Quality of Life Assessment in Clinical Trials Methods and Practice

by Staquet, Maurice J.; Hays, Ron D.; Fayers, Peter M.

• ISBN13: 9780192627858
• ISBN10: 0192627856
• Format: Hardcover
• Copyright: 1998-04-23
• Publisher: Oxford University Press

Summary

Researchers in all clinical fields are becoming increasingly aware of the importance of quality of life measurements in judging the efficacy of a given treatment, and it is becoming more common for psychological criteria to play an important role in the evaluation of therapies. In the past ten years a number of methods have been developed for carrying out such assessments. Quality of life research does however use special statistical methods which might well be unfamiliar to the clinician. Quality of life assessment in clinical trials: methods and practice explores these methods in a non-mathematical manner, comparing and contrasting the tools available to the clinician, and highlighting any potential pitfalls. It describes the methods used to collect and analyse quality of life data. The book will have widespread appeal to clinical trialists and researchers from a wide range of specialties.

Table of Contents

List of Contributors	ix
Part I Introduction	3	(16)
1 Understanding and using health-related quality of life instruments within clinical research studies	3	(16)
Richard A. Berzon
Part II Primary issues specific to quality of life trials	19	(74)
2 Guidelines for measuring health-related quality of life in clinical trials	19	(18)
David Osoba
3 Sample sizes for randomized trials measuring quality of life	37	(14)
David Machin
Peter M. Fayers
4 Cross-cultural issues in the use of quality of life measures in randomized controlled trials	51	(18)
Sonja M. Hunt
5 Profile versus utility based measures of outcome for clinical trials	69	(24)
Robert M. Kaptan
Part III Decision theory and preference assessment	93	(64)
6 Introduction to decision theory and utilities	93	(26)
Frank A. Sonnenberg
7 Using decision theory in clinical research: applications of quality-adjusted life-years	119	(24)
Carolyn E. Schwartz
Elissa A. Laitin
8 Possibilities for summarizing health-related quality of life when using a profile instrument	143	(14)
Ron D. Hays
Jordi Alonso
Stephen Joel Coons
Part IV Psychometry	157	(70)
9 Questionnaire scaling: models and issues	157	(12)
Dennis A. Rericki
Nancy Kline Leidy
10 Assessing reliability and validity of measurement in clinical trials	169	(14)
Ron D. Hays
Roger T. Anderson
Dennis Rericki
11 Item response theory models	183	(8)
Ron D. Hays
12 Factor analysis	191	(36)
Peter M. Fayers
David Machin
Part V Data analysis	227	(72)
13 Methods of analysis for longitudinal studies of health-related quality of life	227	(22)
Diane L. Fairclough
14 Analysis of incomplete quality of life data in clinical trials	249	(32)
Desmond Curran
Peter M. Fayers
Geert Molenberghs
David Machin
15 Using the Q-TWiST method for treatment comparisons in clinical trials	281	(18)
Shari Gelber
Richard D. Gelber
Bernard F. Cole
Aron Goldhirsch
Part VI Interpreting and reporting results of QoL clinical trials	299	(50)
16 Clinical interpretation of health-related quality of life data	299	(16)
Eva Lydick
Barbara P. Yawn
17 Summarizing quality of life data using graphical methods	315	(22)
Peter M. Fayers
David Machin
18 Guidelines for reporting results of quality of life assessments in clinical trials	337	(12)
Maurice J. Staquet
Richard A. Berzon
David Osoba
David Machin
Index	349