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Objective: Use of point-of-care (POC) troponin (cTn) testing in the Emergency Department (ED) is well established. However, data examining POC cTn measurement in the prehospital setting, during ambulance transport, are limited. The objective of this study was to prospectively test the performance of POC cTn measurement by paramedics to detect myocardial infarction (MI) among patients transported to the ED for acute chest pain. Methods: A prospective cohort study of adults with non-traumatic chest pain was conducted in three Emergency Medical Services agencies (December 2016 to January 2018). Patients with ST-elevation MI on ECG were excluded. During ambulance transport paramedics initiated intravenous access, collected blood, and used a POC device (i-STAT; Abbott Laboratories) to measure cTn. Following ED arrival, participants received standard evaluations including clinical blood draws for cTn measurement in the hospital central lab (AccuTnI +3 assay; Beckman Coulter, or cTnI-Ultra assay; Siemens). Blood collected during ambulance transport was also analyzed for cTn in the central lab. Index visit MI was adjudicated by 3 experts using central lab cTn measures from the patient's clinical blood draws. Test characteristics (sensitivity, specificity, and predictive values) for detection of MI were calculated for POC and central lab cTn measurement of prehospital blood and compared with McNemar's test. Results: During the study period prehospital POC cTn results were obtained on 421 patients, of which 5.0% (21/421) had results >99th percentile upper reference limit. MI was adjudicated in 16.2% (68/421) during the index visit. The specificity and positive predictive value of the POC cTn measurement were 99.2% (95% CI 97.5-99.8%) and 85.7% (95% CI 63.7-97.0%) for MI. However, the sensitivity and NPV of prehospital POC cTn were 26.5% (95% CI 16.5-38.6%) and 87.5% (95% CI 83.9-90.6%). Compared to POC cTn, the central lab cTn measurement of prehospital blood resulted in a higher sensitivity of 67.9% (95% CI 53.7-80.1%, p  < 0.0001), but lower specificity of 92.4% (95% CI 88.4-95.4%, p  = 0.0001). Conclusions: Prehospital POC i-STAT cTn measurement in patients transported with acute chest pain was highly specific for MI but had low sensitivity. This suggests that prehospital i-STAT POC cTn could be useful to rule-in MI, but should not be used to exclude MI.

Study Objective: We determine whether implementation of the HEART (History, ECG, Age, Risk Factors, Troponin) Pathway is safe and effective in emergency department (ED) patients with possible acute coronary syndrome through 1 year of follow-up., Methods: A preplanned analysis of 1-year follow-up data from a prospective pre-post study of 8,474 adult ED patients with possible acute coronary syndrome from 3 US sites was conducted. Patients included were aged 21 years or older, evaluated for possible acute coronary syndrome, and without ST-segment elevation myocardial infarction. Accrual occurred for 12 months before and after HEART Pathway implementation, from November 2013 to January 2016. The HEART Pathway was integrated into the electronic health record at each site as an interactive clinical decision support tool. After integration, ED providers prospectively used the HEART Pathway to identify patients with possible acute coronary syndrome as low risk (appropriate for early discharge without stress testing or angiography) or nonlow risk (appropriate for further inhospital evaluation). Safety (all-cause death and myocardial infarction) and effectiveness (hospitalization) at 1 year were determined from health records, insurance claims, and death index data., Results: Preimplementation and postimplementation cohorts included 3,713 and 4,761 patients, respectively. The HEART Pathway identified 30.7% of patients as low risk; 97.5% of them were free of death and myocardial infarction within 1 year. Hospitalization at 1 year was reduced by 7.0% in the postimplementation versus preimplementation cohort (62.1% versus 69.1%; adjusted odds ratio 0.70; 95% confidence interval 0.63 to 0.78). Rates of death or myocardial infarction at 1 year were similar (11.6% versus 12.4%; adjusted odds ratio 1.00; 95% confidence interval 0.87 to 1.16)., Conclusion: HEART Pathway implementation was associated with decreased hospitalizations and low adverse event rates among low-risk patients at 1-year follow-up., (Copyright © 2020 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.)

Clinical Trial Registration: clinicaltrials.gov (NCT02709135)., Competing Interests: Abbott Point of Care provided a research grant to support the work presented in this manuscript. Dr. Stopyra received research funding from Abbott Point of Care and Roche Diagnostics. Dr. Mahler receives additional research funding from Roche Diagnostics, Ortho Clinical Diagnostics, Siemens, Creavo Medical Technologies, the Donaghue Foundation, AHRQ, PCORI, and NHLBI (1 R01 HL118263-01, L30 HL120008). Dr. Mahler also serves as the chief medical officer of Impathiq, Inc. Dr. Miller also receives research funding / support from Siemens, Abbott Point of Care, and 1 R01 HL118263 These commercial affiliations do not alter our adherence to PLOS ONE policies on sharing data and materials.

