Moorthy L Nandini, Peterson Margaret G E, Baratelli Maria, Harrison Melanie J, Onel Karen B, Chalom Elizabeth C, Haines Kathleen, Hashkes Philip J, Lehman Thomas J A
Robert Wood Johnson Medical School, University of Medicine and Dentistry of New Jersey, New Brunswick, NJ 08901, USA.
Arthritis Rheum. 2007 Oct 15;57(7):1165-73. doi: 10.1002/art.22988.
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.
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.
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).
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.
儿童系统性红斑狼疮（SLE）是一种慢性波动性疾病，对生活质量（QOL）有显著影响。目前尚无专门针对儿童SLE的健康相关生活质量（HRQOL）量表。我们的目的是开发并验证一种新的专门针对儿童SLE的HRQOL量表。
我们基于对SLE患儿及其父母的定性研究结果，开发了青少年狼疮影响简易测量量表（SMILEY）。SMILEY有儿童和父母的平行报告，采用5级评分量表作答。SMILEY包括4个领域：对自身的影响、限制、社交以及SLE的负担。在这项横断面研究中，我们检验了SMILEY的表面效度、内容效度、结构效度和同时效度；内部一致性；重测信度；以及儿童与父母报告的一致性。18岁及以下的SLE患儿及其父母完成了相应的儿童和父母SMILEY报告，以及其他QOL和身体功能量表。合格的医生评估了SLE的活动度、损伤程度和严重程度。
86名SLE患儿和80名父母参与了研究。发现SMILEY具有表面效度、内容效度、结构效度和同时效度（斯皮尔曼等级相关系数[r(s)]≥0.4）；重测信度（组内相关系数[ICC]为0.9）；以及内部一致性（α=0.9）。儿童与父母的SMILEY报告之间存在中度一致性（ICC为0.7，r(s)=0.5，P<0.001）。
SMILEY是一种简短、易于理解、有效且可靠的专门针对儿童SLE的QOL量表。由于SMILEY评估了儿童对受SLE影响的QOL的自我认知，我们预计它在临床实践、临床试验和结局研究中具有很大的实用价值。
