bluuebunny/crossref_metadata_2025 huggingface dataset:
95347 Examining the Impact of the BPCA: Promoting Pediatric Inclusion in Clinical Trials and Pediatric-Specific Drug Information
Authors: Ly Annie , Church Terry
Published: March 2021

ABSTRACT IMPACT: It provides insight in the relationship between pediatrics and clinical research and how pediatric participation in CT translates to clinical significance in form of drug labels, which inform clinicians on how to prescribe pediatric medications. OBJECTIVES/GOALS: Assessing the extent that the Best Pharmaceuticals for Children Act (BPCA) advances pediatric inclusion in clinical trials (CTs) and the availability of pediatric-specific drug information METHODS/STUDY POPULATION: The BPCA provides the U.S. Food and Drug Administration (FDA) authority to solicit sponsors whose drugs may benefit pediatric populations. Participation is voluntary and provides additional market exclusivity and pediatric information. CTs that received marketing exclusivity from 2016-2018 under BPCA were reviewed using Clinicaltrials.gov to access the legislation’s impact. CTs were categorized according to eligibility: (1) pediatric and adult groups, (2) pediatrics, and (3) pediatric sub-groups. Studies were excluded for ambiguous age data. Studies open to both groups were evaluated for pediatric participation. Each drug was searched in DailyMed.com for published pediatric indications. RESULTS/ANTICIPATED RESULTS: Between 2016 - 2018, 22 drugs received marketing exclusivity under BPCA. Of the 196 CTs conducted for these drugs, 135 were available to adults and pediatrics, 10 were available to the entire pediatric population, and 51 were available to specific pediatric sub-populations. Exclusion criteria permitted only 118 of the CTs for assessment where eligibility included both pediatric and adult populations, of which 65 of these had less than 1% pediatric representation. Of the 22 drugs, 20 have pediatric indications. Over this three-year period, the number of CTs where adults and pediatrics were eligible were greater than CTs for pediatric only or pediatric subpopulations. DISCUSSION/SIGNIFICANCE OF FINDINGS: It is prevalent for BPCA compliant CTs to include both; 65% of drugs (13/20) with pediatric indications had more studies involving both groups than only pediatrics. Adequate pediatric CT representation is necessary for developing pediatric drug labeling with meaningful data for clinical indications.
27229 Team Science: A Two-Year Follow-Up Case Study of Rutgers’ Ideation Forum
Authors: Arman Hosen , Razeq Ziyad , Reichmann Nancy , Lattime Edmund , Parekkadan Biju
Published: March 2021

ABSTRACT IMPACT: This study will provide important insight about effective team formation from coming up with an idea to successfully implementing that idea, as well as will highlight the implementation, evolution, and future directions of a team science initiatives. OBJECTIVES/GOALS: The goal of this study is to describe the feasibility of initiating an ideation forum to catalyze team formation, explore the process by which themes and teams are selected to participate in the forum setting, and assess the progress of participating teams post-forum through internal and external funding and other synergistic research activities. METHODS/STUDY POPULATION: Three ideation forums took place between 2018-2019 at Rutgers University, with a defined process and collection of data. The method of intervention to trigger team science, specifically the methodology employed to identify teams and produce new collaborative ideas, will first be described to show the feasibility of such an event to encourage team formation. In post-hoc analysis, we compare various success matrices of participating teams received seed funding versus teams that didn’t receive any funding to assess the progress of teams in the research ideation forum incubation process. RESULTS/ANTICIPATED RESULTS: Triggering team science through ideation forums is feasible and, in fact, quite productive to creating a durable response in formed teams showing continued productivity in publications, fundraising, and other academic metrics. DISCUSSION/SIGNIFICANCE OF FINDINGS: Our case review can illuminate how academic institutions can support team science research through ideation forums. In addition, this study lays an initial foundation for improvements in ideation forum creation and new metrics that can be shared broadly to compare across other institutions.
00005 Urine tumor DNA detects minimal residual disease in muscle-invasive bladder cancer treated with curative-intent radical cystectomy
Authors: Chen Kevin , Chauhan Pradeep S. , Babbra Ramandeep K. , Feng Wenjia , Kim Eric H. , Smith Zachary L. , Arora Vivek K. , Chaudhuri Aadel A.
Published: March 2021

