Outcomes Research/Health Services Research/Comparative Effectiveness
2460: Change in duration of postoperative antibiotic prophylaxis in esophagectomy patients: Outcomes in a single academic institution
- Sue Wang, Gavitt A. Woodard, Calixto-Hope Lucas, Stanley J. Rogers, David M. Jablons
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- 10 May 2018, p. 79
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OBJECTIVES/SPECIFIC AIMS: Ivor-Lewis esophagectomy (ILE) is an invasive surgical procedure with a high incidence of postoperative pneumonia. Antibiotic prophylaxis could reduce respiratory infections but increase Clostridium difficile and antibiotic resistance. Our institution reduced the duration of piperacillin-tazobactam prophylaxis following ILE from 4 to 1 day or less in January 2015. We evaluated short-term outcomes in ILE patients before and after this institutional change. METHODS/STUDY POPULATION: Retrospective cohort study of all ILE patients from 2012 to 2016. We confirmed antibiotic duration directly from nursing medication administration records. The primary outcomes of this study were rates of C. difficile and postoperative pneumonia. Secondary outcomes include other infection, length of hospital stay, and readmission within 30 days. We used logistic regression to analyze impact of days of antibiotics and χ2 or Fischer exact tests for categorical variables. RESULTS/ANTICIPATED RESULTS: Of 104 ILE patients, 40.4% (n=42) were after January 2015, 11.5% developed pneumonia and 5.8% developed C. difficile colitis. ILE patients received more days of antibiotics before the institutional change compared with after (6.1 vs. 2.9 d, p<0.01). For a 1-day increase in antibiotic duration, the odds of acquiring C. difficile increased significantly by 1.2 (p=0.03). Before compared with after the institutional change, rates of C. difficile were 8.1% Versus 2.4% (p>0.2), rates of pneumonia were 11.3% Versus 11.9% (p>0.2), and length of stay was 10.9 Versus 10.5 days (p>0.2), respectively. DISCUSSION/SIGNIFICANCE OF IMPACT: Institutional policy can have an impact on patient outcomes. Antibiotic stewardship is associated with reduced rates of inpatient C. difficile. Our study suggests reduced antibiotics are not associated with pneumonia, although larger studies are necessary to confirm this finding. Surgeons should consider the benefit of decreased rates of C. difficile before administering prolonged antibiotic prophylaxis following esophagectomies.
2466: Communication frequency and content between parents of concussed youth and systems of care
- Sarah Terry, Molly Cox, Alexandra Linley, Jilian O’Neill, Laura Dreer
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- 10 May 2018, p. 80
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OBJECTIVES/SPECIFIC AIMS: To characterize parent communication frequency and content between systems of care (medical, school, and sports/recreation) of concussed youth who are in prolonged recovery. METHODS/STUDY POPULATION: In this ongoing study, 16 concussed youth (average age=14.9 years, SD=1.5; 31.2% female and 68.8% male) and their parent study partner (average age=44.3 years, SD=4.3; 87.3% female and 12.5% male) have been enrolled to date from sports medicine clinics. Demographic information was obtained during the initial clinic intake session. Weekly phone calls were also conducted with the parent and child until the child was considered asymptomatic (ie, reporting no symptoms on the SCAT3), to collect data on communication with the school, sport/recreation, and medical systems throughout the recovery process. For the purpose of this study, we evaluated communication patterns of those parents who had a child in prolonged recovery (ie, symptomatic 14 d or more post-concussion injury). Communication variables included frequency (ie, number of times a parent contacted or attempted to contact a system of care) and content or topic discussed during the contact event. RESULTS/ANTICIPATED RESULTS: Of the 16 enrolled participants to date, 68.8% (n=11) experienced concussion related symptoms 14 days postinjury (M=22.2, SD=4.6) at the time of their 2 week follow-up call and were thus considered to be in prolonged recovery. Of those 11, 81.8% (n=9) of parents reported communicating with the school system at some point between the initial clinic intake session and the 2 week follow-up phone call. The frequency of communication for this period ranged between 0 and 10 instances of contact (M=2.5, SD=2.9). Of the 11 prolonged cases, 8 participants were members of sports teams. Sixty-three percent (n=5) of those parents with a child on a sports team communicated with a coach while none of the parents contacted a team athletic trainer. The frequency of communication with the coach ranged from 0 to 8 (M=1.5, SD=2.5) over the course of 2 weeks from enrollment. With regards to the medical system, the majority of parents (72.7%, n=8) communicated at least once with a medical professional during the same time period. The frequency of communication with the medical system ranged from 0 to 8 (M=2.2, SD=2.6) points of