Characteristics, healthcare utilization, and outcomes of patients with HER2-low breast cancer.

PURPOSE: Treatment for HER2-low [defined as ImmunoHistoChemistry (IHC) 1 + or 2 + and negative/normal in Situ Hybridization (ISH)] breast cancer patients is rapidly evolving, yet we lack critical information about the HER2-low population. METHODS: We conducted a retrospective cohort study of women aged 18 years or older diagnosed with breast cancer between 2010 and 2016 in North Carolina. Analyses were conducted for the overall cohort and a stage IV sub-cohort. We examined demographic and clinical characteristics, and characterized prevalence of HER2-low disease and healthcare utilization. We estimated adjusted rate ratios for the association between HER2 classifications and utilization outcomes, and hazard ratios for 3-year all cause mortality (stage IV only). RESULTS: The overall and stage IV cohorts included 12,965 and 635 patients, respectively. HER2-low patients represented more than half of both cohorts (59% overall, 53% stage IV). HER2-low patients were more likely than IHC 0 patients to have hormone receptor (HR)-positive disease. In the stage IV cohort, HER2-low patients were more likely to be Black (26% vs. 16% IHC 0, p = 0.0159). In both cohorts, rates of hospitalizations were slightly higher among HER2-low patients. There were no survival differences between HER2-low and IHC 0 among stage IV patients. CONCLUSION: New treatment options for HER2-low breast cancer may have potential for significant impact at the population level particularly for patients with stage IV disease. In light of racial differences between HER2-low and IHC 0 patients observed in our cohort, research- and practice-based efforts to ensure equitable adoption of new treatment guidelines for patients with HER2-low metastatic breast cancer will be essential.

Medications for Opioid Use Disorder and Mortality and Hospitalization Among People With Opioid Use-related Infections.

BACKGROUND: Severe skin and soft tissue infections related to injection drug use have increased in concordance with a shift to heroin and illicitly manufactured fentanyl. Opioid agonist therapy medications (methadone and buprenorphine) may improve long-term outcomes by reducing injection drug use. We aimed to examine the association of medication use with mortality among people with opioid use-related skin or soft tissue infections. METHODS: An observational cohort study of Medicaid enrollees aged 18 years or older following their first documented medical encounters for opioid use-related skin or soft tissue infections during 2007-2018 in North Carolina. The exposure was documented medication use (methadone or buprenorphine claim) in the first 30 days following initial infection compared with no medication claim. Using Kaplan-Meier estimators, we examined the difference in 3-year incidence of mortality by medication use, weighted for year, age, comorbidities, and length of hospital stay. RESULTS: In this sample, there were 13,286 people with opioid use-related skin or soft tissue infections. The median age was 37 years, 68% were women, and 78% were white. In Kaplan-Meier curves for the total study population, 12 of every 100 patients died during the first 3 years. In weighted models, for every 100 people who used medications, there were four fewer deaths over 3 years (95% confidence interval = 2, 6). CONCLUSION: In this study, people with opioid use-related skin and soft tissue infections had a high risk of mortality following their initial healthcare visit for infections. Methadone or buprenorphine use was associated with reductions in mortality.

Race, geography, and risk of breast cancer treatment delays: A population-based study 2004-2015.

BACKGROUND: Treatment delays affect breast cancer survival and constitute poor-quality care. Black patients experience more treatment delay, but the relationship of geography to these disparities is poorly understood. METHODS: We studied a population-based, retrospective, observational cohort of patients with breast cancer in North Carolina between 2004 and 2017 from the Cancer Information and Population Health Resource, which links cancer registry and sociodemographic data to multipayer insurance claims. We included patients >18 years with Stage I-III breast cancer who received surgery or chemotherapy as their first treatment. Delay was defined as >60 days from diagnosis to first treatment. Counties were aggregated into nine Area Health Education Center regions. Race was dichotomized as Black versus non-Black. RESULTS: Among 32,626 patients, 6190 (19.0%) were Black. Black patients were more likely to experience treatment delay >60 days (15.0% of Black vs. 8.0% of non-Black). Using race-stratified modified Poisson regression, age-adjusted relative risk of delay in the highest risk region was approximately twice that in the lowest risk region among Black (relative risk, 2.1; 95% CI, 1.6-2.6) and non-Black patients (relative risk, 1.9; 95% CI, 1.5-2.3). Adjustment for clinical and sociodemographic features only slightly attenuated interregion differences. The magnitude of the racial gap in treatment delay varied by region, from 0.0% to 9.4%. CONCLUSIONS: Geographic region was significantly associated with risk of treatment delays for both Black and non-Black patients. The magnitude of racial disparities in treatment delay varied markedly between regions. Future studies should consider both high-risk geographic regions and high-risk patient groups for intervention to prevent delays.

