Therapeutic hypothermia in severe hypoxic-ischemic encephalopathy: a cost-effectiveness analysis.

BACKGROUND: The incidence of hypoxic-ischemic encephalopathy (HIE) is 0.5 per 1,000 live births. Current standard treatment is therapeutic hypothermia (cooling) begun within 6 hours of life. In infants with severe HIE, this results in fewer deaths; however, more infants survive with major neurodevelopmental disability. OBJECTIVE: We sought to determine whether cooling is cost-effective compared to no cooling in cases of severe HIE, and to compare it to the cost-effectiveness of cooling in cases of moderate HIE. STUDY DESIGN: A decision analytic model using TreeAge Pro (2020) software was designed comparing cooling to no cooling in a cohort of 5,800 term neonates with HIE. Model inputs were derived from the literature. Utilities were applied to life expectancy to generate quality-adjusted life years (QALYs). All costs and QALYs were discounted at an annual rate of 3%. The strategy was considered cost-effective if the incremental cost-effectiveness ratio (ICER) was below the willingness-to-pay threshold of $100,000 per QALY. Sensitivity analyses were conducted to assess the robustness of the results. RESULTS: Cooling for the management of severe HIE resulted in increased costs and increased QALYs, with an ICER of 6,864. In our theoretical cohort, cooling resulted in 835 fewer neonatal deaths, but 52 additional cases of severe neurological disability with cooling due to increased survival. When varying the probability of a healthy child with cooling in univariate sensitivity analysis, cooling was found to be the cost-effective strategy across all ranges and the dominant (lower costs, higher QALYs) strategy above 68% (baseline estimate: 63%). Multivariate sensitivity analysis found cooling was the cost-effective strategy 99.7% of the time. CONCLUSION: Cooling is the cost-effective intervention with improved outcomes for neonates with severe perinatal hypoxic-ischemic encephalopathy over a wide range of assumptions. Despite the increased cost, more neonates survive morbidity free when compared with no cooling.

Cost-Effectiveness of Implantable Cardioverter-Defibrillators in Children with Cardiac Conditions Associated with Risk for Sudden Cardiac Death.

Children at high risk for sudden cardiac death (SCD) receive implantable cardioverter-defibrillators (ICD) for prevention, but the cost effectiveness of ICDs in children at intermediate risk is unclear. Our objective was to create a cost-effectiveness model to compare costs and outcomes in children at risk of SCD, with and without ICD. Utilizing hypertrophic cardiomyopathy as the proxy disease, a theoretical cohort of 8150 children was followed for 69 years. Model inputs were derived from the literature, with an incremental cost-effectiveness ratio (ICER) willingness-to-pay threshold of $100,000/quality-adjusted life year (QALY) used to delineate cost effectiveness. Outcomes included prevalence of severe neurological morbidity (SNM), SCD, cost, and QALYs. In children at intermediate risk of SCD (4-6% over 5 years), ICD resulted in 56 fewer cases of SNM, 2686 fewer deaths. In children at high risk (> 6% over 5 years), ICD placement resulted in 74 fewer cases of SNM and 3663 fewer deaths from cardiac causes. The costs of ICD were higher, but placement was cost effective with an ICER of $3009 per QALY in intermediate risk children, but ICD therapy was a dominant strategy in high-risk children. Sensitivity analysis demonstrated ICD placement was cost-effective until the annual probability of SCD was < 0.22%. The model was robust over a wide range of values. For children at risk of SCD, prophylactic ICD implantation is cost effective, resulting in improved outcomes and increased QALYs, despite increased costs. These findings highlight the economic benefits of ICD utilization in this population.

Cost-effectiveness of in-home automated external defibrillators for children with cardiac conditions associated with risk of sudden cardiac death.

BACKGROUND: Children at high risk for sudden cardiac death (SCD) (>6% over 5 years) receive an implantable cardioverter-defibrillator (ICD), but no guidelines are available for those at lower risk. For children at intermediate risk for SCD (4%-6% over 5 years), the utility and cost-effectiveness of in-home automated external defibrillators (AEDs) are unclear. OBJECTIVE: The purpose of this study was to assess the cost-effectiveness of in-home AED for children at intermediate risk for SCD. METHODS: Using hypertrophic cardiomyopathy (HCM) as the proxy disease, a theoretical cohort of 1550 ten-year-old children with HCM was followed for 69 years. Baseline annual risk of SCD was 0.8%. Outcomes were SCD, severe neurologic morbidity (SNM), cost, and quality-adjusted life-years (QALYs). Model inputs were derived from the literature, with a willingness-to-pay threshold of $100,000 per QALY. RESULTS: Among children at intermediate risk for SCD, in-home AED resulted in 31 fewer cases of SCD but 3 more cases of SNM. There were 319 QALYs gained. Although costs were higher by $28 million, the incremental cost-effectiveness ratio was $86,458, which is below the willingness-to-pay threshold. CONCLUSION: For children at intermediate risk for SCD and HCM, in-home AED is cost-effective, resulting in fewer deaths and increased QALYS for a cost below the willingness-to-pay threshold. These findings highlight the economic benefits of in-home AED use in this population.

Induction of labor at 39 weeks of gestation versus expectant management for low-risk nulliparous women: a cost-effectiveness analysis.

