延迟反应的两阶段组序列设计 - 应用相应的方法有什么意义?
Stephen Schüürhuis1, Gernot Wassmer2, Meinhard Kieser3
1Institute of Biometry and Clinical Epidemiology, Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Institute of Biometry and Clinical Epidemiology, Charitéplatz 1, Berlin, 10117, Germany. stephen.schueuerhuis@charite.de.
BMC medical research methodology
|October 17, 2024
概括
临床试验中的组序设计往往忽视了患者反应延迟. 考虑到这些延迟,性能收益有限,这表明实际可行性应该指导设计选择.
科学领域:
- 生物统计学 生物统计学
- 临床试验设计 临床试验设计
- 统计学方法论 统计学方法论
背景情况:
- 群组顺序设计通常假设患者招募和结果测量之间没有滞后.
- 在实践中,响应延迟可能会影响统计分析,特别是在具有中间分析的试验中.
- 现有的方法,比如汉普森和詹尼森的错误支出边界,解决了延迟反应.
研究的目的:
- 为了比较那些解释延迟反应的组序列设计的性能,与那些不解释延迟反应的组序列设计的性能.
- 评估使用 R 包 rpact 的设计,并提供对整体和条件性能的见解.
- 为了确定性能增长是否证明了设计的复杂性,并结合了延迟反应.
主要方法:
- 研究延迟反应组顺序测试 (DR-GSD) 设计的扩展.
- 在现有框架中纳入非约束性较低的招聘停止边界.
- 通过使用R包协议评估设计性能,并定义了合适的性能指标.
主要成果:
- DR-GSD框架可以适应具有附加约束的约束性和非约束性规则.
- 延迟响应方法的性能提升在很大程度上取决于中间样本大小和数据量.
- 通过整合延迟反应获得的整体绩效收益被发现是有限的.
结论:
- 这项研究提供了对组序列设计之间的性能差异的见解,包括和没有延迟响应考虑.
- 鉴于边际性能差异,运营可行性应该是试验设计讨论的关键因素.
- 这些发现扩展了关于组序设计及其实际应用的现有文献.
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