from distinct CEREC hubs evaluated and classified each proposal as TS or TR. Consensus (at least 87% agreement) was reached for 12 proposals, 6 TS and 6 TR. Reviewers provided comments describing the rationale for their classifications for 70% of the proposals. Qualitative analysis of the reviewers’ comments and rationale by classification (TS, TR, or unclassified) revealed common themes within and differences between groups and shed light on what defines TS and TR. The most frequent themes that distinguished TS from TR were generalizability across multiple diseases and a focus on increasing research efficiency. DISCUSSION/SIGNIFICANCE: NIH is focused on research that meets the new definition of TS. Investigators seeking to address this funding priority should explicitly state the relevance of their research to multiple diseases and to the acceleration of future research. Programs seeking to attract TS projects should instruct applicants to include this information.

OBJECTIVES/GOALS: CTSA Hubs represent complex centers where teams work to meet multiple goals of the CTSA grant. An existing challenge is to work collaboratively across teams. To address this challenge, a Translational Operations Group (TOG) was established. Results show enhanced intra-hub collaboration and communication while reducing inefficiencies. METHODS/STUDY POPULATION: The TOG is composed of all CTSA hub module program managers who are charged with operationalizing vision into reality. The TOG was formed in 2021 as a mechanism to integrate new team members, provide connection, and improve cross-core awareness and collaboration. Leveraging team science principles, a team charter was developed outlining specific TOG aims and objectives. Collectively, shared goals were identified with establishment of group norms, effective communication pathways, shared resources and knowledge and meeting cadence. Leadership of the group rotates among the TOG members annually further engaging all TOG members. Pre and Post (one year) surveys were developed and provided to TOG members to gauge TOG effectiveness and perceptions of TOG members. RESULTS/ANTICIPATED RESULTS: Survey results demonstrate the effectiveness of the TOG concept in promoting core/module awareness and goals, intra-core/module interconnectedness, and forming connections and integration into the CTSA hub ecosystem. Psycho-social questions demonstrated an increase in organizational self-esteem within the pre to post survey period in relation to the specific TOG member’s core/module and the CTSA hub as a whole. DISCUSSION/SIGNIFICANCE: Formation of a TOG has been successful within a virtual environment where connection is challenging. Integration of members to the operational activities is critical to foster a positive work environment, reduce silo effects, and provide a space for sharing resources and knowledge. Annual reflection of priorities contribute to the ongoing success.

Routine, nonmedical and ancillary medical costs associated with participation in clinical research create barriers to enrollment for economically disadvantaged individuals. To the extent that race, ethnicity, and gender are linked to SES, such barriers impact efforts to diversify clinical research enrollment. But payment policies and practices often reflect the longstanding and singular concern that payment to participants will bias decision-making and compromise informed consent. We argue that this concern must be viewed in a larger ethical context in which the untoward consequences for the individual participant and for the broader research enterprise are considerable when either inadequate or no payment is provided for expenses incurred (“reimbursement”) and time committed (“compensation”). Fairness in payment and protection from undue influence of payment on the informed consent process are important but distinct ethical considerations. Fundamentally, approaches to payment that leave participants financially worse off as a consequence of taking part in research are inherently unjust as they have a differential impact on recruitment and retention based on socioeconomic status. Sponsors, funders, investigators, and IRBs must be cognizant of the impact of inadequate payment on clinical trial inclusion of historically understudied groups. We address practical and fair payment strategies to advance inclusion, the additional barrier of ancillary medical costs, and potential unintended consequences of payment.