Association of Receipt of Systemic Treatment for Melanoma With Insurance Type in North Carolina.

BACKGROUND: Previous studies of hospital-based patients with metastatic melanoma suggest sociodemographic factors, including insurance type, may be associated with the receipt of systemic treatments. OBJECTIVES: To examine whether insurance type is associated with the receipt of systemic treatment among patients with melanoma in a broad cohort of patients in North Carolina. METHODS: We conducted a retrospective cohort study between 2011 and 2017 of patients with stages III-IV melanoma using data from the North Carolina Central Cancer Registry linked to Medicare, Medicaid, and private health insurance claims across the state. The primary outcome was the receipt of any systemic treatment, and the secondary outcome was the receipt of immunotherapy. RESULTS: A total of 372 patients met the inclusion criteria. The average age was 68 years old (interquartile range: 56-76) and 61% were male. Within the cohort 48% had Medicare only, 29% had private insurance, 12% had both Medicare and Medicaid, and 11% had Medicaid only. A total of 186 (50%) patients received systemic treatment for melanoma, 125 (67%) of whom received immunotherapy. The use of systemic therapy, including immunotherapy, increased significantly over time. Having Medicaid-only insurance was independently associated with a 45% lower likelihood of receiving any systemic treatment [0.55 (95% CI: 0.35, 0.85)] and a 43% lower likelihood of receipt of immunotherapy [0.57 (95% CI: 0.34, 0.95)] compared with private insurance. CONCLUSIONS: Stage III-IV melanoma patients with Medicaid-only insurance were less likely to receive systemic therapy or immunotherapy than patients with private insurance or Medicare insurance. This finding raises concerns about insurance-based disparities in treatment access.

Evaluating the implementation and impact of navigator-supported remote symptom monitoring and management: a protocol for a hybrid type 2 clinical trial.

BACKGROUND: Symptoms in patients with advanced cancer are often inadequately captured during encounters with the healthcare team. Emerging evidence demonstrates that weekly electronic home-based patient-reported symptom monitoring with automated alerts to clinicians reduces healthcare utilization, improves health-related quality of life, and lengthens survival. However, oncology practices have lagged in adopting remote symptom monitoring into routine practice, where specific patient populations may have unique barriers. One approach to overcoming barriers is utilizing resources from value-based payment models, such as patient navigators who are ideally positioned to assume a leadership role in remote symptom monitoring implementation. This implementation approach has not been tested in standard of care, and thus optimal implementation strategies are needed for large-scale roll-out. METHODS: This hybrid type 2 study design evaluates the implementation and effectiveness of remote symptom monitoring for all patients and for diverse populations in two Southern academic medical centers from 2021 to 2026. This study will utilize a pragmatic approach, evaluating real-world data collected during routine care for quantitative implementation and patient outcomes. The Consolidated Framework for Implementation Research (CFIR) will be used to conduct a qualitative evaluation at key time points to assess barriers and facilitators, implementation strategies, fidelity to implementation strategies, and perceived utility of these strategies. We will use a mixed-methods approach for data interpretation to finalize a formal implementation blueprint. DISCUSSION: This pragmatic evaluation of real-world implementation of remote symptom monitoring will generate a blueprint for future efforts to scale interventions across health systems with diverse patient populations within value-based healthcare models. TRIAL REGISTRATION: NCT04809740 ; date of registration 3/22/2021.

Affordable Care Act and cancer stage at diagnosis in an underserved population.