contact. Themes that arose for communicating with the school system included informing school personnel of academic accommodations prescribed by the physician, explaining absences, and concerns about missed academic work and grades. The content of communication with the sports system (ie, coach) pertained to return-to-play issues as well as progress updates on recovery. Themes for communication with the medical system were centered on scheduling appointments, attending follow-up medical appointments, and starting return-to-play protocols. DISCUSSION/SIGNIFICANCE OF IMPACT: Parents of concussed youth who were still in prolonged recovery, for the most part, appear engaged in communicating with multiple systems of care. However, a subset of parents did not participate in contact with these systems. Further discussion of these findings will highlight areas for improvement in concussion management as well as strategies parents can utilize to advocate for their child in terms of return-to-learn and recovery.
2479: Validating acute urinary retention using diagnosis and procedure codes
- Scott Martin Vouri, Seth Strope, Margaret Olsen
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- 10 May 2018, p. 80
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OBJECTIVES/SPECIFIC AIMS: We evaluated the accuracy of diagnosis and procedure codes to identify acute urinary retention (AUR) due to lack of existing validation studies. METHODS/STUDY POPULATION: We performed a cross-sectional validation study at a single medical institution in the emergency department (ED) and outpatient Urology Clinic in men ≥45 years. International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) diagnosis codes 788.20, 788.21, 788.29 for urinary retention and Current Procedural Terminology, Fourth Edition (CPT-4) codes 51701, 51702, 51703 for urinary catheterization were used to identify men with potential AUR. Four algorithms using ICD-9-CM and CPT-4 codes were compared against medical record review. Sensitivity, specificity, positive predictive value, negative predictive value, and area under the curve were calculated for both the ED and Urology Clinic. RESULTS/ANTICIPATED RESULTS: A total of 333 treated and released men in the ED were identified using facility billing data, and 245 men using physician billing data in the Urology Clinic were identified using the codes for urinary retention or urinary catheterization. Of the 4 algorithms, any ICD-9-CM diagnosis code for urinary retention was the preferred algorithm with a sensitivity and specificity of 0.95 and 0.91 using ED facility billing data and a sensitivity and specificity of 0.95 and 0.58 using Urology physician billing data. DISCUSSION/SIGNIFICANCE OF IMPACT: Use of the ICD-9-CM diagnosis codes for urinary retention performed well at identifying AUR in the ED. This study provides justification to use urinary retention diagnosis codes (specifically 788.20 and 788.29) in future studies to identify AUR using administrative data, especially in the ED.
2483: Evaluating a community research consult service: Getting to outcomes and impacts
- Clara Pelfrey, Katrice Cain, Mary Ellen Lawless, Earl Pike, Ashwini Sehgal
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- 10 May 2018, p. 80
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OBJECTIVES/SPECIFIC AIMS: This study describes the design, operation, and evaluation of a community-based research (CBR) consult service within the setting of a Clinical and Translational Science Award (CTSA) institution. To our knowledge, there are no published evaluations of a CBR consult service at a CTSA hub. METHODS/STUDY POPULATION: A CBR consult service was created to support faculty, healthcare providers/research coordinators, trainees, community-based organizations, and community members. A framework was developed to assess the stages of client engagement and to foster clear articulation of client needs and challenges. A developmental evaluation system was integrated with the framework to track progress, store documents, continuously improve the consult service, and assess research outcomes. RESULTS/ANTICIPATED RESULTS: This framework provides information on client numbers, types, services used, and successful outreach methods. Tracking progress reveals reasons that prevent clients from completing projects and facilitates learning outcomes relevant to clients and funding agencies. Clients benefit from the expert knowledge, community connections, and project guidance provided by the consult service team, increasing the likelihood of study completion and achieving research outcomes. DISCUSSION/SIGNIFICANCE OF IMPACT: Our evaluation suggests that clients benefit by (1) gaining the collective knowledge of the experts comprising the team, (2) learning the process of doing CBR, including the required steps to reach completion, and (3) gaining a project management mentality promoting translational research outcomes. This study offers a framework by which CTSA institutions can expand their capacity to conduct and evaluate CBR while addressing challenges that inhibit community engagement.
