Preoperative Blood Transfusions and Morbidity in Neonates Undergoing Surgery.

BACKGROUND: Blood transfusions in the neonatal patient population are common, but there are no established guidelines regarding transfusion thresholds. Little is known about postoperative outcomes in neonates who receive preoperative blood transfusions (PBTs). METHODS: Using the American College of Surgeons National Surgical Quality Improvement Program-Pediatric Participant Use Data Files from 2012 to 2015, we identified all neonates who underwent surgery. Mortality and composite morbidity (defined as any postoperative complication) in neonates who received a PBT within 48 hours of surgery were compared with that in neonates who did not receive a transfusion. RESULTS: A total of 12 184 neonates were identified, of whom 1209 (9.9%) received a PBT. Neonates who received a PBT had higher rates of preoperative comorbidities and worse postoperative outcomes when compared with those who did not receive a transfusion (composite morbidity: 46.2% vs 16.2%; P < .01). On multivariable regression analysis, PBTs were independently associated with increased 30-day morbidity (odds ratio [OR] = 1.90; 95% confidence interval [CI]: 1.63-2.22; P < .01) and mortality (OR = 1.98; 95% CI: 1.55-2.55; P < .01). In a propensity score-matched analysis, PBTs continued to be associated with increased 30-day morbidity (OR = 1.53; 95% CI: 1.29-1.81; P < .01) and mortality (OR = 1.58; 95% CI: 1.24-2.01; P = .01). CONCLUSIONS: In a propensity score-matched model, PBTs are independently associated with increased morbidity and mortality in neonates who undergo surgery. Prospective data are needed to better understand the potential effects of a red blood cell transfusion in this patient population.

Reducing resource utilization for patients with uncomplicated appendicitis through use of same-day discharge and elimination of postoperative antibiotics.

BACKGROUND: There is controversy over certain aspects of post-appendectomy care for children with uncomplicated appendicitis. Some institutions have embraced the practice of same-day discharge after appendectomy, while others are hesitant due to concerns about increased readmissions or emergency department (ED) visits. Similarly, some surgeons have transitioned to treating gangrenous appendicitis with a single perioperative dose, while others are concerned about increased risk of infection in this population. METHODS: We developed a pathway for the management of patients undergoing appendectomy for uncomplicated acute appendicitis which included same-day discharge and elimination of postoperative antibiotics for patients with gangrenous appendicitis. We compared outcomes for children treated at our institution before and after implementation of the protocol. RESULTS: We identified 575 patients undergoing appendectomy for uncomplicated appendicitis (307 pre- and 268 post-protocol). We observed a significant decrease in postoperative length-of stay (10.6 to 2.6 h, p < 0.0001). There were no increases in postoperative complications, such as superficial (2.6% vs 1.1%, p = 0.19) or organ-space surgical-site infection (1.6% vs 0.4%, p = 0.14), percutaneous drain placement (1.3% vs 0%, p = 0.06), postoperative ED visits (5.5% vs 5.2%, p = 0.87) or readmission (3.3% vs 1.5%, p = 0.17). CONCLUSIONS: These findings suggest that incorporating same-day discharge for simple appendicitis and eliminating postoperative antibiotics for children with gangrenous appendicitis does not increase complication rates. Implementation of similar pathways across institutions has the potential to significantly reduce resource utilization for children undergoing appendectomy for uncomplicated appendicitis. TYPE OF STUDY: Retrospective comparative study. LEVEL OF EVIDENCE: Level III.

Standardized pathway for feeding tube placement reduces unnecessary surgery and improves value of care.

