药物流行病学研究中负控制的使用情况和实用性
American journal of epidemiology
|October 18, 2023
概括
负对照对于在使用真实数据的药物安全性研究中检测偏差非常有价值. 然而,许多研究未能验证这些负控的核心假设,限制了它们的有效性.
科学领域:
- 药学流行病学 药学流行病学
- 现实世界的数据分析分析.
- 生物统计学 生物统计学
背景情况:
- 药物安全性和有效性研究中的真实世界数据 (RWD) 面临着各种偏见的挑战.
- 负对照越来越多地用于解决这些偏差在药物流行病学研究.
研究的目的:
- 系统地评估消极对照的使用和效用,以解决药物流行病学研究中的偏差.
- 评估文献中负控的方法和应用领域.
主要方法:
- 通过2020年9月进行了系统的文献搜索.
- 两位独立审查员评估了研究资格,并从184项纳入研究中抽象了数据.
- 确定了常见的研究设计 (队列),数据类型 (行政) 和偏见目标 (未测量的混).
主要成果:
- 负对照被用于偏差检测 (81%),偏差校正 (9%),P值校准 (4%) 和方法性能评估 (17%).
- 队列研究和行政数据是最常见的研究设计和数据类型.
- 虽然对偏差检测有效,但许多研究没有充分检查负控的基本假设.
结论:
- 负对照是使用RWD的药理学流行病学研究中偏差检测的强大工具.
- 需要改进方法和坚持假设检查,以确保可靠的负控利用.
- 进一步的研究应侧重于验证负控制假设,以提高它们在现实世界证据生成中的有用性.
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