Turkish lupusPRO: cross-cultural validation study for lupus

Abstract

LupusPRO is a disease-targeted patient-reported outcome measure that was developed and validated from and among US patients with systemic lupus erythematosus (SLE). We herein report the results of the cross-cultural adaptation and validation study of the Turkish translated version of the LupusPRO. Turkish LupusPRO and the Medical Outcomes Study Short Form (SF-36) (Turkish) were administered to the Turkish lupus patients. Disease activity was ascertained using the physician global assessment (PGA), Safety of Estrogens in Lupus Erythematosus National Assessment-Systemic Lupus Erythematosus Disease Activity Index (SELENA-SLEDAI), and flare (defined by LFA-Lupus Foundation of America). Disease damage was assessed with Systemic Lupus International Collaborating Clinics/American College of Rheumatology damage index (SDI). Also, second Turkish LupusPRO tests were given to the patients to be completed within 2-3 days and sent back to us. Internal consistency reliability, test-retest reliability, and convergent and criterion validity (against disease activity or health status) were tested. All reported p values are two-tailed. The conceptual framework of the LupusPRO was evaluated using confirmatory factor analysis appropriate for categorical data. One hundred two SLE subjects (94 % women) were enrolled. The median (IQR) age and mean disease duration (±SD) were 38.5 (18) years and 60.3 (±56.3) months, respectively. The mean ± SD, SLEDAI, and SDI scores were 3.1 ± 3.7 and 0.52 ± 0.75, respectively. There were 25 patients who had flares at the time of study. Forty-two patients with no change in their health status completed and sent back the second LupusPRO test and were included in the test-retest analysis. Test-retest reliability of LupusPRO domains ranged from 0.87 to 0.97, while internal consistency reliability of the domains ranged from 0.63 to 0.94. Convergent validity with corresponding domains of SF-36 was present. Health-related quality-of-life domains performed well against disease activity measures (PGA, total SLEDAI, LFA flare, and SF-6D-overall health status), establishing its criterion validity. Item-to-factor loadings representing the hypothesized item-to-scale relationships were satisfactory. The model fit for the hypothesized item-to-scale relationships was also satisfactory. The Turkish version of the LupusPRO is valid and appears to perform comparably to the English and Spanish language versions. It can be used as a patient-reported outcome parameter in clinical trials, as well as longitudinal studies for testing responsiveness to change.

Validation of the LupusPRO in Chinese Patients From Hong Kong With Systemic Lupus Erythematosus

“…Of the currently available disease‐targeted PRO tools for SLE (), LupusPRO is the only PRO tool that allows a comprehensive evaluation of both the aspects. The tool has been found to have fair psychometric properties (including measurement equivalence) in different languages and countries () and is responsive to changes in disease activity ().…”

“…Unlike other lupus‐specific questionnaires, such as the UK LupusQoL (), it consists of both 8 health‐related and 4 non–health‐related domains to enable an understanding of the broader burden of the disease. The LupusPRO has been cross culturally adapted and validated in various countries (Canada, Philippines) and different languages, such as Turkish, Spanish, French, and Filipino (). However, it has not been validated in Chinese.…”

Sex Differences in Quality of Life in Patients With Systemic Lupus Erythematosus

“…QoL was measured using the LupusPRO tool , which has been validated in several languages and shows measurement equivalence . The LupusPRO tool has response options on a 1–5 point Likert scale, where 0 = none of the time, 1 = a little of the time, 2 = some of the time, 3 = most of the time, 4 = all of the time, 5 = not applicable (recoded as 0 for scoring).…”

Patient-Reported Outcomes in Systemic Lupus Erythematosus

“…The developers also sought to include issues pertinent to male SLE patients and assess non-HRQOL domains. Cross-cultural validations of the English version of LupusPRO has been established in Canada [76] and the Philippines [77], and the validity of translations into French-Canadian [78], Spanish [79], Turkish [80], and Chinese [81] have also been reported. The 43-item questionnaire includes eight HRQOL domains such as lupus symptoms, physical health, and body image, as well as four non-HRQOL domains including desires/goals and satisfaction with care.…”