ACRT‐AFMR‐SCTS annual meeting abstracts

SPEAKER ABSTRACTS

                          (SD 010)

AHRQ AND NIH PROGRAM OFFICER PANEL DISCUSSION

Session Chair: Orringer E ¹

¹University of North Carolina Chapel Hill, Chapel Hill, NC, USA

A panel of NIH and AHRQ program officers will discuss their institutions, institutes, and the role of program officers in extramural grant support. Panel members will discuss opportunities for trainees to interact with program officers to facilitate career development. The research focus and areas of emphasis for extramural grants, and career development awards will be discussed. The panel will then take questions from the audience.

                          (SD 020)

WRITING A SUCCESSFUL CAREER DEVELOPMENT AWARD: TIPS AND PITFALLS

Session Chairs: Seely EW ¹, Gelato M²

¹Brigham and Women’s Hospital, Boston, MA, USA; ²Stony Brook University, Stony Brook, NY, USA

Career development awards (also called K awards) provide an important step in the evolution to independent grant funding. This interactive workshop will review the purpose of K awards, the varied options for K award funding, and provide tips for success in your K application. You will receive perspectives and advice from senior investigators, current K recipients as well as from NIH to help you achieve success in your K application. Specifically, we will review choosing the K award that is right for you, defining your research question, writing your research plan, crafting your career development plan, the role of your mentor in your K award, the K award review process and revising your K award application. Co‐sponsored by the Association for Patient Oriented Research.

                          (SD 030)

REDCAP – PLANNING, COLLECTING, AND MANAGING DATA FOR THE CLINICAL AND TRANSLATIONAL RESEARCH ENTERPRISE

Session Chair: Harris PA ¹

¹Vanderbilt University, Nasvhille, TN, USA

REDCap (Research Electronic Data Capture) is a software program designed to assist research teams with data planning, capture, storage and dissemination. The program was created to provide researchers an ‘easy way to do the right thing’ when planning and implementing study data collection strategies. REDCap software is available at no financial charge to academic and nonprofit institutions through a consortium network (http://www.project‐redcap.org). Within this growing network of 192 institutional partners, REDCap is supporting approximately 15,000 end‐users and 7,000 research‐related projects. The software fills a common need at research institutions, providing cost‐efficient, secure, centralized web based data collection services for diverse research portfolios. The centralized data collection model protects all stakeholders (institution, researcher and research participant) by offering a secure alternative to spreadsheets and nonsecure file‐based database programs This panel presentation includes experts from Vanderbilt University (Paul Harris), Mayo Clinic (Michael Lin), Cleveland Clinic (John Sharp), and the Medical University of South Carolina (Jihad Obeid). Panel topics will include: (A) REDCap Project Overview – Supporting Data Capture, Management and Dissemination; (B) REDCap Consortium Overview – Supporting Diverse Environments; (C) REDCap Permutations – Supporting Diverse Study Designs; and (D) Real‐World Research Projects – Supporting Diverse Research Teams.

                          (SD 040)

PROFESSIONALISM IN TRANSLATIONAL SCIENCE TRAINING

Session Chair: Pichert JW ¹

¹Vanderbilt Medical School, Nashville, TN, USA

A critical community study was going awry. Dr.__, one of the investigators, heard of it and yelled angrily at a meeting of the research team’s academic members, “I don’t have time for careless so‐called colleagues and lazy research assistants to screw up my hard work.” Then she turned to leave and barked, “You people better not eat or sleep until you’ve fixed the problems, called back the participants, and rerun the study.” Although many features distinguish a profession, one of the most important is responsibility for its members’ conduct. Unfortunately, clinical and translational (C&T) research professionals may not be trained to deal with disruptive behaviors (aka bullying, lateral violence, and, more commonly, passive‐aggressive resistance) that can compromise research ethics, short‐change quality, undermine trust and communication, hinder transmission of findings, and worse. Much has been written about fabrication, fraud, plagiarism, IRB‐related deviations, and ill‐informed consents. This session, however, addresses less‐often‐discussed disruptive behaviors that threaten C&T research quality. Without proper tools and commitment, C&T researchers seem to tolerate some disruptive behavior despite its potential to threaten patient safety, harm team morale and increase costs. Addressing unprofessional behavior in C&T research begins with a commitment to reduce tolerance for such behavior and requires (a) an organizational infrastructure, (b) a tiered “disruptive behavior pyramid” to guide interventions, and (3) training elements and resources adaptable to organizations that conduct high quality C&T research. Hickson GB, Pichert JW, Webb LE, Gabbe SG. A complementary approach to promoting professionalism: identifying, measuring and addressing unprofessional behaviors, Acad Med 82:1040–1048, 2007.

                          (SD 050)

BALANCE IN EXPERTISE: BUILDING NEW MODELS IN CLINICAL AND TRANSLATIONAL RESEARCH

Session Chair: Mitchell P ¹

¹University of Washington, Seattle, WA, USA

The purpose of this concurrent session is to highlight interdisciplinary research spanning the spectrum of translational research from bench science to community practice. Panelists will illustrate current findings from different translational perspectives. Interdisciplinary collaborations representing medicine, molecular biology, nursing, social work, and other disciplines will demonstrate the strength of these approaches in research. Examples will showcase research in genomics, women’s health, and health disparities. Moderator, Pamela Mitchell (University of Washington). Panelists: Elaine Larson (Columbia University), Deborah Lyon (Virginia Commonwealth University), Loretta Sweet‐Jemmott (University of Pennsylvania)

                          (SD 060)

LONGEVITY'S IMPACT ON TRANSLATIONAL SCIENCE

Session Chairs: Strong R ¹, Bernard MA²

¹University of Texas Health and Science Center at San Antonio, San Antonio, TX, USA; ²National Institutes of Health, Bethesda, MD, USA

The increases in longevity from 1900 to the present have resulted largely from improvements in prenatal and neonatal care, public health and treatment of infectious diseases. In 1900, the three leading causes of death were by infectious diseases. Today, the three leading causes of death are age‐related diseases, including heart disease, cancer, and stroke. There is a growing consensus that additional increases in longevity may come by targeting the aging process, thereby simultaneously targeting multiple diseases. Preclinical studies have revealed a wealth of therapeutic targets and at least one compound that slows aging and increases longevity in mice. The speakers in this session will discuss the barriers to translation of preclinical research, the pitfalls encountered in clinical trials of antiaging interventions and the implications of life‐extension for health care and public policy.

                          (SD 070)

DEVELOPMENTAL ORIGINS OF ADULT HEALTH AND DISEASE

Session Chairs: Smoyer W¹, Ingelfinger J^2,3

¹The Ohio State University, Columbus, OH, USA; ²Massachusetts General Hospital, Boston, MA, USA; ³Harvard Medical School, Boston, MA, USA

This session will present pediatric clinical and translational research that focuses on the fetal origins of major adult diseases, including heart disease, obesity, and diabetes. The session will begin with an overview of the early observations and subsequent research leading to the development of our understanding of how early life events, including the prenatal period, can have a major impact on the subsequent health of individuals throughout their lives. This overview will be followed by three presentations focused more specifically on how the spectrum of preclinical to T1 to T4 research on the fetal origins of three of the most common and important human diseases (heart disease, obesity, and diabetes) is improving our understanding of the origins and potential interventions for human disease.

                          (SD 080)

MOVING FROM K TO R: COMPETING SUCCESSFULLY FOR YOUR NEXT GRANT

Session Chairs: Moore C ¹, Begg MD²

¹University of Pittsburgh, Pittsburgh, PA, USA; ²Mailman School of Public Health of Columbia University, New York, NY, USA

Scholars will learn how to compete successfully for their next NIH grant application, be that an independent K award (K01, K08, K23) or an R‐series grant (R01, R03, R21). By discussing specific “scenarios” in which KL2 scholars have competed successfully for their next NIH grant, scholars will learn about strategies that work and common mistakes to avoid. For example, scholars who currently have a KL2 award but would benefit from an additional mentored K award will learn how to develop an argument justifying why they need a K01, K08, or K23 from the NIH, including what changes or additions to their KL2 plan would be needed. Scholars will also learn key differences between a small grant (R03) and an exploratory/developmental grant (R21), the benefits and risks associated with these mechanisms, and under what circumstances such mechanisms should be used. Finally, scholars will learn how to maximize their chances of competing successfully for R01 support, including how to avoid common mistakes made by new investigators as well as specific scenarios when recruiting a more senior investigator to serve as a “co‐principal investigator” should be considered. Examples of successful applications will be discussed, and audience participation will be encouraged.

                          (SD 090)

MENTOR TRAINING TRIAL: A NATIONAL CTSA STUDY

Session Chair: Fleming M ¹

¹University of Wisconsin, Madison, WI, USA

The purpose of this seminar is to present the initial findings of a 16 site national mentor training trial led by a research team at the University of Wisconsin Madison Institute for Clinical Translational Research. A total of 285 mentor‐mentee pairs across the sites were randomized into a control of experimental group. The mentees were primarily K scholars. Mentors assigned to the intervention arm of the trial participated in an 8 hour training program delivered over four sessions. The training was delivered at each site by two local facilitators who partcipated in a two day trainer of the trainer workshop. Pre‐post measures focused on changes in active mentoring and mentoring activities of the mentors as reported by both the mentee and the mentor. The session will present baseline data and the mentor training experience across the 16 sites. The post‐intervention interviews of the 285 mentor‐mentees will be completed in the summer of 2011. This is the first large scale educational trial to test the effectiveness of a mentor training program for mentors who conduct clinical translational science. The 16 site consortium who participated in this trial, expect the training curriculum tested in this study, will provide the framework for mentor training across the CTSAs.

                          (SD 100)

CREATING NETWORKS FOR TRAINING IN HEALTH AND HEALTHCARE DISPARITIES RESEARCH

Session Chair: Bibbins‐Domingo K ¹

¹University of California, San Francisco, San Francisco, CA, USA

Research in health and healthcare disparities is an important component of clinical and translational research. Training programs that prepare scholars to conduct research in health and healthcare disparities must consider the multifaceted nature of this research. This session brings together leaders from across CTSAs and RCMIs who are actively engaged in developing networks of training programs in health and healthcare disparities. The aims of this panel discussion are (a) to discuss components of successful training programs in disparities research and challenges in the development of such programs, and (b) to highlight current efforts in the development of networks across institutions engaged in training in disparities research.

                          (SD 110)

HEALTH CARE REFORM – THE NECESSITY OF TRANSLATIONAL SCIENCE

Session Chair: Rich E ¹

¹Mathematica Center on Health Care Effectiveness, Princeton, NJ, USA

The Educational Session Health Care Reform – The Necessity of Translational Science will be led by Eugene Rich, M.D., Senior Fellow and Director at Mathematica’s Center on Health Care Effectiveness (CHCE). The five main objectives of this session are to (1) summarize the evidentiary questions posed by current health systems problems (2) review the types of scientific inquiry relevant to answering these questions, (3) outline the opportunities to support evidence‐based approaches to health care reform, (4) summarize some barriers to success in using translational science to guide health care reform, and (5) identify next steps for evidence based health care reform. The introduction and main presentation, The Scientific Foundation for Evidence‐based Health Care Reform, will be given by Eugene Rich. Following the main presentation Ann Bonham, Ph.D., Chief Scientific Officer at AAMC, Lisa Rubenstein, M.D., M.S.P.H., Professor of Medicine at VA Greater Los Angeles and UCLA, and a Senior Natural Scientist at RAND and Hoangmai (Mai) Pham M.D., M.P.H., Senior Advisor, Center for Medicare and Medicaid Innovation will provide a reaction to the main presentation and personal comments on the topic. Appropriate development and application of translational science can and should play a critical role in improving the quality and efficiency of US health care.

                          (SD 120)

OBESITY: WHAT ARE THE CRITICAL ISSUES, WHERE IS THE EVIDENCE BASE, AND HOW DO WE DEVELOP SOLUTIONS?

Session Chairs: Atkinson RL ¹, Allison D²

¹Virginia Commonwealth University, Richmond, VA, USA; ²University of Alabama at Birmingham, Birmingham, AL, USA

This symposium will examine the current status of knowledge about the causes of obesity, identify thoughts about new etiologies that have not been well considered previously, suggest potential solutions, and identify research areas that will need to be addressed to understand this complex disease. Dr. Richard Atkinson will talk on old and new thoughts for the causes of obesity. Dr. Nikhil Dhurandhar will discuss infectious agents that have been shown to cause obesity and the implications for a portion of obesity being an infectious disease. Dr. Giovanni Cizza will discuss how our environment affects body weight and body fat including the effects of stress, amount of sleep, exposure to light, and circadian rhythms. Dr. David Allison will address the state of knowledge of obesity currently, the quality and quantity of prior research on obesity, how some of the things we “know” about obesity are suspect, how these novel ideas of the causes of obesity fit into the whole picture, and where we should go from here in research and potential treatments.

                          (SD 130)

DATABASES FOR CLINICAL TRANSLATIONAL RESEARCH: REPURPOSING AND DESIGNING FOR UNANTICIPATED NEEDS

Session Chairs: Pollock BH ¹, Sullivan DC²

¹University of Texas Health Science Center at San Antonio, San Antonio, TX, USA; ²Duke University, Durham, NC, USA

The use of databases for clinical and translational research with an emphasis on database design considerations to support future unanticipated needs will be discussed. Imaging measures can serve as end points for clinical outcomes. As new ‘imaging biomarkers’ are developed and applied, it is critical that the way in which an image was collected and the way it was measured (person or algorithm, software revision, observation conditions, etc.) be recorded in a secure, standardized fashion. We will discuss database design requirements for research image sharing to support future needs. Administrative health care databases have been developed for: tracking quality and volume; billing; health services planning; and public health surveillance. When repurposed, they offer an extremely useful research resource. Rigorous and innovative study design can typically make use of this wealth of information to provide meaningful answers to significant health care questions. We present an example of how administrative databases can be repurposed to estimate the prevalence of undiagnosed disease. Selection of appropriate administrative databases, their flaws and strengths, and innovative uses will be discussed. The data already collected in various clinical and epidemiological studies often contain subsets that could be aggregated for secondary analyses, including those used for comparative effectiveness research. However, the lack of sufficient meta data describing these studies often prevents these subsets from being identified and utilized. We present a graphical user interface for the representation of such meta data, to facilitate not only the acquisition, storage, and primary analysis of a particular study’s data, but also to enable data sharing through novel query tools for unplanned analyses across studies with different designs and populations.

                          (SD 140)

TOOLS FOR MEETING THE NIH RESPONSIBLE CONDUCT OF RESEARCH (RCR) REQUIREMENTS

Session Chair: Vollmer SH ¹

¹University of Alabama at Birmingham, Birmingham, AL, USA

Nationally experienced Responsible Conduct of Research (RCR) educators and resource developers will explain the new NIH requirements for teaching RCR, which include face‐to‐face training. The speakers will offer methods and curricula that have proved successful in meeting these requirements in different contexts; an emphasis will be placed on teaching effective collaboration skills. On‐line resources will be presented, including a knowledge base of wisdom, techniques and educational resources, CTSPedia, which offers useful advice when faced with a specific question (on topics ranging from biostatistics to reproducible results to residency training), and a narrative tool for teaching decision making when faced with an ethical choice.

                          (SD 150)

WHAT CORE COMPETENCIES SHOULD EVERY TRANSLATIONAL SCIENTIST HAVE?

Session Chair: McDonald MA ¹

¹Duke University School of Medicine, Durham, NC, USA

A key component of the Clinical and Translational Science Awards (CTSA) is the development of training and educational programs for translational scientists. To build nationwide education programs the core competencies for translational science need to be identified and defined. The Education and Career Development Key Function Committee (KFC) of the National CTSA developed core competencies for 14 thematic areas. This comprehensive collection of core competencies for translational science from T1 bench to T2 research and clinical patient care, including Community Engaged Research (CEnR) covers a wide and diverse range of knowledge, skills, concepts and principles. Given this breadth it may not be realistic to expect that every translational scientist must gain full competency in each thematic area. Therefore, what are the core shared competencies that anyone who identifies themselves as a translational scientist should have? The answer has implications for the design and creation of competency‐based training and graduate programs throughout the CTSAs and beyond. This session will address this question and serve as a forum for discussion with participation from those attending. Panel members include T1 bench scientists, T2 researchers, and Community Engaged researchers, all of whom are involved in developing competency based education and training programs for translational scientists.

                          (SD 160)

BEST PRACTICES IN COMMUNITY ENGAGED RESEARCH

Session Chair: Vukotich CJ ¹

¹University of Pittsburgh, Pittsburgh, PA, USA

Community Engaged Research (CEnR) includes the community as an equal partner in the research process and is an important component of translational science. CEnR provides for different methods for research that the community wants, and that benefits the community. Community Based Participatory Research (CBPR) engages community organizations to be part of the entire research process, from conceptual formation and protocol design, to implementation through the use of data and translation in policy and practice. School Based Research (SBR) is a specialized part of CBPR that works with an important and interesting population. Schools are part of the community, but also their own small community. Practice‐Based Research (PBR) is conducted in medical or other health care settings, with an emphasis on rapid translation of research evidence into practice. It engages community organizations and clients. CEnR may use Community Health Workers (CHW) as part of the research or intervention team. This panel will provide a practice‐based look at CEnR. It will inform on why CEnR is important, provide examples of success with lessons learned on how to be successful, how to do community engaged research, and provide insight on how their research may engage the community.

                          (SD 170)

EFFORTS TO PROMOTE TRANSLATIONAL SCIENCE TRAINING FOR PH.DS: AN INITIATIVE OF THE HOWARD HUGHES MEDICAL INSTITUTE

Session Chair: Galey W ¹

¹Howard Hughes Medical Institute, Chevy Case, MD, USA

Recognizing the need to help graduate programs create and implement curricula to train Ph.D. scientists with an understanding of medicine and pathobiology, the Howard Hughes Medical Institute (HHMI) established an institutional grant program in 2006. This initiative, known as “Med into Grad,” provides institutional funds to integrate the learning of medicine and pathobiology into new or existing Ph.D. graduate programs. The goals of this effort are: (1) to train a cadre of basic biomedical scientists prepared to participate in the translation of emerging biological knowledge into medical and public health practices; and (2) assure that scientists are aware of the problems and challenges faced by practitioners in the diagnosis, treatment and prevention of disease. HHMI has supported 25 such programs over the last five years. While the programs have their own unique features and vary in the implementation of program strategies, several elements are emerging as common to most successful programs. The unique features and common elements will be discussed by program directors and HHMI administrators.

                          (SD 180)

TRANSLATIONAL DEVELOPMENT OF SPECIMEN AND IMAGING BIOMARKERS: EARLY DIAGNOSIS VERSUS OVERDIAGNOSIS

Session Chairs: Sullivan DC ¹, McClain D²

¹Duke University, Durham, NC, USA; ²The University of Utah Health and Sciences Center, Salt Lake City, UT, USA

There is considerable interest in developing biomarkers that can be used for faster, more cost‐effective strategies for evaluating drugs and better definition of patients who will benefit from treatment. In this session we have selected lung cancer and Alzheimer’s disease as examples to illustrate how specimen and imaging biomarkers are developed, evaluated and validated for use in either therapy development or clinical practice. The term biomarkers includes a wide range of in vitro and in vivo tests. In vitro analysis of specimens can yield enormous amounts of molecular information from very small samples. However, this information reflects a single locus in space and time, and many physiological parameters (e.g. pH or oxygenation) may be lost in sample preparation. Imaging tests provide less molecular information but provide anatomically and/or temporally localized information, and may provide a more accurate reflection of integrated physiological status. Thus these tests provide different, and sometimes complementary, information. Validation of biomarkers is complicated by the variability within and between patients, by the human observer component, by the variability across devices from different manufacturers, and by the need to standardize methods across institutions and centers. The return on investment for diagnostic tests is low compared to therapeutic drugs, so there are potentially important opportunities for academic groups to participate in biomarker evaluation. Speakers in this session will address the issues associated with testing biomarkers of risk (screening tests) for lung cancer, and the research questions that follow from the recently identified benefit of CT screening. Much work is also going on to evaluate composite biomarkers to match lung cancer patients with the most effective therapies for their tumor’s molecular signature. In Alzheimer’s disease, a large longitudinal natural history study (ADNI) has accumulated a wealth of data for evaluating both imaging and specimen biomarkers for risk assessment, diagnosis and treatment monitoring. Speakers will address the current status of Alzheimer’s biomarkers research as a paradigm for biomarker work in other chronic diseases.

                          (SD 190)

NEW MODELS FOR DRUG DEVELOPMENT

Session Chairs: Kaitin KI¹, Whitely RJ²

¹Tufts University, Boston, MA, USA; ²University of Alabama, Mobile, AL, USA

Where will the life‐saving and life‐extending drugs of tomorrow come from? It is clear that the extant model of drug development is yielding too few new products to sustain the growth of the research‐based pharmaceutical industry, long the dominant source of these medicines. New models of drug development are needed to ensure that newer and better medicines continue to be developed to treat a host of diseases for which inadequate or no treatments currently exist. This session will explore current restructuring efforts within the commercial sector, the growth and impact of academic‐industry partnerships, and the role of the Food and Drug Administration, through the Critical Path Initiative, in supporting new drug development.

                          (SD 200)

MEETINGS WITH NIH AND AHRQ PROGRAM OFFICERS

Session Chairs: Desmond NL ¹, Ulane R¹

¹NIMH/NIH, Bethesda, MD, USA

NIH and AHRQ Program Officers will meet with small groups of scholars to discuss their individual career development plans, including grant application strategies. Program officers from different institutes will be available for a 1½ hour block that scholars can utilize to have direct discussions with NIH and AHRQ staff about research, training and career development grants in clinical and translational research.

                          (SD 210)

TRAJECTORIES FOR SUCCESS IN CLINICAL RESEARCH: NO ONE PATH FITS ALL

Session Chair: Schoenbaum E ¹

¹Albert Einstein College of Medicine, Bronx, NY, USA

In today’s world early investigators are faced with competing demands that can aid or abet successful research careers. Careers are variously affected by medical subspecialty, institutional resources, student loans, family life, etc. How one navigates opportunities and demands can make a difference in satisfaction and success as a clinical researcher. This session offers the “career stories” from three clinical researchers who are on different paths and each is successful. This session is targeted to clinical research scholars and early investigators. After the presentations, questions will be taken.

                          (SD 220)

FOUNDATION OPPORTUNITIES IN BASIC, TRANSLATIONAL, AND CLINICAL RESEARCH TRAINING

Session Chair: Myers B¹

¹Doris Duke Charitable Foundation, New York, NY, USA

Many private foundations support career development programs in biomedical research. In this session, we will hear from three foundations that have programs for physician‐scientists in early career stages with a focus on basic, translational, clinical, and health services research. The Career Award for Medical Scientists from the Burroughs Wellcome Fund supports physician‐scientists who are in advanced postdoctoral/fellowship training, and the award extends into the early years of faculty service. Projects are in basic biomedical, disease‐oriented, translational, or molecular, genetic, or pharmacological epidemiology research. The Clinical Scientist Development Award from the Doris Duke Charitable Foundation is an award for Instructors or Assistant Professors to facilitate the transition to independent clinical research careers. Projects cover a range of research areas from mechanisms of disease to health outcomes. The Doris Duke Charitable Foundation also has a program that supports one year of mentored clinical research for medical students. For nearly 40 years, the Robert Wood Johnson Foundation Clinical Scholars program has fostered the development of physicians to be leaders in research areas such as problems of health care delivery and financing, clinical decision making, biomedical ethics, medical history and health care policy. The over 1100 graduates of the program have become a critical mass guiding changes in the US health care system. During the session, the three programs will be described, including programmatic goals, eligibility and selection criteria, and information on outcomes of program alumni when available.

                          (SD 230)

OPPORTUNITIES FOR RESEARCH CAREER DEVELOPMENT THROUGH THE VA

Session Chair: Gleason T ¹

¹Department of Veterans Affairs, Washington, DC, USA

The Department of Veterans Affairs (VA) Office of Research and Development has a rich research training history of clinician and nonclinician scientists interested in advancing knowledge for issues related to Veterans’ health. This session will be an opportunity to hear about the VA research career development and career path, especially for those interested in pursuing clinical research. Funding opportunities and real life examples will be presented.

                          (SD 240)

CAN PHARMACOGENETICS DELIVER ON PERSONALIZED HEALTHCARE? LESSONS LEARNED

Session Chairs: Trikalinos T ¹, Khoury M²

¹Tufts Medical Center, Boston, MA, USA; ²Centers for Disease Control and Prevention, Atlanta, GA, USA

Over the past few years, technological advances allowed the rapid generation of torrents of genetic and genomic data, thereby presenting the opportunity to improve patient care and public health through numerous genomic applications. At the same time, translation of these data into knowledge and evidence‐based action is severely lagging. Evidence on the relationship between genomic factors and clinical outcomes, and the costs, benefits and harms of genomic applications in real‐world settings takes long to generate and is at risk of being obsolete by the time it is published. Of equal import, the existing framework for evaluating the clinical utility of genomic applications is not optimal, and this complicates the translational process. Realizing the promise of genomics in treating and preventing disease, improving health, and reducing health disparities is the major challenge faced by comparative effectiveness researchers. The first talk will provide an introduction to translational research in genomic applications in practice and prevention, and outline what expectations are realistic. The second talk will discuss current thinking on science‐ and infrastructure‐based recommendations towards facilitating the discovery and validation of pharmacogenetic markers, and speeding their thoughtful translation and integration into clinical practice, with emphasis on cancer conditions. The third talk will describe approaches to evaluating and interpreting evidence on pharmacogenetic tests by virtue of applied examples. The fourth talk will discuss lessons learnt from studying pharmacogenetic tests in noncancer conditions using a wide spectrum of methodologies, from conducting primary studies to decision and economic analyses.

                          (SD 250)

THE PROMISE, THE PITFALLS, AND THE POLICY IMPLICATIONS OF WHOLE GENOME SEQUENCING

Session Chair: Athey B ¹

¹University of Michigan, Ann Arbor, MI, USA

Over the past 20 years, more than 100 genome‐wide association studies have been conducted for more than 40 common diseases. While these studies have led to the identification of hundreds of risk‐related genetic variants, identification of specific disease‐risk genes has proven to be a daunting challenge. What is needed is comprehensive analysis of well‐characterized patients at the DNA sequence level, a goal that is now feasible with next‐generation sequencing technology. Indeed, recent advances in third‐generation DNA sequencing machines hold the promise of reducing the cost of sequencing a single human genome to less than $3,000. With these genetic data, investigators will be more effectively positioned to define disease pathways, validate drug targets, and develop diagnostics that will lead to targeted and personalized therapies, as well as preventative strategies that reduce disease‐risk. However, there are many pitfalls before the potential of this “personalized medicine” paradigm can be achieved. Some of these include further reducing the cost and increasing the speed of next‐generation sequencing technologies; convincing Medicare and private insurers to reimburse costs of pharmacogenetic testing; encouraging pharmaceutical companies to integrate “genetic biomarker” information into the design of early‐stage clinical trials; and facilitating the development and implementation of diagnostics based on genetic information. This symposium will examine the promises, the pitfalls, and the policy implications of next‐generation sequencing as a revolutionary new tool for personalized medicine.

CLINICAL EPIDEMIOLOGY ABSTRACTS

                                   P1

A COMPARISON OF WORKER AGGRESSION EXPOSURE MEASUREMENT METHODS

Iennaco JD ¹, Fennie K¹, Bowers L², Dixon J¹, Whittemore R¹, Busch S³, Scahill L¹

¹Yale University School of Nursing, New Haven, CT, USA; ²City University London, London, United Kingdom; ³Yale University School of Public Health, New Haven, CT, USA

OBJECTIVES/SPECIFIC AIMS: To compare the feasibility and agreement of three methods of counting worker exposure to verbal and physical aggression, using standard methods (incident report, restraint logs), questionnaire, and event counters in inpatient psychiatric settings. METHODS/STUDY POPULATION: This pilot study determines the feasibility of using an event counter to measure aggression exposure. Handheld counters will be used by clinical staff on 2 randomly selected adult units for consecutive periods after data is collected by standard methods and by questionnaire on 4 inpatient units. RESULTS/ANTICIPATED RESULTS: Using counters and end of shift logs, clinician aggression exposure will be identified. It is anticipated that counter methods will provide a more accurate count of actual verbal and physical aggression exposure than other methods. Questionnaires are expected to specify more events than standard methods, given that standard methods are only used when injury or actual physical restraint of a patient occurs. Questionnaires document a broader range of behaviors, but do not provide a method for identifying individual worker exposure to aggression as counters do. Use of counters will also be compared to self report of perceived aggression exposure via survey. DISCUSSION/SIGNIFICANCE OF IMPACT: Rates of aggression exposure currently measure only the most severe events and underestimate the actual exposure of workers to aggression, where most events are never counted. The ability to identify actual aggression exposure levels and evaluate effects of varied exposure may lead to identification of health and work outcomes. In addition a measure of the current state of exposure is provided so that efforts to reduce aggression exposure can be monitored for their effectiveness.

                                   P2

A RETROSPECTIVE STUDY OF MORTALITY AND ADHERENCE AMONG HIV/AIDS PATIENTS AT ALERT HOSPITAL

Araya H ¹, Bahiru E¹, Harris C²

¹Stanford School of Medicine, Palo Alto, CA, USA; ²Albert Einstein College of Medicine, New York, NY, USA

OBJECTIVES/SPECIFIC AIMS: The objective of this study is to characterize the HIV/AIDS inpatient population at the All African Leprosy Tuberculosis Rehabilitation Research, and Training Center (ALERT), one of the few facilities in Ethiopia providing long term care to HIV/AIDS patients. We aimed to study the mortality rate, most prevalent opportunistic infections, and adherence to treatment. The characterization of the HIV/AIDS patient population at ALERT will be instrumental for the hospital as they attempt to improve the standard of care for their patients and advocate for funding to augment their inpatient services and diagnostic capabilities. METHODS/STUDY POPULATION: This was a retrospective chart review of 276 patients admitted to the inpatient HIV/AIDS treatment services at ALERT in 2008. We stratified the data by age, gender, CD4 count, WHO staging and ART treatment. RESULTS/ANTICIPATED RESULTS: Preliminary data analysis showed the top four most prevalent opportunistic infections to be tuberculosis, pneumonia, crypotcoccal meningitis, and CNS toxoplasmosis. We found that 40% of the patients in the cohort never started treatment, even though close to 95% of the patients had a CD4 count of less than 350 which is the WHO cutoff CD4 count to start treatment. Close to 70% of the patients on ART treatment had good adherence (approximately 95% adherence) based on self‐report. DISCUSSION/SIGNIFICANCE OF IMPACT: We observed the hospital mortality rate (approximately 45%) to be higher than the overall HIV/AIDS mortality rate for the country (35%). We are currently conducting further statistical analysis to assess the effects of the top four opportunistic infections, adherence, as well as other variables such as CD4 count and WHO staging on mortality using regression models. We hope to discover more explanations and make deductions through further analysis of the data.

                                   P3

ACUTE PREDICTORS OF POSTCONCUSSION SYNDROME(PCS)

Babcock Cimpello L ¹, Byczkowski TL¹, Bazarian JJ²

¹Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, USA; ²University of Rochester Medical Center, Rochester, NY, USA

OBJECTIVES/SPECIFIC AIMS: The objectives are to determine (1) incidence of PCS and (2) acute clinical variables associated with PCS in children with mild traumatic brain injury (mTBI). METHODS/STUDY POPULATION: This is a subanalysis of children <19 years in a previously established mTBI cohort. Variables were collected prospectively in the emergency department(ED). A 3 month follow‐up call included the Rivermead Post Concussion Symptom Questionnaire (RPQ). PCS was defined as having ≥3 symptoms on the RPQ that were worse than pre‐mTBI. Bivariable and multivariable analyses were conducted to examine the associations of variables to PCS. RESULTS/ANTICIPATED RESULTS: 508 of 652 children enrolled completed the follow‐up. 29.9% had PCS. Children with PCS were similar to those without PCS in terms of gender, race, mechanism severity, prior TBI, GCS, amnesia, abnormal brain CT, and receipt of PCS instructions. However, they were older (μ= 14.4 vs. 12.7 yrs) and significantly more likely (p‐value <0.05) to have presented with loss of consciousness (LOC)(61 vs. 50%), headache (HA)(84 vs. 66%), or nausea/vomit (N/V)(44 vs. 33%); and to have undergone brain CT imaging (63 vs. 49%), received analgesics in ED (67 vs. 51%), been admitted (17 vs. 8%), had longer school absenteeism (μ= 7.9 vs. 2.3 days) and pursuing a lawsuit (20 vs. 6%) than those without PCS. Multivariable analysis showed that age (OR 1.1; 95% CI: 1.0, 1.2) and HA (OR 2.2 95% CI: 1.3, 3.6) were associated with PCS; however, gender, GCS, amnesia or N/V were not. Those with LOC were 50% more likely to develop PCS but this association was NS (OR 1.5; 95% CI: 0.96, 2.4). When HA was removed from the model, N/V became associated with PCS (OR 1.7; 95% CI: 1.1, 2.5). DISCUSSION/SIGNIFICANCE OF IMPACT: One‐fourth of children with mTBI seen in the ED develop PCS. Older children with LOC plus headache or nausea/vomiting should be considered at risk of developing PCS.

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ARE THE SCORES PRODUCED BY ADVERSE DRUG EVENT QUESTIONNAIRES DISCORDANT WITH THE ACTUAL PROBABILITY OF A DRUG/ADVERSE EVENT ASSOCIATION?

Boyce RD ¹, Visweswaran S¹, Day R¹, Handler S¹

¹University of Pittsburgh, Pittsburgh, PA, PA, USA

OBJECTIVES/SPECIFIC AIMS: Causality assessment questionnaires (CAQs) are psychometric scales that are often used to help drug experts to make transparent assessments of potential causal relationships between drugs and adverse events (AEs) while maintaining inter‐ and intra‐rater reliability. A CAQ score threshold is usually chosen to distinguish plausible causal associations from implausible ones. We hypothesize that the scores produced by such expert‐weighted CAQs are often discordant with the actual probability of a drug‐AE association. METHODS/STUDY POPULATION: We used two weighting schemes derived for the Koh CAQ, one expert‐weighted and the other probabilistic, to test if the scores produced from the expert‐weighted version of the scale were ever discordant with the actual probability of a drug‐event association. RESULTS/ANTICIPATED RESULTS: We found that the probability that scores produced for two drug‐AE evaluations would be discordant with the actual probability of each drug‐AE association increases monotonically over the majority of possible score thresholds. DISCUSSION/SIGNIFICANCE OF IMPACT: The results indicate that the scores produced by the expert‐weighted Koh CAQ are often discordant with the actual probability of a drug‐event association. We anticipate that this is a property of all CAQs that derive scores from expert‐weighted responses. The implication is that the use a score threshold above which a drug‐event is considered plausible might in some cases be irrational (from a decision‐theoretic point of view) for expert‐weighted CAQs. Similarly, there might be situations where comparing scores produced by an expert‐weighted CAQ to identify the most likely causal drug for an AE would be irrational.

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ASSOCIATION OF SERUM ALBUMIN WITH MARKERS OF NUTRITIONAL STATUS IN HIV INFECTED AND UNINFECTED RWANDAN WOMEN

Dusingize J ¹, Anastos K¹, Hoover D², Shi Q³, Kiefe E¹

¹Einstein College of Medicine, Bronx, NY, USA; ²Rutgers University, Piscataway, NJ, USA; ³NY Medical College, Valhalla, NY, USA

OBJECTIVES/SPECIFIC AIMS: Serum albumin is often used to measure nutritional status. We assessed the association of albumin with other measures of nutritional status in Rwandan women METHODS/STUDY POPULATION: We enrolled 710 HIV‐positive and 226 HIV‐negative women in a cross‐sectional study. Data collected included medical and demographic parameters, CD4 count, albumin; anthropometric measurements and results of Bioelectrical Impedance Analysis (BIA) performed by trained study nurses. Fat‐free mass index (FFMI) and fat index (FI) were calculated by dividing fat free and fat mass each by (height) 2. Outcomes were body mass index (BMI), FFMI, FI and sum of thigh, triceps and subscapular skin‐folds (TTS). RESULTS/ANTICIPATED RESULTS: In a separate age adjusted linear regression models for each outcome in HIV‐negative women, serum albumin was not significantly associated with BMI, p= 0.20, FFMI, p= 0.07 or FI, p= 0.47 and had a weak significant association with TTS, p= 0.049. In HIV+ women albumin was significantly associated with all outcomes in models after adjusting for age and CD4 cell count: BMI, FFMI, FI p < 0.0001 for all, and TTS, p= 0.003. An interaction term between HIV status and serum albumin was significant for all outcomes in models fit to all women. DISCUSSION/SIGNIFICANCE OF IMPACT: Serum albumin did not predict BMI, FFMI or FI in HIV‐negative women, suggesting that it is not a good marker of nutritional status. Its association with these measurements in HIV‐positive women may result from its known value as a measure of advanced illness. This suggests that albumin should not be used as a proxy for nutritional status without further study of its association with validated measures.

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BEHAVIOR, PSYCHIATRIC DIAGNOSES and WEIGHT IN EARLY CHILDHOOD

Lowry KW ^1,2, Lavigne JV^1,2

¹Children’s Memorial Hospital, Chicago, IL, USA; ²Northwestern University, Chicago, IL, USA

OBJECTIVES/SPECIFIC AIMS: Obesity is a known risk factor for poor behavioral control and psychiatric comorbidities. Existing research has not examined behavioral observations or psychiatric diagnoses in children 5 years of age or younger. This study examined the association between child weight and (1) parent‐reported behavior problems, (2) observed noncompliance, (3) the presence or absence of psychiatric diagnoses, and (4) whether demographic variables moderated these associations. METHODS/STUDY POPULATION: This was an archival review of a cross‐sectional observation study. Participants were 283 2‐ to 5‐year‐old children (M = 3.7 yrs). Data was collected during home visits and included (1) parent‐report questionnaires, (2) a semistructured parent interview, and (3) a standardized play observation. Subsequently, trained mental health professionals reviewed the protocols in their entirety and assigned psychiatric diagnoses if warranted. RESULTS/ANTICIPATED RESULTS: Parent‐reported externalizing behavior problems (B = 0.319, SE B = 0.157, p= 0.04) and observed noncompliance (B = 46.557, SE B = 21.955, p= 0.04) were significantly associated with higher child weight. Lower family SES (B = 8.087, SE B = 4.047, p= 0.047) was also associated with heavier child weight. The impact of externalizing behavior problems on weight was stronger in girls (B = 0.706, SE B = .341, p= 0.04). Child race/ethnicity was not associated with child weight. Parent‐reported internalizing behavior problems and psychiatric diagnoses were not associated with child weight. DISCUSSION/SIGNIFICANCE OF IMPACT: Child externalizing behavior problems were associated with higher weight in young children. These findings suggest that parents may perceive the behavior of heavier children to be difficult to manage, but these families may not receive intervention as the intensity of behavior problems were not severe enough to warrant psychiatric diagnoses.

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BIOMARKERS OF METABOLIC SYNDROME PREDICT ACCELERATED DECLINE OF LUNG FUNCTION IN NYC FIREFIGHTERS THAT WERE EXPOSED TO WORLD TRADE CENTER PARTICULATES

Naveed B ¹, Comfort A¹, Ferrier N¹, Kwon S¹, Rom WN¹, Prezant DJ², Weiden MD¹, Nolan A¹

¹New York University School of Medicine, NY, NY, USA; ²NYC Fire Department, Brooklyn, NY, USA

OBJECTIVES/SPECIFIC AIMS: The first year post 9/11/2001, the FEV1 of FDNY rescue workers declined 439 mL, stabilizing to a 25 ml/yr decline in the subsequent 7 years. Airflow obstruction predominated in firefighters who sought a subspecialty pulmonary evaluation for treatment. We are investigating the relationship between biomarkers of metabolic syndrome (MS) and decline in lung function. METHODS/STUDY POPULATION: Treatment cohort (N= 1720) was stratified by FEV1 into obstructed, FEV1 < 76% predicted (LLN), or normal airflow, FEV1>76%. A pilot analysis assayed 41 patients’ serum drawn 5 months post 9/11 for 15 biomarkers of MS by Luminex, (obstructed N= 10, normal N= 31). All patients had normal pre‐9/11 lung function. Serum cholesterol (CHOL) and triglycerides (TG) were available on 157 patients, 20/157 were obstructed. Data presented as means ± SD; p values ≤0.05 by t‐test considered significant. RESULTS/ANTICIPATED RESULTS: BMIs at time of serum sampling were no different between normal and obstructed individuals. At subspecialty PFT, obstructed patients had higher BMIs with an accelerated decline in lung function post 9/11, increased airway reactivity, and evidence of air trapping based on elevated RV when compared to normals. Obstructed subjects had significantly greater CHOL and CHOL/HDL ratios; higher levels of sE‐Selectin, tPAI‐1, and s‐ICAM; and a trend towards elevated levels of TG and C‐peptide. DISCUSSION/SIGNIFICANCE OF IMPACT: Blood drawn post‐WTC exposure identified a subgroup of patients with markers of MS. This subgroup had subsequent increased weight gain and decline in lung function. The finding of MS biomarkers prior to lung function decline raises the possibility that the combination of irritant exposure and mediators of MS interact and promote lung injury.

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COMMUNITY‐BASED SURVEY OF FACTORS RELATED TO OVERWEIGHT/OBESITY AMONG HISPANICS IN THE SOUTH BRONX

Marmolejos V ¹, Salazar Y¹, Buitrago JC¹, Ramos M¹, Boutin‐Foster C², Kanna B^1,2

¹Lincoln Hospital, Bronx, NY, USA; ²Weill‐Cornell‐CTSC, New York, NY, USA

OBJECTIVES/SPECIFIC AIMS: Rates of obesity are increasing rapidly in the United States (US) making it a major public health concern. In New York City, 30.6% of Bronx residents are obese, making it highest among all five boroughs. There are ethnic disparities of obesity and related factors that need to be identified and addressed among New Yorkers. METHODS/STUDY POPULATION: We conducted a cross‐sectional validated survey at Lincoln Medical and Mental Health Center outpatient clinics between 2009 and 2010. The survey had different components of responses, such as demographics, diet, exercise, and body mass index (BMI kg/m2). Subjects were divided into obese/overweight group based on BMI greater than 25 and normal BMI group. Odds ratio (OR), 95% confidence intervals (CI) and p values are reported. RESULTS/ANTICIPATED RESULTS: Of 700 respondents, 650 (92%) were Hispanics. Among Hispanics, 220 (34%) were obese, and 472 (72.4%) were either obese or overweight. 419 (65%) were at least high school educated, and 383 (59%) have lived in US > 10 years. On stepwise multivariate analysis, overweight/obese BMI group of Hispanics had significant greater odds of mature adult age (age <35 yrs‐ OR 0.60, 95% CI 0.41–0.90, p= 0.012), male gender (male‐ OR 1.94, 95% CI 1.3–2.9, p= 0.001); lack of at least high school education (at least high school‐ OR 0.64, 95% CI 0.44–0.94, p= 0.024) and greater than 10 years of residence in US (time in US >10 years‐ OR 2.07, 95% CI 1.4–3.1, p= 0.000). Among obese individuals (BMI > 30 kg/m2), the odds were higher among only those who were lacking high school education or lived in US for > 10 years. DISCUSSION/SIGNIFICANCE OF IMPACT: The study findings show that adult immigrant Hispanics with lower educational status and greater time of residence in the US have a greater probability of being overweight or obese.

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COMPLETENESS OF ROTAVIRUS(ROTA) VACCINATION (VAC) AND ITS IMPACT ON ROTA DISEASE

Immergluck LH ^1,3, Khizer S³, Chan T^1,3, Alema‐Mensah E¹, Brown E¹, Farley M^4,5, Jerris R^2,3

¹Morehouse School of Medicine, Atlanta, GA, USA; ²Emory University, Atlanta, GA, USA; ³Children’s Healthcare of Atlanta, Atlanta, GA, USA; ⁴Georgia Emerging Infections Program, Atlanta, GA, USA; ⁵Atlanta VA Medical Center, Atlanta, GA, USA

OBJECTIVES/SPECIFIC AIMS: Determine the prevalence of rota positive (+) stools and the impact of rota vac on disease burden, METHODS/STUDY POPULATION: There are two parts to this project (1) Case control study of children with +/– rota tests for 3 consecutive seasons (S1‐S3), beginning Dec 2006‐Jun 2007 from 2 pediatric hospitals and (2) active surveillance of children with symptoms of acute gastroenteritis (AGE) during Dec 2009‐Jun 2010 from 3 pediatric hospitals. Rates were determined for rota disease and rota vac in children born after April 1, 2006. Rota vac status was collected from state immunization registry and from contact with primary care providers. RESULTS/ANTICIPATED RESULTS: There were 138 (27%) cases and 365 (73%) controls during the three seasons and vac records were obtained for all cases and controls; the rota + rates were highest for S1, 63/185 (34%) compared to S2, 21/132 (16%) or S3, 54/186 (29%), p < 0.05. Vac rates for S1‐S3 were (214/503) 43%, (185/503) 37%, and (137/503) 27% for rota vac dose 1, 2, and 3, respectively. Among those who received 1 of 3 rota vac doses, fewer were cases than controls at the time of rota test: S1 Cases: 8/55 (14.5%) versus S1 Controls: 47/55 (85%); S2 Cases: 3/71 (4%) vs S2 Controls: 68/71 (96%); S3 Cases: 7/88 (8%) versus S3 Controls:81/88 (92%); this trend was seen for 2nd and 3rd rota vac doses, p < 0.001.During active surveillance, 227 children were enrolled and 209 stool samples were tested for rota; only 30 were + for rota (30/209,14%). DISCUSSION/SIGNIFICANCE OF IMPACT: There is a downward trend of rota + cases among children seeking care from pediatric hospitals in Atlanta. Cases were more likely than controls to have incomplete rota vac at the time of rota testing.

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CONNECTIVE TISSUE DISEASE ASSOCIATED VASCULOPATHIC WOUNDS

Shanmugam VK ¹, Schilling AL¹, Attinger CE¹

¹Georgetown University Hospital, Washington, DC, USA

OBJECTIVES/SPECIFIC AIMS: Lower extremity ulcers are a known complication of connective tissue diseases (CTD). The primary hypothesis of this research is that delayed wound healing in CTD is a manifestation of dysregulation of vasculogenic and angiogenic pathways, and that lower‐extremity ulcers associated with CTD will provide a useful compartmental model for studying these pathways. METHODS/STUDY POPULATION: Retrospective chart review was completed on consecutive patients scheduled in the Georgetown University Hospital Center for Wound Healing between January 1 and March 31, 2009. Exclusion criteria included absence of an open ulcer or failure to be evaluated during the study period. Data collected included demographics; ulcer location and duration; ulcer size; outcome of surgical interventions including debridement, grafting, and wound vacuum closure device; and comorbid conditions including CTD, diabetes and vascular disease. The primary end point was correlation between wound duration and CTD. The secondary end points were outcomes, including healing; time to healing; and surgical interventions in the patients with CTD compared to those without CTD. RESULTS/ANTICIPATED RESULTS: Of the 520 scheduled patients, 337 had an open ulcer. The remaining 183 patients either did not attend the visit, or did not have an ulcer at the time of the visit. Of the patients with ulcers, 23.7% had an underlying CTD. Diabetes was present in 191 patients (56.6%), venous disease in 125 (37.1%) and arterial disease in 109 (32.3%). DISCUSSION/SIGNIFICANCE OF IMPACT: In this consecutive cohort of patients presenting to a tertiary wound healing center, 23.7% had associated CTD. We intend to use delayed wound healing in CTD as a model for studying tissue markers of angiogenesis and vasculogenesis on formalin fixed paraffin embedded specimens.

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DENTAL SERVICE UTILIZATION AND ASSOCIATED FACTORS AMONG LATINO ADOLESCENTS IN CALIFORNIA

Orellana MF ¹, Cubas IP¹

¹UCSF, San Francisco, CA, USA

OBJECTIVES/SPECIFIC AIMS: The objective of this study is to identify and explain disparities in dental service utilization among Latino adolescents in California. METHODS/STUDY POPULATION: For this secondary analysis, the 2007 CHIS adolescent questionnaire was used, based on a random digit dialing telephone survey. The odds ratios (OR) and 95% confidence interval (CI) were calculated using multiple logistic regression modeling, taking into account the complex survey design and sample weights. RESULTS/ANTICIPATED RESULTS: A total of 1,769 Non‐Hispanic white and 1,227 Latino adolescents participated. Language spoken at home (English or Spanish), immigrant status and race were all significant determinant of frequency of dental visits. Latino (OR = 0.49 CI 0.53–0.68); immigrants (OR = 0.52 CI 0.37–0.74), and adolescents that spoke Spanish at home (OR = 0.60 CI 0.43–0.84) were less likely to have a dental visit in the past year. In terms of preventive visits, immigrants (OR = 0.87 CI 0.60–1.25), Latino (0.91 CI 0.72–1.15), and adolescents that live in a Spanish speaking household (OR = 0.93 CI 0.76–1.13) had less preventive visits, although not significant. Adolescents with dental insurance were more likely to have had a past‐year dental visit. DISCUSSION/SIGNIFICANCE OF IMPACT: The Latino population is the fastest growing and the largest minority group in the U.S. One‐half of the Latino population is younger than 27 years of age, and 20 percent of all children younger than 5 years of age are Latinos. In California, the most populous state, Latinos surpassed whites as the state’s largest racial/ethnic group amongst children; yet, little is known about dental service utilization and associated factors among Latino adolescents in California. This study will help identify and explain disparities in this population.Without this basic understanding, these inequities cannot be addressed.

