在麻醉学随机对照试验中错误报告相关患者和研究设计元素:一项观察性研究
Igor Vuković1, Shelly Melissa Pranić2
1Department of Anesthesiology, Resuscitation and Intensive Care Medicine, General and Veteran Hospital "Hrvatski ponos" Knin, 22300 Knin, Croatia.
麻醉学临床试验数据显示,ClinicalTrials.gov与出版物之间存在重大报告不一致. 这突出了临床决策和元研究数据完整性和可靠性的问题.
科学领域:
- 麻醉学 麻醉学
- 临床试验 临床试验
- 数据报告质量数据报告质量
背景情况:
- 麻醉学临床试验数据报告的质量没有得到充分的检查.
- 在注册试验数据和公布的研究结果之间可能存在不一致.
研究的目的:
- 调查世卫组织数据集项目,结果和不良事件的报告的一致性.
- 将ClinicalTrials.gov报告的数据与麻醉相关随机对照试验 (RCT) 的同行评审出版物进行比较.
主要方法:
- 在ClinicalTrials.gov (2009-2022) 上注册的258个麻醉相关RCT的横截面研究.
- 检查了8个数据类别的报告,包括结果,不良事件和入学日期.
- 评估遵守注册截止日期,分析报告可靠性和差异.
主要成果:
- 33.3%的试验报告结果有差异,62.4%的严重不良事件,67.4%的其他不良事件.
- 报告的主要结果比二次结果 (27.9%) 更一致 (77.5%).
- 选择标准和入学日期是最不一致的报道;只有所有原因死亡率报告随着时间的推移而有所改善.
结论:
- 麻醉学临床试验数据继续被错误报告,影响数据完整性.
- 同行评审过程应利用试验注册数据进行验证.
- 差异引发了对注册和公布数据的可靠性的担忧,这些数据用于临床决策和元研究.
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