绘制策略,以评估和增加已发布的不成比例信号的有效性:一个元研究研究
Michele Fusaroli1, Francesco Salvo2,3, Claire Bernardeau4
1Pharmacology Unit, Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy. michele.fusaroli2@unibo.it.
Drug safety
|July 8, 2023
概括
研究人员使用各种方法来验证药物不良反应的不成比例信号. 这项研究绘制了这些策略的地图,揭示了异质性,并为改进的分析准则铺平了道路.
科学领域:
- 药物监督 药物监督 药物监督
- 药物安全研究 药物安全研究
- 生物统计学 生物统计学
背景情况:
- 不成比例性分析对于从自发报告系统中生成关于潜在药物不良反应 (ADR) 的假设至关重要.
- 评估和增强这些不成比例信号的有效性对于可靠的药物安全信号检测至关重要.
研究的目的:
- 绘制研究人员用来评估和加强已公布的不成比例信号的有效性的各种方法的地图.
- 在评估不成比例信号有效性时,确定共同的策略和异质性领域.
主要方法:
- 到2020年1月1日,对已发表的不成比例性分析进行系统的文献搜索.
- 随机选择并分析了100项跨越五个领域的研究:理由,分析设计,个案评估,补充数据源和结果上下文化.
主要成果:
- 用多种策略来评估和增强信号有效性,95%的研究引用了现有证据 (观察数据,监管文件).
- 实施了统计调整 (34项研究) 和偏差纠正策略 (33项研究). 在35项研究中进行了个案评估,通常侧重于时间合理性.
- 在78%的文章中,使用文献和监管文件,包括观察数据 (45),其他不成比例分析 (37) 和案例报告 (36) 的结果被语境化.
结论:
- 在用于验证不成比例信号的方法和策略中存在显著的异质性.
- 绘制这些策略是评估它们的有用性和为未来的不成比例分析制定标准指南的基本步骤.
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