Background LupusPRO is a disease targeted patient reported outcome measure that was developed and validated in patients with Systemic Lupus Erythematosus (SLE) in the USA. Its Spanish vesion has also been recently validated.
Objectives We aimed to develop and validate the Turkish version of the LupusPRO.
Methods The Turkish version was prepared by forward and backward translations of the 43 item English LupusPRO (T1) by native Turkish speakers and was pretested in five Turkish individuals living in the USA. The final Turkish version was then offered. Each subject met ACR classification criteria for SLE and resided in Turkey. SF-36 (Turkish) was also administered. Disease activity was assessed using the physician’s global assessment (PGA) and SELENA-SLEDAI, and flare (Yes/No). Disease damage was assessed using the SLICC-ACR SDI. For test-retest reliability (TRT), patients were instructed to re-do the Turkish LupusPRO test within 2-3 days. Internal consistency reliability (ICR), criterion validity (against measures of disease activity or health status) and convergent validity (corresponding domains of the SF36) were also assessed. A ‘p-value’ <0.05 was considered significant. The conceptual framework of the LupusPRO was evaluated using confirmatory factor analysis appropriate for categorical data.
Results 102 SLE subjects (94% women) were enrolled. The mean ±SD age (yrs) and disease duration were 39.0 ±11.7 and 5.0 ±4.6, 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. PGA scores were; 0 for 26%, 1 for 60%, 2 for 11% and, 3 for 5% of the patients. 42 patients were included in the test-retest analysis. Psychometric properties of the Turkish LupusPRO are shown in the table. 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.
Conclusions The Turkish version of the LupusPRO is valid and appears to perform comparably to the English version. It can be used as a patient-reported outcome parameter in clinical trials, as well as longitudinal studies for testing responsiveness to change.
Disclosure of Interest A. Kaya: None Declared, B. Goker: None Declared, E. Cura: None Declared, M. Tezcan: None Declared, A. Tufan: None Declared, R. Mercan: None Declared, B. Bitik: None Declared, S. Haznedaroglu: None Declared, M. Ozturk: None Declared, J. Block: None Declared, R. Mikolaitis-Preuss: None Declared, M. Jolly Grant/research support from: Lupus Foundation of America, MedImmune, Glaxo SmithKline
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