Damuzzo Vera, Agnoletto Laura, Rampazzo Roberta, Cammalleri Francesca, Cancanelli Luca, Chiumente Marco, Costantino Stefano, Michielan Silvia, Milani Federica, Sartori Alessia, Rivano Melania, Mengato Daniele
Department of Pharmaceutical and Pharmacological Sciences, School of Hospital Pharmacy, University of Padua, 35122 Padua, Italy.
National Association of Hospital Pharmacy Students-ReNaSFO, 20122 Milan, Italy.
Neurol Int. 2021 Dec 3;13(4):682-694. doi: 10.3390/neurolint13040065.
Health-related quality of life is frequently included in patient-reported outcomes aimed at evaluating the effectiveness of disease-modifying drugs for multiple sclerosis, but recent data about Italian patients are missing. A multicenter observational and cross-sectional study was performed by students of hospital pharmacy to update existing data on quality of life and to correlate it with the pharmacological and medical history of patients. Quality of life (QoL) was assessed using the MS-QoL54 questionnaire, and the pharmacist collected patients' characteristics, medical and pharmacological history, and Expanded Disability Status Scale (EDSS). Three hundred and forty-nine patients with multiple sclerosis were recruited from 16 centers between May 2018 and June 2019 (median age = 44.1 years; 68.9% women). The composite indexes of physical and mental well-being showed direct correlation with each other (R = 0.826; < 0.001), and EDSS disability was an independent negative predictor of both indexes (R = 35.08% < 0.001 and R = 15.74% < 0.001, respectively). A trend of association between Physical Health Composite Score and different classes of oral disease-modifying drugs (DMDs) was observed. Our study found a decrease in QoL correlated with teriflunomide, which deserves further investigation. This experience demonstrates that joint action between scientific society and students association can be successful in conducting a no-profit multicenter observational study in a real-world setting.
与健康相关的生活质量经常被纳入患者报告的结局指标中,旨在评估用于治疗多发性硬化症的疾病修饰药物的疗效,但目前缺少有关意大利患者的最新数据。医院药学专业的学生开展了一项多中心观察性横断面研究,以更新现有的生活质量数据,并将其与患者的用药史和病史相关联。使用MS-QoL54问卷评估生活质量(QoL),药剂师收集患者的特征、用药史和病史以及扩展残疾状态量表(EDSS)。2018年5月至2019年6月期间,从16个中心招募了349例多发性硬化症患者(中位年龄=44.1岁;68.9%为女性)。身心健康综合指数彼此呈正相关(R=0.826;P<0.001),EDSS残疾程度是这两个指数的独立负性预测因子(分别为R=35.08%,P<0.001和R=15.74%,P<0.001)。观察到身体健康综合评分与不同类别的口服疾病修饰药物(DMDs)之间存在关联趋势。我们的研究发现,与特立氟胺相关的生活质量下降值得进一步研究。这一经验表明,科学协会和学生协会之间的联合行动能够成功地在现实环境中开展一项非营利性多中心观察性研究。