Development of the alopecia areata patient priority outcomes instrument, a new patient reported outcome measure

Objectives: Alopecia areata (AA) is an autoimmune T-cell mediated disease characterized by nonscarring hair loss. Beyond the primary symptom of hair loss, it results in serious functional and psychosocial impacts. Although there are existing patient-reported outcome (PRO) instruments for use in this population, none of them is fit for purpose, according to FDA PRO Guidance, in the context of use (COU) in a clinical trial program to support claims of treatment benefit. The aim of this research was to better understand patient treatment priorities for AA and guide selection of relevant measurement concepts for a fit for purpose PRO measure.
Source: Journal of the American Academy of Dermatology - Category: Dermatology Source Type: research