OBJECTIVES/SPECIFIC AIMS: The goal of this study was to determine if there are any sex differences in the pathophysiological effects of sFR. METHODS/STUDY POPULATION: Male Fischer rats (4-month-old) were maintained on a control (CT) (ad libitum regular chow; n=8) or sFR (60% reduction of daily food intake, n=8) diet for 2 weeks. On days 1, 2, 3 and 14, the rats were placed in metabolic cages for food and water intake and 24-hour urine collection. Body weight (BW) is measured daily. After 2 weeks, the animals are given free access to normal chow for 3 months. Short-term and long-term effects of sFR on blood pressure and heart rate will be measured. RESULTS/ANTICIPATED RESULTS: After 2 weeks, the male CT group gained 7% BW (p <0.05), while BW in the sFR males was reduced by 12% (p<0.05 vs. CT). In contrast, female controls did not gain BW while the sFR females lost 18% of their BW. Water intake was reduced by 35%, which was similar to the reduction in females (p=0.18). The hematocrit of sFR male rats was higher (51.1%) than the CT group (45.2%, p<0.05), which was most likely due to the 6% reduction in plasma volume. A similar effect on hematocrit was observed in sRF females. Similarly, also to female rats, sFR had no effect on Na+ and K+ plasma or urine concentrations by day 14 in the male rats. DISCUSSION/SIGNIFICANCE OF IMPACT: sFR has similar effects on electrolyte balance in males and females. Ongoing studies will determine if there is any sex difference in the effects of sFR on blood pressure, heart rate and susceptibility to hypertension and cardiac injury.

OBJECTIVES/GOALS: 1) Investigate the network level interactions of attention and learning during an attention network task (ANT) and an implicit learning contextual cueing (CC) task. 2) Assess the effect attention rehabilitation strategies have on behavioral and neural responses pre/post-attentional intervention. METHODS/STUDY POPULATION: This study involves refractory epilepsy patients with implanted intracranial electrodes and moderate-to-severe traumatic brain injury (m/sTBI) survivors. In epileptic patients, we will identify connectivity of cortical regions via the ANT, which probes components of attention (alerting, orienting, and executive control) and a CC task that probes implicit learning. We hypothesize that modulation of attention and learning can be seen at the network level. In TBI we will assess improvement following two attention rehabilitation paradigms behaviorally; and use our results from epileptic patients to guide measurement of treatment-related neuroplastic change via scalp electroencephalography. RESULTS/ANTICIPATED RESULTS: When the proposed objectives are complete, we expect to determine how the implicit learning rate in m/sTBI changes as a result of both direct attention and metacognitive-strategy training, and discern the neuroanatomical networks associated with attention and implicit learning based on connectivity results. We expect to identify intracranial regions and networks that exhibit modulatory effects associated with attention and implicit learning. Additionally, we anticipate that deficits in attention will be mitigated following training and hypothesize that implicit learning rate will improve in TBI patients as a result of both attentional rehabilitation paradigms. DISCUSSION/SIGNIFICANCE OF IMPACT: Characterizing intracranial activity in epilepsy patients will give electrophysiology data unattainable in TBI patients. This intracranial perspective will enable us to propose mechanisms of action that may result from our interventions and enable critique of current rehabilitation treatments.