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DISPARITY IN ETIOLOGY AND LENGTH OF STAY IN WOMEN WITH CHRONIC PELVIC PAIN: CALIFORNIA HOSPITAL DISCHARGE DATA

Troutman W ¹, Shaheen M¹, Pan D¹

¹Charles Drew University, Los Angeles, CA, USA

OBJECTIVES/SPECIFIC AIMS: The objective is to determine the disparity and predictors of etiology and length of hospital stay among women admitted to California hospitals with the diagnosis of Chronic Pelvic Pain (CPP) during years 2001–2007. This study will test the hypotheses: (1) young, uninsured women of minority group are more likely to be diagnosed with an infectious etiology of CPP relative to whites. METHODS/STUDY POPULATION: Admission data from California hospitals were reviewed and analyzed for the time period of 2001 to 2007. Eligibility included women diagnosed with CPP aged 18 years and older that were hospitalized due to infections or noninfectious etiology during the periods 2001–2007. We analyzed the data using descriptive, bivariate and multivariate statistics. RESULTS/ANTICIPATED RESULTS: Of the 122,001 patients with CPP, 120,131 (98.5%) were due to infectious diseases and 1,941 (1.5%) were due to infectious diseases. The etiology of CPP hospitalization varied by age, race/ethnicity, and insurance status (p < 0.05). Blacks and hispanics, age 35–64 years, with medical/medicare had higher odds of being hospitalized due to infectious type relative to white (p < 0.05). The percentage of CPP subjects hospitalized due to infection decreased overtime (99% in 2001 versus 97% in 2007, p < 0.05). Subjects with infectious causes had higher adjusted odds of being hospitalized relative to those admitted due to infectious causes (p < 0.05). Median length of stay was 2 days for white and 3 days for others. Infectious CPP stayed more days than non infectious one (p < 0.05). DISCUSSION/SIGNIFICANCE OF IMPACT: Our data showed an increase in the hospitalization due to infectious CPP over time as well as disparity in the etiology and length of hospital stay. Since CPP is a diagnosis of exclusion with broad implications to society, more attentions are needed related to diagnosis of CPP among minority uninsured women.

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EOSINOPHILIA/INFLAMMATORY BOWEL DISEASE (EOS/IBD): ASSOCIATION WITH SEVERE COLITIS AND PRIMARY SCLEROSING CHOLANGITIS

Barrie A ¹, El Mourabet M¹, Weyant K¹, Clarke K¹, Regueiro M¹, Yadav D¹, Saul M¹, Binion D¹

¹University of Pittsburgh, Pittsburgh, PA, USA

OBJECTIVES/SPECIFIC AIMS: Eosinophils have been implicated in the pathogenesis of inflammatory bowel disease (IBD; Crohn’s disease (CD), ulcerative colitis (UC)). The natural history of IBD patients with peripheral eosinophilia is undefined. We sought to characterize the prevalence and clinical characteristics of IBD patients with eosinophilia from a tertiary referral cohort. METHODS/STUDY POPULATION: We queried a prospective, consented registry of IBD patients followed in a referral center. Peripheral eosinophilia was identified by electronic medical record (EMR) query identifying patients who had an absolute eosinophil count > 0.4 × 10E9/L (Eos/IBD group). RESULTS/ANTICIPATED RESULTS: Out of 890 IBD patients, EMR analysis identified 27 individuals with an elevated absolute eosinophil count designated Eos/IBD. The Eos/IBD cohort included 16 UC and 11 CD patients. Among Eos/IBD patients with UC, the majority were male with pan‐colitis and backwash ileitis. Among Eos/IBD patients with CD, the majority were female with ileocolitis. 100% of the Eos/IBD patients required hospitalization for IBD management. Medical management of the Eos/IBD patients included corticosteroids (96%), immunomodulators (70%) and biologics (56%). Surgical intervention was required in 59% of the Eos/IBD patients (CD 91%, UC 38%). Primary sclerosing cholangitis was seen in 26% of the Eos/IBD patients (6 UC and 1 CD), and 71% of these individuals required liver transplantation. DISCUSSION/SIGNIFICANCE OF IMPACT: Eos/IBD is a rare subgroup of IBD associated with severe colitis refractory to medical therapy and aggressive PSC. Eos/IBD may have a unique immunopathogenic basis which underlies refractory chronic inflammation. Further studies are warranted to characterize molecular mechanisms underlying Eos/IBD and to determine optimal approaches for therapy.

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INCIDENCE, SEVERITY, AND TREATMENT OF COMMUNITY‐ACQUIRED MRSA (CA‐MRSA) SKIN AND SOFT TISSUE INFECTIONS (SSTI) IN 12 MEDICAL CLINICS IN TEXAS

Frei CR ^1,2, Parchman ML^2,3, Forcade NA^1,2, Du LC³, Nyren NR³, Treviño L³, Peña J³, Mann M³, Muñoz A³, Treviño S³, Mortensen E², Wickes B², Pollock BH², Jorgensen JH²

¹University of Texas, Austin, TX, USA; ²University of Texas Health Science Center, San Antonio, TX, USA; ³South Texas Ambulatory Research Network (STARNet), San Antonio, TX, USA

OBJECTIVES/SPECIFIC AIMS: Quantify the incidence, measure the severity, and describe treatment patterns in patients who present to medical clinics in Texas with SSTIs. METHODS/STUDY POPULATION: Twelve clinics participated in this prospective, community‐based study. Clinicians consented patients, collected clinical information, pictures, and wound swabs; data were processed centrally. MRSASelect™ was used for identification. Susceptibilities were determined for five antibiotics via Etest^®. RESULTS/ANTICIPATED RESULTS: Overall, 80/135 (59%) patients had CA‐MRSA; 39/80 (49%) were male, 65/79 (82%) were Hispanic, 24/80 (30%) had diabetes, and 34/80 (43%) had a SSTI within the last 12 months. Most (60/80, 75%) had abscesses; 38/60 (63%) abscesses were ≥5 cm in diameter. The majority of patients experienced pain scores of 7 or higher out of 10 (54/80, 68%). Many presented with erythema (64/80, 80%), drainage (43/80, 54%), or ulceration (25/80, 31%). Most received incision and drainage plus an antibiotic (46/78, 60%). Trimethoprim/sulfamethoxazole (TMP/SMX) was the most common monotherapy prescribed (78%), followed by doxycycline (4%), clindamycin (3%), and mupirocin (2%). MIC50 and percent susceptible were (n= 80): vancomycin (1.5 μg/mL, 100%), doxycycline (0.047, 100%), TMP/SMX (0.047, 100%), clindamycin (0.06, 94%), and linezolid (1.0, 100%). DISCUSSION/SIGNIFICANCE OF IMPACT: Many patients presenting to medical clinics in Texas have CA‐MRSA SSTIs. Most of these patients receive incision and drainage plus anti‐MRSA antibiotics.

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INTERPRETING CHANGE IN CEREBRAL PALSY: VARIABILITY BETWEEN INDIVIDUAL PERCEPTIONS AND STANDARDIZED MEASURES

Vargus‐Adams J ^3,2, Martin LK³, Maignan SH¹, Klein AC¹, Salisbury S²

¹Department of Occupational Therapy and Physical Therapy, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, USA; ²Division of Biostatistics and Epidemiology, Department of Pediatrics, Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, USA; ³Division of Pediatric Rehabilitation, Department of Pediatrics, Cincinnati Children’s Hospital Medical Center and Department of Physical Medicine and Rehabilitation, University of Cincinnati School of Medicine, Cincinnati, OH, USA

OBJECTIVES/SPECIFIC AIMS: To establish minimal clinically important differences (MCIDs) for three common cerebral palsy (CP) outcome measures. METHODS/STUDY POPULATION: 122 children (79 male) ages 4–12 years with CP, as well as parents and medical professionals, provided concurrent ratings of clinical status in several domains (gross motor, self‐care, social function, quality of life, and overall functioning). The Gross Motor Function Measure–66 (GMFM), Pediatric Evaluation of Disability Inventory (PEDI), and Cerebral Palsy Quality of Life Questionnaire for Children (CP‐QOL) were administered at baseline and 6 months. We compared outcome measure change scores with changes in status ratings using established methodology for calculating MCIDs to describe the relationships between measures and status ratings. RESULTS/ANTICIPATED RESULTS: MCIDs could not be established. The average outcome measure change scores across five categories of improvement/worsening did not show a pattern. No relationship could be established between degree of change in respondents’ clinical status ratings and the change in scores on the GMFM, PEDI, and CP‐QOL. DISCUSSION/SIGNIFICANCE OF IMPACT: The methodology used to establish MCIDs in this study was not effective for the GMFM, PEDI, or CP‐QOL in CP. These findings highlight the difficulty of defining and documenting ‘meaningful’ change when evaluating interventions for children with CP.

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LEFT VENTRICULAR HYPERTROPHY (LVH) AMONG AFRICAN AMERICAN (AA) AND NON‐AA CHILDREN WITH PRIMARY HYPERTENSION

Pruette CS ¹, Fivush BA¹, Flynn JT², Brady TM¹

¹Johns Hopkins University, Baltimore, MD, USA; ²Seattle Children’s Hospital, Seattle, WA, USA

OBJECTIVES/SPECIFIC AIMS: LVH has been shown to be more prevalent among African American (AA) children with primary hypertension (HTN) compared to non‐AA children with primary HTN. It is unclear whether this difference in the prevalence of LVH persists after adjusting for various clinical characteristics. The objective of the study was to determine the impact of race on LVH in children with PHTN. METHODS/STUDY POPULATION: Cross‐sectional study of 140 children aged 3–21 seen at 3 tertiary medical centers from 1995–2005 for initial evaluation of high BP and ultimately diagnosed with PHTN. Univariate and multivariate logistic regression analyses were utilized to determine the odds of LVH among AA versus non‐AA children with PHTN. RESULTS/ANTICIPATED RESULTS: Overall prevalence of LVH was 43%; 60% among AA children, 37% among non‐AA children (p= 0.02). Univariate logistic regression revealed a 2.6 times increased odds of LVH in AA versus non‐AA children with PHTN. This increase was no longer present after adjusting for confounders, leaving BMI z‐score as the only significant predictor (OR 1.6, 95% CI (1.12–2.42)) of LVH among children with PHTN. DISCUSSION/SIGNIFICANCE OF IMPACT: AA children with PHTN have more LVH at initial presentation, however after adjusting for BMI z‐score and other confounders, AA children were no more likely to have LVH than non‐AA children. Overweight/obesity may play a larger role in the development of LVH than race in children with PHTN.

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MEDIATORS OF THE EFFECT OF NEIGHBORHOOD POVERTY ON PHYSICAL FUNCTIONING AMONG BREAST CANCER SURVIVORS: A LONGITUDINAL STUDY

Pruitt SL ^1,2, McQueen A^1,2, Deshpande AD^1,2, Jeffe DB^1,2, Schootman M^1,2

¹Washington University School of Medicine, Saint Louis, MO, USA; ²Alvin J. Siteman Cancer Center at Barnes‐Jewish Hospital and Washington University School of Medicine, Saint Louis, MO, USA

OBJECTIVES/SPECIFIC AIMS: This study sought to identify mediators of the effect of neighborhood poverty on physical functioning using longitudinal data from a Missouri cancer registry‐based sample of 909 female breast‐cancer survivors. METHODS/STUDY POPULATION: Survivors were recruited one year after diagnosis (Y1) and completed two telephone interviews, at Y1 and one year later (Y2). The association between census‐tract‐level poverty and physical functioning (RAND SF‐36) was tested using a multilevel a priori path model with 19 hypothesized mediators, demographic and socioeconomic confounders, and covariates. Hypothesized mediators included clinical and treatment variables, psychosocial factors (depression, stress, social support), perceived neighborhood characteristics, behavioral risk factors (leisure time physical activity, smoking, body mass index, alcohol use), and comorbidity. RESULTS/ANTICIPATED RESULTS: In unadjusted analysis, women living in neighborhoods with higher poverty were more likely to report lower physical functioning at Y2 (β=−0.19, p < 0.001). The adjusted model fit the data well (χ²(8) = 12.25, p= 0.14; CFI = 0.996; RMSEA = 0.024). The effect of neighborhood poverty on physical functioning was fully mediated by physical activity and body mass index. DISCUSSION/SIGNIFICANCE OF IMPACT: Breast cancer survivors living in neighborhoods with greater poverty reported lower physical functioning, but this effect was fully explained by physical activity and body mass index. Health promotion interventions aimed at improving survivors’ lifestyles may help to ameliorate neighborhood socioeconomic disparities in physical functioning.

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PREDICTORS OF FOREARM FRACTURE RISK IN AFRICAN AMERICAN CHILDREN

Ryan LM ¹, Teach S¹, Brandoli C¹, Singer S¹, Wood R¹, Freishtat R¹, Wright J¹, Tosi L¹, Chamberlain J¹

¹Children’s National Medical Center, Washington, DC, USA

OBJECTIVES/SPECIFIC AIMS: Pediatric forearm fractures are increasing in incidence. Modifiable factors, including overweight status and/or deficient bone health (low dietary calcium intake and hypovitaminosis D), may contribute to risk and are prevalent in African American (AA) children. Our objective is to determine the association of forearm fractures with weight and bone health in AA children. METHODS/STUDY POPULATION: This case‐control study is enrolling AA children, ages 5–9 years, with and without forearm fractures. BMI, calcium intake, serum 25‐hydroxy vitamin D level and bone mineral density (BMD) are measured. Bivariable and multivariable analyses test associations of weight and bone health with fracture status. RESULTS/ANTICIPATED RESULTS: We have enrolled 65 cases and 72 controls. Mean age and proportion who were male did not differ comparing cases to controls. Mean BMI percentile for cases [73.1 (± 25.8)] was significantly higher than controls [59.0 (± 30.0)] (p= 0.008). More cases (30/58, 52%) than controls (22/68, 32%) had a BMI ≥85th percentile (OR = 2.2, 95% CI = 1.1–4.6). There was no difference in proportion of cases (24/52, 46%) and controls (19/63, 30%) meeting recommended daily dietary calcium intake for age (OR = 2.0,95%CI = 0.9–4.3). Mean 25‐hydroxy vitamin D level for cases [21.7(± 6.9)ng/mL] was similar to controls [22.6 (± 7.3) ng/mL](p= 0.45). Proportion of cases (29/59, 49%) and controls (27/69, 39%, OR = 1.5, 95% CI = 0.7–3.0) with vitamin D insufficiency and mean total body z‐score for cases [0.7 (± 1.0)] versus controls [1.0 (± 1.1)](p= 0.10) were not statistically different. DISCUSSION/SIGNIFICANCE OF IMPACT: These data support an association between overweight status and risk for childhood forearm fracture. Our findings also suggest that vitamin D status and BMD may play a role in the increasing rates of childhood forearm fracture.

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PREVALENCE AND RISK FACTORS FOR VITAMIN D DEFICIENCY IN IBD IN NORTH FLORIDA

Gaidos J ¹, Sultan S¹, Dahl W¹, Valentine JF¹

¹University of Florida, Gainesville, FL, USA

OBJECTIVES/SPECIFIC AIMS: Vitamin D (vit D) is important in adaptive immunity and inflammation. Deficiency is more prevalent in inflammatory bowel disease (IBD) than in the general population. Identified risk factors for vit D deficiency in IBD suggest a nutritional deficiency as the underlying etiology, however, the major source of vit D is through sun exposure. We performed an IRB approved prospective cohort study to determine the prevalence of vit D deficiency in the IBD population in Northern Florida and assess risk factors for deficiency. METHODS/STUDY POPULATION: Between Aug and Oct 2010, 117 adult IBD patients seen in the UF IBD clinics were consented and enrolled. Deficiency is defined as a 25‐hydroxy vit D (25‐OH D) level of <20 ng/mL and insufficiency as a level of 20–29 ng/mL. Data collected included dietary intake of vit D, sun exposure history and colorimeter readings, BMI, medications, small bowel resections, disease activity, CRP, and serum 25‐OH D. Patients with suboptimal vit D levels were started on supplementation and a follow‐up level was obtained. RESULTS/ANTICIPATED RESULTS: Of the 117 patients, 92.3% are white, 47.9% male, 69.2% CD and 26.5% UC. The mean age is 41.9 yrs, mean BMI 25.9, mean CRP 7.5. 35.9% were on a biologics, 29.9% on steroids, 23.9% on a multivitamin and 22.2% on vit D supplements. The mean vit D level was 26.6 (range 4–93). Deficiency was found in 24.5% and insufficiency found in 46.2%. Univariate and multivariate analysis will be performed when enrollment is completed. DISCUSSION/SIGNIFICANCE OF IMPACT: With the preliminary data, the prevalence of suboptimal vit D levels in IBD patients is 70.7%. Despite our location in a geographic region with an adequate duration of sunlight of appropriate UV length, there is still a surprisingly high prevalence of deficiency. Future studies will determine the effect of adequate vit D supplementation on the course of IBD.

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PROGNOSTIC DEMOGRAPHIC AND TUMOR CHARACTERISTICS IN BREAST CANCERS BY 25‐OH VITAMIN D LEVELS

Peppone LJ ¹, Rickles A¹, Rosier RN¹, Morrow GR¹, Huston AG¹, Mustian KM¹, Skinner KA¹

¹University of Rochester, Rochester, NY, USA

OBJECTIVES/SPECIFIC AIMS: There is a paucity of research examining vitamin D levels and prognostic variables in breast cancer patients. The aim of this study is to identify the associations between 25‐OH vitamin D levels, demographic variables, and prognostic pathological characteristics of breast cancers. METHODS/STUDY POPULATION: This study cohort consists of 155 women who underwent breast cancer surgery at the University of Rochester between 1/09 and 9/10. Vitamin D levels were obtained shortly before or following surgery. Prognostic variables included age, race, menopausal status, Oncotype DX score, TNM staging, ER status, PR status, and HER2 expression. ANCOVA, linear regression, and logistic regression were used to determine the association between prognostic variables and 25‐OH vitamin D levels. RESULTS/ANTICIPATED RESULTS: Non‐Caucasian (OR = 3.8; p < 0.01) and premenopausal (OR = 3.5; p < 0.01) breast cancer patients were significantly more likely to have suboptimal 25‐OH vitamin D levels than Caucasian and postmenopausal patients, respectively. A significant correlation (r=–0.42; p= 0.04) between decreasing vitamin D levels and increasing Oncotype score was noted. Breast cancer patients who had ER‐ and triple‐negative breast tumors were more likely to have suboptimal levels of 25‐OH vitamin D (ER‐ OR = 2.4; p= 0.07) (triple‐negative OR = 2.6; p= 0.09). Women with invasive breast tumors had lower mean 25‐OH vitamin D levels (invasive: 30.5 ng/ml vs. in situ: 36.9 ng/ml; p= 0.04) than women with in situ tumors. DISCUSSION/SIGNIFICANCE OF IMPACT: Breast cancer patients with suboptimal vitamin D levels were more likely to have tumors with more aggressive tumor profiles, worse prognostic markers (ER‐ and triple‐negative tumors), and high recurrence risk (Oncotype scores). Further research is needed to elucidate the biological relationship between vitamin D and breast cancer.

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PROGNOSTIC FACTORS FOR LEFT ATRIOVENTRICULAR VALVE REPLACEMENT FOLLOWING PRIMARY ATRIOVENTRICULAR SEPTAL DEFECT REPAIR

Patel SS ¹, Burns TL¹, Kochilas L²

¹University of Iowa, Iowa City, IA, USA; ²University of Minnesota, Minneapolis, MN, USA

OBJECTIVES/SPECIFIC AIMS: Development of significant left atrioventricular valve (LAVV) regurgitation occurs in some patients following atrioventricular septal defect (AVSD) repair, necessitating additional surgical interventions, including valve replacement. Descriptions of the medical course of these patients are sparse and consistent prognostic factors for LAVV replacement have not yet been identified. METHODS/STUDY POPULATION: The experience of the Pediatric Cardiac Care Consortium (1982 to 2007) was reviewed to identify early outcomes of and prognostic factors for LAVV replacement following primary AVSD repair. RESULTS/ANTICIPATED RESULTS: Three hundred seventy patients with previously repaired AVSDs who underwent reoperation of the LAVV were included in the analysis–243 underwent LAVV repair, 127 LAVV replacement. Median time to first reoperation following primary repair was 0.67 years in the repair subgroup and 0.18 years in the replacement subgroup (p= 0.0002). Multivariable age‐, weight‐, and AVSD repair era‐adjusted predictors of earlier time to valve replacement included presence of Down syndrome and postoperative mitral valve stenosis. Thirty‐day survival was significantly poorer in the replacement subgroup compared to the repair subgroup (p= 0.0002). Multivariable age‐, weight‐, and AVSD repair era‐adjusted predictors of in‐hospital death following valve replacement included presence of Down syndrome (hazard ratio 2.16, 95% CI 1.11–4.20) and larger prosthetic valve size/weight ratio (hazard ratio 1.63 per mm/kg, 95% CI 1.24–2.15). DISCUSSION/SIGNIFICANCE OF IMPACT: Earlier mortality after LAVV replacement in patients with previously repaired AVSDs can be predicted by the presence of Down syndrome and prosthetic valve size/weight ratio. The ability to predict outcomes may be useful in choosing between valve repair and replacement strategies.

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RISK BEHAVIORS AMONG RECENTLY INCARCERATED HIV‐INFECTED INJECTION DRUG USERS

Westergaard R ¹, Kirk GD^1,2, Richesson D², Mehta S²

¹Johns Hopkins University, Baltimore, MD, USA; ²Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA

OBJECTIVES/SPECIFIC AIMS: HIV‐infected injection drug users (IDUs) are frequently incarcerated. The period immediately following incarceration has been associated with increased high‐risk sexual activity and increased frequency of illicit drug use. The purpose of this study was to describe patterns of drug‐injecting behaviors of HIV‐infected IDUs following incarceration, and to assess whether risk behaviors differed among IDUs with and without successful virologic suppression in response to antiretroviral therapy. METHODS/STUDY POPULATION: We assessed needle‐sharing and shooting gallery attendance among HIV‐infected injection drug users who were followed in a community‐based cohort study. We compared frequency of high‐risk behaviors from visits when particpants reported recent incarceration to those when no incarceration was reported. The proportion of IDUs reporting risk behaviors was then compared for those receiving or not receiving effective antiretroviral therapy. RESULTS/ANTICIPATED RESULTS: From 1998–2010, 437 IDUs contributed 2075 study visits to the dataset. Incarceration was reported at 413 study visits. At visits following a reported incarceration, participants were more likely to report needle sharing (23% vs. 12%) and shooting gallery attendance (9% vs. 1%) than if no incarceration occurred. IDUs with elevated HIV RNA were equally likely to engage in high risk behaviors as IDUs with undetectable HIV RNA. DISCUSSION/SIGNIFICANCE OF IMPACT: Among HIV‐infected IDUs, HIV transmission risk behaviors are particularly common during periods following incarceration. IDUs who are not effectively treated with ART, and as a result are more infectious, are no less likely to engage in high risk behavior.

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SYSTEMIC, BUT NOT VASCULAR INFLAMMATORY BURDEN INCREASES WITH AGE AND PROMOTES A HIGH‐RISK PHENOTYPE ACROSS AFRICAN AMERICAN–CAUCASIAN ETHNICITY

Erdembileg A ¹, Byambaa E¹, Ozturk Z^1,2, Zhang W¹, Tracy RP³, Kim K¹, Beckett LA¹, Berglund L^1,4

¹UC Davis, Davis, CA, USA; ²University of Istanbul, Istanbul, Turkey; ³University of Vermont, Colchester, VT, USA; ⁴VA Northern California Health Care System, Sacramento, CA, USA

OBJECTIVES/SPECIFIC AIMS: We studied two sets of inflammatory markers, representing a) systemic (CRP and fibrinogen) and b) vascular (Lp‐PLA2 and PTX‐3) inflammation and their association with age and gender. METHODS/STUDY POPULATION: We determined CRP, fibrinogen, Lp‐PLA2 activity and PTX‐3 levels and other CVD risk factors in 336 Caucasians and 224 African Americans undergoing coronary angiography. RESULTS/ANTICIPATED RESULTS: Trend patterns of vascular inflammatory markers (Lp‐PLA2 and PTX‐3) did not change with age for either gender, although significant ethnic differences were observed. In contrast, different trends were seen for systemic inflammatory markers. In men, but not in women, CRP levels increased significantly with age and the pattern of change with age differed between Caucasians and African Americans (p < 0.01), suggesting an ethnic difference. Specifically, there were less substantial changes in CRP levels associated with age as in Caucasian men compared to African American men. Fibrinogen levels showed a significant increase with age in all gender/ethnicity groups. We found a significant contribution of obesity (measured as BMI) on the magnitude of association of markers of systemic inflammation (CRP and fibrinogen) with age in both ethnic and gender groups. However, the trend patterns of vascular inflammatory markers did not change with age even after adjustment for obesity. DISCUSSION/SIGNIFICANCE OF IMPACT: The findings suggest an increase in the systemic, but not vascular inflammatory burden with aging. Our results unveil the importance of assessing patterns of inflammatory markers over age and gender in promoting a high‐risk phenotype across ethnicity.

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THE EFFECT OF TASK PRIORITIZATION ON PERFORMANCE OF UPPER AND LOWER LIMBS DURING DUAL TASK IN YOUNG AND OLD INDIVIDUALS

Oh‐Park M ¹, Holtzer R^2,1, Mahoney J², Wang C¹, Raghavan P³, Verghese J¹

¹Albert Einstein College of Medicine, Bronx, NY, USA; ²Ferkauf School of Psychology, Yeshiva University, Bronx, NY, USA; ³New York University School of Medicine, New York, NY, USA

OBJECTIVES/SPECIFIC AIMS: Many activities of daily living involve simultaneous performance of upper and lower limbs. However, the effect of aging on subtask performance during dual‐tasking with specific task prioritization is not well studied. We investigated the effect of age on upper and lower limb performance during walking while carrying a tray under specific task prioritization. METHODS/STUDY POPULATION: Sixteen old (63–86 years) and 18 young (17–28 years) adults performed two single tasks (walking of preferred pace, holding a tray while standing) and two dual tasks (walking while holding a tray focusing attention on keeping the tray stable‐WTAT, and walking while holding a tray focusing attention on walking‐WTAW). Four gait parameters and the maximum range of tray tilt were measured. RESULTS/ANTICIPATED RESULTS: During WTAT compared to single task, both age groups showed significant change in upper and lower limb performance. Old individuals showed more increase in tray tilt, but less change in gait performance compared to young individuals. During WTAW, there was no significant change in either tray stability or gait performance except reduced stride length in both groups. During WTAT a larger proportion of older group showed higher dual task cost (change compared to single task) on tray stability and lower costs on gait compared to the young group (56.3% versus 16.7%, p= 0.03). DISCUSSION/SIGNIFICANCE OF IMPACT: Task prioritization during dual tasking differentially affects performance in upper and lower limbs in old and young individuals. These findings may have ramifications on developing training strategies to learn or relearn complex motor activities in seniors.

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TRAUMATIC EVENTS IN WOMEN VETERANS: PATTERNS ASSOCIATED WITH DEPRESSION, PTSD, BORDERLINE PERSONALITY DISORDER, AND COMORBID PTSD AND BORDERLINE PERSONALITY DISORDER

Morcuende MA ¹, Sadler A², Torner J¹

¹University of Iowa, Iowa City, IA, USA; ²Iowa City VA Medical Center, Iowa City, IA, USA

OBJECTIVES/SPECIFIC AIMS: To study the association between type and timing of traumatic events and diagnosis of PTSD+BPD. METHODS/STUDY POPULATION: Cross‐sectional study of a Midwestern cohort of VA enrolled women veterans. Participants (N= 875) completed a computer‐assisted telephone interview assessing demographics, childhood and adult rape history, combat and civilian traumas, and self‐report of lifetime diagnoses of depression, PTSD, or BPD. Subjects with other mental health diagnoses were excluded. Analyses were conducted using contingency tables and chi‐square tests. RESULTS/ANTICIPATED RESULTS: Depression was diagnosed in 36% of participants, PTSD in 23%, BPD in 2%, and BPD+PTSD in 4%. Women with PTSD+BPD were more likely to report having been raped two or more times (75%) compared to women with depression (37%), PTSD (50%), or BPD (55%) (p < 0.0001). More participants with PTSD+BPD (58%) and BPD (55%) had their first rape in childhood, compared to those with depression (35%) or PTSD (36%) (p < 0.0001). Women with PTSD+BPD (64%) were more likely to report rape in two or more time periods (childhood, adult civilian life, or military life) compared to those with depression (22%), PTSD (31%), or BPD (40%) (p < 0.0001). Women with BPD+PTSD (61%) were more likely to report three or more types of trauma (childhood rape, adult rape, combat trauma, or civilian trauma) compared to those with depression (24%), PTSD (40%), or BPD (40%) (p < 0.0001). DISCUSSION/SIGNIFICANCE OF IMPACT: These findings support previous research indicating extensive exposure to lifetime trauma in women veterans. Women with history of childhood rape and exposure to different types of trauma over time are at elevated risk of diagnosis with both PTSD+BPD. Current treatment models focused only on PTSD ignore necessary interventions for BPD.

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USING VITAL STATISTICS DATA TO BETTER UNDERSTAND THE GEOGRAPHY OF YOUTH DEATH AND TEEN BIRTH IN CALIFORNIA

Geraghty EM ¹

¹University of California, Davis, Sacramento, CA, USA

OBJECTIVES/SPECIFIC AIMS: The U.S. youth death rate is higher than many peer nations and teen birth not only puts an individual adolescent girl’s reproductive health at risk, but also poses a threat to long‐term community health. State vital statistics data can be used to better understand the geography of youth death and teen birth at a local level. This research examines geographic pockets of excess youth death and teen birth in California and seeks to understand some of the environmental determinants of risk. METHODS/STUDY POPULATION: A geographic information system was used to develop age and gender adjusted standardized mortality rates (SMRs) among youth age 0 to 19 years at the zip code level. For teen birth, the percentage of births to teens was compared to the teen birth rate by zip code. Resulting maps were subjected to hot spot analysis to find statistically significant clusters for both excess youth death (SMR greater than the crude death rate) and teen birth. Statistical analysis using STATA (STATACorp, College Station, TX) was performed on other available variables to better understand the factors associated with youth death and teen birth. RESULTS/ANTICIPATED RESULTS: Maps will show the distribution of hot spots of teen birth and youth death in California. Statistical analysis shows the existence of racial and ethnic disparities in teen births and the attainment of early prenatal care for young women. Young men, age 15–19 are at highest risk for premature death, particularly during weekends and summer months. DISCUSSION/SIGNIFICANCE OF IMPACT: Geographic and statistical analysis of youth death and teen birth help develop and target preventive strategies to vulnerable youth. Results of this work are intended to support strategic efforts to reduce youth disparities and improve youth well‐being in California.

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VALIDATION OF AUTOMATED STRATEGIES TO IDENTIFY RISK FACTORS FOR POSTOPERATIVE ACUTE LUNG INJURY

Kor DJ ¹, Warner DO¹, Alsara A¹, Li G¹, Gajic O¹

¹Mayo Clinic, Rochester, MN, USA

OBJECTIVES/SPECIFIC AIMS: Delayed identification of patients at risk for acute lung injury (ALI) may prevent the implementation of ALI prevention and early treatment strategies. The objective of this study was to develop and validate time‐efficient automated electronic strategies for identifying preoperative risk factors for postoperative ALI. METHODS/STUDY POPULATION: Following IRB approval, the electronic medical records of 249 patients undergoing high‐risk surgery were evaluated. Two independent data extraction strategies were compared. The first utilized manual chart review and the second a web‐based query‐building tool. Web‐based searches were derived and refined in a derivation cohort of 83 patients and subsequently validated in an independent cohort of 166 patients. Agreement between the two strategies were assessed. RESULTS/ANTICIPATED RESULTS: Kappa statistics ranged from 0.34 (95% CI 0.00 – 0.86) for amiodarone to 0.85 for cirrhosis (95% CI 0.57–1.00). Agreements between manual and automated electronic data extraction were almost perfect for 3 variables (diabetes mellitus, cirrhosis, H2‐receptor antagonists), substantial for 3 (chronic obstructive pulmonary disease, PPI, statins), moderate for gastroesophageal reflux disease, and fair for 2 variables (restrictive lung disease and amiodarone). The web‐based queries outperformed manual data collection in terms of sensitivities, ranging from 77% to 100% (median = 100%) for automated queries vs. 0% to 100% (median = 87%) for manual data extraction. Specificities were uniformly high (≥97%) for both strategies. DISCUSSION/SIGNIFICANCE OF IMPACT: Automated electronic free text query building is an iterative process, but ultimately results in accurate, highly efficient data extraction. These strategies may be useful when determining risk for time‐sensitive conditions such as postoperative ALI.

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VIRAL LOAD IS NOT ASSOCIATED WITH ACUTE OTITIS MEDIA (AOM) DEVELOPMENT AFTER UPPER RESPIRATORY TRACT INFECTION (URI) CAUSED BY HUMAN METAPNEUMOVIRUS (HMPV)

Nokso‐Koivisto J ¹, Pyles R¹, Miller A¹, Patel JA¹, Loeffelholz M¹, Casola A¹, Garofalo R¹, Chonmaitree T¹

¹University of Texas Medical Branch, Galveston, TX, USA

OBJECTIVES/SPECIFIC AIMS: To compare the rate of AOM complicating URI caused by hMPV and other respiratory viruses and to determine if hMPV viral load is associated with AOM complication. METHODS/STUDY POPULATION: Nasopharyngeal aspirates (NPAs) were collected within 7 d of URI onset as part of a prospective study (2003–2007) of healthy children (6 mos‐3 yr) who were followed for 1 y for the occurrence of AOM. Viral studies were performed by culture, respiratory syncytial virus (RSV) EIA, microarray PCR (RSV, parainfluenza 1–3, influenza A and B), and RT‐PCR (adeno‐, entero‐, rhino‐ and coronavirus). Archived NPAs were used for hMPV quantitative PCR. RESULTS/ANTICIPATED RESULTS: Archived NPAs from 633 episodes of 864 URI episodes in 189 children were evaluated. The median age was 18 mos (6–45 mos). Of the 633 URI episodes, 42 (6.6%) were positive for hMPV; 30 (4.5%) had hMPV as the sole virus. Altogether 229 (36%) URI episodes were complicated by AOM; 9 (30%) URI episodes with hMPV as a single virus were complicated by AOM. The rate of URIs complicated by AOM for other viruses was highest with RSV, followed by adeno‐, influenza‐, corona‐, entero‐, parainfluenza‐ and rhinoviruses (44, 40, 38, 36, 33, 29 and 28%, respectively). In children with AOM complicating URI, hMPV viral load was lower (median 4.1 × 10⁶ copies/ml) than those without AOM (3.1 × 10⁸), but the difference was not significant (p= 0.11). hMPV viral load was significantly higher (median 4.4 × 10⁸) in children with fever compared to those without (1.6 × 10⁶) (p < 0.01). DISCUSSION/SIGNIFICANCE OF IMPACT: hMPV was detected in 6.6% of 633 URI episodes; 4.5% as the only virus. The rate of AOM complicating hMPV‐induced URI is 30%. Viral load was associated with presence of fever, but not with AOM development.

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VITAMIN D, FASTING GLUCOSE, FASTING INSULIN AND INSULIN RESISTANCE: A CO‐TWIN CONTROL ANALYSIS IN A COHORT OF ADOLESCENT TWINS FROM RURAL CHINA

Arguelles LM ^1,2, Liu X^1,2, Van Horn L³, Ariza A^2,1, Wang G², Liu R², Hong X^2,5, Langman C⁴, Wang X^2,1

¹Department of Pediatrics, Northwestern University Feinberg School of Medicine, Chicago, IL, USA; ²The Mary Ann and J. Milburn Smith Child Health Research Program, Children’s Memorial Hospital, Chicago, IL, USA; ³Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA; ⁴Department of Kidney Diseases, Northwestern University Feinberg School of Medicine, Chicago, IL, USA; ⁵Institute for Biomedicine, Anhui Medical University, Hefei, China

OBJECTIVES/SPECIFIC AIMS: To examine the relationship of 25(OH)D levels with fasting glucose, fasting insulin, and insulin resistance (IR) in rural Chinese adolescent monozygotic (MZ) and dizygotic (DZ) twins using a co‐twin control analysis. METHODS/STUDY POPULATION: This report included 354 adolescent twins from the Anqing region of China, aged 13 to 18 years. Adiposity measures included body mass index (BMI), total body fat (BF), and percent body fat (%BF), measured by dual‐energy x‐ray absorptiometry (DEXA). RESULTS/ANTICIPATED RESULTS: Linear models of the within‐pair association showed a significant inverse association between log 25(OH)D and log fasting insulin and log fasting HOMA‐IR in MZ twins: β(se) =–0.37 (0.16), p= 0.02 and β(se) =–0.39 (0.17), p= 0.02, respectively, but no association was found in DZ twins. DISCUSSION/SIGNIFICANCE OF IMPACT: Our co‐twin control analysis demonstrated an inverse relationship of vitamin D with fasting insulin and IR in MZ twins, but not in DZ twins, indicating that it is important to take into consideration individual genetic variations.

CLINICAL TRIAL ABSTRACTS

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A PILOT STUDY OF LAMIVUDINE IN COMBINATION WITH VORINOSTAT FOR ADULT T‐CELL LEUKEMIA/LYMPHOMA

Cortese M ¹, Godbold J¹, Cunningham R¹, Gabrilove JL¹

¹Mount Sinai School of Medicine, New York, NY, USA

OBJECTIVES/SPECIFIC AIMS: The primary objective: to determine the safety and tolerability lamivudine +/– vorinostat in Adult T‐Cell Leukemia/Lymphoma (ATLL). The secondary objectives: to determine overall disease free and overall survival; to assess symptom burden measured by MDASI; to measure changes in histone acetylation, cell cycle and induction of apoptosis; to evaluate changes in HTLV‐1 DNA and RNA; to assess changes in cytotoxic T‐lymphocyte effector frequency; and to determine changes in the levels of plasma vascular endothelial cell and basic fibroblast growth factors. METHODS/STUDY POPULATION: Patients will initiate treatment with lamivudine 150 mg bid prior to receiving chemotherapy. Patients will receive two cycles of chemotherapy (CHOP, ESHAP or ICE). Responses following the completion of two cycles of chemotherapy + lamivudine will be evaluated. Patients who achieve a response of stable disease or better will be assigned to successive cohorts: lamivudine alone or in combination with vorinostat 100 mg, 200 mg or 400 mg po QD X 14 days followed by 7 days rest. A dose escalation, utilizing successive cohorts, will be conducted to determine the maximum tolerated and biologically active dose of vorinostat. A maximum of 24 patients will be recruited. RESULTS/ANTICIPATED RESULTS: In the context of this study, we expect that lamivudine 150 mg bid in combination with vorinostat will be safe and tolerable for ATLL patients. In addition, we anticipate improved survival with decreased symptom burden with this regimen. DISCUSSION/SIGNIFICANCE OF IMPACT: Patients diagnosed with ATLL; there are limited therapeutic options and outcomes are universally fatal. Anti‐proliferative regimens have been utilized to initially reduced tumor burden; however, these initial reductions are usually extremely short lived with rapid recurrence of disease. Further clinical research is needed to improve patient survival.

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CYSTATIN C AS A PROGNOSTIC MARKER OF WORSENING RENAL FUNCTION IN ACUTE HEART FAILURE

Bennett‐Gittens RL ^1,2, Butler J², Quarshie A¹, Ofili E¹

¹Morehouse School of Medicine, Atlanta, GA, USA; ²Emory School of Medicine, Atlanta, GA, USA

OBJECTIVES/SPECIFIC AIMS: (1) To determine the sensitivity and specificity of changes in cystatin C as a potential diagnostic marker for worsening renal function (WRF) in patients with acute heart failure (AHF). (2) To determine the predictive value of cystatin C for short term outcomes; length of hospitalization and readmission to hospital. METHODS/STUDY POPULATION: This is an ancillary study of the Diuretic Optimization Strategies Evaluation (DOSE) study, a multicenter, double‐blinded, randomized control trial in which 308 patients were admitted for AHF, diuresed with moderate to high dose loop diuretics then followed for 60 days. We will explore the development of WRF using serum creatinine and cystatin C levels. The performance of cystatin C as a marker of WRF will be evaluated by receiver operating characteristics curve analysis to determine the best cutoff. The association between the change in cystatin C, length of hospitalization and readmissions will be determined. RESULTS/ANTICIPATED RESULTS: The mean age of the DOSE cohort was 66 years, 27% were women, and 25% African American. 94 patients or 30.5% developed WRF using the definition of an increase in creatinine of 0.3 mg/dl. The median length of stay of the index hospitalization was 5 days. 130 patients (43%) experienced death, rehospitalization, or an emergency room visit within 60 days. DISCUSSION/SIGNIFICANCE OF IMPACT: Cystatin C has emerged as a novel marker of renal function that is independent of age, gender, diet, or lean muscle mass leading to the suggestion that it may be preferred to creatinine as an endogenous serum marker to assess renal function. We anticipate that the results of this study will contribute to the scientific literature on the optimal serum biomarker for early detection of clinically significant WRF.

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DETERMINANTS OF INTRAVENOUS ALCOHOL SELF‐ADMINISTRATION IN SOCIAL DRINKERS

Stangl B ¹, Vatsalya V¹, Cooke M¹, Zametkin M¹, Ramchandani V¹

¹NIAAA, Bethesda, MD, USA

OBJECTIVES/SPECIFIC AIMS: The objective of this study was to examine the influence of subjective measures of alcohol effects and personality measures on intravenous (IV) alcohol self‐administration in social drinkers. METHODS/STUDY POPULATION: Healthy social drinkers (N= 45) underwent two self‐administration sessions; each consisted of a 25‐min priming phase where subjects were prompted to push a button to receive individually standardized alcohol infusions, followed by a 2‐hour phase with ad lib access to the same alcohol infusions. Self‐administration measures included number of button presses (NBP), peak (PEAK) and average (AVG) Breath Alcohol Concentration (BrAC), and time to peak BrAC (TP). Subjective measures included Drug Effects Questionnaire (DEQ), Alcohol Urge Questionnaire (AUQ) and Alcohol Effects Questionnaire (AEFQ). Personality measures included the NEO‐PI‐R, UPPS‐P Impulsive Behavior Scale, Barratt’s Impulsivity Scale (BIS) and Sensitivity to Punishment and Sensitivity to Reward Questionnaire (SPSRQ). RESULTS/ANTICIPATED RESULTS: Results indicated a significant positive correlation between motor and attentional impulsivity measures and AVG and PEAK. Sensitivity to reward was positively correlated with AVG, PEAK, and NBP. AEFQ measures were also positively correlated with TP and NBP. The NEO‐PI‐R and UPPS‐P were not correlated with self‐administration measures. DEQ measures of drug liking and drug wanting, and the AUQ total score following priming were significantly associated with AVG, NBP and PEAK. DISCUSSION/SIGNIFICANCE OF IMPACT: IV Alcohol self‐administration measures were significantly associated with measures of impulsivity and reward sensitivity, as well as measures of drug liking and urges during priming. Results support a relationship between impulsivity and priming effects of alcohol and alcohol intake behavior.

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FASTER IS BETTER: INVESTIGATING THE EFFECT OF A NOVEL WARMING DEVICE ON PHARMACODYNAMICS OF RAPID ACTING INSULIN IN YOUTH WITH TYPE 1 DIABETES (T1D)

Cengiz E ¹, Tamborlane W¹, Weinzimer S¹

¹Yale School of Medicine, New Haven, CT, USA

OBJECTIVES/SPECIFIC AIMS: Accelerating the rates of insulin absorption and action may improve the performance of both open‐ and closed‐loop systems that rely on subcutaneous insulin pumps. This study is undertaken to investigate the effect of a novel insulin infusion site warming device, InsuPatch, on insulin action. METHODS/STUDY POPULATION: The glucose clamp technique was used to examine the effect of InsuPatch on the pharmacodynamics of a 0.2 u/kg bolus of aspart insulin in pump‐treated subjects. Studies were performed on 2 separate mornings with and without the activation of InsuPatch device. On both days, the basal infusion was suspended and glucose levels maintained between 80–100 mg/dl by a variable rate dextrose infusion for up to 5 hours after the bolus. To date, 8 subjects (14 ± 2 yrs, 3 female, A1c 7.3 ± 0.6%) have completed both clamps. RESULTS/ANTICIPATED RESULTS: As hypothesized, the time to peak insulin action (T_maxGIR)and time to early half maximal activity (T_{early 50%}) occurred much earlier with InsuPatch than without InsuPatch (T_maxGIR: 84 ± 18 min vs.133 ± 27 min, p= 0.0003; T_{early 50%}: 41 ± 15 min vs. 66 ± 16 min, p= 0.01).The area under the time action profile during the first ninety minutes of clamp (AUC_{GIR 0–90min}) was significantly greater with the InsuPatch than without the InsuPatch (343 ± 141 vs. 226 ± 100, p = <0.0001); whereas, bioavailability (AUC_{GIR0–300min} 1192 ± 334 vs. 1124 ± 429, p= 0.6) did not differ with and without infusion site warming. DISCUSSION/SIGNIFICANCE OF IMPACT: Our preliminary data suggest that warming of the infusion site is an effective means to accelerate the time to peak action of rapid‐acting insulin analogs in pump‐treated patients. Such improvements in time action responses may provide a means to obtain better control of postmeal glucose excursions with open and closed‐loop insulin delivery.

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IMMUNE RESPONSE TO HUMAN PAPILLOMAVIRUS VACCINE IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE RECEIVING IMMUNOSUPPRESSORS

Rivera‐Acosta JE ¹, Torres E¹, Romaguera J¹

¹UPR‐MSC, San Juan, USA

OBJECTIVES/SPECIFIC AIMS: Many inflammatory bowel disease patients receive immunosuppressing agents for their disease. It is well documented that patients receiving immunosuppressors are at increased risk of malignancy, including cervical cancer. The long‐term goal of this study is to establish the safety and efficacy of the HPV quadrivalent vaccine in preventing cervical neoplasia in IBD patients. The specific aim of this study is to determine the seroconversion to HPV‐6/11/16/18 serotypes after vaccination with Quadrivalent HPV vaccine in Puerto Rican IBD patients using immunosuppressive agents. Also we want to determine the prevalence of abnormal cervical histology in Puerto Rican IBD patients. METHODS/STUDY POPULATION: Quadrivalent HPV vaccine will be administered to all participants who are cytologically negative and seronegative, by both ELISA and PCR, for at least one of the HPV serotypes no more than 90 days before study entry. They will be vaccinated at 0, 2 and 6 months. We will collect serum from study participants at months 7, 12 and 30 for assessment of HPV‐6/11/16/18 antibody titers. Inclusion criteria for study participants are: (1) a diagnosis of IBD, (2) ages between 9 and 45 years, (3) no previous diagnosis of malignancy or immunologic related condition. Subjects will be recruited at the University of Puerto Rico Center for IBD clinics. RESULTS/ANTICIPATED RESULTS: Our hypothesis is that patients with IBD on immunosuppresor therapy will develop seroconversion to HPV vaccine in a similar way than age‐, parity‐matched healthy controls. DISCUSSION/SIGNIFICANCE OF IMPACT: The development of an adequate immunoresponse after immunization with HPV qaudrivalent vaccine in patients with IBD is unknown. Further research, in both Puerto Ricans and immunosupressed population, is warranted to establish effectiveness of HPV vaccine and to develop guidelines for screening and follow‐up.

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NEUROPROTECTIVE EFFECTS OF COGNITIVE ENHANCEMENT THERAPY AGAINST GRAY MATTER LOSS IN EARLY SCHIZOPHRENIA

Eack SM ¹, Hogarty GE¹, Cho RY¹, Prasad KM¹, Greenwald DP¹, Hogarty SS¹, Keshavan MS^2,1

¹University of Pittsburgh, Pittsburgh, PA, USA; ²Harvard Medical School, Boston, MA, USA

OBJECTIVES/SPECIFIC AIMS: To examine the effects of Cognitive Enhancement Therapy (CET), a comprehensive cognitive rehabilitation program, on gray matter changes in patients with early course schizophrenia. METHODS/STUDY POPULATION: Outpatients in the early course of schizophrenia or schizoaffective disorder were randomly assigned and treated in a two‐year trial with CET (n= 30) or an active Enriched Supportive Therapy (EST) control (n= 23), and assessed annual using structural MRI and a comprehensive cognitive battery. CET is an integrated approach to the remediation of social and nonsocial cognitive deficits in schizophrenia that utilizes computer‐assisted cognitive training and group‐based secondary socialization techniques. EST focuses on illness management and stress reduction through an individualized psychotherapeutic approach. RESULTS/ANTICIPATED RESULTS: Voxel‐based morphometry analyses of gray matter change indicated significant differential patterns of density change between treatment groups in a left hemispheric social‐cognitive network cluster including the amygdala, fusiform, and parahippocampal gyrus. Subsequent volumetric analyses revealed that while individuals receiving EST showed a loss of gray matter volume in this social‐cognitive network over the two years of study, patients receiving CET exhibit a preservation, and at times, significant increases in gray matter volume in these regions. Mediator analyses indicated that CET effects on social cognition were partially mediated by protection against gray matter loss in this social‐cognitive network. DISCUSSION/SIGNIFICANCE OF IMPACT: CET is an effective approach for the remediation of social and nonsocial cognitive deficits in schizophrenia that may achieve its efficacy through acting on social cognition brain networks.

