意识障碍的共同数据元素:结果和终点工作组的建议
Yelena G Bodien1,2, Kerri LaRovere3, Daniel Kondziella4,5
1Department of Neurology, Center for Neurotechnology and Neurorecovery, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA. ybodien@mgh.harvard.edu.
Neurocritical care
|August 14, 2024
概括
对意识障碍 (DoC) 的标准化结果测量对于一致的研究至关重要. 这项研究建议使用共同数据元素 (CDE) 来评估DoC恢复,从而提高跨研究的可比性.
科学领域:
- 神经科学是一个神经科学.
- 神经学 神经学
- 关键护理医学 关键护理医学
背景情况:
- 意识障碍 (DoC) 的临床管理缺乏标准化的结果措施,这阻碍了恢复评估和研究可比性.
- 现有的措施往往以绩效为基础,仅为个人使用而验证,并未专门设计用于全方位的DoC结果.
- 国家神经疾病和中风研究所 (NINDS) 的共同数据元素 (CDEs) 为神经学研究提供了标准化的框架.
研究的目的:
- 为有意识障碍 (DoC) 的人推标准化结果和终点共同数据元素 (CDEs).
- 解决DoC研究中使用的结果指标的不一致性,并促进跨研究的比较.
- 为神经临床护理协会治疗昏迷运动的DoC CDE开发倡议做出贡献.
主要方法:
- 治疗昏迷运动结果和终点CDE工作组采用了五步过程,该工作组包括神经临床护理,神经病学和神经科学专家.
- 这个过程包括审查现有的NINDS CDE,提名和审查新的CDE,对CDE进行分类,并反复批准建议.
- 案例报告表格是作为CDE开发过程的一部分开发的.
主要成果:
- 确定了20个现有的NINDS结果和终点CDE措施,用于成人和18个儿童,以评估昏迷恢复.
- 为成人提出了14项新的结果和终点CDE措施,为儿童提出了5项.
- 这些选定和拟议的CDE涵盖了DoC的全部恢复结果.
结论:
- 开发的DoC结果和终点CDE代表了在DoC研究中标准化结果评估的基本步骤.
- 最终的目标是协调DoC研究,使严重脑损伤或疾病后的结果能够更准确地评估.
- 随着新证据的出现,需要采用代方法来完善这些CDE.
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