OBJECTIVES/SPECIFIC AIMS: 1. To evaluate the effects of masculinizing chest reconstruction on the quality of life of female-to-male transgender individuals. 2. To develop and validate a quality of life survey for female-to-male transgender individuals undergoing masculinizing chest reconstruction gender-affirming surgery. METHODS/STUDY POPULATION:. We developed and refined the GENDER-Q using focus groups and exploratory interviews with FTM individuals that were recorded, transcribed, and coded. All consenting FTM patients undergoing chest reconstruction at UCSF Parnassus Medical center between 2017-2019 who meet World Professional Association for Transgender Health (WPATH) criteria for gender dysphoria will be enrolled in the study. The GENDER-Q will be co-administered with the WHO Quality of Life-BREF survey pre-operatively, 6 weeks post-operatively, and one year post-operatively through REDCAP, an online survey database. RESULTS/ANTICIPATED RESULTS: Approximately 70 patients will be enrolled in the study. Preliminary results detect statistically significant mean quality of life post-operative improvements in all three sections (Physical Health, Gender Presentation, Psychological Health) of the GENDER-Q at 6-week follow up that is maintained at one-year (p< 0.005). Statistically significant improvements were similarly achieved and maintained with the WHO QOL-BREF survey (p< 0.05). The mean reported improvement from baseline to follow-up appears to be more pronounced in the GENDER-Q survey compared to WHO QOL-BREF. The median time to complete the pre and post-operative surveys was 10 minutes. Calculation of Cronbach’s (0.67-0.81) and the Pearson Correlation Coefficient for each section revealed excellent internal validity. DISCUSSION/SIGNIFICANCE OF IMPACT: There are few studies assessing quality of life outcomes in transgender patients undergoing gender-affirming surgeries. A standardized and validated assessment tool will provide the means for which data can be pooled in large multi-center studies. Providing further evidence to support the positive health outcomes of gender-affirming surgeries can lead to broader access and reduce healthcare disparities among transgender populations.

OBJECTIVES/SPECIFIC AIMS: The Johns Hopkins University Clinicaltrials.gov (CT.gov) Program has previously reported on a study showing reduction of “Late Results – per FDAAA” from 111 to 0. What we hope to do here is to focus on non-late results records. Over the years, some institutions spend their efforts solely on late results in order to avoid any penalties from the Food and Drug Administration (FDA). However, there are a number of variables that labels “problem records” within the Protocol and Registration System (PRS). These records are also subject to penalties. Our goal has been to minimize problem records and establish processes to improve and maintain our institutional compliance in regards to regulations governing clinical trials registration and results reporting. METHODS/STUDY POPULATION: The Johns Hopkins University implemented a Clinicaltrials.gov program solely mandated to assist Principal Investigators (PIs) and other study team members with clinical trial registration and results reporting. The program has developed processes in its duty towards reducing problem records in the PRS. Full-time staff have been assigned to assist research teams with registration and results reporting, while ensuring compliance with all relevant regulations. Several methods have been utilized to track metrics, such as monthly reports and internal databases. Features within the PRS have also been used to draw attention to newly-identified problem records on a daily basis in order to rectify these issues with the study team promptly. In order to ensure compliance, our office communicates with study teams regarding the problems within their CT.gov record that requires attention. In challenging cases, our program will also collaborate with the CT.gov PRS Team at the NIH to facilitate the process and avoid multiple review cycles, which can delay registration or the posting of results. Our Program has also formed internal collaborations with the Institutional Review Board (IRB) which allows us to verify study status and view active study team members. This is especially useful in cases where the study team members who are listed on the CT.gov record cannot be reached or the contact information is outdated (a common occurrence with older studies). With access in the IRB, we can contact the current study team members who may not be listed in CT.gov and assist them to resolve any outstanding issues of non-compliance within their CT.gov record. RESULTS/ANTICIPATED RESULTS: From September 2015 (before our program was established) to September 2016 (three months after the institution of our program), the total amount of problem records increased from 44% (339/774) to 45% (383/852). Since then, the processes we have developed resulted in a decline in problem records to 30% (282/955) in September 2017, and a further decline to 8% (83/1075) as of September 2018. The short rise that was observed in 2016, was a potential indicator that if our program was not instituted, it would have been more difficult to maintain compliance. DISCUSSION/SIGNIFICANCE OF IMPACT: According to the FDA Draft Guidance released in September 2018 referring to the Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank, there are a number of ways to violate the FDA regulations, resulting in potential monetary penalties, which include “failing to submit required clinical trial information or submitting clinical trial information that is false or misleading”. These regulations apply to results as well as registration and study status updates. By paying attention to all problems that are identified by the PRS, institutions can rectify errors and remain complaint with all regulations that govern clinical trial registration and results reporting.

OBJECTIVES/SPECIFIC AIMS: The aim of the study is to examine the relation between dental fluorosis, serum and water levels of fluoride and Chronic Kidney Disease (CKD) among children. A link between dental fluorosis, fluoride level and CKD can be an indicator of the blind danger of fluoride toxicity that poses a great threat to the human health. METHODS/STUDY POPULATION: Dental fluorosis, serum and water levels of fluoride and CKD were examined in children 6-19 years old, using data from the National Health and Nutrition Examination Survey1999-2012 and 2013-2016. We used multiple logistic regression to adjust for the confounders (demographics, insurance, dental visit, and co-morbidity) to assess the relation between dental fluorosis, serum and water levels of fluoride and CKD. STATA 14.0 was used to analyze the data (sample design and weight). P < 0.05 is statistically significant. RESULTS/ANTICIPATED RESULTS: The prevalence of CKD was 13.9% and dental fluorosis was 34.3%. In the multivariate model, plasma fluoride level was independently associated with CKD (Adjusted Odds Ratio (AOR) = 1.68, 95% Confidence Interval (CI) = 1.06-2.68, p = 0.029) but not with dental fluorosis (AOR = 1.4, 95% CI = 0.87-2.2, p = 0.17) or water fluoride level (AOR = 0.91, 95% CI = 0.59-1.396, p = 0.659). DISCUSSION/SIGNIFICANCE OF IMPACT: Results indicated that serum fluoride level is independently associated with CKD but dental fluorosis and water fluoride level were not related to CKD. Increase awareness and screening for fluorosis in children are needed for early detection and prevention of organ damage. Prospective studies related to fluorosis and tissue damage are needed.

