数字终点临床验证方法:范围审查协议摘要
Sílvia Rego1,2, Ana Rita Henriques3, Sofia Silvério Serra3
1Fraunhofer Portugal Research Center for Assistive Information and Communication Solutions, Porto, Portugal.
JMIR research protocols
|October 26, 2023
概括
本范围审查绘制了临床验证数字终点的方法,这对于试验和医疗保健至关重要. 它确定了差距,并指导未来的研究,以获得监管的接受和患者的好处.
科学领域:
- 数字健康数字健康
- 临床验证 临床验证
- 医疗信息学医学信息学
背景情况:
- 数字技术使得临床试验中的持续数据收集成为可能.
- 数字终点正在出现用于诊断,监测和治疗.
- 缺乏具体的指导方针阻碍了数字终点的临床验证.
研究的目的:
- 进行范围审查,映射数字终点临床验证的现有方法.
- 确定数字终端验证中当前的实践和标准化的潜在领域.
主要方法:
- 在多个电子数据库 (PubMed,Scopus,Embase,IEEE Xplore,ACM数字图书馆,CENTRAL,Web of Science,JBI) 中进行全面的文献搜索.
- 包含使用相关搜索术语的灰色文献.
- 坚持乔安娜·布里格斯研究所 (JBI) 的方法论,用于范围审查.
主要成果:
- 没有发现关于这个特定主题的先前审查.
- 该审查将系统评估数字终点临床验证的方法.
- 结果将根据设备,终端类型和临床应用对验证方法进行分类.
结论:
- 对数字终端验证方法的范围审查至关重要.
- 这一广泛的审查将针对各种设备的数字终点,而不是特定于疾病.
- 结果将指导研究人员,突出文献上的差距,并为监管机构的接受提供新的验证方法.
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