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Transition of care: lessons from the Standardizing Care to Improve Outcomes in Pediatric End Stage Renal Disease (SCOPE) dialysis collaborative.

Acknowledging the importance of preparing the pediatric dialysis patient for successful transfer to adult providers, centers from the Standardizing Care to Improve Outcomes in Pediatric End Stage Renal Disease (SCOPE) Dialysis Collaborative developed transition tools and performed iterative implementation of a transition of care (TOC) program to gain real-life insight into drivers and barriers towards implementation of a transition program for patients receiving dialysis. A TOC innovation workgroup was developed in 2019 from within SCOPE Collaborative that developed nine educational modules, along with introductory letter and assessment tool to be utilized by SCOPE centers. A 4-month pilot implementation study among six centers of varying patient population (age ≥ 11years) was performed. TOC tools were further refined, and broader implementation within the collaborative was performed. Interim assessment of TOC tool utilization and implementation success was performed among 11 centers, as a foundation towards broader discussion regarding process, barriers, and success towards TOC implementation among 26 centers. Transition champion was a key driver of successful implementation, and lack of institutional support and collaboration with adult dialysis centers were important barriers towards sustainability. COVID pandemic and increased staff turnover affected longer term implementation of TOC program. Successful transition and transfer of adolescents/young adults with kidney failure on dialysis remains a challenge. This study represents the experience of the largest cohort of pediatric dialysis centers, with diversity in population size and geography, towards development and implementation of a TOC program. This adds to the resources available to assist centers towards transition and transfer, with particular focus on transitioning patients on dialysis.

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Pharmacologic Restraint Use During Mental Health Admissions to Children's Hospitals.

Primary mental health admissions are increasing across US children's hospitals. These patients may experience agitation requiring pharmacologic restraint. This study characterized pharmacologic restraint use in medical inpatient units by primary mental health diagnosis. This retrospective, cross-sectional study used the Pediatric Health Information System database. The study included children aged 5 to 17 years admitted with a primary mental health diagnosis between 2016 and 2021. Rates of pharmacologic restraint use per 1000 patient days were determined for 13 mental health diagnoses and trended over time with Poisson regression. Of 91 898 hospitalizations across 43 hospitals, 3% of admissions and 1.3% of patient days involved pharmacologic restraint. Trends in the rate of pharmacologic restraint use remained stable (95% confidence interval [CI], 0.7-2.1), whereas the incidence increased by 141%. Diagnoses with the highest rates of pharmacologic restraint days per 1000 patient days included autism (79.4; 95% CI, 56.2-112.3), substance-related disorders (45.0; 95% CI, 35.9-56.4), and disruptive disorders (44.8; 95% CI, 25.1-79.8). The restraint rate significantly increased in disruptive disorders (rate ratio [RR], 1.4; 95% CI, 1.1-1.6), bipolar disorders (RR, 2.0; 95% CI, 1.4-3.0), eating disorders (RR, 2.4; 95% CI, 1.5-3.9), and somatic disorders (RR, 4.2; 95% CI, 1.9-9.1). The rate significantly decreased for autism (RR, 0.8; 95% CI, 0.6-1.0) and anxiety disorders (RR, 0.3; 95% CI, 0.2-0.6). Pharmacologic restraint use among children hospitalized with a primary mental health diagnosis increased in incidence and varied by diagnosis. Characterizing restraint rates and trends by diagnosis may help identify at-risk patients and guide targeted interventions to improve pharmacologic restraint utilization.

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Disparities in Pharmacologic Restraint for Children Hospitalized in Mental Health Crisis.