OBJECTIVES/SPECIFIC AIMS: Helping researchers assess and effectively translate innovations into healthcare improvements is a complex process (Terry et. al., 2013). The Clinical Translational Science Awards (CTSA)—supported by the National Institute of Health (NIH) under the auspices of the National Center for Advancing Translational Sciences (NCATS)— provide the resources and support needed to strengthen our nation’s clinical and translational research (CTR) enterprise. In 2008, Stanford University was awarded a CTSA from the NIH, establishing Spectrum (the Stanford Center for Clinical and Translational Research and Education). Under the Spectrum umbrella, the Byers Center for Biodesign manages the MedTech Pilot Program with the goal of translating discoveries into novel health technologies that address important unmet health needs. The MedTech Pilot Program is an innovative funding mechanism that seeks to (1) stimulate clinical translational research, (2) help promising projects bridge the gap between the bench and the patients’ bedside, and (3) encourage collaborative, transdisciplinary work. Specifically, the Pilot Program offers up to $50,000 to support projects involving medical devices and mobile technologies used for (1) therapeutic applications and (2) device-based patient-specific (or POC) diagnostic applications. This analysis of the MedTech Pilot Program will: 1) describe the Program’s structure and process; 2) highlight the intensive, hands-on mentorship and practical guidance awardees receive that enables them to more efficiently and effectively advance their projects toward patient care; and 3) characterize the progress of the 36 funded projects. METHODS/STUDY POPULATION: Key elements of the Pilot Program’s infrastructure and mentoring processes as they relate to project outcomes were identified. Additionally, outcomes data were collected from two sources: (1) annual survey of Pilot Awardees and (2) publicly available information relevant to the pilot projects. RESULTS/ANTICIPATED RESULTS: The Pilot Program’s framework and infrastructure has supported a diverse group of transdisciplinary projects. These projects were evaluated using both traditional and non-traditional metrics (e.g., patents, startups, publications). The initial investment of $1.5 million to fund 36 projects has led to over $88 million dollars in additional funding. Additionally, taking full advantage of the expertise in Silicon Valley, strong mentorship has helped advance projects along the clinical and translational path. DISCUSSION/SIGNIFICANCE OF IMPACT: The Pilot Program has benefited Stanford innovators and researchers by providing seed funding to help promising projects bridge the gap between the bench and the bedside. The intensive, hands-on mentorship, early pilot funding, and practical guidance pilot awardees receive effectively help translate their technologies into patient care.

OBJECTIVES/SPECIFIC AIMS: Patients with undiagnosed obstructive sleep apnea (OSA) will often present to an otolaryngologist with symptoms of chronic rhinosinusitis (CRS). Differentiating CRS from OSA may help obviate unnecessary and costly work-up for CRS. This study analyzes symptom profiles of such patients to help identify which require polysomnography. METHODS/STUDY POPULATION: This is a three-year retrospective analysis of adult patients seen in an academic practice with a rhinologic chief complaint. The 22-Item Sinonasal Outcomes Test (SNOT-22) survey, which is a validated patient-reported outcome measure widely adopted for CRS featuring a symptom scale of 1 (least severe) to 5 (most severe), was completed by patients with untreated OSA confirmed on polysomnography without CRS (OSA group) and a control group of CRS patients (CRS group). Results were compared using Chi-square test (categorical) and Wilcoxon rank-sum test (continuous) with Bonferroni correction, and multiple logistic regression. RESULTS/ANTICIPATED RESULTS: 43 patients were included in the OSA group [mean apnea-hypopnea index: 27.9 (SD: 21.2)] and 124 patients were included in the CRS group. The CRS group demonstrated significantly higher scores in nasal (p < 0.001), extra-nasal (p < 0.001) and ear/facial symptom domains (p = 0.001) while the OSA group reported higher psychological (p = 0.028) and sleep symptom domain scores (p = 0.052). As for the cardinal symptoms of CRS, nasal discharge and loss of smell were significantly higher in the CRS group (both p < 0.001), whereas facial pain (p = 0.117) and nasal obstruction (p = 0.198) were not significantly different between the two groups. After adjustment, for every 1-point increase in a patient’s score for ear pain, thick nasal discharge and loss of smell or taste, their odds of having CRS increased by a factor of 3.18 [(95% CI 1.61-6.29), p = 0.001], 1.60 [(95% CI 1.22-2.10], p = 0.001] and 1.36 [(95% CI 1.04-1.78), p = 0.025], respectively, compared to having OSA. OSA patients were more likely to choose a sleep-related symptom as a “most important complaint” (MIC) (p < 0.001). Facial pain and nasal obstruction were the most common MIC in the rhinologic domain for OSA patients, whereas thick nasal discharge and post-nasal discharge were the most common MIC for CRS patients. DISCUSSION/SIGNIFICANCE OF IMPACT: For patients presenting with rhinologic symptoms, the SNOT-22 can help identify those with undiagnosed OSA. OSA should be suspected in patients with sleep and psychological dysfunction as their primary complaints without the significant nasal drainage and anosmia that characterizes CRS.

