Xiao-Hua Zhou & Nancy A. Obuchowski 
Statistical Methods in Diagnostic Medicine 

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.

Inhaltsverzeichnis

List of Figures xix

List of Tables xxiii

0.1 Preface xxix

0.2 Acknowledgements xxxi

Part I. Basic Concepts and Methods

1. Introduction 3

2. Measures of Diagnostic Accuracy 13

3. Design of Diagnostic Accuracy Studies 57

4. Estimation and Hypothesis Testing in a Single Sample 103

5. Comparing the Accuracy of Two Diagnostic Tests 165

6. Sample Size Calculations 193

7. Introduction to Meta-analysis for Diagnostic Accuracy Studies 231

Part II. Advanced Methods

8. Regression Analysis for Independent ROC Data 263

9. Analysis of Multiple Reader and/or Multiple Test Studies 297

10. Methods for Correcting Verification Bias 329

11. Methods for Correcting Imperfect Gold Standard Bias 389

12. Statistical Analysis for Meta-analysis 435

Appendix A. Case Studies and Chapter 8 Data 449

Appendix B. Jackknife and Bootstrap Methods of Estimating Variances and Confidence Intervals 477

Über den Autor

Xiao-Hua Zhou, Ph D, is Professor of Biostatistics at the
University of Washington and Director and Research Career Scientist
at the Biostatistics Unit of the Veterans Affairs Puget Sound
Healthcare System. He is a Fellow of the American Statistical
Association and the author of more than 100 published articles on
statistical methods in diagnostic medicine and causal inferences.

Nancy A. Obuchowski, Ph D, is Vice Chairperson of the
Department of Quantitative Health Sciences at the Cleveland Clinic
Foundation. A Fellow of the American Statistical Association, she
has written more than 100 journal articles on the design and
analysis of studies of screening and diagnostic tests.

Donna K. Mc Clish, Ph D, 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.