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PREDICTING CARDIAC DYSFUNCTION DURING CHEMOTHERAPY

Geisberg CA ¹, Dickey A¹, Silverstein C², Smith HM¹, Sawyer D¹

¹Vanderbilt, Nashville, TN, USA; ²University of California Los Angles, Los Angles, CA, USA

OBJECTIVES/SPECIFIC AIMS: Women treated for breast cancer with anthracyclines (AC) are at risk for developing heart failure. Cardiotoxicity is monitored by ejection fraction (EF), an insensitive marker for early cardiac dysfunction. No current biomarkers exist which predict early cardiotoxicity. Neuregulin (NRG) is an essential cardiac growth factor that is activated by physiological stress and exercise signaling through the Her2+ (ErbB) receptors. NRG is critical for maintaining cardiac function and detectable in serum. Therefore, we hypothesized that women treated with AC would exhibit a change in NRG, and this change would detect early cardiac dysfunction. METHODS/STUDY POPULATION: In a prospective study, we enrolled 31 breast cancer women receiving AC. Prior to and following AC treatment, participants completed exercise questionnaires, echocardiograms, and gave a serum sample. Subclinical cardiac dysfunction was defined as >5% decrease in EF from baseline or the development of diastolic dysfunction. RESULTS/ANTICIPATED RESULTS: Of the 31 women treated with AC, 12 patients experienced subclinical cardiac dysfunction. Those who developed subclinical cardiac dysfunction had a statistically significant change in baseline and post‐AC NRG levels (mean 7.45 ng/ml and 5.98 ng/ml, p= 0.04) versus women with no change in EF (mean 2.90 ng/ml and 2.67 ng/ml, p= 0.14 respectively). Although not statistically significant, women with subclinical cardiac dysfunction also had lower reported baseline physical exercise (16.9 vs. 19.3 Met/hrs/wk, respectively). DISCUSSION/SIGNIFICANCE OF IMPACT: In conclusion, NRG levels drop with AC treatment, and this drop may have prognostic potential for detecting early cardiac dysfunction. Future studies may investigate the effects of an activity intervention prior to AC treatment to determine if physical exercise prevents the decline in NRG levels during AC.

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PREPARING THE STUDY DATASET FROM CLINICALTRIALS. GOV FOR ANALYSIS AND USING MESH THESAURUS FOR REGROUPING CLINICAL TRIALS BY CLINICAL SPECIALTY

Tasneem A ¹, Ananth H¹, Bolte J², Chakraborty S¹, Chiswell K¹, McCourt B¹, Zarin D³, Califf R²

¹DCRI, Durham, NC, USA; ²DTMI, Durham, NC, USA; ³NLM, NIH, Bethesda, MD, USA

OBJECTIVES/SPECIFIC AIMS: Development of a relational database for the purpose of analyzing aggregate data from ClinicalTrials.gov and a methodology for regrouping clinical trials by clinical specialty using MeSH thesaurus. METHODS/STUDY POPULATION: A relational database was developed for analyzing entire study dataset downloaded in Sep 2010 from ClinicalTrials.gov as .xml files. Studies will be regrouped by 16 clinical specialty using MeSH thesaurus. We developed a methodology for creating, validating, and implementing a subset of the MeSH thesaurus and using it for specialty grouping. MeSH descriptors within this subset are reviewed and annotated by domain experts within each clinical discipline at Duke University. RESULTS/ANTICIPATED RESULTS: A database of 96,346 studies from ClinicalTrials.gov is now ready for analyses. Annotation of MeSH descriptors by domain experts is nearing completion and these can be used to create study dataset for corresponding specialty groups. The data quality review informs each the preparation of each extracted analysis dataset. DISCUSSION/SIGNIFICANCE OF IMPACT: As data accumulate in ClinicalTrials.gov, the ability for aggregated descriptive characterization of the overall portfolio of the clinical research enterprise is increasingly desired. For analyses of the contents of this database, development of a relational dataset is critical. For the purpose of study data analysis within each specialty group as well as comparative analyses with other groups, it is desired to subset studies by clinical specialty. Use of this MeSH‐based method meets this need and may be applicable to other purposes. We conclude by discussing the opportunities and challenges of analyzing ClinicalTrials.gov database. Funded by FDA; sponsored by the Clinical Trials Transformation Initiative.

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PROSPECTIVE RANDOMIZED CONTROLLED TRIAL OF RESTRICTIVE FLUID MANAGEMENT IN TRANSIENT TACHYPNEA OF THE NEWBORN

Stroustrup A ^1,3, Holzman IR^2,3

¹Division of Newborn Medicine, Department of Pediatrics, and Department of Preventive Medicine, New York, NY, USA; ²Division of Newborn Medicine, Department of Pediatrics, New York, NY, USA; ³Mount Sinai School of Medicine, New York, NY, USA

OBJECTIVES/SPECIFIC AIMS: To determine whether fluid restriction speeds resolution of respiratory distress in neonates with transient tachypnea of the newborn (TTN). METHODS/STUDY POPULATION: Late preterm neonates diagnosed with TTN were randomized to either standard fluid management or restricted fluid management. Neonates in the restricted fluid group received 20 mL/kg/day total fluids less daily than neonates in the standard fluid group for the first 3 days of life. The primary study outcome was duration of respiratory support. Secondary outcomes were length of time to first enteral feed and time to discharge from the NICU. RESULTS/ANTICIPATED RESULTS: Sixty‐four patients completed the study protocol. No adverse events due to fluid restriction occurred. Survival analysis demonstrated no difference in duration of respiratory support between the two groups as a whole (p= 0.215). In the subpopulation of patients requiring respiratory support ≥ 48 hours there was a significant reduction in duration of respiratory support among fluid restricted patients (p= 0.019). DISCUSSION/SIGNIFICANCE OF IMPACT: Transient tachypnea of the newborn is a self‐limited respiratory distress syndrome caused by delayed pulmonary salt channel switching and fluid clearance. Although TTN is a common diagnosis, little data underlie fluid management for the disease. In our study, mild fluid restriction was safe in otherwise healthy term and late preterm neonates with TTN. Fluid restriction reduced duration of respiratory distress in neonates with severe TTN. This is the first study to demonstrate benefit of a treatment for TTN beyond supportive care. We recommend mild fluid restriction for all patients with TTN who require respiratory support.

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PROTEOMICS IMPROVES THE PREDICTION OF BURNS MORTALITY

Finnerty CC ^1,2, Ju H^2,3, Spratt H^2,3, Victor SS², Jeschke MG¹, Hegde SD¹, Bhavnani SK^2,3, Luxon BA², Brasier AR², Herndon DN¹

¹Dept of Surgery, UTMB/SHC, Galveston, TX, USA; ²Inst. for Translational Sciences/Sealy Center for Molecular Medicine,UTMB, Galveston, TX, USA; ³PMCH, UTMB, Galveston, TX, USA

OBJECTIVES/SPECIFIC AIMS: Reliable prediction of mortality in severely burned patients remains elusive. Here, we investigated the effect of combining proteomics variables with clinical covariates (inhalation injury, burn size, age) on the early identification of burn patients who will die. METHODS/STUDY POPULATION: 332 children with total burn surface area (TBSA) exceeding 25%, were admitted and consented to an IRB‐approved experimental protocol. Serum hormones, acute phase proteins, and cytokines were measured at the time of admission. Mathematical models were used to determine the association of each analyte with patient outcome. RESULTS/ANTICIPATED RESULTS: Principal component analysis demonstrated that serum protein abundance and the clinical covariates each provided independent information regarding patient survival. Because analyses using data‐driven generalized additive models demonstrated that the relationships between analytes and mortality were not linear, we performed nonlinear modeling using multivariate adaptive regression splines (MARS). Combining serum analytes with clinical assessments in MARS‐based modeling increased overall outcome prediction accuracy from 52% to 81% and increased area under the receiver operating characteristic curve from 0.82 to 0.95. DISCUSSION/SIGNIFICANCE OF IMPACT: These results show that the accuracy of the MARS classifier can be substantially improved by combining protein abundance information with clinical covariates.

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THEORETICAL SYNERGY TO IMPROVE POSITIVE HEALTH RESEARCH

Robb SL ¹, Haase JE¹

¹Indiana University, Indianapolis, IN, USA

OBJECTIVES/SPECIFIC AIMS: Investigators seeking to enhance positive health have few models to guide their selection of targeted variables. The purpose of this presentation is to describe the linking of two theoretical models to address the psychosocial adjustment of adolescents/young adults (AYA) undergoing stem cell transplant. METHODS/STUDY POPULATION: Components of the Haase Resilience in Illness Model (RIM), also called the Adolescent Resilience Model, include protective factors of derived meaning (hope, spiritual perspective), perceived social support from friends and health care providers, family environment (communication, adaptability, cohesiveness), and positive coping (confrontive, optimistic, supportant). Risk factors are illness‐related distress and defensive coping. The RIM components are targeted through a therapeutic music video (TMV) intervention based on Robb’s Contextual Support Model of Music Therapy. Robb’s theory hypothesizes that effective music therapy interventions contain elements of (1) structure; (2) autonomy support; and (3) supportive relationships. RESULTS/ANTICIPATED RESULTS: Contextual support elements of the TMV intervention influence RIM outcomes of resilience via multiple paths. For example, focus on developing the music video supports AYA transition from defensive to positive coping, offers a means to communicate traumatic events and unspoken thoughts and emotions experienced during diagnosis/treatment, and encourages family and provider support. These, in turn, can foster the resilience outcomes of self‐transcendence, mastery/confidence, and self‐esteem. DISCUSSION/SIGNIFICANCE OF IMPACT: The theoretical synergy described in this presentation was used to test the TMV through a multisite, randomized clinical trial and provides a model for the synergistic use of theory to inform intervention and study design.

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TOPICAL THALIDOMIDE GEL FOR ORAL LESIONS AND RELATED ORAL PAIN ASSOCIATED WITH CHRONIC GRAFT‐VERSUS‐HOST DISEASE: A PILOT STUDY

Fall‐Dickson JM ¹, St. John L¹, Childs R², Pavletic SZ³, Wu T⁴, Cozzarelli T¹, Schroeder E¹, Gordon S^5,3

¹NINR, NIH, Bethesda, MD, USA; ²NHLBI, NIH, Bethesda, MD, USA; ³NCI, NIH, Bethesda, MD, USA; ⁴NINDS, NIH, Bethesda, MD, USA; ⁵University of Maryland Dental School, Baltimore, MD, USA

OBJECTIVES/SPECIFIC AIMS: Oral cGVHD affects up to 80% of patients with cGVHD. No optimal therapy exists. This parallel groups, randomized, placebo‐controlled, double‐blind pilot study tested topical thalidomide gel 20 mg (IND #76,793) versus placebo (Orobase^® plain product) in oral ulcerative cGVHD. METHODS/STUDY POPULATION: The protocol was approved by IRB. Written informed consent was obtained. Patients 18–80 years of age with oral biopsy confirmed cGVHD were eligible. Exclusion criteria included contraindications for thalidomide use, and inability to stop other topical treatments for oral cGVHD. Primary efficacy end point was at least 80% decrease in ulcers’ total mm2 baseline to week 4. Investigational gel was used 4 times/day for 4 weeks to up to 3 oral ulcers. RESULTS/ANTICIPATED RESULTS: Thalidomide group (n= 3; 8 target ulcers) had 66% mean oral ulcer mm2 reduction vs. 59% in placebo group (n= 3; 7 target ulcers). Four of 8 ulcers resolved in the thalidomide group versus 2/7 in placebo group. There were no serious adverse events. Adverse events were 5 possibly related to thalidomide (4 moderate; 1 mild), and 1 mild for placebo. Variable baseline pain score means ranged from mild to moderate. Thalidomide group had no oral pain at week 2 and 3, with sensory and affective pain increasing between week 3 to 4 but staying below baseline. Placebo group had decreased pain scores at week 4 with exception of sensory pain with swallow. DISCUSSION/SIGNIFICANCE OF IMPACT: Preliminary data suggest topical thalidomide may have single agent activity in oral cGVHD. Further testing of topical thalidomide for oral cGVHD is warranted.

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TRANSLATING EVIDENCE‐BASED DIABETES PREVENTION AND SELF‐MANAGEMENT EDUCATION INTO A FAITH‐BASED SETTING

Newlin K ¹, Arbauh N¹, Sewer O¹, Burgess T¹

¹NYU, New York, NY, USA

OBJECTIVES/SPECIFIC AIMS: Test an evidenced‐based lifestyle intervention in a faith‐based setting, combining diabetes prevention and self‐management education strategies, with explicit incorporation of community‐based participatory research. (1) Examine the effect of an intensive lifestyle intervention on physiological (HbA1c and body mass index [BMI]) and psychosocial (quality of life [QOL], depression, and diabetes risk perception) outcomes in Black women with or at‐risk for prediabetes. (2) Examine the effect of an intensive lifestyle intervention on physiological (HbA1c and BMI) and psychosocial (QOL and depression) outcomes in Black women with type 2 diabetes (T2D). METHODS/STUDY POPULATION: Study Design: A one‐group pretest‐posttest design. Sample: Convenience sampling is ongoing with inclusion criteria including the following: (1) black American self‐identity; (2) female gender; (3) > 21 years of age; (4) with or at‐risk for prediabetes or diabetes; and (5) usual primary care source. Exclusion criteria include: (1) pregnancy or lactation; (2) serious mental illness; and (3) comorbidities (e.g., cancer) that may preclude completion of the study. Measures: Physiological (HbA1c and BMI) and psychosocial (Center for Epidemiological Studies Depression Scale, Medical Outcomes Survey [MOS SF‐12], and Risk Perception Survey for Developing Diabetes) measures are being collected. Analytic Strategy: Univariate statistics to describe the sample. Paired t‐tests to evaluate distal and proximal changes in outcome measures at 3‐ and 6‐months. RESULTS/ANTICIPATED RESULTS: The intervention is ongoing with preliminary results anticipated for report at the April 2011 ACRT/SCTS Joint Annual Meeting. DISCUSSION/SIGNIFICANCE OF IMPACT: Findings will contribute to the science of translating diabetes prevention and self‐management education strategies into community settings to effectively address the diabetes epidemic burdening Black Americans.

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WEIGHT LOSS INTERVENTIONS IN CHRONIC KIDNEY DISEASE

Navaneethan SD ¹, Fealy C², Schauer PR³, Sehgal AR⁴, Kirwan JP²

¹Cleveland Clinic, Cleveland, OH, USA; ²Cleveland Clinic – Pathobiology, Cleveland, OH, USA; ³Cleveland Clinic – Bariatric and Metabolic institute, Cleveland, OH, USA; ⁴MetroHealth Medical Center, Case Western Reserve University, Cleveland, OH, USA

OBJECTIVES/SPECIFIC AIMS: Obesity is an independent risk factor for the development of cardiovascular disease and chronic kidney disease (CKD).We propose to ascertain the effects of lifestyle modification or bariatric surgery on renal outcomes among obese CKD patients. METHODS/STUDY POPULATION: This is a prospective cohort study in which data will be collected pre‐ and postintervention (at 3 and 6 month follow‐up) to examine the impact of weight loss attained with lifestyle modifications (12 weeks of hypocaloric diet and supervised exercise) or bariatric surgery on adipokines including plasma adiponectin and leptin, markers of inflammation, insulin resistance, urinary protein excretion, and glomerular filtration rate (GFR) in obese (body mass index >35 kg/m2) CKD patients (GFR 30–59 ml/min/1.73 m²). RESULTS/ANTICIPATED RESULTS: Weight loss attained through either intervention will result in lowering urinary protein excretion and stabilization of renal function among obese CKD patients. Intentional weight loss will result in amelioration of endothelial dysfunction, inflammation, insulin resistance and an increase in HMW adiponectin levels that then mediate these renal outcomes. DISCUSSION/SIGNIFICANCE OF IMPACT: If weight loss in CKD patients results in stabilization of GFR and an increase in plasma adiponectin levels, then the study presents the opportunity for: (a) a long‐term study to analyze the sustained renal benefits such as retarding progression to end‐stage renal disease, (b) further study, of the mechanism of increased plasma adiponectin levels on urinary protein excretion, and (c) a clinical trial to compare the efficacy and long‐range benefits of different weight loss interventions in CKD patients.

ETHICS ABSTRACTS

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CASE STUDIES IN ETHICS IN BIOSTATISTICS: A VICTR PROGRAM IN RCR EDUCATION

Heitman E ¹, Lane KB¹

¹Vanderbilt University Medical Center, Nashville, TN, USA

OBJECTIVES/SPECIFIC AIMS: Promote practical understanding of ASA’s standards of ethics and core concepts of research integrity and RCR Enhance professional identify and solidarity among VUMC’s biostatisticians Leverage biostatisticians’ role in VICTR studies to increase the ethical quality of study design and data management, and promote research ethics consultation for complex issues Widen scope of VICTR’s educational offerings in research ethics and RCR METHODS/STUDY POPULATION: Members of Vanderbilt’s Center for Biomedical Ethics and Society offer a regular case conference in ethics in biostatistics as part of the education program of the Vanderbilt Institute for Clincal and Translational Research (VICTR). Participants include faculty, staff, and trainees from Biostatistics and across VICTR. Using the American Statistical Association’s (ASA) Ethical Guidelines for Statistical Practice as a framework, conferences examine current ethical challenges that arise in VICTR‐funded research. RESULTS/ANTICIPATED RESULTS: ASA’s Guidelines parallel ORI’s core areas of RCR, providing a good gounding for required RCR instruction. Case studies developed jointly with biostatistics faculty from real (deidentified) events allows participants to develop practical skills in ethical analysis and decision making in research. DISCUSSION/SIGNIFICANCE OF IMPACT: Emphasis on links between statistical methods, statisticians’ professionalism, and integrity of research places biostatisticians in a front‐line leadership role in ethics in VICTR research. Capacity building among biostatisticians improves awareness of ethical issues and increases appropriate use of research ethics consultation service to address complex and unusual issues.

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DEFINING AND IMPROVING RESEARCH ETHICS CONSULTATION SERVICE OUTCOMES IN A TRANSLATIONAL SCIENCES ENVIRONMENT

Farroni JS ¹, Carter MA¹

¹University of Texas Medical Branch at Galveston, Galveston, TX, USA

OBJECTIVES/SPECIFIC AIMS: Our long‐term goal is to promote a cultural shift within the Institute for Translational Sciences (ITS) at the University of Texas Medical Branch at Galveston (UTMB) towards making research integrity a fundamental element of all activities of the translational research enterprise. The objective of this study is to develop the tools and process infrastructure for the research ethics consultation service and evaluate quality outcomes. METHODS/STUDY POPULATION: Tools are being developed to provide greater consistency in capturing research ethics services and stakeholder feedback. Several working groups will be convened to harmonize research ethics consultation forms and a pilot retrospective analysis will be conducted to assess these tools. A prospective study will be conducted which will measure substantive elements of research ethics consultation and feedback to evaluate service outcomes. RESULTS/ANTICIPATED RESULTS: We expect to (1) determine the needs of our institutional stakeholders, (2) develop a robust mechanism to evaluate and asses the quality of our Research Ethics Consultation Service, and (3) implement procedures and documentation tools that will increase both the efficiency and satisfaction with the consultation service. DISCUSSION/SIGNIFICANCE OF IMPACT: The unique environment of the ITS, along with the expertise of the Ethics Support personnel, will enable us to make significant contributions towards measuring the intrinsic value of translational research ethics. This project will promote continued excellence in translational research through improvement of ethics education, development of ethics policies and best practices, and foster continued collaboration with translational researchers.

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PREDICT: PATIENT PERSPECTIVES ON A PROGRAM TO IMPLEMENT PROSPECTIVE CLINICAL PHARMACOGENOMIC TESTING

Brothers KB ¹, Wright F¹, Clayton EW¹

¹Vanderbilt University Medical Center, Nashville, TN, USA

OBJECTIVES/SPECIFIC AIMS: (1) To identify barriers to the clinical implementation of pharmacogenomics by clarifying patient perspectives on, and especially concerns about, multiplex clinical pharmacogenomic testing. (2) To explore how patients want to be notified that clinical pharmacogenomic testing is available and how patients prefer to give their consent for such testing. METHODS/STUDY POPULATION: We conducted five focus group sessions with 12–13 participants each. Participants were asked to respond to a case story about a patient who underwent prospective, multiplex genetic testing for pharmacogenomic purposes. Participants were asked to identify positive and negative aspects of this testing, and what informed consent procedures they would prefer before undergoing testing themselves. Transcribed discussions were coded by two investigators, and a third investigator negotiated discrepancies in coding. RESULTS/ANTICIPATED RESULTS: Participants generally supported pharmacogenomic testing as a way to avoid adverse drug reactions and “trial‐and‐error” prescribing, and as a tool for preparedness in the event of a health crisis. They were wary of the possibility that the test might generate disease susceptibility results, and they were concerned about the privacy of the information generated by the test. DISCUSSION/SIGNIFICANCE OF IMPACT: The uptake and acceptance of pharmacogenomic testing by patients will depend on the quality of the conversations that patients are able to have with their physicians prior to testing. Since patient comfort is much higher with targeted pharmacogenomic testing compared with disease susceptibility testing, policies and tools capable of ensuring this targeted scope will help ease translational efforts. This research will assist in the design of storage and data access policies appropriate to clinical pharmacogenomic test results.

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THE VANDERBILT EXPERIENCE WITH AD HOC ETHICS REVIEW OF CTSA‐SUPPORTED RESEARCH PROPOSALS

Lane KB ^1,2, Heitman E^1,2

¹Vanderbilt University Med. School, Nashville, TN, USA; ²Center For Biomedical Ethics and Society, Nashville, TN, USA

OBJECTIVES/SPECIFIC AIMS: Provide a streamlined method to allow research ethics input prior to the initiation of a clinical study without adding a layer of review. METHODS/STUDY POPULATION: The Vanderbilt Institute for Clinical and Translational Research (VICTR) administers the Vanderbilt CTSA award and provides opportunities for the design and implementation of T0–T2 human translational research. Proposals go through a review to assure appropriate use of grant and institutional support requests. The process includes biostatistics, human subjects protection, and facilities review designed to identify possible enhancements before the endeavor starts. A Scientific Review Committee (SRC) composed of faculty with diverse research experience reviews each proposal and, using the NIH scoring system, rates the merits of the proposals. While administrative review focuses on compliance with regulatory requirements for human research, VICTR’s SRC also allows for ethics review on issues beyond human subjects protection. Biostatistical review addresses utility and power to guard against enrolling subjects in trials unlikely to provide measurable effect. The SRC includes a member from The Center for Biomedical Ethics and Society, whose participation provides early input of ethics expertise without an additional step that an ethics consultation might require. RESULTS/ANTICIPATED RESULTS: The SRC has provided ethics review over a 3 yr period in this way. Issues addressed to have included anticipating incidental findings, unintended consequences, appropriate study personnel, study design, collaboration, and data management. DISCUSSION/SIGNIFICANCE OF IMPACT: This method allows early feedback and provides the ability to recognize when more detailed ethics discussions or consultation may be warranted.

HEALTH SERVICES RESEARCH ABSTRACTS

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A MULTILEVEL ASSESSMENT OF LOCAL HEALTH DEPARTMENT PREVENTION ACTIVITIES IN RELATION TO COUNTY OBESITY PREVALENCE IN THE US

Stamatakis KA ¹, Leatherdale ST³, Marx C¹, Yan Y¹, Colditz GA¹, Brownson RC^1,2

¹Washington University in St. Louis School of Medicine, St. Louis, MO, USA; ²Washington University in St. Louis Brown School of Social Work, St. Louis, MO, USA; ³Cancer Care Ontario, Toronto, ON, Canada

OBJECTIVES/SPECIFIC AIMS: The system of local health departments (LHD) in the US has the potential to advance a locally oriented public health response in obesity control and reduce geographic disparities. However, the extent to which obesity prevention programs correspond to local obesity levels is unknown. This study assesses the extent to which LHDs across the US have responded to local levels of obesity by examining the association between jurisdiction level obesity prevalence and the existence of obesity prevention programs. METHODS/STUDY POPULATION: Data on LHD organizational characteristics from the Profile Study of Local Health Departments and county‐level estimates of obesity from the Behavioral Risk Factor Surveillance System were analyzed (n= 2,300). Since local public health systems are nested within state infrastructure, multilevel models were used to examine the relationship between county‐level obesity prevalence and LHD obesity prevention programming and to assess the impact of state‐level clustering. RESULTS/ANTICIPATED RESULTS: There was no association between area obesity prevalence and LHD activities. A substantial portion of the variance in LHD activities was explained by state‐level clustering. DISCUSSION/SIGNIFICANCE OF IMPACT: This paper identified a gap in the local public health response to the obesity epidemic. Results underscore the importance of taking into account multiple levels of infrastructure in examining predictors of LHD performance and in designing intervention strategies for improving implementation of evidence‐based practice in local settings.

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A SELF‐ADMINISTERED QUESTIONNAIRE TO IDENTIFY PATIENTS AT RISK FOR MEDICATION‐RELATED PROBLEMS

Snyder M ^1,2, Pater KS³, Lennox R⁴, Hudmon KS¹, Doebbeling B^5,6, Smith R³

¹Purdue University College of Pharmacy, Indianapolis, IN, USA; ²Indiana Clinical and Translational Sciences Institute, Indianapolis, IN, USA; ³University of Pittsburgh School of Pharmacy, Pittsburgh, PA, USA; ⁴Chestnut Global Partners, Bloomington, IL, USA; ⁵Indiana University School of Medicine, Indianapolis, IN, USA; ⁶Regenstrief Institute, Inc, Indianapolis, IN, USA

OBJECTIVES/SPECIFIC AIMS: (1) Develop a brief self‐administered questionnaire to identify patients experiencing medication‐related problems, (2) Determine whether incorporation of the questionnaire into community pharmacy practice affects the incidence and type of adverse drug events reported by patients over six months, and (3) Characterize treatment plans created by pharmacists and patients in response to risk information. METHODS/STUDY POPULATION: The 78 items comprising the original Drug Therapy Concerns (DTC)Scale item pool were administered to 394 patients. Using clinical judgment and factor analysis, we are reducing the item pool for psychometric testing with 200 additional patients. These patients will complete the abbreviated DTC and meet with a pharmacist who will determine the presence of medication‐related problems. Receiver‐operator characteristic curves will aid in identifying a score to use as a problem predictor. An additional 200 patients will then be randomized to either (1) complete the abbreviated DTC and discuss results with their pharmacist, or (2) usual care. Groups will be followed for 6 months. RESULTS/ANTICIPATED RESULTS: The 394 participants had a median age of 51 years (range 18–90); most were female (55.8%), Caucasian (80.1%), had at least a high school education (97.4%), and reported taking a median of 4 medications (range 1–22). Next steps are to finalize the abbreviated DTC and estimate agreement in medication‐related problem identification among study pharmacists (n= 6) prior to initiating prospective data collection. DISCUSSION/SIGNIFICANCE OF IMPACT: n/a

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ANALYSIS OF AN ACUTE HEMATOGENOUS OSTEOMYELITIS (AHO) PATHWAY AT CHILDREN'S NATIONAL MEDICAL CENTER (CNMC)

Parikh K ¹, Hyun D¹, Hoffner W¹, Rassbach C¹, DeBiasi R¹

¹Children’s National Medical Center, Washington DC, MD, USA

OBJECTIVES/SPECIFIC AIMS: A clinical pathway was developed at CNMC to standardize care of osteomyelitis. (1) To evaluate AHO pathway implementation through prepathway and postpathway comparisons, specifically focusing on percentage of blood cultures obtained, MRI use, and time to MRI. (2) To compare clinical outcomes, specifically length of stay and rates of pathogen identification, between the pre and postpathway groups. METHODS/STUDY POPULATION: Retrospective cohort study reviewing patient charts with principal discharge diagnosis of osteomyelitis from pre‐pathway (January 1, 2005 to March 31, 2008) and postpathway (April 1, 2008 to October 31, 2010) periods. Original medical records were reviewed. RESULTS/ANTICIPATED RESULTS: 46 charts were reviewed, 22 patients in the prepathway group and 24 patients in postpathway group. Demographic factors between the two cohorts were similar, including age (7 yrs vs. 7.25 yrs) and sex (64% male vs. 58% male) as well as severity level (2.1 vs. 2.1). Since pathway initiation, 96% of the patients received blood cultures compared to only 77% prepathway and 96% of patients had a MRI study for diagnosis compared to 73% prepathway. A clinically significant decrease in time to MRI was noted from 48 hours prepathway to 20 hours postpathway. However, mean length of stay was 6.5 days in both cohorts. Pathogen identification was 73% in the prepathway group and only 58% in the postpathway group. DISCUSSION/SIGNIFICANCE OF IMPACT: Implementation of the AHO pathway at CNMC has been successful, with a notable increase blood culture rates, increase MRI use for diagnosis, and a decrease in time from admission to MRI. However, clinical outcomes like LOS and pathogen identification were not improved. Further investigation is needed to determine why these clinical outcomes were not improved.

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ASSOCIATION BETWEEN CARDIOSELECTIVE BETA‐ BLOCKER TREATMENT AND MORTALITY AMONG PATIENTS HOSPITALIZED FOR ACUTE EXACERBATIONS OF CHRONIC OBSTRUCTIVE LUNG DISEASE IN THE PRESENCE OF COMORBID ISCHEMIC HEART DISEASE AND HEART FAILURE

Stefan MS ^1,2, Rothberg MB^1,2, Priya A¹, Pekow P^1,3, Lindenauer PK^1,2

¹Baystate Medical Center, Springfield, MA, USA; ²Tufts University School of Medicine, Boston, MA, USA; ³University of Massachusetts School of Public Health, Amherst, MA, USA

OBJECTIVES/SPECIFIC AIMS: Background : Beta‐blockers (BB) are beneficial in patients with ischemic heart disease (IHD) and heart failure (HF); however there is limited evidence about the benefits or risks of continuing BB therapy during acute exacerbations of chronic obstructive pulmonary disease (AECOPD) among these patients. Objective: To compare outcomes of patients hospitalized for AECOPD with coexistent IHD and/or HF treated with an inhaled beta2 agonist (B2A) combined with a cardioselective beta‐blocker (CSBB) to those treated with a B2A alone. METHODS/STUDY POPULATION: Retrospective cohort study at 415 hospitals of patients hospitalized for AECOPD with coexistent IHD or HF. Multivariable logistic regression, propensity score adjustment and matching, will be used. Treatment: CSBB in the first 2 hospital days Outcomes: inpatient mortality, mechanical ventilation started after day 3, readmission for AECOPD, HF or IHD within 30 days RESULTS/ANTICIPATED RESULTS: Preliminary Results: Of 93,449 patients meeting inclusion criteria 25,806 (28%) were treated with CSBB in the first 2 hospital days; including 35% of patients with IHD, 36% of patients with HF. Compared to untreated patients, those who received a BB were older (median age, 72 vs. 70), had lower inpatient mortality (2% vs. 3.1%, p < 0.0001) and lower AECOPD readmissions (7.4% vs. 8.8%, p < 0.0001). DISCUSSION/SIGNIFICANCE OF IMPACT: Among patients hospitalized for AECOPD with coexistent HF or IHD, CSBB are associated with a decreased risk of in‐hospital death. Our current focus is developing propensity‐adjusted multivariable models for the association between BB use and outcomes.

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BELIEFS AND ATTITUDES OF LUNG CANCER PROVIDERS ABOUT MINORITY PATIENTS

Smith C ¹, Wisnivesky J¹

¹Mount Sinai School of Medicine, New York, NY, USA

OBJECTIVES/SPECIFIC AIMS: The outcome of patients with lung cancer remains poor, particularly among individuals of ethnic and racial minorities. Potential sources of disparities have been suggested including patient, system and provider‐level factors. In this study, we surveyed physicians to determine their beliefs regarding treatment preferences of minority and nonminority patients with lung cancer. METHODS/STUDY POPULATION: We provided a self‐administered questionnaire to physicians caring for lung cancer patients at 5 medical centers in New York City. The questionnaire asked about physicians’ views with respect to beliefs and preferences of minority and nonminority lung cancer patients. RESULTS/ANTICIPATED RESULTS: Of 160 eligible physicians, 112 (70%) returned survey responses. Providers were more likely to think minority patients had higher views of fatalism (lung cancer was meant to be, if diagnosed with lung cancer it is too late to do anything about it, everything is a part of God’s plan; p < 0.0001 for all comparisons). Although providers feel in general comfortable discussing these beliefs, they reported being less likely to do so with the minority patients (p < 0.0001). When compared to white patients providers believe Hispanic and black patients are less likely to accept surgery as well as other cancer treatments (chemotherapy and radiation therapy). Similarly, providers considered that minorities were more likely to want to involve their family on prognosis discussions and treatment decisions. Finally, providers reported that minorities are less receptive to a DNR directive or palliative care referral. DISCUSSION/SIGNIFICANCE OF IMPACT: There are significant differences among providers regarding minority preferences and beliefs about lung cancer care. Understanding the influence and relative importance of these factors is an important step towards developing interventions to improve outcomes of minority patients with lung cancer.

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CHARACTERISTICS OF PRIMARY CARE PHYSICIANS ASSOCIATED WITH RECOMMENDED CARE FOR CHILDREN WITH SPECIAL HEALTH CARE NEEDS

Kuo D ¹, Robbins J¹, Burns K¹, Casey P¹

¹University of Arkansas for Medical Sciences, Little Rock, AR, USA

OBJECTIVES/SPECIFIC AIMS: The objectives of this study were to examine physician characteristics associated with (1) recommended care practices for CSHCN, (2) willingness to care for more CSHCN. METHODS/STUDY POPULATION: Cross‐sectional, statewide survey of PCPs in Arkansas. PCPs with a Medicaid caseload of ≥100 children were mailed a paper survey four times over 2 months. Survey content was informed by prior literature defining recommended practices for CSHCN. Predictor variables included physician specialty field, demographics, practice type, and % patients with public insurance. Descriptive and multivariate regression analyses described characteristics of PCPs associated with recommended care practices and a willingness to care for more CSHCN. RESULTS/ANTICIPATED RESULTS: Of 565 mailed surveys, 203 (36%) were returned. Half (51%) practiced in a group setting and 37% practiced in a solo/2 person practice, with pediatricians more likely to see CSHCN. Practicing in a solo/2 person practice was associated with having a written care plan (AOR 9.7, 95% CI 2.6, 35.8), providing extra time (AOR 3.5, 95% CI 1.5, 8.5), and providing community referrals (AOR 3.1, 95% CI 1.3, 7.0). Female gender was associated with extra time (AOR 2.3, 95% CI 1.1, 4.8) and providing community referrals (AOR 2.8, 95% CI 1.3, 6.2). Physicians with >50% of children on Medicaid were more likely to be willing to care for more CSHCN (AOR 2.8, 95% CI 1.2, 6.4). DISCUSSION/SIGNIFICANCE OF IMPACT: Female physicians and physicians in smaller practices were more likely to deliver recommended practices for CSHCN, but only physicians with a higher % of publicly insured children were willing to care for more CSHCN. Future research should identify barriers to optimal CSHCN care for PCPs who work in larger practices and practices with a higher proportion of privately insured patients.

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COST‐EFFECTIVENESS OF POSTNEPHRECTOMY SCREENING PROTOCOLS IN THE DETECTION OF RECURRENT CANCER

Strope SA ¹

¹Washington University, St. Louis, MO, USA

OBJECTIVES/SPECIFIC AIMS: To assess the cost‐effectiveness of published surveillance protocols designed to detect asymptomatic cancer recurrence after definitive treatment for renal cancer. METHODS/STUDY POPULATION: Using a Markov simulation model, we estimated the cost and benefit of competing published algorithms for surveillance imaging after radical nephrectomy or partial nephrectomy for low stage kidney cancer. We then performed sensitivity analysis around the assumptions for cancer detection with different screening protocols. RESULTS/ANTICIPATED RESULTS: At a willingness to pay of 100,000 per cancer recurrence detected, the surveillance regimens with the highest costs appeared to be warranted. However, in sensitivity analysis, small changes in assumptions about the sensitivity of different imaging modalities caused lower cost strategies to be as effective with greatly reduced costs. DISCUSSION/SIGNIFICANCE OF IMPACT: Surveillance of kidney cancer patients in the survivorship period is able to detect recurrent disease in an asymptomatic state. Proposed screening protocols vary extensively in their cost, and may not have significantly different results at a population level in low risk disease.

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DEPRESSIVE SYMPTOMOTOLOGY AMONG ADULTS WITH ASTHMA: THE ROLE OF ASTHMA SEVERITY

Yonas M ¹, Marsland AL¹, Gu C¹, Moore C¹, Wenzel S¹

¹University of Pittsburgh, Pittsburgh, PA, USA

OBJECTIVES/SPECIFIC AIMS: Epidemiologic evidence shows higher rates of major depressive disorder (MDD) among individuals with asthma. To further understand this association, we examined whether increased asthma severity was associated with symptoms of depression and rates of MDD. METHODS/STUDY POPULATION: For this purpose, we assessed symptoms of depression among individuals with mild/moderate asthma (n= 32), severe asthma (n= 46) and healthy controls (n= 31) recruited from the Severe Asthma Research Network (SARP). Depression was measured with the Beck Depression Inventory (BDI). In addition to the full score, we created a modified BDI score dropping the 5 items that assess somatic symptoms that may be a result of asthma, e.g., sleep disturbance. RESULTS/ANTICIPATED RESULTS: The sample consisted of 109 individuals (mean age 37 years, 71% female, 84% Caucasian, 11% African American, 12%, with 4% non‐Hispanic/Latino ethnicity). Comparisons of means showed symptoms of depression, as assessed by the full and modified scale scores, among individuals with asthma than controls (ps < 0.0001). In addition, when compared with individuals with mild/moderate asthma, severe asthmatics reported more symptoms of depression on the modified scale (p= 0.04), with a similar trend using the full BDI (p= 0.06). Of individuals with asthma, 20.5% met the clinical cutoff for MDD as compared to 0% of the controls. Higher depression symptoms trend was observed in the severe asthma group versus mild/moderate asthma (p= 0.065). DISCUSSION/SIGNIFICANCE OF IMPACT: Our findings provide support for higher rates of depressive symptoms among individuals with severe asthma when compared with their mild/moderate asthma counterparts. Further research is warranted to determine the direction of these cross‐sectional associations.

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DOES WEIGHT STATUS AFFECT HOSPITAL LENGTH OF STAY FOR PERSONS WHO HAVE HAD A STROKE?

Felix HC ¹, Mays GP¹

¹UAMS, Little Rock, AR, USA

OBJECTIVES/SPECIFIC AIMS: The study’s aim was to assess differences in hospital length of stay between obese individuals hospitalized for a stroke and matched non‐obese individuals hospitalized for a stroke METHODS/STUDY POPULATION: Persons who responded to the 2001–07 Medical Expenditures Panel Survey (MEPS) who were hospitalized for a stroke. Propensity scores were used to construct a comparison group of nonobese persons (n= 83) who had been hospitalized for a stroke and were similar to the group of obese persons (n= 123) who had been hospitalization for stoke. Multivariate regression modeling was then used to account for residual differences between the two groups and assess differences in hospital length of stay between the groups. RESULTS/ANTICIPATED RESULTS: Obese persons have a 4.32% shorter hospital length of stay for stroke than nonobese persons; although, the difference was not statistically significant. DISCUSSION/SIGNIFICANCE OF IMPACT: Further research is warranted to account for potential bias introduced through exclusion of MEPS respondents due to death, institutionalization or other reasons; and to include clinical measures to assess the severity of stroke.

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EXPLORING PERSPECTIVES ABOUT THE ACCEPTABILITY OF A PROPOSED SMOKE‐FREE COUNSELING INTERVENTION

Tong E ¹, Paterniti D¹, Tsoh J², Chen MS¹

¹University of California, Davis, Sacramento, CA, USA; ²University of California San Francisco, San Francisco, CA, USA

OBJECTIVES/SPECIFIC AIMS: Tobacco is the leading preventable cause of morbidity and mortality. Smoke‐free policies, based on the fact that secondhand smoke harms others, encourage smokers to quit and protect nonsmokers from exposure. However, these public health policies have not yet been fully translated into clinical interventions. METHODS/STUDY POPULATION: We conducted focus groups about a potential smoke‐free counseling intervention that uses adult dyads of smokers and household nonsmokers. The intervention involves group education on secondhand smoke concerns, dyad‐level motivational interviewing, and individual lab results of smoke exposure. Besides participant questionnaires, focus group transcripts were analyzed for themes related to the acceptability of the intervention. RESULTS/ANTICIPATED RESULTS: A total of 36 participants were recruited for 6 focus groups, separated by smoking status. The dyads were spousal/partner (55%) or friends (17%). Most smokers (77%) were at least contemplating quitting. Almost all (94%) nonsmokers tried to eliminate home exposure in the past year, and 72% tried to support the smoker to quit. Respective ratings by smokers and nonsmokers of the intervention components as “useful” include: group education (83%, 94%), counseling (72%, 100%), and lab results (89%, 71%). Themes that emerged include (1) conducting group education with fellow smokers/nonsmokers to build support and reduce conflict, (2) increasing the intensity of contact, (3) explaining the lab more, and (4) addressing concerns about sampling hair. DISCUSSION/SIGNIFICANCE OF IMPACT: The proposed smoke‐free counseling intervention was acceptable to participants. Educational material and protocol for a pilot intervention will be revised according to themes elicited.

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FACTORS INFLUENCING QUALITY OF LIFE IN LATE LIFE DISABILITY

Smith AK ¹, King J¹, Yourman L¹, Ahalt C¹, Eng C¹, Knight S¹, Perez‐Stable E¹, Covinsky K¹

¹University of California, San Francisco, San Francisco, CA, USA

OBJECTIVES/SPECIFIC AIMS: We conducted a study of quality of life in a diverse population of elders with late life disability. METHODS/STUDY POPULATION: We used qualitative methodology. Subjects were recruited from San Francisco’s On Lok program, the first Program of All‐inclusive Care for the Elderly (PACE). All On Lok enrollees are disabled and meet Medicaid criteria for nursing home placement. We interviewed elders in English, Spanish, and Cantonese who had a mini‐mental status >20. Respondents were asked to rate their “overall quality of life” on a 5‐point scale (excellent to poor). Open ended questions explored the reasons for their rating, with specific probes about disability and dependence. RESULTS/ANTICIPATED RESULTS: We interviewed 60 older adults (mean age 78, 62% women, 27% European American, 23% African American, 12% Latino, 37% Chinese American, mean 3 ADL dependencies). 76% of respondents rated their quality of life as good or better. Six domains emerged that dependent elders felt were important to their quality of life: physical (disability, pain, nonpain symptoms); psychological (depression, anxiety, resilience); cognitive (cognitive impairment); ethical (autonomy, dignity); spiritual/religious (hope, religious coping); and social (life‐space, isolation/support). Examples quote: “It’s unfortunate that a lot of your family or other people feel that once you’re old you don’t know anything anymore and you just – kind of in the way” (dignity). DISCUSSION/SIGNIFICANCE OF IMPACT: In this diverse group of very disabled elders, most rated their quality of life as at least good. Many of the factors that influence quality of life, including life‐space, resilience, religious coping, and respect for dignity, are missing from standard assessments of quality of life (e.g., SF‐36).

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FEASIBILITY, SAFETY, AND EFFICACY OF A SCALABLE, HOSPITAL AT HOME MODEL OF CARE

Summerfelt W ¹, Sulo S¹, Sacks L¹, Powder S¹, Rakowski R², London A³, Chess D², Robinson A²

¹Advocate Health Care, Park Ridge, IL, USA; ²Intersections, Bridgeport, CT, USA; ³London Group Int’l, Toronto, ON, Canada

OBJECTIVES/SPECIFIC AIMS: BACKGROUND: Providing hospital‐level services in patients’ homes in Hospital at Home models of care for select diagnoses, has proven to be clinically safe, cost‐effective, and preferred by patients, caregivers and providers. However, scaling these models has been limited by challenges in providing physician resources into the home. OBJECTIVE: Evaluate the feasibility, safety, and efficacy of a scalable substitutive Hospital at Home model, the Advocate Home Hospitalization Program: Powered by Clinically Home (AHHP) that uses virtual physicians via 2‐way real‐time enhanced video. METHODS/STUDY POPULATION: Design: Prospective, nonrandomized design comparing patients who required hospital admission for COPD, CHF, DVT, and pneumonia. Patients treated in AHHP were compared to patients clinically eligible for AHHP but presented for care outside of AHHP admitting hours. INTERVENTION: Hospital at Home model was enhanced by use of wireless biometric measures and 2‐way real time biometrically enhanced physician home visits. MEASURES: Patient, caregiver, and provider satisfaction, quality and clinical measures; functional status; adverse events; service utilization; and costs. RESULTS/ANTICIPATED RESULTS: The treatment group was more satisfied (p < .05) and had lower readmission rates (p < .05) with equivalent quality. We anticipate lower costs, lower adverse events, and similar clincial quality. DISCUSSION/SIGNIFICANCE OF IMPACT: AHHP is feasible and efficacious for patients and families. Improved scalability of Hospital at Home models will prove useful to health systems adapting to new paradigms of health service delivery.

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GENDER DIFFERENCES IN PARENTAL PERCEPTIONS OF MENTAL HEALTH NEEDS AND SERVICES

Larson J ¹, dosReis S², Frosch E¹, Solomon B¹

¹Johns Hopkins, Takoma Park, MD, USA; ²University of Maryland, Baltimore, MD, USA

OBJECTIVES/SPECIFIC AIMS: (1) To evaluate gender differences in mental health service use after referral from a pediatric clinic; and (2) To explore differences in the way parents describe the mental health needs of girls and boys. METHODS/STUDY POPULATION: One hundred forty‐eight children aged 2–17 were referred from an urban pediatric primary care clinic to a community children’s mental health clinic. Referring providers completed a form documenting reason for referral and demographics. Mental health service use was obtained from the mental health clinic. In‐depth interviews with 37 of the families explored the factors impacting parents’ decisions to attend the mental health evaluation. Univariate analyses were used to examine group differences; regression analyses were used to examine likelihood of attending the initial mental health evaluation. Interviews are being analyzed using grounded theory to examine differences by gender in how parents discuss mental health problems. RESULTS/ANTICIPATED RESULTS: Boys were more frequently referred than girls (93/148 vs. 55/148). Forty‐six percent of referred children attended the initial mental health evaluation. Attendance at the initial evaluation did not differ by gender. Logistic regression showed that girls had a 2.45 (95% CI: 1.17–5.11) greater odds of having 3 or more mental health visits as compared to boys, with 42% of girls attending 3 or more visits versus 24% of boys (p= 0.03). Qualitative analyses to enrich these findings are currently underway. DISCUSSION/SIGNIFICANCE OF IMPACT: There were no gender differences in attending the initial mental health evaluation, but girls were more likely to continue with treatment. Qualitative analysis is underway to explore how families describe the mental health needs of boys and girls, and how this may influence service use.

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LENGTH OF STAY FOR PEDIATRIC PSYCHIATRIC PATIENTS: A REASON FOR OVERCROWDING

Waseem M ^1,2, Leber M^1,2

¹Lincoln Medical & Mental Health Center, Bronx, NY, USA; ²Weill Medical College of Cornell Unversity, New York, NY, USA

OBJECTIVES/SPECIFIC AIMS: To determine the length of stay (LOS) of patients with psychiatric diagnoses in an Emergency Department METHODS/STUDY POPULATION: This is a retrospective cohort study reviewing all children under 19 years of age, who presented to an Urban ED with psychiatric symptoms, from January 2004 to December 2007. A control group with nonpsychiatric diagnoses was selected over a random 4‐day period. ED length of stay (in minutes) was compared to that of patients with psychiatric diagnoses. LOS was determined from the time of triage to disposition (discharge or admission). Patients with psychiatric diagnoses were classified into one of two categories: major psychiatric diagnoses (bipolar disorder, psychoses, major depression, suicidal attempt or ideation, homicidal ideation, and hallucination) and minor psychiatric diagnoses (ADHD, adjustment disorder, anxiety or panic attack, and behavioral issues). RESULTS/ANTICIPATED RESULTS: A total of 1,468 patients with psychiatric diagnoses visited the ED. The control group had 345 patients. 382 patients were in the major psychiatric diagnoses group and 1,086 patients were in minor psychiatric diagnoses group. Mean LOS of nonpsychiatric patients was 160 minutes (95% CI 142–177), LOS for minor psychiatric patients was 737 minutes (95% CI 670–803) and 1,127 minutes major psychiatric patients (95% CI 972–1,283). The median LOS of nonpsychiatric patients was 129 minute, minor psychiatric patients 328 minutes and major psychiatric patients 4,37.5 minutes. Kruskal‐Wallis test showed a significant difference between each group (p= 0.0001). DISCUSSION/SIGNIFICANCE OF IMPACT: Describing the steps and duration of time it takes to treat and discharge pediatric psychiatric patients should be discussed at a National Task Force meeting.Guidelines could then be provided to help relieve the ED of their increasing burden.

