旋转报告在手术的试点随机对照试验中很常见:一项方法调查
Tyler McKechnie1, Tania Kazi2, Victoria Shi2
1Division of General Surgery, Department of Surgery, McMaster University, Hamilton, ON, Canada; Department of Health Research Methodology, Evidence, and Impact, McMaster University, Hamilton, ON, Canada.
The Journal of surgical research
|January 1, 2025
概括
大多数手术试点和可行性试验都报告了旋转,重点是疗效而不是可行性. 这种错误陈述令人担忧,因为这些试验应该探索未来最终研究的可行性.
科学领域:
- 手术研究方法论手术研究方法论
- 临床试验设计 临床试验设计
- 基于证据的医学 基于证据的医学
背景情况:
- 旋转报告,强调有效性而不是可行性,在试点和可行性试验中没有得到充分的研究.
- 本研究通过评估手术试点和可行性试验中的旋转报告来解决知识差距.
研究的目的:
- 为了确定在手术试点和可行性试验中旋转报告的普遍性.
- 确定使用的旋转报告类型及其与研究特征的关联.
主要方法:
- 进行了手术试点和可行性随机试验的方法调查.
- 在2011年和2021年的Medline,Embase和Cochrane控制试验中央注册表中进行了文献搜索.
- 旋转报告以重点关注疗效,统计学上显著的发现或对可行性结果的错误陈述来定义.
主要成果:
- 在包含的72项试验中,81.9%的试验显示了旋转报告.
- 大多数专注于疗效 (80.6%) 或统计学意义 (47.2%),而不是可行性.
- 旋转报告从2011年的94.7%下降到2021年的67.6%,但仍然普遍存在.
结论:
- 很大一部分手术试点和可行性试验不适当地强调临床结果和统计学意义而不是可行性.
- 这种旋转报告令人担忧,因为试点试验对于为最终试验的设计提供信息至关重要.
- 需要进一步的研究和指导方针,以确保在早期的手术试验中准确报告可行性结果.
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