bluuebunny/crossref_metadata_2025 huggingface dataset:
2281 Prophylactic broad-spectrum antibiotics for childhood malnutrition
Authors: Langdon Amy Elizabeth , Sun Xiaoqing , Isanaka Sheila , Dantas Gautam
Published: November 2018

OBJECTIVES/SPECIFIC AIMS: A course of oral broad-spectrum antibiotics frequently has a positive effect on morbidity and mortality in severe acute malnutrition (SAM), but the actual mechanism for this effect is unknown. This mechanism is especially important to find and quantify because of the possibility that using antibiotics prophylactically may accelerate the danger from antibiotic resistant infections. This study aims to answer (1) how antibiotic therapy improves the nutritional recovery and (2) how much it affects the prevalence of resistance genes in the microbiome. METHODS/STUDY POPULATION: Stool samples were collected from children with SAM between 6 and 60 weeks of age who received either one week of amoxicillin or placebo (n=164). The children were followed for 12 weeks with longitudinal sampling, and a subset were followed out to 2 years. All samples were frozen at −80°C and prepared for metagenome shotgun sequencing via the Illumina Nextera platform. RESULTS/ANTICIPATED RESULTS: Antibiotic treatment at the start of the nutritional program is associated with significant improvements in weight gain, mid-upper-arm circumference, and graduation from the treatment program. It is also associated with qualitative decreases in early-life fermenter Lactobacillus and known enteropathogen Campylobacter. Two years after the use of amoxicillin, the Shannon diversity index is significantly higher than that of malnourished children (effect size 0.507, 95% CI: 0.204–0.630, p=0.0007), while children who received placebo are not distinguishable from malnourished children by the same metric (effect size 0.147, 95% CI: −0.311, 0.630, p=0.5878). Sustained antibiotic resistance gene enrichment within the microbiota did not occur, as the enrichment effects disappears by week 4 of follow-up. DISCUSSION/SIGNIFICANCE OF IMPACT: The use of amoxicillin to treat uncomplicated SAM has therapeutic benefits visible by anthropometry and by content of the gut microbiota. The main concern with the use of prophylactic antibiotics for this purpose is the effect on antibiotic resistance gene enrichment in the children’s microbiota. This concern was not supported here. The benefit/cost ratio for the use of prophylactic antibiotics for individuals in this cohort is positive when weighing effects on anthropometry, microbiome, and antibiotic resistance. The results of this study impact the treatment of millions of children each year at nutritional therapy clinics around the world.
2189 Scrambler therapy: Potential new treatment for central neuropathic pain?
Authors: Mealy Maureen A. , Kozachik Sharon L. , Cook Lawrence , Nolan Marie T. , Smith Thomas J. , Levy Michael
Published: November 2018

OBJECTIVES/SPECIFIC AIMS: Central neuropathic pain is a severely disabling consequence of conditions that cause tissue damage in the central nervous system (CNS) such as multiple sclerosis (MS) and neuromyelitis optica (NMO). It impacts mood, mobility and quality of life, but is often refractory to common treatments. Scrambler Therapy is an emerging non-invasive pain modifying technique that utilizes transcutaneous electrical stimulation of nociceptive fibers with the intent of re-organizing maladaptive signaling pathways. It has been examined for treatment of peripheral neuropathy with favorable safety and efficacy outcomes, but its use in central neuropathic pain has not been reported. We aim to explore acceptability and safety of Scrambler Therapy through a Phase II sham-controlled trial in NMO, and describe its use to date in central neuropathic pain. METHODS/STUDY POPULATION: Two patients with longstanding central neuropathic pain who failed multiple drug trials were treated as proof-of-concept, supporting the recent launch of a Phase II randomized controlled trial in NMO where patients receive 10 daily Scrambler treatments versus sham. Safety and acceptability from those recruited to date will be reported. Acceptability is measured by adherence and responses to patient surveys. RESULTS/ANTICIPATED RESULTS: We plan to recruit 22 patients, randomized 1:1 into experimental and sham arms. We will present acceptability and safety data for Scrambler use in patients with NMO who have been recruited by the time of this conference, as well as effectiveness data from two cases that have been completed outside of the trial. One case involved a 65-year-old woman with a 4-year history of central neuropathic pain following a C3-C5 TM. Her numerical rating scale (NRS) pain score was reduced to 0/10 from a baseline score of 5/10. The second case involved a 52-year-old woman with a 13-year history of pain following a medullary cavernoma bleed. Her baseline NRS pain score was 9/10, which was reduced to 0.5/10 post-treatment. No adverse events were reported. Pain relief was sustained at 30 days’ post-treatment. DISCUSSION/SIGNIFICANCE OF IMPACT: We are investigating the acceptability and efficacy of Scrambler Therapy for central neuropathic pain treatment in NMO. Proof-of-concept was supported by two patients whose pain scores improved considerably more in response to this treatment than with previous pharmacologic and non-pharmacologic interventions. Results from this trial may support future investigation in other disorders that cause damage in the CNS, including MS and TM.
2273 Synthetic cannabinoid usage among psychiatric inpatients
Authors: Mann Claire L. , Nia Anahita B. , Spriggs Sharron , Carbonaro Steven , DeFrancisco Daniel , Parvez Lyla , Perkel Charles , Hurd Yasmin
Published: November 2018