BACKGROUND: Children requiring gastrostomy tubes (GT) have high resource utilization. In addition, wide variation exists in the decision to perform concurrent fundoplication, which can increase the morbidity of enteral access surgery. We implemented a hospital-wide standardized pathway for GT placement. METHODS: The standardized pathway included mandatory preoperative nasogastric feeding tube (FT) trial, identification of FT medical home, and standardized postoperative order set, including feeding regimen and parent education. An algorithm to determine whether concurrent fundoplication was indicated was also created. We identified children referred for GT placement from 2015 to 2018 and compared concurrent fundoplication rates and outcomes pre- and postimplementation. RESULTS: We identified 332 patients who were referred for GT. Of these, 15 avoided placement. Concurrent fundoplication decreased postpathway (48% vs 22%, p < 0.0001). After adjusting for reflux and cardiac disease, prepathway patients were 3.5 times more likely to undergo concurrent fundoplication. ED visits (46% vs 27%, p = 0.001) and postoperative LOS (median (IQR) 10 days (5-36) to 5.5 days (1-19), p = 0.0002) decreased. CONCLUSIONS: A standardized pathway for GT placement prevented unnecessary GT placement and fundoplication with reduction in postoperative LOS and ED visits. This approach can significantly reduce resource utilization while improving outcomes. TYPE OF STUDY: Prognosis study. LEVEL OF EVIDENCE: Level II.

Robot-assisted repair of a urogenital sinus with an anorectal malformation in a patient with McKusick-Kaufman syndrome.

INTRODUCTION: A urogenital sinus (US) and an anorectal malformation (ARM) are a rare constellation of anomalies, and the optimal surgical approach is unclear. Open and laparoscopic approaches have been described for US and ARM, but no data exist to support robotic assistance in children. CASE: A 20-month-old Amish female presented to the study center with fever and abdominal pain. Abdominal ultrasound showed a large fluid-filled vagina, urinalysis was positive, and she was admitted for antibiotic therapy. Magnetic resonance imaging (MRI) confirmed hydrocolpos. An examination under anesthesia including cystoscopy demonstrated a short perineal body, an anteriorly displaced anus by muscle stimulation, and no vaginal opening. An ultrasound-guided, percutaneous vaginostomy tube was placed, and 650 cc of pus was drained. Vaginal and urine cultures grew similar strains of Escherichias coli. After a course of antibiotics, she underwent a robot-assisted mobilization of the intra-abdominal vagina and uterus, posterior sagittal anorectoplasty, vaginal pull-through, and a diverting colostomy. There were no intra-operative complications. Her Foley catheter was removed on post-operative day #3, and she voided spontaneously and was discharged in good condition. She remained in the hospital for ostomy teaching, but pain control and diet were not barriers to discharge after 12 h. CONCLUSION: Robotic mobilization of the intra-abdominal vagina in a pediatric patient with US and ARM is technically feasible and can be accomplished safely. Further comparative studies to other approaches are lacking. In this case, the robot allowed for good visualization, intra-operative collaboration between multiple specialties for complex patients with aberrant anatomy, and easy dissection in a narrow pre-pubertal pelvis and would be an approach that the study group uses in future cases.

Necrotizing enterocolitis totalis: High mortality in the absence of an aggressive surgical approach.

BACKGROUND: Necrotizing enterocolitis is the leading case of gastrointestinal-related morbidity in premature infants. Necrotizing enterocolitis totalis is an aggressive form of necrotizing enterocolitis, which has traditionally been managed with comfort care. Recent advances in management of short bowel syndrome have resulted in some reported long-term survival. METHODS: Using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, studies that reported outcomes in children with necrotizing enterocolitis totalis were identified. The definition of necrotizing enterocolitis totalis was captured along with length of follow-up, patient demographics, and outcomes. RESULTS: A total of 766 articles were screened, of which 166 were selected for full article review. Of these, 32 articles included data on 414 patients with necrotizing enterocolitis totalis. In the majority of studies (52%), necrotizing enterocolitis totalis was not defined. Aggressive surgical therapy (defined as bowel resection or fecal diversion) was undertaken in 32 patients (7.7%), with a mortality rate of 68.8%. In contrast, nonaggressive surgical therapy was undertaken in 382 patients (92.3%), and the mortality in these patients was 95%. Long-term outcomes for necrotizing enterocolitis totalis survivors, such as length of time on parenteral nutrition, progression to liver and/or small bowel transplant, and quality of life, were not reported. CONCLUSION: We found that there is no accepted definition of necrotizing enterocolitis totalis. Aggressive surgical therapy is rarely pursued, which likely drives the overall high mortality rate. This study underscores the importance of standardizing the definition of necrotizing enterocolitis totalis and capturing short and long-term outcomes prospectively. With more aggressive surgical therapy, more infants are likely to survive this abdominal catastrophe, which was once thought to be uniformly fatal.

