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Context: Neonatal abstinence syndrome (NAS) is a postnatal drug withdrawal syndrome primarily caused by maternal opiate use. No national estimates are available for the incidence of maternal opiate use at the time of delivery or NAS.Objectives: To determine the national incidence of NAS and antepartum maternal opiate use and to characterize trends in national health care expenditures associated with NAS between 2000 and 2009.Design, Setting, and Patients: A retrospective, serial, cross-sectional analysis of a nationally representative sample of newborns with NAS. The Kids' Inpatient Database (KID) was used to identify newborns with NAS by International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) code. The Nationwide Inpatient Sample (NIS) was used to identify mothers using diagnosis related groups for vaginal and cesarean deliveries. Clinical conditions were identified using ICD-9-CM diagnosis codes. NAS and maternal opiate use were described as an annual frequency per 1000 hospital births. Missing hospital charges (<5% of cases) were estimated using multiple imputation. Trends in health care utilization outcomes over time were evaluated using variance-weighted regression. All hospital charges were adjusted for inflation to 2009 US dollars.Main Outcome Measures: Incidence of NAS and maternal opiate use, and related hospital charges.Results: The separate years (2000, 2003, 2006, and 2009) of national discharge data included 2920 to 9674 unweighted discharges with NAS and 987 to 4563 unweighted discharges for mothers diagnosed with antepartum opiate use, within data sets including 784,191 to 1.1 million discharges for children (KID) and 816,554 to 879,910 discharges for all ages of delivering mothers (NIS). Between 2000 and 2009, the incidence of NAS among newborns increased from 1.20 (95% CI, 1.04-1.37) to 3.39 (95% CI, 3.12-3.67) per 1000 hospital births per year (P for trend < .001). Antepartum maternal opiate use also increased from 1.19 (95% CI, 1.01-1.35) to 5.63 (95% CI, 4.40-6.71) per 1000 hospital births per year (P for trend < .001). In 2009, newborns with NAS were more likely than all other hospital births to have low birthweight (19.1%; SE, 0.5%; vs 7.0%; SE, 0.2%), have respiratory complications (30.9%; SE, 0.7%; vs 8.9%; SE, 0.1%), and be covered by Medicaid (78.1%; SE, 0.8%; vs 45.5%; SE, 0.7%; all P < .001). Mean hospital charges for discharges with NAS increased from $39,400 (95% CI, $33,400-$45,400) in 2000 to $53,400 (95% CI, $49,000-$57,700) in 2009 (P for trend < .001). By 2009, 77.6% of charges for NAS were attributed to state Medicaid programs.Conclusion: Between 2000 and 2009, a substantial increase in the incidence of NAS and maternal opiate use in the United States was observed, as well as hospital charges related to NAS. [ABSTRACT FROM AUTHOR]

Objective: This prospective study aimed to describe the clinical course in terms of glycemic outcomes, body weight, and adverse events during the first 12 weeks following a switch from glucagon-like peptide-1 receptor agonists (GLP-1 RAs) directly to tirzepatide 5 mg., Methods: Participants were ≥18 years with type 2 diabetes (T2D), glycated hemoglobin (HbA1c) ≥6.5% to ≤9.0%, body mass index ≥25 kg/m 2 and were on a stable treatment dose of GLP-1 RAs (liraglutide every day [1.2, 1.8 mg], semaglutide once-weekly [0.5, 1.0, 2.0 mg], or dulaglutide once-weekly [0.75, 1.5, 3.0, and 4.5 mg]) for ≥3 months at baseline. The primary end point was HbA1c change from baseline at week 12. Secondary end points included change from baseline in fasting serum glucose, body weight, and glucose assessed by continuous glucose monitoring. Safety was also assessed., Results: Participants were 58.3 years on average, with baseline HbA1c 7.39%, body mass index 35.18 kg/m 2 , T2D duration around 12.4 years, and included 55% females. Semaglutide (55%) and dulaglutide (42%) were the most commonly used GLP-1 RAs at baseline with semaglutide 1.0 mg and dulaglutide 1.5 mg being the most common treatment doses. At week 12, mean HbA1c changed from baseline by -0.43%, fasting serum glucose by -7.83 mg/dL, and body weight by -2.15 kg (all P < .01). Glycemic outcomes and body weight improved in participants in all baseline GLP-1 RA subgroups. Twenty participants (13.2%) developed gastrointestinal events. Three (2%) participants discontinued tirzepatide due to adverse events. There were no severe hypoglycemic events or deaths., Conclusion: In this prospective study, when people with T2D on stable GLP-1 RA treatment were switched directly to tirzepatide 5 mg, they experienced improved glycemic outcomes and additional weight reduction with an acceptable risk of adverse gastrointestinal events over 12 weeks., Competing Interests: Disclosure S.J. reports consultancy fees from Eli Lilly and Company and Sanofi. G.A. received consulting fees from Dexcom, Insulet, and Medscape. J.S.P., P.S., E.G.V., and B.D.B. are employees and shareholders of Eli Lilly and Company., (Copyright © 2024 AACE. Published by Elsevier Inc. All rights reserved.)

