Quality of Life Assessment in Clinical Trials: Methods and Practice

Abstract

Part 1 - Introduction Understanding and using health-related QOL instruments within clinical research studies Part 2 - Primary issues specific to quality of life trials Guidelines for measuring health-related QOL in clinical trials Sample sizes for randomized trials measuring QOL Cross-cultural issues in the use of QOL measures in randomized controlled trials Profile versus utility based measures of outcome for clinical trials Part 3 - Decision theory and preference assessment Introduction to decision theory and utilities Using decision theory in clinical research: applications of QALY Possibilities for summarizing health-related QOL when using a profile instrument Part 4 - Psychometry Questionnaire scaling: models and issues Assessing reliability and validity of measurement in clinical trials Item response theory models Factor analysis Part 5 - Data analysis Methods of analysis for longitudinal studies of health-related QOL Analysis of incomplete QOL data in clinical trials Using the Q-Twist method for treatment comparisons in clinical trials Part 6 - Interpreting and reporting results of QOL clinical trials Clinical interpretation of health-related QOL data Summarizing QOL data using graphical methods Guidelines for reporting results of QOL assessment in clinical trials Index

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