Short-term outcomes in children undergoing restorative proctocolectomy with ileal-pouch anal anastomosis.

INTRODUCTION: Patients with familial adenomatous polyposis (FAP) and ulcerative colitis (UC) commonly undergo restorative proctocolectomy with ileal-pouch anal anastomosis (RP-IPAA). We sought to describe patient characteristics and postoperative outcomes in this patient population. METHODS: Using the National Surgical Quality Improvement Program-Pediatric Participant Use Files from 2012 to 2015, children who were 6-18years old who underwent RP-IPAA for FAP or UC were identified. Postoperative morbidity, including reoperation and readmission were quantified. Associations between preoperative characteristics and postoperative outcomes were analyzed. RESULTS: A total of 260 children met the inclusion criteria, of which 56.2% had UC. Most cases were performed laparoscopically (58.1%), and the operative time was longer with a laparoscopic versus open approach (326 [257-408] versus 281 [216-391] minutes, p=0.02). The overall morbidity was 11.5%, and there were high reoperation and readmission rates (12.7% and 21.5%, respectively). On bivariate analysis, preoperative steroid use was associated with reoperation (22.5% versus 10.9%, p=0.04). On multivariable regression analysis, obesity was independently associated with reoperation (odds ratio: 3.34 [95% confidence intervals: 1.08-10.38], p=0.04). CONCLUSIONS: Children who undergo RP-IPAA have high rates of overall morbidity, reoperation, and readmission. Obesity was independently associated with reoperation. This data can be used by practitioners in the preoperative setting to better counsel families and establish expectations for the postoperative setting. TYPE OF STUDY: Retrospective Comparative Study. LEVEL OF EVIDENCE: Level III.

Hospital variation in rates of concurrent fundoplication during gastrostomy enteral access procedures.

BACKGROUND: This study aimed to determine whether (1) the propensity for concurrent fundoplication during gastrostomy varies among hospitals, and (2) postoperative morbidity differs among institutions performing fundoplication more or less frequently. METHODS: Children who underwent gastrostomy with or without concurrent fundoplication were identified in the American College of Surgeons National Surgical Quality Improvement Program Pediatric (ACS-NSQIP-P). A hierarchical multivariate regression modeled the excess effects that hospitals exerted over propensity for concurrent fundoplication adjusting for preoperative clinical variables. Hospitals were designated as low outliers (significantly lower-adjusted odds of concurrent fundoplication than the average hospital with similar patient mix), average hospitals, and high outliers based on their risk-adjusted concurrent fundoplication practice. The postoperative morbidity rates were compared among low-outlier, average, and high-outlier hospitals. RESULTS: Between 2011 and 2013, 3775 children underwent gastrostomy at one of 54 ACS-NSQIP-P participating hospitals. The mean hospital concurrent fundoplication rate was 11.7% (range 0-64%). There was no significant difference in unadjusted morbidity rate in children with concurrent fundoplication, 11.0% compared to 9.7% in children without concurrent fundoplication. After controlling for clinical variables, 8 hospitals were identified as low outliers (fundoplication rate of 0.4%) and 16 hospitals were identified as high outliers (fundoplication rate of 34.6%). The average unadjusted morbidity rate among hospitals with low, average, and high odds of concurrent fundoplication were 9.6, 10.6, and 8.4%, respectively. CONCLUSION: Hospitals vary significantly in propensity for concurrent fundoplication during gastrostomy yet postoperative morbidity does not differ significantly among institutions performing fundoplication more or less frequently.

Outcomes in Children Undergoing Surgery for Congenital Pulmonary Airway Malformations in the First Year of Life.

