INTRODUCTION:A large proportion of postoperative mortality after pediatric surgery occurs among neonates with specific high-risk diagnoses. The extent to which there is hospital-level mortality variation among patients with these diagnoses and whether this variation is associated with differences in failure to rescue (FTR) is unclear.METHODS:The Pediatric Health Information System® database (2012-2020) was used to identify patients who underwent surgery for eight high-risk neonatal diagnoses: gastroschisis; volvulus; necrotizing enterocolitis; intestinal atresia; meconium peritonitis; tracheoesophageal fistula; congenital diaphragmatic hernia; and perinatal intestinal perforation. Hospitals were stratified into tertiles of reliability-adjusted inpatient mortality rates (lower than average mortality - tertile 1 [T1]; higher than average mortality - tertile 3 [T3]). Multivariable hierarchical regression was used to evaluate the association between hospital-level, reliability-adjusted mortality and FTR.RESULTS:Overall, 20,838 infants were identified across 48 academic, pediatric hospitals. Adjusted hospital mortality rates ranged from 4.0% (95% CI, 0.0-8.2) to 16.3% (12.2-20.4). Median case volume (range, 80-1,238) and number of NICU beds (range, 24-126) were not significantly different across hospital tertiles. Compared to the hospitals with the lowest postoperative mortality (T1), the odds of FTR were significantly higher in hospitals with the highest (T3) postoperative mortality (odds ratio 1.97 [1.50-2.59]).CONCLUSIONS:Significant variation in neonatal hospital mortality for high-risk diagnoses does not appear to be explained by hospital structural characteristics. Rather, difference in FTR suggests quality improvement interventions targeting early recognition and management of postoperative complications could improve surgical quality and safety for high-risk neonatal care.

OBJECTIVES:To evaluate the association between pediatric hospital performances in terms of failure to rescue (FTR), defined as postoperative mortality after a surgical complication, and mortality among patients without a surgical complication. DESIGN:Retrospective cohort study. SETTING:Forty-eight academic, pediatric hospitals; data obtained from Pediatric Health Information System database (Child Health Corporation of America, Shawnee Mission, KS) (2012-2020). PATIENTS:Children who underwent at least one of 57 high-risk operations associated with significant postoperative mortality. EXPOSURES:Hospitals were stratified into quintiles of reliability adjusted FTR (lower than average FTR in quintile 1 [Q1], higher than average FTR in quintile 5 [Q5]). Multivariable hierarchical regression was used to evaluate the association between hospital FTR performance and mortality among patients who did not have a surgical complication. MEASUREMENTS AND MAIN RESULTS:Among 203,242 children treated across 48 academic hospitals, the complication and overall postoperative mortality rates were 8.8% and 2.3%, respectively. Among patients who had a complication, the FTR rate was 8.8%. Among patients who did not have a complication, the mortality rate was 1.7%. There was a 6.5-fold increase in reliability adjusted FTR between the lowest and highest performing hospitals (lowest FTR hospital-2.7%; 95% CI [1.6-3.9]; highest FTR hospital-17.8% [16.8-18.8]). Complex chronic conditions were highly prevalent across hospitals (Q1, 72.7%; Q2, 73.8%; Q3, 72.2%; Q4, 74.0%; Q5, 74.8%; trend test p < 0.01). Relative to Q1 hospitals, the odds of mortality in the absence of a postoperative complication significantly increased by 33% at Q5 hospitals (odds ratio 1.33; 95% CI [1.07-1.66]). This association was consistent when limited to patients with a complex chronic condition and neonates. CONCLUSION:FTR may be a useful and valid surgical quality measure for pediatric surgery, even when considering patients without a postoperative complication. These findings suggest practices and processes for preventing FTR at high performing pediatric hospitals might help mitigate the risk of postoperative mortality even in the absence of a postoperative complication.

