Generation of evidence supporting the content validity of SF-36, FACIT-F, and LupusQoL, and novel patient-reported symptom items for use in patients with systemic lupus erythematosus (SLE) and SLE with lupus nephritis (LN).

Rebecca Williams-HallPamela BerryNicola WilliamsonMelissa BarclayAnna RobertsAdam GaterChloe TolleyHelena BradleyAmy WardElizabeth HsiaQing ZurawPatricia DeLongZahi Touma Vibeke Strand

Published in: Lupus science & medicine (2022)

Findings provide evidence of content validity for concepts assessed by the SF-36, FACIT-F, LupusQoL and the novel PRO symptom severity items, supporting use of these PROs to comprehensively assess disease impact in future SLE and LN clinical trials.

Keyphrases

patient reported
systemic lupus erythematosus
disease activity
clinical trial
rheumatoid arthritis
current status
study protocol
double blind
phase iii