Autologous stem cell boost improves persistent immune effector cell associated hematotoxicity following BCMA directed chimeric antigen receptor T (CAR T) cell therapy in multiple myeloma.

Persistent Immune Effector Cell Associated Hematotoxicity (ICAHT) is a significant side effect of BCMA CAR T-Cell therapy in patients with relapsed multiple myeloma (MM). The use of stem cell boosts in ICAHT has been described, however studies have been limited by small patient numbers and short follow up. Herein, we report on our multi-institutional experience of ICAHT, defined by an absolute neutrophil count (ANC) of ≤ 1000, thrombocytopenia with a platelet count ≤ 50,000 or/and anemia as hemoglobin (hgb) ≤9 g/dL, in patients who received BCMA CAR T therapy, and the effects of subsequent stem cell boost on hematopoietic reconstitution and clinical outcome. In this study, ICAHT was observed in 60% (n = 61/101) of patients at D + 21, and risk factors for its development included history of a prior ASCT, higher number of prior lines of therapy, a decreased platelet count prior to lymphodepletion and history of ICANS. 28% of patients with ICAHT received a stem cell boost at a median of 116 days due to profound and prolonged cytopenias often requiring ongoing transfusion support. Stem cell boost significantly improved cytopenias at 3 and 6 months follow up without any adverse effects on PFS and OS, underscoring the safety of this procedure.

Asthma as a Risk Factor for Hospitalization in Children and Youth With COVID-19: A Retrospective Cohort Study.

BACKGROUND: Studies examining the association between asthma and hospitalization among children and youth with coronavirus disease 2019 (COVID-19) have yielded mixed results. Both asthma and COVID-19 hospitalization are characterized by racial, ethnic and socioeconomic disparities which also pattern geographically, yet no studies to date have adjusted for neighborhood context in the assessment of this association. METHODS: Mixed effects logistic regression was used to estimate the association between asthma and hospitalization due to COVID-19 in a sample of 28,997 children and youth diagnosed with COVID-19 in Milwaukee County, Wisconsin, from March 1, 2020, to May 31, 2022. Models adjusted for individual-level sociodemographic factors (age, gender, race, ethnicity and city/suburb residence) and season of diagnosis were examined as moderators. Random intercepts by census tract accounted for geographic variation in neighborhood factors and census tract-level measures of education, health and environment, and social and economic factors were assessed via childhood opportunity indices. RESULTS: Asthma history was statistically significantly associated with hospitalization due to COVID-19 among children and youth. Hospitalization rates varied statistically significantly by census tract, and results were unchanged after accounting for childhood opportunity indices and census tract. Season of diagnosis was not found to moderate the effect of asthma history on COVID-19 hospitalization. CONCLUSION: Our study suggests that asthma history is a risk factor for hospitalization in the context of COVID-19 infection among children and youth, warranting observation and follow-up of children with asthma as well as continued measures to prevent COVID-19 in this population.

Auto-diuresis Predicts Return of Bowel Function.

PURPOSE: Feeding a ventral hernia repair (VHR) patient before the return of bowel function (ROBF) can lead to distention and emesis. Many patients spontaneously diurese after surgery. We hypothesized that this auto-diuresis would signal ROBF. MATERIALS AND METHODS: A total of 395 patients who underwent open, laparoscopic, or mixed VHR were evaluated for correlation between fluid status and ROBF or discharge. ROBF within 24 hours and discharge within 24 hours or 48 hours were used as outcome measures. RESULTS: Patients remained an average 3.59 days after surgery in the hospital and the average ROBF was on day 2.99. The first shift of ≥700 mL of urine predicted ROBF ( P =0.03) and discharge ( P =0.04) within 24 hours. The first shift output of ≥500 mL predicted discharge within 48 hours ( P =0.02). CONCLUSION: Auto-diuresis after surgery is correlated to ROBF and discharge. Accurate fluid measurement can predict bowel function and allow early diet and discharge.

Evaluation of anti-factor Xa concentrations using a body mass index-based enoxaparin dosing protocol for venous thromboembolism prophylaxis in trauma patients.