OBJECTIVES/SPECIFIC AIMS: Objective: To assess the impact of corticosteroid therapy on in-hospital mortality in IPF patients admitted with acute respiratory failure. METHODS/STUDY POPULATION: Methods: Patients with IPF were retrospectively identified in the University of California San Francisco medical center’s electronic health records from January 1, 2010 to June 1, 2018. Cases with IPF were defined as age 50 years or older, having at least two codes one month apart for idiopathic fibrosing alveolitis or post-inflammatory fibrosis (ICD-9 516.3, 516.31 or 515.0 or ICD-10 codes J84.9, J84.10, J84.111 or J84.112), and a subsequent hospitalization for acute respiratory failure or acute respiratory symptoms. The prevalence of pre-selected co-morbidities, clinical events (ICU admission, mechanical ventilation, lung transplantation) and clinical outcomes were assessed. A propensity score model for corticosteroid use was constructed using a multivariable logistic regression with inclusion of corticosteroid-associated demographic and baseline variables (univariate p-value < 0.25). A marginal structural model (MSM) was used to address time-dependent confounding and mediating effects of ICU admission and mechanical ventilation by applying inverse probability weighting for receipt of corticosteroid treatment. Secondary outcome analysis was performed on patients who survived hospital admission. RESULTS/ANTICIPATED RESULTS: Results: A total of 132 patients with IPF and an acute respiratory admission were identified. 48 patients (36%) received corticosteroids during their admission. Applying inverse weighting to time-dependent co-variates (ICU admission and invasive mechanical ventilation) in a MSM, corticosteroid therapy was not associated with risk of in-hospital mortality (odds ratio 1.82; 95% CI, 0.47-6.99; p = 0.39). After adjusting for corticosteroid therapy using a propensity score, corticosteroid therapy remained unassociated with in-hospital mortality (odds ratio 1.53, 95% confidence interval [CI] 0.37, 6.29; p = 0.55). There was no difference in discharge disposition or time to hospital readmission by corticosteroid treatment. There was a possible increase in time to death following discharge in patients receiving corticosteroids (Figure). DISCUSSION/SIGNIFICANCE OF IMPACT: Conclusions: This study suggests that treatment of acute exacerbations of interstitial lung disease with corticosteroids does not improve short-term outcomes, including in-hospital mortality, all-cause non-elective re-hospitalization or death within 6 months of discharge. Further research in larger cohorts is needed to more definitively assess this relationship.

OBJECTIVES/SPECIFIC AIMS: Evaluate how access and affordability has changed before and after the implementation HIEs in three subpopulations. The subpopulations are individuals who are currently insured through the HIE but were previously: 1. Insured through Employment-based insurance (PEBI subpopulation) 2. Insured through Private Insurance (PPI subpopulation) and 3. Uninsured (PU subpopulation). The three access and affordability measures are: Outcome measure 1. Did not fill a prescription in the past year due to cost Outcome measure 2. Could not get needed medical exam in the past year due to cost and Outcome measure 3. Had problems paying medical bills in the past year. METHODS/STUDY POPULATION: We analyzed the de-identified public use data from the 2012 and 2015 Ohio Medicaid Assessment Survey (OMAS). Sponsored by the Ohio Department of Medicaid, Ohio Department of Health, and the Ohio State University, the OMAS is a representative cross-sectional survey of non-institutionalized Ohio residents, regardless of their Medicaid status. In order to “longitudinalize” the 2012 and 2015 cross-sectional data of the OMAS, we employed a propensity score-based approach. We started with the 2015 OMAS, and carefully characterized each of the PEBI, PPI, and PU subpopulations along 17 demographic, health utilization, health behavior, and health status covariates using a propensity score model. Then, we identified controls for the three subpopulations within the 2012 OMAS data using the propensity scores. Finally, we estimated the odds ratios for the three outcome measures between 2012 and 2015. RESULTS/ANTICIPATED RESULTS: In 2015 there were approximately 201,381 adults (unweighted count = 996) who were insured through the HIE in Ohio. Of those individuals, 17.7% fell into the PEBI subpopulation, 17.6% fell into the PPI subpopulation, and 53.3% fell into the PU subpopulation; the balance of the respondents (11.4%) reported previously having Medicaid, or “Other” insurance. There are several key differences in the covariates at baseline between the three subpopulations. In general, the PU subpopulation tended to younger, more minority, more socioeconomically disadvantaged, and more likely to not have a primary care provider compared to both the PEBI and PPI subpopulations. In the 2012 data, we were able to identify 170 controls for the PEBI subpopulation, 167 controls for the PPI subpopulation, and 516 controls for the PU subpopulation. Compared to 2012, in 2016 (after the implementation of the HIEs):. Outcome measure 1: The PEBI subpopulation was more likely to report not filling a prescription in the past year due to cost (there were no significant changes in the PPI or PU subpopulations). Outcome measure 2: The PEBI subpopulation was more likely to report not getting a needed medical exam or medical supplies in the past year due to cost. The PPI subpopulation was less likely to report not getting a needed medical exam or medical supplies in the past year due to cost. There were no significant changes for the PU subpopulation for this outcome measure. Outcome measure 3: There were no changes in the “had problems paying medical bill in the past year” outcome across the three subpopulations. DISCUSSION/SIGNIFICANCE OF IMPACT: This is among the most detailed studies of health insurance exchanges known to the investigators. Analyzing outcomes at the subpopulation level illustrates that there have been unbalanced gains in access and affordability as a result of the HIEs. In general, those who were previously insured through employer-based insurance saw their access and affordability decrease; those previously insured through private insurance saw modest increases to access and affordability; and perhaps most surprising, those that were previously uninsured saw no changes to their access and affordability. Future studies will incorporate 2017 OMAS data (when it becomes available) to see if these trends persist over time. During this time of rapid health systems and health policy change, our study adds an important contribution to the discussion surrounding how to best deliver highly effective and efficient health care.

