Impact of Cardiac Risk Factors in the Postsurgical Outcomes of Patients With Cleft Lip.

ABSTRACT: Congenital cardiac comorbidities represent a potentially elevated risk for complications in patients undergoing cleft lip repair. National databases, such as the National Surgical Quality Improvement Program Pediatric (NSQIP-P) allow for analysis of large national datasets to assess these risks and potential complications. The aim of this study is to assess the risk of complications in patients undergoing cleft lip repair with congenital cardiac co-morbidities using the NSQIP-P.The 2012 to 2014 NSQIP-P databases were queried for patients undergoing cleft lip repair. Data abstracted for analysis included demographic, clinical, and outcomes data. Patients with cleft lip were stratified based on the presence or absence of congenital cardiac comorbidities. Univariate analysis and step-wise, forward logistic regression were performed to compare these groups.Nationally, between 2012 and 2014, 2126 patients underwent cleft lip repair, 227 with cardiac disease, and 1899 without cardiac disease. Weights were similar between the groups at the time of surgery, though patients with cardiac comorbidities were older. Postoperatively, cardiac disease patients were more likely to experience an adverse event. Specifically, they were more likely to experience reintubation, reoperation, longer length of stay, and death. Rates of surgical site infection and dehiscence were not different between the groups.This study demonstrates that cleft lip repair in patients with congenital heart defects is safe. However, patients undergoing cleft lip repair with comorbid congenital cardiac disease were more likely to experience adverse events. Cardiac patients require special preoperative evaluation before repair of their cleft lip, but do not appear to experience worse wound-related outcomes.

Impact of Cardiac Risk Factors in the Postsurgical Outcomes of Patients With Cleft Palate: Analysis of the 2012-2014 NSQIP Database.

OBJECTIVE: To assess the risk of complication in patients undergoing cleft palate repair with congenital cardiac comorbidities in a large, national cohort. DESIGN: Retrospective review. PATIENTS/SETTING: Using the 2012-2014 National Surgical Quality Improvement Program (NSQIP) Pediatric database, patients undergoing cleft palate repair were selected for analysis. Patients with cleft palate repairs were stratified based on the presence or absence congenital cardiac comorbidities. Univariate and stepwise forward logistic regression were conducted. MAIN OUTCOME MEASURES: It is hypothesized that risk of postoperative adverse events in patients with congenital cardiac comorbidities is higher than in patients without cardiac disease. RESULTS: Nationally, between 2012 and 2014, 3240 patients underwent cleft palate repair, 422 (13.0%) with cardiac disease, and 2818 (87.0%) without cardiac disease. Patients with cardiac disease were smaller (10.5 [6.6] kg vs 11.6 [8.6] kg, P < .01) and more likely to be premature (4.6% vs 13.0%, P < .01) compared to those without cardiac disease. Postoperatively, patients with cardiac conditions were more likely to experience an adverse event (8.8% vs 4.2%, P < .01). Specifically, they were more likely to experience reintubation (1.7% vs 0.4%, P < .01), reoperation (2.1% vs 0.6%, P < .01), and longer length of stay (2.7 [7.0] vs 1.6 [2.8] days, P < .01). Rates of surgical site infection and dehiscence were not different. CONCLUSIONS: Cleft palate repair in patients with concurrent congenital cardiac defects is a safe procedure but carries elevated risk in the postoperative period as demonstrated in this analysis of the NSQIP-Pediatric database. Technical risks are equivalent. Additional anesthesia and surgical awareness of these potential complications is essential to minimize perianesthesia risks.

Increased complications in pediatric surgery are associated with comorbidities and not with Down syndrome itself.