The Patient Protection and Affordable Care Act (ACA) has increased insurance coverage among underserved individuals, but the effect of ACA on cancer diagnosis is currently debated, particularly in Medicaid non-expansion states. Therefore, we aimed to assess the effect of ACA implementation on stage at diagnosis among underserved cancer patients in Texas, a Medicaid non-expansion state. We used data from the institutional registry of the JPS Center for Cancer Care, which serves an urban population of underserved cancer patients. Eligible individuals were aged 18 to 64 years and diagnosed with a first primary invasive solid tumor between 2008 and 2015. We used a natural experiment framework and interrupted time-series analysis to assess level (i.e. immediate) and slope (over time) changes in insurance coverage and cancer stage at diagnosis between pre- and post-ACA periods. Our study population comprised 4808 underserved cancer patients, of whom 51% were racial/ethnic minorities. The prevalence of uninsured cancer patients did not immediately change after ACA implementation but modestly decreased over time (PR = 0.94; 95% CL: 0.90, 0.98). The prevalence of early- and advanced-stage diagnosis did not appreciably change overall or when stratified by screen-detectable cancers. Our results suggest that ACA implementation decreased the prevalence of uninsured cancer patients but had little effect on cancer stage at diagnosis in an underserved population. Given that Texas is a Medicaid non-expansion state, Medicaid expansion and alternative approaches may need to be further explored to improve earlier cancer diagnosis among underserved individuals.

Hypofractionated radiation in older women with breast cancer.

BACKGROUND: American Society of Radiation Oncology Choosing Wisely campaign recommends hypofractionated radiation and against routine use of intensity-modulated radiation therapy (IMRT) in early-stage estrogen receptor-positive breast cancer. We analyzed guideline recommendation adherence and financial implications in a modern Medicare cohort of women treated across the southeastern United States. METHODS: Our study population comprised Medicare patients over 65 years of age with breast cancer diagnosis from 12 cancer centers in the Southeast United States with stage 0-II breast treated with lumpectomy from 2012 to 2015. Hypofractionation was defined as 4 or fewer weeks of radiation treatments. Factors associated with utilization of hypofractionation and IMRT were identified using Poisson regression. Median costs during radiation treatments were compared for hypofractionation and IMRT. RESULTS: In older women (median age 71), 75% were treated with conventional fractionation, and 20% received IMRT. Hypofractionated women were more likely to have a positive estrogen(ER) or progestorone(PR) receptor status, lower comorbidity scores, and be treated at a high volume center (all P < 0.05). IMRT was utilized in 20% of patients and was more common in women treated with conventional fractionation (P < 0.001). Positive ER/PR status (P < 0.001) and utilization of hormonal blockade (P = 0.02) were associated with increased utilization of IMRT. CONCLUSION: In an older cohort of patients with early-stage breast cancer, a majority were treated with conventional fractionated radiation, while approximately 20% were treated with IMRT. Both of which were associated with increased cost relative to hypofractionation.

Radiation therapy utilization in Medicare beneficiaries with early-stage breast cancer.

BACKGROUND: There is increasing evidence that radiation therapy (RT) can be omitted for select older patients who are compliant with hormonal blockade, but there is no recent claim-based analysis for determining patterns of care and guiding possible treatment recommendations. METHODS: Medicare beneficiaries who were 65 years old or older and were diagnosed with breast cancer at 1 of 12 cancer centers affiliated with an academic center in the southeastern United States were analyzed. Stage 0 or I patients treated with lumpectomy from 2012 to 2014 were identified. Patient, treatment, and center characteristics were analyzed for the utilization of RT. RESULTS: Among 800 women treated with lumpectomy, 64% received adjuvant radiation. The median age was 74 years. The omission of RT was more likely in older patients, stage 0 patients, and patients with more comorbidities (P < .01). Hormonal blockade was used in 41% of the patients who did not receive RT. The utilization of hormonal blockade with the omission of RT was more likely in patients with fewer comorbidities (P < .01). CONCLUSIONS: In an older cohort of patients who otherwise would have qualified for the omission of radiation, two-thirds were treated with radiation. Future guideline recommendations should address omission in the context of hormonal blockade compliance because only 41% of the patients used hormonal blockade when radiation was not delivered. Cancer 2018;124:475-81. © 2017 American Cancer Society.

Concordance with NCCN treatment guidelines: Relations with health care utilization, cost, and mortality in breast cancer patients with secondary metastasis.

