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心血管试验中对辅助干预,其他方法因素和治疗估计的报告不足:一项超流行病学研究
Jonas Bührer1,2, Cinzia Del Giovane1, Baris Gencer1,3
1Institute of Primary Health Care (BIHAM), University of Bern, Switzerland.
心血管试验中对辅助干预措施的报告不足是常见的,导致治疗效果估计被夸大. 这表明,在已发表的研究中,治疗效益可能被高估了.
科学领域:
- 心血管医学 心血管医学
- 临床试验方法论 临床试验方法论
- 基于证据的医学基于证据的医学.
背景情况:
- 在临床试验中准确估计治疗效果对于基于证据的医学至关重要.
- 辅助干预,即与主要干预一起进行的治疗,可以显著影响结果.
- 对辅助干预措施的报告不足对试验结果的有效性构成威胁.
研究的目的:
- 评估对近期心血管疾病试验中预计治疗效果的共同干预措施报告不足的影响.
- 确定不充分的共同干预报告的流行情况及其与效应大小的关联.
主要方法:
- 在Medline/Embase (2011-2021) 的系统搜索中,确定了164项在高影响力期刊上发表的心血管试验.
- 两位审查员评估了联合干预,盲目化,偏见风险,资金和设计的报告充分性.
- 超回归分析 (几率比率) 量化了方法因素和效果大小之间的关联.
主要成果:
- 74%的试验报告的辅助干预措施不足,54%没有提供任何信息.
- 同时干预报告不足与更大的初级终点治疗估计相关 (ROR,1.08;95% CI,1.01-1.15).
- 对于盲目化,偏离预期的干预措施或行业资助,没有发现任何显著的关联.
结论:
- 没有充分报告辅助干预的试验显示了更大的治疗效果估计.
- 这表明,由于报告不足,心血管研究中的治疗益处可能被高估了.
- 改善对共同干预措施的报告标准是必要的,以确保对试验结果的准确解释.
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