BACKGROUND: Down syndrome (DS) is a genetic condition associated with multiple comorbidities. While physicians may perceive that DS patients have more postoperative complications, the literature remains unclear. This study compared postoperative complications for children with and without DS who underwent abdominal and thoracic procedures. METHODS: The National Surgical Quality Improvement Program Pediatric was queried for patients aged <18 years, who underwent abdominal and noncardiac thoracic operations (by Current Procedural Terminology codes) from 2012 to 2015. The analysis compared patients based on the presence or absence of DS. The primary outcome was a composite of all postoperative complications as defined by the National Surgical Quality Improvement Program Pediatric. The analysis utilized chi-square, Student's t-test, and univariate and multiple logistic regression. RESULTS: There were 91,478 patients included, of which 1476 (1.6%) had a diagnosis of DS. Patients with DS had higher rates of preoperative nutritional support (38.8% versus 15.0%), developmental delay (61.9% versus 10.4%), and cardiac risk factors (76.5% versus 13.8%). The overall rate of postoperative complications was 11.1%, with a greater proportion in DS patients (16.2% versus 10.8%, P < 0.001). On univariate analysis, DS was associated with increased odds of postoperative complications (odds ratio 1.6 95% confidence interval 1.4-1.9) compared with the non-DS group; however, DS was not a risk factor after adjusting for other covariates (adjusted odds ratio 0.86 95% confidence interval 0.7-1.1). CONCLUSIONS: A higher proportion of postoperative complications were observed in patients with DS. However, after adjusting for other risk factors, DS was not an independent risk factor. The increased rate of complications is likely related to the presence of multiple comorbidities in DS.

Does compliance with antibiotic prophylaxis in pediatric simple appendicitis matter?

BACKGROUND: Institutional protocols for preincisional antibiotic prophylaxis can standardize care and improve outcomes. However, challenges remain in compliance with such protocols for urgent or emergent operations. We hypothesized that compliance with an institutional protocol for antibiotic prophylaxis for appendectomy for appendicitis in pediatric patients results in reduced surgical site infections (SSIs) after simple appendectomy. METHODS: This retrospective study assessed all pediatric patients (≤18 y) who underwent appendectomy for confirmed simple appendicitis at a tertiary children's hospital between 2012 and 2015. Demographic, admission, and outcome data were recorded. Compliance with the protocol was assessed. Univariate analyses were performed to identify factors associated with any SSI and protocol noncompliance. RESULTS: Overall compliance with antibiotic prophylaxis occurred in 590 of 697 patients (85%). Compliance was high with timing (91%), spectrum (95%), and protocol-recommended drug (87%). Admission antibiotics alone were administered in 65 patients (9%), preincisional antibiotics alone in 254 patients (36%), and both in 378 patients (55%). Patients included in the analysis received a median of 2 (range 1-6) doses of antibiotics preoperatively. Ten patients (1.4%) developed an SSI. Only receipt of any antibiotics within an hour of incision was associated with decreased odds of SSI (odds ratio 0.22, 95% confidence interval 0.06-0.87). No factors were associated with noncompliance. CONCLUSIONS: An institutional appendicitis protocol yields high compliance with prophylactic antibiotic administration and associated low SSI rates, but at a cost of antibiotic over-administration. Further efforts are necessary to sustain compliance while also practicing appropriate antibiotic stewardship.

Debriefing: the forgotten phase of the surgical safety checklist.

BACKGROUND: The debriefing phase of the surgical safety checklist (SSC) provides the operative team an opportunity to share pertinent intraoperative information and communicate postoperative plans. Prior quality improvement initiatives at our institution focused on the preincision phase of the SSC; however, the debriefing phase has not been evaluated. We aimed to assess adherence to the debrief checklist at our institution and identify areas for improvement. MATERIALS AND METHODS: An observational study was conducted from 2014 to 2016 with a convenience sample of pediatric surgery cases at an academic children's hospital over 8-wk periods annually to evaluate the debriefing checklist across 14 subspecialties. Intraoperative team members' adherence to eight prespecified checkpoints was assessed. Descriptive statistics, Pearson's chi square, Kruskal-Wallis rank test, and Cohen's kappa for interrater reliability were used (P < 0.05 was significant). RESULTS: A total of 603 cases were observed (2014 n = 191; 2015 n = 195; 2016 n = 217). The debriefing checklist was conducted in 90.6%, 90.3%, and 94.9% of observed cases each year respectively with the median number of checklist items completed relatively unchanged (8, 7, and 7, range 0-8). However, the checklist was only fully completed in 55%, 48%, and 50% of cases over the study period (P = 0.001) with no debriefing at all in approximately 9% of cases in 2014 and 2015 versus 5% in 2016 (P < 0.001). Interrater reliability annually was >0.65. CONCLUSIONS: Despite slight increases annually in overall compliance to the debriefing checklist, only half of all checklists were completed in full. Future efforts to augment adherence are needed and will include interventions targeting the debriefing phase and increasing operating room efficiency.

