Objectives/Goals: This study aimed to investigate the role of artificial intelligence (AI) in translational science, including personalization of interventions and drug development. Methods/Study Population: A comprehensive literature search was conducted via PubMed, the Cumulative Index for Nursing and Allied Health Literature (CINAHL), Cochrane Library, Medline, and Web of Science. The risk of bias in the eligible studies was assessed using the risk of bias in nonrandomized studies. Data were systematically extracted and analyzed. Results/Anticipated Results: The literature search yielded 2129 records, from which 20 studies that met the eligibility criteria were included. Meta-analysis demonstrated the high specificity of AI-based diagnostics, reassuring the reliability of AI. Furthermore, AI applications significantly improved biomarker identification through machine learning algorithms, enhancing prognostic accuracy and treatment personalization. Moreover, AI showed enhanced diagnostic precision with high sensitivity and specificity in cancer detection, further validating its role in healthcare. AI-driven risk stratification was used in chemotherapy decisions. Discussion/Significance of Impact: This study highlights the transformative power of AI in translational oncology research with applications in drug development and personalized patient care in cancer treatment and research.

ABSTRACT IMPACT: The model of the Clinical Research Support Center at the University of Minnesota of streamlining clinical trial infrastructure can be leveraged by the larger clinical trial community to create valuable efficiencies and facilitate faster initiation of research activities by supporting researchers from concept to dissemination. OBJECTIVES/GOALS: Substantial time, energy, and money are spent bridging disparate resources in research. We describe how the University of Minnesota’s (UMN) Clinical Research Support Center (CRSC) streamlines trial infrastructure, creating valuable efficiencies to support researchers from concept to dissemination. METHODS/STUDY POPULATION: The CRSC, established in 2018 through the Clinical and Translational Science Award (CTSA) program, brings resources together in a single, centralized, and convenient location to help researchers navigate the UMN clinical research startup process and specifically to assist with the development and initiation of a research study from feasibility assessment to project opening. Diverse expertise in components of human subject research is available to support the broad scope of projects at a large institution like the UMN. We present how CRSC services, when coordinated by Clinical Research Specialists, have been used to improve access to clinical research resources during the start up process. RESULTS/ANTICIPATED RESULTS: Since inception in 2018, the CRSC has provided support to over 1700 studies with 437 research projects referred to a Clinical Research Specialist within the CRSC. Of those projects, 97 (22.2%) received comprehensive support from the following expert groups: regulatory guidance (n=74), biostatistics (n=68), clinical (hospital or clinic) partners (n=60), recruitment (n=36), budget development assistance (n=30), and (bio)informatics (n=27). Successful examples of synergies to streamlining study start up include shortening the window between protocol development support from Clinical Research Specialists and IRB submission preparation through to Regulatory Specialists to 3 days. DISCUSSION/SIGNIFICANCE OF FINDINGS: Providing cross-functional support to research teams through the CRSC increases the likelihood of quicker and successful execution and completion of research initiation and subsequently impacts the dissemination of that research to patients and the broader community.

OBJECTIVES/GOALS: Duke University developed a Project Tracker system to provide transparency into the complex study start-up process for Industry sponsored clinical trials. Partnering with process owners, investigators, research teams, and IT developers, we aimed to reduce timelines for IRB approval, Contract Execution, and Billing/Calendar setup. METHODS/STUDY POPULATION: In 2019, a partnership of administrative stakeholders and IT developers began engaging with the primary populations involved in study start-up: research study teams (STs) and research administrators (RAs). A series of workgroups and feedback sessions revealed common themes with a slightly different scope: STs were interested in the progress of individual projects awaiting approval whereas RAs needed an aggregate view of start-up metrics over time and a way to help troubleshoot delays for individuals. Both groups were hindered by data captured across multiple systems, limited understanding of the entire approval process, and an absence of reliable indicators for delays or outstanding requirements. RESULTS/ANTICIPATED RESULTS: In mid-2021, we delivered a Project Tracker system comprised of two main components, accessible via Dukes myRESEARCHhome portal: 1) a Tableau metrics dashboard for RAs that aggregates retrospective data quarterly, visualizing time to completion of approval workflow milestones with defined outliers, filterable by investigator, unit, or sponsor. 2) a project status tracker for STs (with a complementary view for RAs) that consolidates status information for projects awaiting approval, visualizing the process in a linear fashion with clear indicators of progress and steps awaiting study team action. This involved defining the milestones for each workflow, mapping milestones to application variables, combining the variables in a common data mart, and developing the interfaces with user-centered design. DISCUSSION/SIGNIFICANCE: Given its recent implementation, the impact of the tool on start-up timelines cannot yet be determined. However, our development process led to key insights: a simplified process visualization limited to key milestones allows STs and RAs to understand responsibilities, address delays and data discrepancies, and reinforce institutional process.

