Rush University, Chicago, IL, USA.
Semin Arthritis Rheum. 2012 Aug;42(1):56-65. doi: 10.1016/j.semarthrit.2011.12.005. Epub 2012 Apr 4.
Systemic lupus erythematosus (SLE) can significantly affect both health and non-health-related quality of life (HRQOL and non-HRQOL). However, of the existent published patient-reported outcome (PRO) tools, none were developed from US patients, an ethnically diverse population. Furthermore, these tools do not address men with SLE or assess non-HRQOL issues. Herein, we present the development and validation of the Lupus Patient-Reported Outcome tool (LupusPRO) and discuss its clinical utility and research value compared with other PRO tools currently available for SLE.
Beginning with a conceptual framework, items for LupusPRO were generated using feedback from women and men with SLE. The tool underwent iterations based on patient feedback and clinimetric and psychometric analyses. Validity (content, construct, and criterion) and reliability (internal consistency and test-retest) for the 44-item LupusPRO tool are presented.
Consistent with the conceptual framework, items were identified that were related to HRQOL and non-HRQOL constructs. HRQOL domains included (1) lupus symptoms; (2) physical health (physical function, role physical); (3) pain-vitality; (4) emotional health (emotional function and role emotional); (5) body image; (6) cognition; (7) procreation; and (8) lupus medications. Non-HRQOL domains were (1) available social support and coping; (2) desires-goals; and (3) satisfaction with medical care. Internal consistency reliability (0.68-0.94), test-retest reliability (0.55-0.92), content, construct (r > 0.50 with SF-36), and criterion (r > -0.35 with disease activity) validity were fair to good.
LupusPRO is a valid and reliable disease-targeted patient-reported health outcome tool that is generalizable to SLE patients in the United States of varied ethnic backgrounds and either gender.
系统性红斑狼疮（SLE）会显著影响健康相关和非健康相关的生活质量（HRQOL 和非 HRQOL）。然而，已有的发表的患者报告结局（PRO）工具都不是基于美国患者（一个种族多样化的人群）开发的。此外，这些工具没有涉及到男性 SLE 患者，也没有评估非 HRQOL 问题。在此，我们介绍了狼疮患者报告结局工具（LupusPRO）的开发和验证，并讨论了与目前可用于 SLE 的其他 PRO 工具相比，它的临床实用性和研究价值。
从概念框架开始，使用来自 SLE 女性和男性患者的反馈来生成 LupusPRO 的项目。该工具根据患者反馈以及临床和心理测量学分析进行了迭代。呈现了 44 项 LupusPRO 工具的有效性（内容、结构和标准）和可靠性（内部一致性和重测）。
与概念框架一致，确定了与 HRQOL 和非 HRQOL 结构相关的项目。HRQOL 领域包括：（1）狼疮症状；（2）身体健康（身体功能、角色身体）；（3）疼痛活力；（4）心理健康（情绪功能和角色情绪）；（5）身体形象；（6）认知；（7）生育；和（8）狼疮药物。非 HRQOL 领域包括：（1）可用的社会支持和应对方式；（2）愿望目标；和（3）对医疗保健的满意度。内部一致性可靠性（0.68-0.94）、重测可靠性（0.55-0.92）、内容、结构（与 SF-36 相关 > 0.50）和标准（与疾病活动相关 > -0.35）的有效性是合理的。
LupusPRO 是一种有效且可靠的针对疾病的患者报告健康结局工具，可推广至美国不同种族背景和性别的 SLE 患者。