BACKGROUND: Treatment of congenital pulmonary airway malformations (CPAMs) is generally surgical resection; however, there is controversy regarding the optimal timing of surgical intervention, especially in asymptomatic patients. STUDY DESIGN: Using the American College of Surgeons National Surgical Quality Improvement Program-Pediatric Participant Use Files from 2012 to 2015, children who underwent lung resection for CPAMs were identified. Outcomes in children who underwent lung resection during the neonatal period were compared with those who underwent resection beyond the neonatal period, but during the first year of life (non-neonates). RESULTS: A total of 541 patients (20.7% neonates and 79.3% non-neonates) were identified. Neonates had higher rates of preoperative comorbidities and worse postoperative outcomes when compared with non-neonates (morbidity 19.6% vs 5.4%, p < 0.0001). On multivariable regression analysis, the presence of preoperative symptoms (defined as oxygen dependence or ventilatory support) was independently associated with increased morbidity (odds ratio 3.91 [range 1.6 to 9.57], p = 0.003). In a subgroup analysis of asymptomatic neonates compared with asymptomatic non-neonates, there was no difference in overall morbidity (7.4% vs 4.4%, p = 0.33). CONCLUSIONS: These data suggest that lung resection for CPAMs in the neonatal period in asymptomatic children are not associated with increased 30-day morbidity. The presence of preoperative symptoms was independently associated with increased morbidity in a multivariable regression model. More data are needed to better understand the long-term outcomes and better define the optimal timing of surgery in this patient population.

Case Volume and Revisits in Children Undergoing Gastrostomy Tube Placement.

OBJECTIVES: Emergency department (ED) visits and hospital readmissions are common after gastrostomy tube (GT) placement in children. We sought to characterize interhospital variation in revisit rates and explore the association between this outcome and hospital-specific GT case volume. PATIENTS AND METHODS: We conducted a retrospective cohort study from 38 hospitals using the Pediatric Health Information System database. Patients younger than 18 years who had a GT placed in 2010 to 2012 were assessed for a GT-related (mechanical or infectious) ED visit or inpatient readmission at 30 and 90 days after discharge from GT placement. Risk-adjusted rates were calculated using generalized linear mixed-effects models accounting for hospital clustering and relevant demographic and clinical attributes, then compared across hospitals. RESULTS: A total of 15,642 patients were included. A median of 468 GTs were placed in all the 38 hospitals during 3 years (range: 83-891), with a median of 11.4 GT placed per 1000 discharges (range: 2.4-16.7). Median ED visit for each hospital at 30 days after discharge was 8.2% (range: 3.7%-17.2%) and 14.8% at 90 days (range: 6.3%-26.1%). Median inpatient readmissions for each hospital at 30 days after discharge was 3.5% (range: 0.5%-10.5%) and 5.9% at 90 days (range: 1.0%-18.5%). Hospital-specific GT placement per 1000 discharges (rate of GT placement) was inversely correlated with ED visit rates at 30 (P = 0.007) and 90 days (P = 0.020). The adjusted 30- and 90-day readmission rate and the adjusted 30- and 90-day ED return rates decreased with increasing GT insertion rate (P < 0.001). CONCLUSION: Higher hospital GT insertion rates are associated with lower ED revisit rates but not inpatient readmissions.

Emergency Department Visits and Readmissions among Children after Gastrostomy Tube Placement.

OBJECTIVES: To define the incidence of 30-day postdischarge emergency department (ED) visits and hospital readmissions following pediatric gastrostomy tube (GT) placement across all procedural services (Surgery, Interventional-Radiology, Gastroenterology) in 38 freestanding Children's Hospitals. STUDY DESIGN: This retrospective cohort study evaluated patients <18 years of age discharged between 2010 and 2012 after GT placement. Factors significantly associated with ED revisits and hospital readmissions within 30 days of hospital discharge were identified using multivariable logistic regression. A subgroup analysis was performed comparing patients having the GT placed on the date of admission or later in the hospital course. RESULTS: Of 15 642 identified patients, 8.6% had an ED visit within 30 days of hospital discharge, and 3.9% were readmitted through the ED with a GT-related issue. GT-related events associated with these visits included infection (27%), mechanical complication (22%), and replacement (19%). In multivariable analysis, Hispanic ethnicity, non-Hispanic black race, and the presence of ≥3 chronic conditions were independently associated with ED revisits; gastroesophageal reflux and not having a concomitant fundoplication at time of GT placement were independently associated with hospital readmission. Timing of GT placement (scheduled vs late) was not associated with either ED revisits or hospital readmission. CONCLUSIONS: GT placement is associated with high rates of ED revisits and hospital readmissions in the first 30 days after hospital discharge. The association of nonmodifiable risk factors such as race/ethnicity and medical complexity is an initial step toward understanding this population so that interventions can be developed to decrease these potentially preventable occurrences given their importance among accountable care organizations.

