关于CNBSS试验的基本缺陷:一篇科学评论
Jean M Seely1, Peter R Eby2, Martin J Yaffe3
1University of Ottawa, Department of Medical Imaging, The Ottawa Hospital, Ottawa, Ontario, Canada.
Journal of breast imaging
|February 28, 2024
概括
加拿大国家乳腺查研究 (CNBSS) 试验存在重大方法缺陷,包括功率不足和乳房扫描质量差. 这些问题可能导致人们低估了乳房镜的价值.
科学领域:
- 在瘤学瘤学.
- 放射学 放射学是一门学科.
- 临床试验方法论 临床试验方法论
背景情况:
- 40年前进行的加拿大国家乳腺查研究 (CNBSS) 试验继续影响全球乳腺癌查政策.
- 他们的发现是基于低估了乳房扫描的死亡率降低,特别是在40-49岁的女性.
- 这对乳腺癌死亡率和发病率的增加有影响.
研究的目的:
- 审查随机对照试验 (RCT) 的原则.
- 评估CNBSS试验是否符合RCT原则.
- 确定CNBSS试验中的基本缺陷及其对查乳房镜检查有效性的影响.
主要方法:
- 审查已建立的随机对照试验 (RCT) 原则.
- 对CNBSS 1和CNBSS 2试验的方法和执行进行了批判性评估.
- 将CNBSS试验条件与现代基于人口的查性乳房造影程序进行比较.
主要成果:
- 在CNBSS试验中出现了重大缺陷,包括不充分的统计能力和低质量的乳房造影,敏感度差.
- 包括有症状的女性和违反随机化的情况进一步损害了试验的完整性.
- CNBSS试验未能证明查性乳房学对死亡率有好处,这将其与其他主要RCT区分开来.
结论:
- 由于CNBSS试验的方法缺陷,它们的研究结果对当前乳腺癌查政策的信息不可靠.
- 进行CNBSS试验的条件并不代表当代查环境.
- 鉴于CNBSS数据的局限性以及乳房扫描技术和实践的进步,重新评估查指南是有必要的.
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