Pediatric Delirium and All-Cause PICU Readmissions Within 1 Year.

OBJECTIVES: Delirium in critically ill children is associated with increased in-hospital morbidity and mortality. Little is known about the lingering effects of pediatric delirium in survivors after hospital discharge. The primary objective of this study was to determine whether children with delirium would have a higher likelihood of all-cause PICU readmission within 1 calendar year, when compared with children without delirium. DESIGN: Retrospective cohort study. SETTING: Tertiary care, mixed PICU at an urban academic medical center. PATIENTS: Index admissions included all children admitted between September 2014 and August 2015. For each index admission, any readmission occurring within 1 year after PICU discharge was captured. INTERVENTION: Every child was screened for delirium daily throughout the PICU stay. MEASUREMENTS AND MAIN RESULTS: Among 1,145 index patients, 166 children (14.5%) were readmitted at least once. Bivariate analyses compared patients readmitted within 1 year of discharge with those not readmitted: complex chronic conditions (CCCs), increased severity of illness, longer PICU length of stay, need for mechanical ventilation, age less than 6 months, and a diagnosis of delirium were all associated with subsequent readmission. A multivariable logistic regression model was constructed to describe adjusted odds ratios for readmission. The primary exposure variable was number of delirium days. After controlling for confounders, critically ill children who experienced greater than 2 delirium days on index admission were more than twice as likely to be readmitted (adjusted odds ratio, 2.2; CI, 1.1-4.4; p = 0.023). A dose-response relationship was demonstrated as children with longer duration of delirium had increased odds of readmission. CONCLUSIONS: In this cohort, delirium duration was an independent risk factor for readmission in critically ill children. Future research is needed to determine if decreasing prevalence of delirium during hospitalization can decrease need for PICU readmission.

Quantitative Electroencephalographic Markers of Delirium in the Pediatric Intensive Care Unit: Insights From a Heterogenous Convenience Sample.

OBJECTIVE: Little is known about the underlying neurophysiology of pediatric delirium. In adult patients, the sensitivity of EEG to clinical symptoms of delirium has been noted, with a slowing of background activity (alpha) and an increase in slow-wave activity (delta-theta). In this pilot study, the authors extended this investigation to a pediatric cohort. METHODS: In a convenience sample, 23 critically ill children were screened for delirium, using the Cornell Assessment for Pediatric Delirium (CAPD), every 12 hours throughout their pediatric intensive care unit stay as part of standard intensive care unit procedure, and EEGs were performed as part of their clinical care. After hospital discharge, EEGs were reviewed using quantitative analysis, and the maximum delta-alpha ratio (DAR; eyes closed) was derived for each 12-hour period. DAR values were compared between delirious and nondelirious episodes, and the linear relationship between DAR and CAPD was assessed. RESULTS: Higher DARs were associated with episodes of delirium. The DAR also positively correlated with CAPD assessments, with higher DARs relating to higher delirium scores. CONCLUSIONS: Future prospective studies may further investigate this relationship in a more homogeneous and larger sample, and the DAR should be considered to track delirium and assess the effectiveness of therapeutic interventions.

Association Between Pediatric Delirium and Quality of Life After Discharge.

OBJECTIVE: Delirium occurs frequently in critically ill children, with highest rates reported in children under 5 years old. The objective of this study was to measure the residual effect of delirium on quality of life at 1 and 3 months after hospital discharge. DESIGN: Prospective observational cohort study. SETTING: Urban academic PICU. PATIENTS: Children younger than five years of age at time of admission to the PICU. INTERVENTIONS: All children were screened for delirium (using the Cornell Assessment for Pediatric Delirium) throughout their stay in the PICU. Quality of life was measured using the Infant-Toddler Quality of Life questionnaire at three time points: baseline, 1 month, and 3 months after hospital discharge. Infant-Toddler Quality of Life scores were compared between children who did and did not develop delirium. MEASUREMENTS AND MAIN RESULTS: Two hundred seven children were enrolled. One hundred twenty-two completed the 1-month follow-up, and 117 completed the 3-month follow-up. Fifty-six children (27%) developed delirium during their PICU stay. At follow-up, Infant-Toddler Quality of Life scores for the PICU cohort overall were consistently lower than age-related norms. When analyzed by delirium status, children who had experienced delirium scored lower in every quality of life domain when compared with children who did not experience delirium. Even after controlling for severity of illness, delirious patients demonstrated an average 11-point lower general health score than nondelirious patients (p = 0.029). CONCLUSION: This pilot study shows an independent association between delirium and decreased quality of life after hospital discharge in young children.

