bluuebunny/crossref_metadata_2025 huggingface dataset:
4237 TL1 Team Approach to Peripartum Obsessive-Compulsive Disorder: a meta-analysis of the perceived impact of gestation and delivery on symptomology
Authors: Cooke Danielle Laine , Henderson Rebecca , McNamara Joseph , Mathews Carol
Published: July 2020

OBJECTIVES/GOALS: Obsessive compulsive disorder (OCD) is a serious and impairing disorder. The peripartum is associated with changes in pre-existing OCD, including exacerbation and improvement of the disorder. This meta-analysis seeks to understand the proportion of women reporting a change in OCD during this time. METHODS/STUDY POPULATION: Nine studies with independent samples examining change in obsessive-compulsive symptomology (OCS) in the peripartum were included in the meta-analysis. Studies were included if the sample examined with women with a clinical diagnosis of OCD that pre-existed pregnancy onset. The meta-analysis was conducted using R Studio with Meta, Metafor and Weightr packages. A moderation analysis was conducted to examine the impact of gestational period on OCD symptoms. Gestational periods were defined as pregnancy, postpartum, or the peripartum. Peripartum refers to a collapsed postpartum/pregnant period such that the period was not identified or specified during data collection. RESULTS/ANTICIPATED RESULTS: The summary proportion of women who experienced no change in symptoms was 46.7% (CI: 42.0-51.4%). No change by period was: pregnancy 49.6% (CI: 36.3-62.9%); postpartum 45.6% (CI: 41.4-49.9%); peripartum 52.4% (CI: 42.4-50.3%). The summary proportion of women who experienced exacerbation was 39.2% (CI: 33.5-45.5%). Exacerbation by period: pregnancy 35.5% (CI: 24.8-47.9%); postpartum 42.9% (CI: 34.8-51.4%); peripartum 34.6% (CI: 23.7-47.4%). The summary proportion of women who experienced improvement was 11.5% (CI: 9.3-14.4%). Improvement by period: pregnancy 42.9% (CI: 14.7-77.0%); postpartum 7.8% (CI: 5.7-10.4%); peripartum 19.6% (CI: 13.7-27.3%). Gestational period had a moderating effect. DISCUSSION/SIGNIFICANCE OF IMPACT: During the peripartum 46% report no change, 40% a worsening and 12% an improvement. Improvement typically occurs during pregnancy and may be followed by a postpartum worsening. This may reflect a hormonally-sensitive subsection of women impacted by the acute changes that occur during this time.
4391 Big data analysis of adolescent obesity, pregnancy and kidney function
Authors: Bielopolski Dana , Singh Neha , Jiang Caroline , MacArthur Robert Bruce , Vasquez Kimberly , Moftah Dena , Kost Rhonda G , Tobin Jonathan N.
Published: July 2020

OBJECTIVES/GOALS:

1.

Examine the associations among BMI and markers of cardiometabolic risk, including blood pressure, lipids and blood glucose.

2.

Assess prevalence of kidney function deterioration, identified as hyperfiltration and moderately increased albuminuria (MIA), in obese compared to normal weight adolescents.

METHODS/STUDY POPULATION: De-identified electronic health records (EHR) data were extracted for female adolescents, aged 12-21 years, and their offspring through 24 months, who received health care services (Jan 2012 to Dec 2016) in NYC from 12 academic health centers and community health centers that are part of PCORnet NYC Clinical Data Research Network (NYC-CDRN). Data were analyzed using SAS (version 3.2.5). Patient characteristics overall and for study subgroups were examined using standard summary statistics. Trends in cardio-renal variables were examined by BMI groups coded according to NHANES as underweight, normal weight, overweight or obese. Multiple linear regression analyses will control for covariates. RESULTS/ANTICIPATED RESULTS: Data from 651,066 adolescent females ages 12-21 were retrieved. Analysis was performed on a subset of 202,214 unique patients (26% white, 15% black, 12.9% Latina) for whom there was complete data for BMI and blood pressure. Distribution of BMI was 6% underweight, 59% normal weight, 19% overweight, and 17% obese. There were significant differences in mean systolic (SBP, mean±SD mmHg: 102±12, 108±11, 112±12, 116±12) and diastolic blood pressure (DBP, mean±SD mmHg: 62±10, 66±8, 68±8.9, 70±9) across the four BMI groups with an increasing trend (p-values<0.0001). We will examine renal function trends, and whether these cardio-renal differences persist when controlling for age, race and ethnicity. DISCUSSION/SIGNIFICANCE OF IMPACT: Although SBP/DBP means were within normal limits across BMI groups, significant increasing trends suggest that women in higher BMI groups may be at increased risk for hypertension and potentially for renal dysfunction. We will examine contributions of race/ ethnicity and age to these associations.
4521 Collecting, Interpreting and Utilizing Retrospective Clinical Data from Data Warehouses
Authors: Sonn Brandon Joseph , Monte Andrew
Published: July 2020