Variation in intraoperative and postoperative red blood cell transfusion in pediatric surgery.

BACKGROUND: Intraoperative and postoperative red blood cell (RBC) transfusions are relatively frequent events tracked in the American College of Surgeons' National Surgical Quality Improvement Program-Pediatric (ACS-NSQIP-P). This study sought to quantify variation in RBC transfusion practices among hospitals. STUDY DESIGN AND METHODS: This is an observational study of children older than 28 days who underwent a general, neurologic, urologic, otolaryngologic, plastic, or orthopedic operation at 50 hospitals in participating in the ACS-NSQIP-P during 2011 to 2012. The primary outcome was whether or not a RBC transfusion was administered from incision time to 72 hours postoperatively. Transfusions of fresh-frozen plasma, cryoprecipitate, and platelets were excluded from data abstraction due the rarity of their administration. A multivariate hierarchical risk-adjustment model estimated the risk-adjusted hospital RBC transfusion odds ratio (OR) and designated hospitals by transfusion practice. RESULTS: The mean RBC transfusion rate was 1.5%. Five preoperative variables were associated with greater than threefold increased odds of having an intraoperative or postoperative RBC transfusion; young age; 29 days to 1 year (OR, 5.9; p < 0.001) and 1 to 2 years (OR, 3.4; p < 0.001); American Society of Anesthesiologists Class IV (OR, 3.2; p < 0.001); procedure linear risk (OR, 3.1; p < 0.001); preoperative septic shock (OR, 14.5; p < 0.001); and preoperative cardiopulmonary resuscitation (OR, 8.1; p < 0.001). Twenty-five hospitals had RBC transfusion practices significantly different than risk-adjusted mean (17 higher and eight lower). CONCLUSION: Intraoperative and postoperative RBC transfusion practices vary widely among hospitals after controlling for patient and procedural characteristics.

Estimating Adverse Events After Gastrostomy Tube Placement.

OBJECTIVE: Gastrostomy feeding tube placement in children is associated with a high frequency of adverse events. This study sought to preoperatively estimate postoperative adverse events in children undergoing gastrostomy feeding tube placement. METHODS: This was an observational study of children who underwent gastrostomy with or without fundoplication at 1 of 50 participating hospitals, using 2011-2013 data from the American College of Surgeons' National Surgical Quality Improvement Program Pediatric. The outcome was the occurrence of any postoperative complications or mortality at 30 days after gastrostomy tube placement. The preoperative clinical characteristics significantly associated with occurrence of adverse events were included in a multivariate logistic model. The area under the receiver operating characteristic curve was computed to assess model performance and split-set validated. RESULTS: A total of 2817 children were identified as having undergone gastrostomy tube placement. The unadjusted rate of adverse events within 30 days after gastrostomy tube placement was 11%. Thirteen predictor variables were identified. Notable preoperative variables associated with a greater than 75% increase in adverse event rate were preoperative sepsis/septic shock (odds ratio [OR], 10.76, 95% confidence interval [CI], 3.84-30.17), central nervous system tumor (OR, 3.36; 95% CI, 1.42-7.95), the primary procedure as indicated by the current procedural terminology (CPT) linear risk variable (OR, 1.93; 95% CI, 1.50-2.49), severe cardiac risk factors (OR, 1.88; 95% CI, 1.17-3.03), and preoperative seizure history (OR, 1.90; 95% CI, 1.38-2.62). The area under the receiver operating characteristic curve was 0.71 with the derivation data set and 0.71 upon split-set validation. CONCLUSIONS: Preoperatively estimating postoperative adverse events in children undergoing gastrostomy tube placement is feasible.

Improving quality on the pediatric surgery service: Missed opportunities and making it happen.

In surgery, quality improvement efforts have evolved from the traditional case-by-case review typical for morbidity and mortality conferences to more accurate and comprehensive data collection accomplished through participation in national registries such as the National Surgical Quality Improvement Program. Gaining administrative support to participate in these kinds of initiatives and commitment of the faculty and staff to make change in a data-driven manner rather than as a reaction to individual events can be a challenge. This article guides the reader through the process of interacting with administrative leadership to gain support for evidence-based quality improvement endeavors. General principles that are discussed include stakeholder engagement, taking advantage of preexisting resources, and the sharing of data in order to shape QI efforts and demonstrate their effectiveness.

