评估临床决策支持软件 (CDSS):对于强有力的证据生成的挑战
Mah Laka1, Drew Carter1, Tracy Merlin1
1Adelaide Health Technology Assessment (AHTA), School of Public Health, University of Adelaide, Adelaide, SA, Australia.
International journal of technology assessment in health care
|February 8, 2024
概括
目前的医疗器械框架不充分评估计算机化临床决策支持软件 (CDSS). 活体健康技术评估方法对于评估这些不断发展的数字健康技术和确保患者安全至关重要.
科学领域:
- 数字卫生技术数字卫生技术
- 医疗信息学 医疗信息学
- 医疗器械规则 医疗器械规则
背景情况:
- 计算机化临床决策支持软件 (CDSS) 是数字健康技术,通常被规范为医疗设备.
- 现有的医疗器械评估框架很难充分评估CDSS的独特价值和安全性.
- 在评估CDSS方面存在挑战,原因是它们的动态性质和复杂的医疗保健系统中的整合.
研究的目的:
- 确定评估CDSS作为医疗器械的挑战.
- 调查目前在澳大利亚的CDSS评估实践.
- 探索现有框架是否适用于评估快速发展的数字健康技术.
主要方法:
- 定性研究方法.
- 采访了11名参与数字卫生技术实施和评估的专业人士.
- 使用诱导和演方法对采访数据进行主题分析.
主要成果:
- 目前的CDSS评估采用狭的视角,未能捕捉到对社会技术环境的影响.
- 静态评估框架无法解释不断发展的技术和动态的临床环境如何影响CDSS的性能.
- 持续监测CDSS是具有挑战性的,特别是在软件更新后,这些更新可能会改变功能和患者安全影响.
结论:
- 强调需要"生活卫生技术评估"方法,以快速发展的数字卫生技术,如CDSS.
- 强调观察 (现实世界) 证据的重要性,以了解技术和环境变化对CDSS绩效的影响.
- 建议转向更适应和持续的评估方法,以确保CDSS的持续安全性和有效性.
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