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在最具影响力的期刊中设计的心血管试验
Behnood Bikdeli1,2,3, John W Welsh2, Yasir Akram4
1Columbia University Medical Center/ New York-Presbyterian Hospital (B.B., G.W.S.).
Circulation
|June 11, 2019
概括
心血管非劣势性试验经常声称成功,但经常存在方法上的局限性. 最近的试验显示质量有所改善,但偏见的风险仍然存在,影响结果的解释.
科学领域:
- 心血管医学
- 临床试验方法
- 医学研究评价
背景情况:
- 在心血管研究中,非劣势性试验越来越常见.
- 这些试验的方法质量尚不清楚.
- 这项研究评估了顶级医学期刊中的非劣势心血管试验.
研究的目的:
- 描述非劣势心血管试验的方法质量.
- 识别可能偏向结果的特征.
- 检查这些试验中的报告标准和时间趋势.
主要方法:
- 在JAMA,Lancet或NEJM (1990-2016) 发表的已知心血管非劣势试验.
- 提取了关于非劣势边际,研究成功和潜在偏差因素 (主要和次要) 的数据.
- 两位独立审查员评估了方法和报告限制的数据.
主要成果:
- 确定了111项试验;非劣势差异很大.
- 86项试验声称没有劣势,但23项试验没有达到劣势.
- 只有7%的试验具有所有偏差因素的低风险;常见的问题包括缺乏治疗意向/每方案分析确认和不合理的利率.
- 随着时间的推移,试验的发表量增加,最近的试验显示限制的风险较低.
结论:
- 高影响力的期刊中的非劣势性试验经常声称非劣势性,但通常具有方法和报告的限制.
- 非劣势差额的变化和潜在偏差可能会影响试验结论的可靠性.
- 虽然最近的试验显示质量有所改善,但仔细评估限制对于解释结果至关重要.
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