Clinical Epidemiology/Clinical Trial
3099 Risk of substance abuse onset in adults diagnosed with epilepsy or migraine
- Stephanie Jones, Jeffrey E. Korte, Dulaney Wilson
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- 26 March 2019, p. 53
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OBJECTIVES/SPECIFIC AIMS: The study investigated whether adults diagnosed with epilepsy or migraine (a neurological disorder with common features to epilepsy) are at increased risk for developing substance abuse disorders following diagnosis compared to (presumably healthy) adults with lower extremity fracture (LEF). METHODS/STUDY POPULATION: A retrospective cohort analysis was conducted using a subset of surveillance data of hospital admissions, emergency department visits and outpatient visits in South Carolina, USA from January 1, 2000 through December 31, 2011. Individuals aged 18 years or older were identified using the International Classification of Disease, 9th Revision Clinical modification (ICD-9) with a diagnosis of epilepsy (epilepsy-cohort 1; n = 78,547; 52.7% female, mean age [SD] 51.3 years [19.2]), migraine (migraine-cohort 2; n = 121,155; 81.5% female, mean age [SD] 40.0 years [14.5]), or LEF (control cohort; n = 73,911; 55.4% female, mean age [SD] 48.7 years [18.7]). Individuals with substance abuse or dependence diagnosis following epilepsy, migraine, or LEF were identified with ICD-9 codes. Cox proportional hazard regression analyses modelled the time to substance abuse diagnosis comparing epilepsy to LEF and comparing migraine to LEF. RESULTS/ANTICIPATED RESULTS: Adjusting for insurance payer, age and sex, adults with epilepsy are diagnosed with substance abuse disorders at 2.5 times the rate of those with LEF [HR 2.54 (2.43, 2.67)] and adults with migraine are diagnosed with substance abuse disorders at 1.10 times the rate of those with LEF [HR 1.10 (1.04, 1.16)]. An interaction between exposure and insurance payer was found with hazard ratios comparing epilepsy to LEF of 4.56, 3.60, and 1.94 within the commercial payer, uninsured and Medicaid strata, respectively. DISCUSSION/SIGNIFICANCE OF IMPACT: Compared to adults with LEF, adults with epilepsy had a substantially higher hazard of subsequent substance abuse, while adults with migraine showed a small, but still significant, increased hazard of subsequent substance abuse.
3384 Serum Metabolites from the Trimethylamine Pathway Associate with Left Ventricular Diastolic Function: The Bogalusa Heart Study
- Alexander C. Razavi, Camilo Fernandez, Xuenan Mi, Jiang He, Lydia Bazzano, Jovia Nierenberg, Shengxu Li, Tanika N. Kelly
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- Published online by Cambridge University Press:
- 26 March 2019, pp. 53-54
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OBJECTIVES/SPECIFIC AIMS: This population-based study aims to assess the individual and collective relationship between TMA-associated metabolites and echocardiographic parameters of left ventricular diastolic function. METHODS/STUDY POPULATION: The study cohort consisted of 1,039 adult participants of the Bogalusa Heart Study (35.13% black, 57.94% female, aged 33.60 to 57.47 years). Left ventricular diastolic function was assessed via two dimensional and tissue Doppler echocardiography. Echocardiographic parameters of diastolic function included peak early (E, cm/s) and late transmitral flow velocities (A, cm/s), septal mitral annular velocity (e’, cm/s), left ventricular isovolumic relaxation time (IVRT, ms), and peak early diastolic transmitral flow velocity deceleration time (DT, ms). Metabolomic analysis of fasting serum samples was conducted via ultrahigh performance liquid chromatography-tandem mass spectroscopy. Six metabolites in the TMA pathway, carnitine, choline, TMAO, betaine, ergothioneine, dimethylglycine, and two composite variables, the betaine/choline ratio as well as the weighted sum of the six TMA-associated metabolites (TMA score), were selected a priori and tested for association with echocardiographic parameters of diastolic function. Raw metabolite values were divided by their respective standard deviation to create an exposure variable for each individual metabolite. The betaine/choline ratio was calculated utilizing the raw value of each metabolite. The z-score method was used to transform the six metabolites to the same scale and these values were used to calculate the TMA score. Multivariable-adjusted linear regression models were employed to assess the relationship of TMA-associated metabolites with echocardiographic measures of diastolic function. Covariates adjusted for included sex, age, race, education, alcohol drinking, cigarette smoking, heart rate, systolic blood pressure, glomerular filtrate rate, body mass index, low density lipoprotein cholesterol, high density lipoprotein cholesterol, hemoglobin A1c, serum triglycerides, as well as blood pressure-, lipid-, and glucose-lowering medications. RESULTS/ANTICIPATED RESULTS: After stringent Bonferroni correction for multiple testing, four TMA-associated metabolites as well the TMA score were significantly associated with diastolic function. TMAO was inversely associated with IVRT (ß = −0.002 (0.00); p-value = 2.00E-03). Betaine (ß = 0.40 (0.08); p-value = 2.10E-07), carnitine (ß = 0.30 (0.07); p-value = 7.80E-05), dimethylglycine (ß = 0.27 (0.07); p-value = 3.00E-04), and the TMA score (ß = 0.10 (0.02); p-value = 3.40E-05), were positively associated with the septal E/e’ ratio. No significant associations were observed between metabolites or metabolite composite scores from the TMA pathway and the E/A ratio or DT. DISCUSSION/SIGNIFICANCE OF IMPACT: This is the first population-based study to assess the role of TMA-associated metabolites in left ventricular diastolic function. Betaine, carnitine, dimethylglycine, and a metabolite score combining serum metabolites from the TMA pathway were positively associated with the septal E/e’ ratio, suggesting that a higher concentration of TMA-associated metabolites correlates with impaired diastolic function. These results suggest that both individual and grouped metabolites from the TMA pathway may serve as early biomarkers for pre-clinical diastolic dysfunction, an important causal factor for HFpEF. Future longitudinal, multi-omic studies incorporating microbiome, metabolomic and dietary analyses are needed to characterize the risk of ventricular diastolic function and HFpEF in the setting of exposure to TMA-associated metabolites.
3341 Sex Differences in Vitamin D and Urinary Stone Disease
- Damian Nicolas Di Florio, Erika J. Douglass, Katelyn A. Bruno, Anneliese R. Hill, Jessica E. Mathews, William E. Haley, DeLisa Fairweather
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- 26 March 2019, p. 54
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OBJECTIVES/SPECIFIC AIMS: More men than women develop urinary stones and their prevalence alters in women with menopause suggesting a steroidal influence. In men the incidence of stones is highest during July and August suggesting that environmental factors such as Vitamin D (VitD), a steroid, may affect stone formation. Previous studies have found differences in the development of stones between men and women; however, the reasons for sex differences in stone formation and type remain unclear. METHODS/STUDY POPULATION: We examined VitD levels in men and women (n = 18,753) that had no diseases based on a lack of an ICD-9 or ICD-10 code in their electronic medical record. We found that normal, healthy women had significantly higher levels of sera VitD compared to men (p = 6x10-6). We then examined whether sex differences existed for key endpoints/data from the Mayo Clinic Urinary Stone Disease (USD) Registry, which has around 1,600 urinary stone patients that are well-phenotyped according to sex, age and stone type. RESULTS/ANTICIPATED RESULTS: Control women were found to have higher sera VitD levels than men, but the sex difference no longer exists in kidney stone disease patients. When we further separated by race, we found that differences in VitD levels reappeared; this suggests that race also plays a role in sera VitD variances. DISCUSSION/SIGNIFICANCE OF IMPACT: We are developing a disease severity score, which we will use to correlate to sera VitD levels in patients according to sex, age and race. Future analyses will take into account whether subjects had VitD and calcium supplementation. This project begins to explore the mechanism behind the sex differences known to exist in urinary stone disease, which is critically needed to provide improved diagnosis and therapy for this debilitating disease.
