OBJECTIVES/GOALS: Innovative educational approaches and training modalities are important for training a diverse workforce in the authentic skills needed to advance all phases of clinical and translational research. Endeavors to study and develop policies that promote the translational science spectrum are steeped in value judgments. Learning how to navigate moral ambiguity and ethical reasoning enlightens our understanding of stakeholder obligations, roles and responsibilities. Ethics education can be challenging if learners are insufficiently engaged in the necessary critical reflection. In this course, decision-making in public health is informed through the analysis of the ethical issues, developing alternative courses of action and providing justification for actions taken in response to real-world dilemmas. The course is provided to students with a variety of backgrounds (science, health, policy) in a Master of Public Health degree program. Course objective were to: 1) Identify ethical issues in public health policy, practice, and research using appropriate concepts and terms; 2) Recognize the full spectrum of determinants of health and related information needed to resolve ethical conflicts in public health policy, practice, and research; 3) Present varied and complex information in written and oral formats; 4) Assess potential solutions to ethical conflicts in public health policy, practice, and research and 5) Decide ethical courses of action for public health policy, practice, and research. We adopted an open pedagogy as a guiding praxis to inform public health ethics discourse amongst our learners. In this way, learner agency was maximized to develop course materials within a generalized framework and shared with each other through the perspectives of each individual. The goal was to not only analyze complex ethical dimensions of public health issues but also gain insights into the disciplinary lenses of one’s peers. METHODS/STUDY POPULATION: Each week was divided into two sessions, a seminar and workshop. Course instructors introduce topics in a one-hour session and then allow students to decide what information is needed for a second session where the ethical issues of the topic will be discussed. Information-gathering tasks are then distributed amongst students in areas that are not their specialty, e.g. social history to be researched by learner with a biology background. The second session then involves the reporting back of background information by each student and a discussion of the ethical issues that arise. Through this process, the ability to communicate with others in different disciplines is supported, while exploring other disciplines and then engaging in ethical discussion and reasoning. Topics were introduced during the seminar session each week over the span of five weeks: 1) global public health, 2) disease prevention & control, 3) environmental & occupational public health, 4) resource allocation & priority setting and 5) research ethics. Learners were tasked with identifying the needed information to address the ethical, policy, and research aspects of the public health question(s) presented in these seminars. Students independently submitted resources they discovered to course instructors prior to the workshop. The following session began with a workshop where learners briefly presented their findings and deliberated on specific facets of the public health issue from that previous seminar while discussing a specific case. Students were assessed on their preparation (submission of identified resources), workshop presentation and participation. Research Preparation: In each seminar, the class decided what key information would be required to support the discussion at the workshop, which revolved around a relevant case study on that week’s topic. Course instructors facilitated the groups identification of material to be researched and the delegation of tasks within the group. Each student submitted a summary document (template provided) to course instructors prior to class for their area of research related to the case. Research Presentation: At the beginning of each workshop, each student was asked to present the research work to the rest of the class so that everyone has the same information for the case study discussion. These short (5-10 minutes) presentations followed the format of the preparation summary. Participation/collaboration: Both the seminar and the workshop asked students to be active learners within the class, participating in discussion, strategizing for information-gathering tasks, presenting researched material and arguments to others, and participating in case study discussion. Participation was assessed in relation to the value of the contributions made by students. RESULTS/ANTICIPATED RESULTS: The open pedagogy allowed the learners to construct the necessary materials to discuss issues with each other and develop not only a deeper understanding of the ethical dimension of public health issues but a shared understanding of each other’s disciplinary lenses. Course feedback was generally very positive, with learners either agreeing (33%) or strongly agreeing (67%) that the course was effective overall. In asking what learners liked best about the course, some indicated the “open pedagogy learning style” and “I liked the discussion format.” The positive comments mostly highlighted the discussion format. Areas for improvement noted by the learners included wanting “a longer course to cover more topics” and that the material was covered in “too short a time frame.” Other comments included that the course “was a bit disorganized” or that “the discussions were not very structured.” While the discussions by their very nature were unstructured, there is opportunity to refine this pedagogy to find right balance of learner agency. DISCUSSION/SIGNIFICANCE OF IMPACT: The goal of this teaching method was to empower the learner with the important critical thinking skills to navigate challenging ethical dilemmas in public health they may encounter in their careers. These skills include the identification of the ethical or moral conflict(s), collecting the necessary information to examine/resolve the dilemma, think creatively about the information that is unavailable and how to discuss/disseminate information to a broad constituency. This an educational model that is easily adaptable for learners working in other areas of the translational research spectrum, e.g. basic, pre-clinical, clinical and implementation sciences.

