评估手腕道释放的随机对照试验在统计上很脆弱:系统性审查
Julian V Javier1, Michaela Corvi2, Graham Sabo1
1Department of Orthopedic Surgery, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
概括
随机对照试验 (RCT) 对于手腕道释放 (CTR) 的统计结果往往是脆弱的. 平均只有5名患者可以扭转研究结果,敦促谨慎解释和报告统计稳定性指标.
科学领域:
- 整形外科手术 整形外科手术
- 生物统计学 生物统计学
- 临床试验方法论 临床试验方法论
背景情况:
- 随机对照试验 (RCT) 对于手腕道释放 (CTR) 经常报告P值而不评估统计稳定性.
- 这限制了影响手术决策的研究结果的可靠性.
研究的目的:
- 评估RCT评估CTR方法的统计稳定性,使用脆弱性指数 (FI),反向脆弱性指数 (rFI) 和脆弱率 (FQ) 来评估RCT的统计稳定性.
主要方法:
- 在PubMed,Embase和Medline进行了系统的文献搜索,搜索2000年1月1日至2024年1月31日之间发表的CTR的RCT.
- 针对研究结果计算了脆弱度指标 (FI,rFI,FQ),以量化统计的稳定性.
主要成果:
- 包括12个具有43个结局的RCT.
- 汇总的中位脆弱性指数 (FI) 为5 (四分位数范围为4-6.5),表明5名患者的中位数可能会改变统计学意义.
- 这表明,CTR RCT中结果的统计学意义可能是脆弱的.
结论:
- 分析CTR方法的RCT中的统计结果显示其脆弱性,需要谨慎解释.
- 建议在全面的可靠性评估中与P值一起共同报告FI,rFI和FQ,以帮助外科医生的决策.
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