OBJECTIVES/GOALS: Utilizing clinical electronic health record (eHR) data pulled en masse from data warehouses provides unique challenges when applying it to retrospective studies. Use of this data in conjunction with metabolomic and genomic results to predict response to lisinopril or ondansetron has been completed. METHODS/STUDY POPULATION: Study population consists of >2000 subjects recruited from the Emergency Medicine Specimen Bank at University of Colorado Denver (UCD). All patients presenting to the emergency department are approached to participate which significantly increases demographic diversity of our study populations. Clinical data is pulled from Health Data Compass (data warehouse at UCD that collects all electronic health record (EHR) data to be able to deliver de-identified). Effectiveness of lisinopril and ondansetron were investigated using metabolomic data collected via ultra-high performance liquid chromatography mass spectrometry and genomic data from Illumina chip technology to find relevant correlations. RESULTS/ANTICIPATED RESULTS: Obtaining retrospective clinical data from data warehouses comes with significant challenges to be addressed. Verifying all clinical variables from patient EHRs is a crucial step that requires extensive quality control steps. As well, ensuring data validity, appropriateness of data points pulled as relate to the study criteria and identifying alternate EHR data points is needed. Chart review is a critical step necessary to surmount these challenges. Additionally, use of retrospective EHR data often necessitates the development of novel definitions of clinical effectiveness that can be abstracted from the EHR– such as how to determine decrease in nausea without a visual analogue scale. DISCUSSION/SIGNIFICANCE OF IMPACT: Utilizing data warehouses to deliver EHR data provides a valuable tool for completing retrospective precision medicine projects. The validation of definitions for clinical outcomes identifiable retrospectively are necessary and provide novel guidance for future studies.
4462 Effects of Injectable, Erythropoietin and Glucocorticoids Combinational Therapy on Erythrocyte Sedimentation Rate Following Spinal Cord Injury
Authors: Nia Anna , Khanipov Kamil , Golovko George
Published: July 2020

OBJECTIVES/GOALS: Inflammation following traumatic injury to the spinal cord persists long after the primary insult and is known to increase complication rates and prolong recovery time. We investigated the effects of Erythropoietin (EPO) in combination with Glucocorticoids on the levels of erythrocyte sedimentation rate (ESR), an overall measure of inflammation. METHODS/STUDY POPULATION: Electronic medical records from approximately 38 million patients in 27 Healthcare Organizations were analyzed using the TriNetX Analytics platform. Patients with spinal cord injuries (SCI) were defined with the ICD-10 code, G95 and two unique cohorts were defined for patients treated with injectable EPO in combination with injectable Glucocorticoids within 6 months of SCI or only injectable Glucocorticoids with no injectable EPO. ESR rates were queried from patient cohorts to evaluate the potential effects of the two treatment pathways on the ESR. Most recent lab results within 6 months before initiating treatment and 1-year post-treatment were defined as “before” and “after” treatment, respectively. Changes in ESR lab results were evaluated using unpaired t-test with Welch’s Correction. RESULTS/ANTICIPATED RESULTS: A total of 14,370 patients satisfied the inclusion criteria. 89 patients were treated with injectable EPO in combination with Glucocorticoids within 6 months of SCI. The ESR lab results were available for 33 patients before treatment with a mean of 63±33 mm/h. The ESR lab results were available for 22 patients after treatment with a mean of 51.7±34.1 mm/h. 14,281 patients were treated with Glucocorticoids (no injectable EPO) within 6 months of SCI. The ESR lab results were available for 2,042 patients before treatment with a mean of 29.2±30.5 mm/h. The ESR lab results were available for 2,184 patients after treatment with a mean of 32.6±30 mm/h. Patients treated with combinational therapy showed a reduction in ESR of 11.3 mm/h, while those treated with only Glucocorticoids showed an increase in ESR of 3.4 mm/h. DISCUSSION/SIGNIFICANCE OF IMPACT: The present results demonstrated that combinational therapy with injectable, EPO and glucocorticoids exhibited a significant reduction in ESR level. The study suggests that EPO and glucocorticoid might have a synergistic effect on reducing the inflammation following SCI. This approach might help reduce the therapeutic dose of glucocorticoids. Conflict of Interest Description: The authors declare that they have no competing interests. CONFLICT OF INTEREST DESCRIPTION: The authors declare that they have no competing interests.
4471 Interactions of the Infant Nasopharyngeal Microbiota and Subjects’ Clinical Traits in Development of Viral Upper Respiratory Tract Infections and Acute Otitis Media
Authors: Khanipov Kamil , Golovko George , Nia Anna , Evangelista Lorraine , Fofanov Yuriy
Published: July 2020

