Explore the vast range of titles available.

Objectives/Goals: In 2018, a novel analytic resource navigation process was developed at Duke University to connect potential collaborators, leverage resources, and foster a community of quantitative researchers and scientists. We provide information about how this process works along with guidance for academic medical centers to develop similar initiatives. Methods/Study Population: Quantitative and qualitative scientists with expertise in data science, biostatistics, epidemiology, and related fields play a critical role in data collection, study design, analysis, interpretation, and implementation. The analytic resource navigation process connects researchers with quantitative scientists and relies on strong institutional knowledge of methodological expertise, understanding of research goals, educating researchers, and ongoing evaluation to understand unmet needs. University staff serve as navigators to help researchers identify the needed expertise, find potential collaborators, and track outcomes. Duke University’s tracking system for this navigation process, implemented in 2019, underwent a nearly five-year evaluation (November 2019 – September 2024). Results/Anticipated Results: In the nearly five-year evaluation of the process, 1247 requests from 813 unique researchers were navigated with a success rate of 93.8%. A total of 323 requests (256 unique researchers) were navigated in year 1, 285 requests (239 unique researchers) in year 2, 210 requests (179 unique researchers) in year 3, and 247 requests (192 unique researchers) in year 4. In the current year (partial year 5, 11/1/2023 – 9/18/2024), 182 requests have been navigated (159 unique researchers). Unsuccessful linkages occurred in 35 requests (2.8%) and 42 requests (3.4%) were withdrawn. Among the cases of unsuccessful navigation, 26 failed due to effort (e.g., insufficient effort available to meet the researcher’s deadline), 2 failed due to lack of expertise at the institution, and 4 failed due to a lack of sufficient funding. Discussion/Significance of Impact: The navigation process provides a critical resource for researchers who need to develop collaborations and a method for institutions to understand collaboration needs. Implementation requires training knowledgeable navigators, maintaining updated information about quantitative and qualitative methodologists, and institutional support.

Objectives/Goals: To identify the genomic mechanisms underlying cross-species regulation of longevity among mammals and birds and to characterize the impact of those conserved pathways on human aging. More broadly, this study aims to develop a novel evolutionary approach to understand the genetics of complex traits. Methods/Study Population: High-quality genome sequences for 194 bird species and 295 mammal species with reliable longevity and body size data were obtained from publicly available resources. The data include coding sequence alignments of 16,863 mammalian and 14,565 avian one-to-one orthologous genes. Gene-wise relative evolutionary rates (RERConverge) and maximum likelihood phylogenetics (PAML) were computed to assess for evidence of purifying selection and positive selection for longevity. As part of ongoing analysis, human orthologs of selected results will be examined in the UK Biobank for validation. Results/Anticipated Results: Preliminarily, we have found a signal of concordant positive selection between two classes of vertebrates separated by hundreds of millions of years. Several genes show signals of positive selection in long-lived species of both birds and mammals. Ongoing work focuses on elucidating the relationship between relative evolutionary rates and positive selection, the overlap in selection signature between long-lived animals with large body sizes and those who are exceptionally long lived for their body size, and further elaborating on convergence between mammals and birds. Discussion/Significance of Impact: Currently, most scientific knowledge about aging is from experiments on short-lived model organisms. By systematically studying the genomes of long-lived mammals and birds, we aim to develop a new method for studying complex traits and uncover novel insights into the mechanisms of longevity.

