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

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 processes of...

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Detalles Bibliográficos
Autores principales: Majercak, Kayleigh R., Perfetto, Eleanor M., Villalonga-Olives, Ester
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8777546/
https://www.ncbi.nlm.nih.gov/pubmed/35061149
http://dx.doi.org/10.1186/s41687-022-00411-8