OBJECTIVES/GOALS: Identify the interactions between nasopharyngeal bacterial pathogens, commensals, and patient clinical characteristics in relation to the development of viral upper respiratory tract infections (URI) and acute otitis media (AOM) in infants. METHODS/STUDY POPULATION: The subjects were part of a prospective, longitudinal study (2008–2014) of infants to evaluate the prevalence and risks for the development of URI and AOM. Healthy infants (n = 362) were enrolled from near birth and followed to the first episode of AOM up to 12 months of age. Nasopharyngeal specimens and clinical traits were collected at monthly intervals between 1-6 months, month 9, and during viral URI episodes. Subjects were closely followed for AOM development. 16S rRNA sequencing was performed on the nasopharyngeal swabs to identify their bacterial composition. Multidimensional (2, 3, and 4 dimensional) co-presence, co-exclusion, and one-way relation patterns were identified between the microbiome compositions, health status, and other collected clinical traits. RESULTS/ANTICIPATED RESULTS: We analyzed 971 specimens collected monthly and during URI and AOM episodes from 139 infants. Of the 139 enrolled subjects, 96% had 2 or more healthy samples, 77% contracted URI/AOM during the study period, and 60% had at least 1 healthy sample before URI/AOM onset. Otopathogens (Moraxella, Haemophilus, and Streptococcus), Staphylococcus, and Pseudomonas were the most common pathogenic genera. Corynebacterium, Dolosigranulum, and Acinetobacter were 3 most abundant commensal bacterial genera. Samples from infants with AOM in the first year had a significantly higher relative abundance of Haemophilus, Enterobacter, and Yersinia, and lower relative abundance of Corynebacterium, and Pseudomonas compared to samples from infants who did not develop AOM. DISCUSSION/SIGNIFICANCE OF IMPACT: Identification of complex multidimensional interaction patterns within microbial communities and environmental factors is vital to understanding disease onset risk and prevention. Prophylactic microbiome and environmental factor modulation between enterotypes could be used to reduce URI/AOM onset in infants.
4099 Principles of Statistical Education for Translational Scientists in the Age of Rigor, Reproducibility, and Reporting
Authors: Bagiella Emilia , Christos Paul , Kim Mimi , Lee Shing , Vaughan Roger , Zhong Judy
Published: July 2020

OBJECTIVES/GOALS: To describe principles, best practices, and techniques recommended to instill deep understanding of the application and interpretation of statistical techniques and statistical inference among translational scientists and trainees, that best support the concepts of scientific Rigor, Reproducibility and Reporting. METHODS/STUDY POPULATION: Each of the six New York City Area Biostatistics, Epidemiology and Research Design (BERD) resources have strong educational programs, novel curricular components, and creative strategies, implemented by award winning educators. To capitalize on shared knowledge, innovation, and resources, the six teams formed the New York City Area BERD Collaborative (NYC-ABC) comprised of BERD resources from Mt. Sinai, Cornell, Einstein, Columbia, Rockefeller, and NYU. The collaborative suggests principles, concepts, tools and approaches to support the concepts of scientific Rigor, Reproducibility and Reporting in translational science. RESULTS/ANTICIPATED RESULTS: Principles:

Value of team science approach and including biostatisticians early and often.

Carefully designing experiments to reduce bias and increase precision.

Trainees’ focus is often on “statistical significance” and the p-value. Consequences of data dredging/p-hacking, and the impact of sample size and other factors on statistical significance.

Emphasizing the effect size and answering the scientific hypothesis when reporting results.

Statistical code used to produce results should be well annotated and raw data posted online to enhance reproducibility.

Approaches:

Incorporate effective multiple modalities (i.e. didactic, demonstrative, hands on workshops, applications, and tools).

Approach from “the drivers’ seat” perspective, rather than strictly mathematical.

Endorse flipped classroom approach

DISCUSSION/SIGNIFICANCE OF IMPACT: Like any complex discipline, biostatistical education can be approached from several dimensions, but it remains essential to focus on fundamental goals of science. We remind our trainees that the goal of science is to create knowledge, not to “find significance”. Deep understanding of inferential methods and proper interpretation of results are key. CONFLICT OF INTEREST DESCRIPTION: None.
4182 Use of Machine Learning for Surgical Outcomes Research: what are the clinical implications?
Authors: Armijo Priscila Rodrigues , Bonthu Sindhura , Schiller Alicia , Zhu Qiuming , Tanner Tiffany
Published: July 2020

OBJECTIVES/GOALS: Multivariate regression is used for surgical outcomes analyses; but does not allow for evaluation of all variables. Machine learning could be the perfect alternative to address this issue. Our aim was to evaluate whether machine learning is a feasible alternative to evaluate surgical outcomes. METHODS/STUDY POPULATION: H-CUP National Inpatient Sample database was queried for adult patients with colorectal cancer who underwent colorectal resection, while the NSQIP database was queried for adult patients with rectal cancer who underwent proctectomy. A multivariate regression analysis was performed to assess risk factors associated with 30-day complications following those procedures. Subsequently, machine learning techniques of under-sampling and oversampling were applied to the same datasets for the evaluation of risk factors for the same outcome. These techniques were used to achieve a larger population sample size and to detect statistical significance. Results between the two methodologies were compared. RESULTS/ANTICIPATED RESULTS: Multivariate regression revealed that open approach, gender, race, geographic location, number of comorbidities, and type of insurance was associated with increased 30-day mortality in colorectal resection patients. Conversely, the use of machine learning revealed that preoperative weight loss, preexistent chest heart failure, renal failure or perivascular disease were strongly associated with 30-day mortality. For proctectomy patients, multivariate regression found no association between surgical approach and 30-day mortality. However, machine learning revealed gender, hypertension, and reoperation to be strongly associated with 30-day mortality. DISCUSSION/SIGNIFICANCE OF IMPACT: Machine learning enabled multiple combinations that were not possible to examine in a conventional multivariate regression analysis. Machine learning compared to traditional multivariate regression produced significantly different outcomes, highlighting the need for in depth of these methodologies.
4016 Combined Eating Disorder and Weight-Loss Online Guided-Self Help Intervention: Updated Results from an Ongoing Pilot Study
Authors: Monterubio Grace Elise , Fitzsimmons-Craft Ellen E. , Wilfley Denise E.
Published: July 2020

