Validation of the Functional Assessment of Chronic Illness Therapy-Fatigue Scale in Patients with Moderately to Severely Active Systemic Lupus Erythematosus, Participating in a Clinical Trial

Validation of the Functional Assessment of Chronic Illness Therapy-Fatigue Scale in Patients with Moderately to Severely Active Systemic Lupus Erythematosus, Participating in a Clinical Trial
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DOI:
10.3899/jrheum.100799
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发表时间:
2011-04-01
影响因子:
3.9
通讯作者:
Cella, David
Cella, David
中科院分区:
医学2区
文献类型:
--
作者:
Lai, Jin-Shei;Beaumont, Jennifer L.;Cella, David

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目标。疲劳是系统性红斑狼疮(SLE)的常见症状。我们的目的是验证13个项目的慢性病治疗功能评估(FAIT)-疲劳量表在系统性红斑狼疮患者。在基线、12周、24周和52周,中度到重度活动期的肾外系统性红斑狼疮患者完成面部疲劳、医疗结果研究简表36(SF-36)问卷、简明疼痛问卷(BPI)和患者全球评估视觉模拟量表(Patient-GA)。这些患者正在参加一项利妥昔单抗临床试验。由医生在相同的访问中完成不列颠群岛狼疮评估小组(BILAG)疾病活动性指数和医生全球评估视觉模拟量表(MESTER-GA)。基线时,有254名患者完成了面部疲劳量表。克朗巴赫的阿尔法在所有的访问中都是0.95。在横断面分析中,面部疲劳分数在BILAG总域评级定义的组之间存在差异。面部疲劳与SF-36、BPI、Patient-GA呈中高相关(r=0.5-0.8),与BILAG总分、医生-GA相关较差(r=0.1-0.3)。在12周、24周和52周,面部疲劳量表的平均改善程度在改善的患者中高于那些在BILAG一般领域保持不变的患者。与基线相比,面部疲劳量表评分在BILAG总域评分恶化的患者中保持稳定。分布和基于锚的估计表明最小重要性差异(MID)范围为3-6个点。面部疲劳量表是衡量系统性红斑狼疮患者疲劳感的有效工具。此SLE样本中的MID与之前在其他人群中衍生的MID相似。由于在这项研究中很少有患者经历了BILAG全身和肌肉骨骼领域的恶化,有必要进行进一步的研究来评估面部疲劳对这些领域恶化的反应性。(2011年1月15日首次发布;J Rheumatol 2011年;38:672-9;DOI:10.3899/jrangum.100799)
Objective. Fatigue is a common symptom of systemic lupus erythematosus (SLE). Our objective was to validate the 13-item Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale in patients with SLE.Methods. The FACIT-Fatigue, Medical Outcomes Study Short-Form-36 (SF-36) questionnaire, Brief Pain Inventory (BPI), and Patient Global Assessment Visual Analog Scale (Patient-GA) were completed at baseline and at Weeks 12, 24, and 52 by patients with moderately to severely active extrarenal SLE. The patients were participating in a rituximab clinical trial. The British Isles Lupus Assessment Group (BILAG) disease activity index and the Physician Global Assessment Visual Analog Scale (Physician-GA) were completed by physicians at the same visits.Results. At baseline, 254 patients completed the FACIT-Fatigue scale. Cronbach's alpha was > 0.95 at all visits. In cross-sectional analyses, FACIT-Fatigue scores differentiated between groups defined by BILAG General domain ratings. FACIT-Fatigue had moderate-high correlations (r = 0.5-0.8) with SF-36, BPI, and Patient-GA, but poor correlations with BILAG total score and Physician-GA (r = 0.1-0.3). At Weeks 12, 24, and 52, mean FACIT-Fatigue scale improvement was higher in patients who improved versus those who remained unchanged on the BILAG General domain. FACIT-Fatigue scale scores remained stable for patients with worsened BILAG General domain ratings compared to baseline. Distribution and anchor-based estimates suggested a minimally important difference (MID) range of 3-6 points.Conclusion. The FACIT-Fatigue scale is a valid and responsive measure of fatigue in patients with SLE. MID in this SLE sample is similar to that derived previously in other populations. Since few patients experienced worsening BILAG General and Musculoskeletal domains in this study, further research is warranted to evaluate the responsiveness of FACIT-Fatigue to worsening of these domains. (First Release Jan 15 2011; J Rheumatol 2011;38:672-9; doi:10.3899/jrheum.100799)