Pediatric traumatic injury (PTI) has substantial physical and emotional health impacts, sometimes resulting in hospitalization and/or the development of posttraumatic stress disorder (PTSD) and depression in children. Caregivers are a key source of support for children following PTI; however, many caregivers experience their own distress and psychological reactions following injury. The CAARE (Caregivers' Aid to Accelerate Recovery after pediatric Emergencies) model is a technology-assisted, stepped care intervention to support the emotional and behavioral recovery of preadolescent children hospitalized after PTI and their caregivers. The CAARE model seeks to provide a systematic, evidence-based screening and intervention procedure that is feasible to implement within pediatric trauma centers. This protocol paper describes a study to evaluate the effectiveness of the CAARE model in improving quality of life, clinical and functional outcomes, and treatment engagement in children and their caregivers following PTI. We also aim to explore potential inequities regarding race, ethnicity, and injury type. This hybrid type 1 effectiveness-implementation trial design allows for the examination of contextual factors related to implementation of CAARE. This paper includes a description of the intervention and control conditions, participant selection and recruitment procedures, assessment measures, and planned quantitative and qualitative methodologies. Potential implications and future directions are discussed. This study was registered in ClinicalTrials.gov (NCT04579198).

4521 Background: tRCC accounts for approximately 50% of pediatric RCC and 1-5% of RCC cases overall. tRCC, driven by TFE3 or TFEb fusions or amplifications ( TFEb ), are often aggressive with no existing standard for systemic therapy. Methods: AREN1721 was a prospective randomized COG-led NCTN phase 2 trial of nivolumab/axitinib combination therapy vs. axitinib alone (closed early for feasibility) vs. nivolumab alone in children and adults with advanced unresectable or metastatic tRCC. Prior exposure to anti-PD1/PDL1 therapies or axitinib was prohibited. The primary endpoint was progression-free survival (PFS), defined as the time from randomization to the earliest of disease progression based on immune-modified RECIST criteria or death. The final protocol version targeted enrollment of 28 eligible patients to detect a hazard ratio (HR) of 0.40 for the comparison of nivolumab/axitinib vs. nivolumab alone using a one-sided log-rank test with alpha = 0.15. Results: Despite aggressive approaches for trial recruitment, AREN1721 was closed after enrolling 15 patients (13 eligible) from 2019 to 2023 secondary to poor accrual. Median age 16 years (range 7-42) with 9/13 age < 18 years; 9/13 were male. Six patients were randomized to nivolumab+axitinib, 2 to axitinib alone, and 5 to nivolumab alone. There were no unexpected toxicities. Thirty-three percent of patients randomized to nivolumab+axitinib experienced partial response, compared to 0% in the other arms, and 0% of patients on the combination arm experienced primary disease progression. Addition of axitinib to nivolumab significantly improved PFS (p = 0.0004), extending median PFS from 1.8 to 10.5 months. Overall survival also improved (p = 0.003) with the addition of axitinib. Conclusions: Nivolumab+axitinib combination therapy was statistically more active than nivolumab single agent therapy, which itself was inactive. Whether anti-PD1 pathway inhibitors add benefit to anti-VEGF therapy for tRCC remains to be determined. Optimizing trial recruitment is critical for this rare but aggressive cancer. Clinical trial information: NCT03595124 . Descriptive statistics by arm. Characteristic Arm A: Axitinib/Nivolumab N = 6 Arm B: Axitinib N = 2 Arm C: Nivolumab N = 5 Overall N = 13 p-value 1 Age (Years) 0.715 Mean (SD) 18 (9) 19 (6) 18 (14) 18 (10) Median (Q1, Q3) 16 (10, 21) 19 (15, 23) 15 (12, 16) 16 (12, 21) Min, Max 9, 32 15, 23 7, 42 7, 42 Age Category >0.999 Age < 18 4 (67%) 1 (50%) 4 (80%) 9 (69%) Age 18+ 2 (33%) 1 (50%) 1 (20%) 4 (31%) Prior Anti-VEGF therapy 1 (17%) 0 (0%) 1 (20%) >0.999 No prior systemic therapy 5 (83%) 2 (100%) 4 (80%) 11 (85%) Best Overall Response 0.019 Partial Response 2 (33%) 0 (0%) 0 (0%) 2 (15%) Stable Disease 4 (67%) 2 (100%) 1 (20%) 7 (54%) Progressive Disease 0 (0%) 0 (0%) 4 (80%) 4 (31%) 1 Kruskal-Wallis rank sum test; Fisher's exact test.