3458 Temporal Trends and Outcomes of Opioid Abuse among Adolescents & Young Adult Sickle Cell Disease Patients
- Nnaemeka E Onyeakusi, Adebamike Oshunbade, Fahad Mukhtar, Adeyinka Adejumo, Semiu Gbadamosi, Chinonso Onwudiwe
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- 26 March 2019, pp. 54-55
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OBJECTIVES/SPECIFIC AIMS: In this study, we aim to describe temporal trends in opioid abuse among adolescents and 11-21years and young adults 22-35years with Sickle cell disease hospitalized for sickle cell crisis. We also aim to evaluate clinical and healthcare utilization outcomes of opioid abuse in the same population. In addition, we hope to assess for difference in effect by age category. METHODS/STUDY POPULATION: Our study is a cross-sectional study of data secondarily sourced from the 2007-2014 National Inpatient Sample(NIS), a component of the Healthcare Utilization Project (HCUP). Variables were identified using ICD-9-CM codes. We selected inpatient stays for patients aged 11-35 years admitted for sickle cell crisis. Opioid abuse was the primary outcome of interest. Secondary outcomes were inpatient mortality, total charge, length of stay and select clinical outcomes. We analyzed our data for trends and outcomes. We performed trend analysis of prevalence rates between 2007-2014 by age categories. Propensity-Matched Score regression models were deployed to assess for associations between opioid abuse and outcomes while adjusting for relevant covariates. Sub-group analysis of opioid abuse by age was assessed for outcomes of interest. Trend analysis was performed on Joinpoint Software v4.6.0, (National Cancer Institute, NIH, Bethesda, MD). Outcome analysis was performed on SAS v9.4 (SAS Institute, Cary, NC). Statistical significance was set at 95% and p-value of 0.05, two-tailed. RESULTS/ANTICIPATED RESULTS: Of 86,827 inpatients admitted for sickle cell crisis, 2,363 (2.73%) had a diagnosis of opioid abuse while 84,464 (97.27%)did not abuse opioids. 27,004 (31.01%) of admitted patients were 11-21 years while 59,823 (68.99%) were 21-35 years. We found statistically significant APCs (Annual Percentage Change) showing increasing trends in both age categories for years under review, (18.47% [95% CI 15.39-21.63]; p-value <0.001 in young adults vs. 10.31% [95% CI 3.58-17.49]; p-value 0.009 in adolescents). The difference in APCs between both age categories were also significant (−8.16% [95% CI [−14.26-2.05]; p-value 0.009). There were no parallelism or coincidence in the trend lines. Opioid abuse was found to be associated with significantly longer length of stay (7.74 vs 6.05 days), higher total charge ($40,797 vs $32,164), (aOR 1.44; 95% CI [1.19-1.75]) seizures, sepsis (aOR 1.62; 95% CI [1.35-1.94]) and pulmonary hypertension (aOR 1.36; 95% CI [1.12-1.66]). No significant association was found for inpatient mortality, transfusion, cardiac dysrhythmias, pulmonary embolism and acute kidney injury. Significant interaction existed between opioid abuse and age for total charge (for $41,869 vs $29,371 among adolescents & $40,632 vs $32,550 among young adults; interaction p-value 0.03). DISCUSSION/SIGNIFICANCE OF IMPACT: Trends show a significant increase in the prevalence of opioid abuse among adolescents and an increasingly higher prevalence when adolescents transition to young adults. Opioid abuse among sickle cell patients is associated with significant poor healthcare resource utilization and clinical outcomes. Public health interventions to prevent worsening opioid abuse prevalence are expected to improve patient outcomes.
3110 The association between components of the Life’s Simple Seven and incident end stage renal disease in the Southern Community Cohort Study
- Mindy Pike, Cassianne Robinson-Cohen, Jennifer Morse, Thomas G. Stewart, William J. Blot, T. Alp Ikizler, Loren Lipworth
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- 26 March 2019, p. 55
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OBJECTIVES/SPECIFIC AIMS: The Life’s Simple 7 (LS7) metric was created by the American Heart Association with the goal of educating the public on seven modifiable factors that contribute to heart health. While it is well documented that these ideal health behaviors lower risk of cardiovascular disease (CVD) in the general population, the association between the LS7 ideal health metrics and end stage renal disease (ESRD) risk has not been examined in a lower socioeconomic population at high risk for both ESRD and CVD. Our objective is to examine the association between the LS7 score and incident ESRD in a cohort of white and black men and women in the southeastern US, where rates of CVD and ESRD are high. METHODS/STUDY POPULATION: The Southern Community Cohort Study recruited ~86,000 low-income blacks and whites in the southeastern US (2002-2009). Utilizing a nested case-control design, our analysis included 1628 incident cases of ESRD identified via linkage of the cohort with the United States Renal Data System (USRDS) from January 1, 2002 to March 31, 2015. Controls (n = 4884) were individually matched 3:1 with ESRD cases based on age, sex, and race. Demographic, medical, and lifestyle information were obtained via baseline questionnaire. The AHA definitions for ideal health were used for non-smoking (never or quit >12 months), body mass index (BMI<25kg/m2) and physical activity (>75 min/week of vigorous physical activity or >150min/week of moderate/vigorous activity). Modified definitions were used for consuming a healthy diet [Healthy Eating Index (HEI10) score>70] and for blood pressure, fasting plasma glucose, and total cholesterol, based on self-reported no history of diagnosis of hypertension, diabetes, and hypercholesterolemia, respectively. The number of ideal health parameters were summed to generate the LS7 score, which ranged from 0-7 with higher scores indicating more ideal health. Adjusted odds ratios (95% confidence intervals) for incident ESRD associated with LS7 score were calculated using conditional logistic regression models, adjusting for income and education. The SCCS ESRD case-cohort dataset will be available by TS 2019 and analyses will be completed to adjust for baseline estimated glomerular filtration rate (eGFR) as a marker of kidney function and to examine whether eGFR modifies the relationship between LS7 and incident ESRD. RESULTS/ANTICIPATED RESULTS: At baseline, mean age was 54 years, 55% (3600) of participants were women, and 87% (5656) were black. A total of 58% (943) of ESRD cases were non-smokers compared to 54% (2633) of controls. ESRD cases had higher prevalence of BMI>25 kg/m2 (81% vs. 74%), hypertension (84% vs. 59%), hypercholesterolemia (48% vs. 34%), and diabetes (66% vs. 22%) compared to controls. A total of 18% (839) of controls and 12% (194) of ESRD cases met ideal exercise recommendations, and 20% of either cases (302) or controls (916) had a HEI10 score above 70. The median LS7 score for controls and ESRD cases was 3 and 2, respectively, and 17% (983) of participants had a low score (0-1) while 2% (105) met 6 or 7 ideal health metrics. Higher LS7 score was associated with lower odds of ESRD (P-trend<0.001). Participants with LS7 score >3 (above median) had 75% reduced odds of ESRD (OR 0.25; 95% CI 0.22, 0.29) compared to those with a score of 2 or less. DISCUSSION/SIGNIFICANCE OF IMPACT: In the SCCS population, the presence of any 3 or more ideal health behaviors is associated with reduced odds of developing ESRD. The components of the LS7 represent important modifiable risk factors that may be targets for future interventions driven by the patient. The attributable risk due to each factor is needed to dissect which ideal behaviors are the most beneficial.
