Neurology, Public Health and Disability Unit, Scientific Directorate, Neurological Institute C. Besta IRCCS Foundation, Milan, Italy.
Headache. 2013 Feb;53(2):297-309. doi: 10.1111/j.1526-4610.2012.02279.x. Epub 2012 Oct 24.
OBJECTIVE: To describe a short-term "real-life" longitudinal evolution of migraine course, quality of life, and disability in a sample of patients attending to a specialty center and to evaluate the association between the changes in patient-reported outcomes, number of reported headaches, their severity, and treatment consumption. BACKGROUND: Clinical trials demonstrated that symptomatic and preventive therapies reduce migraine headache frequency and severity, thus improving quality of life and reducing disability. However, the longitudinal trajectory of health outcomes of patients under specific treatments but out of the setting of a clinical trial is almost unexplored. DESIGN: Longitudinal observational study with a 3-month follow-up. METHODS: Adult patients suffering from migraine, both with and without aura, were consecutively enrolled and administered the Migraine Disability Assessment, World Health Organization Disability Assessment Schedule, second version, and the Medical Outcome Survey 36-Item Short-Form Health Survey. Analysis of variance for repeated measures was used to assess longitudinal differences between baseline and the 3-month follow-up at employed assessments, number of days with headache in the previous 3 months and average judgment on attacks' severity, number of triptans and anti-inflammatory drugs consumed for acute treatment of attacks; effect size was used to determine magnitude of change. Baseline differences between completers and non-completers was evaluated with the independent-sample t-test. Pearson's correlation was used to cross-sectionally assess the association between total number of headache in the previous 6 months, average headache severity, total number of triptans and anti-inflammatory drugs taken, and the scores observed at follow-up for the 3 assessment instruments. The independent-sample t-test was used to assess cross-sectional differences between subjects taking preventive therapy and those taking only acute ones for total number of headaches, their severity, and total number of triptans and anti-inflammatory taken, considering scores referred to the 3-month follow-up evaluation. RESULTS: One hundred and two patients were enrolled (85.3% females; mean age 43.5) and 85 patients (85.9% females; mean age 44.3) completed the 3-month follow-up; no relevant differences between completers and non-completers were observed. Small changes (effect size <0.50) were observed in longitudinal analysis, in particular for World Health Organization Disability Assessment Schedule scales, while frequency and severity of headaches were substantially stable. Few significant correlations were observed, in particular between the total number of days with headache and Migraine Disability Assessment score (0.54; P < .01), and between the total number of days with headache and the total number of triptans taken (0.46; P < .01). Compared with patients taking acute medication only, those on preventive therapy reported worse general health (mean 50.3, standard deviation [SD] 21.0 compared with mean 63.8, SD 16.5; t = 3.31, P = .001) and consumed less anti-inflammatory drugs (mean 3.5, SD 5.6 compared with mean 7.5, SD 9.1; t = 2.25, P = .014). CONCLUSIONS: In this study, migraine frequency and intensity were almost stable over 3 months, and an evident trend toward improvement was found in disability and in some health-related quality of life aspects, particularly in the social activity domain. Our results clearly indicate that continuity of care has a positive impact on patients' health status and functioning, also in stable patients already on anti-migraine therapy, and that the use of patient-oriented outcome measures is a viable way to capture such improvements.
目的:描述在专门中心就诊的患者样本中偏头痛病程、生活质量和残疾的短期“真实生活”纵向演变,并评估患者报告的结果变化、报告的头痛次数、其严重程度和治疗消费之间的关联。
背景:临床试验表明,症状性和预防性治疗可减少偏头痛发作频率和严重程度,从而改善生活质量并降低残疾程度。然而,在特定治疗下但不在临床试验环境中的患者健康结果的纵向轨迹几乎没有被探索过。
设计:具有 3 个月随访的纵向观察性研究。
方法:连续纳入患有偏头痛(有或无先兆)的成年患者,并对其进行偏头痛残疾评估、世界卫生组织残疾评估量表第 2 版和医疗结果调查 36 项简明健康调查问卷的评估。采用重复测量方差分析来评估基线和 3 个月随访时在就业评估中、前 3 个月的头痛天数和对发作严重程度的平均判断、用于急性治疗发作的曲普坦和抗炎药物的平均使用量之间的纵向差异;效应大小用于确定变化的幅度。采用独立样本 t 检验评估完成者和未完成者之间的基线差异。采用皮尔逊相关分析来横截面上评估偏头痛发作的总天数、平均头痛严重程度、曲普坦和抗炎药物总使用量与 3 项评估工具的随访时得分之间的相关性。采用独立样本 t 检验评估偏头痛发作的总天数、严重程度和曲普坦和抗炎药物总使用量在服用预防性治疗和仅服用急性治疗的患者之间的横断差异,考虑到对 3 个月随访评估的评分。
结果:共纳入 102 名患者(85.3%为女性;平均年龄 43.5 岁),85 名患者(85.9%为女性;平均年龄 44.3 岁)完成了 3 个月的随访;完成者和未完成者之间没有明显差异。纵向分析中观察到小的变化(效应大小 <0.50),特别是在世界卫生组织残疾评估量表方面,而头痛的频率和严重程度基本稳定。观察到一些显著的相关性,特别是头痛天数的总数与偏头痛残疾评估评分之间的相关性(0.54;P < 0.01),以及头痛天数的总数与曲普坦使用量之间的相关性(0.46;P < 0.01)。与仅服用急性药物的患者相比,服用预防性药物的患者报告的总体健康状况较差(平均值为 50.3,标准差 [SD] 为 21.0,而平均值为 63.8,SD 为 16.5;t = 3.31,P = 0.001),并且使用的抗炎药物较少(平均值为 3.5,SD 为 5.6,而平均值为 7.5,SD 为 9.1;t = 2.25,P = 0.014)。
结论:在这项研究中,偏头痛发作的频率和强度在 3 个月内几乎保持稳定,残疾和一些健康相关生活质量方面出现了明显的改善趋势,特别是在社会活动领域。我们的结果清楚地表明,连续性护理对患者的健康状况和功能有积极影响,即使是已经接受抗偏头痛治疗的稳定患者也是如此,并且使用以患者为中心的结果测量方法是捕捉此类改善的可行方法。
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