The Community Research Liaison Model (CRLM) is a novel model to facilitate community-engaged research (CEnR) and community–academic research partnerships focused on health priorities identified by the community. This model, informed by the Principles of Community Engagement, builds trust among rural communities and expands capacity for community and investigator-initiated research. We describe the CRLM development process and how it is operationalized today. We followed a multi-phase process to design and implement a community engagement model that could be replicated. The resulting CRLM moves community–academic research collaborations from objectives to outputs using a conceptual framework that specifies our guiding principles, objectives, and actions to facilitate the objectives (i.e., capacity, motivations, and partners), and outputs. The CRLM has been fully implemented across Oregon. Six Community Research Liaisons collectively support 18 predominantly rural Oregon counties. Since 2017, the liaison team has engaged with communities on nearly 300 community projects. The CRLM has been successful in facilitating CEnR and community–academic research partnerships. The model has always existed on a dynamic foundation and continues to be responsive to the lessons learned by the community and researchers. The model is expanding across Oregon as an equitable approach to addressing health disparities across the state.

OBJECTIVES/GOALS: Our purpose is to promote traffic toward the NJ ACTS Regulatory Cores recently launched website and increase investigator engagement through marketing strategies on LinkedIn. Landscaping to characterize the profiles of researchers on LinkedIn was also completed to estimate the feasibility of engaging with a target population on LinkedIn. METHODS/STUDY POPULATION: Insight gathering was performed to analyze what percentage of researchers possessed a LinkedIn profile and actively used their accounts. A sample population consisting of 284 NJ ACTS members were analyzed to summarize the type of researchers on LinkedIn, and their likelihood of responding to LinkedIn marketing campaigns. Efforts to launch a company LinkedIn page and collect followers were completed. Different methods of promotion were evaluated, including direct vs. mass email outreach to over 600+ researchers at Rutgers. Effectiveness of our platform was measured by comparing/overlaying Regulatory website traffic with LinkedIn traffic, as well as tracking the metrics of LinkedIn posts. RESULTS/ANTICIPATED RESULTS: Among 284 NJ ACTS members, 76% (n=215) possess a LinkedIn profile, but only 21% (n=59) are actively interacting with material on LinkedIn, such as creating, commenting, or sharing posts. Among the NJ ACTS LinkedIn users, 27% of individuals (n=57/215) responded to a direct outreach. Retention of the created organizational page was strong, as most users who visited the Regulatory Core page were likely to become followers. Massive email outreach to 600+ researchers within RBHS did not yield a strong LinkedIn following, however it did result in strong signals of website traffic during the days after the promotion was sent. Engagement with posts on LinkedIn can also be amplified and messaging proliferated when colleagues reshare Regulatory posts on their personal feeds. DISCUSSION/SIGNIFICANCE: 3/4 of academic researchers are likely to be on LinkedIn but may not be active users of the platform. The most effective outreach is through direct messaging as opposed to broader, less individualized tactics (including mass email outreach). Evidence suggests potential to utilize LinkedIn to proactively engage in regulatory-related activities.

OBJECTIVES/GOALS: Limited specialty care within safety net health systems reduces availability of follow-up appointments for chronic conditions. We evaluated patient acceptability of a 6 month series of telemedicine group medical visits for chronic migraine at a county hospital-based clinic as a potential method to improve access to specialty care in this setting. METHODS/STUDY POPULATION: We developed and implemented a pilot program of monthly physician-led telemedicine group visits to provide routine follow-up care for adults with chronic migraine. Visits were conducted through the neurology clinic at LAC+USC medical center, a safety net hospital in Los Angeles and included an educational component, peer support, and the opportunity to address individual needs or refill medications. We assessed headache severity (HIT-6) and mood (PHQ-9) through telephone surveys before and 6 months after patients’ first telemedicine group visit and compared timepoints using paired t-tests. Patient acceptability of the group visits was elicited through focus groups and key themes identified using grounded field theory. RESULTS/ANTICIPATED RESULTS: Baseline data was available for 18/20 pilot participants. Patients were predominantly female (89%) with mean age of 46 (SD 8.6). Mean HIT-6 was 65/78 reflecting a very severe impact on daily life, and mean PHQ-9 was 8.7 reflecting mild depressive symptoms. There was no statistically significant change in either HIT-6 (mean difference 2.36, p=0.34) or PHQ-9 (mean difference 2.09, p=0.12) after group participation. Key themes from the focus groups included lack of prior exposure to other people with similar headache burden and logistical barriers to care, such as difficulty contacting a provider or extended clinic wait times. Primary patient-reported benefits included more frequent access to a provider and peer support. DISCUSSION/SIGNIFICANCE: Telemedicine group visits for chronic migraine are feasible in a safety net context and were well-received by patients. However, this pilot study did not show a benefit of telemedicine group visits for headache control or mood symptoms.