3244 The Autonomic Nervous System as a Potential Therapeutic Target in Huntington Disease
- Jordan L Schultz, Lyndsay Harshman, John Kamholz, Peggy Nopoulos
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- 26 March 2019, p. 55
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OBJECTIVES/SPECIFIC AIMS: This study (1) investigated the presence and severity of autonomic nervous system (ANS) dysfunction in patients with pre-symptomatic Huntington Disease (HD) and (2) determined if pharmacologic manipulation of the ANS could modify the progression of HD. METHODS/STUDY POPULATION: Using a unique data set of children at-risk for HD (the Kids-HD study), markers of autonomic function (resting heart rate [rHR], blood pressure [BP], and core body temperature [CBT]) were compared between pre-symptomatic, gene-expanded children (psGE) and healthy developing children using mixed models analyses controlling for sex, age, and body mass index. Included participants had to be < 18 years old and be at least 10 years from their predicted motor diagnosis of HD. Using the Enroll-HD database, inverse-propensity score weighted, Cox Regression analyses investigated the effects of beta-blockers on the timing of motor diagnosis of presymptomatic, adult patients with HD. RESULTS/ANTICIPATED RESULTS: Compared to healthy controls, the psGE participants had significantly (p<0.05) higher mean rHR, systolic BP percentile, and CBT compared to the healthy controls (elevated by 4.01 bpm 0.19°C, and 5.96 percentile points, respectively, in the psGE group). Participants from Enroll-HD who were using a beta-blocker prior to motor diagnosis (n=65) demonstrated a significantly lower annualized risk of motor diagnosis [HR=0.56, p=0.03], compared to other participants with HD (n=1972). DISCUSSION/SIGNIFICANCE OF IMPACT: Sympathetic nervous system activity is elevated in patients with HD decades prior to their predicted motor diagnosis. Furthermore, modulation of the sympathetic nervous system with beta-blockers significantly lowers the annualized risk of motor diagnosis of HD.
3529 The main effects of threat appraisal on the well-being of African Americans living with HIV/AIDS in the Washington, D.C. metropolitan area, and the role of religious social support as a buffer
- Agnes Meave Otieno
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- Published online by Cambridge University Press:
- 26 March 2019, pp. 55-56
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OBJECTIVES/SPECIFIC AIMS: This study considered how threat appraisal and religious social support associate with subjective well-being and subjective experience of pain. Appraisal in this study refers to the individual’s perception and interpretation of the significance of learning of his/her HIV status. The study incorporated the stress-buffering model to propose that the beneficial effects of religious social support will modify the association between threat appraisal and well-being for PLHIV in a palliative care setting. Well-being was assessed both as the participant’s subjective report of their well-being, and their subjective report of their experience with bodily pain. Participants’ subjective report of well-being was hypothesized to be inversely associated with threat appraisal, and positively associated with religious social support. Subjective experience with bodily pain was hypothesized to be directly associated with threat appraisal, and inversely associated with religious social support. It was further also hypothesized that religious social support modifies the impact of threat-appraisal on well-being such that higher levels of religious social support reduce the observed effect of threat appraisal. METHODS/STUDY POPULATION: This was a cross-sectional study using baseline data from a randomized clinical trial–the FACE palliative care study in Washington, DC (FACE: FAmily CEntered Advance Care Planning). Participants were PLHIV who received their HIV care from 5 Washington, DC hospital-based HIV-specialty clinics. The FACE 3000 study paired participants into dyads of patient and surrogate decision-maker. The patient is a PLHIV for whom the advanced care planning care study is geared. The surrogate decision-maker is considered the patient’s healthcare proxy who agrees to honor and advocate for the patient’s treatment preferences, if the patient were unable to communicate with the health care team directly. Some surrogates are HIV positive, however due to their role as the patient’s healthcare proxy, some of their surveys contain different content from those of the patient’s. Potentially eligible participants in the FACE study received a secondary screening to determine eligibility to ensure competency to participate in end-of-life decision making. For this analysis, only the patient data was used. RESULTS/ANTICIPATED RESULTS: Subjective well-being showed significant associations with total threat appraisal, and four threat appraisal sub-constructs. Those with lower threat appraisals reported higher values of well-being compared to those with higher threat appraisals. Results from the regression analysis indicated that only one of the threat appraisal sub-constructs was significantly associated with a participant’s subjective experience of pain. Overall, religious social support did not seem to buffer the effect of threat appraisal on well-being or subjective experience of pain. Findings from this study suggest that subjective well-being is associated with cognitive threat appraisal and this finding could assist PLHIV and their caregivers in understanding the coping processes of HIV-infected people. DISCUSSION/SIGNIFICANCE OF IMPACT: Due to stigmatization, an HIV diagnosis can influence a person’s physical, behavioral, psychological, and even spiritual health (McIntosh & Rosselli, 2012). As a stressor, it can compromise immune function to worsen the effects of the infection, while mentally depressing an individual and contributing to adverse coping mechanisms (e.g. alcohol consumption, drug use) (McIntosh & Rosselli, 2012). How someone copes with stress (threat appraisal) may contribute to health-promoting or health-damaging behaviors (Fife, Scott, Fineberg, & Zwickl, 2008). Hence, the quality of life of those managing HIV/AIDS remains a pressing concern. Findings from this study suggest that Lazarus and Folkman’s theoretical framework on the cognitive appraisal of threat could assist PLHIV and their caregivers in understanding the coping processes in PLHIV. For service providers, recognizing early threat appraisals and damaging coping mechanisms can be useful, especially for patients receiving an initial HIV diagnosis. For example, an understanding of the patient’s HIV appraisal can provide insight into the barriers to optimal care and adherence to ART and, potentially, help to reduce these barriers (Anderson, 1995). Furthermore, with the advancements of HIV medication, living with HIV has become a chronic condition, though as a stressor, it also poses long-term effects on the psychopathology of an individual living with HIV(McIntosh & Rosselli, 2012). Studies such as this study can help illuminate interventions aimed at reducing the psychological impact of HIV on a person’s life. For example, support groups have been developed and structured to provide social support and have been demonstrated to increase the perceived well-being among PLHIV (Hyde, Appleby, Weiss, Bailey, & Morgan, 2005). This has further expanded into the consideration of online-based support groups for PLHIV (Blackstock, Shah, Haughton, & Horvath, 2015). In another light, but still within psychosocial interventions for managing HIV infection, mindfulness meditation has been used pervasively in studies assessing its use as an intervention to reduce depression and perceived stress in people living with HIV in order to increase both physical and psychological health (Moskowitz etal., 2015). Interventions, such as mindful meditation, have risen as we understand more about appraisal pathways and coping strategies (such as seeking social support), and how they influence both physiological and psychological responses (Moskowitz etal., 2015) to affect the health of a person. Therefore, longitudinal research aimed toward management of the psychological and social consequences of HIV is central to promoting an accurate understanding of the quality of life for PLWH (Anderson, 1995).