OBJECTIVES/GOALS: * To analyze and compare disease support (funding, research productivity, drug development) and burden between systemic lupus erythematosus (SLE), which particularly affects Black women, and similar conditions that affect other groups of Americans. * To address the discrepancy of prevalence estimates of SLE in America. METHODS/STUDY POPULATION: This cross-sectional study examined publicly available data on disease funding metrics and research productivity indicators. We utilized the NIH Report database to calculate the total NIH funding and career development awards for SLE from January 1, 2008, to December 31, 2023 (estimated). We reviewed Form 990-T tax returns of SLE organizations to calculate private funding. We examined US-based interventional trials related to SLE on ClinicalTrials.gov between 2008 and 2024, using the terms SLE and lupus. We assessed FDA drug approvals for SLE from 2008 to 2024. We reviewed publicly available SLE disease characteristics such as prevalence, incidence, demographics, costs, and mortality rates. We repeated these methods for conditions like SLE but with different patient demographics. RESULTS/ANTICIPATED RESULTS: We will formulate SLE support based on its avaialble federal and private funding, clinical trials, and drug approvals. We will determine the ratio of SLE support to disease burden and compare it to other conditions that affect different demographics in the US. There is currently a discrepancy in the range of prevalence of SLE in the US (178,362 to 1.5 million), so we will work with specialists to provide a better understanding of the actual prevalence. DISCUSSION/SIGNIFICANCE: SLE is a chronic disorder that is associated with hospitalizations, organ failure, and premature mortality. It has established disparities in incidence, treatment, and outcomes along gender, racial, and socioeconomic lines. Our study highlights the need for policy changes within research funding to address disparities and improve outcomes.

OBJECTIVES/GOALS: Health care accounts for an estimated 10% of U.S. greenhouse gas (GHG) emissions. Concerted efforts to decrease waste are needed including critical appraisal of single use items. The purpose of this study was to conduct life cycle analyses (LCA) of a pediatric single use laryngoscope to inform environmental impact and identify targets to reduce waste. METHODS/STUDY POPULATION: LCA was used to quantify the environmental impact of a single use pediatric laryngoscope. LCA is an industry standard measure of energy consumption, water consumption, and GHG emissions encompassing a “cradle-to-grave” assessment. The GREET model (Greenhouse gases, Regulated Emissions and Energy use in Technologies) and Open LCA model were used as sources for product/raw material data. Separate analysis was completed for the battery powering the light emitting diode (LED) lights. RESULTS/ANTICIPATED RESULTS: The LCA revealed 598.2 g of CO2 equivalents for the 121g single use pediatric laryngoscope. There were an estimated 26,849 cases that used single use laryngoscope last year at our free-standing children’s hospital resulting in 16.1 metric tons of CO2 equivalents. This is equivalent to 41,273 miles driven by an average gasoline powered vehicle. The 1.5 V battery was the highest contributor to the laryngoscope’s GHG emissions. While the battery has an estimated 2,800 hours of life, single use laryngoscopes are reported in the literature as being used for only an average of 30 seconds to 2 minutes. DISCUSSION/SIGNIFICANCE: Single use laryngoscopes are high contributors to GHGs. Specifically, the batteries contained in the laryngoscopes are wasteful and challenging to remove and recycle. Future efforts to decrease waste in the OR should target use of similar items that have reusable battery components to improve environmental sustainability.

OBJECTIVES/GOALS: Investigators have an ethical obligation to return study results back to participants in a timely and layperson-friendly manner, but most do not. This lack of communication can erode trust in the research enterprise. One solution to this issue is Plain Language Summaries (PLS). METHODS/STUDY POPULATION: We investigated and collected best practices for PLS and results dissemination as part of formative research for a pilot PLS project. This pilot was used to inform the development of our own PLS resources, which we will share broadly with other CTSAs. We employed a two-part system for analysis. First, we examined extant PLS resources from five major, publicly accessible sources spanning academia, government, publishing, and nonprofits for themes and best practices. Then, we examined actual PLS from each source and collected more specific feedback. We examined PLS structure, length, inclusion of graphics, multiple language availability, readability, and potential for improvement. RESULTS/ANTICIPATED RESULTS: Guidance sources recommended that PLS have logical and organized structures, and included essential trial information (e.g., study drug, adverse events). Suggestions for length varied widely, from 250 words to 15 pages. Guidance also recommended the use of media, including infographics, audio, and video. Only pharma guidance recommended multilingual PLS. Actual PLS included many common trial elements, including study purpose, treatment description, results, and adverse events. PLS in our analyses were 10-12 pages, and contained many infographics, including flow charts of study phases, visual explanations of treatment and participant demographics, and adverse event tables. None were multilingual, and most were readable at the 7th grade level, although one used undergraduate-level language. DISCUSSION/SIGNIFICANCE: General guidance was similar across sources. In our analyses of PLS, we found novel recommendations, such as including auditory pronunciation guides, and personalized thank you letters to participants. In future research, we recommend focusing on novel dissemination methods such as short interactive videos and patient-actor testimonials.