OBJECTIVES/GOALS: Aims 1&2: Develop (1) and implement (2) online, guided self-help intervention for ED psychopathology and weight reduction. Aim 3: Follow-up to track remission of ED psychopathology and symptoms and WL maintenance at end of treatment and 6-months. METHODS/STUDY POPULATION: N = 60 college students meeting criteria (clinical/sub-clinical binge-type ED with BMI > 25) will complete a baseline survey and then will be randomized into a condition. Students in the intervention group (n = 30) will be offered 8 weeks of an online, guided self-help intervention for ED and WL. Students in the control group (n = 30) will receive an email message to seek support from Student Health Services. All participants will receive follow-ups 9 weeks and 6 months after baseline. Data analysis will compare Eating Disorder Examination Questionnaire (EDE-Q) scores and WL (change in BMI) at all three time-points. Group comparisons will be assessed via two-way mixed-model ANOVA. RESULTS/ANTICIPATED RESULTS: Recruitment is still ongoing. Data collected by the time of the conference will be presented on the poster. DISCUSSION/SIGNIFICANCE OF IMPACT: Online, guided self-help interventions have been used for WL, as well as for treatment of EDs separately, but no program exists to manage these commonly comorbid conditions concurrently. Thus, this pilot study will examine the effectiveness of combined programs to breach this treatment gap.
4135 Digital Mental Health Interventions for PTSD & Resilience: A Systematic Review
Authors: Torres Marie , Martinez-Taboas Alfonso , Martinez Karen G
Published: July 2020

OBJECTIVES/GOALS: 1) In this literature review we want to explore the literature on DMHI (Interventions delivered via digital technologies, such as smartphones, websites, or text messaging), specifically designed to treat Posttraumatic Stress Disorder (PTSD), and/or to promote positive change & resilience after trauma. 2) We also want to evaluate the literature in terms of the theoretical model used in each DMHI, engagement, effectiveness, & potential harms/challenges. METHODS/STUDY POPULATION: We will review the literature that describes DMHI for PTSD, resilience, & positive change in persons exposed to psychological trauma (Exposure to actual or threatened death, serious injury, or sexual violence, as defined by the fifth edition of the Diagnostic & Statistical Manual of Mental Disorders). We will review the following databases: PsychINFO, EBSCOhost, PubMed, & PsychiatryOnline. The following inclusion criteria will be used: 1) Interventions delivered by computer, smartphones, or online, 2) studies published between 1999-2019. Exclusion criteria will include reviews, opinion, or discussion articles, & unpublished works. RESULTS/ANTICIPATED RESULTS: We expect to find that the most popular therapeutic model for DMHI is cognitive behavioral therapy. We also expect to find a higher number of web-based interventions, as opposed to phone-based interventions, or other types of DMHI. We also expect to find variable drop-out rates, low engagement, & small to moderate effect sizes. DISCUSSION/SIGNIFICANCE OF IMPACT: We expect our contribution to center on evaluating available DMHI for psychological trauma. This systematic literature review is expected to provide scientific justification for the development (or validation), & implementation of a DMHI that takes into account the results of previous studies. This contribution is expected to be significant because it will help in choosing, or developing an effective future intervention with DMHI. CONFLICT OF INTEREST DESCRIPTION: There is no conflict of interest in this study.
4173 An interactive, online Research Education Hub built with a standard Learning Management System focused of education and career development for students, postdocs, faculty, and research staff
Authors: Lackey Russell , Vitale Alfred , van Wijngaarden Edwin
Published: July 2020

OBJECTIVES/GOALS: The University of Rochester CTSI Research Education Hub is designed to: 1) connect the local research community with essential internal and external educational resources; 2) create a community of inquiry and collaboration across the translational science workforce pipeline within the university. METHODS/STUDY POPULATION: The Research Education Hub (RE-Hub) utilizes the university’s widely used Learning Management System (LMS), Blackboard, and accessible to anyone at the university with a BlackBoard account. The RE-Hub greets users with an overview, an introduction of key local faculty experts in relevant research methodologies, and links to institutional research programs and helpdesks. Users are provided with curated educational resources organized by topic areas including, but not limited to, research methodology, statistical analysis, and grantsmanship. Discussion boards were created for users to ask general research questions and to connect with others in the translational research community. RESULTS/ANTICIPATED RESULTS: The RE-Hub was designed in Fall 2019 with the purpose of increasing utilization of university resources, including workshops, seminars, methods forums and consultation resources to improve translational science at the university. The RE-Hub was designed to be flexible and responsive to the changing needs of the local research community. User feedback will be used to identify improvements in the organization and content of the RE-Hub. Future improvements will include additional topic areas that span translational competencies, additional materials added to existing topic areas, and facilitation of better collaboration and integration of career development programs and grantsmanship resources. DISCUSSION/SIGNIFICANCE OF IMPACT: The Research Education Hub provides the University of Rochester translational science research community with a space to explore educational resources, to interact with colleagues and ask research related questions, and to help develop and/or improve other educational programs at the university.
4243 Developing clinical research units to improve quality, efficiency, and cost effectiveness within an academic institution
Authors: Tsao Peg , Dunn Ashley , Mahaffey Kenneth W
Published: July 2020