ABSTRACT IMPACT: Urine tumor DNA non-invasively detects minimal residual disease and infers tumor mutational burden in locally advanced bladder cancer prior to radical cystectomy, which may potentially enable the selection of patients for bladder-sparing treatment or facilitate personalized adjuvant immunotherapy. OBJECTIVES/GOALS: Standard-of-care treatment for muscle-invasive bladder cancer (MIBC) is radical cystectomy. The inability to assess minimal residual disease (MRD) non-invasively limits our ability to offer bladder-sparing treatment. We sought to develop a liquid biopsy solution via urine tumor DNA (utDNA) analysis. METHODS/STUDY POPULATION: We applied uCAPP-Seq, a targeted sequencing method for detecting utDNA, to urine cell-free DNA samples acquired on the day of radical cystectomy from 42 patients with bladder cancer. utDNA variant-calling was performed non-invasively without prior tumor mutational knowledge. The overall utDNA level for each patient was represented by the non-silent mutation with the highest variant allele fraction after removing germline variants. Urine was similarly analyzed from 15 healthy adults. Tumor mutational burden (TMB) was inferred from the number of non-silent mutations detected in urine cell-free DNA by applying a linear relationship derived from TCGA whole exome sequencing of 409 MIBC tumors. RESULTS/ANTICIPATED RESULTS: utDNA levels were significantly higher in patients with residual disease detected in their surgical pathology compared to those who achieved a pathologic complete response (P = 0.002). Using an optimal utDNA threshold to define MRD detection, positive utDNA MRD significantly predicted the absence of pathologic complete response with a sensitivity of 81% and specificity of 81%. Positive utDNA MRD also portended significantly worse progression-free survival (HR = 7.4; P = 0.03) compared to negative utDNA MRD. Furthermore, we applied a linear relationship (Pearson r = 0.84; P < 0.0001) to identify patients with high inferred TMB who may have been candidates for early immune checkpoint blockade. DISCUSSION/SIGNIFICANCE OF FINDINGS: utDNA MRD analysis prior to surgery correlated significantly with pathologic response and progression-free survival, which may help select patients for bladder-sparing treatment. utDNA can also non-invasively infer TMB, which could facilitate personalized adjuvant therapy for patients in the future.
16306 Genomic epidemiology of SARS-CoV-2 across New Mexico and the Mountain West
Authors: Domman Daryl , Schwalm Kurt , Kunde Twila , Hicks Joseph , Edwards Michael , Hull Noah , Manley Wanda , Romero-Severson Ethan , Goldberg Emma , Dinwiddie Darrell
Published: March 2021

ABSTRACT IMPACT: Genomic data can be used by policy and decision makers to guide, and assess the impact of, public health responses to the COVID-19 pandemic. OBJECTIVES/GOALS: Our objective is to investigate the transmission and population dynamics of SARS-CoV-2 in New Mexico and other Mountain West states using whole genome sequencing. Understanding how the virus is spreading within and between communities is vital for the design of rational, evidence-based control measures. METHODS/STUDY POPULATION: We obtained an aliquot of 500ul - 1 ml of inactivated viral transport media (VTM) from positive SARS-CoV-2 nasopharyngeal swabs as determined by qPCR from the New Mexico Department of Health, TriCore Reference Laboratory, Idaho Bureau of Laboratories, and Wyoming Public Health Laboratory. We extracted viral RNA from the VTM, and sequenced the genomes using the methodology as described by the widely adopted ARTIC amplicon tiling protocol for SARS-CoV-2. Viral genomes were then sequenced on either an Illumina MiSeq or an Oxford Nanopore Technologies (ONT) GridION. We placed these samples within the context of globally representative sequences made available via the GISAID database. Consensus sequences were aligned and added into this global dataset using the Nextstrain augur pipeline. RESULTS/ANTICIPATED RESULTS: We sequenced over 1,000 SARS-CoV-2 genomes thus far from New Mexico (n=861), Wyoming (n=213) and Idaho (n=44). We used this sequence data to infer the transmission dynamics and spread of the virus, both within states and in context of regional and international spread. We inferred at least 128 separate introductions of the virus into New Mexico and at least 29 introductions into Wyoming. The origins of these introductions are diverse, spread across multiple regions in the US and abroad. We also sequenced samples from an individual who had multiple positive tests over time. Our results suggest that this individual was re-infected with a different strain than that of the initial infection. DISCUSSION/SIGNIFICANCE OF FINDINGS: Our data show that New Mexico and other Mountain West states have continually experienced many introductions of the virus that then seed local outbreaks. By understanding the number of introductions over time, we can assess the impact of travel restrictions on transmission. Our data also supports that some individuals can be re-infected.
17547 Transitions of Care among Patients with Diabetes in the Deep South: Factors Associated with Hospital Readmissions
Authors: McDaniel Cassidi C. , Chou Chiahung
Published: March 2021

ABSTRACT IMPACT: Because diabetes disproportionately affects residents in the Deep South, identifying factors increasing the risk of hospital readmissions unique to this population can translate to tailored interventions and strategies to improve transitions of care and patients’ health outcomes. OBJECTIVES/GOALS: Patients with diabetes (PWD) are susceptible to hospital readmissions due to inadequate transitions of care (TOC). To better understand how to improve TOC, the objective of the study is to identify factors associated with readmissions among PWD in Alabama disproportionally affected by diabetes. METHODS/STUDY POPULATION: This retrospective cohort study utilizes electronic health record data from an urban health system in Alabama. The study population includes adults (≥18 years old) diagnosed with diabetes who were hospitalized between 2016 and 2020. Women who are pregnant during hospitalization or diagnosed with gestational diabetes are excluded. Patient’s index hospitalization is identified with a 3-month washout period preceding admission. The primary outcome is all-cause 30-day readmission. Characteristics are compared between patients with and without readmissions. Factors significantly associated with readmissions are identified with multiple logistic regression, adjusted for potential confounders. RESULTS/ANTICIPATED RESULTS: The sample size is expected to be around 30,000 individual PWD. Anticipated results include estimation of the all-cause 30-day readmission rate experienced by the PWD in Alabama. It is expected that various factors will be associated with either higher or lower odds of readmission, interpreted via odds ratios and 95% confidence intervals. Factors investigated are driven by previously identified risk factors of readmission from the literature, including but not limited to sociodemographic variables, lab values (A1C, glucose, serum albumin, serum sodium, etc.), vital signs (blood pressure), comorbidities, medications, length of stay, insurance coverage, geographic location, and social history. DISCUSSION/SIGNIFICANCE OF FINDINGS: Findings will establish evidence-based knowledge about TOC for PWD in the Deep South, specifically Alabama. Identifying factors associated with readmissions among PWD in Alabama will inform TOC intervention studies tailored to populations in the Deep South to effectively mitigate readmissions.
13715 Leveraging Clinical Research Infrastructure to Correct Identification of Patients’ Primary Care Physicians in a Community Hospital
Authors: Magda Laura , Perish Emily , Sherrod Darielle , Dubin Lisa , Clark-Howard Shavon , Aguilar Ashley , Cormier Mary , Smith Joshua , Meltzer David
Published: March 2021

