预期注册与随机对照试验偏差风险降低有关:一个元研究研究
Yuan Tian1, Haofei Lu2, Wenxuan Zhou3
1Proof of Concept Center, Eastern Hepatobiliary Surgery Hospital, Third Affiliated Hospital, Second Military Medical University, Naval Medical University, Shanghai, China.
预先注册的随机对照试验 (RCT) 比未注册的试验显示出更少的偏差. 预期注册与更好的偏见控制和研究中潜在的偏见 (RoB) 总体风险降低有关.
科学领域:
- 临床试验方法论 临床试验方法论
- 研究诚信研究诚信
- 基于证据的医学 基于证据的医学
背景情况:
- 试验登记对于透明度和减少研究偏见至关重要.
- 了解注册状态和偏差风险 (RoB) 之间的关联对于评估研究质量至关重要.
研究的目的:
- 研究随机对照试验 (RCT) 中试验注册与偏差风险 (RoB) 之间的关联.
主要方法:
- 关于与药物相关的危害 (2015-2020年) 的系统审查中的RCT的分析.
- 评估注册状态 (未注册,追溯,前) 和ROB.
- 多变量逻辑回归来确定关联.
主要成果:
- 预期注册与防止随机化,分配隐藏和盲目的偏见的保障有关.
- 与未注册试验相比,前性注册试验的总体偏差风险较低.
- 虽然从统计学上来说没有显著意义,但前性注册显示出与后性注册相比,个人和整体ROB较低的趋势.
结论:
- 预期注册的试验更有可能实施适当的偏差控制程序.
- 预期试验注册作为RCT偏差总体风险降低的指标.
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