3258 The Relationship Between the Severity of Influenza-Related Illness and Timing of Seasonal Influenza Vaccination in Hospitalized Patients with Influenza
- Julia Haston, Shikha Garg, Angela Campbell, Jill Ferdinands, Monica Farley, Evan Anderson
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- 26 March 2019, pp. 56-57
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OBJECTIVES/SPECIFIC AIMS: The overall goal of this project is to determine whether timing of seasonal influenza vaccination affects the severity of illness in vaccinated individuals who are hospitalized with influenza. This will be assessed with the following aims: 1. To determine whether differences in demographic and clinical characteristics exist among patients with short duration between seasonal influenza vaccination and influenza-related hospitalization and those with longer duration. 2. To determine whether time between seasonal influenza vaccination and hospitalization is associated with the duration of influenza-related hospitalization. 3. To determine whether time between seasonal influenza vaccination and hospitalization is associated with the rate of influenza-related ICU admission among patients hospitalized with influenza. 4. To determine whether time between seasonal influenza vaccination and hospitalization is associated with the rate of influenza-related death among adults hospitalized with influenza. METHODS/STUDY POPULATION: The Influenza Hospitalization Surveillance Network (FluSurv-NET) is a surveillance platform of influenza-related hospitalizations through the CDC Emerging Infections Program (EIP). FluSurv-NET conducts active surveillance for influenza-related hospitalizations of both children and adults in selected counties in California, Colorado, Connecticut, Georgia, Maryland, Michigan, Minnesota, Ohio, Oregon, New Mexico, New York, Tennessee, and Utah with a total catchment population of over 27 million people (~9% of the US population). Using this platform, we will retrospectively evaluate four influenza seasons using FluSurv-NET data to look at the timing of influenza vaccination and severity of illness among patients with influenza-related hospitalization. We will conduct a multivariate analysis to assess for differences in severe outcomes including duration of hospitalization, ICU admission, and death among patients with varying lengths of time between influenza vaccination and influenza-related hospitalization. Separate analyses will be performed among different age groups and influenza type/subtypes, as well as specific seasons as a surrogate for most common circulating strain. RESULTS/ANTICIPATED RESULTS: We hypothesize that patients with chronic medical conditions and those at the extremes of age will have a longer duration between vaccination and hospitalization as they are more likely to get vaccinated earlier. We also hypothesize that patients with longer duration between seasonal influenza vaccination and hospitalization will have a longer duration of hospitalization and a higher rate of other severe outcomes (e.g., ICU admission, death). Such data would suggest that immune protection wanes during the influenza season. DISCUSSION/SIGNIFICANCE OF IMPACT: Limited data suggest that vaccine-induced influenza immunity may wane during the influenza season. It is not known whether the impact of influenza vaccination upon severity of disease might wane with increasing time between vaccination and influenza infection. In contrast to many previous studies evaluating vaccine effectiveness which have assessed medically-attended influenza illness as a primary outcome, our dataset is a large cohort of hospitalized patients which allows us to assess rare yet critical outcomes such as ICU admission and death. This study will also have a substantially larger amount of pediatric data than previous studies, which will provide the opportunity to determine whether timing of vaccination affects children and adults differently. Improving our understanding of whether influenza vaccine-induced protection might wane over time could ultimately impact U.S. influenza vaccination policy resulting in decreased morbidity and mortality attributed to influenza each season.
3542 Torsade de pointes/QT prolongation risks with antibiotics: A contemporary analysis of the FDA Adverse Event Reporting System
- Chengwen Teng, Daryl Kevin S. Gaspar, Christopher Frei
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- 26 March 2019, p. 57
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OBJECTIVES/SPECIFIC AIMS: Macrolides, linezolid, imipenem-cilastatin, fluoroquinolones, penicillin combinations, and ceftriaxone are known to be associated with Torsade de pointes/QT prolongation (TdP/QTP). Other antibiotics may also lead to TdP/QTP, but no study has systemically compared TdP/QTP risks of different antibiotics using recent data. Therefore, the objective of this study was to evaluate the association between TdP/QTP and antibiotics in recent years using the FDA Adverse Event Report System (FAERS). METHODS/STUDY POPULATION: FAERS reports from January 1, 2015 to December 31, 2017 were analyzed. The Medical Dictionary for Regulatory Activities (MedDRA) was used to identify TdP/QTP cases. We calculated the Reporting Odds Ratios (RORs) and corresponding 95% confidence intervals (95%CI) for the association between antibiotics and TdP/QTP. An association was considered to be statistically significant when the lower limit of the 95%CI was greater than 1. RESULTS/ANTICIPATED RESULTS: A total of 2,042,801 reports (including 5,221 TdP/QTP reports) were considered, after inclusion criteria were applied. Macrolides had the greatest proportion of TdP/QTP reports, representing 2.9% of all macrolide reports. TdP/QTP RORs (95%CI) for the antibiotics were (in descending order): macrolides 11.73 (9.74-14.12), linezolid 9.39 (6.45-13.68), amikacin 8.94 (4.22-18.92), imipenem-cilastatin 5.01 (2.38-10.56), fluoroquinolones 4.67 (3.96-5.52), penicillin combinations 3.52 (2.56-4.86), cephalosporins 1.90 (1.14-3.16), metronidazole 1.49 (0.74-2.99), vancomycin 1.26 (0.70-2.28), clindamycin 0.83 (0.27-2.58), trimethoprim-sulfamethoxazole 0.82 (0.31-2.18), and amoxicillin 0.57 (0.18-1.78). DISCUSSION/SIGNIFICANCE OF IMPACT: This study confirms prior evidence for TdP-QTP risks with macrolides, linezolid, imipenem-cilastatin, fluoroquinolones, penicillin combinations, and cephalosporins. This study provides new evidence for TdP-QTP risks with amikacin. Macrolides had the highest TdP/QTP ROR among the antibiotics evaluated in this study.
3317 Translating simulation-based team leadership training into patient-centered outcomes
- Rosemarie Fernandez, Elizabeth D. Rosenman, Anne K. Chipman, Sarah Brolliar, Marie C. Vrablik, Anthony T Misisco, Jeff Olenick, James Grand, Colleen Kalynych, Steve W. J. Kozlowski, Georgia T. Chao
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- 26 March 2019, pp. 57-58
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OBJECTIVES/SPECIFIC AIMS: The objective of this research was to assess the clinical impact of simulation-based team leadership training on team leadership effectiveness and patient care during actual trauma resuscitations. This translational work addresses an important gap in simulation research and medical education research. METHODS/STUDY POPULATION: Eligible trauma team leaders were randomized to the intervention (4-hour simulation-based leadership training) or control (standard training) condition. Subject-led actual trauma patient resuscitations were video recorded and coded for leadership behaviors (primary outcome) and patient care (secondary outcome) using novel leadership and trauma patient care metrics. Patient outcomes for trauma resuscitations were obtained through the Harborview Medical Center Trauma Registry and analyzed descriptively. A one-way ANCOVA analysis was conducted to test the effectiveness of our training intervention versus a control group for each outcome (leadership effectiveness and patient care) while accounting for pre-training performance, injury severity score, postgraduate training year, and days since training occurred. Association between leadership effectiveness and patient care was evaluated using random coefficient modeling. RESULTS/ANTICIPATED RESULTS: Sixty team leaders, 30 in each condition, completed the study. There was a significant difference in post-training leadership effectiveness [F(1,54)=30.19, p<.001, η2=.36] between the experimental and control conditions. There was no direct impact of training on patient care [F(1,54)=1.0, p=0.33, η2=.02]; however, leadership effectiveness mediated an indirect effect of training on patient care. Across all trauma resuscitations team leader effectiveness correlated with patient care (p<0.05) as predicted by team leadership conceptual models. DISCUSSION/SIGNIFICANCE OF IMPACT: This work represents a critical step in advancing translational simulation-based research (TSR). While there are several examples of high quality translational research programs, they primarily focus on procedural tasks and do not evaluate highly complex skills such as leadership. Complex skills present significant measurement challenges because individuals and processes are interrelated, with multiple components and emergent nature of tasks and related behaviors. We provide evidence that simulation-based training of a complex skill (team leadership behavior) transfers to a complex clinical setting (emergency department) with highly variable clinical tasks (trauma resuscitations). Our novel team leadership training significantly improved overall leadership performance and partially mediated the positive effect between leadership and patient care. This represents the first rigorous, randomized, controlled trial of a leadership or teamwork-focused training that systematically evaluates the impact on process (leadership) and performance (patient care).
