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剖宫产术中使用血液回收和异体输血的成本效益:一项随机对照试验的结果。

Cost-effectiveness of cell salvage and donor blood transfusion during caesarean section: results from a randomised controlled trial.

机构信息

Health Economics Unit, University of Birmingham, Birmingham, UK.

Selwyn Crawford Department of Anaesthetics, Birmingham Women's Hospital, Birmingham, UK.

出版信息

BMJ Open. 2019 Feb 19;9(2):e022352. doi: 10.1136/bmjopen-2018-022352.

Abstract

OBJECTIVES

To evaluate the cost-effectiveness of routine use of cell salvage during caesarean section in mothers at risk of haemorrhage compared with current standard of care.

DESIGN

Model-based cost-effectiveness evaluation alongside a multicentre randomised controlled trial. Three main analyses were carried out on the trial data: (1) based on the intention-to-treat principle; (2) based on the per-protocol principle; (3) only participants who underwent an emergency caesarean section.

SETTING

26 obstetric units in the UK.

PARTICIPANTS

3028 women at risk of haemorrhage recruited between June 2013 and April 2016.

INTERVENTIONS

Cell salvage (intervention) versus routine care without salvage (control).

PRIMARY OUTCOME MEASURES

Cost-effectiveness based on incremental cost per donor blood transfusion avoided.

RESULTS

In the intention-to-treat analysis, the mean difference in total costs between cell salvage and standard care was £83. The estimated incremental cost-effectiveness ratio (ICER) was £8110 per donor blood transfusion avoided. For the per-protocol analysis, the mean difference in total costs was £92 and the ICER was £8252. In the emergency caesarean section analysis, the mean difference in total costs was £55 and the ICER was £13 713 per donor blood transfusion avoided. This ICER is driven by the increased probability that these patients would require a higher level of postoperative care and additional surgeries. The results of these analyses were shown to be robust for the majority of deterministic sensitivity analyses.

CONCLUSIONS

The results of the economic evaluation suggest that while routine cell salvage is a marginally more effective strategy than standard care in avoiding a donor blood transfusion, there is uncertainty in relation to whether it is a less or more costly strategy. The lack of long-term data on the health and quality of life of patients in both arms of the trial means that further research is needed to fully understand the cost implications of both strategies.

TRIAL REGISTRATION NUMBER

ISRCTN66118656.

摘要

目的

评估在有出血风险的剖宫产产妇中常规使用血液回收与现行标准护理相比的成本效益。

设计

伴随多中心随机对照试验的基于模型的成本效益评估。对试验数据进行了三项主要分析:(1)基于意向治疗原则;(2)基于方案原则;(3)仅分析接受紧急剖宫产的参与者。

地点

英国 26 个产科单位。

参与者

2013 年 6 月至 2016 年 4 月招募的 3028 名有出血风险的产妇。

干预

血液回收(干预)与无回收的常规护理(对照)。

主要结局测量

基于避免每例供者输血的增量成本的成本效益。

结果

意向治疗分析中,细胞回收与标准护理之间的总费用平均差异为 83 英镑。估计的增量成本效益比(ICER)为避免每例供者输血 8110 英镑。对于方案分析,总费用的平均差异为 92 英镑,ICER 为 8252 英镑。在紧急剖宫产分析中,总费用的平均差异为 55 英镑,ICER 为避免每例供者输血 13713 英镑。这一 ICER 受到这些患者更有可能需要更高水平的术后护理和额外手术的影响。对于大多数确定性敏感性分析,这些分析的结果被证明是稳健的。

结论

经济评估结果表明,尽管常规使用血液回收在避免供者输血方面比标准护理略为有效,但在该试验的两个治疗组之间,哪种策略更具成本效益仍存在不确定性。由于试验两个治疗组均缺乏关于患者健康和生活质量的长期数据,因此需要进一步研究以全面了解两种策略的成本影响。

试验注册号

ISRCTN66118656。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/922d/6398743/30b813c5edd6/bmjopen-2018-022352f01.jpg

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