Bayesian network meta-regression for aggregate ordinal outcomes with imprecise categories.

IF 1.3 4区 医学 Q4 PHARMACOLOGY & PHARMACY
Yeongjin Gwon, Ming-Hui Chen, May Mo, Xun Jiang, H Amy Xia, Joseph G Ibrahim
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引用次数: 0

Abstract

Comparing emerging treatment options is often challenging because of the sparseness of direct comparisons from head-to-head trials and inconsistencies in outcome measures among published placebo-controlled trials for each treatment. One potential solution is to aggregate the different outcome measures into a single ordinal response variable for consistent evaluation. The ordinal response variable will inevitably contain unknown response categories because they cannot be directly derived from published data in the literature. In this paper, we propose a statistical methodology to overcome such a common but unresolved issue in the context of network meta-regression for aggregate ordinal outcomes. Specifically, we introduce unobserved latent counts and model these counts within a Bayesian framework. The proposed approach includes several existing models as special cases and also allows us to conduct a proper statistical analysis in the presence of trials with certain missing categories. We then develop an efficient Markov chain Monte Carlo sampling algorithm to carry out Bayesian computation. Variations of the deviance information criterion and widely applicable information criterion are used for the assessment of goodness-of-fit under different distributions of the latent counts. A case study demonstrating the usefulness of the proposed methodology is conducted using aggregate ordinal outcome data from 18 clinical trials in treating Crohn's Disease.

具有不精确分类的累计有序结果的贝叶斯网络元回归。
比较新出现的治疗方案往往是具有挑战性的,因为直接比较头对头试验的稀疏性,以及每种治疗的已发表的安慰剂对照试验的结果测量不一致。一个可能的解决方案是将不同的结果测量汇总到一个有序的响应变量中,以进行一致的评估。序数响应变量不可避免地包含未知的响应类别,因为它们不能直接从文献中发表的数据中推导出来。在本文中,我们提出了一种统计方法来克服这样一个共同的,但未解决的问题,在网络元回归累计有序结果的背景下。具体来说,我们引入了未观察到的潜在计数,并在贝叶斯框架内对这些计数进行建模。所建议的方法包括几个现有的模型作为特殊情况,也允许我们在存在某些缺失类别的试验时进行适当的统计分析。然后,我们开发了一种高效的马尔可夫链蒙特卡罗采样算法来进行贝叶斯计算。在不同的潜在计数分布下,使用偏差信息准则的变化和广泛适用的信息准则来评估拟合优度。一项案例研究利用18项治疗克罗恩病的临床试验的累计顺序结果数据,证明了所提出方法的有效性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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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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