OBJECTIVES/GOALS: Impaired vascular function, a subclinical marker of cardiovascular disease, has been identified in prediabetes. Dietary nitrate supplementation has been shown to improve vascular function. However, this has not been studied in prediabetes. The purpose was to determine the effects of dietary nitrate on vascular function in prediabetes. METHODS/STUDY POPULATION: Five individuals with prediabetes (4 men, 1 woman; 55 ± 17 yr; HbA1c = 5.8 ± 0.2) participated in a double-blind, placebo-controlled, repeated measures study. Participants were randomly assigned to a 3-day nitrate supplementation (nitrate-rich beetroot juice, 12.9 mmol, 140 mL), or a placebo supplementation (nitrate-depleted beetroot juice, 0.05 mmol, 140 mL). Following supplementation, participants reported to the lab for measures of vascular function in the lower limb. Doppler ultrasonography was used to measure flow-mediated dilation (FMD) and post-occlusive reactive hyperemia (RH) of the superficial femoral artery in response to a 5-min bout of leg ischemia. RESULTS/ANTICIPATED RESULTS: FMD did not differ between the nitrate-rich (2.87 ± 2.01%) and placebo (2.24 ± 1.69%) conditions (p = 0.48; d = 0.35). Furthermore, peak RH did not differ between the nitrate-rich (1503 ± 443 ml/min) and placebo (1762 ± 414 ml/min) conditions (p = 0.36; d = 0.46). DISCUSSION/SIGNIFICANCE: These preliminary results suggest that dietary nitrate supplementation in the form of beetroot juice does not improve vascular function in individuals with prediabetes.

Participant recruitment for research is a persistent bottleneck that can be improved by leveraging electronic health records (EHRs). Despite emerging evidence for various EHR-driven approaches, guidance for those attempting to select and use such approaches is limited. The national Recruitment Innovation Center established the EHR Recruitment Consult Resource (ERCR) service line to support multisite studies through implementation of EHR-driven recruitment strategies. As the ERCR, we evolved a guide through 17 consultations over 3 years with multisite studies recruiting in diverse biomedical research domains. We assessed literature and engaged domain experts to identify five key EHR-driven recruitment strategies: direct to patient messages, candidate lists for mailings/calls, direct to research alerts, point of care alerts, and participant registries. Differentiating factors were grouped into factors of study population, study protocol and recruitment workflows, and recruitment site capabilities. The decision matrix indicates acceptable or preferred strategies based on the differentiating factors. Across the ERCR consultations, candidate lists for mailing or calls were most common, participant registries were least frequently recommended, and for some studies no EHR-driven recruitment was recommended. Comparative effectiveness research is needed to refine further evidence for these and potentially new strategies to come.

The goal of this study was a re-analysis of a randomized controlled trial evaluating the effectiveness of Attachment and Biobehavioral Catchup (ABC), an early childhood parenting intervention. We compared the effectiveness of ABC for enhancing parental sensitivity and child behavior among 79 dyads who received the intervention as delivered by peer support specialists (n = 49 dyads) or master’s-level clinicians (n = 30 dyads). Peer support parent coaches were non-inferior at enhancing parental sensitivity and parental intrusiveness as parent coaches with a master’s degree. This research has important clinical implications for increasing access to ABC for parents involved in the child welfare system.

Inadequate training in the interpersonal skills of conducting informed consent conversations has long been noted as a challenge for clinical research recruitment and retention. To address this critical gap, Tufts Clinical and Translational Science Institute developed regular trainings for clinical research coordinators and other research staff on the practical skills of communicating informed consent using community members as simulated patients for role-playing exercises. In this paper, we assess the reach and effectiveness of these trainings and describe the impact of employing community stakeholders as simulated patients. We found that by embedding community members in the trainings, clinical research coordinators get to hear diverse perspectives, experience a range of patient responses, and learn from the lived experience of the communities that research tries to serve. Utilizing community members as trainers also helps to dismantle traditional power dynamics by demonstrating the organization’s commitment to inclusiveness and community engagement. Based on these findings, we suggest that training on informed consent include more simulated consent exercises that feature interaction with community members who can provide real-time feedback to coordinators.

