Suppr超能文献

疫苗的定量信号检测:分层、背景和屏蔽对葛兰素史克自发报告数据库的影响

Quantitative signal detection for vaccines: effects of stratification, background and masking on GlaxoSmithKline's spontaneous reports database.

作者信息

Zeinoun Ziad, Seifert Harry, Verstraeten Thomas

机构信息

GlaxoSmithKline Biologicals, Rixensart, Belgium.

出版信息

Hum Vaccin. 2009 Sep;5(9):599-607. doi: 10.4161/hv.9216. Epub 2009 Sep 7.

Abstract

Disproportionality analyses are increasingly gaining acceptance as signal detection tools for drug adverse events. Their application to vaccine adverse events has not been well evaluated. Disproportionality analyses based on the Multi-Item Gamma Poisson Shrinkage principle (MGPS) were applied to spontaneous adverse events reports for five vaccines with different reporting profiles. Sensitivity analyses were used to assess the potential impact of changing key parameters. We used the Company's in-house spontaneous adverse events database. We evaluated the impact of stratification, the comparator dataset and the potential for masking. We conducted a semi-quantitative assessment by comparing the changes in the disproportionality scores and the number of vaccine-event pairs that exceeded an arbitrary threshold as a measure of the impact of any of these choices. The results show that stratification by age and region has a significant impact. The effect of the comparator dataset was dependent on the vaccine being evaluated. The potential for a masking effect was only weakly noticeable. In conclusion, we opt to start with a conservative approach in which we will supplement our primary stratification against the vaccine database with unstratified analyses as well as analyses against the entire database. We recommend that similar studies be performed before introducing disproportionality analyses to a new vaccine adverse events database.

摘要

作为药物不良事件的信号检测工具,不成比例分析越来越受到认可。其在疫苗不良事件中的应用尚未得到充分评估。基于多项目伽马泊松收缩原理(MGPS)的不成比例分析应用于五种具有不同报告特征的疫苗的自发不良事件报告。敏感性分析用于评估关键参数变化的潜在影响。我们使用了公司内部的自发不良事件数据库。我们评估了分层、对照数据集和掩盖可能性的影响。我们通过比较不成比例得分的变化以及超过任意阈值的疫苗-事件对数量来进行半定量评估,以此衡量这些选择中任何一个的影响。结果表明,按年龄和地区分层有显著影响。对照数据集的效果取决于所评估的疫苗。掩盖效应的可能性仅微弱明显。总之,我们选择从保守方法开始,即我们将用未分层分析以及针对整个数据库的分析来补充我们针对疫苗数据库的主要分层。我们建议在将不成比例分析引入新的疫苗不良事件数据库之前进行类似研究。

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型,支持多种主流文档格式。

立即体验