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The diagnostic capabilities, palliative procedures, and critical care therapies for neonates with single ventricle heart disease have rapidly evolved. We aimed to review current trends for intensivists and cardiologists caring for this population. Enhanced diagnostics and 3-dimensional modeling can be instrumental in planning care pathways for these neonates. Additionally, the ability to palliate many of these patients with catheter-based therapies rather than traditional surgical approaches has allowed for reduced morbidity. There are significant improvements in the understanding of how critical care therapies affect survival and neurodevelopmental outcomes in this population. Despite advancements in the understanding of longer-term outcomes in this population, much remains to be discovered about how initial palliation, critical care strategies, surgical techniques, and extracorporeal support can be optimized for the most favorable neurodevelopmental outcomes, survival, and quality of life. This will be the major focus of future research through larger collaboratives.

A 4-hour-old infant with profound cyanosis on an alprostadil infusion was urgently transferred to Rady Children’s Hospital with suspected CHD. Upon arrival, urgent echocardiography was performed but could not confirm the presence of discrete pulmonary veins or pulmonary venous drainage. Given the difficulty in delineating the anatomy, a cardiac CT scan was performed and demonstrated a nearly atretic common pulmonary vein with multiple small collaterals that drained to systemic veins. Due to the high risk of mortality associated with operative repair, the decision was made to proceed with compassionate withdrawal of care. The described anatomy of common pulmonary vein atresia remains rare, and to our knowledge, fewer than 40 cases have been reported in the literature. Albeit rare, common pulmonary vein atresia should be considered in the differential diagnosis of a severely cyanotic neonate.

INTRODUCTION AND OBJECTIVE:Patients with non-muscle invasive bladder cancer (NMIBC) often require invasive monitoring and treatment. As new treatments emerge, our objective was to evaluate patient ...

Objective: To assess the feasibility of enrollment and collecting PRO data as part of routine clinical urologic care for bladder and prostate cancer patients and examine overall patterns and racial variations in PRO use and symptom reports over time. Subjects/Patients and Methods: We recruited 76 patients (n=29 Black and n=47 White) with prostate or bladder cancer at a single, comprehensive cancer center. The majority of prostate cancer patients had intermediate risk (57%) disease and underwent either radiation or prostatectomy. Over half (58%) of bladder cancer patients had muscle invasive disease and underwent cystectomy. Patients were asked to complete PRO symptom surveys using their preferred mode [web- or phone-based interactive voice response (IVR)]. Symptom summary reports were shared with providers during visits. Surveys were completed at three time points and assessed urinary, sexual, gastrointestinal, anxiety/depression, and sleep symptoms. Feasibility of enrollment and survey completion were calculated, and linear mixed effects models estimated differences in outcomes by race and time. Results: 63% of study participants completed all PRO measures at all three time points. Black patients were more likely to select IVR as their survey mode (40% vs 13%, p

TOPIC: Critical Care TYPE: Medical Student/Resident Case Reports INTRODUCTION: Electronic cigarette or vaping product use-associated lung injury (EVALI) is potentially life-threatening disease that has become increasingly recognized over the last years. However, the extra-pulmonary manifestations of this disease are not as well described. We present a patient who simultaneously developed acute EVALI and stress induced cardiomyopathy. CASE PRESENTATION: A 35-year-old female with a recent heavy vaping history presented to hospital via EMS due to disorganized behavior. Her past medical history was notable for polysubstance abuse and an extensive neuropsychiatric history. Her vital signs were notable for sinus tachycardia, hypotension and hypoxia with an oxyhemoglobin saturation 65%. Her physical exam was notable for cyanosis, rales to pulmonary auscultation and use of accessory muscles. She was intubated and started on empiric antibiotics for community acquired pneumonia, and vasopressors. A computer tomography pulmonary angiography (CTPE) was negative for acute pulmonary embolism but showed scattered bilateral airspace opacities with dependent consolidations (fig 1.). Relevant laboratory on admission included procalcitonin 28.17, WBC count 12.9 and troponin 1.58. SARs-COV-2, serum blood cultures, legionella antigen, streptococci pneumoniae antigen and HIV were negative. Urine toxicology was positive for cannabinoids. Bronchoalveolar lavage later demonstrated 50,000 TNC with neutrophil predominance. EKG showed sinus tachycardia and nonspecific ST depression. Echocardiogram revealed severe diffuse hypokinesis with left ventricular ejection fraction (LVEF) of 13%. During her ICU course she continued on mechanical ventilation with lung protective strategy, systemic glucocorticoids and antibiotics. Vasopressors were subsequently weaned off. Repeated echocardiogram on ICU day five demonstrated a recovered LVEF at 55%. Patient's hypoxemia improved, and she was successfully extubated on ICU day eight. DISCUSSION: Pulmonary injury is the most well described clinical manifestation of EVALI, however a large majority of these patients also present with gastrointestinal symptoms and malaise, suggesting a systemic disease process. Our patient had newly reduced LVEF suggestive of stress induced cardiomyopathy which consequently improved with standard and supportive care. CONCLUSIONS: It is important to maintain a high index of suspicion of secondary organ damage, as prompt diagnosis and treatment of EVALI associated cardiac dysfunction can have an impact in short- and long-term prognosis. REFERENCE #1: Kligerman S, Raptis C, Larsen B, Henry TS, Caporale A, Tazelaar H, Schiebler ML, Wehrli FW, Klein JS, Kanne J. Radiologic, Pathologic, Clinical, and Physiologic Findings of Electronic Cigarette or Vaping Product Use-associated Lung Injury (EVALI): Evolving Knowledge and Remaining Questions. Radiology. 2020 Mar;294(3):491-505. doi: 10.1148/radiol.2020192585. Epub 2020 Jan 28. PMID: 31990264. DISCLOSURES: No relevant relationships by David barounis, source=Web Response No relevant relationships by Xavier Fonseca, source=Web Response No relevant relationships by Dana Mueller, source=Web Response

