Statistical Methods in Diagnostic Medicine
暫譯: 診斷醫學中的統計方法

Zhou, Xiao-Hua, Pennello, Gene A., Sun, Jiarui

  • 出版商: Wiley
  • 出版日期: 2026-05-11
  • 售價: $5,010
  • 貴賓價: 9.5$4,759
  • 語言: 英文
  • 頁數: 576
  • 裝訂: Hardcover - also called cloth, retail trade, or trade
  • ISBN: 1394220219
  • ISBN-13: 9781394220212
  • 相關分類: 機率統計學 Probability-and-statistics
  • 海外代購書籍(需單獨結帳)

商品描述

The definitive resource for ensuring diagnostic tests meet the highest standards of statistical rigor and clinical effectiveness

Statistical Methods in Diagnostic Medicine, 3rd Edition by Xiao-Hua Zhou, Jiarui Sun, Gene A. Pennello, Nancy A. Obuchowski and Donna K. McClish delivers the most comprehensive treatment of statistical methodologies for diagnostic test evaluation available today. The authors of the 2nd Edition - Peking University PKU Distinguished Chair Professor Zhou, Cleveland Clinic Professor Obuchowski, and Virginia Commonwealth University Professor Donna McClish - team with U.S. Food and Drug Administration senior mathematical statistician Pennello and doctoral researcher Sun to address a critical challenge facing medical professionals: ensuring that diagnostic tests used in clinical practice are accurate, methodologically sound, free from bias, and effective.

This edition provides practitioners and researchers with the statistical foundation necessary to design, analyze, and validate diagnostic studies that can withstand regulatory scrutiny and clinical demands. The book has been thoroughly revised to incorporate the latest advances in diagnostic test methodology, featuring significant expansions in biomarker evaluation and benefit-risk assessment. The authors have restructured content to improve cohesion through integrated case studies that span multiple chapters, while updating each section with contemporary methods and streamlining discussions of older techniques to focus on the most relevant approaches for today's diagnostic challenges.

Readers will also find:

  • Three entirely new chapters covering statistical methods for risk prediction, quantitative imaging biomarkers, and efficacy and effectiveness of biomarkers and other tests.
  • Enhanced coverage of sample size calculations, accuracy estimation methods, and comparative analysis techniques for competing diagnostic tests
  • Advanced analytical approaches including methods for comparing correlated ROC curves in multi-reader studies and techniques for correcting verification bias
  • Comprehensive treatment of regression analysis applications in diagnostic accuracy research with updated methodological guidance
  • Integrated case studies that demonstrate real-world application of statistical methods across different diagnostic scenarios and study designs

Perfect for biostatisticians, applied statisticians, clinical researchers, and regulatory professionals working in diagnostic medicine, Statistical Methods in Diagnostic Medicine will also benefit graduate students and researchers interested in gaining the statistical expertise needed to design robust diagnostic studies.

商品描述(中文翻譯)

確保診斷測試符合最高統計嚴謹性和臨床有效性的權威資源

診斷醫學中的統計方法,第三版,由周小華、孫佳瑞、基因·A·佩內洛、南希·A·奧布霍斯基和唐娜·K·麥克利什共同編寫,提供了當前最全面的診斷測試評估統計方法論的處理。第二版的作者——北京大學PKU傑出講座教授周小華、克里夫蘭診所教授奧布霍斯基和維吉尼亞聯邦大學教授唐娜·麥克利什——與美國食品藥品監督管理局的高級數學統計師佩內洛和博士研究生孫佳瑞合作,解決醫療專業人員面臨的一個關鍵挑戰:確保臨床實踐中使用的診斷測試準確、方法論上可靠、無偏見且有效。

本版為實踐者和研究人員提供了設計、分析和驗證能夠經受監管審查和臨床需求的診斷研究所需的統計基礎。該書已全面修訂,以納入診斷測試方法論的最新進展,並在生物標記評估和效益風險評估方面進行了重要擴展。作者重新結構內容,以通過跨多個章節的綜合案例研究來改善內容的連貫性,同時更新每個部分以反映當代方法,並簡化對舊技術的討論,專注於當前診斷挑戰中最相關的方法。