Commercialization/Entrepreneurship/Regulatory Science
3466 Innovative 3D Printed Intravaginal Rings: Developing AnelleO PRO, the First Intravaginal Ring for Infertility
- Rima Janusziewicz, Janus S. Rahima Benhabbour
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- 26 March 2019, p. 58
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OBJECTIVES/SPECIFIC AIMS: The study aims to develop and test a biocompatible 3D-printed IVRs for the mechanical and release properties of a model drug, β-estradiol, then translate these methods to the target drug, progesterone. The goals include demonstrating decoupling of mechanical and release properties of the rings, release profiles driven by geometry and efficacy in sheep animal models to evaluate device safety. METHODS/STUDY POPULATION: A novel 3D-printing platform, continuous liquid interface production (CLIP), pioneered by Carbon, enables the fabrication of complex designs on a timescale that is amenable to manufacturing. The process utilizes computational-aided design (CAD), specifying shape and geometry, which is recreated via a photopolymerization process. IVRs are fabricated with CLIP using a biocompatible resin at a rate of approximately 15 min. per ring. Rings were fabricated and assessed for the release of a model drug, β-estradiol. The process was then translated to the target drug, progesterone. Rings were evaluated for radial compression and in vitro release in simulated vaginal fluid (SVF). RESULTS/ANTICIPATED RESULTS: Intravaginal rings (IVRs) were designed and fabricated to be geometrically complex in an effort to control release. Ring geometry and subsequent pore size was achieved through the use of unit cells. Several design parameters were explored including unit cell type, size, and band presence in two resins of differing mechanical properties. Through design, a wide range of radial compressive properties were achieved which spanned values covered by commercially available rings. The release of β-estradiol in SVF was found to span 57 – 115 days and resulted in near or complete release of the total loaded drug. Changing the internal geometric design of the ring was found to have minimal influence on the compression properties, thus the mechanical and release characteristics of the rings were largely decoupled. DISCUSSION/SIGNIFICANCE OF IMPACT: This is a novel approach to the design and fabrication of intravaginal rings for the treatment of infertility. The use of CAD and the decoupling of release from mechanical properties allows for us to move away from the one-size one-dose fits all approach to IVRs.
3570 The Regulatory Landscape of Products to Treat Opioid Overdose
- Pooja Singh, Kaylene Okada, Amelia Spinrad, Nancy Pire-Smerkanich, Eunjoo Pacifici
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- 26 March 2019, pp. 58-59
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OBJECTIVES/SPECIFIC AIMS: Since 1971, Naloxone has been the only FDA approved opioid antagonist indicated for use after opioid overdose. New formulations of Naloxone have been introduced into the market, including an injectable, auto-injector, and nasal spray. However, Naloxone is short-acting and as such often requires multiple doses and may induce severe withdrawal symptoms. This study examines the regulatory framework to understand the evolution of products indicated to treat opioid overdose and the landscape of therapies in development. Furthermore, this study examines how the Food and Drug Administration (FDA) and other government agencies have approached the opioid crisis. METHODS/STUDY POPULATION: A PubMed search of “naloxone AND opioid overdose” with the filter “humans” was conducted to understand Naloxone’s regulatory framework. The term “naloxone” was searched on the Drugs@FDA: Approved Drug Products database. Additionally, “nalmefene” was searched on ClinicalTrials.gov. To examine the opioid antagonist market landscape, a PubMed search of “opioid antagonist AND opioid overdose” with the filters “humans” and “clinical trial,” and a ClinicalTrials.gov search of “opioid antagonist and opioid overdose,” were conducted. Government agency reports were reviewed and cataloged. RESULTS/ANTICIPATED RESULTS: Preliminary findings suggest a lack of innovation in the development of novel opioid antagonists. Most literature review findings focused on already-marketed Naloxone products, including the original injectable approved in 1971, the 2014 Evzio Auto-Injector, and the 2015 Narcan Nasal Spray (Figure 1). For example, there were 14 results yielded from the FDA approvals database, but none of these results represented a new opioid antagonist molecule. A longer-acting opioid antagonist, Nalmefene injectable, was approved in 1995 but has since been removed from the market due to low sales. Our initial ClinicalTrials.gov search using condition “opioid overdose” and other terms “opioid antagonist”,revealed no new studies being conducted on alternative opioid antagonist treatments for opioid overdose. Findings only focused on the distribution, co-dispensing, intervention, pharmacokinetics/pharmacodynamics (PK/PD) of Naloxone (Figure 2). However, a Google search yielded one new trial with an opioid antagonist by Opiant Pharmaceuticals, almost fifty years after FDA’s approval of Naloxone. A ClinicalTrials.gov search was then performed using the search term “nalmefene” to find whether Opiant Pharmaceuticals’ trial was in the ClinicalTrials.gov database. However, the Opiant trial is phase I, and as such does not require reporting on ClinicalTrials.gov. In 2017, the National Institutes of Health (NIH) launched an initiative for longer-acting opioid antagonist formulations. In 2018, Opiant Pharmaceuticals announced positive phase I results for intranasal Nalmefene. The potential return of Nalmefene in intranasal form may play a significant role in reducing overdoses, especially in cases where a longer-acting opioid antagonist is necessary. Opiant Pharmaceuticals’ trial commenced after the NIH announced their initiative; furthermore, the NIH’s National Institute on Drug Abuse granted the company $7.4 million to further the investigation of this drug. We will continue to research drugs that have previously been studied for the indication of treating opioid overdose in the United States and abroad and catalog them. DISCUSSION/SIGNIFICANCE OF IMPACT: The abuse and misuse of opioids in the United States has caused an epidemic accounting for over 115 opioid-overdose deaths each day, devastating our nation, both socially and economically. The United States spends $78.5 billion annually to combat the misuse of these drugs. Due to the severity of the opioid crisis, efforts to better understand approved therapies and investigational products in development to treat opioid overdose will be of significance moving forward. This research can inform agencies who are developing strategies to reduce opioid overdoses and pharmaceutical product developers about the current opioid antagonist landscape.
