随机化检验在内部预试验自适应设计样本量调整中的应用
Application of randomization test in the sample size adjustment for internal pilot study
王素珍 1李婵娟 2夏结来2
作者信息
- 1. 潍坊医学院卫生统计学教研室,山东,潍坊,261042
- 2. 第四军医大学军事预防医学系卫生统计学教研室,陕西,西安,710033
- 折叠
摘要
目的:探讨随机化检验(Randomization test)在内部预试验IPs(Internal Pilot Study)自适应设计样本量调整中对Ⅰ型错误和检验效能的影响.方法:利用蒙特-卡罗(MonteCarlo)法模拟样本量较小时的IPS样本量调整,分别采用随机化检验和t检验分析最后数据并比较二者对Ⅰ型错误、检验效能值的影响.结果:重计算的第二阶段样本量波动性较大,t检验不能很好地抑制Ⅰ型错误,随机化检验能较好的抑制Ⅰ型错误,检验效能略有降低.结论:在临床试验样本量较小的情况下,内部预试验盲态下样本量调整后随机化检验能保护Ⅰ型错误不增大,同时保证检验效能亦满足要求.
Abstract
AIM: To probe into the effect of randomization test on type Ⅰ error and power when it is used to ananlyze the data from IPS (Internal Pilot Study) with samplesize adjustment. METHODS: Monte Carlo was used to simulate IPS samplesize adjustment on condition that IPS samplesize is small. Randomization test and t test were used simultaneously to analyze the final data in order to compare the different effect of two methods on type Ⅰ error and power. RESULTS: While the recalcultion sample size for the second phase is volatilely fluctuant, t test can not prevent type Ⅰ error from inflating. However, randomization test can prevent type Ⅰ error from inflating better with little lower of power. CONCLUSION: The randomization test for the final data can not only prevent type Ⅰ error from inflating, but also maintain the desired power if we re-estimate the sample size under blinded IPS when it has small sample size.
关键词
临床试验/样本量调整/内部预试验/随机化检验/蒙特·卡罗模拟/Ⅰ型错误/检验效能Key words
clinical trial/samplesize adjustment/internal pilot study/randomization test/monte carlo simulation/type Ⅰ error/power引用本文复制引用
出版年
2009
NETL
NSTL
维普
万方数据