OBJECTIVES/SPECIFIC AIMS: Synthetic cannabinoids (SC) are widely available and are associated with acute psychosis. Our recent study indicated that SC using psychiatric inpatients admitted in 2014 had more psychotic symptoms, aggression, and agitation compared with cannabis [marijuana (MJ)] using patients. The current study will review more charts and will characterize the demographics and presentations of current SC Versus MJ using patients. METHODS/STUDY POPULATION: A chart review was conducted of patients admitted to a New York City inpatient dual diagnosis psychiatric unit from 2014 to 2016. Inclusion criteria were self-reported current SC use or MJ use, or urine toxicology (+) for MJ. RESULTS/ANTICIPATED RESULTS: In total, 585 charts met inclusion criteria, 168 reported current SC use (40 f, 128 m SC users; 122 f, 295 m MJ users). SC using patients were younger (p=0.050), more likely to be Black (p=0.003), and homeless or living in a shelter (p=0.001). SC users were also more likely to be agitated (OR: 2.26) and aggressive (OR: 2.04) and have psychotic symptoms (OR: 3.03) compared with MJ users. SC users received more PRN medication (p<0.001) and had longer lengths of stay (p=0.001). DISCUSSION/SIGNIFICANCE OF IMPACT: Results demonstrate that current SC users had a different demographic profile compared with current MJ users. Our results also support our previous findings: SC using patients were more likely to be agitated and aggressive and were more likely to demonstrate positive psychotic symptoms.
2521 Use of forced air warming devices to induce fever-range hyperthermia in critically ill septic patients
Authors: Drewry Anne M. , Ablordeppey Enyo A. , Kollef Marin H. , Hotchkiss Richard S.
Published: November 2018

OBJECTIVES/SPECIFIC AIMS: Afebrile septic patients are twice as likely to die and develop nosocomial infections as compared with those with fever; the reason for these differences is unknown. One hypothesis is that elevated temperatures directly boost immunity and inhibit microorganism growth. However, there is little data examining the clinical effects of warming septic patients. The goal of this study was to determine whether warming afebrile septic patients to fever-range hyperthermia with noninvasive forced air warmers is feasible and safe. METHODS/STUDY POPULATION: This is an ongoing randomized trial on afebrile mechanically ventilated patients with severe sepsis. The intervention consisted of 48 hours of external warming with a forced air warming device to a goal core temperature of 1.5°C higher than the lowest recorded temperature within the 24 hours preceding enrollment. Efficacy of the intervention and adverse event data (i.e., increases in heart rate and vasopressor doses) were collected. Clinical outcomes included 28-day mortality and acquisition of secondary infections. RESULTS/ANTICIPATED RESULTS: In total, 18 patients were randomized to the control and warming groups, respectively. Baseline characteristics (including demographics, comorbidities, and illness severity scores) were similar among the 2 groups, except the control group had more males (61% vs. 28%, p=0.04). Median (IQR) body temperature averaged over the 48-hour intervention period was higher in the warming group [38.2 (37.6, 38.6) vs. 37.1 (36.4, 37.4) °C, p<0.001). Patients in the warming group achieved core temperatures above their goal for a median of 37 (IQR 11, 45) hours during the 48-hour intervention period. There were no differences in heart rate or vasopressor dose changes or acquisition of secondary infections between the groups. Eight (44.4%) control patients and 3 (16.7%) warmed patients died by day 28 (p=0.07). DISCUSSION/SIGNIFICANCE OF IMPACT: Externally warming severe septic patients with forced air warming devices effectively raises core body temperature and is safe. Additional research will focus on cellular and immunological changes seen in warmed Versus control patients.
2485 Advancing research professionals through competency assessments
Authors: Brouwer Rebecca N. , Snyder Denise , Hannah Deborah , Deeter Christine
Published: November 2018

OBJECTIVES/SPECIFIC AIMS: Describe the framework for tier advancement of research professionals. Describe the various forms of assessments of competencies. How competencies are used to provide transparency into professional development opportunities. Discuss the results of the first tier advancement opportunity for research staff. METHODS/STUDY POPULATION: These processes were developed at Duke, an academic medical center with over 2000 active clinical research protocols and 300 new clinical trials per year. Roughly 500 employees are categorized into tiered classifications, allowing them opportunities for advancement through competency testing. Approximately 10% opted for tier testing, and their results will be shared. RESULTS/ANTICIPATED RESULTS: Competency assessments were developed for all 42 of Duke’s research professional competencies, some using 2 modalities of testing. Almost 12% of the research professionals classified in tiered positions opted to attempt the tier advancement process. Of those, 37 completed, and the vast majority reached their desired tier. Results by competency will be provided. DISCUSSION/SIGNIFICANCE OF IMPACT: The use of objectively assessed competencies is an important step in the development of a workforce. By (1) maintaining alignment with industry standards for competencies, (2) holding staff to a high bar, and (3) offering a consistent approach to career growth, Duke is working to develop and maintain a workforce that supports high quality research.
2140 Clinical and translational research (CTR) platform for undergraduate health sciences programs (UHSP) at University of Puerto Rico-Medical Sciences Campus (UPR-MSC) and Universidad Central del Caribe (UCC): Pipeline for students and faculty
Authors: García Rubén G. , Irizarry-Ramírez Margarita , Rivera Efraín F. , Noboa Carlamarie , Moscoso-Álvarez José , González-Méndez María E. , Vázquez Mildred I. R.
Published: November 2018