Objective: The aim was to determine the association between risk adjusted hospital perioperative mortality rates, postoperative complications, and failure to rescue (FTR) after inpatient pediatric surgery. Background: FTR has been identified as a possible explanatory factor for hospital variation in perioperative mortality in adults. However, the extent to which this may be the case for hospitals that perform pediatric surgery is unclear. Methods: The Pediatric Health Information System database (2012–2020) was used to identify patients who underwent one of 57 high-risk operations associated with significant perioperative mortality (n=203,242). Academic, pediatric hospitals (n=48) were stratified into quintiles based on risk adjusted inpatient mortality [lower than average, quintile 1 (Q1); higher than average, quintile 5 (Q5)]. Multivariable hierarchical regression was used to evaluate the association between hospital mortality rates, complications, and FTR. Results: Inpatient mortality, complication, and FTR rates were 2.3%, 8.8%, and 8.8%, respectively. Among all patients who died after surgery, only 34.1% had a preceding complication (Q1, 36.1%; Q2, 31.5%; Q3, 34.7%; Q4, 35.7%; Q5, 32.2%; trend test, P=0.49). The rates of observed mortality significantly increased across hospital quintiles, but the difference was <1% (Q1, 1.9%; Q5; 2.6%; trend test, P<0.01). Relative to Q1 hospitals, the odds of complications were not significantly increased at Q5 hospitals [odds ratio (OR): 1.02 (0.87–1.20)]. By comparison, the odds of FTR was significantly increased at Q5 hospitals [OR: 1.60 (1.30–1.96)] with a dose-response relationship across hospital quintiles [Q2—OR: 0.99 (0.80–1.22); Q3—OR: 1.26 (1.03–1.55); Q4—OR: 1.33 (1.09–1.63)]. Conclusions: The minority of pediatric surgical deaths are preceded by a postoperative complication, but variation in risk adjusted mortality across academic, pediatric hospitals may be partially explained by differences in the recognition and management of postoperative complications. Additional work is needed to identify children at greatest risk of postoperative death from perioperative complications as opposed to those at risk from pre-existing chronic conditions.

PURPOSE:Approximately 800 children annually suffer unintentional firearm injuries and deaths from unsecured firearms in the United States. These injuries are preventable, and may be avoided by providing parents with firearm safety guidance (FSG). The purpose of this study was to evaluate the experience of pediatric providers in delivering FSG following incorporation of the American Academy of Pediatrics (AAP) infographic.METHODS:Qualitative study completed July 2019-December 2019. Community pediatricians in Houston, Texas were provided the AAP firearm safety infographic and encouraged to provide FSG routinely during well-child visits with firearm-owning parents. Efficacy, feasibility of use and barriers to FSG were assessed via focus groups. Content analysis was utilized to identify emergent themes from provider experiences.RESULTS:Forty-four pediatricians across eight clinics delivered FSG using the AAP infographic. Of these, thirty-four participated in focus groups discussing their experience. Only 34% of those in the focus groups had routinely provided FSG prior to the study. The AAP infographic was a useful tool because of its visibility, valuable information, and assistance with broaching the topic of firearm safety with parents. Three themes were identified from qualitative analysis: methods of successful delivery of FSG (62%), patient responses to FSG (25%), and barriers to delivery of FSG (13%). Parents were generally receptive to the guidance.CONCLUSIONS:The AAP firearm safety infographic, which is free and publicly available, can be a valuable and satisfactory tool for delivery of firearm safety guidance by pediatric providers, including surgeons. Further study is needed to assess whether the guidance changes parental storage behaviors.LEVEL OF EVIDENCE:Level VI.

