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Activity Number: 212633
Type: Professional Development
Date/Time: Monday, August 1, 2016 : 1:00 PM to 5:00 PM
Sponsor: Biometrics Section
Abstract #321884
Title: Patient-Reported Outcomes: Measurement, Implementation, and Interpretation (ADDED FEE)
Author(s): Joseph Cappelleri* and Andrew Bushmakin*
Companies: Pfizer

Patient-reported outcomes are often relevant in studying a variety of diseases and outcomes that cannot be assessed adequately without a patient's evaluation and whose key questions require a patient's input on the impact of a disease or treatment. To be useful to patients, researchers, and decision makers, a patient-reported outcome (PRO) must undergo a validation process to support that it measures what it is intended to measure accurately and reliably. Some key elements in the development of a PRO measure will be covered in this course. The core topics of validity and reliability of a PRO measure will be discussed. Exploratory and confirmatory factor analyses-techniques to understand the underlying structure of a PRO measure-will be described. The topic of mediation modeling will be presented as a way to identify and explain the mechanism that underlies an observed relationship between an independent variable and a dependent variable via the inclusion of a third variable called the mediator variable. Also discussed will be longitudinal analysis and item response theory. Approaches to interpret PRO results will be elucidated to make results useful and meaningful. Illustrations will be provided mainly through real-life examples and simulated examples. No prerequisites.

Authors who are presenting talks have a * after their name.

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