A risk calculator predicting postoperative adverse events in neonates undergoing major abdominal or thoracic surgery.

PURPOSE: This study sought to demonstrate the feasibility of a risk calculator for neonates undergoing major abdominal or thoracic surgery with good discriminative ability. METHODS: The American College of Surgeons' National Surgical Quality Improvement Program Pediatric (ACS-NSQIP-P) 2011-12 data were queried for neonates who underwent major abdominal or thoracic surgery. The outcome of interest was the occurrence of any adverse event, including mortality, within 30-days postoperatively. The preoperative clinical characteristics significantly associated with any adverse event were used to build a multivariate model. The model's discriminative ability was assessed with the area under the receiver operating characteristic curve (AUROC). The model was split-set validated with 2013 data. RESULTS: A total of 2967 neonates undergoing major abdominal or thoracic surgery were identified. The overall rate of adverse events was 23.3%. Sixteen variables were found to be associated with adverse events. Four variables increased the odds of adverse events at least two-fold: dirty or infected wound class [odds ratio (OR)=2.1] dialysis (OR=3.8), hepatobiliary disease (OR=2.1), and inotropic agent use (OR=2.6). The AUROC=0.79 for development data and 0.77 on split-set validation. CONCLUSION: Preoperatively estimating the probability of postoperative adverse events in neonates undergoing major abdominal or thoracic surgery with good discrimination is feasible.

Risk-adjusted hospital outcomes for children's surgery.

UNLABELLED: BACKGROUND The American College of Surgeons National Surgical Quality Improvement Program-Pediatric was initiated in 2008 to drive quality improvement in children's surgery. Low mortality and morbidity in previous analyses limited differentiation of hospital performance. METHODS: Participating institutions included children's units within general hospitals and free-standing children's hospitals. Cases selected by Current Procedural Terminology codes encompassed procedures within pediatric general, otolaryngologic, orthopedic, urologic, plastic, neurologic, thoracic, and gynecologic surgery. Trained personnel abstracted demographic, surgical profile, preoperative, intraoperative, and postoperative variables. Incorporating procedure-specific risk, hierarchical models for 30-day mortality and morbidities were developed with significant predictors identified by stepwise logistic regression. Reliability was estimated to assess the balance of information versus error within models. RESULTS: In 2011, 46 281 patients from 43 hospitals were accrued; 1467 codes were aggregated into 226 groupings. Overall mortality was 0.3%, composite morbidity 5.8%, and surgical site infection (SSI) 1.8%. Hierarchical models revealed outlier hospitals with above or below expected performance for composite morbidity in the entire cohort, pediatric abdominal subgroup, and spine subgroup; SSI in the entire cohort and pediatric abdominal subgroup; and urinary tract infection in the entire cohort. Based on reliability estimates, mortality discriminates performance poorly due to very low event rate; however, reliable model construction for composite morbidity and SSI that differentiate institutions is feasible. CONCLUSIONS: The National Surgical Quality Improvement Program-Pediatric expansion has yielded risk-adjusted models to differentiate hospital performance in composite and specific morbidities. However, mortality has low utility as a children's surgery performance indicator. Programmatic improvements have resulted in actionable data.

American College of Surgeons National Surgical Quality Improvement Program Pediatric: a beta phase report.

