Multi-institutional Retrospective Cohort Study Research Articles

Does Sequencing of Adjuvant Therapy Influence Outcome for Stage IIIC Endometrial Carcinoma? A Multi-institutional Analysis

In GOG-258, patients who received upfront chemoradiotherapy had more distant relapses compared to those treated with systemic chemotherapy alone, although vaginal and nodal recurrence rates were lower with the addition of adjuvant radiotherapy (RT). Given the importance of both systemic and local therapies, this study evaluates clinical outcomes by the sequence and type of adjuvant therapy for patients with stage IIIC endometrial cancer (EC). In a multi-institutional retrospective cohort study, clinical and treatment data from 12 academic centers were collected for patients with stage IIIC EC treated with curative intent. All patients had surgical staging and received chemotherapy and radiation. Adjuvant treatment (AT) regimens were classified as: adjuvant chemotherapy followed by sequential radiation (ACTRT), concurrent chemoradiation followed by chemotherapy (CCTRT), systemic chemotherapy before and after RT (Sandwich), adjuvant RT followed by chemotherapy (ARTCT) or chemotherapy concurrent with vaginal cuff brachytherapy alone (CCTBT). Overall survival (OS) and recurrence-free survival (RFS) rates were estimated by Kaplan-Meier method and covariates were compared by log-rank test. Chi-square tests were used to compare categorical variables. A total of 670 eligible patients were included (Table) with a median follow-up of 44.1 months. The estimated 5-year OS and RFS rates were 71.5% and 65.5%, respectively. On univariate analysis (UVA) for OS, older age, non-white race, non-endometrioid histology, grade 3 tumor, 2 or more positive nodes, adnexal involvement, cervical involvement, stage IIIC2 vs. IIIC1, and in-field recurrence were associated with worse OS (all p<0.02). On UVA for RFS, older age, non-endometrioid histology, grade 3 tumor, lymphovascular invasion, adnexal involvement, cervical involvement and stage IIIC2 were associated with recurrence. The sequence and type of adjuvant therapy was not correlated with OS or RFS (p = 0.08 and 0.8, respectively). The most common pattern of recurrence was distant metastasis only (66%). Site of first recurrence was significantly different by adjuvant treatment regimen (p = 0.02): ACTRT, CCTRT and Sandwich had a higher proportion of distant metastasis whereas ARTCT and CCTBT had more para-aortic nodal recurrences. Pelvic control was highest for ACTRT. The sequence and type of adjuvant therapy did not impact OS or RFS rates, which were comparable to those of the prospective GOG 258 and PORTEC-3 studies. Adjuvant radiotherapy resulted in excellent pelvic control. Most recurrences were distant despite upfront systemic chemotherapy given in most patients, highlighting the need for novel regimens.Abstract 102; TableFactornAge, Median62Race Caucasian African-American Other480 83 47Stage IIIC1 IIIC2430 240Histology Endometrioid Non-endometrioid441 229Grade 1-2 3320 346RT EBRT BT Both176 94 400Adjuvant therapy ACTRT CCTRT Sandwich ARTCT CCTBT290 112 165 26 77 Open table in a new tab

Programmed Death Receptor Ligand One Expression May Independently Predict Survival In Non-Small Cell Lung Carcinoma Brain Metastases Patients Receiving Immunotherapy

Programmed death receptor ligand one (PD-L1) expression is known to predict response to PD-1/PD-L1 inhibitors in non-small cell lung cancer (NSCLC). However, the predictive role of this biomarker in brain metastases (BMs) is unknown. The aim of this study was to assess whether PD-L1 expression predicts survival in patients with NSCLC BMs treated with PD-1/PD-L1 inhibitors, after adjusting for established prognostic models. In this multi-institutional retrospective cohort study, we identified NSCLC-BM patients treated with PD-1/PD-L1 inhibitors after local BM treatment (radiotherapy or neurosurgery) but before intracranial progression. Cox proportional hazards models were used to assess predictive value PD-L1 expression for overall survival (OS) and intracranial progression free survival (IC-PFS). Forty-eight BM patients with available PD-L1 expression were identified. PDL1 expression was positive in 33 patients (69%). Median survival was 26 months. In univariable analysis, PD-L1 predicted favorable OS (HR = 0.44; 95% CI 0.19 – 1.02; p = 0.055). This effect persisted after correcting for lung-graded prognostic assessment (lung-GPA) and other identified potential confounders (HR = 0.24; 95% CI = 0.10 – 0.61; p = 0.002). Moreover, when modeled as a continuous variable, there appeared to be a proportional relationship between percentage of PD-L1 expression and survival (HR = 0.86 per 10% expression, 95% CI 0.77 – 0.98, p = 0.02). In contrast, PD-L1 expression did not predict IC-PFS in uni- or multivariable analysis (adjusted HR = 0.54, 95% CI 0.26 – 1.14, p = 0.11). In patients with NSCLC-BMs treated with PD-1/PD-L1 checkpoint inhibitors and local treatment, PD-L1 expression may predict OS independent of lungGPA. IC-PFS did not show association with PD-L1 expression, although the present analysis may lack power to assess this. Larger studies are required to validate these findings.