Objective: Investigate patterns of infant perioperative mortality, describe the infant diagnoses with the highest mortality burden, and evaluate the association between types of postoperative complications and mortality in infants. Background: The majority of mortality events in pediatric surgery occur among infants (ie, children <1 y old). However, there is limited data characterizing patterns of infant perioperative mortality and diagnoses that account for the highest proportion of mortality. Methods: Infants who received inpatient surgery were identified in the National Surgical Quality Improvement Program-Pediatric database (2012–2019). Perioperative mortality was stratified into mortality associated with a complication or mortality without a complication. Complications were categorized as wound infection, systemic infection, pulmonary, central nervous system, renal, or cardiovascular. Multivariable logistic regression was used to evaluate the association between different complications and complicated mortality. Results: Among 111,946 infants, the rate of complications and perioperative mortality was 10.4% and 1.6%, respectively. Mortality associated with a complication accounted for 38.8% of all perioperative mortality. Seven diagnoses accounted for the highest proportion of mortality events (40.3%): necrotizing enterocolitis (22.3%); congenital diaphragmatic hernia (7.3%); meconium peritonitis (3.8%); premature intestinal perforation (2.5%); tracheoesophageal fistula (1.8%); gastroschisis (1.4%); and volvulus (1.1%). Relative to wound complications, cardiovascular [odds ratio (OR): 19.4, 95% confidence interval (95% CI): 13.9–27.0], renal (OR: 6.88; 4.65–10.2), and central nervous system complications (OR: 6.50; 4.50–9.40) had the highest odds of mortality for all infants. Conclusions: A small subset of diagnoses account for 40% of all infant mortality and specific types of complications are associated with mortality. These data suggest targeted quality improvement initiatives could be implemented to reduce adverse surgical outcomes in infants.

Introduction Red blood cell transfusion (RBCT) is commonly administered in neonatal surgical care in the absence of clear clinical indications such as active bleeding or anemia. We hypothesized that higher RBCT volumes are associated with worse postoperative outcomes. Methods Neonates within the National Surgical Quality Improvement Program–Pediatric database who underwent inpatient surgery (2012–2016) were stratified by weight-based RBCT volume: <20cc/kg, 20–40cc/kg, and >40cc/kg. Postoperative complications were categorized as wound, systemic infection, central nervous system (CNS), renal, pulmonary, and cardiovascular. Multivariable logistic regression and cubic spline analysis were used to evaluate the association between RBCT volume, postoperative complications, and 30-day mortality. Sensitivity analysis was conducted by performing propensity score matching. Results Among 9,877 neonates, 1,024 (10%) received RBCTs. Of those who received RBCT, 53% received <20cc/kg, 27% received 20–40cc/kg, and 20% received >40cc/kg. Relative to neonates who were not transfused, RBCT volume was associated with a dose-dependent increase in renal complications, CNS complications, cardiovascular complications, and 30-day mortality. With cubic spline analysis, a lone inflection point for 30-day mortality was identified at a RBCT volume of 30 – 35 cc/kg. After propensity score matching, the dose-dependent relationship was still present for 30-day mortality. Conclusion Total RBCT volume is associated with worse postoperative outcomes in neonates with a significant increase in 30-day mortality at a RBCT volume of 30 – 35 cc/kg. Future prospective studies are needed to better understand the association between large RBCT volumes and poor outcomes after neonatal surgery. Level of evidence Level IV, Retrospective cohort study

Background: Our purpose is to describe the structure, function and outcomes of our multidisciplinary pediatric thyroid program and to evaluate our experience in comparison to other high-volume centers. Methods: We reviewed all thyroid operations performed 10/2012 through 09/2019, and examined number of cases per year, patient demographics, procedures, final diagnoses and results. Primary outcomes were hypoparathyroidism and recurrent laryngeal nerve (RLN) injury at 12 months. Data were analyzed using descriptive statistics and univariate analyses.Results: We performed 294 thyroid operations on 279 patients. Seventy-nine percent were female. Median age was 15 years (IQR: 12-17). Operations included total thyroidectomy (65%), lobectomy (30%) and completion thyroidectomy (5%). Most common diagnoses were Graves' disease (35%), malignancy (29%), and benign nodule (20%). We developed an evidence-based clinical pathway and conducted weekly multidisciplinary meetings. A clinical data specialist reviewed process and outcome measures routinely. Overall, 6 patients (2.0%) had hypoparathyroidism and 2 (0.7%) had unilateral RLN injury at 12 months. Two of the patients with clinical suspicion of permanent hypoparathyroidism were ultimately weaned off calcium. Both patients with RLN injury had extensive locally advanced malignant disease involving the nerve.Conclusions: Our multidisciplinary team achieved excellent long-term outcomes for pediatric thyroid surgery comparable to other high-volume pediatric and adult centers.Level of Evidence IV (c) 2021 Elsevier Inc. All rights reserved.