2484: Establishment of the Tennessee-sickle cell disease network as a mechanism for engaging a rare disease population in patient centered outcomes research
- Tilicia Mayo-Gamble, Velma McBride Murry, Michael R. DeBaun
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- 10 May 2018, pp. 80-81
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OBJECTIVES/SPECIFIC AIMS: Despite the high prevalence of individuals diagnosed with sickle cell disease (SCD) in Tennessee, comprehensive care and education for patients with SCD is not as widely available as healthcare services for individuals managing other chronic illnesses. We aimed to engage SCD stakeholders in patient-centered outcomes research (PCOR) as a mechanism for advancing care and translational research for this rare disease population. METHODS/STUDY POPULATION: Through a partnership with the Sickle Cell Foundation of Tennessee, we implemented Community Health Ambassadors to systematically engage patient partners with SCD and their caregivers, aged 18–50 from rural and urban communities throughout Tennessee, in PCOR to establish a sustainable infrastructure, focused on connecting the SCD community through a service providing community-based organization to offer (1) information on how to connect with other families; and be informed about SCD community activities, or educational offerings; (2) training in basic research principals; and (3) opportunities to contribute to PCOR, including feedback on effective and practical ways for providing input on research efforts through patient centered input, comparing urban and rural area preferences. Community ambassadors utilized health fairs, clinic days at various hospitals and community centers, and social media to spread awareness of the project, in addition to boosting the recruitment process. RESULTS/ANTICIPATED RESULTS: A statewide SCD network was developed to offer social support and increase access to education, medical care, and engagement in research activities. Findings include: recruitment of 150 patients and 35 executive committee members (local physicians, community leaders, adults with SCD and parents of children with SCD). DISCUSSION/SIGNIFICANCE OF IMPACT: Most rural and urban families affected by SCD have no systematic way to engage in, or lend their expertise to, PCOR. A statewide network of patient partners, community stakeholders, researchers, and medical professionals will ultimately increase the standard of care for patients, and provide valuable insight for SCD research. The opportunity to create the underpinnings for coordinated patient-centered education for patients with SCD and their caregivers holds promise for developing a scalable PCOR process model for replication and implementation in other states and emulate this model with other rare disease populations.
2496: Improving minority health and reducing health disparities: Research at the intersection of health disparity science and clinical and translational science
- Meryl Sufian, Derrick Tabor, Phuong-Tu Le
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- 10 May 2018, p. 81
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OBJECTIVES/SPECIFIC AIMS: (1) To explain and discuss minority health and health disparities and the mechanisms, for example, individual behaviors and lifestyle, genetics and epigenetics, physical and cultural environment, and clinical events and health care, that lead to health disparities. (2) To explore the intersection between health disparity science and clinical and translational science. (3) To present and discuss the NIMHD Framework and how it can be used to guide multilevel research to address minority health and health disparities. (4) To highlight examples of NIMHD-funded novel and innovative research relevant to clinical and translational research from a health disparities perspective. METHODS/STUDY POPULATION: The NIMHD Research Framework will be introduced that is currently being used by NIMHD to address minority health and health disparity research. The Framework looks at targeted populations in relation to biological, behavioral, physical, and sociocultural environmental domains of influence as well as the health care system. These domains have different levels of influence: individual, family/interpersonal, community, and population. Targeted populations include NIH-designated health disparity populations, that include racial/ethnic minorities, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minorities. The following research opportunities are among the many opportunities offered by NIMHD: Disparities in Surgical Care and Outcomes Social Epigenomics for Minority Health and Health Disparities Addressing Health Disparities Among Immigrant Populations. RESULTS/ANTICIPATED RESULTS: Select examples of NIMHD supported minority health and health disparities research that intersects with clinical and translational research will be presented. Candidate examples include: Genetic Architecture of