bluuebunny/crossref_metadata_2025 huggingface dataset:
48842 Sponsor types of US interventional COVID-19 studies listed in ClinicalTrials.gov
Authors: Lee Irene , Cooper Lisa , Lechner Doreen Waldron
Published: March 2021

ABSTRACT IMPACT: Increase understanding of the types of sponsors responding to the COVID-19 pandemic. OBJECTIVES/GOALS: The COVID-19 pandemic has impacted millions of lives globally. To learn more about this disease and find potential diagnostic, treatment, and preventative products, the healthcare community has initiated a staggering number of clinical trials. Clinicaltrials.gov was reviewed to determine the types of sponsors who are conducting COVID-19 studies. METHODS/STUDY POPULATION: Clinicaltrials.gov was searched using terms ‘COVID-19’ and ‘SARS-Cov-2’. Search results were further defined to include only ‘Interventional’ studies. Of these, only studies with sites located in the United States were selected and for which the ‘Condition’ included at least one of the following terms: ‘COVID’, ‘COVID-19’, ‘Coronavirus’, ‘SARS-Cov-2’, ‘SARS’, or ‘2019-nCoV'. Study sponsors were then categorized as: (1) commercial, (2) academic, or (3) other, based on ‘Sponsor’ information within each study listing. A Google search was conducted for any sponsor that was not easily categorized to obtain additional information to support the proper assessment of sponsor type. The types of sponsors were analyzed over time using the ‘First Posted’ date of each study listing. RESULTS/ANTICIPATED RESULTS: A total of 3662 studies were retrieved, of which 2075 were ‘Interventional’ studies. The studies were further reduced to 681 studies by including only United States sites and the desired ‘Condition’. The percentage of studies from this refined dataset, by sponsor type, were found to be 63% academic, 34% commercial, and 3% other. The relationship between time and sponsor type demonstrated that academic sponsors had the highest percentage of study postings in the first month (March) of the COVID-19 pandemic compared to commercial and other sponsors. Following this first month, academic study postings gradually declined, while commercial sponsors had an increase in postings per month into July, followed by a gradual decline. Few other sponsor type postings were made and occurred primarily in August. DISCUSSION/SIGNIFICANCE OF FINDINGS: The number and timing of listings may be a reflection of study intention and regulatory pathway requirements. Additional variables, such as inconsistent terminology, collaborators, funding, and study start date may influence results. Further analysis may reveal how modification of listing information may result in expedited pandemic response.
57437 Effects of Prebiotics on the Gut Microbiome Profile, Beta-cell Function and Immune Markers in Newly-Diagnosed Type 1 Diabetes
Authors: Ismail Heba M. , Evans-Molina Carmella , DiMeglio Linda A.
Published: March 2021

ABSTRACT IMPACT: The proposed research study will provide critical pilot data on the effect of using the prebiotic (HAMS-AB) on the gut microbiome profile, Beta-cell function and immune markers in humans with T1D. OBJECTIVES/GOALS: The overall objective of this study is to assess how the prebiotic high amylose maize starch that has been acetylated and butyrylated (HAMS-AB) impacts the gut microbiome profile, short chain fatty acid (SCFA) production, glycemia, Beta-cell function/health and immune responses in newly diagnosed youth with type 1 diabetes (T1D). METHODS/STUDY POPULATION: We are performing a pilot randomized cross-over trial. We plan to recruit 12 newly-diagnosed T1D youth with residual Beta-cell function between 12-16 years of age. We will profile the gut microbiome using metagenomics, measure stool SCFA levels using mass spectrometry, assess glycemia using continuous glucose monitoring, assess insulin production using mixed meal tolerance testing, assess Beta-cell stress using proinsulin/C-peptide levels, and test immune responses by examining cytokine levels and frequency, phenotype and function of T cell markers in peripheral blood. RESULTS/ANTICIPATED RESULTS: Thus far, we have enrolled 3 participants, 1 has completed the study. Baseline assessments indicate that we have technical feasibility of performing the above studies and measurements. Recruitment and enrollment are ongoing. We hypothesize that the use of HAMS-AB in newly diagnosed youth with T1D will (i) improve the gut microbiome profile, (ii) increase SCFA production, (iii) improve overall glycemia and Beta-cell function and (iv) modulate the immune system and mitigate autoimmunity. DISCUSSION/SIGNIFICANCE OF FINDINGS: Given the failure to develop a cure for T1D despite multiple completed intervention studies and the unknown long-term effects of immune-modulatory therapy on those at risk for or those diagnosed with T1D, prebiotics such as HAMS-AB may offer a simple, safe, yet inexpensive and tolerated dietary alternative approach to mitigating disease.
99164 Resting Functional Connectivity of Networks Associated with Preoccupation in Alcohol Use Disorder Predicts Time to Relapse
Authors: Koithan Emily M. , Nyoi Kai Xuan , Hendrickson Timothy , Verdoorn Hannah , Gilmore Casey , Mueller Bryon , Kushner Matt , Lim Kelvin , Camchong Jazmin
Published: March 2021