Prophylactic versus symptomatic Ladd procedures for pediatric malrotation.

BACKGROUND: Intestinal malrotation can lead to volvulus resulting in necrosis, sepsis, and death. For symptomatic patients, treatment includes the Ladd procedure. However, debate remains regarding the timing and need for intervention for asymptomatic infants. We evaluated our experience with Ladd procedures including a clinical practice of prophylactic surgery for asymptomatic patients. MATERIALS AND METHODS: A retrospective review of pediatric patients undergoing the Ladd procedure was performed. Prophylactic Ladd procedures were identified as those occurring before any malrotation-related symptoms. Results were analyzed with student t test, Mann-Whitney U, and chi-squared tests. RESULTS: From 2011-2014, 42 patients (prophylactic = 19, symptomatic = 23) underwent the Ladd procedure. The median age (IQR, interquartile range) of patients was 9.6 (3.9-18) mo and 18 (2.4-52) mo for prophylactic and symptomatic patients, respectively (P = 0.38). In patients who underwent symptomatic Ladd procedures, nine (39%) had volvulus and one (4.3%) had bowel necrosis at time of surgery. No prophylactic Ladd procedure patients required reoperation, whereas six (26%) symptomatic patients required malrotation-related reoperations (P = 0.02). Median (IQR) days to full enteral feeds were 5.0 d (3.3-6.8) versus 7.4 (5.0-11; P = 0.11), whereas median days to discharge were 8.0 d (6.1-11) versus 11 d (7.5-32) until discharge (P = 0.09) for prophylactic and symptomatic patients, respectively. CONCLUSIONS: Although symptomatic patients represent sicker children, the postoperative complications appear to be higher. For infants with known malrotation, prophylactic operations may be beneficial and should be considered. A larger, prospective study to demonstrate effectiveness and generalizability for prophylactic Ladd procedure is warranted.

Room for "quality" improvement? Validating National Surgical Quality Improvement Program-Pediatric (NSQIP-P) appendectomy data.

INTRODUCTION: Accurate data are essential for the validity of clinical registries. This study aimed to validate NSQIP-P data, assess representativeness, and evaluate risk-adjusted predictive ability at a single institution. METHODS: A prospective appendectomy-specific pediatric surgery research database (RD) maintained by clinical researchers was compared to the NSQIP-P data for appendectomies performed in 2016 at a tertiary children's hospital. NSQIP-P sampled data collected by trained surgical clinical reviewers (SCRs) were compared to matched RD patients. Both datasets used NSQIP-P definitions. Using χ2, datasets were compared by patient demographics, disease severity (simple vs. complicated), and outcomes. RESULTS: 458 appendectomies for acute appendicitis were performed in 2016, of which 250 (55%) were abstracted by SCRs and matched to RD patients. Patient demographics were similar between datasets. Disease severity (NSQIP-P:50% complicated vs RD:31% complicated) and composite morbidity (NSQIP-P:6.0% vs RD:14.4%) were significantly different (both p < 0.01). Demographics and outcomes were similar between matched (n = 250) and unsampled patients in the RD (n = 208). NSQIP-P's risk-adjusted predicted morbidity was significantly lower than morbidity observed in all (n = 458) RD patients (NSQIP-P:9.9% vs RD:14.2%, p < 0.01). CONCLUSIONS: Though constituting a representative sample, NSQIP-P appendectomy data were inconsistent with department data. Discrepancies appear to be the result of underreporting of outcome variables and disease misclassification. TYPE OF STUDY: Retrospective comparative review. LEVEL OF EVIDENCE: Level III.