OBJECTIVES/GOALS: The Stanford CTSA Program has started to create Clinical Research Units (CRUs) with the goal to establish CRUs in all clinical departments by the end of 2020. CRUs will be responsible for managing the portfolio of projects proposed and conducted by faculty within departments. CRUs will be responsible for reviewing all clinical research studies. METHODS/STUDY POPULATION: CRUs will be an integral part of the Stanford’s research infrastructure, tasked with 5 key functions to ensure clinical research conducted by Stanford investigators: scientific merit, feasibility, funding, compliance, progress. Each CRU will review all clinical research projects proposed by investigators within the department prior to moving forward with IRB review. Studies will be evaluated annually to ensure compliance with the protocol, applicable laws and regulations, and recruitment goals. The Stanford CTSA will provide guidelines, SOPs and personnel to assist CRUs. In fall 2019, a landscape analysis of SoM clinical departments was conducted to identify:

1)

similar existing CRU-like systems,

2)

unique needs of departments/divisions for developing CRUs and

3)

barriers to implementation.

RESULTS/ANTICIPATED RESULTS: Challenges the pilot CRU has faced include communication and concerns regarding additional obstacles to conducting research. However, as study teams moved through the initial CRU formation, the feedback was overwhelmingly positive. Study teams were appreciative of the constructive feedback and the support for setting up studies. Results from the landscape analysis identified CRU-like systems in 5 departments and highlighted concerns regarding resources needed to implement CRUs. Based on feedback from the landscape analysis, a faculty and operational lead was identified in each clinical department to oversee CRU implementation. Facilitated by CTSA personnel, CRU leads have met quarterly since April 2019. Meetings consist of discussing expectations, sharing ideas and identifying potential roadblocks. DISCUSSION/SIGNIFICANCE OF IMPACT: CRUs will constitute a new organizational structure that consists of teams of investigators and staff to promote high quality, efficient clinical research and enhance collaborative opportunities. The CRU leadership will champion new initiatives in CTR and create pathways for investigators to access research infrastructure and resources. CONFLICT OF INTEREST DESCRIPTION: NA.
4576 Driving Research: An Interdisciplinary, Vibrant, Engaged Network (DRIVEN)
Authors: Reamey Rebecca Avery
Published: July 2020

OBJECTIVES/GOALS: We focus on the following mission aligned activities centered upon optimizing the culture around inclusion, equity and diversity in the clinical and translational research faculty at UAB:

To identify, support and promote Diversity, Equity and Inclusion (DEI) faculty award recognition and leadership program participation locally, regionally and nationally

To identify, support and promote senior faculty representation on DEI-focused regional, national, and international scientific advisory committees of foundation, professional society and federal programs

To identify opportunities and support the development of competitive DEI-focused foundation, professional society and federal grant applications

To support the academic advancement, promotion and tenure among DRIVEN community

To sponsor and convene professional development and social activities for the DRIVEN community

METHODS/STUDY POPULATION: A partnership of the Center for Clinical and Translational Science Training Academy and the Scientific Community of Outcomes Researchers (SCOR), DRIVEN is a multi-faceted solution to enhance workforce diversity by promoting individual and collective professional development, recognition, and advancement to foster an inclusive, equitable, and diverse research workforce. DRIVEN provides a platform, a community, and a common place where individuals can access resources to more easily identify opportunities aligned with their specific research goals, as well as peer and network support at every step along their professional journey. DRIVEN is uniquely aligned to assist investigators with applying for funding through NIH diversity supplements, foundation opportunities, and other national awards. RESULTS/ANTICIPATED RESULTS: DRIVEN provides networking opportunities, information, and writing support for funding opportunities. Since its inception, less than a year ago, we have seen an increase in writing groups, matched investigators with funding opportunities, and provided networking opportunities for mentors and mentees to meet and for peer mentoring to occur. The interest and momentum surrounding DRIVEN both from internal advisory groups and external advisory groups is significant and will only continue with the endorsement of UAB leadership. DRIVEN is expected to be used as a tool for the recruitment and retention of diverse faculty not only within the UAB community but across the CCTS Partner Network thus changing healthcare in the region. DISCUSSION/SIGNIFICANCE OF IMPACT: According to the NIH, research shows that diverse teams who capitalize on innovative ideas and distinct perspectives outperform less diverse teams. Not only is achieving diversity in the biomedical research workforce critical, but providing diverse researchers with access to support and community is competitive necessity.
4143 HiREC Endowment: Building Models in Research Capacity for Infrastructure Sustainability and Productivity
Authors: de Laurido Lourdes E. Soto , Frontera Walter R. , Huertas Aracelis
Published: July 2020

