1. Validation and Reliability of a Disease-Specific Quality of Life Measure in Patients with Cutaneous Lupus Erythematosus: CLEQoL
M.E. Ogunsanya,1 S.K. Cho,2 A. Hudson,2 B.F. Chong2
1College of Pharmacy, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA 2Department of Dermatology, University of Texas Southwestern Medical Center, Dallas, Texas, USA
British Journal of Dermatology. DOI: /bjd.17636

2. Lead researcher
Motolani Ogunsanya, B.Pharm, PhD

3. Introduction What’s already known?
Cutaneous Lupus Erythematosus (CLE) negatively affects the quality of life (QoL) of patients.
Assessing QoL in patients with CLE has mostly entailed instruments that were not derived specifically for use in patients with CLE.

4. Objective
To demonstrate the reliability and validity of a disease-specific QoL measure for CLE – cutaneous lupus erythematosus quality of life (CLEQoL).

5. Methods
101 patients with CLE were recruited from the University of Texas (UT) Southwestern Medical Center and Parkland Health and Hospital Systems dermatology clinics in Dallas, Texas, USA.
Each patient was asked to complete the CLEQoL and the Short Form 36 (SF-36).
Patient demographics, Cutaneous Lupus Activity and Severity Index (CLASI) scores, and Visual Analog Scales (VAS) scores assessing pain, fatigue, and pruritus/itch were also collected.

6. Methods
Cronbach’s alpha (α) was used to assess the internal consistency of the CLEQoL as a measure of reliability.
Structural validity was measured via exploratory factor analysis and convergent validity was measured via Spearman correlations (r) between the CLEQoL and the SF-36.
Data was analyzed using SPSS version 24 and significance was set to p<0.05.

7. Results
Patients were mostly female (n=88, 87.1%) and African- American/Black (n=59, 58.4%).
Discoid lupus was the most predominant CLE subtype (n=72, 71.3%).
Patients had an average age of 48±13 years, and an average disease duration of 10±11 years.

8. Results
Cronbach’s alpha coefficients, measuring internal consistency, ranged from 0.67 to 0.97, with an overall scale coefficient of 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%.
The CLEQoL domains were confirmed using the corresponding domains of the SF-36, VAS scales, and the CLASI.

9. Results
A significant correlation was detected between the CLEQoL and SF-36 domains (r ranging from to -0.65, p<0.001).
CLASI activity correlated positively with the functioning (r=0.24 p <0.05), emotions (r=0.26, p <0.05), and symptoms (r=0.32 p <0.05) domains.
CLASI damage correlated positively with the body image/cosmetic effects (r=0.41 p <0.001) and photosensitivity (r=0.25, p <0.05).
The three VAS measurements all correlated positively with the five CLEQoL domains (r ranging from , p<0.001).

10. Discussion
Before now, patient reported outcome (PRO) measures used to assess QoL in CLE were either generic or did not capture CLE specific measures such as body image and photosensitivity.
The creation of a CLE-specific PRO measure fills a critical gap in the literature.

11. Discussion
All CLEQoL domains had good internal consistency, demonstrating a reliability similar to that seen from the Skindex.
The cumulative variance of 71.06% between the five domains displayed the CLEQoL’s exceptional structural validity, as a scale should explain at least 50% of the total variance.
The CLEQoL demonstrated acceptable convergent validity when compared to the SF-36.

12. Conclusions What does this study add?
The CLEQoL demonstrated sufficient reliability, structural and convergent validity in assessing QoL in CLE patients.

13. The Research Team Motolani Ogunsanya B.Pharm., PhD Benjamin Chong
MD, MSCS
Andrew Hudson
Medical Student
Sung Kyung Cho
Medical Student