Lupus (SLE) in individuals with Asian ancestry; A Novel Racial Disparity Marker for Risk Prediction in Triple Negative Breast Cancer Patients; Self-Applied Wearable Ultrasound Therapy for Osteoarthritis Management in Rural Central NY; Design and Development of a Multifunctional Self-service Health Screening Kiosk. DISCUSSION/SIGNIFICANCE OF IMPACT: Despite notable improvements gained as a result of medical and scientific advances, there continues to be an alarming disproportionate burden of illness and lack of representation in research among minority and other socially disadvantaged and underserved populations. To meet this challenge, NIMHD is committed to supporting a wide range of clinical and translational research aimed at the development of innovative strategies and approaches to reduce and, eventually, eliminate health disparities. NIMHD’s mission, research priorities, and funding opportunities are relevant to the efforts and interests of clinical and translational scientists, especially those interested in the translation of research findings into interventions, products, and tools that may improve minority health and quality of life, increase adherence to medication and treatment regimens, increase access, and improve the delivery of health services.
2497: Risk factors for poor retention in HIV care using clinic and statewide surveillance data
- Rebecca Duron, Michael Mugavero, Andrew Westfall
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- 10 May 2018, p. 81
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OBJECTIVES/SPECIFIC AIMS: Approximately 50% of people who have been diagnosed with HIV are either not linked to a care provider or not retained in medical care. This has substantial implications for both individual and public health outcomes. On an individual level, being retained in care is necessary for continuous receipt of antiretroviral therapy and sustained viral suppression. The public health implications of poor retention in HIV care are also serious, as it is estimated that people with HIV who are not retained in medical care are responsible for a majority of HIV transmissions, even more than the number of transmissions attributable to those who are HIV infected but undiagnosed. State departments of health routinely collect surveillance data including positive HIV test results, CD4 counts and viral load measures for monitoring trends in HIV infection. A shift in the use of these surveillance measures, guided by the CDC, has brought forth the opportunity to use these data for direct patient services and, more specifically, to direct re-engagement and retention in care efforts. Although the risk factors for poor retention in HIV care have been characterized using information from individual or multiple clinics, this study seeks to incorporate state surveillance data into the retention measures. METHODS/STUDY POPULATION: This retrospective cohort study was performed at the University of Alabama at Birmingham 1917 HIV/AIDS Clinic among patients with at least one attended HIV primary care visit during the calendar year of 2015. Retention during the calendar year of 2016 was then measured as whether or not a patient had 2 or more completed clinic visits which were separated by more than 90 days (in accordance with the Health Resources and Services Administration or HRSA guidelines, a National HIV Quality Indicator). For patients who did not have any primary care visit in 2016, the Alabama Department of Public Health will provide a status of care (out of care, in care elsewhere, died, moved out of state, and cannot locate) based on HIV laboratory results reported from all clinics and labs across the state and/or mortality information. A multinominal regression model of the status of care will be fitted to demographic, clinical, laboratory, and behavioral patient reported outcomes captured during an index visit in 2015. RESULTS/ANTICIPATED RESULTS: Data were recently obtained and is currently being analyzed on 3107 patients included in this study. We anticipate that there will be differences in the factors significantly associated with patients classified as out of care, poorly retained (patients who have only one completed clinic visit), and retained in care by the HRSA measure during calendar year 2016. DISCUSSION/SIGNIFICANCE OF IMPACT: By incorporating state surveillance data into our analysis, we expect to obtain a more precise picture of the risk factors for poor retention among HIV patients. For the first time, we will be able to determine if patients lost to our HIV clinic (~10% annually) are entirely lost to medical care or are seeking care elsewhere as indicated by HIV lab data reported to public health via surveillance. Identified risk factors will then be able to better inform the efforts to proactively improve the efficiency for HIV patient retention and re-engagement, and therefore lead to better individual outcomes for HIV patients and reduce the incidence of new HIV cases.
