Kaya Arif, Goker Berna, Cura Elife Senem, Tezcan Mehmet Engin, Tufan Abdurrahman, Mercan Rıdvan, Bitik Berivan, Haznedaroglu Seminur, Ozturk Mehmet Akif, Mikolaitis-Preuss Rachel A, Block Joel A, Jolly Meenakshi
Department of Internal Medicine, Division of Rheumatology, Gazi University Medical Faculty, Ankara, Turkey,
Clin Rheumatol. 2014 Aug;33(8):1079-84. doi: 10.1007/s10067-013-2345-9. Epub 2013 Aug 11.
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.
LupusPRO是一种针对疾病的患者报告结局指标，它是在美国系统性红斑狼疮（SLE）患者中开发并验证的。我们在此报告LupusPRO土耳其语翻译版本的跨文化适应和验证研究结果。对土耳其狼疮患者进行了土耳其语LupusPRO和医学结局研究简表（SF - 36）（土耳其语版）的评估。使用医生整体评估（PGA）、红斑狼疮雌激素安全性全国评估 - 系统性红斑狼疮疾病活动指数（SELENA - SLEDAI）和病情复发（由美国狼疮基金会定义）来确定疾病活动度。用系统性红斑狼疮国际协作临床中心/美国风湿病学会损伤指数（SDI）评估疾病损伤情况。此外，对患者进行了第二次土耳其语LupusPRO测试，要求他们在2 - 3天内完成并寄回给我们。测试了内部一致性信度、重测信度以及收敛效度和效标效度（相对于疾病活动度或健康状况）。所有报告的p值均为双侧。使用适用于分类数据的验证性因子分析对LupusPRO的概念框架进行了评估。招募了102名SLE受试者（94%为女性）。年龄中位数（四分位间距）和平均病程（±标准差）分别为38.5（18）岁和60.3（±56.3）个月。SLEDAI和SDI的平均±标准差得分分别为3.1±3.7和0.52±0.75。研究时有25名患者出现病情复发。42名健康状况无变化的患者完成并寄回了第二次LupusPRO测试，被纳入重测分析。LupusPRO各领域的重测信度在0.87至0.97之间，而各领域的内部一致性信度在0.63至0.94之间。与SF - 36相应领域存在收敛效度。与疾病活动度测量指标（PGA、总SLEDAI、LFA病情复发和SF - 6D - 总体健康状况）相比，健康相关生活质量领域表现良好，确立了其效标效度。代表假设的项目与量表关系的项目 - 因子负荷令人满意。假设的项目与量表关系的模型拟合也令人满意。LupusPRO的土耳其语版本有效，并且似乎与英语和西班牙语版本表现相当。它可作为临床试验以及测试对变化反应性的纵向研究中的患者报告结局参数。
