An essential, up-to-date guide to the design of studies and selection of the correct QoL instruments for observational studies and clinical trials.

Quality of Life (QoL) outcomes or Person/Patient Reported Outcome Measures (PROMs) are now frequently being used in randomised controlled trials (RCTs) and observational studies. This book provides a practical guide to the design, analysis and interpretation of studies that use such outcomes.

QoL outcomes tend to generate data with discrete, bounded and skewed distributions. Many investigators are concerned about the appropriateness of using standard statistical methods to analyse QoL data and want guidance on what methods to use. QoL outcomes are frequently used in cross-sectional surveys and non-randomised health-care evaluations.

• Provides a user-friendly guide to the design and analysis of clinical trials and observational studies in relation to QoL outcomes.
• Discusses the problems caused by QoL outcomes and presents intervention options to help tackle them.
• Guides the reader step-by-step through the selection of appropriate QoLs.

• Features exercises and solutions and a supporting website providing downloadable data files.

Illustrated throughout with examples and case studies drawn from the author’s experience, this book offers statisticians and clinicians guidance on choosing between the numerous available QoL instruments.

Stephen J. Walters – School of Health and Related Research, University of Sheffield. Dr Walters has had experience both in research and teaching, and is currently the Senior Lecturer in Medical Statistics at Sheffield University. He has conducted numerous grant-funded research projects, and has nearly 150 publications to his name. These include 85 articles in a range of refereed journals, 2 co-authored books, and contributed chapters in three other books.