OBJECTIVES/GOALS: Characterize formal informatics methods and approaches for enabling reproducible translational research. Education of reproducible methods to translational researchers and informaticians. METHODS/STUDY POPULATION: We performed a scoping review [1] of selected informatics literature (e.g. [2,3]) from PubMed and Scopus. In addition we reviewed literature and documentation of translational research informatics projects [4–21] at the University of Utah. RESULTS/ANTICIPATED RESULTS: The example informatics projects we identified in our literature covered a broad spectrum of translational research. These include research recruitment, research data requisition, study design and statistical analysis, biomedical vocabularies and metadata for data integration, data provenance and quality, and uncertainty. Elements impacting reproducibility of research include (1) Research Data: its semantics, quality, metadata and provenance; and (2) Research Processes: study conduct including activities and interventions undertaken, collections of biospecimens and data, and data integration. The informatics methods and approaches we identified as enablers of reproducibility include the use of templates, management of workflows and processes, scalable methods for managing data, metadata and semantics, appropriate software architectures and containerization, convergence methods and uncertainty quantification. In addition these methods need to be open and shareable and should be quantifiable to measure their ability to achieve reproducibility. DISCUSSION/SIGNIFICANCE OF IMPACT: The ability to collect large volumes of data collection has ballooned in nearly every area of science, while the ability to capturing research processes hasn’t kept with this pace. Potential for problematic research practices and irreproducible results are concerns.

Reproducibility is a core essentially of translational research. Translational research informatics provides methods and means for enabling reproducibility and FAIRness [22] in translational research. In addition there is a need for translational informatics itself to be reproducible to make research reproducible so that methods developed for one study or biomedical domain can be applied elsewhere. Such informatics research and development requires a mindset for meta-research [23].

The informatics methods we identified covers the spectrum of reproducibility (computational, empirical and statistical) and across different levels of reproducibility (reviewable, replicable, confirmable, auditable, and open or complete) [24–29]. While there are existing and ongoing efforts in developing informatics methods for translational research reproducibility in Utah and elsewhere, there is a need to further develop formal informatics methods and approaches: the Informatics of Research Reproducibility.

In this presentation, we summarize the studies and literature we identified and discuss our key findings and gaps in informatics methods for research reproducibility. We conclude by discussing how we are covering these topics in a translational research informatics course.

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OBJECTIVES/GOALS: To ameliorate the leaky pipeline of physician-scientists, we must address the factors that cause medical trainees to disengage from research. Here we describe the development of standardized Physician-Scientist Training Program guidelines that may be implemented across disciplines to address these challenges. METHODS/STUDY POPULATION: Maintenance of a robust pool of physician-scientists is critical to meet the rapidly growing need for novel therapeutics. A variety of factors contribute to the decline of this pool. Key among these are a lengthy training period that segregates research from clinical training, thus impeding research progress and milestones that allow for a successful research career. Through engagement of residency program directors and Vice Chairs of Research, we have created a series of guidelines that promote residency research tracks and enable better integration of research and clinical training time. Guidelines have been piloted in the Departments of Pediatrics, Medicine and Surgery in the context of 2 new R38-supported programs. RESULTS/ANTICIPATED RESULTS: Our physician-Scientist Training Program (PSTP) guidelines were developed by our central Office of Physician-Scientist Development (OPSD) after a successful pilot of an integrated research residency program in the Department of Pediatrics [Duke Pediatric Research Scholars (DPRS); Hurst, et al, 2019], which has included 36 resident and fellow scholars over 3 years. To date, eight clinical departments have adopted our PSTP guidelines as part of their R38-supported or pending programs. The OPSD has recently created a tracking database for scholar metrics, which will further promote PSTP development by enabling centralized reporting on scholar success to individual programs. DISCUSSION/SIGNIFICANCE OF IMPACT: PSTP guidelines enable effective implementation of new programs by sharing best practices and lessons learned, standardizing expectations, and defining metrics of success. By promoting proven strategies for integrated clinical and research training, PSTP guidelines may aid in retaining trainees pursuing research careers.