ABSTRACT IMPACT: Correctly identifying and documenting patients’ primary care physicians in community hospital settings may improve clinical care and coordination for patients, potentially leading to a reduction in hospitalizations, while simultaneously increasing patient education and expanding the limits of electronic health record systems. OBJECTIVES/GOALS: Clinical research infrastructure can be leveraged to detect inaccuracies in primary care physician (PCP) identification and documentation in a community hospital. As a result, collaboration between clinical research and hospital clinical operations can produce long-term solutions required by patient-centered, learning health care systems. METHODS/STUDY POPULATION: Hospitalized patients at a community hospital were asked to verify the name of their PCP. The PCP name given by the patient was then compared to the PCP on file in the EHR system. A corrected list of PCP names for each patient was sent by a clinical research program to hospital management on a weekly basis and used to update the EHR. RESULTS/ANTICIPATED RESULTS: A total of 272 hospitalized patients were screened on the basis of eligibility and asked to verify their PCP name. Overall, 35.3% (N=96) of patients had incorrectly listed PCPs in the EHR system. DISCUSSION/SIGNIFICANCE OF FINDINGS: Accurate PCP identification processes may enable broader clinical communication and potentially reduce future hospitalizations by improving coordination of care. The benefits of collaboration between research and clinical activities may provide an opportunity to justify greater investment in clinical research in community settings.
48847 Assessing Transition Outcomes in Sickle Cell Disease (SCD) Prior To Implementation of A Formal Transition Program
Authors: Sheppard Sydney , Kanter Julie
Published: March 2021

ABSTRACT IMPACT: To identify potential facilitators and barriers to a successful transition in care. OBJECTIVES/GOALS: Improvements in care for children with sickle cell disease (SCD) have increased survival into adulthood. However, mortality rates are increasing in young adults. One of the challenges is providing appropriate care during transition from pediatric to adult care. The goal is to identify facilitators and barriers to a successful transition in care. METHODS/STUDY POPULATION: The UAB SCD Center serves a large area of Alabama. The pediatric program is in Birmingham and has outreach clinics in three other cities. The adult program only has one clinic located in Birmingham. With IRB approval, we performed a retrospective chart review of individuals with SCD (all genotypes) aged 18-24 (as of 1/31/2019) who were seen at least twice prior to age 18 (in pediatrics) and have confirmed SCD. Charts were reviewed for demographics, genotype, last known insurance, SCD therapy, clinic location, and transition status. Analyses were undertaken to determine predictors of successful transition (defined as coming to an appointment with an adult hematologist) and unsuccessful transition (defined as lost to follow-up (LTFU) without transfer of care). RESULTS/ANTICIPATED RESULTS: There were 544 individuals meeting inclusion criteria. Of this group, 234 were LTFU, 189 transitioned, 36 moved, and 15 died. Seventy patients are still under pediatric care and were excluded. Sixty-eight percent of patients that transitioned had their last pediatric visit in Birmingham, compared to only 32% of those that transitioned from outreach sites (p<.01). Patients were more likely to successfully transition if they had sickle cell anemia (HbSS or HbSÃŸ0) (p<.01) and if they were receiving hydroxyurea or chronic transfusion therapy (p<.01). DISCUSSION/SIGNIFICANCE OF FINDINGS: Geography, genotype, and SCD therapy are potential drivers for transition. Genotype in pediatrics likely confers disease severity, suggesting patients with worse SCD may be more likely to successfully transition. Novel strategies are needed to improve transition of care for patients outside of Birmingham and those with less severe disease.
73061 The UAB COVID-19 Collaborative Outcomes Research Enterprise (CORE): Developing a Learning Health System in Response to the Global Pandemic
Authors: Anderson Jami L. , Reamey Becky , Levitan Emily , Tunagur Alia , Mugavero Michael J.
Published: March 2021

