{"title":"A Bayesian two-stage group sequential scheme for ordinal endpoints","authors":"Chengxue Zhong, Hongyu Miao, H. Pan","doi":"10.1093/jrsssc/qlad026","DOIUrl":null,"url":null,"abstract":"\n 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.","PeriodicalId":49981,"journal":{"name":"Journal of the Royal Statistical Society Series C-Applied Statistics","volume":"1 1","pages":""},"PeriodicalIF":1.0000,"publicationDate":"2023-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of the Royal Statistical Society Series C-Applied Statistics","FirstCategoryId":"100","ListUrlMain":"https://doi.org/10.1093/jrsssc/qlad026","RegionNum":4,"RegionCategory":"数学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"STATISTICS & PROBABILITY","Score":null,"Total":0}
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.
期刊介绍：
The Journal of the Royal Statistical Society, Series C (Applied Statistics) is a journal of international repute for statisticians both inside and outside the academic world. The journal is concerned with papers which deal with novel solutions to real life statistical problems by adapting or developing methodology, or by demonstrating the proper application of new or existing statistical methods to them. At their heart therefore the papers in the journal are motivated by examples and statistical data of all kinds. The subject-matter covers the whole range of inter-disciplinary fields, e.g. applications in agriculture, genetics, industry, medicine and the physical sciences, and papers on design issues (e.g. in relation to experiments, surveys or observational studies).
A deep understanding of statistical methodology is not necessary to appreciate the content. Although papers describing developments in statistical computing driven by practical examples are within its scope, the journal is not concerned with simply numerical illustrations or simulation studies. The emphasis of Series C is on case-studies of statistical analyses in practice.
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