ABSTRACT IMPACT: Our research has the potential to impact human health by identifying a neural network that can be used to predict time to relapse in individuals with alcohol use disorder. OBJECTIVES/GOALS: Preoccupation towards alcohol use (e.g. craving, rumination, and poor executive control) is a maladaptive behavior associated with relapse risk. We investigated whether alterations in resting state networks known to mediate preoccupation could predict time to relapse in alcohol use disorder (AUD). METHODS/STUDY POPULATION: 50 participants with alcohol use disorder (AUD) (Age: M=41.76, SD=10.22, 19 females) were recruited from an addiction treatment program at ˜2 weeks of abstinence. fMRI data were preprocessed with the Human Connectome Project pipeline. Strength of resting state functional connectivity (RSFC) within two networks known to mediate the ‘Preoccupation go’ (PG) and ‘Preoccupation stop’ (PS) stages of addiction were calculated. T-tests were conducted to compare RSFC between subsequent abstainers and relapsers (after 4 months). Linear regressions were conducted to determine whether RSFC (of PG and PS networks) can predict time to relapse. Craving measures were included in the model. RESULTS/ANTICIPATED RESULTS: 19 AUD relapsed during the 4-month follow-up period. There were no RSFC group effects (subsequent abstainers and relapsers) in the PG or PS networks. Number of days to relapse could be predicted by PG RSFC (F(1,17)=14.90, p=0.001, r 2=0.47). Time to relapse increased by 13.19 days for each PG RSFC unit increase. Number of days to relapse could be predicted by PS RSFC (F(1,17)=9.39, p=0.002, r ²=0.36). Time to relapse increased by 12.94 days for each PS RSFC unit increase. After adding a self-report craving measure (i.e. Penn Alcohol Craving Scale) in the prediction model, both PG and PS RSFC still significantly predicted time to relapse. Craving metric did not predict time to relapse. DISCUSSION/SIGNIFICANCE OF FINDINGS: RSFC in preoccupation networks during short-term abstinence predicted time to relapse. These preliminary findings highlight promising targets for AUD neuromodulation interventions aimed to reduce relapse. Future larger scale studies that examine the effects of covariates and mediators are needed.
70329 Automated Lungs Segmentation and Airways Skeletonization from CT Scans in Patients with Cystic Fibrosis
Authors: Chong Chie Juan A. , Territo Paul R. , Salama Paul
Published: March 2021

ABSTRACT IMPACT: Improve healthcare of patients with Cystic Fibrosis by reducing the time needed to generate results. OBJECTIVES/GOALS: We developed an automated framework capable of segmenting the lungs, extract the airways, and create a skeletonize map of the airways from CT scans of Cystic Fibrosis patients. As future expansion, the framework will be expanded to measure the airways diameters, detect the abnormal airways, and count the number of visible airways generations. METHODS/STUDY POPULATION: For this study, 35 CT scans from CF patients with different levels of severity were used to test the developed framework. The lungs segmentation was performed using an algorithm based on Gaussian Mixture Models for mild cases, and for severe cases a technique that uses convex hull and the recurrent addition of ‘dots’ was implemented. The airways extraction was performed using a 26-points connected components algorithm in conjunction with a curve fitting technique over the histogram of voxel values. Medial axis transform was used to perform the skeletonization of the extracted airways, and airways diameters determined via ray-casting. RESULTS/ANTICIPATED RESULTS: The framework was able to correctly obtain the segmented lungs in all 35 sample volumes regardless of disease severity. In contrast, it tends to fail to skeletonize the airways for severe cases where the framework is unable to differentiate between abnormal lungs conditions and dilated airways. Fine tuning is required to achieve better results. The expected result of the future implemented sections of the framework are focused to characterize the extracted airways by: 1) measuring the airways diameters; 2) detect and count the number of abnormal airways sizes; and 3) count the number of visible airways branching which will permit determination of stage and grade of the lungs of CF patients. DISCUSSION/SIGNIFICANCE OF FINDINGS: The proposed framework allows a fast and reproducible way to segment the lungs and create a skeletonized map of the airways that are independent of clinical training. In addition, this framework will be extended to obtain measurements of airway dilation and branching level, which could provide a deeper insight of the airways in CF patients.
73432 Assessment of multi-pollutant ambient air composition on type 2 diabetes mellitus using machine learning.
Authors: Riches Naomi Oiwa , Gouripeddi Ramkiran , Facelli Julio C.
Published: March 2021

ABSTRACT IMPACT: We explored the use of machine learning to explore how multi-pollutant air quality is related to type 2 diabetes, which is more representative than the single pollutant models often employed to assess this relationship. OBJECTIVES/GOALS: Single pollutant air pollution models have correlated air pollution components with type 2 diabetes mellitus (DM). However, air pollution is a complex mixture, therefore, we explored the relationship between multi-pollutant air quality and DM incidence using machine learning. METHODS/STUDY POPULATION: Annual diabetes incidence from the CDC for each US county was downloaded for the years 2007-2016. Daily air pollution concentrations for PM2.5, PM10, CO, SO2, NO2, and O3 were downloaded from the US EPA for the years 2006-2015. K-means clustering, an unsupervised machine learning method, was employed to partition all air pollution components, for each day and county monitored, into the optimal number of clusters. Change in DM incidence was matched to air pollution clusters by county, lagged by one year. Additionally, NASA satellite-derived air pollution data will be compared to EPA data to inspect as a potential source for future clustering analysis of counties that do not have an EPA monitor. RESULTS/ANTICIPATED RESULTS: The largest increase of annual DM incidence was associated with the cluster having the highest average PM10, PM2.5, and CO, and the second greatest average NO2 concentrations. Inversely, the most significant decrease of annual DM incidence was associated with the cluster having the lowest PM10, PM2.5, and CO. While average PM10, PM2.5, SO2, NO2, and CO showed a rising tendency with elevating change of DM incidence, ozone did not show any such trend. It is anticipated that the NASA satellite-derived air pollution data will approximate the EPA air quality data and will be usable in assessing the air pollution-DM relationship for areas currently not monitored by the EPA. DISCUSSION/SIGNIFICANCE OF FINDINGS: Using an unsupervised k-means algorithm, we showed multiple ambient air components were related to increased incidence of T2DM even when average concentrations were below the National Ambient Air Quality Standards. This work could help guide policy making regarding air quality standards in the future.
67409 Quantifying Unmeasured Confounding in Relationship between Treatment Intensity and Outcomes among Older Patients with Hodgkin Lymphoma (HL) using Surveillance, Epidemiology and End Results (SEER)-Medicare Data
Authors: Rodday Angie Mae , Hahn Theresa , Lindenauer Peter K. , Parsons Susan K.
Published: March 2021