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NEIGHBORHOOD VIOLENCE AND STRESS: EXPLORING COMMUNITY PERCEPTIONS OF INFLUENCES ON CHILDHOOD ASTHMA

Yonas M ¹, Burke JG¹, Rak K¹, Kelly VM⁴, Moore RS⁵, Marsland AL², Wenzel S³

¹U Pittsburgh, Pittsburgh, PA, USA; ²U Pittsburgh‐Psychology, Pittsburgh, PA, USA; ³U Pittsburgh‐Asthma Institute, Pittsburgh, PA, USA; ⁴Steps to a Healthy Community, Pittsburgh, PA, USA; ⁵Community College of Allegheny County, Pittsburgh, PA, USA

OBJECTIVES/SPECIFIC AIMS: Disproportionately high asthma morbidity and mortality persists among socioeconomically disadvantaged children. Known environmental risk factors only partially explain persistent disparities. While evidence shows that exposure to chronic stress predicts asthma exacerbations, the impact of neighborhood‐level factors on stress and asthma morbidity remains poorly understood. METHODS/STUDY POPULATION: This study utilized concept mapping to engage residents, 11 adults and 10 youth, to identify neighborhood factors that may influence, positively or negatively, childhood asthma. Study activities include systematic brainstorming, sorting, rating and cluster mapping activities which characterized perceptions of the factors influencing the care and control of childhood asthma. RESULTS/ANTICIPATED RESULTS: Participants identified 72 discrete items related to asthma such as pollution, stress, shootings, teasing, health insurance, and smoking. Items were organized and prioritized by the group into 5 clusters, such as Environmental Triggers and Stressors. For items related to stressors, visual depictions were created illustrating the pathways by which stressors impact lung function through feelings of anxiety and acute panic responses. DISCUSSION/SIGNIFICANCE OF IMPACT: Utilization of an engaged research approach led to the contextualization of a range of unique neighborhood related stressors. Results will inform testable hypotheses regarding neighborhood influences on childhood asthma care and control in future quantitative research and to inform the design of behavioral and public health asthma care and control programs for youth.

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POSTSIXTY MORTALITY AND TRANSITION IN THE GLOBAL BURDEN OF DISEASE

Seligman BJ ¹, Cullen MR¹, Horwitz RI¹

¹Stanford University School of Medicine, Stanford, CA, USA

OBJECTIVES/SPECIFIC AIMS: The World Health Organization’s Global Burden of Disease (GBD) reports are an important tool for global health policy makers, however the accuracy of estimates for countries undergoing an epidemiologic transition is unclear. We attempted to validate the life table model used to generate estimates for all‐cause mortality in developing countries. METHODS/STUDY POPULATION: Data were obtained for males and females from the Human Mortality Database for all countries with available data every ten years from 1900 to 2000. These provided inputs for the GBD life table model and served as comparison observed data. RESULTS/ANTICIPATED RESULTS: Above age sixty model estimates of survival for both sexes differed substantially from those observed. Prior to the year 1960 for males and 1930 for females, estimated survival tended to be greater than observed; following 1960 for both males and females estimated survival tended to be less than observed. Viewing observed and estimated survival separately, observed survival past sixty increased over the years considered. For males, the increase was from a mean (SD) probability of 0.22 (0.06) to 0.46 (0.1). For females, the increase was from 0.26 (0.06) to 0.65 (0.08). By contrast, estimated survival past sixty decreased over the same period. Among males, estimated survival probability declined from 0.54 (0.2) to 0.09 (0.06). Among females, the decline was from 0.36 (0.12) to 0.15 (0.08). DISCUSSION/SIGNIFICANCE OF IMPACT: These results show that the GBD mortality model did not accurately estimate survival past sixty as developed countries transitioned in the twentieth century and may be similarly flawed in developing countries now undergoing transition. Estimates of older‐age populations and their attributable disease burden should be reconsidered.

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RELIABILITY OF SAFE HOSPITAL CARE FOR CONGESTIVE HEART FAILURE PATIENTS

Huddleston J ^1,2, Gabriel S¹, Fowler J²

¹Mayo Clinic, Rochester, MN, USA; ²Arizona State University, Teme, AZ, USA

OBJECTIVES/SPECIFIC AIMS: To determine the reliability of inpatient health care delivery for congestive heart failure patients – hospitalizations free of adverse events (AE). METHODS/STUDY POPULATION: All patients hospitalized with congestive heart failure from January 1, 2005 to December 31, 2007 were included. Clinical records, administrative data and AE data repositories were utilized for abstraction of information. The Global Trigger Tool methodology identified AEs – unplanned illness resulting from evaluation or treatment of medical conditions. Multivariate regression analyses determined patient characteristics related to occurrence and timing of an AE. Time‐dependent analyses were performed to determine cumulative density, hazard and probability density functions. Recurring conditions and of competing causes of AEs were analyzed. RESULTS/ANTICIPATED RESULTS: One thousand seven hundred eleven patients hospitalized with CHF with mean age 83 years and 44% were men. Mean Charlson Index was 3.8 (sd 2.4). 38% had at least one AE (requiring additional monitoring or higher). Spontaneous hazard rate in the time to first AE was 0.019 events per hour. None of the patient‐specific characteristics collected statistically influenced the probability of an AE occurring. However, age and Charlson Index were related to time to first AE. Of those who had AEs, 35% had at least one more. 70% of events occurred within 72 hours of admission [R(t) = 0.20). Event recurrence was not markedly influenced by patient characteristics. Medication related adverse events occurred more frequently and sooner during the hospitalization. DISCUSSION/SIGNIFICANCE OF IMPACT: National reports indicate that care is not getting safer. Majority of work to date focused on the patient state. Analysis methods for assessing AE must begin to include aspects of care delivery system. These offer the highest potential to mitigating AE.

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SCREENING AND INTERVENTIONS FOR SUBSTANCE USE IN DENTAL CLINICS: A SURVEY OF DENTISTS ON CURRENT CLINICAL PRACTICES, POLICIES AND BARRIERS

McNeely J ¹, Wright S¹, Rotrosen J^1,3, Shelley D^1,2, Matthews AG⁴, Buccholz M², Curro F²

¹NYU School of Medicine, New York, NY, USA; ²NYU College of Dentistry, New York, NY, USA; ³VA NY Harbor Healthcare System, New York, NY, USA; ⁴EMMES Corporation, Rockville, MD, USA

OBJECTIVES/SPECIFIC AIMS: Substance use has substantial effects on oral health, and dental visits provide an opportunity to address substance use disorders. We surveyed dentists to learn whether they might play a role in substance use screening and interventions. METHODS/STUDY POPULATION: All dentists active in the PEARL dental practice‐based research network were invited to complete a web‐based survey in summer 2010. The 41‐item survey assessed clinic policies and dentists’ practices, attitudes, and perception of barriers regarding screening, counseling, and referrals for substance use. RESULTS/ANTICIPATED RESULTS: One hundred forty‐three dentists completed the survey (68% response rate). Almost all respondents felt it was important to screen patients for tobacco (99%), alcohol (92%) and illicit drug (93%) use, though actual screening rates were much lower. Counseling or referrals were infrequently provided for users of alcohol (29%) and illicit drugs (25%), but were more common for tobacco (63%). The most frequently identified barrier to addressing substance use was insufficient knowledge/training. Other barriers were lack of referral sites, staff resistance, and time constraints. If reimbursement were available, many dentists said they would offer counseling and assistance for tobacco (67%), alcohol (52%), and illicit drugs (48%); an affirmative response was significantly more likely among the 43 dentists who saw Medicaid patients (p < 0.01). DISCUSSION/SIGNIFICANCE OF IMPACT: Dentists recognize the importance of screening for substance use, but lack the clinical training and systems that might allow them to intervene. If these barriers were reduced, dentists could be willing partners in addressing substance use disorders.

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TELEMEDICINE TO IMPROVE DEPRESSION CARE IN HOMECARE

Sheeran T ^2,1, Rabinowitz T^3,4, Reilly CF¹, Lotterman J¹, Bruce ML¹

¹Weill Cornell Medical College, White Plains, NY, USA; ²Rhode Island Hospital and Brown Medical School, Providence, RI, USA; ³University of Vermont College of Medicine, Burlington, VT, USA; ⁴Fletcher Allen Health Care, Burlington, VT, USA

OBJECTIVES/SPECIFIC AIMS: Telehealth is commonly used in homecare to manage illnesses for elderly patients, but typically not for depression. The goals of this Cornell CTSC‐supported pilot study were to test the acceptability and early outcomes of a depression care management (DCM) program using existing telehealth equipment. METHODS/STUDY POPULATION: This study partnered 3 homecare agencies in VT, NY, and FL during 2009 and 2010. Each used different telehealth equipment, programmed with the protocol, which enabled patients to report on mood, antidepressants, and request telehealth nurse phone calls. Each telehealth nurse received a full day of DCM training. As a pilot, all consenting patients received the protocol. Eligible patients were age 65+, depressed or admitted with a depression diagnosis or on antidepressants, English or Spanish speaking, and nondemented. Patients received the telemonitor, which collected data and transmitted it to the agency. The telehealth nurse managed the patients’ depression. Research assistants conducted in‐home interviews to assess symptoms and satisfaction with the protocol. Telehealth nurses were surveyed about the protocol. RESULTS/ANTICIPATED RESULTS: We recruited a diverse sample of 48 English and Spanish speaking patients. Patients and nurses reported high levels of satisfaction. Among patients with depression, baseline mean severity scores were “Markedly Severe” (HAMD). At follow‐up, mean scores were “Mild.”DISCUSSION/SIGNIFICANCE OF IMPACT: Results support the feasibility of using homecare’s existing telemonitors to provide DCM. Acceptance levels were high across both patients and telehealth nurses. Preliminary findings suggest that symptoms improved, although this outcome must be verified in a randomized trial.

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THE EFFECTS OF A HEALTH INFORMATION TECHNOLOGY SUPPORTED QUALITY IMPROVEMENT INITIATIVE ON HEALTHCARE DISPARITIES

Jean‐Jacques M ¹, Thompson JA¹, Persell SD¹, Hasnain‐Wynia R¹, Baker DW¹

¹Northwestern University, Feinberg School of Medicine, Chicago, IL, USA

OBJECTIVES/SPECIFIC AIMS: To assess the impact of a multifaceted health information technology supported quality improvement (QI) initiative on racial disparities in the quality of ambulatory care. METHODS/STUDY POPULATION: In February 2008, a QI initiative consisting of point of care reminders, clinical decision support, and regular audit and feedback to providers was implemented throughout a large academic general internal medicine practice. The QI initiative targeted 17 measures of chronic disease and preventive care. The chronic disease measures included process of care and intermediate outcome measures for coronary heart disease, heart failure, hypertension, and diabetes; the preventive care measures included cancer screening, women’s health, and immunization. Time series models were used to assess changes in the proportion of patients satisfying each quality measure, stratified by race, and changes in racial disparities for each quality measure from February 2008 through February 2010. RESULTS/ANTICIPATED RESULTS: Quality of care improved for 14 of 17 measures for white patients and 10 of 17 measures for black patients. Quality improved for both black and white patients for 5 of 8 process of care measures, 4 of 5 preventive care measures, but none of the 4 intermediate outcome measures. Of the 8 measures with racial disparities at baseline, disparities declined for 3, remained stable for 4, and increased for 1 measure after implementation of the QI initiative. DISCUSSION/SIGNIFICANCE OF IMPACT: Generalized QI initiatives (i.e. programs that aim to improve the quality of care for patients overall but are not specifically tailored to address healthcare disparities) may lead to some improvements in racial disparities in the quality of chronic disease and preventive care, but will not be sufficient to eliminate healthcare disparities.

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THE ROLE OF SCIENTIFIC EVIDENCE IN CREATING TOBACCO POLICIES FOR THE DISADVANTAGED

Apollonio D¹

¹UCSF, San Francisco, CA, USA

OBJECTIVES/SPECIFIC AIMS: Although clinical research often identifies effective public health interventions, many are not enacted into policy, leading to unnecessary death and disease. This problem is particularly acute in research on tobacco use, which causes 435,000 annual deaths in the United States and over 80% of all lung cancer deaths. Approximately 200,000 of these deaths occur in alcohol, drug abuse and mental health populations in treatment, where smoking rates are 2–4 times that of the general population. Existing literature reports that smoking cessation therapy is effective in these populations, but only three states mandate that such therapy be made available in treatment facilities as a condition of licensure. METHODS/STUDY POPULATION: This paper reviews the public commentary and background information on proposed and existing state policies to assess how the use of clinical evidence in the policymaking process is associated with legislative and regulatory outcomes. To date three states (New Jersey, New York, and Virginia) have established regulations that require the provision of smoking cessation therapy in residential substance abuse treatment centers and/or psychiatric hospitals, although other states have proposed similar policies. My study population consists of a retroactive review of these state‐level policies, enacted between 2002 and 2010. RESULTS/ANTICIPATED RESULTS: I hypothesize that increased reliance on clinical research in the policymaking process encourages the adoption of laws that provide disadvantaged populations in treatment the right to tobacco cessation treatment. DISCUSSION/SIGNIFICANCE OF IMPACT: Few studies attempt to identify how clinical research is translated into public health interventions or what encourages the enactment of such evidence‐informed policy. Yet this knowledge is critical in ensuring that clinical research findings are used to save lives.

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THE WHAT AND WHEN OF HOW HOSPICE NURSES PREPARE FAMILIES FOR DEATH

Kehl KA ¹

¹University of Wisconsin‐Madison, Madison, WI, USA

OBJECTIVES/SPECIFIC AIMS: Hospice nurses are usually responsible for preparing the family for death, but little is known about what is included in such preparation. The aims of this study were to: (1) Identify the content and timing of nurses preparation of families for death, (2) Describe how RNs tailor such messages and (3) The differences between hospice certified and other nurses concerning preparing families. METHODS/STUDY POPULATION: Mailed surveys were sent to all 1,542 RN members of HPNA who identified “hospice” as their primary practice. Data was extracted from the survey using Cardiff Teleforms. Descriptive and comparative statistical analysis was conducted using R (http://www.r‐project.org). RESULTS/ANTICIPATED RESULTS: The response rate was 56.7%. Most nurses agreed that families can be prepared for physical changes (97.7%) and for care giving tasks (96.7%). Preparatory information is usually given at admission (88.0%) or when the patient’s condition (70.6%)changes. Preparation is usually done over time (79.6%). Most preparation is tailored. Factors affecting the tailoring of the messages include: patient signs/symptoms (85.7%), how much the family wants to know (84.9%), family cultural background (84.6%), and family education (84.4%). Certified nurses were more likely to work for a longer time in hospice, larger agencies and have case management responsibilities. There were no differences in educational status between groups. Certified nurses were more likely to agree that families can be prepared for care giving tasks (p= 0.03), to use written materials (p= 0.01) and to discuss symptoms such as dysphagia (p= 0.02), cold extremities (p= 0.02) and vital sign changes (p= 0.07). DISCUSSION/SIGNIFICANCE OF IMPACT: The results of this study may be used to support development and testing of education for nurses and a tailored intervention for family caregivers that will assist with preparation for the patient’s death.

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TO YELP (.COM) OR NOT? RELATIONSHIP BETWEEN CONSUMER GENERATED CONTENT RATINGS AND MEASURED PATIENT SATISFACTION IN HOSPITALS

Bardach N ¹, Dudley RA¹

¹UCSF, San Francisco, CA, USA

OBJECTIVES/SPECIFIC AIMS: Patient experience ratings of hospitals are posted on national public reporting and consumer generated content (CGC) websites for use in patient hospital choice. We sought to assess how hospitals were rated on a CGC website compared to the scientifically generated ratings on a national public reporting website. METHODS/STUDY POPULATION: Data sources: The most current patient satisfaction ratings for all hospitals online at Hospitalcompare.hhs.gov (Oct 2008–Sept 2009). We limited our sample to the most popular cities on Yelp.com and searched for the remaining hospitals on Yelp.com and gathered the following: overall rating (scale:1–5 stars), number of ratings, distribution of ratings, and time period in which the ratings were given. We compared overall distributions of scores and correlation (Pearson’s product moment) of individual hospital performance between the two sources. RESULTS/ANTICIPATED RESULTS: Of the hospitals in the national dataset (N= 4358), 807 were in a popular Yelp city. Of those, 465 had any ratings on yelp.com (range: 1–74 ratings, mean: 5 ratings per hospital), with ratings dated from 5/9/2005 to 12/12/2010. The distribution of ratings between the two sources were similar, with more high ratings than low, but more very low ratings than low‐middle ratings. The correlation was 0.40 between hospitals with high ratings on both sites (p < 0.001). DISCUSSION/SIGNIFICANCE OF IMPACT: Though consumer generated ratings of hospitals are not scientifically generated, they have some numerical similarity to scientifically designed measures of patient satisfaction. The information on consumer generated websites may be a useful additional resource for patients looking to choose a hospital.

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UNDERSTANDING CONTRIBUTORS TO RACIAL DIFFERENCES IN VARYING LEVELS OF BLOOD PRESSURE CONTROL IN DURHAM, NORTH CAROLINA

Simmons DN ¹, Grubber J¹, Bosworth H¹

¹Duke University/Durham VAMC, Durham, NC, USA

OBJECTIVES/SPECIFIC AIMS: Potential explanatory factors for hypertension control may be associated with blood pressure (BP) control ranges among different races. METHODS/STUDY POPULATION: Baseline data for hypertensive patients was obtained from a five‐year RCT. Various factors were examined by BP control status. Since the optimal level of BP control is unclear and may vary with certain patient populations, BP levels were stratified. Logistic regression was used to determine the association between race and controlled BP (120–139 mmHg and/or 80–89 mmHg) relative to both uncontrolled BP (≥140 mmHg and/or ≥90 mmHg) and more tightly controlled BP (<120 mmHg and/or <80 mmHg), with and without adjustment for potential explanatory factors of racial differences in BP control. RESULTS/ANTICIPATED RESULTS: The odds of having uncontrolled BP relative to controlled BP were higher in African Americans than in Caucasians (age‐adjusted OR = 3.2). The age‐adjusted association between African Americans and uncontrolled BP was reduced by at least 10% when financial situation (OR = 2.9) or BMI (OR = 2.7) were included. The association was decreased when both factors were included in the model simultaneously (OR = 2.5). Although not statistically significant, the odds of tightly controlled BP relative to controlled BP were also higher in African Americans than Caucasians (48% versus 44%; OR = 1.2; 95% CI 0.8–1.7). No other statistically significant disparities were shown for two ranges of controlled BP categories. DISCUSSION/SIGNIFICANCE OF IMPACT: Modifiable factors, like BMI, may be used to reduce the racial differences in cardiovascular morbidity. In the subset of participants whose BP was controlled at baseline, there were no significant racial disparities, though African Americans were more likely to have tighter control–diastolic BP <80 mmHg may increase cardiac event risk in patients >65 years old.

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UNDERSTANDING DEPRESSION AMONG DIVERSE AFRICAN AMERICAN WOMEN

Holden KB ¹

¹Morehouse School of Medicine, Atlanta, GA, USA

OBJECTIVES/SPECIFIC AIMS: The purpose of the study was to foster greater understanding about the relationship of selected biological, psychological, and socio‐cultural factors to depressive symptoms among African American women. METHODS/STUDY POPULATION: The sample was comprised of 63 African American women from an urban community (n= 15), a community based primary healthcare center (n= 23), and a small private academic institution (n= 25). These women participated in a health and wellness empowerment session which included their completion of a battery of self‐report assessment measures, participation in a focus group, and involvement in an educational presentation about depression. Quantitative data analyses were carried out through the use of SPSS‐X. RESULTS/ANTICIPATED RESULTS: Depression was reported highest among the community group; yet the clinical sample of women most reported being formally diagnosed with depression. For the total sample, depression scores were found to be significant and positively associated with negative and ruminative thinking/automatic thoughts, self‐esteem, stressful life events, social support, and depression stigma. Depression was found to be significant and negatively associated with resiliency and spiritual well‐being. The strongest predictors of depression for the total sample were negative and ruminative thinking and low self‐esteem. DISCUSSION/SIGNIFICANCE OF IMPACT: It is crucial that careful attention be provided to heightening awareness of the unique risk and protective factors for African American women relative to depression. It is essential that culturally relevant strategies and models for the prevention of disease and the promotion of mental wellness among African American women from diverse sectors of the community be discerned.

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WARFARIN ANTICOAGULATION AFTER TOTAL HIP OR KNEE REPLACEMENT – INR PATTERNS AND CLINICAL OUTCOMES

Nutescu E ¹, Bautista A¹, Gao W¹, Galanter W¹, Schumock G¹, Lambert B¹

¹Univ of Illinois Chicago, Chicago, IL, USA

OBJECTIVES/SPECIFIC AIMS: To evaluate clinical practice INR patterns and outcomes associated with warfarin use in patients managed in a university‐based antithrombosis clinic (ATC). METHODS/STUDY POPULATION: This was a retrospective observational cohort study of patients undergoing total knee or hip replacement (TKR or THR), receiving warfarin prophylaxis within 24 hours of surgery, who were referred to the ATC for anticoagulation management (January 1998‐January 2009; follow‐up: 3 months postsurgery). RESULTS/ANTICIPATED RESULTS: 400 patients (male: 68%) were evaluated (TKR: 55%; THR: 45%). Mean age (± SD) was 58.4 ± 12.5 years. Mean length of hospital stay was 5.0 ± 1.9 days, and mean length of warfarin therapy was 50 ± 21 days (including outliers). Mean time required to reach therapeutic INR range of 2–3 was 10.0 ± 9.1 days. The within‐patient proportion of INR levels spent in therapeutic range was 28 ± 18%, while the proportion in extended therapeutic range (INR 1.8–3.2) was 39.2 ± 20.5%. The within‐patient proportion of INR levels spent below therapeutic range was 65 ± 22.6% for INR < 2 and 37.7 ± 21.6% for INR < 1.5. Major bleeding occurred in 2 (0.45%) patients. Symptomatic venous thromboembolism (VTE) occurred in 16 (4%) patients (8 inpatients, 8 outpatients), with a total of 14 (87.5%) events occurring at INR < 2, versus 2 (12.5%) at INR >2 (p < 0.05). DISCUSSION/SIGNIFICANCE OF IMPACT: Despite close monitoring, warfarin use was associated with significant time spent below acceptable anticoagulant levels, which resulted in high rates of symptomatic VTE. That the majority of events occurred at INR levels <2 may indicate the need for more aggressive anticoagulation in the acute postoperative phase.

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WHAT DO THEY WANT NOW? CONTACTS BETWEEN HOSPICE AND FAMILY IN THE LAST WEEK OF LIFE

Kehl KA ¹, van Veldhuisen KM¹

¹University of Wisconsin‐Madison, Madison, WI, USA

OBJECTIVES/SPECIFIC AIMS: There is limited information published about the last week of life in a home hospice. Examining this period can yield much information that may improve care during the final days. The purpose of this study was to describe the reasons and outcomes of contacts, and most frequent symptoms addressed in the last week of life. METHODS/STUDY POPULATION: This descriptive study used six months of records provided by a Midwest hospice. Records from patients who resided in their home, did not receive crisis care and died between January and June, 2008 were examined. Data was extracted and reviewed by trained RNs. SPSS 16 was used for descriptive date analysis. RESULTS/ANTICIPATED RESULTS: 175 patient charts revealed 2,204 contacts. The mean contacts per patient was 12.59 (range 2–29). Most contacts were initiated by the hospice staff (70.0%) or family (29.3%). The most frequent reasons include: symptom management (48.5%), emotional support (24%), personal cares (21.2%) and death (13.7%). The most frequent outcomes were: instruct family (40.65%), RN notified (20.8%) and medication change (7.8%). Symptoms were addressed in 62.6% of the contacts with the most frequent including: increased sleeping or fatigue (28.62% of those with symptoms documented), incontinence (24.0%), pain (23.77%), breathing changes (21.2%) and coma (20.9%). DISCUSSION/SIGNIFICANCE OF IMPACT: Understanding the reasons for contacts in the last week of a hospice patients’ lives can give insight into the questions and problems in family care giving during that time. Future research is needed to explore the differences between documented symptoms and information provided to the family. Interventions need to be developed and tested to provide for the informational needs of family caregivers in the last week of life.

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WHAT INFLUENCES TARGETED DEPRESSION VIDEO VIEWERS’ INTENTIONS TO DISCUSS DEPRESSION?

Fernandez y Garcia E ¹, Kravitz RL¹

¹University of California Davis, Sacramento, CA, USA

OBJECTIVES/SPECIFIC AIMS: Depression care disparities are partly due to stigma inhibiting disclosure of patients’ symptoms. Social marketing may reduce stigma and nondisclosure of depression symptoms. Targeted social marketing interventions to reduce stigma may be more effective than nontargeted interventions. We seek to answer two questions. Do depression video public service announcements (PSAs) designed to target gender and income improve viewers’ intention to discuss depression with a professional, compared to nontargeted depression PSAs and control? Using the Theory of Planned Behavior (TPB), how does targeting improve that intention?METHODS/STUDY POPULATION: In two studies using factorial designs, participants will be randomly assigned to view either a fully targeted (gender and income), partially targeted, or nontargeted PSA or control. Study 1 will assess reliability of study instruments and the degree of targeting (measured as identification) of the PSAs. Study 2 will provide estimates of intention to disclose depression symptoms and the relationships (using structural equation modeling) among intention, targeting concordance, TPB constructs, and participant characteristics (depression symptoms and beliefs, demographics). RESULTS/ANTICIPATED RESULTS: We expect targeting concordance to be significantly and positively associated with identification with depression PSAs and intention to disclose depression symptoms, and identification to modify the effect of viewing the PSAs on viewers’ intention. Subjective norms and attitudes about disclosing depression symptoms will be the most salient constructs of the TPB affected by viewing the PSAs. DISCUSSION/SIGNIFICANCE OF IMPACT: Anticipated results will provide evidence that targeting of social marketing‐based depression stigma reduction strategies can be more helpful than nontargeted strategies and which aspects of targeting are most effective.

OUTCOMES RESEARCH ABSTRACTS

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A SIMPLIFIED PREDICTIVE MODEL FOR HOSPITAL MORTALITY OF CRITICALLY ILL PATIENTS WITH END‐STAGE LIVER DISEASE

Balekian A ¹, Gould MK¹

¹University of Southern California, Los Angeles, CA, USA

OBJECTIVES/SPECIFIC AIMS: To develop and validate a mortality model for ESLD patients using easily‐obtained clinical parameters on admission. METHODS/STUDY POPULATION: Retrospective study of 1,071 ICU admissions (764 admissions for the development cohort, 188 admissions for the validation cohort) for patients with a history of ESLD at a county hospital in Los Angeles, CA. RESULTS/ANTICIPATED RESULTS: Hospital mortality rates for the development and validation cohort were 37.7% and 32.3%, respectively. Mayo end‐stage liver disease (MELD) score had better discrimination in a univariate model (area under curve [AUC] 0.83, p < 0.001) than Acute Physiology and Chronic Health Evaluation (APACHE) II score (AUC 0.73). Multivariate predictors for mortality were MELD, APACHE II, mechanical ventilation, and gender. Adding mechanical ventilation to MELD achieved the largest significant increase in model discrimination (AUC 0.85, p < 0.001). After multivariate adjustment, mortality was associated with female gender (odds ratio [OR] 1.69; 95% confidence interval [CI] 1.10–2.60; p= 0.02) and MELD (OR 1.13 for 1‐point increase; 95% CI 1.11–1.16; p < 0.01). There was a statistically significant interaction between MELD score and gender (p= 0.04). Therefore, our final, simplified model included MELD score, gender, a MELD‐gender interaction term, and mechanical ventilation, which retained a significant association with mortality (OR 4.90; 95% CI 2.70–8.91; p < 0.001). The model discrimination was good in our development cohort (AUC 0.85) and validation cohort (AUC 0.91). DISCUSSION/SIGNIFICANCE OF IMPACT: In ESLD patients, a simple model incorporating MELD score and mechanical ventilation has superior discrimination than APACHE II score in predicting hospital mortality. Gender disparities do exist, and these findings must be confirmed in other populations.

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A TIME‐INSENSITIVE MULTINOMIAL PREDICTIVE MODEL FOR DIAGNOSIS OF ACUTE HEART FAILURE SYNDROME

Contreras JP ^1,2, Schmid CH^1,2, Beshansky JR^1,2, Selker HP^2,1

¹Tufts CTSI, Boston, MA, USA; ²Tufts Medical Center, Boston, MA, USA

OBJECTIVES/SPECIFIC AIMS: To discriminate patients with acute heart failure syndrome (AHFS) among those with symptoms suggestive of acute coronary syndrome (ACS). METHODS/STUDY POPULATION: We used data from all adult patients with symptoms suggestive of ACS enrolled in the ACI‐TIPI clinical trial. Potential risk factors included demographics, presenting symptoms, past medical history and initial 12‐lead ECG. We used multinomial logistic regression to construct a multivariable model simultaneously predicting the relative odds of AHFS, acute myocardial infarction (AMI), angina, nonischemic cardiac disease, pulmonary disease and noncardiac disease for gender, age, pulmonary rales, chest pain, shortness of breath and ECG variables. RESULTS/ANTICIPATED RESULTS: Among 8,347 patients, 4,289 (51.4%) men and 4,058 (48.6%) women with mean age 59 years, final diagnoses were AHFS = 742 (8.9%), AMI = 684 (8.2%), angina = 1,329 (15.9%), nonischemic cardiac disease = 2,300 (28.6%), pulmonary disease = 424 (5.1%) and other noncardiac diseases = 2,778 (33.3%). Presence of rales strongly differentiated AHFS from all other diagnoses. A chief complaint of shortness of breath also differentiated AHFS from cardiac and non‐cardiac diagnoses but not from pulmonary disease. Ischemic ECG changes and chest pain as chief complaint differentiated AMI and angina from AHFS and others diseases. Females were more likely to have nonischemic cardiac or noncardiac diagnoses. Older patients were more likely to have ischemic cardiac diagnoses and less likely to have nonischemic, noncardiac and pulmonary diagnoses. DISCUSSION/SIGNIFICANCE OF IMPACT: Age, gender, 12 lead ECG and three clinical history variables can clearly differentiate cardiac and noncardiac outcomes for patients with suspected ACS using information easily available within 10 minutes of initial patient evaluation.

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ASSESSING THE IMPACT OF BIOMEDICAL RESEARCH

Gordon M ¹, Holmes KL¹, Sarli CC¹

¹Washington University School of Medicine, St. Louis, MO, USA

OBJECTIVES/SPECIFIC AIMS: The objective of this study was to assess the impact of a research study on the knowledge base, change in policy and change in practice. METHODS/STUDY POPULATION: We assessed the impact of the Ocular Hypertension Treatment Study (OHTS), a NIH clinical trial that demonstrated the safety and efficacy of ocular hypotensive medication in the prevention of glaucoma. Bibliographic analysis was performed on 26 peer‐reviewed journal articles resulting from OHTS. Additional research outputs and activities were also examined to locate evidence of research impact. RESULTS/ANTICIPATED RESULTS: Traditional bibliometric analysis was not sufficiently robust enough to adequately assess the impact of OHTS findings and resulting synthesis into clinical practice. Health outcomes not discernable via bibliometric analysis include practice guidelines, CPT Codes, and curriculum materials, among others. Therefore, we developed a model‐based framework reflective of the biomedical research process which included contribution to the knowledge base; change in understanding of a disease; change in policy; change in practice; change in community health; or change in public law or policy. Our framework for assessing the impact of biomedical research has been implemented in a hands‐on, web‐based site, the Becker Medical Library Model for Assessment of Research Impact. DISCUSSION/SIGNIFICANCE OF IMPACT: There are a number of resources available to track diffusion of impact above and beyond citation analysis in order to provide a meaningful assessment of policy, practice and health outcomes. The Becker Medical Library Model for Assessment of Research Impact (http://becker.wustl.edu/impact/assessment/) can help biomedical researchers quantify and document translational impact.

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ASSESSMENT OF TWO NOVEL EMERGENCY TRACHEOTOMY PRODUCTS

Arlow RL ^1,2, Schulman R², Michelson E², Totten V²

¹Case Western Reserve, Cleveland, OH, USA; ²University Hospitals, Cleveland, OH, USA

OBJECTIVES/SPECIFIC AIMS: (1) This cadaver trial will serve as an initial proof of concept and means of optimization of two novel tracheotomy products. (2) This cadaver trial will estimate key outcomes of the two devices for FDA 510(k) clearance and academic publication. METHODS/STUDY POPULATION: (1) Eight nonembalmed cadavers will first be used for proof of concept testing and optimization of the product design. (2) Twelve nonembalmed cadavers will be randomized to tracheostomy then cricothyrotomy by the current standards of care or using the novel products. One emergency medicine physician will then perform the indicated procedure. The study will measure the success rate of obtaining a patent airway by validation with a fiberoptic scope. Parameters to measure include: speed, success rate, number of attempts, location of insertion, and subjective ease of use. RESULTS/ANTICIPATED RESULTS: The eight initial cadavers have shown positive results in reducing speed, increasing success rate, and increasing ease of use. Device modifications are currently being prototyped for the second trial. DISCUSSION/SIGNIFICANCE OF IMPACT: The current emergency cricothyrotomy kits require a high level of skill and up to 70% of the patient population can sustain debilitating complications resulting from improper procedure. Under the current airway protocol, these patients are indicated to receive an emergency cricothyrotomy, which is a temporary airway that must be repaired within 24 hours and replaced with a definitive tracheostomy procedure for long‐term ventilation. The novel products for tracheotomy represent opportunity for safer and more efficacious cricothyrotomy as well as the first device indicated for performance of emergency tracheostomy. The performance of emergency tracheostomy will bring a higher standard of care to the prehospital, in‐hospital, and battlefield emergency health care providers.

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AWARENESS AND IMPLEMENTATION OF THE ASTHMA MANAGEMENT INITIATIVE IN BRONX SCHOOLS

Reznik M ¹, Wylie‐Rosett J², Bauman LJ²

¹Children’s Hospital at Montefiore, Bronx, NY, USA; ²Albert Einstein College of Medicine, Bronx, NY, USA

OBJECTIVES/SPECIFIC AIMS: To assess awareness and implementation of the NYC Department of Health (NYC DOHMH)‐recommended asthma management initiative (Managing Asthma in Schools, MAS) in Bronx inner‐city elementary schools. METHODS/STUDY POPULATION: Qualitative semistructured interviews with 10 nurses and 9 teachers from 14 Bronx elementary schools. We recorded, transcribed and independently coded all interviews for common themes. RESULTS/ANTICIPATED RESULTS: Most nurses were aware of the MAS initiative, but none could describe what MAS recommends. Most nurses said that students with asthma should be identified by a physician‐completed form that parents bring to school’s administration. However, both nurses and teachers reported that the most common way they found out that a student has asthma was by informal conversations with a parent or student. All nurses reported using the American Lung Association’s Open Airways for Schools (OAS), an asthma education curriculum for 3rd–5th grade students with asthma, without knowing it was part of the MAS initiative. However, none implemented it with fidelity, modifying content, number and frequency of lessons. Few nurses provided asthma education to teachers. None of the teachers were aware of MAS, or the school’s procedure for identifying students with asthma; few were aware of school‐based asthma education provided to students with asthma, and few reported receiving formal instruction on what it means to have a student with asthma in their classroom as recommended by the NYC DOHMH. DISCUSSION/SIGNIFICANCE OF IMPACT: Lack of awareness and poor implementation of MAS asthma initiative were common themes among nurses and teachers from several Bronx elementary schools. Increasing awareness and ensuring proper implementation of the existent asthma management initiatives may improve asthma care in inner‐city schools.

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COMBINATION TRANSARTERIAL CHEMOEMBOLIZATION WITH SORAFENIB FOR HEPATOCELLULAR CARCINOMA

Cabrera R ¹, Sing D¹, Caridi J¹

¹University of Florida, Gainesville, FL, USA

OBJECTIVES/SPECIFIC AIMS: The data are limited on transarterial chemoembolzation (TACE) plus sorafenib combination in hepatocellular carcinoma (HCC). We evaluate the safety and efficacy of TACE plus sorfenib (TACE + S) combination in a cohort of patients treated in a single center. METHODS/STUDY POPULATION: From July 2007 consecutive cases of HCC treated with TACE + S were evaluated. Baseline clinical, safety, and toxicity data as well as follow‐up data were collected. Survival curves were calculated. RESULTS/ANTICIPATED RESULTS: Forty three patients (n= 43) received TACE + S combination. The median follow‐up and median time on drug were 61 weeks and 23 weeks, respectively. The majority of the cohort (83%; 39/43) experienced adverse events (AEs). The most common adverse events (AEs) were fatigue (49%), hand‐foot skin reaction (49%), and diarrhea (40%). Grade 3/4 adverse events included fatigue (14%) and hand‐foot skin reaction (14%). Dose reduction was required in 72% (31/43) of patients. Drug interruption was needed in 44% (19/43) of patients. Dose discontinuation was required in 44% (19/43) of patients due to drug related AEs (mainly fatigue, hand foot skin reaction, new or worsening ascites, leukopenia and hypertension related chest pain) or due to radiologic and symptomatic progression (21%). The median survival for the overall TACE + S group was 11.8 months. The median survival of patients with BCLC stage B was 11.8 months (median survival for Child A 14.8 months, Child B 8.5 months). The median survival of patients with BCLC stage C was 11.6 months (Child A 11.8 months, Child B 3.1 months). DISCUSSION/SIGNIFICANCE OF IMPACT: The combination of TACE + S generated no unanticipated side effects but presents a challenging AE profile requiring close monitoring. The overall efficacy decreased in Child B cirrhosis. Further studies using the TACE + S combination are warranted.

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DIABETES KNOWLEDGE IN PREADOLESCENTS WITH TYPE 1 DIABETES

Monaghan M ¹, Cogen F^1,2, Streisand R^1,2

¹Children’s National Medical Center, Washington, DC, USA; ²George Washington University School of Medicine, Washington, DC, USA

OBJECTIVES/SPECIFIC AIMS: To evaluate preadolescents’ diabetes knowledge and the relationships among knowledge, daily care behaviors, and behavioral adherence. METHODS/STUDY POPULATION: Eighty‐three preadolescents ages 9–11 (M age = 10.82 ± .76 yrs) diagnosed with T1D for a mean of 4.18 years (± 2.64 yrs) completed the Diabetes Knowledge Test (DKT) and a self‐report of behavioral adherence. Parents completed a 24‐hour recall interview detailing daily diabetes care. Children were in adequate metabolic control (M HbA1c = 8.04 ± 1.15%); 55% were prescribed conventional insulin regimens, with the remainder prescribed more intensive regimens (22% multiple daily injections; 23% insulin pump). RESULTS/ANTICIPATED RESULTS: On the DKT, preadolescents averaged 70% correct. Most commonly missed items involved nutrition or acute complications (e.g., ketones, hypoglycemia). Diabetes knowledge was not significantly associated with age, disease duration, or regimen type. Controlling for insulin regimen, greater diabetes knowledge was associated with more frequent BG checks (F (3,79) = 6.40, p < .01, R2 = .20). No significant relationships with HbA1c or behavioral adherence emerged. DISCUSSION/SIGNIFICANCE OF IMPACT: Results suggest that youth diabetes knowledge is adequate, yet knowledge about nutrition and acute complications could be improved. Although parents are often involved in care, preliminary results suggest that youth diabetes knowledge is also important and is associated with more frequent BG monitoring. Preadolescents are assuming increased self‐care responsibilities, and providing targeted education to enhance parent and youth knowledge may buffer against the deterioration in diabetes care more common in adolescence. Further studies assessing changes in diabetes knowledge over time and relationship with more specific diabetes‐care behaviors are warranted.

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ELEVATED RED BLOOD CELL DISTRIBUTION WIDTH IS ASSOCIATED WITH SEVERE CORONARY ARTERY DISEASE IN PATIENTS WITH UNSTABLE ANGINA OR NON– ST‐ELEVATION MYOCARDIAL INFARCTION

Ephrem G ¹, Kanei Y¹

¹Beth Israel Medical Center, New York, NY, USA

OBJECTIVES/SPECIFIC AIMS: Red blood cell distribution width (RDW) is a quantitative measure of the variability in size of circulating erythrocytes. Higher levels of RDW have been associated with increased mortality among patients with heart failure, myocardial infarction, coronary artery disease (CAD) or undergoing angiography. Our aim in this study is to examine the role of RDW as an indicator of the severity of CAD in patients with unstable angina (UA) or non ST‐elevation myocardial infarction (NSTEMI). METHODS/STUDY POPULATION: We conducted a retrospective chart review of all adult patients admitted to our institution in 2007 with a diagnosis of UA or NSTEMI who underwent coronary angiography. RDW on admission was retained and, per our lab’s index, a level > 16.3% was considered high. Clinical characteristics and revascularization strategy (medical therapy, percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)) were compared between high and normal RDW groups. RESULTS/ANTICIPATED RESULTS: High RDW was noted in 101 (20%) of the 503 study subjects. These patients were more likely to be females (53% vs 42%, p= 0.04), have heart failure (50% vs 31%, p= 0.0001), and a lower hemoglobin level (11 vs 13 g/dL, p < 0.0001) than those with a normal level. High RDW was associated with a higher recourse to CABG (16% vs 9%; p= 0.05), suggestive of a higher disease burden. In a multivariable logistic regression analysis with age, sex, hemoglobin, heart failure, dyslipidemia, and family history of CAD as additional covariates, high RDW was found to be a statistically significant independent predictor for needing CABG (OR = 2.29; 95% CI (1.11 to 4.74)). DISCUSSION/SIGNIFICANCE OF IMPACT: Patients with high RDW require CABG more often than those with normal RDW. RDW can be an additional tool for risk stratification of patients with UA or NSTEMI.

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FEASIBILITY AND UTILIZATION OF PATIENT REPORTED OUTCOMES ON QUALITY OF LIFE AND DISEASE OUTCOMES IN CROHN'S DISEASE

Atreja A ¹, Ala S¹, Lashner BA¹, Brzezinski A¹, Achkar J¹, Kandiel A¹, Shen B¹, Soll AH²

¹Cleveland Clinic, Cleveland, OH, USA; ²UCLA, Los Angeles, CA, USA

OBJECTIVES/SPECIFIC AIMS: (1) To assess feasibility and accuracy of web‐based reporting of PRO quality indicators, quality of life and medication adherence) in patients with Crohn’s disease (CD) (2) To determine the impact of capturing PRO and decision support on clinical decision making and outcomes for patients with CD. METHODS/STUDY POPULATION: This pilot study, funded by ACG clinical research awards, is designed as a two‐armed, prospective, randomized clinical trial with change in Short Inflammatory Bowel Disease Questionnaire (SIBDQ) as primary outcome. Patients are randomized to receive intervention (self management + physician alerting) or control (web access without self‐management or alerting). RESULTS/ANTICIPATED RESULTS: The first phase of the study (design and development of the web portal) is completed. The second phase of the study (randomized control trial) is ongoing. 151 patients agreed to be part of study. Seventy‐one logged‐in CrohnsPromise at least once and entered details of CD (median age, 43.4 ± 13.5; women, 64.8%; white 97.2%). 62 patients (87.3%) reported all CD meds that were consistent with that documented in electronic health records.5 alerts fired so far with a median SIBDQ change of 6 points. DISCUSSION/SIGNIFICANCE OF IMPACT: CrohnsPromise allows easy capture and tracking of patient reported outcomes and phenotype information that can be used in routine clinical practice and translational research. Once logged‐in, majority of the patients can enter details about CD and PRO without any additional assistance. Further research needs to be done to understand behavior of patients who never log‐in in order for CrohnsPromise to serve as a representative cross‐institutional platform to improve patient care and facilitate translational research.

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FREE GINGIVAL MARGIN RESPONSES TO MARGINAL RESTORATION PLACEMENT

Ramirez K ¹, Fernandez O¹, Elias A², Blanco A²

¹University of Costa Rica, San Jose, Costa Rica; ²University of Puerto Rico, San Juan, Puerto Rico

OBJECTIVES/SPECIFIC AIMS: The purpose of this research is to observe the clinical behavior of the dentogingival complex dimension (DGCD) on the facial aspect of teeth prepared to receive a crown and its final placement. The specific aim of this study is to: (1) Determine the DGCD at baseline; (2) Determine the position of the crown marginal line using the free gingival margin as reference at 3 and 6 months of final crown placement; (3) Determine periodontal status at baseline, after 3 and 6 months. METHODS/STUDY POPULATION: At baseline, before tooth preparation for crown placement plaque assessment; sulcus probing depth; bleeding on probing and the DGCD will be taken. After tooth preparation, the distance between the osseous crest and the crown margin position will be measured, without any prior recommendation, where to place the margin location given to the restorative dentist. A questionnaire will be provided to the restorative dentist about prosthodontic parameters. Patients will be examined at 3 and 6 months after crown placement and plaque accumulation, sulcus probing depth, and bleeding on probing will be measured, as well the distance between the free gingival margin and the crown preparation line. RESULTS/ANTICIPATED RESULTS: Our central hypothesis is that there will be no negative effect on gingival health (inflammation) and aesthetics (gingival recession), if the restorative dentist places the margin of a crown preparation at 2 mm from the osseous crest. DISCUSSION/SIGNIFICANCE OF IMPACT: The work proposed will determine the DGCD and free gingival margin responses, and will provide evidence‐based information to achieve healthy gingiva and aesthetics. By identifying important measurements that can help prevent the occurrence of alterations such as inflammation and recession, we will be able to achieve a successful treatment.

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HIGH ANTIPHOSPHOLIPID ANTIBODY LEVELS REFLECT CHRONIC ENDOTHELIAL DAMAGE IN NON–AUTOIMMUNE‐ASSOCIATED THROMBOSIS

Broder A ¹, Putterman C¹

¹Montefiore Medical Center, Bronx, NY, USA

OBJECTIVES/SPECIFIC AIMS: Persistently elevated antiphospholipid antibody (aPL Ab) levels are associated with an increased risk of arterial and venous thrombosis, but factors that may affect aPL Ab levels are not well studied. We conducted a cross‐sectional study to explore factors associated with high aPL Ab levels and lupus anticoagulant (LAC) positivity in people without autoimmune diseases, hospitalized with deep vein thrombosis (DVT), pulmonary embolism (PE) or a cerebrovascular accident (CVA). METHODS/STUDY POPULATION: We included patients hospitalized in a large urban tertiary care center with a primary discharge diagnosis of DVT, PE or CVA, who had lupus anticoagulant (LAC), anticardiolipin, anti‐beta2 glycoprotein I, and antiphosphatidylserine IgG, IgM, and IgA measured. RESULTS/ANTICIPATED RESULTS: 95 patients with DVT or PE, and 180 patients with CVA were included. Statin use was associated with the OR of 14.6, 95%CI (2.0, 105.3), p= 0.008 of either LAC positive or at least one aPL Ab > 40 units, compared with no statin use in a multivariate model. Furthermore, patients who had low LDL and were on statins were 46.9 times more likely to have at least one aPL Ab > 40 units and/or LAC positive, 95% CI (2.4, 917), p= 0.011, compared with people with low LDL not on statins. Patients with DVT or PE who had type 2 diabetes (T2DM) were 4 times more likely (95% CI (1.1, 15), p= 0.04) to have at least one low positive aPL Ab, compared with DVT or PE patients without T2DM, even after adjusting for age, race, and ethnicity. DISCUSSION/SIGNIFICANCE OF IMPACT: High levels of aPL Abs may reflect long‐standing endothelial damage caused by long‐standing hyperlipidemia and T2DM.

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HISTORIC PROSTATE CANCER SCREENING AND TREATMENT OUTCOMES FROM A SINGLE INSTITUTION

Cross D ¹, Ritter M³, Reding DJ^2,1

¹Marshfield Clinic Research Foundation, Marshfield, WI, USA; ²Marshfield Clinic, Marshfield, WI, USA; ³University of Wisconsin School of Medicine and Public Health Department of Human Oncology, Madison, WI, USA

OBJECTIVES/SPECIFIC AIMS: To determine the current and historic outcomes of individuals diagnosed and treated for prostate cancer in a single institution. We compare outcomes between PSA screened individuals and those diagnosed without a PSA screen. We compare the outcomes from different treatment options selected within our population. METHODS/STUDY POPULATION: Setting: Marshfield Clinic, the largest private multispecialty group practice in Wisconsin, providing health care services annually to approximately 385,000 unique patents. Participants: Individuals who have been diagnosed with prostate cancer in our tumor registry between 1960 and 2009. Methods: We collected the age at diagnosis; stage and grade of the tumor; PSA values before, at, and after diagnosis; initial cancer treatment; follow‐up time; subsequent treatments; evidence of metastasis; age of death; and cause of death if known; through electronic chart abstraction from the tumor registry and the electronic medical record. This study was approved by the Marshfield Clinic IRB. RESULTS/ANTICIPATED RESULTS: The average age of prostate cancer diagnosis has decreased from age 70–71 to 67. This decrease in age occurred with increased PSA screening. Currently approximately 74% of those diagnosed have at least one PSA test. Age, grade, and stage were the biggest predictors of prostate cancer outcome. We did not detect survival differences between prostate cancer treatments when age, stage and grade were controlled. DISCUSSION/SIGNIFICANCE OF IMPACT: Individuals diagnosed and treated for prostate cancer within the Marshfield Clinic follow national trends with a decreased age of diagnosis with the advent of PSA screening. Treatment outcomes were comparable to national trends.

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HOW DOES MOTIVATION AFFECT POSTOPERATIVE WEIGHT LOSS?

Ahmed SM ¹, Kiely K², Higa J², Hernandez‐Boussard T², Morton J²

¹Stanford University, School of Medicine, Stanford, CA, USA; ²Stanford Univeristy School of Medicine, Department of Surgery, Stanford, CA, USA

OBJECTIVES/SPECIFIC AIMS: Few studies have examined patients’ motivations for undergoing bariatric surgery. We aim to determine the effects of readiness to change on postsurgical outcomes. METHODS/STUDY POPULATION: 116 consecutive patients undergoing bariatric surgery [gastric bypass (RYGB), laparoscopic gastric band (LGB) and sleeve gastrectomy (SG)] were administered questionnaires at preoperative and 6 months postoperative visits to assess motivation for surgery and readiness to change (University of Rhode Island Change Assessment, URICA). Data were analyzed with ANOVAs and Pearson’s chi‐squares as appropriate. RESULTS/ANTICIPATED RESULTS: Preoperatively, RYGB and SG patients were more confident of postoperative success than LGB patients ((RYGB, 94%; LGB, 84.5%; SG, 93.8%; p= 0.028). Across the surgery subtypes, there was no difference in RTC scores (RYGB, 11.5; LGB, 11.9; SG, 11.7; p= 0.60). There was a trending positive correlation between preoperative RTC score and 6 months excess weight loss (%EWL) (r= 0.19, p= 0.061). There was a significant decrease in RTC scores between preoperative and 6 month post op visits (10.7 vs 9.2, p < 0.01) and a significant positive correlation between this difference and % EWL at 6 months (r= 0.48, p < 0.01). For all procedures, there was a positive significant correlation between patient confidence of success at 6 months post op and % EWL at 6 months (r= 0.53, p < 0.01). DISCUSSION/SIGNIFICANCE OF IMPACT: This is the first study assessing the effects of readiness to change on postoperative outcomes across all surgery subtypes. RTC scores may affect short term weight loss. There was a significant change in RTC scores pre‐ and postoperatively, and this change is correlated with increased weight loss at 6 months post op. Identifying strategies to augment RTC may be useful in ensuring long term weight loss.