OBJECTIVES/GOALS: Penn instituted a Professional Development Core (PDC) to complement existing CTS education programs. Sessions were designed to advance participant knowledge and skills in key competency areas including communication, expectation setting, implicit bias and organizational structure, self-efficacy and resilience in order to enhance abilities to successfully execute career and research goals. METHODS/STUDY POPULATION: The PDC enrolled 4 cohorts totaling 87 trainees and scholars from 2016-2019. This included 35% predoctoral trainees (27 MD, 3 PhD), 39% postdoctoral trainees (29 MD, 3 PhD, 2 VMD/DVM), and 26% junior faculty (16 MD, 6 MD/PhD, 1 PhD). The two-year curriculum consists of 14 lunchtime sessions held bimonthly during academic terms. Session structures include a variety of interactive presentations, activities and facilitated discussions as well as reading material, assessment tools, and case studies. Facilitators include topic experts in academia, entrepreneurship, communications, and professional and personal development. The program is evaluated qualitatively through student satisfaction surveys after each session. RESULTS/ANTICIPATED RESULTS: Of the 2018-2019 participants, 90.8% rated the overall quality of PDC sessions as Very Good (56.05%) or Outstanding (34.75%). DISCUSSION/SIGNIFICANCE OF IMPACT: Feedback indicates that the group benefited from combining predoctoral and postdoctoral trainees, although not all content was immediately relevant to early stage trainees. Trainees appreciated the opportunity to engage with experts in disciplines typically considered outside of traditional science but critical to CTS career success. The flexibility of the curriculum allowed for inclusion of timely topics, newer suites of sessions focus on the multiple dimensions of valuing your science.

OBJECTIVES/GOALS: The purpose of the mentored writing workgroup developed at The CCTS at the Rockefeller University (CCTS RU) was to promote scholarship among clinical research nurses (CRN). The goal was to publish and/or present their projects at national professional association meetings. METHODS/STUDY POPULATION: A two-part writing workshop was presented at RU in December 2018 and January 2019. Members of the RU nursing staff and CRNs from local institutions were invited to attend. Twenty-four CRNs participated in the workshops. The first workshop focused on the writing process, styles of writing and how to get started. The second concentrated on components of a manuscript, categories of papers, selection of the journal, and communications with the editorial team. After the workshops, the CRNs from RU was offered the opportunity to participate in the mentored writing workgroup. To participate, the CRN had to agree to attend scheduled writing meetings and submit written work for each session. The scheduled submission of written materials ensured the CRN was committed to completing their manuscripts or presentations. RESULTS/ANTICIPATED RESULTS: Three CRNs from RU participated in the writing workgroup. Two papers were accepted for publication, and one manuscript is under-review, two abstracts accepted by an international professional organization, and two presentations conducted at an area nursing school and medical center. DISCUSSION/SIGNIFICANCE OF IMPACT: A mentored writing workgroup wherein participants commit to attend writing meetings and to submit written materials in a scheduled-matter can promote scholarship. CONFLICT OF INTEREST DESCRIPTION: NA.

OBJECTIVES/GOALS: Regardless of their career choices, today’s biomedical researchers need to blend great science with core skills ininnovation and entrepreneurship (I&E). The objective of this NIH-funded education program was to develop and test a pragmatic training program to teach relevant I&E skills. METHODS/STUDY POPULATION: We used a modified Delphi approach to identify 15 relevant competencies for I&E and the essential topics to include in the program. Learner interviews identified preferences for online training programs (short, high-quality audio-visual content, ability to self-navigate, peer and instructor interactions). The inaugural program included 7 short, online courses that addressed how to identify and validate opportunities for innovation, sell your innovation to diverse audiences, assess its ethical consequences, work in teams, and develop resilience as an innovator. It also included mentor support, a team-based capstone project, and an optional in-person boot camp. RESULTS/ANTICIPATED RESULTS: 51 students enrolled and 41 participants from 9 institutions completed the program, including pre- and post-doctoral students and junior faculty. They organized into 10 teams to complete the capstone project, with 6 teams pitching their innovation to fellow students and mentors at the boot camp. Students rated satisfaction with courses highly overall, with 79% stating they would be disappointed if the program was no longer available. Preliminary results suggest participants increased their knowledge about and ability to perform tasks taught throughout the program. Suggestions for improvement included providing more practical advice and real-world examples to complement educational videos. DISCUSSION/SIGNIFICANCE OF IMPACT: The inaugural E4B program was well received and effective in increasing I&E skills. Improvements will include increased opportunity for mentor interactions and for advanced entrepreneurial training. The program is open for biomedical research trainees from all institutions with a CTSA award.