OBJECTIVES/GOALS: Venous thromboembolism (VTE) is a major cause of morbidity and mortality. Due to its relatively low incidence, prospective studies are limited. This makes administrative claims a promising data source to study VTE. We sought to examine the reproducibility of results using different VTE definitions from the published literature. METHODS/STUDY POPULATION: We conducted a retrospective analysis of a random 10% sample of the 2010-2022 IQVIA LifeLink PharMetrics Plus™ database, an administrative claims database representative of the commercially insured population of the United States. We selected cancer patients undergoing major gastrointestinal surgery, who have a higher risk for postoperative VTE (deep venous thrombosis [DVT] and/or pulmonary embolism [PE]). VTE was defined using ICD-9-CM and ICD-10-CM codes using definitions from 4 individual published studies. We compared the 4 definitions with respect to the incidence of VTE and factors associated with post-discharge VTE using standard univariate and multivariable logistic regression models. The same logistic regression models were used for each of the 4 definitions. RESULTS/ANTICIPATED RESULTS: There were substantial differences in VTE coding among the 4 definitions (range 107 to 225 ICD-9/10 codes for DVT and 12 to 24 codes for PE). The eligible population comprised 2,360 patients (49% female) with a median age of 49 years (interquartile range 47-52 years). During the index surgery hospitalization, a total of 58, 62, 63, and 83 patients developed VTE using the 4 definitions. In the 2,126 patients eligible for VTE prophylaxis, a total of 108, 68, 73, and 107 patients developed post-discharge VTE (range for DVT 35 to 81, range for PE 39 to 76). On multivariable analysis, factors independently associated with VTE included age using 1 of 4 definitions, esophageal surgery type using 3 of 4 definitions, and liver surgery type and Elixhauser score using all 4 definitions. DISCUSSION/SIGNIFICANCE: The incidence of VTE is directly affected by differences in ICD-9/10 codes used. Definitions for important clinical outcomes should be standardized when using administrative claims data in order to improve reproducibility of findings.

OBJECTIVES/GOALS: Patient recruitment, enrollment, and retention continues to be one of the leading barriers to successful clinical trials, and results do not always reflect the diversity of the general population. This systematic review aims to assess the impact of decentralized methods on recruitment, retention, and diversity on recent clinical research. METHODS/STUDY POPULATION: A systematic search of the literature, using databases such as PubMed, Cochrane Library and EMBASE to find publications reporting on the aspect of recruitment in decentralized clinical trials was performed. The titles and abstracts of the publications were assessed, excluded those lacking sufficient or pertinent information regarding decentralization in clinical trials. The remaining publications were reviewed for those reporting sufficient data regarding the impact of decentralization on the aspect of recruitment in clinical trials to be included in the focused analysis. Studies reporting on participant retention and diversity in addition to recruitment were emphasized. RESULTS/ANTICIPATED RESULTS: This systematic search returned 13 studies highlighting the role of decentralized clinical trial methods impacting participant recruitment, retention, and diversity in clinical trials. Out of the 13 studies, 10 reported improved recruitment using virtual or decentralized methods, and 7 of these reported improvements when compared alongside with traditional methods. 7 studies reported a positive impact on participant retention, with 4 of these directly comparing decentralized methods with traditional methods. Lastly, of these studies, 5 were reported to have trended towards diversity in the demographics of the sample population, including race or geographic location. DISCUSSION/SIGNIFICANCE: Related reviews have stated a lack of published comparable data to determine if DCTs (Decentralized Clinical Trials) improved recruitment and retention. Results suggest this review addresses such a gap, by providing data on how decentralized methods can benefit recruitment and retention, potentially highlighting a new standard.