Background: Colorectal cancer is the second leading cause of cancer-related death in the United States, in part, because one third of Americans fail to get screened. In a prior randomized controlled trial, we found that an iPad patient decision aid called Mobile Patient Technology for Health-CRC (mPATH-CRC) doubled the proportion of patients who completed colorectal cancer screening., Methods: All data for the current analysis were collected as part of a randomized controlled trial to determine the impact of mPATH-CRC on receipt of colorectal cancer screening within 24 weeks. Participants were enrolled from six community-based primary care practices between June 2014 and May 2016 and randomized to either usual care or mPATH-CRC. Six potential mediators of the intervention effect on screening were considered. The Iacobucci method was used to assess the significance of the mediation., Results: A total of 408 patients had complete data for all potential mediators. Overall, the potential mediators accounted for approximately three fourths (76.3%) of the effect of the program on screening completion. Perceived benefits, self-efficacy, ability to state a screening decision, and patient-provider discussion were statistically significant mediators. Patient-provider discussion accounted for the largest proportion of the effect of mPATH-CRC (70.7%)., Conclusions: mPATH-CRC increased completion of colorectal cancer screening by affecting patient-level and system-level mediators. However, the most powerful mediator was the occurrence of a patient-provider discussion about screening. Digital interventions like mPATH-CRC are an important adjunct to the patient-provider encounter., Impact: Understanding the factors that mediated mPATH-CRC's success is paramount to developing other effective interventions., (©2020 American Association for Cancer Research.)

Background: The History Electrocardiogram Age Risk factor Troponin (HEART) Pathway and Emergency Department Assessment of Chest pain Score (EDACS) are validated accelerated diagnostic pathways designed to risk stratify patients presenting to the emergency department with chest pain. Data from large multisite prospective studies comparing these accelerated diagnostic pathways are limited., Methods: The HEART Pathway Implementation is a prospective three-site cohort study, which accrued adults with symptoms concerning for acute coronary syndrome. Physicians completed electronic health record HEART Pathway and EDACS risk assessments on participants. Major adverse cardiac events (death, myocardial infarction and coronary revascularisation) at 30 days were determined using electronic health record, insurance claims and death index data. Test characteristics for detection of major adverse cardiac events were calculated for both accelerated diagnostic pathways and McNemar's tests were used for comparisons., Results: 5799 patients presenting to the emergency department were accrued, of which HEART Pathway and EDACS assessments were completed on 4399. Major adverse cardiac events at 30 days occurred in 449/4399 (10.2%). The HEART Pathway identified 38.4% (95% CI 37.0% to 39.9%) of patients as low-risk compared with 58.1% (95% CI 56.6% to 59.6%) identified as low-risk by EDACS (p<0.001). Major adverse cardiac events occurred in 0.4% (95% CI 0.2% to 0.9%) of patients classified as low-risk by the HEART Pathway compared with 1.0% (95% CI 0.7% to 1.5%) of patients identified as low-risk by EDACS (p<0.001). Thus, the HEART Pathway had a negative predictive value of 99.6% (95% CI 99.1% to 99.8%) for major adverse cardiac events compared with a negative predictive value of 99.0% (95% CI 98.5% to 99.3%) for EDACS., Conclusions: EDACS identifies a larger proportion of patients as low-risk than the HEART Pathway, but has a higher missed major adverse cardiac events rate at 30 days. Physicians will need to consider their risk tolerance when deciding whether to adopt the HEART Pathway or EDACS accelerated diagnostic pathway., Trial Registration Number: NCT02056964., Competing Interests: Competing interests: SM also receives research funding/support from Abbott Point of Care, Roche Diagnostics, Siemens, PCORI and NHLBI (1 R01 HL118263-01, L30 HL120008). SM is the Chief Medical Officer for Impathiq Inc. JS receives research funding/support from Abbott Point of Care, Roche Diagnostics and and NHLBI (1 R01 HL118263-01). CM receives research funding/support from Siemens, Abbott Point of Care and 1 R01 HL118263. ACS receives research funding from NHLBI (1 R01 HL118263-01)., (© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.)