Anxiety and Type 1 Diabetes Management: Guardian and Child Report in a Pediatric Endocrinology Clinic.

BACKGROUND: Childhood anxiety prevents optimal diabetes management yet may be underrecognized by guardians. OBJECTIVE: We aimed to investigate associations among anxiety, diabetes treatment adherence, and diabetes symptom control through child and guardian report. METHODS: Cross-sectional pilot study surveying a convenience sample of children (ages 2-21) in a pediatric endocrinology clinic. Behavior Assessment System for Children, Second Edition 2, Self-Care Inventory Report, and Pediatric Quality of Life measured anxiety, diabetes treatment adherence, and diabetes symptom control. Analyses were performed with Spearman correlations. RESULTS: Prevalence of anxiety and related behaviors was higher when reported by children (13% and 24%) vs. guardians (5% and 13%). Child-reported anxiety was associated with worse symptom control in all ages (Pediatric Quality of Life [rs = -0.55, P < 0.01]) and worse treatment adherence in children aged ≤12 (Self-Care Inventory Report [rho = -0.601, P = 0.023]). Guardian-reported anxiety was associated with worse symptom control (Peds QL [rs = -0.38, P = 0.02]). Child- and guardian-reported anxiety were positively correlated (rho = 0.426, P = 0.017)-particularly for children aged >12 (rho = 0.686, P = 0.003)-although not significantly for children ≤ 12 (rho = 0.201, P = 0.473). CONCLUSION: Anxiety in children with type 1 diabetes varies with the domain of diabetes management (treatment adherence vs. symptom control) and reporting source (child vs. guardian). Children aged ≤12 exhibited a stronger relationship between higher anxiety and worse diabetes management with worse treatment adherence and symptom control in the presence of higher anxiety. Guardians of younger children were less effective at recognizing symptoms. Challenges identifying anxiety and its detrimental effects on diabetes management suggest routine screening of anxiety in pediatric endocrinology clinics is especially salient.

C-Reactive Protein and Procalcitonin Levels May Not Predict Delirium in Critically Ill Children.

OBJECTIVES: The objective of this study was to investigate the relationship between C-reactive protein and procalcitonin and the diagnosis of delirium in critically ill children. DESIGN: Retrospective cohort study. SETTING: Tertiary care urban academic PICU. PATIENTS: All PICU patients (ages 0-21 yr) admitted between January 1, 2015, and December 31, 2017, who had a C-reactive protein and/or procalcitonin level drawn within the first 14 days of their PICU stay. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Each patient was screened for delirium and/or coma bid using the Cornell Assessment of Pediatric Delirium. Patient information including demographics, delirium status, and laboratory values were extracted from the electronic medical record. Seven-hundred thirty-four patients were enrolled, with C-reactive protein and procalcitonin levels drawn in 664 and 587 patients, respectively. Thirty-seven percent of patients (n = 274) were delirious on at least one study day. In bivariate analysis, C-reactive protein was not related to either delirium or coma. Procalcitonin was highest on days with coma and lowest on days with delirium. There was no statistically significant relationship between inflammatory markers and any subtype of delirium. CONCLUSIONS: Despite evidence of inflammatory markers being predictive of delirium in adults, in this retrospective pediatric cohort, no association was found between C-reactive protein or procalcitonin levels and development of delirium.

