bluuebunny/crossref_metadata_2025 huggingface dataset:
4420 Characterizing medical comorbidity prior to autism diagnosis in children before age two.
Authors: Failla Michelle D , Schwartz Kyle , Chaganti Shikha , Woynaroski Tiffany G , Cutting Laurie , Landman Bennett , Cascio Carissa
Published: July 2020

OBJECTIVES/GOALS: Autism spectrum disorder (ASD) is a developmental disorder with a high financial and personal burden. Individuals with ASD experience significant comorbid medical conditions. We identified conditions that appear prior to ASD diagnosis in order to potentially improve early screening practices. METHODS/STUDY POPULATION: We used electronic health record data from an anonymized database at Vanderbilt University Medical Center for individuals with ASD and matched controls to analyze comorbid conditions prior to an ASD diagnosis. Data were censored to include only individuals who first appeared in the databank prior to two years of age (ntotal = 1551, ncontrols = 976, nASD = 575). Comorbidities (~1800 conditions) were compared between the ASD and matched control group using a novel tool (pyPheWAS) to examine presence, count, and duration of comorbidities that occurred between 0-2 years old and before ASD diagnosis. RESULTS/ANTICIPATED RESULTS: Convulsions (p = 0.000404, ß = 0.807), constipation (p = 0.000789, ß = 0.894), and strabismus (p = 0.00243, ß = 1.155) were the most significant comorbid conditions prior to age 2 in individuals who would later be diagnosed with ASD. The group with ASD also had more visits associated with convulsions (p = 0.00511, ß = 0.195), diseases of the esophagus (p = 0.0117, ß = 1.675), and allergic reactions to food (p = 0.0119, ß = 0.540) prior to their diagnosis. The ASD group was also seen for a longer duration regarding convulsions (p = 0.000273, ß = 0.695), constipation (p = 0.00157, ß = 0.712), and malaise and fatigue (p = 0.00188, ß = 0.903) before ASD diagnosis. DISCUSSION/SIGNIFICANCE OF IMPACT: Precise comorbid condition profiles in early childhood may help uncover biomarkers leading to better prediction of a future ASD diagnosis. Medical conditions that precede the onset of measurable behavioral symptoms may enhance early screening, treatment, and intervention in ASD.
4557 Defining the relationship between kidney structure and function in patients with and without diabetes and hypertension
Authors: Quinn Ghazal Zekavat , Palmer Matthew , Cohen Jordana , Sheng Xin , Susztak Katalin
Published: July 2020

OBJECTIVES/GOALS: Histopathological descriptions of kidney tissue provide more information about kidney disease severity and prognosis than serum measures, yet most patients with chronic kidney disease do not undergo kidney biopsy. We aim to develop a method to determine the degree of renal injury in patients with diabetes and hypertension without the need for biopsy. METHODS/STUDY POPULATION: Clinical data and renal tissue samples were collected from 864 patients undergoing tumor-associated nephrectomy in seven medical centers in the United States. Exclusion criteria included age < 18, presence of pyelonephritis or non-diabetic or hypertensive renal disease or incomplete clinical or histopathologic data. 19 histologic parameters were scored in a blinded manner by one renal pathologist. We examined the relationship between and functional variables (such as estimated glomerular filtration rate (eGFR)). Polynomial regression analysis was performed to model histopathologic variables and important clinical parameters such as eGFR RESULTS/ANTICIPATED RESULTS: 607 samples met inclusion criteria and were stratified as: control (no history of diabetes or hypertension, n = 160), hypertension alone (n = 224) and both diabetes and hypertension (n = 223). Interstitial fibrosis (IF) and glomerulosclerosis (GS) had the strongest correlations with eGFR. Regression analysis was used to model histopathologic score for a given eGFR. We found that diabetes and hypertension modified the relationship between tubulointerstitial fibrosis and eGFR. For example, while hypertensive patients without diabetes had 33% IF at an eGFR of 30 ml/min/1.73m2 (r2 = 0.64, p<0.01), hypertensive patients with diabetes had 32% IF at an eGFR of 30 ml/min/1.73m2 (r2 = .43, p<0.01) and control patients had approximately 23% IF at an eGFR of 30 ml/min/1.73m2 (r2 = 0.22, p<0.01). DISCUSSION/SIGNIFICANCE OF IMPACT: Here, we describe the relationship between renal structural changes and renal function and show that hypertension significantly modifies the relationship at a given eGFR. These data can be used to reasonably predict renal structural changes given clinical information without the need for renal biopsy and may provide prognostic value.
4219 Discrepancies in flavor preferences among adult ever users of various tobacco products in the US – Findings from The Population Assessment of Tobacco and Health Study (2015-2016)
Authors: Schneller Liane M , Li Dongmei , Quiñones-Tavárez Zahíra , Goniewicz Maciej , Quisenberry Amanda , Xie Zidian , Rahman Irfan , McIntosh Scott , O’Connor Richard , Ossip Deborah J.
Published: July 2020