Background: The aim of this study was to develop a predictive model to classify people with type 2 diabetes (T2D) into expected levels of success upon bolus insulin initiation., Methods: Machine learning methods were applied to a large nationally representative insurance claims database from the United States (dNHI database; data from 2007 to 2017). We trained boosted decision tree ensembles (XGBoost) to assign people into Class 0 (never meeting HbA1c goal), Class 1 (meeting but not maintaining HbA1c goal), or Class 2 (meeting and maintaining HbA1c goal) based on the demographic and clinical data available prior to initiating bolus insulin. The primary objective of the study was to develop a model capable of determining at an individual level, whether people with T2D are likely to achieve and maintain HbA1c goals. HbA1c goal was defined at <8.0% or reduction of baseline HbA1c by >1.0%., Results: Of 15 331 people with T2D (mean age, 53.0 years; SD, 8.7), 7800 (50.9%) people met HbA1c goal but failed to maintain that goal (Class 1), 4510 (29.4%) never attained this goal (Class 0), and 3021 (19.7%) people met and maintained this goal (Class 2). Overall, the model's receiver operating characteristic (ROC) was 0.79 with greater performance on predicting those in Class 2 (ROC = 0.92) than those in Classes 0 and 1 (ROC = 0.71 and 0.62, respectively). The model achieved high area under the precision-recall curves for the individual classes (Class 0, 0.46; Class 1, 0.58; Class 2, 0.71)., Conclusions: Predictive modeling using routine health care data reasonably accurately classified patients initiating bolus insulin who would achieve and maintain HbA1c goals, but less so for differentiation between patients who never met and who did not maintain goals. Prior HbA1c was a major contributing parameter for the predictions., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: NRK, JKH, MCB, CS, and RHP were employees of Optum Insight at the time this work was done and are currently employees of Optum Labs and stockholders of UnitedHealth Group. ELE, BDB, and DEF are employees and stockholders of Eli Lilly and Company; ESM was employee and stockholder of Eli Lilly and Company at the time when this study was conducte; ELE, ESM, BDB, DEF, was employed at Eli Lilly and Company when the study was conducted.

Introduction: Effectively engaging people with type 2 diabetes (T2D) earlier in their health journeys is critical to prevent downstream complications. Digitally based diabetes programs are a growing component of care delivery that have the potential to engage individuals outside of traditional clinic-based settings and use personalized data to pair people to tailored diabetes self-management interventions. Knowing an individuals' diabetes empowerment and health-related motivation can help drive appropriate recommendations for personalized interventions. We aimed to characterize diabetes empowerment and motivation towards changing health behaviors among participants in Level2, a T2D specialty care organization in the USA that combines wearable technology with personalized clinical support., Methods: A cross-sectional online survey was conducted among people enrolled in Level2 (February-March 2021). Distributions of respondent-reported diabetes empowerment and health motivation were analyzed using Motivation and Attitudes Toward Changing Health (MATCH) and Diabetes Empowerment Scale Short Form (DES-SF) scales, respectively. Associations between MATCH and DES-SF scores with Level2 engagement measures and glycemic control were analyzed., Results: The final analysis included 1258 respondents with T2D (mean age 55.7 ± 8.4 years). Respondents had high average MATCH (4.19/5) and DES-SF (4.02/5) scores. The average MATCH subscores for willingness (4.43/5) and worthwhileness (4.39/5) were higher than the average ability subscore (3.73/5). Both MATCH and DES-SF scores showed very weak correlations with Level2 engagement measures and glycemic control (ρ = - 0.18-0.19)., Conclusions: Level2 survey respondents had high average motivation and diabetes empowerment scores. Further research is needed to validate sensitivity of these scales to detect changes in motivation and empowerment over time and to determine whether differences in scores can be used to pair people to personalized interventions., (© 2023. The Author(s).)

Background: Does initiation of a continuous glucose monitor (CGM) or insulin pump lower health care utilization and/or costs?, Methods: Distinct cohorts of people with type 1 diabetes (T1D) or type 2 diabetes (T2D) using a blood glucose monitor (BGM), CGM, pump, or CGM with pump were identified from a large claims database. Patients ≥40 years old with 12 months of continuous enrollment before and after the device start date qualified for the study. Outcomes included one-year medical utilization and costs (minus device) for events such as hospitalizations and office visits. Generalized linear models were fitted, controlling for numerous baseline covariates. The Holm method corrected for the multiplicity of hypotheses tested., Results: Of the 8235 total patients, the BGM control group was the largest, had the lowest percentage of patients with T1D, and was significantly different from the device groups in most baseline categories. Formally, only two comparisons were statistically significant: Compared with BGM, the pump cohort had greater adjusted first-year total medical and office visit costs. Other secondary outcomes such as days hospitalized, emergency department visits and labs, favored pump. Most endpoints were favorable for CGM. Results for CGM with pump generally were intermediate between CGM and pump alone., Conclusions: During a one-year follow-up, unadjusted medical costs of both CGM and pump appear lower than BGM, but multivariable modeling yielded adjusted savings only for CGM use. Economic benefits might be observable sooner for CGMs than for pumps. Generalized linear models fitted to health care utilization event rates produced favorable results for both CGM and pump.

