评分临床试验质量的危险性,用于元分析
1Clinical Epidemiology Study Group, Institute for Medical Education, University of Berne, Switzerland.
JAMA
|September 24, 1999
概括
质量评估尺度的选择显著影响了元分析的结论. 个别的方法方面,而不是总结分数,应该指导试验质量评估可靠的结果.
科学领域:
- 临床试验方法论 临床试验方法论
- 证据综合 证据综合
- 医疗保健服务研究 医疗服务研究
背景情况:
- 建议进行临床试验质量评估,但缺乏标准化的方法.
- 许多质量评估尺度存在,导致最佳实践的混.
- 本研究研究了不同质量尺度对元分析结果的影响.
研究的目的:
- 确定质量评估规模的类型是否会影响元分析研究的结论.
- 评估治疗效果与质量评估分数之间的关联.
- 探索特定的方法领域对研究结果的影响.
主要方法:
- 一项对17项试验的元分析,比较低分子量肝素 (LMWH) 与用于术后血栓形成预防的标准肝素.
- 利用25种不同的质量评估尺度将试验分类为高质量或低质量.
- 采用回归模型来检查治疗效果,总结分数和分配隐藏和盲目的关键领域之间的关联.
主要成果:
- 根据使用的质量尺度,聚合的相对风险差异很大,有些表明LMWH和标准肝素之间没有显著差异,而另一些则显示LMWH优越性.
- 高质量的试验在所有尺度上并不总是显示出比低质量的试验更大的治疗效果.
- 开放结果评估与LMWH的夸大效应大小有关 (35%的增加).
结论:
- 质量评估尺度的总结分数在识别高质量的试验方面存在问题.
- 对相关的方法方面进行个别评估至关重要.
- 具体的方法因素对效果大小的影响需要仔细探索.
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