A multi-institutional analysis of sternoclavicular joint coverage following osteomyelitis.

BackgroundSternoclavicular joint (SCJ) osteomyelitis is a rare pathology requiring urgent intervention. Several operative approaches have been described with conflicting reports. Here, we present a multi-institutional study utilizing multiple surgical pathways for SCJ reconstruction.MethodsA multi-institutional retrospective cohort study was conducted to identify patients who underwent surgical repair for sternoclavicular osteomyelitis between 2008 and 2019. Patients were stratified according to reconstruction approach: single-stage reconstruction with advancement flap and delayed-reconstruction with flap following initial debridement. Demographics, operative approach, type of reconstruction, and postoperative outcomes were analyzed.ResultsThirty-two patients were identified. Mean patient age was 56.2±13.8 years and 68.8% were male. The average body mass index (BMI) was 30.0±8.8 kg/m2. The most common infection etiologies were intravenous drug use and bacteremia (both 25%). Fourteen patients (43.8%) underwent one-stage reconstruction and 18 (56.2%) underwent delayed twostaged reconstruction. Both single and delayed-stage groups had comparable rates of reinfection (7.1% vs. 11.1%, respectively), surgical site complications (21.4% vs. 27.8%), readmissions (7.1% vs. 16.6%), and reoperations (7.1% vs. 5.6%; all P>0.05). The single-stage reconstruction group had a significantly lower BMI (26.2±5.7 kg/m2 vs. 32.9±9.1 kg/m2; P<0.05) and trended towards shorter hospital length of stay (11.3 days vs. 17.9 days; P=0.01).ConclusionsBoth single and delayed-stage approaches are appropriate methods with comparable outcomes for reconstruction for SCJ osteomyelitis. When clinically indicated, a single-stage reconstruction approach may be preferable in order to avoid a second operation as associated with the delayed phase, and possibly shortening total hospital length of stay.

Concomitant gastrostomy tube insertion during laparoscopic Nissen fundoplication for gastro-esophageal reflux disease: analysis of risk factors for fundoplication failure.

Laparoscopic Nissen fundoplication(LNF) and gastrostomy tube (GT) placement may be performed concomitantly in children with gastro-esophageal reflux disease (GERD) and failure to thrive. We aimed to evaluate the rate and risk factors for LNF failure in children undergoing concomitant LNF/GT. A retrospective multi-institutional cohort study was conducted, reviewing patients that underwent LNF (2005-2014). Data collected included patient demographics, comorbidities, and type of GT (laparoscopy- or endoscopy-assisted). The primary outcome measure was LNF failure. Data was compared using contingency tables or Mann-Whitney tests, when appropriate. An exploratory analysis by Kaplan-Meier survival and Cox proportional hazards analysis was performed to determine predictors of time to LNF failure after LNF/GT. Of 189 children that underwent LNF, 99 (52%) had a concomitant GT (55% laparoscopy-, 45% endoscopy-assisted). LNF failed in 15% after LNF/GT and in 17% after LNF alone (p = 0.84), at a median age of 23months (IQR 8-41). Using univariate analysis, we found that a younger age at the time of surgery (p = 0.05), prematurity (p = 0.0018), esophageal atresia (p = 0.01), and endoscopy-assisted GT (p = 0.02) were potential predictors of LNF failure after LNF/GT. After multivariate regression analysis, prematurity (p = 0.007) remained significantly associated with LNF failure after LNF/GT. No predictive factors for LNF failure after LNF alone were identified. Concomitant GT insertion and LNF is a common practice, as half of the children that undergo LNF also received GT insertion. Children born preterm or with esophageal atresia comprise a fragile population at high-risk of LNF failure after LNF/GT. Prospective, multicentric studies are needed to evaluate the best GT technique to use in children undergoing LNF.

Number of nodal metastases and the American Joint Committee on cancer staging of head and neck cutaneous squamous cell carcinoma: A multicenter study.