OBJECTIVES/SPECIFIC AIMS: (1) Obtain publically available citation data, funding data, and generate multiple networks topologies based on dynamic queries of individual faculty. (2) Determine successful pathways that lead to tenure, and career advancement, in addition to determining the effect of CTSA programs on faculty collaboration. (3) Develop publically available commercial interface for the study of faculty networks METHODS/STUDY POPULATION: For our study we included all available citation and funding data publically available on all CTSA programs (as of 2015) with historical data dating back to 2005. We then included the top 25 collegiate institutions who may not have had a CTSA program (eg, Princeton University). We then developed network topologies for each university network, and explore the evolution of individuals in these networks, and the effects of faculty development—as an example in the University of Rochester network, we singled out the directors of the CTSA program there to understand their level of centrality and overall impact on network development, with key observations being that early publications across varying domains lead to stronger network performance. Although individuals who did not benefit from such development, may have succeeded but if they did were likely to leave the institution for elsewhere. RESULTS/ANTICIPATED RESULTS: A secondary goal of this project is to evaluate the effectiveness of the Clinical & Translational Science Institute (CTSI) since its inception in 2006. The mission of CTSI is to advance the field of translational science and research, to link other departments at URMC and community stakeholders by research collaboration, publication, and goals to improve population health, and provide translational education and training to students, researchers, and physicians. To determine how the induction of CTSI affects collaboration within the URMC network, we examined the role of funding in the CTSI network. This was done around the second successful funding around 2013. In doing so we can see that not only did the funding request affect the network topology, but opened new collaborations which were not present prior to the request. DISCUSSION/SIGNIFICANCE OF IMPACT: We have developed an automated method, which is superior to manual methods necessary for citation generation and funding data analysis of faculty growth in citation networks. This technique is applicable to all institutions, not just those in a CTSA environment, but demonstrates the benefit of cross-collaborative efforts, in the case of the URMC network we can state the following. The key takeaway is for individuals to succeed in the URMC collaborative environment they should create their own network and expand it and eventually rise to prominence. There are 2 pathways to this you can take the Dewhurst approach which is to seek out collaborations among internal peers and scale up. Or you can take the Nedergaard approach which is develop the special network, and gain enough public recognition outside of the network that you are capable of leaving it (Fig. 2d). In either case, collaborations among communities and diverse out-degree networks allow faculty to succeed in their given field. Given the wealth of data which has been curated in this fashion, there are numerous explicit questions that can be asked of the data. One of the unique approaches of this data is that is highly reproducible, which allows various questions to be asked. Future work would try to determine what optimal pathways are in a given network to success, and who are ideal collaborators, and collaborations to avoid. Given this information, custom pathways to career success for individual faculty can be developed, moving beyond purely institutional level co-citation networks, which do little to advance faculty development at scale. In Figs 1c and d, the network increased by 75% in terms of graph density (0.007) and decreased by 18.8% (16) in terms of diameter. What this suggest in that the interconnectivity of the network grew dramatically, while the ability for new members to integrate into it increased. This also apparent when one examines the modularity of the network down by 3.6% (0.857), this suggest that the network has as many communities but these communities are less isolated that those in the previous funding year, meaning fields are becoming more transdisciplinary in their collaborations. This was the result of the presence of a CTSA program, thus demonstrating the effectiveness of such institutions, however, our analysis also lays the framework for applying this to other institutions which may be considering a CTSA. Or maintaining the success of a given CTSA program, and ultimately determining where faculty should place their efforts and choose which programs to pursue career advancement.

OBJECTIVES/GOALS: Implementation science evaluations are often too time-intensive to provide actionable feedback during implementation, suggesting the need for more agile methods. We present an evaluation of the World Health Organization’s Emergency Care Toolkit implementation in Zambia using rapid qualitative methods to provide timely feedback. METHODS/STUDY POPULATION: We evaluated the implementation of the Emergency Care Toolkit in eight general and referral hospitals in Zambia in 2023 using a rapid-cycle, qualitative template analysis approach grounded in the Consolidated Framework for Implementation Research (CFIR). We gathered qualitative data from operational field notes, focus groups, and key informant interviews of administrators, clinicians, nurses, and support staff in all eight hospitals in Zambia. We parsimoniously applied CFIR constructs and tool-specific codes, focused on barriers and facilitators, to allow for rapid but comprehensive cross-case analysis. The results were used to generate a matrix of stakeholder-relevant, plain-language barriers and facilitators for each tool. RESULTS/ANTICIPATED RESULTS: We completed eight site visits with focus groups and interviews following initial implementation in September 2023 to gather firsthand knowledge related to implementation of the Toolkit. The CFIR-focused coding accelerated analysis by centering on barriers and facilitators for each tool while maintaining a comprehensive evaluation framework. Summary tables of barriers and facilitators were easily interpreted by lay stakeholders. Visualization in tables allowed for identification of common themes across tools and hospitals, making comprehensive recommendations to the implementation and dissemination process quickly possible. We anticipate the study findings will empower implementing partners to make timely, actionable improvements. DISCUSSION/SIGNIFICANCE: Rapid-cycle qualitative implementation evaluations allow for rigorous yet timely feedback on the implementation process compared to traditional methods. This efficient strategy is particularly important in resource-constrained environments where inefficient implementation wastes limited resources and create delays that cost lives.

