对人口调整间接比较的方法审查揭示了不一致的报道,并表明了出版偏差
Arnaud Serret-Larmande1, Belkacem Zenati2, Agnès Dechartres2
1INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, AP-HP, Hôpital Pitié-Salpêtrière, Département de Santé Publique, Centre de Pharmacoépidémiologie, Sorbonne Université, Paris, France; ECSTRRA Team UMR-1153 INSERM, AP-HP Saint Louis Hospital, Université Paris Cité, Paris, France.
Journal of clinical epidemiology
|September 17, 2023
概括
人口调整间接比较 (PAIC) 越来越多地使用,但缺乏方法透明度. 研究表明,报告偏见有利于使用可用的个人患者数据 (IPD) 进行治疗.
科学领域:
- 卫生经济学和研究成果研究成果
- 生物统计学 生物统计学
- 药品市场的准入 药品市场的准入
背景情况:
- 经人口调整的间接比较 (PAICs) 允许在不同试验中使用单个患者数据 (IPD) 来进行治疗评估.
- 在药品市场准入申请中,PAIC经常被用于将新疗法与竞争对手疗法进行比较.
研究的目的:
- 描述PAIC的使用情况.
- 评估PAICs的方法和报告.
- 为了描述PAICs的结果.
主要方法:
- 在PubMed的系统文献搜索中,对2010年1月1日至2022年4月2日期间发表的文章进行了系统的文献搜索.
- 包括的文章报告至少有一个PAIC.
- 数据的提取和选择是由两个审稿人独立执行的.
主要成果:
- 分析了133份详细介绍288个PAIC的出版物.
- 观察到PAIC出版物的显著增加,特别是在瘤血液学方面,制药行业的参与很大.
- 方法报告不一致,只有三篇文章充分详细说明了所有方面. 强烈的偏见有利于IPD的治疗方法,56%的人报告了显著的益处,而只有一个PAIC支持聚合数据.
结论:
- 越来越多的PAIC使用需要改进方法标准和透明度.
- 有证据表明,PAIC中存在报告偏差,这可能会影响其可靠性.
- 改进的指导方针对于确保PAIC结果在市场准入决策中的可信度至关重要.
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