We aimed to determine if the number of nodal metastases is an independent predictor of survival in HNcSCC, whether it provides additional prognostic information to the AJCC N and TNM stage and identify optimal cut-points for risk stratification. Retrospective multi-institutional cohort study of patients with parotid and/or cervical nodal metastases from HNcSCC treated with curative intent by surgery ± adjuvant therapy. The impact of number of nodal metastases on disease-specific and overall survival was assessed using multivariate Cox regression. Optimal cut-points for prognostic discrimination modelled using the AIC, BIC, C-index and PVE. The study cohort included 1128 patients, with 962 (85.3%) males, median age of 72.9 years (range: 18-100 years) and median follow-up 3.4 years. Adjuvant radiotherapy was administered to 946 (83.9%) patients. Based on objective measures of model performance, number of nodal metastases was classified as 1-2 (N = 816), 3-4 (N = 162) and ≥5 (N = 150) nodes. In multivariate analyses, the risk of disease-specific mortality progressively increased with 3-4 nodes (HR, 1.58; 95% CI: 1.03-2.42; p = 0.036) and ≥5 nodes (HR, 2.91; 95% CI: 1.99-4.25; p < 0.001) with similar results for all-cause mortality. This simple categorical variable provided superior prognostic information to the TNM stage. Increasing number of nodal metastases is an independent predictor of mortality in HNcSCC, with categorization as 1-2, 3-4 and ≥5 nodes optimizing risk stratification and providing superior prognostic information to TNM stage. These findings may aid in the development of future staging systems as well as identification of high-risk patients in clinical trials.

75. PROGRAMMED DEATH RECEPTOR LIGAND ONE EXPRESSION MAY INDEPENDENTLY PREDICT SURVIVAL IN NON-SMALL CELL LUNG CARCINOMA BRAIN METASTASES PATIENTS RECEIVING IMMUNOTHERAPY

BACKGROUNDProgrammed death receptor ligand one (PD-L1) expression is known to predict response to PD-1/PD-L1 inhibitors in non-small cell lung cancer (NSCLC). However, the predictive role of this biomarker in brain metastases (BMs) is unknown. The aim of this study was to assess whether PD-L1 expression predicts survival in patients with NSCLC BMs treated with PD-1/PD-L1 inhibitors, after adjusting for established prognostic models.METHODSIn this multi-institutional retrospective cohort study, we identified NSCLC-BM patients treated with PD-1/PD-L1 inhibitors after local BM treatment (radiotherapy or neurosurgery) but before intracranial progression. Cox proportional hazards models were used to assess predictive value PD-L1 expression for overall survival (OS) and intracranial progression free survival (IC-PFS).RESULTSForty-eight BM patients with available PD-L1 expression were identified. PD-L1 expression was positive in 33 patients (69%). Median survival was 26 months. In univariable analysis, PD-L1 predicted favorable OS (HR = 0.44; 95% CI 0.19 – 1.02; p = 0.055). This effect persisted after correcting for lung-graded prognostic assessment (lung-GPA) and other identified potential confounders (HR = 0.24; 95% CI = 0.10 – 0.61; p = 0.002). Moreover, when modeled as a continuous variable, there appeared to be a proportional relationship between percentage of PD-L1 expression and survival (HR = 0.86 per 10% expression, 95% CI 0.77 – 0.98, p = 0.02). In contrast, PD-L1 expression did not predict IC-PFS in uni- or multivariable analysis (adjusted HR = 0.54, 95% CI 0.26 – 1.14, p = 0.11).CONCLUSIONSIn patients with NSCLC-BMs treated with PD-1/PD-L1 checkpoint inhibitors and local treatment, PD-L1 expression may predict OS independent of lung-GPA. IC-PFS did not show association with PD-L1 expression, although the present analysis may lack power to assess this. Larger studies are required to validate these findings.

Institutional variation in recovery after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy: An opportunity for enhanced recovery pathways.

Variations in care have been demonstrated both within and among institutions in many clinical settings. By standardizing perioperative practices, Enhanced Recovery After Surgery (ERAS) pathways reduce variation in perioperative care. We sought to characterize the variation in cytoreductive surgery (CRS)/heated intraperitoneal chemotherapy (HIPEC) perioperative practices among experienced US medical centers. Data from the US HIPEC Collaborative represents a retrospective multi-institutional cohort study of CRS and CRS/HIPEC procedures performed from 12 major academic institutions. Patient characteristics and perioperative practices were reported and compared. Institutional variation was analyzed using hierarchical mixed-effects linear (continuous outcomes) or logistic (binary outcomes) regression models. A total of 2372 operations were included. CRS/HIPEC was performed most commonly for appendiceal histologies (64.2%). The rate of complications (overall 56.3%, range: 31.8-70.9) and readmissions (overall 20.6%, range: 8.9-33.3) varied by institution (P < .001). Institution-level variation in perioperative practice patterns existed among measured ERAS pathway process/outcomes (P < .001). The percentages of variation with each process/outcome measure attributable solely to institutional practices ranged from 0.6% to 66.6%. Significant variation exists in the perioperative care of patients undergoing CRS/HIPEC at major US academic institutions. These findings provide a strong rationale for the investigation of best practices in CRS/HIPEC patients.