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NEEDS AND CONCERNS OF THE ELDERLY AND THEIR CAREGIVERS IN A RURAL SETTING IN VELLORE, SOUTH INDIA

Thomas M ¹, Vermund S¹

¹Vanderbilt University School of Medicine, Nashville, TN, USA

OBJECTIVES/SPECIFIC AIMS: The majority of India’s rural elderly are often neglected by their caregivers. The social support provided for the elderly population in the Sathumadurai village of Vellore, South India has not been studied previously. (1) To identify needs and problems of the elderly regarding social support. (2) To identify needs and problems of caregivers regarding relationships with the elderly. (3) To determine suggestions the elderly and caregivers have for improving quality of life in a rural setting. METHODS/STUDY POPULATION: This qualitative and cross‐sectional study was conducted in India, and the analysis was conducted at the Vanderbilt School of Medicine. Focus group discussions were conducted for groups of female caregivers, male caregivers, and female elderly. A questionnaire was administered to the elderly population to provide a larger perspective regarding elderly social support. RESULTS/ANTICIPATED RESULTS: One hundred sixty‐two questionnaires were returned by people age 60 and older with 0% missing information. When adjusting for other predictors, on average, social support decreased by 2.73 points when age increases from 62 to 72 and increased by 3.47 points when SES increases from 2 to 8.8. Social support was 2.78 points less for individuals with no income when compared to those with income. DISCUSSION/SIGNIFICANCE OF IMPACT: Rural elderly who were older, had a lower SES, or no income had decreased social support by caregivers. Collecting information regarding the needs of the elderly and their caregivers is vital to determining the services provided to these groups. An elderly daycare in the village was implemented as a result of this study.

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OBESITY, VITAMIN D DEFICIENCY AND CARDIO‐RENAL RISK FACTORS IN AFRICAN AMERICAN CHILDREN: NATIONAL HEALTH AND NUTRITION SURVEY 2002–2004 DATA

Chandramohan G ^1,2, Kermah D³, Norris K³

¹Harbor‐UCLA Medical Center, Torrance, CA, USA; ²Los Angeles Bio Medical Research Institute, Torrance, CA, USA; ³Charles Drew University of Medicine and Science, Los Angeles, CA, USA

OBJECTIVES/SPECIFIC AIMS: The recent data reveals prevalence of Vitamin D deficiency is higher than expected in children, particularly among the African American ethnicity. Prevalence of obesity is also high in this population. Thus, we looked at the interrelationship among obesity, vitamin D deficiency and various cardio‐renal (CR) risk factors independently and in clusters, in AA children. METHODS/STUDY POPULATION: A cross‐sectional analysis of children between the ages of 6–17 years from the National Health and Nutrition Survey conducted between 2002–2004 was performed. Serum 25 (OH)D deficiency was defined as < 30 ng/ml. Statistical analysis was done using SUDAAN software program. RESULTS/ANTICIPATED RESULTS: There were 1506 AA children, boys 51.4%, Tall 71.9%, obese 22.2%, high BP 9%, with dyslidemia 40.8% and those with high fasting blood sugar 5.7%. There were significant differences in the distribution and the mean of VitD level according to age, gender, obesity status and the lipid profile. Further, the odd ratio to have VitD deficiency was significant when obesity and high blood pressure were combined using statistical regression modeling, however, there was no association noted when nonobese and high BP were combined. When obese and normal BP were combined there was a significant association noted again. DISCUSSION/SIGNIFICANCE OF IMPACT: There was significant increase in the risk of vitD deficiency observed in obese children. This risk was 2 fold higher than the controls when obese children had high BP. Therefore, the risk of vitD deficiency is perhaps a nutritional rather than an inherited effect. These findings shed light into the pathophysiology of CR risk factors in this population.

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ORBITAL FRACTURE CLINICAL DECISION RULE DEVELOPMENT: BURDEN OF DISEASE AND USE OF A MANDATORY ELECTRONIC SURVEY INSTRUMENT

Ashwell Z ¹, Yadav K¹, Cowan E², Wall SP³, Gennis P²

¹GWU, Washington, DC, USA; ²Jacobi Med Ctr, Bronx, NY, USA; ³NYU SOM, New York, NY, USA

OBJECTIVES/SPECIFIC AIMS: In preparation to derive a clinical decision rule (CDR) to improve use of CT for diagnosing orbital fractures, the authors sought to estimate the annual incidence of orbital fractures in emergency departments (EDs) and the usage of computed tomography (CT) to make these diagnoses. The authors also sought to evaluate a mandatory electronic data collection instrument (EDCI) administered to providers to facilitate data collection. METHODS/STUDY POPULATION: National estimates were made by analyzing the 2007 NHAMCS database, while hospital system billing and coding data was used to make local estimates. An EDCI was integrated into the CT ordering system such that providers had to complete the form in order to perform a CT. Since the EDCI had to be filled out for every CT ordered, data collection efficiency was measured by compliance (counting the number of unrealistic data collection instrument answers), and by timing a convenience sample of providers completing the EDCI. RESULTS/ANTICIPATED RESULTS: Out of 116.8 million ED visits in the U.S. in 2007, 4.1 million patients were treated for injuries of the eye and face. Of those, 820,252 patients underwent CT imaging, with 102,999 patients (12.5%) diagnosed with an orbital fracture. In our local hospital system with 122,500 annual ED visits, 752 CT Orbits were performed, with 172 (23%) suffering orbital fractures. The EDCI compliance rate was 94.9%, and took less than 5 minutes to complete. DISCUSSION/SIGNIFICANCE OF IMPACT: National and local data demonstrate a low yield for CT imaging in identifying orbital fractures. Hands‐free data collection using a mandatory electronic data collection instrument linked to computerized provider order entry can provide prospective, consecutive patient data needed to develop a CDR for the selective use of CT imaging in orbital trauma.

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OUTCOMES IN CLOSTRIDIUM DIFFICILE TOXIN–/DNA+ DIARRHEA

Polage C ¹, Chin D¹, Leslie J¹, Solnick J¹

¹UC Davis, Sacramento, CA, USA

OBJECTIVES/SPECIFIC AIMS: Clostridium difficile (CD) is an important cause of healthcare associated diarrhea and death. Symptoms are due to toxin‐mediated injury. Immunity is associated with asymptomatic carriage. Observations that some patients with toxin‐ diarrhea have CD by culture or PCR and reports of rare toxin‐ patients with severe disease have led to calls for toxin tests to be replaced by DNA detection. We hypothesized that CD complications should be rare in toxin‐ patients and that most toxin–/DNA+ patients are immune carriers. As a preliminary test, we retrospectively determined the frequency of CD complications and duration of diarrhea among inpatients tested for CD toxins. METHODS/STUDY POPULATION: Medical records were reviewed for inpatient admissions with CD toxin test(s) 2005–2009. A convenience sample from 2009 had stool tested by CD PCR. All cause mortality and CD complications (e.g., colitis, megacolon, colectomy) were tabulated for 2005–2009. Diarrhea days (≥3 stools/day) were measured for 2009. RESULTS/ANTICIPATED RESULTS: For 2005–2009, 1107/7319 (15.1%) patients were toxin+ during 1247/8866 (14.1%) admissions. CD complications were documented in 6/1107 (0.5%) toxin+ and 2/6212 (0.03%) toxin‐ patients (p < 0.05). The 6 month all cause mortality rate was 14.4% (n= 180) for toxin+ patients vs. 9.5% (n= 727) in toxin‐ patients (p < 0.001). In 2009, toxin+ patients (n= 200) had 3.25 [95% CI 2.83, 3.67] diarrhea days versus 2.43 [2.31, 2.54] days in toxin‐ patients (n= 1495). Among 50 PCR tested patients, toxin+/DNA+ patients (n= 5) had 3.25 [1.57, 4.93] diarrhea days while toxin–/DNA+ (n= 19) and toxin–/DNA– patients (n= 26) had 2.44 [1.43, 3.45] and 2.52 [1.73, 3.32] diarrhea days. DISCUSSION/SIGNIFICANCE OF IMPACT: CD complications were rare. Toxin–/DNA+ patients may have less diarrhea than toxin+ patients. A prospective observational study is planned to measure outcomes in toxin+/DNA–, toxin+/DNA+, toxin–/DNA+, toxin–/DNA– inpatients with diarrhea.

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PATIENT‐CENTERED ONLINE MANAGEMENT OF PSORIASIS: A RANDOMIZED CONTROLLED EQUIVALENCY TRIAL

Chambers C ¹, Parsi K¹, Schupp C¹, Armstrong AW¹

¹UC Davis School of Medicine, Department of Dermatology, Sacramento, CA, USA

OBJECTIVES/SPECIFIC AIMS: Previous research suggests that technology‐enabled healthcare delivery may improve patient satisfaction, reduce costs, and improve access to dermatologic specialty care. Rigorous outcomes research utilizing validated outcomes measures are scarce, but necessary for adoption of novel healthcare delivery models. The purpose of this study was to compare the clinical equivalence of a novel patient‐centered online healthcare delivery model with standard in‐office care for the follow‐up management of psoriasis patients. METHODS/STUDY POPULATION: Sixty‐four participants with psoriasis were randomized to receive follow‐up care either in‐office or online over a 24‐week period. Clinically validated disease severity and quality of life measures, including the Psoriasis Area Severity Index (PASI), Investigator Global Assessment (IGA), and Dermatology Life Quality Index (DLQI) were used to assess the effectiveness of each care model. RESULTS/ANTICIPATED RESULTS: Both the in‐office and online groups showed improvement in psoriasis disease severity as measured by mean improvement in PASI after 24 weeks (online group: μ=–3.2, p < 0.0001, in‐office: μ=–2.6, p= 0.0015). No significant differences existed in the mean change in PASI between the two groups (Mean difference in PASI change = 0.6, 95% CI: –2.2 to 2.3, a priori delta = 2.5). IGA and DLQI scores also improved during the study period, and no significant differences existed between the in‐office and online groups (p= 0.7). DISCUSSION/SIGNIFICANCE OF IMPACT: Compared to traditional in‐office care, the patient‐centered online model resulted in similar improvements in psoriasis disease severity and quality of life. Patient‐centered online care can be an effective alternative to standard in‐office care for the follow‐up management of psoriasis.

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PATTERNS OF VERBAL DEFICITS IN CHILDREN WITH CHROMOSOMAL ABNORMALITIES

Sepelyak K ^1,2, Dunkin B¹, Hong D¹, Haas B¹, Reiss A¹

¹Center for Interdisciplinary Brain Sciences Research, Stanford, CA, USA; ²Stanford School of Medicine, Stanford, CA, USA

OBJECTIVES/SPECIFIC AIMS: Patients with Williams syndrome (WS) and Turner syndrome (TS) have characteristic cognitive deficits with selective sparing of verbal abilities. However, studies suggest that only some verbal abilities are spared while others are impaired. We aim to examine specific areas of verbal functioning to determine which are disproportionately impaired in children with WS and TS. METHODS/STUDY POPULATION: We have administered the Wechsler Scale of Intelligence for Children, Fourth Edition (WISC‐IV) and the NEPSY Developmental Neuropsychological Battery to 88 subjects ages 6 to 17 (6 WS boys, 7 WS girls, 49 TS girls, 26 typically developing (TD) girls). We are still recruiting and will be testing more WS and TD subjects. Specific verbal abilities tested include: vocabulary, similarities, meaning comprehension, phonological processing, speeded naming, and comprehension of instructions. Between‐group comparisons on verbal subscales will be conducted using multivariate analyses of covariance and linear regression models. RESULTS/ANTICIPATED RESULTS: Preliminary analysis confirms that there are significant differences in overall verbal abilities between the 3 groups (average verbal IQ is 92, 54, and 117, for TS, WS, and TD, respectively). TD subjects tend to perform consistently across verbal subtests. Qualitatively, girls with TS have slightly lower scores in phonological processing and speeded naming compared to their other subtest scores. Children with WS have disproportionately low scores in vocabulary, comprehension, and comprehension of instructions. DISCUSSION/SIGNIFICANCE OF IMPACT: The pattern of impairment of specific verbal abilities can offer clues about the root cause of the overall verbal deficit. It may also help therapists to utilize intervention approaches that are more tailored to their patients’ strengths and weaknesses.

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PERFORMANCE OF VISUAL METHODS FOR CERVICAL CANCER SCREENING AMONG HIV‐INFECTED WOMEN IN WESTERN KENYA

Huchko MJ ¹, Maloba M², Cohen CR¹, Bukusi E²

¹University of California, San Francisco, San Francisco, CA, USA; ²Kenya Medical Research Institute, Nairobi, Kenya

OBJECTIVES/SPECIFIC AIMS: Visual inspection–based methods for cervical cancer screening are being promoted in resource‐limited settings, albeit with limited evaluation in HIV‐infected women. Thus, we compared the performance of two visual inspection techniques among HIV‐infected women in Kenya. METHODS/STUDY POPULATION: Women underwent cervical cancer screening at the two hospital‐based HIV clinics in Kisumu. One site performed primary screening using visual inspection with acetic acid (VIA), while the other site performed visual inspection with Lugol’s iodine (VILI). Positive results on either screening exam were confirmed with colposcopy and cervical histology. Women in the VIA group were offered same‐day colposcopy. In the VILI group, women were given a return appointment on a different day in order to allow the iodine staining to fade. RESULTS/ANTICIPATED RESULTS: Between October 2007 and May 2010, 3,490 women underwent cervical cancer screening. There was no difference in average age (34.7 vs. 35.6), CD4+ T‐cell count (387/μL vs. 374/μL) or WHO stage between the women who underwent VIA versus those who underwent VILI. The overall test‐positive rate was 19% (452/2379) for VIA and 15% (132/1011) for VILI (p < 0.05). The positive predictive value of VIA for CIN2/3 was 34.5% and for VILI was 46% (p < 0.05). In the VIA group, 3 (0.7%) women did not undergo colposcopy, versus 17 (12.9%, p < 0.05) in the VILI group. DISCUSSION/SIGNIFICANCE OF IMPACT: VILI may be a superior method to VIA for diagnosis of CIN2/3 among HIV‐infected women in resource‐limited settings, although referral for colposcopy led to higher rates of loss‐to‐follow‐up. Validation of see‐and‐treat strategies using VILI should be explored to capitalize on the relatively high positive predictive value of this test.

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PILOT ANALYSIS OF RISK FACTORS FOR JOINT PAIN OVER 12 WEEKS IN WOMEN TAKING AROMATASE INHIBITORS

Castel LD ¹, Hartmann K¹, Deppen S¹, Mayer I¹, Johnson D², Boomershine C¹, Abramson V¹, Chakravarthy A¹, McLellan S¹, Friedman D¹, Cella D³

¹Vanderbilt University Medical Center, Nashville, TN, USA; ²University of Texas Southwestern Medical Center, Dallas, TX, USA; ³Northwestern University Feinberg School of Medicine, Chicago, IL, USA

OBJECTIVES/SPECIFIC AIMS: Over 100,000 breast cancer patients begin a 5‐year course of aromatase inhibitors (AIs) each year to prevent cancer recurrence. While AI‐related joint pain likely leads to nonadherence, adequate data on joint pain predictors and trajectories are needed. We studied joint pain over patients’ first 12 weeks of AI therapy. METHODS/STUDY POPULATION: Postmenopausal female outpatients initiating AI (N= 52) completed a baseline survey prior to AI initiation, and followup surveys every 2 weeks thereafter for 12 weeks. Pain was measured in 16 joints using a 0–10 numeric rating scale. Baseline risk factors assessed included performance status, physical function, comorbidities, menopausal symptoms, time since menopause onset, age, education, social support, and depression. Exploratory linear regression with clustered robust standard errors was used to analyze risk factors individually for worsening pain. RESULTS/ANTICIPATED RESULTS: Mean age was 61.7 years (SD = 9.6). Most women were fully active (n= 21) and not depressed (n= 47) at baseline. Mean worst pain in any joint prior to AI initiation was 2.7 (SD = 3.0). Women who had worse performance status (β= 1.1[0.3–1.9), more severe menopausal symptoms (β= 0.2[0.1–0.2]), worse physical function (β= 0.1[0.03–0.2]), or existing musculoskeletal comorbidities (β= 3.0[1.6–4.4]) at baseline had greater risk for increasing joint pain over 12 weeks. DISCUSSION/SIGNIFICANCE OF IMPACT: In measuring and describing joint pain over the course of AI therapy, findings from the Breast Cancer Adjuvant Therapy cohort are expected to help inform adherence interventions, toward ensuring the clinical effectiveness of AIs in preventing cancer recurrence.

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RURAL‐URBAN SURVIVAL DISPARITIES AMONG BREAST CANCER PATIENTS ELIGIBLE FOR POSTMASTECTOMY RADIATION THERAPY

Martinez SR ¹, Mayadev J¹, Canter RJ¹, Lara PN¹

¹UC Davis Cancer Center, Sacramento, CA, USA

OBJECTIVES/SPECIFIC AIMS: We previously reported that rural patients receive lower rates of postmastectomy radiation therapy (RT) relative to their urban counterparts. We hypothesized that rural patients would have poorer survival resulting from this disparity in use of RT. METHODS/STUDY POPULATION: We used the Surveillance, Epidemiology, and End Results database to identify BCa patients treated with mastectomy in Sacramento and its surrounding 13 counties between 2000 and 2006. Patients were without distant metastases and had tumors >5 cm size or ≥4 metastatic lymph nodes. A United States Department of Agriculture scale designated counties as rural or urban. Multivariate Cox proportional hazards models predicted all‐cause and disease‐specific mortality. Other than rural‐urban status, covariates included age, race/ethnicity, tumor size, tumor grade, hormone receptor status, number of nodal metastases, and use of RT. We further stratified our models for use of RT and county status. Risks of mortality were reported as hazard ratios (HR) with 95% confidence intervals (CI). RESULTS/ANTICIPATED RESULTS: Of 1,507 patients, about 39% did not receive RT and 56.5% were from urban counties. Multivariate analysis showed rural status did not influence OS (HR 0.94, CI 0.75–1.18; p= 0.61) or DSS (HR 0.92, CI 0.71–1.20; p < 0.56); patients not receiving RT had an increased risk of all‐cause mortality (HR 1.82, CI 1.43–2.32; p < 0.001) and disease‐specific mortality (HR 1.69, CI 1.27–2.24; p < 0.001). Among rural patients, lack of RT negatively influenced OS (HR 1.55, CI 1.07–2.25; p= 0.02) and DSS (HR 1.57, CI 1.02–2.42; p= 0.04). DISCUSSION/SIGNIFICANCE OF IMPACT: Rural status does not appear to be an independent predictor of OS or DSS. Our data indicate that the survival disparity noted among rural BCa patients may be due, in part, to decreased use of RT in rural populations.

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SOCIAL MECHANISMS OF TRANSDISCIPLINARY TEAMS

Lotrecchiano GR ^2,1

¹The George Washington University, Washington, DC 20010, DC, USA; ²Children’s Research Institute, Washington DC, DC, USA

OBJECTIVES/SPECIFIC AIMS: Determine social structuring mechanisms and how they emerge in Cross Disciplinary Team Science. METHODS/STUDY POPULATION: A descriptive case study on the identification of theoretical and emergent codes that describe the social interactions of actors part of networks charged with crossing disciplinary and social boundaries will be used. Sampling will be drawn from the National Urea Cycle Disorders Consortium. Data will be collected that is ultimately relevant to the network (macro) policy, team (meso) evaluation, and individual (micro) experience. A five phase approach will include a network level survey about competing and complimentary values, a national focus group, individual interviews, team observations, and a F2F local focus group. Sociograms will be created using Atlas.ti software, and an analysis using Linguistic Inquiry and Word Count (LIWC) software. RESULTS/ANTICIPATED RESULTS: A micro‐meso level analysis will consider the role of reciprocity in the shaping of identity in TD and diverse teams. This process allows for the micro level exchanges between actor agents and their respective disciplines. Within these relationships social mechanisms can be observed that are both the product of and contributors to knowledge creation and ultimately contribute to the macro level context. DISCUSSION/SIGNIFICANCE OF IMPACT: This study will test generally under tried theories of social dynamism and emergence embedded in CDTS. It will provide empirical inquiry into the definition and mechanisms of CDTS environments to inform how they can be maintained. The study will elucidate the role of interaction in the emergence of new knowledge through a focus on the micro‐meso relationships. These discoveries will prove critical in identifying natural conditions, policy creation, leadership characteristics, and training necessary for truly effective CDTS.

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SURVIVAL TREE ANALYSIS: BRANCHING OUT TO REFINE THE LUNG ALLOCATION SYSTEM

Gries CJ ¹, Landsittel DP¹, Pilewski JM¹

¹University of Pittsburgh, Pittsburgh, PA, USA

OBJECTIVES/SPECIFIC AIMS: The Lung Allocation System (LAS) model was developed using Cox regression to balance transplant urgency with transplant benefit. LAS poorly predicts posttransplant survival (1‐yr AUC = 0.58). Survival trees may provide a more clinically useful tool and may more accurately predict transplant survival as it yields interpretable subgroups and include interactions and nonlinear associations. The purpose of this study is to explore the utility of survival trees for assessing posttransplant survival in order to refine lung organ allocation. METHODS/STUDY POPULATION: Lung transplant recipient transplanted between 1998–2009 were identified in the Organ Procurement and Transplantation Network database. Multiple imputation was performed for missing data. Survival trees were fit in R statistical software to formulate a prognostic model of transplant survival over 5 years. RESULTS/ANTICIPATED RESULTS: Survival tree analysis provided comparable results to existing models with a highly significant results (p < 0.01) and a hazard ratio of 1.6 between the best and worst subgroups, but also offered a more clinically interpretable model based on specific patient subgroups, rather than weighted linear combinations. Preliminary results reveal significant predictors of 5 year survival occured at split points such as wedge pressure of 12 mmHg, O2 of 2.5 L, age of 63 years and several values of cardiac output. DISCUSSION/SIGNIFICANCE OF IMPACT: Subsequent analyses should explore ensemble models and resampling approaches to further improve the prognostic value of tree models. The use of this approach should be considered in further refinements of the LAS given its clinical interpretation and potential for fitting more complex relationships.

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THE ASSOCIATION BETWEEN DEEP VEIN THROMBOSIS AND DEHYDRATION IN NEUROREHABILITATION STROKE AND BRAIN INJURY PATIENTS—A RETROSPECTIVE STUDY

Oranusi V ^1,2, Shaheen M²

¹Rancho Los Amigos National Rehabilitation Center, Los Angeles, CA, USA; ²Charles Drew University, Los Angeles, CA, USA

OBJECTIVES/SPECIFIC AIMS: The aim is to study the association between DVT and dehydration, and identify risk factors for DVT in patients admitted for rehabilitation following an acute stroke or Brain injury. METHODS/STUDY POPULATION: Retrospective review of computerized medical records of patients discharged from Los Angeles County Neurorehabilitation Center with Diagnosis of DVT and Acute Stroke or Brain injury (traumatic, intracranial hemorrhage, and Hypoxic) from 1/2007 to 12/2009. Included are patients who have been diagnosed with DVT during their admission for inpatient rehabilitation. All patients have received appropriate DVT prophylaxis per recommendation of American Stroke association and have documented FIM scores for Locomotion by a physical therapist during admission at the center as an assessment of severity of impairment. Patients who were previously diagnosed with DVT prior to admission to center or those with hypercoagulability will be excluded. Presence of dehydration will be assumed if patient has laboratory evidence of Prerenal azothemia (defined as a BUN/Cr ratio of greater than 20 to one) and or presence of hemoconcentration. Included also are demographics, insurance status, length of stay, and mortality. DATA ANALYSIS: Descriptive and bivariate analysis. Using multivariate logistic regression, the association between DVT and dehydration as well as with other risk factors in debilitated and/or paralyzed stroke or BI patients during inpatient rehabilitation will be determined. RESULTS/ANTICIPATED RESULTS: In progress. DISCUSSION/SIGNIFICANCE OF IMPACT: Dehydration is often seen in patients admitted for neurorehabilitation after stroke or brain injury; however the role of dehydration as a major risk factor for DVT in patients who received appropriate DVT prophylaxis has not been emphasized.

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THE EFFECT OF PREOPERATIVE RADIOTHERAPY ON COMPLICATION RATE AFTER MICROSURGICAL HEAD AND NECK RECONSTRUCTION

Momeni A ¹, Kattan AS²

¹Stanford University Plastic/Reconstructive Surgery, Stanford, CA, USA; ²Stanford University School of Medicine, Stanford, CA, USA

OBJECTIVES/SPECIFIC AIMS: The introduction of radiotherapy (XRT) has resulted in increased survival of patients diagnosed with head and neck malignancies. However, the potentially deleterious impact of radiotherapy on reconstructive efforts continues to be the subject of intense debate. The present study was designed to evaluate the effects of preoperative radiotherapy on complication rates in patients undergoing microsurgical reconstruction of head and neck defects after oncosurgical resection. METHODS/STUDY POPULATION: A retrospective cohort study was conducted of all patients who underwent immediate microsurgical reconstruction of postablative defects over a 3‐year period. Study subjects were divided into two groups: Group 1: those who did not receive XRT, and Group 2: those who received preoperative XRT. Parameters retrieved and analyzed included age, gender, comorbid conditions, tobacco history, presence of recurrent disease, ischemia time, ICU and hospital stay, as well as postoperative complications. Complications were further classified as flap‐related as well as “medical.”RESULTS/ANTICIPATED RESULTS: A total of 60 patients were included in this study (Group 1: 26 patients; Group 2: 34 patients). Results were similar between the study groups with the exception of a higher rate of flap‐related complications in patients undergoing radiotherapy. A total of 19 patients (31.7%) experienced flap‐related complications with 12% of patients being in Group 1 (N= 3) vs. 47% of patients in Group 2 (N= 16) (p= 0.003). DISCUSSION/SIGNIFICANCE OF IMPACT: Our data suggest that preoperative radiotherapy is associated with a significant increase in postoperative flap‐related complications. As no firm evidence exists as to the whether pre‐ or postoperative radiotherapy is advantageous, we propose postoperative radiotherapy whenever possible.

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THE USE OF TELEMEDICINE FOR QUANTITATIVE ASSESSMENT IN BATTEN DISEASE

Cialone J ¹, Augustine EF¹, Newhouse N¹, Vierhile A¹, Marshall FJ¹, Rothberg PG¹, Mink JW¹

¹University of Rochester, Rochester, NY, USA

OBJECTIVES/SPECIFIC AIMS: Batten disease is an inherited rare neurodegenerative disease of childhood. The Unified Batten Disease Rating Scale (UBDRS) is a reliable research tool designed to quantify disease progression, but was designed for in‐person administration. Our objective was to determine the validity of the UBDRS and assess the reliability and feasibility of telemedicine administration of the UBDRS subjects with juvenile Batten disease (JNCL; CLN3 disease). We hypothesized that the UBDRS is a valid tool that can be administered reliably by telemedicine. METHODS/STUDY POPULATION: UBDRS validity was assessed in 80 subjects with JNCL. The reliability of tele‐administration of the UBDRS was evaluated in 8 subjects. RESULTS/ANTICIPATED RESULTS: Both the physical (r= 0.73, p < 0.001) and capability subscales (r= 0.73, p < 0.001) of the UBDRS correlated strongly with age. The physical subscale correlated with the capability subscale (R=–0.84, p < 0.001), but did not correlate with the behavior subscale (R=–0.02, p= 0.85). These results demonstrate face, convergent, and discriminative validity. Correlation between raters in telemedicine administration of the UBDRS physical subscale was 0.95 (p < 0.01), indicating excellent reliability. DISCUSSION/SIGNIFICANCE OF IMPACT: The UBDRS is a valid instrument in Batten disease. Our results indicate that it is feasible to administer the UBDRS reliably with telemedicine. Telemedicine can be a useful research tool in rare neurological disease research.

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USE OF ELECTRONIC HEALTH RECORD DATA IN CLINICAL RESEARCH

Sharp J ¹

¹Cleveland Clinic, Cleveland, OH, USA

OBJECTIVES/SPECIFIC AIMS: With the increased use of electronic health records (EHRs), there is a growing opportunity for secondary use of this clinically rich data in research. Four use cases will be presented. While challenges exist with this type of data, there are distinct advantages to using this data in several research contexts. METHODS/STUDY POPULATION: A review of the recent literature on secondary use of EHR data shows four major use cases: (1) research subject recruitment, (2) disease registries, (3) comparative effectiveness research, and (4) to record adverse events for postmarketing evaluation of drugs and devices. RESULTS/ANTICIPATED RESULTS: Some of the studies represent early pilot work with full utilization of secondary data yet to come; this is particularly true in research subject recruitment. Research registries is the most mature of these uses with many medical centers actively maintaining registries and clinical data respositories for research. Comparative effectiveness research is a newer phenomenon but important from a funding standpoint, likely to produce more secondary use. Drug and device safety is a high priority but few studies have examined this issue from using EHR data. DISCUSSION/SIGNIFICANCE OF IMPACT: Secondary use of EHR data in research is a growing branch of medical informatics. As EHRs propagate, there are also increase societal concerns about privacy and security which must be addressed. The federal incentives to adopt EHRs and the Meaningful Use requirements may enhance the potential of use of EHR data in research.

TRANSLATIONAL BASIC‐TO‐CLINICAL ABSTRACTS

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BRCA1 METHYLATION IS A MARKER OF TRIPLE NEGATIVE AND BASAL‐LIKE BREAST CANCERS

Grushko T ¹, Nwachukwu C¹, Prat A², Huo D¹, Xu J¹, He X², Charoenthammaraksa S¹, Wei M¹, Nanda R¹, Perou CM², Olopade OI¹

¹University of Chicago, Chicago, IL, USA; ²University of North Carolina, Chapel Hill, NC, USA

OBJECTIVES/SPECIFIC AIMS: Triple negative (TN) breast cancers are aggressive and overrepresented in young patients and women of African ancestry. Basal‐like (BL) tumors, a subset of sporadic TN tumors, share morphological and gene expression features with tumors from BRCA1‐mutation carriers, suggesting similar aberrations affecting BRCA1. We explore BRCA1 inactivation and its association with TN and the BL subtype. METHODS/STUDY POPULATION: Using MSP and immunohistochemistry, 202 primary breast cancers, including 107 African Americans were analyzed for BRCA1 promoter methylation and expression of ER, PR, HER2, EGFR and cytokeratins 5/6. Intrinsic molecular subtyping was evaluated by cDNA microarrays. Tumor subtypes were correlated with BRCA1 methylation and clinicopathologic features. RESULTS/ANTICIPATED RESULTS: Among 198 breast cancers, 28% were TN. BRCA1 methylation was detected in 43% of TNs and 17% of non‐TNs (p < 0.001). Proportion of BRCA1 methylation differed by subtype (p < 0.01) and was highest in the BL tumors. Interestingly, BRCA1‐methylated TN tumors had better outcome than unmethylated TN tumors (p= 0.034). Gene expression data confirmed BRCA1‐methylated cases fall in the BL subtype, and show lower BRCA1 and higher PARP1 mRNA expression compared to all other tumors. DISCUSSION/SIGNIFICANCE OF IMPACT: BRCA1 inactivation via promoter methylation occurs in half of sporadic TN and BL tumors and may be an early event in the development of a subset of these tumors, as observed in BRCA1‐mutation carriers. Our findings justify PARP inhibition strategy for treatment and/or prevention of hereditary and sporadic BRCA1‐deficient TN and BL breast cancers. Supported by HCI K12CA139160 and P50‐CA58223–09A1.

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A CO‐CLINICAL TRIAL PLATFORM FOR PERSONALIZED LUNG CANCER THERAPY

Li T ¹, Desai S¹, Calhoun RF¹, Cooke DT¹, Kudere V¹, Tepper C¹, Davis R¹, Beckett LA¹, Mack P¹, Lara, Jr. PN¹, Gandour‐Edwards R¹, Goodwin N¹, Gandara DR¹

¹UC Davis, Sacramento, CA, USA

OBJECTIVES/SPECIFIC AIMS: A novel co‐clinical trial strategy (concurrent evaluations of patients and patient‐derived xenografts [PDXs] in immunodeficient NSG mice) will be validated as a platform in personalized cancer therapy. METHODS/STUDY POPULATION: Utilizing a transdiciplinary research collaboration between the UCD Cancer Center and The Jackson Laboratory, we have generated non–small cell lung cancer (NSCLC) PDXs in NSG mice which we will use to correlate tumor drug response in mice and corresponding patients. Responses/nonresponses in patients and serially passaged PDX tumors will be molecularly characterized (mutations, RT‐PCR, microarray gene expression) and compared with. RESULTS/ANTICIPATED RESULTS: As of August, 21 of 35 engrafted NSCLC tumors were engrafted for at least 3 months; 15 of these tumors (71%) entered log phase growth. Seven first human‐to‐mouse generation (P0) tumors have been subjected for histomorphological and genomic analyses and passaged to first mouse‐to‐mouse (P1) tumors. Six tumors were discontinued as they showed no progressive tumor growth in a 9‐month incubation time. Our preliminary data suggest that the NSG mouse model provides a superior engraftment rate of 71% compared to other available mouse models, with a good histomorphological correlation between PDX tumors and original human NSCLC tumor. Further molecular and genomic data are being analyzed. DISCUSSION/SIGNIFICANCE OF IMPACT: To our knowledge, this is the largest cohort of NSCLC PDX models yet established. Further characterization is needed to define their role as a clinical relevant research platform for selecting and validating clinically relevant drug target(s) for individual patients based on molecular biomarker profiling and in vivo drug testing.

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A PATHOGENESIS BASED ADJUVANT THERAPEUTIC FOR BISPHOSPHONATE‐ASSOCIATED OSTEONECROSIS OF THE JAW (BON)

Scheper M ¹, Weikel D¹, Almubarak H¹, Zhang M¹, Brahim J¹, Meiller T¹

¹University of Maryland and Greenebaum Cancer Center, Baltimore, MD, USA

OBJECTIVES/SPECIFIC AIMS: The purpose of this translational study was to investigate the role a high calcium phosphate (CaPO4) therapy has in neutralizing local acidic pH, inducing BP scavenging and inhibiting connective tissue fibrosis; to reduce the effect zoledronic acid (ZA) has on oral soft tissues. METHODS/STUDY POPULATION: Saliva from patients using or not using a BP; and with or without BON was measured for pH. Fibroblast and keratinocyte cell lines were exposed to ZA (0.5–10 μM), acidity 5.5 to 7.0 pH and high CaPO4 solution. We used visual inspection; TUNEL; immunohistochemistry; survivin, caspase 3, cleaved caspase 9 and Ki‐67 expression; MTS; scratch migration; and flow cytometry assays to measure the effects of ZA and ZA plus CaPO4. RESULTS/ANTICIPATED RESULTS: The results shown that patients with BON have more acidic saliva than those taking a BP without BON or in those not taking a BP. Additionally, immunohistochemistry and Western blot shows the soft tissue surrounding BON lesions overexpress caspase 3. A dose dependent response effect on apoptosis, cell proliferation and cell cycle was observed with increasing ZA concentrations. Finally, we have shown that ZA and acidity induce a conversion of fibroblasts to myofibroblasts, possibly inducing a localized fibrotic impairment of wound healing. Overall, CaPO4 therapy reversed salivary acidity, the in vitro effects of ZA, and the conversion to myofibroblasts. DISCUSSION/SIGNIFICANCE OF IMPACT: The combined results from this study demonstrate that the effect ZA and BON have on salivary acidity; soft tissue apoptosis, cell proliferation; and conversion to myofibroblasts can be reversed by using a supersaturated CaPO4 solution, supporting the potential role of CaPO4 as an adjunct therapy for BON by facilitating soft tissue healing.

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ABSENCE OF DYSTROPHIN COMPROMISES THE PASSIVE PROPERTIES OF THE EXTENSOR DIGITORUM LONGUS MUSCLE IN MICE

Hakim C ¹, Duan D¹

¹University of Missouri, Columbia, MO, USA

OBJECTIVES/SPECIFIC AIMS: Absence of dystrophin, a cytoskeletal protein, causes Duchenne muscular dystrophy (DMD). DMD is a lethal muscle wasting disease that affects 1:3500 boys. In dystrophin deficient muscle, the sarcolemma gets damage by contraction force. Subsequent, the muscle undergoes a pathological change where muscle cell is replaced by fibrotic tissues. Little is known about the passive properties of the dystrophin‐deficient muscle. Here, we hypothesize that the change in muscle pathology renders the muscle stiffer. Dystrophin is also highly expressed at the muscle‐tendon junction (MTJ). Thus, we further hypothesize that dystrophin deficiency compromises the MTJ strength. METHODS/STUDY POPULATION: To test these hypotheses, we examined the stress‐strain response in the extensor digitorum longus (EDL) muscle of mdx mouse, a mouse model for DMD. RESULTS/ANTICIPATED RESULTS: At the ages of 2, 6, 14 and 20 months, the mdx EDL muscles were significantly stiffer than those of age‐matched normal controls. Further, the mdx EDL muscle showed a higher relaxation rate. In normal and ≤6‐m‐old mdx mice, muscle failure occurred within the muscle. Interestingly, in ≥14‐month‐old mdx, the muscle failed at the proximal MTJ. Electron microscopy revealed substantial MTJ degeneration in aged but not young mdx mice. DISCUSSION/SIGNIFICANCE OF IMPACT: In summary, our results suggest that the passive properties of the EDL muscle and MTJ strength are compromised in mdx. More importantly, the increase of muscle stiffness could contribute to the immobilization observed in DMD patient. Our findings open the door to investigate whether novel gene/cell/pharmacological therapies can halt the deterioration of the passive properties and improve mechanical function.

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ACTIVATION OF THE THALAMO‐CORTICAL ALERTING NETWORK IN ATTENTION‐DEFICIT/HYPERACTIVITY DISORDER

Clerkin S ¹, Tang C¹, Halperin J^2,1

¹Mount Sinai School of Medicine, New York, NY, USA; ²Queens College – CUNY, Flushing, NY, USA

OBJECTIVES/SPECIFIC AIMS: We utilized functional magnetic resonance imaging (fMRI) to test a neurodevelopmental model of ADHD, which posits that deficits in subcortical alerting/arousal mechanisms contribute to the development of ADHD and remain present in adulthood, regardless of symptom remission. METHODS/STUDY POPULATION: A longitudinal sample of 25 probands who were diagnosed with ADHD in childhood and 25 controls were clinically evaluated and scanned using fMRI. We utilized a cued reaction time (RT) task that evokes activation within subcortical and cortical regions of the brain associated with alerting. Cue‐related activation was compared between controls and probands, and probands were further divided into ADHD persisters and remitters. Significance was set at p < 0.01, uncorrected; k= 100. RESULTS/ANTICIPATED RESULTS: Adults with ADHD and controls activated similar brain regions during alerting, however, controls demonstrated greater activation in the supplementary motor area (SMA), anterior cingulate (ACC), and dorsolateral prefrontal cortex. Both remitters and persisters differed from controls in activation of these regions; however, activation in remitters did not differ significantly from persisters. Conclusions: The differences observed in SMA, ACC, and DLPFC suggests subtle discrepancies in the alerting system among young adults with and without a childhood diagnosis of ADHD. In addition differences in brain activation did not differ between those who demonstrated symptom persistence or remittance. DISCUSSION/SIGNIFICANCE OF IMPACT: These data provide preliminary support for the tested neurodevelopmental model of ADHD, and identify a neural system that can be targeted for treatment.

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ACTIVITY PATTERNS OF ADULTS WITH PREDIABETES IN THE RAPID STUDY

Hays LM ¹, Saha C², Harris F², Ackermann RT²

¹Indiana University School of Nursing, Indianapolis, IN, USA; ²Indiana University School of Medicine, Indianapolis, IN, USA

OBJECTIVES/SPECIFIC AIMS: At least 57 million Americans have prediabetes, placing them at high risk for developing type 2 diabetes. Weight loss and physical activity have been shown to prevent or delay type 2 diabetes. This study describes baseline physical activity (PA) patterns using an objective measure of PA (accelerometry) of adults with prediabetes enrolled in an ongoing RCT. Baseline PA is described and relationships between demographic variables and PA are examined. METHODS/STUDY POPULATION: Participants were recruited from primary care clinics and were mostly female (72%), African American (57%) with a mean age of 52 years (SD 12). Mean BMI was 37 kg/m2 (SD 8.3). Relationships between race, gender, age, and PA were explored using Wilcoxon rank‐sum test and Spearman rank correlation tests. RESULTS/ANTICIPATED RESULTS: Of the 353 participants who were asked to wear a monitor for 7 days, 93 (26%) wore the monitor for 7 days, 169 (48%) for 4–6 days, 64 (18%) for 1–3 days, and 27 (8%) for 0 days. Sixty‐four percent of subjects with 4 or more valid days of monitor wear (n= 262) engaged in 0 minutes of moderate or vigorous PA. The remaining 36% had a median time of 6.4 min/day (Q1‐Q3: 2.7–18.9 min/day). Only 14 participants (4%) met PA recommendations of 30 or more minutes of moderate intensity PA on at least 5 of 7 days. PA declined with increasing age (r=–0.31 p < 0.001). There were no significant differences in daily PA between males and females or between African American and non‐Hispanic white participants. DISCUSSION/SIGNIFICANCE OF IMPACT: Although challenging to implement in a community‐based trial, accelerometers demonstrate the low levels of PA among subsegments of underserved populations with prediabetes. Given these results, there may be tremendous opportunities to prevent diabetes more effectively through efforts that maximize regular PA.

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APOPTOTIC ROLE OF NOTCH‐NFKB PATHWAY IN T‐ALL THERAPEUTIC RESPONSE

Riz I ¹, Hawley RG¹

¹Clinical and Translational Science Institute at Children’s National and George Washington University Medical Center, Washington, DC, USA

OBJECTIVES/SPECIFIC AIMS: Relapse is a major problem in acute lymphoblastic leukemia (ALL), the most common cancer among children. Elevated expression of NFkB target genes was associated with increased ALL relapse. NFkB regulates survival, migration and invasiveness of cancer cells – important features contributing to relapse – and thus NFkB inhibition was suggested to be included to existing therapeutic protocols. On the other hand, there are examples indicating that intracellular stress activates NFkB pro‐apoptotic function. Anticancer drugs often cause such stress, for instance, DNA damage response. We asked how NFkB function is altered by intracellular stress induced by conventional anti‐ALL therapy and whether inhibition of NFkB benefits current protocols. METHODS/STUDY POPULATION: FACS, qRT‐PCR, siRNA, confocal microscopy, immunoprecipitation, mass spectrometry. Cell cultures with or without stromal cell feeder layers and leukemic mice. RESULTS/ANTICIPATED RESULTS: Our data indicate that inhibition of NFkB or NOTCH1, a developmental factor activating NFkB in T‐ALL, decreased cell death induced by etoposide, bortezomib or vincristine. We provide a mechanistic explanation to clinical observations showing lack of improvement from additional courses of treatment combining dexamethasone (partially acts via inhibition of NFkB) and vincristine (induces stress associated with mitotic perturbations). However, we suggest that it is still important to inhibit the cell migration and invasion arms of NOTCH and NFkB activities. We therefore propose to focus on the downstream target genes involved in these processes, such as CCR7. DISCUSSION/SIGNIFICANCE OF IMPACT: Understanding the NFkB response to chemotherapy will help to design a more effective combination strategy that will prevent relapse.

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ASSESSMENT OF A PORCINE DIAPHRAGM AND GOLD NANOMATERIAL COMPOSITE FOR WOUND HEALING

Cozad M ¹, Bachman S², Grant S¹

¹University of Missouri Dept of Biological Engineering, Columbia, MO, USA; ²University of Missouri Dept of General Surgery, Columbia, MO, USA

OBJECTIVES/SPECIFIC AIMS: The purpose of this study was to assess the biocompatibility of a diaphragm and gold nanomaterial composite and determine its ability to promote cell attachment and proliferation for wound healing. METHODS/STUDY POPULATION: Porcine diaphragms were collected, decellularized, and cross‐linked to gold nanorods (AuNR) and nanoparticles (AuNP) at various concentrations. Scanning electron microscopy (SEM) was used to evaluate scaffold morphology and confirm the presence of gold nanomaterials. Cell Proliferation Reagent WST‐1 was used to assess the viability of cells on the composites relative to decellularized scaffolds. The LIVE/DEAD Viability/Cytotoxicity Kit was used to visualize cell attachment and morphology. Enhancement of L‐929 proliferation was assessed using Quant‐iT PicoGreen dsDNA Reagent. Ability of the composites to reduce the number of free radicals was measured using the OxiSelect ROS Assay Kit. RESULTS/ANTICIPATED RESULTS: SEM images depicted gold nanomaterials dispersed on a diaphragm microstructure that was maintained throughout the cross‐linking process. Cross‐linked, AuNP‐1X, and AuNP‐4X were as biocompatible as Decellularized while AuNR‐1X was less biocompatible than Crosslinked. Confocal microscopy images depicted proper cell morphology and an increase in the number of attached cells. AuNR‐1/2X showed an initially higher cell population while AuNP‐1X and AuNP‐4X showed greater proliferation. Increasing AuNP concentrations on the composites resulted in increasing free radical levels. DISCUSSION/SIGNIFICANCE OF IMPACT: The diaphragm and gold nanomaterial composites used demonstrated good biocompatibility, cell attachment and proper morphology, and enhanced cell proliferation with free radical generation being dependent on particle shape and concentration.

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BAR‐CODED SMALL RNA DEEP SEQUENCE PROFILES OF URINE CELL AND EXOSOME MICRORNA

Ben‐Dov IZ ¹, Brown M¹, Whalen VM¹, Tuschl T¹

¹The Rockefeller University, New York, NY, USA

OBJECTIVES/SPECIFIC AIMS: We aimed to develop an inexpensive method to profile miRNA in urine for biomarker identification. METHODS/STUDY POPULATION: Duplicate 50 ml urine samples were obtained from 20 volunteers. RNA was extracted from cells and from ultra‐filtered exosome preparations. One cDNA library was transcribed from 20 bar‐coded samples. Synthetic RNA was included for calibration, and miRNA profiles were based on read frequencies. RESULTS/ANTICIPATED RESULTS: Participants’ age was 23–31 years. Medical history, physical examination and laboratory evaluation were normal. Cells in urine were scarce and median RNA recovery was 10 ng per 50 ml, while exosomes yielded additional 80 pg RNA per sample. On average, 440,000 reads were recovered per sample, miRNA constituting 31%. MiRNA differed in cells and exosomes, but a more striking difference was noted between genders. An unexpected finding involved the abundance of miR‐124 and miR‐9, both considered brain‐specific. In addition, miR‐320a, also found in neurons, was the most abundant miRNA in urine yet differed between genders and between urine fractions. Test‐retest variability (r= 0.67) was lower than between‐subject variability (r= 0.39 for exosomes and 0.57 in cells). DISCUSSION/SIGNIFICANCE OF IMPACT: Our study shows the feasibility of multisample urine miRNA profiling by bar‐coded sequencing. Meaningful profiles are observed despite minute amount of RNA. The observed variability, presumably due to differences in cell populations, suggests a role for urine miRNA as biomarkers of disease progression and response to treatment, but also as a diagnostic aid.

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BDCA‐1 EXPRESSION DEFINES FUNCTIONALLY DISTINCT SUBSETS OF HUMAN MYELOID DENDRITIC CELLS

Gupta MR ¹, Kolli D¹, Garofalo RP¹

¹UTMB, Galveston, TX, USA

OBJECTIVES/SPECIFIC AIMS: Dendritic cell (DC) populations are defined by lineage and expression of blood dendritic cell antigens (BDCA). Expression of either BDCA‐3 or BDCA‐1 identifies subsets of human myeloid dendritic cells (mDC). Genomic array studies link BDCA‐3+ to murine CD8a+ and BDCA‐1+ to murine CD11b+ mDCs. Based on known functions of murine DCs, subsets are thought to play distinct roles in immune regulation,but human mDCs studies are limited. Using FACS sorting and analysis,we isolated 2 distinct mDC subsets from peripheral blood to study cytokine response to in vitro incubation with TLR agonists and CD40L. METHODS/STUDY POPULATION: Peripheral blood mononuclear cells (PBMCs) were isolated from blood of healthy adult donors by Ficoll‐hypaque density centrifugation. PBMCS were DC enriched by depletion of lineage positive cells with magnetically labeled microbeads and stained with flourochrome conjugated antibodies for FACS sorting and analysis. CD11c+ cells were sorted by expression of BDCA‐3+,BDCA‐1+ or BDCA‐3+,BDCA‐1– and incubated in 96‐well plates with CD40L,Poly I:C,LPS,ssRNA or media for 48 hrs. The cell free supernatant was analyzed for cytokines. RESULTS/ANTICIPATED RESULTS: We found all mDCs expressed BDCA‐3 yet differed in BDCA‐1 expression. Similar to CD8a+ DCs, gene expression of CLEC9A and XCR1 was identified by rtPCR in BDCA‐1– DCs. BDCA‐1+ and BDCA‐1– DCs demonstrated differential cytokine production in response to agonist. Moreover, incubation with CD40L and poly I:C induced more robust cytokine responses from BDCA‐1+ DCs,while LPS and ssRNA induced greater responses from BDCA‐1– DCs. DISCUSSION/SIGNIFICANCE OF IMPACT: We show that BDCA‐1 expression defines functionally distinct mDC subsets. These data suggest their roles in immune regulation may be determined by the agonist rather than cell type. The preferential response of cell types to different agonists is also likely important in immune responses to pathogens.