OBJECTIVES/GOALS: Flavorings differ between brands and tobacco products, potentially altering the sensory perceptions. This study aimed to examine discrepancies in flavor preference across various non-cigarette tobacco products among a national representative sample of US adult regular tobacco users. METHODS/STUDY POPULATION: Data from the Population Assessment of Tobacco and Health (PATH) Study Wave 3 (W3) were used. Weighted prevalence of flavor preference for various tobacco products, including electronic nicotine delivery systems (ENDS), traditional cigars, cigarillos/filtered cigars, hookah and snus/smokeless, was presented for 9,037 adult current and new former users of multiple flavored tobacco products. Within-subject flavor discrepancies were assessed using generalized estimating equations (GEE) models considering the complex sampling design of the PATH study. RESULTS/ANTICIPATED RESULTS: Most regular users of a flavored tobacco products reported using one flavor category per product. Fruit flavors, followed by tobacco, were the most common flavor categories among ENDS (32% and 25%, respectively) and hookah users (44% and 36%, respectively). Tobacco flavor was the most common among regular users of traditional cigars (80%), cigarillos/filtered cigars (55%), and smokeless tobacco (79%). Polytobacco users of ENDS and traditional cigars had the largest discrepancy, where about 68-76%% used different flavor categories when switching products. Conversely, polytobacco users of traditional cigars and cigarillos/filtered cigars had the lowest discrepancy (23-25%). DISCUSSION/SIGNIFICANCE OF IMPACT: Many consumers of multiple tobacco products had different flavor preferences when switching between products. In the event of a partial or full flavor ban for ENDS, these findings raise questions about consumer loyalty to a particular tobacco product or a particular flavor category. Conflict of Interest Description: MLG serves as a paid consultant for Johnson & Johnson and has received research grant from Pfizer, manufacturers of smoking cessation medications. The other authors have no conflicts to declare. CONFLICT OF INTEREST DESCRIPTION: MLG serves as a paid consultant for Johnson & Johnson and has received research grant from Pfizer, manufacturers of smoking cessation medications. The other authors have no conflicts to declare.
4541 Harnessing the Power of the Electronic Medical Record in Interstitial Lung Disease
Authors: Farrand Erica , Vittinghoff Eric , Collard Harold
Published: July 2020

OBJECTIVES/GOALS: Harnessing the EHR to support clinical research is critical for the study of rare diseases such as interstitial lung disease (ILD). However no studies have compared EHR and research-quality data in the ILD population. Our objectives were to (1) identify ILD patients and extract clinical data from an EHR system and (2) assess the performance of ILD data capture. METHODS/STUDY POPULATION: Case validated algorithms were implemented to identify patients from the University of California San Francisco EHR and extract key ILD clinical information including, demographic variables, process measures and patient outcomes. Key clinical information were defined based on consensus statements and ILD clinical trials. A subset of ILD patients, had variables recorded in both the EHR and a separate ILD longitudinal research database. The completeness of EHR data capture and level of agreement were compared between three data collection methods: (1) data manually and systematically collected for an ILD research database (gold standard), (2) data automatically extracted from structured fields in the EHR, and (3) data extracted from unstructured data sources. RESULTS/ANTICIPATED RESULTS: We identified 5857 ILD patients in the EHR, of which 2100 patients had data available in the both the EHR and research database. Baseline demographic variables, co-morbidities, use of diagnostic testing, pharmacotherapy were accurately extracted from structured fields. Outcome measures, including lung physiology, radiographic patterns, pathology results, and health related quality of life (HRQoL) were unevenly extracted from structured fields alone. With the exception of HRQoL, these measures were accurately captured in unstructured EHR sources. Notably, certain metrics were better defined in the EHR, including health care resource utilization metrics, acute exacerbations, medication side effects, supplemental oxygen use and specialty care referrals (rheumatology, lung transplant, palliative care, etc). DISCUSSION/SIGNIFICANCE OF IMPACT: A large real-world ILD cohort can be algorithmically extracted from the EHR along with key clinical variables with accuracy comparable to protocol-driven research databases. Rigorous assessment of the types of disease-specific variables that are present in EHR-derived data will inform future interventions to improve the fidelity, accessibility and use of the EHR in clinical research.
4474 READ-TV: Research and Exploratory Analysis Driven Time-data Visualization
Authors: Gaizo John Del , Alekseyenko Alexander , Catchpole Kenneth
Published: July 2020

OBJECTIVES/GOALS:

A web interface that allows for easy upload of CSV text data to time-based visualizations

Implementation of change points analysis to identify and display points where event rates increased or decreased

customizable plots where the user can change point shapes, color, etc.