Small renal masses in Latin-American population: characteristics and prognostic factors for survival, recurrence and metastasis \u2013 a multi-institutional study from LARCG database

BackgroundTo evaluate demographic, clinical and pathological characteristics of small renal masses (SRM) (≤ 4 cm) in a Latin-American population provided by LARCG (Latin-American Renal Cancer Group) and analyze predictors of survival, recurrence and metastasis.MethodsA multi-institutional retrospective cohort study of 1523 patients submitted to surgical treatment for non-metastatic SRM from 1979 to 2016. Comparisons between radical (RN) or partial nephrectomy (PN) and young or elderly patients were performed. Kaplan-Meier curves and log-rank tests estimated 10-year overall survival. Predictors of local recurrence or metastasis were analyzed by a multivariable logistic regression model.ResultsPN and RN were performed in 897 (66%) and 461 (34%) patients. A proportional increase of PN cases from 48.5% (1979–2009) to 75% (after 2009) was evidenced. Stratifying by age, elderly patients (≥ 65 years) had better 10-year OS rates when submitted to PN (83.5%), than RN (54.5%), p = 0.044. This disparity was not evidenced in younger patients. On multivariable model, bilaterality, extracapsular extension and ASA (American Society of Anesthesiologists) classification ≥3 were predictors of local recurrence. We did not identify significant predictors for distant metastasis in our series.ConclusionsPN is performed in Latin-America in a similar proportion to developed areas and it has been increasing in the last years. Even in elderly individuals, if good functional status, sufficiently fit to surgery, and favorable tumor characteristics, they should be encouraged to perform PN. Intending to an earlier diagnosis of recurrence or distant metastasis, SRM cases with unfavorable characteristics should have a more rigorous follow-up routine.

Racial Disparity in Postpartum Readmission due to Hypertension among Women with Pregnancy-Associated Hypertension.

Postpartum hypertension is a leading cause of readmission in the postpartum period. We aimed to examine the prevalence of racial/ethnic differences in postpartum readmission due to hypertension in women with antepartum pregnancy-associated hypertension. This was a multi-institutional retrospective cohort study of all women with antepartum pregnancy-associated hypertension diagnosed prior to initial discharge from January 2009 to December 2016. Antepartum pregnancy-associated hypertension, such as gestational hypertension, preeclampsia (with or without severe features), hemolysis, elevated liver enzyme, low platelet (HELLP) syndrome, and eclampsia was diagnosed based on American College of Obstetricians and Gynecologists Task Force definitions. Women with chronic hypertension and superimposed preeclampsia were excluded. Our primary outcome was postpartum readmission defined as a readmission due to severe hypertension within 6 weeks of postpartum. Risk factors including maternal age, gestational age at admission, insurance, race/ethnicity (self-reported), type of antepartum pregnancy-associated hypertension, marital status, body mass index (kg/m2), diabetes (gestational or pregestational), use of antihypertensive medications, mode of delivery, and postpartum day 1 systolic blood pressure levels were examined. Multivariable logistic regression models were performed to calculate adjusted odds ratios (aORs) and 95% confidence intervals (95% CIs). Of 4,317 women with pregnancy-associated hypertension before initial discharge, 66 (1.5%) had postpartum readmission due to hypertension. Risk factors associated with postpartum readmission due to hypertension included older maternal age (aOR = 1.44; 95% CI: 1.20-1.73 for every 5 year increase) and non-Hispanic black race (aOR = 2.12; 95% CI: 1.16-3.87). In women with pregnancy-associated hypertension before initial discharge, non-Hispanic black women were at increased odds of postpartum readmission due to hypertension compared with non-Hispanic white women.