Digital Health, Social Media, and AI
3220 Can you read me now? Clinician variations in managing and responding to secure messages from patients
- Joy Li-Yueh Lee, Michael Weiner, Marianne Matthias
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- 26 March 2019, p. 59
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OBJECTIVES/SPECIFIC AIMS: To identify areas of variation in primary care clinician responses to secure messaging and to assess the quality of secure messages by clinicians. METHODS/STUDY POPULATION: This mixed-methods study included twenty one primary care clinicians from a Midwestern safety net hospital and Veterans Affairs medical center. Participants were presented with five short clinical vignettes and corresponding secure messages from hypothetical patients and asked to compose responses. Participants were interviewed about their cognitive approach to the responses as well as perspectives on quality of care as related to electronic communications. RESULTS/ANTICIPATED RESULTS: Every participant recalled having patients who misused secure messaging for urgent issues, suggesting the need for more patient education and the possible adverse consequences of overlooked messages. The study also uncovered key differences in several areas, include clinician timeliness, message management, the circumstances in which they would use messaging, and the content of the messages (including patient-centeredness). While participants agreed that messages about clinical issues should not be resolved via secure messaging, there was a lack of consensus regarding emotionally charged messages and messages dealing with medication adjustments. Some participants spoke of the need for more guidance in knowing when best to use secure messaging. “Sometimes,” one physician said, “it feels like we’re just making up [rules for secure messaging].” Although clinician responses were uniformly respectful, the patient-centeredness varied in the use of jargon and social talk, as well as clarity for patients. DISCUSSION/SIGNIFICANCE OF IMPACT: This study revealed variations in provider approaches to secure messaging, and the content of responses. These variations reflect lack of consensus about how care is delivered via secure messaging, and reveal the need for clinician guidance. They also suggest possible negative patient consequences if secure messaging is used ineffectively. The extent to which variations are undesirable remains unknown. Future work will explore the consequences of such variations.
3098 Combined Eating Disorder and Weight Loss Online Guided-Self Help Intervention: A Pilot Study
- Grace Elise Monterubio, Denise E. Wilfley, Ellen E. Fitzsimmons-Craft
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- 26 March 2019, p. 59
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OBJECTIVES/SPECIFIC AIMS: Among college students with binge-type eating disorders who are overweight (BMI >25), does use of an online, guided self-help program for EDs combined with healthy weight-loss (WL) methods lead to reductions in ED symptoms and weight loss compared to controls referred to standard in-person treatment (Student Health Services)? Aim 1: Develop online, guided self-help program for intervention of ED psychopathology and weight reduction. Aim 2: Implement online, guided self-help program for intervention of ED psychopathology and weight reduction. Aim 3: Follow-up to track remission of ED psychopathology and symptoms and WL maintenance. METHODS/STUDY POPULATION: Up to N=60 college students who meet the criteria (clinical or sub-clinical binge-type ED and have a BMI > 25) and elect to participate will complete a baseline survey to enroll in the study, then will be randomized into a condition. Students in the intervention group (n=30) will be offered 8 weeks of online, guided self-help intervention for ED and WL. Students in the control group (n=30) will receive an email message encouraging them to seek support from Student Health Services for their WL and eating behavior concerns, along with appropriate contact information. All participants will receive follow-up 9 weeks after completing initial baseline, and a final follow-up survey 6-months after completing their baseline. RESULTS/ANTICIPATED RESULTS: Analysis of intervention and control groups will compare average Eating Disorder Examination Questionnaire (EDEQ) scores and WL (change in BMI) at the end of the intervention (9 weeks) and at 6-month follow-up. Group comparisons will be assessed via two-way mixed model ANOVA. DISCUSSION/SIGNIFICANCE OF IMPACT: Online, guided self-help interventions have been used for WL, as well as for treatment of EDs separately, but no program exists to manage these conditions together. Thus, the use of online intervention for ED psychopathology and WL in individuals with clinical and sub-clinical EDs is the next step. The goal of this study is to implement a program to reduce weight and shape concerns, reduce disordered eating symptoms, such as bingeing, and compensatory behaviors associated with binge-type EDs, while also reducing weight for individuals with EDs and comorbid overweight/obesity. This project will pilot an online, guided self-help ED intervention that offers cognitive behavioral based tools to improve ED symptoms in college students, while also teaching the healthy methods of behavioral WL, for students with clinical/sub-clinical binge-type EDs with comorbid overweight/obesity in order to examine effectiveness of the program compared to referral to Student Health Services for ED and WL concerns. Furthermore, the use of an online, guided self-help intervention is more scalable and can circumvent many of the barriers to traditional in-person treatment.
3558 Do Recognition, Behavioral Intentions, and Attitudes of Adolescent Relationship Abuse (ARA) Serve as Protective Factors Against Future ARA and Cyber Dating Abuse (CDA)?
- Linden Wu, Elizabeth A. Schlenk, Susan M. Sereika, Elizabeth Miller
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- 26 March 2019, p. 60
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OBJECTIVES/SPECIFIC AIMS: To create prevention strategies targeting ARA and CDA, it is critical to educate and mold adolescent recognition, behavioral intentions, and attitudes regarding healthy dating relationships. Thus, the purpose of this study was to examine if high school students’ recognition of ARA, the students’ behavioral intentional to intervene during ARA episode of someone they know, and the students’ attitudes about the importance of healthy relationship serve as a protective factors against experiencing ARA. Aim 1: Do baseline (T1) recognition, behavioral intentions, and attitudes serve as protective factors against experiencing ARA in high school students at 3-month follow-up (T2)? Aim 2: Do baseline (T1) recognition, behavioral intentions, and attitudes serve as protective factors against CDA in high school students at 3-month follow- up (T2)? METHODS/STUDY POPULATION: To examine the relationships between recognition, behavioral intentions, and attitudes of ARA and CDA, a secondary analysis using a descriptive correlational design was used to analyze electronic survey data from a large randomized controlled parent study. The parent study consisted of 1,011 high school students ages 14 to 19 years who sought health service through one of eight school-based health clinics in California. This secondary analysis consisted of 819 students, with 640 (78.1%) female, 178 (21.7%) males, and 1 (0.2%) transgender participant. There were 42 (5.1%) Caucasians, 141 (17.2%) Asians, 218 (26.7%) African Americans, 313 (38.2%) Hispanics, 42 (5.1%) American Indians/Alaskan Natives, and 63 (7.7%) students who responded multi-racial. To measure recognition of ARA, a 10-item, 5-point Likert scale was used with responses ranging from 1=“not abusive” to 5=“extremely abusive” (Cronbach’s a = 0.85). To assess behavioral intentions to intervene, a 5-item, 5-point Likert scale was used to ask participants how likely they would be to stop the ARA behavior if they witness a peer perpetrating ARA with responses ranging from 1=“very unlikely” to 5=“very likely” (Cronbach’s a = 0.89). A 6-item, 3-point Likert healthy relationship tool measured participants’ attitudes regarding healthy relationship with responses ranging from 1=“not important” to 3=“very important”. Both ARA and CDA were assessed using a “yes/no” response choice for the lastthree months. To account for the hierarchical nature of the data analysis, a binary logistic regression was used in SPSS 24. To take into account the clustering coefficients of the eight different school clinics and as well as the parent study’s intervention and control groups, these clusters were examined as co-variates. Sex, race, and age were included as covariates, also. RESULTS/ANTICIPATED RESULTS: The relationship status of high school students consisted of 262 (32.0%) who were single, 97 (11.8%) who were going out, dating, or hooking up with more than one person, 423 (51.7%) who were seriously dating one person, and 37 (4.5%) who were not sure. At 3-month follow-up assessment, 111 (13.6%) of high school students experienced ARA, and 476 (58.1%) experienced CDA. The mean recognition of ARA score was 3.90 + 0.67, mean behavioral intentions score was 4.00 + 0.83, and mean attitudes score was 2.54 + 0.37. When examining the full ARA model including all three predicators controlling for the demographics and group assignment, none of the predictor variables were significant (p>0.05) in predicting ARA in high school students. Also, all three predictors were not significant in predicting ARA in the main effects model. When examining the full CDA model, with no interaction, all three predictors were significant. Recognition had 0.784 decrease odds (95% CI = 0633-0.971, p = 0.026) of predicting CDA. However the odds of CDA increase non-linearly up to the mean (2.537709) for the attitudes variable after which the odds then decreases non-linearly. The odds of CDA is increasing non-linearly up to 3.073913 for the behavioral intention variable after which the odds then decrease non-linearly. DISCUSSION/SIGNIFICANCE OF IMPACT: Adolescence is typically a time of exploration, transition, and social development. Researchers should investigate the efficacy of ARA and CDA prevention programs that focus on recognition, behavioral intentions, and attitudes to educate adolescents on healthy relationships. Results showed that behavioral intention to intervene and attitudes about healthy relationship can serve as protective factors against CDA. From our data, more students experienced CDA compared to ARA. Thus, it may by useful to recognize the use of technology as a social force within the adolescent culture in defining adolescents’ experiences of healthy relationships and potential experience of CDA.