Children hospitalized with a mental health crisis often receive pharmacologic restraint for management of acute agitation. We examined associations between pharmacologic restraint use and race and ethnicity among children admitted for mental health conditions to acute care nonpsychiatric children's hospitals. We performed a retrospective cohort study of children (aged 5-≤18 years) admitted for a primary mental health condition from 2018 to 2022 at 41 US children's hospitals. Pharmacologic restraint use was defined as parenteral administration of medications for acute agitation. The association of race and ethnicity and pharmacologic restraint was assessed using generalized linear multivariable mixed models adjusted for clinical and demographic factors. Stratified analyses were performed based on significant interaction analyses between covariates and race and ethnicity. The cohort included 61 503 hospitalizations. Compared with non-Hispanic Black children, children of non-Hispanic White (adjusted odds ratio [aOR], 0.81; 95% confidence interval [CI], 0.72-0.92), Asian (aOR, 0.82; 95% CI, 0.68-0.99), or other race and ethnicity (aOR, 0.68; 95% CI, 0.57-0.82) were less likely to receive pharmacologic restraint. There was no significant difference with Hispanic children. When stratified by sex, racial/ethnic differences were magnified in males (aORs, 0.49-0.68), except for Hispanic males, and not found in females (aORs, 0.83-0.93). Sensitivity analysis revealed amplified disparities for all racial/ethnic groups, including Hispanic youth (aOR, 0.65; 95% CI, 0.47-0.91). Non-Hispanic Black children were significantly more likely to receive pharmacologic restraint. More research is needed to understand reasons for these disparities, which may be secondary to implicit bias and systemic and interpersonal racism.

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Variation in Length of Stay by Level of Neonatal Care Among Moderate and Late Preterm Infants.

Moderate and late preterm infants are a growing subgroup of neonates with increased care needs after birth, yet standard protocols are lacking. We aim to describe variation in length of stay (LOS) by gestational age (GA) across hospitals within the same level of neonatal care and between different levels of neonatal care. Retrospective cohort study of hospitalizations for moderate (32-33 weeks GA) and late (34-36 weeks GA) preterm infants in 2019 Kid's Inpatient Database. We compared adjusted LOS in this cohort and evaluated variation within hospitals of the same level and across different levels of neonatal care. This study includes 217 051 moderate (26.2%) and late (73.8%) preterm infants from level II (19.7%), III (66.3%), and IV (11.1%) hospitals. Patient-level (race and ethnicity, primary payor, delivery type, multiple gestation, birth weight) and hospital-level (birth region, level of neonatal care) factors were significantly associated with LOS. Adjusted mean LOS varied for hospitals within the same level of neonatal care with level II hospitals showing the greatest variability among 34- to 36- week GA infants when compared with level III and IV hospitals (P < .01). LOS also varied significantly between levels of neonatal care with the greatest variation (0.9 days) seen in 32-week GA between level III and level IV hospitals. For moderate and late preterm infants, the level of neonatal care was associated with variation in LOS after adjusting for clinical severity. Hospitals providing level II neonatal care showed the greatest variation and may provide an opportunity to standardize care.

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Adjusting for Congenital Heart Surgery Risk Using Administrative Data.

Congenital heart surgery (CHS) encompasses a heterogeneous population of patients and surgeries. Risk standardization models that adjust for patient and procedural characteristics can allow for collective study of these disparate patients and procedures. We sought to develop a risk-adjustment model for CHS using the newly developed Risk Stratification for Congenital Heart Surgery for ICD-10 Administrative Data (RACHS-2) methodology. Within the Kids' Inpatient Database 2019, we identified all CHSs that could be assigned a RACHS-2 score. Hierarchical logistic regression (clustered on hospital) was used to identify patient and procedural characteristics associated with in-hospital mortality. Model validation was performed using data from 24 State Inpatient Databases during2017. Of 5,902,538 total weighted hospital discharges in the Kids' Inpatient Database 2019, 22,310 pediatric cardiac surgeries were identified and assigned a RACHS-2 score. In-hospital mortality occurred in 543 (2.4%) of cases. Using only RACHS-2, the mortality mode had a C-statistic of 0.81 that improved to 0.83 with the addition of age. A final multivariable model inclusive of RACHS-2, age, payer, and presence of a complex chronic condition outside of congenital heart disease further improved model discrimination to 0.87 (P< 0.001). Discrimination in the validation cohort was also very good with a C-statistic of 0.83. We created and validated a risk-adjustment model for CHS that accounts for patient and procedural characteristics associated with in-hospital mortality available in administrative data, including the newly developed RACHS-2. Our risk model will be critical for use in health services research and quality improvement initiatives.

