在急性中风 (2010-2020) 随机临床试验中利用和报告患者报告的结果措施
Joseph S Hostnik1, Brent Strong2, Mathew J Reeves2
1College of Human Medicine (J.S.H.), Michigan State University, East Lansing.
Stroke
|March 21, 2024
概括
一半的急性中风试验使用患者报告的结果测量 (PROM),但它们很少是主要的结果. 为了更好的以患者为中心的研究,需要在试验设计和出版中改进PROM报告.
科学领域:
- 临床试验 临床试验
- 神经学 神经学
- 健康 结果 研究 研究 结果
背景情况:
- 患者报告的结果措施 (PROMs) 捕捉患者的健康状况.
- 在临床试验中对PROMs的兴趣正在增长.
- 在急性中风试验中使用PROM并未得到很好的定义.
研究的目的:
- 为了确定在急性中风试验中包含PROM的频率.
- 评估这些试验中PROM的方法报告质量.
主要方法:
- 在9个高影响期刊 (2010-2020) 中搜索MEDLINE随机对照试验 (RCT).
- 包括2/3期试验,测试中风1个月内的干预措施.
- 从出版物和协议中抽象的结果措施,将PROM定义为自我报告的健康状况措施.
主要成果:
- 在116项符合条件的试验中,57%包括至少一个PROM;只有1项使用它作为主要结果.
- 欧洲QOL,中风影响量表和SF-36是常见的PROM.
- 在后期的试验 (2016年后),第三期试验和出血性中风试验中,PROM的含量增加了.
- 关于PROM的报告质量普遍不佳,只有22%的人发现了统计学上显著的结果.
结论:
- 在大约一半的急性中风试验中,PROM被列入次要结局,但在报告的结果中起不大作用.
- 在试验设计和报告中加强对PROM的关注对于以患者为中心的中风研究至关重要.
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