270 Background: The standard of care for low-grade non‐muscle‐invasive bladder cancer (LG NMIBC) is transurethral resection of the bladder tumor, which can worsen health‐related quality of life (HRQOL). The “OPTimized Instillation of Mitomycin for Bladder Cancer Treatment” (Optima II, clinicaltrials.gov: NCT03558503) is a Phase 2b, open label, single arm, multicenter trial evaluating a nonsurgical alternative as a primary treatment. Patients receive six weekly instillations of UGN-102, a mitomycin-containing reverse thermal gel with a sustained release time of up to 8 hours. We report on HRQOL changes between baseline and the primary endpoint of 3 months. Methods: A total of 63 patients enrolled in the Optima II trial at 20 sites in the U.S. and 2 sites in Israel between October 2018 and October 2020. Of the 63 patients enrolled, 44 were in the HRQOL cohort and completed a quarterly questionnaire. The QLQ-NMIBC24 has six subscales (urinary symptoms, malaise, future health worries, bloating and flatulence, sexual functioning, and male sexual problems) and five single items (intravesical treatment issues, sexual intimacy, worry about contaminating partner, sexual enjoyment, and female sexual problems) assessed with 24 items. Items were rescaled to 0-100 and reverse-coded so that higher scores indicate worse symptom burden. Longitudinal score changes were evaluated using the Sign test. We examined demographic and clinical characteristics associated with HRQOL change scores with regression modeling. A p-value of ≤0.01 was used. Results: The HRQOL cohort was 61% men, 57% age 65+, and 89% non-Hispanic White. Clinically, most LG NMIBC patients had multiple tumors (88%) with prior NMIBC episodes (77%), and two or more prior transurethral resection of bladder procedures (TURBT) (85%). Approximately half (55%) had their most recent TURBT surgery within 12 months of trial enrollment. No patients had missing HRQOL data at baseline or the primary end point of 3 months. The chemoablative reverse thermal gel used as a primary treatment did not cause decrements in patient-reported urinary symptoms, bloating/ flatulence, malaise, fever, general health, or future health worries. Sexual function mildly worsened between baseline and 3 months, and abated by 6 months. Demographic and clinical characteristics were not correlated with HRQOL change scores. By 3 months, 31/44 (70%) LG NMIBC patients achieved a complete response (negative endoscopic examination, cytology, and for-cause biopsy) and 0 experienced a recurrence. By 12 months, 8/44 (18%) patients had a recurrence. Conclusions: Adults with LG NMIBC in a Phase 2b trial who received a mitomycin-containing reverse thermal gel with sustained release maintained their HRQOL through 3 months. A Phase 3 trial is warranted. Clinical trial information: NCT03558503.