OBJECTIVES/SPECIFIC AIMS: The University of Puerto Rico-Medical Sciences Campus and Universidad Central del Caribe, through the Title V Cooperative Project, devised a clinical and translational research (CTR) platform to pipeline students/faculty of undergraduate health sciences programs into CTR. Educational interventions in CTR—introductory intervention (II) and Annual Symposium (AS)—were designed to promote awareness, stimulate interest of students and faculty in CTR. METHODS/STUDY POPULATION: In the II the participants (n=159) were surveyed before and after a presentation and panel discussion about CTR. In addition, after the sessions—plenary, panel, and workshop—about CTR, the participants of AS (n=42) were surveyed for satisfaction and learning experience in CTR. RESULTS/ANTICIPATED RESULTS: Most participants of the II, 134 (84.3%) were students. In total, 58 (58, 36.5%) completed the post II survey. Of these, 53.4% satisfactorily defined the CTR concept Versus only 31.0% that could define CTR in the pre survey, 47 (81.7%) were unable to identify a CTR researcher and 45 (78.3 %) expressed interest in learning about CTR. In total, 28 (28, 66.7%) participants of the AS completed the satisfaction survey, out of which 17 (60.6%) were students. One hundred percent (100%) agreed that the AS served as a vehicle to increase their knowledge in CTR. DISCUSSION/SIGNIFICANCE OF IMPACT: The educational interventions demonstrated to be an effective strategy to promote awareness and stimulate interest of students and faculty in CTR. In addition, the results obtained, provided valuable baseline information for the planning—development of training cycles in CTR.
2346 Development of toolkits to support for researchers integrating dissemination and implementation science into their translational research
Authors: Tabak Rachel , Proctor Enola , Baumann Ana A. , Morshed Alexandra , V McKay , Prusaczyk B. , Gerke D. , Ramsey A. , Lewis E. , Small S. , Kryzer E.
Published: November 2018

OBJECTIVES/SPECIFIC AIMS: To use a systematic and iterative process to develop and refine toolkits to support dissemination and implementation (D&I) research. METHODS/STUDY POPULATION: Participants included research staff from the Dissemination and Implementation Research Core (DIRC), a research methods core from the Institute of Clinical and Translational Science at Washington University in St. Louis, other D&I experts from the University, and national experts from the D&I field. This project used education design research methodology and a systematic and iterative process involving several phases. The first phase (preliminary research and initial development) consisted of analysis of the educational problem and its context, and led to the development of toolkit prototypes and plans for their implementation. In the second phase (development and formative evaluation), toolkits were iteratively evaluated with emphasis on content validity and consistency and effectiveness as perceived by the users. Finally, in the summative evaluation, the toolkits were evaluated based on their use as intended. RESULTS/ANTICIPATED RESULTS: Our team identified the target audience as DIRC customers and investigators from disciplines across the University, and found that resources for beginners to D&I were lacking. The team developed 8 toolkits: (1) Introduction to D&I; (2) How to develop D&I Aims; (3) D&I Designs; (4) Implementation Outcomes; (5) Implementation Organizational Measures; (6) Assessing Barriers and Facilitators; (7) D&I Designs; and (8) Guideline research. These prototypes were iteratively revised for content validity and consistency. Finally, each toolkit was evaluated by two national experts in D&I science, and further refined. DISCUSSION/SIGNIFICANCE OF IMPACT: This systematic and cyclical process led to the development of 8 toolkits to support researchers in D&I science, which are now available on the DIRC Web site. This set the stage for development of new toolkits as additional needs are identified.
2292 Evaluating the impact of a K-award on clinical and translational research
Authors: Samuels Elias M. , Perorazio Thomas E. , Champagne Ellen , Eakin Brenda
Published: November 2018

OBJECTIVES/SPECIFIC AIMS: Identify the impact of the provision of clinical and translational research training awards on investigators’ pursuit of clinical and translational research careers. METHODS/STUDY POPULATION: Propensity score matching and qualitative analysis/investigators receiving MICHR’s KL2 research training awards. RESULTS/ANTICIPATED RESULTS: While the evaluations of the impact of this service have shown participants find them to be valuable it is expected that participation in the workshop may be more beneficial to investigators with certain types of prior research experiences and who utilize more CTSA research support. DISCUSSION/SIGNIFICANCE OF IMPACT: Because this evaluation of a research service incorporate data representing investigator’s receipt of different CTSA resources, the findings can be used to inform the ongoing coordination of these services in ways that optimize their impact on the production of clinical and translational research. There is an enduring need for evaluations of CTSA programs to account for investigators’ use of different constellations of research services in order to identify what combinations of services over time are most effective at fostering successful clinical and translational research careers.
2514 Disparities in care among patients presenting to the emergency department for nephrolithiasis
Authors: Schoenfeld Daniel , Mohn Larkin , Agalliu Ilir , Stern Joshua
Published: November 2018

