University of Santo Tomas Hospital, Manila, Philippines.
Lupus. 2013 Mar;22(3):262-7. doi: 10.1177/0961203312474086. Epub 2013 Jan 22.
LupusPRO is a disease-targeted patient-reported outcome measure that was developed and validated among US patients with systemic lupus erythematosus (SLE). We report the cross-cultural validation results of the LupusPRO English-language version among Filipino SLE patients.
The 43-item LupusPRO was pretested in 15 SLE individuals, then administered to 106 SLE patients, along with short-form SF36 and the EQ5D visual analogue scale. A mail/drop-back LupusPRO and change in health status item survey were returned within two to three days. Demographics, clinical and serological characteristics, disease activity and damage measured by PGA, SELENA-SLEDAI, LFA Flare, and SLICC-ACR SLE damage index (SDI) were collected. Internal consistency reliability (ICR), test-retest reliability (TRT), convergent validity (corresponding SF36 domains) and criterion validity (against general health and disease activity measures) were tested. Reported p values are two tailed.
A total of 121 Filipino SLE subjects (95% women, median age 31.0 ± 16 years) with at least a high school level of English instruction participated. Median (IQR) PGA, SLEDAI and SDI were 0.0 (1.0), 2.0 (10) and 0 (1), respectively. ICR exceeded 0.7 for all domains except the lupus symptoms domain. TRT was greater than 0.85 for all LupusPRO domains. Convergent and criterion validity were observed against corresponding SF36 domains and disease activity measures. The tool was well received by patients. Confirmatory factor analysis showed good fit.
English LupusPRO has fair psychometric properties among SLE patients in the Philippines, and is now available for inclusion in clinical trials and longitudinal studies to test responsiveness to change.
LupusPRO 是一种针对疾病的患者报告结局测量工具，在美国系统性红斑狼疮 (SLE) 患者中进行了开发和验证。我们报告了 LupusPRO 英文版本在菲律宾 SLE 患者中的跨文化验证结果。
对 15 名 SLE 患者进行了 43 项 LupusPRO 的预测试，然后向 106 名 SLE 患者发放了 LupusPRO 量表，同时还发放了简短版 SF36 和 EQ5D 视觉模拟量表。在两到三天内，患者通过邮件/回邮的方式返回 LupusPRO 和健康状况变化项目的调查。收集了人口统计学、临床和血清学特征、PGA、SELENA-SLEDAI、LFA Flare 和 SLICC-ACR SLE 损伤指数 (SDI) 测量的疾病活动度和损伤。测试了内部一致性可靠性 (ICR)、重测信度 (TRT)、收敛有效性 (与相应的 SF36 领域相对应) 和标准有效性 (与一般健康和疾病活动度测量相对应)。报告的 p 值为双尾。
共有 121 名菲律宾 SLE 患者（95%为女性，中位年龄 31.0±16 岁）参与了至少具有高中英语教学水平的研究。PGA、SLEDAI 和 SDI 的中位数（IQR）分别为 0.0（1.0）、2.0（10）和 0（1）。除狼疮症状领域外，所有领域的 ICR 均超过 0.7。所有 LupusPRO 领域的 TRT 均大于 0.85。与相应的 SF36 领域和疾病活动度测量相对应，观察到了收敛有效性和标准有效性。该工具受到了患者的好评。验证性因子分析显示拟合良好。
在菲律宾的 SLE 患者中，英文 LupusPRO 具有良好的心理测量学特性，现在可用于纳入临床试验和纵向研究，以测试对变化的反应能力。
