OBJECTIVES/SPECIFIC AIMS: Our Goal is to enroll 500 students over 10 years into the CTSI 500 Stars Initiative. Student family members and community members are essential to career achievement and success; as such, the program also engages student families, along with key community members, as part of an Advisory Group, throughout the entire student experience. Besides programmatic and planning activities, students, family, and community members participate in our CTSI Community Engagement Science Café monthly series, where students may also present on a number of research and health-related topics of interest. The Advisory Group meets every 3–4 months in ensuring continuous engagement and overall program success. METHODS/STUDY POPULATION: Our Initiative takes both direct and supportive roles in offering 2 educational and training pathways; namely, our Summer Internship Program (6–8 wk duration) and our Students Modeling a Research Topic (SMART) Year-round Education Program (usually offered in Fall and Spring academic semesters) for high school students only. In the SMART Teams program, we work with regional public and private school districts to train science teachers, and assist them in developing and/or enhancing their science curriculum, thus creating pathways towards careers in translational science settings. Our aim is that students who participate in the year-round program (along with additional students) subsequently participate in our summer program. Therefore, overall program engagement is continuous throughout the year. In Summer, 2017 we engaged with well-established regional partners and collaborators (CTSI affiliated numerous public school districts, and community-based organizations) to move the translational workforce along existing regional diversity education and training pipelines. A Kick-off event was held on June 15, 2107 and attended by students and family members. We offered 6–8 weeks of hands-on experiences working with faculty researcher mentors and their research teams conducting real-life studies, in addition to professional experiences in research “support” settings, as well as in the community. We also developed established a “Summer” SMART (Students Modeling a Research Topic) Teams Program and a Summer “Advanced” SMART Teams Program, where a number of students were placed at 2 CTSI partner and collaborator institutions. The primary goal of the SMART Teams experience is to introduce students to translational science by building upon laboratory research to better understand clinical and community impact of disease within a patient population. Overall, internship sites included research labs, protein modeling labs, numerous research support settings, clinical care settings, and community sites for those students who were interested in population health sciences. In addition, students were offered career enrichment and professional development lunch and learn sessions, career panel sessions presented by long term, expert professionals in various fields translational science, and confidence building and networking sessions. Students also participated in a community volunteer day activity, a trip to the Chicago Science Museum, and numerous CTSI engagement activities (Science Cafés, simulation lab tours, etc.). RESULTS/ANTICIPATED RESULTS: The 2018 year-round program will initiate in the Fall. Our 2017 Summer Internship Program received 192 students/trainees applications of whom 133 were underrepresented minorities (URMs). We enrolled 109 participants, including 83 URMs (84 high school students and 25 college students). A total of 53 Wisconsin high schools and 19 colleges and universities (local and out of state) participated. Students engaged in all activities as outlined in the Methods section. At the end of the summer program, students created and presented posters as part of the closing ceremony. Certificates of completion were given to the students by program leadership and the Al Hurvis/ADAMM leadership (program funding agency). Students wore white lab coats to create an atmosphere of cohesion and accomplishment. Parents and other family members attended the closing ceremony, demonstrating strong support for students and the program. Our anticipated results for CTSI 500 Stars Initiative is to increase diversity in the Translational Science Workforce via education and training of 500 high school and college students over 10 years. We will also remain engaged and track student’s various venues for at least 10 years to determine the outcome of their experiences towards careers in Translational Science settings. We will continue to engage community members and community-based organizations as collaborators and advisors to participate in every stage of our activities. Moreover, we plan to broaden our reach by establishing additional relationships with additional high schools and middle schools to further enhance the 500 Stars Initiative. In addition, we will develop metrics by which to measure the validity and success of our program. DISCUSSION/SIGNIFICANCE OF IMPACT: The aim of the CTSI 500 Stars Initiative is to provide real-life, practical experiences in translational science settings as a part of our efforts to train and cultivate the translational science workforce, while also engaging patients, families and community members in every phase of the translational process. Targeting under-represented minority students contributes towards increasing diversity in the workforce. It is also our hope that by increasing URMs in the workforce, there will be positive impact on communities of color, with respect to increasing participation in their health care decision making and in clinical/translational research; thus, ultimately leading to better health outcomes in the communities we live and serve. Our overall framework is to engage, educate, enrich, empower, elevate, enable students towards careers in clinical and translational settings.

