Cynthia Gyamfi-Bannerman1, John A F Zupancic2, Grecio Sandoval3, William A Grobman4, Sean C Blackwell5, Alan T N Tita6, Uma M Reddy7, Lucky Jain8, George R Saade9, Dwight J Rouse10, Jay D Iams11, Erin A S Clark12, John M Thorp13, Edward K Chien14, Alan M Peaceman4, Ronald S Gibbs15, Geeta K Swamy16, Mary E Norton17, Brian M Casey18, Steve N Caritis19, Jorge E Tolosa20, Yoram Sorokin21, J Peter VanDorsten22. 1. Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Columbia University, New York, New York. 2. Department of Neonatology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts. 3. George Washington University Biostatistics Center, Washington, DC. 4. Department of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois. 5. Department of Obstetrics and Gynecology, University of Texas Health Science Center at Children's Memorial Hermann Hospital, Houston. 6. Department of Obstetrics and Gynecology, University of Alabama, Birmingham. 7. Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland. 8. Department of Obstetrics and Gynecology, Emory University, Atlanta, Georgia. 9. Department of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston. 10. Department of Obstetrics and Gynecology, Brown University, Providence, Rhode Island. 11. Department of Obstetrics and Gynecology, Ohio State University, Columbus. 12. Department of Obstetrics and Gynecology, University of Utah Health Sciences Center, Salt Lake City. 13. Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill. 14. MetroHealth Medical Center, Case Western Reserve University, Cleveland, Ohio. 15. Department of Obstetrics and Gynecology, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora. 16. Department of Obstetrics and Gynecology, Duke University, Durham, North Carolina. 17. Department of Obstetrics and Gynecology, Stanford University, Stanford, California. 18. Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center, Dallas. 19. Department of Obstetrics and Gynecology, University of Pittsburgh, Pittsburgh, Pennsylvania. 20. Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland. 21. Department of Obstetrics and Gynecology, Wayne State University, Detroit, Michigan. 22. Department of Obstetrics and Gynecology, Medical University of South Carolina, Charleston.
Abstract
Importance: Administration of corticosteroids to women at high risk for delivery in the late preterm period (34-36 weeks' gestation) improves short-term neonatal outcomes. The cost implications of this intervention are not known. Objective: To compare the cost-effectiveness of treatment with antenatal corticosteroids with no treatment for women at risk for late preterm delivery. Design, Setting, and Participants: This secondary analysis of the Antenatal Late Preterm Steroids trial, a multicenter randomized clinical trial of antenatal corticosteroids vs placebo in women at risk for late preterm delivery conducted from October 30, 2010, to February 27, 2015. took a third-party payer perspective. Maternal costs were based on Medicaid rates and included those of betamethasone, as well as the outpatient visits or inpatient stay required to administer betamethasone. All direct medical costs for newborn care were included. For infants admitted to the neonatal intensive care unit, comprehensive daily costs were stratified by the acuity of respiratory illness. For infants admitted to the regular newborn nursery, nationally representative cost estimates from the literature were used. Effectiveness was measured as the proportion of infants without the primary outcome of the study: a composite of treatment in the first 72 hours of continuous positive airway pressure or high-flow nasal cannula for 2 hours or more, supplemental oxygen with a fraction of inspired oxygen of 30% or more for 4 hours or more, and extracorporeal membrane oxygenation or mechanical ventilation. This secondary analysis was initially started in June 2016 and revision of the analysis began in May 2017. Exposures: Betamethasone treatment. Main Outcomes and Measures: Incremental cost-effectiveness ratio. Results:Costs were determined for 1426 mother-infant pairs in the betamethasonegroup (mean [SD] maternal age, 28.6 [6.3] years; 827 [58.0%] white) and 1395 mother-infant pairs in the placebo group (mean [SD] maternal age, 27.9 [6.2] years; 794 [56.9%] white). Treatment with betamethasone was associated with a total mean (SD) woman-infant-pair cost of $4681 ($5798), which was significantly less than the mean (SD) amount of $5379 ($8422) for women and infants in the placebo group (difference, $698; 95% CI, $186-$1257; P = .02). The Antenatal Late Preterm Steroids trial determined that betamethasone use is effective: respiratory morbidity decreased by 2.9% (95% CI, -0.5% to -5.4%). Thus, the cost-effectiveness ratio was -$23 986 per case of respiratory morbidity averted. Inspection of the bootstrap replications confirmed that treatment was the dominant strategy in 5000 samples (98.8%). Sensitivity analyses showed that these results held under most assumptions. Conclusions and Relevance: The findings suggest that antenatal betamethasone treatment is associated with a statistically significant decrease in health care costs and with improved outcomes; thus, this treatment may be an economically desirable strategy.
RCT Entities:
Importance: Administration of corticosteroids to women at high risk for delivery in the late preterm period (34-36 weeks' gestation) improves short-term neonatal outcomes. The cost implications of this intervention are not known. Objective: To compare the cost-effectiveness of treatment with antenatal corticosteroids with no treatment for women at risk for late preterm delivery. Design, Setting, and Participants: This secondary analysis of the Antenatal Late Preterm Steroids trial, a multicenter randomized clinical trial of antenatal corticosteroids vs placebo in women at risk for late preterm delivery conducted from October 30, 2010, to February 27, 2015. took a third-party payer perspective. Maternal costs were based on Medicaid rates and included those of betamethasone, as well as the outpatient visits or inpatient stay required to administer betamethasone. All direct medical costs for newborn care were included. For infants admitted to the neonatal intensive care unit, comprehensive daily costs were stratified by the acuity of respiratory illness. For infants admitted to the regular newborn nursery, nationally representative cost estimates from the literature were used. Effectiveness was measured as the proportion of infants without the primary outcome of the study: a composite of treatment in the first 72 hours of continuous positive airway pressure or high-flow nasal cannula for 2 hours or more, supplemental oxygen with a fraction of inspired oxygen of 30% or more for 4 hours or more, and extracorporeal membrane oxygenation or mechanical ventilation. This secondary analysis was initially started in June 2016 and revision of the analysis began in May 2017. Exposures: Betamethasone treatment. Main Outcomes and Measures: Incremental cost-effectiveness ratio. Results: Costs were determined for 1426 mother-infant pairs in the betamethasone group (mean [SD] maternal age, 28.6 [6.3] years; 827 [58.0%] white) and 1395 mother-infant pairs in the placebo group (mean [SD] maternal age, 27.9 [6.2] years; 794 [56.9%] white). Treatment with betamethasone was associated with a total mean (SD) woman-infant-pair cost of $4681 ($5798), which was significantly less than the mean (SD) amount of $5379 ($8422) for women and infants in the placebo group (difference, $698; 95% CI, $186-$1257; P = .02). The Antenatal Late Preterm Steroids trial determined that betamethasone use is effective: respiratory morbidity decreased by 2.9% (95% CI, -0.5% to -5.4%). Thus, the cost-effectiveness ratio was -$23 986 per case of respiratory morbidity averted. Inspection of the bootstrap replications confirmed that treatment was the dominant strategy in 5000 samples (98.8%). Sensitivity analyses showed that these results held under most assumptions. Conclusions and Relevance: The findings suggest that antenatal betamethasone treatment is associated with a statistically significant decrease in health care costs and with improved outcomes; thus, this treatment may be an economically desirable strategy.
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