Advances in perioperative quality and safety.

For decades, safe surgery focused on intraoperative technique and decision-making. The traditional hierarchy placed the surgeon as the leader with ultimate authority and responsibility. Despite the advances in surgical technique and equipment, too many patients have suffered unnecessary complications and suboptimal care. Today, we understand that the conduct of safe and effective surgery requires evidence-based decision-making, multifaceted treatment approaches to prevent complications, and effective communication in and out of the operating room. In this manuscript, we describe three significant advances in quality and safety that have changed the approach to surgical care: the National Surgical Quality Improvement Program, evidence-based bundled prevention of surgical site infections, and the Surgical Safety Checklist.

Enhanced neonatal surgical site infection prediction model utilizing statistically and clinically significant variables in combination with a machine learning algorithm.

BACKGROUND: Machine-learning can elucidate complex relationships/provide insight to important variables for large datasets. This study aimed to develop an accurate model to predict neonatal surgical site infections (SSI) using different statistical methods. METHODS: The 2012-2015 National Surgical Quality Improvement Program-Pediatric for neonates was utilized for development and validations models. The primary outcome was any SSI. Models included different algorithms: full multiple logistic regression (LR), a priori clinical LR, random forest classification (RFC), and a hybrid model (combination of clinical knowledge and significant variables from RF) to maximize predictive power. RESULTS: 16,842 patients (median age 18 days, IQR 3-58) were included. 542 SSIs (4%) were identified. Agreement was observed for multiple covariates among significant variables between models. Area under the curve for each model was similar (full model 0.65, clinical model 0.67, RF 0.68, hybrid LR 0.67); however, the hybrid model utilized the fewest variables (18). CONCLUSIONS: The hybrid model had similar predictability as other models with fewer and more clinically relevant variables. Machine-learning algorithms can identify important novel characteristics, which enhance clinical prediction models.

Adherence to the Pediatric Preinduction Checklist Is Improved When Parents Are Engaged in Performing the Checklist.

BACKGROUND: The World Health Organization recommends including the parents in completion of the pediatric surgical safety checklist. At our hospital, the preinduction surgical safety checklist is conducted in the preoperative holding with anesthesia, nursing, and often with the parents of children undergoing an operative procedure. We hypothesized that adherence to the preinduction checklist is better when parents are engaged in surgical safety checklist performance. METHODS: An observational study of adherence to the preinduction checklist for nonemergent pediatric operations was performed (2016-2017). Adherence was defined as verbalization of checkpoints. Only checkpoints (patient identification, procedure, site marking, weight, allergies, and NPO status) relevant to parental knowledge were evaluated. Parental engagement was based on: positive body language, eye contact, lack of distractions, and understanding of checkpoints. RESULTS: 484 preinduction surgical safety checklists were observed (interrater reliability >0.7). Partial completion occurred in 55% cases; only 41% checklists were fully completed. Parents were present for 81% of checklists, and more checkpoints were performed when parents were present (5, IQR 4-6) versus absent (2, IQR 1-3, P < .001). Increased preinduction adherence was associated with increased parent engagement by linear regression analysis (1.20, 95%CI 1.05-1.33). Staff confirmed more checkpoints with engaged parents (28-78%) versus when parents were not engaged (1-9%, P < .001 for all checkpoints). CONCLUSION: Overall preinduction surgical safety checklist performance was poor (less than half of checklists fully completed). In contrast, checklist adherence improved with parental presence and engagement during performance of the checklist.

The impact of cardiac risk factors on short-term outcomes for children undergoing a Ladd procedure.