Background: The majority of failure to rescue (FTR), or death after a postoperative complication, in pedi-atric surgery occurs among infants and neonates. The purpose of this study is to evaluate the association between gestational age (GA) and FTR in infants and neonates. Methods: National cohort study of 46,452 patients < 1 year old within the National Surgical Quality Improvement Program-Pediatric database who underwent inpatient surgery. Patients were categorized as preterm neonates, term neonates, or infants. Neonates were stratified based on GA. Surgical procedures were classified as low-(< 1% mortality) or high-risk ( > 1%). Multivariable logistic regression and cubic splines were used to evaluate the association between GA and FTR. Results: Preterm neonates had the highest FTR (28%) rates. Among neonates, FTR increased with decreas-ing GA ( > 37 weeks, 12%; 33-36 weeks, 15%; 29-32 weeks, 30%; 25-28 weeks 41%; < 24 weeks, 57%). For both low-and high-risk procedures, FTR significantly (trend test, p < 0.01) increased with decreasing GA. When stratifying preterm neonates by GA, all GAs < 28 weeks were associated with significantly higher odds of FTR for low-(OR 2.47, 95% CI [1.38-4.41]) and high-risk (OR 2.27, 95% CI [1.33-3.87]) procedures. A lone inflection point for FTR was identified at 31-32 weeks with cubic spline analysis. Conclusions: The dose-dependent relationship between decreasing GA and FTR as well as the FTR in-flection point noted at GA 31-32 weeks can be used by stakeholders in designing quality improvement initiatives and directing perioperative care. Level of evidence: Level IV, Retrospective cohort study (c) 2021 Elsevier Inc. All rights reserved.

Remote ischemic conditioning (RIC) is a maneuver involving brief cycles of ischemia reperfusion in an individual’s limb. In the early stage of experimental NEC, RIC decreased intestinal injury and prolonged survival by counteracting the derangements in intestinal microcirculation. A single-center phase I study demonstrated that the performance of RIC was safe in neonates with NEC. The aim of this phase II RCT was to evaluate the safety and feasibility of RIC, to identify challenges in recruitment, retainment, and to inform a phase III RCT to evaluate efficacy. RIC will be performed by trained research personnel and will consist of four cycles of limb ischemia (4-min via cuff inflation) followed by reperfusion (4-min via cuff deflation), repeated on two consecutive days post randomization. The primary endpoint of this RCT is feasibility and acceptability of recruiting and randomizing neonates within 24 h from NEC diagnosis as well as masking and completing the RIC intervention. We created a novel international consortium for this trial and created a consensus on the diagnostic criteria for NEC and protocol for the trial. The phase II multicenter-masked feasibility RCT will be conducted at 12 centers in Canada, USA, Sweden, The Netherlands, UK, and Spain. The inclusion criteria are: gestational age < 33 weeks, weight ≥ 750 g, NEC receiving medical treatment, and diagnosis established within previous 24 h. Neonates will be randomized to RIC (intervention) or no-RIC (control) and will continue to receive standard management of NEC. We expect to recruit and randomize 40% of eligible patients in the collaborating centers (78 patients; 39/arm) in 30 months. Bayesian methods will be used to combine uninformative prior distributions with the corresponding observed proportions from this trial to determine posterior distributions for parameters of feasibility. The newly established NEC consortium has generated novel data on NEC diagnosis and defined the feasibility parameters for the introduction of a novel treatment in NEC. This phase II RCT will inform a future phase III RCT to evaluate the efficacy and safety of RIC in early-stage NEC.

