Abstract
Background
Cutaneous lupus erythematosus (CLE) is a potentially disfiguring, chronic autoimmune disease with extremely variable skin manifestations, negatively affecting quality of life (QoL) of patients. Patient‐reported outcome (PRO) measures used in assessing QoL in CLE patients have been either generic or developed without input from patients with CLE.
Objectives
To demonstrate the reliability and validity of a disease‐specific QoL measure for CLE – the cutaneous lupus erythematosus quality of life (CLEQoL).
Methods
A total of 101 patients with a clinical diagnosis of CLE were recruited, and each patient was asked to complete the CLEQoL. Internal consistency was used as a measure of reliability. Validity was measured in two ways – structural validity via exploratory factor analysis and convergent validity via Spearman correlations between CLEQoL and the Short Form 36 (SF‐36). Patient demographic and disease characteristics were collected. Data was analyzed using SPSS and significance was set to p<0·05.
Results
The average age of our CLE patients was 48±13 with discoid lupus (n=72, 71·3%) being the most predominant CLE subtype. Patients were mostly female (n=88, 87·1%) and African‐American/Black (n=59, 58·4%). Internal consistency ranged from 0·67 to 0·97. A total of five domains, functioning, emotions, symptoms, body image/cosmetic effects and photosensitivity, were extracted with a total explained variance of 71·06%. CLEQoL‐related domains correlated with SF‐36 domains (r ranging from ‐0·39 to ‐0·65).
Conclusion
The CLEQoL was found to be a valid and reliable PRO measure for assessing QoL in patients with CLE. Demonstrating that the CLEQoL has strong psychometric properties is an important step towards the development of a disease‐specific PRO measure that future clinical trials can use.
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