BACKGROUND: The impact of National Comprehensive Cancer Network (NCCN) treatment guideline concordance on costs, health care utilization, and mortality for patients with breast cancer and secondary metastases is unknown. METHODS: From 2007 to 2013, women with early-stage breast cancer who received treatment for secondary metastases (n = 5651) were evaluated for first recorded systemic therapy concordance with NCCN guidelines within the Surveillance, Epidemiology, and End Results Program-Medicare linked database. Generalized linear and mixed effects models evaluated factors associated with nonconcordance and the relation between concordance status and health care utilization and costs. Mortality risk was estimated with Cox regression. RESULTS: Eighteen percent of the patients received nonconcordant therapy, with the most common being single-agent, human epidermal growth factor receptor 2 (HER2)-targeted therapy (36%), therapy mismatched with the estrogen receptor/HER2 status (11%), unapproved bevacizumab regimens (10%), and adjuvant regimens in a metastatic setting (6%). A younger age, a hormone receptor-negative status, and a HER2-positive status were associated with nonconcordance (P < .05). Nonconcordance was associated with 22% and 21% increased rates of emergency department visits and hospitalizations, respectively, and $1765 higher average monthly Medicare costs. Differences in adjusted mortality risk were noted by the category of nonconcordance; single-agent, HER2-targeted therapy was associated with decreased mortality risk (hazard ratio [HR], 0.66; 95% confidence limit [CL], 0.57-0.76), and increased mortality risk was observed with unapproved bevacizumab use (HR, 1.40; 95% CL, 1.13-1.74). CONCLUSIONS: Most patients (82%) received treatment consistent with NCCN guidelines. Nonconcordant treatment was associated with higher health care utilization and costs, with mortality differences observed by the type of guideline deviation. Consideration of both patient and financial outcomes will be important as health systems increase the emphasis on guideline-based care.

Healthcare utilization, Medicare spending, and sources of patient distress identified during implementation of a lay navigation program for older patients with breast cancer.

PURPOSE: Despite benefits for patients, sustainability of breast cancer navigation programs is challenging due to the lack of reimbursement for navigators. This analysis describes distress reported by breast cancer patients to navigators and the impact of navigation on healthcare utilization for older adults with breast cancer. METHODS: We conducted a retrospective cohort study of Medicare administrative claims data and patient-reported distress assessments. The primary outcome was Medicare spending per beneficiary per quarter. Secondary outcomes included (1) the number of hospitalizations or ER visits in each quarter; (2) distress levels; and (3) causes of distress reported by patients to their navigators. A subset analysis was conducted for stage I/II/III versus stage IV patients. RESULTS: 776 navigated and 776 control patients were included in the analysis. The average age at diagnosis was 74 years; 13% of the subjects were African American; 95% of patients had stage I-III. Medicare spending declined faster for the navigated group than the matched comparison group by $528 per quarter per patient (95% CL -$667, -$388). Stage I/II/III navigated patients showed a statistically significant decline in Medicare spending, ER visits, and hospitalizations over time compared to the matched comparison group. No differences were observed for stage IV patients. Eighteen percent of patients reported moderate distress. Informational and physical distress were more common in late stage than in early-stage breast cancer. CONCLUSIONS: Lay navigation reduced healthcare utilization in older adults with breast cancer, with the greatest impact observed in early-stage breast cancer patients.

Associations Between Race, Perceived Psychological Stress, and the Gut Microbiota in a Sample of Generally Healthy Black and White Women: A Pilot Study on the Role of Race and Perceived Psychological Stress.

OBJECTIVE: Racial health disparities persist among black and white women for colorectal cancer. Understanding racial differences in the gut microbiota and related covariates (e.g., stress) may yield new insight into unexplained colorectal cancer disparities. METHODS: Healthy non-Hispanic black or white women (age ≥19 years) provided survey data, anthropometrics, and stool samples. Fecal DNA was collected and isolated from a wipe. Polymerase chain reaction was used to amplify the V4 region of the 16SrRNA gene and 250 bases were sequenced using the MiSeq platform. Microbiome data were analyzed using QIIME. Operational taxonomic unit data were log transformed and normalized. Analyses were conducted using linear models in R Package "limma." RESULTS: Fecal samples were analyzed for 80 women (M (SD) age = 39.9 (14.0) years, 47 black, 33 white). Blacks had greater average body mass index (33.3 versus 27.5 kg/m, p < .01) and waist circumference (98.3 versus 86.6 cm, p = .003) than whites. Whites reported more stressful life events (p = .026) and greater distress (p = .052) than blacks. Final models accounted for these differences. There were no significant differences in dietary variables. Unadjusted comparisons revealed no racial differences in alpha diversity. Racial differences were observed in beta diversity and abundance of top 10 operational taxonomic units. Blacks had higher abundances than whites of Faecalibacterium (p = .034) and Bacteroides (p = .038). Stress was associated with abundances of Bifidobacterium. The association between race and Bacteroides (logFC = 1.72, 0 = 0.020) persisted in fully adjusted models. CONCLUSIONS: Racial differences in the gut microbiota were observed including higher Bacteroides among blacks. Efforts to cultivate an "ideal" gut microbiota may help reduce colorectal cancer risk.

