评估框架应用于麻醉试验的应用
Anurika P De Silva1, Kate Leslie2, Sabine Braat3
1Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia; Methods and Implementation Support for Clinical and Health (MISCH) research Hub, Faculty of Medicine, Dentistry and Health Sciences, University of Melbourne, Melbourne, Australia.
估计框架有助于麻醉试验精确定义治疗效果,解决随机化后的事件,如药物改变或死亡. 清晰的估计和定义对于相关和可理解的临床试验结果至关重要.
科学领域:
- 麻醉学 麻醉学
- 临床试验 临床试验
- 生物统计学 生物统计学
背景情况:
- 在随机试验中,间歇性事件 (例如,救援药物,停药,死亡) 是常见的.
- 这些事件可能会使试验结果的解释变得复杂.
- 处理间流事件的标准方法通常不清楚.
研究的目的:
- 描述估计和框架在麻醉试验中的应用.
- 解释估计和框架如何精确地定义治疗效应.
- 为了说明在麻醉研究中处理相互流动的事件.
主要方法:
- 使用国际人用药品技术要求协调理事会 (ICH) 的附录 E9(R1).
- 应用estimand框架来定义治疗效应.
- 用一个假设的手术后痴呆症试验来说明.
主要成果:
- 估计和框架将试验目标与设计,实施,分析和解释结合起来.
- 它提供了在麻醉试验中管理常见的间流事件的策略.
- 方便精确定义感兴趣的治疗效应.
结论:
- 清晰的估计和定义对于规划麻醉试验至关重要.
- 确保估计的治疗效果清楚地理解和临床相关.
- 帮助有效地回答关键的临床问题.
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