Delirium and Developmental Disability: Improving Specificity of a Pediatric Delirium Screen.

OBJECTIVES: Children with developmental disabilities are at high risk for developing delirium when critically ill. However, existing pediatric delirium screening tools were designed for children with typical development. The objective of this study was to improve the specificity of the Cornell Assessment for Pediatric Delirium, to allow for accurate detection of delirium in developmentally delayed children admitted to the PICU. We hypothesized that the Cornell Assessment for Pediatric Delirium, when combined with fluctuation in level of awareness as measured by the Richmond Agitation-Sedation Scale, would be valid and reliable for the diagnosis of delirium in developmentally delayed children. DESIGN: Prospective observational double-blind cohort study. SETTING: Tertiary care academic PICU. PATIENTS: Children with moderate to severe developmental delay. INTERVENTIONS: Each child was evaluated by the bedside nurse with the Cornell Assessment for Pediatric Delirium once every 12 hours and the Richmond Agitation-Sedation Scale every 4 hours. Cornell Assessment for Pediatric Delirium (score ≥ 9) + Richmond Agitation-Sedation Scale fluctuation (change in Richmond Agitation-Sedation Scale score of at least 2 points during a 24-hr period) was compared with the criterion standard psychiatric evaluation for diagnosis of delirium. MEASUREMENTS AND MAIN RESULTS: Forty children participated; 94 independent paired assessments were completed. The psychiatrists' diagnostic evaluations were compared with the detection of delirium by the Cornell Assessment for Pediatric Delirium and Richmond Agitation-Sedation Scale. Specificity of the Cornell Assessment for Pediatric Delirium + Richmond Agitation-Sedation Scale fluctuation was 97% (CI, 90-100%), positive predictive value of Cornell Assessment for Pediatric Delirium + Richmond Agitation-Sedation Scale fluctuation was 89% (CI, 65-99%); and negative predictive value remained acceptable at 87% (95% CI, 77-94%). In addition, to confirm interrater reliability of the criterion standard, 11 assessments were performed by two or more psychiatrists in a blinded fashion. There was perfect agreement (κ = 1), indicating reliability in psychiatric diagnosis of delirium in developmentally delayed children. CONCLUSION: When used in conjunction with Richmond Agitation-Sedation Scale score fluctuation, the Cornell Assessment for Pediatric Delirium is a sensitive and specific tool for the detection of delirium in children with developmental delay. This allows for reliable delirium screening in this hard-to-assess population.

Impact of anesthesiologist's fellowship status on the risk of general anesthesia for unplanned cesarean delivery.

BACKGROUND: Neuraxial analgesia is preferred over general anesthesia for cesarean delivery (CD), particularly in the presence of a labor epidural catheter. We hypothesize that care by a non-obstetric anesthesiologist as compared to care by an obstetric anesthesiologist is associated with a higher risk for use of general anesthesia for CD for patients with a preexisting labor epidural catheter. METHODS: To determine whether fellowship status of the covering anesthesiologist was a risk factor for general anesthesia, we retrospectively investigated the rate of general anesthesia use in patients with epidural catheters placed for labor analgesia who subsequently required CD. To standardize the practice environment under which these cases occurred, we examined only cases which occurred during coverage by the call team on nights, weekends, and holidays. RESULTS: There were 1820 cases in which a patient had epidural labor analgesia followed by a CD. Nine hundred and twelve cases were covered by an obstetric anesthesiologist and 908 cases were covered by a non-obstetric anesthesiologist. General anesthesia was used in only 16 of these cases. General anesthesia was more likely to be performed by non-obstetric fellowship trained anesthesiologists (1.54% or 14/908 compared to 0.22% or 2/912; P = 0.002). CONCLUSIONS: This investigation suggests that the presence of an obstetric fellowship-trained anesthesiologist may be a predictor of decreased rate of general anesthesia use in patients with preexisting indwelling labor epidural catheters.

Benzodiazepines and Development of Delirium in Critically Ill Children: Estimating the Causal Effect.

