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    A Phase 1/2 Trial of a Combination of Paclitaxel and Trastuzumab With Daily Irradiation or Paclitaxel Alone With Daily Irradiation After Transurethral Surgery for Noncystectomy Candidates With Muscle-Invasive Bladder Cancer (Trial NRG Oncology RTOG 0524)

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    PURPOSE: Bladder preservation therapy is an effective treatment for muscle-invasive urothelial carcinoma (UC). In this study we treated noncystectomy candidates with daily radiation and weekly paclitaxel for 7 weeks. Patients whose tumors showed her2/neu overexpression were additionally treated with weekly trastuzumab. METHODS AND MATERIALS: Sixty-eight evaluable patients were treated with radiation therapy and either paclitaxel + trastuzumab (group 1) or paclitaxel alone (group 2). Groups were assigned on the basis of her2/neu immunohistochemistry results. Patients received 1.8-Gy fractions to a total dose of 64.8 Gy. The primary endpoint of the study was treatment-related toxicity, and secondary endpoints included complete response (CR) rate, protocol completion rate, and survival. RESULTS: A total of 20 evaluable patients were treated in group 1 and 46 patients in group 2. Acute treatment-related adverse events (AEs) were observed in 7 of 20 patients in group 1 (35%) and 14 of 46 patients in group 2 (30.4%). Protocol therapy was completed by 60% (group 1) and 74% (group 2) of patients. Most incompletions were due to toxicity, and the majority of AEs were gastrointestinal, including 1 grade 5 AE (group 1). Two other deaths (both in group 2) were unrelated to protocol therapy. No unexpected cardiac, hematologic, or other toxicities were observed. The CR rate at 1 year was 72% for group 1 and 68% for group 2. CONCLUSIONS: In patients with muscle-invasive UC who are not candidates for cystectomy, daily radiation combined with paclitaxel is an effective treatment strategy with a high completion rate and moderate toxicity. In patients with her2/neu-positive tumors, a group generally considered to have worse outcomes, the addition of trastuzumab appears to result in comparable efficacy and toxicity. Further biomarker-driven trials should be undertaken in advancing treatment of this challenging disease

    Elective Direct Current Cardioversion for Patients with Atrial Fibrillation: A Registry Analysis of Adverse Events and Recurrence

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    Background Synchronized direct current cardioversion (CV) is a common treatment for atrial fibrillation (AF) if primary treatment with anti-arrhythmic drugs fails. However, direct current CV, without pretreatment precautions, is associated with an increased risk of embolic stroke, presumably due to dislodgement of intracardiac thrombi. In order to prevent such complications, patients are typically treated with systemic anticoagulants for at least 3 weeks prior to cardioversion. (1) Warfarin has historically been the standard for anticoagulant treatment in AF. Warfarin reduces the risk of embolic stroke by 66% in AF patients. In addition, warfarin is relatively inexpensive and unaffected by renal function, which makes it a popular anticoagulant drug. (2) Direct oral anticoagulants (DOACs such as apixaban, dabigatran, rivaroxaban and edoxaban) are becoming more prevalent in use. DOACs directly inhibit clotting factors instead of targeting Vitamin K as warfarin does. Apixaban, rivaroxaban and edoxaban are reversible inhibitors of Factor Xa. Dabigatran is a reversible inhibitor of thrombin. DOACs are being increasingly used in place of warfarin to prevent embolic stroke in AF but there is limited data on their efficacy and safety in the setting of elective CV for AF, particularly compared to warfarin. Hypothesis Our hypothesis was that DOACs are not inferior to warfarin in preventing adverse events and recurrent AF following elective CV. To test this, we analyzed 30-day outcomes from an ongoing three-year outpatient CV registry. We sought to determine the following objectives: • The rate of adverse events within 30 days following all cardioversions on patients treated with warfarin vs. DOACs. • The rate of AF recurrence within 30 days post-cardioversion in patients on warfarin vs. DOAC