ABSTRACT IMPACT: E-values can help quantify the amount of unmeasured confounded necessary to fully explain away a relationship between treatment and outcomes in observational data. OBJECTIVES/GOALS: Older patients with HL have worse outcomes than younger patients, which may reflect treatment choice (e.g., fewer chemotherapy cycles). We studied the relationship between treatment intensity and 3-year overall survival (OS) in SEER-Medicare. We calculated an E-value to quantify the unmeasured confounding needed to explain away any relationship. METHODS/STUDY POPULATION: This retrospective cohort study of SEER-Medicare data from 1999-2016 included 1131 patients diagnosed with advanced stage HL at age ≥65 years. Treatment was categorized as: (1) full chemotherapy regimens (‘full regimen’, n=689); (2) partial chemotherapy regimen (‘partial regimen’, n=175); (3) single chemotherapy agent or radiotherapy (‘single agent/RT’, n=102), or (4) no treatment (n=165). A multivariable Cox regression model estimated the relationship between treatment and 3-year OS, adjusting for disease and patient factors. An E-value was computed to quantify the minimum strength of association that an unmeasured confounder would need to have with both the treatment and OS to completely explain away a significant association between treatment and OS based on the multivariable model. RESULTS/ANTICIPATED RESULTS: Results from the multivariable model found higher hazards of death for partial regimens (HR=1.81, 95% CI=1.43, 2.29), single agent/RT (HR=1.74, 95% CI=1.30, 2.34), or no treatment (HR=1.98, 95% CI=1.56, 2.552) compared to full regimens. We calculated an E-value for single agent/RT because it has the smallest HR of the treatment levels. The observed HR of 1.74 could be explained away by an unmeasured confounder that was associated with both treatment and OS with a HR of 2.29, above and beyond the measured confounders; the 95% CI could be moved to include the null by an unmeasured confounder that was associated with both the treatment and OS with a HR of 1.69. Of the measured confounders, B symptoms had the strongest relationship with treatment (HR=2.08) and OS (HR=1.38), which was below the E-value. DISCUSSION/SIGNIFICANCE OF FINDINGS: Patients with advanced stage HL who did not receive full chemotherapy regimens had worse 3-year OS, even after adjusting for potential confounders related to the patient and disease. The E-value analysis made explicit the amount of unmeasured confounding necessary to fully explain away the relationship between treatment and OS.
95262 Making telehealth accessible for patients who are visually impaired: A scoping review
Authors: Zawada Stephanie
Published: March 2021

ABSTRACT IMPACT: By outlining telehealth access disparities in the vision-impaired population, this scoping review has identified a set of effective and clinically appropriate implementation strategies and interventions for improving the technical, provider-level, and system-level accessibility of telehealth for vision-impaired patients. OBJECTIVES/GOALS: Evidence-based recommendations that ensure telehealth access for vision-impaired patients are critical to reducing health disparities. This review identifies, evaluates, and proposes strategies for public and private sector stakeholders to increase telehealth access for vision-impaired patients during the pandemic and beyond. METHODS/STUDY POPULATION: This scoping review included five steps: 1) the implementation of an iterative search strategy using relevant keywords to query 4 electronic databases (PubMed, Cochrane, Google Scholar, and Europe PMC) for relevant articles, 2) the application of a set of inclusion criteria to filter database results for article evaluation, 3) a quality assessment of the articles retained, 4) the extraction and summary of data from each assessed article, and 5) a narrative synthesis of the qualitative literature reviewed. RESULTS/ANTICIPATED RESULTS: To date, 21 articles that fit the inclusion criteria, published between 2006 and 2020, have been identified. To ensure the most robust collection of existing literature is aggregated, the iterative search strategy and inclusion criteria sorting process will be underway until December 20. The assessment of articles, and extraction and summary of data contained within said articles, will be finalized on January 20. The narrative synthesis will be complete on February 1. The poster and abstract will be complete by February 20. DISCUSSION/SIGNIFICANCE OF FINDINGS: Future research should examine outcomes associated with the implementation of accessible telehealth programs to identify remaining barriers. To improve outcomes for vision-impaired patients, policymakers, providers, payers, and industry must collaborate to promote accessibility in telehealth design and implementation.
29043 Using Milestones to Judge the Progress of Clinical Informatics Fellows Compared with their Personal Goals
Authors: Bell Douglas S. , Baldwin Kevin , Cheng Eric , Pfeffer Michael
Published: March 2021

