专家对低收入和中等收入国家的子宫前风险查工具达成共识:开发新的目标产品配置文件
Annie R A McDougall1,2, Tahlia R Guneratne1, Kate Mills1
1Women's, Children's and Adolescent's Health Program, Burnet Institute, Melbourne, Australia.
PLOS global public health
|March 2, 2026
概括
开发了一个新的目标产品配置文件 (TPP),以指导为低资源环境创建孕前风险查工具. 该概况旨在改善服务不足地区孕妇的早期检测和护理.
科学领域:
- 产科和妇科 产科和妇科
- 全球健康 全球健康
- 医疗器械开发 医疗器械开发
背景情况:
- 低收入和中等收入国家 (LMICs) 缺乏准确,可行和负担得起的妊娠前风险查工具.
- 现有的查方法不能充分满足资源有限的环境的需求,阻碍了对孕妇的及时预防性护理.
- 目标产品概况 (TPP) 对于指导开发新医疗产品以满足特定健康需求至关重要.
研究的目的:
- 为专门为低收入和中等收入国家 (LMICs) 设计的先兆子风险查工具开发第一个目标产品配置文件 (TPP).
- 建立准确,可行和负担得起的查工具的标准,以改善孕产妇健康结果.
- 促进在服务不足的地区开发和实施有效的妊娠前检测方法.
主要方法:
- 采用了混合方法的方法,包括利益相关者采访,在线多语言调查和公众咨询.
- 各种全球利益相关者 (临床医生,制造商,研究人员) 参与,以确保广泛适用.
- 用描述性统计和定性内容分析来确定共识变量和新兴主题.
主要成果:
- 在TPP的25个变量中,在23个变量上达成共识 (≥75%的协议).
- 反导致TPP被修改成三个不同的部分:生物物理,生物化学和数字工具.
- 开发的TPP提供了一个全面的框架,用于开发产前风险查工具.
结论:
- 这一TPP是该类型的第一个预孕风险查工具,特别是对于LMICs.
- 它将加速开发,评估和采用急需的孕妇查工具.
- 该TPP的目标是通过确保工具满足LMICs的现实需求来弥合孕前症护理的差距.
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