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在现实世界中,随机临床试验参与者和败血症患者之间的差异
Xue Bai1, Peng Zeng2, Bo Wang1
1Department of Critical Care Medicine, West China Hospital, Sichuan University, Chengdu, China.
Journal of critical care
|July 6, 2023
概括
败血症的随机对照试验 (RCT) 通常包括年轻的患者,并发病率较少,死亡率高于一般败血症患者. 商业支持影响患者的选择,影响了概括性.
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
- 流行病学 流行病学
背景情况:
- 随机对照试验 (RCT) 的外部有效性或通用性对于治疗决策至关重要.
- 本研究评估了大型多中心RCT中的败血症患者与一般败血症患者相比的代表性.
- 研究的主要人口和临床因素包括年龄,疾病严重程度,并发症和死亡率.
研究的目的:
- 通过将试验参与者与更广泛的败血症患者群体进行比较,评估败血症RCT的概括性.
- 在大型败血症临床试验中确定患者选择中的潜在偏差.
- 为提高未来败血症研究的外部有效性制定策略.
主要方法:
- 在MEDLINE,PubMed和Cochrane控制试验中心注册册中对败血症RCT进行系统的文献搜索 (≥100名患者,≥2个地点,2000-2019).
- 对试验参与者的加权平均年龄计算,并与来自MIMIC和EICU数据库的败血症人群进行比较.
- 多变量回归分析以确定与年龄差异相关的因素,包括商业支持.
主要成果:
- 败血症RCT参与者明显年轻 (平均年龄62.28岁) 比MIMIC (64.47岁) 和EICU (65.20岁) 数据库中的患者 (p < 0.001).
- 试验参与者具有较少的并发症,如糖尿病 (13.96%与30.64%-35.75%相比; p < 0.001).
- 与MIMIC (20.72%) 和EICU (17.53%) 种群相比,RCT参与者 (29.33%) 的加权死亡率更高 (p < 0.001). 商业支持的试验包括更严重的患者.
结论:
- 败血症RCT参与者平均年龄较小,并与一般败血症患者群体在并发症和死亡率上有所不同.
- 商业资金似乎影响了败血症试验中的患者选择,这可能会影响概括性.
- 解决这些患者选择差异对于改善败血症RCT发现的外部有效性和临床适用性至关重要.
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