3132 Machine Learning for Prediction of Pathologic Pneumatosis Intestinalis Using CT Scans
- Kadie Clancy, Esmaeel Dadashzadeh, Christof Kaltenmeier, JB Moses, Shandong Wu
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- 26 March 2019, pp. 60-61
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OBJECTIVES/SPECIFIC AIMS: This retrospective study aims to create and train machine learning models using a radiomic-based feature extraction method for two classification tasks: benign vs. pathologic PI and operation of benefit vs. operation not needed. The long-term goal of our study is to build a computerized model that incorporates both radiomic features and critical non-imaging clinical factors to improve current surgical decision-making when managing PI patients. METHODS/STUDY POPULATION: Searched radiology reports from 2010-2012 via the UPMC MARS Database for reports containing the term “pneumatosis” (subsequently accounting for negations and age restrictions). Our inclusion criteria included: patient age 18 or older, clinical data available at time of CT diagnosis, and PI visualized on manual review of imaging. Cases with intra-abdominal free air were excluded. Collected CT imaging data and an additional 149 clinical data elements per patient for a total of 75 PI cases. Data collection of an additional 225 patients is ongoing. We trained models for two clinically-relevant prediction tasks. The first (referred to as prediction task 1) classifies between benign and pathologic PI. Benign PI is defined as either lack of intraoperative visualization of transmural intestinal necrosis or successful non-operative management until discharge. Pathologic PI is defined as either intraoperative visualization of transmural PI or withdrawal of care and subsequent death during hospitalization. The distribution of data samples for prediction task 1 is 47 benign cases and 38 pathologic cases. The second (referred to as prediction task 2) classifies between whether the patient benefitted from an operation or not. “Operation of benefit” is defined as patients with PI, be it transmural or simply mucosal, who benefited from an operation. “Operation not needed” is defined as patients who were safely discharged without an operation or patients who had an operation, but nothing was found. The distribution of data samples for prediction task 2 is 37 operation not needed cases and 38 operation of benefit cases. An experienced surgical resident from UPMC manually segmented 3D PI ROIs from the CT scans (5 mm Axial cut) for each case. The most concerning ~10-15 cm segment of bowel for necrosis with a 1 cm margin was selected. A total of 7 slices per patient were segmented for consistency. For both prediction task 1 and prediction task 2, we independently completed the following procedure for testing and training: 1.) Extracted radiomic features from the 3D PI ROIs that resulted in 99 total features. 2.) Used LASSO feature selection to determine the subset of the original 99 features that are most significant for performance of the prediction task. 3.) Used leave-one-out cross-validation for testing and training to account for the small dataset size in our preliminary analysis. Implemented and trained several machine learning models (AdaBoost, SVM, and Naive Bayes). 4.) Evaluated the trained models in terms of AUC and Accuracy and determined the ideal model structure based on these performance metrics. RESULTS/ANTICIPATED RESULTS: Prediction Task 1: The top-performing model for this task was an SVM model trained using 19 features. This model had an AUC of 0.79 and an accuracy of 75%. Prediction Task 2: The top-performing model for this task was an SVM model trained using 28 features. This model had an AUC of 0.74 and an accuracy of 64%. DISCUSSION/SIGNIFICANCE OF IMPACT: To the best of our knowledge, this is the first study to use radiomic-based machine learning models for the prediction of tissue ischemia, specifically intestinal ischemia in the setting of PI. In this preliminary study, which serves as a proof of concept, the performance of our models has demonstrated the potential of machine learning based only on radiomic imaging features to have discriminative power for surgical decision-making problems. While many non-imaging-related clinical factors play a role in the gestalt of clinical decision making when PI presents, we have presented radiomic-based models that may augment this decision-making process, especially for more difficult cases when clinical features indicating acute abdomen are absent. It should be noted that prediction task 2, whether or not a patient presenting with PI would benefit from an operation, has lower performance than prediction task 1 and is also a more challenging task for physicians in real clinical environments. While our results are promising and demonstrate potential, we are currently working to increase our dataset to 300 patients to further train and assess our models. References DuBose, Joseph J., et al. “Pneumatosis Intestinalis Predictive Evaluation Study (PIPES): a multicenter epidemiologic study of the Eastern Association for the Surgery of Trauma.” Journal of Trauma and Acute Care Surgery 75.1 (2013): 15-23. Knechtle, Stuart J., Andrew M. Davidoff, and Reed P. Rice. “Pneumatosis intestinalis. Surgical management and clinical outcome.” Annals of Surgery 212.2 (1990): 160.
3032 MKit: Pilot Results of Primary Prevention Sexual Violence WebApp
- Michelle Munro-Kramer, Lindsay Cannon, Jose Bauermeister, Yasamin Kusunoki, Quyen Ngo, Rob Stephenson
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- 26 March 2019, p. 61
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OBJECTIVES/SPECIFIC AIMS: Sexual violence (SV) is a public health crisis. High rates of SV are observed among college-age youth, yet holistic interventions are currently lacking. The purpose of this study was to conduct a pilot feasibility and acceptability test of a WebApp, MKit, which translates a clinical life skills approach to influence the health and well-being of university students. METHODS/STUDY POPULATION: We randomized two residence halls at a public university in the Midwest into a control group (n=139) that received typical university programming around SV and healthy relationships, or an intervention group (n=122) receiving MKit and the usual SV programming. We used online surveys to assess acceptability, feasibility, and usability at 3- and 5-months. Focus groups were conducted with a subsample of participants at 5-months to further investigate safety. RESULTS/ANTICIPATED RESULTS: The mean number of uses of MKit was 2.84 in a 5-month period. The majority of intervention participants endorsed the acceptability and usability of MKit as easy to use, well integrated, accessible, and easy to learn quickly. There were no concerns regarding personal safety. DISCUSSION/SIGNIFICANCE OF IMPACT: MKit provides a promising resource platform to deliver messages regarding healthy relationships and SV within the university context. By delivering SV-related content through a holistic life skills approach, MKit may offer new opportunities to reach and engage a wide range of students on how to foster healthy relationships.