OBJECTIVES/GOALS: We explain our multi-platform, multi-audience approach to stakeholder engagement/communication, discuss KPIs for our Instagram accounts, and highlight five top performing posts. Finally, we provide tips to Hubs who would like to tailor and optimize their social media approach. METHODS/STUDY POPULATION: We employed Uses & Gratifications theory and formative research with stakeholders to inform our social media strategy. We run two Instagram accounts (main CTSI & Community Engagement [CE]), one Facebook page (CE), and one Twitter/X page (main CTSI). To understand impact, we collected social media analytics on both Instagram accounts (main CTSI and Community Engagement-specific accounts) to ascertain four social media-related Key Performance Indicators since the inception of the two accounts: reach, impressions, growth rate, and engagement. Additionally, we examined the five top-performing posts on each account that gave us insights into trending topics and ideas for future content. RESULTS/ANTICIPATED RESULTS: From January 2023 to October 2023, the reach for the main account was 3,578 and 38,235 for CE. The number of profile visits for the main account was 474 and 2,703 for CE. Engagement data on Instagram is only available for the last 90 days. For the main account, the number of post likes, comments and shares was 622 and 2,700 for CE. The views and reach for the five top-performing posts on the main and CE accounts ranged in the thousands. The content of the top-performing posts for the main CTSI account varied between highlighting our KL2 scholars' accomplishments, recap of campus-wide research events, and advertisements for upcoming educational webinars. CE’s top posts varied between highlighting their work in a South LA housing community, recaps of large community health events, and interviews with local key leaders. DISCUSSION/SIGNIFICANCE: CTSA Hubs have an ethical obligation to keep their local academic and community audiences apprised of their activities. Creating a formative research and theoretically-informed social media plan that varies by platform, and regularly evaluating performance insights allows us to track the type of content that appeals to our multiple audiences.

OBJECTIVES/GOALS: This work aims to explore how citizen science serves as a transformative frame work to bridge scientific knowledge, focusing on its potential to enhance transdisciplinary learning in artificial intelligence (AI) biomedical and clinical sciences by facilitating near-peer mentoring. METHODS/STUDY POPULATION: Our group of eight friends comprise a multicultural and multidisciplinary cohort including students from the USA, Philippines, Indonesia, and Guatemala pursuing PhD degrees in electrical and computer engineering, epidemiology, physics, and MD, PharmD, and DMD degrees. We engage in shared online courses, collaborative projects, and abstract submissions. Employing our collective knowledge, we design interactive learning experiences, support each other’s initiatives, and collaboratively develop lectures and presentations. We in tend to expand collaborations in biomedical AI education while fostering principles of experiential and collaborativelearning, constructivism, and authentic inquiry. RESULTS/ANTICIPATED RESULTS: Our recent successes include submittedconference abstracts on data science and AI education in pharmacy and the facilitation of a guest lecture in health informatics. Additionally, we are currently collaborating on seven biomedical machine learning projects in radio frequency engineering, aiming for conference submissions. Moving forward, our goal is to expand our group, support the formation of similar communities, and promote data science and AI literacy in biomedical and clinical contexts. We aspire to extend this knowledge to families, classmates, and eventually patients, facilitating a broader understanding of the role of AI in healthcare. DISCUSSION/SIGNIFICANCE: We believe diverse expertise and pedagogical theories can help demonstrate the potential of citizen science to democratize scientific experience. By nurturing collaborative networks our efforts aim to bridge gaps between disciplines and enhance the broader public’s understanding of AI in healthcare.

