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产前皮质类固醇治疗与无治疗在有晚期早产风险的妇女中的成本效益:一项随机临床试验的二次分析。

Cost-effectiveness of Antenatal Corticosteroid Therapy vs No Therapy in Women at Risk of Late Preterm Delivery: A Secondary Analysis of a Randomized Clinical Trial.

机构信息

Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Columbia University, New York, New York.

Department of Neonatology, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts.

出版信息

JAMA Pediatr. 2019 May 1;173(5):462-468. doi: 10.1001/jamapediatrics.2019.0032.

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 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.

摘要

重要性

对有晚期早产(34-36 周妊娠)风险的女性给予皮质类固醇治疗可改善短期新生儿结局。该干预措施的成本影响尚不清楚。

目的

比较产前皮质类固醇治疗与无治疗高危晚期早产风险女性的成本效益。

设计、地点和参与者:这是一项对多中心随机临床试验的二次分析,该临床试验比较了有晚期早产风险的女性使用产前皮质类固醇与安慰剂治疗,于 2010 年 10 月 30 日至 2015 年 2 月 27 日进行。从第三方付款人的角度进行分析。产妇费用基于医疗补助费率,包括倍他米松的费用,以及为管理倍他米松所需的门诊或住院费用。新生儿护理的所有直接医疗费用均包括在内。对于入住新生儿重症监护病房的婴儿,根据呼吸疾病的严重程度分层计算综合每日费用。对于入住常规新生儿病房的婴儿,使用文献中的全国代表性成本估算值。有效性以研究的主要结局衡量:由接受持续气道正压通气或高流量鼻导管治疗 2 小时以上、吸入氧分数 30%或以上的补充氧气 4 小时以上以及体外膜氧合或机械通气组成的复合治疗的婴儿比例。该二次分析最初于 2016 年 6 月开始,并于 2017 年 5 月开始对分析进行修订。

暴露

倍他米松治疗。

主要结局和测量指标

在倍他米松组(平均[SD]产妇年龄 28.6 [6.3]岁;827 [58.0%]白人)和安慰剂组(平均[SD]产妇年龄 27.9 [6.2]岁;794 [56.9%]白人)中确定了 1426 对母婴对的成本。使用倍他米松治疗的母婴对总成本平均(SD)为 4681 美元(5798 美元),显著低于安慰剂组 5379 美元(8422 美元)的母婴总成本(差异 698 美元;95%CI 186-1257 美元;P = 0.02)。产前晚期早产类固醇试验确定倍他米松的使用有效:呼吸发病率降低 2.9%(95%CI -0.5%至-5.4%)。因此,每例呼吸道疾病发病率降低的成本效益比为-23986 美元。对.bootstrap 复制的检查证实,在 5000 个样本中(98.8%),治疗是占主导地位的策略。敏感性分析表明,在大多数假设下,这些结果仍然成立。

结论和相关性

研究结果表明,产前倍他米松治疗与医疗保健成本的统计学显著降低和结局改善相关;因此,这种治疗可能是一种经济上理想的策略。

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