Comparing Clinical Measurement Methods E-Book

Bendix Carstensen

• Herausgeber: John Wiley & Sons
• Kategorie: Wissenschaft und neue Technologien
• Serie: Statistics in Practice
• Sprache: Englisch

Seitenzahl: 170

Veröffentlichungsjahr: 2011

Beschreibung

This book provides a practical guide to analysis of simple and complex method comparison data, using Stata, SAS and R. It takes the classical Limits of Agreement as a starting point, and presents it in a proper statistical framework. The model serves as a reference for reporting sources of variation and for providing conversion equations and plots between methods for practical use, including prediction uncertainty. * Presents a modeling framework for analysis of data and reporting of results from comparing measurements from different clinical centers and/or different methods. * Provides the practical tools for analyzing method comparison studies along with guidance on what to report and how to plan comparison studies and advice on appropriate software. * Illustrated throughout with computer examples in R. * Supported by a supplementary website hosting an R-package that performs the major part of the analyses needed in the area. * Examples in SAS and Stata for the most common situations are also provided. * Written by an acknowledged expert on the subject, with a long standing experience as a biostatistician in a clinical environment and a track record of delivering training on the subject. Biostatisticians, clinicians, medical researchers and practitioners involved in research and analysis of measurement methods and laboratory investigations will benefit from this book. Students of statistics, biostatistics, and the chemical sciences will also find this book useful.

Leseprobe

Contents

Acknowledgments

1 Introduction

2 Method comparisons

2.1 One measurement by each method

2.2 Replicate measurements by each method

2.3 More than two methods

2.4 Terminology and notation

2.5 What it is all about

3 How to …

3.1 … use this chapter

3.2 Two methods

3.3 More than two methods

4 Two methods with a single measurement on each

4.1 Model for limits of agreement

4.2 Non-constant difference between methods

4.3 A worked example

4.4 What really goes on

4.5 Other regression methods for non-constant bias

4.6 Comparison with a gold standard

4.7 Non-constant variance

4.8 Transformations

4.9 Summary

5 Replicate measurements

5.1 Pairing of replicate measurements

5.2 Plotting replicate measurements

5.3 Models for replicate measurements

5.4 Interpretation of the random effects

5.5 Estimation

5.6 Getting it wrong and getting it almost right

5.7 Summary

6 Several methods of measurement

6.1 Model

6.2 Replicate measurements

6.3 Single measurement by each method

7 A general model for method comparisons

7.1 Scaling

7.2 Interpretation of the random effects

7.3 Parametrization of the mean

7.4 Prediction limits

7.5 Estimation

7.6 Models with non-constant variance

7.7 Summary

8 Transformation of measurements

8.1 Log transformation

8.2 Transformations of percentages

8.3 Other transformations

8.4 Several methods

8.5 Variance components

8.6 Summary

9 Repeatability, reproducibility and coefficient of variation

9.1 Repeatability

9.2 Reproducibility

9.3 Coefficient of variation

10 Measures of association and agreement

10.1 Individual bioequivalence criterion

10.2 Agreement index

10.3 Relative variance index

10.4 Total deviation index

10.5 Correlation measures

10.6 Summary

11 Design of method comparison studies

11.1 Sample size

11.2 Repeated measures designs

11.3 Summary

12 Examples using standard software

12.1 SAS

12.2 Stata

12.3 R

13 The MethComp package for R

13.1 Data structures

13.2 Function overview

References

Index

Statistics in Practice

Advisory Editor

Human and Biological SciencesStephen Senn University College London, UK

Earth and Environmental SciencesMarian Scott University of Glasgow, UK

Industry, Commerce and FinanceWolfgang Jank University of Maryland, USA

Founding EditorVic Barnett Nottingham Trent University, UK

Statistics in Practice is an important international series of texts which provide detailed coverage of statistical concepts, methods and worked case studies in specific fields of investigation and study.

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This edition first published 2010

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Library of Congress Cataloguing-in-Publication Data

Carstensen, Bendix.

Comparing clinical measurement methods: a practical guide/Bendix Carstensen.

p.; cm. Includes bibliographical references and index. ISBN 978-0-470-69423-7 (cloth)

1. Clinical trials - Evaluation. 2. Clinical trials - Statistical methods. I. Title.

[DNLM: 1. Clinical Medicine. 2. Case-Control Studies. 3. Models, Statistical. 4. Regression Analysis. 5. Statistics as Topic - methods. WA 950 C321c 2010] R853.C55C37 2010 610.72'4-dc22

2010010826

Statistics in Practice

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Berger – Selection Bias and Covariate Imbalances in Randomized Clinical Trials

Berger and Wong – An Introduction to Optimal Designs for Social and Biomedical Research

Brown and Prescott – Applied Mixed Models in Medicine, Second Edition

Carstensen – Comparing Clinical Measurement Methods Chevret (Ed) – Statistical Methods for Dose-Finding Experiments Ellenberg, Fleming and DeMets – Data Monitoring Committees in Clinical Trials: A Practical Perspective

Hauschke, Steinijans & Pigeot – Bioequivalence Studies in Drug Development: Methods and Applications

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Molenberghs and Kenward – Missing Data in Clinical Studies O’Hagan, Buck, Daneshkhah, Eiser, Garthwaite, Jenkinson, Oakley & Rakow – Uncertain Judgements: Eliciting Expert’s Probabilities Parmigiani – Modeling in Medical Decision Making: A Bayesian Approach

Pintilie – Competing Risks: A Practical Perspective Senn – Cross-over Trials in Clinical Research, Second Edition Senn – Statistical Issues in Drug Development, Second Edition Spiegelhalter, Abrams and Myles – Bayesian Approaches to Clinical Trials and Health-Care Evaluation

Walters – Quality of Life Outcomes in Clinical Trials and Health-Care Evaluation

Whitehead – Design and Analysis of Sequential Clinical Trials,

Revised Second Edition

Whitehead – Meta-Analysis of Controlled Clinical Trials

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Winkel and Zhang – Statistical Development of Quality in Medicine

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Lehtonen and Pahkinen – Practical Methods for Design and Analysis of Complex Surveys, Second Edition

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Taroni, Aitken, Garbolino and Biedermann – Bayesian Networks and Probabilistic Inference in Forensic Science

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Acknowledgments

My workplace, Steno Diabetes Center, has throughout the last decade provided an excellent academic working environment for me and has generously given me space to pursue the statistical aspects of method comparison studies.

I am grateful to Lyle Gurrin, School of Population Health, University of Melbourne, for a long-standing collaboration on this topic and particularly for his efforts in shaping the MethComp package. My wife, Lene Theil Skovgaard, Department of Biostatistics, University of Copenhagen, has exercised a remarkable patience with this endeavor as well as an astonishingly clear insight into the problems treated. Without her assistance the book would have been less complete, with more goofs and much delayed. I dedicate this book to my children Rolf, Thor, Mira and Vega, whose never failing distrust in my intellect kept the book at a tolerable level. Any incomprehensible sections and errors in the book are therefore attributable to me alone.