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BIOABSORBABLE STENTS FOR INTERIM RELIEF OF PULMONARY ARTERY STENOSIS IN A PRECLINICAL PEDIATRIC MODEL

Breinholt JP ¹, Sturek M¹

¹Indiana University School of Medicine, Indianapolis, IN, USA

OBJECTIVES/SPECIFIC AIMS: (1) Determine the time course and severity of pulmonary artery stenosis (PAS) elicited by intravascular injury methods. (2) Determine the histology of stenotic pulmonary arteries after stent‐induced dilation and stent bioabsorption. (3) Evaluate vessel growth after stent bioabsorption. METHODS/STUDY POPULATION: We will generate a novel model of PAS in juvenile pigs using an intravascular balloon that delivers a vessel sclerosant to simulate disease. The stent will be implanted at the lesion site and monitored by ultrasound and intermittent angiography. After stent bioabsorption, histologic vessel changes from dilation injury and healing will be evaluated. One cohort will be monitored for 6 months post–stent dissolution to evaluate the somatic growth of the disease segment after intervention. RESULTS/ANTICIPATED RESULTS: We anticipate that bioabsorbable stents will alleviate PAS. Some recoil may occur as the stent dissolves, but healing while the stent is intact will result in a larger vessel diameter. We further hypothesize that later somatic growth will be inhibited by scarring that occurs as the result of angioplasty injury. DISCUSSION/SIGNIFICANCE OF IMPACT: Balloon expandable stents are manufactured for adult use. Currently, stents intended for biliary or renal applications are placed in large vessels of children, but can be too large or rigid for smaller patients. Coronary stents developed for small arteries can fit the large vessels of small children, but cannot be further dilated to accomodate somatic growth. Bioabsorbable coronary stents can be implanted in locations that will undergo growth. Prior to creating a narrowing from surrounding somatic growth, the stent dissolves and prevents the need for later surgical intervention.

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CAPSULAR SWITCHING ENHANCES VIRULENCE OF EMERGING STREPTOCOCCUS PNEUMONIAE SEROTYPE 6C IN EXPERIMENTAL OTITIS MEDIA (EOM)

Sabharwal V ¹, Stevenson A¹, Figueira M¹, Pelton SI¹

¹BMC, Boston, MA, USA

OBJECTIVES/SPECIFIC AIMS: Capsular switch events in which a pneumococcal strain is the recipient of the capsule operon from a donor strain of a different capsular serotype have been described with increasing frequency following the introduction of PCV7. These capsular switch events enable pneumococci to acquire new phenotypic traits through natural transformation. Thus, vaccine serotype chassis with acquired non vaccine capsules, creating new combinations with increased virulence compared to the original strain, may be created. We compared the capacity of serotypes 6A wt, 6C wt, and 6A‐C capsular transformant to produce EOM in a chinchilla model. METHODS/STUDY POPULATION: A virulent 6A and non virulent 6C strain were used to create a capsular transformant with the 6A chassis and the 6C capsule. The 6A wt, 6C wt and the 6A‐C strains were compared by PFGE. Complement (C3) binding, using flow cytometry, was measured for each of the strains. Virulence was determined in the chinchilla EOM model, which employs initial nasopharyngeal colonization followed by barotrauma. The proportion of chinchillas that developed culture positive EOM, density of middle ear infection and proportion of chinchillas with bacteremia were compared. RESULTS/ANTICIPATED RESULTS: The 6A‐C and the 6A wt were identical on PFGE. The 6A‐C bound less complement compared to 6C wt. EOM was found in 15/22 (68%) ears challenged with 6A‐C transformant compared to 4/32 (12.5%) with 6Cwt [p= 0.00003]. Disease due to 6C wt was characterized by low density infection (˜10E2) when compared 6A‐C transformant (˜10E4) and 6A wt (˜10E5). DISCUSSION/SIGNIFICANCE OF IMPACT: The capsular transformant 6A‐C demonstrates reduced C3 binding and increased virulence (both proportion of ear infected and density of infection) compared to 6C wt confirming the potential of capsular switch events to result in new phenotypes.

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CBT MOBILEWORK: A TECHNOLOGICAL SOLUTION TO IMPROVE DEPRESSION OUTCOMES

Callan JA ¹, Dunbar‐Jacob J¹, Rotondi A¹, Siegle GJ¹, Spring M¹, Dey A²

¹University of Pittsburgh, Pittsburgh, PA, USA; ²Carnegie Mellon University, Pittsburgh, PA, USA

OBJECTIVES/SPECIFIC AIMS: (1) demonstrate the use of CBT MobileWork; (2) present data evaluating the functionality and usability of the CBT MobileWork intervention in a controlled setting with unipolar depressed patients receiving CBT; and (3) present data from heuristic interviews with experienced CBT therapists to examine the therapeutic comprehensiveness, potential problems, and likelihood of success in a depressed population. METHODS/STUDY POPULATION: Dr. Callan and associates are now developing and testing CBT MobileWork to provide a solution to the barriers that depressed patients experience in completing these assignments. CBT MobileWork, is a smartphone application for the completion of common CBT homework assignments “on the go.” Dr. Callan and her colleagues have conducted iterative usability testing to refine the prototype to enhance usability and satisfaction of the application in 8 depressed patients in CBT and 5 CBT therapists. RESULTS/ANTICIPATED RESULTS: Ratings of Icons indicate lower ratings of Monitoring homework for both patients and therapists; lower ratings for E‐Mail Icon and Activity‐Related homework icon for patients, and Problem Solving Homework for therapists. Revision may be necessary to improve identification. Lower ratings by therapists and/or patients were given to these CBT MobileWork features and Homework assignments: Monitoring; Portion of the Pie; Prioritizing; Fire Drill; Breaking Down Task; Steps to Solving a Problem; Downward Arrow; Advice I Would Give a Friend; Increasing Social Support, and Being More Social. DISCUSSION/SIGNIFICANCE OF IMPACT: Expanded CBT homework menus offers therapists and patients greater flexibility to individualize assignments. This work has the potential to improve the potency of a well‐established therapy for depression.

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CHRONIC STRESS AND SALIVARY GENE EXPRESSION

Mallick A ^1,2, Bergen A¹, Nishita D¹, Wei X¹, Michel M¹, David SP^1,2, Swan GE¹, Reid MW^3,4, Simons A^3,5, Andrews JA³

¹SRI International, Menlo Park, CA, USA; ²Stanford Medical School, Stanford, CA, USA; ³Oregon Research Institute, Eugene, OR, USA; ⁴University of Oregon, Eugene, OR, USA; ⁵Notre Dame University, Notre Dame, IN, USA

OBJECTIVES/SPECIFIC AIMS: We seek to understand correlates of chronic stress and their influence on the development of substance use in a population‐based cohort (OYSUP). METHODS/STUDY POPULATION: We evaluated clinical and salivary RNA metrics and differential expression of candidate genes in saliva samples from 48 individuals (31% female, 55% ever‐smoking) randomly selected from two groups stratified by high versus low severe negative life events as measured by Life Events and Difficulties Schedule (Brown & Harris, 1978). We used multiple analytical platforms, multiple reference genes and 18 replicates of all gene expression assays. We chose 38 candidate genes previously identified as differentially expressed in a genome‐wide scan of RNA in 11 caregivers of brain cancer patients and 10 control subjects matched on age, gender, ethnicity and marital status and free of major stressors during the prior year. RESULTS/ANTICIPATED RESULTS: We observed significant differences in smoking status (p= 0.035) and RNA integrity score (p= 0.039) between stress strata. We analyzed qPCR data using both comparative standard curve and relative standard curve methods because 34% of assays had efficiency estimates <90%. Assay data showed high linearity and low variability. We observed significant under expression of 5 assays in the high stress stratum using both methods, 4 of which interrogate glucocorticoid receptor regulated genes. Analyses showed significant associations of RNA yield, integrity score, gender, ever‐smoking and/or stress with results of normalized gene expression in 22/37 assays. DISCUSSION/SIGNIFICANCE OF IMPACT: A gene expression signature of chronic stress previously observed in hematopoietic samples is observed in the unfractionated saliva of young adults.

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COAGULATION MONITORING DURING NEONATAL AND PEDIATRIC EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO)

Bembea M ¹, McElrath Schwartz J¹, Shah N¹, Lehmann C¹, Kickler T¹, Pronovost P¹, Strouse JJ¹

¹Johns Hopkins University, Baltimore, MD, USA

OBJECTIVES/SPECIFIC AIMS: To compare means of coagulation monitoring during ECMO. METHODS/STUDY POPULATION: Prospective observational study of ECMO patients in a tertiary PICU. Anti‐FXa, antithrombin (AT) and factor VIII (FVIII) were measured in blood samples collected at 6, 12 and every 24 hours on ECMO. Demographic and clinical data were collected prospectively. RESULTS/ANTICIPATED RESULTS: Twenty‐eight patients age 1 day‐18 years were enrolled from 04/2008 to 03/2010. Median age was 9 days (IQR: 3 days‐10 years), median ECMO duration was 4 days (IQR: 2.5–12 days) and primary ECMO indications were: respiratory failure, 15/28(53.6%), cardiac failure, 7/28(25%), extracorporeal cardiopulmonary resuscitation, 5/28(17.8%), and sepsis, 1/28(3.6%). Median anti‐FXa was 0.4 IU/ml (IQR:0.2–0.6), median AT was 59% (IQR:46–69) and median FVIII was 59%(IQR:36–92). Median ACT was 210 sec (IQR:200–225) and median Heparin infusion rate was 35 U/kg/hour (IQR:15–50). Anti‐FXa, AT and Heparin infusion rate increased with each day on ECMO by 0.01 IU/mL (95%CI:0.004–0.015, p= 0.001), 1% (95%CI:0.77%–1.33%, p < 0.001) and 0.73 U/kg/hour (95%CI:0.53–0.93, p < 0.001), respectively. ACT decreased with each day on ECMO: –0.52 sec (95%CI: –0.83–0.21, p= 0.001). FVIII remained stable throughout the ECMO course and patients with high FVIII did not appear to develop Heparin resistance. Anti‐FXa and AT activity were positively correlated with Heparin infusion rates (r= 0.44, p < 0.001 and r= 0.35, p < 0.001), while there was no correlation between ACT and Heparin infusion rate (r= 0.08, p= 0.863). These results were maintained after controlling for blood product administration. DISCUSSION/SIGNIFICANCE OF IMPACT: Further studies of anti‐FXa and AT are warranted to determine their usefulness for ECMO anticoagulation monitoring.

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COGNITIVE AND IMAGING PROFILES IN INDIVIDUALS WITH GERMLINE HETEROZYGOUS PTEN MUTATIONS AND AUTISM

Frazier T ^1,2, Eng C^1,2

¹Cleveland Clinic, Cleveland, OH, USA; ²Case Western Reserve University, Cleveland, OH, USA

OBJECTIVES/SPECIFIC AIMS: The primary aim of this study is to characterize the cognitive and structural imaging profile of macrocephalic individuals with autism and germline heterozygous PTEN mutations (ASD‐PTEN+/–) and compare these to: (a) individuals with autism and macrocephaly without PTEN mutations (ASD‐PTEN+/+) and (b) healthy controls without macrocephaly. METHODS/STUDY POPULATION: We anticipate collecting DNA, cognitive, and phenotypic data from 80 individuals with macrocephaly and autism and 30 age‐ and sex‐matched controls. Of these 80 individuals, we anticipate that 15 will harbor a mutation in PTEN. We plan to collect structural neuroimaging volumes from 15 ASD‐PTEN+/– individuals, from 30 ASD‐PTEN+/+ individuals, and from 30 healthy controls. Inclusion criteria include: ages 2–50, autism spectrum diagnosis, and no known genetic condition. Phenotypic evaluation includes the Autism Diagnostic Interview‐Revised, an interview collecting the history of autism symptoms, and the Scales of Independent Behavior‐Revised, a measure of daily living skills. Cognitive data collection includes verbal and nonverbal ability, attention, working memory, and long‐term memory. RESULTS/ANTICIPATED RESULTS: Over 7 months, we have collected data from 22 patients (19 male; median age = 8, range 3–24) and have an additional 8 patients scheduled for the next 2 months. All patients have met criteria for an autism spectrum diagnosis. One patient had a PTEN mutation. This individual had a significant strength in nonverbal ability, but had otherwise low cognitive and functional skills. Other patients have shown highly variable symptom and cognitive patterns. DISCUSSION/SIGNIFICANCE OF IMPACT: Key next steps will be continuing recruitment, beginning neuroimaging, and recruitment of healthy controls. We anticipate completion of recruitment within the 2‐year proposed time frame.

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CORRELATION OF ACUTE PHASE REACTANTS WITH HIGH‐RISK FEVER‐NEUTROPENIA (F‐N)

Mian A ¹, James L¹, Becton D¹, Bhutta A¹, Prodhan P¹

¹University of Arkansas for Medical Sciences, Little Rock, AR, USA

OBJECTIVES/SPECIFIC AIMS: Acute phase reactants at F‐N presentation are predictive of clinical outcome. METHODS/STUDY POPULATION: Prospective study of children receiving chemotherapy. Blood samples collected at F‐N presentaion and tested for C‐reactive protein (CRP), Soluble IL‐2 receptor (s‐IL2R), interleukins (IL)‐1,3,6,8,10 and tumor necrosis factor‐alpha (TNF). Clinical outcome data were correlated with the bio‐markers. “High‐risk” F‐N included any of the following criteria: prolonged hospitalization (>7 days), admission to PICU, or a positive bacterial blood culture. “Low‐ risk” patients had none of the above. Cluster analysis performed on all variables using Pearson correlation coefficient. Multivariate logistic regression analysis was performed to develop a risk based predictive model, which was validated using a Receiver Operating Characteristic (ROC) curve. RESULTS/ANTICIPATED RESULTS: Interim analysis performed on dataset that included 51 F‐N events. Univariate analysis showed 56% were high‐risk while 44% were low‐risk F‐N. Median values for CRP, s‐IL2R, IL‐6, and IL‐8 were significantly different between high and low‐risk F‐N. Cluster analysis showed strong correlation between IL‐6, IL‐8, IL‐10 and TNF. Logistic regression analysis showed at F‐N presentation, CRP (p= 0.02) and s‐IL2R (p= 0.06) were biomarkers that correlated with high‐risk F‐N. At F‐N presentation, increase in CRP from 42 mg/L to 196 mg/L was associated with 7‐fold increased likelihood of “high‐risk F‐N”. Similarly, rise in s‐IL‐2R from 262 pg/ml to 692 pg/ml increased the likelihood of high‐risk F‐N by 5‐fold. This risk stratified predictive model was validated using Receiver Operating Characteristic curve (AUC = 0.84) DISCUSSION/SIGNIFICANCE OF IMPACT: CRP and sIL‐2R at FN presentation correlate with high‐risk F‐N and may be useful as screening tools for risk‐stratification.

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CORRELATION OF HPV DNA DETECTION IN PAIRED URINE AND CERVICAL SAMPLES

Mendez K ¹, Romaguera J¹, Ortiz AP³, Unger ER², Steinau M²

¹UPR School of Medicine, Guaynabo, Puerto Rico; ²Center for Disease Control and Prevention, Atlanta, GA, USA; ³UPR School of Public Health, San Juan, Puerto Rico

OBJECTIVES/SPECIFIC AIMS: The objective of this application is to evaluate urine HPV testing using a PCR based linear array system, as an easier, more comfortable and effective screening method compared with the standard cervical testing. Specific aims: (1)To determine if HPV detection in urine is comparable to cervical testing, (2)To determine if HPV viral load correlates with cytology and histology results, and (3)To evaluate acceptance of urine self sampling. METHODS/STUDY POPULATION: Cross‐sectional study of women attending OBGYN Clinics of the UPR for evaluation of abnormal cytology. Our pilot study population will include 100 women sexually active, nonpregnant, aged 21–60 years, with intact uterus, residents of PR and attending clinics for evaluation of abnormal Pap smear. Women will be excluded if cognitive or physically impaired to participate. Data about demographics, risk factors for HPV infection and urine self sampling acceptability will be collected. Participants will collect a self urine sample. Then a pelvic exam by a gynecologist will be done to collect cervical specimens. Colposcopy and cervix biopsies will be performed. Samples will be sent to CDC HPV laboratory where DNA extraction, HPV Detection and Typing will be performed. Viral loads will be obtained with RT‐PCR. RESULTS/ANTICIPATED RESULTS: Our hypothesis is that HPV detection in urine self samples could be done using PCR based linear array and it will be a more acceptable and sensitive method for HPV screening. DISCUSSION/SIGNIFICANCE OF IMPACT: The rationale of this study is that urine specimen approach should facilitate HPV detection in women with poor access to a gynecologist and should be more attractive to all patients. It will increase compliance with screening and follow up protocols.

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DEFINING CELLULAR BIOMARKERS FOR PREDICTING RESPONSE TO CORTICOSTEROID THERAPY IN SEVERE ASTHMA

Pazdrak K ¹, Straub C¹, Kurosky A¹

¹University of Texas Medical Branch, Galveston, TX, USA

OBJECTIVES/SPECIFIC AIMS: There are currently no validated tests that measure glucocorticosteroid (GC) sensitivity in severe asthma. Eosinophils, inflammatory cells which play an important role in asthma, respond to glucocorticoids in a manner which parallels the response to steroid therapy seen in asthma patients. Using comparative proteomics we selected proteins in GC‐resistant eosinophils in order to establish cellular markers of steroid resistance in asthma. METHODS/STUDY POPULATION: Proteomic data of over 200 proteins in steroid‐resistant eosinophils were used as reference set to seek biomarkers of steroid responsiveness in cells obtained from patients with steroid resistant; steroid refractory and steroid sensitive asthma. RESULTS/ANTICIPATED RESULTS: Our study showed that steroid‐resistant eosinophils display considerable alterations in their proteomic profile, resulting in activation of protein phosphatase 5, dephosphorylation of GC receptors and defect in induction of DUSP1 protein. We surmise that identified components of the GC signaling pathways may serve as potential diagnostic markers of steroid resistance in patients with severe asthma. DISCUSSION/SIGNIFICANCE OF IMPACT: The absence of therapeutic alternatives in severe asthma with resistance to steroids poses a genuine health challenge and also a financial burden, as steroid‐resistant patients account for more than 50% of asthma‐related healthcare costs. These results are expected to have a significant impact because; the identified mechanisms and their components are highly likely to provide new targets for therapeutic interventions, as well as potential diagnostic markers for steroid resistance.

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DERMATOPROTEOME ARRAYS – A NOVEL IMMUNOASSAY METHOD FOR STRATIFICATION OF SYSTEMIC AND CUTANEOUS LUPUS ERYTHEMATOSUS PHENOTYPES

Chong BF ¹, Tseng L¹, Pazandak AB¹, Li Q¹, Olsen NJ², Mohan C¹

¹University of Texas Southwestern Medical Center, Dallas, TX, USA; ²Penn State College of Medicine, Hershey, PA, USA

OBJECTIVES/SPECIFIC AIMS: Autoantibodies unique to cutaneous lupus (CLE) patients that are not found in systemic lupus (SLE) have yet to be identified, and would aid in their diagnosis and classification. Autoantigen arrays can measure multiple autoantibodies simultaneously in patient sera. The primary aim is to characterize autoantibody profiles of CLE patients with and without SLE using these arrays. METHODS/STUDY POPULATION: Dermatoproteome arrays were constructed by spotting 102 purified autoantigens involved in various autoimmune systemic and cutaneous diseases onto Whatman FAST slides. Diluted patient sera from 17 CLE patients without SLE, 12 CLE patients with SLE, 11 SLE patients without CLE, and 14 normal healthy controls were incubated on these arrays, and labeled with Cy3‐anti‐human IgG and Cy5‐anti‐human IgM. A Genepix 4000B scanner detected these fluorescent antibodies and generated images for analysis. RESULTS/ANTICIPATED RESULTS: Autoantibodies against 11 nuclear antigens showed an incremental rise from normal controls, CLE patients without SLE, CLE patients with SLE, and SLE patients without CLE (p < 0.05). IgG autoantibodies against heparan sulfate proteoglycans was up‐regulated in CLE patients with and without SLE versus the other groups. DISCUSSION/SIGNIFICANCE OF IMPACT: The stepwise up‐regulation of autoantibodies against nuclear antigens in CLE without SLE, CLE with SLE, and SLE without CLE patients stratifies CLE and SLE patients. Given that lymphocytes congregate around the epidermal‐dermal junction in CLE skin, heparan sulfate proteoglycans may represent potential autoantigens for CLE. Dermatoproteome arrays can potentially serve as useful tools in distinguishing lupus subtypes, diagnosing SLE and CLE, and understanding disease etiology.

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DETECTING NEUROCHEMICAL CHANGES IN CHRONIC PELVIC PAIN SYNDROME (CPPS) USING MAGNETIC RESONANCE SPECTROSCOPY (MRS)

Awodele O ¹, Lin A², Dimitrakov J²

¹Howard College of Medicine, Washington, DC, USA; ²Harvard Medical School, Boston, MA, USA

OBJECTIVES/SPECIFIC AIMS: We aimed to measure changes in cerebral metabolites in patients diagnosed with CPPS. METHODS/STUDY POPULATION: In this study, we compared male patients (n= 9) with diagnosed CPPS with age‐matched males with no pain history (n= 9) and also with female patients (n= 10) with diagnosed CPPS using proton MR spectroscopy collected at 3T. Single voxel MRS were acquired in two pain processing cortical regions (anterior cingulate gyrus (ACG) and occipital grey matter (OCM)). Proton MRS spectral analysis was performed by using the linear combination model which provided absolute concentrations and neurometabolite ratio concentrations. One‐dimensional raw spectra of correlation spectroscopy (COSY) were concatenated into 2D COSY. RESULTS/ANTICIPATED RESULTS: Comparison of the 1D MRS results from the OGM of male with CPPS and male controls only showed a trend of reducing concentration of N‐acetyl (NAA)/creatine (Cr)+PCr in males with CPSS (p= 0.053). We report for the first time, 2D COSY data acquired in patients with CPPS which revealed significant increase in Threonine/Cr in males with CPPS in the OGM. When female patients with CPPS were compared with males with CPPS, 1D MRS showed significant changes only in the ACG: concentrations of both glutamate and macromolecules were reduced in males. Also a close trend toward significance (p= 0.051) was noted for NAA in males with CPPS. In the OGM, 2D COSY results showed significant increase in glutamate and glutamine (Glx), phenylalanine (Phe) and aspartate (Asp) in males with CPPS. DISCUSSION/SIGNIFICANCE OF IMPACT: Neuronal loss or damage maybe associated with CPPS pathophysiology and gender bias in pain processing may exist.

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DEVELOPING A PRACTICAL BRAIN‐COMPUTER INTERFACE SYSTEM BASED ON ECOG

Wang W ¹, Collinger JL^1,2, Tyler‐Kabara EC¹, Weber DJ^1,2, Schwartz AB¹, Boninger ML^1,2

¹University of Pittsburgh, Pittsburgh, PA, USA; ²Human Engineering Research Laboratories, Department of Veterans Affairs, Pittsburgh, PA, USA

OBJECTIVES/SPECIFIC AIMS: Brain‐computer interface (BCI) technology aims to establish a direct link for transmitting information between the brain and external devices. It has the potential to offer a natural and rich control signal for robotic devices, prosthetic limbs, or functional electrical stimulators to reanimate paralyzed limbs. Our group’s clinical research interest is to translate basic BCI research into clinically viable BCI devices. We propose electrocorticography (ECoG) as a realistic approach that strikes an optimal balance in the tradeoffs associated with neural signal quality, invasiveness, system complexity, and maintenance. METHODS/STUDY POPULATION: We have conducted preclinical ECoG studies with a direct focus on decoding hand posture from ECoG signals. We implanted custom‐designed miniature high‐density ECoG grids over the hand area of the motor cortex in neurosurgical patients undergoing subdural epilepsy monitoring. Participants performed various hand movement tasks, including a self‐paced individual finger movement task and an object‐grasping task. RESULTS/ANTICIPATED RESULTS: The high‐gamma band of ECoG signals recorded from the motor cortex shows a significant increase in power during hand movement, and it encodes significant information about hand grasping movement. When we regressed powers of various frequency bands against the first three principal components of hand movement, the high‐gamma band yields a high r² value, indicating that ECoG signals encode significant information about hand grasping movement. We accurately predicted hand flexion based on ECoG signals. DISCUSSION/SIGNIFICANCE OF IMPACT: This suggests that it may be possible to restore basic hand function for daily activities using an ECoG‐based BCI system.

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DIFFERENTIAL HOST TRANSCRIPTIONAL RESPONSE ACROSS CLINICAL MALARIA STATES

Krupka M ¹, Seydel KB², Chang‐Yun L¹, Ye K¹, Taylor TE², Daily JP¹

¹Albert Einstein College of Medicine, Bronx, NY, USA; ²Blantyre Malaria Project, Blantyre, Malawi

OBJECTIVES/SPECIFIC AIMS: Malaria is a leading cause of morbidity and mortality worldwide. Though Plasmodium falciparum accounts for most malarial fatalities, infection with P. falciparum is not always synonymous with disease. A large percentage of children in endemic areas carry this parasite without characteristic fevers. Furthermore, of those who are symptomatic, only a subset will develop a severe disease syndrome, which are associated with a 15% mortality rate. Why some individuals develop symptomatic disease and/or severe disease is not clearly understood. However, patterns of host immunity and specific pro‐inflammatory cytokines have been associated with these different clinical states. We aimed to explore the role of the immune system, and more broadly the host response, across the different clinical states. METHODS/STUDY POPULATION: We studied human whole genome transcription expression profiles ex‐vivo from children admitted with coma and P. falciparum parasitemia in Blantyre, Malawi during the 2009 malarial season. If an asymptomatic parasite burden was found on routine outpatient visits following their hospital stay, another sample was drawn. Transcriptional profiles from both severe and asymptomatic visits were compared to healthy control patients. RESULTS/ANTICIPATED RESULTS: Individual genes as well as gene sets obtained from KEGG and the literature associated with CM vs. other clinical states were identified. Individual genes were significant if p value = <0.01 and fold change = ≥1.6. Gene set significance was determined using the Gene Set Enrichment Analysis (GenePattern, Cambridge, MA) software. DISCUSSION/SIGNIFICANCE OF IMPACT: This data provides insight into the pathophysiology of the clinical malaria states and may contribute to identification of adjunctive therapy to improve survival rates.

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DIFFERENTIAL PROTEIN EXPRESSION IN SMALL INTESTINAL CARCINOIDS AND LIVER METASTASES

Kim M ¹, Wang D², Cui M², Curran T¹, Ward S², Warner RR¹, Roayaie S³, Shafir M³, Zhang D², Itzkowitz S¹

¹Mount Sinai School of Medicine, New York, NY, USA; ²Mount Sinai School of Medicine, New York, NY, USA; ³Mount Sinai School of Medicine, New York, NY, USA

OBJECTIVES/SPECIFIC AIMS: Small intestinal carcinoids (SICs) are often detected late in their clinical course. Little is known about the molecular pathways important in the development of metastasis. We have recently developed a Protein Pathway Array to screen for changes in protein and phosphoprotein expression in tissues. The objective of our study was to identify key pathways important in the mechanism of SIC metastasis development. METHODS/STUDY POPULATION: Primary tumors and liver metastases from 5 patients with metastatic SICs were harvested. Extracted proteins were separated by SDS gel, and Western blots were performed with 136 antibodies. Band densities were determined using BioRad Image system. Significant Analysis of Microarray was used to select the proteins differentially expressed between different groups. Unsupervised hierarchical clustering analysis was performed. RESULTS/ANTICIPATED RESULTS: Of the 136 proteins analyzed, 52 proteins were expressed in these samples. 9 proteins were up‐regulated in primary SICs compared with matched normal small bowel mucosa. Cyclin E was down‐regulated in primary SIC tissue compared to normal small bowel mucosa. Compared to normal liver tissue, SIC liver metastases demonstrated up‐regulation of P‐ERK and p27 but down‐regulation of CDK2 and CDC25B. When comparing primary SIC with their paired liver metastases, cyclin E demonstrated a significant up‐regulation in the liver metastasis. DISCUSSION/SIGNIFICANCE OF IMPACT: Few studies have compared gene or protein expression in primary and metastatic SIC tumors resected simultaneously. Our findings using Protein Pathway Array reveal changes in a limited number of proteins, suggesting that these may be targets for therapy.

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DNA METHYLATION PROFILE OF BARRETT'S ESOPHAGUS IN PUERTO RICAN HISPANICS

Magno P ^1,2, Suarez EL³, Meltzer SJ², Cruz‐Correa M^1,2

¹Puerto Rico Cancer Center, University of Puerto Rico, San Juan, USA; ²Division of Gastroenterology, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA; ³Department of Biostatistics and Epidemiology, University of Puerto Rico School of Public Health, San Juan, USA

OBJECTIVES/SPECIFIC AIMS: The objective of this project is to establish a DNA methylation pattern for use in cancer surveillance in Barrett’s esophagus patients. The objective will be achieved through two specific aims: (1) To determine the prevalence of DNA promoter hypermethylation and mRNA levels of expression of 7 candidates genes in Barrett’s esophagus with different grades of dysplasia and adenocarcinoma, (2) To validate a methylation profile for Barrett’s esophagus predictive of esophageal cancer development. METHODS/STUDY POPULATION: Samples from Barrett’s esophagus and esophageal adenocarcinoma will be collected from participants. A risk‐factor questionnaire to abstract clinicopathological data and environmental exposures will be administered prior to endoscopy. DNA promoter hypermethylation of candidate genes from gDNA will be assessed using MethyLight assay. Epigenetic gene silencing will be confirmed by RT‐PCR analysis. Differences in methylation patterns associated with different dysplastic Barrett’s esophagus, and esophageal adenocarcinoma will be assessed using multinomial regression models. RESULTS/ANTICIPATED RESULTS: The anticipated result of this study is to predict the development of esophageal adenocarcinoma from Barrett’s esophagus based on a DNA methylation profile. DISCUSSION/SIGNIFICANCE OF IMPACT: Barrett’s esophagus is a major risk factor for esophageal adenocarcinoma. Identifying biomarkers for screening Barrett’s esophagus patients at high risk of cancer would allow us to do early intervention such as endoscopic therapy and chemoprevention.

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EFFECT OF GADOLINIUM CONTRAST ON IRON METABOLISM PATHWAYS AND INHIBITION BY IRON CHELATOR

Swaminathan S ¹, Bose C¹, Shah SV¹, Hiatt KM¹

¹University of Arkansas for Medical Sciences, Little Rock, AR, USA

OBJECTIVES/SPECIFIC AIMS: Nephrogenic systemic fibrosis (NSF) is characterized by tissue accumulation of iron and infiltration of fibrocytic cells. Cellular pathways that participate in iron dysmetabolism of NSF are unknown. CD163‐Ferroportin pathway is central to iron metabolism in the body. METHODS/STUDY POPULATION: We evaluated the in vitro effects of gadolinium contrast (Omniscan) on cultured human peripheral blood mononuclear cells (PBMC). PBMC were cultured with Omniscan (0.1 to 2.5 mmol/Kg BW). Between Day 5–8, adherent cells were isolated and evaluated with flow cytometry and immunofluorescence for phenotype and protein expression confirmed with western blot. We performed additional in vitro studies with oral iron chelator deferiprone to evaluate its effect on Omniscan‐induced changes. Immunohistochemistry was performed on NSF biopsy specimen for cellular markers. RESULTS/ANTICIPATED RESULTS: Omniscan treatment induced increased number of adherent spindle cells. Omniscan‐treated cells strongly expressed markers of Iron metabolism such as CD163, HO‐1, H‐Ferritin and Iron export protein‐ Ferroportin and less Hepcidin. Iron chelator significantly decreased the development of CD163+ adherent spindle cells. Spindle cells in NSF skin biopsies expressed CD163 and Ferroportin. DISCUSSION/SIGNIFICANCE OF IMPACT: Omniscan induces development of CD163+ spindle cells in vitro and CD163+ / Ferroportin‐1+ cells accumulate in human NSF. Activation of CD163‐Ferroportin pathway and inhibition of hepcidin in vitro by Omniscan, taken along with inhibition of CD163+ spindle cell differentiation by deferiprone suggests a potent role of CD163 pathway and iron export in NSF pathogenesis

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EFFECT OF MILD THERAPEUTIC HYPOTHERMIA ON FENTANYL AND MIDAZOLAM CLEARANCE IN A RAT MODEL OF CARDIAC ARREST

Empey PE ¹, Miller TM¹, Melick JA², Kochanek PM², Poloyac SM¹

¹School of Pharmacy, U of Pittsburgh, Pittsburgh, PA, USA; ²Safar Center for Resuscitation Research, U of Pittsburgh, Pittsburgh, PA, USA

OBJECTIVES/SPECIFIC AIMS: Concern regarding unknown drug dose‐response relationships complicates medication dosing during therapeutic hypothermia after cardiac arrest (CA). Cooling (<32°C) is known to substantially decrease cytochrome p450 (CYP)‐mediated drug metabolism in vitro and limited data suggest that levels of drugs that are CYP3A substrates increase clinically. The study objective was to determine the clearance of the clinically relevant CYP3A substrates fentanyl and midazolam during mild therapeutic hypothermia following CA. METHODS/STUDY POPULATION: An asphyxial CA rat model was used and body temperature (33°C or 37.5°C) was controlled by surface cooling 1 h postinsult to mimic the timing and target temperature achieved clinically. Fentanyl (50 ug/kg/h) or midazolam (1 mg/kg/h) was given IV and plasma levels were assayed over 8–10 h by UPLC‐MS/MS (≥6 rats/group). Systemic clearance was calculated by noncompartmental pharmacokinetics. Metabolite hepatic microsomal formation rates were measured in vitro at 37°C and 33°C and Michaelis‐Menton parameters were determined. RESULTS/ANTICIPATED RESULTS: The temperature groups were well‐matched. Cooling reduced the systemic clearances of both midazolam (66.4 ± 9.5 to 56.3 ± 9.1 mL/min/kg) and fentanyl (61.5 ± 11.5 to 48.9 ± 8.6 mL/min/kg). Microsomal metabolite formation rates were lower at 33°C and were driven by reductions in maximal enzyme velocity rather than affinity. DISCUSSION/SIGNIFICANCE OF IMPACT: Cooling to 33°C after CA modestly decreases midazolam and fentanyl systemic clearance in rats. Given that cooling is applied for 24–48 h after CA in patients, and that hepatic clearance may be compromised, consideration of the impact of therapeutic hypothermia on concurrent drug therapy is warranted. Support: KL2RR024154, R01GM073031, S10RR023461, NS30318.

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EFFECT OF SEX AND ANALGESICS IN MOUSE NOCICEPTION MEASURED BY A NEUROSPECIFIC ASSAY

Spornick N ¹, Khaibullina A¹, Finkel J¹, Quezado Z¹

¹Sheikh Zayed Institute for Pediatric Surgical Innovation, Washington, DC, USA

OBJECTIVES/SPECIFIC AIMS: There is ample evidence that nociception and opioid analgesia are impacted by sex and that women have lower tolerance to several stimuli (heat, pressure, electrical, and cold) compared with men. Here we study the effect of sex and analgesics on nociception in C57Bl/6, using an assay that delivers sine‐wave electrical stimuli at 2000, 250, and 5 Hz in order to preferentially stimulate Aβ, Aδ, and C sensory fibers respectively. METHODS/STUDY POPULATION: The stimulation at each frequency is delivered at predetermined increments, audible vocalization is defined as the nocifensive behavior, and the intensity of stimulation that elicits vocalization as current vocalization threshold cVT. We measured cVT before and after administration of morphine intrathecally (0–2 ug/kg). RESULTS/ANTICIPATED RESULTS: During basal conditions, C57Bl/6 males had significantly higher mean cVT compared with females in 2000, 250, and 5 Hz. With increasing doses of morphine, cVT percent change from baseline increased and were significantly higher in response to 5 Hz compared with 250 and 2000 Hz Current vocalization threshold percent change from baseline at 1 h was significantly ordered: 5 Hz > 250 Hz (p < 0.0001) and 250 Hz > 2000 Hz (p= 0.0002). These results suggest that the response to 5 Hz simulation was mostly affected by morphine. By 3 hours after morphine injection, there was no overall effect of morphine on cVT (p= 0.1263). DISCUSSION/SIGNIFICANCE OF IMPACT: While females have lower cVT than males at baseline, opioid‐analgesia was not impacted by the animal’s sex. Therefore, using sine‐wave electrical stimulation at frequencies that reportedly preferentially stimulate Aβ, Aδ, and C sensory nerve fibers, this nociceptive assay enables the evaluation of sex‐related differences and its impact on opioid analgesia in mice.

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EFFECT OF VITAMIN D3 ON MUSCLE FIBER SIZE

Ceglia L ^1,2, Silva Morais MD², Harris SS², Bischoff‐Ferrari H^3,2, Fielding RA², Dawson‐Hughes B²

¹Tufts Medical Center, Boston, MA, USA; ²Tufts University, Boston, MA, USA; ³University of Zurich, Zurich, Switzerland

OBJECTIVES/SPECIFIC AIMS: Histological analysis of muscle biopsies in adults with vitamin D deficiency reveals a predominance of type 2 (T2, fast‐twitch) muscle fiber atrophy. We sought to determine whether supplementation with vitamin D3 in older vitamin D insufficient women affects the change in T2 muscle fiber cross‐sectional area (CSA) over 4 months. METHODS/STUDY POPULATION: In this randomized, double‐blind, placebo‐controlled pilot study, 16 healthy women (65–85 y) were assigned to receive vitamin D3 4000 IU/d or placebo for 4 months. Serum 25‐hydroxyvitamin D (25OHD) level and a muscle biopsy of the vastus lateralis were performed at baseline and 4 months. Sections were probed with T2a and T2x myosin heavy chain isoform‐specific antibodies. RESULTS/ANTICIPATED RESULTS: Mean baseline 25OHD was similar in the 2 groups [placebo (n= 9): 18.9 ± 3.3 ng/ml; vitamin D (n= 7): 16.0 ± 4.8 ng/ml]. As expected, mean final 25OHD differed in the 2 groups (placebo: 21.6 ± 6.9 ng/ml; vitamin D: 32.0 ± 4.9 ng/ml; p= 0.002). Mean baseline T2 muscle fiber CSA did not differ significantly in the 2 groups (placebo: 2332 ± 460 μm2; vitamin D: 2263 ± 391 μm2). However, there was a trend toward a greater percent (%) change in T2 muscle fiber CSA with vitamin D3 supplementation (placebo: −1 ± 18%; vitamin D: 11 ± 19%, p= 0.173). Although not statistically significant, a positive linear association was noted between change in 25OHD and % change in T2 muscle fiber CSA (r= 0.353, p= 0.171). DISCUSSION/SIGNIFICANCE OF IMPACT: These findings are consistent with a potential beneficial effect of vitamin D3 on T2 muscle fiber size. A larger study sample is needed to definitively establish an increase in T2 fiber area with vitamin D3 supplementation.

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ENRICHING TARGETED SEQUENCING EXPERIMENTS FOR RARE DISEASE ALLELES

Edwards TL ¹, Song Z², Li C²

¹Vanderbilt University, Nashville, TN, USA; ²Vanderbilt University, Nashville, TN, USA

OBJECTIVES/SPECIFIC AIMS: Next‐generation targeted resequencing of associated genomic regions is a common approach for follow‐up for associated common alleles. However, it is prohibitively expensive to resequence all subjects from a well‐powered GWAS with sufficient depth to call rare genotypes. Many studies may use next‐generation sequencing for SNP discovery in a subset of subjects, with the intent to genotype rare SNPs captured by resequencing. This approach is reasonable, but may be inefficient if samples are not carefully selected for the resequencing study. We have developed an approach, SampleSeq, to select samples for targeted resequencing studies that increases the yield of rare disease alleles substantially over random sampling of subjects or based on genotypes at associated SNPs from GWAS data. METHODS/STUDY POPULATION: We assume that the prevalence of the trait is known, that genotypes are available at a trait‐associated SNP in LD with the causal variant and HWE in the population at both SNPs. Let Ga and Gd be the genotypes at the marker and disease locus, respectively. Let Y be the disease status, 1 for cases and 0 for controls. Our goal is to calculate the expected count of allele d, E(Gd | Ga, Y), given each subject’s genotype at SNP A and affection status, and select subjects accordingly. We evaluate our method with simulations. RESULTS/ANTICIPATED RESULTS: SampleSeq outperformed competing sampling strategies when the disease allele was rare, and performed very similar to other strategies when the disease allele was common. DISCUSSION/SIGNIFICANCE OF IMPACT: This work describes SampleSeq, a method for optimal selection of subjects for resequencing of associated genomic regions. This method will preserve resources for subsequent steps of an investigation by estimating the sample size required to capture disease alleles of a target frequency in an arbitrary number of regions.

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ESTABLISHING A CLINICAL AND TRANSLATIONAL RESEARCH PLATFORM FOR STUDYING PEDIATRIC BRAIN TUMORS

Nazarian J ¹, Saratsis AM¹, Perez JP¹, Yadavilli S¹, Yoon P¹, Magge S¹

¹Children’s National Medical Center, Washington, DC, USA

OBJECTIVES/SPECIFIC AIMS: Diffuse intrinsic pontine gliomas (DIPGs) are high grade brainstem gliomas (BSGs) that remain uniformly fatal. Factors contributing to the lack of progress include tissue unavailability, and lack of robust animal models of the disease. Recent studies suggest that BSGs exhibit molecular behavior distinct from other high grade gliomas, which could account for the lack of response to otherwise effective treatments. Our goal was to generate a platform for addressing the two obstacles mentioned above in combating pediatric brain tumors. METHODS/STUDY POPULATION: We have launched a clinical study (ClinicalTrials.gov) for postmortem specimen collection and have worked closely with various institutions and foundations to promote specimen donation and established a biobank of BSG frozen specimens. We have recently published the first genetically engineered murine model of BSG. We have also expanded our collaboration to other CTSI‐funded sites. Our goal is to develop nano‐particle mediated drug delivery using the BSG murine model. RESULTS/ANTICIPATED RESULTS: We show BSG mouse pathogenic similarity with 63% of high grade pediatric BSGs. We provide preliminary data and show that at least 17 proteins show similar dysregulation in BSG mouse and human formalin fixed samples. We have also generated preliminary proteomics data of the BSG mouse and present potential biomarkers. DISCUSSION/SIGNIFICANCE OF IMPACT: Inspired by the NIH “bench‐to‐bedside approach,” we have assembled a dedicated team that includes oncologists, neurosurgeons, a neurologist, a clinical coordinator and scientists. The success of the team has already led to acquisition of additional frozen BSG samples and generation of preliminary data. Our ultimate goal is to define the biology of BSGs and DIPGs and develop effective therapeutics based on our understanding of the disease.

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EXPRESSION OF INFLAMMATORY CYTOKINES BY EXCESS ADIPOSE TISSUE IN PATIENTS WITH GYNECOLOGIC MALIGNANCIES

Zemlyak A ¹, Zakhaleva J¹, Pearl M¹, Mileva I¹, Gelato M¹, Mynarcik D¹, McNurlan M¹

¹Stony Brook University Medical Center, Stony Brook, NY, USA

OBJECTIVES/SPECIFIC AIMS: To compare levels of gene expression for TNFα, IL‐6, IkB kinase, CD 68 and leptin in samples of adipose tissue from obese and lean individuals with gynecologic malignancies and healthy controls. METHODS/STUDY POPULATION: This is a retrospective study of patients of the gynecology‐oncology group at Stony Brook University Medical Center between 2006–2008. Patients from control group underwent abdominal operations for benign conditions. Obesity was defined as BMI > 30. Pieces of omental adipose tissue were collected during surgery. Relative amounts of RNA were calculated for IkB, TNFa, IL‐6, CD68 and leptin and normalized to GAPDH. Age and smoking status of cancer and control groups were compared with t‐ and chi‐square tests. Levels of IkB, TNFa, IL‐6 leptin and CD68 were compared between obese and lean patients with t‐test. Parameters different between cancer and control groups were included in the multivariable logistic regression model. RESULTS/ANTICIPATED RESULTS: The sample size was 78. There were 46 cancer patients and 32 controls. Mean age of cancer patients was 59.6 vs 51.2 in control group (p= 0.001). There were 24 patients with endometrial, 17 with ovarian and 5 with cervical cancer. Majority (67.4%) of cancer patients had stage 1 disease. There were 23.9% vs 21.9% smokers (p= 0.83)in both groups. Significant differences were found between lean and obese patients in the levels of IkB (p= 0.014) and CD68 (p= 0.018) expression, but not in the other genes. IkB, TNFa, IL‐6 or CD68 were not associated with cancer status of patients. Leptin expression had weak negative association with cancer(OR = 0.90, 95%CI =[0.84–0.97], p= 0.006). DISCUSSION/SIGNIFICANCE OF IMPACT: IkB, TNFa, IL‐6 or CD68 expression by adipose tissue is not associated with positive cancer status. Leptin has mild protective association against cancer.

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FISH OIL PROTECTS AGAINST DIET‐INDUCED INSULIN RESISTANCE AND MODIFIES CERAMIDE COMPOSITION AND MITOCHONDRIAL PHYSIOLOGY IN SKELETAL MUSCLE

Lanza I ¹, Blachnio‐Zabielska A¹, Zabielski P¹, Jakaitis D¹, Ali B¹, Nair K¹

¹Mayo Clinic, Rochester, MN, USA

OBJECTIVES/SPECIFIC AIMS: Omega3 fatty acids (EPA, DHA) have documented health benefits, including protection from development of insulin resistance. We investigated how fish oil affects muscle mitochondrial function and ceramide content as potential mechanisms of these insulin sensitizing effects. METHODS/STUDY POPULATION: Mice were fed for 10 weeks with normal fat diet (NFD, 10% fat), high fat diet (HFD, 60% fat), or high fat diet + fish oil (HFD+N3, 60% fat with 3.4% kcals from DHA and EPA). RESULTS/ANTICIPATED RESULTS: Glucose tolerance (OGTT) significantly declined in HFD but not HFD+N3. Quadriceps muscle oxidative capacity (high‐resolution respirometry) was significantly higher in HFD and HFD+N3 compared to NFD. Respiratory control ratios and P:O measurements indicated greater mitochondrial efficiency in HFD compared to NFD or HFD+N3. H2O2 production (Amplex Red) and NADPH oxidase activity (lucigenin) were similarly elevated in HFD and HFD+N3 compared to NFD. Total ceramide content (mass spectrometry) was higher in HFD and HFD+N3 groups in muscle homogenates, sarcoplasmic and myofibrillar fractions, but not in mitochondrial fractions. Analysis of ceramide composition revealed that the unsaturation index was higher in HFD, but similar in NFD and HFD+N3 in all cellular fractions. DISCUSSION/SIGNIFICANCE OF IMPACT: Our data indicate that DHA+EPA protect against HFD‐induced glucose intolerance and also decrease mitochondrial coupling possibly through changes in the unsaturation of ceramides in skeletal muscle.

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FUNCTIONAL ACTIVATION AND CONNECTIVITY DIFFERENCES IN ADOLESCENT MARIJUANA USERS EXPERIENCING REWARDS AND LOSSES

Acheson A ¹, Dawes MA¹, Laird AR¹, Mathias CW¹, Dougherty DM¹

¹UT Health Science Center at San Antonio, San Antonio, TX, USA

OBJECTIVES/SPECIFIC AIMS: The purpose of this study was to investigate reward circuitry in adolescent marijuana users, who have an increased risk for a future substance use disorders. It is possible that the increased risk for substance use disorders may be related to alterations in reward circuitry. METHODS/STUDY POPULATION: We compared 15 frequent marijuana‐using adolescents (>5 uses per week) and 15 nonuser controls performing task a computer task where they were required to guess whether a simulated coin flip would be ‘heads’ or ‘tails’ and perform a perceptual motor control task. Participants were instructed that they would win 1 dollar for each correct guess and loses 1 dollar each incorrect guess, however the task was programmed so wins and losses were equal regardless of choices. RESULTS/ANTICIPATED RESULTS: Across all participants, ‘wins’ were associated with cingulate, middle frontal, superior frontal, and inferior frontal gyrus and declive activations, and “losses” were associated with cingulate, middle frontal and occipital gyri and declive activations. Marijuana users had greater middle and inferior frontal gyri, caudate and claustrum activity during wins and greater anterior and posterior cingulate, middle frontal gryrus, insula, clastrum and declive activity during. We next found evidence for group differences in functional connectivity among these regions following both conditions. DISCUSSION/SIGNIFICANCE OF IMPACT: These findings provide evidence that adolescent marijuana use is associated with altered regulation of reward, although it is unclear if this alteration is a consequence of marijuana use or a preexisting trait. These results provide supportive evidence that alterations in reward circuitry may contribute to the increased risk for future substance use disorders in adolescent frequent marijuana users.

