Multicenter validation of a new quality of life measure in pediatric lupus.
OBJECTIVE
Pediatric systemic lupus erythematosus (SLE) is a chronic fluctuating disease that significantly impacts quality of life (QOL). There is no pediatric SLE-specific health-related QOL (HRQOL) scale. Our objective was to develop and validate a new pediatric SLE-specific HRQOL scale.


METHODS
We developed the Simple Measure of the Impact of Lupus Erythematosus in Youngsters (SMILEY) based on results of qualitative research of children with SLE and their parents. SMILEY has parallel child and parent reports with a 5-faces scale for responses. SMILEY comprises 4 domains: effect on self, limitations, social, and burden of SLE. In this cross-sectional study, we examined face, content, construct, and concurrent validity; internal consistency; test-retest reliability; and child-parent agreement for SMILEY. Children </=18 years of age with SLE and their parents completed corresponding child and parent SMILEY reports, as well as other QOL and physical function scales. Qualified physicians assessed SLE activity, damage, and severity.


RESULTS
Eighty-six children with SLE and 80 parents participated. SMILEY was found to have face, content, construct, and concurrent validity (Spearman's rank correlation [r(s)] >/=0.4); test-retest reliability (intraclass correlation coefficient [ICC] 0.9); and internal consistency (alpha = 0.9). Moderate agreement was found between child and parent SMILEY reports (ICC 0.7, r(s) = 0.5, P < 0.001).


CONCLUSIONS
SMILEY is a brief, easily understood, valid, and reliable pediatric SLE-specific QOL scale. Because SMILEY assesses children's self-perception of QOL as impacted by SLE, we predict that it will have great utility in clinical practice, clinical trials, and outcomes research.
Moorthy
L Nandini
LN
Robert Wood Johnson Medical School, University of Medicine and Dentistry of New Jersey, New Brunswick, NJ 08901, USA. lnmoorthy@mac.com
Peterson
Margaret G E
MG
Baratelli
Maria
M
Harrison
Melanie J
MJ
Onel
Karen B
KB
Chalom
Elizabeth C
EC
Haines
Kathleen
K
Hashkes
Philip J
PJ
Lehman
Thomas J A
TJ
D000293:Adolescent; D002648:Child; D005260:Female; D006305:Health Status Indicators; D006801:Humans; D008180:Lupus Erythematosus, Systemic; D008297:Male; D017063:Outcome Assessment, Health Care; D011594:Psychometrics; D036301:Qualitative Research; D011788:Quality of Life