OBJECTIVES/GOALS: Large-panel genomic tumor testing (GTT) is a new technology that promises to make cancer treatment more precise. However, patients may have unrealistic expectations of its benefits. The goal of this project is to assess expectations for GTT among cancer patients in community oncology practices. METHODS/STUDY POPULATION: A survey assessing expectations of the benefits of GTT was administered to cancer patients participating in a statewide study of GTT implementation, prior to receiving test results. Descriptive and regression analyses were conducted to assess expectations and the factors associated with these expectations. The study sample (N = 1,139) consisted of patients with a range of cancer types (22% gynecologic, 14% lung, 10% colon, 10% breast,and 46% other malignancies). Mean age was 64 years (standard deviation = 11); 668 (59%) were women; 71% had no college degree; 57% came from households with less than $50,000 US dollars household income; and 73% lived in a rural area. RESULTS/ANTICIPATED RESULTS: Generally, patients had high expectations that they would benefit from GTT (M = 2.81 on 0-4 scale) and positive attitudes toward it (M = 2.98 on 0-4 scale). Patients also had relatively poor knowledge about GTT (48% correct answers on an objective test of GTT knowledge). Greater expectations for GTT were associated with lower knowledge (b = –0.46; p < .001), more positive attitudes (b = 0.40; < .001), and lower education (b = –0.53; < .001). DISCUSSION/SIGNIFICANCE: This research suggests patients have high expectations that they will benefit from GTT, which is associated with low knowledge, positive attitudes, and low education. Interventions may be needed to boost understanding and moderate expectations, particularly for disadvantaged patients.

ABSTRACT IMPACT: We hosted the Indiana Clinical and Translational Sciences Annual meeting virtually this year which resulted in positive feedback survey scores over 90% and an estimated 87% cost savings OBJECTIVES/GOALS: COVID-19 has forced many in-person meetings to become virtual, not unlike our 2020 Indiana Clinical and Translational Sciences Institute Annual Meeting. However, where anecdotal feedback has shown dissatisfaction with some on-line meetings, we were able to exceed our goals of engaging our audience, securing positive feedback and even saving money. METHODS/STUDY POPULATION: More than 500 people attended the virtual 2020 Indiana Clinical and Translational Sciences Institute (CTSI) Annual Meeting on September 11. The event had two plenary speakers and was completely online, utilizing both Zoom and Microsoft Teams to connect participants with the presenters. Brian Druker, MD, director of the Knight Cancer Institute at Oregon Health & Science University, was the winner of this year’s August M. Watanabe Prize in Translational Research. He gave the first plenary presentation titled, ‘Imatinib as a Paradigm of Targeted Cancer Therapies.’ Consuelo Wilkins, MD, Vice President for Health Equity at Vanderbilt University Medical Center, gave the second plenary titled, ‘Confronting Racial Inequities through Research.' Concurrent online breakout rooms hosted the live poster session. RESULTS/ANTICIPATED RESULTS: Despite being conducted online, the virtual Indiana CTSI annual meeting registered more participants than in years past and secured high feedback scores of 90%, all while experiencing 87% cost savings over last year’s in-person meeting. By utilizing Microsoft Teams as a technology for attendees to the meeting to 'chat’ and 'network’ with one another during the poster presentations and virtual lunch break we were able to demonstrate the implementation of translational science through online plenary and general session presentations as well as the poster presentations. Mailing certificates to the poster winners in advance, allowed them to share their accolades with the audience by holding up their certificates once their winning posters were announced. An e-annual report also supported the success of the meeting. DISCUSSION/SIGNIFICANCE OF FINDINGS: The cost savings and traditionally high feedback scores received through this year’s Indiana CTSI annual meeting, mean virtual meetings are a viable way to disseminate and implement translational science. In addition the 2020 Indiana CTSI annual report received a Gold MarComm award, providing third party recognition of its impact.