OBJECTIVES/SPECIFIC AIMS: To mobilize and engage CHWs/promotores as stakeholders, we aim to promote the capacity for CHWs participate in patient centered research (PCOR) by locally implementing a structured research training curriculum for CHWs. Main Questions: How the process of mobilization and engagement would be implemented at local/state level? What would be project challenges, risks and barriers at each and across sites? What modifications would be made to the initial PCOR for CHWs training curriculum and toolkit based on local feedback from collaborators, in both English and Spanish? What would be lessons learned on mobilization, engagement of, and sustainability for CHW training organizations as partners in PCOR? METHODS/STUDY POPULATION: Measures: Monthly calls and quarterly reports from local organizations on activities, deliverables status, modifications, project implementation challenges/barriers and solutions (experienced and potential) to achieve goals of training 10 PCOR CHW Champions and a total of 360 CHWs/promotores trained in PCOR. Input from Note taker reports, Feedback and Evaluation Forms from training attendees at each session. Co-authorship of team members on dissemination activities (submissions for presentations, posters, blogs entries, webinars). Activities/Procedures: Via a highly participatory, consensus-driven decision-making approach, each of the organizations in the target states provide input into refining the toolkit for local use, select the training champions and develop CHW/promotor outreach and recruitment plans, and deliver the PCOR training to CHWs. In addition, the organizations will also set up a local stakeholder CHW/promotores advisory group. Environmental scan and literature review continues on training content areas to complement field experience in implementing the trainings at local sites. Project information tools developed (info sheet for local organizations, informational slide set to be used at calls and statewide seminars, a templates for flyer for training recruitment, agenda, certificates). FL and TN pilot of the translation of the curriculum, addressing problematic concepts and terms, collecting feedback forms eliciting input on terminology variations across Spanish speaking populations and literacy levels. Project Collaborators: Día de la Mujer Latina, a patient advocacy group in Texas with CHW trainings in several states and Puerto Rico Chula Vista Community Collaborative, a community health empowerment organization in Southern California Progresso Community Center, a Latino-focused health coalition based in Tennessee Florida Community Health Worker Coalition, a statewide partnership dedicated to the support and promotion of the CHW profession in Florida. RESULTS/ANTICIPATED RESULTS: Results: Trainings per State - Y1 Jan- October 2018 Totals: 11 PCOR Champions and 252 PCOR-Trained CHWs in CA-TX-TN Y2 Plans (October 2018-September 2019): Will continue to collect CHW trainee demographic data, CHW certification and patient/patient advocate status. Will conduct qualitative and quantitative analysis of all quarterly reports, Note taker, and trainee Feedback and Evaluation forms. Will reach goal of 360 PCOR-trained CHWs in FL, CA, TX and TN. Will continue to submit abstracts on our story on building patient and stakeholder capacity to participate as partners in patient-centered outcomes research, engagement and mobilization, from topic generation through the dissemination of research results. From evaluation analysis of content and process measures, we will discuss sustainability strategies as shared learning collaborative. DISCUSSION/SIGNIFICANCE OF IMPACT: Challenges/Decision Points Y1: On Mobilization and Engagement: Across partners, different levels of readiness/capacities/structures, and access to local resources Process application for request for content and guest instructor approvals to the Texas Department of State Health Services (DSHS) for CHW and CHW Instructor credit Co-branding of informational products (recruitment flyers, agendas, certificates), slides of Welcome section On Content and Curriculum Development: Address different levels of literacy Format (1-day vs spread, in person/online, prescriptive vs open) Clear distinction between service provision and research; paradigm shift of transfer of skills Inserting examples of unethical health research past activities with both African American and Hispanic/Latino populations Reinstating phases of clinical studies basic information Creating a study research design activity in Chapter 1 CHW role as member of research team Adding PCORI-funded project summary fact sheet per state On translations: Diversity of nuances of meaning in vocabulary for concepts On sustainability: Different degrees of organizational and personal involvement Next for newly PCOR-trained CHWs Meaningfully engaging patients and other stakeholders is increasingly recognized as requisite to generate research findings that are trusted, meaningful, and useful to clinicians, patients, and their families. One key engagement strategy used for engaging specific patients/caregivers and patient advocates in underserved communities is leveraging our partnerships with Community Health Workers (CHWs). Moreover, there is a documented need for higher level of training skills to undertake activities such as community health assessments, program evaluations and clinical studies. University of Miami (UM) along FL partners has successfully developed a 7-hr specialized toolkit on patient-centered research for CHWs and trained 148 CHWs/promotores (original plans were for 100) across the six major statewide regions. Evaluation data resulted in 100% of attendees responses’ as excellent and 99% would recommend it to others. Qualitative comments included “even though the training was tailored for research, I feel that it applies to many other aspects of the CHW role” and “I feel more empowered in my role after hearing explicitly the opportunities…for a CHW to be more involved in the research process”. UM has partnered with stakeholders in FL, Texas, southern California and Tennessee to develop a Spanish version of the PCOR for CHWs Training Toolkit (including a slide deck, Facilitator’s Guide and Student Workbook) that can be culturally and linguistically appropriate, to train local CHWs/promotores as PCOR CHW Champions. Attendees will receive lunch and a certificate of participation upon completion of the module. In turn, they agree to train local CHWs in their region. These 7 credit hrs could be used as credits towards state certification requirements, in states with CHW certification programs. This partnership for the mobilization and engagement of CHWs/promotores aims to strengthen their capacity to be involved in PCOR at the local and national level and increase the organizational capacity of CHW representative organizations in their promotion of PCOR. This type of research aims to help patients and those who care for them make better-informed decisions about the healthcare choices they face every day, guided by those who will use that information. In doing so, CHWs/promotores are contributing to PCOR in addressing health disparities and achieving health equity as a more culturally and linguistically diverse healthcare workforce and PCOR research team members.

