Bayesian spatial cluster signal learning with application to adverse event (AE).

IF 1.2 4区 医学 Q4 PHARMACOLOGY & PHARMACY Journal of Biopharmaceutical Statistics Pub Date : 2024-03-21 DOI:10.1080/10543406.2024.2325148
Hou-Cheng Yang, Guanyu Hu
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Abstract

There is growing interest in understanding geographic patterns of medical device-related adverse events (AEs). A spatial scan method combined with the likelihood ratio test (LRT) for spatial-cluster signal detection over the geographical region is universally used. The spatial scan method used a moving window to scan the entire study region and collected some candidate sub-regions from which the spatial-cluster signal(s) will be found. However, it has some challenges, especially in computation. First, the computational cost increased when the number of sub-regions increased. Second, the computational cost may increase if a large spatial-cluster pattern is present and a flexible-shaped window is used. To reduce the computational cost, we propose a Bayesian nonparametric method that combines the ideas of Markov random field (MRF) to leverage geographical information to find potential signal clusters. Then, the LRT is applied for the detection of spatial cluster signals. The proposed method provides an ability to capture both locally spatially contiguous clusters and globally discontiguous clusters, and is manifested to be effective and tractable using hypothetical Left Ventricular Assist Device (LVAD) data as an illustration.

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贝叶斯空间聚类信号学习在不良事件(AE)中的应用。
人们对了解医疗器械相关不良事件(AEs)的地理模式越来越感兴趣。目前普遍采用空间扫描法结合似然比检验(LRT)来检测地理区域的空间集群信号。空间扫描法使用移动窗口扫描整个研究区域,并收集一些候选子区域,从中发现空间集群信号。然而,这种方法也面临一些挑战,尤其是在计算方面。首先,当子区域数量增加时,计算成本会增加。其次,如果存在较大的空间集群模式并使用灵活的窗口,计算成本也会增加。为了降低计算成本,我们提出了一种贝叶斯非参数方法,该方法结合了马尔可夫随机场(MRF)的思想,利用地理信息来寻找潜在的信号集群。然后,应用 LRT 检测空间集群信号。所提出的方法既能捕捉局部空间上连续的集群,也能捕捉全局上不连续的集群,并以假设的左心室辅助装置(LVAD)数据为例,证明了该方法的有效性和可操作性。
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来源期刊
Journal of Biopharmaceutical Statistics
Journal of Biopharmaceutical Statistics 医学-统计学与概率论
CiteScore
2.50
自引率
18.20%
发文量
71
审稿时长
6-12 weeks
期刊介绍: The Journal of Biopharmaceutical Statistics, a rapid publication journal, discusses quality applications of statistics in biopharmaceutical research and development. Now publishing six times per year, it includes expositions of statistical methodology with immediate applicability to biopharmaceutical research in the form of full-length and short manuscripts, review articles, selected/invited conference papers, short articles, and letters to the editor. Addressing timely and provocative topics important to the biostatistical profession, the journal covers: Drug, device, and biological research and development; Drug screening and drug design; Assessment of pharmacological activity; Pharmaceutical formulation and scale-up; Preclinical safety assessment; Bioavailability, bioequivalence, and pharmacokinetics; Phase, I, II, and III clinical development including complex innovative designs; Premarket approval assessment of clinical safety; Postmarketing surveillance; Big data and artificial intelligence and applications.
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