协议公布率和文章,注册表和RCT中的协议之间的比较
Sylvain Mathieu1,2,3, Jean-Baptiste Bouillon-Minois4, Laurent Renard Triché5,6,7
1Rheumatology Department, CHU Clermont-Ferrand, Clermont-Ferrand, France. smathieu@chu-clermontferrand.fr.
BMC medical research methodology
|February 1, 2025
概括
与单独注册相比,发布临床试验协议并不能显著改善主要结果和样本大小的一致性. 试验注册足以确保研究中的数据完整性和透明度.
科学领域:
- 临床研究方法论 临床研究方法论
- 基于证据的医学基于证据的医学.
- 科学透明度 科学透明度
背景情况:
- 确保临床研究的透明度至关重要,以防止误导性发现.
- 实行了强制性临床试验注册,但协议发布对结果和样本大小的影响尚不清楚.
- 本研究调查了随机对照试验中协议发布率和主要结果和样本大小的一致性.
研究的目的:
- 确定随机对照试验 (RCT) 的试验协议发布和注册率.
- 为了比较已发表的协议,已注册的试验和已发表的文章之间的初级结果 (PO) 和样本大小 (SS) 的一致性.
- 评估协议公布的附加值,超出试验注册的透明度.
主要方法:
- 在MEDLINE上通过PubMed进行了文献搜索,以查找RCT报告.
- 数据提取的重点是试验登记,协议发布以及PO和SS的比较.
- 分析对已发表的文章,试验注册表和公开可用的协议中的信息进行了比较.
主要成果:
- 在分析的589个RCT中,24.8%的RCT已经发表了试验方案,42.4%的RCT在试验完成前发表了试验方案.
- 89.6%的RCT被注册,其中44%在研究开始前被注册.
- 在PO和SS中,在发表的协议和文章之间,或在文章和注册表之间,没有发现显著的差异.
- 具有更高影响因子或通用范围的期刊显示了更高的协议发布和注册率,以及PO和SS的更大一致性.
结论:
- 试验注册本身似乎足以保持初级结果和样本大小的一致性.
- 虽然公开协议可能会提高同行评审的透明度,但它对结果报告的一致性没有显著的额外好处.
- 专注于强大的试验注册实践是确保研究完整性的关键.
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