对RCT中缺失SOFA分数数据频率相对于ICU停留时间相对的观察性研究
Denise Molinnus1, Michael Beulertz2, Johannes Bickenbach2
1Department of Intensive Care Medicine. Medical Faculty, RWTH Aachen University, Aachen, Germany. dmolinnus@ukaachen.de.
Scientific reports
|July 12, 2024
概括
在临床试验中缺少序列器官衰竭评估 (SOFA) 评分是常见的,特别是在更长的重症监护病房停留期间. 不完整的数据可能会影响死亡率预测的有效性.
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
- 生物统计学 生物统计学
背景情况:
- 序列器官衰竭评估 (SOFA) 评分对于评估重症患者器官功能障碍至关重要.
- 由于随机对照试验 (RCT) 中缺少的数据,SOFA评分作为预测死亡率的替代终点的有效性和适用性受到质疑.
研究的目的:
- 在RCT中对系统性审查进行二次分析,以量化SOFA得分与临床试验中的严重疾病成年人死亡率预测之间的关系.
- 调查缺失的SOFA分数数据的影响,重点关注重症监护病房 (ICU) 住院时间和数据归算方法.
主要方法:
- 一项系统性审查的二次分析,包括87个临床试验和12064名重症患者.
- SOFA评分测量分为早期 (≤4天),中期 (5-10天) 和晚期 (>10天) 的类别.
- 分析不同时间框架的缺失数据百分比和处理方法.
主要成果:
- 只有一个研究报告了完整的早期SOFA评分数据;32%的研究缺少早期数据,晚期测量数据增加到64%.
- 增加ICU停留时间与缺失SOFA评分数据的更高发生率相关.
- 在处理缺失数据的方法中没有观察到一致的趋势;忽视缺失数据可能会低估治疗效果的变化.
结论:
- 缺失的SOFA评分数据很普遍,在ICU住院期间随着时间的推移而增加,可能会损害SOFA评分分析的有效性.
- 研究中缺少数据和归算方法的报告不足,限制了SOFA得分作为代孕妇死亡终点的可靠性.
- 临床决策者在解释利用SOFA评分的研究结果时必须考虑这些局限性.
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