Goligher Ewan C, Pouchot Jacques, Brant Rollin, Kherani Raheem B, Aviña-Zubieta J Antonio, Lacaille Diane, Lehman Allen J, Ensworth Stephanie, Kopec Jacek, Esdaile John M, Liang Matthew H
Division of Rheumatology, Immunology, and Allergy, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, USA.
J Rheumatol. 2008 Apr;35(4):635-42. Epub 2008 Mar 1.
To determine the minimal clinically important difference (MCID) for 7 measures of fatigue in patients with systemic lupus erythematosus (SLE).
Study subjects completed 7 fatigue instruments [Fatigue Severity Scale (FSS), Multidimensional Assessment of Fatigue (MAF), Multidimensional Fatigue Inventory (MFI), Vitality scale of the MOS-SF-36, Chalder Fatigue Scale (CFS), Functional Assessment of Chronic Illness Therapy-Fatigue, and a global Rating Scale (RS)] and then participated in a series of interviews with other study participants comparing their fatigue with one another. Each interview participant rated the difference in their fatigue levels on a 7-point transition scale. The MCID was estimated from the mean difference in fatigue scores between each pair of interview participants based on their subjective rating of fatigue contrast. The MCID was also estimated using linear regression modeling.
Eighty patients with SLE participated. Patients reported significant levels of fatigue [mean normalized (0 = none, 100 = maximum) fatigue scores for the 7 instruments ranged from 49.8 (CFS) to 71.1 (FSS)]. The MCID of "a little more" fatigue tended to be greater than the MCID for a "little less fatigue" and differed significantly for FSS and MAF. The MCID of normalized scores estimated by linear regression ranged from 7.0 (CFS) to 14.3 (MFI).
Fatigue is a common and debilitating component of SLE. Estimates of MCID will help to interpret changes observed in a fatigue score and will be critical in estimating sample size requirements for clinical trials including fatigue as an outcome.
确定系统性红斑狼疮（SLE）患者疲劳的7项指标的最小临床重要差异（MCID）。
研究对象完成7项疲劳量表[疲劳严重程度量表（FSS）、多维疲劳评估量表（MAF）、多维疲劳量表（MFI）、MOS-SF-36活力量表、查尔德疲劳量表（CFS）、慢性病治疗功能评估-疲劳量表以及一个整体评定量表（RS）]，然后与其他研究参与者进行一系列访谈，相互比较疲劳程度。每位访谈参与者根据7分转换量表对他们的疲劳水平差异进行评分。基于访谈参与者对疲劳差异的主观评分，从每对访谈参与者疲劳得分的平均差异中估算MCID。还使用线性回归模型估算MCID。
80例SLE患者参与研究。患者报告有显著程度的疲劳[7项量表的平均标准化（0=无，100=最高）疲劳得分范围为49.8（CFS）至71.1（FSS）]。“稍多一点”疲劳的MCID往往大于“稍少一点疲劳”的MCID，且FSS和MAF的MCID有显著差异。通过线性回归估算的标准化得分的MCID范围为7.0（CFS）至14.3（MFI）。
疲劳是SLE常见且使人衰弱的一个组成部分。MCID的估算将有助于解释疲劳得分中观察到的变化，对于估算将疲劳作为一项指标的临床试验所需样本量至关重要。
