A Practical Approach to Quantitative Validation of Patient-Reported Outcomes

ebook A Simulation-based Guide Using SAS · Statistics in Practice

By Andrew G. Bushmakin

cover image of A Practical Approach to Quantitative Validation of Patient-Reported Outcomes

Sign up to save your library

With an OverDrive account, you can save your favorite libraries for at-a-glance information about availability. Find out more about OverDrive accounts.

   Not today

Find this title in Libby, the library reading app by OverDrive.

Download Libby on the App Store Download Libby on Google Play

Search for a digital library with this title

Title found at these libraries:

Library Name Distance
Loading...

A Simulation-Based Guide Using SAS
In A Practical Approach to Quantitative Validation of Patient-Reported Outcomes, two distinguished researchers, with 50 years of collective research experience and hundreds of publications on patient-centered research, deliver a detailed and comprehensive exposition on the critical steps required for quantitative validation of patient-reported outcomes (PROs). The book provides an incisive and instructional explanation and discussion on major aspects of psychometric validation methodology on PROs, especially relevant for medical applications sponsored by the pharmaceutical industry, where SAS is the primary software, and evaluated in regulatory and other healthcare environments.

Central topics include test-retest reliability, exploratory and confirmatory factor analyses, construct and criterion validity, responsiveness and sensitivity, interpretation of PRO scores and findings, and meaningful within-patient change and clinical important difference. The authors provide step-by-step guidance while walking readers through how to structure data prior to a PRO analysis and demonstrate how to implement analyses with simulated examples grounded in real-life scenarios.

Readers will also find:

  • A thorough introduction to patient-reported outcomes, including their definition, development, and psychometric validation
  • Comprehensive explorations of the validation workflow, including discussions of clinical trials as a data source for validation and the validation workflow for single and multi-item scales
  • In-depth discussions of key concepts related to a validation of a measurement scale
  • Special attention is given to the US Food and Drug Administration (FDA) guidance on development and validation of the PROs, which lay the foundation and inspiration for the analytic methods executed
  • A Practical Approach to Quantitative Validation of Patient-Reported Outcomes is a required reference that will benefit psychometricians, statisticians, biostatisticians, epidemiologists, health service and public health researchers, outcome research scientists, regulators, and payers.

    STATISTICS IN PRACTICE

    A series of practical books outlining the use of statistical techniques in a wide range of applications areas:

  • HUMAN AND BIOLOGICAL SCIENCES
  • EARTH AND ENVIRONMENTAL SCIENCES
  • INDUSTRY, COMMERCE AND FINANCE
  • A Practical Approach to Quantitative Validation of Patient-Reported Outcomes