OBJECTIVES/SPECIFIC AIMS: The prevalence of kidney stone disease has increased significantly in the United States in the last 2 decades. While several studies have reported that disparities in access to and quality of medical care exist, there is a need for a more thorough investigation of factors that negatively impact patients seeking care specifically for kidney stone disease. We sought to examine whether kidney stone patients received different standard of care in the emergency department (ED) according to their race/ethnicity, gender, age, body mass index, socioeconomic status (SES), and insurance status. METHODS/STUDY POPULATION: We conducted a retrospective study of patients presenting to the ED at Montefiore Medical Center between January 1, 2014 and December 31, 2016. Patients with a diagnosis of nephrolithiasis were identified using ICD-9/10 codes and electronic chart review was used to assess each patient’s ED course as well as to gather sociodemographic information. The primary outcomes of interest were administration of pain medication, prescription of alpha-1 antagonists to facilitate stone passage and whether or not patients received CT scan or ultrasound. Associations of these outcomes with age categories, sex, race/ethnicity, body mass index category, SES and insurance status were examined using multivariate logistic regression models. RESULTS/ANTICIPATED RESULTS: A total of 1200 patients were included in this analysis of which 616 (51%) were women. A large proportion of patients were minorities (40% Hispanic and 15% non-Hispanic African-American), whereas 21% were Caucasian and 24% declined to report race/ethnicity. Patients between the ages of 55–64 and those older than 65 were less likely to receive pain medication compared to younger patients aged <35 years (OR=0.48, 95% CI: 0.27–0.86 and OR=0.46, 95% CI: 0.21–1.00, respectively). Women were less likely than men to undergo any form of diagnostic imaging (OR=0.52, 95% CI: 0.35–0.76) including CT scan (OR=0.50, 95% CI: 0.35–0.72). Similarly, patients in the lowest quintile of SES received less imaging than patients in higher SES categories (OR=0.50; 95% CI: 0.27–0.90). Furthermore, African Americans (both genders) and women were less likely to be prescribed an alpha antagonist medication (e.g., tamsulosin) to facilitate stone passage compared with White patients (OR=0.61, 95% CI 0.36–1.03) and men (OR=0.68, 95% CI: 0.49–0.92), respectively. DISCUSSION/SIGNIFICANCE OF IMPACT: We found that multiple disparities exist among patients presenting to the ED for nephrolithiasis. A more thorough investigation into the causes of these disparities is warranted to limit their impact on patient care.
2148 Understanding the health effects of binding and tucking for gender affirmation
Authors: Poteat Tonia , Malik Mannat , Cooney Erin
Published: November 2018

OBJECTIVES/SPECIFIC AIMS: Gender affirmation is a critical aspect of the health and well-being of transgender individuals. For many transgender people, this includes changing one’s physical appearance to align with one’s felt gender. Some gender-affirming body modifications require medical interventions such as hormone therapies and surgeries. Other modifications, such as tucking to create a flat-appearing lower pelvis and binding to create a flat-appearing chest, require no external intervention. The published literature is slowly growing on the health effects of gender affirming medical interventions; however, other body modifications are understudied. As part of our needs assessment of the transgender community, we sought to understand the frequency and health impact of binding and tucking. METHODS/STUDY POPULATION: A quantitative online survey was developed based on qualitative interviews with 20 community-based key informants. The survey was available online, in English, for 6 months. Eligible participants were 18 years of age or older, lived in the Baltimore metropolitan area, and identified as transgender and/or a sex different from what was assigned on their original birth certificate. RESULTS/ANTICIPATED RESULTS: 139 participants provided complete data: 45% were assigned male at birth (AMAB) and 55% were assigned female at birth (AFAB). In total, 54% were Black, 40% White, and 9% Latinx. Of AFAB participants, 80% had bound their chest tissue. Of those who had bound, 51% bound 7 days/week, 62% bound 8+ hours per day, and 68% were concerned about the health effects of binding. The most common symptoms associated with binding were back pain (65%), shortness of breath (48.6%), bad posture (32%), chest pain (30%), and light-headedness (30%). Of AMAB participants, 71% had ever tucked, 85% of those tucked 7 days per week, 79% tucked 8+ hours per day, and 50% were concerned about the health effects of tucking. Most common symptoms included itching (28%), rash (21%), testicular pain (17%), penile pain (14%), and skin infections (12%). DISCUSSION/SIGNIFICANCE OF IMPACT: The majority of transgender participants used binding or tucking for gender-affirming body modification and at least half of them have concerns about associated health effects. Clinicians should ask transgender patients about binding and tucking behaviors and assess for common symptoms. More research is needed to better understand the benefits and risks of gender-affirming binding and tucking behaviors.
2314 (In)Adequacy of prophylactic central lymph node dissection for papillary thyroid cancer in the United States: An analysis of 18,755 patients
Authors: Ji Keven Seung Yong , Oyekunle Taofik , Sosa Julie A. , Roman Sanziana A.
Published: November 2018

