" . . . 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.

Nancy A. Obuchowski, PhD, 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. 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.

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