OBJECTIVES: Benzodiazepine use may be associated with delirium in critically ill children. However, benzodiazepines remain the first-line sedative choice in PICUs. Objectives were to determine the temporal relationship between administration of benzodiazepines and delirium development, control for time-varying covariates such as mechanical ventilation and opiates, and evaluate the association between dosage of benzodiazepines and subsequent delirium. DESIGN: Retrospective observational study. SETTING: Academic tertiary care PICU. PATIENTS: All consecutive admissions from January 2015 to June 2015. INTERVENTIONS: Retrospective assessment of benzodiazepine exposure in a population that had been prospectively screened for delirium. MEASUREMENTS AND MAIN RESULTS: All subjects were prospectively screened for delirium throughout their stay, using the Cornell Assessment for Pediatric Delirium, with daily cognitive status assigned as follows: delirium, coma, or normal. Multivariable mixed effects modeling determined predictors of delirium overall, followed by subgroup analysis to assess effect of benzodiazepines on subsequent development of delirium. Marginal structural modeling was used to create a pseudorandomized sample and control for time-dependent variables, obtaining an unbiased estimate of the relationship between benzodiazepines and next day delirium. The cumulative daily dosage of benzodiazepines was calculated to test for a dose-response relationship. Benzodiazepines were strongly associated with transition from normal cognitive status to delirium, more than quadrupling delirium rates (odds ratio, 4.4; CI, 1.7-11.1; p < 0.002). Marginal structural modeling demonstrated odds ratio 3.3 (CI, 1.4-7.8), after controlling for time-dependent confounding of cognitive status, mechanical ventilation, and opiates. With every one log increase in benzodiazepine dosage administered, there was a 43% increase in risk for delirium development. CONCLUSIONS: Benzodiazepines are an independent and modifiable risk factor for development of delirium in critically ill children, even after carefully controlling for time-dependent covariates, with a dose-response effect. This temporal relationship suggests causality between benzodiazepine exposure and pediatric delirium and supports limiting the use of benzodiazepines in critically ill children.

Delirium and Mortality in Critically Ill Children: Epidemiology and Outcomes of Pediatric Delirium.

OBJECTIVES: Delirium occurs frequently in adults and is an independent predictor of mortality. However, the epidemiology and outcomes of pediatric delirium are not well-characterized. The primary objectives of this study were to describe the frequency of delirium in critically ill children, its duration, associated risk factors, and effect on in-hospital outcomes, including mortality. Secondary objectives included determination of delirium subtype, and effect of delirium on duration of mechanical ventilation, and length of hospital stay. DESIGN: Prospective, longitudinal cohort study. SETTING: Urban academic tertiary care PICU. PATIENTS: All consecutive admissions from September 2014 through August 2015. INTERVENTIONS: Children were screened for delirium twice daily throughout their ICU stay. MEASUREMENTS AND MAIN RESULTS: Of 1,547 consecutive patients, delirium was diagnosed in 267 (17%) and lasted a median of 2 days (interquartile range, 1-5). Seventy-eight percent of children with delirium developed it within the first 3 PICU days. Most cases of delirium were of the hypoactive (46%) and mixed (45%) subtypes; only 8% of delirium episodes were characterized as hyperactive delirium. In multivariable analysis, independent predictors of delirium included age less than or equal to 2 years old, developmental delay, severity of illness, prior coma, mechanical ventilation, and receipt of benzodiazepines and anticholinergics. PICU length of stay was increased in children with delirium (adjusted relative length of stay, 2.3; CI = 2.1-2.5; p < 0.001), as was duration of mechanical ventilation (median, 4 vs 1 d; p < 0.001). Delirium was a strong and independent predictor of mortality (adjusted odds ratio, 4.39; CI = 1.96-9.99; p < 0.001). CONCLUSIONS: Delirium occurs frequently in critically ill children and is independently associated with mortality. Some in-hospital risk factors for delirium development are modifiable. Interventional studies are needed to determine best practices to limit delirium exposure in at-risk children.