OBJECTIVE: The aim of this study was to evaluate the effectiveness of a body mass index (BMI)-based enoxaparin prophylaxis dosing protocol at achieving target anti-factor Xa (anti-Xa) concentrations in the trauma population. METHODS: This retrospective chart review evaluated anti-Xa concentrations in adult trauma patients who received prophylactic enoxaparin over a three-month period. The primary outcome was the percentage of patients that achieved target anti-Xa concentrations after ≥3 doses of enoxaparin. Secondary outcomes included correlations of anti-Xa concentrations with enoxaparin dose per BMI, total body weight (TBW), and estimated blood volume (EBV). The prevalence of clinically relevant bleeding and venous thromboembolism was also recorded. Multivariable logistic regression was used to identify associated variables for target anti-Xa concentration attainment. RESULTS: Ninety-nine consecutive patients were included in the study. Included patients were predominately male (69.7%) and Black (50.5%) with a mean age of 44.1 years. Target anti-Xa concentrations were achieved in 62.6% of patients. Anti-Xa concentrations were moderately correlated with enoxaparin dose per EBV (ρ = 0.57), followed by dose per TBW (ρ = 0.46), and dose per BMI (ρ = 0.20). Multivariable logistic regression demonstrated that categorization of enoxaparin dose per EBV and per TBW were the only statistically significant predictors of reaching target anti-Xa concentrations (p = <0.001). CONCLUSIONS: In adult trauma patients, the rate of achieving target anti-Xa concentrations remains suboptimal and provides room for further improvement. Enoxaparin dose per EBV was more closely correlated with anti-Xa concentrations when compared to TBW and BMI. Dosing per EBV and TBW was the only variables associated with reaching target anti-Xa concentrations within the study. Further investigation is warranted to elucidate optimal EBV- and TBW-based dosing regimens.

Extending INR testing intervals in warfarin patients at a multi-center anticoagulation clinic.

Warfarin has been used as an anticoagulant by millions of patients due to its effectiveness, availability, and low cost. Evidence on the safe extension of international normalized ratio (INR) testing frequency remains an area of interest, especially during the recent COVID-19 pandemic. The purpose of this study is to safely extend INR testing intervals in patients throughout a multisite, system-wide anticoagulation clinic. Updates were made to the pharmacist's collaborative practice agreement (CPA) and nurse protocol to optimize practice and allow INR testing interval extension up to a maximum of 8-weeks. The primary outcome was the change in duration between INR tests (INR testing interval) measured before and after providing staff education on clinic updates. The mean duration between INR tests (SD) was 23.69 days (11.29) in the pre-intervention period and 25.58 days (13.91) in the post-intervention period. During the COVID-19 pandemic (post2), intervals were extended further to 27.81 days (14.96), demonstrating a statistically significant increase in INR testing interval from pre-intervention to post-intervention and to post2 (p < 0.001 and p < 0.001, respectively). A secondary outcome indicated the mean time in therapeutic range (SD) showed no significant difference in pre-intervention 70.11% (25.95) versus post-intervention of 69.76% (25.69) with a difference of - 0.35% (29.93) (p = 0.956) or versus the post2 of 68.82% (27.20) with a difference of - 1.29% (33.20) (p = 0.120). This study showed that changes to the CPA and protocol allowed for a significant increase in INR testing interval while simultaneously maintaining a mean time in therapeutic range > 60% for the clinic population.

Characterization of Underrepresented Populations in Modern Era Clinical Trials Involving Radiation Therapy.

PURPOSE: The demographic composition of modern radiation therapy (RT) clinical trials is incompletely studied. Understanding and minimizing disparities in clinical trials is critical to ensure health equity and the generalizability of research findings. METHODS AND MATERIALS: Clinicaltrials.gov was searched to identify RT clinical trials that occurred from 1996 to 2019. A total of 1242 trials were reviewed for patient characteristics. The demographic composition of the studies was summarized by the frequency and percentage of patients by race, gender, and ethnicity. The racial composition of the study population was compared with the 2018 US Census using a 1-sample χ2 test. Subgroup racial composition was compared using χ2 tests of independence. Analyses used a complete case approach. RESULTS: A total of 122 trials met the inclusion criteria, and 121 of these (99.1%) reported race. Trial subgroups included 63 trials in the United States (51.6%), 9 proton therapy trials (7.4%), 34 RT toxicity mitigation or prevention trials (27.9%), 24 trials for female cancer (19.7%), and 17 trials for male cancer (13.9%). US clinical trials overall, US RT toxicity mitigation or prevention trials, US trials for female cancer, and US trials for male cancer had significantly different racial compositions compared with the 2018 US Census data (P < .001 for all). Compared with all clinical trials, those for proton therapy had the largest magnitude of significantly lower enrollment of participants who identified their race as Black, Asian, or other (P < .001). CONCLUSIONS: This study characterized the racial composition of prospective RT clinical trials in a modern cohort. The racial population represented across multiple categories in the United States differed significantly from US census data and was most pronounced in trials evaluating proton therapy. This is a benchmark study for future efforts to characterize and balance the participation of underrepresented populations in RT clinical trials.