ABSTRACT IMPACT: We report a novel metric for assessing clinical informatics fellows relative to their personal goals, using standardized milestones that have been approved for the field by ACGME. OBJECTIVES/GOALS: ACGME has defined 20 milestones that serve as the goals for fellows in clinical informatics. Each fellow is rated from 1 to 5 on the achievement of each milestone, where 1 is entry-level, 4 is the level expected of a graduating fellow, and 5 is aspirational. We assessed fellows’ progress toward the personal goal levels that they set for each milestone. METHODS/STUDY POPULATION: At the start of the fellowship, we asked each fellow to rate the personal target levels that they want to achieve for each milestone. Since the default target level of achievement for a graduating fellow is a 4, we asked fellows to document exceptions from this target. We calculated a metric for each fellow’s achievement of each milestone as their achievement rating (assigned by mentors and rotation leaders during the semi-annual Clinical Competency Committee meeting) divided by the fellow’s desired level of achievement. In summarizing across the milestones, we counted those milestones having achievement metrics >=1.0 as ‘achieved,’ and then for milestones that were not achieved, we calculated an average for the fellow. RESULTS/ANTICIPATED RESULTS: As of June, 2020, our two graduating 2nd-year fellows had fully met 9/20 and 18/20 milestones, respectively. For the unmet milestones they averaged 81% and 85% achievement. The largest shortfalls were 75% achievements in Assessing User Needs for one fellow, and in Recognition of Errors for the other. One of our three 1st-year fellows had fully met 3/20 milestones; the other two had met none at 1st-year’s end. For unmet milestones, the 1st-year fellows’ average achievement metrics were 69%, 67%, and 52%. The greatest shortfalls were in Resource Utilization (creating job descriptions, budgeting etc.) and in Communication with Patients and Families. However, the rotations that would expose them to project management and to patient-facing systems such as MyChart come in our 2nd-year. DISCUSSION/SIGNIFICANCE OF FINDINGS: Assessing milestones met plus the percent achievement for those not yet met provides a useful metric for comparing fellows and identifying areas in need of more training. Although milestones will soon change to reflect the recent practice analysis for clinical informatics, we expect that this approach to assessing fellows will remain equally useful.
30315 Successes in the COVID-19 Era: Novel Peer-Mentoring Series for Junior and Mid-Career Academic Faculty Across a University Campus
Authors: Chernick Lauren , Lee Teresa , Lovinsky-Desir Stephanie , Span Marisa , Reyes-Soffern Gissette , Woo Baidal Jennifer , Taylor Anne L. , Shimbo Daichi , Lapiner Clara , Anderson Brett
Published: March 2021

ABSTRACT IMPACT: Partnering with academic offices to promote peer-mentoring in a virtual format is feasible, novel, and well-received across a major academic campus. Particularly during a pandemic, the success of this programmatic effort highlights the continued need for peer-to-peer support. OBJECTIVES/GOALS: To identify feasibility and key lessons learned from the planning and implementation of a virtual, interdisciplinary group peer-mentoring series, implemented broadly across an academic medical center in New York City. METHODS/STUDY POPULATION: ASPIRE! (Accountability & Safe-Space to Promote, Inspire, Recharge, & Empower one another!) is a group of seven interdisciplinary mid-career academic women faculty, who began collaborations as CTSA KL2 scholars. Our mission is to support interdisciplinary peer coaching for advancement of gender and racial equity among academic faculty and leaders. We designed and implemented a series of virtual symposia focused on essential struggles for clinicians and investigators at during the COVID-19 pandemic. Partnering with Columbia’s CTSA, Office for Women and Diverse Faculty, and Office for Research, we invited leaders in psychiatry/psychology, early childhood education, organization/team management, and academic advancement as keynote speakers and facilitated peer-mentoring virtual breakouts. RESULTS/ANTICIPATED RESULTS: These efforts resulted in the completion of four separate 1.5-hour symposia, each with keynote speakers, discussions with academic leaders, and 30-minute breakout peer-mentoring sessions. Session topics included Calibrating Expectations, Helping Families Thrive, Managing Remote Teams, and Faces and Phases of Stress. Enrollment ranged from 30 to 70 participants per session. Participants reported: (1) Keynotes focused on actionable solutions stimulated the most productive conversations; (2) Peers from different disciplines and career stages provided a range of actionable recommendations tested within local contexts; (3) The greatest learning came from the peer-to-peer breakout group sessions. DISCUSSION/SIGNIFICANCE OF FINDINGS: Partnering with academic offices to promote interdisciplinary, peer-mentoring in a virtual format is feasible, novel, and can be well-received across a major academic campus during the COVID-19 pandemic. The success of this programmatic effort highlights the continued need for expanded peer-to-peer support in academia.
38460 Independent Investigator Incubator (I3) yields external funding within three years for the majority of junior faculty
Authors: Spence John Paul , Santangelo Christina R. , Buddenbaum Jennifer L. , Carroll Aaron E. , Allen Matthew R.
Published: March 2021