Delirium in Hospitalized Children with Cancer: Incidence and Associated Risk Factors.

OBJECTIVE: To assess the incidence of delirium and its risk factors in hospitalized children with cancer. STUDY DESIGN: In this cohort study, all consecutive admissions to a pediatric cancer service over a 3-month period were prospectively screened for delirium twice daily throughout their hospitalization. Demographic and treatment-related data were collected from the medical record after discharge. RESULTS: A total of 319 consecutive admissions, including 186 patients and 2731 hospital days, were included. Delirium was diagnosed in 35 patients, for an incidence of 18.8%. Risk factors independently associated with the development of delirium included age <5 years (OR = 2.6, P = .026), brain tumor (OR = 4.7, P = .026); postoperative status (OR = 3.3, P = .014), and receipt of benzodiazepines (OR = 3.7,P < .001). Delirium was associated with increased hospital length of stay, with median length of stay for delirious patients of 10 days compared with 5 days for patients who were not delirious during their hospitalization (P < .001). CONCLUSIONS: In this cohort, delirium was a frequent complication during admissions for childhood cancer, and was associated with increased hospital length of stay. Multi-institutional prospective studies are warranted to further characterize delirium in this high-risk population and identify modifiable risk factors to improve the care provided to hospitalized children with cancer.

Cost Associated With Pediatric Delirium in the ICU.

OBJECTIVE: To determine the costs associated with delirium in critically ill children. DESIGN: Prospective observational study. SETTING: An urban, academic, tertiary-care PICU in New York city. PATIENTS: Four-hundred and sixty-four consecutive PICU admissions between September 2, 2014, and December 12, 2014. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: All children were assessed for delirium daily throughout their PICU stay. Hospital costs were analyzed using cost-to-charge ratios, in 2014 dollars. Median total PICU costs were higher in patients with delirium than in patients who were never delirious ($18,832 vs $4,803; p < 0.0001). Costs increased incrementally with number of days spent delirious (median cost of $9,173 for 1 d with delirium, $19,682 for 2-3 d with delirium, and $75,833 for > 3 d with delirium; p < 0.0001); this remained highly significant even after adjusting for PICU length of stay (p < 0.0001). After controlling for age, gender, severity of illness, and PICU length of stay, delirium was associated with an 85% increase in PICU costs (p < 0.0001). CONCLUSIONS: Pediatric delirium is associated with a major increase in PICU costs. Further research directed at prevention and treatment of pediatric delirium is essential to improve outcomes in this population and could lead to substantial healthcare savings.

Association between Platelet Transfusion and Delirium in Critically Ill Children.

Delirium is a frequent, serious, and preventable complication in critically ill children. Inflammation has been implicated as a mechanism for the development of delirium. Platelet transfusions may potentiate the body's pro-inflammatory responses. We hypothesized that receipt of platelets would be associated with delirium development in a pediatric intensive care unit (PICU). We performed a single-center retrospective cohort analysis including children admitted to the PICU between 2014 and 2018 who were transfused platelets within the first 14 days of admission. Data obtained included severity of illness, level of respiratory support, exposure to medications and blood products, as well as daily cognitive status. To account for time-dependent confounding, a marginal structural model (MSM) was constructed to delineate the relationship between platelet transfusion and next-day delirium. MSM demonstrated a 75% increase in the development of next-day delirium after transfusion of platelets (aOR 1.75, 95% CI 1.03-2.97). For every 1 cc/kg of platelet transfused, odds of next-day delirium increased by 9% (odds ratio 1.09, 95% CI 1.03-1.51). We reported an independent association between platelet transfusion and next-day delirium/coma after accounting for time-dependent confounders, with a dose-response effect. Minimizing platelet transfusions as much as clinically feasible may decrease delirium risk in critically ill children.

Does the Type of Reconstruction Matter? A Propensity Score Analysis of Immediate Postmastectomy Implant and Flap Reconstruction.