Pediatric Feeding Disorder: A Nationwide Prevalence Study.

OBJECTIVE: To assess the prevalence of pediatric feeding disorder (PFD) in US children. STUDY DESIGN: We conducted a retrospective cohort study of Medicaid Databases from Arizona (2009-2017) and Wisconsin (2005-2014) (public insurance databases) and The Truven Health Analytics MarketScan Commercial Claims and Encounters Database (2009-2015) (a nationwide private insurance database). Diagnoses and procedures were identified from inpatient and outpatient claims using the International Classification of Diseases (ICD)-9 and ICD-10 diagnostic codes and ICD and Current Procedural Terminology-4 procedure codes. Children with PFD were identified by presence of 1 or more PFD diagnosis and absence of any eating disorder diagnoses within a calendar year. RESULTS: We identified 126 002 and 367 256 children 5 years of age or younger with PFD with public and private insurance, respectively. Over a 5-year period (2009-2014) the prevalences of PFD in children with public insurance in Arizona and Wisconsin were 32.91 (95% CI, 32.61-33.20) and 34.73 (95% CI, 34.37-35.09) children per 1000 child-years, respectively. Similarly, the prevalence of PFD in private insurance carriers was 21.07 (95% CI, 21.00-21.14) children per 1000 child-years. The prevalence trends showed a significant linear increase in children within both insurance cohorts. In 2014, the annual prevalence of PFD was 1 in 23, 1 in 24, and 1 in 37 in children under 5 years in the publicly insured cohorts in Wisconsin, Arizona, and the privately insured cohort, respectively. CONCLUSIONS: The prevalence of feeding disorders in the US rivals that of commonly diagnosed conditions such as eating disorders and autism.

Comparison of Attitudes of Wisconsin Health Care Providers and Pharmacists Toward Vaccine Administration and Perceived Barriers.

OBJECTIVE: To measure the attitudes of pharmacists and other health care providers towards vaccine administration, overall acceptance of pharmacists as immunization providers, and perceived immunization barriers in Wisconsin. METHODS: The authors conducted a cross-sectional study utilizing an online survey to assess the attitudes of pharmacists and other health care providers toward their role as immunization providers and perceived barriers to providing immunizations. The survey was distributed between November 2018 and February 2019. RESULTS: Two hundred thirty-six pharmacists and 51 other health care providers completed the survey. Of the pharmacists who responded, 203 (86%) provided immunizations. Most respondents (97.9% of pharmacists and 90.2% of other health care providers) see vaccinations as a shared professional responsibility. Both pharmacists (82.6%) and other health care providers (79.6%) believe pharmacists have adequate training to administer vaccines to patients. Immunizing pharmacists identified 2 primary barriers to providing immunizations: patients refusing vaccines for financial reasons (55%) and patients not having insurance coverage for vaccines received in a pharmacy (55%). In contrast, the primary barrier identified by non-immunizing pharmacists is other responsibilities taking precedence over vaccinating (75%). Other health care providers identified determining whether their patients' insurance will reimburse for a vaccine (52%) as their primary barrier toward providing immunizations. CONCLUSION: These surveys provide a baseline measure of the attitudes of Wisconsin pharmacists and other health care providers toward immunization provision and offer opportunities for comparison. Our findings highlight barriers, such as insurance coverage for immunizations, that may prevent pharmacists from increasing vaccination rates in Wisconsin.

Racial and Ethnic Variation Associated With Human Papillomavirus Genotype in Anal Dysplasia.

