Publications by authors named "Anna C Snavely"

27 Publications

  • Page 1 of 1

EMS blood collection from patients with acute chest pain reduces emergency department length of stay.

Am J Emerg Med 2021 Apr 26;47:248-252. Epub 2021 Apr 26.

Department of Emergency Medicine, Wake Forest School of Medicine, USA.

Background: Expediting the measurement of serum troponin by leveraging EMS blood collection could reduce the diagnostic time for patients with acute chest pain and help address Emergency Department (ED) overcrowding. However, this practice has not been examined among an ED chest pain patient population in the United States.

Methods: A prospective observational cohort study of adults with non-traumatic chest pain without ST-segment elevation myocardial infarction was conducted in three EMS agencies between 12/2016-4/2018. During transport, paramedics obtained a patient blood sample that was sent directly to the hospital core lab for troponin measurement. On ED arrival HEART Pathway assessments were completed by ED providers as part of standard care. ED providers were blinded to troponin results from EMS blood samples. To evaluate the potential impact on length of stay (LOS), the time difference between EMS blood draw and first clinical ED draw was calculated. To determine the safety of using troponin measures from EMS blood samples, the diagnostic performance of the HEART Pathway for 30-day major adverse cardiac events (MACE: composite of cardiac death, myocardial infarction (MI), coronary revascularization) was determined using EMS troponin plus arrival ED troponin and EMS troponin plus a serial 3-h ED troponin.

Results: The use of EMS blood samples for troponin measures among 401 patients presenting with acute chest pain resulted in a mean potential reduction in LOS of 72.5 ± SD 35.7 min. MACE at 30 days occurred in 21.0% (84/401), with 1 cardiac death, 78 MIs, and 5 revascularizations without MI. Use of the HEART Pathway with EMS and ED arrival troponin measures yielded a NPV of 98.0% (95% CI: 89.6-100). NPV improved to 100% (95% CI: 92.9-100) when using the EMS and 3-h ED troponin measures.

Conclusions: EMS blood collection used for core lab ED troponin measures could significantly reduce ED LOS and appears safe when integrated into the HEART Pathway.
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http://dx.doi.org/10.1016/j.ajem.2021.04.073DOI Listing
April 2021

Association of a Health Equity Curriculum With Medical Students' Knowledge of Social Determinants of Health and Confidence in Working With Underserved Populations.

JAMA Netw Open 2021 03 1;4(3):e210297. Epub 2021 Mar 1.

Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.

Importance: National organizations recommend that medical schools train students in the social determinants of health.

Objective: To develop and evaluate a longitudinal health equity curriculum that was integrated into third-year clinical clerkships and provided experiential learning in partnership with community organizations.

Design, Setting, And Participants: This longitudinal cohort study was conducted from June 2017 to October 2020 to evaluate the association of the curriculum with medical students' self-reported knowledge of social determinants of health and confidence working with underserved populations. Students from 1 large medical school in the southeastern US were included. Students in the class of 2019 and class of 2020 were surveyed at baseline (before the start of their third year), end of the third year, and graduation. The class of 2018 (No curriculum) was surveyed at graduation to serve as a control. Data analysis was conducted from June to September 2020.

Exposures: The curriculum began with a health equity simulation followed by a series of modules. The class of 2019 participated in the simulation and piloted the initial 3 modules (pilot), and the class of 2020 participated in the simulation and the full 9 modules (full).

Main Outcomes And Measures: A linear mixed-effects model was used to evaluate the change in the self-reported knowledge and confidence scores over time (potential scores ranged from 0 to 32, with higher scores indicating higher self-reported knowledge and confidence working with underserved populations). In secondary analyses, a Kruskal-Wallis test was conducted to compare graduation scores between the no, pilot, and full curriculum classes.