Objectives/Goals: To strengthen postdocs’ skills in developing and reviewing competitive proposals, advancing translational research by leveraging core facilities at Indiana University, Purdue University, and the University of Notre Dame, fostering collaboration, and preparing participants of the program for future funding success. Methods/Study Population: The Postdoc Challenge is a state-wide program for postdoctoral scholars across Indiana to gain hands-on experience in developing and reviewing competitive grant proposals. Participants compete for a $5,000 award to use any of the Indiana Clinical and Translational Science Institute (CTSI)-approved core facilities. Through workshops and following NIH guidelines for the review process, participants refine their proposal-writing skills and serve as reviewers for peers’ proposals. The program is designed to support translational research, utilizing the core facilities at Indiana University, Purdue University, and the University of Notre Dame. Participants are trained in grant proposal writing, reviewing using NIH criteria, and engaging in peer discussions, developing critical skills necessary for future funding success. Results/Anticipated Results: Since its launch in 2014, the Indiana CTSI Postdoc Challenge has funded 54 postdoctoral researchers, with 276 applications reviewed. The program has strengthened participants’ grant proposal writing skills and peer review capabilities. Career outcomes include several postdocs securing assistant professor positions and other prestigious roles, such as an Associate Principal Investigator at the National Biodefense Analysis and Countermeasures Center, and a Toxicologist at the CDC. Participants also report enhanced collaboration, greater access to core facilities, and significant career advancement, including support for international postdocs seeking permanent residency. Discussion/Significance of Impact: The Postdoc Challenge has significantly improved postdoctoral researchers’ grant proposal writing and peer review skills, helping them secure faculty and research positions. By fostering collaboration across Indiana’s top universities and utilizing core facilities, the program accelerates translational research and career success.

OBJECTIVES/SPECIFIC AIMS: The objectives of this study were (1) to examine research participant levels of satisfaction, experiences, and perceptions; and (2) to determine best practices for researchers for engaging research volunteers in clinical trials, and thereby reducing barriers to participation. METHODS/STUDY POPULATION: A self-administered IRB approved survey on satisfaction and perceptions of research participants in clinical and translational studies was developed. The study questions were validated by 5 key informants from each of the 3 research centers who were asked to provide constructive feedback on the clarity and relevance of the questions. The final survey was a 25-item questionnaire that used a Likert scale and focused on 5 domains to reflect satisfaction with “Staff delivery of care,” “Environment,” “Center Operations,” “Study specific questions,” and “overall experiences.” Questions to reflect participant perceptions were open ended. A convenience sample of all participants currently enrolled in research studies at CTSA institutions (GU, HU, and MHRI) was obtained. In total, 131 participants completed the survey. Of these, 15 were “surrogate” partners. RESULTS/ANTICIPATED RESULTS: Eighty-two (60%) of the participants were African Americans, 40 (29%) were Whites; 94 (67%) were first time study participants. Over 90% of those surveyed strongly agreed that they were “treated well,” that their “privacy was respected,” and that they “felt comfortable asking questions of the staff.” Eighty-four percent indicated they would participate in future studies while over 91% indicated they would recommend a family member or a friend. Only 46% of participants coming for their first research visit strongly agreed that the “compensation received was satisfactory.” However, 74% of participants returning for follow-up or who had been enrolled in a previous study felt the compensation was appropriate. Seventy-four percent of those enrolled for the first time indicated “knowing the duration of this study” as compared with only 38% of repeat visitors. When asked what they liked most about participating in a research study their primary responses were “contribution to science” and “knowledge about their diseases.” Conversely, when asked what they liked least about the study they responded that the blood draws were uncomfortable and there were often barriers to transportation and parking. DISCUSSION/SIGNIFICANCE OF IMPACT: The results of this survey demonstrated that the majority of research participants rate their experience as highly favorable even among those who had never participated in clinical research previously. In some existing literature, it has been reported that financial compensation was a major motivation to participation in studies involving healthy volunteers. In this current study, however, financial compensation did not appear to be the primary motivation for participation. The participants’ at all 3 sites stated that the main reason for their participation was the increased knowledge about their disease and the contribution to science. Negative experiences cited were primarily discomfort with blood draw, transportation, and parking logistics. Most importantly, a majority of the participants stated they would participate in future studies and would recommend a family member or a friend for a clinical study. In our sample, there was no difference in the favorable ratings as determined by race/ethnicity. In conclusion, the findings of this study inform the community with regard to how the research participants rate their experiences, and thus motivate others to participate in clinical research. Reasons for participants to withdraw from trials may be associated to their dissatisfaction with a trial or with the study staff. Thus, the degree of satisfaction with the research staff and the trial itself is crucial to reducing drop-out rates and increasing compliance with study procedures. Hence participant satisfaction is key to increasing participation in clinical trials, particularly among African Americans and other racial and ethnic minorities.

