观察分析与预期分析——它如何适合药物警戒工具包?

IF 3.8 2区 医学 Q1 PHARMACOLOGY & PHARMACY
Lionel Van Holle
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引用次数: 0

摘要

观察值与预期值(O/E)分析已以前所未有的规模用于COVID-19大规模疫苗接种的安全监测。它们的使用范围改变了它的本质,它由医学专业知识和流行病学的混合组成,变得更加算法化和自动化。通过这样做,观察到的与预期的分析变得更接近歧化分析(DPA),这也是一种观察到的与预期的分析,在计算预期的方式上有所不同。对这两种方法的优势和局限性进行定性评估后得出结论:算法O/E更有可能低估低报,更有可能对感兴趣的条件定义的不对称差异敏感,并且更依赖于更多种类的数据源或医学知识,这些数据源或医学知识可能对新出现的安全问题(暴露、背景发病率和风险窗口)不准确。如果对常规的歧化进行一些调整(分层和/或亚分组),使之成为有针对性的歧化,这将解释疫苗的流行病学特征和感兴趣的事件,那么有针对性的DPA就有可能从信号检测方法提升为信号评估方法,从而有利地取代算法的O/E分析。对敏感性分析框架的建立进行研究,整合歧化设置的几个标准化选择,以及每种选择的偏差测量(定性或定量),对于药物警戒领域来说,可能比设计用于O/E分析的唯一目的来估计特殊不良事件的背景发生率的研究更有益。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Observed Versus Expected Analysis-How Does It Fit in the Pharmacovigilance Toolkit?

Observed versus expected (O/E) analyses have been used in an unprecedented scale for the safety monitoring of the COVID-19 mass vaccination. The extent of their usage changed its nature, which consisted of a mixture of medical expertise and epidemiology, into something more algorithmic and automated. By doing so, the observed versus expected analysis became closer to disproportionality analysis (DPA), which is also a type of observed versus expected analysis that differs in the way the expected is calculated. A qualitative assessment of the strengths and limitations of both methods concludes that the algorithmic O/E is more likely to underestimate under-reporting, is more likely to be sensitive to asymmetrical differences in the definition of the condition of interest, and is more dependent on a greater variety of data sources or medical knowledge that might not be accurate for emerging safety issues (exposure, background incidence rate, and risk window). Provided some adjustment (stratification and/or subgrouping) of the routine disproportionality into a targeted disproportionality occurs, which would account for the epidemiological specifics of the vaccine and event-of-interest, the targeted DPA has the potential to be promoted from a signal detection method into a signal evaluation method that could advantageously replace the algorithmic O/E analysis. Research on the setup of a sensitivity analysis framework integrating several standardized choices of disproportionality settings, along with measures (qualitative or quantitative) of the biases for each choice, could be more beneficial for the pharmacovigilance field than studies designed to estimate the background incidence rates of adverse events of special interest for the sole purpose of being used in O/E analyses.

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来源期刊
Drug Safety
Drug Safety 医学-毒理学
CiteScore
7.60
自引率
7.10%
发文量
112
审稿时长
6-12 weeks
期刊介绍: Drug Safety is the official journal of the International Society of Pharmacovigilance. The journal includes: Overviews of contentious or emerging issues. Comprehensive narrative reviews that provide an authoritative source of information on epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes. In-depth benefit-risk assessment of adverse effect and efficacy data for a drug in a defined therapeutic area. Systematic reviews (with or without meta-analyses) that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics. Editorials and commentaries on topical issues. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Drug Safety Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.
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