ABSTRACT IMPACT: Interdisciplinary networks represent critical components of translational science and learning system development. Our work impacts translational research by presenting an evidence-based approach to developing interdisciplinary networks in response to the COVID-19 pandemic; the approach presented may have broad applications within other academic institutions and medical centers. OBJECTIVES/GOALS: As a local response to the COVID-19 pandemic, we established the University of Alabama at Birmingham COVID-19 Collaborative Outcomes Research Enterprise (CORE) as an interdisciplinary learning health system (LHS) to achieve an integrated health services and outcomes research response amid the pandemic. METHODS/STUDY POPULATION: We adapted a learning system framework, based upon a scoping review of the literature and the Knowledge to Action Framework for implementation science. Leveraging this framework, we developed an institutional-level collaborative network of extant expertise and resources to rapidly develop an interdisciplinary response to COVID-19. The network was designed to quickly collect newly published or clinical information related to COVID-19, to evaluate potential usefulness of this information, and to disseminate the new knowledge throughout the interdisciplinary network; we strove to engage a wide variety of expertise and skills in the network. Thus, we subsequently used social network analysis to examine the emergence of informal work patterns and diversified network capabilities based on the LHS framework. RESULTS/ANTICIPATED RESULTS: We identified three principal characteristics of institutional LHS development including: 1.) identifying network components; 2.) building the institutional collaborative network; and 3.) diversifying network capabilities. Seven critical components of LHS were identified including: 1.) collaborative and executive leadership, 2.) research coordinating committee, 3.) oversight and ethics committee, 4.) thematic scientific working groups, 5.) programmatic working groups, 6.) informatics capabilities, and 7.) patient advisory groups. Evolving from the topical interests of the initial CORE participants, three scientific working groups (health disparities, neurocognition, and critical care) were developed to support the learning network. DISCUSSION/SIGNIFICANCE OF FINDINGS: Interdisciplinary collaborative networks are critical to the development of LHS. The COVID-19 CORE LHS framework served as a foundational resource that may support further institutional-level efforts to develop responsive learning networks. The LHS approach presented may have broad applications within other academic institutions and centers.
95818 Physical and Cognitive Resilience and Alzheimer’s Disease in a Tibetan Buddhist Monastic Community
Authors: Namdul Tenzin , MacLehose Richard , Buchwald Dedra
Published: March 2021

ABSTRACT IMPACT: The findings of this study could lend us insights into behavioral intervention that could potentially prevent or slow the onset of Alzheimer’s disease. OBJECTIVES/GOALS: This study examines the association between cognitive and physical resilience and Alzheimer’s disease in a Tibetan Buddhist monastic community in southern India. METHODS/STUDY POPULATION: The study will employ mixed methods of semi- and unstructured interviews and surveys. The interviews will be conducted among 60 monks of age 50+ in six Tibetan monastic colleges in southern India. The interviews will comprise general questions related to monks’ monastic educations and practices, as well as clinical cognitive interviews. Interviewees will be randomly sampled from a census of monks at the six monasteries. Owing to COVID-19 crisis, we will begin data collection, starting with interviews via zoom in mid-December 2020. The survey, which includes demographic information, cognitive assessments, meditative practices, health, memory and physical activity, will be conducted among 400 monks. The survey will be performed onsite and is tentatively scheduled in the summer of 2021. RESULTS/ANTICIPATED RESULTS: The study will help to identify factors associated with physical and cognitive resilience and develop measures to quantify and describe meditative and cognitive practices. These data will be used to both adapt validated measures developed in Western populations for use with this unique population and to develop new items on physical and cognitive resilience to include in the planned survey. Furthermore, the study will provide information about the prevalence of Mild Cognitive Impairment and Alzheimer’s disease and related dementias in this population and development of the survey to capture culturally appropriate measures, including on meditation. The findings could eventually lend us insights into behavioral intervention that could potentially prevent or slow the onset of Alzheimer’s in wider population. DISCUSSION/SIGNIFICANCE OF FINDINGS: Cognitive and physical resilience are understood to confer significant benefits to health outcomes and healthy aging. However, the factors related to resilience, particularly in older adults, are poorly understood. This study will estimate the link between frequency and intensity of meditative practices and physical and cognitive resilience.
29791 Bird-delivered ivermectin as a novel urban West Nile virus prevention strategy
Authors: Holcomb Karen M , Nguyen Chilinh , Komar Nicholas , Foy Brian D , Barker Christopher M
Published: March 2021

ABSTRACT IMPACT: Successful implementation of this control strategy will result in a commercially available ivermectin-treated birdfeed that the public can use to protect themselves from infection with West Nile virus (WNV) by reducing mosquito survival and thereby suppressing WNV transmission around their homes. OBJECTIVES/GOALS: We assessed the efficacy and feasibility of ivermectin (IVM)-treated birds as a mosquito control strategy for local reduction of West Nile virus (WNV) transmission. We conducted a randomized field trial in backyard chickens and developed a mathematical model informed by field data to predict the impact of treated wild birds on transmission. METHODS/STUDY POPULATION: We placed 48 chickens in four treated and four untreated control flocks in backyards coops across Davis, CA and administered IVM daily in feed to treated flocks (Jul-Sep 2019). We assessed entomological indices weekly (i.e. Culex mosquito abundance, WNV infection prevalence, and parity rate) around each coop, monitored serum IVM levels in treated chickens, and tested for WNV antibodies in all chickens. Shifting our focus to wild birds, we developed a spatially-implicit mathematical model of WNV transmission near IVM-treated birdfeeders. Model parameters for bird movement were based on our telemetry of 27 birds in Fort Collins, CO (Aug-Sep 2020). Using the model, we predicted optimal deployment of treated feeders to provide local WNV control. RESULTS/ANTICIPATED RESULTS: WNV seroconversions were reduced in treated vs. untreated flocks, indicating a reduction in WNV transmission intensity at treated coops (P = 0.03). A sustained, but insignificant reduction in number of infected mosquitoes was observed near treated coops (P = 0.59); small sample sizes and below normal WNV prevalence in the study area limited our power. We anticipate that optimal spacing and number of IVM-treated birdfeeders required for effective WNV control in neighborhoods will depend on feeder usage rates by common bird species irrespective of WNV competence; broad availability of IVM-treated bloodmeals to mosquitoes will be more effective in reducing transmission than targeting the few species responsible for viral amplification. DISCUSSION/SIGNIFICANCE OF FINDINGS: IVM is a novel method for controlling zoonotic pathogens in the US and has the potential for targeted mosquito control to reduce pesticide usage. Evaluating spatial deployment of IVM-treated bird feed for local reduction in WNV transmission is a stepping stone to commercial deployment of this WNV control strategy.
83569 Receipt of Pharmacologic Weaning Therapy and Developmental Delay
Authors: Campbell Angela G. , Zhang Pengyue , Gharbi Sami , Wiehe Sarah
Published: March 2021