    Addressing medication adherence technology needs in an aging population

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    Full text access available through link. PervasiveHealth \u2717: Proceedings of the 11th EAI International Conference on Pervasive Computing Technologies for Healthcare Using technology to inspire behavior change motivated by a health goal is a challenge. Technologies, often rooted in sound scientific principles, sometimes do not perform as expected in real world scenarios. Quite often the barriers to use are not inherent in the behavior change model of the product or service, but are issues associated with the failure to appropriately consider the needs of the end users when designing an intervention. We deployed a large, multi-stage research study with aging adults to assess the facilitators and barriers of technologies aimed to create or support behavior changes related to medication adherence. Using the Fogg Behavior model, we analyzed the triggers made on behavior change through data from surveys, in-home interviews, participatory design workshops and the deployed technologies. Our results indicate that the user experience associated with delivery of the content is at least as important as the content. Additionally, experienced users are far better prepared to help researchers identify potential design issues than novice users. Because our participants were knowledgeable about the technologies and the features that worked and did not work, the concluding participatory design sessions were highly efficient in providing feedback on the type of mechanisms that resonate with this population and could lead to higher levels of behavior change in future technologies

    Characterization of Rapid Sequence Intubation in the Emergency Department

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    Poster Presentation 2017 ASHP Midyear Clinical Meeting / Orlando, Florida / Poster # 10-096 • Rapid sequence intubation (RSI) is a sequential process performed to facilitate safe and emergent tracheal intubation • Based on the urgency of RSI, medication errors may occur due to the need for immediate selection of medications and accurate dosing • To characterize the overall RSI process in the emergency department • Identify possible areas for education and improvement • Identify adverse events associated with RSI medication

    Providing Patients with Implantable Cardiac Device Data through a Personal Health Record: A Qualitative Study

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    oai:researchrepository.parkviewhealth.org:mirro-articles-1003Background Patients at risk for sudden cardiac death or having suffered cardiac arrest may receive an implantable cardioverter defibrillator (ICD). This device provides monitoring and therapy for life-threatening heart rhythms. Remote monitoring of ICDs has decreased the time between abnormal heart rhythm events and clinic follow-up. Currently, the data transmitted from the device are reviewed and stored by the clinic, but patients do not have access to the data. While connecting patients directly with their ICD data has potential to enhance engagement in their care and improve health outcomes, patient attitudes and perceptions about receiving ICD data have not been explored. Objective This research is the first demonstration of delivering ICD data to patients through a personal health record (PHR) using a novel technical framework. The objective of this study was to use a PHR interface as a technology probe to explore patients’ experiences with directly receiving their ICD data from remote monitoring. Methods We enrolled 21 patients with an ICD undergoing remote monitoring at a large outpatient cardiology clinic in Indiana, United States. Participants received their ICD data from remote monitoring through a PHR over 3 months. In-depth, semistruc-tured interviews were conducted at 3 months and analyzed using thematic analysis. Results Participants were 36 to 90 years old, mean age (SD) of 67 (14) years, predominately male (76%), and white (95%). Key themes were ICD questions and concerns, experiences with remote monitoring, PHR use, and feedback about the ICD data summary. The findings showed that overall, patients desired information that provides reassurance, is easy to understand, and is presented in a meaningful way. Conclusion Sharing ICD data from remote monitoring requires adequate context and scaffolding to support patient understanding. Engaging patients with information that is useful and valuable to them through a PHR may require appropriate and individua-lized tailoring of information

    Improved Outcomes Associated with the Liberal Use of Thoracic Epidural Analgesia in Patients with Rib Fractures

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    OBJECTIVE: Each year, more than 150,000 patients with rib fractures are admitted to US trauma centers; as many as 10% die. Effective pain control is critical to survival. One way to manage pain is thoracic epidural analgesia. If this treatment reduces mortality, more frequent use may be indicated. METHODS: We analyzed the patient registry of a level II trauma center. All patients admitted with one or more rib fractures (N = 1,347) were considered. Patients who were not candidates for epidural analgesia (N = 382) were eliminated. Mortality was assessed with binary logistic regressions. RESULTS: Across the total population, mortality was 6.7%; incidence of pneumonia was 11.1%; mechanical ventilation was required in 23.8% of patients, for an average duration of 10.0 days; average stay in the hospital was 7.7 nights; and 49.7% of patients were admitted to the ICU for an average of 7.2 nights. Epidural analgesia was administered to 18.4% of patients. After matching samples for candidacy, patients who received epidurals were 3.7 years older, fractured 2.6 more ribs, had higher injury severity scores, and were more likely to present with bilateral fractures, flail segments, pulmonary contusions, hemothoraces, and pneumothoraces. Despite greater injury severity, mortality among these patients was lower (0.5%) than those who received alternative care (1.9%). Controlling for age, injury severity, and use of mechanical ventilation, epidural analgesia predicted a 97% reduction in mortality. CONCLUSION: Thoracic epidural analgesia associates with reduced mortality in rib fracture patients. Better care of this population is likely to be facilitated by more frequent reliance on this treatment

    Changing Guidelines for Preoperative Fasting.