OBJECTIVES/GOALS: Responsive infant feeding (RIF) promotes healthy dietary patterns and infant weight gain. Research is needed to assist caregivers recognize infant hunger/satiety cues and overcome barriers to using RIF. The Learning Early Infant Feeding Cues (LEIFc) intervention was designed to fill this gap by using a validated coaching approach to promote RIF. METHODS/STUDY POPULATION: Guided by the Obesity-Related Behavioral Intervention Trials (ORBIT) model, this proof-of-concept study tests the feasibility and fidelity of the LEIFc intervention in mother-infant dyads (N=25). Study visits from the 3rd trimester of pregnancy to 4 months postpartum (PP) are conducted in family homes. Use of RIF via subjective (survey) and objective (video) measures is collected at 1 and 4 months PP. Prenatally written and video material on infant feeding and infant hunger/satiety cues is provided. At 2 and 3 months PP, coaching during a feeding session is provided by a trained interventionist using the SS-OO-PP-RR (super, Setting the Stage, Observation & Opportunities, Problem Solving & Planning, Reflection & Review) approach. Qualitative data on LEIFc are provided by the interventionist and participants. RESULTS/ANTICIPATED RESULTS: To date 25 dyads have been enrolled and 4 have completed all study visits. Preliminary analyses showed that subjective measure of awareness of infant cues increased post intervention (pre, M=4.38 vs post, M=4.63). LEIFc has been well accepted by participants including use of the SS-OO-PP-RR approach. Data suggests refinement to LEIFc is needed to include breastfeeding and mental health support as well as a longer duration of intervention through at least 6 months PP. An experienced interventionist is key to success of the research. All lost to follow-up (n=7) have occurred before the first PP visit suggesting that at study visit closer to birth is needed. Enrollment will continue through December 2022 and data collection through April 2023. DISCUSSION/SIGNIFICANCE: After refinement, the LEIFc intervention will be tested in a pilot RCT. The long-term goal is to implement LEIFc in the curricula of federally funded maternal-child home visiting programs who serve vulnerable populations; those that often have infant feeding practices that do not align with recommendations and are less likely to use RIF.

OBJECTIVES/SPECIFIC AIMS: To evaluate the extent to which the curriculum delivered via an innovative program, the Early Scholars Certificate in Clinical and Translational Science (CCTS) at the University of Iowa (UI), develops a translational science workforce pipeline by increasing awareness of and interest in translational science as a career goal for highly prepared undergraduates. METHODS/STUDY POPULATION: The CCTS’s objective is to increase the awareness of the philosophy and tools of translational science and to incorporate critical evaluation and self-appraisal of the translational aspects of a scholar’s own research. CCTS is a 16-semester-hour (sh) academic certificate program introducing translational science concepts and careers to undergraduate students. The CCTS is a selective program with requirements including a minimum GPA, minimum sh completed, completion of course prerequisites, and already engaged and supported by mentored research. The curriculum includes electives in the area of their research interests (6 sh); graduate level Epidemiology (3 sh); Biostatistics (3 sh); and 2 core Translational Research courses (4 sh total). The first core course, an Introduction to Translational Research, is a survey course providing students the opportunity to learn how translational research is conceived and developed. It is designed to instruct the student how to interpret their research in a translational T1 to T4 paradigm. The program’s capstone course, Practicum in Translational Research, provides undergraduate students the opportunity to address how their research experience translates into clinical practice. Student’s spend the majority of this course’s contact hours in a shadowing experience with a clinician in the area of their research. Students reflect on this shadowing experience and its relevance to their academic and professional goals. The students also spend time developing skills in peer review—not only learning to provide constructive feedback to other research professionals, but also how to receive and integrate the feedback. The course includes a mock research fair where both UI faculty and classmates provide feedback that is later integrated into their capstone projects—a poster presentation at the UI Carver College of Medicine Research Fair as well as a final translational paper. As part of the ongoing evaluation of the program and graduates, we examined the participant data, the course satisfaction with content, the change in understanding of translational science, and the intention to incorporate translational science into research and career goals. We also conducted course evaluation surveys and qualitative analysis of a focus group and interviews. RESULTS/ANTICIPATED RESULTS: Since 2015, the CCTS program has introduced translational science curriculum to 20 undergraduate participants (men/woman 40%/60%; 5% Hispanic or Latino; 15% Center for Diversity and Enrichment Eligible). Areas of academic interest include: biology, genetics, engineering, bioinformatics, biochemistry, neuroscience, psychology, and microbiology. Graduates of the Certificate and degree program to date (n=8) have gone onto: Fullbright awards (1), medical school/Masters in public health (1), combined MD/PhD programs (2), biomedical PhD program (1), or currently work in translational science positions in industry (2). In questionnaire and focus group results, we found that in general, students reported increased understanding of the translational spectrum and felt the certificate program helped them clarify their educational or career goals. Data from both the focus group and the questionnaire demonstrate that students are strongly positive about the program in general, including its quality, faculty and guest speakers, structure, goals, opportunities, personality, and personnel. All students highly valued many elements of the program and each course, and particularly the opportunity for clinical shadowing. Among the questionnaire findings for 2016–17, all students (100%) rated program quality “excellent,” and 7 of 8 (87.5%) “strongly agreed” that they better understood translational science, that they saw themselves continuing in translational science research after graduation, and they were better able to communicate how their lab research fits within the translational spectrum. In each case 1 of 8 “agreed.” Participants also generally felt that their career goals had been affirmed or realigned, and that they were better able to communicate the meaning of translational science to multiple audiences. Responses on changes to career aspirations and plans were mixed, and are ambiguous. Questionnaire Item 4, “My UI curricular and/or co-curricular plans changed as a result of the CCTS program,” which had mixed responses, asked specifically about the CCTS program as a reason for change, but it is not clear if, whether, or how the program specifically wants to change curricular plans. In the focus group, students reported using their individual shadowing and lab experience in determining preferences and intentions about future career choices (e.g., whether or not to apply to medical school and/or pursue basic science research). Participants perceived the shadowing experience, complementing or contrasting their lab research, as particularly relevant in deciding about their future careers. Other themes that emerged from the focus group and/or open section of the questionnaire demonstrate the impact of various course elements on participants’ understanding of translational science and potential careers, including: quality of instruction, program and course content (including guest speakers, the shadowing experience, and the poster development process); the exposure to a range of possibilities along the translational spectrum and the expansion of ideas about what research could look like; the value of connections (to faculty, researchers and clinicians, and other CCTS students and alumni); the attributes of the cohort; and the “personality” of the program and personnel. DISCUSSION/SIGNIFICANCE OF IMPACT: Developing a pipeline for translational science workforce development has been problematic because a lack of the understanding of the need of translational research and a structuring a time efficient program for early career clinical and basic scholars. Undergraduates making critical decisions about educational paths and career goals and plans may not be aware of opportunities in translational science or the type of choices they need to make to prepare for such opportunities. Our data demonstrates that CCTS was an effective way of introducing translational science concepts and career paths to undergraduate students and potentially a powerful way to encourage them to consider these career paths. Participants in our program improved their knowledge of the field and expressed interest and intention to incorporate translational science training into their career plans. However, improvements can be made in the CCTS program. Additionally, CTSAs should consider ways to incorporate findings like these into a wider sphere of training to help develop and strengthen a translational science workforce for the future. The exposure to a variety of translational science career possibilities and specialties was important to students. Based on both focus group discussion and questionnaire data, a few students did expand slightly their sense of career possibilities, but the larger benefit may be their concrete experiences that validate or solidify their interests, making them more skilled at talking about and supporting their career goals on applications and in interviews. Shadowing did not always encourage students to go into clinical medicine, but often solidified interests or leanings students already had, giving them a more grounded basis for refining their decisions. For some students, shadowing a clinician confirmed ideas of being a physician; for others, it steered them away from it. Some now found ethical challenges, bureaucracy, or emotional challenges daunting or newly necessary to consider before focusing on clinical careers. This may be just what students need at this point, and emphasizes for them the relation between different kinds of research and application within translational science. Our evaluation suggests that CCTS contributes to academic choices for career development and additionally can help attract highly skilled students into TS research, including students of color. Future work to evaluate CCTS impact on graduates’ career outcomes will inform the translational research direction and content. In terms of program design, it could be useful to build in multiple opportunities for students to understand the diversity of translational science careers and provide students more exposure to different possibilities in clinical and translational work.

