Clinical outcome measures for cutaneous lupus erythematosus

被引:16
作者
Albrecht, J. [1 ]
Werth, V. P. [2 ,3 ]
机构
[1] John H Stroger Jr Hosp Cook Cty, Div Dermatol, Dept Med, Chicago, IL 60612 USA
[2] Philadelphia VA Med Ctr, Philadelphia, PA 19104 USA
[3] Univ Penn, Sch Med, Philadelphia, PA 19104 USA
基金
美国国家卫生研究院;
关键词
cutaneous lupus erythematosus; disease activity; patient outcome assessment; reproducibility of results; skin; validity; QUALITY-OF-LIFE; DISEASE SEVERITY; SURFACE-AREA; INDEX; RELIABILITY; INSTRUMENTS; VALIDATION; VALIDITY; INVOLVEMENT; PSORIASIS;
D O I
10.1177/0961203310370049
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Cutaneous lupus erythematosus (CLE) is a clinically heterogeneous group of rare skin diseases that only rarely have been subjected to controlled clinical trials. This may have been partly due to a lack of suitable validated outcome instruments. Recently, the Food and Drug Administration (FDA) mandated that organ-specific trials for lupus erythematosus need to use a combination of different outcome measures. The patient's condition needs to be assessed in terms of quality of life, the patient's global response, and organ-specific instruments that measure activity of the disease as well as damage due to the disease. For the skin, the only formally validated and published instrument is currently the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI). This paper discusses the background of the development of the CLASI as well as issues related to its use and interpretation in the context of clinical research of CLE. Lupus (2010) 19, 1137-1143.
引用
收藏
页码:1137 / 1143
页数:7
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