Identifying Risk Factors for Complicated Post-operative Course in Tetralogy of Fallot Using a Machine Learning Approach.

Introduction: Tetralogy of Fallot (TOF) repair is associated with excellent operative survival. However, a subset of patients experiences post-operative complications, which can significantly alter the early and late post-operative course. We utilized a machine learning approach to identify risk factors for post-operative complications after TOF repair. Methods: We conducted a single-center prospective cohort study of children <2 years of age with TOF undergoing surgical repair. The outcome was occurrence of post-operative cardiac complications, measured between TOF repair and hospital discharge or death. Predictors included patient, operative, and echocardiographic variables, including pre-operative right ventricular strain and fractional area change as measures of right ventricular function. Gradient-boosted quantile regression models (GBM) determined predictors of post-operative complications. Cross-validated GBMs were implemented with and without a filtering stage non-parametric regression model to select a subset of clinically meaningful predictors. Sensitivity analysis with gradient-boosted Poisson regression models was used to examine if the same predictors were identified in the subset of patients with at least one complication. Results: Of the 162 subjects enrolled between March 2012 and May 2018, 43 (26.5%) had at least one post-operative cardiac complication. The most frequent complications were arrhythmia requiring treatment (N = 22, 13.6%), cardiac catheterization (N = 17, 10.5%), and extracorporeal membrane oxygenation (ECMO) (N = 11, 6.8%). Fifty-six variables were used in the machine learning analysis, of which there were 21 predictors that were already identified from the first-stage regression. Duration of cardiopulmonary bypass (CPB) was the highest ranked predictor in all models. Other predictors included gestational age, pre-operative right ventricular (RV) global longitudinal strain, pulmonary valve Z-score, and immediate post-operative arterial oxygen level. Sensitivity analysis identified similar predictors, confirming the robustness of these findings across models. Conclusions: Cardiac complications after TOF repair are prevalent in a quarter of patients. A prolonged surgery remains an important predictor of post-operative complications; however, other perioperative factors are likewise important, including pre-operative right ventricular remodeling. This study identifies potential opportunities to optimize the surgical repair for TOF to diminish post-operative complications and secure improved clinical outcomes. Efforts toward optimizing pre-operative ventricular remodeling might mitigate post-operative complications and help reduce future morbidity.

Financial incentives and wearable activity monitors to increase ambulation after cystectomy: A randomized controlled trial.

OBJECTIVES: Financial incentive programs are effective in increasing physical activity for overweight, ambulatory adults. We sought to determine the potential effect size and direction of financial incentives on ambulation after radical cystectomy. MATERIALS AND METHODS: We performed a pilot randomized controlled trial of daily financial incentives to meet postoperative step goals among adults with Eastern Cooperative Oncology Group performance status ≤2 who underwent radical cystectomy for bladder cancer at a single center. Step counts were measured over a 3- to 14-day preoperative period and 30-day postoperative period using a wearable activity monitor. Postoperative daily step goals of 10%, 25%, 40%, and 55% of mean preoperative daily step counts were set for postoperative weeks 1 through 4, respectively. The primary outcome was the number of postoperative days on which the step goals were met. Secondary outcomes included the number of daily postoperative steps taken and the length of stay. Participants randomized to the intervention arm received $1.50 for every day the goal was met with a 20% chance of a $100 reward if the step goal was met on >75% of the first 30 postoperative days. Questionnaires assessing self-reported physical activity, disability, and social support were administered preoperatively at 30 days postoperatively. RESULTS: Thirty-three patients were analyzed, 11 in the control and 22 in the intervention arms. There were no statistically significant differences between incentive and control arms for the primary outcome (4.5/30 days vs. 9/30 days, P = 0.53). Results after adjusting for differences in baseline characteristics were similar (RR 1.00, 95% CI 0.24-4.19, P = 1.00). There were also no differences in average daily postoperative steps (median 979 vs. 1191, 95% CI -810 to 1,400, P = 0.59), length of stay (7.5 vs. 7, 95% CI -2.7 to 5.1, P = 0.56), or self-reported measures of disability, activity, and social support. CONCLUSIONS: While this trial was a pilot study and not powered to detect a difference between groups, there was no suggestion of any clinically important impact of this financial incentive on postoperative ambulation. While a fully-powered trial is feasible, given the small range of plausible benefit, such a trial would be unlikely to influence clinical practice.