BACKGROUND: No randomized controlled trials have compared implant and flap reconstruction. Recently, worse longitudinal outcomes have been suggested for flap reconstruction. The authors compared long-term oncologic outcomes of postmastectomy breast reconstruction using propensity score matching. METHODS: A retrospective study of postmastectomy reconstruction was achieved using the Weill Cornell Breast Cancer Registry between 1998 and 2019. Patients were matched using propensity scores based on demographic, clinical, and surgical characteristics. Kaplan-Meier estimates, Cox-regression models, and restricted mean survival times (RMST) were used to evaluate patient outcomes. RESULTS: Before matching, 1395 implant and 586 flap patients were analyzed. No difference in overall survival and recurrence were observed. Multivariable models showed decreased survival for Medicare/Medicaid [hazard ratio (HR), 3.09; 95% CI, 1.63 to 5.87; P < 0.001], pathologic stage II (HR, 2.98; 95% CI, 1.12 to 7.90; P = 0.028), stage III (HR, 4.88; 95% CI, 1.54 to 15.5; P = 0.007), 11 to 20 lymph nodes positive (HR, 3.66; 95% CI, 1.31 to 10.2; P = 0.013), more than 20 lymph nodes positive (HR, 6.41; 95% CI, 1.49 to 27.6; P = 0.013). RMST at 10 years after flap reconstruction showed 2 months of decreased survival time compared with implants (9.56 versus 9.74 years; 95% CI, -0.339 to -0.024; P = 0.024). After matching, 563 implant and 563 flap patients were compared. Reconstruction was not associated with overall survival and recurrence. RMST between implant and flap reconstruction showed no difference in each 5-year interval over 20 years. CONCLUSION: Postmastectomy breast reconstruction was not associated with a difference in long-term oncologic outcomes over a 20-year period. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Delirium in Children Undergoing Hematopoietic Cell Transplantation: A Multi-Institutional Point Prevalence Study.

Introduction: Delirium occurs frequently in adults undergoing hematopoietic cell transplantation, with significant associated morbidity. Little is known about the burden of delirium in children in the peri-transplant period. This study was designed to determine delirium rates, define risk factors (demographic and treatment related), and establish feasibility of multi-institutional bedside screening for delirium in children undergoing hematopoietic cell transplant. Methods: This is a multi-institutional point prevalence study. All subjects were prospectively screened for delirium twice daily using the Cornell Assessment of Pediatric Delirium over a 10-day period. De-identified data, including basic demographics and daily characteristics, were extracted from the electronic medical record. Results: Eleven North American institutions were included, 106 children were enrolled, and 883 hospital days were captured. Delirium screening was successfully completed on more than 98% of the study days. Forty-eight children (45%) developed delirium over the course of the 10-day study. Children were diagnosed with delirium on 161/883 study days, for an overall delirium rate of 18% per day. Higher delirium rates were noted in children <5 years old (aOR 0.41 for children over 5 years), and in association with specific medications (melatonin, steroids, and tacrolimus). Conclusion: Delirium was a frequent occurrence in our study cohort, with identifiable risk factors. Delirium screening is highly feasible in the pediatric hematopoietic cell transplant patient population. A large-scale prospective longitudinal study following children throughout their transplant course is urgently needed to fully describe the epidemiology of pediatric delirium, explore the effects of delirium on patient outcomes, and establish guidelines to prevent and treat delirium in the peri-transplant period.

Sleep in Hospitalized Children With Cancer: A Cross-Sectional Study.