OBJECTIVES/SPECIFIC AIMS: (1) To explain and discuss minority health and health disparities and the mechanisms, for example, individual behaviors and lifestyle, genetics and epigenetics, physical and cultural environment, and clinical events and health care, that lead to health disparities. (2) To explore the intersection between health disparity science and clinical and translational science. (3) To present and discuss the NIMHD Framework and how it can be used to guide multilevel research to address minority health and health disparities. (4) To highlight examples of NIMHD-funded novel and innovative research relevant to clinical and translational research from a health disparities perspective. METHODS/STUDY POPULATION: The NIMHD Research Framework will be introduced that is currently being used by NIMHD to address minority health and health disparity research. The Framework looks at targeted populations in relation to biological, behavioral, physical, and sociocultural environmental domains of influence as well as the health care system. These domains have different levels of influence: individual, family/interpersonal, community, and population. Targeted populations include NIH-designated health disparity populations, that include racial/ethnic minorities, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minorities. The following research opportunities are among the many opportunities offered by NIMHD: Disparities in Surgical Care and Outcomes Social Epigenomics for Minority Health and Health Disparities Addressing Health Disparities Among Immigrant Populations. RESULTS/ANTICIPATED RESULTS: Select examples of NIMHD supported minority health and health disparities research that intersects with clinical and translational research will be presented. Candidate examples include: Genetic Architecture of Lupus (SLE) in individuals with Asian ancestry; A Novel Racial Disparity Marker for Risk Prediction in Triple Negative Breast Cancer Patients; Self-Applied Wearable Ultrasound Therapy for Osteoarthritis Management in Rural Central NY; Design and Development of a Multifunctional Self-service Health Screening Kiosk. DISCUSSION/SIGNIFICANCE OF IMPACT: Despite notable improvements gained as a result of medical and scientific advances, there continues to be an alarming disproportionate burden of illness and lack of representation in research among minority and other socially disadvantaged and underserved populations. To meet this challenge, NIMHD is committed to supporting a wide range of clinical and translational research aimed at the development of innovative strategies and approaches to reduce and, eventually, eliminate health disparities. NIMHD’s mission, research priorities, and funding opportunities are relevant to the efforts and interests of clinical and translational scientists, especially those interested in the translation of research findings into interventions, products, and tools that may improve minority health and quality of life, increase adherence to medication and treatment regimens, increase access, and improve the delivery of health services.