Programmed Death Receptor Ligand One Expression May Independently Predict Survival in Patients With Non-Small Cell Lung Carcinoma Brain Metastases Receiving Immunotherapy

Programmed death receptor ligand 1 (PD-L1) expression is known to predict response to PD-1/PD-L1 inhibitors in non-small cell lung cancer (NSCLC). However, the predictive role of this biomarker in brain metastases (BMs) is unknown. The aim of this study was to assess whether PD-L1 expression predicts survival in patients with NSCLC BMs treated with PD-1/PD-L1 inhibitors, after adjusting for established prognostic models. In this multi-institutional retrospective cohort study, we identified patients with NSCLC-BM treated with PD-1/PD-L1 inhibitors after local BM treatment (radiation therapy or neurosurgery) but before intracranial progression. Cox proportional hazards models were used to assess the predictive value of PD-L1 expression for overall survival (OS) and intracranial progression-free survival (IC-PFS). Forty-eight patients with BM with available PD-L1 expression were identified. PD-L1 expression was positive in 33 patients (69%). Median survival was 26 months. In univariable analysis, PD-L1 predicted favorable OS (hazard ratio [HR], 0.44; 95% confidence interval [CI], 0.19-1.02; P = .055). This effect persisted after correcting for lung-graded prognostic assessment and other identified potential confounders (HR, 0.24; 95% CI, 0.10-0.61; P = .002). Moreover, when modeled as a continuous variable, there appeared to be a proportional relationship between percentage of PD-L1 expression and survival (HR, 0.86 per 10% expression; 95% CI, 0.77-0.98; P = .02). In contrast, PD-L1 expression did not predict IC-PFS in uni- or multivariable analysis (adjusted HR, 0.54; 95% CI, 0.26-1.14; P = .11). In patients with NSCLC-BMs treated with PD-1/PD-L1 checkpoint inhibitors and local treatment, PD-L1 expression may predict OS independent of lung-graded prognostic assessment. IC-PFS did not show association with PD-L1 expression, although the present analysis may lack power to assess this. Larger studies are required to validate these findings.

Characteristics and outcomes of children with congenital heart disease needing diaphragm plication.

Diaphragm dysfunction following surgery for congenital heart disease is a known complication leading to delays in recovery and increased post-operative morbidity and mortality. We aimed to determine the incidence of and risk factors associated with diaphragm plication in children undergoing cardiac surgery and evaluate timing to repair and effects on hospital cost and length of stay. We conducted a multi-institutional retrospective observational cohort study. Forty-three hospitals from the Pediatric Health Information System database were included, and a total of 112,110 patients admitted between January 2004 and December 2014 were analysed. Patients less than 18 years of age who underwent cardiac surgery were included. Risk Adjustment for Congenital Heart Surgery was utilized to determine procedure complexity. The overall incidence of diaphragm dysfunction was 2.2% (n = 2513 out of 112,110). Of these, 24.0% (603 patients) underwent diaphragm plication. Higher complexity cardiac surgery (Risk Adjustment for Congenital Heart Surgery 5-6) and age less than 4 weeks were associated with a higher likelihood of diaphragm plication (p-value < 0.01). Diaphragmatic plication was associated with increased hospital length of stay (p-value < 0.01) and increased medical cost. Diaphragm plication after surgery for congenital heart disease is associated with longer hospital length of stay and increased cost. There is a strong correlation of prolonged time to plication with increased length of stay and medical cost. The likelihood of plication increases with younger age and higher procedure complexity. Methods to improve early recognition and treatment of diaphragm dysfunction should be developed.

Prognostic ability of the sequential organ failure assessment score in accidental hypothermia: a multi-institutional retrospective cohort study

BackgroundSevere accidental hypothermia (AH) is life threatening. Thus, prognostic prediction in AH is essential to rapidly initiate intensive care. Several studies on prognostic factors for AH are known, but none have been established. We clarified the prognostic ability of the Sequential Organ Failure Assessment (SOFA) score in comparison with previously reported prognostic factors among patients with AH.MethodsThe J-point registry database is a multi-institutional retrospective cohort study for AH in 12 Japanese emergency departments. From this registry, we enrolled patients who were treated at the intensive care unit (ICU) in various critical care medical centers. In-hospital mortality was the primary outcome. We investigated the discrimination ability of each candidate prognostic factor and the in-hospital mortality by applying the logistic regression models with areas under the receiver operating characteristic curve (AUROC) with 95% confidence interval (CI).ResultsOf the 572 patients with AH registered in the J-point registry, 220 were eligible for the analyses. The in-hospital mortality was 23.2%. The AUROC of the SOFA score (0.80; 95% CI: 0.72–0.86) was the highest among all factors. The other factors were serum potassium (0.65; 95% CI: 0.55–0.73), lactate (0.67; 95% CI: 0.57–0.75), quick SOFA (qSOFA) (0.55; 95% CI: 0.46–0.65), systemic inflammatory response syndrome (SIRS) (0.60; 95% CI: 0.50–0.69), and 5A severity scale (0.77; 95% CI: 0.68–0.84).DiscussionAlthough serum potassium and lactate had relatively good discrimination ability as mortality predictors, the SOFA score had slightly better discrimination ability. The reason is that lactate and serum potassium were mainly reflected by the hemodynamic state; conversely, the SOFA score is a comprehensive score of organ failure, basing on six different scores from the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Meanwhile, the qSOFA and SIRS scores underestimated the severity, with low discrimination abilities for mortality.ConclusionsThe SOFA score demonstrated better discrimination ability as a mortality predictor among all known prognostic factors in patients with AH.

