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在初级和二级脚扭伤预防方面,临床试验有多强大?
C M Bleakley1, J Wagemans2, A P Schurz3
1Faculty of Life and Health Sciences, Ulster University, Belfast, United Kingdom.
概括
关于预防脚扭伤的随机对照试验 (RCT) 在统计学上很脆弱. 很少有结果事件变化,往往比患者退出更少,可以改变意义,突出需要强大的报告指标.
科学领域:
- 运动医学 运动医学
- 临床试验 临床试验
- 生物统计学 生物统计学
背景情况:
- 脚扭伤是常见的伤害,随机对照试验 (RCT) 研究预防策略.
- 评估这些RCT的统计稳定性对于可靠的证据合成至关重要.
研究的目的:
- 为了确定RCT的统计稳定性,RCT重点关注脚扭伤的初级和二级预防.
- 评估研究特征对统计稳定性的影响.
主要方法:
- 在2023年8月之前,对数据库进行了系统的搜索.
- 包括使用保守干预措施预防脚扭伤的并行设计RCT,结果分歧.
- 使用脆弱性指数 (FI) 和脆弱性系数 (FQ) 来量化统计稳定性.
主要成果:
- 包括45个RCT;中位数FI为4 (IQR1-6),表明很少需要事件来改变显著性.
- 在各个子组 (研究目标,分析方法,后续持续时间,预注册) 中,FI是一致的.
- 中位数FQ为0.015 (IQR为0.005-0.046),80%的研究中断人数超过FI.
结论:
- 关于预防脚扭伤的RCT显示出统计学上的脆弱性.
- 少数结果事件逆转,往往超过患者退出,可以改变研究意义.
- 对二分结果的稳健报告需要P值和FI或FQ等指标.
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