ABSTRACT IMPACT: This research highlights Adverse Childhood Experiences as a potential risk factor and intervention target contributing to the disproportionate number of individuals with sickle cell disease affected by asthma, a well-established catalyst to the increased morbidity and mortality impacting this high-risk population. OBJECTIVES/GOALS: Adverse Childhood Experiences (ACEs) are strongly associated with asthma. A disproportionate number of individuals with sickle cell disease (SCD) also have asthma. Asthma is strongly associated with increased SCD morbidity and mortality. This study compared the prevalence of asthma among children and adolescents with SCD with and without ACEs. METHODS/STUDY POPULATION: This retrospective cohort study involved 45 children and 30 adolescents with SCD. ACEs were captured using the Center for Youth Wellness Adverse Childhood Experiences Child and Teen Questionnaires, which encompass the original 10 ACEs as well as 7 (child) and 9 (teen) expert-recommended ('expanded') ACEs. ACE exposures were categorized as: Original 0-1 vs. ≥2; Original + Expanded 0-1 vs. ≥2. Asthma prevalence was compared among ≥2 and 0-1 ACE groups using the chi-square (or Fisher’s exact) test. A binary logistic regression was performed to predict the likelihood of asthma while adjusting for characteristics (age, household income and gender) that were statistically different among ACE comparison groups at baseline. RESULTS/ANTICIPATED RESULTS: Among the 45 child participants, 64% had a history of asthma; whereas 50% of teens had a history of asthma. Asthma prevalence was higher among teens with ≥2 vs. 0-1 Original ACEs (89% v. 33%, p=0.014). A history of ≥2 ACEs remained significant (p=0.024) among teens after adjusting for age, household income and gender. There was no significance in asthma prevalence among child ACE comparison groups. DISCUSSION/SIGNIFICANCE OF FINDINGS: Adolescents with ≥2 ACEs had a higher prevalence of asthma compared to subjects with 0-1 ACE. This study, coupled with the cumulative nature of ACEs and the graded-dose response relationship between ACEs and poor health outcomes, highlight the need for larger, longitudinal studies examining the relationship between ACEs, asthma and SCD outcomes.

OBJECTIVES/SPECIFIC AIMS: To use a systematic and iterative process to develop and refine toolkits to support dissemination and implementation (D&I) research. METHODS/STUDY POPULATION: Participants included research staff from the Dissemination and Implementation Research Core (DIRC), a research methods core from the Institute of Clinical and Translational Science at Washington University in St. Louis, other D&I experts from the University, and national experts from the D&I field. This project used education design research methodology and a systematic and iterative process involving several phases. The first phase (preliminary research and initial development) consisted of analysis of the educational problem and its context, and led to the development of toolkit prototypes and plans for their implementation. In the second phase (development and formative evaluation), toolkits were iteratively evaluated with emphasis on content validity and consistency and effectiveness as perceived by the users. Finally, in the summative evaluation, the toolkits were evaluated based on their use as intended. RESULTS/ANTICIPATED RESULTS: Our team identified the target audience as DIRC customers and investigators from disciplines across the University, and found that resources for beginners to D&I were lacking. The team developed 8 toolkits: (1) Introduction to D&I; (2) How to develop D&I Aims; (3) D&I Designs; (4) Implementation Outcomes; (5) Implementation Organizational Measures; (6) Assessing Barriers and Facilitators; (7) D&I Designs; and (8) Guideline research. These prototypes were iteratively revised for content validity and consistency. Finally, each toolkit was evaluated by two national experts in D&I science, and further refined. DISCUSSION/SIGNIFICANCE OF IMPACT: This systematic and cyclical process led to the development of 8 toolkits to support researchers in D&I science, which are now available on the DIRC Web site. This set the stage for development of new toolkits as additional needs are identified.

A number of publications have discussed approaches to training the scientific workforce in comparative effectiveness research (CER) and patient-centered outcomes research (PCOR). To meet this need, funders have offered resources for developing educational materials and establishing training programs. To extend these efforts into specific researcher communities, the Agency for Healthcare Research and Quality developed an R25 Funding Opportunity Announcement that called for basic, advanced, and experiential training for a specific researcher community in collaboration with associated program partners. This paper describes the strategies developed by the 5 subsequently funded programs, their specific researcher communities and program partners, and the challenges associated with developing in-person and online programs. We focus on lessons learned that can be translated into developing training programs nationwide and on training for the special populations of interest. We also discuss the creation of a sustainable network for training and the conduct of comparative effectiveness research/patient-centered outcomes research in targeted communities.

