Recurrent event data are common in clinical studies when participants are followed longitudinally, and are often subject to a terminal event. With the increasing popularity of large pragmatic trials and a heterogeneous source population, participants are often nested in clinics and can be either susceptible or structurally unsusceptible to the recurrent process. These complications require new modeling strategies to accommodate potential zero-event inflation as well as hierarchical data structures in both the terminal and non-terminal event processes. In this paper, we develop a Bayesian semiparametric model to jointly characterize the zero-inflated recurrent event process and the terminal event process. We use a point mass mixture of non-homogeneous Poisson processes to describe the recurrent intensity and introduce shared random effects from different sources to bridge the non-terminal and terminal event processes. To achieve robustness, we consider nonparametric Dirichlet processes to model the residual of the accelerated failure time model for the survival process as well as the cluster-specific frailty distribution, and develop a Markov Chain Monte Carlo algorithm for posterior inference. We demonstrate the superiority of our proposed model compared with competing models via simulations and apply our method to a pragmatic cluster-randomized trial for fall injury prevention among the elderly.
翻译:在临床研究中,当参与者得到纵向跟踪时,经常事件数据在临床研究中是常见的,而且经常受到终极事件的影响。随着大量务实试验和不同来源人群越来越受欢迎,参与者往往被嵌入诊所,并且可能易受到或从结构上看不易到经常性过程。这些复杂情况要求制定新的示范战略,以适应终极和非终极事件过程中潜在的零活动通货膨胀和等级数据结构。在本文件中,我们开发了一种巴伊西亚半参数模型,以共同确定零膨胀的经常性事件过程和终极事件过程的特点。我们使用非相异的Poisson过程的点质量混合体来描述经常强度,并采用不同来源的共享随机效应来连接非终点和终极事件过程。为了实现稳健,我们考虑采用非分数的Drichlet进程来模拟生存过程的加速失败时间模型的剩余部分,以及特定群组的弱点分布,并开发一个用于后期事件的演判过程的Markov连锁计算法。我们展示了我们提议的模型的优越性,通过模拟模型与相互竞争的老年伤害模拟和运用的方法来进行实际的预防。