Disparities in Human Papillomavirus Vaccine Series Completion by Adolescent Males: A Retrospective Cohort Study.

OBJECTIVE: Human papillomavirus (HPV) vaccine has been recommended for male patients for the prevention of genital warts and precancerous anal lesions since 2009. Our objective was to characterize race and insurance-based disparities in HPV vaccine completion among male patients who initiated the HPV vaccine series. METHODS: This was a retrospective cohort study of adolescent male patients in a primary care network who initiated the HPV vaccine series from October 2009 to December 2013. We measured vaccine series completion as the primary outcome. We evaluated associations between outcomes and race and insurance status, controlling for potential confounders and effect modification with multivariable logistic regression. Analyses were stratified by vaccine recommendation era (permissive vs routine). RESULTS: In total, 42% of males in the cohort (16,691) completed the vaccine series. In the permissive vaccine era (2009-2011), non-black patients (53%) were more likely to complete than black patients (32%) and non-Medicaid patients (49%) were more likely to complete than Medicaid patients (33%). These differences persisted in the routine recommendation era (2012-2013). In both the permissive and routine eras, Medicaid insurance was associated with a larger reduction in the predicted probability of vaccine series completion for non-black patients. Adherence to the recommended vaccination schedule was low, with a median time to completion of 8.9 months. Using the updated completion schedule (2016), we found that completion rates were greater (54.1%) with continued differences based on race (60% vs 45.7% for non-black vs black patients) and insurance (57.4% vs 46.4% completion for non-Medicaid vs Medicaid patients). CONCLUSIONS: We found significant disparities in HPV vaccine series completion rates among male patients based on race and insurance, unchanged based on era of initiation or visit frequency.

Re-Treatment after Ureteroscopy and Shock Wave Lithotripsy: A Population Based Comparative Effectiveness Study.

PURPOSE: Shock wave lithotripsy and ureteroscopy are the most commonly performed surgeries for kidney and ureteral stones, but the comparative effectiveness of these interventions at the population level is unclear. We compared re-treatment for shock wave lithotripsy and ureteroscopy. MATERIALS AND METHODS: A retrospective cohort study using all-payer claims data for all patients who underwent shock wave lithotripsy or ureteroscopy from 1997 to 2016 at 74 hospitals in South Carolina was performed. The primary outcome measure was subsequent shock wave lithotripsy or ureteroscopy within 6 months of initial surgery. Pseudorandomized trials of ureteroscopy vs shock wave lithotripsy were performed for each year, applying propensity scores to balance hospital and patient characteristics. Discrete time failure models were fit using propensity score weighted logistic regression. RESULTS: Overall 136,152 ureteroscopy and shock wave lithotripsy surgeries were performed in 95,227 unique patients with re-treatment representing 9% of all surgeries. A total of 74,251 index surgeries were shock wave lithotripsy (59.9%) and 49,743 were ureteroscopy (40.1%). Shock wave lithotripsy was associated with a 20% increased odds of re-treatment (OR 1.20; 95% CI 1.13-1.26). The probability of re-treatment was 7.5% for ureteroscopy and 10.4% for shock wave lithotripsy. Shock wave lithotripsy had the greatest risk of re-treatment at months 2 (OR 1.85; 95% CI 1.64-2.10) and 3 (OR 1.76; 95% CI 1.50-2.06). Patients with initial shock wave lithotripsy were more likely to have shock wave lithotripsy for re-treatment (84.6%) than those patients who had initial ureteroscopy were to have ureteroscopy (29.3%). CONCLUSIONS: Compared to ureteroscopy, shock wave lithotripsy was associated with increased odds of re-treatment. These results have implications for shared decision making and value based surgical treatment of nephrolithiasis.