OBJECTIVE:Firearm injuries are a leading cause of morbidity among youth, yet acute pain management practices have not been well characterized. Our objective was to evaluate acute pain medication administration by key sociodemographic characteristics and injury severity after nonfatal firearm injuries. METHODS:We performed a retrospective cross-sectional analysis utilizing Pediatric Health Information System at 40 US children's hospitals from 2016 to 2021. We included inpatient and emergency department (ED) only encounters for patients 0-21 years old with a firearm injury diagnosis. The main outcome was administration of analgesic medications: none, nonopioid only, or at least 1 opioid. We included sociodemographic and injury severity score. Multivariable logistic regression was utilized to determine characteristics associated with the outcome. RESULTS:We included 4924 patients with nonfatal firearm injuries. By ED discharge versus admission, 39.0% versus 3.5% received no analgesia. For the 2522 patients discharged from the ED, younger children were more likely to receive no analgesia. Non-Hispanic White and Hispanic patients were more likely to receive no analgesia compared to non-Hispanic Black patients (adjusted odds ratios [aOR] 1.67 [95% confidence intervals 1.31, 2.31]; aOR 1.53 [1.18, 1.98], respectively). Receipt of opioids was lower among 5-9-year-old patients (aOR 0.40 [0.29, 0.54]), females (aOR 0.77 [0.62, 0.97]), and non-Hispanic White (aOR 0.59 [0.62, 0.75) and Hispanic patients (aOR 0.52 [0.40, 0.67]). CONCLUSIONS:Among youth with nonfatal firearm injuries, analgesia administration varied greatest in the ED-discharged population. This suggests a need for further investigation into pain management practices focused on differences and potential undertreatment of pain in youth with nonfatal firearm injury.

INTRODUCTION:This study aimed to characterize the 30-d outcomes of nephrectomies for renal tumors (RTs) in children and identify predictors of operative morbidity. METHODS:We queried the National Surgical Quality Improvement Program-Pediatric database for children aged <18 y with RTs who underwent nephrectomy from 2012 to 2021. Relevant clinical variables relating to patient demographics, outcomes, and type of nephrectomy were extracted. The primary outcome variable was any major adverse outcome (MAO). The secondary outcome variable was intra- or post-operative transfusion of blood products. Multivariable logistic regression was conducted to identify possible predictors of the primary or secondary outcomes after multiple imputations to account for missing data. RESULTS:We identified 1759 patients with a median age of 3.6 y (interquartile range: 1.9-5.8 y) and an equal sex distribution (51.4% female). Approximately 4.7% of patients had an MAO and 29.8% had a transfusion event. On multivariate regression, the predictors most strongly associated with MAO were a history of chronic lung disease (adjusted odds ratio [aOR] = 1.329, 95% confidence interval [CI] = 1.206-1.465), preoperative nutritional support (aOR = 1.129, 95% CI = 1.074-1.188), and prior inotropic support (aOR = 1.100, 95% CI = 1.010-1.198). A nephron sparing approach was associated with a slightly higher odds of both MAO (aOR = 1.044, 95% CI = 1.015-1.074) and intra-/post-operative transfusion (aOR = 1.109, 95% CI = 1.045-1.177). CONCLUSIONS:Patients undergoing nephrectomy for RTs had low rates of surgical mortality and complications. A nephron sparing approach appeared to be associated with a slightly higher odds of operative morbidity-this may be because patients selected for nephron sparing surgery likely had higher stage, bilateral tumors, or a genetic predisposition to developing RTs.

Wilms tumor (WT) is the most common pediatric renal tumor, and with multidisciplinary treatment overall outcomes are excellent. However, a small subset of patients with WT will relapse. The ideal treatment of relapsed WT is yet to be defined. Ongoing studies through the Children's Oncology Group Renal Tumors Committee (COG-RTC) and the International Society of Paediatric Oncology Renal Tumor Study Group (SIOP-RTSG) aim to improve risk stratification and treatment strategies. Members met at the SIOP 55th Annual Congress 2023 to outline available data and knowledge gaps and develop future research priorities.