PURPOSE: The American College of Surgeons (ACS) National Surgical Quality Improvement Program Pediatric (NSQIP-P) expanded to beta phase testing with the enrollment of 29 institutions. Data collection and analysis were aimed at program refinement and development of risk-adjusted models for inter-institutional comparisons. METHODS: Data from the first full year of beta-phase NSQIP-P were analyzed. Patient accrual used ACS-NSQIP methodology tailored to pediatric specialties. Preliminary risk adjusted modeling for all pediatric and neonatal operations and pediatric (excluding neonatal) abdominal operations was performed for all cause morbidity (other than death) and surgical site infections (SSI) using hierarchical logistic regression methodology and eight predictor variables. Results were expressed as odds ratios with 95% confidence intervals. RESULTS: During calendar year 2010, 29 institutions enrolled 37,141 patients. 1644 total CPT codes were entered, of which 456 accounted for 90% of the cases. 450 codes were entered only once (1.2% of cases). For all cases, overall mortality was 0.25%, overall morbidity 7.9%, and the SSI rate 1.8%. For neonatal cases, mortality was 2.39%, morbidity 18.7%, and the SSI rate 3%. For the all operations model, risk-adjusted morbidity institutional odds ratios ranged 0.48-2.63, with 9/29 hospitals categorized as low outliers and 9/29 high outliers, while risk-adjusted SSI institutional odds ratios ranged 0.36-2.04, with 2/29 hospitals low outliers and 7/29 high outliers. CONCLUSION: This report represents the first risk-adjusted hospital-level comparison of surgical outcomes in infants and children using NSQIP-P data. Programmatic and analytic modifications will improve the impact of this program as it moves into full implementation. These results indicate that NSQIP-P has the potential to serve as a model for determining risk-adjusted outcomes in the neonatal and pediatric population with the goal of developing quality improvement initiatives for the surgical care of children.

Pediatric American College of Surgeons National Surgical Quality Improvement Program: feasibility of a novel, prospective assessment of surgical outcomes.

PURPOSE: The American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) provides validated assessment of surgical outcomes. This study reports initiation of an ACS NSQIP Pediatric at 4 children's hospitals. METHODS: From October 2008 to June 2009, 121 data variables were prospectively collected for 3315 patients, including 30-day outcomes and tailoring the ACS NSQIP methodology to children's surgical specialties. RESULTS: Three hundred seven postoperative complications/occurrences were detected in 231 patients representing 7.0% of the study population. Of the patients with complications, 175 (75.7%) had 1, 39 (16.9%) had 2, and 17 (7.4%) had 3 or more complications. There were 13 deaths (0.39%) and 14 intraoperative occurrences (0.42%) detected. The most common complications were infection, 105 (34%) (SSI, 54; sepsis, 31; pneumonia, 13; urinary tract infection, 7); airway/respiratory events, 27 (9%); wound disruption, 18 (6%); neurologic events, 8 (3%) (nerve injury, 4; stroke/vascular event, 2; hemorrhage, 2); deep vein thrombosis, 3 (<1%); renal failure, 3 (<1%); and cardiac events, 3 (<1%). Current sampling captures 17.5% of cases across institutions with unadjusted complication rates ranging from 6.8% to 10.2%. Completeness of data collection for all variables exceeded 95% with 98% interrater reliability and 87% of patients having full 30-day follow-up. CONCLUSION: These data represent the first multiinstitutional prospective assessment of specialty-specific surgical outcomes in children. The ACS NSQIP Pediatric is poised for institutional expansion and future development of risk-adjusted models.

American College of Surgeons National Surgical Quality Improvement Program Pediatric: a phase 1 report.

BACKGROUND: There has been a long-standing desire to implement a multi-institutional, multispecialty program to address surgical quality improvement for children. This report documents results of the initial phase of the American College of Surgeons National Surgical Quality Improvement Program Pediatric. STUDY DESIGN: From October 2008 to December 2009, patients from 4 pediatric referral centers were sampled using American College of Surgeons National Surgical Quality Improvement Program methodology tailored to children. RESULTS: A total of 7,287 patients were sampled, representing general/thoracic surgery (n = 2,237; 30.7%), otolaryngology (n = 1,687; 23.2%), orthopaedic surgery (n = 1,367; 18.8%), urology (n = 893; 12.3%), neurosurgery (n = 697; 9.6%), and plastic surgery (n = 406; 5.6%). Overall mortality rate detected was 0.3% and 287 (3.9%) patients had postoperative occurrences. After accounting for demographic, preoperative, and operative factors, occurrences were 4 times more likely in those undergoing inpatient versus outpatient procedures (odds ratio [OR] = 4.71; 95% CI, 3.01-7.35). Other factors associated with higher likelihood of postoperative occurrences included nutritional/immune history, such as preoperative weight loss/chronic steroid use (OR = 1.49; 95% CI, 1.03-2.15), as well as physiologic compromise, such as sepsis/inotrope use before surgery (OR = 1.68; 95% CI, 1.10-1.95). Operative factors associated with occurrences included multiple procedures under the same anesthetic (OR = 1.58; 95% CI, 1.21-2.06) and American Society of Anesthesiologists classification category 4/5 versus 1 (OR = 5.74; 95% CI, 2.94-11.24). Specialty complication rates varied from 1.5% for otolaryngology to 9.0% for neurosurgery (p < 0.001), with specific procedural groupings within each specialty accounting for the majority of complications. Although infectious complications were the predominant outcomes identified across all specialties, distribution of complications varied by specialty. CONCLUSIONS: Based on this initial phase of development, the highly anticipated American College of Surgeons National Surgical Quality Improvement Program Pediatric has the potential to identify outcomes of children's surgical care that can be targeted for quality improvement efforts.