OBJECTIVES/SPECIFIC AIMS: We hypothesize that VL testing varies by geographic sub-region, country, age, gender, mode of transmission, year of diagnosis, and country of origin; and also that a higher prevalence of VL testing may be associated with higher prevalence of population-level VL suppression. Our primary aim is to determine country- and regional-level factors that are associated with viral load testing amongst HIV patients. Our secondary aim is to explore the association between prevalence of viral load testing and viral load suppression at the population level. METHODS/STUDY POPULATION: This is a retrospective analysis of de-identified individual-level data reported to the European Surveillance System (TESSy). The TESSy is a database of communicable diseases (including HIV) for the ECDC and WHO European Regional Office. It captures data from 31 European Union/European Economic Area (EU/EEA) countries and 23 non-EU/EEA countries. Stored data is from year 2000. TESSy is used for data analysis and production of outputs for public health action. The patient cohort include adults older 18 years, whose last clinic attendance was reported in 2014 or later, or whose viral load test was reported in the year of the visit or the year before the year of their last reported clinic attendance. Patient demographic data include age, sex, mode of transmission, country of origin (migrants), country of diagnosis, geographic region, last clinic attendance, viral load and therapy status. Geographic region will be categorized into East, West and Centre as per WHO guidelines. Countries will be categorized and analyzed according to their European Union (EU)-, European Economic Area (EEA)- and income (GDP)-status, using current World Bank and International Monetary Fund (IMF) guidelines. All statistical analysis will be performed in R-Studio and R i386 3.0.2. Missing data will be characterized in terms of quantity (how much is missing) and pattern (random versus non-random) and impact on covariates to be tested. Multiple data imputations would be used in cases where missing data is found to be at random. Data from external sources like UNAIDS, World Bank and IMF will also be used for comparison and validation of TESSy data for imputation of missing data. Continuous variables will be analyzed through appropriate parametric and non-parametric tests while categorical variables will be analyzed through methods of proportion. Multivariate logistic regression methods will be used to explore the associations between VL testing and VL suppression separately with age, sex, year of diagnosis, country of origin (migrants), mode of transmission, in the total population, then at country- and regional-level. The same associations will be explored using a country’s EU and EEA status (EU versus EEA versus non-EU/EEA), and income status (high versus upper middle versus lower middle versus low). DISCUSSION/SIGNIFICANCE OF IMPACT: Even though this is a retrospective analysis of a database with likely significant missing data that may affect analysis of data and interpretation of results, our study will impact all levels of HIV policy across Europe. The strengths of this study likely outweigh the limitation imposed by missing data and include potential regional-, country- and demographic-specific public health, epidemiologic and ART program policy initiatives. Also our analysis of pattern of missing data may inform a more efficient and meaningful data collection and input into TESSy database.

OBJECTIVES/SPECIFIC AIMS: To identify characteristics of counties with persistently high opioid-overdose rates and low capacity to deliver medications for OUD (MOUD). METHODS/STUDY POPULATION: Setting: County-level opioid-overdose death data, 2013-2016, and 2017 publicly-available treatment provider data for MOUD: buprenorphine-waivered providers, opioid treatment programs (OTPs), and extended-release naltrexone providers. Participants: Populations in 3,142 U.S. counties. 24,851 buprenorphine-waivered providers; 1,517 OTPs; and 5,222 extended-release naltrexone providers. Measurements: The outcome variable, “opioid high-risk county”, was a binary indicator of high (above average) opioid-overdose rates with low (below median) MOUD availability rates. We used spatial logistic regression models to determine correlates of being a high-risk county. RESULTS/ANTICIPATED RESULTS: 46.4% of all counties, and 71.2% of rural counties, lacked a publicly-available MOUD provider in 2017. In adjusted models, rural counties had 53% greater odds of being high-risk than urban counties. Counties in the East South Central, West South Central, and South Atlantic divisions had over twice the odds of being high-risk than counties in the West North Central division. Primary care provider density, greater traversability, and a higher proportion of the population under age 25 were all protective against a county being opioid high-risk. DISCUSSION/SIGNIFICANCE OF IMPACT: Counties with both low MOUD provider availability and high opioid-overdose death rates are significantly more likely to be rural, have less primary care providers per capita, and in the southern regions. Strategies to increase MOUD must account for these factors.

OBJECTIVES/SPECIFIC AIMS: By combining clinical knowledge of hoarding disorder (HD) with qualitative methods from cultural anthropology, we hope to build a patient-centered approach that will allow us to better understand the clinician perspectives on patient motivations and explanatory models of individuals with HD, and improve treatment outcomes. We describe the ways that these methodologies are productively merged in this project as a result of TL1 collaboration, and present a preliminary picture of methodological and theoretical issues uncovered as part of this processes. We further describe the analytical methods used for this project, and explore issues raised through the combination of psychological and anthropological data and insights. METHODS/STUDY POPULATION: This study represents an attempt to combine the qualitative methodologies of cultural anthropology with the clinical knowledge of psychology and psychiatry in order to better understand gaps between provider and patient beliefs and knowledge about hoarding disorder. This study will present preliminary methodological issues arising from interviews with hoarding experts. RESULTS/ANTICIPATED RESULTS: This study will discuss preliminary issues including shared language, strengths and limitations of both disciplines, and factors for consideration when combining these disparate methodologies. It will close with recommendations for consideration when moving forward with similar collaborations. DISCUSSION/SIGNIFICANCE OF IMPACT: This project seeks to unite psychological and social factors that may contribute to the lived experience of individuals with HD in order to better understand the way that HD is manifested. It also unites disparate methodologies to provide us with a more holistic and complete picture of the experience of HD. While HD has been studied within psychiatry, it has never been assessed using the qualitative methods of anthropology. These methods provide the possibility of expanding knowledge about the ways that this disorder is experienced by individuals and their families, and potentially impacted by shared beliefs and cultures. Furthermore, qualitative data of this nature provides a patient perspective on the experience of HD as a psychiatric illness. This patient perspective can be used to better inform treatment, improve patient outcomes, and to allow providers and researchers to gain a fuller understanding of this complex population.

OBJECTIVES/SPECIFIC AIMS: We present an alternative strategy to retain NTFs at an injected CNS tissue site by endowing them with binding affinity for carbohydrates that are abundant on the cell surface and within extracellular matrices. METHODS/STUDY POPULATION: We are creating recombinant fusions in which glial cell-derived neurotrophic factor (GDNF) is linked to galectin-3 (G3), a human protein that binds to extracellular beta-galactoside glycans and glycosaminoglycans. GDNF-G3 fusion proteins will circumvent major therapeutic shortcomings of early GDNF human trials by anchoring GDNF to the midbrain in a preclinical animal model of PD over a therapeutically-relevant timescale in order to achieve DA neuron rescue. Further, in PD patients, we have detected significantly dysregulated dopamine signaling in peripheral, blood-derived monocytes, suggesting a systemic dopamine signaling change in PD. RESULTS/ANTICIPATED RESULTS: Based on results from published human NTF administration trials, we anticipate that a successful intervention using GDNF-G3 will result in rescue or delayed degeneration of midbrain dopaminergic neurons in a murine PD model. Outcome measures include behavioral PD phenotype testing via rotarod and pole descent compared to non-parkinsonian control animals, as well as corroborating immunohistological evidence from immunohistochemical examination of post-mortem brain tissue from the same animals to examine degree of degeneration. DISCUSSION/SIGNIFICANCE OF IMPACT: Current treatments for PD, whether pharmacological or surgical, center on alleviating movement symptoms that impair daily function - in other words, largely palliative care. Little has been accomplished by way of rescue of dopaminergic neurons or slowing disease progression using standard-of-care therapy. If successful, GDNF-G3 constructs administered intracranially at the site of degeneration would represent a milestone on the path to treating the basic pathology associated with PD, while addressing major shortcomings in earlier NTF-delivery attempts, namely NTF diffusion away from target site.