To evaluate age, TNW, or tumor diameter (TD) as continuous prognostic variables for outcomes in early stage FHWT after accounting for biology and treatment. Patient age (< 2 vs. ≥ 2 years) and tumor nephrectomy weight (TNW; < 550g vs. ≥ 550 grams) have been used to risk stratify children with stage I favorable histology Wilms tumor (FHWT) on Children’s Oncology Group (COG) studies and select patients for omission of chemotherapy. Included patients had stage I or II FHWT per central review and were treated with nephrectomy only, EE4A, or DD4A on COG trials. Restricted cubic splines models were used to estimate the stage-specific effects of age, TNW, and TD on event-free survival (EFS) and overall survival (OS), accounting for treatment and biology. In pooled analyses of 775 stage I and 936 stage II patients, age was not significantly associated with EFS or OS for stage I or II patients after accounting for adverse biology that is more prevalent with older age. Greater TNW and larger TD were associated with increased risk of relapse in stage I and increased risk of death in stage II, but not when restricted to patients less than 4 years old. Age, TNW, and TD are each prognostic for EFS or OS in some cohorts of patients with stage I or II FHWT. However, after accounting for adverse biology that becomes more prevalent at older ages, these factors are no longer independently prognostic. The next COG FHWT study will implement and validate these findings.

BACKGROUND:Small percutaneously placed pigtail catheters (PCs) for traumatic hemothorax (HTX) are safe and effective in adults but have not been evaluated in children. We hypothesized that PC would have similar efficacy and complication rates compared with chest tubes (CTs). METHODS:A retrospective study of hemodynamically stable pediatric trauma patients (younger than 18 years) with HTX or hemopneumothorax was conducted at 41 trauma centers (January 2010 to December 2022). Catheter failure was defined as a requirement for surgery, additional tube placement, or thrombolytics. Multivariable logistic regression analysis adjusting for age, sex, mechanism of injury, and Injury Severity Score (ISS) was used to evaluate the associated risk of failure. RESULTS:Of 548 patients, 477 had CT and 71 PC. The median age (CT: 15.7 vs. PC: 15.6, p = 0.49) and ISS (CT: 17 vs. PC: 16, p = 0.17) were similar between cohorts. Penetrating trauma patients more often received CTs (62.6% vs. 35.2%, p < 0.0001). Failure rate was similar between CT versus PC (17.6% vs. 12.6%, p = 0.38). While the overall complication rate (respiratory distress, effusion, empyema, pneumonia, infection, deep venous thrombosis) was higher in the PC group on univariate analysis (19.7% vs. 11.9% in CT, p = 0.02), the risk of complications was not increased on multivariable analysis (odds ratio, 1.05; 95% confidence interval, 0.95-1.15; p = 0.3). Length of stay and intensive care unit length of stay were similar between cohorts (all p > 0.05). Logistic regression analysis revealed that PC was not associated with the risk of failure (odds ratio, 0.95; 95% confidence interval, 0.87-1.04; p = 0.31). There was an increased risk of complications with ISS of >15 (odds ratio, 1.17; 95% confidence interval, 1.10-1.26; p < 0.0001) and lower risk with penetrating injury (odds ratio, 0.86; 95%confidence interval, 0.80-0.92; p = 0.0001). CONCLUSION:There was no difference in risk of failure between PC and CT for pediatric HTX/hemopneumothorax and no difference in risk of complications after adjustment for confounders. Pigtail catheters had similar safety and efficacy compared with larger-bore CTs in this large multi-institutional study. LEVEL OF EVIDENCE:Therapeutic/Care Management; Level IV.