Economic models in type 1 diabetes have relied on a change in haemoglobin A1c as the link between the blood glucose trajectory and long-term clinical outcomes, including microvascular and macrovascular disease. The landscape has changed in the past decade with the availability of regulatory approved, accurate and convenient continuous glucose monitoring devices and their ability to track patients' glucose levels over time. The data emerging from continuous glucose monitoring have enriched the clinical understanding of the disease and indirectly of patients' behaviour. This has triggered the development of new measures proposed to better define the quality of glycaemic control, beyond haemoglobin A1c. The objective of this paper is to review recent developments in clinical knowledge brought into focus with the application of continuous glucose monitoring devices, and to discuss potential approaches to incorporate the concepts into economic models in type 1 diabetes. Based on a targeted review and a series of multidisciplinary workshops, an influence diagram was developed that captures newer concepts (e.g. continuous glucose monitoring metrics) that can be integrated into economic models and illustrates their association with more established concepts. How the additional continuous glucose monitoring-based indicators of glycaemic control may contribute to economic modelling beyond haemoglobin A1c, and more accurately reflect the economic value of novel type 1 diabetes treatments, is discussed., (© 2022. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Introduction: Diabetes has been identified as a high-risk comorbidity for COVID-19 hospitalization. We evaluated additional risk factors for COVID-19 hospitalization and in-hospital mortality in a nationwide US database., Methods: This retrospective study utilized the UnitedHealth Group Clinical Discovery Database (January 1, 2019-July 15, 2020) containing de-identified nationwide administrative claims, SARS-CoV-2 laboratory test results, and COVID-19 inpatient admissions data. Logistic regression was used to understand risk factors for hospitalization and in-hospital mortality among people with type 2 diabetes (T2D) and in the overall population. Robustness of associations was further confirmed by subgroup and sensitivity analyses in the T2D population., Results: A total of 36,364 people were identified who were either SARS-CoV-2 + or hospitalized for COVID-19. T2D was associated with increased COVID-19-related hospitalization and mortality. Factors associated with increased hospitalization risk were largely consistent in the overall population and the T2D subgroup, including age, male sex, and these top five comorbidities: dementia, metastatic tumor, congestive heart failure, paraplegia, and metabolic disease. Biguanides (mainly metformin) were consistently associated with lower odds of hospitalization, whereas sulfonylureas and insulins were associated with greater odds of hospitalization among people with T2D., Conclusion: In this nationwide US analysis, T2D was identified as an independent risk factor for COVID-19 complications. Many factors conferred similar risk of hospitalization across both populations; however, particular diabetes medications may be markers for differential risk. The insights on comorbidities and medications may inform population health initiatives, including prevention efforts for high-risk patient populations such as those with T2D., (© 2021. The Author(s).)

Background: The aim of this study was to determine how clusters or subgroups of insulin-treated people with diabetes, based upon healthcare resource utilization, select social demographic and clinical characteristics, and diabetes management parameters, are related to health outcomes including acute care visits and hospital admissions., Methods: This was a non-experimental, retrospective cluster analysis. We utilized Aetna administrative claims data to identify insulin-using people with diabetes with service dates from 01 January 2015 to 30 June 2018. The study included adults over the age of 18 years who had a diagnosis of type 1 (T1DM) or type 2 diabetes mellitus (T2DM) on insulin therapy and had Aetna medical and pharmacy coverage for at least 18 months (6 months prior and 12 months after their index date, defined as either their first insulin prescription fill date or their earliest date allowing for 6 months' prior coverage). We used K-means clustering methods to identify relevant subgroups of people with diabetes based on 13 primary outcome variables., Results: A total of 100,650 insulin-using people with diabetes were identified in the Aetna administrative claims database and met study criteria, including 11,826 (11.7%) with T1DM and 88,824 (88.3%) with T2DM. Of these 79,053 (78.5%) people were existing insulin users. Seven distinct clusters were identified with different characteristics and potential risks of diabetes complications. Overall, clusters were significantly associated with differences in healthcare utilization (emergency room visits, inpatient admissions, and total inpatient days) after multivariable adjustment., Conclusions: This analysis of healthcare claims data using clustering methodologies identified meaningful subgroups of patients with diabetes using insulin. The subgroups differed in comorbidity burden, healthcare utilization, and demographic factors which could be used to identify higher risk patients and/or guide the management and treatment of diabetes.

Objective: We sought to describe patient characteristics associated with prolonged post-operative length of stay in a contemporary cohort of infants who underwent isolated repair of aortic coarctation., Methods: We reviewed patients less than 1 year of age who underwent isolated repair of aortic coarctation at our institution from 2009 to 2016. Prolonged post-operative length of stay was defined as length of stay within the upper tertile for the cohort. Bivariate and multi-variable analyses were performed to determine independent risk factors for prolonged length of stay., Results: We reviewed 95 consecutive patients who underwent isolated repair of aortic coarctation, of whom 71 were neonates at the time of diagnosis. The median post-operative length of stay was 6.5 days. The upper tertile for post-operative length of stay was greater than 10 days; 32 patients within this tertile and 1 patient who died at 8.5 days after surgery were analysed as having prolonged post-operative length of stay. In a multi-variable analysis, pre-maturity (odds ratio: 3.5, 95% confidence interval: 1.2, 10.7), genetic anomalies (odds ratio: 4.7, 95% confidence interval: 1.2, 18), absence of pre-operative oral feeding (odds ratio: 7.4, 95% confidence interval: 2.4, 22.3), and 12-hour vasoactive-ventilation-renal score greater than 25 (odds ratio: 7.4, 95% confidence interval: 1.9, 29) were independently associated with prolonged length of stay., Conclusions: In neonates and infants who underwent isolated repair of aortic coarctation, pre-maturity, genetic anomalies, lack of pre-operative oral feedings, and 12-hour vasoactive-ventilation-renal score more than 25 were independent risk factors for prolonged post-operative length of stay. Further study on the relationship between pre-operative oral feedings and post-operative length of stay should be pursued.