ABSTRACT IMPACT: This study evaluates the long term effects of pharmacologic weaning therapy for opiate exposed infants. OBJECTIVES/GOALS: Infants born to chronic opioid users often suffer from neonatal abstinence syndrome (NAS), a condition characterized by tremors, diarrhea, hyperirritability and an inconsolable high-pitched cry. Symptoms are treated with pharmacologic weaning therapy, but long-term effects of this treatment have not been established. METHODS/STUDY POPULATION: A sample of infants born between 2011-2017 was obtained from a large metropolitan hospital system. All infants who were exposed to opioids and received a Finnegan score were included in the sample (N=1,807). The analysis utilizes three dependent variables to measure developmental delay: motor delay, language delay or any delay, which includes general/non-specific delay in addition to motor and language delay. The treatment is defined as receipt of pharmacologic therapy with methadone or morphine. Maximum Finnegan score was also included as a continuous measure of the extent of the infant’s withdrawal symptoms. Linear models were utilized to determine a relationship between pharmacologic therapy and developmental delay with Maximum Finnegan score as an interaction term. RESULTS/ANTICIPATED RESULTS: In the linear models examining the main effects of weaning therapy on developmental delay, there was no relationship between pharmacologic therapy and motor delay (p=.260), language delay (p=.542) or any developmental delay (p=.176). When maximum Finnegan score was entered into the model as an interaction term the relationships were not significant. DISCUSSION/SIGNIFICANCE OF FINDINGS: These results suggest that while pharmacologic weaning is an appropriate treatment for withdrawal symptoms in infants, it is not a deterrent against developmental delays associated with NAS. This provides support suggest an increased focus on non-pharmacologic interventions such as breastfeeding as the first line of treatment for NAS infants.
17890 Cardiovascular risk factors in victims of child sexual abuse
Authors: Perez-Laras Linda R. , Marzán-Rodríguez Melissa , Laras Linda
Published: March 2021

ABSTRACT IMPACT: The impact of this study is to encourage health professionals to screen for violent experiences as potential risk factors for CVD and adapt interventions from the non-abused in children as in adults. OBJECTIVES/GOALS: This study aims to assess the relationship between child sexual abuse and cardiovascular risk factors (CVDRF) that present in children. The objectives will provide the prevalence of CVDRF, their association with types of sexual victimization, and a score to assess the impact. METHODS/STUDY POPULATION: This study is a chart review, cross-sectional study. The Puerto Rico Health Justice Center (PRHJC) is a forensic, transdisciplinary, victim-centered, trauma-informed, and evidence-based service. The demographic variables collected are age, sex; the cardiovascular risk factors variables include a level of physical activity, tobacco exposure/alcohol, vital signs (blood pressure, BMI), lipid profile, and C-reactive protein. Sexual violence variables are the type of victimization (sexual assault, sexual molestation), the number of victimizations, and the relationship with the offender. RESULTS/ANTICIPATED RESULTS: A previous study, which examined types of evidence related to the prosecution of sexual violence cases, found that among female victims, 54% was a victim of sexual assault, and 59% had at least one health concern. The study’s hypothesis includes that older and female victims have a higher prevalence of cardiovascular disease risk factors. Also, children victims of sexual assault will have more cardiovascular risk factors than victims of sexual molestation. The age group, sex, number of victimizations, and relationship with the offender will also impact the relationship between the type of victimization and cardiovascular risk factors. DISCUSSION/SIGNIFICANCE OF FINDINGS: Early identification of child sexual abuse is needed to prevent long-term health impacts. The study’s results will be significant in developing clinical guidelines for health care providers to identify child sexual abuse as a predictor of cardiovascular risk factors and encourage victim advocates to identify cardiovascular risk factors.
91756 A participatory approach to develop regional health priorities for clinical and translational research
Authors: Watanabe-Galloway Shinobu , Estabrooks Paul , Palm David , Navarrette Sean , Keeler Heidi , King Keyonna , Frankel Emily
Published: March 2021