OBJECTIVES/GOALS: To assess the impact of FLTCs on CTR on S and F from health professions and basic science academic programs island wide in Puerto Rico. Cycles supported by the Title V Cooperative Project at University of Puerto Rico-Medical Sciences Campus (UPRMSC) and Universidad Central del Caribe (UCC)(Title V). METHODS/STUDY POPULATION: After offering FLTCs in CTR to S and F from UPRMSC and UCC, Title V expanded it to S and F from other institutions island wide in PR. These FLTCs were offered the 2nd semester of 2018 and consisted of 20 hours of interdisciplinary sessions in: introduction to and definition of CTR; preparation of a CTR-presentation; how to interview/share a presentation of a CT researcher and to prepare a research question in CTR. To assess the knowledge of S and F in the above-mentioned skills and their continuation in the 2nd level of CTR training, surveys were administered: pre-test, at the beginning, post-test, sometime during the FLTCs, and satisfaction at the end of the FLTCs. RESULTS/ANTICIPATED RESULTS: Fifty eight (58) S/F from UPRMSC, UCC and 7 other institutions participated. Forty two (42,72%) answered a pre-test and 31/42 (74%) completed the post-test. Results showed that S/F: who correctly defined CTR increased from 7% to 77 %; their ability to identify a CT researcher increased from 10% to 83%. Fifty five percent (55 %) (21/38) S/F that were certified in the FLTCs, answered the satisfaction survey. One hundred percent (100%) indicated that the materials offered contributed in the identification of a CT researcher and a topic in CTR; 100% answered that the FLTCs contributed higher knowledge in and provided new skills in CTR. Moreover, 31/38 (82%) S/F started the 2nd level of training. DISCUSSION/SIGNIFICANCE OF IMPACT: The FLTCs were successful in increasing S/F knowledge of CTR and to further engage in 2nd level of trainings. Title V impact extended island wide, increasing the diversity of represented health professions and science fields among participants. The interventions were deemed to be of high quality.

OBJECTIVES/GOALS: We have developed a comprehensive Translational Research Navigation Program to guide investigators all the way from protocol development through study closure. As the program evolved, we initially developed organizational tools and then restructured them into a series of checklists to ensure that critical elements were not excluded or duplicated. METHODS/STUDY POPULATION: A series of checklists to assure that all research elements, including regulatory, scientific, and institutional, are addressed from protocol inception through study closure were developed by clinical research coordinators/navigators. The checklists are periodically updated and modified to reflect changing local and national regulations and policies. The first tool became the “Protocol Development Checklist” and then additional tools were developed and modified into a suite of navigation checklists that include “Protocol Implementation Checklist,” “Protocol Conduct Checklist,” and “Protocol Completion Checklist.” RESULTS/ANTICIPATED RESULTS: The checklists have been incorporated into the Translational Research Navigation Program and have enhanced the organization and quality of protocols throughout their lifespan. For example, implementation of the Protocol Development Checklist resulted in a reduction in time to IRB approval (currently 10 days), and implementation of the Protocol Implementation Checklist has impacted the time from IRB approval to study start-up. The Protocol Conduct Checklist has aided investigators in being better prepared and more organized for study conduct activities and the Protocol Closure Checklist has assured timely protocol closure and regulatory compliance, including reporting to ClinicalTrials.gov. DISCUSSION/SIGNIFICANCE OF IMPACT: Protocol checklists are powerful tools to enhance thoroughness, organization, and quality of the clinical research process. The Rockefeller University protocol checklists are available to the CTSA and Scientific Communities. CONFLICT OF INTEREST DESCRIPTION: NA.

OBJECTIVES/GOALS: Physician-scientists play a vital role in biomedical research but this chosen career path has many challenges, such as long training periods and funding. The University of Rochester (UR) CTSI pipeline programs address this by enabling medical trainees to partake in enriched research experiences. METHODS/STUDY POPULATION: The UR CTSI TL1 is a training grant from the National Center for Advancing Translational Science (NCATS), which funds predoctoral trainees. The TL1-funded physician-scientist pipeline includes the Academic Research Track (ART) year-out program and the Medical Science Training Program (MSTP). We describe the characteristics and training outcomes of TL1-funded trainees. We also obtained testimonials of current and former trainees regarding their career component decision-making, and their perception of programs, in order to identify how best to address the challenges of the physician-scientist workforce, and to facilitate the transition between the clinic and bench. RESULTS/ANTICIPATED RESULTS: From 2006-2019, the UR CTSI has had 56 ART trainees and 17 MSTP trainees complete training; six trainees have transitioned into the MSTP after completing the ART program. As of 2019, 63 of 67 graduated trainees (94%) have continued their engagement in CTS after graduation. Importantly, our programs have facilitated the careers of 31 women (39.7%) and 12 under-represented minorities (15.4%). We will present a breadth of qualitative data to inform which parts of the TL1-related programs have been successful, and which parts could use programmatic improvement to aid the transition into the physician-scientist workforce. DISCUSSION/SIGNIFICANCE OF IMPACT: Physician-scientist training barriers in the US have resulted in a shortage of these professionals in the clinical and translation workforce. Our data show the UR CTSI has been successful in addressing several of these challenges via the TL1-funded ART, MSTP, and ART/MSTP dual program pipeline.