Study Objective: Out-of-hospital naloxone has been championed as a lifesaving solution during the opioid epidemic. However, the long-term outcomes of out-of-hospital naloxone recipients are unknown. The objectives of this study are to describe the 1-year mortality of presumed opioid overdose victims identified by receiving out-of-hospital naloxone and to determine which patient factors are associated with subsequent mortality., Methods: This was a regional retrospective cohort study of out-of-hospital records from 7 North Carolina counties from January 1, 2015 to February 28, 2017. Patients who received out-of-hospital naloxone were included. Out-of-hospital providers subjectively assessed patients for improvement after administering naloxone. Naloxone recipients were cross-referenced with the North Carolina death index to examine mortality at days 0, 1, 30, and 365. Naloxone recipient mortality was compared with the age-adjusted, at-large population's mortality rate in 2017. Generalized estimating equations and Cox proportional hazards models were used to assess for mortality-associated factors., Results: Of 3,085 out-of-hospital naloxone encounters, 72.7% of patients (n=2,244) improved, whereas 27.3% (n=841) had no improvement with naloxone. At day 365, 12.0% (n=269) of the improved subgroup, 22.6% (n=190) of the no improvement subgroup, and 14.9% (n=459) of the whole population were dead. Naloxone recipients who improved were 13.2 times (95% confidence interval 13.0 to 13.3) more likely to be dead at 1 year than a member of the general populace after age adjusting of the at-large population to match this study population. Older age and being black were associated with 1-year mortality, whereas sex and multiple overdoses were not., Conclusion: Opioid overdose identified by receiving out-of-hospital naloxone with clinical improvement carries a 13-fold increase in mortality compared to the general population. This suggests that this is a high-risk population that deserves attention from public health officials, policymakers, and health care providers in regard to the development of long-term solutions., (Copyright © 2019 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.)

Introduction: Knowing patients' smoking history helps guide who may benefit from preventive services such as lung cancer screening. The accuracy of smoking history electronic health records remains unclear., Methods: This was a secondary analysis of data collected from a portal-based lung cancer screening decision aid. Participants of an academically affiliated health system, aged 55-76 years, completed an online survey that collected a detailed smoking history including years of smoking, years since quitting, and smoking intensity. Eligibility for lung cancer screening was defined using the Centers for Medicare and Medicaid Services criteria. Data analysis was performed May-December 2018, and data collection occurred between November 2016 and February 2017., Results: A total of 336 participants completed the survey and were included in the analysis. Of 175 participants with self-reported smoking intensity, 72% had packs per day and 62% had pack-years recorded in the electronic health record. When present, smoking history in the electronic health records correlated well with self-reported years of smoking (r =0.78, p≤0.0001) and years since quitting (r =0.94, p≤0.0001). Self-reported smoking intensity, including pack-years (r =0.62, p<0.0001) and packs per day (r =0.65, p≤0.0001), was less correlated. Of those participants eligible for lung cancer screening by self-report, only 35% met criteria for screening by electronic health records data alone. Others were either incorrectly classified as ineligible (23%) or had incomplete data (41%)., Conclusions: The electronic health records frequently misses critical elements of a smoking history, and when present, it often underestimates smoking intensity, which may impact who receives lung cancer screening., (Copyright © 2019 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.)

Background: To report our experience utilizing a multidisciplinary clinic (MDC) at Indiana University (IU) since the publication of the International Germ Cell Cancer Collaborative Group (IGCCCG), and to compare our overall survival (OS) to that of the National Cancer Institute (NCI) Surveillance, Epidemiology, and End Results (SEER) Program., Patients and Methods: We conducted a retrospective analysis of all patients with metastatic germ-cell tumor (GCT) seen at IU from 1998 to 2014. A total of 1611 consecutive patients were identified, of whom 704 patients received an initial evaluation by our MDC (including medical oncology, pathology, urology and thoracic surgery) and started first-line chemotherapy at IU. These 704 patients were eligible for analysis. All patients in this cohort were treated with cisplatin-etoposide-based combination chemotherapy. We compared the progression-free survival (PFS) and OS of patients treated at IU with that of the published IGCCCG cohort. OS of the IU testis cancer primary cohort (n = 622) was further compared with the SEER data of 1283 patients labeled with 'distant' disease. The Kaplan-Meier method was used to estimate PFS and OS., Results: With a median follow-up of 4.4 years, patients with good, intermediate, and poor risk disease by IGCCCG criteria treated at IU had 5-year PFS of 90%, 84%, and 54% and 5-year OS of 97%, 92%, and 73%, respectively. The 5-year PFS for all patients in the IU cohort was 79% [95% confidence interval (CI) 76% to 82%]. The 5-year OS for the IU cohort was 90% (95% CI 87% to 92%). IU testis cohort had 5-year OS 94% (95% CI 91% to 96%) versus 75% (95% CI 73% to 78%) for the SEER 'distant' cohort between 2000 and 2014, P-value <0.0001., Conclusion: The MDC approach to GCT at high-volume cancer center associated with improved OS outcomes in this contemporary dataset. OS is significantly higher in the IU cohort compared with the IGCCCG and SEER 'distant' cohort., (© The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