customizable and advanced filtering support

support for plot comparisons and exports

METHODS/STUDY POPULATION: We used the R/Shiny framework to develop a web application for visualization of time stamped data. The Research and Exploratory Analysis Driven Time-data Visualization (READ-TV) application allows for user-friendly mining for longitudinal patterns in data. READ-TV is built specifically for FD analysis, but is easily adaptable to other clinical use cases, as we allow for the use of general metadata on events and cases.The building of a quantitative framework for event analysis starts with the application of homogeneous Poisson processes, which relate the times of occurrence of events in terms of an underlying rate. To understand the changes in this underlying rate, changepoint analysis is used to model the rate as a function of time using piecewise constant approximations. The changepoint analysis allows us to identify the specific periods of time where the rate of FD is increased relative to a baseline or a desired operating range. RESULTS/ANTICIPATED RESULTS: READ-TV application allows for import of time stamped event data from multiple cases. Event and case metadata are supported to facilitate filtering and mining of interesting subsets of data. Stem plots are used for visualization of selected event timelines in chosen cases. This visualization is accompanied with summary of the number and estimates of rates of occurrence of specific event types (e.g. types of FD). Change-point analysis is implemented using the ‘changepoint‘ R library. These analyses allow the users to quickly understand whether the rates of events (FD) is changing across the case timeline and where exactly these changes are occurring. DISCUSSION/SIGNIFICANCE OF IMPACT: We have demonstrated the READ-TV application to the team of the AHRQ-funded Human Factors and Systems Integration in High Technology Surgery (HF-SIgHTS) study. The ability to visualize and perform quantitative analysis of the study data was received with unanimous positive feedback and enthusiasm. We continue READ-TV development focusing on (1) increased user-friendliness using the HF-SIgHTS as our focus group, (2) increased functionality, and (3) use of more general localization terminology to allow for other applications.
4501 Statistical Modeling for Predicting Correct Drug Dose in the Presence of Conflicting Dose Information Extracted from Electronic Health Records
Authors: Williams Michael Lee , Weeks Hannah L , Beck Cole , McNeer Elizabeth , Choi Leena
Published: July 2020

OBJECTIVES/GOALS: Diverse medication-based studies require longitudinal drug dose information. EHRs can provide such data, but multiple mentions of a drug in the same clinical note can yield conflicting dose. We aimed to develop statistical methods which address this challenge by predicting the valid dose in the event that conflicting doses are extracted. METHODS/STUDY POPULATION: We extracted dose information for two test drugs, tacrolimus and lamotrigine, from Vanderbilt EHRs using a natural language processing system, medExtractR, which was developed by our team. A random forest classifier was used to estimate the probability of correctness for each extracted dose on the basis of subject longitudinal dosing patterns and extracted EHR note context. Using this feasibility measure and other features such as a summary of subject dosing history, we developed several statistical models to predict the dose on the basis of the extracted doses. The models developed based on supervised methods included a separate random forest regression, a transition model, and a boosting model. We also considered unsupervised methods and developed a Bayesian hierarchical model. RESULTS/ANTICIPATED RESULTS: We compared model-predicted doses to physician-validated doses to evaluate model performance. A random forest regression model outperformed all proposed models. As this model is a supervised model, its utility would depend on availability of validated dose. Our preliminary result from a Bayesian hierarchical model showed that it can be a promising alternative although performing less optimally. The Bayesian hierarchical model would be especially useful when validated dose data are not available, as it was developed in unsupervised modeling framework and hence does not require validated dose that can be difficult and time consuming to obtain. We evaluated the feasibility of each method for automatic implementation in our drug dosing extraction and processing system we have been developing. DISCUSSION/SIGNIFICANCE OF IMPACT: We will incorporate the developed methods as a part of our complete medication extraction system, which will allow to automatically prepare large longitudinal medication dose datasets for researchers. Availability of such data will enable diverse medication-based studies with drastically reduced barriers to data collection.
4363 TCF7L2 variants in African American patients with bipolar disorder and high BMI
Authors: Jackson Linsey , Coombes Brandon , Balls-Berry Joyce E. , Biernacka Joanna
Published: July 2020

OBJECTIVES/GOALS: In a previous genome-wide association study of European Americans, rs12772424, a variant in the gene encoding transcription factor 7-like 2 (TCF7L2), was shown to have a SNP-BMI interaction association with bipolar disorder (BD). The objective of this study was to replicate this finding in an African American (AA) sample. METHODS/STUDY POPULATION: Using a sample of 659 controls and 323 BD cases from the Genetic Association Information (GAIN) Study of BD, we conducted analyses to assess association between BD and the interaction of BMI with genetic variation in TCF7L2. For this study we identified 4572 single nucleotide polymorphisms (SNPs) in a 1Mb region around the candidate SNP rs1272424. Based on variants identified in the prior analysis of the larger European American dataset we selected SNPs for analysis in the AA data. This allowed for a smaller AA sample, and still maintained adequate power for statistical significance. RESULTS/ANTICIPATED RESULTS: We anticipate observing an effect of TCF7L2 variation on the relationship between BD and BMI in the AA data. We also anticipate that combining results from the European and African American patients may help narrow down potentially functional variants in TCF7L2 that influence the association between BD and BMI. DISCUSSION/SIGNIFICANCE OF IMPACT: Psychiatric genetics studies lack ancestral diversity among participants, decreasing their generalizability, and possibly increasing health disparities, especially for diseases like BD, which is often misdiagnosed and untreated in AAs. This work propels us towards understanding the genetics of BD and obesity in this underrepresented population.
4382 All IN for Health: Promoting good health and engaging a health research volunteer community in the Hoosier state
Authors: Hall Jessica , Drury Christine , Egan Carmel
Published: July 2020

OBJECTIVES/GOALS:

To improve and expand health and research literacy throughout Indiana by sharing health-focused resources and research outcomes.

