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Abstract：
Patient-reported outcomes (PROs) are essential for understanding the effects of MS and its treatments on patients\' lives; they play an important role in multiple sclerosis (MS) research and practice. We present the protocol for an observational study to prospectively assess the effect of cladribine tablets on PROs and their correlation to disability and physical activity in adults with highly active relapsing MS switching from a first disease modifying drug (DMD) to cladribine tablets in routine clinical practice at study sites in Italy. The primary objective will be to evaluate changes from baseline in the impact of highly active MS on self-assessed physical functioning 52 weeks after the switch to cladribine tablets using the Multiple Sclerosis Impact Scale-29 (MSIS-29). Secondary objectives will include self-assessed psychological impact of highly active MS in daily life and general health after the switch to cladribine tablets as well as changes in cognitive function, anxiety, and depression symptoms. Additional PRO measures will include the Hospital Anxiety and Depression Scale (HADS), the EuroQoL 5-Dimension 5-Level (EQ-5D-5L), the Work Productivity and Activity Impairment Questionnaire: Multiple Sclerosis (WPAI:MS), and the Patient-Reported Outcomes Measurement Information System (PROMIS). Wearable devices will acquire activity data (step counts, walking speed, time asleep, and energy expenditure). Additional clinical, radiological, and laboratory data will be collected when available during routine management. The findings will complement data from controlled trials by providing insight from daily clinical practice into the effect of cladribine tablets on the patient\'s experience and self-assessed impact of treatment on daily life.
摘要：
患者报告的结果（PRO）对于了解MS及其治疗对患者生活的影响至关重要；它们在多发性硬化症（MS）的研究和实践中起着重要作用。我们提出了一项观察性研究的方案，以前瞻性评估克拉屈滨片剂对PROs的影响及其与成人残疾和体力活动的相关性，这些成人患有高活性复发性MS，从第一种疾病改善药物（DMD）转换为克拉屈滨片剂在意大利研究中心的常规临床实践中。主要目标是使用多发性硬化症影响量表-29（MSIS-29）评估高活性MS对转换为克拉屈滨片剂52周后自我评估的身体功能的影响从基线的变化。次要目标将包括转换为克拉屈滨片剂后，高度活跃的MS在日常生活和一般健康中的自我评估心理影响以及认知功能的变化。焦虑,抑郁症状。其他PRO措施将包括医院焦虑和抑郁量表（HADS），EuroQoL5维5级(EQ-5D-5L)，工作效率和活动障碍问卷：多发性硬化症（WPAI：MS），和患者报告结果测量信息系统(PROMIS)。可穿戴设备将获取活动数据(步数、步行速度,时间睡着了，和能量消耗)。额外的临床，放射学,和实验室数据将在常规管理期间收集。通过提供每日临床实践中克拉屈滨片剂对患者体验的影响以及治疗对日常生活的自我评估影响的见解，这些发现将补充对照试验的数据。