Objectives: Thrombosis is a cause of morbidity in 4-15% of children who undergo pediatric cardiac surgery. Data on how to prevent this complication are sorely needed. We aimed to identify risk factors for thrombosis following pediatric cardiac surgery and determine if use of low molecular weight heparin prophylaxis is associated with a reduction in thrombosis risk., Design: Retrospective cohort study., Setting: Tertiary pediatric cardiovascular ICU., Patients: Patients who underwent cardiac surgery between June 2014 and December 2015., Interventions: None., Measurements and Main Results: Data from patients with venous or arterial thrombosis confirmed by radiologic studies were matched two-to-one to controls based on age, Society of Thoracic Surgeons-European Association for Cardio-Thoracic Surgery mortality category, and gender. Thrombosis was detected in 33 patients (6.2%): 25 patients (76%) had venous thromboses, five patients (15%) had arterial thromboses, and three patients (9%) had both. Median time to thrombosis detection was 13 days (25-75%; 7-31 d). On multivariate analysis, which included adjustment for postoperative disease severity, fresh frozen plasma exposure was independently associated with thrombosis (odds ratio, 3.7; 95% CI, 1.4-9.4). Twenty-eight patients (85%) had central venous catheter-related thromboses. Low molecular weight heparin prophylaxis use in this subset of patients was not statistically different from controls (50% vs 45%, respectively; p = 0.47). On multivariable analysis, fresh frozen plasma exposure was also independently associated with central venous catheter-related thrombosis (odds ratio, 3.6; 95% CI, 1.2-10.6)., Conclusions: The occurrence of thrombosis after pediatric cardiac surgery at our institution was 6.2%, similar to what has been reported in other studies, despite frequent use of low molecular weight heparin. Further study is needed to determine the role of low molecular weight heparin for thromboprophylaxis and the relationship between fresh frozen plasma and thrombosis risk in children who undergo cardiac surgery.

: media-1vid110.1542/5789654354001PEDS-VA&#95;2017-3082 Video Abstract BACKGROUND: Management of pediatric emergencies is challenging for ambulatory providers because these rare events require preparation and planning tailored to the expected emergencies. The current recommendations for pediatric emergencies in ambulatory settings are based on 20-year-old survey data. We aimed to objectively identify the frequency and etiology of pediatric emergencies in ambulatory practices., Methods: We examined pediatric emergency medical services (EMS) runs originating from ambulatory practices in the greater Indianapolis metropolitan area between January 1, 2012, and December 31, 2014. Probabilistic matching of pickup location addresses and practice location data from the Indiana Professional Licensing Agency were used to identify EMS runs from ambulatory settings. A manual review of EMS records was conducted to validate the matching, categorize illnesses types, and categorize interventions performed by EMS. Demographic data related to both patients who required treatment and practices where these events occurred were also described., Results: Of the 38 841 pediatric EMS transports that occurred during the 3-year period, 332 (0.85%) originated from ambulatory practices at a rate of 42 per 100 000 children per year. The most common illness types were respiratory distress, psychiatric and/or behavioral emergencies, and seizures. Supplemental oxygen and albuterol were the most common intervention, with few critical care level interventions. Community measures of low socioeconomic status were associated with increased number of pediatric emergencies in ambulatory settings., Conclusions: Pediatric emergencies in ambulatory settings are most likely due to respiratory distress, psychiatric and/or behavioral emergencies, or seizures. They usually require only basic interventions. EMS data are a valuable tool for identifying emergencies in ambulatory settings when validated with external data., Competing Interests: POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose., (Copyright © 2018 by the American Academy of Pediatrics.)

Recent advances in data collection during routine health care in the form of Electronic Health Records (EHR), medical device data (e.g., infusion pump informatics, physiological monitoring data, and insurance claims data, among others, as well as biological and experimental data, have created tremendous opportunities for biological discoveries for clinical application. However, even with all the advancement in technologies and their promises for discoveries, very few research findings have been translated to clinical knowledge, or more importantly, to clinical practice. In this paper, we identify and present the initial work addressing the relevant challenges in three broad categories: data, accessibility, and translation. These issues are discussed in the context of a widely used detailed database from an intensive care unit, Medical Information Mart for Intensive Care (MIMIC III) database.