There is evidence that systems-based factors influence surgical outcomes of intraoperative and postoperative morbidity. The goal of this study was to provide an exploratory analysis of systems-based variables and their associations with surgical outcomes in gynecologic oncology patients. We merged electronic records from operating room software with billing claims from major surgeries performed from 2011 to 2013, at a tertiary care academic medical center. Univariate and bivariate analyses were performed to evaluate the relationship between baseline demographic and clinical covariates (age, comorbidity, procedure type, and surgeon volume), the main exposure variables (case start time, case order, and personnel handoffs), and the primary outcome of 30-day postoperative complications. Multiple logistic regression models were created to analyze the contributing effect of each systemic variable on postoperative complications. The overall rate of postoperative complications among patients was 31.4% (n = 182). Although traditional risk factors of comorbidity, procedure type, and case length were the strongest primary drivers of complication risk, there was a significant relationship between handoffs among surgical scrub technicians and postoperative complications (odds ratio: 2.12; 95% CI: 1.00-4.47). As a novel finding in surgical quality and safety research, this supports greater efforts into integrating key staffing information into studies of systemic variables and surgical outcomes.

Objectives: To evaluate progression-free survival (PFS) and overall survival (OS) outcomes in women diagnosed with uterine papillary serous carcinoma (UPSC) who have had (UPSCBR+) or have not had (UPSCBR-) an antecedent history of breast cancer and to correlate their outcomes to prior tamoxifen exposure., Methods: Data were collected for women diagnosed with UPSC at two academic institutions between January 1997 and July 2012. Patient demographics, tumor histology, stage, and treatments were recorded. Patients were divided into two groups: those with and without a personal history of breast cancer. Within the UPSCBR+ cohort, we identified those with a history of tamoxifen use. Cox regression modeling was used to explore associations between selected covariates of interest and the time-to-event outcomes of PFS and OS., Results: Of 323 patients with UPSC, 46 (14%) were UPSCBR+. Of these, 15 (33%) had a history of tamoxifen use. UPSCBR+ patients were older than UPSCBR- (median years, 72 vs. 68, p=0.004). UPSCBR+ women showed no significant difference in PFS or OS compared to UPSCBR- (p=0.64 and p=0.73 respectively), even after controlling for age (p=0.15 and p=0.48 respectively). Within the UPSCBR+ cohort, there was no difference in PFS or OS with or without tamoxifen exposure (p=0.98 and p=0.94 respectively)., Conclusions: There was no difference in PFS or OS between the UPSCBR+ and UPSCBR- cohorts. We did not demonstrate significant OS or PFS differences in women who took tamoxifen prior to their endometrial cancer diagnosis. These findings have implications for counseling, and should be encouraging to women who are facing their second cancer diagnosis., (Copyright © 2017 Elsevier Inc. All rights reserved.)

Background: There are currently no assessments of the impact of surgical complications on health-related quality of life in gynecology and gynecologic oncology. This is despite complications being a central focus of surgical outcome measurement, and an increasing awareness of the need for patient-reported data when measuring surgical quality., Objective: We sought to measure the impact of surgical complications on health-related quality of life at 1 month postoperatively, in women undergoing gynecologic and gynecologic oncology procedures., Study Design: This is a prospective cohort study of women undergoing surgery by gynecologic oncologists at a tertiary care academic center from October 2013 through October 2014. Patients were enrolled preoperatively and interviewed at baseline and 1, 3, and 6 months postoperatively. Health-related quality of life measures included validated general and disease-specific instruments, measuring multiple aspects of health-related quality of life, including anxiety and depression. The medical record was abstracted for clinical data and surgical complications were graded using validated Clavien-Dindo criteria, and women grouped into those with and without postoperative complications. Bivariate statistics, analysis of covariance, responder analysis, and multivariate modeling was used to analyze the relationship of postoperative complications to change health-related quality of life from baseline to 1 month. Plots of mean scores and change over time were constructed., Results: Of 281 women enrolled, response rates were 80% (n = 231/281) at baseline, and from that cohort, 81% (n = 187/231), 74% (n = 170/231), and 75% (n = 174/231) at 1, 3, and 6 months, respectively. The primary analytic cohort comprised 185 women with completed baseline and 1-month interviews, and abstracted clinical data. Uterine (n = 84, 45%), ovarian (n = 23, 12%), cervical (n = 17, 9%), vulvar (n = 3, 2%), and other (n = 4, 2%) cancers were represented, along with 53 (30%) cases of benign disease. There were 42 (24%) racial/ethnic minority women. Minimally invasive (n = 115, 63%) and laparotomy (n = 60, 32%) procedures were performed. Postoperative complications occurred in 47 (26%) of patients who experienced grade 1 (n = 12), grade 2 (n = 29), and grade 3 (n = 6) complications. At 1 month, physical (20.6 vs 22.5, P = .04) and functional (15.4 vs 18.3, P = .02) well-being, global physical health (43.1 vs 46.3, P = .02), and work ability (3 vs 7.2, P = .001) were lower in postoperative complication vs non-postoperative complication women. Relative change, however, in most health-related quality of life domains from baseline to 1 month did not differ between postoperative complication and nonpostoperative complication groups. Postoperative complication patients did have increased odds of sustained or worsened anxiety at 1 month vs baseline (odds ratio, 2.5; 95% confidence interval, 1.2-5.0) compared to nonpostoperative complication patients., Conclusion: Collectively, women who experienced postoperative complications after gynecologic and gynecologic oncology procedures did not appear to have differences in most health-related quality of life trends over time compared to those who did not. An exception was anxiety, where postoperative complications were associated with sustained or worsened levels of high anxiety after surgery., (Copyright © 2016 Elsevier Inc. All rights reserved.)