To encourage and increase health research participation throughout Indiana by promoting health research opportunities, including clinical studies.

METHODS/STUDY POPULATION:

Discover and understand community concerns and barriers to good health and clinical research participation by providing a platform for individuals and communities to share their voices.

Educate Indiana residents on the importance of participating in health research.

Engage with the community to meet them where they are (online) and continue to build relationships throughout the state.

Promote healthy living for Indiana residents by sharing health education and resources from existing state health organizations and initiatives.

Develop and maintain the largest statewide database of research volunteers.

RESULTS/ANTICIPATED RESULTS:

The anticipated results from this program include engagement of all populations and all communities throughout the state in conversation and education around good health and health research, as well as participation in health research across the CTSI’s partner organizations. Large-scale growth is expected in both the online community and consented volunteer registry is expected to include and engage racially and ethnically diverse populations, as well as special health populations, such as representatives of rural communities, aged, rare disease survivors, and transgender individuals.

DISCUSSION/SIGNIFICANCE OF IMPACT:

Thorough this work, the Indiana CTSI has developed a unique program, educating the public about health research and opportunities to participate, while simultaneously supporting research departments with marketing promotion of their efforts, and a ready statewide volunteer community.
4032 An exploration of the perceptions of young women with breast cancer with varying health literacy levels about the usefulness of cancer educational materials
Authors: Parker Pearman , McSweeney Jean C , Zorn Kristin , Hadden Kristie , Greene Carolyn , Su L. Joseph , Meade Cathy
Published: July 2020

OBJECTIVES/GOALS: Young women (18 – 45 years of age) with breast cancer have complex medical and psychosocial needs. Educational materials are often used as tools in patient-centered communication. However, these materials disseminate complex health information in print-heavy formats and can be difficult to understand for women with varying health literacy levels. METHODS/STUDY POPULATION: In the first phase of this study, the principal investigator (PI) will recruit 40 diverse women to participate in four focus groups (FG) to explore the perceived usefulness of the most frequently used cancer educational materials. The PI will also obtain demographics and heath literacy levels of the FG participants using the Newest Vital Sign. In the second phase, the PI will assess the literacy demands of the ten most frequently used cancer educational print materials and five most frequently used websites described by the FG participants. The perceptions of the usefulness of materials and the literacy demands will then be used to appraise the effectiveness of materials within patient-centered cancer communication. RESULTS/ANTICIPATED RESULTS: Results from this study will provide a patient-centered blueprint that will be used to design more effective educational materials that treatment centers can incorporate into their patient-centered cancer communication process. The next step of this research will be to determine providers’ perceptions of cancer education materials used to exchange information within the patient-centered communication process. This will complement the patient findings and inform the development of the provider aspect of a communication intervention centered on designing educational materials for women with various health literacy levels within the patient-centered cancer communication process. DISCUSSION/SIGNIFICANCE OF IMPACT: Detecting the usefulness of cancer educational materials, as perceived by young women with breast cancer, is foundational to developing communication interventions that improve cancer outcomes. This study will identify how materials can be improved in the critical informational-exchange component of the patient-communication process.
4507 Developing and implementing a Principal Investigator (PI) primer to improve the conduct of human research at the University of Minnesota
Authors: Wright Jessica , Maas Jennifer , Hoffman Megan
Published: July 2020

OBJECTIVES/GOALS:

1.

Assess the institutional and individual training needs and gaps in the conduct of human research for PIs at the University of Minnesota.

2.

Define the training program’s learning objectives.

3.

Develop and implement an in-person training session that addresses the gaps.

METHODS/STUDY POPULATION:

Establish a planning committee

Identify required and optional training that is already available for PIs, then determine gaps

Understand research training needs based on conversations with departmental and human research protection program leaders.

Develop learning objectives and curriculum based on Federal and Local regulations, guidelines, and policies.

Establish a feedback loop regarding research compliance with the HRPP, to assess trends and ensure continuous improvement.

Evaluate the training program’s participants using confidence and satisfaction measures.

RESULTS/ANTICIPATED RESULTS: Developed and piloted a 90-minute in-person training program entitled “PI Primer” with the goals of:

Increasing awareness and knowledge of the role and responsibilities of the Principal Investigator (PIs) according to the International Harmonization for Good Clinical Practice (ICH-GCP), Federal Regulations (FDA, DHHS, ect.), and University of Minnesota Policies.

Identifying root causes for receiving an FDA 483 (inspection findings).

Addressing and preventing common inspection findings (CAPA).

Describe individual and institutional conflict of interest (COI), and identify the key steps necessary to manage COIs.

