适应性,集群随机对照试验的特性:一个模拟研究小组
Erin Nolan1,2,3, Joshua Dizon4,5, Christopher Oldmeadow4,5
1School of Medicine and Public Health, The University of Newcastle, Callaghan, NSW, Australia. Erin.Nolan@hmri.org.au.
Implementation science : IS
|July 2, 2025
概括
适应性设计是可行的集群随机试验与少数集群,提供效率的收益. 然而,高的类内相关性可能导致错误的决策,降低可行性.
科学领域:
- 医疗保健服务研究 医疗服务研究
- 临床试验方法论 临床试验方法论
- 实施科学 实施科学
背景情况:
- 优化实施策略涉及复杂的多组件干预措施,通过集群随机试验 (cRCT) 进行评估.
- 由于招聘挑战,传统的固定cRCT面临电力限制.
- 适应式设计比固定式设计提供了潜在的效率改进.
研究的目的:
- 评估适应性设计的可行性,以便在少数集群中实施cRCT.
- 在模拟的自适应cRCT中评估操作特征和适应性临时决策.
- 为了比较适应式与固定式设计在功率和I型错误方面的性能.
主要方法:
- 进行了四臂集群随机对照试验 (cRCT) 的模拟研究.
- 使用固定和自适应设计参数模拟试验,包括中间分析和手臂放下规则.
- 贝叶斯层次模型被用来分析模拟数据,比较功率和I型错误率.
主要成果:
- 与固定设计相比,自适应设计显示出小的功率增长,而不会增加I型错误.
- 由于较高的类内相关性 (ICC) 和较小的样本大小,功率增益减少.
- 高ICC增加了在适应性设计中错误放下最有效臂的可能性.
结论:
- 适应性设计是可行的实施cRCTs与少数集群.
- 在高ICC的存在下,可行性受到损害,增加了错误的适应性决定的风险.
- 在资源有限的环境中实施适应性设计时,必须仔细考虑ICC.
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