OBJECTIVES/GOALS: The RPPR Tool was created to accurately and systematically track our CTSA’s overall program goals and core’s progress in real time. It establishes and centralizes the continuous collection of key performance indicators and fosters accountability and transparency among cores and leadership. METHODS/STUDY POPULATION: Using the University of Chicago’s Annual Progress Report REDCap data dictionary, UI Institute for Clinical and Translational Science (ICTS) core managers convened to explore the adaptability of the reporting format for the CTSA. The team developed the more user friendly and easily accessible RPPR Reporting Tool using REDCap to better fit our CTSA. The RPPR in REDCap provides a central location to monitor the activities for each core, gather status updates, generate performance reports, and identify key performance indicators and challenges to prevent failures in the future. All data are transparent and accessible on-demand to individual core managers, evaluators, and ICTS leadership. RESULTS/ANTICIPATED RESULTS: UI’s RPPR Tool has improved the compliance with ongoing monitoring and reporting of CTSA program’s performance. Documenting all relevant information in a centralized space has eased the administrative and evaluation burden of preparing the RPPR. Furthermore, REDCap as a commonly used tool allows the core managers to complete this reporting with minimal guidance. This tool encourages each core to be accountable for documenting their respective progress. The transparency of the reporting allows the Co-PIs along with the leadership team to access the data at any given time to stay updated on the ICTS’ overall progress and to make the appropriate improvements as needed. DISCUSSION/SIGNIFICANCE OF IMPACT: The RPPR is a required component of all CTSA grants. UI’s RPPR Tool has been instrumental in comprehensively tracking progress of the ICTS and its contributions to translational research. UI is collaborating with CTSA peers to improve the RPPR Tool, so it can become an asset for any CTSA to adapt.

OBJECTIVES/GOALS: The goal of this project was to assess the scientific impact of Miami CTSI’s Mentored Career Development (KL2) Program using bibliometric tools and network visualization in addition to the traditional metrics used to provide a comprehensive evaluation. METHODS/STUDY POPULATION: Scholarly productivity of KL2 scholars were tracked using REDCap. For bibliometric data analysis and visualization, publications were queried using iCite (NIH Office of Portfolio Analysis) and Web of Science database. A total of 173 publications produced by eight KL2 scholars from 2013-2018 were analyzed and categorized into pre-award, during award, and post-award periods. iCite was used to assess scientific influence and translation. Scientific networks and collaboration were visualized using VOSviewer (Centre for Science and Technology Studies, Leiden University). CTSA Common Metrics were tracked using the Results Based Accountability framework. RESULTS/ANTICIPATED RESULTS: Albeit of modest size, the Miami CTSI’s KL2 Program had significant scientific productivity and impact in its first five years. Our KL2 scholars’ publications were cited twice as frequently as other papers in their fields. Further, 48% of publications post KL2 award were above the NIH 50th percentile and had higher citation impact compared to the average NIH-funded paper; 11% were in the top 10% NIH citation ranking. In contrast, only 20% of the publications pre-KL2 award were above the NIH 50th percentile. The program also promoted research collaboration; network visualizations indicate larger co-authorship and organization networks of KL2 scholars post-award. DISCUSSION/SIGNIFICANCE OF IMPACT: Bibliometric and data visualization approaches helped us better identify trends and gauge effectiveness of the KL2 program. These findings provided useful insight into the scientific influence and impact of our scholars’ work.

OBJECTIVES/GOALS: Connections IN Health’s goal is to coordinate, integrate, and enrich health coalition work through extended connections among community and academic stakeholders within and across coalitions and geographies within Indiana. We aim to evaluate stakeholder connections to assess coalition effectiveness and the quality of partnership networks. METHODS/STUDY POPULATION: We will collect data longitudinally to evaluate Connections IN Health using a unique triangulation of effectiveness surveys, social network analysis, and health data. Cross-sectional functioning and social network analysis surveys were distributed to coalition members before the transition to Connections IN Health engagement (baseline) and will be distributed again each year thereafter to identify changes in coalition perceived effectiveness and changes in the structure/nature of partnership networks after implementation of the partnership. We plan to utilize publicly available health data to measure proximal changes in health outcomes at the neighborhood level and use Pearson’s correlations to check for associations between perceived coalition effectiveness and health outcomes. RESULTS/ANTICIPATED RESULTS: We found low baseline scores in perceived effectiveness, especially in the areas of leadership, operational understanding, and satisfaction, from the coalition members. From our social network analysis, we found relatively low cohesion scores (measured as network density) among each of the coalition networks, and even lower scores for collaboration among coalition members. We expect to see positive increases in perceived coalition effectiveness, as well as an increase in the density and level of collaboration among coalition networks as Connections IN Health develops. Finally, we expect to see positive changes in proximal health outcomes associated with our measures of coalition effectiveness. DISCUSSION/SIGNIFICANCE OF IMPACT: The results of our project will be distributed back to the coalition leaders and members in order to sustain and improve the coalitions. The visualization of the coalition member’s network can be used to demonstrate opportunities for enhanced partnerships and collaboration.

