Background: Adherence to Multiple Sclerosis (MS) treatment is considered one of the crucial factors for ensuring optimal clinical outcomes. Research has shown that the use of self-injector devices improves patient compliance with treatment. Therefore, the main purpose of this study is to evaluate the ease of use of RebiSmart® 2.0 in clinically isolated syndrome/relapsing-remitting MS patients during 12 months treatment period.Methods: A total number of 290 subjects entered into data collection; 249 (86%) of them completed the whole 12 months study period. The primary endpoints and the secondary endpoints were assessed by the User Study Questionnaire. Adherence data were retrieved from RebiSmart® 2.0 (Menu - Dose History) on the respective patient's visit. Outcome measures also included Expanded Disability Status Score, Kurtzke Functional Systems, and Modified Social Support Survey, Modified Social Support Survey-5.Results: This study demonstrated a very high proportion (>95%) of patients with a positive rating of the overall ease of use and the overall convenience of RebiSmart®. The proportion of patients with a positive rating of the ease of use by individual domains and the functions of RebiSmart® were also high (>80%).Conclusion: The findings demonstrate a very good perception of the usability of the device by patients overall and in its individual functions.

中文翻译：

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一项观察性研究证明了注射器装置RebiSmart®的附着性和易用性。

背景：坚持多发性硬化症（MS）治疗被认为是确保最佳临床结果的关键因素之一。研究表明，使用自动注射器设备可以改善患者对治疗的依从性。因此，本研究的主要目的是评估RebiSmart®2.0在12个月治疗期临床分离的综合征/复发缓解型MS患者中的易用性。方法：共有290名受试者参加了数据收集。其中249位（86％）完成了整个12个月的学习期。主要终点和次要终点由用户研究问卷进行评估。在相关患者就诊时从RebiSmart®2.0（菜单-剂量历史记录）中检索依从性数据。结果指标还包括扩展的残疾状况评分，Kurtzke功能系统，改进型社会支持调查，改进型社会支持调查-5。结果：本研究表明，非常高的患者比例（> 95％）对RebiSmart®的总体易用性和总体便利性给予积极评价。对各个领域的易用性和RebiSmart®功能给予积极评价的患者比例也很高（> 80％）。结论：研究结果表明，患者对设备的整体使用情况和使用情况有很好的认识在其各自的功能。