OBJECTIVES/SPECIFIC AIMS: This population-based study aims to assess the individual and collective relationship between TMA-associated metabolites and echocardiographic parameters of left ventricular diastolic function. METHODS/STUDY POPULATION: The study cohort consisted of 1,039 adult participants of the Bogalusa Heart Study (35.13% black, 57.94% female, aged 33.60 to 57.47 years). Left ventricular diastolic function was assessed via two dimensional and tissue Doppler echocardiography. Echocardiographic parameters of diastolic function included peak early (E, cm/s) and late transmitral flow velocities (A, cm/s), septal mitral annular velocity (e’, cm/s), left ventricular isovolumic relaxation time (IVRT, ms), and peak early diastolic transmitral flow velocity deceleration time (DT, ms). Metabolomic analysis of fasting serum samples was conducted via ultrahigh performance liquid chromatography-tandem mass spectroscopy. Six metabolites in the TMA pathway, carnitine, choline, TMAO, betaine, ergothioneine, dimethylglycine, and two composite variables, the betaine/choline ratio as well as the weighted sum of the six TMA-associated metabolites (TMA score), were selected a priori and tested for association with echocardiographic parameters of diastolic function. Raw metabolite values were divided by their respective standard deviation to create an exposure variable for each individual metabolite. The betaine/choline ratio was calculated utilizing the raw value of each metabolite. The z-score method was used to transform the six metabolites to the same scale and these values were used to calculate the TMA score. Multivariable-adjusted linear regression models were employed to assess the relationship of TMA-associated metabolites with echocardiographic measures of diastolic function. Covariates adjusted for included sex, age, race, education, alcohol drinking, cigarette smoking, heart rate, systolic blood pressure, glomerular filtrate rate, body mass index, low density lipoprotein cholesterol, high density lipoprotein cholesterol, hemoglobin A1c, serum triglycerides, as well as blood pressure-, lipid-, and glucose-lowering medications. RESULTS/ANTICIPATED RESULTS: After stringent Bonferroni correction for multiple testing, four TMA-associated metabolites as well the TMA score were significantly associated with diastolic function. TMAO was inversely associated with IVRT (ß = −0.002 (0.00); p-value = 2.00E-03). Betaine (ß = 0.40 (0.08); p-value = 2.10E-07), carnitine (ß = 0.30 (0.07); p-value = 7.80E-05), dimethylglycine (ß = 0.27 (0.07); p-value = 3.00E-04), and the TMA score (ß = 0.10 (0.02); p-value = 3.40E-05), were positively associated with the septal E/e’ ratio. No significant associations were observed between metabolites or metabolite composite scores from the TMA pathway and the E/A ratio or DT. DISCUSSION/SIGNIFICANCE OF IMPACT: This is the first population-based study to assess the role of TMA-associated metabolites in left ventricular diastolic function. Betaine, carnitine, dimethylglycine, and a metabolite score combining serum metabolites from the TMA pathway were positively associated with the septal E/e’ ratio, suggesting that a higher concentration of TMA-associated metabolites correlates with impaired diastolic function. These results suggest that both individual and grouped metabolites from the TMA pathway may serve as early biomarkers for pre-clinical diastolic dysfunction, an important causal factor for HFpEF. Future longitudinal, multi-omic studies incorporating microbiome, metabolomic and dietary analyses are needed to characterize the risk of ventricular diastolic function and HFpEF in the setting of exposure to TMA-associated metabolites.

