下关节出血试验:切割,滑动或保持mRS分数和WFNS等级
Akshitkumar M Mistry1, Jeffrey Saver2, William Mack3
1Department of Neurosurgery, University of Louisville, Louisville, KY.
medRxiv : the preprint server for health sciences
|October 24, 2023
概括
随机对照试验对动脉瘤下关节出血 (SAH) 具有挑战性,因为独特的患者严重程度分布. 本研究分析了世界神经外科医生联合会 (WFNS) 的评级如何影响SAH临床试验的结果和样本大小.
科学领域:
- 神经学 神经学
- 临床试验 临床试验
- 脑卒中研究 脑卒中研究
背景情况:
- 使用随机对照试验 (RCT) 创建动脉瘤下关节出血 (SAH) 的证据落后于其他类型的中风.
- 与其他中风亚型相比,SAH患者具有独特的特征和结果,需要量身定制的试验设计.
研究的目的:
- 分析世界神经外科医生联合会 (WFNS) 等级分配对SAHRCT样本大小计算的影响.
- 讨论各种结果分析方法和策略,以控制SAH试验设计中的WFNS等级分布.
主要方法:
- 模拟分析了WFNS等级分布对修改的排名表 (mRS) 结果的影响.
- 对分析SAH试验数据的不同统计方法的评估.
- 关于WFNS等级的试验资格标准的评估.
主要成果:
- WFNS等级的独特分布显著影响了SAH RCT中所需的样本大小.
- 不同的mRS分析方法和WFNS等级控制策略对试验效率产生不同的影响.
结论:
- 在设计SAHRCT时,研究人员必须仔细考虑WFNS等级分布.
- 适应性方法可以提高理解治疗效果的精度,并优化对SAH患者的试验设计.
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