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Establishing Costs for Commercial Chimeric Antigen Receptor T-Cell (Tisagenlecleucel; Kymriah) in Children and Young Adult B-Cell Acute Lymphoblastic Leukemia; A Merged Analysis from the Prwcc and PHIS

Background: Chimeric antigen receptor (CAR) T cell therapy has achieved remarkable efficacy in children and young adult (CAYA) B-cell acute lymphoblastic leukemia (B-ALL). Nonetheless, this therapy is highly personalized, technically complex, and costly to manufacture. The USA FDA approved the first CAR T cell therapy (Kymriah) in Aug 2017, for relapsed/refractory CAYA B-ALL. The list price of Kymriah is $475,000, not accounting for costs related to delivery of care, inpatient hospitalization, toxicity management or follow-up. A half-decade of clinical experience has amassed since commercialization, yet financial analyses remain sparse. Here, we conduct the first study to understand costs for commercial CAR in CAYA B-ALL. Methods: Ten centers participating in both the Pediatric Real-world CAR Consortium (PRWCC) and Pediatric Health Information System (PHIS; Children's Hospital Association, Lenexa, KS) were eligible for study (08/2017-03/2020). Clinical data from the PRWCC database was merged with PHIS using age, diagnosis, center and lymphodepletion dates. Utilizing center and year specific charge-to-cost ratio, PHIS provided data for inpatient admission associated costs, but not outpatient care. For patients that were infused outpatient and subsequently admitted, only inpatient cost was available and analyzed for the first 60 days post-infusion. For patients that were infused inpatient, cost was calculated from the first day of admission for lymphodepletion or Kymriah infusion to 60 days post-infusion. The 60-day follow up was chosen as most of the clinical activity and toxicities occur within the 60 days post-infusion. Each patient was assigned a cost of $475,000 for Kymriah (list price). For the subset of patients who underwent allogeneic hematopoietic cell transplantation (alloHCT) following Kymriah, the median inpatient cost was assessed for 1-year post-alloHCT. Cost data was analyzed as medians and ranges. Univariable and multivariable logistic regression models were used to identify factors associated with the higher median cost associated with inpatient admissions. Results: 109 Kymriah-recipients were included. Patient characteristics are listed in Table 1. The incidence of grade 1-2 and ≥3 CRS was 42% and 23%, respectively, and grade 1-2 and ≥3 ICANS was 17% and 6%, respectively. Relapse/refractory disease at day 30 and 60 post-Kymriah infusion was 11% and 16%, respectively. AlloHCT was performed in 17 (16%) patients. Median time to alloHCT from Kymriah infusion was 148 days (36-354). The median number of admissions was 1 (0-5) and median length of all hospitalization was 18 days (0-69), 99% patients required inpatient admission. Thirty-six patients (33%) required intensive care unit (ICU) admission with a median ICU stay of 5 days (1-24). The median total cost (Kymriah + inpatient cost) per patient was $615,845 ($475,000-1,578,321). Breakdown of median total cost (excluding Kymriah) was: room/board $33,676 ($0-454,256), pharmacy $65,854 ($0-515,132), laboratory/pathology cost $10,496 ($0-201,900) and other cost $8,204 ($0-573,163). One-year median cost associated with inpatient admissions for alloHCT was $556,712 ($105,670-1,919,275), combined median cost associated with Kymriah + alloHCT was $1,263,316 ($696,768-2,404,447). Factors associated with higher inpatient cost were public insurance ($96,287, p=0.002); inpatient Kymriah infusion ($395,182, p&amp;lt;0.001); CRS grade≥3 ($342,176, p&amp;lt;0.001); ICANS grade ≥3 ($354,013, p=0.010); ICU stay ($346,737 p&amp;lt;0.001). Multivariable analysis demonstrated that only inpatient infusion of Kymriah significantly associated with higher cost (Table 2). Conclusion: In this cost analysis across CAYA receiving Kymriah, we describe the total inpatient treatment-associated cost, with inpatient infusion emerging as a main driver of cost. With increased clinical experience, outpatient infusions and early interventions to avoid high-grade toxicity and ICU-level care have become more common and potentially more cost-effective. Our data justifies efforts to deliver Kymriah in the outpatient setting, when safe and feasible, and to provide support systems to facilitate this. Additionally, Kymriah drug cost accounts for the bulk (73%) of the overall median cost, highlighting that efforts to lower drug costs may permit enhanced access globally.