OBJECTIVES/GOALS: Mobile health applications are widely used by the public but vary in how they are classified and regulated. This study examines the evidence of the safety and efficacy of mobile medical applications specifically focusing on those that are used to manage diabetes. METHODS/STUDY POPULATION: To understand the current regulatory landscape of mobile health applications (mHealth apps) for diabetes, a literature survey was conducted using the Pubmed database. Top mHealth apps were identified by searching the Apple store website using 10 key terms associated with diabetes management applications. A maximum of ten results, when available for each key term, were studied by exploring the FDA databases to understand how the products were regulated and if any were subject to recalls. These selected mHealth apps were also searched on clinicaltrials.gov to see if there were ongoing or completed clinical trials and if the trials were designed to include efficacy and safety outcome measures. RESULTS/ANTICIPATED RESULTS: Of the 71 mHealth apps for diabetes management that were identified, 16 were regulated. These products spanned a diverse range of functions including device data and decision support systems. Although 11 had clinical trial data demonstrating efficacy, only 4 had data demonstrating both efficacy and safety. Two of the regulated applications were subject to product recalls due to programming errors that resulted in incorrect insulin dose recommendations. These two applications had clinical trials evaluating efficacy but not safety. The companies noted that the incorrect insulin calculation from their respective mHealth app could cause either a low- or high-impact hypoglycemic event. DISCUSSION/SIGNIFICANCE OF IMPACT: With little to no clinical trial data to support their safety and efficacy, mHealth apps in the diabetes marketplace pose risks for patients as evidenced by recent safety-related recalls. The results of this study indicate that these products may need to be more tightly regulated.

OBJECTIVES/GOALS: Securing seed funding and external support can be a daunting process. Institutions are increasingly looks for quantitative assurance of impact and accountability. This study investigates factors predictive of seed funding selection, including pace of submissions as well as external support. METHODS/STUDY POPULATION: Using Generalized Logistic Mixed Models (GLMMs), we model factors found to be predictive of researcher success, and model demographic factors as well, to understand the complex interplay of researcher background, professional networks and preparation, and researcher persistence. The following factors were modeled as potentially predictive of researcher success: faculty rank; co-PI; h-index; rate of application; prior award funding amounts; and research-focused social media posts. RESULTS/ANTICIPATED RESULTS: After effects are finalized, we expect that pace of seed fund applications and the strength co-PIs, as measured by h-indices, to be significant predictors of researcher success for both securing seed funding and external support. DISCUSSION/SIGNIFICANCE: This study identifies features associated with eventual research program success and can be used to support accountability and impact efforts at an institutional level. Research institutes strive to ensure equal access to these opportunities and train applicants to produce improved project proposals. Results from this study inform these efforts.

Accelerating innovation translation is a priority for improving healthcare and health. Although dissemination and implementation (D&I) research has made significant advances over the past decade, it has attended primarily to the implementation of long-standing, well-established practices and policies. We present a conceptual architecture for speeding translation of promising innovations as candidates for iterative testing in practice. Our framework to Design for Accelerated Translation (DART) aims to clarify whether, when, and how to act on evolving evidence to improve healthcare. We view translation of evidence to practice as a dynamic process and argue that much evidence can be acted upon even when uncertainty is moderately high, recognizing that this evidence is evolving and subject to frequent reevaluation. The DART framework proposes that additional factors – demand, risk, and cost, in addition to the evolving evidence base – should influence the pace of translation over time. Attention to these underemphasized factors may lead to more dynamic decision-making about whether or not to adopt an emerging innovation or de-implement a suboptimal intervention. Finally, the DART framework outlines key actions that will speed movement from evidence to practice, including forming meaningful stakeholder partnerships, designing innovations for D&I, and engaging in a learning health system.