OBJECTIVES: Many children with cancer have repeated and prolonged hospitalizations, and in-hospital sleep disruption may negatively affect outcomes. Our objective for this study was to characterize sleep quality and quantity in hospitalized children with cancer by using parental surveys and actigraphy, to evaluate the association between subjective and objective sleep measures, and to describe hospital-associated risk factors related to poor sleep. METHODS: Cross-sectional study of children aged 0 to 18 years old admitted to a pediatric oncology ward. Parents completed a baseline sleep questionnaire describing their child's sleep at home before hospitalization, followed by daily questionnaires describing their child's sleep for up to 3 nights while in the hospital. A subgroup of children aged 5 to 18 years wore actigraphs during the same time period. Demographic and clinical data were extracted from the electronic medical record. The primary outcome was inadequate sleep, defined by the total sleep duration adjusted for age. RESULTS: Among 56 participants over 135 hospital nights, 66% (n = 37) reported inadequate sleep. Actigraphy was completed on 39 nights (29%), with a median total sleep time of 477 (interquartile range 407-557) minutes. There was a strong correlation between subjective questionnaire measures and actigraphic measures (r = 0.76). No patient-specific demographic factors were related to inadequate sleep. A multivariable model indicated the following hospital-related factors were associated with inadequate sleep: noise (adjusted odds ratio [aOR] 3.0; confidence interval [CI] 1.2-7.7), alarms (aOR 3.1; CI 1.2-8.3), child's worries (aOR 2.8; CI 1.1-7.2), and receipt of benzodiazepines (aOR 2.9; CI 1.2-7.5). CONCLUSIONS: A majority of children experienced inadequate sleep during hospitalization. Subjective report of sleep duration correlated well with objective measures of sleep by actigraphy. Several potentially modifiable factors were independently associated with poor sleep. Further interventional studies are required to test approaches to optimize sleep in hospitalized children with cancer.

Combination of post-operative radiotherapy and cetuximab for high-risk cutaneous squamous cell cancer of the head and neck: A propensity score analysis.

OBJECTIVES: The objective of this study was to investigate the safety, tolerability and preliminary efficacy of radiotherapy plus cetuximab in high risk CSCC patients. MATERIALS AND METHODS: Patients with high-risk CSCC diagnosed between 2006 and 2013 were analyzed. Patients were divided into two groups: radiotherapy alone versus radiotherapy plus cetuximab. Among 68 patients meeting study criteria, we identified 29 treated with cetuximab plus RT and 39 with RT alone. Primary analysis examined disease-free and overall survival, freedom from local and distant recurrence in the propensity score matched cohort. Propensity score analysis was performed with weighted factors including: Charlson Comorbidity Index score, age. KPS, primary location, T and N stage, recurrent status, margin status, LVSI, PNI and grade. Toxicity was assessed using the CTCAE v4.0. RESULTS: Median follow-up for living patients was 30 months. Patients in the cetuximab group were more likely to have advanced N stage, positive margins and recurrent disease. After propensity score matching the groups were well balanced. Six patients experienced ≥ grade 3 acute toxicity in the cetuximab group. The 1-year, 2-year and 5-year progression free survival (PFS) for patients in the cetuximab group were 86%, 72% and 66%, respectively. The 1-year, 2-year and 5-year overall survival (OS) for patients in the cetuximab group was 98%, 80% and 80%, respectively. CONCLUSIONS: Although limited by small numbers, the combination of cetuximab and radiotherapy in CSCC appears well tolerated there were more long-term survivors and less distant metastasis in the cetuximab group. These promising finding warrant further studies.

Radiation Oncology Physician Practice in the Modern Era: A Statewide Analysis of Medicare Reimbursement.