OBJECTIVES/SPECIFIC AIMS: The incidence of papillary thyroid cancer (PTC) has sharply increased in recent decades. Though thyroid resection is the best treatment modality, there is significant variation in practice involving use of prophylactic central lymph node dissection (PCLND) at time of thyroidectomy. Recently, a threshold number for lymph node (LN) yield was determined to assure adequacy of lymphadenectomy in evaluating occult nodal disease via PCLND for pathologic T3, clinical N0, M0 PTC patients, for whom guidelines recommend PCLND. This study assesses the prevalence of adequate prophylactic LN dissection (APLND) and determines its association with patient, and disease characteristics. METHODS/STUDY POPULATION: Adult patients receiving surgery for pT3 cN0 M0 PTC >1 cm were identified from the National Cancer Data Base, 2004–2015. APLND for pT3 stage was defined as removing 8 or more LNs, based on recent literature. Univariate and multivariate logistic regression models were employed to determine factors associated with APLND and inadequate prophylactic LN dissection (IPLND). RESULTS/ANTICIPATED RESULTS: In total, 18,755 patients were included: 2905 (10.1%) had APLND; 15,849 (89.9%) had IPLND. Rate of APLND increased from 4.9% to 17.9% over the decade. Patients receiving APLND were younger than those receiving IPLND (47 vs. 52 years, respectively, p<0.001). The proportion of cases found to be LN positive in the APLND group was 64.5%, while that in the IPLND group was 18.2% (p<0.001). After adjustment, Whites were more likely than Blacks to receive APLND [OR 1.86 (95% CI 1.51–2.30), p<0.001]. The adjusted OR of receiving APLND was higher at academic centers [1.76 (1.29–2.41), p<0.001] and at integrated centers [1.77 (1.25–2.51), p<0.001], compared with community facilities. After adjustment, patients with multifocal tumors were more likely to receive APLND than those with unifocal tumors [1.28 (1.17–1.41), p<0.001]. Unplanned 30-day readmission rate was higher in the APLND group (2.4%) compared to the IPLND group (1.7%, p<0.001); this remained significant after adjustment [OR for APLND 1.80 (1.31–2.47), p<0.001]. There was no significant difference in the likelihood of receiving radioactive iodine between patients who underwent APLND Versus IPLND [1.00 (0.90–1.00), p=0.6]. DISCUSSION/SIGNIFICANCE OF IMPACT: APLND is associated with a higher likelihood of finding metastatic LNs, and an increased risk of unplanned short-term readmissions. The rate of APLND has increased over time, but still only a minority of thyroid cancer patients undergo adequate prophylactic surgery. Disparities exist based on patient, facility, and disease characteristics. Further work is needed to study the association between adequacy of dissection and disease recurrence.
2251 Assessing research impact: It takes a team
Authors: Dunn Ashley , Bass Michelle B.
Published: November 2018

OBJECTIVES/SPECIFIC AIMS: Dissemination of research findings through the published literature is a complex but critical part of the scholarly communication process. Additionally, this time point on the translational spectrum is a key objective of the National Clinical Association for Advancing Translational Sciences (NCATS). Tracking the dissemination of research outputs can be difficult to identify and evaluate. The purpose of this case study was 2-fold: (1) identify tools and resources available freely to the public and through university subscriptions used to assess research output; and (2) compare the effectiveness of these tools oat tracking output at different levels of granularity. METHODS/STUDY POPULATION: The authors, Spectrum staff (D.A.) and School of Medicine librarian (M.B.), attended webinars hosted by other Academic Medical Center libraries conducting work on impact tracking and learned from vendor product managers about available tools and resources during on-site campus visits. Publications from Stanford’s Clinical and Translational Science Award (CTSA) were used to track the diffusion of research outputs (e.g., number of citations, document types, research areas, relative citation ratio, CTSAs collaboration) via library subscription services (e.g., Web of Science and Scopus) and freely available tools (e.g., iCite and PubMed). RESULTS/ANTICIPATED RESULTS: The authors found certain tools were more inclusive in retrieving grant funded research outputs. For example, in the case of UL1 grant (UL1TR001085, UL1TR000093, UL1RR025744), on a grant-level output, there were discrepancies in the number of publications retrieved: (1) PubMed found 644 outputs; (2) Web of Science found 497 outputs; and (3) Scopus found 190 outputs. After de-duplication, the search across Web of Science (WoS), Scopus, and PubMed yielded 899 publications. In total, 389 outputs were unique to PubMed; 165 were unique to WoS; and 90 were unique to Scopus. Future analysis will be conducted to identify the source of unique outputs from each database (e.g., conference proceeding, specific journals). Additional analysis based on other units of research outputs (e.g., author-level outputs and article-level outputs) are expected to yield similar discrepancies. DISCUSSION/SIGNIFICANCE OF IMPACT: Citation analysis is a valuable method of assessing research output and, to a larger extent, research impact in a given field. It can help investigators illustrate qualifications for undertaking new projects, highlight collaborations across schools and departments, justify a grant renewal, and/or highlight accomplishments for promotion. However, systematic and comprehensive evaluations are needed in tandem with citation analysis/bibliometric analysis to assess the translation and uptake of research outputs and activities that result in research impact. Furthermore, both investigators and staff need adequate time and training to process research outputs/activities and to effectively organize them in easily understood visualizations.
2276 Development of the expanded access oversight committee at Michigan Medicine
Authors: Weatherwax Kevin , Hutchinson Ray , Mashour George , Gravelin Misty
Published: November 2018

