注册的随机对照试验对透镜的可靠性
Grace Freeman-Spratt1, William Spratt1, Jonathan Vu1
1Department of Obstetrics and Gynaecology, Monash University, Clayton, Australia.
概括
许多在临床试验注册册表上注册的歇斯托罗斯扫描随机对照试验 (RCT) 并未公布. 已发表的胰腺镜RCT显示出严重的可信度问题,特别是关于参与者退出和数据报告.
科学领域:
- 妇科 妇科 妇科 妇科
- 临床试验方法论 临床试验方法论
- 医学研究 透明度 医疗研究 透明度
背景情况:
- 对基于证据的实践来说,评估透镜随机对照试验 (RCT) 的出版状况和可信度至关重要.
- 许多注册的试验可能不会被公布,这可能会扭曲证据基础.
研究的目的:
- 评估在临床试验注册册表上注册的透镜RCT的出版结果.
- 评估已发表的透镜RCT的方法可靠性.
主要方法:
- 在23个临床试验注册表和MEDLINE系统搜索歇斯托里学RCT (2012年3月至2022年3月).
- 使用随机对照试验可靠性 (TRACT) 检查清单对已发表的RCT进行评估.
- 与未知结果的研究作者联系.
主要成果:
- 在576个已识别的RCT中,有170篇已发表的文章被评估了可信度.
- 主要的可信度问题包括零参与者退出 (53%) 和相同的组大小 (44%).
- 在缺席或追溯登记中也发现了重要的问题 (分别为25%和14%).
结论:
- 有相当一部分注册的宫镜实验试验仍未公布,原因往往不清楚.
- 发表的透镜RCT的可靠性令人担忧,突出了方法改进的需要.
- 未来的研究应该专注于解决参与者学,报告特征和追溯注册问题.
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