SESSION TITLE: Pulmonary Hypertension
SESSION TYPE: Original Investigation Slide
PRESENTED ON: Monday, October 24, 2016 at 04:30 PM - 05:30 PM
PURPOSE: The PAH-SYMPACT is a patient reported outcome (PRO) instrument developed based on interviews with PAH patients and following the process outlined in the FDA's PRO guidance. Its psychometric characteristics are being evaluated using data from SYMPHONY - a phase IIIb PAH study with macitentan. After item reduction, the final instrument consists of 11 symptom and 11 impact items across 4 domains (cardiopulmonary symptoms [CP], cardiovascular symptoms [CV], physical impact and cognitive/emotional impacts). The objective of the current analyses was to evaluate the psychometric properties of the PAH-SYMPACT domain scores.