OBJECTIVES/SPECIFIC AIMS: Expanded Access is an avenue for patients with no available treatment options to access investigational drugs and devices for clinical therapy. This process requires physicians treating these patients to submit requests to the FDA and the local IRB, processes which are typically unfamiliar to clinicians. METHODS/STUDY POPULATION: With the goal of reducing burden and ensuring access to investigational products, Michigan Medicine established the Expanded Access Oversight Committee in January 2015. This committee brought together key stakeholders to develop appropriate policy and infrastructure to support these requests. RESULTS/ANTICIPATED RESULTS: Outcomes from this committee have resulted in a uniform process with a single point of entry for interested physicians and patients. With standardized policy implemented across the institution, a revised IRB application has been developed that is more tailored to Expanded Access and an informed consent document has been developed specific to the clinical use of investigational therapies. To ensure timely execution of these agreements, the contracts office has streamlined the process for negotiating Expanded Access agreements with manufacturing companies. Further development has begun with the Michigan Clinical Research Unit to provide space for clinical visits in Expanded Access cases, allowing for initiation of outpatient therapy. These changes have allowed Michigan Medicine to support triple the number of Expanded Access requests, including more than 45 Expanded Access requests in fiscal year 2018. DISCUSSION/SIGNIFICANCE OF IMPACT: Institutional support for Expanded Access requests within a large academic medical center is feasible and can increase access to investigational therapies bfor patients.
2214 Nutritional outcomes in pediatric oncology patients less than 3 years of age
Authors: Runco Daniel , Mertens Ann , Wasilewski-Masker Karen
Published: November 2018

OBJECTIVES/SPECIFIC AIMS: Brain tumors are the most common solid tumor diagnosed in children and their location predisposes patients to oromotor dysfunction leading to feeding difficulties. Brain tumor patients experience feeding difficulties more frequently than other pediatric malignancies, largely due to central nervous system directed chemotherapy, radiation, and surgery. Treatment increases the risk of malnutrition and increases risk for infection, ICU admissions, and death. Infants and children (less than 3 years of age) are at higher risk for malnutrition due to rapidly changing nutritional requirements and the underdevelopment of motor skills. Incidence and prevalence of malnutrition in pediatric cancer patients is not well known. METHODS/STUDY POPULATION: This is an observational, retrospective study of our center’s pediatric cancer patients. Patients are classified by diagnosis, treatment intensity (ITR-2), vital status, and heights and weights (with standardized Z-scores) will be recorded with through 2 years after diagnosis. Adaptation of Intensity of Treatment Rating ITR-2. Nutrition consultation, ICU admissions, and use of parenteral or enteral nutrition will be recorded. Weight loss greater than a 5-percentile point change or Z-score decrease greater than 0.5 will be treated as a binary outcome and considered significant weight loss. RESULTS/ANTICIPATED RESULTS: Preliminary analysis has identified 465 eligible subjects as described above: brain tumor (n=45) and nonbrain tumor patients (n=420). Patient Schema. This study is still in progress and aims to better identify incidence of malnutrition during pediatric cancer therapy. It is expected that a greater number of nonbrain tumor patients compared with brain tumor patients will be malnourished as defined by decrease in Z-score greater than 0.5 at any point in therapy or falling below the 5th percentile of weight for age. Weight loss will be associated with higher number of ICU admissions and higher treatment intensity score. Finally, we expect to find that patients with a larger decrease in Z-score for age will be more likely to die during therapy. DISCUSSION/SIGNIFICANCE OF IMPACT: In addition to this study being valuable in better defining incidence of malnutrition, this data will serve as preliminary data in defining target populations for focused nutritional intervention during cancer therapy. Using this established and published intensity rating scale, we may be able to identify better methods of identifying and preventing malnutrition during cancer therapy.
2567 OHRP meets ToS: Cloud-based technologies in human subject research
Authors: Pascalev Assya
Published: November 2018

OBJECTIVES/SPECIFIC AIMS: To identify new ethical challenges in human subject research related to the use of cloud-based platforms for data collection. METHODS/STUDY POPULATION: Ethical analysis. RESULTS/ANTICIPATED RESULTS: The OHRP regulations protecting the data, privacy and confidentiality of human subjects and the Terms of Service regulations governing data use by cloud-based platforms are vastly different. The gap between these 2 sets of laws and regulations leaves human subjects vulnerable to harm during the data collection process via clod-based tools. DISCUSSION/SIGNIFICANCE OF IMPACT: Recognizing the risks related to data gathering via cloud-based platforms, and educating researchers and research subjects about these risks and how to minimize them will strengthen the protections of participants and will enhance the informed consent process resulting in increased trust and greater willingness to participate in human subject research.
2489 Perceptions of “translation” and the application of research across disciplines at the University of Michigan
Authors: Gravelin Misty , Ramsey Meagan , Lota Kanchan , Mashour George
Published: November 2018