OBJECTIVES/GOALS: Improve infrastructure, resources, partnerships, and metrics to enhance the research environment for Hispanic researchers as a Minority Serving Institution. To support the research infrastructure in our Campus to encourage a research culture of sustainability and productivity. METHODS/STUDY POPULATION: Development of four research capacity-building models to enhance the pathway of junior researchers as independent researchers:1. MSc Phase I-Scholar Award 2 years in a Post Doctoral Master in CTR ; 2. Advanced CTR Award 1 year to support research infrastructure development in submitting a grant to NIH with the mentoring of a Visiting Endowed Chair; 3. Mini Infrastructure Research Award 1 year provides funds to increase research productivity; 4. Award on Excellence in CTR recognizes a faculty member with a distinguished research portfolio that support HiREC Career Coach and Mentoring approach. HiREC targets junior faculty, early and mid-career researchers from our two partners Schools. RESULTS/ANTICIPATED RESULTS: HiREC has been recognize as support for research infrastructure development. Since 2011, 10 MSc Phase I-Scholar Awards have been granted increasing the pool of trained Hispanics researchers in P. R., the Advanced CTR Award of $50,000 each, from March, 2019, was granted to 2 women researchers from the SoM and 2 Visiting Endowed Chair were accepted as candidates. The Mini Infrastructure Research Award, since 2017, supported the development of 2 Science labs, data analysis, 3 peer review publications and other research capacity building. Two researchers from the SoM were honored with the HiREC 2018 Award on Excellence in CTR heighten the institutional recognition of top researchers’ endeavors. DISCUSSION/SIGNIFICANCE OF IMPACT: It’s imperative to pursue specific strategies that lead to successful research capacity-building models. By acknowledging institutional research infrastructure needs, trendy scientific and technological knowledges and researchers’ needs, HiREC have been able to successfully accomplish its mission. CONFLICT OF INTEREST DESCRIPTION: Authors have no conflict of interest in this research.
4531 Setting the Stage for Research Success: Creation of Standardized Physician-Scientist Training Program Guidelines to Facilitate Research During Clinical Training
Authors: Freel Stephanie A. , Barrett Katherine , Hurst Jillian , Gbadegesin Rasheed , Permar Sallie
Published: July 2020

OBJECTIVES/GOALS: To ameliorate the leaky pipeline of physician-scientists, we must address the factors that cause medical trainees to disengage from research. Here we describe the development of standardized Physician-Scientist Training Program guidelines that may be implemented across disciplines to address these challenges. METHODS/STUDY POPULATION: Maintenance of a robust pool of physician-scientists is critical to meet the rapidly growing need for novel therapeutics. A variety of factors contribute to the decline of this pool. Key among these are a lengthy training period that segregates research from clinical training, thus impeding research progress and milestones that allow for a successful research career. Through engagement of residency program directors and Vice Chairs of Research, we have created a series of guidelines that promote residency research tracks and enable better integration of research and clinical training time. Guidelines have been piloted in the Departments of Pediatrics, Medicine and Surgery in the context of 2 new R38-supported programs. RESULTS/ANTICIPATED RESULTS: Our physician-Scientist Training Program (PSTP) guidelines were developed by our central Office of Physician-Scientist Development (OPSD) after a successful pilot of an integrated research residency program in the Department of Pediatrics [Duke Pediatric Research Scholars (DPRS); Hurst, et al, 2019], which has included 36 resident and fellow scholars over 3 years. To date, eight clinical departments have adopted our PSTP guidelines as part of their R38-supported or pending programs. The OPSD has recently created a tracking database for scholar metrics, which will further promote PSTP development by enabling centralized reporting on scholar success to individual programs. DISCUSSION/SIGNIFICANCE OF IMPACT: PSTP guidelines enable effective implementation of new programs by sharing best practices and lessons learned, standardizing expectations, and defining metrics of success. By promoting proven strategies for integrated clinical and research training, PSTP guidelines may aid in retaining trainees pursuing research careers.
4235 The Use of Checklists Throughout the Lifecourse of a Clinical Research Study: The Rockefeller University Checklist Suite
Authors: Brassil Donna , Vaughan Roger , Hurley Arlene , Dowd Kathleen , Hutt Richard , Coller Barry S.
Published: July 2020

OBJECTIVES/GOALS: We have developed a comprehensive Translational Research Navigation Program to guide investigators all the way from protocol development through study closure. As the program evolved, we initially developed organizational tools and then restructured them into a series of checklists to ensure that critical elements were not excluded or duplicated. METHODS/STUDY POPULATION: A series of checklists to assure that all research elements, including regulatory, scientific, and institutional, are addressed from protocol inception through study closure were developed by clinical research coordinators/navigators. The checklists are periodically updated and modified to reflect changing local and national regulations and policies. The first tool became the “Protocol Development Checklist” and then additional tools were developed and modified into a suite of navigation checklists that include “Protocol Implementation Checklist,” “Protocol Conduct Checklist,” and “Protocol Completion Checklist.” RESULTS/ANTICIPATED RESULTS: The checklists have been incorporated into the Translational Research Navigation Program and have enhanced the organization and quality of protocols throughout their lifespan. For example, implementation of the Protocol Development Checklist resulted in a reduction in time to IRB approval (currently 10 days), and implementation of the Protocol Implementation Checklist has impacted the time from IRB approval to study start-up. The Protocol Conduct Checklist has aided investigators in being better prepared and more organized for study conduct activities and the Protocol Closure Checklist has assured timely protocol closure and regulatory compliance, including reporting to ClinicalTrials.gov. DISCUSSION/SIGNIFICANCE OF IMPACT: Protocol checklists are powerful tools to enhance thoroughness, organization, and quality of the clinical research process. The Rockefeller University protocol checklists are available to the CTSA and Scientific Communities. CONFLICT OF INTEREST DESCRIPTION: NA.
4124 An innovative Tool for Completing the Clinical and Translational Science Award (CTSA) Research Performance Progress Report (RPPR) using REDCap
Authors: Subramain Maran , O’Quinn DeAnna , Davis Heath
Published: July 2020