The expression of markers of cellular senescence increases exponentially in multiple tissues with aging. Age-related physiological changes may contribute to adverse outcomes in cancer survivors. To investigate the impact of high dose chemotherapy and stem cell transplantation on senescence markers in vivo, we collected blood and clinical data from a cohort of 63 patients undergoing hematopoietic cell transplantation. The expression of p16 INK4a , a well-established senescence marker, was determined in T-cells before and 6months after transplant. RNA sequencing was performed on paired samples from 8 patients pre- and post-cancer therapy. In patients undergoing allogeneic transplant, higher pre-transplant p16 INK4a expression was associated with a greater number of prior cycles of chemotherapy received (p=0.003), prior autologous transplantation (p=0.01) and prior exposure to alkylating agents (p=0.01). Transplantation was associated with a marked increase in p16 INK4a expression 6months following transplantation. Patients receiving autologous transplant experienced a larger increase in p16 INK4a expression (3.1-fold increase, p=0.002) than allogeneic transplant recipients (1.9-fold increase, p=0.0004). RNA sequencing of T-cells pre- and post- autologous transplant or cytotoxic chemotherapy demonstrated increased expression of transcripts associated with cellular senescence and physiological aging. Cytotoxic chemotherapy, especially alkylating agents, and stem cell transplantation strongly accelerate expression of a biomarker of molecular aging in T-cells., (Copyright © 2016 The Authors. Published by Elsevier B.V. All rights reserved.)

Objective: To examine associations between non-modifiable patient factors and patient satisfaction (PS) among women presenting to a gynecologic oncology clinic., Methods: This is a cross sectional analysis of patients presenting for surgical management by a gynecologic oncologist at a tertiary care academic medical center. The Patient Satisfaction Questionnaire (PSQ-18) that measures PS in seven domains of health care was administered. Scores were converted to "satisfied" versus "unsatisfied/equivocal". Demographic and medical factors were obtained from the medical record. Chi-square, t-tests, and multivariable logistic regression were used., Results: 208 patients completed the baseline patient satisfaction questionnaire and the median PSQ-18 score was 70.5 (range: 42-90). Median age was 58years (range: 22-93). Several non-modifiable factors were associated with PS. White patients had higher interpersonal PS than minorities (86% v 65%, p=0.002). The uninsured had lower interpersonal (60% v 86%, p=0.003) and accessibility PS (33% v 67%, p=0.03). Increasing education and less time travelled to care were both associated with higher interpersonal (p=0.03, p=0.05) and accessibility PS (p=0.01, p=0.01). There was no association between clinical factors (BMI, comorbidities, cancer) and PS. In multivariable analysis, the strongest predictor of interpersonal PS was white race while the strongest predictors of accessibility PS were time travelled to care and insurance status., Conclusions: Patient satisfaction scores among patients presenting to a gynecologic oncology clinic are associated with non-modifiable demographic, financial and geographic factors. Pay for performance measures that use summed patient satisfaction scores may penalize hospitals for patient-mix driven differences., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Objective: To report the changes in patient-reported quality of life for women undergoing gynecologic oncology surgeries., Methods: In a prospective cohort study from 10/2013-10/2014, women were enrolled pre-operatively and completed comprehensive interviews at baseline, 1, 3, and 6months post-operatively. Measures included the disease-specific Functional Assessment of Cancer Therapy-General (FACT-GP), general Patient Reported Outcome Measure Information System (PROMIS) global health and validated measures of anxiety and depression. Bivariate statistics were used to analyze demographic groups and changes in mean scores over time., Results: Of 231 patients completing baseline interviews, 185 (80%) completed 1-month, 170 (74%) 3-month, and 174 (75%) 6-month interviews. Minimally invasive (n=115, 63%) and laparotomy (n=60, 32%) procedures were performed. Functional wellbeing (20 → 17.6, p<0.0001) decreased at 1-month, and recovered by 3 and 6months. Emotional wellbeing increased (16.3 → 20.1, p<0.0001) and anxiety decreased (54.2 → 49.0, p<0.0001) at 1-month, and were stable at 3 and 6months. Physical wellbeing scales were not sensitive to surgery. These patterns were consistent across procedure type, cancer diagnosis, and adjuvant therapy administration. In an exploratory analysis of the interaction of QOL and quality, patients with increased postoperative healthcare resource use were noted to have higher baseline levels of anxiety., Conclusions: For women undergoing gynecologic oncology procedures, temporary declines in functional wellbeing are balanced by improvements in emotional wellbeing and decreased anxiety symptoms after surgery. Not all commonly used QOL surveys are sensitive to changes during the perioperative period and may not be suitable for use in surgical quality metrics., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Purpose: Accurate assessment of toxicity allows for timely delivery of supportive measures during radiation therapy for head and neck cancer. The current paradigm requires weekly evaluation of patients by a provider. The purpose of this study is to evaluate the feasibility of monitoring patient reported symptoms via mobile devices., Methods and Materials: We developed a mobile application for patients to report symptoms in 5 domains using validated questions. Patients were asked to report symptoms using a mobile device once daily during treatment or more often as needed. Clinicians reviewed patient-reported symptoms during weekly symptom management visits and patients completed surveys regarding perceptions of the utility of the mobile application. The primary outcome measure was patient compliance with mobile device reporting. Compliance is defined as number of days with a symptom report divided by number of days on study., Results: There were 921 symptom reports collected from 22 patients during treatment. Median reporting compliance was 71% (interquartile range, 45%-80%). Median number of reports submitted per patient was 34 (interquartile range, 21-53). Median number of reports submitted by patients per week was similar throughout radiation therapy and there was significant reporting during nonclinic hours. Patients reported high satisfaction with the use of mobile devices to report symptoms., Conclusions: A substantial percentage of patients used mobile devices to continuously report symptoms throughout a course of radiation therapy for head and neck cancer. Future studies should evaluate the impact of mobile device symptom reporting on improving patient outcomes.