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Trends in sedation-analgesia practices in pediatric liver transplant patients admitted postoperatively to the pediatric intensive care unit: An analysis of data from the pediatric health information system (PHIS) database.

Children admitted to the pediatric intensive care unit (PICU), after liver transplantation, frequently require analgesia and sedation in the immediate postoperative period. Our objective was to assess trends and variations in sedation and analgesia used in this cohort. Multicenter retrospective cohort study using the Pediatric Health Information System from 2012 to 2022. During the study period, 3963 patients with liver transplantation were admitted to the PICU from 32 US children's hospitals with a median age of 2 years [IQR: 0.00, 10.00]. 54 percent of patients received mechanical ventilation (MV). Compared with patients without MV, those with MV were more likely to receive morphine (57% vs 49%, p < .001), fentanyl (57% vs 44%), midazolam (45% vs 31%), lorazepam (39% vs. 24%), dexmedetomidine (38% vs 30%), and ketamine (25% vs 12%), all p < .001. Vasopressor usage was also higher in MV patients (22% vs. 35%, p < .001). During the study period, there was an increasing trend in the utilization of dexmedetomidine and ketamine, but the use of benzodiazepine decreased (p < .001). About 50% of patients who undergo liver transplant are placed on MV in the PICU postoperatively and receive a greater amount of benzodiazepines in comparison with those without MV. The overall utilization of dexmedetomidine and ketamine was more frequent, whereas the administration of benzodiazepines was less during the study period. Pediatric intensivists have a distinctive opportunity to collaborate with the liver transplant team to develop comprehensive guidelines for sedation and analgesia, aimed at enhancing the quality of care provided to these patients.

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1304. Early Surgical Procedures and Clinical Outcomes Among Children Hospitalized with Acute Hematogenous Osteomyelitis

Abstract Background Surgical biopsy and drainage may have diagnostic and therapeutic benefits for children with acute hematogenous osteomyelitis (AHO). However, it remains unknown whether routinely expediting surgical procedures improves clinical outcomes compared to a “wait-and-see” approach. We aimed to determine whether hospitals that frequently perform early surgery for AHO have improved clinical outcomes compared to hospitals that rarely perform early surgery. Methods Admissions for AHO at 48 hospitals were identified in the Pediatric Health Information System from 1/2015 through 10/2022 for patients 6 months to 18 years with a discharge diagnosis of osteomyelitis using a previously validated algorithm to exclude chronic osteomyelitis, non-hematogenous infections, and significant comorbidities. Encounters assigned a surgical procedure code on hospital day 0 or 1 were classified as undergoing “early surgery” and hospitals were stratified based on proportion of AHO patients receiving early surgery. Clinical outcomes at the 16 hospitals with the lowest rates of early surgery (rare group) were compared to those from the 16 hospitals with the highest rates of early surgery (frequent group). Categorical variables were compared using chi-square tests and continuous with Wilcoxon Rank-Sum tests. Results There were 2102 encounters in the rare group and 2040 encounters in the frequent group. Median proportion of AHO patients undergoing early surgery was 20% in the rare group compared to 37% in the frequent group (Range 10% to 54%). Length of stay in the frequent group was marginally lower (4.4 vs 4.1 days, P &amp;lt; 0.001), as was length of intravenous antimicrobials (4.5 vs 4.3 days, P&amp;lt; 0.001). Patients were more likely to be critically ill at frequent early surgery hospitals (1% vs 5%, P&amp;lt; 0.001), more likely to have a central line placed (8% vs 11%, P=0.002), and more likely to have a pathogen identified (50% vs 59%, P&amp;lt; 0.001). Cost per admission was slightly higher in the frequent group ($12960 vs $13759, P&amp;lt; 0.001). Conclusion Frequency of early surgical procedures for pediatric AHO varies across institutions. Clinical outcomes and resource utilization for children with AHO are similar between institutions that rarely and frequently expedite surgical procedures. Disclosures Samuel R. Dominguez, MD, PhD, Biofire Diagnostics: Advisor/Consultant|Biofire Diagnostics: Grant/Research Support|Cobio Diagnostics: Board Member|Karius: Advisor/Consultant|Pfizer: Grant/Research Support

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