ABSTRACT IMPACT: Regional health issues can be best addressed at the population-level and input from the communities is vital for prioritization of health issues. OBJECTIVES/GOALS: The Great Plains IDeA-CTR (GP IDeA-CTR) was developed to increase clinical and translational research (CTR) that can address regional health priorities. Here we describe a collaborative process used to identify regional health priorities using existing surveillance data and community input. METHODS/STUDY POPULATION: We used a participatory approach that included a partnership between the GP IDeA CTR Community-Engagement and Biostatistics, Epidemiology, and Research Design Cores to ensure priorities were data driven and also aligned with community-based perceptions of need. First, aggregated surveillance data across Nebraska, North Dakota, and South Dakota was presented to the GP IDeA CTR Community Advisory Board (CAB). Second, CAB members formed small groups and considered the information and generated priority health area lists. Third, small group lists were considered and discussed by the full CAB to finalize priority areas. Finally, the CAB reviewed the priorities annually thereafter. RESULTS/ANTICIPATED RESULTS: We identified priority areas for CTR that included (1) behavioral health, (2) injury prevention, (3) obesity, (4) technology to improve health care access, (5) connecting clinical/community services, and (5) addressing health disparities. These priorities align with population-based surveillance data that show lack of mental health care access, high prevalence of obesity, higher incidence of accidents, and existing racial, ethnic, and geographic health disparities. The CAB highlighted that research was also needed to improve how people can access the health innovations developed through CTR to address the other priority health issues with a goal to have an impact on population health. DISCUSSION/SIGNIFICANCE OF FINDINGS: By integrating data- and community-driven approaches we identified regional health priority areas that if addressed, can have significant impact in the GP IDeA CTR region. The priorities are listed on all GP IDeA-CTR funding announcements to encourage CTR in these areas.
10271 How The Kidney Reacts to Nutritional Changes?
Authors: Bielopolski Dana , Ronning Andrea , Tobin Jonathan N. , Kost Rhonda G.
Published: March 2021

ABSTRACT IMPACT: Understanding the mechanism underlying the DASH diet may shed light on the physiologic process by which nutrition influences blood pressure and potentially lead the way to new therapeutics that target ion channels. OBJECTIVES/GOALS: Hypertension is a disease of the westernized world, as it stems from lifestyle habits. Lower salt consumption reduces blood pressure, yet DASH diet is much more effective, lowering blood pressure as efficiently as one anti-hypertensive drug. The precise mechanism through which DASH achieves its effect is not understood, and this is the project goal. METHODS/STUDY POPULATION: We hypothesize that exposing hypertensive volunteers to a high potassium and low sodium DASH diet will change the composition of renal ion channel in an aldosterone-dependent manner, leading to excretion of both sodium and potassium and a reduction in blood pressure. To assess how the nutritional change changes ion channel composition in the kidneys’ epithelium in aldosterone-induced manner, we will monitor urine exosomes, which contain epithelial cell membranes. We designed an in-hospital nutritional studies recruiting 20 volunteers. Patients will consume carefully designed menu, and measurements will be collected daily: blood pressure, biologic samples including blood and urine electrolytes, aldosterone, and urine for exosomes. RESULTS/ANTICIPATED RESULTS: We have collected data from 5 research volunteers so far.following exposure to the high potassium diet, Aldosterone blood levels increased while blood level of both potassium and sodium was maintained within normal limits. Urinary ratio of electrolytes, sodium:potassium was reversed 5-7 days following nutritional change from 6 to 1. Both manual and automated 24-hour blood pressure measurements confirmed blood pressure reduction following nutritional change. The following illustrates the impact the diet had on a participant’s 24-hour ambulatory blood pressure. Daily mean blood pressure was reduced from 120/76 mmHG to 112/68, mean awake blood pressure was reduced from 125/80 mmHG to 117/72 mmHG, and mean sleep blood pressure was reduced from 112/69 to 103/60 mmHG DISCUSSION/SIGNIFICANCE OF FINDINGS: Understanding the mechanism underlying the DASH diet may shed light on the physiologic process by which nutrition influences blood pressure and potentially lead the way to new therapeutics that target ion channels. By introducing our participants to a healthier lifestyle, they could maintain lower blood pressure without requiring medication.
19144 Effect of Mesalamine on Metabolic Syndrome risk factors in Ulcerative Colitis Patients: A Retrospective study
Authors: Castillo Eliseo , Paniz Graziella Rangel , Arroyo-Mercado Fray , Ling Christina L. , Snow Harry , Choi Eunice
Published: March 2021

ABSTRACT IMPACT: Currently, there are no medications to treat metabolic syndrome and our research sheds light on a potential therapeutic that could prove beneficial for this disease that affects one-third of the US population. OBJECTIVES/GOALS: Our goal was to determine the role of the GI tract in MetS, specifically how approved GI-directed medications affect metabolic parameters. Thus, we assessed the effects of mesalamine, a common therapeutic utilized to treat mild to moderate UC, on metabolic parameters in comorbid UC and MetS patients METHODS/STUDY POPULATION: This was a retrospective study with data extracted from Cerner’s HealthFacts database across the United States (US). Inclusion criteria included adult patients (≥18 years old) with a diagnosis of UC and at least 3 of the 5 metabolic risk factors which included i) dyslipidemia, ii) low HDL, iii) hyperglycemia, iv) hypertension, and v) increased abdominal obesity as determined by elevated BMI. A total of 6197 patients across the US between the years of 2007 and 2017 were included. We pulled patients who had a mesalamine prescription within +/- 7 days of an encounter in which they were diagnosed with UC (index date) and the closest values to 3 and 12 months after the index date. Mean age for patients was 53.8 ±19.9, with predominance of female sex (52.9%) and white race (78.0%). RESULTS/ANTICIPATED RESULTS: There was an observed reduction in BMI, fasting glucose, and increase in HDL levels post start of mesalamine treatment along with a decrease in inflammatory markers (ESR and CRP) (p<0.001). DISCUSSION/SIGNIFICANCE OF FINDINGS: The GI tract contributes to numerous disorders associated with metabolic dysfunction. Our retrospective analysis revealed mesalamine treatment in comorbid UC and MetS patients improved metabolic parameters, providing evidence that targeting the GI tract in these individuals potentially improves dysregulated metabolic processes.
53746 Body Composition and Metabolic Profiles in Infants of Diabetic Mothers (IDM) as Predictors of Hunger Signaling Gene Expression
Authors: Azuma Dara , Maron Jill
Published: March 2021