Significant morbidity and mortality have historically been reported for surgical resection of gastric and gastroesophageal junction tumors. We evaluated our experience to determine morbidity and mortality and evaluated demographic and pathologic risk factors associated with postoperative outcome and long-term survival. A retrospective, Institutional Review Board-approved, single-institution database identified 102 patients who underwent resection with curative intent for gastroesophageal junction or gastric carcinoma from 2004 to 2012. The method of Kaplan and Meier was used to describe overall survival and estimate median survival. Of 102 patients, 74 were male and 28 were female. Of these, 24 patients were > 70 years of age at surgery (median = 62.9). Forty esophagectomies, 25 total gastrectomies, and 37 subtotal gastrectomies were performed. Two patients died (one esophagectomy and one gastrectomy). Forty-one developed a complication: 17 minor and 35 major, including six anastomotic leaks. Patients with low preoperative albumin (P = 0.01) and increased age (P = 0.05) were associated with having a postoperative complication; extent of nodal dissection (P = 0.48), jejunostomy (0.24), performance status (P = 0.77), type of surgery (P = 0.74), and neoadjuvant therapy (P = 0.24) were not associated. More extensive nodal dissection was associated with a decreased risk of death (P = 0.007). Having any complication (P = 0.20), an anastomotic leak (P = 0.17), worse grade of complication (P = 0.15), presence of feeding jejunostomy tube (P = 0.17), and neoadjuvant therapy (P = 0.30) were not associated with changes in overall survival. Thorough lymph node dissection improves survival without increasing postoperative morbidity. The data advocate for increased lymph node yield and close attention to nutritional support in gastroesophageal carcinoma patients.

Aims: A prospectively enrolled patient cohort was used to assess whether the prediction of CYP2D6 phenotype activity from genotype data could be improved by reclassification of diplotypes or alleles., Methods: Three hundred and fifty-five patients receiving tamoxifen 20 mg were genotyped for CYP2D6 and tamoxifen metabolite concentrations were measured. The endoxifen : N-desmethly-tamoxifen metabolic ratio, as a surrogate of CYP2D6 activity, was compared across four diplotypes (EM/IM, EM/PM, IM/IM, IM/PM) that are typically collapsed into an intermediate metabolizer (IM) phenotype. The relative metabolic activity of each allele type (UM, EM, IM, and PM) and each EM and IM allele was estimated for comparison with the activity scores typically assigned, 2, 1, 0.5 and 0, respectively., Results: Each of the four IM diplotypes have distinct CYP2D6 activity from each other and from the EM and PM phenotype groups (each P < 0.05). Setting the activity of an EM allele at 1.0, the relative activities of a UM, IM and PM allele were 0.85, 0.67 and 0.52, respectively. The activity of the EM alleles were statistically different (P < 0.0001), with the CYP2D6*2 allele (scaled activity = 0.63) closer in activity to an IM than an EM allele. The activity of the IM alleles were also statistically different (P = 0.014)., Conclusion: The current systems for translating CYP2D6 genotype into phenotype are not optimally calibrated, particularly in regards to IM diplotypes and the *2 allele. Additional research is needed to improve the prediction of CYP2D6 activity from genetic data for individualized dosing of CYP2D6 dependent drugs., (© 2015 The British Pharmacological Society.)

