Background/Purpose: The LupusPRO, a disease targeted Patient Reported Outcome measure, was developed and validated in US patients with Systemic Lupus Erythematosus (SLE). We aimed to validate English and French versions of the LupusPRO among SLE patients in Canada.

Methods: The English version of the LupusPRO was administered to English-speaking SLE patients in Canada and the French version to French-speaking patients. Patients also completed the MOS SF-36. Physicians assessed disease activity (SELENA-SLEDAI and visual analogue scale) and damage (SLICC-ACR SDI and visual analogue scale). A mail back LupusPRO was completed within 2-3 days of the index visit. Internal consistency reliability (ICR), test-retest reliability (TRT), concurrent validity (corresponding domains of the SF-36) and criterion validity (against disease activity and damage) were tested. Confirmatory factor analysis results were available thus far only for the English version. All reported p values are two tailed.

Results: A total of 222 Canadian SLE patients participated – 123 English speaking and 99 French speaking (table 1). Among the English-speaking patients, the ICR of the LupusPRO domains ranged from 0.60-0.93, while TRT ranged from 0.62-0.95. Concurrent validity with corresponding domains of the SF-36 was present and the LupusPRO domains performed well against disease activity and/or damage measures establishing its criterion validity. Confirmatory factor analysis showed a good fit.

Among the French-speaking patients, the ICR of the LupusPRO domains ranged from 0.81-0.93, except for Lupus Symptoms (0.58), Procreation (0.79) and Coping (0.44) domains. By deleting the item on religiosity/spirituality from the Coping domain, the ICR of this domain improved to 0.64. TRT ranged from 0.72-0.95. Concurrent validity with corresponding domains of the SF-36 was present. Lupus Symptoms domain correlated with disease activity as assessed by the total SLEDAI (r -0.26, p 0.01) and physician completed visual analog scale (r -0.49, p 0.001). Other domains also performed well against disease activity and/or damage.

Conclusion: The English and French versions of the LupusPRO have fair psychometric properties among Canadian patients with SLE, and are now available to be included in clinical trials and in longitudinal studies for testing of responsiveness to change.

Table 1. Description of the study cohort

	English-speaking patients N= 123	French-speaking patients N = 99
Age (Mean, SD) years	47.7 (14.8)	45.2 (14.5)
Female (%)	94	97
Ethnicity (%)   Caucasian   Asian   African-Caribbean   Other	– 60.0 23.0 9.0 8.0	– 73.7 6.1 11.1 9.1
SELENA SLEDAI (Median, IQR) MD-Activity VAS (Median, IQR) SDI (Median, IQR) MD-Damage VAS (Median, IQR)	4.0 (6.0) 0.2 (0.95) 1.0 (3.0) 0.3 (2.8)	3.0 (6.0) 0.2 (1.00) 1.0 (2.0) 0.2 (3.4)

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/cross-cultural-validation-of-english-and-french-versions-of-a-disease-specific-patient-reported-outcome-measure-for-lupus-in-canada/