OBJECTIVES/GOALS: The RPPR Tool was created to accurately and systematically track our CTSA’s overall program goals and core’s progress in real time. It establishes and centralizes the continuous collection of key performance indicators and fosters accountability and transparency among cores and leadership. METHODS/STUDY POPULATION: Using the University of Chicago’s Annual Progress Report REDCap data dictionary, UI Institute for Clinical and Translational Science (ICTS) core managers convened to explore the adaptability of the reporting format for the CTSA. The team developed the more user friendly and easily accessible RPPR Reporting Tool using REDCap to better fit our CTSA. The RPPR in REDCap provides a central location to monitor the activities for each core, gather status updates, generate performance reports, and identify key performance indicators and challenges to prevent failures in the future. All data are transparent and accessible on-demand to individual core managers, evaluators, and ICTS leadership. RESULTS/ANTICIPATED RESULTS: UI’s RPPR Tool has improved the compliance with ongoing monitoring and reporting of CTSA program’s performance. Documenting all relevant information in a centralized space has eased the administrative and evaluation burden of preparing the RPPR. Furthermore, REDCap as a commonly used tool allows the core managers to complete this reporting with minimal guidance. This tool encourages each core to be accountable for documenting their respective progress. The transparency of the reporting allows the Co-PIs along with the leadership team to access the data at any given time to stay updated on the ICTS’ overall progress and to make the appropriate improvements as needed. DISCUSSION/SIGNIFICANCE OF IMPACT: The RPPR is a required component of all CTSA grants. UI’s RPPR Tool has been instrumental in comprehensively tracking progress of the ICTS and its contributions to translational research. UI is collaborating with CTSA peers to improve the RPPR Tool, so it can become an asset for any CTSA to adapt.
4051 Assessing outcomes of Miami CTSI’s Mentored Career Development KL2 Program: Using bibliometric and network visualization approaches to complement traditional outcome metrics
Authors: Das Rosalina , Diaz Jessica , Avissar Patricia , Rundek Tatjana , Scott Gwendolyn B. , Fornoni Alessia , Wright Jonelle E. , Dominguez Sheela , Issenberg Barry S. , Sacco Ralph L.
Published: July 2020

OBJECTIVES/GOALS: The goal of this project was to assess the scientific impact of Miami CTSI’s Mentored Career Development (KL2) Program using bibliometric tools and network visualization in addition to the traditional metrics used to provide a comprehensive evaluation. METHODS/STUDY POPULATION: Scholarly productivity of KL2 scholars were tracked using REDCap. For bibliometric data analysis and visualization, publications were queried using iCite (NIH Office of Portfolio Analysis) and Web of Science database. A total of 173 publications produced by eight KL2 scholars from 2013-2018 were analyzed and categorized into pre-award, during award, and post-award periods. iCite was used to assess scientific influence and translation. Scientific networks and collaboration were visualized using VOSviewer (Centre for Science and Technology Studies, Leiden University). CTSA Common Metrics were tracked using the Results Based Accountability framework. RESULTS/ANTICIPATED RESULTS: Albeit of modest size, the Miami CTSI’s KL2 Program had significant scientific productivity and impact in its first five years. Our KL2 scholars’ publications were cited twice as frequently as other papers in their fields. Further, 48% of publications post KL2 award were above the NIH 50th percentile and had higher citation impact compared to the average NIH-funded paper; 11% were in the top 10% NIH citation ranking. In contrast, only 20% of the publications pre-KL2 award were above the NIH 50th percentile. The program also promoted research collaboration; network visualizations indicate larger co-authorship and organization networks of KL2 scholars post-award. DISCUSSION/SIGNIFICANCE OF IMPACT: Bibliometric and data visualization approaches helped us better identify trends and gauge effectiveness of the KL2 program. These findings provided useful insight into the scientific influence and impact of our scholars’ work.
4526 Coping with End of Life Care: Compassion Fatigue and Burnout Effects on Cortisol Patterns of Health Care Providers Caring for Children
Authors: Sanchez-Plazas Liza Carolina , Garcia Ricardo L. , Komatz Kelly
Published: July 2020