Results: A total of 314 students (160 women [51.0%], 205 [65.3%] non-Hispanic White participants) completed at least 1 survey, including 125 students in the pilot, 121 in the full, and 68 in the no curriculum classes. One hundred forty-one students (44.9%) were interested in primary care. Total self-reported knowledge and confidence scores increased between baseline and end of clerkship (15.4 vs 23.7, P = .001) and baseline and graduation (15.4 vs 23.7, P = .001) for the pilot and full curriculum classes. Total scores at graduation were higher for the pilot curriculum (median, 24.0; interquartile range [IQR], 21.0-27.0; P = .001) and full curriculum classes (median, 23.0; IQR, 20.0-26.0; P = .01) compared with the no curriculum class (median, 20.5; IQR, 16.25-24.0).

Conclusions And Relevance: In this cohort study of medical students, a dedicated health equity curriculum was associated with a significant improvement in students' self-reported knowledge of social determinants of health and confidence working with underserved populations.
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http://dx.doi.org/10.1001/jamanetworkopen.2021.0297DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7921901PMC
March 2021

Brain Tumor Microenvironment and Angiogenesis in Melanoma Brain Metastases.

Front Oncol 2020 21;10:604213. Epub 2021 Jan 21.

Lineberger Comprehensive Cancer Center, The University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.

Background: High tumor-infiltrating lymphocytes (TILs) and hemorrhage are important prognostic factors in patients who have undergone craniotomy for melanoma brain metastases (MBM) before 2011 at the University of Pittsburgh Medical Center (UPMC). We have investigated the prognostic or predictive role of these histopathologic factors in a more contemporary craniotomy cohort from the University of North Carolina at Chapel Hill (UNC-CH). We have also sought to understand better how various immune cell subsets, angiogenic factors, and blood vessels may be associated with clinical and radiographic features in MBM.

Methods: Brain tumors from the UPMC and UNC-CH patient cohorts were (re)analyzed by standard histopathology, tumor tissue imaging, and gene expression profiling. Variables were associated with overall survival (OS) and radiographic features.

Results: The patient subgroup with high TILs in craniotomy specimens and subsequent treatment with immune checkpoint inhibitors (ICIs, n=7) trended to have longer OS compared to the subgroup with high TILs and no treatment with ICIs (n=11, p=0.059). Bleeding was significantly associated with tumor volume before craniotomy, high melanoma-specific expression of basic fibroblast growth factor (bFGF), and high density of CD31+αSMA- blood vessels. Brain tumors with high versus low peritumoral edema before craniotomy had low (17%) versus high (41%) incidence of brisk TILs. Melanoma-specific expression of the vascular endothelial growth factor (VEGF) was comparable to VEGF expression by TILs and was not associated with any particular prognostic, radiographic, or histopathologic features. A gene signature associated with gamma delta (gd) T cells was significantly higher in intracranial than same-patient extracranial metastases and primary melanoma. However, gdT cell density in MBM was not prognostic.

Conclusions: ICIs may provide greater clinical benefit in patients with brisk TILs in MBM. Intratumoral hemorrhage in brain metastases, a significant clinical problem, is not merely associated with tumor volume but also with underlying biology. bFGF may be an essential pathway to target. VEGF, a factor principally associated with peritumoral edema, is not only produced by melanoma cells but also by TILs. Therefore, suppressing low-grade peritumoral edema using corticosteroids may harm TIL function in 41% of cases. Ongoing clinical trials targeting VEGF in MBM may predict a lack of unfavorable impacts on TIL density and/or intratumoral hemorrhage.
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http://dx.doi.org/10.3389/fonc.2020.604213DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7860978PMC
January 2021

Current Practices for Screening and Addressing Financial Hardship within the NCI Community Oncology Research Program.

Cancer Epidemiol Biomarkers Prev 2021 Apr 21;30(4):669-675. Epub 2020 Dec 21.

Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, North Carolina.