Objectives/Goals: (1) Conduct a pilot study documenting prevalence of tinnitus in a sample of Puerto Rican adults at the Audiology Clinic of the Medical Sciences Campus-University of Puerto Rico, (2) categorize patterns of tinnitus, (3) document intervention received for tinnitus, and (4) study sociodemographic characteristics of Puerto Rican adult participants with tinnitus. Methods/Study Population: A descriptive retrospective study was performed reviewing 121 clinical records of patients seen at the Audiology Intramural Clinic of the Medical Sciences Campus of the Universidad de Puerto Rico between 2022 and 2023. They were analyzed to determine the prevalence of tinnitus among this cohort. The study was submitted to the Office of Human Participants for revision and approval under the exempt category. The data were used to categorize the type of tinnitus, episodic versus constant, tonal versus non-tonal and the sociodemographic description of the sample. Results/Anticipated Results: From these 121 records, 70.2% (n = 85) were females and 29% (n = 29.8) were males. Subject ages ranged between 21 and 65 years. About 30% reported being single 30.6% (n = 37), followed by 21.5% (n = 26) reporting being married. From the 62 revised clinical records of subjects that reported tinnitus, 24% (n = 29) classified their tinnitus, in terms of how long they experience its presence, as constant, while 14% (n = 17) classified their tinnitus as intermittent. From the 62 revised clinical records, 44 participants (36.4%) described their tinnitus as tonal and 64.6 % as a complex sound of those patients 38 (31.4%) reported the tinnitus as a high-frequency pitch sound. Of the 62 patient records, the majority (98.4%) informed that they never received the treatment for tinnitus. Discussion/Significance of Impact: The results indicate that more than half of adults evaluated in the UPR Audiology Intramural Clinic (51%) had tinnitus. Age range was broad developing at any age but most prevalent in middle-aged females. Manifested permanent as a tonal or a complex sound. About 98.4% informed that they never received treatment, therefore, there is a need to ensure intervention.

Objectives/Goals: Our goal is to enhance communication and documentation in collaborative biostatistics by refining data management and metadata processes. We aim to capture critical data collection and generation information, improve transparency and reproducibility, and foster stronger researcher partnerships for more effective collaborations. Methods/Study Population: Traditional statistical analysis plans (SAP) often miss essential contextual knowledge from collaborators, leading to gaps that hinder reproducibility and limit future data use. Biostatistics teams at the University of Kentucky have updated their strategies to better capture important details about data origins and collection processes. By focusing on clear, comprehensive documentation early in the research process, we aim to preserve foundational data insights and improve collaboration efficiency. Our Biostatistics, Epidemiology, and Research Design (BERD) team has established best practices for addressing data management structures with collaborators across medical and healthcare fields – covering all project stages, from initial data collection to metadata creation and dataset finalization. Results/Anticipated Results: We will detail the processes used to improve data management structures and the observed results of these processes. For example, initiating deeper discussions about data origins and collection processes as early as possible in the collaboration has resulted in a more comprehensive project narrative that lays the foundation for effective collaboration. By engaging with project leaders early in the process, we can confirm that critical details about how data were collected and processed are documented, improving both the transparency and reproducibility of research findings. Streamlining the processes of capturing this information makes it more accessible and useful for those with limited statistical backgrounds, which is particularly relevant for faculty and staff in BERD communities and Clinical and Translational Science Awards Programs. Discussion/Significance of Impact: Nuanced data documentation structures are crucial for transforming raw data into meaningful, reusable datasets. Our initiatives promote clear communication, enhanced efficiency, and streamlined workflows. Translational science researchers can benefit from improving data management and metadata to boost long-term collaborative success.

OBJECTIVES/GOALS: The overall goals of this project are: (1) to demonstrate the utility of staff with cross-disciplinary skills in biostatistics and epidemiology as program managers for CTSA BERD Cores, and (2) examine streamlined processes in project triaging, consultations, and data extractions for CTSA service requests when individuals are in this role. METHODS/STUDY POPULATION: Biostatistics and epidemiology are partnered disciplines incorporated in a variety of research areas, especially in human health sciences and health care. For interdisciplinary teams, including individuals trained in both specialties results in efficient research collaborations. When these individuals are program managers for research navigation, processes become more effective and expedited for project timelines and workflows across the CTSA. Examples of this integration are described in vignettes from project triaging, statistical consultations, and data extractions from CTSA service requests. Process comparisons of previous and current workflows are presented to show the advantages of utilizing this type of program manager within these areas of BERD. RESULTS/ANTICIPATED RESULTS: This project defines three areas of integration for a program manager with cross-disciplinary training in biostatistics and epidemiology: (1) project triaging to statistical teams, (2) study design and analysis consultations, and (3) data extractions. Each of these areas demonstrates prior processes that once would require multiple steps in CTSA service requests (including time, resources, and personnel) and identified common issues (slow response to requests, data re-extractions, and challenges providing statistical support) that are now avoided with a manager with cross-training in biostatistics and epidemiology methods. The advantages and disadvantages of integrating these individuals are also described. DISCUSSION/SIGNIFICANCE: BERD Cores seeking improvements to research navigation processes can gain efficiency by incorporating program managers with cross-disciplinary training in biostatistics and epidemiology. BERD Cores may also use this as a case study for translational science with innovation to longstanding challenges in CTSA research workflows.