Objectives: Establishing protocols to wean mechanical ventilation and assess readiness for extubation, with the goal of minimizing morbidity associated with extubation failure and prolonged mechanical ventilation, have become increasingly important in contemporary PICUs. The aim of this quality improvement initiative is to establish a respiratory therapist-led daily spontaneous breathing trial protocol to standardize extubation readiness assessment and documentation in our PICU., Design: A quality improvement project., Setting: Single center, tertiary care Children's Hospital PICU., Patients: All intubated patients admitted to PICU requiring conventional mechanical ventilation between February 2013 and January 2016., Interventions: A working group of pediatric intensivists, respiratory therapists, nurses, and information technology specialists established the protocol, standardized documentation via the electronic medical record, and planned education. Daily spontaneous breathing trial protocol implementation began in February 2015. All patients on mechanical ventilation were screened daily at approximately 4 AM by a respiratory therapist to determine daily spontaneous breathing trial eligibility. If all screening criteria were met, patients were placed on continuous positive airway pressure of 5 cm H2O with pressure support of 8 cm H2O for up to 2 hours. If tolerated, patients would be extubated to supplemental oxygen delivered via nasal cannula in the morning, after intensivist approval. Daily audits were done to assess screening compliance and accuracy of documentation., Measurements and Main Results: We analyzed data from 398 mechanically ventilated patients during daily spontaneous breathing trial period (February 2015-January 2016), compared with 833 patients from the pre-daily spontaneous breathing trial period (February 2013-January 2015). During the daily spontaneous breathing trial period, daily screening occurred in 92% of patients. Extubation failure decreased from 7.8% in the pre-daily spontaneous breathing trial period to 4.5% in daily spontaneous breathing trial period. The use of high-flow nasal cannula slightly increased during the project, while there was no change in duration of mechanical ventilation or the use of noninvasive ventilation., Conclusions: An interprofessionally developed respiratory therapist-led extubation readiness protocol can be successfully implemented in a busy tertiary care PICU without adverse events.

Objective: In a multicenter cohort of neonates recovering from cardiac surgery, we sought to describe the epidemiology of extubation failure and its variability across centers, identify risk factors, and determine its impact on outcomes., Methods: We analyzed prospectively collected clinical registry data on all neonates undergoing cardiac surgery in the Pediatric Cardiac Critical Care Consortium database from October 2013 to July 2015. Extubation failure was defined as reintubation less than 72 hours after the first planned extubation. Risk factors were identified using multivariable logistic regression with generalized estimating equations to account for within-center correlation., Results: The cohort included 899 neonates from 14 Pediatric Cardiac Critical Care Consortium centers; 14% were premature, 20% had genetic abnormalities, 18% had major extracardiac anomalies, and 74% underwent surgery with cardiopulmonary bypass. Extubation failure occurred in 103 neonates (11%), within 24 hours in 61%. Unadjusted rates of extubation failure ranged from 5% to 22% across centers; this variability was unchanged after adjusting for procedural complexity and airway anomaly. After multivariable analysis, only airway anomaly was identified as an independent risk factor for extubation failure (odds ratio, 3.1; 95% confidence interval, 1.4-6.7; P = .01). Neonates who failed extubation had a greater median postoperative length of stay (33 vs 23 days, P < .001) and in-hospital mortality (8% vs 2%, P = .002)., Conclusions: This multicenter study showed that 11% of neonates recovering from cardiac surgery fail initial postoperative extubation. Only congenital airway anomaly was independently associated with extubation failure. We observed a 4-fold variation in extubation failure rates across hospitals, suggesting a role for collaborative quality improvement to optimize outcomes., (Copyright © 2017 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Introduction: The use of administrative health data for research has prompted questions about its validity for this purpose., Objective/study Design: The purpose of this study was to determine the concordance of Pediatric Health Information System (PHIS) perioperative antibiotic charges with the institution's medication administration data for males <10 years old and who underwent outpatient penile/inguinal procedures from July 2013 to March 2015., Results: There was 93.9% positive and negative agreement between perioperative antibiotic charges versus administration. The sensitivity and specificity were 96.8% and 87.2%, respectively. The positive and negative predictive values were 94.6% and 92.2%, respectively., Conclusion: This study indicated strong agreement between PHIS pharmacy charges and medication administration., (Copyright © 2017. Published by Elsevier Ltd.)