Background: Cancer-related financial hardship is associated with poor care outcomes and reduced quality of life for patients and families. Scalable intervention development to address financial hardship requires knowledge of current screening practices and services within community cancer care.

Methods: The NCI Community Oncology Research Program (NCORP) 2017 Landscape Assessment survey assessed financial screening and financial navigation practices within U.S. community oncology practices. Logistic models evaluated associations between financial hardship screening and availability of a cancer-specific financial navigator and practice group characteristics (e.g., safety-net designation, critical access hospital, proportion of racial and ethnic minority patients served).

Results: Of 221 participating NCORP practice groups, 72% reported a financial screening process and 50% had a cancer-specific financial navigator. Practice groups with more than 10% of new patients with cancer enrolled in Medicaid (OR = 2.81, = 0.02) and with less than 30% racial/ethnic minority cancer patient composition (OR = 3.91, < 0.01) were more likely to screen for financial concerns. Practice groups with less than 30% racial/ethnic minority cancer patient composition (OR = 2.37, < 0.01) were more likely to have a dedicated financial navigator or counselor for patients with cancer.

Conclusions: Most NCORP practice groups screen for financial concerns and half have a cancer-specific financial navigator. Practices serving more racial or ethnic minority patients are less likely to screen and have a designated financial navigator.

Impact: The effectiveness of financial screening and navigation for mitigating financial hardship could be tested within NCORP, along with specific interventions to address cancer care inequities..
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http://dx.doi.org/10.1158/1055-9965.EPI-20-1157DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8026561PMC
April 2021

Sex and race differences in safety and effectiveness of the HEART pathway accelerated diagnostic protocol for acute chest pain.

Am Heart J 2021 02 6;232:125-136. Epub 2020 Nov 6.

Department of Emergency Medicine, Wake Forest School of Medicine (WFSOM), Winston-Salem, NC; Departments of Implementation Science and Epidemiology and Prevention, WFSOM, Winston-Salem, NC.

Background: The HEART Pathway is an accelerated diagnostic protocol for Emergency Department patients with possible acute coronary syndrome. The objective was to compare the safety and effectiveness of the HEART Pathway among women vs men and whites vs non-whites.

Methods: A subgroup analysis of the HEART Pathway Implementation Study was conducted. Adults with chest pain were accrued from November 2013 to January 2016 from 3 Emergency Departments in North Carolina. The primary outcomes were death and myocardial infarction (MI) and hospitalization rates at 30 days. Logistic regression evaluated for interactions of accelerated diagnostic protocol implementation with sex or race and changes in outcomes within subgroups.

Results: A total of 8,474 patients were accrued, of which 53.6% were female and 34.0% were non-white. The HEART Pathway identified 32.6% of females as low-risk vs 28.5% of males (P = 002) and 35.6% of non-whites as low-risk vs 28.0% of whites (P < .0001). Among low-risk patients, death or MI at 30 days occurred in 0.4% of females vs 0.5% of males (P = .70) and 0.5% of non-whites vs 0.3% of whites (P = .69). Hospitalization at 30 days was reduced by 6.6% in females (aOR: 0.74, 95% CI: 0.64-0.85), 5.1% in males (aOR: 0.87, 95% CI: 0.75-1.02), 8.6% in non-whites (aOR: 0.72, 95% CI: 0.60-0.86), and 4.5% in whites (aOR: 0.83, 95% CI: 0.73-0.94). Interactions were not significant.

Conclusion: Women and non-whites are more likely to be classified as low-risk by the HEART Pathway. HEART Pathway implementation is associated with decreased hospitalizations and a very low death and MI rate among low-risk patients regardless of sex or race.
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http://dx.doi.org/10.1016/j.ahj.2020.11.005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7952042PMC
February 2021

Caregiver engagement practices in National Cancer Institute Clinical Oncology Research Program settings: Implications for research to advance the field.

Cancer 2021 Feb 2;127(4):639-647. Epub 2020 Nov 2.

Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, North Carolina.

