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评估孕期及产后女性血栓预防未来研究的价值:信息价值分析

Estimating the value of future research into thromboprophylaxis for women during pregnancy and after delivery: a value of information analysis.

作者信息

Davis Sarah, Pandor Abdullah, Sampson Fiona C, Hamilton Jean, Nelson-Piercy Catherine, Hunt Beverley J, Daru Jahnavi, Goodacre Steve

机构信息

Sheffield Centre for Health and Related Research, University of Sheffield, Sheffield, United Kingdom.

Sheffield Centre for Health and Related Research, University of Sheffield, Sheffield, United Kingdom.

出版信息

J Thromb Haemost. 2024 Apr;22(4):1105-1116. doi: 10.1016/j.jtha.2023.12.035. Epub 2024 Jan 11.

DOI:10.1016/j.jtha.2023.12.035
PMID:38215911
Abstract

BACKGROUND

Risk assessment models (RAMs) are used to select women at increased risk of venous thromboembolism (VTE) during pregnancy and the puerperium for thromboprophylaxis.

OBJECTIVES

To estimate the value of potential future studies that would reduce the decision uncertainty associated with offering thromboprophylaxis according to available RAMs in the following groups: high-risk antepartum women (eg, prior VTE), unselected postpartum women, and postpartum women with risk factors (obesity or cesarean delivery).

METHODS

A decision-analytic model was developed to simulate clinical outcomes, lifetime costs, and quality-adjusted life-years for different thromboprophylaxis strategies, including thromboprophylaxis for all, thromboprophylaxis for none, and RAM-based thromboprophylaxis. The expected value of perfect information analysis was used to determine which factors are associated with high decision uncertainty. The value of future research studies was estimated using expected value of sample information analysis. Costs were assessed from a health and social services perspective.

RESULTS

The expected value of perfect information analysis identified high decision uncertainty for high-risk antepartum women (£21.8 million) and obese postpartum women (£13.4 million), which was largely attributable to uncertainty regarding the effectiveness of thromboprophylaxis in reducing VTE. A randomized controlled trial of thromboprophylaxis compared with none in obese postpartum women is likely to have substantial value (£2.8 million; 300 participants per arm). A trial in women with previous VTE would have higher value but would be less acceptable.

CONCLUSION

Future research should focus on estimating the effectiveness of thromboprophylaxis in obese postpartum women with additional risk factors who have not had a previous VTE.

摘要

背景

风险评估模型(RAMs)用于筛选出在孕期及产褥期静脉血栓栓塞症(VTE)风险增加的女性,以便进行血栓预防。

目的

评估未来潜在研究的价值,这些研究将减少根据现有RAMs对以下人群进行血栓预防时的决策不确定性:高危产前女性(如既往有VTE)、未筛选的产后女性以及有风险因素(肥胖或剖宫产)的产后女性。

方法

建立了一个决策分析模型,以模拟不同血栓预防策略的临床结局、终身成本和质量调整生命年,包括对所有人进行血栓预防、不进行血栓预防以及基于RAMs的血栓预防。采用完全信息分析的期望值来确定哪些因素与高决策不确定性相关。使用样本信息分析的期望值来估计未来研究的价值。从卫生和社会服务角度评估成本。

结果

完全信息分析的期望值显示,高危产前女性(2180万英镑)和肥胖产后女性(1340万英镑)存在高决策不确定性,这主要归因于血栓预防在降低VTE有效性方面的不确定性。一项针对肥胖产后女性进行血栓预防与不进行血栓预防对比的随机对照试验可能具有重大价值(280万英镑;每组300名参与者)。一项针对既往有VTE的女性的试验价值更高,但可接受性较低。

结论

未来研究应聚焦于评估在没有既往VTE且有其他风险因素的肥胖产后女性中血栓预防的有效性。

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