Urology Consultation and Emergency Department Revisits for Children with Urinary Stone Disease.

PURPOSE: We determined the association between urology consultation and emergency department revisits for children with urinary stones. MATERIALS AND METHODS: This retrospective cohort study included patients 18 years old or younger who presented to an emergency department in South Carolina with a urinary stone from 1997 to 2015. The primary exposure was urology consultation during the index emergency department visit. The primary outcome was a stone related emergency department revisit occurring within 180 days of discharge from an index emergency department visit. Secondary outcomes included computerized tomography use, inpatient admission and emergent surgery. RESULTS: Of 5,642 index emergency department visits for acute urinary stones 11% resulted in at least 1 stone related emergency department revisit within 180 days. Of revisits 59% occurred within 30 days of discharge and 39% were due to pain. The odds of emergency department revisit were highest within the first 48 hours of discharge home (OR 22.6, 95% CI 18.0 to 28.5) and rapidly decreased thereafter. Urology consultation was associated with a 37% lower adjusted odds of emergency department revisit (OR 0.63, 95% CI 0.44 to 0.90) and 68% lower odds of computerized tomography use across all emergency department visits (OR 0.32, 95% CI 0.15 to 0.69). Among patients who revisited the emergency department the frequency of pain complaints was 27% in those with a urological consultation at the index visit and 39% in those without. CONCLUSIONS: Urology consultation was associated with decreased emergency department revisits and computerized tomography use in pediatric patients with urinary stones. Future studies should identify patients who benefit most from urology consultation and ascertain processes of care that decrease emergency department revisits among high risk patients.

Health Profiles of Newly Arrived Refugee Children in the United States, 2006-2012.

OBJECTIVES: We conducted a large-scale study of newly arrived refugee children in the United States with data from 2006 to 2012 domestic medical examinations in 4 sites: Colorado; Minnesota; Philadelphia, Pennsylvania; and Washington State. METHODS: Blood lead level, anemia, hepatitis B virus (HBV) infection, tuberculosis infection or disease, and Strongyloides seropositivity data were available for 8148 refugee children (aged < 19 years) from Bhutan, Burma, Democratic Republic of Congo, Ethiopia, Iraq, and Somalia. RESULTS: We identified distinct health profiles for each country of origin, as well as for Burmese children who arrived in the United States from Thailand compared with Burmese children who arrived from Malaysia. Hepatitis B was more prevalent among male children than female children and among children aged 5 years and older. The odds of HBV, tuberculosis, and Strongyloides decreased over the study period. CONCLUSIONS: Medical screening remains an important part of health care for newly arrived refugee children in the United States, and disease risk varies by population.

Sociodemographic Differences in Human Papillomavirus Vaccine Initiation by Adolescent Males.

PURPOSE: The purpose of this study was to describe patterns of human papillomavirus (HPV) vaccine initiation by males and characterize sociodemographic differences. METHODS: We conducted a retrospective cohort study of 11- to 18-year-old males in a large primary care network who had a preventive or acute visit between October 2009 and December 2013. Outcomes measured were HPV vaccine series initiation and initiation at the first eligible visit. Logistic regression measured independent associations between outcomes and sociodemographic characteristics, adjusting for potential confounders including visit frequency, insurance changes, and the presence of complex medical conditions. RESULTS: Of 58,757 eligible patients, most were white (57%) with private insurance (77%). During the study period, 39% of the cohort initiated the vaccine series, and 7% initiated at their first eligible visit. Black patients with private (adjusted odds ratio [aOR], 1.99; 95% confidence interval [CI], 1.73-2.30) and Medicaid insurance (aOR, 2.90; 95% CI, 2.56-3.30) had significantly higher odds of HPV vaccine initiation compared with white patients with private insurance. A similar trend was found for Hispanic patients with private (aOR, 1.45; 95% CI, 1.26-1.67) and Medicaid insurance (aOR, 2.15; 95% CI, 1.78-2.60). These differences were present both in the preroutine recommendation period (2009-2011) and the postroutine recommendation period (2012-2013). CONCLUSIONS: Traditionally marginalized populations have higher odds of HPV vaccine initiation, both at the first eligible visit and overall. Although the true mechanism underlying these differences remains unknown, potential candidates include provider recommendation patterns and differential vaccine acceptance within these groups.