Introduction. Family health history (FHx) is an important factor in breast and ovarian cancer risk assessment. As such, multiple risk prediction models rely strongly on FHx data when identifying a patient’s risk. These models were developed using verified information and when translated into a clinical setting assume that a patient’s FHx is accurate and complete. However, FHx information collected in a typical clinical setting is known to be imprecise and it is not well understood how this uncertainty may affect predictions in clinical settings. Methods. Using Monte Carlo simulations and existing measurements of uncertainty of self-reported FHx, we show how uncertainty in FHx information can alter risk classification when used in typical clinical settings. Results. We found that various models ranged from 52% to 64% for correct tier-level classification of pedigrees under a set of contrived uncertain conditions, but that significant misclassification are not negligible. Conclusions. Our work implies that (i) uncertainty quantification needs to be considered when transferring tools from a controlled research environment to a more uncertain environment (i.e, a health clinic) and (ii) better FHx collection methods are needed to reduce uncertainty in breast cancer risk prediction in clinical settings.

Clinicians who are interested in becoming principal investigators struggle to find and complete training that adequately prepares them to conduct safe, well-designed clinical and translational research. Degree programs covering these skills require a significant time investment, while online trainings lack engagement and may not be specific to local research contexts. Staff at Tufts Clinical and Translational Science Institute sought to fill the gap in junior investigator training by designing an eight-module, noncredit certificate program to teach aspiring clinician-investigators about good clinical practice, clinical research processes, and federal and local regulatory requirements. The first iteration of this program was evaluated using pre- and posttest questionnaires and by gathering clinician learner feedback in a focus group. Based on the pre- and posttest questionnaires, learners experienced an increase in self-efficacy and confidence related to clinical research competencies. Feedback from learners also highlighted important program strengths, including an engaging program format, a manageable time commitment, and an emphasis on identifying crucial research resources. This article describes one approach to creating a meaningful and efficient clinical trial training program for clinicians.

The Trial Innovation Network has established an infrastructure for single IRB review in response to federal policies. The Network’s single IRB (sIRBs) have successfully supported over 70 multisite studies via more than 800 reliance arrangements. This has generated several lessons learned that can benefit the national clinical research enterprise, as we work to improve the conduct of clinical trials. These lessons include distinguishing the roles of the single IRB from institutional Human Research Protections programs, establishing a consistent sIRB review model, standardizing collection of local context and supplemental, study-specific information, and educating and empowering lead study teams to support their sites.

OBJECTIVES/GOALS: Using the NIH’s expanded definition of underrepresented populations in the biomedical, clinical, behavioral and social science research enterprise, we examined the impediments for conducting translational research experienced by those from underrepresented groups. [https://acts.slayte.com/calls/detail/740a13de-316c-11ee-90f4-0e0ce905385c/draft/389221c1-434e-11ee-90f4-0e0ce905385c#_ftn1] #_ftn1 METHODS/STUDY POPULATION: One hundred and ninety-nine people completed a survey distributed to 750 persons who had interacted with our Center’s service cores as users, awardees, mentors, committee members, seminar attendees, and/or participated Center sponsored programming (response rate = 26.5%). The survey addressed barriers to conducting clinical and translational research at the respondent’s institution, awareness of and interest in using specific Advance RI-CTR services, and satisfaction with their institution’s efforts to support clinical and translational research. RESULTS/ANTICIPATED RESULTS: Women reported access to collaboration across institutions as a barrier to clinical and translational research that existed to a great extent (28%) significantly more than men (10%). More than half (53%) of the other underrepresented researchers surveyed identified insufficient grant administration supportas a barrier that occurs to a great extent, compared with 35% of researchers who were not from an underrepresented group. Other barriers reported more frequently among underrepresented researchers included lack of pilot project funding, inadequate space for conducting research, lower access to collaborators across institutions, and difficulty obtaining advice on regulatory issues and commercial development. DISCUSSION/SIGNIFICANCE: Efforts to address the barriers identified by underrepresented groups will include, but not be limited to, improving collaborations across institutions, support for grant administration, and a discussion of plans for the Center to augment and advocate at the partner institutions on behalf of these underrepresented individuals.