2501: Depression and mental health service use: Data from National Health and Nutrition Examination Survey (NHANES) 2006–2012
- Magda Shaheen, Senait Teklehaimanot
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- 10 May 2018, pp. 81-82
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OBJECTIVES/SPECIFIC AIMS: Examine mental health service use and its correlates among depressed group in a national sample of population≥20 years old. METHODS/STUDY POPULATION: Analysis of data for adult≥20 years old from the NHANES 2006–2012. Depression was assessed using the 9-item PHQ. The use of mental health and antidepressant drug were used to indicate the service use. We utilized multiple logistic regressions to determine the independent association between service use and each independent variable (demographics, health status, food security, chronic conditions, and depression severity) controlling for other independent variables. Data were presented as adjusted odds ratio (AOR), 95% confidence interval (95% CI), and p-value of statistical significance. p-value of<0.05 indicates statistical significance. RESULTS/ANTICIPATED RESULTS: Of the 17,824 subjects, 22% had mild to severe depression. Among the depressed group, 25% used antidepressant, 17% used mental health service. For the use of mental health services among the depressed group, African-American (AA), ≥60 years old, uninsured and foreign born were less likely to use the mental health service relative to other groups [AOR=0.58 (95% CI=0.45–0.75), 0.21 (95% CI=0.14–0.33), 0.61 (95% CI=0.45–0.83), 0.41 (95% CI=0.17–0.99), respectively, p<0.05]. For the use of antidepressant drug among the depressed group, AA, Hispanics, uninsured and foreign born were less likely to use antidepressant drug relative to other groups [OR=0.26 (95% CI=0.20–0.33), 0.42 (95% CI=0.31–0.57), 0.41 (95% CI=0.31–0.56), 0.20 (95% CI=0.10–0.78), respectively, p<0.05). For the use of mental health services and/or antidepressant drug among the depressed group, 40–59 years old, AA, Hispanics, uninsured, foreign born were less likely to use mental health services and/or antidepressant drug relative to other groups [OR=0.52 (95% CI=0.38–0.72), 0.35 (95% CI=0.28–0.43), 0.52 (95% CI=0.40–0.69), 0.53 (95% CI=0.41–0.68), 0.30 (95% CI=0.13–0.68), respectively, p<0.05). DISCUSSION/SIGNIFICANCE OF IMPACT: Our study showed that minority (AA and Hispanics), foreign born and uninsured with depression were less likely to use mental health services and/or antidepressant drug relative to other groups. Culturally and linguistically adapted intervention that involves community and providers to increase awareness about depression and the available services/treatment among minority, immigrant, and uninsured population are needed.
2520: Participant recruitment program at the University of Michigan CTSA
- Meghan Spiroff, Lisa Connally, Anita Johnson, Aalap Doshi, Patricia Piechowski
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- 10 May 2018, p. 82
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OBJECTIVES/SPECIFIC AIMS: Across the Clinical and Translational Science Award (CTSA) Consortium, participant recruitment into clinical trials is essential to advance science. Without proper participant recruitment, clinical trials do not result in gains in scientific knowledge, wastes time, funds, and other resources (Mahon et al., 2015). METHODS/STUDY POPULATION: Participant recruitment programs across the consortium are inconsistent in staffing, program services, and program goals. The participant recruitment program at the University of Michigan’s (U-M) Michigan Institute for Clinical & Health Research (MICHR) provides expertise, tools, and resources to facilitate participant recruitment in clinical and health research studies. RESULTS/ANTICIPATED RESULTS: We will explain our program infrastructure, staffing, services, and discuss how we maintain an engaged registry with over 27,000 participants interested in research studies at U-M. DISCUSSION/SIGNIFICANCE OF IMPACT: Proper recruitment into clinical trials results in findings that are relevant for genetic, cultural, linguistic, racial/ethnic, gender, and age differences (Cottler et al., 2013). We hope to share our best practices that aid in the development and success of participant recruitment across the CTSA Consortium.