OBJECTIVES/SPECIFIC AIMS: Autism spectrum disorder (ASD) affects 1 in 68 people and includes restricted, repetitive behavior, and social communication deficits. Aspects of face processing (i.e., identity, emotion perception) are impaired in some with ASD. Neuroimaging studies have shown aberrant patterns of brain activation and connectivity of face processing regions. However, small sample sizes and inconsistent results have hindered clinical utility of these findings. The study aims to establish consistent patterns of brain responses to faces in ASD and provide directions for future research. METHODS/STUDY POPULATION: Neuroimaging studies were identified through a multi-database search according to PRISMA guidelines. In total, 23 studies were retained for a sample size of 383 healthy controls and 345 ASD. Peak coordinates were extracted for activation likelihood estimation (ALE) in GingerALE v2.3.6. Follow-up ALE analyses investigated directed Versus undirected gaze, static Versus dynamic, emotional Versus neutral, and familiar Versus unfamiliar faces. RESULTS/ANTICIPATED RESULTS: Faces produced bilateral activation of the fusiform gyrus (FG) in healthy controls (−42 −52 −20; 22 −74 −12, p<0.05, FDR) and left FG activation in ASD (−42 −54 −16, p<0.05, FDR). Activation in both groups was lateral to the mid-fusiform sulcus. Follow-up results pending. DISCUSSION/SIGNIFICANCE OF IMPACT: Reduced right FG activation to faces may inform biomarker or response to intervention studies. Mid-fusiform sulcus proved a reliable predictor of functional divides should be investigated on a subject-specific level.

Objectives/Goals: Port-site metastasis (PSM), defined as the spread of malignancies to the abdominal wall at the site of surgical ports, poses a significant challenge in cancer management. The objective of this summary overview is to describe the prevalence of and risk factors associated with PSM in various gynecological cancers after laparoscopic surgery. Methods/Study Population: Study design: Systematic Review and Meta analysis Search strategy: All international databases, without language limitations, from January 1990 to December 2023. Inclusion/exclusion criteria: Cohort, case–control, or cross-sectional observational studies reporting the frequency of, or risk factors for PSM in young and middle-aged women will be included (using the PRISMA checklist). Data extraction: two reviewers independently extracting pertinent data (using the STROBE checklist). Quality assessment and risk of bias: The quality of each study will be assessed according to the Quality Assessment Tool for Observational Studies. Results/Anticipated Results: This meta-analysis of 36 studies evaluated the proportion of successes across various populations, with a pooled proportion of 0.02 (95% CI: 0.01–0.02) based on a random-effects model. Significant heterogeneity was identified (I²  =  88.12%), reflecting notable variability between studies. Despite this, the overall effect was statistically significant (p  =  0.00). A subgroup analysis will be conducted to explore potential sources of heterogeneity, considering factors such as cancer stage, diagnostic methods, surgical approach (conventional or robotic), and study type (retrospective/prospective). Discussion/Significance of Impact: By identifying the prevalence of, and the risk factors for, PSM, this study will better inform personalized treatment approaches, surveillance strategies, and surgical decision-making to improve patient-related outcomes and long-term survival in women with gynecological malignancies.