Purpose: Guidelines recommend surgical antibiotic prophylaxis for clean-contaminated procedures but none for clean procedures. The purpose of this study was to describe variations in surgical antibiotic prophylaxis for outpatient urological procedures at United States children's hospitals., Materials and Methods: Using the PHIS (Pediatric Health Information System®) database we performed a retrospective cohort study of patients younger than 18 years who underwent clean and/or clean-contaminated outpatient urological procedures from 2012 to 2014. We excluded those with concurrent nonurological procedures or an abscess/infected wound. We compared perioperative antibiotic charges for clean vs clean-contaminated procedures using a multilevel logistic regression model with a random effect for hospital. We also examined whether hospitals that were guideline compliant for clean procedures, defined as no surgical antibiotic prophylaxis, were also compliant for clean-contaminated procedures using the Pearson correlation coefficient. We examined hospital level variation in antibiotic rates using the coefficient of variation., Results: A total of 131,256 patients with a median age of 34 months at 39 hospitals met study inclusion criteria. Patients undergoing clean procedures were 14% less likely to receive guideline compliant surgical antibiotic prophylaxis than patients undergoing clean-contaminated procedures (OR 0.86, 95% CI 0.84-0.88, p <0.0001). Hospitals that used antibiotics appropriately for clean-contaminated procedures were more likely to use antibiotics inappropriately for clean procedures (r = 0.7, p = 0.01). Greater variation was seen for hospital level compliance with surgical antibiotic prophylaxis for clean-contaminated procedures (range 9.8% to 97.8%, coefficient of variation 0.36) than for clean procedures (range 35.0% to 98.2%, coefficient of variation 0.20)., Conclusions: Hospitals that used surgical antibiotic prophylaxis appropriately for clean-contaminated procedures were likely to use surgical antibiotic prophylaxis inappropriately for clean procedures. More variation was seen in hospital level guideline compliance for clean-contaminated procedures., (Copyright © 2017 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Objectives: To describe the epidemiology of extubation failure and identify risk factors for its occurrence in a multicenter population of neonates undergoing surgery for congenital heart disease., Study Design: We conducted a prospective observational study of neonates ≤30 days of age who underwent cardiac surgery at 7 centers within the US in 2015. Extubation failure was defined as reintubation within 72 hours of the first planned extubation. Risk factors were identified with the use of multivariable logistic regression analysis and reported as OR with 95% CIs. Multivariable logistic regression analysis was conducted to examine the relationship between extubation failure and worse clinical outcome, defined as hospital length of stay in the upper 25% or operative mortality., Results: We enrolled 283 neonates, of whom 35 (12%) failed their first extubation at a median time of 7.5 hours (range 1-70 hours). In a multivariable model, use of uncuffed endotracheal tubes (OR 4.6; 95% CI 1.8-11.6) and open sternotomy of 4 days or more (OR 4.8; 95% CI 1.3-17.1) were associated independently with extubation failure. Accordingly, extubation failure was determined to be an independent risk factor for worse clinical outcome (OR 5.1; 95% CI 2-13)., Conclusions: In this multicenter cohort of neonates who underwent surgery for congenital heart disease, extubation failure occurred in 12% of cases and was associated independently with worse clinical outcome. Use of uncuffed endotracheal tubes and prolonged open sternotomy were identified as independent and potentially modifiable risk factors for the occurrence of this precarious complication., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Background: Information concerning tracheostomy after operations for congenital heart disease has come primarily from single-center reports. We aimed to describe the epidemiology and outcomes associated with postoperative tracheostomy in a multi-institutional registry., Methods: The Society of Thoracic Surgeons Congenital Heart Database (2000 to 2014) was queried for all index operations with the adverse event "postoperative tracheostomy" or "respiratory failure, requiring tracheostomy." Patients with preoperative tracheostomy or weighing less than 2.5 kg undergoing isolated closure of patent ductus arteriosus were excluded. Trends in tracheostomy incidence over time from January 2000 to June 2014 were analyzed with a Cochran-Armitage test. The patient characteristics associated with operative mortality were analyzed for January 2010 to June 2014, including deaths occurring up to 6 months after transfer of patients to long-term care facilities., Results: From 2000 to 2014, the incidence of tracheostomy after operations for congenital heart disease increased from 0.11% in 2000 to a high of 0.76% in 2012 (p < 0.0001). From 2010 to 2014, 648 patients underwent tracheostomy. The median age at operation was 2.5 months (25th, 75th percentile: 0.4, 7). Prematurity (n = 165, 26%), genetic abnormalities (n = 298, 46%), and preoperative mechanical ventilation (n = 275, 43%) were common. Postoperative adverse events were also common, including cardiac arrest (n = 131, 20%), extracorporeal support (n = 87, 13%), phrenic or laryngeal nerve injury (n = 114, 18%), and neurologic deficit (n = 51, 8%). The operative mortality was 25% (n = 153)., Conclusions: Tracheostomy as an adverse event of operations for congenital heart disease remains rare but has been increasingly used over the past 15 years. This trend and the considerable mortality risk among patients requiring postoperative tracheostomy support the need for further research in this complex population., (Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Tracheostomy following congenital heart disease (CHD) surgery is a rare event and associated with significant mortality. Hospital survival has been reported from 20% to 40%. Late mortality for these patients is not well characterized., Methods: We performed a retrospective observational study of patients who had a tracheostomy following CHD surgery (excluding isolated patent ductus arteriosus ligation) between January 2000 and December 2013. Patients were categorized into single-ventricle or biventricular physiology groups. Demographics, genetic syndromes, pulmonary disease, and comorbidities were collected. Outcomes including hospital survival, long-term survival, and weaning from positive pressure ventilation are reported. Bivariate and time-to-event models were used., Results: Over a 14-year period, 61 children (0.9% incidence) had a tracheostomy placed following CHD surgery. There were 12 single-ventricle patients and 49 biventricular patients. Prematurity, genetic syndromes, lung/airway disease, and other comorbidities were common in both CHD groups. Gastrostomy tubes were used more frequently in biventricular physiology patients (91.8%) versus single-ventricle patients (66.7%, P = .04). Survival to hospital discharge was 50% in the single-ventricle group compared to 86% in biventricular patients (P = .01). Long-term survival continued to be poor in the single-ventricle group comparatively (three years, 27.8% vs 64.8%, P = .01). Gastrostomy tube placement was independently associated with survival in both groups (P = .002)., Conclusion: Tracheostomy is performed following many types of surgery for CHD and is commonly associated with other comorbidities. Both hospital and long-term survival are substantially lower in children with single-ventricle physiology as compared to patients with biventricular physiology., (© The Author(s) 2016.)