OBJECTIVES/SPECIFIC AIMS: There is no consensus on what constitutes translational research. To effectively support translation of research into practical settings, universities must determine who is involved, in which disciplines, and what results. In addition, it is unclear whether these researchers would see “translational research” as describing their work. METHODS/STUDY POPULATION: A survey assessing perceptions, successes, and barriers to the application of research was distributed to faculty, fellows, and graduate students within the University of Michigan. This survey included a question on the definition of translational research. RESULTS/ANTICIPATED RESULTS: Investigators of every rank and school participated (n=865), and all schools reported forms of applied research. Over 70% of participants said it was important to use research results beyond academia, and those responses represented diverse successes ranging from product development to artistic endeavors. Common barriers to such as lack of time and funding were also widely experienced. The definitions of translational research were divided between strictly health-oriented or broadly focused application. However, both definitions and familiarity with the term differed by field. DISCUSSION/SIGNIFICANCE OF IMPACT: Translation of research is widespread throughout the university, and many would define translational research to include their research discipline. Strategic university policies could benefit society by enhancing translation and application across many disciplines.
2013 Trends in anogenital warts incidence: Potential impact of human papillomavirus vaccination, TennCare 2006–2015
Authors: Shing Jaimie Z. , Griffin Marie , Pemmaraju Manideepthi , Mitchel Edward , Hull Pamela
Published: November 2018

OBJECTIVES/SPECIFIC AIMS: We aimed to assess trends in incidence of genital warts across human papillomavirus (HPV) vaccine-eligible and nonvaccine-eligible age groups to determine the impact of the HPV vaccine among Medicaid enrollees in the state of Tennessee. METHODS/STUDY POPULATION: We analyzed 2006–2014 medical and pharmaceutical claims data from TennCare (Tennessee’s Medicaid program) enrollees aged 15–64 years. Incident cases of genital warts were defined as persons 12 months disease free and: (1) a diagnosis of condyloma acuminatum, or (2) a diagnosis of viral warts and genital-specific procedure, or (3) a prescription for genital warts medication and genital-specific procedure. Mann-Kendall trend tests were performed to assess for significant trends in incidence of genital warts by sex and age group; average annual percent changes were calculated to quantify these trends. RESULTS/ANTICIPATED RESULTS: Our analysis is in progress. We hypothesize that we will observe declines in genital warts among younger, vaccine-eligible age groups and no changes in older, nonvaccine-eligible age groups, with largest declines among females aged 15–19 years from 2006 to 2014. We also expect to see declines among younger males due to herd protection, with greater declines after 2011, when the vaccine was approved for males. DISCUSSION/SIGNIFICANCE OF IMPACT: Significant declines among younger compared with older age groups would suggest HPV vaccine effectiveness for preventing genital warts.
2181 Age-related change in 5-HT6 receptor availability in healthy male volunteers measured with 11C-GSK215083 PET
Authors: Radhakrishnan Rajiv , Nabulsi Nabeel , Gaiser Edward , Gallezot Jean-Dominique , Henry Shannan , Planeta Beata , Lin Shu-fei , Ropchan Jim , Williams Wendol , Morris Evan , D’Souza Deepak Cyril , Huang Yiyun , Carson Richard E. , Matuskey David
Published: November 2018

OBJECTIVES/SPECIFIC AIMS: The serotonin receptor 6 (5-HT6) is a potential therapeutic target given its distribution in brain regions that are important in depression, anxiety, and cognition. This study sought to investigate the effects of age on 5-HT6 receptor availability using 11C GSK215083, a PET ligand with affinity for 5-HT6 in the striatum and 5-HT2A in the cortex. METHODS/STUDY POPULATION: In total, 28 healthy male subjects (age range: 23–52 years) were scanned with 11C-GSK215083 on the HR+PET scanner. Time-activity curves in regions-of-interest were fitted with multilinear analysis-1 method. Binding potentials (BPND) were calculated using cerebellum as the reference region and corrected for partial volume effects. RESULTS/ANTICIPATED RESULTS: In 5-HT6 rich areas, regional 11C-GSK215083 displayed a negative correlation between BPND and age in the caudate (r=−0.41, p=0.03) (14% change per decade), and putamen (r=−0.30, p=0.04) (11% change per decade), but not in the ventral striatum and pallidum. Negative correlation with age was also seen in cortical regions (r=−0.41, p=0.03) (7% change per decade), consistent with the literature on 5-HT2A availability. DISCUSSION/SIGNIFICANCE OF IMPACT: This is the first in vivo study in humans to examine the effect of age on 5-HT6 receptor availability. The study demonstrated a significant age-related decline in 5-HT6 availability (BPND) in the caudate and putamen.
2204 Characterizing specialized pro-resolving lipid mediators and synthesis pathways in veterans with peripheral artery disease
Authors: Ramirez Joel , Zahner Greg J. , Khetani Sukaynah A. , Spaulding Kimberly A. , Hills Nancy K. , Grenon S. Marlene
Published: November 2018