ABSTRACT IMPACT: The Independent Investigator Incubator program provides 1:1 mentoring from ‘super-mentors’ to enhance junior faculty careers in research. OBJECTIVES/GOALS: In 2014, the Indiana University School of Medicine (IUSM) in collaboration with the Indiana CTSI established the Independent Investigator Incubator (I3) Program. The I3 Program is designed to provide 1:1 mentoring for new research faculty during the crucial early years of their careers. Our goal is to provide an overview of the I3 design and 5-year data. METHODS/STUDY POPULATION: The I3 Program employs a resource-sharing, centralized design that provides concentrated 1:1 mentorship from a senior faculty ‘super mentor’ as well as other resources, such as grant writing support. Unlike many mentorship programs, I3 mentors closely interact with the mentees within the School and are compensated for their efforts (5% full-time equivalency per mentee, max of 15%). The number of ‘super mentors’ has grown from 6 to 15 faculty over 5 years, and mentors typically serve 4 to 5 mentees. Mentee applications are accepted on a rolling enrollment basis. The I3 mentees represent a diverse group based on sex, ethnicity, terminal degree, academic track, and discipline. Mentors and mentees have annual reviews through the program. RESULTS/ANTICIPATED RESULTS: In five years, 110 mentees have enrolled in the I3 program. Upon entering, 53% had no external funding, 28% had internal funding, 12% had K-awards, 7% had R03/R21 awards. Over the first five years, 75% have received extramural funding. The median funding was $340,000 with nearly a third of mentees securing grants > 1 million in direct costs. For mentees who joined the program in its first three years (n=59), the average time to a notable extramural grant (defined as a NIH or foundation grant >$300K direct costs) was 2.2 years (median - 2.6 years). Nearly all mentees were satisfied with their mentor pairing based on the mentor’s ‘availability’ and ‘valuable feedback,’ and all mentees wanted the mentoring relationship to continue DISCUSSION/SIGNIFICANCE OF FINDINGS: Since 2014, the I3 Program has had a positive impact on the careers of junior faculty at IUSM as determined by faculty satisfaction and funding metrics. Future focus areas will include developing criteria/models for graduating from the program to balance fiscal sustainability with mentee needs during their transition to mid-career.
22370 Mechanical Analysis of Posterior Spinal Fusion Assemblies Intended to Cross the Cervicothoracic Junction
Authors: Sherrill John T. , Bumpass David B. , Mannen Erin M.
Published: March 2021

ABSTRACT IMPACT: A comparative evaluation of the mechanical properties of commonly used posterior spinal fusion assemblies will allow surgeons to choose an assembly based on desired properties. The results will better inform surgical decision making and may lead to improved patient outcomes. OBJECTIVES/GOALS: The objective of this study is to evaluate and compare the mechanical properties of three posterior spinal fusion assemblies commonly used to cross the cervicothoracic junction. Fusion success depends on immobilization of vertebrae. The results will better inform surgical decision making and may improve patient outcomes. METHODS/STUDY POPULATION: Three titanium alloy posterior spinal fusion assemblies intended to cross the cervicothoracic junction underwent static compressive bending, tensile bending, and torsion as described in ASTM F1717 to a torque of 2.5 Nm: 3.5mm rods (Assembly A), 3.5mm to 5.5mm dilating rods (Assembly B), and two 3.5mm rods connected to two 5.5mm rods (Assembly C). Five samples of each assembly were attached to ultrahigh molecular weight polyethylene blocks via multiaxial screws for testing. The distance from the axis of rotation to the point of attachment of the rod and cervical screw was used as the lever arm to calculate the force required to create the desired torque for each test: lever arm of 37mm, requiring 67.6N of force to generate 2.5Nm of torque. Force and displacement were recorded, and stiffness of each construct calculated. RESULTS/ANTICIPATED RESULTS: An ANOVA was performed and resulted in p-values all p<0.005, indicating the test groups were significantly different. Therefore, pairwise t-tests with Bonferroni corrections (p<0.017) were used to determine pairs that were significantly different. Assembly A (3.5mm rods only) was found to be significantly less stiff than Assembly B (dilating rods) and Assembly C (3.5mm-connector-5.5mm rods) in each mode of bending: compression bending, tension bending, and torsion. Assembly A had a significantly greater range of motion in compression bending and torsion, but not tension bending, when compared to Assembly B and Assembly C. The only significant difference between Assembly B and Assembly C was found in the stiffness value of compression bending. DISCUSSION/SIGNIFICANCE OF FINDINGS: The results of this study indicate that incorporating a 5.5mm rod in a fusion assembly adds significant stiffness to the posterior spinal fusion construct. When stability of a fusion is of heightened concern, as demonstrated by the ASTM F1717 vertebectomy (worst case scenario) model, including 5.5mm rods increases the likelihood of fusion success.
52739 Trauma Care in Nigeria and Recommendations for Sustainable Improvement to Nigeria’s Trauma Care System: A Systematic Literature Review
Authors: Usoro Agnes , Dickson Mercy , Osula Valerie , Ezeigwe Angelica K.
Published: March 2021