BACKGROUND: Human Papillomavirus (HPV) is known to cause dysplasia and cancer. In cervical disease, there are documented differences in prevalence of HPV genotypes among racial/ethnic groups. Little is known about prevalence of HPV genotypes in anal dysplasia. This study aimed to evaluate association between HPV genotypes and race/ethnicity in a racially heterogenous population with anal dysplasia. METHODS: This was a single-institution retrospective review of patients treated for anal dysplasia between 2008 and 2019. HPV genotype, obtained via anal swab testing, was recorded as HPV 16, HPV 18, or other non-16/18 high-risk (HR) HPV genotypes. Univariate and multivariate logistic regression analyses were used to evaluate the association between patient factors and HPV genotype. RESULTS: Of 517 patients meeting inclusion criteria, 46.8% identified as White, 37.1% as Black, 13.2% as Hispanic, and 2.9% as other/unknown. Race/ethnicity (P = 0.016) and sex (P < 0.001) were significantly associated with differences in prevalence of HPV genotypes. Black (odds ratio 1.56, 95% confidence interval 1.00-2.44) and male (odds ratio 2.35, 95% confidence interval 1.42-3.92) patients were significantly more likely to have non-16/18 HR HPV genotypes. CONCLUSIONS: In a racially and socioeconomically diverse cohort of patients with anal dysplasia, Black race and male sex were associated with increased likelihood of infection with a non-16/18 HR HPV genotype. Many of these genotypes are not covered by currently available vaccines. Further study is warranted to evaluate anal HPV genotypes in a larger cohort, as this may have important implications in HPV vaccination and anal dysplasia screening efforts.

Immunizations at Wisconsin Pharmacies: Results of a statewide vaccine registry analysis and pharmacist survey.

BACKGROUND: There is currently limited data in the United States on the proportion of immunization doses given at pharmacies outside the influenza vaccine. This study aims to obtain baseline information on the percentage of vaccine doses administered at pharmacies in Wisconsin and to understand the immunization barriers for Wisconsin pharmacists, to inform interventions to increase immunization access at pharmacies. METHODS: Aggregated data from the Wisconsin Immunization Registry (WIR) was obtained for all vaccines administered at pharmacies to patients over the age of six from July 2017 through June 2018. In addition, a survey on attitudes towards and barriers to vaccination was sent to 2000 Wisconsin pharmacists with 236 respondents yielding a 12% response rate. RESULTS: WIR data demonstrates that zoster and influenza vaccines have the highest proportion of doses administered at pharmacies (39% and 20%, respectively). Human papillomavirus (HPV) vaccines have the lowest proportion of doses at 0.2%. Pharmacy survey shows that 86% provide immunizations. Most stock influenza vaccines (84%), whereas much fewer stock HPV vaccines (21%). The greatest immunization barriers for the pharmacy respondents include billing and reimbursement challenges and competing demands for staff. CONCLUSIONS: Despite the barriers, community pharmacies have significant potential to address vaccination gaps. Physicians, patients, and legislative bodies are generally well-accepting of pharmacists as immunizers. Pharmacists, in order to be fully utilized as immunizers, must engage in active communication with patients and be willing to collaborate with physicians. Legislative policy and health insurance reimbursement reforms are also necessary to facilitate further pharmacist participation in immunization.

Non-parametric recurrent events analysis with BART and an application to the hospital admissions of patients with diabetes.

Much of survival analysis is concerned with absorbing events, i.e., subjects can only experience a single event such as mortality. This article is focused on non-absorbing or recurrent events, i.e., subjects are capable of experiencing multiple events. Recurrent events have been studied by many; however, most rely on the restrictive assumptions of linearity and proportionality. We propose a new method for analyzing recurrent events with Bayesian Additive Regression Trees (BART) avoiding such restrictive assumptions. We explore this new method via a motivating example of hospital admissions for diabetes patients and simulated data sets.

Dosimetric Predictors of Cardiotoxicity in Thoracic Radiotherapy for Lung Cancer.

