单病例随机对照(N-of-1)试验的样本量估计方法

Sample size estimation for single case randomized controlled trial(N-of-1 trial)

随着单病例随机对照试验(N-of-1试验)受到越来越多的关注,其样本量估算是困扰科研人员的重要问题。本文主要介绍了N-of-1试验的模型和假设,在模型基础上,提出固定模型和随机模型的样本量估计方法,并给出对应的应用条件、公式及实例。以期国内研究人员实施N-of-1试验方案时,能够使用正确的样本量估计方法,从而提高我国N-of-1试验的研究质量。

With increasing amount of attention being paid to single case randomized controlled trial(N-of-1 trials),sample size estimation has become an important issue for clinical researchers.This paper mainly introduces the model and hypothesis of N-of-1 trials.Based on the hypothetical model,sample size estimation methods of fixed model and random model are proposed.The premises of the model application,formulas and examples are then given.It is expected in case of conduction N-of-1 trials,the correct methods are used to estimate sample size and improve the research quality of N-of-1 trials.