OBJECTIVES/GOALS: The objectives are to assess the impact of cumulative grief on the development of Compassion Fatigue (CF) and Burnout Syndrome (BS) in HCPs who care for dying children. We will also evaluate the relationship between CF and cortisol patterns in HCPs. METHODS/STUDY POPULATION: Cross-sectional study to be conducted in a Pediatric Hospital in Puerto Rico. A sample of 50 pediatric nurses will be selected to collect the data to evaluate the occurrence of CF and BS among HCP caring for children during end of life (EoL). Study subjects will include nurses who care for dying children in the Intensive Care Units and Oncology ward. Nurses working in the pediatric ward will be included as the control group. Three validated instruments (Spanish Version) will be administered (Professional Quality of Life vIV, Maslach Burnout Inventory- HSS, briefCOPE scale). Cortisol samples in saliva and hair will also be taken to determine levels in these HCPs. RESULTS/ANTICIPATED RESULTS: Our expected outcome is that CF and BS will be more frequent in HCPs caring for children during EoL compared with controls and that EoL nurses will have higher scores on CF scale and more frequent dysregulated cortisol patterns. DISCUSSION/SIGNIFICANCE OF IMPACT: Understanding how HCPs cope with grief caused by child death and the occurrence of CF and BO in our hispanic population allowing us to develop support strategies based on the specific HCPs needs. This knowledge will help improve HCPs’ well-being and may diminish the physiologic impact on cortisol.
4300 Evaluation and structure of the pilot funding program at the University of North Carolina CTSA Hub (NC TraCS)
Authors: Morozumi Kalene , Patel Tanha , Carey Tim , Buse John B , Carnegie Andrea , Corbie-Smith Giselle , Dave Gaurav , Cassely Mary Beth , Kerr Paul
Published: July 2020

OBJECTIVES/GOALS: The goals of this evaluation were 1) to describe the pilot grant application cycle and processes at NC TraCS, 2) to illustrate the impact of pilot grants on extramural grant funding, and 3) to provide a framework for other institutions to utilize for the evaluation of pilot grant programs. METHODS/STUDY POPULATION: From 2009-2019 the NC TraCS pilot program funded 925 projects, varying from $2,000 to $100,000. Pilot grants are available to any researcher affiliated with the university as well as partner institutions and community stakeholders. For this evaluation we analyzed data on pilot applicants (demographics, type of pilot, funding status, resubmissions, etc.) and outcomes (extramural funding, publications, etc.) yielded from funded pilots. In addition to summary statistics, we also calculated return on investment (ROI) for the program as a whole and by specific grant type. We will use bibliometric network analysis to assess productivity, citation impact, and scope of collaboration. RESULTS/ANTICIPATED RESULTS: There have been 2,777 submitted proposals with an acceptance rate of 33.3%. Unfunded proposals can resubmit, 61.8% of resubmitted applications are successfully funded, and 29.6% of funded applications are resubmissions. The $2,000 awards accounted for 43.4% of all grants awarded but only accounted for 6.4% of all pilot funds awarded. Success of proposals was proportional to the number of applications from each academic unit. 60.8% of funded applicants were affiliated with the School of Medicine and account for 65.3% of all funding awarded from 2009-2019. Additionally, we plan on analyzing return on investment rates to illustrate the impact of pilot awards on future research funding. DISCUSSION/SIGNIFICANCE OF IMPACT: Pilot grants can lead to subsequent extramural grants, publications, and successful translation of research into practice. This evaluation will assist our institution in understanding the impact of pilot grants and will provide a road map for other institutions evaluating their own programs.
4365 Family-Based Study of Sleep in Autism Spectrum Disorder without Intellectual Disability
Authors: Smidt Stacey Elkhatib , Ghorai Arpita , Gehringer Brielle , Dow Holly , Smernoff Zoe , Taylor Sara , Zhang Jing , Rader Daniel , Almasy Laura , Brodkin Edward , Bucan Maja
Published: July 2020

OBJECTIVES/GOALS: Autism spectrum disorder (ASD) is characterized by difficulties in communication and social interaction as well as restricted and repetitive behaviors. Sleep problems are a common concern in children with ASD that can persist into adulthood. This study aims to further explore sleep in ASD without intellectual disability (ASD w/o ID). METHODS/STUDY POPULATION: We recruited individuals of both sexes with ASD w/o ID (probands) and relatives as part of the Autism Spectrum Program of Excellence (ASPE) at the University of Pennsylvania. Actimetry data were collected via a wrist-worn tri-axial accelerometer for 21 days. Data from 212 participants were considered. We analyzed sleep data using the algorithms GGIR, ChronoSapiens, and PennZzz. The sleep traits of proband and sibling pairs were compared using paired t-test or Wilcoxon signed-rank test. We used the Social Responsiveness Scale, Second Edition (SRS-2) to assess social impairment and restricted/repetitive traits. We compared SRS-2 scores to sleep traits using partial Spearman or Pearson correlations adjusting for age (171 participants). RESULTS/ANTICIPATED RESULTS: Probands demonstrated later sleep onset (p = 0.03), decreased M10 average (10-hour period of highest activity/day; p = 0.006), decreased relative amplitude (measure of rest-activity rhythm; p <0.001), and decreased total daytime activity (p = 0.005) compared to siblings. Regarding social function and restricted/repetitive traits, adult males showed an inverse correlation between SRS-2 total score and sleep efficiency (r = −0.2, p = 0.04) and a positive correlation between SRS-2 total score and intradaily variability (r = 0.3, p = 0.02). Adult females showed an inverse correlation between SRS-2 total score and M10 average (r = −0.3, p = 0.02) and between SRS-2 total score and relative amplitude (self-report r = −0.4, p = 0.001; informant r = −0.3, p = 0.005). DISCUSSION/SIGNIFICANCE OF IMPACT: This study focuses on the analysis of sleep traits in ASD including the relationship between social function and sleep. Thus far, the most robust findings are decreased daytime activity and relative amplitude in individuals with ASD w/o ID compared to siblings. We have also shown that ASD social impairment may be related to sleep dysfunction.