DISCUSSION/SIGNIFICANCE OF IMPACT: OHRP’s guidance on the “Responsibilities of Investigators” states that it is the Institution’s responsibility to provide human research training on a wide variety of topics to ensure the ethical conduct of research and protection of participants. PI Primer provides an in-person forum for investigators to build upon required responsible conduct of research and good clinical practice training to be able to apply the role and responsibilities of a PI to their own research. PI Primer also establishes a network of PIs in order to enhance connectivity and shared learning.
4552 Pediatrician Readiness to Participate in Clinical Trials: Roles of interest, barriers and interventions
Authors: Boateng Beatrice , Snowden Jessica , Munoz-Mendoza Diana , Nesmith Clare , Barr Frederick , James Laura , Perry Tamara
Published: July 2020

OBJECTIVES/GOALS: Clinical trials are the gold standard for developing evidence-based medicine. However, 20% of pediatric randomized clinical trials are discontinued and about 30% of completed trials go unpublished. (Pica and Bourgeois, 2016) Although patient recruitment is the most cited barrier to completing clinical trials, trials funded by academia are more likely discontinued compared to those funded by industry. This study is an attempt to gain additional insights into clinical trials in academic pediatrics. METHODS/STUDY POPULATION: Junior pediatrics faculty (Instructors and Assistant Professors) were recruited to participate in an online survey through RedCAP. The physicians were asked if they had prior experiences with clinical trials and whether they have interest in participating in clinical trials. Those interested were asked three additional questions: what role they were interested in, barriers to participating and interventions they thought would educate them about participating in clinical trials. RESULTS/ANTICIPATED RESULTS: Ninety two (92) out of 119 (77%) junior pediatrics faculty completed the survey. Twenty (20) pediatric subspecialties were represented and respondents were on various academic pathways. A third of the respondents (35%) had previously participated in clinical trials. A majority of the faculty respondents (84; 70%) are on the clinical educator pathway. The 13 respondents who were not interested in clinical trials indicated their preference for patient care, education and quality improvement. Of those interested in clinical trials, the top three preferred roles were site co-investigator (68%), help designing future protocol (47%) and site principal investigator (44%). Other than time, the top barriers to participation were a lack of awareness of what it takes to lead or engage in clinical trials (53%) and a lack of training on clinical trials (45%). Mentoring from an experienced clinical trialist emerged as the top preferred intervention (78%). DISCUSSION/SIGNIFICANCE OF IMPACT: Although limited to one institution, the findings of this study provide insights into pediatric faculty interest in clinical trials. If academic pediatricians are provided with mentoring, there could be an uptick in completed and published clinical trials involving pediatric populations.
4047 EEG as a Predictor of Post-Stroke Recovery: A Systematic Review and Meta-Analysis
Authors: Vatinno Amanda , Ramakrishnan Viswanathan , Simpson Annie , Bonilha Heather , Seo Na Jin
Published: July 2020

OBJECTIVES/GOALS: The objective of this study is to perform a systematic review and meta-analysis on the prognostic utility of electroencephalography (EEG) in stroke recovery. METHODS/STUDY POPULATION: A literature search was conducted using three electronic databases, including PubMed, Scopus, and CINAHL. Key search terms were “EEG,” “stroke,” and “rehabilitation”. Only peer-reviewed journal articles published in English that examined the relationship between EEG and a standardized clinical outcome measure(s) at a later time in stroke patients were included. Two independent raters completed data extraction and assessed methodological quality of the studies with the Downs and Black form. A linear meta-regression was performed across subsets of individual studies that utilized a common clinical outcome measure to determine the association between EEG and clinical outcome while adjusting for sample size and study quality. RESULTS/ANTICIPATED RESULTS: 56 papers met the inclusion criteria and were included in the systematic review. The prognostic value of EEG was evidenced at both the acute and chronic stages of stroke. The addition of EEG enhanced prognostic accuracy more than initial clinical assessment scores and/or lesion volume alone. In the meta-analysis, a subset of 10 papers that utilized the National Institutes of Health Stroke Scale (NIHSS) and a subset of 7 papers that utilized the Modified Rankin Scale (MRS) were included. Analysis demonstrated an association between EEG and the subsequent clinical outcome measures. DISCUSSION/SIGNIFICANCE OF IMPACT: Currently, prognosis is largely based on initial behavioral impairment level. However, post-stroke recovery outcomes are heterogeneous despite similar initial clinical presentations. Uncertain prognosis makes it difficult for clinicians to develop personalized treatment plans for patients. Improved prognosis for recovery may guide clinical management for stroke survivors by helping clinicians determine the maximally efficient course of treatment and care. This study suggests that prognostic accuracy may be enhanced using EEG.
4049 Evaluating Miami CTSI’s Pilot, Translational, and Clinical Studies Program using research success measures and CTSA Common Metrics
Authors: Das Rosalina , Avissar Patricia , Diaz Jessica , Dominguez Sheela C , Issenberg Barry S. , Dietrich Dalton W. , Sacco Ralph L.
Published: July 2020

