Quality of Life Assessment in Clinical Trials: Methods and Practice

Abstract

Researchers are becoming aware of the importance of quality of life measurements in judging the efficacy of a given treatment. This title explores these treatment methods in a non-mathematical manner, comparing and contrasting the tools available to the clinician, and highlighting any potential pitfalls. List of Contributors -- 1. Understanding and using health-related quality of life instruments within clinical research studies -- 2. Guidelines for measuring health-related quality of life in clinical trials -- 3. Sample sizes for randomized trials measuring quality of life -- 4. Cross-cultural issues in the use of quality of life measures in randomized controlled trials -- 5. Profile versus utility based measures of outcome for clinical trials -- 6. Introduction to decision theory and utilities -- 7. Using decision theory in clinical research: applications of quality-adjusted life-years -- 8. Possibilities for summarizing health-related quality of life when using a profile instrument -- 9. Questionnaire scaling: models and issues -- 10. Assessing reliability and validity of measurement in clinical trials -- 11. Item response theory models -- 12. Factor analysis -- 13. Methods of analysis for longitudinal studies of health-related quality of life -- 14. Analysis of incomplete quality of life data in clinical trials -- 15. Using the Q-TWiST method for treatment comparisons in clinical trials -- 16. Clinical interpretation of health-related quality of life data -- 17. Summarizing quality of life data using graphical methods -- 18. Guidelines for reporting results of quality of life assessments in clinical trials -- Index.