Dexamethasone and risk of bleeding in children undergoing tonsillectomy.

OBJECTIVE: To determine whether dexamethasone use in children undergoing tonsillectomy is associated with increased risk of postoperative bleeding. STUDY DESIGN: Retrospective cohort study using a multihospital administrative database. SETTING: Thirty-six US children's hospitals. SUBJECTS: Children undergoing same-day tonsillectomy between the years 2004 and 2010. METHODS: We used discrete time failure models to estimate the daily hazards of revisits for bleeding (emergency department or hospital admission) up to 30 days after surgery as a function of dexamethasone use. Revisits were standardized for patient characteristics, antibiotic use, year of surgery, and hospital. RESULTS: Of 139,715 children who underwent same-day tonsillectomy, 97,242 (69.6%) received dexamethasone and 4182 (3.0%) had a 30-day revisit for bleeding. The 30-day cumulative standardized risk of revisits for bleeding was greater with dexamethasone use (3.11% vs 2.71%; standardized difference 0.40% [95% confidence interval, 0.13%-0.67%]; P = .003), and the increased risk was observed across all age strata. Dexamethasone use was associated with a higher standardized rate of revisits for bleeding in the postdischarge time periods of days 1 through 5 but not during the peak period for secondary bleeding, days 6 and 7. CONCLUSIONS: In a real-world practice setting, dexamethasone use was associated with a small absolute increased risk of revisits for bleeding. However, the upper bound of this risk increase does not cross published thresholds for a minimal clinically important difference. Given the benefits of dexamethasone in reducing postoperative nausea and vomiting and the larger body of evidence from trials, these results support guideline recommendations for the routine use of dexamethasone.

Variation in quality of tonsillectomy perioperative care and revisit rates in children's hospitals.

OBJECTIVE: To describe the quality of care for routine tonsillectomy at US children's hospitals. METHODS: We conducted a retrospective cohort study of low-risk children undergoing same-day tonsillectomy between 2004 and 2010 at 36 US children's hospitals that submit data to the Pediatric Health Information System Database. We assessed quality of care by measuring evidence-based processes suggested by national guidelines, perioperative dexamethasone and no antibiotic use, and outcomes, 30-day tonsillectomy-related revisits to hospital. RESULTS: Of 139,715 children who underwent same-day tonsillectomy, 10,868 (7.8%) had a 30-day revisit to hospital. There was significant variability in the administration of dexamethasone (median 76.2%, range 0.3%-98.8%) and antibiotics (median 16.3%, range 2.7%-92.6%) across hospitals. The most common reasons for revisits were bleeding (3.0%) and vomiting and dehydration (2.2%). Older age (10-18 vs 1-3 years) was associated with a greater standardized risk of revisits for bleeding and a lower standardized risk of revisits for vomiting and dehydration. After standardizing for differences in patients and year of surgery, there was significant variability (P < .001) across hospitals in total revisits (median 7.8%, range 3.0%-12.6%), revisits for bleeding (median 3.0%, range 1.0%-8.8%), and revisits for vomiting and dehydration (median 1.9%, range 0.3%-4.4%). CONCLUSIONS: Substantial variation exists in the quality of care for routine tonsillectomy across US children's hospitals as measured by perioperative dexamethasone and antibiotic use and revisits to hospital. These data on evidence-based processes and relevant patient outcomes should be useful for hospitals' tonsillectomy quality improvement efforts.