Rigorous scientific review of research protocols is critical to making funding decisions, and to the protection of both human and non-human research participants. Given the increasing complexity of research designs and data analysis methods, quantitative experts, such as biostatisticians, play an essential role in evaluating the rigor and reproducibility of proposed methods. However, there is a common misconception that a statistician’s input is relevant only to sample size/power and statistical analysis sections of a protocol. The comprehensive nature of a biostatistical review coupled with limited guidance on key components of protocol review motived this work. Members of the Biostatistics, Epidemiology, and Research Design Special Interest Group of the Association for Clinical and Translational Science used a consensus approach to identify the elements of research protocols that a biostatistician should consider in a review, and provide specific guidance on how each element should be reviewed. We present the resulting review framework as an educational tool and guideline for biostatisticians navigating review boards and panels. We briefly describe the approach to developing the framework, and we provide a comprehensive checklist and guidance on review of each protocol element. We posit that the biostatistical reviewer, through their breadth of engagement across multiple disciplines and experience with a range of research designs, can and should contribute significantly beyond review of the statistical analysis plan and sample size justification. Through careful scientific review, we hope to prevent excess resource expenditure and risk to humans and animals on poorly planned studies.

Observational studies are notoriously susceptible to bias, and parallel-group randomized trials are important to identify the best overall treatment for eligible patients. Yet, such trials can be expected to be a misleading indicator of the best treatment for some subgroups or individual patients. In selected circumstances, patients can be treated in n-of-1 trials to address the inherent heterogeneity of treatment response in clinical populations. Such trials help to accomplish the ultimate goal of all biomedical research, to optimize the care of individual patients.

This paper explores the development of the Dissemination and Implementation Science Collaborative (DISC) at the Medical University of South Carolina, established through the Clinical and Translational Science Award program. DISC aims to accelerate clinical and translational science by providing training, mentorship, and collaboration opportunities in dissemination and implementation (D&I) science. Through DISC, investigators, trainees, and community partners are equipped with the knowledge and skills to conduct D&I research and translate findings into practice, particularly in South Carolina’s public health and healthcare landscape. We describe efforts to achieve the major overarching aims of DISC, which include conducting scientific workforce training, providing mentorship and consultation, and advancing methods and processes for D&I research. By sharing DISC experiences, successes, and challenges, this paper aims to support the growth of D&I research and capacity-building programs, fostering collaboration and shared resources in the field.

OBJECTIVES/GOALS: Hypertension is a major risk factor for coronavirus disease 2019 (COVID-19) severity. Our goal was to determine if hypertension worsens lung pathology induced by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in hamsters. METHODS/STUDY POPULATION: Male hamsters (7-8 weeks old) were infused with angiotensin II (AII; 200 ng/kg/min via osmotic minipump) for 4 weeks to induce hypertension. During the last week of the infusion, the hamsters were inoculated intranasally with vehicle (V) or SARS-CoV-2 (S; 1 x 105 plaque forming units/ml). Half of the hamsters were sacrificed 1 day post-inoculation (dpi-1) and the other half on dpi-6. Two scoring systems were applied to lung tissue sections stained with hematoxylin and eosin to determine the degree and severity of lung pathology: the first system assessed all pertinent alterations in the lungs, while the second system only assessed the pathology related to the pulmonary vasculature. Lung histopathology scores were calculated as the sum of the airway and lung alveolar scores in arbitrary units (AU). RESULTS/ANTICIPATED RESULTS: Studies revealed that the SARS-CoV-2-infected hamsters exhibited a 76-fold higher total airway score compared to vehicle controls [(AU): V, 0.25 ± 0.1; S, 19.00 ±1.35; p<0.05; n=4]. Total lung alveolar scores (27-fold) [(AU): V, 0.30 ± 0.11; S, 8.0 ± 4.1; p<0.05; n=4] and total vascular scores (17-fold) [(AU): V, 0.35 ± 0.2; S, 6.0 ±1.4; p<0.05; n=4] were also markedly higher compared to controls on dpi-1. AII increased blood pressure, which was sustained through the 4-week infusion period. Under these conditions, body weight slightly dropped by 4.5%. Ongoing studies are assessing the effect of hypertension on the % of airway, alveoli and vessels affected, airway and alveolar severity, and bronchiolar epithelial and type II pneumocyte hyperplasia. DISCUSSION/SIGNIFICANCE: Establishing the hypertensive hamster as a small animal model of COVID-19 will facilitate investigations into why preexisting hypertension is a risk factor for disease severity. These studies could lead to the development of novel therapeuticsfor treating COVID-19 patients with hypertension.