Quality of Life Assessment has progressed considerably since the publication of the first highly acclaimed edition of this book in 1998. Quality of life has now become an indispensable outcome measure in many randomised clinical trials and other studies. Thus, it is timely to provide not just an update, but a completely new edition that reviews the current state of art and also discusses topical issues including areas where active research is in progress. The first section discusses the development and evaluation of generic and disease-targeted questionnaires. Having decided the items to be included the thrust of the next section covers how to convert these into usable forms. Section 3 addressing analysis and the methods of analysing studies with missing data is followed by chapters on interpretation of results and exploring the role of single-item questions. The final section of the book looks beyond the individual clinical trial and how we can use clinical trial and other data to make macro-decisions. A strong international team of experts cover a wide range of topics, emphasizing new and innovative approaches that are of practical and clinical importance, reviewing the current state of the art and illustrating the benefits and potential of health related quality of life assessment in clinical trials.

Preface 1. Developing and evaluating questionnaires 1.1. Generic versus disease-targeted instruments, Ron Hays 1.2. Developing questionnaires, Elaine McColl 1.3. Reliability and validity, including responsiveness, Ron Hays & Dennis Revicki 1.4. Evaluating multi-item scales, Ron Hays & Peter Fayers 1.5. Rasch models & IRT, Bryce Reeve & Peter Fayers 2. Adapting and using questionnaires 2.1. Translating and evaluating questionnaires - cultural issues, Patrick Marquis 2.2. CAT and item banking, Jakob Bjorner & John Ware 2.3. Developing a questionnaire using IRT - a case study of fatigue, David Cella 2.4. Proxy assessments and context effects, Elaine McColl & Peter Fayers 3. Analysis 3.1. Analysing longitudinal studies of QOL, Diane Fairclough 3.2. Preventing missing data, Dennis Revicki & Diane Fairclough 3.3. Analysing studies with missing data, Diane Fairclough 3.4. Differential item functioning (DIF) for analysing cultural differences, Mogens Groenvold & Morten Petersen 3.5. Reporting analyses from clinical trials, Dennis Revicki 4. Interpreting QoL in individuals and groups 4.1. Individualised QoL, Ciaran O'Boyle, Stefan Hofer & Lena Ring 4.2. Meaningful differences, David Osoba & Madeleine King 4.3. Health-related QoL outcomes in clinical trials, David Osoba 4.4. Response shift, Carolyn Schwartz, Mirjam Sprangers & Peter Fayers 4.5. Individual patient monitoring, Galina Velikova & Penny Wright 5. Measures for clinical trials 5.1. Self-rated health, Jakob Bjorner, Peter Fayers & Ellen Idler 5.2. Generic adult health status measures, Stephen Coons & Jim Shaw 5.3. Measurement of HRQL in child/adolescent clinical trials, Jeanne Landgraf 5.4. Developing disease-targeted measures for neurolgic conditions, Barbara Vickrey 6. Beyond clinical trials 6.1. Values and valuation, Paul Kind 6.2. Preference-based measures, David Feeny 6.3. Discrete choice experiments, Mandy Ryan & Karen Gerard 6.4. Combining clinical trials - meta analysis, Peter Fayers & Neil Scott

`A useful resource for those undertaking or appraising trials. I know of no other books that deal with the subject in such detail, and it contains some gems. In future, when I am taking part in the design or conduct of clinical trials, I will repeatedly return to this book for advice.' Journal of the Royal Society of Medicine