OBJECTIVES/SPECIFIC AIMS: To complete a needs assessment and action planning process that engaged clinical and translational research network members in identifying needs through survey feedback, characterizing the needs in small group sessions, and developing recommendations for action at the network’s annual scientific meeting. METHODS/STUDY POPULATION: The project included (1) a survey of 357 members across partner institutions from the Great Plains IDeA CTR Network, (2) 6 - 90 minute brainstorming sessions to characterize needs identified through survey assessment, and (3) 6 - 60 minute sessions to develop recommendations for network improvement based on the characterization activity. Approximately 75 members participated in the characterization and recommendation sessions. RESULTS/ANTICIPATED RESULTS: Seven areas of need from the survey were identified based upon the frequency of identification by network members (support to move research across the translational spectrum, database design and management, data access and sharing, data analysis, recruitment and retention of subjects, support for members who have submitted grants but were repeatedly unsuccessful, mentoring). Members indicated which characterization sessions they were interested in attending and based on the enrollment numbers needs related to unsuccessful grant submitters and mentoring were combined as were needs related to database design and data access-sharing. Sessions resulted in 8 inter-related recommendations for network action that included to (1) develop GP-CTR directory/registry of clinicians, researchers, system partners, that can be used to identify people that want to be involved in research partnerships or mentoring, (2) create a GP CTR Navigators Program to will provide support to network members throughout the collaborative research and grant preparation process, (3) identify and disseminate information about assets (funding, databases/registries) that exist amongst network partners that can be leveraged by member, (4) develop a searchable repository of evidence-based interventions for T3/T4 efforts, (5) review GP CTR supported professional development, and technological resource offerings and identify potential gaps, (6) facilitate opportunities for peer support/networking, (7) provide guidance to GP CTR network institutions looking to adopt policies that will support translational research collaboration, and (8) identify potential barriers to GP CTR network engagement (i.e., infrastructure, communication, marketing). DISCUSSION/SIGNIFICANCE OF IMPACT: This process allowed for a wide range of network members to contribute to actionable recommendations for CTR leadership to move into action and improve the scientific network’s ability to conduct clinical and translational research.

OBJECTIVES/SPECIFIC AIMS: As the issues facing our global society become more complex, university faculty are called upon to address these contemporary problems using interdisciplinary approaches. But do reappointment, promotion, and tenure (RPT) guidelines reflect and reward this fundamental change in the nature of higher education and scholarly inquiry? After collecting all of the RPT guidelines across the university, our research team at the University of Cincinnati (UC) conducted a content analysis of these documents to determine how collaborative work is defined, interpreted, and supported. In addition, we also sought to identify differences in how collaborative work is valued across disciplines and how that value has changed over time. METHODS/STUDY POPULATION: An initial database was assembled that included two distinct data samples: historical and current. Both included RPT criteria for over 100 disciplinary units at the university. Working with the initial comprehensive database, the team narrowed content by selecting all language related to collaborative work using several relevant keywords or keyword fragments (team, collaborat[*], disciplin[*], and interprofessional). This process resulted in a subset of data reflecting the area of interest that could then be coded. Three investigators independently coded common portions of the data for categories. The investigators met regularly to compare the results of their coding, and discrepancies between the investigators’ coding schemes were resolved through discussion. The final, common coding scheme will used to code the remainder of the data by each independent investigator. The team meets weekly to discuss significant passages and assign codes, and then reach consensus related to important themes that are identified. Specifically, we will examine the frequency with which collaborative activities are included, the value and emphasis given to them, and the differences across units. Having a historical sample and a current sample also allows us to analyze trends over time and further compare disciplinary differences. RESULTS/ANTICIPATED RESULTS: UC is a diverse institution that includes world-renowned creative schools (the College Conservatory of Music and the College of Design, Architecture, Art, and Planning), as well as traditional colleges of medicine, nursing, pharmacy, allied health, engineering, business, arts and sciences, etc. UC also includes two branch campuses that specialize in associate’s degree level education. Given the diversity in educational and research missions across these areas, we anticipate discovering several themes within the RPT guidelines, primarily centered around the traditional foundations of faculty work such as service, research, and teaching. We anticipate strong differences by college and disciplinary focus, with emphasis on collaborative work and engagement increasing as RPT guidelines become more current. DISCUSSION/SIGNIFICANCE OF IMPACT: Our experience is that faculty members want to engage in collaborative work when possible and appropriate, but their perception is that independent contributions to their field are more highly valued than interdisciplinary work. As universities rush to endorse and promote interdisciplinary, team-oriented research and teaching, this study will afford a better understanding of the types of activities valued at one large and diverse urban institution, grounded in the actual language of RPT criteria.

