接种非典型肺炎-CoV-2 疫苗运动对世界卫生组织药物警戒数据库中比例失调指标的影响:病例/非病例分析中的竞争偏差研究

IF 2.2 4区 医学 Q3 PHARMACOLOGY & PHARMACY Therapie Pub Date : 2024-11-01 DOI:10.1016/j.therap.2024.03.002
Francis Adjaï , Dorine Fournier , Charles Dolladille , Bénédicte Lebrun-Vignes , Kevin Bihan
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引用次数: 0

摘要

导言2019年冠状病毒病(COVID-19)疫苗接种活动导致了大量药物警戒安全报告,这些报告已记录在世界卫生组织(WHO)药物警戒数据库(VigiBase)中,2022年7月占记录病例的10%以上。信息成分(IC)是根据观察到的病例报告数量和预期的病例报告数量计算出来的统计失衡度量。信息成分 95% 可信区间下限的正值(IC0.25)表明药物与不良反应之间可能存在因果关系。本研究旨在评估 COVID-19 疫苗安全性申报浪潮对 Vigilyze IC0.25 的影响,从而以具体实例说明竞争偏倚。方法我们使用监管活动医学字典(MedDRA)首选术语(PTs)任意选择了 21 种药物不良反应,分为两类:已知与 COVID-19 疫苗相关的 PT("预期")和其他 PT("意外")。数据从 VigiLyze 中提取。我们创建了两组:V+(完整数据库,包括 COVID-19 疫苗报告)和 V-(相同提取,不包括 COVID-19 疫苗报告)。我们对 V- 组重新计算了 IC0.25,并比较了两种选择设置(V+ 组和 V- 组)中阳性信号的演变情况。我们观察到,在撤销 COVID-19 报告后,大多数 "意外 "PT 失去了潜在信号。本研究是首次评估 COVID-19 疫苗报告对药物警戒自动信号检测的影响的研究之一。在这项研究中,我们观察到药物警戒报告的浪潮会影响 IC0.25 等比例失调估计值,进而对自动信号检测产生影响;一些信号消失了(几乎所有 PT 都与 COVID-19 疫苗有关),而另一些信号出现了(大部分 PT 与 COVID-19 疫苗无关),这说明了竞争偏差。结论我们的研究表明,涉及药物使用变化的健康危机会影响药物不良反应报告和药物警戒数据库,从而导致竞争偏差和比例失调分析的变化。对于使用比例失调定量分析的卫生专业人员来说,重要的是不仅要使用指标的粗略值,还要使用PTs的种类和信号随时间的变化(考虑到危机等重大事件)。
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Impact of the vaccination against SARS-CoV-2 campaign on disproportionality indicator from the WHO pharmacovigilance database: A competition bias study from case/non-case analysis

Introduction

The coronavirus disease 2019 (COVID-19) vaccination campaign has resulted in numerous pharmacovigilance's safety reports which were recorded in the World Health Organization (WHO) pharmacovigilance database (VigiBase) and represent in July 2022 more than 10% of cases recorded. The information component (IC) is a statistical disproportionality measure based on the observed and expected numbers of case reports. A positive value of the lower endpoint of a 95% credibility interval for the information component (IC0.25) suggests a possible causal relationship between the drug and the adverse reaction. This study aimed to evaluate the impact of the wave of COVID-19 vaccines safety declarations on IC0.25 from Vigilyze and thus illustrate with a concrete example the competition bias.

Methods

We arbitrarily selected 21 adverse drug reactions using Medical Dictionary for Regulatory Activities (MedDRA) preferred terms (PTs), divided in two types: PTs known to be related to COVID-19 vaccines (“expected”) and others (type “unexpected”). Data were extracted from VigiLyze. We created two groups: V+ (the full database, including COVID-19 vaccines reports) and V− (the same extraction without COVID-19 vaccine reports). IC0.25 was recomputed for the group V− and we compared the positive signal evolution in the two settings of selection (V+ and V− groups).

Results

The number of positive potential signals was significantly different in the groups V+ and V− for IC0.25. We observed that most of the “unexpected” PTs lost potential signal after the withdrawal of COVID-19 reports. On the contrary, the majority of ‘expected’ PTs had potential new signals after the withdrawal of COVID-19 reports.

Discussion

This study is one of the first to evaluate the effect of COVID-19 vaccines reporting on Automated Signal Detection of Pharmacovigilance. In this study, we observed that a wave of pharmacovigilance reporting can affect disproportionality estimators such as IC0.25 and then have an impact on automated signal detection; some signals disappear (almost with all PTs related to COVID-19 vaccines) and others appear (mostly with PTs not related to COVID-19 vaccines), illustrating the competition bias.

Conclusion

We show that a health crisis involving a change in drug use can affect adverse drug reactions reporting and pharmacovigilance databases, leading to competition bias and a change in the disproportionality analyses. For health professionals who use quantitative disproportionality analysis, it is important not only to use the crude values of indicators but also the kind of PTs and the evolution of the signal over time (take into account major events such as crises).
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来源期刊
Therapie
Therapie 医学-药学
CiteScore
3.50
自引率
7.70%
发文量
132
审稿时长
57 days
期刊介绍: Thérapie is a peer-reviewed journal devoted to Clinical Pharmacology, Therapeutics, Pharmacokinetics, Pharmacovigilance, Addictovigilance, Social Pharmacology, Pharmacoepidemiology, Pharmacoeconomics and Evidence-Based-Medicine. Thérapie publishes in French or in English original articles, general reviews, letters to the editor reporting original findings, correspondence relating to articles or letters published in the Journal, short articles, editorials on up-to-date topics, Pharmacovigilance or Addictovigilance reports that follow the French "guidelines" concerning good practice in pharmacovigilance publications. The journal also publishes thematic issues on topical subject. The journal is indexed in the main international data bases and notably in: Biosis Previews/Biological Abstracts, Embase/Excerpta Medica, Medline/Index Medicus, Science Citation Index.
期刊最新文献
Contents Editorial board The Christmas adverse event syndrome: An analysis of the WHO pharmacovigilance database Impact of the vaccination against SARS-CoV-2 campaign on disproportionality indicator from the WHO pharmacovigilance database: A competition bias study from case/non-case analysis Hospitalized cocaine detoxification patients in Paris, France: Increased patient levels and changing population characteristics since 2011
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