OBJECTIVES/GOALS: Vaginal ring delivery of antiretroviral drugs may provide protection against acquisition of HIV-1 when used as pre-exposure prophylaxis. As part of a randomized placebo-controlled safety trial of a tenofovir disoproxil fumarate (TDF) intravaginal ring (IVR), we assessed product acceptability through surveys of 17 women after continuous ring use. METHODS/STUDY POPULATION: Sexually active, HIV negative women between the ages of 18 and 45 were enrolled to investigate the safety and pharmacokinetics of three months of continuous TDF IVR use. The study was designed to include 40 US participants randomly assigned (3:1) to a TDF or placebo IVR. Twelve were randomized to TDF and five were assigned to the placebo group before the study was electively discontinued due to development of vaginal ulcerations in eight women in the TDF group. Acceptability data regarding TDF and placebo ring use was gathered via self-administered, computer-based questionnaires at the one- and three-month study visits. Participants were asked about overall attitudes and feelings regarding the TDF and placebo IVR, vaginal changes associated with ring use, and their experiences with ring use during menses and with sex. RESULTS/ANTICIPATED RESULTS: The mean age of participants was 30 years (range 18 - 42). Sixteen of 17 (94%) participants completed all study questions at both visits. When asked about ring likeability at one-month, 12 of 16 (75%) women reported overall liking the ring, including 5 of 8 (63%) who developed ulcerations. Vaginal changes described during ring use included 8 participants who indicated that the “vagina was wetter” and 2 who reported that the “vagina was drier.” Additionally, 10 of 12 (83%) who had their period during the first month of the study were not bothered by ring use during menses, and 11 of 16 (69%) stated that the ring was not bothersome with use during sex. When asked at the three-month visit, most reported that they would prefer to wear the ring rather than use a condom during sex, however, condom use was low at baseline in this population. DISCUSSION/SIGNIFICANCE OF IMPACT: Despite unanticipated ulcers, the IVRs were acceptable, especially when used with menses and during sex. Regardless of the group assigned or vaginal changes experienced, and even amongst those who developed ulcerations, the women had positive attitudes towards the ring, which is promising for future use of vaginal rings as a method for HIV prevention.

Objectives/Goals: Artificial Intelligence(AI)and automation are rapidly transforming healthcare, yet their integration into clinical workflows often falls short due to technical, ethical, and organizational challenges. A standardized, quality-driven approach can aid the AI implementation process and ensure value delivery. Methods/Study Population: Trust emerges as the central hurdle, encompassing both patient and provider confidence in AI systems. Patients raise concerns over safety, transparency, and the physician-patient relationship, while providers express apprehension towards algorithmic opacity, data quality, and legal ambiguity. To address these concerns, the Understand, Transform, Sustain (UTS) framework offers a behavior-based, systems-level approach to AI deployment. Developed by Mayo Clinic’s Quality Academy, UTS integrates process improvement (PI) principles across three phases, emphasizing stakeholder engagement, transparency, and patient safety throughout the AI lifecycle. Results/Anticipated Results: The Understand phase identifies inefficiencies by mapping workflows, collecting data, and recognizing areas for improvement, ensuring appropriate priorities are addressed. In the Transform phase, interventions are designed, implemented, and tested through improvement cycles and feedback loops. Data to build algorithms are carefully evaluated to avoid biases, and AI output is assessed for opacity risk to maintain transparency and explain ability. The Sustain phase monitors outcomes and standardizes practices for long-term value. Data audits and automated extraction tools are applied for fidelity and harmonization, promoting scalability and collaboration among organizations. Discussion/Significance of Impact: While keeping human intelligence central to AI integration, UTS ensures sustained efficiency and trust – critical for successful healthcare transformation. This framework positions itself as a catalyst for responsible innovation, aligning technological advancement with clinical priorities and patient protection.

