随机非劣等性试验中的分析方法:方法调查审查协议的方法调查
Daniel Xie1, Sameer Parpia2,3, Tyler McKechnie2,4
1Department of Integrated Biomedical Engineering and Health Sciences, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada.
JMIR research protocols
|March 13, 2026
概括
本研究审查了非劣势 (NI) 试验中的分析种群. 它检查了意图治疗 (ITT) 与每协议 (PP) 的方法,以确保可靠的试验结论.
科学领域:
- 临床试验方法论 临床试验方法论
- 生物统计学 生物统计学
背景情况:
- 非劣势性试验 (NI) 越来越多地用于将实验性干预与标准护理进行比较.
- 分析群体的选择,如意图治疗 (ITT) 或每协议 (PP),显著影响NI试验结论的稳定性.
- 在NI环境中,ITT分析通常被认为不如PP分析那么保守.
研究的目的:
- 进行对当代非劣等性试验中使用的分析人口集的方法审查.
- 评估最近NI研究中不同分析群体的流行率和特征.
主要方法:
- 在MEDLINE,Embase,Emcare和Cochrane CENTRAL中进行全面的电子文献搜索.
- 纳入标准侧重于2024年发表的非劣质性试验.
- 主要结果:用于初级试验分析的分析人群 (ITT,PP,as-treated);次要结果:NI边际,效果估计,置信区间 (CI).
- 描述性统计将用于分析.
主要成果:
- 最初的搜索确定了1209项研究.
- 403项非劣势性试验被认为符合数据提取的条件.
- 数据提取始于2025年1月,预计将在2026年1月结束.
结论:
- 本方法调查将详细介绍NI试验初级分析中使用的分析群体.
- 该研究旨在确定与NI试验中选择特定分析方法相关的因素.
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