患有慢性阻塞性肺病的患者是否有资格参加调查三重治疗的随机对照试验:一项使用例行收集数据的研究
Hannah R Whittaker1, Aria Torkpour2, Jennifer Quint3
1School of Public Health, Imperial College London, London, UK. h.whittaker@imperial.ac.uk.
Respiratory research
|January 18, 2024
概括
很少有慢性阻塞性肺病 (COPD) 患者符合三重治疗临床试验的资格标准. 需要现实世界的证据来了解COPD在更广泛的人群中的治疗有效性.
科学领域:
- 肺部病理学 肺部病理学
- 临床试验 临床试验
- 现实世界的证据.
背景情况:
- 随机对照试验 (RCT) 经常使用严格的资格标准,可能会排除临床实践中患者的代表性患者.
- 本研究研究了三重疗法RCT在慢性阻塞性肺病 (COPD) 中的概括性.
研究的目的:
- 确定英格兰有资格参加三重疗法随机对照试验的COPD患者的比例.
- 确定限制患者参与COPD临床试验的关键资格标准.
主要方法:
- 在MEDLINE和ClinicalTrials.gov搜索了关于COPD三重治疗的RCT.
- 从已识别的RCT中提取了资格标准.
- 将RCT标准应用于来自英格兰的大型初级保健COPD患者数据库 (n=79,810).
主要成果:
- 确定了26个研究三重治疗的RCT.
- 在所有RCT中,只有11.2%的COPD患者的中位数符合符合资格标准.
- 恶化的病史和先前的药物使用是最常见的排除标准.
结论:
- 结果表明,三重治疗的RCT群体可能不反映临床实践中遇到的更广泛的COPD患者群体.
- 现实世界的证据研究对于评估所有COPD患者的三重疗法的有效性至关重要.
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