Capturing the patient experience in systemic lupus erythematosus: Are widely used measures fit-for-purpose and adherent to FDA PRO guidance recommendations?

Capturing the patient experience in systemic lupus erythematosus: Are widely used measures fit-for-purpose and adherent to FDA PRO guidance recommendations?

Abstract Background The 2009 Food and Drug Administration (FDA) patient-reported outcome (PRO) guidance outlines characteristics of rigorous PRO-measure development. There are a number of widely used PRO measures for Systemic Lupus Erythematosus (SLE), but it is unknown how well the development proc...

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Bibliographic Details
Main Authors: Kayleigh R. Majercak, Eleanor M. Perfetto, Ester Villalonga-Olives
Format: Article
Language:English
Published: SpringerOpen 2022-01-01
Series:Journal of Patient-Reported Outcomes
Subjects:
Patient-reported outcome
Systemic lupus erythematosus
Clinical outcome assessments
FDA PRO guidance
Fit-for-purpose
Patient experience
Online Access:https://doi.org/10.1186/s41687-022-00411-8

Internet

https://doi.org/10.1186/s41687-022-00411-8

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