ABSTRACT IMPACT: This work highlighs the significant burden of Trauma in Nigeria and will help inform policy decisions on improving Nigeri’s current Trauma care system OBJECTIVES/GOALS: To evaluate trauma care delivery at the pre-hospital, hospital and health systems level in Nigeria in order to identify the burden of trauma, gaps in the delivery of trauma care, and interventions, implemented or recommended, to improve upon the limitations to trauma care delivery. METHODS/STUDY POPULATION: A two-concept search - one being trauma and the other being Nigeria - of the Pubmed (Medline) and Embase databases, in addition to Global Index Medicus and grey literature was performed between September 2018 and September 2019. The search yielded 3,970 articles that underwent title screening and 331 articles that underwent abstract screening. 101 articles were identified for full text screening and the majority were extracted for inclusion into the review. The extracted literature was grouped into 4 categories - articles outlining the burden of trauma in Nigeria, and articles outlining the delivery of trauma care at the pre-hospital, hospital and health systems level. RESULTS/ANTICIPATED RESULTS: Results were classified as an identified challenge or an intervention, recommended or implemented, to address Nigeria’s trauma care system. There was a highlighted need for pre-hospital infrastructure, training of frontline providers, continued competency assessments of frontline providers, in-hospital diagnostic resources, and trauma care surveillance systems to guide health policy. DISCUSSION/SIGNIFICANCE OF FINDINGS: There is a significant burden of trauma in Nigeria. Coordinated interventions and policies at the pre-hospital level, the hospital level, as well as the health systems level are needed in order to address the gaps in Nigeria’s current trauma care system.
11989 The Impact of a Perinatal Mental Health Clinic on Psychopathology
Authors: Cooke Danielle
Published: March 2021

ABSTRACT IMPACT: This research is intended to provide researchers and clinicians information on factors that impact psychiatric health outcomes in a specialty perinatal mood disorders clinic. OBJECTIVES/GOALS: The present study seeks to examine factors that impact psychiatric outcomes at the University of Florida Department of Obstetrics and Gynecology Perinatal Mood Disorders Clinic (PMDC). METHODS/STUDY POPULATION: A hierarchical multinomial logistic regression will be conducted to evaluate predictors that may influence patients receiving a referral to specialty care, a return to primary care or being lost to follow up. Included predictors are changes in insurance status, baseline depression scores, and baseline obsessive-compulsive symptoms (OCS). A multinomial logistic regression will be conducted to determine if OCS and depressive symptoms predict referral to/establishment of psychotherapeutic care. A secondary binary logistic regression will be conducted to evaluate predictors that may predict reduction in depressive symptoms among women seen for more than one session. Included predictors of outcome include time (weeks in psychiatric treatment), OCS at baseline, and referral to psychological therapy. RESULTS/ANTICIPATED RESULTS: Data collection is multiphasic and ongoing via a retrospective chart review of patients seen in the PMDC. Hypotheses include that experiencing a change in insurance will significantly increase the risk of being lost to follow up, as compared to referral to specialty clinic or returning to primary care. It is also predicted that individuals with higher depressive symptoms or OCS will be more likely likely to be assigned to specialty care than to be lost to follow up or primary care. It is believed that greater time in psychiatric care, and lower OCS will increase the likelihood of reductions in depressive symptoms. DISCUSSION/SIGNIFICANCE OF FINDINGS: This study seeks to provide information on predictors that influence outcome this specialty clinic, while extending the limited literature that has examined the influence of OCS on depressive symptoms. It is the hope of the authors to provide information on intervenable factors that influence psychiatric outcomes in a perinatal specialty clinic.
50048 Closing the cross-institutional referral loop: Assessment of consultation note quality
Authors: Savoy April , Sangani Amee , Weiner Michael
Published: March 2021

ABSTRACT IMPACT: Results will inform the design of health information technologies that assess and improve clinicians’ interpersonal communication supporting co-management of care across health institutions. OBJECTIVES/GOALS: Poor communication and co-management of comorbidities during the referral process increase physician workload, patient burden, and safety risks. In this preliminary study, our objective was to understand how consultants’ notes support physician collaboration within and across health care institutions. METHODS/STUDY POPULATION: We reviewed medical records. Accessing the Indiana Network for Patient Care database, consultation notes were randomly selected from four specialties: cardiothoracic surgery, neurology, rheumatology, and oncology. These specialties were identified, in advance, as challenging in interprofessional communication. The notes reviewed were associated with in-person consultations at a medical network in the Midwest from 2016 to 2019, including internal and cross-institutional (i.e., external) referrals. The Quality of Consult Assessment tool was adapted to assess note quality and co-management facilitation. Two researchers reviewed all records independently. A consensus meeting was then held to discuss and resolve discrepancies. RESULTS/ANTICIPATED RESULTS: Medical records of ten patients with comorbidities were reviewed. The mean age was 67 (SD= 12 years); one patient was a child. All consultation notes contained clinical recommendations. Seventy percent of notes referred to explicit consultant responsibilities. Conversely, only one contained explicit responsibilities for referrers. Medical records denoted reliance on support staff to send messages among referrers, consultants, and patients via phone calls and facsimile. The use of fax machines to send medical records to referrers was more prominent after cross-institutional consultations. DISCUSSION/SIGNIFICANCE OF FINDINGS: Clinical documentation supported specialty referrals for transitions of care rather than co-management of care. Accessing medical records across institutions contributed to a lack of clinical context, and workflow inefficiencies, when attempting to co-manage clinical care.
11492 Mapping CTSA hub activities across the EQ-DI framework to discover opportunities for interaction between health equity and dissemination & implementation science; the case of University of Colorado and University of Rochester
Authors: Nooraie Reza Yousefi , Kwan Bethany , Orlando Elissa , Bennett Nancy M.
Published: March 2021