BACKGROUND: A large, recent multicenter trial found that induction of labor at 39 weeks for low-risk nulliparous women was not associated with an increased risk of cesarean delivery or adverse neonatal outcomes. OBJECTIVE: We sought to examine the cost-effectiveness and outcomes associated with induction of labor at 39 weeks vs expectant management for low-risk nulliparous women in the United States. STUDY DESIGN: A cost-effectiveness model using TreeAge software was designed to compare outcomes in women who were induced at 39 weeks vs expectantly managed. We used a theoretical cohort of 1.6 million women, the approximate number of nulliparous term births in the United States annually that are considered low risk. Outcomes included mode of delivery, hypertensive disorders of pregnancy, macrosomia, stillbirth, permanent brachial plexus injury, and neonatal death, in addition to cost and quality-adjusted life years for both the woman and neonate. Model inputs were derived from the literature, and a cost-effectiveness threshold was set at $100,000/quality-adjusted life years. RESULTS: In our theoretical cohort of 1.6 million women, induction of labor resulted in 54,498 fewer cesarean deliveries and 79,152 fewer cases of hypertensive disorders of pregnancy. We also found that induction of labor resulted in 795 fewer cases of stillbirth and 11 fewer neonatal deaths, despite 86 additional cases of brachial plexus injury. Induction of labor resulted in increased costs but increased quality-adjusted life years with an incremental cost-effectiveness ratio of $87,691.91 per quality-adjusted life year. In sensitivity analysis, if the cost of induction of labor was increased by $180, elective induction would no longer be cost effective. Similarly, we found that if the rate of cesarean delivery was the same in both strategies, elective induction of labor at 39 weeks would not be a cost-effective strategy. In probabilistic sensitivity analysis via Monte Carlo simulation, we found that induction of labor was cost effective only 65% of the time. CONCLUSION: In our theoretical cohort, induction of labor in nulliparous term women at 39 weeks of gestation resulted in improved outcomes but increased costs. The incremental cost-effectiveness ratio was marginally cost effective but would lead to an additional 2 billion dollars of healthcare costs. Whether individual clinicians and healthcare systems offer routine induction of labor at 39 weeks will need to depend on local capacity, careful evaluation and allocation of healthcare resources, and patient preferences. KEY WORDS: cesarean delivery, decision analysis, healthcare resources, induction of labor, low-risk nulliparous women, mode of delivery, obstetric outcomes.

Gestational Weight Gain during Pregnancy as an Important Factor Influencing a Successful Trial of Labor following Two Previous Cesareans.

OBJECTIVE: We sought to identify factors associated with a successful trial of labor (TOL) following two cesarean deliveries (CDs) in a contemporary North American cohort. STUDY DESIGN: This is a retrospective cohort study of term, nonanomalous, singleton, vertex pregnancies attempting a vaginal birth after cesarean (VBAC) following a history of two previous CDs in the United States from 2012 to 2014. Maternal and intrapartum factors were analyzed using chi-square tests and multivariable logistic regression. RESULTS: A total of 22,762 women met the inclusion criteria and underwent TOL. Of these, 12,192 (53.6%) had a VBAC. Using multivariate logistic regression, previous vaginal delivery and delivery at 40 to 41 weeks' gestation were associated with VBAC; maternal age, education, Medicaid insurance, non-Caucasian race/ethnicity, weight (overweight or obese), and gestational weight gain above the Institute of Medicine guidelines (adjusted odds ratio: 0.88; 95% confidence interval: 0.81-0.95) were associated with CD. Induction of labor did not affect the VBAC rate. CONCLUSION: For those desiring a TOL after two previous CDs, prospective studies are needed to assess interventions that limit gestational weight gain as well as the safety and optimal timing of an induction of labor. The decision to attempt a TOL should be guided by counseling regarding the risks, benefits, and chances of a successful TOL.

Continuous Subcutaneous Insulin Infusion versus Multiple Daily Injections of Insulin for the Management of Type 1 Diabetes Mellitus in Pregnancy: Association with Neonatal Chemical Hypoglycemia.

OBJECTIVE: We hypothesized that patients with type 1 diabetes mellitus (T1DM) who were managed during their pregnancy with a continuous subcutaneous insulin infusion (CSII) would have a lower incidence of neonatal hypoglycemia (NH) than patients managed with multiple daily injections (MDI) of insulin. STUDY DESIGN: This was a retrospective cohort of 95 women with T1DM who delivered singleton, term neonates between 2007 and 2014. The primary outcome was incidence of NH (capillary plasma glucose ≤ 45 mg/dL) in the first 24 hours after birth. RESULTS: The incidence of NH was 66.0% (62/95). The NH rate was significantly higher in women managed with CSII versus MDI (62 vs. 38%, p = 0.024). Neonates with NH had a higher birth weight (3,867 ± 658 vs. 3,414 ± 619 g, p = 0.002). When analyzing intrapartum glucose management, mothers of neonates with NH had significantly less time managed on an insulin infusion (median interquartile range 7 [3.5-30.5] vs. 17.5 [2.0-17.5] hours, p = 0.014). In multivariable analysis, only maternal body mass index (BMI) (p = 0.035) and time on an insulin infusion (p = 0.043) were significantly associated with NH. CONCLUSION: In our population of patients with T1DM, CSII was more prevalent in the NH group; however, when controlling for other factors, intrapartum glucose management and early maternal BMI were the only variables associated with NH.