{"title":"用线性回归模型分析三个诊断组的协变量调整约登指数和相关截断点。","authors":"Asieh Maghami-Mehr, Hamzeh Torabi, Hossein Nadeb, Yichuan Zhao","doi":"10.1080/10543406.2025.2558141","DOIUrl":null,"url":null,"abstract":"<p><p>In medical diagnostic studies involving a transitional intermediate stage of disease progression, the Youden index offers a valuable summary measure for evaluating test accuracy across three diagnostic groups. However, ignoring covariate effects may lead to misleading assessments. To address this, we incorporate covariate information using linear regression models with normally distributed errors, enabling maximum likelihood estimation of the covariate-adjusted Youden index and its corresponding optimal cut-off points. We further develop several types of confidence intervals for these parameters, including generalized confidence intervals, Bayesian credible intervals, and bootstrap-based intervals. The finite-sample performance of the proposed estimators and interval procedures is evaluated via Monte Carlo simulations. Finally, we apply our methods to a diabetic dataset to illustrate their practical utility.</p>","PeriodicalId":54870,"journal":{"name":"Journal of Biopharmaceutical Statistics","volume":" ","pages":"1-25"},"PeriodicalIF":1.2000,"publicationDate":"2025-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Linear regression models for analyzing the covariate-adjusted Youden index and associated cut-off points in three diagnostic groups.\",\"authors\":\"Asieh Maghami-Mehr, Hamzeh Torabi, Hossein Nadeb, Yichuan Zhao\",\"doi\":\"10.1080/10543406.2025.2558141\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>In medical diagnostic studies involving a transitional intermediate stage of disease progression, the Youden index offers a valuable summary measure for evaluating test accuracy across three diagnostic groups. However, ignoring covariate effects may lead to misleading assessments. To address this, we incorporate covariate information using linear regression models with normally distributed errors, enabling maximum likelihood estimation of the covariate-adjusted Youden index and its corresponding optimal cut-off points. We further develop several types of confidence intervals for these parameters, including generalized confidence intervals, Bayesian credible intervals, and bootstrap-based intervals. The finite-sample performance of the proposed estimators and interval procedures is evaluated via Monte Carlo simulations. Finally, we apply our methods to a diabetic dataset to illustrate their practical utility.</p>\",\"PeriodicalId\":54870,\"journal\":{\"name\":\"Journal of Biopharmaceutical Statistics\",\"volume\":\" \",\"pages\":\"1-25\"},\"PeriodicalIF\":1.2000,\"publicationDate\":\"2025-09-17\",\"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/10.1080/10543406.2025.2558141\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Biopharmaceutical Statistics","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/10543406.2025.2558141","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
Linear regression models for analyzing the covariate-adjusted Youden index and associated cut-off points in three diagnostic groups.
In medical diagnostic studies involving a transitional intermediate stage of disease progression, the Youden index offers a valuable summary measure for evaluating test accuracy across three diagnostic groups. However, ignoring covariate effects may lead to misleading assessments. To address this, we incorporate covariate information using linear regression models with normally distributed errors, enabling maximum likelihood estimation of the covariate-adjusted Youden index and its corresponding optimal cut-off points. We further develop several types of confidence intervals for these parameters, including generalized confidence intervals, Bayesian credible intervals, and bootstrap-based intervals. The finite-sample performance of the proposed estimators and interval procedures is evaluated via Monte Carlo simulations. Finally, we apply our methods to a diabetic dataset to illustrate their practical utility.
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.