BACKGROUND/PURPOSE: The purpose of this study was to describe the outcomes of children with and without congenital heart disease who undergo a Ladd procedure. METHODS: The 2012-2014 National Surgical Quality Improvement Program Pediatric (NSQIP-P) data were queried for patients undergoing a Ladd procedure. Utilizing NSQIP-P definitions, patients were categorized into four cardiac risk groups (none, minor, major, severe) based on severity of cardiac anomalies, previous cardiac procedure(s), and ongoing cardiac dysfunction. Ladd procedures were elective/non-elective. Outcomes included length of stay, adverse events, and mortality. RESULTS: 878 patients underwent Ladd procedures. 633 (72%) patients had no cardiac risk factors and 84 (10%), 109 (12%), and 52 (6%) had minor, major, and severe cardiac risk factors, respectively. Children with congenital heart disease experienced increased morbidity and mortality and longer hospital stays (all p<0.05). Elective Ladd procedures were associated with similar morbidity but shorter length of stay and lower mortality than non-elective procedures. Older age at time of operation was associated with fewer adverse events. CONCLUSIONS: Although overall mortality remains low, children with higher risk cardiac disease experience increased morbidity and mortality when undergoing a Ladd procedure. Older age at the time of the Ladd procedure was associated with improved outcomes in children.

Surgical site infection reporting: more than meets the agar.

BACKGROUND/PURPOSE: Surgical site infection (SSI) rate in pediatric appendicitis is a commonly used hospital quality metric. We hypothesized that surveillance of organ-space SSI (OSI) using cultures alone would fail to capture many clinically-important events. METHODS: A prospective, multidisciplinary surveillance program recorded 30-day SSI and hospital length of stay (LOS) for patients <18years undergoing appendectomy for perforated appendicitis from 2012 to 2015. Standardized treatment pathways were utilized, and OSI was identified by imaging and/or bacterial cultures. RESULTS: Four hundred ten appendectomies for perforated appendicitis were performed, and a total of 84 OSIs (20.5%) were diagnosed with imaging. Positive cultures were obtained for 39 (46%) OSIs, whereas 45 (54%) had imaging only. Compared to the mean LOS for patients without OSI (5.2±2.9days), LOS for patients with OSI and positive cultures (13.7±5.4days) or with OSI without cultures (10.4±3.7days) was significantly longer (both p<0.001). The OSI rate identified by positive cultures alone was 9.5%, whereas the clinically-relevant OSI rate was 20.5%. CONCLUSIONS: Using positive cultures alone to capture OSI would have identified less than half of clinically-important infections. Utilizing clinically-relevant SSI is an appropriate metric for comparing hospital quality but requires agreed upon standards for diagnosis and reporting. LEVEL OF EVIDENCE: II. TYPE OF STUDY: Diagnostic study.

Meaningful use and good catches: More appropriate metrics for checklist effectiveness.

BACKGROUND: The benefit of utilizing surgical safety checklists has been recently questioned. We evaluated our checklist performance after implementing a program that includes checklist-related good catches. METHODS: Multifaceted interventions aimed at the preincision checklist and 5 prospective audits were conducted from 2011-2015. We documented adherence to the checklist (verbalization of each checkpoint), fidelity (meaningful performance of each checkpoint), and good catches (events with the potential to cause the patient harm but that were prevented from occurring). Good catches were divided into quality improvement-based categories (processes, medication, safety, communication, and equipment). RESULTS: A total of 1,346 checklist performances were observed (range, 144-373/yr). Adherence to the preincision checklist improved from 30% to 95% (P < .001), while adherence to the preinduction and debriefing checklists decreased (71% to 56%, P = .002) and remained unchanged (76%), respectively. Preincision fidelity decreased from 86% to 76% (P = .012). Good catches were identified during 16% of preincision checklist performances; process issues were most common (32%) followed by issues of medication administration (30%) and safety (22%). CONCLUSION: Implementation of a systematic checklist program resulted in significant and sustainable improvement in performance. Meaningful use and associated good catches may be more appropriate metric than actual patient harm for measuring checklist effectiveness. Although not previously described, checklist-related good catches represent an unknown benefit of checklists.