在重症监护试验中的联合注册:特征和后果
France Clarke1, Lori Hand1, Adam Deane2
1Department of Health Research Methods, Evidence, and Impact, McMaster University, 1280 Main Street West, Hamilton, ON L8S 4L8, Canada.
在临床试验中同时注册是常见的,三分之一的参与者被纳入多个研究. 患有SARS-CoV-2的患者更有可能被联合注册,但这没有影响试验结果.
科学领域:
- 临床研究 临床研究
- 医学试验 医学试验
- 患者招募 患者招募
背景情况:
- 临床试验的联合注册涉及参与者同时被纳入多个研究.
- 了解共同注册模式对于优化试验效率和数据完整性至关重要.
- REVISE试验调查了应激预防研究中的共同注册情况.
研究的目的:
- 描述参与共同注册的患者,中心和研究.
- 为了确定联合注册与试验指标的关联.
- 评估联合注册对患者结果的影响.
主要方法:
- 使用了描述性分析和多层回归.
- 从压力预防试验的参与者收集了数据.
- 检查了重症监护室 (ICU) 环境中共同注册的模式和预测因素.
主要成果:
- 在4821名参与者中,35.7%参与了145项独特的研究.
- 患有SARS-CoV-2感染的患者更有可能被联合注册 (OR 1.85).
- 联合注册并没有改变潘托普拉对胃肠道出血或90天死亡率的疗效.
结论:
- 三分之一的REVISE试验参与者被共同招募,主要是在学术随机试验中.
- 患有SARS-CoV-2的患者和经验丰富的协调员管理的患者更频繁地被联合注册.
- 同注册并没有改变潘托普拉对初级试验结果的治疗效果.
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