OBJECTIVES/SPECIFIC AIMS: Missing data is a common problem in research studies that may lead to inconclusive or inaccurate results. It may even lead to harm secondary to wrong research conclusions. The purpose of this ancillary study is to measure the differences in missing data following implementation of a variety of mechanisms to improve data quality and documentation in a global quality improvement study. Many of the sites involved in the study were in low-income or middle-income countries with minimal research infrastructure. Missing data is defined as “values that are not available that would be meaningful for analysis if they were observed” (The prevention and treatment of missing data, New Engl J Med 367; 14, nejm.org, October 4, 2012). METHODS/STUDY POPULATION: All study sites used REDCap software to enter various data points including hospital and ICU admission and discharge dates as well as whether items on a Checklist relevant to processes of care in the ICU were reviewed. After initial general data collection phase, we categorized data as “must have” and “good to have.” “Must have” variables were defined as data variables that were essential for the study outcomes. “Good to have” variables would not affect the main outcomes of the study if missing. We measured completeness of data using the in-built REDCap data quality check feature. We used several strategies to encourage reduction of missing data. We initially did random data checks but noted that the amount of missing data was substantial and could not be adequately addressed this way. Second, we created excel sheets highlighting missing data for each site and notified sites. This proved onerous to create and made it burdensome for sites to identify easily where data was missing. Third, we built a custom report form in REDCap specifically able to identify which “must have” data points were missing. This could be easily accessed by the principal investigator at each site and made completing the data forms more straightforward. We encouraged all sites to complete their data collection by sending weekly data reports to each site highlighting the patients with missing data. An instructional YouTube tutorial was also created and the link was shared with all sites to demonstrate how to use the custom built report form in REDCap and how to appropriately fill in the missing data. Since this was a global study, we communicated with sites using a variety of locally favored mechanisms including Zoom, FaceTime, WeChat, WhatsApp as well as email. By harnessing the buy-in of local champions our approach was successful. RESULTS/ANTICIPATED RESULTS: The total number of patients recruited for the CERTAIN study is 4843. The rate of all missing variables improved with the efforts described above. Hospital admission dates were missing in 8.4% pre efforts and 4.2% post efforts (p<0.01). ICU admission dates were missing in 5.5% pre and 2.0% post (p<0.01). Documentation of completion of processes of care (including central line review, urinary catheter review, consideration for blood transfusion) improved significantly from pre to post (p<0.01). DISCUSSION/SIGNIFICANCE OF IMPACT: Missing data can be a problem in all types of research studies. This study provides some preliminary evidence for effective approaches that can reduce the problem of missing data when conducting a global study at sites with limited research infrastructure in place. By addressing the concern about missing data, we can be more confident that our results can be accurately analyzed and interpreted, improving the quality of the research.