讀者還將發現:

  • 三個全新章節,涵蓋風險預測的統計方法、定量影像生物標記以及生物標記和其他測試的有效性和效能。
  • 增強的樣本大小計算、準確性估計方法和競爭診斷測試的比較分析技術的覆蓋。
  • 先進的分析方法,包括在多讀者研究中比較相關ROC曲線的方法和糾正驗證偏差的技術。
  • 對回歸分析在診斷準確性研究中的應用進行全面處理,並提供更新的技術指導。
  • 綜合案例研究,展示統計方法在不同診斷情境和研究設計中的實際應用。

本書非常適合從事診斷醫學的生物統計學家、應用統計學家、臨床研究人員和監管專業人士,診斷醫學中的統計方法也將使研究生和希望獲得設計穩健診斷研究所需統計專業知識的研究人員受益。

作者簡介

Xiao-Hua Zhou, fellow of the American Association for the Advancement of Science, fellow of the American Statistical Association, fellow of Institute of Mathematical Statistics, is PKU Distinguished Chair Professor and Chair of the Department of Biostatistics at Peking University, Beijing, China. His research focuses on statistical methods for diagnostic medicine, causal inference, and clinical trials, with extensive experience in regulatory statistics and biomedical research methodology. He has published more than 290 referred papers in those areas.

Jiarui Sun is Senior Biostatistician in Shanghai Shengdi Pharmaceutical Co., Ltd. and received his Ph.D from the School of Mathematical Science at Peking University, Beijing, China. His research interests include statistical methods for diagnostic accuracy studies, biomarker evaluation, and computational approaches to medical statistics and diagnostic test validation.

Gene A. Pennello, fellow of the American Statistical Association, is a statistical reviewer and research Mathematical Statistician at the U.S. Food and Drug Administration (FDA) in Silver Spring, Maryland. He specializes in statistical methods for medical device evaluation, diagnostic test assessment, and regulatory review processes for medical technologies.

Nancy A Obuchowski, fellow of the American Statistical Association, Professor of Medicine at the Cleveland Clinic Lerner College of Medicine at Case Western Reserve University, has extensive experience in the design, analysis, and development of new statistical methodology for the evaluation of diagnostic and screening tests and quantitative imaging biomarkers.

Donna K. McClish, PhD, is Associate Professor and Graduate Program Director in Biostatistics at Virginia Commonwealth University. She has written more than 100 journal articles on statistical methods in epidemiology, diagnostic medicine, and health services research.

作者簡介(中文翻譯)

周小華,美國科學促進會會士、美國統計學會會士、數學統計學會會士,現為北京大學生物統計學系的特聘教授及系主任。他的研究專注於診斷醫學的統計方法、因果推斷及臨床試驗,並在監管統計和生物醫學研究方法論方面擁有豐富的經驗。他在這些領域已發表超過290篇經審稿的論文。

孫佳瑞是上海盛迪醫藥有限公司的高級生物統計師,並在北京大學數學科學學院獲得博士學位。他的研究興趣包括診斷準確性研究的統計方法、生物標記評估,以及醫學統計和診斷測試驗證的計算方法。

基因·A·佩內洛,美國統計學會會士,現為美國食品藥品監督管理局(FDA)在馬里蘭州銀泉的統計審查員及研究數學統計師。他專注於醫療器械評估、診斷測試評估及醫療技術的監管審查過程中的統計方法。

南希·A·奧布霍斯基,美國統計學會會士,現為凱斯西儲大學克里夫蘭診所勒納醫學院的醫學教授,擁有設計、分析及開發新統計方法以評估診斷和篩檢測試及定量影像生物標記的豐富經驗。

唐娜·K·麥克利什,博士,現為維吉尼亞聯邦大學生物統計學的副教授及研究生項目主任。她在流行病學、診斷醫學及健康服務研究的統計方法方面撰寫了超過100篇期刊文章。