Introduction: Up to a third of children undergoing partial hepatectomy for primary hepatic malignancies experience at least one perioperative complication, with a presumed deleterious effect on both short -and long-term outcomes. We implemented a multidisciplinary treatment protocol in the management of these patients in order to improve complication rates following partial hepatectomy. Methods: A retrospective chart review was completed for all patients < 18 years of age who underwent liver resection at our institution between 2002 and 2019 for primary hepatic cancer. Demographic, intraoperative, postoperative, pathologic, and outcome data were analyzed for perioperative complications using the CLASSIC and ClavienDindo (CD) scales, event-free survival (EFS) and overall survival (OS). Results: A total of 73 patients were included in the analysis with 33 prior-to and 40 after dedicated provider protocol implementation. Perioperative complication rates decreased from 52% to 20% ( p = 0.005) with major complications going from 18% to 10% ( p = 0.31). On multivariable logistic regression, protocol implementation was associated with a reduction in any (OR 0.29 [95% CI 0.09 - 0.89]) but not major complications. On multivariate cox models, post protocol implementation was associated with improved event free survival (EFS) (HR 0.19 (0.036 - 0.195). Among patients with a diagnosis of hepatoblastoma ( n = 62), the occurrence of a major perioperative complication was associated with a worse EFS (HR = 5.45, p = 0.03) on multivariate analysis, however this did not translate into an impact on overall survival. Conclusions: Our results demonstrate that, for children with primary liver malignancies, a dedication of patients to high-volume surgeons can improve rates of complications of liver resections and may improve the oncological outcome of hepatoblastoma. (C) 2021 Elsevier Inc. All rights reserved.

BACKGROUND/PURPOSE:Access to firearms is a preventable cause of unintentional injury and suicide in children. Pediatric physicians provide injury prevention guidance, but firearm safety may not routinely be included. The purpose of this pilot study was to evaluate the effectiveness of firearm safety guidance (FSG) provided by a physician.METHODS:Prospective, randomized-controlled, trial assessing physician-delivered FSG at two pediatric clinics in Houston, Texas. Firearm-owning parents were randomized to physician guidance (PG) versus control (CG) groups. The CG received a handout with firearm safety facts and a free cable lock. The PG additionally received FSG by a physician. Pre- and post-intervention surveys were conducted. Results were analyzed using descriptive statistics and Chi square analysis.RESULTS:Thirty-two families participated; most (70%) were satisfied with the guidance. Pre-intervention safe firearm storage was high in both groups, and the intervention did not lead to improved habits in either group [PG: Pre 93% vs. Post 89%, p = 0.7 and CG: Pre 82% vs. 78%, p = 0.7].There was no difference in use of the free cable lock among groups (44% vs. 22%, p = 0.9). The PG demonstrated improved knowledge of the state child access protection law (PG: Pre 60% vs. Post 100% vs. CG: Pre 29% vs. Post 67%; p = 0.02).CONCLUSIONS:For firearm-owning parents, physician-delivered safe storage guidance may not be more effective than self-directed guidance provided by a handout. A larger trial is underway to confirm the findings of this pilot study.

Purpose: A cascade of complications is believed to be the primary mechanism underlying failure to rescue (FTR), or death of a patient after a postoperative complication. It is unknown whether specific types of index complications are associated with the incidence of secondary complications and FTR after pediatric surgery.Methods: National cohort study of patients within the National Surgical Quality Improvement Program- Pediatric database who underwent inpatient surgery (2012-2019). Index complications were grouped into nine categories (cardiovascular, venous thromboembolism, pulmonary, bleeding/transfusion, renal, central nervous system, wound, infectious, or minor [defined as having an associated mortality rate < 1%]). The association between the type of index complication with FTR, secondary complications, reoperation, un-planned readmission, and postoperative length of stay was evaluated with multivariable logistic regres-sion and generalized linear modeling.Results: Among 425,386 patients, 15.5% had at least one complication, 16.6% had one or more secondary complications, 13.9% reoperation, 14.5% readmission, and 2.4% FTR. Secondary complication (10.8-59.7%) and FTR (0.3-31.1%) rates varied by type of index complication. Relative to patients who had an index minor complication, those with an index infectious complication were most likely to have secondary complication (Odds Ratio [OR] 10.3, 95% CI [9.36-11.4]). Index CV complications were most strongly as-sociated with FTR (OR 30.7 [24.0-39.4]). Index wound complications had the greatest association with reoperation (OR 21.9 [20.5-23.4]) and readmission (OR 18.7 [17.6-19.9]). Index pulmonary complications had the strongest association with length of stay (coefficient 9.39 [8.95-9.83]).Conclusions: Different types of index complications are associated with different perioperative outcomes. These data can help identify patients potentially at risk for suboptimal outcomes and can inform pediatric quality improvement interventions.Type of study: Cohort study.Level of evidence: Level II.(c) 2022 Elsevier Inc. All rights reserved.