Men with clinically localized prostate cancer face an archetypal "preference sensitive" treatment decision. A shared decision making process incorporating patient values and preferences is paramount. We evaluated the benefit of a novel decision making application, and investigated associations between patient preferences and treatment choice.We used a novel, web based application that provides education, preference measurement and personalized decision analysis for patients with newly diagnosed prostate cancer. Preferences are measured using conjoint analysis. The application ranks treatment options according to their "fit" (expected value) based on clinical factors and personal preferences, and serves as the basis for shared decision making during the consultation. We administered the decisional conflict scale before and after completion of the application. Additionally, we compared post-visit perceptions of shared decision making between a baseline "usual care" cohort and a cohort seen after the application was integrated into clinical practice.A total of 109 men completed the application before their consultation, and had decisional conflict measured before and after use. Overall decisional conflict decreased by 37% (p0.0001). Analysis of the decisional conflict subscales revealed statistically significant improvements in all 5 domains. Patients completing the decision making application (33) felt more included in (88% vs 57%, p=0.01) and jointly responsible for (94% vs 52%, p0.0001) the decision about further treatment compared to those receiving usual care (24). More patients who completed the application strongly agreed that different treatment options were discussed (94% vs 74%, p=0.02).Implementation of this web based intervention was associated with decreased decisional conflict and enhanced elements of shared decision making.

Objective: To examine if fluid balance surrounding pediatric intensive care unit (PICU) admission in hematopoietic stem cell transplant (HSCT) patients was associated with mortality, ventilator-free days, and intensive care unit (ICU)-free days. To explore other population-specific factors associated with poor outcome. Materials and Methods: Retrospective review of HSCT patients admitted to 2 quaternary PICUs, Children’s Hospital Los Angeles and University of California San Francisco Benioff Children’s Hospital from January 2009 to December 2014. Results: Of 144 patients, 92 were identified with complete fluid balance data available. No difference in fluid balance between survivors and nonsurvivors in the 24 hours preceding PICU admission ( P = .81) or when the first 24 hours of PICU stay were taken into account ( P = .48) was identified. There was no difference in ventilator-free or ICU-free days. Comparing Pediatric Index of Mortality (PIM)-2, Pediatric Risk of Mortality (PRISM)-3, and a multivariable model using independent risk factors identified through multivariable analysis, the receiver operating characteristic plot for the multivariable model (area under the curve = 0.844 [95% confidence interval: 0.77-0.92]) was superior to both PIM-2 and PRISM-3 in discriminating mortality. Conclusions: Fluid balance immediately preceding and early in the course of admission was not associated with mortality in PICU HSCT patients. A subset of variables was identified which better discriminated mortality in this cohort than accepted PICU severity of illness scores.

Background Preventable complications and readmissions after cystectomy may be detectable via postoperative monitoring of patient-reported outcomes (PROs). However, no study has defined meaningful PROs or the use of mobile communication devices (mobile health [mHealth]) to capture them. The objectives of this study were to determine which high-priority PROs influence patients' perioperative experience, what processes influence these outcomes, how patients and caregivers differ in their experiences, and how mHealth might be used to improve outcomes. Methods Forty-five semistructured, in-depth interviews were conducted with readmitted cystectomy patients, caregivers, and providers with an interview guide that addressed perioperative education, symptoms, function, and the potential for mHealth interventions. Among 15 patients, 10 had an interviewed partner. A thematic analysis of interviews conducted with readmitted patients, caregivers, and providers was performed to examine processes that affected perioperative care and readmission and to determine how mHealth interventions might be implemented. Results Readmitted patients and caregivers ranged in age from 33 to 78 years and were diverse in race and stage. The providers included a diverse representation of physicians, nurses, and other specialists. Cystectomy preoperative education was overwhelming and lacked personalization, and this contributed to a fundamental lack of knowledge regarding normal and abnormal symptoms after surgery. Three connecting themes were identified: 1) cystectomy education overload, 2) a need to define normal symptoms, and 3) education with incremental learning through mHealth. Conclusions A personalized mHealth intervention addressing themes of education overload, the definition of normality, and incremental learning could be realized through mHealth technology and provide the right information for the right patient at the right time.

With legal frameworks changing, administrative data can increasingly be utilised both for official statistics and to facilitate new research, enabling the development of evidence-based policy for the public benefit. Secure access conditions generally apply to using these rich, highly detailed data. However, using data from various sources is difficult when they are fragmented in “silos” between several Research Data Centres (RDCs) as can happen at a national level, and is very likely to be the case at an international level. This is a major obstacle for international comparative research. Based on user consultations, on discussions with international organisations such as OECD and Eurostat and based on lessons learned from projects as, “Data without Boundaries” and the “Nordic Microdata Access Network”, IDAN aims to create a concrete operational international framework enabling access to controlled data for research. IDAN, founded in 2018, involves six RDCs from France, Germany, the Netherlands and the United Kingdom. Initially, the partners’ access systems are being implemented in each partners' premise based on bilateral agreements. This process involves combining requirements of security and surveillance for Safe Rooms, thus paving the way for next steps toward an integrated RDCs network. This presentation will describe how IDAN is setting up a new concrete environment for researchers to work remotely with data from the other partners within their local RDC. The paper will present first project developments, lessons and impact for research that are also of interest for national contexts where administrative data are held in multiple data centres.

