Design and Analysis of Quality of Life Studies in Clinical Trials

ISBN-13: 9781420061178 / Angielski / Twarda / 2010 / 424 str.

Diane L. Fairclough

Opis

Design Principles and Analysis Techniques for HRQoL Clinical Trials
SAS, R, and SPSS examples realistically show how to implement methods Focusing on longitudinal studies, Design and Analysis of Quality of Life Studies in Clinical Trials, Second Edition addresses design and analysis aspects in enough detail so that readers can apply statistical methods, such as mixed effect models, to their own studies. The author illustrates the implementation of the methods using the statistical software packages SAS, SPSS, and R. New to the Second Edition

• Data sets available for download online, allowing readers to replicate the analyses presented in the text
• New chapter on testing models that involve moderation and mediation
• Revised discussions of multiple comparisons procedures that focus on the integration of health-related quality of life (HRQoL) outcomes with other study outcomes using gatekeeper strategies
• Recent methodological developments for the analysis of trials with missing data
• New chapter on quality adjusted life-years (QALYs) and QTWiST specific to clinical trials
• Additional examples of the implementation of basic models and other selected applications in R and SPSS

This edition continues to provide practical information for researchers directly involved in the design and analysis of HRQoL studies as well as for those who evaluate the design and interpret the results of HRQoL research. By following the examples in the book, readers will be able to apply the steps to their own trials.

Clinical trials that include the evaluation of health-related quality of life (QoL) issues are becoming more prevalent, yet many scientists remain unaware of the associated measurement and analysis issues. With an overview of design principles, Design and Analysis of Quality of Life Studies in Clinical Trials presents a range of solutions to analytic issues. This new edition reflects recent developments in methodology with expanded coverage of mixture models and an additional dataset example. The book implements examples using up-to-date SAS and R code and incorporates a number of examples from real QoL clinical trials to illustrate design and analysis methods.

Spis treści

Introduction and Examples. Study Design and Protocol Development. Models for Longitudinal Studies I. Models for Longitudinal Studies II. Moderation and Mediation. Characterization of Missing Data. Analysis of Studies with Missing Data. Simple Imputation. Multiple Imputation. Pattern Mixture and Other Mixture Models. Random Effects Dependent Dropout. Selection Models. Multiple Endpoints. Composite Endpoints and Summary Measures. Quality Adjusted Life-Years (QALYs) and Q-TWiST. Analysis Plans and Reporting Results. Appendices. References.

O autorze

Diane L. Fairclough is a professor in the Department of Biostatistics and Informatics in the Colorado School of Public Health and director of the Biostatistics Core of the Colorado Health Outcomes Program at the University of Colorado in Denver. She is also President of the International Society for Quality of Life Research. Dr. Fairclough’s prior appointments include St. Jude Children’s Research Hospital, Harvard School of Public Health, and AMC Cancer Research Center.