Objective: To describe characteristics and overlap associated with various ventilator-associated infection criteria in the PICU., Design: Retrospective observational study., Setting: A quaternary care children's hospital PICU., Patients: Children ventilated more than 48 hours, excluding patients with tracheostomy., Interventions: None., Measurements and Main Results: Ventilator-associated infection, including pneumonia, infection-related ventilator-associated condition, tracheobronchitis, and lower respiratory tract infection were defined according to criteria from the Centers for Disease Control and Prevention or medical literature. Clinical data were abstracted to assign diagnoses of each ventilator-associated infection. In 300 episodes of mechanical ventilation, there were 30 individual episodes of ventilator-associated infection. Nine episodes met more than one definition. Rates per 1,000 ventilator days were 2.60 for ventilator-associated pneumonia, 2.16 for infection-related ventilator-associated condition, 5.19 for ventilator-associated tracheobronchitis, and 6.92 for lower respiratory tract infection. The rate of any ventilator-associated infection was 12.98 per 1,000 ventilator days. Individual criteria had similar risk factors and outcomes. Risk factors for development of any ventilator-associated infection included older age (p = 0.003) and trauma (p = 0.007), while less cardiac surgery patients developed ventilator-associated infection (p = 0.015). On multivariate analysis, trauma was the only independent risk factor (adjusted odds ratio, 3.10; 95% CI, 1.15-8.38). Developing any ventilator-associated infection was associated with longer duration of mechanical ventilation (p < 0.001) and longer PICU length of stay (p < 0.001) but not PICU mortality (p = 0.523)., Conclusions: There is little overlap in diagnosis of various ventilator-associated infection. However, the risk factors and outcomes associated with individual criteria are similar, indicating that they may have validity in identifying true pathology. Ventilator-associated infection in general is likely a larger problem than indicated by low hospital-reported rates of ventilator-associated pneumonia. There is clinical confusion due to the presence of several diagnostic criteria for ventilator-associated infection. Developing a more inclusive and clinically relevant criterion for diagnosing ventilator-associated infection is warranted to accurately assess their impact and improve guidance for clinicians in evaluating and treating ventilator-associated infection.

Objectives: The study assessed dexmedetomidine utilization and practice variation over time in ventilated pediatric intensive care unit (PICU) patients; and evaluated differences in hospital outcomes between high- and low-dexmedetomidine utilization hospitals., Study Design: This serial cross-sectional analysis used administrative data from PICU admissions in the pediatric health information system (37 US tertiary care pediatric hospitals). Included admissions from 2007 to 2013 had simultaneous dexmedetomidine and invasive mechanical ventilation charges, <18 years of age, excluding neonates. Patient and hospital characteristics were compared as well as hospital-level severity-adjusted indexed length of stay (LOS), charges, and mortality., Results: The utilization of dexmedetomidine increased from 6.2 to 38.2 per 100 ventilated PICU patients among pediatric hospitals. Utilization ranged from 3.8 to 62.8 per 100 in 2013. Few differences in patient demographics and no differences in hospital-level volume/severity of illness measures between high- and low-utilization hospitals occurred. No differences in hospital-level, severity-adjusted indexed outcomes (LOS, charges, and mortality) were found., Conclusion: Wide practice variation in utilization of dexmedetomidine for ventilated PICU patients existed even as use has increased sixfold. Higher utilization was not associated with increased hospital charges or reduced hospital LOS. Further work should define the expected outcome benefits of dexmedetomidine and its appropriate use.

Background: Inpatient administrative data sources describe the care provided to hospitalized children. The Kids' Inpatient Database (KID) provides nationally representative estimates, while the Pediatric Health Information System (PHIS, a consortium of pediatric facilities) derives more detailed information from revenue codes. The objective was to contextualize a diagnosis and procedure-based definition of critical illness to a revenue-based definition; then compare it across hospitals with different levels of pediatric care., Methods: This retrospective, cross-sectional study utilized the 2009 KID, and 2009 inpatient discharges from the PHIS database. Patients <21 years of age (excluding neonates) were included to focus on pediatric critical illness. Critical illness was defined as: (1) critical care services (CC services) using diagnosis and procedures codes and (2) intensive care unit (ICU) care using revenue codes. Demographics, invasive procedures, and categories of critical illness were compared using Chi square and survey-weighted methods. The definitions of critical illness were compared in PHIS hospitals. CC services populations identified in General Hospitals, Pediatric Facilities, and Freestanding Children's hospitals (from KID) were compared to those in PHIS hospitals., Results: Among PHIS hospitals, critically ill discharges identified by CC services accounted for 37.7% of ICU care. CC services discharges were younger and had greater proportion of respiratory illness and invasive procedure use. Critically ill patients identified by CC services in PHIS hospitals were statistically similar to those in Freestanding Children's hospitals. Pediatric Facilities and General Hospitals had more adolescents with more traumas. CC services patients in general hospitals had lower use of invasive procedures and predominance of trauma, respiratory illness, mental health issues, and general infections. Freestanding children's hospitals discharged 22% of the estimated 96,700 CC services cases. Similar proportions of critically ill patients were seen in Pediatric Facilities (31%) and General Hospitals (33%)., Conclusion: The CC services definition captured a more severely ill fraction of critically ill children. Critically ill discharges from PHIS hospitals can likely be extrapolated to Freestanding Children's hospitals and Pediatric Facilities. General Hospitals, which provide a significant amount of pediatric critical care, are different. Studies utilizing administrative data can benefit from multiple data sources, which balance the individual strengths and weaknesses.