INTRODUCTION:Current surgical trainees experience less autonomy in their training than prior generations. Intentionally integrating graduated autonomy into the educational development of fellows would enhance trainee competence while providing the safety net of fellowship programming. The objective of this study was to pilot a competency-based training (CBT) approach for pediatric surgery fellowship programs. METHODS:A CBT approach was developed at a single pediatric surgery fellowship program. Three goals were identified for the development of the CBT structure: 1) demonstrate flexibility for trainees to gain knowledge and skills at individualized paces, 2) readily identify and address knowledge gaps, and 3) facilitate increased autonomy for fellows while in training, in areas where competence has been successfully assessed. The CBT program consisted of five components: operative evaluations, a communication assessment tool (CAT), entrustable professional activities (EPAs), oral exams, and video reviews. Once a fellow completed the minimum requirements of each component, they proceeded to the final review at the clinical competency committee (CCC) meeting. For this pilot, we tracked the changes that were made to the program over the first few years as well as progression of the first six fellows and their participation in the various components. RESULTS:Between 2017 and 2023, six pediatric surgery fellows were evaluated by fourteen pediatric surgery faculty. Three fellows progressed through the pilot program with three procedures (Laparoscopic Appendectomy, Laparoscopic Inguinal Hernia Repair, and Laparoscopic Pyloromyotomy), while the other three fellows progressed through the program with these three initial and two additional procedures (Laparoscopic Gastrostomy Tube Placement and Open Malrotation Repair). The median number of each component completed was: 5 CATs, 101 operative evaluations, 4 oral exams, and 3 video reviews. Fellows achieved competency for 1-4 procedures. From semi-structured interviews, fellows appeared overall satisfied with their experience of the CBT program, stating that these additional sets of tasks and requirements were a helpful thought exercise, provided an extra layer of structure to the curriculum, created a culture of independence and autonomy, and gave added purpose to the first year of training. The principal strength of the program was the structured format leading to graduated autonomy. All fellows reported feeling very prepared to move into a faculty role following graduation from fellowship training. CONCLUSION:Competency-based training may allow for identification of specific gaps in knowledge, skills or abilities and support progressive autonomy among trainees prior to fellowship graduation. Generating further validity evidence and engaging in implementation research are necessary for quality improvement and dissemination of the program.

OBJECTIVE:To evaluate age, TNW, or tumor diameter (TD) as continuous prognostic variables for outcomes in early stage FHWT after accounting for biology and treatment. SUMMARY OF BACKGROUND DATA:Patient age (< 2 vs. ≥ 2 years) and tumor nephrectomy weight (TNW; < 550g vs. ≥ 550 grams) have been used to risk stratify children with stage I favorable histology Wilms tumor (FHWT) on Children's Oncology Group (COG) studies and select patients for omission of chemotherapy. METHODS:Included patients had stage I or II FHWT per central review and were treated with nephrectomy only, EE4A, or DD4A on COG trials. Restricted cubic splines models were used to estimate the stage-specific effects of age, TNW, and TD on event-free survival (EFS) and overall survival (OS), accounting for treatment and biology. RESULTS:In pooled analyses of 775 stage I and 936 stage II patients, age was not significantly associated with EFS or OS for stage I or II patients after accounting for adverse biology that is more prevalent with older age. Greater TNW and larger TD were associated with increased risk of relapse in stage I and increased risk of death in stage II, but not when restricted to patients less than 4 years old. CONCLUSIONS:Age, TNW, and TD are each prognostic for EFS or OS in some cohorts of patients with stage I or II FHWT. However, after accounting for adverse biology that becomes more prevalent at older ages, these factors are no longer independently prognostic. The next COG FHWT study will implement and validate these findings.

To explore clinicopathologic features of children with congenital mesoblastic nephroma (CMN) enrolled on Children’s Oncology Group study AREN03B2 and a historical cohort of CMN patients. CMN is a pediatric renal tumor of infancy, with histologic subtypes of cellular, mixed, and classic. Given its rarity, evidence-based clinical practice guidelines are unavailable. We collected clinicopathologic findings and outcomes data in 2 large cohorts of children with CMN. From 2004-2019, 6412 patients enrolled in AREN03B2 and underwent prospective central review of pathology materials, imaging studies, and operative reports. CMNs were identified and subclassified. Similar data was extracted from a historical cohort of CMNs collected by pathology reviewers between 1973-2001. In total, 535 children were included (139 from AREN03B2; 396 from the historical cohort). In the ARE03B2 cohort, 137 had available follow-up data (median follow-up: 4.5 y). Ten children (7.2%) relapsed, and 4/10 children died of disease. Four of 55 (7.3%) children with local stage II cellular or mixed CMNs relapsed, and 6/37 (16.2%) children with local stage III cellular or mixed CMNs relapsed. No child with local stage I or classic CMNs (of any stage) relapsed. All relapses occurred within 1.5 years of diagnosis, and 4/10 relapses occurred within 3 months. In the historical cohort, 31 children (7.8%) relapsed; all relapses were local stage II or III cellular or mixed. While recurrences are uncommon, they are highly associated with cellular or mixed histologic subtypes and stage, providing key clinical information that may guide consideration of therapy and surveillance.

Firearm injury has overtaken motor vehicle collision as the leading cause of death in children and young adults. To address this public health crisis, a comprehensive understanding of the problem is required. The purpose of this article is to highlight concepts that can help prevent and treat children affected by firearm violence.