2526: Using the multiphase optimization strategy to engineer an optimized STI preventive intervention among college students
- Kari Christine Kugler, Amanda E. Tanner, David L. Wyrick, Jeffrey J. Milroy, Brittany D. Chambers, Alice Ma, Linda M. Collins
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- 10 May 2018, p. 82
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OBJECTIVES/SPECIFIC AIMS: The goal of this study is to develop an effective and efficient STI preventive intervention among college students following the principles and phases of MOST. METHODS/STUDY POPULATION As part of the preparation phase, an explicit conceptual model, drawing heavily on theory and prior research, was used to translate the existing science into 5 candidate intervention components (ie, descriptive norms, injunctive norms, expectancies, perceived benefits of protective behavioral strategies, and self-efficacy). For the optimization phase, in Fall 2016 all first-year students (n=3547) from 4 universities were recruited to participate. Students were randomized to 1 of 32 different experimental conditions that included a combination of the candidate intervention components. Component effectiveness was evaluated using data from an immediate post-intervention survey on respective component mediators (eg, alcohol and sex-related descriptive norms). After a second factorial experiment (Fall 2017), only those intervention components that meet the pre-specified criteria of day ≥0.15 will be included in the optimized intervention. The evaluation phase will evaluate the effectiveness of the optimized STI preventive intervention via a randomized-control trial (Fall 2018). RESULTS/ANTICIPATED RESULTS: Preliminary results from the first factorial experiment suggest that descriptive norms and injunctive norms intervention components were significantly effective in reducing post-intervention perceived alcohol prevalence (β=−0.28, p<0.001) and approval of alcohol (β=−0.33, p<0.001), and sex-related norms (β=−0.23, p<.001). These results, in combination with process data, are being used to inform revisions of the intervention components to be included in a second factorial screening experiment. DISCUSSION/SIGNIFICANCE OF IMPACT: This study demonstrates how an iterative approach to engineering an STI preventive intervention using MOST can affect the behaviors of college students and serve as a foundation for other translational science.
2528: A community-academic partnership to understand the correlates of successful aging in place
- Rhonda G. Kost, Rhonda G. Kost, Kimberly Vasquez, Dozene Guishard, William Dionne, Caroline Jiang, Cameron Coffran, Andrea Ronning, Glenis George-Alexander, Barry S. Coller, Jonathan N. Tobin
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- 10 May 2018, p. 82
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OBJECTIVES/SPECIFIC AIMS: The Rockefeller University-Center for Clinical and Translational Science and Clinical Directors Network (RU-CCTS/CDN) community-academic-partnership engaged with Carter Burden Center for the Aging (CBCA), a multisite senior community services organization serving Upper Eastside and East Harlem, NY, to develop community-engaged research. Many seniors served by CBCA are racial/ethnic minorities, live in poverty, suffer from multiple chronic conditions, depression, and food insecurity; there is no simple measure routinely used to characterize the health/health risks of program participants. Multiple biological, musculoskeletal, psychosocial and nutritional factors collectively contribute to frailty a construct that is variously defined, and has been used as a surrogate or predictor for health outcomes. Aim 1: We will engage seniors, CBCA leadership, New York City Department for the Aging, staff and other stakeholders in research priority-setting, joint protocol writing, research conduct, analysis and dissemination to cultivate a population of elder stakeholders interested in designing and participating in this and future research. Aim 2: We will characterize the health status of the resident and nonresident populations by collecting data across 3 sessions to include validated cardio-metabolic, musculoskeletal, chronic condition prevalence, quality of life, psychosocial, and nutritional assessments. METHODS/STUDY POPULATION: Stakeholders will be engaged through the process of Community Engaged Research Navigation and a series of meetings and exercises to refine priorities and research design, co-write the protocol, provide feedback on conduct, analyze and disseminate results of the project. RESULTS/ANTICIPATED RESULTS: Outcomes will include rates of participation and retention in assessments and engagement activities, themes from qualitative research, contributions to study design, placement of aims on the T0-T48 spectrum, social network analysis, classification of engagement on the spectrum of Community-based Participatory Research (CBPR) and partnership assessment. The primary outcome is frailty (6-minute walk test); We will examine associations among these measures with services utilization data captured electronically by CBCA. A key deliverable of this project will be a REDCap data capture platform that integrates and displays these measures that will be sustainable for CBCA. DISCUSSION/SIGNIFICANCE OF IMPACT: This practice-based research partnership will allow us to extract, replicate and extend the lessons learned about engaging stakeholders in generating hypotheses, operationalizing research, collecting and analyzing data, and disseminating results. The collaboration is built around generating and testing rigorous clinical an health services hypotheses that are derived from real-world practice-based needs and also incorporate basic science measures to embed and examine mechanistic hypotheses. Testing a simple to implement validated surrogate frailty measure will accelerate progress on evidence-based practices to test interventions that enhance healthy aging and serve as a model for future similar partnerships to form a network for community-based senior research. This work aligns with the RU-CCTS grant Hub Research goal to engage populations across the life span, including hard-to-reach and underserved populations, such as minority seniors.