OBJECTIVES/SPECIFIC AIMS: The purpose of the current study is to determine predictors of linkage-to-care (LTC) outcomes among patients screened for hepatitis C virus (HCV) infection in the emergency department (ED). The study is one of the first to report the impact of factors influencing medical eligibility for HCV treatment. By establishing predictors of linkage outcomes, we hope to characterize patients at highest risk of being lost to follow-up. This information can be used to guide the development of targeted interventions and optimize linkage efforts at institutions with similar programs. METHODS/STUDY POPULATION: In 2013, we implemented an opt-out HCV screening program targeting baby boomers presenting to the ED. The screening program was expanded in 2015, and all patients who presented to the ED (an academic ED with 73,000 annual visits) between 2015 and 2018 were offered an HCV antibody test. Confirmatory RNA tests were ordered for all patients with a positive screening test, and those with confirmed infection were contacted (when possible) by a linkage coordinator, who sought to facilitate linkage to outpatient care. Patients were followed until they had been successfully linked to care or were lost to follow-up; successful linkage was defined as a patient attending a scheduled HCV clinic visit. Linkage outcomes (linked vs. not linked) among confirmed cases were analyzed based on previously described LTC barriers, sociodemographic factors, and factors influencing HCV treatment eligibility. Binary multiple logistic regression was used to model the relationship between predictors and LTC outcomes. RESULTS/ANTICIPATED RESULTS: Between August 2015 and June 2018, 48,947 patients were screened for HCV, yielding 4,026 positive results. HCV infection was confirmed in 1,798 patients, 1,651 of whom were eligible for the current study. By July 2018, 884 eligible patients (53.5%) had been successfully linked to care. Odds of linkage failure were decreased among patients with known linkage barriers including mental health disorders (adjusted odds ratio [aOR], 0.28; 95% confidence interval [CI], 0.21-0.37), active substance abuse (aOR, 0.65; 95% CI, 0.47-0.91), and ‘competing’ medical comorbidities (aOR, 0.31; 95% CI, 0.21-0.47); however, odds of linkage failure were increased in the presence of medical comorbidities leading to ineligibility for HCV treatment (aOR, 21.71; 95% CI, 7.02-67.13). Decreased odds of linkage failure were also found among patients belonging to the baby boomer population (aOR, 0.64; 95% CI, 0.46-0.91) and individuals with HBV co-infection (aOR, 0.36; 95% CI, 0.14-0.94). Finally, odds of linkage failure were increased among patients without health insurance (aOR, 1.952; 95% CI, 1.01-3.79) and with public health insurance (aOR, 2.140; 95% CI, 1.08-4.24). While African-American patients exhibited decreased odds of linkage failure in bivariate analyses, this association was not significant in the multivariate analysis. Variables ultimately found not to be predictive of linkage outcome included race, ethnicity, gender, homelessness, and incarceration. DISCUSSION/SIGNIFICANCE OF IMPACT: In contrast with current trends in the literature, our analysis found that patients with any of three well-described linkage barriers (mental health disorder, active substance abuse, and ‘competing’ comorbidities) exhibited decreased odds of linkage failure. It is possible that knowledge of these barriers by linkage personnel led to increased persistence of efforts for such patients, resulting in improved linkage among patients with these barriers. However, another possibility is that individuals with factors such as a mental health disorder or medical comorbidity were more likely to experience a clinical encounter, during which discussions about HCV treatment could take place. It is also possible that other contributing factors were unaccounted for by our analysis, such as internal programmatic issues, patient education and income levels, marital status, or other ‘destabilizing’ factors that would reduce a patient’s likelihood of being contacted by a linkage coordinator. While patients with general medical comorbidities were less likely to experience linkage failure, patients who were ineligible for HCV treatment due to a medical comorbidity were significantly more likely to experience linkage failure. While this finding is intuitive, it is nonetheless troubling, as we would expect patients with severe medical comorbidities to benefit greatly from health counseling, mental health services, substance abuse treatment, or other resources available through linkage. As a result of this finding, we intend to adapt our approach to medically ineligible patients, emphasizing the availability and potential usefulness of such resources. It is unsurprising that uninsured and publicly insured patients were less likely to be successfully linked to care, as HCV treatment continues to be associated with significant financial costs for such patients. However, it is also possible that confounding factors such as education and income level, which were not included in our analysis, would be more predictive of patients’ ability or willingness to undergo HCV treatment. More research is needed to improve linkage-to-care for patients with HCV. In the near future, we intend to conduct an internal evaluation, as well as a positive deviance analysis of other LTC programs, to determine additional ways to improve linkage outcomes for all patients screened for HCV in the ED.

OBJECTIVES/GOALS: Vascularized composite allotransplantation (VCA) restores devastating soft tissue injuries. However, graft viability may be compromised during ischemia time, thus preservation techniques continue to evolve. Here we summarize our preliminary findings from preservation techniques utilizing hyperosmolar extracellular solution (HES) and electric stimulation in a 6 hour ex-vivo perfusion model. METHODS/STUDY POPULATION: A published, MGH rodent hindlimb ex-vivo perfusion model was utilized for this project. Three baseline control elements were taken to compare our results including: a baseline muscle biopsy, harvested hindlimb preserved on ice(4°C) in static cold storage (SCS), and 6 hour perfusion (SNMP) were used to compare results of our four aims. The four aims are shown in Table 1. HES was composed of muscle media and the addition of mannitol until 3 concentrations were made: 300, 500, and 800 mOsm concentrations. In aim 4, the perfusate composition was changed to test a hyper-oncotic purfusate. After 6 hours a muscle biopsy was taken to analyze energy cofactors via liquid chromatography-mass spectrometry, referred to as energy charge. Weight gain (edema), lactate levels, oxygen consumption and energy charge (EC) were used as markers for muscle tissue viability. RESULTS/ANTICIPATED RESULTS: In Aim 1, the higher osmolarity of HES indirectly reduced weight gain but consequentially reduced the EC below 5% when compared to SCS control group. We next incorporate HES into the perfusion model, Aim 2, and noticed a diminution in weight gain. The 500 mOsm group had substantial improvement in EC, lactate production and improved oxygen exchange when compared to a controls: fresh muscle biopsy and SNMP. In Aim 3, after a 6 hour perfusion with the addition of electric stimulation, graft edema improved by 10%, EC improved by 23% and O2 dissociation was highest of all 4 aims. Consequentially, due to muscular contraction the lactate levels were highest. In Aim 4, using a hyper-oncotic perfusate, edema reduced the most during the 6 hour perfusion but revealed lower EC and similar lactate/O2 results. However when left on for 24 hours, edema was significantly higher with lactate build up, EC improved with time as well as O2 dissociation. DISCUSSION/SIGNIFICANCE OF IMPACT: Here we have shown our preliminary results comparing our known ex-vivo perfusion model to multiple hypothesis to improve VCA graft viability. These preservation techniques demonstrate promising results but further studies are ongoing to confirm this encouraging outcome.