Impact of Nonconcordance With NCCN Guidelines on Resource Utilization, Cost, and Mortality in De Novo Metastatic Breast Cancer.

Background: The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) have directed the care of patients with cancer for >20 years. Payers are implementing guideline-based pathway programs that restrict reimbursement for non-guideline-based care to control costs, yet evidence regarding impact of guidelines on outcomes, including mortality, Medicare costs, and healthcare utilization, is limited. Patients and Methods: This analysis evaluated concordance of first treatment with NCCN Guidelines for women with de novo stage IV metastatic breast cancer (MBC) included within the SEER-Medicare linked database and diagnosed between 2007 and 2013. Cox proportional hazards models were used to evaluate the association between mortality and guideline concordance. Linear mixed-effects and generalized linear models were used to evaluate total cost to Medicare and rates of healthcare utilization by concordance status. Results: We found that 19% of patients (188/988) with de novo MBC received nonconcordant treatment. Patients receiving nonconcordant treatment were more likely to be younger and have hormone receptor-negative and HER2-positive MBC. The most common category of nonconcordant treatment was use of adjuvant regimens in the metastatic setting (40%). Adjusted mortality risk was similar for patients receiving concordant and nonconcordant treatments (hazard ratio [HR], 0.85; 95% confidence limit [CL], 0.69, 1.05). When considering category of nonconcordance, patients receiving adjuvant regimens in the metastatic setting had a decreased risk of mortality (HR, 0.60; 95% CL, 0.43, 0.84). Nonconcordant treatments were associated with $1,867 higher average Medicare costs per month compared with concordant treatments (95% CL, $918, $2,817). Single-agent HER2-targeted therapy was the highest costing category of nonconcordance at $3,008 (95% CL, $1,014, $5,001). Healthcare utilization rates were similar for patients receiving concordant and nonconcordant treatments. Conclusions: Despite a lack of survival benefit, concordant care was associated with lower costs, suggesting potential benefit to increasing standardization of care. These findings may influence policy decisions regarding implementation of pathway programs as health systems transition to value-based models.

Treatment patterns for ductal carcinoma in situ with close or positive mastectomy margins.

BACKGROUND: Mastectomy remains an effective treatment for ductal carcinoma in situ (DCIS) but whether further therapy is warranted for close or positive margins is controversial. We aim to characterize the treatment practices of DCIS throughout the United States in patients who undergo mastectomy with close or positive margins to better understand the use of postmastectomy radiation therapy (PMRT). MATERIALS AND METHODS: Using the 2004-2013 National Cancer Database, we identified all female patients with a diagnosis of DCIS who underwent mastectomy. Distributional characteristics were summarized for overall and margin-stratified samples. Characteristic differences were assessed by region and receipt of radiation. Chi-square and independent sample t-tests were used to assess differences for categorical and continuous variables, respectively. RESULTS: In 21,591 patients who met inclusion criteria, 470 patients with close/positive margins were identified. Sixteen percent of patients with close/positive margins received PMRT compared to 1.5% with negative margins (P < 0.01). There was no difference in PMRT and patient race, insurance status, treatment facility, or endocrine therapy. Patients with close/positive margins who received PMRT were more likely to be in an urban setting from the Midwest (24.6%) and Northeast (21.8%) compared to the West (11.0%) and South (10.7%) (P < 0.01). CONCLUSIONS: Use of PMRT for DCIS following mastectomy with close/positive margins differs across the country. Regional variations in treatment patterns reinforce a need to determine whether PMRT improves survival to establish treatment guidelines.

Optimal Measurement Interval for Emergency Department Crowding Estimation Tools.

