A practical approach to quantitative validation of patient-reported outcomes : a simulation-based guide using SAS / Andrew G. Bushmakin and Joseph C. Cappelleri.

Includes bibliographical references and index.

"This book provides a detailed description of the keys steps needed for quantitative validation of patient reported outcomes (PROs). It covers all major aspects of psychometric validation methodology on PROs, including exploratory and confirmatory factor analysis, test-retest reliability, longitudinal analysis, and mediation models. Step-by-step guidance show the reader how to structure the data before PRO analysis, how to implement an analysis in a step-by-step fashion using simulated examples (emanating from published sources), how to delve deeply into concepts by modifying assumptions and parameters and how to prepare a PRO statistical analysis plan and publication. Guidance on the preparation of the Statistical Analysis Plan (SAP) for a quantitative validation of a PRO measure will also be included. In addition, the book will bolster an understanding and learning of quantitative validation methods via practical examples with simulated data and analytic implementations using SAS. The book will be of interest to statisticians and other researchers such as epidemiologists and those involved in outcomes research in the health-care industry, government, and academia"-- Provided by publisher.

About the Author
ANDREW G. BUSHMAKIN earned his M.S. in applied mathematics and physics from the National Research Nuclear University (former Moscow Engineering Physics Institute, Moscow, Russia). He has more than 20 years of experience in mathematical modeling and data analysis. He is a director of biostatistics in the Statistical Research and Data Science Center at Pfizer Inc. He has co-authored numerous articles and presentations on topics ranging from mathematical modeling of neutron physics processes to patient-reported outcomes, as well as several monographs.

JOSEPH C. CAPPELLERI earned his M.S. in statistics from the City University of New York, Ph.D. in psychometrics from Cornell University, and M.P.H. in epidemiology from Harvard University. He is an Executive Director of biostatistics in the Statistical Research and Data Science Center at Pfizer Inc. As an adjunct professor, he has served on the faculties of Brown University, University of Connecticut, and Tufts Medical Center. He has delivered numerous conference presentations and has published extensively on clinical and methodological topics. He is a fellow of the American Statistical Association and recipient of the ISPOR Avedis Donabedian Outcomes Research Lifetime Achievement Award.