重生科学研究的主要结果:美国心脏协会的一致声明
Circulation
|October 5, 2011
概括
为心脏骤停试验选择最好的初级结果是复杂的. 共识建议将时间点与生理条件配对,在大型公共卫生研究中进行长期神经认知评估.
科学领域:
- 心脏病学 心脏病学
- 神经学 神经学
- 临床试验 临床试验
背景情况:
- 心脏骤停疗法依赖于高质量的临床试验.
- 有意义的初级结果选择至关重要,但有争议.
- 一个共识会议召集了专家,NIH和FDA来解决这个问题.
研究的目的:
- 为在心脏骤停临床试验中选择主要结果提供准则.
- 为了解决围绕初级结果选择的争议.
- 为了指导研究人员,临床医生,审查者和监管机构.
主要方法:
- 任命专家,对心血管和神经系统的结果有不同的观点.
- 会议前文件和会议后的共识文件的流通进行审查.
- 讨论的重点是测量时间点,生理评估和终点成本.
主要成果:
- 没有一个单一的初级结局适合所有心脏骤停研究;最好的措施是将时间点与生理条件相结合.
- 较早的研究可能会使用较早的时间点 (例如,自发循环的恢复,生存).
- 较大的试验应该考虑更长的时间点 (例如,90天) 与神经认知和生活质量评估.
结论:
- 大脑性能类别或90天后修改的兰金度量表是许多试验的合理结果.
- 需要一个经过验证,易于管理的神经功能结果测量方法.
- 未来的发展应该优先考虑心脏骤停后患者的神经功能结果措施.
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