BACKGROUND: Higher cardiac radiotherapy (RT) doses when treating lung cancer are associated with worse overall survival (OS), although the direct association between cardiac dose and early cardiotoxicity is poorly understood. We hypothesized that RT doses to the heart and cardiac substructures are associated with under-reported early cardiotoxicity and worse OS. PATIENTS AND METHODS: We conducted an institutional retrospective review of lung cancer patients treated with conventionally fractionated RT from 2010 to 2015. Collected data included pre-RT cardiac risk factors, post-RT cardiotoxicities, and dose-volume parameters for cardiac substructures. Univariate and multivariate analyses were performed to identify predictors of cardiotoxicity and OS. RESULTS: Seventy-six cases were evaluated with 1.2 years median follow-up. Cardiotoxicities included atrial arrhythmia (n = 5), pericardial effusion (n = 16), and valvular disease (n = 1). In univariate analysis, significant dose-volume predictors for cardiotoxicity included mean RT dose to structure of interest, volume of structure of interest receiving ≥30 Gy RT dose, and volume of structure of interest receiving ≥45 Gy RT dose (V45) to the atria, ventricles, and pericardium. Higher ventricular V45 was associated with post-RT cardiotoxicity in multivariate analysis (hazard ratio [HR], 1.50; P = .027). Cardiotoxicity occurrence was a highly significant predictor of OS in multivariate analysis (HR, 12.7; P < .001), but higher ventricular V45 alone was not (HR, 0.78; P = .450). CONCLUSION: Early cardiac events were relatively common after lung cancer RT and associated with multiple cardiac dose-volume parameters. Occurrence of early cardiotoxicity was strongly associated with worse OS. In practice, early cardiotoxicity is under-reported, supporting the need for more detailed cardiac evaluations in high-risk patients to detect and address early cardiotoxicity.

Alvimopan is associated with decreased length of stay for both open and laparoscopic segmental colectomy.

BACKGROUND: Alvimopan has been shown to reduce length of stay after bowel resection. Use remains variable among institutions due to cost and efficacy concerns in laparoscopic surgery. Additionally, alvimopan's effects have not been isolated from other medications within enhanced recovery protocols. The aim of this study was to distinguish the relationship between alvimopan use, length of stay, and cost in both open and laparoscopic segmental colectomies. METHODS: The Vizient dataset was queried to identify patients undergoing open and laparoscopic colectomies from 2015 to 2017. Patient demographics and treatment details were collected. Primary outcomes of interest included duration of stay and total direct costs. RESULTS: In the study, 12,727 patients met inclusion criteria and 3,358 (26.4%) received alvimopan. For both open and laparoscopic groups, alvimopan was associated with decreased length of stay in unadjusted (4.0 vs 6.0 days, P < .01 and 3.0 vs 4.0 days, P < .01, respectively) and adjusted analysis (effect ratio 0.79, P < .01 and 0.85, P < .01, respectively). Alvimopan was associated with a 7% decrease in direct cost after adjustment (effect ratio 0.93, P = .04), with no cost difference in laparoscopic procedures (effect ratio 0.99, P = .71). CONCLUSION: Alvimopan use is associated with decreased length of stay for both open and laparoscopic colon resections, decreased cost in open procedures, and no cost difference for laparoscopic procedures.

Implementation and evaluation of high-dose methotrexate administration guidelines.

BACKGROUND: High-dose methotrexate is used to treat a variety of malignancies. Methotrexate-associated supportive care and the threshold methotrexate level for the discontinuation of supportive care are not consistent among studies. We evaluated the implementation of high-dose methotrexate administration guidelines, which raised the standard threshold methotrexate level for the discontinuation of supportive care from <0.05 to <0.1 µmol. METHODS: A single-center, observational analysis of patients receiving high-dose methotrexate from 1 January 2015 to 31 May 2017 was conducted. The primary endpoint was time from the start of the methotrexate infusion until the discontinuation of the sodium bicarbonate infusion, before and after guideline implementation. RESULTS: Fifty-two patients met the inclusion criteria, which comprised of a total of 136 individual methotrexate doses and were included in the retrospective analysis. Twenty-four patients were included in the prospective analysis, which comprised a total of 46 individual methotrexate doses. The primary endpoint, time until discontinuation of the sodium bicarbonate infusion, was a median of 97.7 h in the retrospective group versus 73.2 h in the prospective group (p = 0.098). Secondary endpoints also favored patients in the prospective group, including hours of hospitalization, number of methotrexate levels checked, weight gained during admission, and adherence to the guideline. CONCLUSION: Among patients who received high-dose methotrexate, implementation of a guideline using a methotrexate threshold of <0.1 µmol was able to significantly decrease the time to discontinuation of supportive care and subsequently may lead to early hospital discharge given that we did not show a statistical significance.

Atrial fibrillation after transhiatal esophagectomy with transcervical endoscopic esophageal mobilization: one institution's experience.