OBJECTIVES/GOALS: The goal of this project was to a) evaluate the first five years of Miami CTSI’s Pilot Translational and Clinical Studies Program using outcome measures that quantify research productivity augmented by the CTSA Common Metrics; and b) use the results to shape future program management. METHODS/STUDY POPULATION: Pilot Program applicant and awardee demographic data were collected during the first 5-year cycle of the Miami CTSI grant. Projects were categorized into the translation spectrum based on type of research using published guidelines. Research productivity from funded pilot projects were tracked annually using internal institutional grant award databases and external databases such as PubMed and NIH Reporter. CTSA Common Metrics were tracked using the Results Based Accountability framework. Relative Citation Ratio (RCR), NIH percentile and translation impact of pilot project publications were determined using the iCite tool (NIH Office of Portfolio Analysis). RESULTS/ANTICIPATED RESULTS: The Miami CTSI’s Pilot Award Program demonstrated notable success in its first five years. Of the twenty-two projects that were funded during that time period, 45% led to follow-on funding for a total of $17.2M—a strong return on investment of 15:1. Further, 77% of awardees had at least one publication. A total of four patents and 43 publications resulted directly from the funded projects. The mean RCR for all publications was 2.7, weighted RCR was 99.87, and nine papers were been cited by clinical documents. Overall, 63% of the projects were classified as T1/T2 (pre-clinical/clinical research) and 37% as T3/T4 (post-clinical translational research/public health). DISCUSSION/SIGNIFICANCE OF IMPACT: Miami CTSI’s Pilot Award Program demonstrated success in scholarly output, follow on funding, and scientific impact. These results will serve as benchmarks going forward and will allow the CTSI to leverage program strengths in collaborating with other institutional internal award mechanisms.
4107 Implementation and evaluation of a novel protocol that uses clinical biomarkers to promote early diagnosis and treatment of Neurodevelopmental Disabilities
Authors: Johnson Tara Lynn , Sivakumar Sowmya , Kapil Namarta , Majmudar Bittu
Published: July 2020

OBJECTIVES/GOALS: Our objective was to establish a new protocol to evaluate new biomarkers to detect Neurodevelopmental Disabilities (NDD) in high-risk infants. As early intervention results in better outcomes, our goal was to implement the protocol to promote earlier NDD diagnosis and referral for treatment. METHODS/STUDY POPULATION: We implemented a new protocol using the General Movement Assessment (GMA), Hammersmith Infant Neurological Examination (HINE), and Capute Scales to evaluate infants who were at high risk of NDD. To determine the success of our protocol with these biomarkers, we studied former premature infants who were evaluated in follow-up clinic from 10/1/2018-10/1/2019. We defined our primary and secondary outcomes as the ages of neurodevelopmental diagnoses and referral to early intervention services before and after implementation of the new protocol, respectively. Our hypotheses were that infants who were evaluated with these biomarkers would be diagnosed with NDD and be referred for treatment at younger ages than their counterparts. RESULTS/ANTICIPATED RESULTS: Approximately 120 patients were evaluated during the time period that was defined. About half were evaluated prior to implementing the GMA and HINE, and the remainder were evaluated using GMA and other developmental measures. We anticipate that infants who underwent GMA will be diagnosed with NDD and referred for therapies at a younger age than their counterparts. DISCUSSION/SIGNIFICANCE OF IMPACT: Through our translational research, we will transform the standard of care for high-risk infants by incorporating clinical biomarkers into day-to-day clinical care for these infants. Implementation of this novel protocol will promote the early diagnosis and referral to treatment for NDD.
4299 The University of North Carolina CTSA Hub (NC TraCS) Service Evaluation: Using Customer Feedback to Improve Services
Authors: McKinley Shayne Thomas , Patel Tanha , Carey Tim , Buse John B , Carnegie Andrea , Corbie-Smith Giselle , Dave Gaurav
Published: July 2020

OBJECTIVES/GOALS: The North Carolina Translational and Clinical Sciences Institute (NC TraCS) supports faculty and staff in carrying out clinical and translational research at UNC-Chapel Hill. To better understand customer satisfaction and impact, a survey was administered among NC TraCS users. METHODS/STUDY POPULATION: NC TraCS has 13 program areas that range from Biostatistics to Community and Stakeholder Engagement. These programs provide services to faculty, staff, students, and outside researchers in the area of clinical and translational science. A customer feedback survey was administered in Spring 2019 to anyone who had used at least one NC TraCS service between March 1st, 2017 and February 28th, 2019. A total of 856 survey invitations were sent. The survey included questions around users’ perception of the ease of access, helpfulness, outcome, and promptness of the services received using 6-point Likert scale. The survey also addressed career impact, communications, and suggestions for improvement. RESULTS/ANTICIPATED RESULTS: We received 268 responses, (31% response). Majority of respondents were satisfied with Overall Helpfulness (95%), Outcome of Service (96%), Ease of Access (93%), and Promptness of Service (90%). They also noted that their careers had at least slightly improved in the following areas: Mentorship (76%), Research Methods (75%), Skill Development (77%), Research Direction (71%) and Collaboration (80%). Furthermore, 96% responded positively to returning to TraCS. The feedback received was shared with service administrators and NC TraCS leadership to identify areas of improvement and further strengthen their services. Concerns, when present, were addressed by service directors or the overall PI’s. DISCUSSION/SIGNIFICANCE OF IMPACT: Need to communicate expectations to customers the expected turn-around time for help emerged as a clear take-away. In response, TraCS leadership is working to improve staffing and workflows for efficient service delivery including expectation management, especially among the most popular services.
4527 Assessing Quality of Life, Depression, and Symptomatology in Puerto Rican Hispanic Patients Hospitalized with Heart Failure
Authors: Gonzalez-Cordero Ariel
Published: July 2020