STUDY OBJECTIVE: Emergency department (ED) crowding is a barrier to timely care. Several crowding estimation tools have been developed to facilitate early identification of and intervention for crowding. Nevertheless, the ideal frequency is unclear for measuring ED crowding by using these tools. Short intervals may be resource intensive, whereas long ones may not be suitable for early identification. Therefore, we aim to assess whether outcomes vary by measurement interval for 4 crowding estimation tools. METHODS: Our eligible population included all patients between July 1, 2015, and June 30, 2016, who were admitted to the JPS Health Network ED, which serves an urban population. We generated 1-, 2-, 3-, and 4-hour ED crowding scores for each patient, using 4 crowding estimation tools (National Emergency Department Overcrowding Scale [NEDOCS], Severely Overcrowded, Overcrowded, and Not Overcrowded Estimation Tool [SONET], Emergency Department Work Index [EDWIN], and ED Occupancy Rate). Our outcomes of interest included ED length of stay (minutes) and left without being seen or eloped within 4 hours. We used accelerated failure time models to estimate interval-specific time ratios and corresponding 95% confidence limits for length of stay, in which the 1-hour interval was the reference. In addition, we used binomial regression with a log link to estimate risk ratios (RRs) and corresponding confidence limit for left without being seen. RESULTS: Our study population comprised 117,442 patients. The time ratios for length of stay were similar across intervals for each crowding estimation tool (time ratio=1.37 to 1.30 for NEDOCS, 1.44 to 1.37 for SONET, 1.32 to 1.27 for EDWIN, and 1.28 to 1.23 for ED Occupancy Rate). The RRs of left without being seen differences were also similar across intervals for each tool (RR=2.92 to 2.56 for NEDOCS, 3.61 to 3.36 for SONET, 2.65 to 2.40 for EDWIN, and 2.44 to 2.14 for ED Occupancy Rate). CONCLUSION: Our findings suggest limited variation in length of stay or left without being seen between intervals (1 to 4 hours) regardless of which of the 4 crowding estimation tools were used. Consequently, 4 hours may be a reasonable interval for assessing crowding with these tools, which could substantially reduce the burden on ED personnel by requiring less frequent assessment of crowding.

Disparities in chronic medical conditions in the Mid-South.

OBJECTIVE: This study examined differences in socio-demographic characteristics and health behaviors relevant to chronic medical conditions (CMCs) in the Mid-South region (Alabama, Mississippi, Louisiana, Kentucky, Tennessee, and Arkansas), and identified subpopulations with increased burden of chronic disease. METHODS: Data were obtained from the 2013 Behavioral Risk Factor Surveillance System. The top five most prevalent CMCs in the Mid-South were analyzed: asthma, high blood pressure (HBP), obesity, arthritis, and depression. Adjusted odds ratios (AOR) and confidence intervals (CI) of race-gender combinations were estimated using logistic regression. Differences in associations between socio-demographic characteristics and CMCs according to income were also examined. RESULTS: The weighted prevalence estimates of the top five CMCs ranged from 66% (asthma) to 20% (depression). Higher income and employment were associated with better outcomes in all five CMCs. Higher educational attainment and physical activity were associated with better HBP, obesity, and arthritis status. Black and white females had higher odds of asthma compared to white males (black AOR = 1.7, CI: 1.1-2.6, white AOR = 1.7, CI: 1.3-2.2). Black males had lower odds of arthritis (AOR = 0.8, CI: 0.6-0.9), while white females had higher odds (AOR = 1.3, CI: 1.2-1.4). Similarly, the odds of depression were lower among black males (AOR = 0.5, CI: 0.4-0.6) and higher among white females (AOR = 2.2, CI: 2.0-2.5). Income-related differences by race were observed for HBP and obesity. CONCLUSION: Disparities in CMCs are associated with income and disproportionately affect the black population. In the Mid-South, race and gender disparities in the top five chronic conditions are more prominent among higher-income rather than lower-income individuals.

The role of patient perception of crowding in the determination of real-time patient satisfaction at Emergency Department.