OBJECTIVES/GOALS: The aim of this study was to design and implement the Pharos application to map the cellular network support structure around Lake Victoria in Western Kenya. Additionally, the Pharos app was used to collect images of disease-relevant vector and plant life surrounding the study sites to train a computer vision algorithm to map disease-relevant areas. METHODS/STUDY POPULATION: Pharos was provided to a 4-person team of healthcare workers. The app was pre-loaded on both iOS and Android devices to be used during the course of normal field activity. Pharos ambiently collects network data and the team was asked to capture images of landmarks relevant to their work in schistosomiasis control. The field team traveled to 4 counties of differing schistosomiasis risk surrounding Kisumu, Kenya in autumn 2022 and will return to these areas in early spring 2023. Cell signal indicators (upload and download speed) were collected and asynchronously uploaded to a database for further analysis. Additionally, all landmark images (cell network towers, landmarks (e.g. schools, churches, public centers), plant life, vectors, and water bodies) were recorded and tagged with GPS coordinates and time stamps. RESULTS/ANTICIPATED RESULTS: Iterative development powered by small, informal, user-centered focus group discussions with the field team led to several key adaptations to the Pharos software. On the first deployment, 1,297 unique upload and download events were recorded across 3 Kenyan cell providers and 1 American provider. 1,197 data points were collected in Kenya using both Android and iOS devices using several versions of the Pharos application. 154 unique landmarks were photographed, but a distinct difference in landmark recording was observed between devices, prompting a transition to iOS-only data collection. Of the landmarks recorded, the majority (120, 77.9%) were landmarks or cell network towers, while 22.1% were water bodies, plant life, or schistosomiasis vectors. DISCUSSION/SIGNIFICANCE: For the first time, high-detail maps of cellular signal and critical schistosomiasis-related landmarks were generated. Future work on this project is focused on training computer vision algorithms using the captured images of environmental and ecological factors to isolate possible areas of human disease transmission.

OBJECTIVES/GOALS: Disparities in pediatric kidney transplantation (KT) result in reduced access and worse outcomes for minority children. We aimed to assess the impact of recent systemic changes on these disparities. METHODS/STUDY POPULATION: Retrospective cohort study of pediatric patients utilizing data from the United States Renal Data System (USRDS) and Scientific Registry of Transplant Recipients (SRTR). We compared access to transplantation, time to deceased donor kidney transplant (DDKT), and allograft failure (ACGF) using Cox proportional hazards in the 4 years preceding KAS to the 4 years post-KAS implementation. RESULTS/ANTICIPATED RESULTS: Compared to the pre-KAS era, patients post-KAS were more likely to be pre-emptively listed (26.8% vs 38.1%, p<0.001) and pre-emptively transplanted (23.8% vs 28.0%, p<0.001), however these benefits were not uniform across racial groups. Only 12.7% and 15.7% of Black and Hispanic children received a pre-emptive transplant compared to 29.6%, 49.8% and 54.4% of White, Asian and Other race children respectively. Compared to White children, Black and Hispanic children had a lower likelihood of transplant listing within 2 years of first dialysis service aHR 0.67 (0.59-0.76) and 0.82 (0.73-0.92), in the post-KAS era. Time to DDKT after listing was comparable across all racial groups in both eras. Black children have disproportionally worse 5-yr ACGF, aHR 1.50 (1.08-2.09), p=0.02. DISCUSSION/SIGNIFICANCE: After KAS implementation there remains equity in time to DDKT, however disparities persist in transplant listing and ACGF among Black children. Further studies are needed to identify granular SES factors impacting delayed referral and systemic barriers to transplant, as well as risk factors for poor allograft outcomes among minority children.

OBJECTIVES/SPECIFIC AIMS: This research project envisions the integration of Homeless Management Information System (HMIS) and UI Health Cerner electronic medical record (EMR) system with the following goals: (1) enable sharing of data about the status of the housing insecure and homeless. (2) Identify and match patient record accurately. (3) Record housing insecurity or homelessness information with structured data elements in the EMR. METHODS/STUDY POPULATION: We created a Master Person Index (MPI) of the homeless individuals from HMSI using OpenEMPI software package, which is an open source implementation of an Enterprise Master Patient Index (EMPI). An entity model was generated based on the selective data elements from HMIS database, which were relevant for the patient identity management and healthcare service management. An automated script was implemented to extract data from HMIS and load it into OpenEMPI to build the MPI. Once the MPI is setup, the Emergency Department users were able to perform patient identity matching and confirm housing insecure or homeless status of their patients by querying the index using the web-based tool. We developed structured data elements to record homelessness information, which will allow us to measure the prevalence of this risk among patients. We are also exploring the possibility to integrate the systems the using the IHE PIX/PDQ profile, which provides ways for healthcare applications to query a patient information server for a patient based on user-defined search criteria, and retrieve a patient’s information directly into the application. RESULTS/ANTICIPATED RESULTS: We implemented a MPI of homeless individuals, which would allow the emergency department users to perform patient identity matching of housing insecure or homeless patients, without undue privacy intrusions. We are confident that IHE PIX/PDQ profile is able to support the integration of healthcare and housing and homeless services systems and enable the data sharing in an efficient way. DISCUSSION/SIGNIFICANCE OF IMPACT: The project addressed the gap in the sharing of data about housing insecure or homeless persons between healthcare and housing and social services that will result in improvements in coordination of care, reduce the cycle time from recognition of risk to the referral to housing and services and improve health outcomes and residential stability. Successful completion of this integration project will give us a model that we can scale to many other communities.