OBJECTIVES/GOALS: Heart failure is a public health problem. Currently, heart failure affects 2-5 % of adults within the age of 65-75 years. (Mosterd & Hoes, 2007)Moreover, rates of hospitalization and rehospitalization among patients with heart failure are high and are associated with poor quality of life(Dunlay et al., 2011)Unsurprisingly, studies have found that poor quality of life is linked to decreased physical activity and increased symptomatology, a perception that can quickly change depending on the patient’s mood. Factors such as age, cultural background, socioeconomical status, ethnicity, and gender are highly correlated with quality of life but have not been studied thoroughly. Quality of life assessment in Puerto Rican Hispanics living with heart failure is non-existent. Objective:•To determine gender-specific differences in quality of life for patients hospitalized due to heart failure in Puerto Rico.•To correlate heart failure symptoms, presence of depression and level of perceived quality of life in Puerto Rican patients hospitalized due to heart failure METHODS/STUDY POPULATION: We will recruit patients admitted with heart failure (n = 300) to the Cardiovascular Hospital of Puerto Rico and The Caribbean between 2019-2021. In the first aim, we will implement the Minnesota Living with Heart Failure Questionnaire to assess the quality of life of Puerto Rican Hispanics diagnosed that life with heart failure and the short form-36 (SF-36) for a generic quality of life assessment. For the second aim, we will provide two instruments: The Geriatrics DepressionScale QuestionnaireShort Form (GDS-SF)and the Memorial Symptom Assessment ScaleShort Form (MSAS-SF) to assess the presence and severity of depression and multiple general symptoms RESULTS/ANTICIPATED RESULTS: We expect that women living with heart failure will have worse quality of life and higher NYHA scale and NT-pro-BNP. DISCUSSION/SIGNIFICANCE OF IMPACT: This contribution is significant because it can clarify the specific risk factors in the Puerto Rican community that are associated with lower quality of life among patients suffering from heart failure. This, in term, can allow physicians to identify which population of HF patients is at risk,and have strategies to improve quality of life
4537 Association between Geographic Socioeconomic Disadvantage and Incidence of Total Hip Replacement Surgery
Authors: Rahman Rafa , Canner Joseph K. , Haut Elliot R. , Humbyrd Casey J.
Published: July 2020

OBJECTIVES/GOALS: Total hip replacement (THR) improves function for those with arthritis, but not all patients have equal access to this elective procedure. To better geographically target healthcare resources, we explored whether geographic socioeconomic disadvantage is associated with incidence of elective THR. METHODS/STUDY POPULATION: We performed a cross-sectional analysis of data in the state of Maryland from 2013-2019. We categorized 5-digit zipcodes into national quartiles of socioeconomic disadvantage using the Area Deprivation Index (ADI). For each zipcode, we calculated the THR incidence rate using Maryland Health Services Cost Review Commission (HSCRC) inpatient and outpatient data in those age 65 years and older. We included only elective THRs. We analyzed the association between a zipcode’s disadvantage quartile and THR incidence rate using multivariate linear regression, correcting for differences across zipcodes in gender, race, and ethnicity distributions, and distance to the nearest hospital performing THRs. RESULTS/ANTICIPATED RESULTS: We analyzed 414 zipcodes with overall average THR rate of 370.8 per 100,000 persons >65yo per year. Relative to zipcodes in the least socioeconomically disadvantaged quartile, those in the second-least disadvantaged had 82.2 fewer THRs per 100,000 persons >65yo per year, those in the second-most disadvantaged had 144.2 fewer, and those in the most disadvantaged had 207.4 fewer (all p65yo per year, those in the second-most disadvantaged had 136.2 fewer, and those in the most disadvantaged had 182.9 fewer (all p <.05). DISCUSSION/SIGNIFICANCE OF IMPACT: More socioeconomically disadvantaged areas have significantly lower rates of elective THR, independent of differences in demographics and hospital proximity. These findings show how disparities can affect access and outcomes, and should inform targeting of community-level education and intervention.
4070 Association of Interpersonal Processes of Care and Health Outcomes in Patients with Type II Diabetes
Authors: Reid Hadley , Lin Olivia M , Fabbro Rebecca L , Johnson Kimberly S , Svetkey Laura P. , Batch Bryan C
Published: July 2020

