Donna K. McClish – författare

An important role of diagnostic medicine research is to estimate and compare the accuracies of diagnostic tests. This book provides a comprehensive account of statistical methods for design and analysis of diagnostic studies, including sample size calculations, estimation of the accuracy of a diagnostic test, comparison of accuracies of competing diagnostic tests, and regression analysis of diagnostic accuracy data. Discussing recently developed methods for correction of verification bias and imperfect reference bias, methods for analysis of clustered diagnostic accuracy data, and meta-analysis methods, Statistical Methods in Diagnostic Medicine explains: * Common measures of diagnostic accuracy and designs for diagnostic accuracy studies * Methods of estimation and hypothesis testing of the accuracy of diagnostic tests * Meta-analysis * Advanced analytic techniques-including methods for comparing correlated ROC curves in multi-reader studies, correcting verification bias, and correcting when an imperfect gold standard is used Thoroughly detailed with numerous applications and end-of-chapter problems as well as a related FTP site providing FORTRAN program listings, data sets, and instructional hints, Statistical Methods in Diagnostic Medicine is a valuable addition to the literature of the field, serving as a much-needed guide for both clinicians and advanced students.

Praise for the First Edition

" . . . the book is a valuable addition to the literature in the field, serving as a much-needed guide for both clinicians and advanced students."—Zentralblatt MATH

A new edition of the cutting-edge guide to diagnostic tests in medical research

In recent years, a considerable amount of research has focused on evolving methods for designing and analyzing diagnostic accuracy studies. Statistical Methods in Diagnostic Medicine, Second Edition continues to provide a comprehensive approach to the topic, guiding readers through the necessary practices for understanding these studies and generalizing the results to patient populations.

Following a basic introduction to measuring test accuracy and study design, the authors successfully define various measures of diagnostic accuracy, describe strategies for designing diagnostic accuracy studies, and present key statistical methods for estimating and comparing test accuracy. Topics new to the Second Edition include:

Methods for tests designed to detect and locate lesions

Recommendations for covariate-adjustment

Methods for estimating and comparing predictive values and sample size calculations

Correcting techniques for verification and imperfect standard biases

Sample size calculation for multiple reader studies when pilot data are available

Updated meta-analysis methods, now incorporating random effects

Three case studies thoroughly showcase some of the questions and statistical issues that arise in diagnostic medicine, with all associated data provided in detailed appendices. A related web site features Fortran, SAS®, and R software packages so that readers can conduct their own analyses.

Statistical Methods in Diagnostic Medicine, Second Edition is an excellent supplement for biostatistics courses at the graduate level. It also serves as a valuable reference for clinicians and researchers working in the fields of medicine, epidemiology, and biostatistics.

Praise for the First Edition

" . . . the book is a valuable addition to the literature in the field, serving as a much-needed guide for both clinicians and advanced students."—Zentralblatt MATH

A new edition of the cutting-edge guide to diagnostic tests in medical research

In recent years, a considerable amount of research has focused on evolving methods for designing and analyzing diagnostic accuracy studies. Statistical Methods in Diagnostic Medicine, Second Edition continues to provide a comprehensive approach to the topic, guiding readers through the necessary practices for understanding these studies and generalizing the results to patient populations.

Following a basic introduction to measuring test accuracy and study design, the authors successfully define various measures of diagnostic accuracy, describe strategies for designing diagnostic accuracy studies, and present key statistical methods for estimating and comparing test accuracy. Topics new to the Second Edition include:

Methods for tests designed to detect and locate lesions

Recommendations for covariate-adjustment

Methods for estimating and comparing predictive values and sample size calculations

Correcting techniques for verification and imperfect standard biases

Sample size calculation for multiple reader studies when pilot data are available

Updated meta-analysis methods, now incorporating random effects

Three case studies thoroughly showcase some of the questions and statistical issues that arise in diagnostic medicine, with all associated data provided in detailed appendices. A related web site features Fortran, SAS®, and R software packages so that readers can conduct their own analyses.

Statistical Methods in Diagnostic Medicine, Second Edition is an excellent supplement for biostatistics courses at the graduate level. It also serves as a valuable reference for clinicians and researchers working in the fields of medicine, epidemiology, and biostatistics.

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 testsAdvanced analytical approaches including methods for comparing correlated ROC curves in multi-reader studies and techniques for correcting verification biasComprehensive treatment of regression analysis applications in diagnostic accuracy research with updated methodological guidanceIntegrated case studies that demonstrate real-world application of statistical methods across different diagnostic scenarios and study designsPerfect 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.

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 testsAdvanced analytical approaches including methods for comparing correlated ROC curves in multi-reader studies and techniques for correcting verification biasComprehensive treatment of regression analysis applications in diagnostic accuracy research with updated methodological guidanceIntegrated 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.

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 testsAdvanced analytical approaches including methods for comparing correlated ROC curves in multi-reader studies and techniques for correcting verification biasComprehensive treatment of regression analysis applications in diagnostic accuracy research with updated methodological guidanceIntegrated 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.