OBJECTIVES/SPECIFIC AIMS: To create the instrument, we employed a modified Delphi approach by conducting a thorough literature review on Leadership to help concretize the relevant constructs, and then usied these extracted constructs as a springboard for the Rockefeller Team Science Educators (TSE’s) to discuss and refine the leadership domain areas, collectively creating domain-specific survey items, and then further discussed and refining the number, grouping, and wording of the items. METHODS/STUDY POPULATION: We piloted the Leadership Survey by having all of the Rockefeller TSEs rate Clinical Scholars. Each item was answered using a six-point Likert scale where a low score indicated poor expression of the specific leadership attribute and a high score represented excellent expression of the specific leadership attribute. RESULTS/ANTICIPATED RESULTS: Means, medians, standard deviations, and ranges of each item were calculated and tabulated. A complete (Pearson) correlation matrix was computed so that the raw inter-item relationships can be observed. For each a priori Domain an equal weighted summary scale was created and tabulated for review. The internal consistency of each a priori scale was assessed by calculating Cronbach’s Alpha (α). Items with low Item to Construct coefficients were candidates for elimination or modification, and overall scales with low’s will undergo further discussion. To challenge our assumptions of the construction and integrity of each domain, we employed exploratory Principal Components Analysis (PCA), followed by orthogonally rotated Factor Analysis (FA). We also forced the PCA / FA analysis to extract the a priori dimensions that allowed us to compare if the empirical and a priori structures match. DISCUSSION/SIGNIFICANCE OF IMPACT: We are partnering with the CTSA programs at Penn and Yale to assess issues of generalizability and scalability. We are working with Vanderbilt to install survey onto REDCap for ease of dissemination. Will continue to assess psychometric properties and refine as we receive more input.

OBJECTIVES/SPECIFIC AIMS: To establish an effective team of researchers working towards developing and validating prognostic models employing use of image analyses and other numerical metadata to better understand pediatric undernutrition, and to learn how different approaches can be brought together collaboratively and efficiently. METHODS/STUDY POPULATION: Over the past 18 months we have established a transdisciplinary team spanning three countries and the Schools of Medicine, Engineering, Data Science and Global Health. We first identified two team leaders specifically a pediatric physician scientist (SS) and a data scientist/engineer (DB). The leaders worked together to recruit team members, with the understanding that different ideas are encouraged and will be used collaboratively to tackle the problem of pediatric undernutrition. The final data analytic and interpretative core team consisted of four data science students, two PhD students, an undergraduate biology major, a recent medical graduate, and a PhD research scientist. Additional collaborative members included faculty from Biomedical Engineering, the School of Medicine (Pediatrics and Pathology) along with international Global Health faculty from Pakistan and Zambia. We learned early on that it was important to understand what each of the member’s motivation for contributing to the project was along with aligning that motivation with the overall goals of the team. This made us help prioritize team member tasks and streamline ideas. We also incorporated a mechanism of weekly (monthly/bimonthly for global partners) meetings with informal oral presentations which consisted of each member’s current progress, thoughts and concerns, and next experimental goals. This method enabled team leaders to have a 3600 mechanism of feedback. Overall, we assessed the effectiveness of our team by two mechanisms: 1) ongoing team member feedback, including team leaders, and 2) progress of the research project. RESULTS/ANTICIPATED RESULTS: Our feedback has shown that on initial development of the team there was hesitance in communication due to the background diversity of our various member along with different cultural/social expectations. We used ice-breaking methods such as dedicated time for brief introductions, career directions, and life goals for each team member. We subsequently found that with the exception of one, all other team members noted our working environment professional and conducive to productivity. We also learnt from our method of ongoing constant feedback that at times, due to the complexity of different disciplines, some information was lost due to the difference in educational backgrounds. We have now employed new methods to relay information more effectively, with the use of not just sharing literature but also by explaining the content. The progress of our research project has varied over the past 4-6 months. There was a steep learning curve for almost every member, for example all the data science students had never studied anything related to medicine during their education, including minimal if none exposure to the ethics of medical research. Conversely, team members with medical/biology backgrounds had minimal prior exposure to computational modeling, computer engineering and the verbage of communicating mathematical algorithms. While this may have slowed our progress we learned that by asking questions and engaging every member it was easier to delegate tasks effectively. Once our team reached an overall understanding of each member’s goals there was a steady progress in the project, with new results and new methods of analysis being tested every week. DISCUSSION/SIGNIFICANCE OF IMPACT: We expect that our on-going collaboration will result in the development of new and novel modalities to understand and diagnose pediatric undernutrition, and can be used as a model to tackle several other problems. As with many team science projects, credit and authorship are challenges that we are outlining creative strategies for as suggested by International Committee of Medical Journal Editors (ICMJE) and other literature.

OBJECTIVES/SPECIFIC AIMS: The objective for the present study is to evaluate qualitatively the Team Leadership Assessment Center (LAC) at UTMB-Galveston. There has been much discussion about the need for leader development within team science (Börner, et al, 2010; Falk-Krzensinski, etal., 2011). The LAC was designed to examine the study participants’ beliefs and perceptions of and competencies in team leadership by means of a multi-trait multi-method approach. Our team competency model involves seven dimensions and twenty-five specific competencies. There were two complementary components to the evaluation: a quantitative survey and a series of qualitative interviews, to be discussed here. METHODS/STUDY POPULATION: The study population for the qualitative component consisted of seventeen volunteers from the pool of fifty-one LAC participants, including trainees (KL2 scholars, TL1 scholars) as well as assistant professors, and early career associate professors. Each volunteer respondent was engaged in a twenty to thirty-minute, recorded, conversational, telephone interview. They were asked to describe and evaluate their LAC experience in their own words, perceptions, and values. The study was reviewed by the Committee for the Protection of Human Subjects at UTMB. RESULTS/ANTICIPATED RESULTS: Major findings from respondents’ overall assessment of their Center experience include:. All respondents stated that the LAC was a worthwhile experience. All respondents stated they would be willing to participate in any follow-up LAC activity. Before the LAC experience, most respondents indicated that they perceived leadership as a condition or feature of a job, appointment, or profession and not an individualistic feature of personality or experience. Ideational or conceptual definitions of leadership were superseded by administrative or managerial tropes. Major categorical indexes were related to occupational status. The generally belief is one is not trained to be a leader, but to perform leadership tasks. Significant differences among respondents tended to cluster around occupational positions and statuses at UTMB, for example:. Surgeons feel they are team oriented and their work is organized according to necessary tasks. Assistant professors and post-docs generally perceive the design of leadership as defined by the demands of their specialized field, not determined institutionally or professionally. A general take-away was the sense that, although some participants did not consider themselves to be “leaders” before the training, most felt that the “pressure” to be or become a leader was relieved a bit by the LAC. One was only expected to develop leadership skills and strategies, not change one’s Self-Identity. DISCUSSION/SIGNIFICANCE OF IMPACT:. The more complex the job status, the less critical is the need to achieve the Self-Identity of “leader.” Complaints about the LAC were very few and non-modal in occurrence. A general recommendation would be for the facilitators of programs like LAC to take cultural differences more into consideration. The most highly rated feature of the LAC is the personal attention given to participants during the one-on-one evaluation profile.

