Assessing Quality of Life in Clinical Trials: Methods and PracticePeter M. Fayers, Ron D. Hays Oxford University Press, 2005 - 467 pages "Quality of life assessment has progressed considerably since the publication of the highly acclaimed first edition of this book in 1998. Quality of life has now became an indispensable outcome measure in many randomized 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 the 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 helped the reader to decide on the items to be included, the thrust of the next section shows how to convert these into usable forms. Section 3, addressing analysis and how to analyse studies with missing data, is followed by chapters on interpretation of results, and the role of single-item questions. The final section of the book goes beyond the individual clinical trial and looks at how we can use clinical trial and other data to make macro-decisions." (Back cover). |
Contents
Generic versus diseasetargeted instruments | 3 |
Developing questionnaires | 9 |
Reliability and validity including responsiveness | 25 |
Evaluating multiitem scales | 41 |
Applying item response theory modelling for evaluating questionnaire item and scale properties | 55 |
Adapting and using questionnaires | 75 |
Translating and evaluating questionnaires cultural issues for international research | 77 |
Computerized adaptive testing and item banking | 95 |
Individualized quality of life | 225 |
Meaningful differences | 243 |
Healthrelated quality of life outcomes in clinical trials | 259 |
Response shift you know its there but how do you capture it? Challenges for the next phase of research | 275 |
Individual patient monitoring | 291 |
Measures for clinical trials | 307 |
Selfrated health | 309 |
Generic adult health status measures | 325 |
Developing a questionnaire using item response theory a case study of fatigue | 113 |
Context effects and proxy assessments | 131 |
Analysis | 147 |
Analysing longitudinal studies of QoL | 149 |
Preventing missing data | 167 |
Analysing studies with missing data | 179 |
The role and use of differential item functioning DIF analysis of quality of life data from clinical trials | 195 |
Reporting analyses from clinical trials | 209 |
Interpreting QoL in individuals and groups | 223 |
Practical considerations in the measurement of HRQoL in childadolescent clinical trials | 339 |
Developing diseasetargeted HRQoL measures for neurologic conditions | 369 |
Beyond clinical trials | 389 |
Values and valuation in the measurement of HRQoL | 391 |
Preferencebased measures utility and qualityadjusted life years | 405 |
Discrete choice experiments | 431 |
Combining clinical trials metaanalyses | 447 |
461 | |
Common terms and phrases
approach attributes baseline breast cancer cancer patients Cella cent Chapter chemotherapy clinical trials cognitive comparisons concepts construct validity correlation DIF analysis differential item functioning disease domains effect effect size end points EORTC estimates evaluation example factor analysis Fairclough fatigue Fayers Feeny Guyatt Hays Health Economics health-related quality HRQOL assessment HRQOL data HRQOL instruments HRQOL measures HRQoL scores HUI2 HUI3 impact important included individual interpretation intervention interviews IRT models item bank item response theory Journal of Clinical longitudinal Medical mental health meta-analysis methods missing data multi-item scales multiple Oncology Osoba outcomes p-values pain parameters Pharmacoeconomics physical functioning population preference-based measures preferences problems prostate cancer proxy Psychological psychometric questionnaire questions randomized Rasch models ratings relevant reliability reported response categories response shift sample self-rated health significant social standard standard gamble statistical symptoms target therapy tion Torrance translation variables Ware well-being