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积极收集和被动监控的临床结果评估 (COA) 的协调框架,用于措施选择
Christine Manta Campbell1, Courtney Webster2,3, Megan Parisi4
1HumanFirst Inc., San Francisco, CA, USA. christine.manta@gohumanfirst.com.
NPJ digital medicine
|March 17, 2024
概括
监管批准越来越需要临床结果评估 (COA) 数据. 这项研究建议将各种COA措施的本体统一到一个单一的框架中,以便更好地选择工具.
科学领域:
- 临床研究是临床研究.
- 医疗信息学 医疗信息学
- 本体学工程学 工程学 工程学
背景情况:
- 监管机构要求临床结果评估 (COA) 数据用于药物和设备批准.
- 使用传统问卷和现代数字健康技术 (DHT) 收集COA数据.
- 资源存在差距,用于对比补充或相关COA措施的工具.
研究的目的:
- 提出一个统一的框架,用于对准积极收集和被动监测的COA的本体学.
- 促进基于证据和适合目的的COA措施的选择.
主要方法:
- 对不同的COA数据源的本体统一策略.
- 制定一个统一的框架,整合积极收集和被动监控的COA.
- 框架设计,以便快速选择措施.
主要成果:
- 一个为COAs.As提出的本体学调整框架.
- 整合基于问卷和DHT衍生的COA数据的方法.
- 展示框架如何支持有效的COA工具选择.
结论:
- 对各种COA措施的本体统一是可行的和有益的.
- 拟议的框架可以简化适当的COA工具的选择.
- 这种方法支持对可靠的临床结果数据的监管要求.
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