Joseph C. Cappelleri, Kelly H. Zou, Andrew G. Bushmakin, Jose Ma. J. Alvir, Demissie Alemayehu, Tara Symonds
Chapman and Hall/CRC – ISBN 9781439873670 – December 2013


  • Describes how to develop, measure, implement, and interpret PRO measures
  • Covers key aspects of PRO methodology, including exploratory and confirmatory factor analysis, item response theory, cross-sectional analysis, longitudinal analysis, and mediation models
  • Highlights recent advances in the assessment of instrument development, reliability, validity, missing data, and multiple testing
  • Explains how to enhance the interpretation of scores from PRO measures
  • Illustrates concepts with real-world applications
  • Enriches the learning experience by providing practical examples with simulated data and analytic implementations using SAS
  • Includes numerous timely references


Advancing the development, validation, and use of patient-reported outcome (PRO) measures, Patient-Reported Outcomes: Measurement, Implementation and Interpretation helps readers develop and enrich their understanding of PRO methodology, particularly from a quantitative perspective. Designed for biopharmaceutical researchers and others in the health sciences community, it provides an up- to-date volume on conceptual and analytical issues of PRO measures.
The book discusses key concepts relating to the measurement, implementation, and interpretation of PRO measures. It covers both introductory and advanced psychometric and biostatistical methods for constructing and analyzing PRO measures. The authors include many relevant real-life applications based on their extensive first-hand experiences in the pharmaceutical industry. They implement a wealth of simulated datasets to illustrate concepts and heighten understanding based on practical scenarios. For readers interested in conducting statistical analyses of PRO measures and delving more deeply into the analytic details, most chapters contain SAS code and output that illustrate the methodology. Along with providing numerous references, the book highlights current regulatory guidelines.