OBJECTIVES/SPECIFIC AIMS: To longitudinally track emerging research collaborations and assess their development and productivity. METHODS/STUDY POPULATION: In four administrations (2011, 2013, 2015, 2017), all full- and part-time University of Rochester Medical Center faculty received an email invitation to complete a research collaborators survey. Respondents indicated whether they were involved in research, and if involved in research, identified collaborators from a drop-down list of investigators in the institution. Space was provided for write-ins. Full- and part-time status, faculty rank, and departmental affiliation was associated with each investigator. Grant data were obtained from a grant management database maintained by the institution’s Office of Research and Project Administration. Grant data included all submissions (funded and not funded), award number, award effective data, award final expiration date, funding amounts, principal investigator and co-investigators. Using Mathematica SNA software, for each year we identified collaborator dyads (including their characteristics such as inter/intradepartmental; investigator characteristics) and networks (e.g. size, density). RESULTS/ANTICIPATED RESULTS: On average, 1800 (range 1730-2034) full- and part-time faculty received email invitations to complete the survey. An average of 403 respondents (range 385-441) completed the survey each administration. While the response rate seems low, the survey was distributed to every faculty member regardless of their primary appointment. Thus it included a large number of individuals whose role is exclusively clinical. Grant data included 4429 awards received between 2011 and 2018, involving 1395 investigators as principal or co-investigators. Survey respondents naming collaborators ranged from 233 to 280 (average 257) with 1594 to 2265 (average 1988) collaborations named each year. Overall density increased from.0204 in 2011 to.0342 in 2017. Density within the group of female investigators increased from.0219 in 2011 to.0412 in 2017. Within the group of male investigators, density increase from.0226 to.0333 in the same time span. Analysis by rank, changes over time and those with grant funding is underway. DISCUSSION/SIGNIFICANCE OF IMPACT: This methodology captured a consistent number of collaborations over an 8 year period. Analyses reveal network growth over time and of increasing heterogeneity (by gender). Analyzing research networks overtime provides an important metric to assess how research networks evolve and devolve and the characteristics of those that grow or stagnate. Further these analyses can demonstrate the impact of support provided to networks or teams by the CTSI, department or other institutional mechanism.

OBJECTIVES/SPECIFIC AIMS: Cardiac radiation exposure following anti-cancer (CA) thoracic radiotherapy (RT) treatment increases risk of heart failure in a dose-dependent manner with a predominantly restrictive cardiomyopathy phenotype and is characterized by a diffuse fibrosis within the myocardium. The peak oxygen pulse (O2Pulse) determined at cardiopulmonary exercise testing (CPET) is the quotient of oxygen consumption (VO2) divided by the heart rate (HR) at peak exercise. Through deduction of the Fick equation (VO2 = cardiac output (CO) x arteriovenous oxygen difference) it provides a noninvasive estimate of the stroke volume response to exercise. Knowledge of the relationship between cardiac radiation dose and O2Pulse may provide mechanistic insight into the cardiac reserve of the CA survivor following thoracic RT. METHODS/STUDY POPULATION: Patients without a history of cardiovascular disease with a history of thoracic RT for CA treatment with significant incidental heart exposure (≥5 Gray (Gy) to ≥10% of the heart volume) underwent treadmill CPET to determine cardiorespiratory fitness and cardiac magnetic resonance (CMR) imaging to quantify central hemodynamics and for myocardial tissue characterization. The mean cardiac radiation dose (MCRD) and %volume of heart dose was determined from dose-volume histograms reflective of the dose contributions from all RT treatments for each patient. The oxygen pulse (milliliters (mL) of O2 per heart beat) was determined by dividing the absolute VO2 by the HR (beats per minute, bpm) at peak exercise and reported as %-predicted values to account for age and gender differences. Data are reported as number (%) or median (interquartile range). A stepwise multivariate linear regression model was created from significant univariate RT and CMR variables to determine independent predictors of %O2Pulse. RESULTS/ANTICIPATED RESULTS: Thirty patients (age = 63 [57-67] years, 18 [60%] female, 2.0 [0.1-28.7] years since completion of RT) underwent study procedures. The peak VO2=1376 mL·min-1 (62% of predicted) and peak HR = 150 (122-164) bpm resulted in a peak O2Pulse of 9.2 mL/beat (82% of predicted). The MCRD = 5.6 [3.7-17.8] Gy was inversely associated with %O2Pulse at univariate analysis (R = −0.514, p < .01), but was not retained at multivariate analysis. The CMR-derived CO ([4.9 (4.09-5.90) Liters/minute], β = +.374, p < .01), CMR-extracellular volume ([ECV, 26.9 (24.8-29.2)%], β = −.536, p < .01), and volume of the heart exposed to ≥30 Gy ([2.5 (0-15.0)Gy], (β = −.345, p = .01) were retained in the model (R2 = .709, F(3,19) = 15.438, p < .001) and were independent predictors of the %O2Pulse. DISCUSSION/SIGNIFICANCE OF IMPACT: In patients with significant heart exposure following RT, %O2Pulse (a surrogate of stroke volume response to exercise) is inversely associated with cardiac radiation dose and is related to central hemodynamics (CO) and markers of diffuse fibrosis (ECV).