Background: The objective of the current study was to evaluate the effect of obesity on pretreatment quality of life (QoL) in gynecologic oncology patients., Methods: The authors analyzed collected data from an institution-wide cohort study of women with gynecologic cancers enrolled from August 2012 to June 2013. The Functional Assessment of Cancer Therapy-General, site-specific symptom scales, and the National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS) global mental and physical health tools were administered. Survey results were linked to clinical data abstracted from medical records (demographics and comorbid conditions). Bivariate tests and multivariate linear regression models were used to evaluate factors associated with QoL scores., Results: A total of 182 women with ovarian, uterine, cervical, and vulvar/vaginal cancers were identified; of these, 152 (84%) were assessed before surgery. Mean body mass index was 33.5 kg/m(2) and race included white (120 patients [79%]), black (22 patients [15%]), and other (10 patients [6.5%]). A total of 98 patients (64.5%) were obese (body mass index ≥30). On multivariate analysis, subscales for functional (17 vs 19; P = .04), emotional (16 vs 19; P = .008), and social (22 vs 24; P = .02) well-being as well as overall Functional Assessment of Cancer Therapy-General scores (77 vs 86; P = .002) and Patient-Reported Outcomes Measurement Information System global physical health scores (45 vs 49; P = .003) were found to be significantly lower in obese versus nonobese patients., Conclusions: Before cancer treatment, obese patients with gynecologic malignancies appear to have worse baseline QoL than their normal-weight counterparts. Emerging models of QoL-based cancer outcome measures may disproportionately affect populations with a high obesity burden. The potential disparate impact of cancer therapy on longitudinal QoL in the obese versus nonobese patients needs to be evaluated., (© 2014 American Cancer Society.)

Objective: Previous studies estimated the incidence of catheter-associated venous thrombosis to be between 2% and 81%. Our goals were to define the incidence rate of catheter-related thrombosis in a hospitalized, noncritically ill, pediatric population and to determine modifiable factors that alter the risk of thrombosis., Methods: A retrospective cohort study was performed at the North Carolina Children's Hospital from 2009 to 2012. Chart review was performed with extraction of patient characteristics and line-related variables. Presence of symptomatic catheter-associated venous thrombosis was the primary outcome. Bivariable analysis and multivariable logistic regression were used to explore associations between line-related variables and thrombosis., Results: A total of 1135 lines were placed in 815 patients for 118,023 catheter-days. Thirty-six were complicated by venous thrombosis (3.2%) yielding a rate of 0.3 events per 1000 catheter-days. In multivariable analysis, increasing age (odds ratio [OR] 1.08, 95% confidence interval [CI] 1.03-1.13; P=.002), renal dialysis (OR 3.2, 95% CI 1.09-9.66; P=.035), and a diagnosis of inflammatory bowel disease or short bowel syndrome (OR 4.3, 95% CI 1.2-15.0; P=.02) were associated with increased risk of thrombosis. Modifiable risk factors, such as line site, size, and lumens, were not significantly associated with thrombosis. No thromboembolic events were observed., Conclusions: We observed a lower incidence rate of catheter-associated venous thrombosis than in most previous reports. No modifiable characteristics altered the risk of thrombosis. Additional investigation of measures to prevent thrombosis is warranted in higher-risk populations, such as patients undergoing dialysis or patients with inflammatory bowel disease., (Copyright © 2015 by the American Academy of Pediatrics.)