Background: Supportive care interventions have demonstrated benefits for both informal and/or family cancer caregivers and their patients, but uptake generally is poor. To the authors' knowledge, little is known regarding the availability of supportive care services in community oncology practices, as well as engagement practices to connect caregivers with these services.

Methods: Questions from the National Cancer Institute Community Oncology Research Program (NCORP)'s 2017 Landscape Survey examined caregiver engagement practices (ie, caregiver identification, needs assessment, and supportive care service availability). Logistic regression was used to assess the relationship between the caregiver engagement outcomes and practice group characteristics.

Results: A total of 204 practice groups responded to each of the primary outcome questions. Only 40.2% of practice groups endorsed having a process with which to systematically identify and document caregivers, although approximately 76% were routinely using assessment tools to identify caregiver needs and approximately 63.7% had supportive care services available to caregivers. Caregiver identification was more common in sites affiliated with a critical access hospital (odds ratio [OR], 2.44; P = .013), and assessments were less common in safety-net practices (OR, 0.41; P = .013). Supportive care services were more commonly available in the Western region of the United States, in practices with inpatient services (OR, 2.96; P = .012), and in practices affiliated with a critical access hospital (OR, 3.31; P = .010).

Conclusions: Although many practice groups provide supportive care services, fewer than one-half systematically identify and document informal cancer caregivers. Expanding fundamental engagement practices such as caregiver identification, assessment, and service provision will be critical to support recent calls to improve caregivers' well-being and skills to perform caregiving tasks.
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http://dx.doi.org/10.1002/cncr.33296DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7854890PMC
February 2021

Identification of very low-risk acute chest pain patients without troponin testing.

Emerg Med J 2020 Nov 4;37(11):690-695. Epub 2020 Aug 4.

Emergency Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.

Background: The HEART Pathway combines a History ECG Age Risk factor (HEAR) score and serial troponins to risk stratify patients with acute chest pain. However, it is unclear whether patients with HEAR scores of 1 require troponin testing. The objective of this study is to measure the major adverse cardiac event (MACE) rate among patients with 1 HEAR scores and determine whether serial troponin testing is needed to achieve a miss rate <1%.

Methods: A secondary analysis of the HEART Pathway Implementation Study was conducted. HEART Pathway risk assessments (HEAR scores and serial troponin testing at 0 and 3 hours) were completed by the providers on adult patients with chest pain from three US sites between November 2014 and January 2016. MACE (composite of death, myocardial infarction (MI) and coronary revascularisation) at 30 days was determined. The proportion of patients with HEAR scores of 1 diagnosed with MACE within 30 days was calculated. The impact of troponin testing on patients with HEAR scores of 1 was determined using Net Reclassification Improvement Index (NRI).

Results: Providers completed HEAR assessments on 4979 patients and HEAR scores<1 occurred in 9.0% (447/4979) of patients. Among these patients, MACE at 30 days occurred in 0.9% (4/447; 95% CI 0.2% to 2.3%) with two deaths, two MIs and 0 revascularisations. The sensitivity and negative predictive value for MACE in the HEAR 1 was 97.8% (95%CI 94.5% to 99.4%) and 99.1% (95% CI 97.7% to 99.8%), respectively, and were not improved by troponin testing. Troponin testing in patients with HEAR 1 correctly reclassified two patients diagnosed with MACE, and was elevated among seven patients without MACE yielding an NRI of 0.9% (95%CI -0.7 to 2.4%).

Conclusion: These data suggest that patients with HEAR scores of 0 and 1 represent a very low-risk group that may not require troponin testing to achieve a missed MACE rate <1%. NCT02056964.
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http://dx.doi.org/10.1136/emermed-2020-209698DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7952041PMC
November 2020

HEART Pathway Implementation Safely Reduces Hospitalizations at One Year in Patients With Acute Chest Pain.