OBJECTIVES/GOALS: The objectives are to assess the impact of cumulative grief on the development of Compassion Fatigue (CF) and Burnout Syndrome (BS) in HCPs who care for dying children. We will also evaluate the relationship between CF and cortisol patterns in HCPs. METHODS/STUDY POPULATION: Cross-sectional study to be conducted in a Pediatric Hospital in Puerto Rico. A sample of 50 pediatric nurses will be selected to collect the data to evaluate the occurrence of CF and BS among HCP caring for children during end of life (EoL). Study subjects will include nurses who care for dying children in the Intensive Care Units and Oncology ward. Nurses working in the pediatric ward will be included as the control group. Three validated instruments (Spanish Version) will be administered (Professional Quality of Life vIV, Maslach Burnout Inventory- HSS, briefCOPE scale). Cortisol samples in saliva and hair will also be taken to determine levels in these HCPs. RESULTS/ANTICIPATED RESULTS: Our expected outcome is that CF and BS will be more frequent in HCPs caring for children during EoL compared with controls and that EoL nurses will have higher scores on CF scale and more frequent dysregulated cortisol patterns. DISCUSSION/SIGNIFICANCE OF IMPACT: Understanding how HCPs cope with grief caused by child death and the occurrence of CF and BO in our hispanic population allowing us to develop support strategies based on the specific HCPs needs. This knowledge will help improve HCPs’ well-being and may diminish the physiologic impact on cortisol.

OBJECTIVES/GOALS: The objective of this study is to perform a systematic review and meta-analysis on the prognostic utility of electroencephalography (EEG) in stroke recovery. METHODS/STUDY POPULATION: A literature search was conducted using three electronic databases, including PubMed, Scopus, and CINAHL. Key search terms were “EEG,” “stroke,” and “rehabilitation”. Only peer-reviewed journal articles published in English that examined the relationship between EEG and a standardized clinical outcome measure(s) at a later time in stroke patients were included. Two independent raters completed data extraction and assessed methodological quality of the studies with the Downs and Black form. A linear meta-regression was performed across subsets of individual studies that utilized a common clinical outcome measure to determine the association between EEG and clinical outcome while adjusting for sample size and study quality. RESULTS/ANTICIPATED RESULTS: 56 papers met the inclusion criteria and were included in the systematic review. The prognostic value of EEG was evidenced at both the acute and chronic stages of stroke. The addition of EEG enhanced prognostic accuracy more than initial clinical assessment scores and/or lesion volume alone. In the meta-analysis, a subset of 10 papers that utilized the National Institutes of Health Stroke Scale (NIHSS) and a subset of 7 papers that utilized the Modified Rankin Scale (MRS) were included. Analysis demonstrated an association between EEG and the subsequent clinical outcome measures. DISCUSSION/SIGNIFICANCE OF IMPACT: Currently, prognosis is largely based on initial behavioral impairment level. However, post-stroke recovery outcomes are heterogeneous despite similar initial clinical presentations. Uncertain prognosis makes it difficult for clinicians to develop personalized treatment plans for patients. Improved prognosis for recovery may guide clinical management for stroke survivors by helping clinicians determine the maximally efficient course of treatment and care. This study suggests that prognostic accuracy may be enhanced using EEG.

OBJECTIVES/GOALS: The goal of this project was to a) evaluate the first five years of Miami CTSI’s Pilot Translational and Clinical Studies Program using outcome measures that quantify research productivity augmented by the CTSA Common Metrics; and b) use the results to shape future program management. METHODS/STUDY POPULATION: Pilot Program applicant and awardee demographic data were collected during the first 5-year cycle of the Miami CTSI grant. Projects were categorized into the translation spectrum based on type of research using published guidelines. Research productivity from funded pilot projects were tracked annually using internal institutional grant award databases and external databases such as PubMed and NIH Reporter. CTSA Common Metrics were tracked using the Results Based Accountability framework. Relative Citation Ratio (RCR), NIH percentile and translation impact of pilot project publications were determined using the iCite tool (NIH Office of Portfolio Analysis). RESULTS/ANTICIPATED RESULTS: The Miami CTSI’s Pilot Award Program demonstrated notable success in its first five years. Of the twenty-two projects that were funded during that time period, 45% led to follow-on funding for a total of $17.2M—a strong return on investment of 15:1. Further, 77% of awardees had at least one publication. A total of four patents and 43 publications resulted directly from the funded projects. The mean RCR for all publications was 2.7, weighted RCR was 99.87, and nine papers were been cited by clinical documents. Overall, 63% of the projects were classified as T1/T2 (pre-clinical/clinical research) and 37% as T3/T4 (post-clinical translational research/public health). DISCUSSION/SIGNIFICANCE OF IMPACT: Miami CTSI’s Pilot Award Program demonstrated success in scholarly output, follow on funding, and scientific impact. These results will serve as benchmarks going forward and will allow the CTSI to leverage program strengths in collaborating with other institutional internal award mechanisms.