Multiple outcomes are often collected in applications where the quantity of interest cannot be measured directly or is difficult or expensive to measure. In a head and neck cancer study conducted at Dana-Farber Cancer Institute, the investigators wanted to determine the effect of clinical and treatment factors on unobservable dysphagia through collected multiple outcomes of mixed types. Latent variable models are commonly adopted in this setting. These models stipulate that multiple collected outcomes are conditionally independent given the latent factor. Mixed types of outcomes (e.g., continuous vs. ordinal) and censored outcomes present statistical challenges, however, as a natural analog of the multivariate normal distribution does not exist for mixed data. Recently, Lin et al. proposed a semiparametric latent variable transformation model for mixed outcome data; however, it may not readily accommodate event time outcomes where censoring is present. In this paper, we extend the work of Lin et al. by proposing both semiparametric and parametric latent variable models that allow for the estimation of the latent factor in the presence of measurable outcomes of mixed types, including censored outcomes. Both approaches allow for a direct estimate of the treatment (or other covariate) effect on the unobserved latent variable, greatly enhancing the interpretability of the models. The semiparametric approach has the added advantage of allowing the relationship between the measurable outcomes and latent variables to be unspecified, rendering more robust inference. The parametric and semiparametric models can also be used together, providing a comprehensive modeling strategy for complicated latent variable problems., (Copyright © 2014 John Wiley & Sons, Ltd.)

Background: Cisplatin is a widely used antineoplastic. One of the major complications of cisplatin use is dose-limiting nephrotoxicity. There are many strategies to prevent this toxicity, including the use of mannitol as a nephroprotectant in combination with hydration., Objective: We aimed to evaluate the rates of cisplatin-induced nephrotoxicity in cancer patients receiving single-agent cisplatin with and without mannitol., Methods: This single-center retrospective analysis was a quasi experiment created by the national mannitol shortage. Data were collected on adult cancer patients receiving single-agent cisplatin as an outpatient from January 2011 to September 2012. The primary outcome was acute kidney injury (AKI)., Results: We evaluated 143 patients who received single-agent cisplatin; 97.2% of patients had head and neck cancer as their primary malignancy. Patients who did not receive mannitol were more likely to develop nephrotoxicity: odds ratio [OR] = 2.646 (95% CI = 1.008, 6.944; P = 0.048). Patients who received the 100 mg/m 2 dosing and patients who had a history of hypertension also had a higher likelihood of developing nephrotoxicity: OR = 11.494 (95% CI = 4.149, 32.258; P < 0.0001) and OR = 3.219 (95% CI = 1.228, 8.439; P = 0.017), respectively., Conclusions: When limited quantities of mannitol are available, it should preferentially be given to patients at particularly high risk of nephrotoxicity. Our analysis suggests that those patients receiving the dosing schedule of 100 mg/m 2 cisplatin every 3 weeks and those with hypertension are at the greatest risk of nephrotoxicity and would benefit from the addition of mannitol., (© The Author(s) 2014.)

Objective: Quality of life (QoL) for women with gynecologic malignancies is predictive of chemotherapy related toxicity and overall survival but has not been studied in relation to surgical outcomes and hospital readmissions. Our goal was to evaluate the association between baseline, pre-operative QoL measures and 30-day post-operative morbidity and health resource utilization by gynecologic oncology patients., Methods: We analyzed prospectively collected survey data from an institution-wide cohort study. Patients were enrolled from 8/2012 to 6/2013 and medical record data was abstracted (demographics, comorbid conditions, and operative outcomes). Responses from several validated health-related QoL instruments were collected. Bivariate tests and multivariable linear and logistic regression models were used to evaluate factors associated with QoL scores., Results: Of 182 women with suspected gynecologic malignancies, 152 (84%) were surveyed pre-operatively and 148 (81%) underwent surgery. Uterine (94; 63.5%), ovarian (26; 17.5%), cervical (15; 10%), vulvar/vaginal (8; 5.4%), and other (5; 3.4%) cancers were represented. There were 37 (25%) cases of postoperative morbidity (PM), 18 (12%) unplanned ER visits, 9(6%) unplanned clinic visits, and 17 (11.5%) hospital readmissions (HR) within 30days of surgery. On adjusted analysis, lower functional well-being scores resulted in increased odds of PM (OR 1.07, 95%CI 1.01-.1.21) and HR (OR 1.11, 95%CI 1.03-1.19). A subjective global assessment score was also strongly associated with HR (OR 1.89, 95%CI 1.14, 3.16)., Conclusion: Lower pre-operative QoL scores are significantly associated with post-operative morbidity and hospital readmission in gynecologic cancer patients. This relationship may be a novel indicator of operative risk., (Copyright © 2014 Elsevier Inc. All rights reserved.)

We conducted a web-based survey among 476 white, Black, and Hispanic parents or caregivers with daughter(s) between the ages of 9-17 to better understand how religion influences HPV vaccine acceptance. Catholic parents were more likely than nonaffiliated parents to have already vaccinated their daughters (vs. being undecided) (OR = 3.26, 95% CI = 1.06, 10.06). Parents with frequent attendance at religious services were more likely than parents who do not attend services to have decided against vaccination (vs. being undecided) (OR = 2.92, 95% CI = 1.25, 6.84). Directions for research and implications for interventions are addressed.