A Practical Approach to Quantitative
Validation of Patient-Reported Outcomes
A Simulation-Based Guide Using SAS

Andrew G. Bushmakin and Joseph C. Cappelleri
Statistical Research and Data Science Center
Pfizer Inc.
Contents


1     Introduction 1
1.1    What Is a PRO Measure? 1
1.2    Development of a PRO Measure 4
1.2.1   Concept Identification 4
1.2.1.1  Literature and Instrument Review 5
1.2.1.2  Patient-Centered Input 6
1.2.2   Item Development 9
1.2.3   Cognitive Interviews 11
1.2.4   A ...