OBJECTIVES/SPECIFIC AIMS: To examine and compare the claims in Bzdok, Altman, and Brzywinski under a broader set of conditions by using unbiased methods of comparison. To explore how to accurately use various machine learning and traditional statistical methods in large-scale translational research by estimating their accuracy statistics. Then we will identify the methods with the best performance characteristics. METHODS/STUDY POPULATION: We conducted a simulation study with a microarray of gene expression data. We maintained the original structure proposed by Bzdok, Altman, and Brzywinski. The structure for gene expression data includes a total of 40 genes from 20 people, in which 10 people are phenotype positive and 10 are phenotype negative. In order to find a statistical difference 25% of the genes were set to be dysregulated across phenotype. This dysregulation forced the positive and negative phenotypes to have different mean population expressions. Additional variance was included to simulate genetic variation across the population. We also allowed for within person correlation across genes, which was not done in the original simulations. The following methods were used to determine the number of dysregulated genes in simulated data set: unadjusted p-values, Benjamini-Hochberg adjusted p-values, Bonferroni adjusted p-values, random forest importance levels, neural net prediction weights, and second-generation p-values. RESULTS/ANTICIPATED RESULTS: Results vary depending on whether a pre-specified significance level is used or the top 10 ranked values are taken. When all methods are given the same prior information of 10 dysregulated genes, the Benjamini-Hochberg adjusted p-values and the second-generation p-values generally outperform all other methods. We were not able to reproduce or validate the finding that random forest importance levels via a machine learning algorithm outperform classical methods. Almost uniformly, the machine learning methods did not yield improved accuracy statistics and they depend heavily on the a priori chosen number of dysregulated genes. DISCUSSION/SIGNIFICANCE OF IMPACT: In this context, machine learning methods do not outperform standard methods. Because of this and their additional complexity, machine learning approaches would not be preferable. Of all the approaches the second-generation p-value appears to offer significant benefit for the cost of a priori defining a region of trivially null effect sizes. The choice of an analysis method for large-scale translational data is critical to the success of any statistical investigation, and our simulations clearly highlight the various tradeoffs among the available methods.

OBJECTIVES/GOALS: To describe how the Community Engagement (CE) Program at the Michigan Institute for Clinical & Health Research (MICHR), a Clinical & Translational Science Award (CTSA) site at the University of Michigan, is adopting human-centered design (HCD) to advance the science of community engagement in translational research and CE’s programmatic efforts. METHODS/STUDY POPULATION: The MICHR CE Program supports academic-community partnerships to transform translational research across the state of Michigan. As the team aims to better engage partners to help guide the direction of their work, CE is collaborating with MICHR’s Design and Innovation Core to incorporate human-centered design (HCD). HCD is an approach that prioritizes the needs, values, and perspectives of direct users during the creation of a new product or service. The MICHR team created interactive HCD activities for two statewide retreats to elicit feedback from community and academic members on ways to enhance community-engaged research (CEnR). Retreat participants worked on a variety of problems, such as barriers to partnering and defining impact for CEnR. These activities generated authentic, contextual, and multi-view data captured in various artifacts for systematic analysis. RESULTS/ANTICIPATED RESULTS: In the first retreat, a HCD activity had participants reflect on their own barriers to partnering in research and potential solutions. In the second retreat, an HCD activity facilitated participants interviewing each other on their views of the impact in CEnR. Results from the first activity identified a set of common barriers to CEnR, some related to partnership formation, communication, and partner equity, among others. These led the CE Program to specific programmatic efforts, such as designing a statewide partnership platform, hiring a communication program manager, and sponsoring community partners to join national conferences. The second retreat activity produced rich data to identify overlaps between different perspectives to inform how impact can be defined and measured in CEnR. DISCUSSION/SIGNIFICANCE OF IMPACT: HCD activities provide means to include community and academic members in the science of CEnR. They allow systematic ways to gather information directly from the diverse set of current or prospective partners of community engagement programs about their needs, experiences, and values, which can be translated to programmatic innovation.