Association between dexmedetomidine use for the treatment of alcohol withdrawal syndrome and intensive care unit length of stay

PurposeAlcohol withdrawal syndrome (AWS) is commonly treated in medical ICUs and typically requires high resource utilization. Dexmedetomidine for AWS has not been extensively investigated, and guidelines regarding its use are lacking. We evaluated the association between dexmedetomidine use in AWS and ICU length of stay (LOS).MethodsWe performed a multi-institutional retrospective cohort study of patients in the ICU with the primary diagnosis of AWS. ICU LOS of those treated with benzodiazepines alone vs. benzodiazepines plus dexmedetomidine was compared. Negative binomial regression was performed to test whether dexmedetomidine use was associated with increased ICU LOS after adjustment for age, gender, body mass index, and the time between hospital and ICU admission.ResultsFour hundred thirty-eight patients from eight institutions were included. Patients treated with benzodiazepines plus dexmedetomidine had higher Clinical Institute Withdrawal Assessment for Alcohol scores at ICU admission, spent longer on the medical wards prior to ICU admission, and had longer unadjusted ICU LOS (p < 0.0001). After covariate adjustment, dexmedetomidine remained associated with longer ICU LOS (relative mean to non-dexmedetomidine group 2.14, 95% CI 1.78–2.57, p < 0.0001).ConclusionsCompared to benzodiazepines alone, dexmedetomidine for the treatment of AWS was associated with increased ICU LOS. These results provide evidence that dexmedetomidine may increase resource utilization.

Should Small Cell Carcinoma of the Cervix be Treated As Localized Small Cell Cancer or Advanced Cervical Cancer: A Retrospective Multi-Institutional Cohort Study

Should Small Cell Carcinoma of the Cervix be Treated As Localized Small Cell Cancer or Advanced Cervical Cancer: A Retrospective Multi-Institutional Cohort Study

Pathologic discordance to clinical management decisions suggests overtreatment in pediatric benign breast disease.

Breast masses in pediatric patients are often managed similarly to adult breast masses despite significant differences in pathology and natural history. Emerging evidence suggests that clinical observation is safe. The purpose of this study was to quantify the clinical appropriateness of the management of benign breast disease in pediatric patients. A multi-institutional retrospective cohort study was completed between 1995 and 2017. Patients were included if they had benign breast disease and were 19years old or younger. A timeline of all interventions (ultrasound, biopsy, or excision) was generated to quantify the number of patients who were observed for at least 90days, deemed appropriate care. To quantify inappropriate care, the number of interventions performed within 90days, and the pathologic concordance to clinical decisions was determined by reviewing the radiology reports of all ultrasounds and pathology reports of all biopsies and excisions. A total of 1,909 patients were analyzed. Mean age was 16.4years old (± 2.1). The majority of masses were fibroadenomas (60.4%). Only half of patients (54.3%) were observed for 90 or more days. 81.1% of interventions were unnecessary, with pathology revealing masses that would be safe to observe. The positive predictive value (PPV) of clinical decisions made based on suspicious ultrasound findings was 16.2%, not different than a PPV of 21.9% (p < 0.25) for decisions made on clinical suspicion alone. Despite literature supporting an observation period for pediatric breast masses, half of patients had an intervention within threemonths with one out of ten patients undergoing an invasive procedure within this time frame. Furthermore, 81.1% of invasive interventions were unnecessary based on final pathologic findings. A formal consensus clinical guideline for the management of pediatric benign breast disease including a standardized clinical observation period is needed to decrease unnecessary procedures in pediatric patients with breast masses.

Multicenter Evaluation of a Modular Dual Mobility Construct for Revision Total Hip Arthroplasty

IntroductionModular Dual Mobility (MDM) constructs in total hip arthroplasty (THA) offer increased hip stability compared with constrained liners, without compromising hip range of motion. The purpose of this study was to evaluate outcomes of revision THA using MDM. MethodsThe study was a multiinstitutional retrospective cohort study of 315 hips that underwent revision THA using MDM between 2011 and 2017. Clinical outcomes and reasons for failure were collected. ResultsThree hundred fifteen patients met 1-year minimum follow-up (mean 3.3 years). Nine hips had instability postoperatively (2.9%), and 30 hips required reoperation (9.5%). Seven had recurrent instability (6.5%) which was associated with liner-only exchange (P = .021) and liner outer diameter of ≤ 38 mm (P = .016). ConclusionRevision THA with MDM provided a low rate of instability and reoperation in a revision cohort. Recurrent instability following use of MDM in revision THA was associated with retention of the acetabular component and polyethylene outer diameter ≤ 38 mm. Level of EvidenceTherapeutic Level III.

