A Bayesian two-stage group sequential scheme for ordinal endpoints

IF 16.4 1区化学 Q1 CHEMISTRY, MULTIDISCIPLINARY

Accounts of Chemical Research Pub Date : 2023-04-01 DOI:10.1093/jrsssc/qlad026

Chengxue Zhong, Hongyu Miao, H. Pan

引用次数: 0

Abstract

Ordinal endpoints are common in clinical studies. For example, many clinical trials for evaluating COVID-19 infection therapies have adopted an ordinal scale as recommended by the World Health Organization. Despite their importance in clinical studies, design methods for ordinal endpoints are limited; in practice, a dichotomized approach is often used for simplicity. Here, we introduce a Bayesian group sequential scheme to assess ordinal endpoints, which considers a proportional-odds (PO) model, a nonproportional-odds (NPO) model, and a PO/NPO-switch model to handle various scenarios. Extensive simulations are conducted to demonstrate desirable performance, and the R package BayesOrdDesign has been made publicly available.

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有序端点的贝叶斯两阶段群序列格式

顺序终点在临床研究中很常见。例如，许多评估COVID-19感染治疗的临床试验采用了世界卫生组织推荐的顺序量表。尽管它们在临床研究中很重要，但顺序终点的设计方法是有限的;在实践中，为了简单起见，通常使用二分法。在这里，我们引入了一个贝叶斯群序列方案来评估有序端点，该方案考虑了比例几率(PO)模型、非比例几率(NPO)模型和PO/NPO切换模型来处理各种场景。进行了大量的模拟以证明理想的性能，并且R包BayesOrdDesign已经公开可用。

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

Accounts of Chemical Research 化学-化学综合

CiteScore

31.40

自引率

1.10%

发文量

312

审稿时长

2 months

期刊介绍： Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance. Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.