意识障碍的共同数据元素:生物标本和生物标志物工作组的建议
Vishank A Shah1, H E Hinson2, Michael E Reznik3,4
1Departments of Anesthesiology and Critical Care Medicine, Neurology, Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Neurocritical care
|December 12, 2023
概括
本研究确定了意识障碍 (DoC) 研究中的生物标志物的关键数据元素. 这些元素的标准化将改善未来的昏迷和DoC研究.
科学领域:
- 神经科学是一个神经科学.
- 生物标志物发现发现
- 临床研究方法论 临床研究方法论
背景情况:
- 意识障碍 (DoC) 研究需要标准化生物标志物用于内型定义,治疗向,结果预测和临床试验患者选择.
- 现有研究缺乏用于DoC的实验室和分子生物标志物的共同数据元素 (CDE) 和关键设计元素 (KDE).
结论:
- 由于质量和可重复性问题,很少有DOC的实验生物标志物符合核心或基本CDE的标准.
- 采用KDE对于标准化方法和协调未来的生物标志物和生物样本研究在DoC中至关重要.
- 开发的CRF为推进DoC研究提供了一个基本要素.
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