OBJECTIVES/GOALS: The objective of the study is to compare two horizontal bone augmentation techniques (bone expansion and bone splitting) that are currently used for horizontally deficient maxillary ridges. Bone expanded in millimeters (mm), implant stability, and patient satisfaction will be compared with each technique. METHODS/STUDY POPULATION: This pilot (prospective cohort) study will be divided in two sites, a private practice and the Oral and Maxillofacial Surgery (OMS) Clinic at the University of Puerto Rico, School of Dental Medicine. A total of 20 patients will be selected, 10 patients in each site. In both sites, pre-operative and post-operative Cone Beam CT radiographs will be taken to measure bone width. Implant stability will be measured using an Osstell. 2 weeks post-surgery, a patient satisfaction questionnaire will be given to patients. A two-sample T test will be used to compare techniques statistically. RESULTS/ANTICIPATED RESULTS: We anticipate that bone expansion will be as good as (non-inferiority) bone splitting in terms of bone expanded in millimeters to desire width, and implant diameter will not be compromised. We also expect that implants placed with the bone manipulation technique will have a higher implant stability at baseline and less pain, discomfort and swelling in terms of patient satisfaction. DISCUSSION/SIGNIFICANCE OF IMPACT: Our contributions here are expected to illustrate clinical and radiographic bone expansion techniques that will enhance implant placement treatment for implantologists and patient’s experience.

Objectives/Goals: While there are many efforts to teach artificial intelligence and data science (AI & DS) methods, the importance of problem formulation in translational research (TR) has received limited attention. The goal of this presentation is to revisit this challenging pedagogical topic and formalize approaches in inculcating its design principles. Methods/Study Population: AI & DS didactic courses cover problem formulation implicitly in their various course modules. Also, problem formulation is a prominent education theme of quantitative fields such as mathematics and physics. Also, data scientists working with TR usually spend considerable time in the data design aspects to quantitively solve the health problem at hand. We used three approaches to building a pedagogical framework for DS problem formulation in TR: (1) review existing literature on problem formulation in TR, applied mathematics and physics; (2) obtain structured responses around teaching problem formulation from AI & DS instructors; and (3) add exemplar DS in TR studies we actively supported. Results/Anticipated Results: Conceptualizing complex problems in a quantifiable manner can often be challenging. The typical processes involved in formulation included starting with a real-world and relatable context, iteratively defining the problem and chunking it into portions related to individual entities, abstracting each chunk to a quantifiable and working statement, identifying appropriate data resources and their constraints, and transforming data into reasonable representations. Strategies to teach problem formulation we identified through our analysis include active learning (problem-based learning and question formulation techniques), stimulating metacognition (problem defining, contextualizing, experimentation, and creativity), and group learning with think aloud and constructive feedback. Discussion/Significance of Impact: Instilling problem formulation skills, acquired over years of experience, in condensed timelines, requires formal pedagogical approaches. Ability to formulate a problem in multiple ways increases the likelihood of finding a tractable solution and can be covered in TR and DS courses and enable increased use of real-world data resources in research.

Objectives/Goals: To identify lipid signatures associated with adverse pregnancy outcomes (APOs) and postpartum weight retention (PPWR) in women entering pregnancy with overweight or obesity and to explore potential epigenetic mechanisms through ongoing DNA methylation (DNAm) analysis. Methods/Study Population: The GROWell: Goals for Reaching Optimal Wellness study was a blinded, randomized clinical trial to improve dietary support during pregnancy and postpartum. Data were collected via online questionnaires, electronic health records (EHRs), and participant-collected dried blood spots (DBS) at 10–16 weeks, 36–38 weeks, and 3 months postpartum. We analyzed DBS data from 49 participants using three lipidomic analytical techniques: weighted lipid correlation network analysis, differential lipid analysis, and partial least squares discriminant analysis. Lipid profiles were characterized and then tested for associations with APOs and PPWR at all three time points. DNAm analysis from the samples is ongoing to determine the epigenetic mechanisms associated with lipid dysregulation and pregnancy outcomes. Results/Anticipated Results: The lipid network analysis revealed positive correlations between specific lipid types and APOs, particularly at 10–16 weeks and postpartum. Notably, triglycerides and phosphatidylcholine were associated with an increased risk of APOs. Additionally, in the third trimester, triglycerides were positively correlated with weight-related variables. Postpartum analysis also showed a positive correlation between elevated triglyceride levels and a history of APOs. The network analysis also revealed positive associations between triglycerides and PPWR, which were most evident at the 36–38 week and postpartum time points. Ongoing methylation analysis is expected to identify genomic regions associated with pregnancy outcomes. Discussion/Significance of Impact: These findings underscore the significant role of lipids in pregnancy outcomes for individuals with overweight or obesity. Identifying lipidomic and methylome biomarkers of risk for APOs and PPWR may help with early detection and intervention, improving maternal and fetal health.