Background Racial differences in cancer-related symptom burden are well-documented, and partly linked to inequities in symptom monitoring. Electronic patient-reported outcomes (ePROs) are useful for symptom monitoring, but have rarely been evaluated in diverse patient populations. We implemented an ePRO tool among a cohort of Black and White cancer patients and evaluated (1) whether ePRO use was perceived as feasible and valuable for symptom management; and (2) if perceptions of feasibility and value differed by race. Methods We recruited 30 Black and 50 White bladder and prostate cancer patients from a single institution. Participants completed ePRO assessments prior to, during, and 3 months following completion of cancer treatment. Participants were given the option of reporting symptoms using a web- or phone-based system. A subset of participants completed end-of-study satisfaction surveys (n=9 Black; n=25 White) and qualitative interviews (n=15 Black; n=25 White) assessing ePRO feasibility and value. We analyzed end-of-study surveys and qualitative interview data, evaluating race-specific differences in user experiences with the ePRO tool. Results Both Black (77.8%) and White (96.0%) participants more commonly reported using the web-based system for symptom reporting, with the majority of participants reporting being “very satisfied” with the web-based system (71.4% Black; 66.7% White). Whites more commonly reported high levels of ease in understanding and answering symptom assessment items compared with Blacks (44.4% Black; 56.0% White). In interviews, Blacks expressed stronger preferences for phone-based and paper-based reporting due to ease in facilitating understanding of symptom items. In terms of perceived value, Blacks more often reported that the ePRO tool was “very helpful” in reminding them of symptoms experienced in the last seven days (55.6% Black; 36.0% White). In interviews, Blacks also described how the ePRO helped them better understand symptoms, while Whites noted finding value in better understanding symptoms and the ability to track their symptoms over time. Black and White respondents commonly reported that doctors communicated with them about ePRO-reported symptoms (88.9% Black; 84.0% White), but Blacks more often reported that the ePRO tool was “very helpful” in speaking to doctors about symptoms (44.4% Black; 24.0% White). In interviews, both Black and White participants indicated that ePRO use prompted more in-depth discussions about symptoms and treatment options with providers. Conclusion Electronic symptom monitoring is perceived as valuable among Black and White cancer patients. Greater perceived value of ePROs among Blacks may have implications for addressing systemic drivers of symptom disparities. As oncology practices move towards broader implementation of ePROs, it will be important to consider the health literacy needs and ePRO modality preferences of patients, in order to promote equitable adoption of electronic symptom monitoring. Citation Format: Cleo A. Samuel, Angela Smith, Ronald Chen, Wendi Elkins, Jennifer Richmond, Zahra Mahbooba, Dana E. Mueller, Ethan Basch, Antonia V. Bennett, Arlene E. Chung, Bryce B. Reeve. Racial differences in feasibility and perceived value of electronic symptom monitoring in a cohort of Black and White bladder and prostate cancer patients [abstract]. In: Proceedings of the Twelfth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2019 Sep 20-23; San Francisco, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl_2):Abstract nr C007.

Taking into account arbitrary crack geometries, crack closure generally occurs independently of the load case. As the standard eXtended Finite Element Method (XFEM) does not prevent unphysical crack face penetration in this case, a formulation allowing for crack face contact is proposed in terms of a penalty formulation for normal contact. The discretization is developed for non-planar cracks intersecting hexahedral elements in an arbitrary manner. Typical problems of many crack face contact implementations within the XFEM, like locking or the introduction of additional degrees of freedom, are avoided by projecting the contact contribution onto the hexahedral element nodes. The method is tested by means of suitable numerical examples, finally presenting an application in form of a multiscale setup with arbitrarily arranged micro cracks in the vicinity of a macro crack front.

A 12-month-old male with a history of failure to thrive and hypothyroidism presented to a pediatric emergency department twice in a 24-hour period with complaint of hematemesis. The patient had a recent upper endoscopy and biopsy as part of a work-up for failure to thrive, but had no other pertinent positives in clinical history. Ultrasound demonstrated findings concerning for an intramural duodenal hematoma. The patient was admitted to the gastroenterology service for intravenous hydration and nasogastric decompression. He did not require any invasive management or blood products. Duodenal hematoma is a known, but very uncommon complication of upper endoscopy.

