当前的MS临床过程描述器是否需要改变,如果是的话,如何改变? 一项针对多发性硬化社区的调查
Alan J Thompson1, Marcello Moccia2, Maria Pia Amato3
1Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, UCL Queen Square Institute of Neurology, NIHR University College London Hospitals Biomedical Research Centre, Faculty of Brain Sciences, University College London, London, UK.
概括
大多数多发性硬化症 (MS) 利益相关者希望更新临床过程描述. 一个新的框架应该将疾病机制与临床表现联系起来,并帮助治疗决策.
科学领域:
- 神经学 神经学
- 临床研究 临床研究
- 疾病分类 疾病分类
背景情况:
- 当前多发性硬化症 (MS) 临床过程描述器整合了临床和磁共振成像 (MRI) 功能.
- 越来越多的人要求将MS描述符与潜在的生物机制保持一致.
研究的目的:
- 研究一种新的,机制驱动的框架来描述MS的含义.
- 评估利益相关者对修订当前多发性硬化症临床过程描述者的观点.
主要方法:
- 一个基于网络的调查分发给全球多发性硬化症的利益相关者.
- 受访者评价了改变当前描述符的必要性,疾病过程的定义,以及它们的临床实用性.
主要成果:
- 来自49个国家的502名受访者中有77%支持改变MS临床过程描述符.
- 利益相关者赞成建立一个框架,为治疗,临床试验设计,患者理解提供信息,并将机制与临床表现联系起来.
- 临床验证和简单的患者沟通对于任何新的框架都至关重要.
结论:
- 在MS利益相关者之间存在共识,修改当前的临床过程描述符.
- 未来的修订需要广泛的利益相关者参与和坚持基本原则.
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