Background: Cardiac tumors in children are rare. Of the cases reported in the literature, nearly all are benign and managed conservatively., Methods: This is a retrospective, observational study of pediatric patients <18 years who presented for surgical evaluation of a cardiac tumor, between 1969 and 2014 at a tertiary care children's hospital. Presentation, pathology, management, and outcomes were evaluated., Results: Over the last 45 years, 64 patients were evaluated for surgical resection of a cardiac tumor. Rhabdomyoma was the most common neoplasm (58%), and 17% of the tumors had malignant pathologies. While 42% of benign cardiac neoplasms required surgical intervention for significant hemodynamic concerns, 73% of malignant neoplasms underwent radical excision, if possible, followed by adjuvant chemotherapy. Despite a 37% mortality in patients with malignant pathology, an aggressive surgical approach can yield long-term survival in some patients. There were no deaths among patients with benign tumors and 17% had postoperative complications mostly related to mitral regurgitation., Conclusion: Cardiac tumors in children are rare but can be managed aggressively with good outcomes. Benign tumors have an excellent survival with most complications related to tumor location. Malignant tumors have a high mortality rate, but surgery and adjuvant chemotherapy allow for prolonged survival in selected patients., (© The Author(s) 2014.)

Our objectives were to review and categorize the existing data sources that are important to pediatric critical care medicine (PCCM) investigators and the types of questions that have been or could be studied with each data source. We conducted a narrative review of the medical literature, categorized the data sources available to PCCM investigators, and created an online data source registry. We found that many data sources are available for research in PCCM. To date, PCCM investigators have most often relied on pediatric critical care registries and treatment- or disease-specific registries. The available data sources vary widely in the level of clinical detail and the types of questions they can reliably answer. Linkage of data sources can expand the types of questions that a data source can be used to study. Careful matching of the scientific question to the best available data source or linked data sources is necessary. In addition, rigorous application of the best available analysis techniques and reporting consistent with observational research standards will maximize the quality of research using existing data in PCCM.

Objective: Timely, high quality communication with families is essential to family-centered decision-making. Quality communication is represented by widespread documentation of prognostic, goals-of-care conversations (PGOCC) in the pediatric intensive care unit (PICU) and should occur without variation by patient characteristics., Methods: Cohort included 645 PICU admissions in the top decile of risk of mortality on admission over six years. Electronic medical records were used to determine PGOCC, diagnosis on admission and complex chronic condition (CCC) status. Multivariate logistic regression and time-to-event analyses were used., Results: Overall, 31% had a documented PGOCC. 51% had CCC status. 11% had an oncologic, 13% had a cardiovascular diagnosis on admission. 94% of patients who died in the PICU had PGOCC documented, but among the 200 patients with documented PGOCC, 78% did not die in the PICU. Oncologic diagnosis on admission was associated with a higher likelihood of PGOCC compared to non-CCC patients (ARR=1.86; SE=0.26) whereas no other diagnosis category reached the level of statistical significance. Median time from admission to PGOCC was 2 days. Age, gender and CCC status were not associated with whether a PGOCC was documented or with time from admission to PGOCC documentation. 45% of PGOCC in the cohort and 50% of conversations in patients with CCC were documented by PICU physicians., Conclusions: This study reveals the opportunity for improvement in documentation of PGOCC for critically ill children. It raises the questions of why there is variation of PGOCC across disease categories and whether PGOCC should be considered a quality measure for family-centered care.

Objective: The objective was to describe the characteristics of pediatric discharges associated with long-term mechanical ventilation (LTMV) compared with those with complex chronic conditions (CCCs), and evaluate trends over time in health care utilization for the discharges associated with LTMV., Methods: The Kids' Inpatient Database, compiled by the Agency for Healthcare Research and Quality, was used. Routine newborn care was excluded. Discharges associated with LTMV were identified by using the International Classification of Diseases, Ninth Revision, code v46.1x and compared with discharges associated with CCCs in 2006 using simple regression and χ(2) analyses. Trends in LTMV-associated discharges from 2000 to 2006 were assessed using variance-weighted least squares regression., Results: In 2006, there were an estimated 7812 discharges associated with LTMV. Compared with discharges for children with CCCs, LTMV discharges had significantly higher mortality, longer lengths of stay, higher mean charges, more emergency department admissions, and more discharges to long-term care. From 2000 to 2006, there was a 55% increase in the number of LTMV discharges and a concurrent 70% increase in aggregate hospital charges. The majority of LTMV discharges occurred in children 4 years old and younger, and ∼50% of the aggregate charges were for children younger than 1 year., Conclusions: Discharges for children associated with LTMV require substantively greater inpatient resource use than other children with CCCs. As the number of discharges and associated aggregate charges increase over time, additional research must examine patterns of care for specific clinical subgroups of LTMV, especially children aged 4 years and younger.