OBJECTIVE: To evaluate the associations between real-time overall patient satisfaction and Emergency Department (ED) crowding as determined by patient percepton and crowding estimation tool score in a high-volume ED. DESIGN: A prospective observational study. SETTING: A tertiary acute hospital ED and a Level 1 trauma center. PARTICIPANTS: ED patients. INTERVENTION(S): Crowding status was measured by two crowding tools [National Emergency Department Overcrowding Scale (NEDOCS) and Severely overcrowded-Overcrowded-Not overcrowded Estimation Tool (SONET)] and patient perception of crowding surveys administered at discharge. MAIN OUTCOME MEASURE(S): ED crowding and patient real-time satisfaction. RESULTS: From 29 November 2015 through 11 January 2016, we enrolled 1345 participants. We observed considerable agreement between the NEDOCS and SONET assessment of ED crowding (bias = 0.22; 95% limits of agreement (LOAs): -1.67, 2.12). However, agreement was more variable between patient perceptions of ED crowding with NEDOCS (bias = 0.62; 95% LOA: -5.85, 7.09) and SONET (bias = 0.40; 95% LOA: -5.81, 6.61). Compared to not overcrowded, there were overall inverse associations between ED overcrowding and patient satisfaction (Patient perception OR = 0.49, 95% confidence limit (CL): 0.38, 0.63; NEDOCS OR = 0.78, 95% CL: 0.65, 0.95; SONET OR = 0.82, 95% CL: 0.69, 0.98). CONCLUSIONS: While heterogeneity exists in the degree of agreement between objective and patient perceived assessments of ED crowding, in our study we observed that higher degrees of ED crowding at admission might be associated with lower real-time patient satisfaction.

Contrast-Enhanced Ultrasound Classification of Previously Indeterminate Renal Lesions.

OBJECTIVES: To determine the utility of contrast-enhanced ultrasound (US) for characterizing renal lesions that were indeterminate on prior imaging. METHODS: This Institutional Review Board-approved retrospective diagnostic accuracy study evaluated all patients who underwent renal contrast-enhanced US examinations from 2006 to 2015 at our tertiary care hospital. We compared the number of lesions definitively characterized by contrast-enhanced US with the indeterminate lesions by prior imaging. The accuracy of contrast-enhanced US was compared with the final diagnosis by histologic examination and follow-up (mean, 3.63 years). Accuracy and agreement estimates were compared with the exact binomial distribution to assess statistical significance. RESULTS: A total of 134 lesions were evaluated with contrast-enhanced US, and 106 were indeterminate by preceding computed tomography, magnetic resonance imaging, or US. Only the largest lesion per patient was included in analysis. A total of 95.7% (90 of 94) of the previously indeterminate lesions were successfully classified with contrast-enhanced US. The sensitivity was 100% (20 of 20; 95% confidence interval [CI], 83%-100%; P < .0001); specificity was 85.7% (18 of 21; 95% CI, 62%-97%; P = .0026); positive predictive value was 87.0% (20 of 23; 95% CI, 66%-97%; P = .0005); negative predictive value was 100% (18 of 18; 95% CI, 81%-100%; P < .001); and accuracy was 90.2% (37 of 41; 95% CI, 80%-98%; P < .0001). CONCLUSIONS: Contrast-enhanced US has a high likelihood of definitively classifying a renal lesion that is indeterminate by computed tomography, magnetic resonance imaging, or conventional US.

Disparities in Cancer Survivorship Indicators in the Deep South Based on BRFSS Data: Recommendations for Survivorship Care Plans.

OBJECTIVES: The purpose of this investigation was to describe cancer survivorship based on the Behavioral Risk Factor Surveillance System (BRFSS) cancer survivorship modules in Alabama, Georgia, and Mississippi, conducted in 2012 and 2014, and to investigate disparities across the US Deep South region. METHODS: The optional BRFSS cancer survivorship module was introduced in 2009. Data from Alabama (2012), Georgia (2012), and Mississippi (2014) were assessed. Demographic factors were analyzed through weighted regression for risk of receiving cancer treatment summary information and follow-up care. RESULTS: Excluding nonmelanoma skin cancer cases, a total of 1105 adults in the Alabama 2012 survey, 571 adults in the Georgia 2012 survey, and 442 adults in the 2014 Mississippi survey reported ever having cancer and were available for analysis. Among Alabamians, those with a higher level of education (odds ratio [OR] 1.4, 95% confidence interval [CI] 1.1-1.7) and higher income (OR 1.3, 95% CI 1.1-1.6) were more likely to receive a written summary of their cancer treatments. Adults older than age 65 were only half as likely to receive a written summary of cancer treatments compared with adults 65 years or younger (OR 0.5, 95% CI 0.3-0.8). We found no significant differences in receipt of treatment summary by race or sex. Among those who reported receiving instructions from a doctor for follow-up care, these survivors tended to have a higher level of education, higher income, and were younger (younger than 65 years). Receipt of written or printed follow-up care was positively associated with higher income (OR 1.4, 95% CI 1.1-1.8) and inversely associated with age older than 65 years (OR 0.9, 95% CI 0.1-0.6) in Georgia. CONCLUSIONS: Addressing the gap identified between survivorship care plan development by the health team and the delivery of it to survivors is important given the evidence of disparities in the receipt of survivorship care plans across survivor age and socioeconomic status in the Deep South.