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    “I don’t know how you can be the decision maker when you don’t understand”: designing a tailored E-health intervention to empower patients living with non-valvular atrial fibrillation

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    Background: Prevention of thromboembolism is key in individuals with non-valvular atrial fibrillation (NVAF) and nonadherence to oral anticoagulant (OAC) therapy is a frequent causative factor of stroke. Many factors contribute to the complexity of medication nonadherence. Thus, education aimed at changing health behaviors must be tailored to address the unique internal motivations and information needs of those confronted with the daily choice to take a medication to prevent stroke. Delivery of tailored health education and medication reminders may be an effective way to empower individuals with NVAF and in consequence, improve OAC adherence. Methods: We applied a patient-centered approach and conducted 1) focus groups, 2) online design survey, and 3) one-on-one design sessions with NVAF patients receiving OAC therapy. Analysis was sequentially conducted for each phase and utilized in the design of a tailored algorithm for patient health messaging to be sent through a personal health record (PHR). Patients with NVAF were recruited from a large institution-based cardiology practice under IRB approval. Results: Focus group participants (N = 17) expressed a desire to have more information related to their condition and demonstrated gaps in knowledge related to NVAF and OACs. Analysis revealed significant themes for preferred content, timing, and delivery of tailored messaging. Design survey (N = 118) and design session (N = 18) findings uncovered nuanced information needs specific to OACs, lifestyle behaviors, and understanding of NVAF. Patients diagnosed with NVAF for a longer period of time (\u3e1 year) expressed greater interest in information regarding lifestyle modifications. In comparison, patients recently diagnosed with NVAF (\u3c1 year) expressed greater interest in information regarding medication side effects. Comprehensive analysis led to development of a tailored algorithm based on specific clinical indications of individuals. These include type of OAC, length of NVAF diagnosis and near real-time adherence rates measured using e-prescribing refill history and smart pill bottle data (Figure 1). Conclusion: Our study revealed that individuals living with NVAF have a desire to better understand and manage their condition, and feel that targeted health information may help them to do so. In this presentation we share the results of an iterative design process to build a tailored messaging algorithm and PHR-based intervention for patients living with NVAF and receiving OAC therapy. The next phase of our work will evaluate the effectiveness of the intervention on patient engagement and the resultant effect on medication adherence and health outcomes

    Who treats lung cancer? Results from a global survey.

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    BACKGROUND: In most Western nations, the medical oncologist plays a significant role in the administration of systemic therapy for lung cancer. In Japan however, treatment for lung cancer has historically been provided by pulmonologists and thoracic surgeons. A comparison of the management of advanced disease between Japan and other nations has not been described. METHODS: An online, self-administered, international survey was sent to 3907 active members of the American Society of Clinical Oncology. Eligible participants were degreed physicians who prescribed systemic agents for adult cancer treatment within the past five years. RESULTS: In total, 281 respondents answered the questions regarding management of lung cancer. Thorough analysis demonstrated that pulmonologists play a significant role in Japan and the Netherlands, where the role of oncologic specialists is not well established. Of note, all the respondents from the Netherlands reported that pulmonary medicine primarily manages systemic chemotherapy in stage IV, adjuvant chemotherapy, and targeted therapy. CONCLUSION: We found there are several nations where non-oncologic specialists play a critical role in the systemic treatment of lung cancer. We expect this practice pattern to continue until the global adoption of the oncologic specialty role

    “Do you dare to compare?” Associations between maternal social comparisons on social networking sites and parenting, mental health, and romantic relationship outcomes.

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    Social comparisons on social networking sites can be problematic for some individuals. However, this has never been examined in a parenting context, where the pressure for mothers to portray themselves as “perfect parents” may be high. The aim of the current study was to examine associations between making social comparisons on social networking sites with mothers’ parenting, mental health, and romantic relationship outcomes. In the iMom Project, 721 mothers completed a number of questionnaires regarding their social media use, parenting behaviors, and health outcomes. Results revealed that making social comparisons on social networking sites was related to parenting outcomes (in the form of higher levels of parental role overload, and lower levels of parental competence and perceived social support), relationship outcomes (in the form of more conflict over social networking sites and perceiving less positive coparenting relationships) and higher levels of maternal depression. This study adds to a growing literature suggesting that making social comparisons online may be associated with a number of negative outcomes, and extends it to the context of mothering. This study has implications for the way that mothers use social media, specifically in the use of social comparisons

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