OBJECTIVES/GOALS: The goal of our multi-institutional team is in our name Holistic Electrical, ultrasonic and Physiological Interventions Unburdening those with Spinal cord injury†(HEPIUS) Lab. Officially, I am a Ph.D. researcher, but the team has empowered me to share insights from being a former spinal cord patient myself – creating a more direct feedback loop. METHODS/STUDY POPULATION: Human-centered design is a method growing in popularity due to its impact on outcomes. Any translational project aspires to utilize some level of patient perspective. Our team has taken several initiatives to make this a part of our core. The team has a dedicated advisor who suffered a spinal cord injury and underwent the current standard of care. There are also non-traditional and unofficial advocates (like myself) on the team. Although I am fully recovered today without any symptoms from a different spinal cord complication, the team equips me with the time and support needed to share my experiences in clinic. The team gives me the opportunity to champion for the most appropriate approaches during official meetings and periodically in the lab whenever a question arises. RESULTS/ANTICIPATED RESULTS: In this poster we aim to discuss the following points: 1.) Team Culture: Those with patient insights will only share if there is an established healthy culture. 2.) Privacy: Just because someone advocates on the behalf of patients does not mean that they need to divulge personal information 3.) Workflow Structure: Sharing patient insight only reaches as far as the organization permits. Thankfully, my team is open to member perspectives and has benefited from several insights already 4.) The art of listening: Patient insights should be listened to and treated with respect, but not as an undebatable suggestion 5.) Rewarding aspects: Sharing patient insights is a very rewarding experience if you feel comfortable enough to share. DISCUSSION/SIGNIFICANCE: Translational teams often rely on statistics, one-time patient interviews, or dedicated individuals in an advocacy role to help guide the project. This poster is intended to highlight some new ways to practice engagement of patient perspectives, while introducing the intricacies of fostering healthy cultures which promote these voices.

ABSTRACT IMPACT: As scientific research is trending towards greater interdisciplinary and collaboration in order to meet the challenges of contemporary science, which has led to increased recognition of the importance of Team Science, this study will promote team science research within NJ ACTS Consortium as well as across the country. OBJECTIVES/GOALS: The objective of this study is to assess the feasibility of using the NIH Reporter database for developing and tracking team science metrics within the CTSA-funded NJ ACTS Consortium, which consists of RU, PU, and NJIT. The NIH Reporter database provides detailed information on single-PI and multiple-PI R01 grants funded by NIH. METHODS/STUDY POPULATION: 58 multi-PI projects and 344 single-PI projects are currently funded within the NJ ACTS consortium. We will use information from the database on funding levels, institutional composition of projects (e.g., within-consortium projects vs. projects with PIs both within and outside of the consortium), numbers of publications, impact factors of publications, and funding supplements obtained to quantify and track NIH R01 Team Science activity in the consortium. RESULTS/ANTICIPATED RESULTS: Preliminary analysis suggests that it will be both feasible and efficient to use the NIH reporter database to develop Team Science metrics and to augment information in the database with information on PI characteristics such as department/center/school/university, academic discipline, and rank/tenure status, as well and detailed composition of research teams, such as the mix in terms of senior and junior scholars. DISCUSSION/SIGNIFICANCE OF FINDINGS: This study will make an important contribution to this movement by demonstrating the feasibility of using the publicly available NIH Reporter Database to quantify the level and success of Team Science in the form of single-PI and multiple-PI R01 grants funded by NIH, which represent extremely important Team Science activities at universities.