OBJECTIVES/SPECIFIC AIMS: The objective of this study was to evaluate the impact of the research and the scientific collaborations as shown in research publication supported by the PRCTRC. METHODS/STUDY POPULATION: Manuscripts published from 2010 to 2017 were retrieved from the Science Citation Index database. Our search criteria included manuscripts: 1) with the PRCTRC grant number and 2) with a PMCID number. Scientometric indicators including h-index (HI), average citation (AC), collaboration coefficient (CC), collaboration index (CI) and degree of collaboration (DC) were calculated using the Web of Science Platform and Stata software for statistical inquiry. Joinpoint was used to calculate the annual percent change (APC). RESULTS/ANTICIPATED RESULTS: A total of 316 publications were identified from 2010-2017, with an average of 39.5 publications per year, and a total of 2,383 citing articles without self-citations. During this period a significant growth (APC = ¬15.3%, p < 0.05) of scientific production was observed. The overall HI was 28, and the AC per item was 9.31. Regarding collaboration, the overall CC was 0.82, the CI was 6.93, and the DC was 99.3. DISCUSSION/SIGNIFICANCE OF IMPACT: This study demonstrated that the PRCTRC scientific production increased statistically significantly. Application of the scientometric indicators allows the PRCTRC assess the research productivity and collaboration to design and implement interventions according to program experience and needs.

OBJECTIVES/SPECIFIC AIMS: The objective of this research was to identify and evaluate published research articles that highlight the use of CTSA institutional websites as a research tool or data source for translational science research. METHODS/STUDY POPULATION: A multifaceted systematic search process was engaged for this literature review process using standard literature database searching, digital journal database searching, and pearl growing. All U.S. based studies and reports from 2006 through the present that addressed the application of websites of CTSA institutions for translational science purposes were included in this review. Identified articles were collected, organized, and analyzed using an excel spreadsheet. There were 2 different data collection and organization protocols, one for studies the other for reports. The first data collection protocol was for identified studies that used individual CTSA Institutional websites as a data source for a research topic. The organization processes for each relevant study article included a customized data extraction process that looked to identify a standard group of key elements from each study: (1) The study’s NCATS CTSA Goal. (2) The type of data searched in the CTSA institutional website. (3) The number of CTSA institutional websites searched. (4) The number of sites that had the needed data. (6) The outcomes reported from the research. The second data collection protocol was for identified reports that referenced single CTSA Institutional websites as performing a specific translational informatics functionality either as a portal to Clinical and Translational Science Award tools and resources or as a direct information source. The organizational process for each relevant report article also included a customized data extraction process that looked to identify a standard group of key elements from each report: (1) NCATS / CTSA Goal (2) Tool or Functionality Promoted (3) Description (4) Website used as portal or direct tool. (5) Target Audience. RESULTS/ANTICIPATED RESULTS: The studies were summarized using the standard group of key elements identified for data extraction and summarized in a table. In 5 of the 6 studies, researchers relied on CTSA member individual website content to mine necessary data. One (1) of the studies employed a mixed methods approach to data acquisition and only relied on CTSA member individual website content for CTSA institutions that did not respond to a user survey. One (1) study used a survey to learn about CTSA website content rather than review the websites. In 5 of the 6 studies, researchers reviewed individual CTSA websites for the purposes of determining the number or percentages of CTSA institutions had specific data. One (1) study instead reviewed the individual websites to develop a broader picture of what the CTSA Consortium offered as a group. The percentage of CTSA websites that had the needed data of the researchers ranged from 32% to 100%. The median and mean scores for CTSA websites having the needed data was 66% and 66.5% respectively. One study did not provide specific information for assessment. All 6 studies included research that fell within at least 2 categories of the 5 NCATS CTSA Goal topics. The category most investigated was translational research processes where 5 of the 6 studies investigated how CTSA websites looked to improve the quality and efficiency of translational research. Three (3) studies investigated how CTSA’s cultivated and trained the clinical and translational science workforce. Two (2) studies investigated how CTSA’s engaged patients and communities in the translational research process. Two (2) studies investigated how CTSA’s promoted the integration of underserved populations. One (1) study investigated ways the CTSA’s used their websites to advance the use of cutting-edge informatics. The outcomes reported included (1) the percentage CTSA individual websites that provided information regarding patient recruitment. (2) A list of generic services provided across the CTSA Individual website medium. (3) The number of CTSA individual website education and training programs. (4) The number and quality of informed consent forms presented online. (5) Investigational New Drug (IND) / Investigational Device Exemption (IDE) training methods for CTSA Investigators. (6) The percentage of KL2 Awards used by Child Health Investigators at CTSA Institutions. The reports (rn=9) were also summarized using the standard group of key elements identified for data extraction and summarized in a table. All six articles reported using their Institutional CTSA website as either a portal or a tool to promote clinical and translational science as outlined through NCATS goals. A CTSA website is used as a portal when it provides links to other sites, tools, or programs. A CTSA Website is used as a tool when it provides the functionality within its web design like providing an online application or database, or interactive training pages. In 8 of the 9 articles, authors reported on CTSA institutional website as either a translational informatics portal or providing informatics functionalities. Four (4) of the articles reported the use of their website for engagement, on either the collaborator or patient level, such as advocacy, education, or subject enrollment. Two (2) articles reported the use of their CTSA website for the cultivation and training of a clinical and translational science workforce. Four (4) articles reported on the use of their CTSA website for the purposes of increasing the quality and efficiency of translational research. None of the articles reported how their sites were used to promote the integration of underserved populations. All the reports identified a CTSA institutional website as a tool to leverage or disseminate CTSA capabilities and functionality. The access point and or warehousing of these capabilities was the CTSA institutional website. The target audience for these publications included researchers, clinical research administrators, IT programmers, community collaborators, and research subjects. The articles that reported on the use of CTSA institutional websites for clinical and translational functionality included topics such as: (1) the introduction of an informatics tool that searches clinical notes to identify clinical data for research. (2) the promotion of an online research subject advocacy program. (3) the introduction of an informatics tool portal that allows researchers flexible, efficient and effective means of collaboration and interaction with data. (4) the promotion of a team development project tool. (5) the introduction of a research participant registry and study promotion and education tool. (6) the promotion of an independent informatics tool registry that could connect to all CTSA websites. DISCUSSION/SIGNIFICANCE OF IMPACT: This research shows that CTSA institutional website functionality and content contributes to the CTSA body of research and the advancement NIH translational science goals.