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
