Assessing Quality of Life in Clinical Trials Methods and Practice

by Fayers, Peter; Hays, Ron

• ISBN13: 9780198527695
• ISBN10: 0198527691
• Edition: 2nd
• Format: Hardcover
• Copyright: 2005-04-28
• Publisher: Oxford University Press

Summary

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 justan 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 withmissing 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 clinicaltrials.

Table of Contents

Contributors	xi
Developing and evaluating questionnaires
Generic versus disease-targeted instruments	3	(6)
Ron Hays
Developing questionnaires	9	(16)
Elaine McColl
Reliability and validity (including responsiveness)	25	(16)
Ron Hays
Dennis Revicki
Evaluating multi-item scales	41	(14)
Ron Hays
Peter Fayers
Applying item response theory modelling for evaluating questionnaire item and scale properties	55	(22)
Bryce Reeve
Peter Fayers
Adapting and using questionnaires
Translating and evaluating questionnaires: cultural issues for international research	77	(18)
Patrick Marquis
Dorothy Keininger
Catherine Acquadro
Christine de la Loge
Computerized adaptive testing and item banking	95	(18)
Jakob Bjorner
Mark Kosinski
John Ware
Developing a questionnaire using item response theory: a case study of fatigue	113	(18)
David Cella
Jin-Shei Lai
Kim Davis
Kelly Dineen
Stacie Hudgens
Richard Gershon
Context effects and proxy assessments	131	(18)
Elaine McColl
Peter Fayers
Analysis
Analysing longitudinal studies of QoL	149	(18)
Diane Fairclough
Preventing missing data	167	(12)
Dennis Revicki
Diane Fairclough
Analysing studies with missing data	179	(16)
Diane Fairclough
The role and use of differential item functioning (DIF) analysis of quality of life data from clinical trials	195	(14)
Mogens Groenvold
Morten Petersen
Reporting analyses from clinical trials	209	(16)
Dennis Revicki
Interpreting QoL in individuals and groups
Individualized quality of life	225	(18)
Ciaran O'Boyle
Stefan Hofer
Lena Ring
Meaningful differences	243	(16)
David Osoba
Madeleine King
Health-related quality of life outcomes in clinical trials	259	(16)
David Osoba
Response shift: you know it's there but how do you capture it? Challenges for the next phase of research	275	(16)
Carolyn Schwartz
Mirjam Sprangers
Peter Fayers
Individual patient monitoring	291	(18)
Galina Velikova
Penny Wright
Measures for clinical trials
Self-rated health	309	(16)
Jakob Bjorner
Peter Fayers
Ellen Idler
Generic adult health status measures	325	(14)
Stephen Coons
James Shaw
Practical considerations in the measurement of HRQoL in child/adolescent clinical trials	339	(30)
Jeanne Landgraf
Developing disease-targeted HRQoL measures for neurologic conditions	369	(22)
Barbara Vickrey
Beyond clinical trials
Values and valuation in the measurement of HRQoL	391	(14)
Paul Kind
Preference-based measures: utility and quality-adjusted life years	405	(26)
David Feeny
Discrete choice experiments	431	(16)
Mandy Ryan
Karen Gerard
Combining clinical trials: meta-analyses	447	(14)
Peter Fayers
Neil Scott
Index	461