OBJECTIVES/GOALS: Barriers to childhood vaccine completion include forgeting vaccine appointments, lack of clinic access (distance and funds), and vaccine hesitancy. We tested the impact of automated and real-time appointment reminders, vaccine hesitancy counseling, and targeted vaccine drives on receiving the third dose of the diphtheria vaccine. METHODS/STUDY POPULATION: An implementation study to determine the feasibility and impact of implementing a mobile health-supported intervention bundle. A digital vaccine registry was developed to manage vaccine uptake data. The intervention bundle was applied sequentially: each registered parent received an automated appointment phone reminder (text and voice). If they delayed for >5 days, they received a real time reminder phone call. If during the real time call vaccine hesitancy was deemed to be a barrier, counseling was provided. If access - lack of funds or long distance - to the clinic was the barrier, vaccination was performed at patient's home on the monthly vaccine drives. We compared vaccine completion (all childhood vaccines before 18 months) during the implementation to the preceding three years. RESULTS/ANTICIPATED RESULTS: We anticipate the implementation will be feasible as >90% of all eligible children will be registered. We expect providers will be accepting and would recommend the intervention to other providers. We anticipate the intervention will result in a >10% increase in childhood vaccine completion compared to the average of the past three years. DISCUSSION/SIGNIFICANCE: We anticipate applying a multifaceted intervention will be acceptable to providers, feasible to implement, and significantly improve childhood vaccine completion rates moving Nigeria closer to achieving the global target of >95% childhood vaccine completion rate.

Objectives/Goals: In neurological animal research, statistical misapplication may lead to overoptimism in a therapy’s potential for successful translation. This pilot study investigated whether human clinical trials that fail have higher prevalence of statistical misapplication in preceding animal experiments, compared to human trials that succeed. Methods/Study Population: Phase 2 clinical trials for 3 neurological conditions were identified on ClinicalTrials.gov and classified as successful or failed based on advancement to Phase 3 and/or preplanned efficacy test results. PRISMA guideline methods were used to systematically search for preclinical animal experiments (same indication and intervention) preceding the start of the human trial. Data were gathered from animal articles by collectors blinded to human trial outcome and included items describing reporting transparency, experimental design and sample sizes, and statistical tests applied. Statistical mistakes were coded based on mismatch between test and design. Rates of mistakes were compared between articles preceding successful and non-successful human trials using weighted point estimates and 95% confidence interval. Results/Anticipated Results: The final sample included 24 trials (16 successful) and 70 associated animal studies. Transparency was poor, with infrequent reporting of group allocation method (39%), sample sizes adequate to evaluate attrition ( Discussion/Significance of Impact: Statistical misapplication is common in animal research, and this pilot study has demonstrated that preclinical statistical mistakes may indeed occur more frequently prior to failed human trials. Mistakes and lack of transparency may lead to overoptimism in preclinical experimental findings, with consequences for subsequent human translation.

Objectives/Goals: This systematic review aims to identify and synthesize evidence on the barriers and facilitators impacting the implementation of transcranial magnetic stimulation (TMS) in clinical practice, enhancing understanding for improved adoption and efficacy. Methods/Study Population: This systematic review follows PRISMA guidelines to identify relevant literature on barriers and facilitators to TMS in North America. We conducted a comprehensive search of databases including PubMed, Scopus, and PsycINFO, targeting studies published from 2000 onward. Eligible studies include qualitative and quantitative research focusing on adults aged 18 years and older in the USA and Canada. Two independent reviewers screened titles, abstracts, and full texts, extracting data on barriers and facilitators related to TMS implementation. Results/Anticipated Results: We anticipate identifying a diverse range of barriers and facilitators related to TMS implementation in North America. Expected barriers may include limited clinician knowledge, patient resistance, and logistical challenges in clinical settings. Facilitators could encompass supportive institutional policies, clinician training, and positive patient outcomes. The synthesis of findings will highlight key themes, guiding future research and practice. We aim to produce actionable recommendations for stakeholders, ultimately enhancing the effective integration of TMS in clinical care for adult populations. Discussion/Significance of Impact: This review will provide crucial insights into the barriers and facilitators of TMS implementation, informing clinicians, policymakers, and researchers. By highlighting actionable strategies, it aims to enhance TMS accessibility and efficacy, ultimately improving patient outcomes and advancing neurotherapeutic practices in North America.