2532: Predictive metabolism studies of varenicline and implications of its metabolites in nicotine addiction
- Keeshaloy Thompson, Milton Brown
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- 10 May 2018, pp. 82-83
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OBJECTIVES/SPECIFIC AIMS: The central goal is to predict the metabolites of varenicline and predictively evaluate their propensities for eliciting an increased binding effect in the brain. METHODS/STUDY POPULATION: Molecular modeling computational software and other cheminformatic tools present a strategic in silico strategy to predict a complete metabolic transformation for the varenicline molecule. Molecular docking tools help to highlight key interactions of the varenicline with key metabolizing enzymes that are differentially expressed across a population. This will assist in validating clinical models for smoking cessation. RESULTS/ANTICIPATED RESULTS: Differentialized binding results depending on whatever metabolite is produced. DISCUSSION/SIGNIFICANCE OF IMPACT: Products of metabolism of varenicline may differ in individuals and across groups, thus, binding effects and the propensity for adverse effects may differ in individuals.
2538: Artificial urinary sphincter (AUS) placement after failed urethral sling: Impact of sling removal and proximal cuff placement
- Arnav Srivastava, Gregory Joice, Madeline Manka, Nikolai Sopko, Edward Wright
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- 10 May 2018, p. 83
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OBJECTIVES/SPECIFIC AIMS: Perineal urethral sling placement is an option for men with mild to moderate post-prostatectomy stress urinary incontinence (SUI). However, men with persistent incontinence after sling placement often require secondary artificial urinary sphincter (AUS) placement, made difficult by the sling occupying the proximal bulbar urethra. This proximal section has a thicker corpus spongiosum which may mitigate cuff-induced ischemia and subsequent urethral atrophy. The authors report a series of AUS placements after failed sling, using sling revision or removal to access the proximal urethra. METHODS/STUDY POPULATION: Cutting the sling arms during urethral cuff placement increased urethral exposure and mobility. If feasible, completely removing the sling allowed the most proximal cuff site; but if dissection was felt unsafe, the mesh was left in situ and the cuff placed distally. This study is a retrospective cohort design of patients with SUI who underwent AUS placement after failed sling from 2010 to 2016. Variables included baseline patient characteristics, SUI severity, intraoperative variables, and postoperative outcomes. AUS failure, defined as infection, erosion or urethral atrophy, was analyzed at 12 and 96 months using univariate and multivariable logistic regression. RESULTS/ANTICIPATED RESULTS: Over the study period, 29 patients underwent AUS placement after failed sling. At the time of AUS placement, mean urethral circumference was 6.2 cm and 68% of patients had a 4.5 cm cuff placed; no cases required a 3.5 cm cuff. Seventy-three percent of cases were after transobturator sling placement (27% bone-anchored) and 45% of slings were explanted. AUS failure rate at 12 and 96 months was 17.8% and 45%, respectively; atrophy was the most common indication. Prior transobturator sling placement had lower rates of both 12 month (9.1% vs. 57%, p=0.006) and 96 month (36% vs. 71%, p=0.11) failure, though the latter was not statistically significant. Sling explant was not a significant predictor of 12 month (p=0.12) or 96 month failure (p=0.17). DISCUSSION/SIGNIFICANCE OF IMPACT: Sling revision during AUS placement helps expose the wider proximal urethra, allowing larger cuff size placement. This procedure appears safe, with low rates of erosion and short-term failure—albeit with high rates of long-term urethral atrophy possibly due to more significant dissection causing devascularization. However, sling removal was not a significant predictor of failure. The transobturator sling’s smaller profile may result in less trauma to urethra—possibly explaining the improved outcomes.
