心血管随机对照试验中的脆弱性与多视角评估的初级连续结果 (2018-2022年):一个横截面调查
Xiaoqin Zhou1,2,3, Weiqiang Ruan1, Guiying Zhang2
1Department of Cardiovascular Surgery, West China Hospital, Sichuan University, Chengdu, P.R. China.
Annals of medicine
|December 3, 2024
概括
少数患者干预可以改变研究结果. 报告连续脆弱性指数 (CFI) 与P值一起,可以更好地理解心血管随机对照试验 (RCT) 的统计稳定性.
科学领域:
- 心血管研究研究心血管研究
- 临床试验方法论 临床试验方法论
- 医学中的统计分析.
背景情况:
- 随机对照试验 (RCT) 对心血管疾病研究至关重要.
- 评估心血管RCT中连续结果的统计稳定性对于临床解释至关重要.
- 现有的方法可能无法完全捕捉试验结果对数据小变化的敏感性.
研究的目的:
- 通过使用连续脆弱性指数 (CFI) 和反向连续脆弱性指数 (RCFI) 评估具有连续结果的心血管RCT的稳定性.
- 确定心血管试验结果统计不稳定的临床意义.
- 探索脆弱性指数与试验特征之间的相关性.
主要方法:
- 一项横截面研究分析了在2018-2022年期间发表在高影响力期刊上的心血管RCT.
- 连续脆弱性指数 (CFI) 和反向连续脆弱性指数 (RCFI) 通过确定改变结果显著性所需的最低患者数量 (P < 0.05) 来计算.
- 导出了脆弱性系数 (CFQ,RCFQ),并使用斯皮尔曼相关性来评估与试验变量之间的关系.
主要成果:
- 在包括的64个RCT (76个结局) 中,中位数CFI为7,中位数CFQ为0.032.
- 非显著的P值表明较大的统计不稳定性 (RCFI中位数=5) 与显著的P值 (CFI中位数=14) 相比.
- 大约36-46.7%的结局表现出"脆弱"的结果,脆弱指数显示出与样本大小和学率的显著关联.
结论:
- 只有7个患者干预的中位数可能会改变心血管RCT结果的意义.
- 建议将持续脆弱性指数 (CFI) 与P值一起报告,以更全面地了解统计结果的稳定性.
- 脆弱性指数为临床试验中连续结果的可靠性提供了有价值的见解.
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