INTRODUCTION: In recent years, major changes in health care policy have affected oncology practice dramatically. In this context, we examined the effect of practice structure on volume and payments for radiation oncology services using the 2013 Medicare Provider Utilization and Payment Data: Physician and Other Supplier Public Use File (POSPUF) for New York State radiation oncologists. METHODS: The Medicare POSPUF data was queried, and individual physicians were classified into freestanding office-based and hospital-based practices. Freestanding practices were further subdivided into urology, hematology-oncology, and other ownership structures. Additional variables analyzed included gender, year of medical school graduation, and Herfindahl-Hirschman Index (HHI). Statistical analyses were performed to assess the impact of the above-mentioned variables on reimbursements. RESULTS: There were 236 New York State radiation oncologists identified in the 2013 Medicare POSPUF dataset, with a total reimbursement of $91,525,855. Among freestanding centers, the mean global Medicare reimbursement was $832,974. Global Medicare reimbursement was $1,328,743 for urology practices, compared to $754,567 for hematology-oncology practices and $691,821 for other ownership structures (p < 0.05). The mean volume of on-treatment visits (OTVs) was 240.5 per year, varying by practice structure. The mean annual OTV volumes for urology practices, hematology-oncology practices, other freestanding practices, and hospital-based programs were 424.6, 311.5, 247.5, and 209.3, respectively. After correcting for gender, physician experience, and HHI, practice structure was predictive of freestanding reimbursement and on treatment visit volume. CONCLUSION: Higher Medicare payment was significantly predicted by the type of practice structure, with urology-based and hematology-oncology practices accounting for the highest total reimbursement and OTV volume.

First Clinical Report on Comparative Treatment and Survival Outcomes in Second Cancers after Primary Head and Neck Cancer: A Population-Based Study.

INTRODUCTION: To compare patients' survival of second primary malignancy (SPM) after head and neck squamous cell carcinoma (HNSCC). METHODS: The Surveillance, Epidemiology, and End Results (SEER) database was utilized (1973-2011). The Kaplan-Meier method with log-rank test was used to compare the overall survival (OS) and cause-specific survival (CSS) among treatment methods from the time of diagnosis of SPMs. Cox proportional regression models were used to adjust the impact for risk factors on CSS. RESULTS: A total of 3,038 patients were identified (5-yr OS 22.6% (21.0-24.3%)). For head and neck (HN) SPMs, the patients who received 'conservative surgery with radiation' had the best 5-yr OS (65.2% (48.9-86.9%)); and the 'conservative surgery' group had the best 5-yr CSS (89.9% (85.6-94.5%)). For lung SPMs, the 'radical surgery' group showed the best survival (2-yr OS 60.8% (56.0-66.1%), 2-yr CSS 70.6% (65.8-75.8%), respectively). Esophagus SPMs had poor prognosis, with no difference among the treatment groups. In lung SPMs, younger age (p<0.001) and black race (p<0.05) were most favorable CSS predictors. CONCLUSIONS: The prognosis of SPMs after HNSCC is worse compared with corresponding primary tumor. Conservative surgery with or without radiation showed the most favorable outcomes in HN SPMs.​.

Low adoption of weight loss medications: A comparison of prescribing patterns of antiobesity pharmacotherapies and SGLT2s.

OBJECTIVE: To characterize the adoption of antiobesity pharmacotherapies, as compared with that of the newest antidiabetes pharmacotherapy, subtype 2 sodium-glucose transport protein inhibitors (SGLT2s), among prescribers in the United States. METHODS: A retrospective analysis of 2012 to 2015 data extracted from the IMS Health National Prescription Audit™ and Xponent™ assessed adoption rates of antiobesity pharmacotherapies and SGLT2s. RESULTS: The number of dispensed antidiabetes prescriptions was 15 times the number of dispensed antiobesity prescriptions. The antiobesity market share was: 74.0% phentermine, 18.6% new antiobesity pharmacotherapies. The mean increase in prescriptions/month were: 25,259 for SGLT2s, 5,154 for new antiobesity pharmacotherapies, and 2,718 for phentermine. Medical specialties prescribing the majority of the analysis medications were Family Medicine/General Practice and Internal Medicine. Endocrinology had the highest prevalence of prescribers of any subspecialty. CONCLUSIONS: The adoption rate of SGLT2s was nearly exponential, while the adoption rate of new antiobesity pharmacotherapies was linear. Considering the relative prevalence of obesity to diabetes and that obesity is a major cause of diabetes, these results are paradoxical and suggest systematic barriers against the prescribing of antiobesity pharmacotherapies. The under-prescribing of antiobesity pharmacotherapies is widely acknowledged, but this is the first prescription data of these new medications to demonstrate its extent in the United States.