Variability in perioperative evaluation and resource utilization in pediatric patients with suspected biliary dyskinesia: A multi-institutional retrospective cohort study

IntroductionBiliary dyskinesia (BD) is a common indication for pediatric cholecystectomy. While diagnosis is primarily based on diminished gallbladder ejection fraction (GB-EF), work-up and management in pediatrics is controversial. MethodsWe conducted a multi-institutional retrospective review of children undergoing cholecystectomy for BD to compare perioperative work-up and outcomes. ResultsSix hundred seventy-eight patients across 16 institutions were included. There was no significant difference in gender, age, or BMI between institutions. Most patients were white (86.3%), non-Hispanic (79.9%), and had private insurance (55.2%). Gallbladder ejection fraction (EF) was reported in 84.5% of patients, and 44.8% had an EF <15%. 30.7% of patients were initially seen by pediatric surgeons, 31.3% by pediatric gastroenterologists, and 23.4% by the emergency department with significant variability between institutions (p < 0.001). Symptoms persisted in 35.3% of patients post-operatively with a median follow-up of 21 days (IQR 13, 34). On multivariate analysis, only non-white race and the presence of psychiatric comorbidities were associated with increased risk of post-operative symptoms. ConclusionThere is significant variability in evaluation and follow-up both before and after cholecystectomy for BD. Prospective research with standardized data collection and follow-up is needed to develop and validate optimal care pathways for pediatric patients with suspected BD. Study typeCase Series, Retrospective Review. Level of evidenceLevel IV.

Evaluating Mortality Risk Adjustment Among Children Receiving Extracorporeal Support for Respiratory Failure.

This study evaluates whether three commonly used pediatric intensive care unit (PICU) severity of illness scores, pediatric risk of mortality score (PRISM) III, pediatric index of mortality (PIM) 2, and pediatric logistic organ dysfunction (PELOD), are the appropriate tools to discriminate mortality risk in children receiving extracorporeal membrane oxygenation (ECMO) support for respiratory failure. This study also evaluates the ability of the Pediatric Risk Estimate Score for Children Using Extracorporeal Respiratory Support (Ped-RESCUERS) to discriminate mortality risk in the same population, and whether Ped-RESCUERS' discrimination of mortality is improved by additional clinical and laboratory measures of renal, hepatic, neurologic, and hematologic dysfunction. A multi-institutional retrospective cohort study was conducted on children aged 29 days to 17 years with respiratory failure requiring respiratory ECMO support. Discrimination of mortality was evaluated with the area under the receiver operating curve (AUC); model calibration was measured by the Hosmer-Lemeshow goodness of fit test and Brier score. Admission PRISM-III, PIM-2, and PELOD were found to have poor ability to discriminate mortality with an AUC of 0.56 [0.46-0.66], 0.53 [0.43-0.62], and 0.57 [0.47-0.67], respectively. Alternatively, Ped-RESCUERS performed better with an AUC of 0.68 [0.59-0.77]. Higher alanine aminotransferase, ratio of the arterial partial pressure of oxygen the fraction of inspired oxygen, and lactic acidosis were independently associated with mortality and, when added to Ped-RESCUERS, resulted in an AUC of 0.75 [0.66-0.82]. Admission PRISM-III, PIM-2, and PELOD should not be used for pre-ECMO risk adjustment because they do not discriminate death. Extracorporeal membrane oxygenation population-derived scores should be used to risk adjust ECMO populations as opposed to general PICU population-derived scores.