OBJECTIVES/GOALS: 1. Understand the association between patient perceptions of care measured by the Interpersonal Processes of Care (IPC) Survey and glycemic control, appointment no-shows/cancellations and medication adherence in patients with type II diabetes. 2. Determine how these relationships differ by race for non-Hispanic White and Black patients. METHODS/STUDY POPULATION: This is a cross-sectional study of a random sample of 100 White and 100 Black Type II diabetic patients followed in Duke primary care clinics and prescribed antihyperglycemic medication. We will recruit through email and phone calls. Enrolled patients will complete the Interpersonal Processes of Care Short Form and Extent of Medication Adherence survey to measure patient perceptions of care (predictor) and medication adherence (secondary outcome). No show appointments and cancellations (secondary outcomes) and most recent hemoglobin A1c (primary outcome) will be collected from the Electronic Medical Record. We will also collect basic demographic information, insurance status, financial security, significant co-morbidities, and number and type (subcutaneous vs oral) of antihyperglycemic medications. RESULTS/ANTICIPATED RESULTS: -The study is powered to detect a 0.6% difference in HbA1c, our primary outcome, between high and low scorers on the Interpersonal Processes of Care subdomains. -We expect that higher patient scores in the positive domains of the IPC survey and lower DISCUSSION/SIGNIFICANCE OF IMPACT: This study will provide information to develop and implement targeted interventions to reduce racial and ethnic disparities in patients with Type II diabetes. We hope to gain information on potentially modifiable factors in patient-provider interactions that can be intervened upon to improve prevention and long-term outcomes in these populations.
4132 Do Research Studies at Oregon Health & Science University Comply with the New NIH Inclusion Across the Lifespan Policy - A “Look Back” over the last 2 Years
Authors: Zauflik Meredith , Wenzel Elizabeth , Zell Adrienne , Eckstrom Elizabeth
Published: July 2020

OBJECTIVES/GOALS: This project aims to ensure that the age ranges of participants in OHSU studies for specific diseases match the demographics of the populations the diseases occur in, as mandated by the new NIH Inclusion of Individuals Across the Lifespan as Participants in Research Involving Human Subjects policy. METHODS/STUDY POPULATION: This study involves retrospective and prospective data. The retrospective phase (“Look Back”), reviewed all investigator-initiated OHSU studies between 2017 and 2018 with prospective consent that were disease related (N = 63). Age range per IRB protocol and per subject enrollment were graphically compared to disease demographics to determine if study age ranges were a “match” or “mismatch” to disease demographics (0 = mismatch, 1 = partial match, 2 = full match). This data will inform the upcoming prospective phase of the study, when the study team will reach out to primary investigators of enrolling studies with education and resources, and track whether this reduces demographic “mismatch.” RESULTS/ANTICIPATED RESULTS: Of the studies, 51 were evaluated in the “Look Back” analysis. 40 studies were full matches for age inclusion matching disease demographics (78%), 40 for disease prevalence range (78%), and 38 for enrolling subjects within the disease demographic range (74%). Studies received the lowest scores in enrolling subjects that match disease prevalence, with 19 earning full points (37%) and 17 earning 0 points (33%). Limitations include difficulty in finding and applying disease demographic and prevalence ranges. In addition, in this data, 12 of the original 63 total studies could not be scored because no subjects had been enrolled or prevalence ranges were not in line with clinical expertise. DISCUSSION/SIGNIFICANCE OF IMPACT: This study highlights that many trials exclude older subjects at the upper age ranges. Future analysis of the prospective phase of the study will allow us to assist research teams in closing these gaps and will determine the Policy’s impact on the recruitment of older adults into research.
4384 Factors Impacting Access to Gender Affirming Care for Gender Diverse Youth in the United States
Authors: Kidd Kacie , Hill Amber L. , Sequeira Gina M. , Rothenberger Scott , Ray Kristin N. , Miller Elizabeth , Montano Gerald T.
Published: July 2020

OBJECTIVES/GOALS: Access to pediatric subspecialty care varies by sociodemographic factors. Providers for gender diverse youth (GDY) are rare, and GDY face health disparities, stigma, and discrimination. We examined the association between GDY access to medical and mental health care and rurality, race, parental education, and other GDY-specific factors. METHODS/STUDY POPULATION: We surveyed parents of GDY (<18 years old) across the United States. Participants were recruited through online communities and listserves specific to parents of GDY. We determined associations between access to gender-specific medical or mental health providers and rurality, race, parental education, as well as other GDY-specific factors including age, time since telling their parent their gender identity, parent-adolescent communication, parent stress, and gender identity using chi-square or Fisher’s exact tests. We calculated adjusted odds ratios using logistic regression models. RESULTS/ANTICIPATED RESULTS: We surveyed 166 parents and caregivers from 31 states. The majority (73.2%) identified as white, 66.5% had earned a bachelor’s degree or higher, and 7.6% lived in a zip code designated rural by the Federal Office of Rural Health Policy. We found no evidence of association between reported GDY access to medical or mental health care and race, parental education, or rurality. We did find a significant univariate association between access to mental health care and feminine (either female or transfeminine/transfemale) gender identity (p = 0.033, OR 2.60, 95% CI 1.06 – 6.36). After controlling for parent-adolescent communication in a backwards elimination logistic regression model, it was no longer significant (p = 0.137, OR 2.05, 95% CI 0.80 – 5.25). DISCUSSION/SIGNIFICANCE OF IMPACT: Despite rurality, race, and parental education impacting access to pediatric subspecialty care, we failed to find these associations among GDY accessing gender care. There is a need to better understand structural and societal barriers to care for this population including the impact of stigma and discrimination.