Health Economics and Outcomes Research, Covance Market Access Services Inc., Gaithersburg, MD, USA.
Health Qual Life Outcomes. 2011 Aug 22;9:71. doi: 10.1186/1477-7525-9-71.
Fibromyalgia (FM) is characterized by chronic, widespread pain, fatigue, and other symptoms; yet few studies have comprehensively assessed its humanistic burden. This observational study evaluates the impact of FM severity on patients' symptoms, health-related quality of life (HRQoL), and productivity in the United States.
203 FM subjects were recruited from 20 physician offices. Subjects completed a questionnaire including the EuroQol 5D (EQ-5D), Fibromyalgia Impact Questionnaire (FIQ), Multidimensional Assessment of Fatigue (MAF), Medical Outcomes Study Sleep Scale (MOS-SS), and Hospital Anxiety and Depression Scale (HADS) and questions about demographics, pain and other symptoms, HRQoL and productivity. FIQ total scores were used to define FM severity, with 0- < 39, 39- < 59, and 59-100, representing mild, moderate, and severe FM, respectively. Sites recorded subjects' clinical characteristics and FM treatment on case report forms using medical records. Summary statistics were calculated for continuous variables and frequency distributions for categorical variables. Differences across FM severity groups were evaluated using the Kruskal-Wallis or Chi-square tests. Statistical significance was evaluated at the 0.05 level.
Mean (SD) age was 47.9 (10.9); 95% were female. Most (92%) were prescribed medication for FM; 24% and 66% reported moderate and severe FM, respectively. Mean (SD) scores were: 6.3 (2.1) for pain intensity; 0.35 (0.35) for EQ-5D; 30.7 (14.2) for MAF; 57.5 (18.4) for MOS-SS Sleep Problems Index; 10.2 (4.8) for HADS anxiety and 9.4 (4.4) for HADS depression. Subjects with worse FM severity reported significantly increased pain severity, HRQoL, fatigue, sleep disturbance, anxiety and depression (p < 0.001). Overall, 50% of subjects reported some disruption in their employment due to FM; this differed across severity levels (p < 0.001). Employed subjects missed a mean (SD) of 1.8 (3.9) workdays during the past 4 weeks; this also differed across severity levels (p = 0.03).
FM imposes a substantial humanistic burden on patients in the United States, and leads to substantial productivity loss, despite treatment. This burden is higher among subjects with worse FM severity.
纤维肌痛症(FM)的特征是慢性、广泛的疼痛、疲劳和其他症状;然而,很少有研究全面评估其对人类的负担。这项观察性研究评估了 FM 严重程度对患者症状、健康相关生活质量(HRQoL)和生产力在美国的影响。
从 20 个医生办公室招募了 203 名 FM 受试者。受试者完成了一份调查问卷,包括欧洲五维健康量表(EQ-5D)、纤维肌痛影响问卷(FIQ)、多维疲劳评估量表(MAF)、医学结局研究睡眠量表(MOS-SS)和医院焦虑抑郁量表(HADS),以及关于人口统计学、疼痛和其他症状、HRQoL 和生产力的问题。FIQ 总分用于定义 FM 严重程度,0- < 39、39- < 59 和 59-100 分别代表轻度、中度和重度 FM。各研究地点使用病历在病例报告表上记录受试者的临床特征和 FM 治疗情况。对连续变量进行了汇总统计,对分类变量进行了频率分布。使用 Kruskal-Wallis 或卡方检验评估 FM 严重程度组之间的差异。统计显著性在 0.05 水平上进行评估。
平均(SD)年龄为 47.9(10.9);95%为女性。大多数(92%)为 FM 开了药;分别有 24%和 66%报告了中度和重度 FM。平均(SD)评分如下:疼痛强度为 6.3(2.1);EQ-5D 为 0.35(0.35);MAF 为 30.7(14.2);MOS-SS 睡眠问题指数为 57.5(18.4);HADS 焦虑为 10.2(4.8);HADS 抑郁为 9.4(4.4)。FM 严重程度越差的患者报告疼痛严重程度、HRQoL、疲劳、睡眠障碍、焦虑和抑郁显著增加(p < 0.001)。总体而言,50%的受试者因 FM 而导致工作受到一定程度的干扰;这在不同的严重程度水平上有所不同(p < 0.001)。在职受试者在过去 4 周内平均(SD)缺勤 1.8(3.9)个工作日;这在不同的严重程度水平上也有所不同(p = 0.03)。
FM 在美国给患者带来了巨大的人文负担,尽管有治疗,但仍导致生产力严重下降。在 FM 严重程度较高的患者中,这种负担更高。