ABSTRACT IMPACT: This study aims to advance the understanding of the biological mechanisms associated with feeding disturbances in infants born to diabetic mothers through non-invasive salivary gene expression analyses and body composition measurements at birth. OBJECTIVES/GOALS: To determine if non-invasive salivary gene expression analyses and body composition measurements at birth could elucidate biological mechanisms associated with aberrant feeding behaviors and disrupted metabolic profiles commonly seen in infants born to diabetic mothers. METHODS/STUDY POPULATION: This prospective cohort study enrolls subjects born at ≥35 weeks’ gestation without a history of intrauterine growth restriction or major congenital anomalies. The diabetic cohort is defined as infants born to mothers with gestational diabetes or type 2 diabetes. The primary outcome is salivary expression of the hunger signaling genes, AMPK and NPY2R. Secondary outcomes include infant body composition measurements, obtained by skinfold measurement and/or air displacement plethysmography, and salivary expression of the adipokines, leptin, ghrelin, and adiponectin. Multiple logistic regression will be used to determine which factors are associated with AMPK and NPY2R expression. RESULTS/ANTICIPATED RESULTS: We propose that poor oral intake seen in infants of diabetic mothers may be due to alterations in the expression of hunger signaling genes (decreased expression of AMPK; increased expression of NPY2R) resulting in a diminished feeding drive in these large for gestational age infants. In addition, infant adiposity and the expression of genes involved in the adipoinsular axis will be inversely proportional to feeding volume intake. Namely, increased neonatal fat mass will be associated with increased expression of leptin and decreased expression of ghrelin and adiponectin. DISCUSSION/SIGNIFICANCE OF FINDINGS: Infants of diabetic mothers are at higher risk of poor oral feeding in the newborn period. This study aims to elucidate the link between neonatal body composition, adipoinsular axis, and hunger signaling to explain this unique feeding phenotype.
44191 As Food Insecurity Worsens During COVID-19, Negative Mental Health Impact on Community Members Increases
Authors: Striley Catherine , Chaudhari Piyush , Varma Deepthi , Cottler Linda
Published: March 2021

ABSTRACT IMPACT: For community engagement to be impactful and reduce health inequity, it needs to address timely needs in the community, including COVID-19 impacts. Here, we describe how pre- and post-COVID-19 food insecurity worsened mental health among community members served by HealthStreet University of Florida community engagement program. OBJECTIVES/GOALS: COVID-19 impacts the economic vitality and the mental health of communities; research and engagement activities must consider the context in which we are practicing and the needs of our community members. METHODS/STUDY POPULATION: HealthStreet, the University of Florida community engagement program, sends Community Health Workers (CHWs) where people congregate to assess social determinants of health and medical histories, used to make referrals to services and research opportunities. CHWs conducted follow-up COVID-19 assessments measuring perceived stress, loneliness, depression, anxiety, binge drinking, and opioid use, as well as high blood pressure and food insecurity. Here, we consider mental health outcomes among 1,300 adults who reported being food insecure either at some time in the past 12 months at baseline, or at the COVID-19 follow-up assessment, and completed both. Chi-Square Test was used to determine p-values. RESULTS/ANTICIPATED RESULTS: Overall, at the COVID-19 follow-up assessment, 37.1% (of 1,300) were still food insecure during COVID-19 (same), 20.3% (had become food insecure during COVID-19 (worse) and 42.6% were no longer food insecure (better). Those who were no longer food insecure were more likely to report less stress, while those still food insecure were more likely to report the highest stress and loneliness (p<0.0001), while the worse off group was in the middle. Those who stayed food insecure were most likely to report depression and anxiety, and also high blood pressure and using opioids (p<.05) compared to those getting worse or better. Binge drinking behavior was not significantly different across groups. DISCUSSION/SIGNIFICANCE OF FINDINGS: Community engagement activities across CTSIs must be sensitive to the needs of their communities. HealthStreet findings show that new and continuing food insecurity negatively influence mental health problems, pointing to the need for engagement to address multiple problems.
51130 Risk of Prolonged Opioid Use After Intensive Care Unit Admission
Authors: Delaney Lia D , Kenney Brooke , Hu May , Englesbe Michael , Brummett Chad , Waljee Jennifer F
Published: March 2021