Clinical research professionals (CRPs) are essential contributors to clinical and translational research endeavors, encompassing roles such as research nurses, research coordinators, data managers, and regulatory affairs specialists. This paper reports on the implementation of a novel training program for the CRPs, the Co-mentoring Circles Program, developed by the University of Florida Health Clinical Research Professionals Consortium, and proposes an initial logic model of CRP workforce development informed by the observations, participant feedback, and the established Translational Workforce Logic Model. The co-mentoring program was delivered through an online didactic curriculum and bi-monthly meetings over nine months, from January to September 2022. The formative evaluation identified the factors that support CRP workforce development through knowledge acquisition and professional relationship building. Finally, this paper proposes a logic model of CRP workforce development, including financial and human inputs, didactic and co-mentoring activities, workforce outputs, outputs related to workforce and clinical research study progress, and resulting impacts of increased national capacity for translational research and increased rate of research translation.

Machine learning (ML) provides the ability to examine massive datasets and uncover patterns within data without relying on a priori assumptions such as specific variable associations, linearity in relationships, or prespecified statistical interactions. However, the application of ML to healthcare data has been met with mixed results, especially when using administrative datasets such as the electronic health record. The black box nature of many ML algorithms contributes to an erroneous assumption that these algorithms can overcome major data issues inherent in large administrative healthcare data. As with other research endeavors, good data and analytic design is crucial to ML-based studies. In this paper, we will provide an overview of common misconceptions for ML, the corresponding truths, and suggestions for incorporating these methods into healthcare research while maintaining a sound study design.

The Students Participating as Ambassadors for Research in Kentucky (SPARK) program provides novel health equity research training and targeted mentorship for undergraduates, particularly those from groups underrepresented in the biomedical and behavioral research and workforce. SPARK aims to address inadequate diversity in the medical and scientific research fields by providing comprehensive research mentorship and skill-building. Unlike most existing research training programs that are brief, focus on laboratory research, or are limited to graduate students and junior faculty, SPARK delivers a 16-month intensive behavioral and population health science training, equipping students with needed tools to conceptualize, plan, execute, and analyze their own health equity research study. Trainees complete didactic coursework on health equity, study design and proposal development, data analysis, and ethics. Students receive a stipend and research expenses, and multiple mentors guide them in creating original research projects for which they serve as Principal Investigator. Students disseminate their findings annually at an academic research conference as a capstone. Evaluation data from the first three cohorts suggest SPARK has been pivotal in preparing students for graduate studies and research careers in health equity and behavioral and population health sciences, providing strong support for further investments in similar undergraduate research training models.

The COVID-19 global pandemic required the rapid development of vaccines with a quick start up of phase 1–3 studies with large enrollment targets. The University of California San Diego was identified as a site for the phase 3 trial of the mRNA-1273-SARS-CoV-2 vaccine. There were many challenges with scaling up a large-scale clinical trial in such a short time. This report describes the processes and procedures that were implemented to successfully complete the enrollment target in under 10 weeks. This required the team to identify existing tools that could rapidly be accessed to develop a database, scheduling system, effective communication, document management, staff time tracking/efficiency, subject scheduling/tracking, project management, and accrual/study performance. The outcome of these efforts resulted in rapid enrollment and study completion in a short time. The lessons learned from this experience can be used by other clinical trial sites faced with similar challenges.