在两期随机交叉设计中,对于行为干预的持续转移,在干预停止后不期望恢复到基线
Stefan Tino Kulnik1,2, Anna Eleonora Carrozzo3,4,5, Rik Crutzen4,6
1Salzburg Research Forschungsgesellschaft m.b.H., Jakob Haringer Strasse 5/3, Salzburg, 5020, Austria. stefan.kulnik@salzburgresearch.at.
Trials
|December 4, 2025
概括
本研究引入了针对临床试验的修改过的交叉设计,适用于干预导致持久影响的场合. 这种方法保持了统计能力,即使有持久的转移效应,这使得它对长期行为变化研究有价值.
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
- 健康行为研究 研究健康行为研究
背景情况:
- 与平行组设计相比,两期随机交叉设计在统计能力和样本大小方面具有优势.
- 一个关键的假设是参与者在干预后恢复到基线,这并不总是现实的.
研究的目的:
- 提出一个替代的交叉设计范式,以适应持久的转移效应.
- 为了证明这种修改后的设计对旨在实现持久变化的干预措施的持续统计能力.
主要方法:
- 描述了一个替代的交叉设计范式,假设不返回基线.
- 使用了样本大小计算和统计模拟.
- 评估的场景带有部分或全部的转移效应.
主要成果:
- 经过修改的交叉设计保持了比平行组设计更大的统计能力.
- 权力等价或优越性被观察到,即使在主体间异质性不可忽视的情况下.
- 在现实的转移假设下,设计是有效的.
结论:
- 修改过的交叉设计是一个可行的选择,当干预的目的是产生持久的影响.
- 如果实验治疗与回归基线假设相矛盾,研究人员应该考虑这种方法.
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