BACKGROUND: There have been numerous studies regarding atrial fibrillation (AF) associated with cardiac and pulmonary surgery; however, studies looking at esophagectomy and atrial fibrillation are sparse. The goal of this study was to review our institution's atrial fibrillation rate following esophagectomy in order to better define the incidence and predisposing factors in this patient population. METHODS: A retrospective chart review of all patients undergoing esophagectomy with transcervical endoscopic mobilization of the esophagus (TEEM) at the Medical College of Wisconsin and Affiliated Hospitals from July 2009 through December 2012. RESULTS: Seventy-one patients underwent TEEM esophagectomy during the study period. Of those, 23 (32.4%) patients developed new atrial fibrillation postoperatively. ICU (Intensive Care Unit) length of stay was 7.1 days for those that did not receive amiodarone, compared to 5.3 days for those that did receive amiodarone (p < 0.025). Those that went into AF spent on average 9.3 days in the ICU compared to 4.7 days for their counterparts that did not go into AF (p < 0.006). Total length of stay was not statistically different between populations [15.1 +/- 11.3 days compared to 13.5 +/- 9.4 days for those who did not go into AF (p < 0.281)]. Receiving preoperative amiodarone was found to reduce the overall incidence of AF. There was a trend towards decreased risk of going into AF in those who received preoperative amiodarone with an adjusted hazard ratio of 0.555 (p = 0.057). CONCLUSION: Similar to data reported in previous literature, postoperative atrial fibrillation was found to increase ICU length of stay as well as overall length of hospital stay. Preoperative amiodarone administration displayed a trend toward decreasing the rates of atrial fibrillation in patients undergoing TEEM.

A 5-item frailty index based on NSQIP data correlates with outcomes following paraesophageal hernia repair.

BACKGROUND: Frailty is a measure of physiologic reserve associated with increased vulnerability to adverse outcomes following surgery in older adults. The 'accumulating deficits' model of frailty has been applied to the NSQIP database, and an 11-item modified frailty index (mFI) has been validated. We developed a condensed 5-item frailty index and used this to assess the relationship between frailty and outcomes in patients undergoing paraesophageal hernia (PEH) repair. METHODS: The NSQIP database was queried for ICD-9 and CPT codes associated with PEH repair. Subjects ≥60 years who underwent PEH repair between 2011 and 2013 were included. Five of the 11 mFI items present in the NSQIP data on the most consistent basis were selected for the condensed index. Univariate and multivariate logistic regressions were used to determine the validity of the 5-item mFI as a predictor of postoperative mortality, complications, readmission, and non-routine discharge. RESULTS: A total of 3711 patients had data for all variables in the 5-item index, while 885 patients had complete data to calculate the 11-item mFI. After controlling for competing risk factors, including age, ASA score, wound classification, surgical approach, and procedure timing (emergent vs non-emergent), we found the 5-item mFI remained predictive of 30-day mortality and patients being discharged to a location other than home (p < 0.05). A weighted Kappa was calculated to assess agreement between the 5-item and 11-item mFI and was found to be 0.8709 (p < 0.001). CONCLUSIONS: Frailty, as assessed by the 5-item mFI, is a reasonable alternative to the 11-item mFI in patients undergoing PEH repair. Utilization of the 5-item mFI allows for a significantly increased sample size compared to the 11-item mFI. Further study is necessary to determine whether the condensed 5-item mFI is a valid measure to assess frailty for other types of surgery.

Association of Locoregional Control With High Body Mass Index in Women Undergoing Breast Conservation Therapy for Early-Stage Breast Cancer.