2542: Incidence of T3a up-staging and survival after partial nephrectomy: Size-stratified rates and implications for prognosis
- Arnav Srivastava, Hiten Patel, Max Kates, Zeyad Schwen, Gregory Joice, Alice Semerjian, Michael Gorin, Phillip Pierorazio, Mohammad E. Allaf
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- 10 May 2018, p. 83
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OBJECTIVES/SPECIFIC AIMS: Due to increased experience and favorable outcomes, the use of partial nephrectomy (PN) to treat renal cell carcinoma has grown in the past decade, with expansion to larger tumors. Performing PN for larger tumors could potentially increase the number of patients up-staged to pT3a after surgery, who may have instead been treated with radical nephrectomy (RN), if known preoperatively. We aimed to estimate the proportion of patients up-staged to T3a disease after PN stratified by size. We also compared size-stratified survival outcomes of up-staged patients to those with T1a, T1b, or T2 kidney cancer. METHODS/STUDY POPULATION: From 1998 to 2013, patients undergoing PN or RN were identified from Surveillance Epidemiology and End Results registries. The proportion of patients receiving PN found to have pT3a disease was quantified by size. Cox proportional hazards models compared cancer-specific (CSS) and overall survival (OS) for PN patients with pT1a, pT1b, and pT2 disease with appropriately size-stratified pT3a patients. Also, PN patients with pT3a disease were compared to size-stratified RN patients with pT3a disease. Comparisons by size were performed within pT3a patients receiving PN. RESULTS/ANTICIPATED RESULTS: From a total of 28,854 patients undergoing PN, the estimated proportion up-staged to pT3a increased along with increasing tumor size: 4.2% for T1a, 9.5% for T1b, and 19.5% for T2. Among patients receiving PN, adjusted survival analysis demonstrated worse CSS for up-staged pT3a patients Versus appropriately stratified pT1a (CSS: HR=1.87, p=0.02), pT1b (CSS: HR=1.91, p=0.01), and pT2 (CSS: HR=2.33, p=0.01) patients. However, when assessing OS, only the size-stratified comparison of up-staged pT3a Versus pT1a disease demonstrated worse OS for the up-staged cohort (OS: HR=1.25, p=0.04). Comparing PN and RN for pT3a disease, size-adjusted analysis revealed no statistical difference in CSS or OS. Lastly, among patients undergoing PN with pT3a disease, patients with larger tumors, measuring 4–7 cm (CSS: HR=2.83, p<0.01; OS: HR=1.44, p=0.04) or 7–16 cm (CSS: HR=8.22, p<0.01; OS: HR=2.64, p<0.01), experienced worse survival than those with smaller pT3a tumors, <4 cm. DISCUSSION/SIGNIFICANCE OF IMPACT: A greater proportion of patients appear to experience T3a up-staging after PN with increasing initial T stage. Up-staged pT3a patients have worse cancer specific survival after PN compared to those with similarly sized localized tumors. Furthermore, the up-staged pT3a patients after PN appear to experience similar survival to pT3a patients undergoing RN. However, pT3a patients undergoing PN had worse survival with increasing tumor size, reinforcing the need for improvements in preoperative staging and identifying patients at risk of up-staging.
Back Cover (IBC, OBC) and matter
CTS volume 1 issue S1 Cover and Back matter
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- Published online by Cambridge University Press:
- 10 May 2018, p. b1
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