OBJECTIVES/SPECIFIC AIMS: Specialized pro-resolving lipid mediators (SPM) actively counter proinflammatory cascades. A deficit of SPMs is one possible mechanism through which inflammation leads to the development of atherosclerotic disease. The purpose of this study is to characterize the profiles of intermediates of SPM synthesis pathways and end-product SPMs in the plasma of patients with peripheral artery disease (PAD). METHODS/STUDY POPULATION: A cross-sectional sample of 52 patients with PAD was recruited at the San Francisco Veterans Affairs Medical Center. PAD was defined as the presence of claudication symptoms and an ankle-brachial index <0.9, or a history of revascularization for claudication. Patients were excluded if they were taking immunosuppressive medications, had a severe acute illness (infection, surgery, illness, critical limb ischemia) within the last 30 days, or had severe hepatic, renal, or nonvascular inflammatory disease. Intermediates of SPM synthesis pathways and end-product SPMs were measured in plasma samples of patients by liquid chromatography-tandem mass spectrometry. RESULTS/ANTICIPATED RESULTS: The average age of the cohort was 69±6.3 and patient comorbidities reflected common comorbidities associated with PAD (hypertension 96%, hyperlipidemia 87%, diabetes mellitus 42%, coronary artery disease 34%). Rutherford categories, measurements of PAD symptom severity, ranged from 0 to III (0 10%, I 40%, II 27%, III 23%). Three EPA products were measured: 18-hydroxyeicosapentaenoic acid (18-HEPE), resolvin E1 (RvE1), and resolvin E2 (RvE2). 18-HEPE, an intermediate of SPM synthesis, was detectable in the plasma of every patient (median: 105 pg/mL, IQR: 54.9–195), whereas the SPM end-products, RvE1 and RvE2, were only detectable in 6 and 10 patients, respectively. In total, 7 DHA products were measured: 14-hydroxydocosahexaenoic acid (14-HDHA), 17-HDHA, resolvin D1 (RvD1), resolvin D2 (RvD2), protectin D1, protectin DX, and maresin 1. The intermediates 14-HDHA (median: 6546 pg/mL, IQR: 3329–12061) and 17-HDHA (median: 644 pg/mL, IQR: 340–1056) were detectable in the plasma of every patient. However, the end-products RvD1, RvD2, protectin D1, protecin DX, and maresin 1 were identified in less than half of the cohort. DISCUSSION/SIGNIFICANCE OF IMPACT: We report the presence of several intermediates of SPM synthesis pathways (18-HEPE, 14-HDHA, and 17-HDHA) in every patient but the presence of SPM end-products in only a limited portion of the cohort. These results suggest that some patients with PAD may have a deficit of SPMs. Further investigation is required to better understand the role of SPMs and mediators of resolution of inflammation in PAD.
2549 Characterizing the expression kinetics of HIV-1 envelope protein
Authors: Oh Djin-Ye , Liu Lihong , Trinité Benjamin , Wright En-Wei Hu-Van , Sahi Vincent , Huang Yaoxing , Levy David N. , Ho David D.
Published: November 2018

OBJECTIVES/SPECIFIC AIMS: Characterize the expression kinetics of HIV-1 Envelope and their relationship to virus production at the cellular level. METHODS/STUDY POPULATION: In vitro and ex vivo laboratory analyses. RESULTS/ANTICIPATED RESULTS: Initial studies addressing the kinetics of cell surface. Envelope (Env) expression reveal that Env expression to peaks on day 2 post infection. Next steps include a series of experiments to compare the kinetics of Env cell surface expression with broadly neutralizing antibody (bNAb)-mediated ADCC and the characterization of virus production kinetics in this same context. To be maximally effective, ADCC elimination of infected cells should occur before peak Env expression. DISCUSSION/SIGNIFICANCE OF IMPACT: Potent bNAbs to HIV-1 recognize vulnerable sites on the HIV-1 Envelope (Env) protein and are of great clinical interest due to their potential use in the prevention and treatment of HIV-1 infection. Their effectiveness depends not only on the neutralization of viral infectivity, but also on the elimination of productively infected cells via antibody-dependent cellular cytotoxicity (ADCC). On a cellular level, ADCC dynamics are determined by the timing and level of Env expression on the surface of HIV-infected cells. This study aims to delineate the expression kinetics of HIV-1 Envelope and their relationship to virus production. We expect that it will provide new insights into the utility of bNAb-mediated ADCC in treating and possibly curing HIV-1 infection; therefore results might have substantial impact on future HIV treatment strategies.
2350 Creating a comprehensive municipal inventory of common ragweed (Ambrosia artemisiifolia) to predict allergenic pollen exposures
Authors: Katz Daniel S. W. , Batterman Stuart
Published: November 2018

OBJECTIVES/SPECIFIC AIMS: One of the key difficulties in predicting allergenic pollen exposures has been a lack of information on source plant location and abundance. However, the increasing availability of spatially explicit data from remote sensing offers new opportunities to create comprehensive inventories of allergenic pollen producing plants. METHODS/STUDY POPULATION: In this study, we use a spatially oriented field survey to map common ragweed (Ambrosia artemisiifolia) in Detroit, MI, USA. We then combine this with remote sensing imagery and LiDAR to predict ragweed presence and potential pollen production across 344 km2 of Detroit. Finally, we compare this with measurements of airborne pollen concentrations collected throughout the city. RESULTS/ANTICIPATED RESULTS: Our initial results show that ragweed is present in ~2% of the city, and its presence and abundance are strongly associated with demolished building (p<0.001). The uneven distribution of ragweed plants across the city leads to substantially higher pollen concentrations in neighborhoods where more buildings have been recently demolished. DISCUSSION/SIGNIFICANCE OF IMPACT: Our approach offers an effective way to quantify allergenic pollen production, airborne concentrations, and exposures across a large metropolitan area. This in turn provides insight on how to best reduce airborne pollen concentrations: in this case, by changing post-demolition land management practices.