Objectives/Goals: 1) Determine the association between wildfire smoke-driven PM2.5 and risk of persistent respiratory symptoms and repeated asthma exacerbations after the acute wildfire period among adults with asthma. 2) Examine how measures to reduce personal exposure to wildfire smoke, including avoiding outdoor activities, modify this association. Methods/Study Population: This is a retrospective study of adults with asthma in WHAT-NOW, a cohort study of people living in Northern California during the 2018 Camp Fire. Daily smoke-driven PM2.5 was estimated for each participant based on their home address or evacuation location. We examined the association between mean PM2.5 exposure and the presence of respiratory symptoms at both the time of the survey (6–16 months post-wildfire) and at least one other post-wildfire time-period, as well as whether they had a medically attended respiratory illness (saw a doctor, visited the ER, or were hospitalized for a respiratory symptom). We examined the interaction of PM2.5 with spending time outdoors during the wildfires. Poisson regression models with robust standard errors were adjusted for age, sex, race, smoking, allergies, and education. Results/Anticipated Results: Among 337 adults with asthma in the WHAT-NOW cohort, one standard deviation higher smoke-driven PM2.5 was associated with higher risk of any persistent respiratory symptom (risk ratio (RR) 1.38, 95% CI 1.07 – 1.78) and having at least one medically attended respiratory illness (RR 1.33, 95% CI 1.07 – 1.65), but not significantly associated with repeated asthma exacerbations (RR 1.30, 95% CI 0.92 – 1.81). However, there was a significant interaction between PM2.5 and outdoor activities during the wildfire on the outcomes of any persistent respiratory symptoms (p = 0.041) and repeated asthma exacerbations (p = 0.028). The association between PM2.5 and repeated asthma exacerbations was greater among people who spent time outdoors (RR 3.36, 95% CI 1.47 – 10.23) than those who did not (RR 1.00, p = 0.99). Discussion/Significance of Impact: This study provides evidence that exposure to wildfire smoke increases respiratory morbidity among adults with asthma beyond the acute wildfire period. Additionally, it suggests that avoiding outdoor activities on smoky days can significantly decrease the risk of future repeated asthma exacerbations associated with smoke exposure.

Objectives/Goals: This study examines prevalence of complete sample size justifications in publications in the top five clinical neurology journals. Secondary goals include comparing study designs and clinical populations to explore whether some may be more likely to include inadequate sample size considerations. Methods/Study Population: Recent studies (n  =  125) in Lancet Neurology , Alzheimer’s and Dementia , JAMA Neurology , Acta Neuropathology , and Brain will be evaluated. For each journal, the 25 most recent empirical articles between 2022 and 2023 will be examined for their inclusion of a justification and reproducible sample size calculation. Inclusion of components of an ideal sample size justification will be evaluated: effect size to be detected (standardized or unstandardized), alpha, power, and from where values were derived. Prevalence and completeness will be compared among study designs, clinical populations, and with regard to journal reporting requirements. Results/Anticipated Results: At the pilot review stage, 17 of 25 included studies had any kind of sample size justification, and only 3 studies had enough information to reproduce their sample size calculations. Retrospective studies included a sample size justification more frequently (81.8% vs. 57.1%), but prospective studies had more complete sample size justifications, when present. We hypothesize that sample size calculations will be more complete in reports of clinical trials and prospective cohort studies, compared to retrospective and cross-sectional designs. Based on our previous research, we do not expect that journal reporting requirements will affect completeness of sample size justifications. Discussion/Significance of Impact: Translational decision-making is informed in part by the robustness of current research. Transparency of sample size considerations in publications can contribute to the formation of less biased opinions of translational readiness and, subsequently, more efficient and effective translation.