Two three-dimensional eight-node brick continuum finite elements are presented which are based on volume averaging techniques. For both elements, the point of departure is the additive split of the strain energy function into a homogeneous and an inhomogeneous part. The first element, called MEI, can be applied for robust computations of incompressibly materials. It is based on a split into a substructure consisting of eight sub-elements inside each finite element, further referred to as macro-element. For each sub-element, the deformation is averaged. The resulting sub-element response is assembled and projected onto the nodes of the macro-element. The second element, called Q1/EI9 (Q1/EI12), uses an enhancement of the inhomogeneous part of the deformation only. For the inhomogeneous part, linear elasticity is assumed, while a compressible Neo-Hooke material is used for the homogeneous part. Thus, an element which is locking and hourglassing free as well as insensitive to initial element distortion is developed. In several examples, the performance of the elements is tested.

106 Background: Men with newly diagnosed localized prostate cancer (LPC) face a complex, preference-sensitive treatment decision. Low “decisional conflict” (DC), defined as uncertainty over treatment choice, is a key component of decision quality. Lower scores on the Decisional Conflict Scale (DCS) are associated with lower likelihood of delaying a decision and assessing blame to a physician for bad outcomes. We hypothesized that using a novel software application to measure and report patients’ preferences for LPC treatment outcomes as part of a pre-consultation intervention would improve decisional quality in men with LPC by reducing DC. Methods: Men with newly diagnosed LPC completed the online WiserCare (WiserCare, Inc) prostate cancer module prior to their initial consultation at the University of North Carolina, Chapel Hill Multi-disciplinary Urologic Oncology Clinic. WiserCare is a software application that provides education, preference assessment, and personalized decision analysis for patients. Preferences are measured using conjoint analysis. WiserCare then generates an individualized report ranking treatment options based on their “fit”(expected value) based on clinical prognostic factors and personal preferences. This report is used with their physician during counseling. We measured DCS scores before and after completion of the WiserCare module. Paired 2-tailed T-tests were to evaluate the changes in DCS scores. Results: 48 men completed the WiserCare module and DCS prior to their initial consultation for newly diagnosed LPC. Overall DCS score decreased by 38% (p

Introduction: In the US, 1 in 4 heart failure (HF) patients is readmitted to the hospital within 30-days of discharge and the cost to Medicare is billions of dollars annually. This has made reducing readmissions a top priority for Medicare. In July 2012, we implemented the TransitionAdvantage (TA) service at 3 hospitals in central North Carolina. The service is designed to reduce readmissions for HF patients by: 1) assigning patients to transition liaisons (TLs) who have been trained in motivational interviewing to facilitate compliance with discharge instructions and 2) using home telemonitoring to closely follow patients’ medical condition after discharge. A focal point of the service is a technology platform that facilitates information flow during care transitions (Figure). Patients’ discharge instructions are uploaded from each hospital’s electronic medical record and stored on the platform which is used by TLs to help with medication adherence and timely follow-up with doctor visits. Post discharge, patients perform daily health checks of their weights, blood pressures and symptoms. This information is uploaded to the platform via interactive voice response (IVR), web or phone call from TLs, and used by TLs to transfer patients to the nurse phone service if patients show early signs of worsening HF. TLs also facilitate the transfer of discharge summaries to patients’ primary care doctors.Methods:We conducted an interim analysis of the impact the TA service has on 30-day readmission using matched historical controls from the 3 hospitals. We used multivariate logistic regression and adjusted the effect of the TA service for differences between the 2 study groups. We also analyzed surveys of patients and their caregivers regarding satisfaction with the service. We anticipate enrolling a total of 320 patients by study’s end (May 31, 2013). This interim analysis describes results for the first 125 patients enrolled in the TA service. Results: The average patient age was 65 years, 53% were women, and 58% were Caucasian. In multivariate analyses, patients in the TA service were 29% less likely to be readmitted within 30-days of hospital discharge (OR50.71, p50.36). It should be noted that the interim analysis was not powered to demonstrate statistical significance. Patient and caregiver satisfaction with the service was high (95% and 90%; respectively). Conclusion: An interim analysis of the TA service suggests a trend towards lower 30 day hospital readmission and high patient and caregiver satisfaction with the services provided. Final results are expected in late2013.