OBJECTIVES/GOALS: a. Summarize barriers and best practices related to effective CRP onboarding, training and professional development b. Identify challenges with the assessment of and mentoring for CRP competency growth. c. Describe opportunities to improve the training and professionalization of the CRP career pathway. METHODS/STUDY POPULATION: Qualitative data from a series of UnMeeting breakout sessions and open-text survey questions were analyzed to explore the complex issues at play when developing high-quality onboarding and continuing education opportunities for CRPs at academic health centers. RESULTS/ANTICIPATED RESULTS: Results suggest there are several barriers to providing training to the CRP workforce, including: balancing foundational onboarding with role-based training, managing logistical challenges and institutional contexts, the need for institutional champions, assessing competency, and providing high-quality mentorship. Several of these themes are interrelated. One common thread present throughout all of these themes is the challenge of effective communication and team science training. DISCUSSION/SIGNIFICANCE: Few institutions have solved all of the issues related to training a competent and adaptable CRP workforce, although some have addressed one or more. This study illustrates the need to work collaboratively within and across institutions to overcome training barriers and support a vital and well-qualified workforce.

OBJECTIVES/GOALS: To develop an untargeted metabolomics assay that can holistically characterize the small molecule signatures of different inborn errors of metabolism (IEM) for biomarker discovery and identification of novel IEMs, with the goal of implementing the assay into the clinical laboratory to improve testing efficiency. METHODS/STUDY POPULATION: A hydrophilic interaction liquid chromatography (HILIC) column and reverse phase (RP) column were assembled in tandem on a SCIEX X500B quadrupole time-of-flight (QTOF) system to create a dual liquid chromatography (LC), tandem mass spectrometry method. The X500B was operated in data-independent acquisition mode with both positive and negative ionization. A mixture of 165 reference standards from eleven compound classes common to IEMs were used to evaluate the capability of the assay to resolve small molecules. Chromatographic resolution for each standard was determined qualitatively by comparison to a reference spectral database. External validation of the assay will be performed by analyzing a commercial library of reference metabolites. RESULTS/ANTICIPATED RESULTS: A total of 88% (146/165) of the standards were detected by the assay. The RP column alone resolved 71% (117/165) of the standards, the HILIC column resolved 33% (55/165), while 17% (29/165) of the standards were resolved by both columns. The HILIC column resolved standards that were more polar, while the RP column resolved more non-polar compounds. To evaluate matrix effects, the reference standard mixture was spiked into pooled plasma. In the presence of plasma 6/146 (4%) of the standards were suppressed to levels below the limit of detection. We expect external validation with the commercial metabolite library will corroborate these results, and that the high-quality spectral data attained from this reference library can be used to improve identification of unknown metabolites in patient samples. DISCUSSION/SIGNIFICANCE: We have shown our untargeted metabolomics assay can detect known biomarkers for IEMs. Clinical implementation of this method could streamline diagnosis of IEMs while simultaneously improving patient outcomes by leveraging the metabolome for biomarker discovery, and improved understanding of IEM mechanisms to inform novel treatment strategies.

Objectives/Goals: This study aims to evaluate common features of mobile health (mHealth) apps and their role in helping caregivers make health decisions for children. Methods/Study Population: A scoping review of literature on caregivers’ use of mHealth apps (published since 2008) was conducted across 5 databases (i.e., Embase, PubMed, CINAHL, Clinicaltrials.gov, and IEEE Xplore). Selected papers were categorized based on app purposes, target users, and mHealth agile development phases. Common features were also identified and analyzed along with users’ pros and cons. Further, primary feature requests were summarized to inform future development. Results/Anticipated Results: This review included 62 studies. Most apps were about maternity and infant care and specific diseases. Major users were caregivers and pregnant women. Around 20% of papers covered multiple phases in the mHealth agile development lifecycle. The effectiveness/clinical trial (phase III) was the most common. E-learning, personalization and customization, and health tracking features were the three most common features of mHealth apps included in this review. More positive feedback was found regarding features than concerns. Caregivers perceived apps as helpful and empowered them to make informed decisions. Concerns were mainly over 1) technical issues, 2) inappropriate design, and 3) ambiguous terms. Requested new features included content comprehensiveness, user engagement, and usage flexibility. Discussion/Significance of Impact: To our knowledge, this is the first review to investigate the usability of mHealth app features in this area. The results offer feasible strategies for developers to improve the effectiveness of apps for caregiver decision-making.