The impact of recreational marijuana commercialization on traumatic injury

BackgroundThe medical legalization of marijuana has been shown to result in an increased risk of motor vehicle injuries. In Colorado, commercialization of recreational marijuana (initiation of retail sales) occurred on January 1, 2014, resulting in the rapid proliferation of its availability. The objective of this study was to determine whether the proportion of injured patients testing positive for marijuana and other drugs changed two years before and two years after commercialization of recreational marijuana in Colorado.MethodsThis retrospective multi-institutional cohort study included all patients admitted with a traumatic injury to six trauma centers (three centers in Colorado and three centers in states without permissive marijuana laws) from 2012 to 2015. The primary outcome was the rate (%) of a positive urine drug screen (UDS) for marijuana. Generalized linear regression models were used to examine the rate of change over time in the pre-commercialization period relative to the post- commercialization period (via an interaction effect), separately for states with and without recreational marijuana legalization.ResultsThere were 40,591 trauma admissions. In Colorado, the rate of marijuana detected with UDS decreased over time pre-commercialization; this trend reversed post-commercialization, when marijuana detection rates increased significantly over time (interaction p = 0.004). At non-Colorado hospitals, the rate over time of marijuana detection was significantly reduced post-commercialization relative to the pre-commercialization period (p < 0.001).ConclusionThere was an overall increased rate over time of marijuana detected among trauma patients at Colorado hospitals but not at non-Colorado hospitals, suggesting an increased use of marijuana or an increased risk of injury while using marijuana following the commercialization of recreational marijuana in Colorado.

What are the Optimal Radiation Fields for FIGO IIIC Endometrial Cancer? A Multi-Institutional Study

In GOG-258, rates of pelvic & para-aortic (PA) nodal failure were lower with the addition of adjuvant radiation (RT) compared to chemotherapy alone, although details on RT fields have not yet been reported. In patients with node positive endometrial cancer, the selection of pelvic (PRT) vs. extended field RT (EFRT) has yet to be defined. This study evaluates outcomes and sites of failure in patients with FIGO stage IIIC endometrial cancer treated with PRT vs. EFRT. In a multi-institutional retrospective cohort study, we identified 143 patients with FIGO IIIC endometrioid endometrial cancer s/p surgical staging who received adjuvant RT from 1/2000-12/2016. RT fields were reviewed and categorized as EFRT if the superior field border included the renal hilum or PRT if below. Baseline characteristics & outcomes were compared by stage (IIIC1 vs. IIIC2) and RT type (PRT vs. EFRT). Actuarial estimates of RFS & OS were calculated by Kaplan-Meier & compared by logrank. Sites of failure were reported as local (vaginal), regional (pelvic or PA nodal) or distant, & within or outside the RT field. Median follow-up was 59.3 months. Clinical and treatment characteristics for 3 treatments groups are described in Table 1: pelvic node positive (IIIC1) & elective EFRT, pelvic node positive (IIIC1) & PRT, and PA node positive (IIIC2) & EFRT. Recurrence rates were lowest for patients with IIIC1 EFRT (5-year RFS 78.9%), but did not significantly differ from IIIC1 PRT (72.5%) or IIIC2 EFRT (69.3%, p =0.44). The 5-year OS rates were similar by group: 91.7% for IIIC1 EFRT, 86.5% for IIIC1 PRT, and 84.9% for IIIC2 EFRT (p=0.65). Of 31 patients with recurrence, most had distant relapse outside the RT field (16, 52%). In-field recurrences were local (3, 13%), regional (13%) or both (1, 3%). Of 78 IIIC1 patients treated with PRT, 7 patients (9%) had PA failure. Most patients with PA relapse had LVI (86%), ≥50% MMI (71%), & grade 3 disease (57%). Adjuvant RT results in excellent survival outcomes for patients with FIGO IIIC endometrial cancer. For patients with positive pelvic nodes, further study is warranted to determine if those with LVI, deep MMI & grade 3 disease benefit from EFRT.Abstract TU_21_3531; Table 1Patient CharacteristicsIIIC1 EFRTIIIC1 PRTIIIC2 EFRTp-value∗Wilcoxon rank sum, Kruskal-WallisN=32 (22.4%)N = 78 (54.5%)N = 33 (23.1%)Median Age (Range)57.5 (33-84)60.5 (41-78)57 (44-74)0.20Grade1238 (25.0)18 (56.3)6 (18.8)23 (29.5)33 (42.3)22 (28.2)11 (33.3)12 (36.4)10 (30.3)0.58LVI25 (78.1)53 (69.7)23 (71.9)0.77MMI ≥50%23 (71.9)49 (62.8)28 (84.8)0.16Gross residual diseaseInvolved LN VaginalOther01 (3.1)01 (1.3)0012 (36.4)01 (3.0)<.0001Median LNs dissected (Range)11.5 (2-46)13 (1-55)12 (0-39)0.99Median LNs involved (Range)1 (1-5)1 (1-10)3 (0-19)0.59Median EBRT dose in Gy (Range)45 (45-50.4)45 (45-56)45 (21.6-54)0.1Systemic Chemotherapy29 (92)63 (81)33 (100)∗ Wilcoxon rank sum, Kruskal-Wallis Open table in a new tab