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FUNCTIONAL COOPERATIVITY BETWEEN THE KLF6‐SV1 AND C‐MYC ONCOGENES IN THE PROGRESSION OF PROSTATE CANCER IN VIVO

Izadmehr S ¹, Narla G¹

¹Mount Sinai School of Medicine, New York, NY, USA

OBJECTIVES/SPECIFIC AIMS: Prostate cancer (PCa) is the second leading cause of cancer‐related death among males in the United States. Beyond the burden in lives affected and lost, more than 192,280 new PCa cases are projected in 2010 alone. Thus, the need to define the genetic basis of this disease is clear. The development of genetically relevant mouse models is a high priority in PCa research. As mice do not spontaneously develop prostate cancer, most of the PCa mouse models involve transgenic overexpression of oncogenes, or targeted deletion of tumor suppressor genes using knockout technology. However, highly penetrant models of widely dispersed metastatic disease have yet to be developed. To address this problem, we have developed a new murine model of PCa that combines transgenic overexpression of oncogenic KLF6‐SV1 and the proto‐oncogene c‐Myc. METHODS/STUDY POPULATION: The development of genetically relevant mouse models is a high priority in PCa research. Most advanced/metastatic murine models of prostate cancer do not recapitulate the human disease. To address this problem and investigate whether the concurrent overexpression of KLF6‐SV1 and c‐Myc accelerates prostate cancer progression, we have generated a novel double transgenic mouse model that overexpresses both human KLF6‐SV1 and human c‐Myc. RESULTS/ANTICIPATED RESULTS: Histology of the double transgenic mice prostates displays a very advanced and aggressive tumor with evidence of stromal invasion, higher Gleason scores (Gleason 10) compared to mice overexpressing either c‐Myc (Adenocarcinoma, Gleason 6–7) or KLF6‐SV1 (PIN, Gleason 3) alone. DISCUSSION/SIGNIFICANCE OF IMPACT: This finding highlights the potential functional cooperativity between two prostate cancer relevant oncogenes in driving the progression of the disease in a novel mouse model.

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GENE VARIANTS ON THE NPY RECEPTOR AND WEIGHT REGAIN AFTER GASTRIC BYPASS SURGERY

Davidson LE ¹, Adams TD^2,1, Hasstedt SJ³, Xin Y¹, Gress RE¹, Hunt SC¹

¹University of Utah, Salt Lake City, UT, USA; ²Intermountain Health & Fitness Institute, LDS Hospital, Salt Lake City, UT, USA; ³Human Genetics, University of Utah, Salt Lake City, UT, USA

OBJECTIVES/SPECIFIC AIMS: Bariatric surgery is considered the most effective therapy for long‐term weight loss in severely obese patients. However, even after experiencing extreme initial weight loss, some patients fail to maintain their reduced weight. We hypothesized that obesity‐related haplotypes in FTO, MC4R, NPY2R and NPFFR2 would be related to postsurgical weight regain. METHODS/STUDY POPULATION: We examined the prospective associations between these gene haplotypes and 4‐year weight regain in subjects who were previously severely obese (n= 212; age = 45 ± 11 years, BMI = 46.7 ± 7.5 kg/m2, 83% female) and underwent Roux‐en‐Y gastric bypass surgery (2‐year postsurgical BMI = 30.0 ± 5.9 kg/m2). Haplotypes from 4 SNPs in NPY2R, 4 SNPs in NPFFR2, and 2 SNPs in MC4R were estimated and subdivided into risk versus nonrisk haplotype carriers based on baseline BMI effects of these haplotypes in a larger sample of 2985 subjects. RESULTS/ANTICIPATED RESULTS: Weight regain from 2 to 6 years post surgery (BMI change = 3.2 ± 3.6 kg/m2) was not associated with FTO, MC4R, or NPFFR2. Patients with obesity‐related haplotypes of NPY2R, however, had greater weight gain (an additional 1.1 kg/m2) at 6 years than those who did not (p < 0.05). DISCUSSION/SIGNIFICANCE OF IMPACT: Gastric bypass patients who are carriers of obesity‐related NPY2R haplotypes may be more susceptible to weight gain in the long term. The weight regain associated with NPY2R is consistent with the presurgical weight association. Risk haplotypes in the NPY2R gene may identify post‐surgical subjects who need more focused weight maintenance intervention.

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GENOTYPE‐PHENOTYPE RELATIONSHIPS IN SCHIZOPHRENIA

Epping EA ¹, Mugge S¹, Andreasen NC¹, Wassink TH¹

¹The University of Iowa, Iowa City, IA, USA

OBJECTIVES/SPECIFIC AIMS: Schizophrenia is a psychiatric disorder with a worldwide prevalence of nearly one percent. Symptoms consist of delusions, hallucinations, emotional blunting and cognitive deficits. Symptoms develop in early adulthood, and typically lead to lifelong disability. Heritable factors significantly contribute to the risk of developing schizophrenia, however, these factors are heterogeneous and are not fully characterized. DNA copy number variants (CNVs) are rare genetic changes that contribute to schizophrenia risk in some individuals most likely by altering levels of gene expression. The objective of this project is to characterize phenotypes of brain structure, cognition, and symptoms in individuals with schizophrenia who have CNVs. METHODS/STUDY POPULATION: Our research group has a well‐characterized sample of individuals with schizophrenia. Data available from these subjects include structural MRI brain scans, measures of symptoms, and cognitive testing. CNVs are ascertained using comparative genomic hybridization. Individuals with novel CNVs will be of particular interest, and we will also be able to characterize potential relationships between common CNVs and phenotypes. RESULTS/ANTICIPATED RESULTS: CNVs identified on chromosomes 2, 17, and 22 are of particular interest. These CNVs are in regions that contain genes important for brain development and function. Phenotypic information from these individuals and other subjects will be presented. DISCUSSION/SIGNIFICANCE OF IMPACT: This project will advance knowledge of the genetic factors that contribute to schizophrenia and how they relate to psychiatric phenotypes, which will be informative for finding new treatments based on mechanisms of illness.

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HPV IS HIGHLY PREVALENT IN THE ORAL CAVITY

Kesebir D ¹, Burk RD¹

¹Albert Einstein College of Medicine, Department of Pediatrics at Children’s Hospital at Montefiore, Bronx, NY, USA

OBJECTIVES/SPECIFIC AIMS: The objective of this cross‐sectional study was to determine the prevalence of, and risk factors for oral HPV using 2 sets of broad spectrum primers. METHODS/STUDY POPULATION: As part of a case‐control study of prostate cancer in Ashkenazim, oral rinse samples were collected as a source of genomic DNA. A random convenience sample of 317 extracted DNA samples was tested for using FAP59/64 and MY09/MY11 primers that preferentially amplify beta /gamma and alpha HPV types, respectively. The HPV DNA types were confirmed by dot blot hybridization and/or direct sequence analysis. Risk factors for oral HPV were evaluated by logistic regression, chi‐square and Fisher’s exact tests. RESULTS/ANTICIPATED RESULTS: 37%(117/317) tested positive for HPV, of which 16% were alpha, 63% were beta, 8% were gamma, and 13% were mixed genera. HPV(+) compared to HPV(–) groups had mean age of 70 y (SD8.5) versus 68 y (SD8.1) (p= 0.01), were divorced/separated (p= 0.02), less likely to have a history of prostate cancer (p= 0.047) and reported ≥7 ETOH drinks/wk (p= 0.058). There were no significant associations with smoking, sun exposure, presence of tonsils, STIs, education, diet and/or autoimmune diseases. Age >60 years had an adjusted OR 2.7 [1.2, 6.5] for oral HPV. Military service was the only significant risk for beta HPV (OR 2.78, p= 0.04). DISCUSSION/SIGNIFICANCE OF IMPACT: A significant proportion of head and neck squamous cell carcinomas (HNSCC), including oral cancers, are associated with HPV. However, the prevalence of the broad range of HPV types has not been determined for the oral cavity. The predominant HPV types are in 3 different genera (alpha, beta, and gamma) and require specialized primers for their detection. Using alpha and beta/gamma HPV primers, oral HPV prevalence was 37% with predominance of (64%) beta HPV. Risk of oral HPV increased with age and military service increased the risk for beta HPV.

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IDENTIFICATION OF SSRI RESPONSE BIOMARKERS FOR DEPRESSION BY UTILIZING A PHARMACOMETABOLOMICS‐INFORMED PHARMACOGENOMIC APPROACH

Ji Y ¹, Hebbring S¹, Zhu H², Jenkins GD¹, Biernacka J¹, Snyder K¹, Drews M¹, Fiehn O³, Zeng Z², Schaid D¹, Mrazek DA¹, Kaddurah‐Daouk R⁴, Weinshilboum RM¹

¹Mayo Clinic, Rochester, MN, USA; ²North Carolina State University, Raleigh, NC, USA; ³University of California, Davis, CA, USA; ⁴Duke University, Durham, NC, USA

OBJECTIVES/SPECIFIC AIMS: Major depressive disorder (MDD) is a common psychiatric disease. Selective serotonin reuptake inhibitors (SSRIs) are an important class of drugs used to treat MDD. However, many patients do not respond adequately to SSRI therapy. We applied a pharmacometabolomics‐informed pharmacogenomic research strategy to identify citalopram/escitalopram treatment outcome biomarkers. METHODS/STUDY POPULATION: Metabolomic profiling using a gas chromatography‐mass spectrometry platform was performed for plasma samples from 20 escitalopram remitters and 20 nonremitters who were enrolled in a large SSRI pharmacogenomic trial at Mayo. Pharmacometabolomic “signals” were then pursued by performing pharmacogenomic investigation of the possible role of inheritance in variation in response to SSRI treatment of MDD. RESULTS/ANTICIPATED RESULTS: Metabolomic analysis of MDD patients treated with SSRIs showed that baseline plasma glycine level was negatively associated with treatment outcome (p= 0.0054). Genotyping of tag single nucleotide polymorphisms (SNPs) for genes encoding glycine synthesis and degradation enzymes was then performed in 529 DNA samples from the Mayo Clinic SSRI study. The rs10975641 SNP in the glycine dehydrogenase gene was associated with treatment outcome phenotypes in both the initial study and 1245 MDD patients in the STAR*D study that was used for replication (p= 0.02). DISCUSSION/SIGNIFICANCE OF IMPACT: These results highlight both a possible role for glycine in SSRI response and the use of pharmacometabolomics to “inform” pharmacogenomics for the discovery of drug response biomarkers in personalized medicine.

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IDENTIFYING THE SOURCE OF RESISTANCE TO EXCITOTOXIC CELL DEATH: IMPLICATIONS FOR HUNTINGTON'S DISEASE

Strong MK ¹, Steward O¹

¹University of California, Irvine, Irvine, CA, USA

OBJECTIVES/SPECIFIC AIMS: The death of specific neuronal populations is the cause of cognitive and motor dysfunction in multiple disorders. There are several neurodegenerative diseases or injuries that have a common factor in their progression, for example: Huntington’s disease (HD), Alzheimer’s disease, traumatic brain injury, multiple sclerosis, Parkinson’s disease, and spinal cord injury are just some that are thought to get worse through excitotoxicity, which is the over‐activation of neurons to the point of cell death. In HD, a specific and distinctive population of cells in the striatum degenerates. It is important to learn more about the role of excitotoxic cell death in this disease, and identify factors that can help to prevent this excitotoxic cell death. METHODS/STUDY POPULATION: Mice are great models to study human disease as well as excitotoxicity because they can express a human mutant protein, and we can investigate the direct effects of an excitotoxin. We have developed a new line of an HD mouse model on a vulnerable strain background, and have tested it for susceptibility. We are also using a microarray analysis to identify the pattern of gene expression that is unique to older mice which carry the human HD transgene. RESULTS/ANTICIPATED RESULTS: Our studies reveal that one of our mouse models of HD displays a surprising resistance to striatal neurodegeneration with age when vulnerability to excitotoxic cell death is tested. A small but selective set of genes are activated in this group that displays activated resistance to cell death. DISCUSSION/SIGNIFICANCE OF IMPACT: Identifying cellular mechanisms that make neurons resistant to excitotoxicity may point the way to powerful new therapies that could alleviate the symptoms in HD and many other neurodegenerative disorders, reducing the financial, emotional and physical burden caused by these disorders.

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IMPLEMENTING WARFARIN PHARMACOGENOMICS

Ramirez AH ¹, Delaney JT¹, Xu H¹, Schildcrout JS¹, Oetjens MT¹, Jeff JM¹, Cowan JD¹, Basford MA¹, Bowton EA¹, Pulley JM¹, Ritchie MD¹, Crawford DC¹, Masys DR¹, Roden DM¹, Denny JC¹

¹Vanderbilt University, Nashville, TN, USA

OBJECTIVES/SPECIFIC AIMS: Variability in warfarin doses, up to 10‐fold, includes a prominent genetic component. We tested whether the association between stable warfarin dose and genetic variants was replicated in BioVU, the Vanderbilt DNA Databank that links DNA samples from >100,000 patients to de‐identified EMRs, and if implementing the published IWPC algorithm using genetic and clinical data improved dose prediction. METHODS/STUDY POPULATION: Stable warfarin dose was defined as the median weekly dose taken from the first window in which a patient had a consistently therapeutic INR between 2 and 3 for at least 3 weeks using natural language processing (NLP) algorithms and verified by human review. Fifteen SNPs in CYP2C9, VKORC1, CALU, CYP4F2, EPHX1, and GGCX were analyzed. RESULTS/ANTICIPATED RESULTS: 1,141 European Americans on stable doses of warfarin (NLP positive predictive value >98%) were identified. Log‐transformed median steady‐state warfarin dosage was associated with seven SNPs including three in VKORC1 in high LD (p < 1.29 × 10–53), CYP2C9*2 (p= 1.47 × 10–11), CYP2C9*3 (p= 3.4 × 10–29), CYP4F2 (p= 3.96 × 10–6), and GGCX (p= 0.04). Together these variants explain 35% of dose variability. Implementing the IWPC algorithm reduced mean absolute error of weekly dose to 9.9 mg/wk from 13.9 mg/wk seen with standard of care fixed 35 mg/week dosing regimen. DISCUSSION/SIGNIFICANCE OF IMPACT: DNA repositories linked to drug outcome data in an EMR can confirm and discover pharmacogenetic associations and reduce dosing error.

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INDOLEAMINE 2,3 DIOXYGENASE (IDO)IN PREECLAMPSIA

Santillan M ¹, Santillan D¹, Pelham CJ¹, Ketsawatsomkron P¹, Yang B¹, Hunter SK¹, Sigmund CD¹

¹University of Iowa Carver College of Medicine, Iowa City, IA, USA

OBJECTIVES/SPECIFIC AIMS: Decreased human placental IDO activity is associated with preeclampsia (PreE). In addition, low mouse IDO activity has been associated with feto‐placental rejection and high blood pressure, both of which are key PreE phenotypes. Yet, the role of IDO in PreE is unknown. We therefore generated an IDO‐deficient (IDO‐KO) C57BL/6 (C57) mouse model to test the hypothesis that IDO‐KO will result in PreE. METHODS/STUDY POPULATION: Wild type (WT) C57 females crossed with WT C57 males are syngeneic control (SC) dams. IDO‐KO females crossed with IDO‐KO males are syngeneic knockout (SK) dams. At gestational day (GD) 18 urine was assayed for protein concentration. Vascular reactivity of aortas and mesenteric arteries at GD18 was examined using wire and pressurized myograph, respectively. RESULTS/ANTICIPATED RESULTS: SK dams demonstrated a significantly higher proteinuria than SC dams (SK: 4334 ± 101 ug/mL vs SC: 2976 ± 160 ug/mL, p < 0.001). Vascular reactivity of aortas and mesenteric arteries at GD 18 was examined by using wire and pressurized myograph, respectively. At all doses of acetylcholine (Ach), aorta from SK dams exhibited a decrease in relaxation compared to SC dams (% relaxation at 3 nM Ach; SK: 31.9 ± 4.7% vs SC: 48.5 ± 5.1%, p < 0.001). In mesenteric arteries, the vasodilatory responses to Ach and sodium nitroprusside were similar between the groups. Initial preliminary BP measured by radiotelemetry suggests that mean arterial pressure at the end of pregnancy is higher in the SK versus SC dams (SK: 126 mmHg vs SC: 115 mmHg). DISCUSSION/SIGNIFICANCE OF IMPACT: We conclude that loss of IDO leads to endothelial dysfunction in aorta and increased proteinuria in pregnancy. Given recent data placing a primary role of fetal tolerance in the pathogenesis of preeclampsia, these data support that IDO is important in the initiating steps of preeclampsia.

                                   P177

INFLUENCE OF EXERCISE TRAINING ON ENDOTHELIAL CELL PHENOTYPIC HETEROGENEITY BETWEEN CORONARY AND SYSTEMIC VASCULATURES IN HYPERCHOLESTEROLEMIC SWINE

Simmons GH ¹, Padilla J¹, Laughlin MH¹

¹University of Missouri, Columbia, MO, USA

OBJECTIVES/SPECIFIC AIMS: The purpose if this study was to test the hypothesis that the athero‐susceptible coronary endothelium expresses higher levels of pro‐oxidant and lower levels of antioxidant protein compared to the systemic conduit arteries, and that exercise training decreases heterogeneity of endothelial cell phenotype between coronary and systemic vessels. METHODS/STUDY POPULATION: Fourteen male hypercholesterolemic swine exercise trained for 16–20 weeks (n= 7) or remained sedentary (n= 7). At sacrifice, endothelial cells were mechanically scraped from isolated segments of carotid, brachial, femoral, renal, and right coronary arteries (RCA), and p67phox, SOD1 and SOD3 protein expression were evaluated by immunoblotting. RESULTS/ANTICIPATED RESULTS: Expression of pro‐oxidant (p67phox) and anti‐oxidant (SOD1 and SOD3) markers in the RCA was not different compared to the carotid artery (prediabetes > 0.05), but was elevated compared to the renal, femoral, and brachial arteries in sedentary animals (all prediabetes < 0.05). In contrast, exercise trained animals exhibited increased p67phox protein expression in the RCA compared to all systemic arteries (all prediabetes < 0.05), whereas no differences were detected in either SOD1 or SOD3 expression throughout the vasculature (both C > 0.05). DISCUSSION/SIGNIFICANCE OF IMPACT: We conclude that exercise training is associated with decreased heterogeneity of antioxidant, but not pro‐oxidant, protein expression between coronary and systemic conduit artery endothelium. Supported by P01 HL052490 (MHL) and T32 AR048523 (GHS and JP)

                                   P180

INSULIN STIMULATES AMINO ACID TRANSPORTER EXPRESSION IN SKELTAL MUSCLE OF YOUNG AND OLDER ADULTS

Drummond M ¹, Timmerman K¹, Fry C¹, Rasmussen B¹, Volpi E¹

¹UTMB, Galveston, TX, USA

OBJECTIVES/SPECIFIC AIMS: Healthy, nondiabetic older adults are resistant to the anabolic effect of insulin on skeletal muscle proteins. Recently, amino acid transport has been identified as an important contributor to mTORC1 activation and muscle protein synthesis. Insulin stimulates the transcription of amino acid transporters, enhances localization of amino acid transporters on the cell membrane, and increases transporter activity. Therefore, we hypothesized that aging may blunt amino acid transporter expression in response to an insulin infusion, thereby reducing intracellular amino acid availability. METHODS/STUDY POPULATION: Five younger and older adults were studied at baseline and during a local insulin infusion in one leg increasing leg plasma insulin to postprandial levels without decreasing amino acid concentrations. Muscle biopsies were taken before, 1.5 and 3 h during insulin infusion. Biopsies were analyzed for mRNA expression of L‐type (LAT1/SLC7A5), A‐type (SNAT2/SLC38A2), proton‐assisted (PAT1/SLC36A1), and cationic (CAT1/SLC7A1) amino acid transporters utilizing RT‐PCR. RESULTS/ANTICIPATED RESULTS: There were no baseline differences in amino acid transporter mRNA expression between young and older subjects (p > 0.05). Insulin increased LAT1/SLC7A5, PAT1/SLC36A1 and CAT1/SLC7A1 mRNA expression similarly in both age groups at the 3 h time point (p < 0.05). DISCUSSION/SIGNIFICANCE OF IMPACT: These data suggest that the ability of insulin to stimulate amino acid transporter expression is not reduced in healthy older adults. Future studies should focus on other mechanisms leading to insulin resistance of muscle protein anabolism in healthy aging.

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INTRAUTERINE EXPOSURE TO DIABETES AND BODY MASS INDEX IN HISPANIC CHILDREN

Page K ¹, Enriquez I¹, Romero A¹, Buchanan T¹

¹University of Southern California, Los Angeles, CA, USA

OBJECTIVES/SPECIFIC AIMS: Our aim is to determine whether intrauterine exposure to gestational diabetes mellitus (GDM) is associated with increased body mass index (BMI) in Hispanic children. METHODS/STUDY POPULATION: Participants are Hispanic offspring, between 4–18 years old, of mothers who participated in our ongoing study on the genetics of type 2 diabetes. Offspring are defined as GDM exposed if their mothers had documented GDM during the pregnancy of interest. Nonexposed offspring are children whose mothers had documented normal glucose levels during pregnancy. Maternal GDM was defined by American Diabetes Association Criteria. Children’s current height and weight, gender, and data of birth and maternal height and weight were obtained from phone interviews with mothers. BMI z‐scores (age and gender based BMI) were determined from children’s current height and weight. This study has been IRB approved at USC. RESULTS/ANTICIPATED RESULTS: Participants included 54 GDM exposed offspring (28 m, 28 f; age 7.9 +/– 4 yrs) and 48 nonexposed offspring (18 m, 30 f; age 8.4 +/– 4 yrs). There was a trend toward higher BMI z‐scores in offspring exposed to maternal GDM compared to nonexposed offspring (1.2 ± 0.2 vs. 0.8 ± 0.1, p= 0.09), even after adjusting for maternal BMI. DISCUSSION/SIGNIFICANCE OF IMPACT: Based on information reported by participant’s mothers, we have found a trend towards greater BMI z‐scores in Hispanic children exposed to GDM in utero compared to nonexposed Hispanic children. Current work is underway to directly measure the height, weight and total body fat of an expanded number of GDM exposed and nonexposed offspring. This work is the first to examine the relationship between exposure to maternal diabetes in utero and childhood adiposity in the Hispanic population, a high‐risk group and the fastest growing segment of the United States population.

                                   P182

IRF8 ALLELE ASSOCIATED WITH MULTIPLE SCLEROSIS MODULATES SERUM INTERFERON ALPHA AND SEROLOGIC PROFILE IN SYSTEMIC LUPUS ERYTHEMATOSUS

Niewold TB ¹, Franek BS¹, Kariuki SN¹, Mikolaitis RA², Jolly M², Utset TO¹, Zervou M³, Boumpas DT³, Goulielmos G³

¹University of Chicago, Chicago, IL, USA; ²Rush University, Chicago, IL, USA; ³University of Crete, Heraklion, Greece

OBJECTIVES/SPECIFIC AIMS: Alleles of IRF8 have been associated with susceptibility to both systemic lupus erythematosus (SLE) and multiple sclerosis (MS). While interferon alpha (IFN‐α) is thought to be causal in SLE, recombinant type I IFN is used as a therapy in MS. We investigated whether the IRF8 alleles associated with these two diseases were associated with differences in serum IFN‐α or serologic profile in SLE patients. METHODS/STUDY POPULATION: The rs12444486 and rs17445836 single nucleotide polymorphisms (SNPs) in IRF8 were genotyped with Taqman primer‐probe sets. We studied 548 SLE patients (258 African‐American, 147 European‐American, and 143 Cretan) and 526 controls matched by ancestral background. All patients had serum IFN‐α and serology data available. RESULTS/ANTICIPATED RESULTS: In case‐control meta‐analysis, we observed a consistent cross‐ancestral background association between IRF8 and SLE at the MS‐associated rs17445836 SNP (OR = 0.66, p= 2.7 × 10⁻³, Cochran’s Q = 0.80). This allele was associated with the presence of anti‐dsDNA autoantibodies in SLE patients in all ancestral backgrounds [meta‐analysis OR = 2.01 (1.09–3.68), p= 0.024]. The same allele was also associated with increased serum IFN‐α activity (meta‐analysis p= 0.017). No significant associations were observed between the SLE‐associated rs12444486 SNP and serum IFN‐α or serologic profile. DISCUSSION/SIGNIFICANCE OF IMPACT: The rs17445836 G allele associated with susceptibility to MS was associated with SLE, and with anti‐dsDNA antibodies and serum IFN‐α in SLE patients of both African American and European ancestry. This is interesting, given the therapeutic effect of type I IFN in MS patients, and the pathogenic effect of this same cytokine in SLE.

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IS SEISMOCARDIOGRAPHY A RELIABLE GATING TOOL FOR CARDIAC IMAGING?

Tridandapani S ¹, Su J², Brand O², Bhatti P²

¹Emory University, Atlanta, GA, USA; ²Georgia Institute of Technology, Atlanta, GA, USA

OBJECTIVES/SPECIFIC AIMS: The objective of this study is to evaluate if seismocardiography (SCM) can predict the quiescent phases within a cardiac cycle. SCM can be obtained by linear accelerometers placed at the chest wall, METHODS/STUDY POPULATION: We have built hardware in‐house to obtain simultaneous ultrasound (US), electrocardiogram (EKG), and SCM data. Twenty subjects will undergo US scanning of the left ventricular wall. US is the gold standard for cardiac motion evaluation for this study. Simultaneously, EKG and SCM recordings will be obtained. Beat‐to‐beat crosscorrelation of the US data will be performed using the EKG R‐R9 interval as the reference period; simultaneously beat‐to‐beat correlation of the SCM data will also be performed. RESULTS/ANTICIPATED RESULTS: The cross‐correlation on the US data will provide information on the quiescent phases of the heart. If the quiescent phases determined by the cross‐correlation of the SCM data tracks the quiescent phases determined by the US data, then SCM can be used to track these quiescent phases. DISCUSSION/SIGNIFICANCE OF IMPACT: Cardiac computed tomography (CCT) with prospective EKG gating is unreliable because the heart is a moving target and EKG is not very good at determining when the heart is relatively immobile within a cardiac cycle on a beat‐to‐beat basis. SCM is a real‐time tracking strategy just like EKG, but tracks motion directly rather than the electrical activity of the heart. If SCM is shown to be a reliable method of prospective‐gating for CCT, this could lead to a reliable, noninvasive, rapid and inexpensive diagnostic tool for evaluating the coronary arteries and eventually replace the more invasive and expensive catheter‐based coronary angiogram.

                                   P184

LONGITUDINAL TRAJECTORIES OF CORTICAL ATROPHY IN SUBTYPES OF PRIMARY PROGRESSIVE APHASIA

Rogalski EJ ¹, Cobia D¹, Harrison TM¹, Wieneke C¹, Weintraub S¹, Mesulam M¹

¹Northwestern University, Chicago, IL, USA

OBJECTIVES/SPECIFIC AIMS: The aim was to examine the longitudinal course of PPA over a two‐year period and to offer quantitative ranges of expected change that could be used to guide the design and evaluation of therapeutic intervention trials. METHODS/STUDY POPULATION: Regional changes of cortical thickness and whole‐brain volume loss as well as neuropsychological performance was assessed at baseline and 2 years later in 12 rigorously characterized patients who fulfilled research criteria for logopenic, agrammatic and semantic PPA subtypes (6 PPA‐L, 2 PPA‐G, and 4 PPA‐S). RESULTS/ANTICIPATED RESULTS: There was substantial progression of clinical deficits and cortical atrophy over two years. Neuropsychological performance patterns lost the sharp distinctions that differentiated one PPA variant from another. Nonetheless, the subtype‐specific differential impairment of word comprehension versus grammatical processing was largely maintained. Peak atrophy sites spread beyond the initial distinctive locations that characterized each of the three subtypes and displayed a more convergent distribution encompassing all three major components of the language network: the inferior frontal gyrus, the temporoparietal junction and lateral temporal cortex. Despite the progression, overall peak atrophy remained lateralized to the left hemisphere. DISCUSSION/SIGNIFICANCE OF IMPACT: The results suggest that the distinctive features, which sharply differentiate the PPA variants at the early to middle stages, may lose their distinctiveness as the degeneration becomes more severe. Given the substantial atrophy over two years, PPA clinical trials may require fewer patients and shorter study durations than Alzheimer’s disease trials to detect significant therapeutic effects.

                                   P185

LOWE SYNDROME‐LIKE PHENOTYPE CAUSED BY A LARGE DELETION THAT INCLUDES CLCN5: A NOVEL CONTIGUOUS DELETION SYNDROME

Lemaire M ¹, Cheong H², Ji W¹, Park H³, Chung H³, Shin J⁴, Lifton RP¹

¹HHMI/Yale School of Medicine, New Haven, CT, USA; ²Seoul National University Children’s Hospital, Seoul, Republic of Korea; ³Seoul National University Bundang Hospital, Seongnam City, Republic of Korea; ⁴Yonsei University Severance Children’s Hospital, Seoul, Republic of Korea

OBJECTIVES/SPECIFIC AIMS: To clarify the genetic basis of our patient’s unusual constellation of clinical findings. METHODS/STUDY POPULATION: The subject of this study is a 5‐year‐old male with clinical features partially consistent with a diagnosis of Lowe syndrome (LS): low molecular weight proteinuria with hypercalciuria and nephrocalcinosis, developmental delay, recurrent seizures, cryptorchidism and stunted growth. However, hypopituitarism (partial TSH and complete GH deficiencies), micropenis, cleft palate and absence of cataracts have not been described in the context of LS. RESULTS/ANTICIPATED RESULTS: All LS subjects have mutation in OCRL1 but our patient did not. Mutations in CLCN5 were then sought since the renal phenotype of Dent’s disease is indistinguishable to that of LS: most CLCN5’s exons failed to amplify by standard PCR. SNP genotyping revealed a 3.5 Mb deletion at Xp11.22 (Illumina 650 K). Sequencing across the deletion breakpoint revealed two distant direct repeats with an intervening inverted repeat. A potential secondary structure derived from these repeats suggests “slipped mispairing” as the cause for this gross deletion. DISCUSSION/SIGNIFICANCE OF IMPACT: Beside CLCN5, the deleted interval contains 14 genes. Of these, the only well‐recognized disease‐causing gene is SHROOM4. Variants in this gene are associated with Stocco dos Santos syndrome, which is characterized by mental retardation, seizures and stunted growth. We propose that the unusual phenotype of our patient is due to a novel contiguous deletion syndrome. The possibility of a deletion hot spot is currently being investigated on a group of patients with large but unmapped deletions in the same genomic region.

                                   P186

MARINOBUFAGENIN AND ANGIOGENIC IMBALANCE ARE THE INDICATORS OF CEREBRAL VASCULAR LEAK SYNDROME IN PREECLAMPSIA

Uddin MN ¹, Jones R², Allen S², Zawieja DC¹, Kuehl TJ^1,2

¹Texas A&M Health Science Center, Temple, TX, USA; ²Scott & White Hospital, Temple, TX, USA

OBJECTIVES/SPECIFIC AIMS: Preeclampsia (PE) is a disorder of pregnancy in which Marinobufagenin (MBG) a ardiotonic bufodienolide is increased. This translational research aims to understand the pathogenesis of PE. METHODS/STUDY POPULATION: We evaluated BBB function and the plasma and urine levels of MBG and angiogenic factors in a rat model of PE. Human brain microvascular endothelial cells (HBMEC) were utilized to examine any alteration in monolayer permeability caused by MBG. In HBMEC, the phosphorylation of ERK1/2, Jnk, p38, and Src was evaluated with MBG and Apoptosis was evaluated. The effect of MBG on endothelial tight junction proteins was determined. Urinary MBG and angiogenic factors were determined in the normal and PE patients. RESULTS/ANTICIPATED RESULTS: Our data indicate increases in BBB permeability in the PE rats and that urinary excretion of MBG is increased. MBG induced an increase in monolayer of HBMEC permeability. MBG caused a significant decrease in the phosphorylation of ERK1/2 and activated the phosphorylation of Jnk, p38, and Src. MBG significantly increased the expression of caspases 3/7, indicating the activation of apoptosis. MBG causes the disruption of endothelial adheren tight junction proteins. The urinary excretion of MBG is higher in PE patients compared to normal. An angiogenic imbalance was observed in PE patients compared to normal. DISCUSSION/SIGNIFICANCE OF IMPACT: We propose the novel hypotheses that MBG precedes PE; MBG causes the disruption of tight junction proteins leading to BBB hyperpermeability via activation MAPK which triggers apoptotic mechanisms resulting in cerebral edema that is a common feature of PE; and angiogenic factors released in this process serve as biomarkers of the extent of vascular imbalance.

                                   P187

MICROTRIAL METHODS FOR TRANSLATING GENETIC FINDINGS INTO PREVENTIVE INTERVENTIONS

Howe GW ¹, Fu S¹

¹George Washington University, Washington, DC, USA

OBJECTIVES/SPECIFIC AIMS: Genetic research on behavioral outcomes holds promise for enhancing the effectiveness of preventive interventions, but poses considerable challenges given the dynamic interplay between genes and environment. We introduce a novel research design, called microtrials, as a means of translating basic genetic findings into prevention trials. Microtrials are defined as randomized experiments testing the effects of relatively brief and focused manipulations designed to suppress specific risk mechanisms, but not to bring about full preventive effect. Findings from microtrials can be used in the development or refinement of targeted preventive interventions. This presentation has three specific aims: (1) present findings on risk mechanisms associated with depression; (2) discuss a set of microtrial studies designed to test the malleability of these mechanisms in high‐risk samples; (3) clarify how findings from these microtrials will be used to refine preventive interventions. METHODS/STUDY POPULATION: We present data from two studies of stress‐triggered depression involving nearly 500 recently unemployed adults. RESULTS/ANTICIPATED RESULTS: Findings implicate several phenotypic and genotypic risk factors that exacerbate the effects of stressors on the development of severe depression or anxiety. Data link these general risk factors to specific mediators thought to be malleable through preventive intervention, including cognitive variables concerning sense of self‐efficacy and strategies for coping with job loss. DISCUSSION/SIGNIFICANCE OF IMPACT: We describe intervention components designed to influence these mechanisms and plans for testing their effects in a series of microtrials designed for individuals at greatest risk, based on phenotypic and genotypic data, and discuss how to use the results of microtrials to build next‐generation preventive interventions specifically tailored to high‐risk populations.

                                   P188

MISREGULATION OF RAD50 IN MELANOMA CELLS

Cheung WL ¹, Owings R¹, Avaritt N¹, Tackett A¹

¹University of Arkansas for Medical Sciences, Little Rock, AR, USA

OBJECTIVES/SPECIFIC AIMS: UV (ultraviolet) radiation has been linked to increased risk of skin cancer including melanoma. Previously, we determined that DNA DSBs, as detected by histone H2AX phosphorylation, are increased in human melanoma tissue. We decided to determine if the downstream effectors of DNA DSB, namely RAD50 expression are altered in human primary melanoma cells. METHODS/STUDY POPULATION: The following cases were retrieved from our archives: 11 melanoma, 7 severe dysplastic nevus, and 11 mild dysplastic nevi. There were no significance difference in age, sex, or location of the lesions between the melanocytic lesions (p > 0.5). Commercially available antibodies against RAD50 (Cell Signalling) were employed and routine immunohistochemistry was performed. The intensity was multiplied by the percentage and the following product is then categorized. Chi‐square analysis was used to determine statistical significance with a p < 0.05 considered significant. RESULTS/ANTICIPATED RESULTS: Melanoma cases showed a statistically significant increase in RAD50 staining compared to cases of mild dysplastic nevi and severe dysplastic nevi. There was positive RAD50 staining in nine of eleven (82%) melanoma cases, two of seven (29%) severely dysplastic nevus cases, and three of eleven (27%) melanoctic nevus cases (p < 0.001). Interestingly, RAD50 staining was localized to the cytoplasm in most of the cases (82%) melanoma cases, while RAD50 were localized to the nucleus in all (100%) cases of dysplastic melanocytic nevi (p < 0.01). DISCUSSION/SIGNIFICANCE OF IMPACT: This is the first study that demonstrates activation and misregulation of the DNA repair pathway in human melanoma cells. RAD50 is clearly increased in melanoma cells and is cytoplasmic indicating aberrant localization of at least one DNA DSB repair protein. Further studies are needed to determine the mechanism responsible for aberrant RAD50 localization in human melanoma cells.

                                   P189

MITOGEN ACTIVATED PROTEIN KINASE 2 IS INDUCED DURING CLOSTRIDIUM DIFFICILE INFECTION

Bobo LD ¹, Dubberke ER¹, Haslam DB¹

¹Washington University School of Medicine, St. Louis, MO, USA

OBJECTIVES/SPECIFIC AIMS: To determine if C. difficile toxin B induces the p38‐mitogen activated protein kinase (P‐MK2)‐inflammatory pathway in vitro, and to evaluate this response in human infection using a P‐MK2 immunoassay (EIA) developed in house for this purpose. METHODS/STUDY POPULATION: (1) In vitro: P‐MK2 and Interleukin (IL‐8) quantified by EIA and cytotoxicity testing after toxin B‐induction of HT‐29 intestinal cells, and after antitoxin B neutralization and p38 and MK2 inhibition. (2) Patient Study: Comparison of fecal P‐MK2, IL‐8 and lactoferrin by EIA (Log10 pg/ml) with presence of C. difficile in a cross‐sectional study of hospitalized patients >18 yrs old with diarrhea, excluding inflammatory bowel disease, and characterization of novel C. difficile study isolate. RESULTS/ANTICIPATED RESULTS:  In vitro: P‐MK2 was induced in a time and dose dependent fashion, corresponding to cytotoxicity and IL‐8 production. Conversely, antitoxin B, and p38 or MK2 inhibitors markedly decreased P‐MK2 to 6.7, 24 and 34%, respectively, and cytotoxicity. Patient Study: Fecal biomarkers for C. difficile positive (n= 10) and negative (n= 81), and p value: P‐M2: 16E1+/–11E2, 0.49+/–E2, 0.001; IL‐8: 52E2+/–10E3,4.04E4+/–78E4, 0.062; lactoferrin: 5.23E2+/–13.7E4, 7.7E7+/–3.4E8,0.234 (Mann‐Whitney U). Sensitivity, specificity, PPV and NPV: P‐MK2: 80,70.4,33,96%;IL‐8: 70, 52, 15.6, 93%; lactoferrin: 60, 63, 16.6,92.7% (ROCC analysis for positive cutoff). Novel phenotype: patient with diarrhea had noncytotoxic stool, undetectable fecal P‐MK2, but toxin B positive isolate by PCR and EIA that was noncytotoxic and unable to induce P‐MK2. DISCUSSION/SIGNIFICANCE OF IMPACT: C. difficile toxin diagnostics lack specificity. P‐MK2 is induced by biologically active toxin, and is likely not a surrogate in C. difficile intestinal disease. P‐MK2 may improve specificity in diagnosis of C. difficile infection.

                                   P193

NOVEL DIETARY TREATMENTS FOR ANOREXIA NERVOSA IN CHILDREN

Higgins J ¹, MacLean P¹, Hagman J¹

¹University of Colorado Denver, Aurora, CO, USA

OBJECTIVES/SPECIFIC AIMS: To define the dietary characteristics that lead to inpatient admission for the treatment of anorexia nervosa (AN) in children and use this information to refine a rat model of AN. This modified rat model of AN can then be used to screen novel dietary treatments for AN insuring that only the most efficacious interventions are tested clinically. METHODS/STUDY POPULATION: 15 females, 12–18 years, were administered a food frequency questionnaire (FFQ) and 24 h dietary recall to assess changes in diet that lead to inpatient admission. Data from diet questionnaires was used to refine a rat model of AN to more closely mimic the human condition. This rat model of AN was subsequently used to determine the effects of a low leucine diet on recovery time (time to 100% of pre‐AN weigh) and body fat content assessed by quantitative magnetic resonance. RESULTS/ANTICIPATED RESULTS: Dietary intake in pediatric AN patients was 1448 ± 181 kCal in the 6 mo prior to admission (FFQ) which had dropped to 1371 ± 295 kCal immediately prior to admission (24 h recall). The macronutrient content of the diet did not change over time (57% carbohydrate, 26% fat, 17% protein). So, AN was induced in Sprague Dawley female rats via free access to a running wheel and 1 h access to low fat diet per day. Upon reaching 75% of initial body weight (AN), rats were refed either a moderate fat, high protein diet (25% fat, 29% protein; control, C) or the same diet with a low leucine content (LoLeu). C rats recovered to 100% of initial weight after 4 d of refeeding with a total of 11% body fat whereas the LoLeu rats took 12 d to recover and had only 4% body fat. DISCUSSION/SIGNIFICANCE OF IMPACT: The LoLeu diet is not a suitable treatment for AN. However, we have developed a good rat model for preclinical testing of novel AN dietary treatments.

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NUTRIENT INTAKE AND SUPPLEMENT USE IN CHILDREN WITH AUTISM SPECTRUM DISORDERS

Stewart PA ¹, Schmidt B¹, Lemcke N¹, Wixom N¹, Peck R¹, Hyman S¹, Foley J¹, Clemons T²

¹URMC, Rochester, NY, USA; ²The EMMES Corporation, Rockville, MD, USA

OBJECTIVES/SPECIFIC AIMS: To examine dietary intake and supplement use in children with autism. METHODS/STUDY POPULATION: NDSR software was used to analyze nutrient intake and supplement use on 126 three day diet records of children with ASD aged 2–11 in a multicenter study of dietary behaviors and nutrition status. Usual intake was compared to the IOM’s Dietary Reference Intakes (DRI). The percentage of children meeting recommended nutrient intake levels and the percentage consuming nutrients above the Upper Limit (UL) from food alone were determined. Nutrients provided by dietary supplements were assessed and compared to the nutrients low in the diet and to ULs for children. RESULTS/ANTICIPATED RESULTS: DRIs were not met in many participants for vitamin D (89%), choline (67%), potassium (99%), and fiber (99%) and UL was exceeded for sodium (77%), niacin (65%), and manganese (26%) from food alone. 65% of children were taking dietary supplements. Multivitamins were the most common dietary supplements consumed followed by fatty acids and probiotics. 97% of the multivitamins used contained vitamin D, while only 37% contained choline, 11% vitamin K, 8% potassium and 0% fiber. The amount of potassium and choline provided by supplements was far below the DRI. Folate, niacin and vitamin A were nutrients in supplements most likely to exceed the UL even before including nutrients from food. DISCUSSION/SIGNIFICANCE OF IMPACT: Many children with ASD do not meet recommended intakes for nutrients. Children who are selective eaters may be better served by consultation with dietitians to correct nutrient imbalances using food rather than with general multivitamin use. When indicated, targeted supplementation may avoid exceeding the UL while meeting the child’s nutritional needs. Support came from US DHHS, HRSA, MCHR to MGH (UA3 MC 11054) and NCRR UL1RR024160

                                   P195

OVEREXPRESSION OF THE RNA‐BINDING PROTEIN HUR IMPAIRS TUMOR GROWTH IN TRIPLE NEGATIVE BREAST CANCER ASSOCIATED WITH DEFICIENT ANGIOGENESIS

Gubin M ¹, Calaluce R¹, Magee JD¹, Hoffman TJ^1,2, Atasoy U^1,2

¹University of Missouri, Columbia, MO, USA; ²Harry S. Truman VA Hospital, Columbia, MO, USA

OBJECTIVES/SPECIFIC AIMS: Breast cancer is the second most common cancer in women and causes the death of 519,000 people worldwide. Many cancer genes are posttranscriptionally regulated by RNA‐binding proteins (RBPs). The RBP HuR binds to the AU‐rich (ARE) regions of mRNAs, such as proto‐oncogenes, stabilizing their mRNA and facilitating their translation into protein. Elevated levels of cytoplasmic HuR directly correlate with increased invasiveness and poor prognosis for many cancers. Additionally, HuR has been described to control genes in multiple areas of the acquired capabilities model of cancer and has been hypothesized to be a tumor‐maintenance gene, allowing for cancers to proliferate once they are established. We investigated the role of HuR in aggressive and difficult to treat triple‐negative breast cancer. METHODS/STUDY POPULATION: n/a. RESULTS/ANTICIPATED RESULTS: MB‐231 cells with higher levels of HuR had alterations in cell cycle kinetics and faster growth. Unexpectedly, HuR overexpression significantly interfered with tumor growth in orthotopic mouse models. Tumors overexpressing HuR had fewer blood vessels than the control tumors. Microarray analysis revealed several genes overexpressed in the tumors with higher levels of HuR, including antiangiogenic TSP1 and TSP2. Additionally, VEGFα was found to be downregulated at the mRNA and protein levels in the tumors overexpressing HuR. Therefore, the putative mechanism seems to be an antiangiogenic effect by increasing expression of TSP1 but also down‐regulating VEGFα. DISCUSSION/SIGNIFICANCE OF IMPACT: Modulating HuR levels may overcome limitations associated with monotherapies targeting tumor vessel formation and could represent a potential theuraputic target for difficult to treat aggressive breast cancer.

                                   P196

P16 EXPRESSION PREDICTS RESPONSE TO NEOADJUVANT CHEMOTHERAPY IN OSTEOSARCOMA

Canter RJ ¹, Borys D²

¹UC Davis Medical Center, Sacramento, CA, USA; ²UC Davis Medical Center, Department of Pathology, Sacramento, CA, USA

OBJECTIVES/SPECIFIC AIMS: Although pathologic response to neoadjuvant chemotherapy is highly correlated with survival among patients with osteosarcoma (OS), there are currently no molecular markers to predict response to chemotherapy. The objective of this study was to investigate the relationship of p16 expression in pre‐treatment OS tumors to pathologic response following neoadjuvant chemotherapy. METHODS/STUDY POPULATION: A tissue microarray was created from paraffin‐embedded pretreatment biopsy specimens of 40 OS patients. Immunohistochemistry was performed with commercially available p16 monoclonal mouse antibody. Expression of p16 was defined as cytoplasmic staining in ≥30% of cells. Percent tumor necrosis was measured in postchemotherapy resection specimens per established protocols, and ≥90% tumor necrosis was considered “good.” Data were abstracted on age, sex, tumor site, and histologic subtype. Univariate and multivariate analysis was performed. RESULTS/ANTICIPATED RESULTS: The median age was 15, 52% were female, and 35% of tumors were located in the femur. P16 expression was present in 62%. Median posttreatment tumor necrosis was 90%, and 55% of patients experienced “good” chemotherapy response. P16 expression correlated positively with median percent necrosis and “good” chemotherapy response (p= 0.004 and 0.003, respectively). On logistic regression analysis, p16 expression was independently associated with chemotherapy response after controlling for age, subtype, sex, and location (OR 18.5, 95% CI 2.3–147.8, p= 0.006). DISCUSSION/SIGNIFICANCE OF IMPACT: Immunohistochemical expression of p16 significantly correlates with chemotherapy response in OS. P16 may be a useful biomarker to guide OS treatment selection.

                                   P198

PILOT STUDY OF PROGRESSIVE STRENGTH TRAINING IN SPINAL MUSCULAR ATROPHY

Lewelt AJ ¹, Krosschell K², Gappmaier E¹, Marcus R¹, White A¹, Lopes P³, Stoddard G¹, Swoboda KJ¹

¹University of Utah, Salt Lake City, UT, USA; ²Northwestern University, Chicago, IL, USA; ³Université Paris Descartes, Paris, France

OBJECTIVES/SPECIFIC AIMS: The objective of this study is to obtain preliminary data on the feasibility, safety, and effectiveness of a supervised, home‐based, progressive strength training (PST) exercise program in children and adolescents with spinal muscular atrophy (SMA). Specific Aim 1: Ascertain the feasibility of participation in and adherence to a 3 days/week, 12 week PST exercise program. Specific Aim 2: Determine the safety and tolerability of PST in study population. Specific Aim 3: Determine candidate outcome measures at baseline 1 and 2, and weeks 6, 12, and 16 after start of PST. METHODS/STUDY POPULATION: Methods: a nonblinded pilot study. Study population: children age 5–21 years with SMA types II or III who are able to cooperate with physical therapist (PT) and live within 60 miles of study center. RESULTS/ANTICIPATED RESULTS: One participant has completed the PST program without study‐related adverse events, reports of pain, or loss of strength. He progressively increased weights, achieved appropriate physical exertion levels, and completed outcome measure visits successfully. Two additional participants have enrolled and will start PST shortly. Several other families have expressed interest in the study and will be scheduled pending availability of PT. DISCUSSION/SIGNIFICANCE OF IMPACT: A 12‐week, supervised, home‐based, 3 days/week PST exercise program appears feasible. The first participant successfully completed the 12‐week PST program and outcome measures. Additional participants will start PST shortly. PT availability is the largest obstacle. This study is the first to provide preliminary data on PST as a potentially feasible, safe, and effective intervention in children and adolescents with SMA.

