核心结果分析在冠状动脉干预试验中设置报告
Aaron Duncan1,2, Frances Shiely3
1University College Cork, Cork, Ireland 120227684@umail.ucc.ie.
Open heart
|April 30, 2024
概括
穿皮冠状动脉干预 (PCI) 试验中采用核心结果集 (COS) 的比例仍然很低,这表明需要提高认识和一致的结果报告. 这项研究强调了试验设计和结果变异性的挑战.
科学领域:
- 心脏病学 心脏病学
- 临床试验方法论 临床试验方法论
- 健康 结果 研究 研究 结果
背景情况:
- 通过皮肤冠状动脉干预 (PCI) 试验的标准化结果报告对于统一的数据解释至关重要.
- 欧洲心脏病学会对PCI试验的核心结果集 (COS) 在2018年发表.
- 本PCI COS对试验报告实践的利用和影响需要评估.
研究的目的:
- 评估PCI试验是否符合已建立的COS.
- 在COS可用之后,评估结果报告实践的变化.
- 检查COS对结果变化,一致性以及患者和公众参与 (PPI) 的影响.
主要方法:
- 在2014-2022年期间对PCI的随机对照试验进行文献搜索.
- 包括研究冠状动脉干预的晚期试验.
- 主要结果:报告所有COS定义结果的试验比例;次要结果:主要结果的数量,PPI的使用,结果的可变性和一致性.
主要成果:
- 55%的PCI试验使用了可用性后的COS,而之前的COS仅为40% (p=0.121).
- 在COS实施后报告的初级结局较少 (2对2.3,p=0.014).
- 在PPI使用中没有显著差异;在COS之前注意到更高的结果可变性,一致性相似.
结论:
- 在PCI试验中,核心结果集 (COS) 的利用率低于最佳,这表明试验设计人员的认识很低.
- 报告临床试验结果的不一致性和异质性仍然存在.
- 在PCI试验设计中,患者和公众参与 (PPI) 显著缺乏.
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