ABSTRACT IMPACT: This study provides a framwork to inform and organize health equity efforts and initiatives at CTSA institutes. OBJECTIVES/GOALS: to map the activities of the Clinical and Translational Science Award (CTSA) Program hubs across the EQ-DI framework, to depict opportunities for interaction between health equity and dissemination & implementation (D&I) science. METHODS/STUDY POPULATION: The EQ-DI framework demonstrates the dynamic interaction between D&I science and health equity. Health equity could be a lens to sensitize and inform D&I planning (through goal-setting and team development), execution (through ‘adaptation’ and D&I strategies), and evaluation (through incorporating health equity in D&I outcome assessment). On the other hand, D&I models, methods, and study designs can operationalize dissemination and implementation of evidence-based interventions to improve equity. Stakeholder engagement is at the center of the framework to inform and direct the sensitization and operationalization cycles. RESULTS/ANTICIPATED RESULTS: We reviewed the activities of Colorado Clinical & Translational Sciences Institute (CCTSI) and University of Rochester Clinical and Translational Science Institute (UR CTSI) to improve health equity and mapped them across the EQ-DI framework. The sensitizing activities included health equity training, eliciting community priorities, and inclusion of health equity as a critical axis in funding mechanisms. The operationalizing activities included D&I methodological training and consultation, collaborative team science, and funding mechanisms to support implementation of health equity EBIs. Community engagement through studios, community liaisons, and consults was a core priority guiding sensitizing and operationalizing activities. DISCUSSION/SIGNIFICANCE OF FINDINGS: The CTSA Program has been a champion for community engagement and translational collaboration to improve individual and population health. CTSA hubs provide infrastructure and resources to facilitate equity-focused D&I.
16322 Post-Hurricane Community Health Assessment through Newspaper Stories and Interprofessional Community Engagement
Authors: Stevens Kathleen R. , Judson Mary , Parker Dan , Piernik-Yoder Bridgett , Lee Wendy , Reistetter Timothy , Vasquez David
Published: March 2021

ABSTRACT IMPACT: Working alongside news staff as community partners is feasible for community engagement to co-create a post-hurricane health assessment and connect it to our academic health center’s disaster response capacity. OBJECTIVES/GOALS: Successful academic-community partnership in post-disaster response depends on shared understanding of impact. Community newspapers could provide valuable insight into health needs and inform strategic recovery plans. Our objective was to determine methodological feasibility of using newspaper stories to identify post-disaster needs. METHODS/STUDY POPULATION: Community-Based Participatory Research principles were applied to engage newspaper staff and conduct qualitative analysis of stories published in the weekly Port Aransas South Jetty newspaper, serving this small rural coastal community. Using directed content analysis, the team derived and validated constructs from Maslow’s Hierarchy of Needs and Phases of Disaster models to create a codebook. Scientists and newspaper staff examined the codebook for congruency regarding interpretation and themes. With copyright permission to access online newspaper files, NVivo software was used to search for Hurricane Harvey-related terms (e.g., ‘Harvey, tropical storm, flood, damage, volunteer’). Stories from 3 days post-Harvey to 6 months post-Harvey were examined and again at anniversary date. RESULTS/ANTICIPATED RESULTS: The weekly South Jetty newspaper was published continuously from August 31, 2017, through the date our study ended, February 22, 2018. Analysis showed themes of the storm and community response to disaster at multiple levels. Harvey caused catastrophic flooding, destruction, on par with 2005 Hurricane Katrina as the costliest storm on record. In Port Aransas, 130 mph winds and a 12-foot storm surge damaged 90% of the buildings. Stories reflected Phases of Response: Pre-disaster, Impact, Heroic, Honeymoon, Disillusionment, and initial phases of Reconstruction and Maslow’s Hierarchy of Needs. Story: ‘It’s not just the physical part of Port Aransas that was hurt by the hurricane. Harvey also wounded the town’s collective psyche. We’ve wept for our losses, then counted our blessings, then wept for our losses again.’ DISCUSSION/SIGNIFICANCE OF FINDINGS: Newspapers were a rich source of post-disaster data. Text and pictures were poignant. Thematic analysis identified stages of recovery. Working alongside news staff as community partners is feasible for community engagement to co-create a post-hurricane health assessment and connect it to our academic health center’s disaster response capacity.
79602 Designing and Implementing an Assessment of Collaboration for a Clinical and Translational Research Community Advisory Board
Authors: Estabrooks Paul , King Keyonna , Palm Dave , Keeler Heidi
Published: March 2021