OBJECTIVES/GOALS: The goals of this evaluation were 1) to describe the pilot grant application cycle and processes at NC TraCS, 2) to illustrate the impact of pilot grants on extramural grant funding, and 3) to provide a framework for other institutions to utilize for the evaluation of pilot grant programs. METHODS/STUDY POPULATION: From 2009-2019 the NC TraCS pilot program funded 925 projects, varying from $2,000 to $100,000. Pilot grants are available to any researcher affiliated with the university as well as partner institutions and community stakeholders. For this evaluation we analyzed data on pilot applicants (demographics, type of pilot, funding status, resubmissions, etc.) and outcomes (extramural funding, publications, etc.) yielded from funded pilots. In addition to summary statistics, we also calculated return on investment (ROI) for the program as a whole and by specific grant type. We will use bibliometric network analysis to assess productivity, citation impact, and scope of collaboration. RESULTS/ANTICIPATED RESULTS: There have been 2,777 submitted proposals with an acceptance rate of 33.3%. Unfunded proposals can resubmit, 61.8% of resubmitted applications are successfully funded, and 29.6% of funded applications are resubmissions. The $2,000 awards accounted for 43.4% of all grants awarded but only accounted for 6.4% of all pilot funds awarded. Success of proposals was proportional to the number of applications from each academic unit. 60.8% of funded applicants were affiliated with the School of Medicine and account for 65.3% of all funding awarded from 2009-2019. Additionally, we plan on analyzing return on investment rates to illustrate the impact of pilot awards on future research funding. DISCUSSION/SIGNIFICANCE OF IMPACT: Pilot grants can lead to subsequent extramural grants, publications, and successful translation of research into practice. This evaluation will assist our institution in understanding the impact of pilot grants and will provide a road map for other institutions evaluating their own programs.

OBJECTIVES/GOALS: Autism spectrum disorder (ASD) is characterized by difficulties in communication and social interaction as well as restricted and repetitive behaviors. Sleep problems are a common concern in children with ASD that can persist into adulthood. This study aims to further explore sleep in ASD without intellectual disability (ASD w/o ID). METHODS/STUDY POPULATION: We recruited individuals of both sexes with ASD w/o ID (probands) and relatives as part of the Autism Spectrum Program of Excellence (ASPE) at the University of Pennsylvania. Actimetry data were collected via a wrist-worn tri-axial accelerometer for 21 days. Data from 212 participants were considered. We analyzed sleep data using the algorithms GGIR, ChronoSapiens, and PennZzz. The sleep traits of proband and sibling pairs were compared using paired t-test or Wilcoxon signed-rank test. We used the Social Responsiveness Scale, Second Edition (SRS-2) to assess social impairment and restricted/repetitive traits. We compared SRS-2 scores to sleep traits using partial Spearman or Pearson correlations adjusting for age (171 participants). RESULTS/ANTICIPATED RESULTS: Probands demonstrated later sleep onset (p = 0.03), decreased M10 average (10-hour period of highest activity/day; p = 0.006), decreased relative amplitude (measure of rest-activity rhythm; p <0.001), and decreased total daytime activity (p = 0.005) compared to siblings. Regarding social function and restricted/repetitive traits, adult males showed an inverse correlation between SRS-2 total score and sleep efficiency (r = −0.2, p = 0.04) and a positive correlation between SRS-2 total score and intradaily variability (r = 0.3, p = 0.02). Adult females showed an inverse correlation between SRS-2 total score and M10 average (r = −0.3, p = 0.02) and between SRS-2 total score and relative amplitude (self-report r = −0.4, p = 0.001; informant r = −0.3, p = 0.005). DISCUSSION/SIGNIFICANCE OF IMPACT: This study focuses on the analysis of sleep traits in ASD including the relationship between social function and sleep. Thus far, the most robust findings are decreased daytime activity and relative amplitude in individuals with ASD w/o ID compared to siblings. We have also shown that ASD social impairment may be related to sleep dysfunction.

