最近在重症监护医学的随机临床试验中报告的严重不良事件 - 一个方法研究协议
Marie Qvist Jensen1, Marie Warrer Munch1, Anders Granholm1
1Department of Intensive Care, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
Acta anaesthesiologica Scandinavica
|September 12, 2024
概括
在针对重症监护室 (ICU) 患者的随机临床试验 (RCT) 中报告严重不良事件 (SAE) 是不一致的. 本研究分析了主要医学期刊上最近的SAE报告,以提高重症监护研究的透明度.
科学领域:
- 关键护理医学 关键护理医学
- 临床试验方法论 临床试验方法论
- 药物监督 药物监督 药物监督
背景情况:
- 严重的不良事件 (SAE) 在重症监护室 (ICU) 患者中很常见.
- 随机临床试验 (RCT) 中发生的SAE报告不足是一个重大问题.
- 目前在重症监护中的SAE报告实践需要详细审查.
研究的目的:
- 描述从2020年起在涉及成年ICU患者的药理干预RCT中报告的SAE.
- 分析主要出版物中关于SAE的报道方式 (患者比例,单个事件或组合).
- 确定与报告重症监护中的SAE相关的因素RCT.
主要方法:
- 在成年ICU患者中对药理学RCT的方法研究.
- 在PubMed索引的10个主要医疗和重症监护期刊的系统搜索.
- 包括所有从2020年起出版的RCT.
主要成果:
- 在初级出版物中报告SAE的RCT比例的分析.
- 报告方法的评估:患者比例,个别事件或联合策略.
- 评估SAE报告与试验特征之间的关联 (例如,多中心,赞助,盲目,样本大小,COVID-19重点).
结论:
- 这项研究将提供至关重要的见解,了解最近对成年ICU患者进行的药物试验中SAE报告的现状.
- 结果将突出在重症监护研究中的SAE的变化和潜在报告不足.
- 更好地了解SAE报告可以提高重症监护RCT的质量和透明度.
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