Mehl, Steven C. MD; Portuondo, Jorge I. MD; Vogel, Adam M. MD, FACS; Lopez, Monica E. MD, FACS; Shah, Sohail R. MD, MSHA, FACS; Wesson, David E. MD; Massarweh, Nadar MD; Fallon, Sara C. MD Author Information

Thyroid and parathyroid tumors are rare in children. The most common types are papillary and follicular carcinoma, collectively referred to as differentiated thyroid cancer (DTC). Compared to adults, children with DTC typically present with more advanced disease but they have an excellent prognosis with a high cure rate and low risk of death, at least in the short-term. Current treatment recommendations are based largely on adult data supplemented by a small number of pediatric reports. This treatment consists of total thyroidectomy for DTC followed in most cases by radioactive I131 for remnant ablation and control of residual occult local and metastatic disease. Long-term follow-up is mandatory.

Mehl, Steven C. MD; Portuondo, Jorge I. MD; Vogel, Adam M. MD, FACS; Lopez, Monica E. MD, FACS; Shah, Sohail R. MD, MSHA, FACS; Wesson, David E. MD; Massarweh, Nader MD; Fallon, Sara C. MD Author Information

Purpose: We previously validated a visual aid for the use in the consent process for an appendectomy showing improved parental satisfaction and understanding. In this study, we evaluated provider satisfaction and perceived value of using the visual aid. Methods: An IRB approved survey was developed assessing provider experience with use of the visual aid. This was distributed and analyzed via Research Electronic Data Capture (RedCap) Database. Results: We administered 58 surveys (45% response rate). Participants included faculty (n = 2), fellows (n = 1), residents (n = 6), and physician assistants (n = 17). The visual aid was used N10 times by 50% of providers. The most common reason for not using the visual aid was not remembering it was available. Nearly half (40%) did not feel the visual aid added any time. 9/20 (45%) felt it added a small amount of time. Slightly over half of providers (52%) felt using the visual aid significantly increased family ability to give informed consent and made the consenting process easier for both providers and families. Conclusion: Using a visual aid in consenting families for appendectomy does not add significant time and subjectively improves the process for providers and increases provider perception of parental understanding. (c) 2020 Elsevier Inc. All rights reserved.

Background: The purpose of this study is to characterize the epidemiology, injury patterns, outcomes and trends of non-accidental trauma (NAT) in the United States using a large national database. Methods: Children <15 years presenting after NAT were identified in the 2007-2014 National Trauma Databank research datasets. Clinical and outcome data were analyzed using descriptive statistics, chi-square and logistic regression. Results: Of 678,503 children admitted for traumatic injuries, 3% (19,149) were victims of NAT. The majority (95%) were under 5 years and 71% under 1 year old. The majority (59%) were male. The median injury severity score (ISS) was 10 (IQR:5-19). African Americans were disproportionally affected (27% vs 17% of all traumas), and the majority had public or no insurance (85%). Incidence was highest in the midwest and lowest in the northeast regions of the country, although trends varied over time. NAT resulted in 43% of trauma deaths in children <1 year and 31% of trauma deaths in children <5. Traumatic brain injury (TBI) was the most commonly encountered diagnosis (50%). Polytrauma was common, and certain injury patterns were identified. Urgent operation was required in 6%, 43% were admitted to intensive care, and 9% died. Mortality was independently associated with TB!, thoracic injury, hollow viscus injury and older age. Conclusion: Non-accidental trauma is a leading cause of trauma mortality in young children. Multiple injuries are common, requiring comprehensive evaluation and early surgical involvement. The data presented in this study could serve as a guide to target injury prevention efforts. Study type: Prognostic and Epidemiological (C) 2019 Elsevier Inc. All rights reserved.

Although surgery plays a very important role in the management of inflammatory bowel disease (IBD) in children, in most cases it is indicated only after medical therapy with corticosteroids and other antiinflammatory drugs, immune modulators, biologics, antibiotics, gut rest, and nutritional support have failed to adequately control the disease or have caused unacceptable side effects or complications.