PURPOSE: Obesity, as measured by the body mass index (BMI), is a risk factor for distant recurrence and decreased survival in breast cancer. We sought to determine whether the BMI correlated with local recurrence and reduced survival in a cohort of predominantly obese women treated with breast conservation therapy. METHODS AND MATERIALS: From 1998 to 2010, 154 women with early-stage invasive breast cancer and 39 patients with ductal carcinoma in situ underwent prone whole breast irradiation. Cox proportional hazards regression, Kaplan-Meier methods with the log-rank test, and multivariate analysis were used to explore the association of the outcomes with the BMI. RESULTS: The median patient age was 60 years, and the median follow-up duration was 73 months. The median BMI was 33.2 kg/m(2); 91% of the patients were overweight (BMI ≥25 kg/m(2)) and 69% of the patients were clinically obese (BMI ≥30 kg/m(2)). The BMI was significantly associated with the locoregional recurrence-free interval for patients with invasive cancer and ductal carcinoma in situ (hazard ratio [HR], 1.09; P=.047). Also, a trend was seen for increased locoregional recurrence with a higher BMI (P=.09) for patients with invasive disease, which was significant when examining the outcomes with a BMI stratified by the median value of 33.2 kg/m(2) (P=.008). A greater BMI was also significantly associated with decreased distant recurrence-free interval (HR, 1.09; P=.011) and overall survival (HR, 1.09; P=.004); this association remained on multivariate analysis (distant recurrence-free interval, P=.034; overall survival, P=.0007). CONCLUSIONS: These data suggest that the BMI might affect the rate of locoregional recurrence in breast cancer patients. A higher BMI predicted a worse distant recurrence-free interval and overall survival. The present investigation adds to the increasing evidence that BMI is an important prognostic factor in early-stage breast cancer treated with breast conservation therapy.

The impact of frailty on outcomes of paraesophageal hernia repair.

BACKGROUND: Frailty is a measure of physiological reserve that has been used to predict outcomes after surgical procedures in the elderly. We hypothesized that frailty would be associated with outcomes after paraesophageal hernia (PEH) repair. METHODS: The National Surgical Quality Improvement Program database (2011-2013) was queried for International Classification of Diseases, Version 9 and Current Procedural Terminology codes associated with PEH repair in patients aged ≥ 60 y. A previously described modified frailty index (mFI), based on 11 clinical variables in National Surgical Quality Improvement Program was used to quantify frailty. Multivariate logistic regression was used to determine the relationship between frailty, complications, and mortality. RESULTS: Of the 4434 PEH repairs that met inclusion criteria, 885 records were included in the final analysis (20%). Excluded patients were missing one or more variables in the mFI. The rate of complications that were Clavien-Dindo Grade ≥ 3 was 6.1%. Mortality was 0.9%. The readmission rate was 8.2%, and 10.9% of patients were discharged to a facility other than home. Relative to mFI scores of 0, 1, 2, and ≥3, the respective occurrence percentages were as follows; Grade ≥3 complication: 3.2%, 4.7%, 9.8%, and 23.3% (P < 0.0001; odds ratio [OR] 3.51; confidence interval [CI] 1.46-8.46); mortality: 0.0%, 0.9%, 1.8%, and 2.3% (P = 0.0974); discharge to facility other than home: 4.4%, 10.9%, 15.7%, and 31.7% (P < 0.0001; OR 4.07; CI 1.29-12.82); and readmission: 8.9%, 6.8%, 8.5%, and 16.3% (P = 0.1703; OR 1.01; CI 0.36-2.84). Complications and discharge destination were significantly correlated with the mFI. CONCLUSIONS: Frailty, as assessed by the mFI, is correlated with postoperative complications and discharge to a facility other than home after PEH repair.

Intrathecal Baclofen Dosing Regimens: A Retrospective Chart Review.

OBJECTIVES: To examine dosing patterns in patients receiving baclofen via intrathecal baclofen pumps to assess for common patterns by diagnosis, ambulation ability, and affected limbs distribution. MATERIALS AND METHODS: This trial study included 25 patients with baclofen pumps selected from the 356 patients enrolled in our center's baclofen pump program. Selection was done by splitting all patients into diagnostic categories of stroke, multiple sclerosis, traumatic/anoxic brain injury, cerebral palsy, and spinal cord injury, and then, five patients were randomly selected from each diagnosis.A systematic chart review was then conducted for each patient from Jan 1, 2008, through September 16, 2013, to look at factors including mean daily dose at end of study, and among those implanted during the study mean initial stable dose and time to initial stable dose. RESULTS: Analysis of mean daily dose across diagnoses found significant differences, with brain injury, cerebral palsy, and spinal cord injury patients having higher doses while multiple sclerosis and stroke patients required lower doses. Nonambulatory patients strongly trended to have higher daily doses than ambulatory patients. Similar trends of mean initial stable dose being higher in a similar pattern as that of end mean daily dose were seen according to diagnoses and ambulatory status, although statistical significance could not be achieved with the small sample size. CONCLUSION: Significant differences in dosing were found between diagnoses and trended to differ by ambulatory status at the end of the study, and similar trends could be observed in achieving initial stable dose.