Ann Emerg Med 2020 11 28;76(5):555-565. Epub 2020 Jul 28.

Departments of Emergency Medicine, Wake Forest School of Medicine, Winston-Salem, NC; Implementation Science and Epidemiology and Prevention, Wake Forest School of Medicine, Winston-Salem, NC.

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.
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http://dx.doi.org/10.1016/j.annemergmed.2020.05.035DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7988839PMC
November 2020

Effect of a Digital Health Intervention on Decreasing Barriers and Increasing Facilitators for Colorectal Cancer Screening in Vulnerable Patients.

Cancer Epidemiol Biomarkers Prev 2020 08 7;29(8):1564-1569. Epub 2020 May 7.

Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, North Carolina.

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.
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http://dx.doi.org/10.1158/1055-9965.EPI-19-1199DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7416430PMC
August 2020

Point-of-Care Troponin Testing during Ambulance Transport to Detect Acute Myocardial Infarction.

Prehosp Emerg Care 2020 Nov-Dec;24(6):751-759. Epub 2020 Mar 3.

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. 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. 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%,  < 0.0001), but lower specificity of 92.4% (95% CI 88.4-95.4%,  = 0.0001). 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.
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http://dx.doi.org/10.1080/10903127.2020.1721740DOI Listing
May 2021

One-Year Mortality and Associated Factors in Patients Receiving Out-of-Hospital Naloxone for Presumed Opioid Overdose.

Ann Emerg Med 2020 05 23;75(5):559-567. Epub 2020 Jan 23.

Department of Emergency Medicine, Wake Forest School of Medicine, Winston-Salem, NC.

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.
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http://dx.doi.org/10.1016/j.annemergmed.2019.11.022DOI Listing
May 2020

A Comparison of Smoking History in the Electronic Health Record With Self-Report.

Am J Prev Med 2020 04 23;58(4):591-595. Epub 2020 Jan 23.

Section of General Internal Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.

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.
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http://dx.doi.org/10.1016/j.amepre.2019.10.020DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7533103PMC
April 2020

Prior breast cancer and tamoxifen exposure does not influence outcomes in women with uterine papillary serous carcinoma.

Gynecol Oncol 2017 03 3;144(3):531-535. Epub 2017 Jan 3.

University of North Carolina, Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Chapel Hill, NC, United States; Lineberger Clinical Cancer Center, University of North Carolina, Chapel Hill, NC, United States.

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.
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http://dx.doi.org/10.1016/j.ygyno.2016.12.024DOI Listing
March 2017

Chemotherapy and Stem Cell Transplantation Increase p16 Expression, a Biomarker of T-cell Aging.

EBioMedicine 2016 Sep 21;11:227-238. Epub 2016 Aug 21.

Department of Medicine, The Lineberger Comprehensive Cancer Center, The University of North Carolina School of Medicine, Chapel Hill, NC, USA; Department of Genetics, The Lineberger Comprehensive Cancer Center, The University of North Carolina School of Medicine, Chapel Hill, NC, USA. Electronic address:

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, 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 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 expression 6months following transplantation. Patients receiving autologous transplant experienced a larger increase in p16 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.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5049997PMC
http://dx.doi.org/10.1016/j.ebiom.2016.08.029DOI Listing
September 2016

Intraoperative Handoffs and Postoperative Complications Among Patients Undergoing Gynecologic Oncology Operations.

J Healthc Qual 2017 Jul/Aug;39(4):e42-e48

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.
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http://dx.doi.org/10.1097/JHQ.0000000000000042DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5183519PMC
April 2018

Who presents satisfied? Non-modifiable factors associated with patient satisfaction among gynecologic oncology clinic patients.

Gynecol Oncol 2016 08 11;142(2):299-303. Epub 2016 Jun 11.

Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, NC, United States; Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, United States; Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, United States.

