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使用复合结果的试验忽视了竞争性风险的存在:心血管研究的方法调查
Hyunwoo Kim1, Hamad Shahbal2, Sameer Parpia3
1Department of Health Research Methods, Evidence, & Impact, McMaster University, Hamilton, Canada.
Journal of clinical epidemiology
|May 28, 2023
概括
只有少数具有复合终点的心血管疾病试验能够充分考虑竞争风险. 这项研究强调了在临床研究中需要改进的统计方法,以确保无偏见的结果.
科学领域:
- 临床试验 临床试验
- 生物统计学 生物统计学
- 心血管研究研究心血管研究
背景情况:
- 复合终点在心血管疾病 (CVD) 试验中很常见.
- 考虑竞争性风险对于准确解释试验结果至关重要.
- 最近的CVD试验可能不一致地应用这些先进的统计方法.
研究的目的:
- 评估最近发表的CVD试验中具有复合终点的竞争性风险分析的频率.
- 确定如何在分析时处理竞争风险.
- 强调临床研究中竞争性风险分析的重要性.
主要方法:
- 2021年1月1日至9月27日期间发表的CVD试验的方法调查.
- 在多个数据库中进行了搜索:PubMed,Medline,Embase,CINAHL和Web of Science.
- 根据包含和类型的竞争性风险分析进行分类研究.
主要成果:
- 在包含的研究中,只有10.3% (14在136个中) 进行并报告了具有竞争力的风险分析.
- 其中,50%的受访者将其用作初级分析,50%的受访者将其用作敏感性分析.
- 分布危险和因果特定危险模型是最常用的方法;没有研究在样本大小计算中包括竞争性风险.
结论:
- 在具有复合终点的心血管疾病试验中,竞争性风险分析的利用不足显著.
- 实施适当的竞争性风险分析对于产生具有临床意义和公正的研究结果至关重要.
- 这些发现突出了改善心血管临床试验的统计实践的迫切需要.
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