ABSTRACT IMPACT: Throughout the COVID-19 pandemic, the UTMB Institute for Translational Sciences has sought to answer our communities’ needs for research, for knowledge of research, and involvement in research, while recognizing that meaningful engagement involves understanding all emergent needs and responding to maximize the health and well-being of those we serve. OBJECTIVES/GOALS: ITS community programs responsive to COVID-19 include:

ο Ongoing communication with community and business stakeholders

ο Social media and public health campaigns promoting safe practices, research updates, and testing information

ο Community initiatives to increase testing among vulnerable populations METHODS/STUDY POPULATION: Like sister hubs across the US, the UTMB ITS has brought available resources to bear on addressing COVID-19 through research, medical response, and public health outreach. Community engagement activities have included facilitating communication, particularly by rapidly translating information for multiple audiences and wherever possible and appropriate, providing opportunities for the patient’s voice to inform and guide development of research. We realized the community’s need for trustworthy and reliable information about COVID-19 early in the pandemic. Key partnerships with community members and organizations were critical in enabling us all to be most responsive in meeting these needs. RESULTS/ANTICIPATED RESULTS: ITS community outreach included developing infographics, media notices, and educational materials related to prevention and testing as well as appropriate use of PPE. These efforts resulted in an article in a regional newspaper, which was disseminated widely through social media networks. ITS faculty also engaged doctoral and MPH trainees to support the Health District’s contact tracing effort. We held several events on mental health impacts as well as discussions related to health disparities. Both activities shaped plans for community-based interventions and research. The ITS also hosted a virtual workshop to facilitate discussion around key research questions related to the pandemic. DISCUSSION/SIGNIFICANCE OF FINDINGS: Throughout the pandemic, the ITS has maintained contact with stakeholders. Our roles have been to communicate, disseminate, translate, provide resources, and build bridges. We also listen, share, and provide opportunities for patients and communities to engage in all phases of the research spectrum.

OBJECTIVES/GOALS: We are launching a multi-center prospective registry for patients with metastatic invasive lobular carcinoma (ILC), the second most common type of breast cancer, to better understand patterns of progression, imaging features of metastatic sites, and if serial cell free DNA measurements can serve as a surrogate marker of disease progression. METHODS/STUDY POPULATION: Patients with biopsy proven metastatic ILC of any receptor subtype will be included in the registry. We will exclude patients with ductal histology only or those with multiple primary malignancies. Patients will be enrolled at four large academic medical centers across the country. Cell free DNA measurements using a tumor informed assay will be obtained every 3 months concurrent with regular clinical imaging. Disease status will be determined by the patient’s medical oncologist by taking into account imaging, tumor markers, symptoms, and cell free DNA measurement. At each time point, patients will be surveyed on their quality of life and their medical oncologists will be asked to rate the clinical utility of the cell free DNA value. Patients will be followed indefinitely. RESULTS/ANTICIPATED RESULTS: We will explore whether the use of serial cell free DNA or a combination of blood-based biomarkers and clinical endpoints can reliably identify treatment response and disease progression in patients with metastatic ILC. Many patients with metastatic ILC have unmeasurable disease on imaging and are thereby excluded from clinical trials. The end goal of this registry is to determine if blood-based biomarkers can be used as a proxy for measurable disease in ILC patients and therefore increase clinical trial enrollment for this subgroup of patients. DISCUSSION/SIGNIFICANCE: The creation of this prospective registry will open the door for future studies of blood-based markers that reflect disease stability and progression, which is an unmet need specifically in ILC. Identification of such markers could lead to a novel treatment response endpoint, changing the way patients are enrolled in trials and managed clinically.