Assessing Quality of Life in Clinical Trials: Methods and Practice

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Oxford University Press, 2005 - Medical - 467 pages
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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 discussesthe 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.
 

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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
Index
461
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About the author (2005)

Peter Fayers is at Department of Public Health, Aberdeen Medical School, Aberdeen, UK. Ron Hays is at UCLA School of Medicine, Division of GIM and Health Services Research, UCLA, Los Angeles, USA.

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