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一个灵活的微随机试验设计和样本大小考虑
Jing Xu1,2, Xiaoxi Yan1, Caroline Figueroa3,4
1Centre for Quantitative Medicine, Duke-NUS Medical School, Singapore.
Statistical methods in medical research
|July 26, 2023
概括
我们提出了一个灵活的微型随机化试验设计,用于移动健康干预. 这种可适应的框架允许在研究期间添加干预组件,改善针对糖尿病和抑郁症等疾病的个性化支持.
科学领域:
- 数字健康数字健康
- 生物统计学 生物统计学
- 行为科学 行为科学
背景情况:
- 移动健康干预利用技术提供个性化支持.
- 及时适应性干预 (JITAI) 提供基于个体需求的及时支持.
- 微随机试验 (MRT) 用于评估JITAI组件.
研究的目的:
- 提出一个灵活的微随机试验 (fMRT) 设计,可以在研究期间添加干预组件.
- 解决现有MRT框架的局限性,这些框架在研究开始时需要固定组件.
- 促进适应性移动健康干预措施的开发和评估.
主要方法:
- 开发了一种灵活的微随机试验设计,允许动态组件添加.
- 为fMRTs引入了一种新的测试统计和样本大小计算器.
- 在纵向数据分析中使用了概括估计方程方法.
- 进行模拟研究以验证样本大小计算器.
主要成果:
- 拟议的fMRT设计为适应性干预研究提供了更大的灵活性.
- 新的测试统计和样本大小计算器为fMRTs提供了准确的估计.
- 模拟研究证实了样本大小计算的可靠性.
- 为了实际使用计算器,开发了一个R光亮的应用程序.
结论:
- 灵活的微随机试验设计提高了移动卫生干预研究的适应性.
- 这一框架支持对动态JITAI的严格评估.
- 开发的统计工具和应用程序帮助研究人员设计和推动未来的适应性干预研究.
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