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.
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http://dx.doi.org/10.1016/j.ygyno.2016.06.009DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4961557PMC
August 2016

The impact of surgical complications on health-related quality of life in women undergoing gynecologic and gynecologic oncology procedures: a prospective longitudinal cohort study.

Am J Obstet Gynecol 2016 10 27;215(4):457.e1-457.e13. Epub 2016 Apr 27.

Division of Gynecologic Oncology, University of North Carolina School of Medicine, Chapel Hill, NC; Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC.

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.
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http://dx.doi.org/10.1016/j.ajog.2016.04.025DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5573237PMC
October 2016

The health-related quality of life journey of gynecologic oncology surgical patients: Implications for the incorporation of patient-reported outcomes into surgical quality metrics.

Gynecol Oncol 2016 05 18;141(2):329-335. Epub 2016 Mar 18.

Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of North Carolina School of Medicine, Chapel Hill, NC, United States; Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, United States.

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.
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http://dx.doi.org/10.1016/j.ygyno.2016.03.003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4978531PMC
May 2016

Use of mobile device technology to continuously collect patient-reported symptoms during radiation therapy for head and neck cancer: A prospective feasibility study.

Adv Radiat Oncol 2016 Apr-Jun;1(2):115-121. Epub 2016 Feb 18.

Department of Radiation Oncology, University of North Carolina, Chapel Hill, North Carolina.

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.
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http://dx.doi.org/10.1016/j.adro.2016.02.001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5506718PMC
February 2016

Postoperative Morbidity in Curative Resection of Gastroesophageal Carcinoma Does Not Impact Long-term Survival.

Am Surg 2015 Dec;81(12):1228-31

Department of Surgery, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.

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.
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December 2015

In vivo assessment of the metabolic activity of CYP2D6 diplotypes and alleles.

Br J Clin Pharmacol 2015 Nov 2;80(5):1122-30. Epub 2015 Aug 2.

University of North Carolina at Chapel Hill, Chapel Hill, NC, 27599, USA.

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.
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http://dx.doi.org/10.1111/bcp.12665DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4631184PMC
November 2015

The incidence of catheter-associated venous thrombosis in noncritically ill children.

Hosp Pediatr 2015 Feb;5(2):59-66

Division of General Pediatrics and Adolescent Medicine, Department of Pediatrics, and.

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.
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http://dx.doi.org/10.1542/hpeds.2014-0041DOI Listing
February 2015

Obesity is associated with worse quality of life in women with gynecologic malignancies: an opportunity to improve patient-centered outcomes.

Cancer 2015 Feb 23;121(3):395-402. Epub 2014 Sep 23.

Division of Gynecologic Oncology, University of North Carolina School of Medicine, Chapel Hill, North Carolina; Cancer Care Quality Training Program, Division of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.

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.
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http://dx.doi.org/10.1002/cncr.29061DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4304903PMC
February 2015

A latent variable transformation model approach for exploring dysphagia.

Stat Med 2014 Nov 29;33(25):4337-52. Epub 2014 Jun 29.

Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, U.S.A.; UNC Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, U.S.A.

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.
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http://dx.doi.org/10.1002/sim.6239DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7263574PMC
November 2014

Rates of Renal Toxicity in Cancer Patients Receiving Cisplatin With and Without Mannitol.

Ann Pharmacother 2014 Jul 28;48(7):863-869. Epub 2014 Apr 28.

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

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 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 cisplatin every 3 weeks and those with hypertension are at the greatest risk of nephrotoxicity and would benefit from the addition of mannitol.
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http://dx.doi.org/10.1177/1060028014533303DOI Listing
July 2014

HPV vaccine decision-making and acceptance: does religion play a role?

J Relig Health 2013 Dec;52(4):1120-30

Department of Sociomedical Sciences, Mailman School of Public Health, Columbia University, 722 West 168th Street, Room 548, New York, NY, 10032, USA,

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.
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http://dx.doi.org/10.1007/s10943-011-9553-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4616263PMC
December 2013