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PTEN ASSOCIATION WITH MTOR PATHWAY ACTIVATION AND OUTCOMES IN BLADDER CANCER

Hansel DE ¹, Orloff M¹, Elson P¹, Yang Y¹, Eng C¹

¹Cleveland Clinic, Cleveland, OH, USA

OBJECTIVES/SPECIFIC AIMS: We have recently identified mTOR pathway activation in urothelial carcinoma(UCa). We next sought to determine the relationship of PTEN, an upstream negative mediator of mTOR, to mTOR activity and outcomes in UCa patients. METHODS/STUDY POPULATION: Patients with UCa (n= 118) were examined for PTEN expression, including intensity of expression (0 to 3)and predominant subcellular localization (nuclear/nonnuclear). Results were correlated with the presence of lymph node (LN) metastases, recurrence‐free survival (RFS) and overall survival by univariate and multivariate analysis. PTEN intron/exon mutational analysis was performed by DGGE and mutational status was correlated with PTEN protein expression in 91 specimens. RESULTS/ANTICIPATED RESULTS: The majority of patients (91/118; 81%) demonstrated moderate to intense expression of PTEN. PTEN was primarily localized to the nucleus in 30/116 (26%) patients. In LN metastases, reduced PTEN intensity was associated with an increased percentage of phospho‐mTOR cells (p= 0.02). PTEN mutational analysis identified 3 variants (c.132C>T, c.511C>G, c.892C>G) which were associated with absent PTEN protein expression and diffuse phospho‐mTOR expression. Reduced RFS was correlated with positive surgical margins (p= 0.09), carcinoma in situ (p= 0.09) and nuclear PTEN (p= 0.08). Reduced overall survival was significantly associated with metastases (p= 0.04) and nuclear PTEN expression (p= 0.04). Stepwise multivariable analysis showed an association between reduced RFS and LN metastases (p= 0.03), carcinoma in situ (0.05) and nuclear PTEN (p= 0.07). DISCUSSION/SIGNIFICANCE OF IMPACT: Alterations in PTEN appear to mediate mTOR pathway activity in UCa, although few mutations result in reduced PTEN expression. Nuclear localization of PTEN is a relatively new finding and its function in mediating cancer behavior is under investigation.

                                   P200

REAL‐TIME LASER SPECKLE IMAGING AS A DIAGNOSTIC TOOL IN THE TREATMENT OF PORT WINE STAIN THROUGH IMAGE‐GUIDED LASER SURGERY

Yang B ^1,3, Yang O^1,3, Nelson J^1,2, Kelly K^1,2, Choi B^1,3

¹Beckman Laser Institute and Medical Clinic, University of California, Irvine., Irvine, CA, USA; ²Department of Dermatology, University of California, Irvine., Irvine, CA, USA; ³Department of Biomedical Engineering, University of California, Irvine., Irvine, CA, USA

OBJECTIVES/SPECIFIC AIMS: Improve the treatment efficacy of port wine stain birthmarks (PWS) using laser speckle imaging (LSI) as a means to develop image‐guided laser surgery. METHODS/STUDY POPULATION: PWS are vascular malformations seen in approximately 12,000 births a year. LSI is a technique in which imaging of coherent light remitted from an object results in a speckle pattern. The spatiotemporal statistics of this pattern is related to the movement of optical scatterers, such as red blood cells, and image processing algorithms are applied to produce speckle flow index (SFI) maps, which are representative of tissue blood flow. If performed in real time, LSI can play an important role in image‐guided surgery for the treatment of PWS. We continuously calculate SFI values for both the treated PWS regions as well as the surrounding normal tissue, and look to see if treated regions show a uniform reduction in flow exhibited by decreased SFI values. If the treated region appears to have high or nonuniform SFI values, that area will undergo retreatment. RESULTS/ANTICIPATED RESULTS: In general, SFI values within treated regions showed a progressive decrease with each treatment pass, as well as a border of hyperemia surrounding the treated region. With real‐time feedback, the physician was in most cases able to achieve uniform vascular shutdown in the region of interest. DISCUSSION/SIGNIFICANCE OF IMPACT: LSI, within image‐guided surgery, can provide an objective measure for determining blood flow, which is essential in the treatment of PWS. Furthermore, LSI has great potential for application in a wide range of disciplines, such as neurosurgery and ophthalmology.

                                   P201

REMOTE PROGRAMMING OF COCHLEAR IMPLANT

Tsay IA ^1,2, Haugen H¹

¹University of Colorado, Denver, Denver, CO, USA; ²Cochlear Americas, Centennial, CO, USA

OBJECTIVES/SPECIFIC AIMS: Evaluate the combination of telemedicine and smart programming software to remove cochlear implant face‐to‐face programming and to improve programming efficiency without impacting the quality of the clinical outcome, the subject’s ability to hear well. METHODS/STUDY POPULATION: Subjects are adult cochlear implant recipients. An audiologist is located in a different room than the subject. Using remote desktop technology to control and to monitor a local computer in front of a subject, the audiologist remotely supervises the interaction between the subject and smart programming software. The remotely programmed result is compared with the subject’s own traditionally programmed result. RESULTS/ANTICIPATED RESULTS: Preliminary data showed no clinically significant differences between the remotely programmed result and the subject’s own traditionally programmed result. DISCUSSION/SIGNIFICANCE OF IMPACT: A cochlear implant (CI) is an electronic hearing device, designed to help people suffering from moderate to profound hearing loss. Surgically implanted into the cochlea, CI provides electrical stimulation to the neurons. A face‐to‐face session is required with an audiologist to custom “program” the device for each individual. Based on the patient’s self‐report of audibility, the audiologist adjusts the current level delivered through the electrodes in order to achieve the appropriate loudness. Most rural areas do not have CI audiologists available, and long travel distances may cause patients to arrive tired and tense, increasing the potential for a poor programming session. Although previous studies demonstrated the feasibility to remotely program a CI, a local representative has always been present at the subject’s location in order to facilitate the process. This study uses smart programming software to eliminate local representative presence, improving efficiency of remote programming procedure.

                                   P202

RESISTANCE TO ANNEXIN A5 ANTICOAGULANT ACTIVITY IN CHILDREN WITH RHEUMATIC DISEASE CORRELATES WITH PERSISTENT ANTIPHOSPHOLIPID ANTIBODIES AND THROMBOSIS

Wahezi DM ¹, Rand JH¹, Rajpathak S¹, Ilowite NT¹

¹Children’s Hospital at Montefiore, Albert Einstein College of Medicine, Bronx, NY, USA

OBJECTIVES/SPECIFIC AIMS: Annexin A5, a potent anticoagulant protein, shields phospholipids on vascular endothelial cells from availability for coagulation reactions. Disruption of this shield by antiphospholipid (aPL) antibodies may play a role in the pathogenesis of antiphospholipid antibody syndrome (APS). In this study, we investigated the association between aPL antibodies and annexin A5 resistance (A5R) in children with rheumatic diseases. METHODS/STUDY POPULATION: Clinical and laboratory data were collected from 90 children with rheumatic diseases. All patients were tested for lupus anticoagulant (LA), anticardiolipin (aCL) and anti‐β2 glycoprotein I (anti‐β2GPI) antibodies. A novel assay, A5R, was performed measuring coagulation times in the presence and absence of annexin A5. RESULTS/ANTICIPATED RESULTS: Patients with persistently positive aPL antibodies had significantly lower mean A5R levels as compared to patients with no aPL antibodies (Persistent positivity of one or more aPL antibodies: mean A5R = 202.58 ± 43.91 vs. 247.10 ± 35.35, <0.001). Patients with an underlying diagnosis of primary APS, SLE, SS or MCTD had significantly higher prevalence of persistently positive aPL antibodies (p < 0.001), thrombotic events (p= 0.014) and lower mean annexin A5R (p= 0.030) as compared to the remainder of the group. Patients with thrombotic events also had significantly lower mean A5R levels (p= 0.048). DISCUSSION/SIGNIFICANCE OF IMPACT: The A5R assay is the first mechanistic assay targeted at the underlying pathogenesis of APS. This is the first report demonstrating that children with rheumatic diseases and persistently positive aPL antibodies demonstrate resistance to annexin A5 anticoagulant activity. Furthermore, patients with prior history of thrombosis were also shown to have reduced A5R.

                                   P203

RESTING STATE NETWORKS IN EARLY STAGE PSYCHOSIS

Kean J ¹, Wang Y¹, West J¹, McDonald BC¹, MaGee T¹, Kronenberger WG¹, Mathews VP¹, Breier A¹, Saykin AJ¹

¹Indiana University School of Medicine, Indianapolis, IN, USA

OBJECTIVES/SPECIFIC AIMS: Investigate differences in functional connectivity between patients with early stage psychosis and healthy control subjects METHODS/STUDY POPULATION: Nine male patients (age 18–27) with early stage psychosis, and 9 healthy controls, matched for age and handedness. RESULTS/ANTICIPATED RESULTS: Quantitative comparison of resting default mode network activation maps between healthy controls and patients with early psychosis shows significantly greater activation lateralized to right dorsolateral prefrontal cortex (DLPFC) and right posterior parietal cortex (p < 0.01, k = 50), similar to the findings of Calhoun and colleagues, when masked to display only DMN network components (masked by HC average DMN at p < 0.001). DISCUSSION/SIGNIFICANCE OF IMPACT: There is increasing evidence of anomalous functional connectivity in patients with psychosis, with some studies reporting decreases in connectivity and others hyperconnectivity. Our results indicating early stage psychosis is associated with decreased functional connectivity and are consistent with reports of disrupted white matter connectivity (Kubicki et al., 2007), which could produce the hypoconnectivity observed in the patient sample.

                                   P207

SIMVASTATIN EFFECTS ON MEVALONATE PATHWAY TARGETS IN THE LUNG

Zeki AA ¹, Bratt J¹, Filosto S¹, Ashfaq M¹, Tzipora G¹, Kenyon NJ¹

¹University of California, Davis, Sacramento, CA, USA

OBJECTIVES/SPECIFIC AIMS: Simvastatin (Sim) inhibits allergic airway inflammation in the ovalbumin (OVA) mouse model. To transition from animals to humans, we investigated whether systemic treatment with Sim inhibits mevalonate (MA) pathway targets in mouse lung and human airway epithelial cells. We hypothesized that Sim treatment of mice and human airway epithelial cells inhibits total cholesterol (TC) synthesis and alters HMG‐CoA reductase (HMGR) expression, the target of the statins. METHODS/STUDY POPULATION: BALB/c mice were sensitized/exposed to 1%OVA aerosol over 2 wks. Sim 40 mg/kg was injected intraperitoneally 30 min before OVA nebulization. HBE1 cells were treated with Sim 10 μM or 20 μM for up to 16 hrs. TC content in whole lung homogenates and HBE1 whole cell lysates was determined. HMGR protein was determined in cell cytosolic and membrane fractions by Western blot. RESULTS/ANTICIPATED RESULTS: In mice, TC content did not differ between OVA or air controls, and Sim did not alter TC content. In HBE1 cells, 16 hrs Sim treatment caused a dose‐dependent 30% decrease in TC, and Sim 20 μM caused a time‐dependent decrease in TC. In mice, Sim decreased HMGR protein expression (100 kDa) by 56% in the OVA group, with no change in the air controls. In HBE1 cells, Sim 20 μM treatment for 4 hrs decreased HMGR protein expression (60 kDa) by 52.6%. DISCUSSION/SIGNIFICANCE OF IMPACT: Sim did not alter lung TC content, but may reduce TC in the airway epithelium via HMGR inhibition. Airway epithelial changes in TC and HMGR expression may be good indicators that statin reached the airway. HMGR enzyme activity and/or statin drug levels may be better indicators of drug reaching the target tissue. Further work and validation of these results will yield a protocol for determining whether orally ingested statins in human asthmatics reach the airway epithelium.

                                   P208

SOLUBLE MUCOSAL IMMUNE MEDIATORS IN THE GENITAL TRACT OF PREGNANT WOMEN WITH GROUP B STRETPTOCOCCUS

Ghartey J ¹, Chazotte C¹, Einstein M¹, Herold B¹

¹Albert Einstein College of Medicine, Bronx, NY, USA

OBJECTIVES/SPECIFIC AIMS: To compare soluble mucosal immune mediators and endogenous antimicrobial activity of genital tract secretions in pregnant women who are or are not colonized with Group B streptococcus (GBS). METHODS/STUDY POPULATION: Seventy pregnant women between 35 and 37 weeks gestational age were enrolled at the time of routine GBS testing. A flocked vaginal swab was collected, diluted in 0.5 mL normal saline, transported to the laboratory on ice, clarified by brief centrifugation, and the supernatants divided into aliquots and stored at –80°C. Concentrations of defensins and secretory leuckocyte protease inhibitor (SLPI) were measured by commercial ELISA. Cytokines were identified by luminex‐based multiplex analysis. Antibacterial activity will be determined by colony‐forming unit assays against E.Coli and GBS. RESULTS/ANTICIPATED RESULTS: Interim analysis of the first 25 participants of which 4 (16%) were colonized with GBS had significantly lower levels of the antimicrobial α‐defensins, human neutrophil peptide 1–3 (HNP 1–3), compared to women who tested negative for GBS (median (IQR) 23.4 ng/mL (21.3–23.9) vs. 55.4 ng/mL (30.7–100, p= 0.02) and trended towards having lower levels of SLPI (median (IQR) 31 ng/mL (31–65.7) vs. 169 ng/mL (34.5–243, p= 0.09). Concentrations of other mediators and endogenous activity are in progress. DISCUSSION/SIGNIFICANCE OF IMPACT: Colonization with GBS is associated with lower levels of protective antimicrobial peptides in the genital tract (HNP1–3 and SLPI). Results of this research serves as the framework for a prospective longitudinal study to differentiate whether the observed reduction in protective mediators increases the risk for GBS colonization or occurs in response to GBS colonization and could lead to novel strategies to enhance mucosal defense and reduce risk for preterm birth and infection.

                                   P209

SOMATIC HYPERMUTATIONS CONFER RHEUMATOID FACTOR ACTIVITY IN HEPATITIS C VIRUS‐ASSOCIATED MIXED CRYOGLOBULINEMIA

Charles ED ¹, Orloff MI¹, Rice CM¹, Dustin LB¹

¹Rockefeller University, New York, NY, USA

OBJECTIVES/SPECIFIC AIMS: Hepatitis C virus (HCV) causes mixed cryoglobulinemia (MC), a vasculitis caused by rheumatoid factor (RF)‐containing immune complexes (ICs). MC is a clonal B cell lymphoproliferative disorder, yet its antigenic stimulus is unknown. We propose that HCV‐IgG ICs simulate B cell expansion and somatic hypermutation (SHM)‐induced affinity maturation, and that SHM is essential for RF activity. Here, we assess the reactivities of HCV MC patients’ clonal Igs and test whether they depend upon SHM. METHODS/STUDY POPULATION: Ig variable (V) region RT‐PCR was performed on three HCV MC patients’ singly‐sorted clonal B cells. Selected Igs were also reverted to germline by PCR. After ligation into IgμC‐ and IgκC‐containing expression vectors, Igs were transfected into J chain‐expressing 293T cells and secreted pentameric IgM was purified. Anti‐human IgG1 RF activity was determined by ELISA. RESULTS/ANTICIPATED RESULTS: Over 80 Igs were cloned and expressed. All VH and Vκ utilized VH1–69/JH4 and Vκ3–20/Jκ2 gene segments, respectively. Nonsynonymous mutations ranged from 0–8 for VH and 0–6 for Vκ. Igs containing SHM had RF activity, with a preference for IgG1>IgG2˜IgG4>IgG3. In contrast, reverted germline Igs had markedly diminished activities for IgG1, IgG2, IgG3 and IgG4. Competition with 100 ng/ml Protein A abrogated RF activity, suggesting specificity for IgG Fc. Swapping of mutated heavy and light chain pairs also abrogated RF activity, suggesting that context‐specific pairing of appropriate IgH and Igk, in addition to SHM, is necessary for these Igs’ RF activity. DISCUSSION/SIGNIFICANCE OF IMPACT: SHM is essential for RF activity in HCV MC patients, suggesting that autoreactivity arises from antigen‐dependent SHM, as opposed to nondeletion of autoreactive germline Igs and expansion of polyreactive, “natural antibodies”.

                                   P211

STATIN PRETREATMENT PREDICTS REPERFUSION IN ACUTE ISCHEMIC STROKE

Ford AL ¹, An H², Powers W², Lin W², Lee J¹

¹Washington University, St. Louis, MO, USA; ²University of North Carolina, Chapel Hill, NC, USA

OBJECTIVES/SPECIFIC AIMS: Statin pretreatment is associated with improved neurological outcomes in ischemic stroke. Although several mechanisms have been examined in animals, few have been studied in humans. We hypothesized: early reperfusion is enhanced in ischemic stroke patients taking statins at stroke onset. METHODS/STUDY POPULATION: Acute ischemic stroke patients underwent two MRIs: <4.5(tp1) and at 6 hrs(tp2) after onset. Mean transit time (MTT) maps showed perfusion deficits at tp1 and tp2. Regions of reperfusion was defined by tp1 perfusion deficits which normalized at tp2. 4 thresholds defined “perfusion deficit” (MTT> 3, 4, 5, or 6 secs) to ensure that results were not based on an arbitrary threshold. Baseline data,% reperfusion, and NIH Stroke Scale change between tp1 and 1 mo (ΔNIHSS) were compared between patients taking statins on admission and those who were not. 2 multivariable regression models identified which clinical variables predicted % reperfusion and NIHSS. RESULTS/ANTICIPATED RESULTS: 31 acute ischemic stroke patients (12 on statins, 19 off) were prospectively enrolled. Baseline data did not differ between the 2 groups. Statin pretreatment resulted in greater % reperfusion compared to the untreated group across all MTT thresholds. At MTT = 4 sec, % reperfusion was 50% (IQR 30%, 56%) in the statin group vs 13% (5%, 36%) in the untreated group, p= 0.01. Of 10 clinical variables, the prediction model for reperfusion included: statin pretreatment, volume of tp1 perfusion deficit, and admission blood pressure. Patients taking statins had greater ΔNIHSS (8.8 pts) at 1 mo compared with untreated patients (4.4 pts), p= 0.03. The prediction model for NIHSS included statin pretreatment and age. DISCUSSION/SIGNIFICANCE OF IMPACT: Statin use prior to ischemic stroke onset is associated with early reperfusion and improved outcome.

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STRESSORS OF PEDIATRIC CANCER CARE: THE INFLUENCE OF INTERPERSONAL INTERACTIONS

Juth V ¹, Cohen Silver R¹, Sender L¹, OCampo P¹

¹University of California Irvine, Costa Mesa, CA, USA

OBJECTIVES/SPECIFIC AIMS: As the understanding and treatment of cancer continues to improve, the population of long‐term adolescent and young adult (AYA) survivors continues to grow. As a result, AYA patients, their families and healthcare providers face a potentially long and stressful shared illness experience. METHODS/STUDY POPULATION: Phase 1, the current study, focuses on the interactions of AYA patients and their primary caregivers in the family unit. This relationship is particularly important as it has a major influence on the AYA’s psychological and physical well‐being, while serving as the primary support system for dealing with treatment procedures and coping in general during this unique developmental life stage. Phase 2 will explore the interactions between pediatric patients, their primary caregiver, and their physicians in the healthcare setting. Phase 3 will consist of an intervention for healthcare providers based on findings from Phases 1 and 2. RESULTS/ANTICIPATED RESULTS: Phases 1 and 2 will identify the common cancer care stressors experienced within the family unit (i.e., AYA patient and his/her primary caregiver) and the healthcare setting (i.e., AYA patient and his/her primary caregiver and healthcare provider), respectively. Phase 3 will be used to assess an intervention designed for healthcare providers that is intended to lessen the stressors within pediatric cancer care. DISCUSSION/SIGNIFICANCE OF IMPACT: Findings from this program of research have the potential to guide future policy so as to promote health and well‐being in cancer survivors and their caregivers, as well as ensure more efficient and cost‐effective utilization of healthcare resources.

                                   P213

THE ADVERSE IMPACT OF DIABETES MELLITUS ON LEFT VENTRICULAR REMODELING AND FUNCTION IN PATIENTS WITH SEVERE AORTIC STENOSIS

Lindman BR ¹, Arnold SV¹, Madrazo JA¹, Zajarias A¹, Johnson SN¹, Perez JE¹, Mann DL¹

¹Washington University School of Medicine, St. Louis, MO, USA

OBJECTIVES/SPECIFIC AIMS: The diabetic heart exhibits increased left ventricular (LV) mass and reduced ventricular function. However, this relationship has not been studied in patients with aortic stenosis (AS). Our objective was to determine how diabetes mellitus (DM) impacts LV remodeling and function in patients with severe AS. METHODS/STUDY POPULATION: Echocardiograms were performed on 114 patients with severe symptomatic AS [mean age 82 years, 47% female, mean aortic valve area (AVA) 0.59 cm2, mean LV ejection fraction (EF) 50%, 47% diabetic] and included measures of LV remodeling and LV function. Multivariable linear regression models investigated the independent effect of DM on these aspects of LV structure and function. RESULTS/ANTICIPATED RESULTS: Compared to nondiabetics (n= 60), diabetics (n= 54) had increased LV mass, LV end‐systolic dimension, LV end‐diastolic dimension, and decreased LVEF and longitudinal systolic strain (p < 0.01 for all). In multivariable analyses adjusting for age, sex, systolic BP, AVA, BSA, and CAD, DM was an independent predictor of increased LV mass (β= 26 g, p= 0.01), LV end‐systolic dimension (β= 0.5 cm, p= 0.008), and LV end‐diastolic dimension (β= 0.3 cm, p= 0.025). After additionally adjusting for LV mass, DM was associated with reduced systolic strain (β= 1.9%, p= 0.023) and a trend toward reduced EF (β=–5%, p= 0.09). DISCUSSION/SIGNIFICANCE OF IMPACT: DM has an additive adverse effect on hypertrophic remodeling—increased LV mass and larger cavity dimensions—and is associated with reduced systolic function in patients with AS beyond known factors of pressure overload. Given the adverse effects of LV hypertrophy and dysfunction in patients with AS, our findings may have important clinical implications.

                                   P214

THE EFFECT OF LOW DOSES OF PLASMID DNA IN THE CONTROL OF AUTOIMMUNE DIABETES

Pileggi GS ¹, Malardo T¹, Clemencio AD¹, Donadi EA¹, Coelho‐Castelo AM¹

¹School of Medicine of Ribeirão Preto, São Paulo University, Ribeirao Preto – SP, Brazil

OBJECTIVES/SPECIFIC AIMS: The aim of this study is to evaluate the role of sequences of plasmid DNA in the control of autoimmune diabetes. METHODS/STUDY POPULATION: Mice were induced to develop diabetes with daily applications of streptozotocin (STZ). A group received plasmid STZ + DNA and the other group only STZ. After the treatment, the pancreatic lymph nodes cells were cultivated and stimulated or not with insulin. These cells were analyzed by flow cytometry (FACS) and the pancreas of each animal was removed for histological analysis. RESULTS/ANTICIPATED RESULTS: FACS analysis showed reduction in the number of insulin‐specific T CD8 cells only in the groups treated with DNA. These cells showed a memory phenotypes labeled by CD44lo/CD62Llo and CD44hi/CD62Lhi. T CD4 cells did not exhibited significant reduction between the groups. In the pancreatic histology it was possible to observe reduced inflammatory infiltrates with better preservation of the islets in the group treated with DNA than in the group treated with STZ. DISCUSSION/SIGNIFICANCE OF IMPACT: The treatment with our plasmid DNA sequence reduced the number of infiltrating TCD8 cells in the pancreas, enhanced the preservation of the islets. These data showed that the treatment with that DNA sequence were capable to reduce the inflammatory injury in the pancreas, suggesting that this strategy could be efficient for the treatment of this pathology.

                                   P217

THE ROLE OF TRPV1 IN MORTALITY AND IMMUNE RESPONSE DURING MURINE SEPSIS

Guptill V ¹, Cui X¹, Middleton L², Quezado Z²

¹NIH, Bethesda, MD, USA; ²Children’s National Medical Center, Washington, DC, USA

OBJECTIVES/SPECIFIC AIMS: Transient receptor potential vanilloid 1 (TRPV1), a nonselective cation channel expressed in sensory neurons, has a pivotal role in nociception. Therapies targeting TRPV1 are being tested in humans and animals to treat pain syndromes. Studies show that TRPV1 has a role in sepsis and the purpose of this study is to determine whether its effect on survival and immune response is beneficial or harmful. METHODS/STUDY POPULATION: We studied effects of genetic [Trpv1‐knock (KO) vs. wild‐type (WT) mice] and pharmacologic TRPV1 disruption with resiniferatoxin (RTX, an agonist) or capsazepine (CPZ, an antagonist) on mortality, bacterial clearance, and cytokine expression during LPS or cecal ligation and puncture (CLP)‐induced sepsis. RESULTS/ANTICIPATED RESULTS: After CLP, Trpv1‐KO had increased mortality risk [2.17 (1.23 to 3.81) hazard ratio (95% CI), p= 0.01] compared with WT. Further, intrathecal RTX vs. vehicle increased mortality risk [1.80 (1.05 to 3.2) hazard‐ratio (95% CI), p= 0.03] in WT but not in Trpv1‐KO mice. After LPS, neither genetic disruption nor pharmacologic activation of TRPV1 with RTX had significant effect on survival compared with controls. In contrast, after LPS, pharmacologic disruption of TRPV1 with CPZ, compared with vehicle, increased mortality risk [1.92 (1.02 to 3.61) hazard‐ratio (95% CI), p= 0.04] in WT animals. Further, after CLP, increased mortality in RTX‐treated‐WT animals was associated with higher blood bacterial count (p= 0.0004) and nitrate/nitrite levels and down regulation of TNF‐α expression (p= 0.004) compared with controls. DISCUSSION/SIGNIFICANCE OF IMPACT: Disruption of TRPV1 can affect mortality, blood bacteria clearance, and cytokine response in sepsis. This is relevant as TRPV1 disruption is being investigated as pain therapy in humans.

                                   P219

TRANSLATIONAL APPROACH TO ASSESSING CARDIOPROTECTIVE EFFICACY OF A NOVEL ANNEXIN‐A1 TRIPEPTIDE IN SEVERAL PRECLINICAL MODELS OF MYOCARDIAL ISCHEMIA/REPERFUSION

Zhang Z ¹, Ma Q¹, Mackensen GB¹, Podgoreanu MV¹

¹Duke University, Durham, NC, USA

OBJECTIVES/SPECIFIC AIMS: Myocardial ischemia/reperfusion (I/R) injury remains a major cause of cardiovascular morbidity and mortality following cardiac surgery. Using several preclinical models of myocardial I/R, we tested the cardioprotective efficacy of a novel tripeptide (ANXA1sp) derived from a glucocorticoid‐regulated protein Annexin‐A1. METHODS/STUDY POPULATION:  In vitro simulated I/R: Adult rat ventricular cardiomyocytes (ARVC) were incubated in normal or high glucose (25 mM), with and without ANXA1sp (30 μM) for 24 h, subjected to 2 h oxygen‐glucose deprivation, followed by 24 h reoxygenation in either normo‐ or hyperglycemic medium. Rat I/R: Sprague‐Dawly rats underwent 75 min of mild hypothermic cardiopulmonary bypass (CPB) with 45 min of cardioplegic arrest (CA) in 4 groups: normo‐ and hyperglycemic (20 mM) CA, each treated with ANXA1sp (3 mg/kg) or vehicle. Pig I/R: Yorkshire pigs subjected to 180 min of mild hypothermic CPB with 60 min of CA received ANXA1sp (4 mg/kg) or vehicle. Efficacy end points assessed at 24 h post‐reoxygenation (ARVC), 24 h (rat) and 6 h (pig) postreperfusion include markers of myonecrosis, apoptosis, leukocyte extravasation, and pump function. RESULTS/ANTICIPATED RESULTS: ANXA1sp attenuated myocardial I/R injury under both normo‐ and hyperglycemic conditions, as confirmed by decreased myocardial necrosis, caspase‐3 activity, and apoptosis. Peptide treated pigs further demonstrated improved myocardial energetics and hemodynamics, none requiring inotropic or vasopressor support. DISCUSSION/SIGNIFICANCE OF IMPACT: Using a translational approach and robust efficacy end points, we report that ANXA1sp elicits cardioprotection in vitro and in small and large animal models of surgical I/R. The effects are not blunted by hyperglycemia. We believe that ANXA1sp represents a novel therapeutic target in cardiac surgical patients.

                                   P220

VALIDATION OF TANDEM MASS SPECTROMETRY STUDY

Cheung WL ¹, Munkberg J¹, Smoller B¹, Byrum S¹, Tackett A¹

¹University of Arkansas for Medical Sciences, Little Rock, AR, USA

OBJECTIVES/SPECIFIC AIMS: The incidence of melanoma continues to rise every year, yet the ability to treat advanced disease has not changed. Our previous and current study aims to identify melanoma markers on FFPE sections by comparing a metastatic melanoma sample and benign nevus with improved protein extraction, gel separation and mass spectrometry analyses. Once this method is validated, additional proteins identified as significant in melanoma cases using mass spectrometry can then be analyzed on a large scale basis in future studies. METHODS/STUDY POPULATION: The melanoma cells or melanocytes were harvested from laser microdissection and then proteins were extracted and analyzed by LC‐mass spectrometer. Data from mass spectrometry studies showed 300 proteins that are differentiately expressed between metastatic melanoma and nevi with high significance. Of the proteins, we found two published possible melanoma markers including SILV and fatty acid synthase (FAS) that were in the top 20 most significant proteins to validate the mass spectrometry results using immunohistochemical stains. 32 formalin fixed paraffin embedded sections were retrieved from our archives including 12 benign nevi, 7 dysplastic nevi, and 13 melanoma cases. The stain patterns were scored based on extent and intensity. RESULTS/ANTICIPATED RESULTS: Higher immunoreactivity for Silver and FAS were detected in the melanoma cases than in the benign and dysplastic nevi cases which was statistically significant (p < 0.001 and p < 0.0015, respectively). DISCUSSION/SIGNIFICANCE OF IMPACT: This study showed that we identified at least two melanoma markers SILV and FAS by mass spectrometry on formalin fixed paraffin embedded sections when comparing metastatic melanoma with a benign nevus. Additional proteins that were found significant by mass spectrometry can now be analyzed by this method on a large scale basis in future studies.

                                   P221

VIP AND BOSENTAN: A SUPERIOR COMBINATION AGAINST PULMONARY HYPERTENSION

Hamidi S ^1,2, Szema A², Lyubsky S², Said S^1,2

¹SUNY, Stony Brook, Stony Brook, NY, USA; ²Northport VA Medical Center, Northport, NY, USA

OBJECTIVES/SPECIFIC AIMS: Despite considerable advances in the treatment of pulmonary arterial hypertension (PAH), the condition remains highly fatal. There is now considerable appeal for combining multiple drugs. Our objective is to answer the questions: Is a combination of vasoactive intestinal peptide (VIP) with endothelin receptor antagonist bosentan more effective than either drug alone in treatment of experimental PH?METHODS/STUDY POPULATION: A single injection of monocrotaline (MCT, s.c.) in rats resulted in PH, with RV hypertrophy (RVH), pulmonary vascular remodeling, and lung inflammation in 3 weeks. The pathology was uniformly fatal within 2 weeks. Three weeks after MCT injection, rats received either placebo or were treated with bosentan (po), VIP (ip), or both together. After hemodynamic measurements, rats were euthanized and examined for pathologic evidence of: pulmonary vascular thickening in lung sections; the degree of RVH and the severity of lung inflammation, assessed by inflammatory cell infiltrates, scored 0–4. Survival was monitored for 45 days after MCT injection. RESULTS/ANTICIPATED RESULTS: MCT caused significant elevation of RV pressure, thickening of smaller pulmonary arteries, perivascular inflammation, and RVH. Treatment with either VIP or bosentan, significantly attenuated all measures of PAH, except for RVH. Rats receiving both VIP and bosentan had the lowest RV pressure, the least vascular thickening, and RVH, and no lung inflammation. All MCT‐treated rats were dead within 3–5 weeks after its injection. Bosentan or VIP alone significantly reduced mortality (70% survival, p < 0.01), and all rats receiving both drugs remained alive (100% survival, p < 0.01). DISCUSSION/SIGNIFICANCE OF IMPACT: Combined therapy with bosentan and VIP improve the likelihood of success in reversing pathologic features of PH, and thus improving the outlook for patients with PAH.

                                   A1

CHILDREN WITH ACUTE CNS DISORDERS USE MORE HOSPITAL RESOURCES THAN DO CHILDREN WITH OTHER ACUTE DISORDERS

Moreau J ¹, Hartman ME³, Fink EL², Angus DC¹, Bell MJ², Linde‐Zwirble WT⁴, Watson RS¹

¹University of Pittsburgh Critical Care Medicine, CRISMA Center, Pittsburgh, PA, USA; ²University of Pittsburgh Critical Care Medicine, Safar Center, Pittsburgh, PA, USA; ³Washington University in St. Louis, Division of Pediatric Critical Care, St. Louis, MO, USA; ⁴ZD Associates, Perkasie, PA, USA

OBJECTIVES/SPECIFIC AIMS: We aimed to determine whether children with acute CNS disorders use more hospital resources than do children hospitalized for other conditions. METHODS/STUDY POPULATION: We studied all 960,022 nonfederal hospitalizations of children 29 days to 19 years old in 2005 in 11 states, including 37% of the US pediatric population. Using ICD‐9 codes, we identified 103,961 patients with acute CNS disorders and dichotomized them both by treatment at a general versus children’s hospital and by use of ICU resources. Length of stay (LOS) and cost of stay (in 2005 dollars) were then calculated. RESULTS/ANTICIPATED RESULTS: Children with acute CNS disorders had nearly 3x greater ICU use than other hospitalized children (30.6% vs.10.6%, p < 0.001) and were much more likely to be hospitalized at a children’s hospital (53.9% vs. 40.2%, p < 0.001). Admission to the ICU and admission to a children’s hospital were both associated with greater resource use regardless of disease status. Overall, mean LOS was 5.5 days for CNS patients and 4.3 days for non‐CNS patients, and the mean costs were nearly twice as high for CNS patients than for non‐CNS patients ($11,402 vs. $6,525, p < 0.001). DISCUSSION/SIGNIFICANCE OF IMPACT: Children with acute CNS disorders receive more critical care and are more often admitted to children’s hospitals than are children hospitalized for other reasons. They also use more resources in all acute settings. The origin of greater resource use for CNS patients should be explored with the hope of identifying potential systems improvements to lower healthcare costs while maintaining or improving outcomes.

                                   A2

ICU USE AND MORTALITY ARE HIGHER AMONG CHILDREN WITH ACUTE CNS DISORDERS THAN CHILDREN WITH OTHER ACUTE DISORDERS

Moreau J ¹, Fink EL², Hartman ME³, Angus DC¹, Bell MJ², Linde‐Zwirble WT⁴, Watson RS¹

¹University of Pittsburgh Critical Care Medicine, CRISMA Center, Pittsburgh, PA, USA; ²University of Pittsburgh Critical Care Medicine, Safar Center, Pittsburgh, PA, USA; ³Washington University in St. Louis, Division of Pediatric Critical Care, Saint Louis, MO, USA; ⁴ZD Associates, Perkasie, PA, USA

OBJECTIVES/SPECIFIC AIMS: We aimed to determine whether children with acute CNS disorders receive more critical care and have higher mortality than children hospitalized for other conditions. METHODS/STUDY POPULATION: We studied all 960,022 nonfederal hospitalizations of children 29 days to 19 years old in 2005 in 11 states, comprising 37% of the US pediatric population. Using ICD‐9 codes, we identified 103,961 patients admitted with acute CNS disorders and classified them as traumatic or nontraumatic. We generated age‐ and sex‐adjusted national hospitalization estimates using Census data from the CDC. RESULTS/ANTICIPATED RESULTS: Nationally, 276,119 children were hospitalized with an acute CNS disorder (3.83/1,000); epilepsy (53.9%) and mild TBI (16.6%) were the most common. Children with acute CNS disorders had nearly 3x greater ICU use than other hospitalized children (30.6% vs. 10.6%, p < 0.001) and made up over a quarter (26.1%) of patients receiving ICU care. Although accounting for only 10.8% of hospital admissions, acute CNS disorders accounted for nearly half (46.3%) of deaths (4,754) nationally. Among ICU patients, children with CNS disorders had higher in‐hospital mortality (4.8% vs.1.6%, p < 0.001) and made up 53.7% of deaths. DISCUSSION/SIGNIFICANCE OF IMPACT: While accounting for a minority of hospital admissions, children with acute CNS disorders more often receive critical care and have higher in‐hospital mortality than do children hospitalized for other reasons. A focus on this population has the potential to greatly benefit the outcomes of critically ill children.

                                   A3

A PILOT STUDY TO IMPROVE PROSPECTIVE MEMORY PERFORMANCE IN PARKINSON DISEASE

Foster E ¹

¹Washington University School of Medicine, St. Louis, MO, USA

OBJECTIVES/SPECIFIC AIMS: Prospective memory, or the ability to remember to carry out previously formed intentions, is essential for functional independence. Individuals with Parkinson disease (PD) have prospective memory deficits which are associated with reduced health‐related quality of life. Implementation intentions are a mnemonic strategy designed to improve prospective memory. The purpose of this pilot study was to test the feasibility and potential efficacy of implementation intentions for individuals with PD. METHODS/STUDY POPULATION: Volunteers with PD (N= 8; age: M = 66.6, SD = 6.5) performed a computerized prospective memory test on two separate occasions about 6 months apart. For the baseline testing session, all participants performed the test under general instructions. For the follow‐up testing session, four participants repeated the test under general instructions (control group), and four participants received implementation intentions training before repeating the test (intervention group). Prospective memory accuracy (proportion correct out of 24 tasks) was compared across groups and testing sessions. RESULTS/ANTICIPATED RESULTS: The groups had similar prospective memory performance at baseline (control: M = 0.65, SD = 0.11; intervention: M = 0.60, SD = 0.19). At follow‐up, the intervention group’s accuracy improved 23% (M = 0.83, SD = 0.12), while the control group’s remained relatively stable (M = 0.63, SD = 0.16). All intervention participants improved from baseline to follow‐up compared to only 2 control participants. DISCUSSION/SIGNIFICANCE OF IMPACT: Prospective memory is a clinically‐relevant cognitive problem in PD; however, there are currently no rehabilitative efforts aimed at addressing it. These results suggest that implementation intentions training is a feasible and efficacious intervention for prospective memory impairment in PD. More rigorous and controlled testing of the effect of implementation intentions is warranted.

                                   A4

THE LIVE DONOR CHAMPION: FINDING LIVE DONORS BY SEPARATING THE ADVOCATE FROM THE PATIENT

Garonzik Wang J ¹, Berger J¹, Ros R¹, Kucirka L¹, Deshpande N¹, Boyarsky B¹, Segev D¹

¹Johns Hopkins, Baltimore, MD, USA

OBJECTIVES/SPECIFIC AIMS: Reported barriers to identification of a live donor include inadequate education, lack of resources, and reluctance to initiate conversations about donation. In general, patients with ESRD are hesistant to discuss their illness and the difficulties associated with dialysis. However, friends or family members are often eager to spread awareness about their loved one’s plight and are empowered by advocating for them. We hypothesize that separating the advocate from the patient will help alleviate the communication barrier experienced by ESRD patients, and lead to increased live donor transplantation. METHODS/STUDY POPULATION: We conducted a pilot study of 15 adult kidney transplant candidates who had been on our wait‐list at least 3 months and lacked any potential live donors. Each recipient selected a Live Donor Champion (LDC): a friend or family member willing to advocate for them and spread awareness of ESRD and live donor transplantation. The candidate and LDC attended 5 monthly meetings that addressed topics ranging from basic transplant education to methods to initiate conversations. Outcomes included comfort level with initiating a conversation, live donor recruitment, and transplantation. RESULTS/ANTICIPATED RESULTS: Comfort with initiating conversations about kidney transplantation increased throughout program. Six potential donors initiated workup and four have reached Phase 2 evaluation. Four program participants accepted deceased donor organ offers, despite the fact that three had repeatedly declined previous offers. They attributed their acceptance to increased knowledge gained through the program. Two patients received a live donor transplant. DISCUSSION/SIGNIFICANCE OF IMPACT: Transplant candidates are ill‐equipped to seek live donors. By separating the advocate from the patient, understandable concerns about initiating conversations are reduced.

                                   A5

COMPLEMENTARY AND ALTERNATIVE MEDICINE USE IN A PEDIATRIC SUBSPECIALTY POPULATION

Sgarlat CM ^1,2, Miller LC¹, Ruthazer R^2,3, Parsons SK^2,3

¹Tufts Medical Center Floating Hospital for Children, Boston, MA, USA; ²Tufts University Sackler School of Graduate Biomedical Sciences, Boston, MA, USA; ³Tufts Clinical and Translational Science Institute, Boston, MA, USA

OBJECTIVES/SPECIFIC AIMS: The purpose of this study was to solicit information on CAM usage from parents seeking care for their children in a pediatric subspecialty clinic. METHODS/STUDY POPULATION: A previously field‐tested survey of CAM usage was adapted for the clinic population. The survey consisted of general demographic questions and specific questions on CAM use. Parents of patients followed in the Pediatric Rheumatology Division at an academic medical center were invited to complete the survey in 2010. RESULTS/ANTICIPATED RESULTS: Of 202 consecutive parents who completed the survey, the majority were mothers (88%) with a mean age of 42 years responding on behalf of their children, who were predominantly female (66%) with a mean age of 12 years. The majority of the respondents were white (91%); 3% were Asian and 2% African American. 63% of patients had juvenile arthritis, although children with other chronic conditions were also included. Overall, 51% of patients were current CAM users or had taken some form of CAM in the past. Of the CAM users, 41% had a parent or family member with a history of CAM use compared with 15% of non‐CAM users. Multivariate logistic regression will be used to further explore factors significantly different in CAM users versus nonusers. DISCUSSION/SIGNIFICANCE OF IMPACT: We found that CAM use is extensive in patients with chronic diseases followed in a pediatric subspecialty clinic. Family use of CAM may be associated with patient CAM use. This is of great importance because little is known about the benefits or potential harms of CAM despite its widespread use. It is important for physicians to understand factors that influence decisions to use CAM in children and what benefits parents are seeking with CAM use.

                                   A6

CARE TRANSITIONS AMONG OLDER ADULTS WITH SCHIZOPHRENIA

Leutwyler H ¹

¹University of California San Francisco, San Francisco, CA, USA

OBJECTIVES/SPECIFIC AIMS: Introduction: Adults who struggle with schizophrenia are living longer. At the same time, data suggest that older adults living with schizophrenia have poor physical health. The purpose of this abstract is to present findings from a qualitative study that explored the understanding of physical health among older adults with schizophrenia. In gathering the individual perspective, participants described how they deal with care transitions and the impact on their physical health. METHODS/STUDY POPULATION: Methods: A grounded theory study was conducted among 28 older adults with schizophrenia that live in a variety of settings using semistructured interviews and participant observation. RESULTS/ANTICIPATED RESULTS: Results: Dealing with care transitions was a process that evolved from the data. Some participants described how they were well‐prepared to live independently and some participants described how they would never be prepared to live independently. Participants also described how their process of dealing with care transitions could impact their physical health. DISCUSSION/SIGNIFICANCE OF IMPACT: Conclusions: How older adults with schizophrenia deal with care transitions are impacted through the neurocognitive issues and symptoms of schizophrenia, the medical system, and level of preparation for independent living. These findings provide insights for the design of future research interventions and clinical practice to promote optimal physical health outcomes for older adults with schizophrenia.

                                   A7

DEVELOPMENT OF A STRUCTURED PARENT TRAINING PROGRAM FOR YOUNG CHILDREN WITH AUTISM

Bearss K ¹, Scahill L¹

¹Yale University, New Haven, CT, USA

OBJECTIVES/SPECIFIC AIMS: Autism spectrum disorders (ASD) are characterized by deficits in social interaction, communication, and the presence of repetitive behaviors. In addition, up to 70% of children with ASDs have behavior problems such as tantrums, aggression, and noncompliance and most show deficiencies in adaptive functioning. Parent training has received much interest due to the central role that parents have in promoting the development of their children with autism. This study aimed to develop a 24‐Week Parent Training manual for preschool‐age children with ASDs and behavioral problems and then evaluate its feasibility and preliminary efficacy. METHODS/STUDY POPULATION: Investigators initially made modifications to the Research Units in Pediatric Psychopharmacology‐Parent Training (RUPP‐PT) manual to insure it was appropriate for preschool age children. The newly developed PT program was then pilot tested in a sample of 16 families who had a preschooler with ASD and disruptive behaviors. 14 of 16 families completed the intervention. Subjects include 7 children with autism, 9 with PDD‐NOS. 81% are Caucasian, 13% Latino, 6% other. 7 are in special education; 9 are in mainstream classrooms. 63% have an IQ above 70. None are on medication. RESULTS/ANTICIPATED RESULTS: Changes in noncompliant, hyperactive, and irritable behavior from baseline to week 24 were significant and produced robust effect sizes (ES) (Home Situations Questionnaire ES = 1.73; Aberrant Behavior Checklist (ABC)‐Irritability ES = 1.04; ABC‐Hyperactivity ES = 0.92). Age equivalent gains on the Vineland were 6 months in Daily Living Skills, 13 months in Communication, and 14 months in Socialization. Finally, parents attended 94% of the 11 core sessions. DISCUSSION/SIGNIFICANCE OF IMPACT: Preliminary data provide support for the effectiveness and acceptability of this structured parent training manual for young children with ASD.

                                   A8

THE SCHOOL‐BASED RESEARCH AND PRACTICE NETWORK

Stebbins S ¹, Vukotich CJ¹

¹University of Pittsburgh, Pittsburgh, PA, USA

OBJECTIVES/SPECIFIC AIMS: The University of Pittsburgh School Based Research and Practice Network (“Network”) was established in July, 2008 and brings together research investigators and public, private, and parochial schools for grades K–12, with the purpose of creating more community‐based research in schools and to improve the school environment through outreach and education. METHODS/STUDY POPULATION: Between 2008 and 2010 Network staff met with superintendents and key administrators in 42 of 44 school districts in Allegheny County, PA (1.2 million people) to establish communication and identify research interests and priorities. In addition, Network staff outreached to researchers from the University of Pittsburgh, Carnegie Mellon University, and the University of Pittsburgh Medical Center to identify projects appropriate for school environments. RESULTS/ANTICIPATED RESULTS: To date, more than 100 researchers have completed the Network’s novel training which helps them understand the advantages and pitfalls of doing research with schools. In addition, the Network has facilitated the placement of research activities in interested schools, now totaling 23 investigators and 7 research projects in over 100 public, private and parochial schools. DISCUSSION/SIGNIFICANCE OF IMPACT: Research with schools is an essential part of community‐engaged research and translation. The work of the Network facilitates both translation of methods and results between the research and school communities. The Network’s methodology and functions can be easily emulated in other regions and states, with benefits for all participants.

                                   A9

ATTENTION TO FACES AND BRAIN RESPONSES IN AUTISM

McPartland J ¹, Perszyk D¹, Crowley M¹, Naples A¹, Mayes L¹

¹Yale Child Study Center, New Haven, CT, USA

OBJECTIVES/SPECIFIC AIMS: Face perception is impacted in autism spectrum disorder (ASD). Event‐related potential (ERP) studies reveal significant delays at basic stages of face processing, as indexed by a face‐sensitive component, the N170. The current study examined the relationship between attention to faces and brain responses in ASD. We specifically investigated whether (a) N170 latency normalizes when point of gaze is controlled or (b) slowed processing is evident irrespective of point of gaze. We predicted that children with ASD would exhibit longer N170 latencies irrespective of the facial feature to which they attended. METHODS/STUDY POPULATION: Children with ASD and typically developing children matched for age, sex, IQ, and handedness participated in the study. Participants viewed neutral faces while EEG was recorded continuously at 250 Hz. To manipulate visual attention, the position of a fixation crosshair preceding faces directed attention to either the (a) eyes, (b) nose, or (c) mouth; a fourth presentation condition used (d) no fixation crosshair. N170 latency and amplitude were extracted across six electrodes over the left and right lateral posterior scalp. RESULTS/ANTICIPATED RESULTS: Repeated measures ANOVA revealed (a) shorter latencies to faces in the right hemisphere irrespective of group or fixation position; (b) longer latency in the ASD group irrespective of hemisphere or fixation position; (c) for both groups, shorter N170 latency to eyes relative to noses, mouths, or with no crosshair, all of which were equivalent. DISCUSSION/SIGNIFICANCE OF IMPACT: Children with ASD showed delayed latency of face‐related brain responses independent of visual attention. These findings emphasize the import of understanding the temporal dynamics of social brain function in ASD and offer insight into therapeutic strategies.

                                   A10

IMPLICATIONS OF ARTERIAL CALCIFICATION ON STENT FUNCTION

Young M ¹, Bishop P¹, Graham L¹

¹Cleveland Clinic, Cleveland, OH, USA

OBJECTIVES/SPECIFIC AIMS: Endovascular stenting of the superficial femoral artery (SFA) is sweeping the world. As promising as these stent therapies are, there has been a relatively high rate of stent fractures observed during patient follow‐up. This research proposes to study the influence of arterial calcification on stent fracture. Models of the SFA will be developed for uncalcified, severely calcified, and average calcified SFA in patients with peripheral arterial disease (PAD). The stent fatigue for each condition will be studied and compared. METHODS/STUDY POPULATION: A detailed examination of clinical patient data and intravascular ultrasound imaging measurements will be obtained from the Peripheral Vascular Core Laboratory at the Cleveland Clinic. Subjects for this study will be aged 18 and above, with a gender and racial mix characteristic of the population with PAD, included in the Cleveland Clinic, Vascular Surgery IRB‐approved Registry. RESULTS/ANTICIPATED RESULTS: We will test the hypothesis that arterial calcification adversely affects stent durability, increasing stent fracture. DISCUSSION/SIGNIFICANCE OF IMPACT: Stent fracture is a serious problem because it could lead to vascular complications such as restenosis and stent occlusion. However, there is little information available on the interplay between vessel pathology and stent function, specifically the effect of arterial calcification on stent function. A calcified environment changes arterial mechanical properties and vessel dynamics, which can adversely affect stent function. Calcium can cause higher compressive stresses and uneven loading conditions, which can lead to a higher incidence of stent failure. Identifying these mechanical factors will allow design of stents that withstand these forces.