{"title":"Simultaneous comparison of the predictive values of two binary diagnostic tests in the presence of categorical covariates.","authors":"José A Roldán-Nofuentes, Saad B Regad","doi":"10.1080/10543406.2025.2547589","DOIUrl":null,"url":null,"abstract":"<p><p>Comparison of predictive values of diagnostic tests is a topic of interest in Medical Statistics, and has been the subject of different studies. In clinical practice, it is frequent to observe categorical covariates when comparing diagnostic tests. In this framework, a global hypothesis test is proposed to simultaneously compare the predictive values of two diagnostic tests when in all of the individuals categorical covariates are observed. This hypothesis test is solved through regression models and also by weighted least squares method for the analysis of categorical data. Simulation experiments were carried out to study the asymptotic behavior of these methods when a binary covariate is observed and when a covariate with three categories is observed, and these were compared to the behavior of the global test when the covariate is ignored. In general, the method based on regression models has shown to have better asymptotic behavior than the other methods. Furthermore, we studied the application of the method based on the regression models when no covariate is observed, for which the individuals in the sample are randomly assigned to a binary dummy random variable. Simulation experiments carried out showed that this method has greater power than the method without the covariate. The results were applied to two examples.</p>","PeriodicalId":54870,"journal":{"name":"Journal of Biopharmaceutical Statistics","volume":"36 6","pages":"1463-1492"},"PeriodicalIF":1.3000,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Biopharmaceutical Statistics","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/10543406.2025.2547589","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/8/26 0:00:00","PubModel":"Epub","JCR":"Q4","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
Abstract
Comparison of predictive values of diagnostic tests is a topic of interest in Medical Statistics, and has been the subject of different studies. In clinical practice, it is frequent to observe categorical covariates when comparing diagnostic tests. In this framework, a global hypothesis test is proposed to simultaneously compare the predictive values of two diagnostic tests when in all of the individuals categorical covariates are observed. This hypothesis test is solved through regression models and also by weighted least squares method for the analysis of categorical data. Simulation experiments were carried out to study the asymptotic behavior of these methods when a binary covariate is observed and when a covariate with three categories is observed, and these were compared to the behavior of the global test when the covariate is ignored. In general, the method based on regression models has shown to have better asymptotic behavior than the other methods. Furthermore, we studied the application of the method based on the regression models when no covariate is observed, for which the individuals in the sample are randomly assigned to a binary dummy random variable. Simulation experiments carried out showed that this method has greater power than the method without the covariate. The results were applied to two examples.
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.