OBJECTIVES/GOALS: Our objective was to establish a new protocol to evaluate new biomarkers to detect Neurodevelopmental Disabilities (NDD) in high-risk infants. As early intervention results in better outcomes, our goal was to implement the protocol to promote earlier NDD diagnosis and referral for treatment. METHODS/STUDY POPULATION: We implemented a new protocol using the General Movement Assessment (GMA), Hammersmith Infant Neurological Examination (HINE), and Capute Scales to evaluate infants who were at high risk of NDD. To determine the success of our protocol with these biomarkers, we studied former premature infants who were evaluated in follow-up clinic from 10/1/2018-10/1/2019. We defined our primary and secondary outcomes as the ages of neurodevelopmental diagnoses and referral to early intervention services before and after implementation of the new protocol, respectively. Our hypotheses were that infants who were evaluated with these biomarkers would be diagnosed with NDD and be referred for treatment at younger ages than their counterparts. RESULTS/ANTICIPATED RESULTS: Approximately 120 patients were evaluated during the time period that was defined. About half were evaluated prior to implementing the GMA and HINE, and the remainder were evaluated using GMA and other developmental measures. We anticipate that infants who underwent GMA will be diagnosed with NDD and referred for therapies at a younger age than their counterparts. DISCUSSION/SIGNIFICANCE OF IMPACT: Through our translational research, we will transform the standard of care for high-risk infants by incorporating clinical biomarkers into day-to-day clinical care for these infants. Implementation of this novel protocol will promote the early diagnosis and referral to treatment for NDD.

OBJECTIVES/GOALS: The objectives of this presentation are to discuss 1) the implementation of Consent to Contact at an Academic Medical Center; 2) the access to lists of potential participants by study teams; and 3) the challenges and adjustments made to the initial conceptualized process. METHODS/STUDY POPULATION: Participant recruitment is critical to the success of all research studies. It is particularly challenging when investigators do not have a patient population from which to recruit. Thus, the University of Miami launched the CTC initiative in 2016 to facilitate study recruitment. Study investigators can request access to a registry of participants who agreed to be contacted and meet the initial study eligibility criteria. A multidisciplinary Operational Committee provides oversight and regulates access to the CTC registry. RESULTS/ANTICIPATED RESULTS: The registry has over 110K patients who have agreed to be contacted for eligible research studies. The demographic distribution of the patients in the registry mirrors the diversity of the UHealth population. As of January 2018, when the registry became available to the research community, 25 study teams from different departments, including the All of Us Research Program, have requested potential participant lists. The process of requesting access to patient lists is adapted to studies’ needs, with particular reference to sensitive populations, such as HIV/AIDS, substance abuse, etc. Results on utilization and satisfaction of the CTC initiative are being collected and will be presented. DISCUSSION/SIGNIFICANCE OF IMPACT: The CTC initiative allows UHealth patients to opt-in to the registry for research studies. The Operational Committee continues to monitor the successful consent of patients to participate in individual research studies and improving the request process.

OBJECTIVES/GOALS: This study aims to assess the outcomes of a new virtual multidisciplinary immune-related toxicity (IR-tox) team implemented at Johns Hopkins Hospital. In particular, to understand if the IR-tox team’s input reduced the number of inpatient hospitalizations for irAEs for referred patients. METHODS/STUDY POPULATION: Since August 2017, nearly 250 patient referrals to the IR-tox team have been created and stored in an electronic database. Through retrospective chart review, hospitalization and irAE management data will be collected for these patients to assess whether rates for suspected irAEs have decreased. These rates will be compared against historical controls. We will assess the features of hospitalized patients, their immunotherapy regimens, and management to identify high-risk groups who may require early intervention. Additionally, we aim to understand what patient features are associated with IR-Tox team referral and subsequent hospitalization. RESULTS/ANTICIPATED RESULTS: The IR-tox team provided a new multidisciplinary channel to help physicians diagnose and manage complex irAEs. The goal of the team was the reduce the number of irAE-related hospitalizations as, historically, 85% of high-grade irAEs have required hospitalization. A clinically meaningful reduction is defined as lowering the hospitalization rate to 75%. Planned analyses includes calculating the hospitalization rate, using descriptive statistics to summarize patient features, multivariate analyses to understand features associated with both IR-Tox team referral and hospitalization, and computing the relative risk reduction to assess the efficacy of subspecialist referral implementation. DISCUSSION/SIGNIFICANCE OF IMPACT: IrAEs are challenging to diagnose and treat. They contribute to a notable proportion of hospitalizations in those treated with immunotherapy. With expanding use of immunotherapy, widespread implementations of IR-Tox teams may help reduce hospitalizations and costs associated with care for irAEs.