预期的随机对照试验是否符合已提交的协议? 从2010年到2023年,对206项试验进行了旋转研究
Roger Erivan1, Bastien Michon2, Guillaume Villatte1
1Université Clermont Auvergne, CHU Clermont-Ferrand, CNRS, SIGMA Clermont, ICCF, F-63000 Clermont-Ferrand, France.
Orthopaedics & traumatology, surgery & research : OTSR
|October 3, 2024
概括
在"骨关节外科杂志" (JBJS) 中,许多前性随机对照试验 (RCT) 显示其协议和已发表的方法之间存在差异. 这突出了发表的骨科研究中的潜在研究完整性问题.
科学领域:
- 整形外科 整形外科 整形外科
- 医学研究方法论医学研究方法论.
- 科学出版业的科学出版.
背景情况:
- 预期随机对照试验 (RCT) 是一个强大的研究设计,但容易受到方法学的扭曲.
- 差异可能来自无法使用的协议,协议修订或对结果的偏见报告.
- 发表在"骨关节外科杂志" (JBJS) 上的RCT中的这种不一致性以前没有被调查过.
研究的目的:
- 确定JBJS中公布的具有可访问协议的RCT的比例.
- 评估已公布的RCT在多大程度上遵守其已提交的协议.
主要方法:
- 2010年1月至2023年11月期间在JBJS发表的RCT文章的回顾性审查.
- 发表文章中描述的初级和二级终点与相应的协议的比较.
- 对阅读器的协议可访问性的评估.
主要成果:
- 在89.3%的文章中引用了议定书,但其中11.1%的文章无法在线访问.
- 总体而言,21.8%的RCT缺乏可访问的协议.
- 主要终点在60.2%的分析文章中保持不变,而39.8%报告了变化.
- 在只有37.9%的研究中,二次终点没有变化.
结论:
- 在JBJS中发表的大量RCT中,其手术前协议与最终出版物中报告的方法之间存在不一致.
- 这些发现表明,在高影响力的骨科研究中,方法透明度和遵守协议可能存在问题.
- 与其他领先期刊类似,JBJS在确保试验协议和发表结果之间完全忠实方面面临挑战.
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