Effectiveness of decision support for families, clinicians, or both on HPV vaccine receipt.

OBJECTIVE: To improve human papillomavirus (HPV) vaccination rates, we studied the effectiveness of targeting automated decision support to families, clinicians, or both. METHODS: Twenty-two primary care practices were cluster-randomized to receive a 3-part clinician-focused intervention (education, electronic health record-based alerts, and audit and feedback) or none. Overall, 22, 486 girls aged 11 to 17 years due for HPV vaccine dose 1, 2, or 3 were randomly assigned within each practice to receive family-focused decision support with educational telephone calls. Randomization established 4 groups: family-focused, clinician-focused, combined, and no intervention. We measured decision support effectiveness by final vaccination rates and time to vaccine receipt, standardized for covariates and limited to those having received the previous dose for HPV #2 and 3. The 1-year study began in May 2010. RESULTS: Final vaccination rates for HPV #1, 2, and 3 were 16%, 65%, and 63% among controls. The combined intervention increased vaccination rates by 9, 8, and 13 percentage points, respectively. The control group achieved 15% vaccination for HPV #1 and 50% vaccination for HPV #2 and 3 after 318, 178, and 215 days. The combined intervention significantly accelerated vaccination by 151, 68, and 93 days. The clinician-focused intervention was more effective than the family-focused intervention for HPV #1, but less effective for HPV #2 and 3. CONCLUSIONS: A clinician-focused intervention was most effective for initiating the HPV vaccination series, whereas a family-focused intervention promoted completion. Decision support directed at both clinicians and families most effectively promotes HPV vaccine series receipt.

Perioperative antibiotic use for spinal surgery procedures in US children's hospitals.

STUDY DESIGN: Retrospective cohort study using the Pediatric Health Information System database. OBJECTIVE: To describe longitudinal patterns of prophylactic antibiotic use and determinants of antibiotic choice for spinal fusion surgical procedures performed at US children's hospitals. SUMMARY OF BACKGROUND DATA: Surgical site infections (SSIs) account for a significant proportion of post-spinal surgery complications, particularly among children with complex conditions such as neuromuscular disease. Antimicrobial prophylaxis with intravenous cefazolin or cefuroxime has been a standard practice, but postoperative infections caused by organisms resistant to these antibiotics are increasing in prevalence. Studies describing the choice of antibiotic prophylaxis for pediatric spinal surgery are lacking. METHODS: We included children 6 months to 18 years of age discharged from 37 US children's hospitals between January 1, 2006, and June 30, 2009, with (1) an International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) procedure code indicating a spinal fusion and (2) combinations of diagnosis codes indicating adolescent idiopathic scoliosis (AIS) (n = 5617) or neuromuscular scoliosis (NMS) (n = 3633). After identifying antibiotics ordered on the operative day, we described variation in broad-spectrum antibiotic use over time and measured associations between patient/surgery characteristics and antibiotic choice. RESULTS: Prophylactic antibiotic choice varied across hospitals and over time. Broad-spectrum antibiotics were used in 37% of AIS and 52% of NMS operations. Seven (19%) hospitals used broad-spectrum coverage for more 80% of all cases. For NMS procedures, broad-spectrum antibiotic use was associated with patient characteristics known to be associated with high SSI risk. Use of vancomycin and broad gram-negative agents increased over time. CONCLUSION: Broad-spectrum antimicrobial prophylaxis varied across hospitals and was often associated with known risk factors for SSI. These results highlight the need for future studies comparing the effectiveness of various prophylaxis strategies, particularly in high-risk subgroups. This research can inform the development of best practice for SSI prevention in spinal fusion procedures.