肝癌治疗的随机对照试验频繁出现脆弱性。
Frequent fragility of randomized controlled trials for HCC treatment.
机构信息
Department of Infectious Diseases, The Key Discipline of Gguangdong Province, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou Medical University, #151 Yanjiang Road, Guangzhou, 510120, Guangdong Province, China.
Department of liver diseases (I), The Hospital Affiliated to Shaanxi University of Chinese Medicine, Xianyang, 712000, Shaanxi Province, China.
出版信息
BMC Cancer. 2021 Apr 9;21(1):389. doi: 10.1186/s12885-021-08133-8.
BACKGROUND
The fragility index (FI) of trial results can provide a measure of confidence in the positive effects reported in randomized controlled trials (RCTs). The aim of this study was to calculate the FI of RCTs supporting HCC treatments.
METHODS
A methodological systematic review of RCTs in HCC treatments was conducted. Two-arm studies with randomized and positive results for a time-to-event outcome were eligible for the FI calculation.
RESULTS
A total of 6 trails were included in this analysis. The median FI was 0.5 (IQR 0-10). FI was ≤7 in 4 (66.7%) of 6 trials; in those trials the fragility quotient was ≤1%.
CONCLUSION
Many phase 3 RCTs supporting HCC treatments have a low FI, which challenges the confidence in concluding the superiority of these drugs over control treatments.
背景
试验结果的脆弱指数（FI）可以为随机对照试验（RCT）中报告的阳性效应提供信心的衡量标准。本研究旨在计算支持 HCC 治疗的 RCT 的 FI。
方法
对 HCC 治疗的 RCT 进行了方法学系统评价。具有随机和阳性结果的两臂研究，且结局为时间事件，适合 FI 计算。
结果
共有 6 项试验纳入本分析。FI 的中位数为 0.5（IQR 0-10）。4 项（66.7%）试验的 FI ≤7；这些试验的脆弱性指数≤1%。
结论
许多支持 HCC 治疗的 III 期 RCT 的 FI 较低，这对这些药物优于对照治疗的结论的可信度提出了挑战。
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