Pilot study using an Internet-based program in informed consent.

PURPOSE: To examine the effect of an internet-based aid to informed consent on parent recall of potential surgical complications. METHODS: Parents of children scheduled for elective inguinal hernia repair were assigned to a control group or were enrolled in an internet-based program designed to aid in the consent process. Nine potential surgical complications were presented to the parent(s) in the consent discussion and in the Internet program. Parent recall of potential surgical complications was assessed immediately after the consent discussion and on the day of surgery. RESULTS: Overall recall of complications was poor in both groups, both immediately and on the day of surgery. Parents in the control group (n = 13) recalled a mean of 2.9 complications immediately and 1.5 on the day of surgery, approaching statistical significance (P = .056). The parents in the internet program group (n = 17) recalled a mean of 2.6 complications immediately and 2.9 on the day of surgery (P = NS). There was no significant difference in immediate recall between the two groups, but there was a trend towards statistically significant improvement in recall in the study group the day of surgery vs. controls (P = .06). CONCLUSION: Although overall recall of potential surgical complications was poor in both groups, there was a trend towards a significant improvement in recall in the study group after viewing the Internet-based program.

Randomized comparison of combination chemotherapy with etoposide, bleomycin, and either high-dose or standard-dose cisplatin in children and adolescents with high-risk malignant germ cell tumors: a pediatric intergroup study--Pediatric Oncology Group 9049 and Children's Cancer Group 8882.

PURPOSE: To determine in a randomized comparison whether combination chemotherapy with high-dose cisplatin (HDPEB) improves the event-free (EFS) and overall (OS) survival of children and adolescents with high-risk malignant germ cell tumors (MGCT) as compared with standard-dose cisplatin (PEB) and to compare the regimens' toxicity. PATIENTS AND METHODS: Between March 1990 and February 1996, 299 eligible patients with stage III and IV gonadal and extragonadal (all stages) MGCT were enrolled onto this Pediatric Oncology Group and Children's Cancer Group study. Chemotherapy included bleomycin 15 units/m(2) on day 1, etoposide 100 mg/m(2) on days 1 through 5, and either high-dose cisplatin 40 mg/m(2) on days 1 through 5 (HDPEB; n = 149) or standard-dose cisplatin 20 mg/m(2) on days 1 through 5 (PEB; n = 150). Patients were evaluated after four cycles of therapy, and those with residual disease underwent surgery. Those with malignant disease in resected specimen received two additional cycles of their assigned regimen. RESULTS: One hundred thirty-four eligible patients with advanced testicular (n = 60) or ovarian (n = 74) tumors and 165 with stage I to IV extragonadal tumors were enrolled. HDPEB treatment resulted in significantly improved 6-year EFS rate +/- SE (89.6% +/- 3.6% v 80.5% +/- 4.8% for PEB; P =.0284). There was no significant difference in OS (HDPEB 91.7% +/- 3.3% v PEB 86.0% +/- 4.1%). Tumor-related deaths were more common after PEB (14 deaths v two deaths). Toxic deaths were more common with HDPEB (six deaths v one death). Other treatment-related toxicities were more common with HDPEB. CONCLUSION: Combination chemotherapy with HDPEB significantly improves EFS for children with high-risk MGCT. The OS is similar in both regimens, and the significant toxicity associated with HDPEB limits its use.