3086 Virtual World-based Cardiac Rehabilitation to Promote Healthy Lifestyle Among Cardiac Patients
- LaPrincess Brewer, Brian Kaihoi, Shawn Leth, Ray Squires, Randal Thomas, Robert Scales, Jorge Trejo-Gutierrez, Stephen Kopecky
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- Published online by Cambridge University Press:
- 26 March 2019, pp. 61-62
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OBJECTIVES/SPECIFIC AIMS: Our aim was to assess the feasibility and acceptability of a VW-based cardiac rehabilitation (CR) program (Destination Rehab) as an extension of a face-to-face conventional CR program. We hypothesized that a VW-based CR program could be successfully implemented as an extension of conventional CR and would have high acceptability among cardiac patients. METHODS/STUDY POPULATION: We recruited 30 adult cardiac patients (10/site) hospitalized at Mayo Clinic Hospitals in Rochester, MN, Jacksonville, FL or Scottsdale, AZ with a diagnosis for CR (eg, acute coronary syndrome (ACS), heart failure, elective percutaneous coronary intervention (PCI)). Other inclusion criteria included at least 1 modifiable, lifestyle risk factor target: sedentary lifestyle (< 3 hours physical activity (PA)/week), unhealthy diet (< 5 servings fruits and vegetables/day) or current smoking (>1 year). Patients participated in an 8-week, health education program using a VW platform from a prior proof-of-concept study and provided intervention usability, usefulness and satisfaction feedback. We assessed cardiovascular (CV) health behaviors (diet, PA) and risk factors (eg, blood pressure (BP), lipids) at baseline and immediate post-intervention. RESULTS/ANTICIPATED RESULTS: Among 30 patients enrolled (mean age; 59 years; 50% women; 65% <college graduate; 32% annual household income <$50,000), 28 (98%) completed the study. The majority (64%) were enrolled in conventional CR with a high session completion rate (median 36 sessions, interquartile range 8-36). The most common CR indication was PCI (68%). There were statistically significant improvements in PA from baseline to post-intervention: vigorous PA, +10.7 (SD 11.7) minutes/day (p = 0.05) and flexibility exercises +0.9 (SD 0.9) days/week for men (p=0.05). There were favorable trends in risk factors: systolic BP (−6.8 mmHg, SD 29.8), total cholesterol (−31.6 mg/dL, SD 46.2) and LDL (−26 mg/dL, SD 44.8) from baseline to post-intervention, although not statistically significant. The majority reported that they would continue to use VW as a resource (76%) and agreed/strongly agreed that the program improved their heart health knowledge (86%) and assisted with adapting healthier lifestyle (100%). Overall, the VW CR program received a rating of 8 (scale 0-10). DISCUSSION/SIGNIFICANCE OF IMPACT: VW-based CR program is a feasible, highly acceptable and innovative platform to influence health behaviors and CV risk and can increase accessibility to disadvantaged populations with higher CVD burdens.
3580 What percent of unnecessary ED visits for chronic conditions can be reduced by extant telemedicine devices?
- Simeon Abiola, Kimberly Arcoleo
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- 26 March 2019, p. 62
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OBJECTIVES/SPECIFIC AIMS: This study will elucidate what percent of unnecessary ED visits for chronic conditions can be reduced by extant telemedicine devices, and which telemedicine devices can yield the greatest reduction in unnecessary ED visits for chronic conditions. METHODS/STUDY POPULATION: We intend to use the Nationwide Emergency Department Sample (NEDS) to estimate the percent of ED visits, with a chronic condition as the principal diagnosis, were only evaluation and management services were rendered. The NEDS is the largest publicly available, all-payer ED database, providing national estimates of ED visits. The NEDS contains information on patient demographics, principal diagnosis (captured by ICD-9-CM codes and defined as the main reason for bringing the patient to the hospital), and procedure codes using Current Procedural Terminology, Fourth Edition (CPT-4). Patients with a chronic condition will be identified using Chronic Condition Indicator developed by the Agency for Healthcare Research and Quality and, from them, patients who only received “evaluation and management” services will be extracted using the CPT-4 codes 99281–99283 and G0380–G0383. Then using our previously developed database, wherein FDA-approved OTC medical devices were allied to chronic conditions by applying the transitive property of equality between telemedicine devices – measurement and measurement – conditions pairs, we will elucidate what percent of unnecessary ED visits for chronic conditions which can be reduced by extant telemedicine devices. RESULTS/ANTICIPATED RESULTS: We anticipate multiple OTC telemedicine devices will be necessary to evaluate and manage common principal conditions. DISCUSSION/SIGNIFICANCE OF IMPACT: Telemedicine is seen as a potentially powerful tool for improving healthcare and reducing cost. UnitedHealthcare, the largest US insurance provider, has partnered with Doctors on Demand, the largest players in the telemedicine app space, and other app-based telemedicine services to provide on-demand access to physicians. However, to reach the full potential of telemedicine, and more specifically towards reducing unnecessary ED visits for chronic conditions, telemedicine services need to include capabilities that will allow for the evaluation and management of chronic conditions. This study is a pragmatic first step towards understanding what telemedicine devices would best augment existing telemedicine services to reduce unnecessary ED utilization.
Education/Mentoring/Professional and Career Development
3163 A Systematic Review of Research Competency Assessments for Clinical Researchers
- Phillip A Ianni, Elias M. Samuels, Brenda Eakin, Thomas E Perorazio
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- 26 March 2019, p. 62
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OBJECTIVES/SPECIFIC AIMS: The purpose of this study was to summarize the existing literature on clinical research competencies and determine what competency assessments currently exist. We also wished to assess which competencies should be included in a research competency assessment tool and to evaluate the validity of current competency assessments. We also examined whether these competency assessments can be used for the purposes of formative and summative evaluation. METHODS/STUDY POPULATION: Prior to conducting our search of the literature, we first compiled a list of search terms (e.g., clinical, research, training, competencies) that could be used to locate articles. We then entered these search terms, in various combinations, on several relevant databases. We evaluated abstracts of the articles revealed by this search to determine whether they met three criteria. The first criterion was that the subjects of the article must be clinical investigators or clinical investigators in training. Relevant disciplines included medicine, public health, nursing, pharmacy, dentistry, and other related fields. The second criterion was that articles should focus on research-based (as opposed to clinical) skills. The last criterion was that research-based competencies (or related terms like skills, abilities, mastery, knowledge) must be assessed in some way. If the abstract suggested that the article met all three criteria, the full article was retrieved and analyzed in-depth. To identify articles that eluded literature search, we then examined the reference section of these articles and examined articles that cited these articles. When no additional articles could be located, the search for articles stopped. Once a pool of potentially eligible articles was identified, the articles underwent peer review by several researchers experienced with clinical research and competency-based education and assessment. Articles that were unanimously judged to meet the criteria were included in the systematic review. RESULTS/ANTICIPATED RESULTS: Approximately 75 articles were selected and reviewed for eligibility. After peer review, we found that only a small fraction of these articles met our criteria for inclusion in the systematic literature review. Our preliminary findings suggest that there are few assessments of clinical research competency and that many of these assessments are poorly validated. DISCUSSION/SIGNIFICANCE OF IMPACT: The findings of the present study suggest that the validation methods used thus far are limited and so the validity of many of these assessments is effectively unproven. Future research on assessments of clinical research competency ought to address these limitations by sampling clinical researchers, using more rigorous validation methods, and by confirming hypothesized factor structures in new samples. The use of better-validated instruments may enhance measurement of trainees’ knowledge and skill levels for the purposes of formative and summative assessment.