ABSTRACT IMPACT: This is the first examination of risk factors for prolonged opioid use after an ICU stay and will inform efforts to strengthen prescribing guidelines and care transition models for patients after critical illness. OBJECTIVES/GOALS: The majority of patients in intensive care units (ICU) receive opioids during admission, and up to 25% receive a prescription at discharge. However, transitions of care and prolonged use after discharge remain unknown. We aim to characterize risk factors for prolonged opioid use after an ICU stay. METHODS/STUDY POPULATION: A retrospective study using insurance claims from Optum Clinformatics ®Data Mart was conducted for opioid-naive adult patients (18-64 years) with an ICU admission from 2010 to 2019. The primary outcome was new persistent opioid use, defined as a continued prescription fill 91-180 days after discharge, in addition to a fill in the first 90 days. The primary exposure was an opioid fill at discharge. The ICU admission was characterized using the Clinical Classification System from the Agency of Healthcare Research and Quality, based on patients’primary diagnosis code. Diagnoses were combined into 11 groups highlighting the affected organ system/mechanism of injury. Logistic regression evaluated the associations of patient demographic and clinical characteristics with the probability of persistent opioid use. RESULTS/ANTICIPATED RESULTS: In this cohort of 90,721 patients discharged from the ICU, 3.3% continued to fill opioids at 6 months. An opioid prescription fill (OR 3.1; 95% CI 28 - 3.3) and benzodiazepine prescription fill (OR 1.6; 95% CI 1.4 - 1.8) within 3 days of ICU discharge were each significantly associated with the development of new persistent opioid use. Patient diagnosis groups of Musculoskeletal/Trauma (OR 2.3; 95% CI 2.0 - 2.6), Neoplasms (OR 1.6; 95% CI 1.5 - 1.9), and GI/Hepatobiliary (OR 1.5; 95% CI 1.3 - 1.8) were significantly more likely to develop new persistent use when compared to the Cardiovascular diagnosis group. DISCUSSION/SIGNIFICANCE OF FINDINGS: Opioid prescriptions at discharge after an ICU stay increase the odds of prolonged opioid use. These results will inform efforts to strengthen prescribing guidelines and care models after a critical illness. Further work will characterize the trajectory of prescribing and patient exposure to high-risk prescribing after ICU discharge.
59473 Clinical and demographic predictors of the need for pharmacotherapy in Neonatal Abstinence Syndrome (NAS)
Authors: Bibi Shawana , Breeze Janis , Terrin Norma , Davis Jonathan
Published: March 2021

ABSTRACT IMPACT: This work has the potential to help clinicians decide which infants exposed to in utero opioids, will need to be treated early or can be discharged home early based on their risk, thus reducing prolonged hospitalization OBJECTIVES/GOALS: To develop and validate a prediction model with inclusion of clinical and demographic risk factors to identify infants with NAS likely to need pharmacotherapy. METHODS/STUDY POPULATION: A pooled cohort of 761 infants from 5 different studies including 2 trials and 3 observational cohorts will be used to develop the model.

All infants >than or equal to 37 weeks gestational age born to mothers with history of OUD will be included. Infants with congenital disorders and severe medical and surgical illnesses will be excluded. Multivariable mixed effects logistic regression modeling will be performed to predict the need for pharmacologic treatment for NAS. Candidate variables will be included based on clinical knowledge and previously published data. Model performance will be evaluated by measuring discrimination using Area Under the Curve (AUC) statistics and calibration. Model will be internally validated using boot strap validation. RESULTS/ANTICIPATED RESULTS: Pending data analysis DISCUSSION/SIGNIFICANCE OF FINDINGS: Opioid Use Disorder in pregnancy has resulted in concurrent rise in NAS incidence. NAS affects opioid exposed infants variably and accurate prediction of its severity and need for treatment remains elusive. Known clinical and demographic factors can predict the need for NAS therapy in opioid exposed infants, aiding clinical decision making.
Comparing country risk and response to COVID-19 in the first 6 months across 25 Organisation for Economic Co-operation and Development countries using qualitative comparative analysis
Authors: Greener Ian
Published: March 2021

This paper explores the contextual and government response factors to the first-wave of the COVID-19 pandemic for 25 the Organisation for Economic Co-operation and Development nations using fuzzy-set qualitative comparative analysis. It considers configurations of: obesity rates; proportions of elderly people; inequality rates; country travel openness and COVID-19 testing regimes, against outcomes of COVID-19 mortality and case rates. It finds COVID-19 testing per case to be at the root of sufficient solutions for successful country responses, combined, in the most robust solutions, with either high proportions of elderly people or low international travel levels at the start of pandemic. The paper then locates its sample countries in relation to existing welfare typologies across two dimensions based on total social expenditure and proportional differences between the GINI coefficient before and after taxes and transfers. It finds that countries generally categorised as “liberal” in most existing typologies did the most poorly in their first-wave COVID-19 response.
A study of Aotearoa New Zealand enterprises: how different are Indigenous enterprises?
Authors: Haar Jarrod , Martin William John , Ruckstuhl Katharina , Ruwhiu Diane , Daellenbach Urs , Ghafoor Azka
Published: March 2021

Indigenous literature suggests Māori businesses are distinct within Aotearoa New Zealand, due to facing unique challenges and having different operating preferences. It could also be argued that Māori and non-Māori enterprises in the private, public and not-for-profit sectors are identical as a function of operating in similar markets. However, there is a paucity of empirical evidence, and the present article rectifies this with a study of 230 Aotearoa enterprises, including 24 Māori. We test differences and find Māori enterprises report higher cultural capital, which relates to employees' knowledge and skills towards working with and respecting cultural values. However, we find no differences across human capital, relational capital, entrepreneurial culture, and organisational performance. The findings suggest that apart from a culturally specific factor, Māori and non-Māori enterprises appear to be similarly enabled, which provides a useful benchmark for understanding Māori business. We discuss the implications for research.