Treatment Summaries and Follow-Up Care Instructions for Cancer Survivors: Improving Survivor Self-Efficacy and Health Care Utilization.

BACKGROUND: Treatment summaries and follow-up care plan information should be provided to cancer survivors. This study examines the association of receiving summaries and care plans with cancer survivor self-efficacy for chronic illness management, and whether self-efficacy was associated with health care utilization. METHODS: Four hundred forty-one cancer survivors (≥2 years from diagnosis and had completed treatment) ≥65 years old from 12 cancer centers across 5 states completed telephone surveys. Survivors responded to three questions about receiving a written treatment summary, written follow-up plan, and an explanation of follow-up care plans. Respondents completed the Stanford Chronic Illness Management Self-Efficacy Scale and reported emergency room visits and hospitalizations in the past year. Three multiple linear regression models estimated the association of written treatment summary, written follow-up care plan, and verbal explanation of follow-up plan with total self-efficacy score. Log-binomial models estimated the association of self-efficacy scores with emergency room visits and hospitalizations (yes/no). RESULTS: Among survivors, 40% and 35% received a written treatment summary and follow-up care plan, respectively. Seventy-nine percent received an explanation of follow-up care plans. Receiving a verbal explanation of follow-up care instructions was significantly associated with higher self-efficacy scores (ß = 0.72, p = .009). Higher self-efficacy scores were significantly associated with lower prevalence ratios of emergency room visits (prevalence ratio, 0.92; 95% confidence interval, 0.88-0.97) and hospitalizations (prevalence ratio, 0.94; 95% confidence interval, 0.89-0.99). CONCLUSION: Explanation of the follow-up care plan, beyond the written component, enhances survivor self-efficacy for managing cancer as a chronic condition-an important mediator for improving health care utilization outcomes. IMPLICATIONS FOR PRACTICE: Older cancer survivors (>65 years) are especially vulnerable to poor outcomes in survivorship because of the complexity of follow-up care and other chronic conditions. Delivering written treatment summaries, written follow-up care plans, and verbal explanations of follow-up care plans all independently increased the self-efficacy for chronic illness management among older survivors. In particular, delivering this information in the verbal format was significantly associated with higher self-efficacy and, subsequently, a lower likelihood of emergency room visits. Understanding the mechanism through which summaries and follow-up care plans may positively influence survivor health is critical to increasing the delivery of the information.

A pilot study of pNGVL4a-CRT/E7(detox) for the treatment of patients with HPV16+ cervical intraepithelial neoplasia 2/3 (CIN2/3).

OBJECTIVE: The purpose of this study was to evaluate the safety, efficacy, and immunogenicity of a plasmid vaccine, pNGVL4a-CRT-E7(detox), administered either intradermally, intramuscularly, or directly into the cervical lesion, in patients with HPV16-associated CIN2/3. METHODS: Eligible patients with HPV16(+) CIN2/3 were enrolled in treatment cohorts evaluating pNGVL4a-CRT-E7(detox), administered by either particle-mediated epidermal delivery (PMED), intramuscular injection (IM), or cervical intralesional injection, at study weeks 0, 4, and 8. Patients were monitored for local injection site and systemic toxicity. A standard therapeutic resection was performed at week 15. The primary endpoints were safety and tolerability. Secondary endpoints included histologic regression and change in cervical HPV viral load. Exploratory endpoints included immune responses in the blood and in the target tissue. RESULTS: Thirty-two patients with HPV16(+) CIN2/3 were enrolled onto the treatment phase of the study, and were vaccinated. Twenty-two of 32 patients (69%) experienced vaccine-specific related adverse events. The most frequent vaccine-related events were constitutional and local injection site in nature, and were grade 1 or less in severity. Histologic regression to CIN 1 or less occurred in 8 of 27 (30%) patients who received all vaccinations and underwent LEEP. In subject-matched comparisons, intraepithelial CD8+ T cell infiltrates increased after vaccination in subjects in the intralesional administration cohort. CONCLUSION: pNGVL4a-CRT-E7(detox) was well-tolerated, elicited the most robust immune response when administered intralesionally, and demonstrated preliminary evidence of potential clinical efficacy.