ABSTRACT IMPACT: This abstract presents a generalizable process to evaluate, and act on, community advisory board perceptions of collaboration effectiveness to improve clinical and translational research network function. OBJECTIVES/GOALS: Community advisory boards (CAB) play an important role in facilitating relevant and externally valid, clinical and translational research (CTR). The objective of this presentation is to describe a participatory process to derive collaboration metrics that can be used to assess CAB effectiveness. METHODS/STUDY POPULATION: During the 4th and 5th years of the Great Plains IDeA CTR award, we used a mixed-methods approach that included CAB (1) discussions related to the need to assess collaboration effectiveness, (2) review of the validated Wilder Collaboration Inventory to identify factors that, if maximized, would improve a sense of team science and enhance productivity, (3) planning for assessment frequency and follow-up processes, and (4) review of collaboration data to determine necessary actions for improvement. Qualitative data were gathered across components of the mixed-methods approach. Quantitative data were collected and reviewed by the CAB (n=11 members) during the 1st quarter of award year 5. RESULTS/ANTICIPATED RESULTS: CAB members expressed an interest in assessing collaboration effectiveness, identified important factors to assess, and agreed that annual assessment and follow-up would be appropriate. Key factors identified and assessed (5-point agreement scale--higher score reflects stronger agreement) were 1) mutual respect/trust (m=4.2); 2) appropriate cross section of members (m=3.6); 3) a shared stake in the process and outcomes (m=3.9); 4) flexibility in decision-making/collaboration (m=4.1); 5) roles and policy guidelines (m=3.6); 6) open communication (m=3.9); 7) goal achievement (m=4.0); 8) shared vision (m=4.0); and 9) skilled leadership (m=4.4). DISCUSSION/SIGNIFICANCE OF FINDINGS: CAB reflection on the initial collaboration assessment resulted in developing plans to broaden membership and clarify roles and policy guidelines related to CAB participation. There was strong consensus related to the utility of this assessment approach.
82003 Network Evaluation of a Community-Campus Partnership: Applying a Systems Science Lens to Evaluating Collaboration and Translation
Authors: Prochaska John D. , Croisant Sharon , Sommer Lesley C. , Treble Neil , Bohn Krista , Wiseman Lori , Singleton Chantele , Hallberg Lance
Published: March 2021

ABSTRACT IMPACT: Using network analysis and a systems science lens, UTMB’s Institute for Translational Sciences is able to quantify the evolution of REACH (its Community-Campus Partnership) as measured by the creation of new partnerships among member entities, promoting the translation and sharing of ideas and resources, and formalization of relationships among members. OBJECTIVES/GOALS: o Present how network analysis and systems science can inform evaluation of community-campus partnerships o Describe results from our experience with evaluating the REACH coalition o Summarize lessons-learned and likely improvements we are considering for our methodology METHODS/STUDY POPULATION: In 2016, we administered a network survey to core members of the Research, Education, and Community Health (REACH) coalition. The survey captured attributes about each organization, including size, populations served, etc. The survey also captured data on the relationships among these organizations, including joint meeting attendance, joint event planning, shared tangible resources, shared information, and formal legal agreements between organizations. These data were analyzed using network analysis methods. The survey was again repeated in 2018, and comparisons were made to evaluate how the network structure had evolved from 2016 to 2018. RESULTS/ANTICIPATED RESULTS: Joint meeting attendance was high in both 2016 and 2018; however, there was evidence of increased sharing of information and tangible resources in 2018. We also observed an increase in joint event planning among partnering agencies. Most strikingly, we observed that the number of formalized agreements (in the form of Memoranda of Understanding or more formalized contracts) between agencies more than doubled between 2016 and 2018. By measuring the evolution of our network of partners, we are able to document the evolution of a community-campus partnership over time. DISCUSSION/SIGNIFICANCE OF FINDINGS: Over the course of 2 years, the coalition signaled an increase in deeper collaborations beyond simply meeting together. The use of network analysis demonstrated utility and provided another dimension for evaluating the development of teams, partnerships, and coalitions.
48352 Mechanisms Underlying Lipidomic Changes in Major Depressive Disorder
Authors: Costa Ana Paula , van Dijr Milenna T. , Talati Ardesheer , Weissmann Myrna M. , McIntire Laura Beth
Published: March 2021

ABSTRACT IMPACT: Lipidomics is emerging as a powerful strategy to identify biomarkers for Major Depressive Disorder, as well as therapeutic targets in lipid metabolic pathways. OBJECTIVES/GOALS: Lipidomics is increasingly recognized in precision psychiatry for global lipid perturbations in patients suffering from Major Depressive Disorder (MDD). We will test the hypothesis that lipid metabolism dysregulation is associated with familial risk of depression. METHODS/STUDY POPULATION: Patients with MDD (G1), children (G2), and grandchildren (G3) have been part of a longitudinal study since 1982. If a parent G2 and grandparent G1 have MDD, G3 is considered a high risk of depression. Biospecimens (saliva and serum) were collected for full exome sequencing and RNA analysis. Samples will also be extracted for lipid content and lipids will be identified by mass spectrometry. A panel of nearly 600 lipid species can reliably be identified and quantified using liquid chromatography paired with tandem mass spectrometry (LC-MS/MS). Dysregulated lipids will be correlated with familial risk of depression in samples of G3. RESULTS/ANTICIPATED RESULTS: We hypothesize that dysregulation of lipids and lipid metabolism will be apparent in biospecimens from the high risk compared to the low risk of depression. Also, alterations in RNA transcriptomics of genes involved in lipid metabolic networks are associated with familial risk of depression. Several differential lipid species were previously identified to be associated with MDD. Reduced phosphatidylcholine(PC), phosphatidylethanolamine(PE), phosphatidylinositol(PI), and increased LysoPC, LysoPE, ceramide, triacylglycerol, and diacylglycerol levels have been correlated to MDD. However, these results need to be replicated in independent studies using lipidomics analysis. DISCUSSION/SIGNIFICANCE OF FINDINGS: It is highly likely that completely novel cellular targets will emerge from these studies by uncovering the convergence of lipidomics and genetic variance of lipid metabolic enzymes as biomarkers for predisposition to MDD as well as potential targets for therapeutic development for MDD.