在过去的5年里,在内学期刊上发表的随机临床试验中遵守注册和选择性结果报告:一项超级研究研究
Filipe Colombo Vitali1, Pablo Silveira Santos1, Aurélio de Oliveira Rocha1
1Department of Dentistry, Federal University of Santa Catarina, Florianopolis, Brazil.
Journal of endodontics
|December 6, 2024
概括
牙周内科的随机临床试验 (RCT) 显示前性注册不佳,结果报告选择性高 (SOR). 改善这些实践对于研究诚信和牙科研究的透明度至关重要.
科学领域:
- 牙科研究 牙科研究
- 临床试验方法论 临床试验方法论
- 研究诚信研究诚信
背景情况:
- 随机临床试验 (RCT) 的未来注册对于研究透明度和防止选择性结果报告 (SOR) 至关重要.
- 遵守注册标准和SOR在牙周内科研究中的流行需要评估.
研究的目的:
- 评估在过去五年内在内牙科学期刊上发表的RCT中遵守试验注册和SOR发生情况.
- 为了确定影响登记实践和SOR在牙周内科临床试验的因素.
主要方法:
- 进行了PubMed和主要的内牙科学期刊的电子搜索.
- 两位审查员评估了登记状态,时间,协议差异和SOR的出版物.
- 后勤回归分析探索了影响注册和SOR的变量.
主要成果:
- 在144个RCT中,72.2%被注册,但只有18.3%的前性.
- 协议差异发生在55.8%的研究中,SOR存在于39.4%的研究中.
- 具有多个结局或追溯注册的研究显著增加了SOR的几率.
结论:
- 在内学期刊上的RCT表明,对未来注册的遵守率很低,SOR的流行率很高.
- 这些发现凸显出需要在内牙科研究中更好地遵守报告准则.
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