Francis Adjaï , Dorine Fournier , Charles Dolladille , Bénédicte Lebrun-Vignes , Kevin Bihan
{"title":"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","authors":"Francis Adjaï , Dorine Fournier , Charles Dolladille , Bénédicte Lebrun-Vignes , Kevin Bihan","doi":"10.1016/j.therap.2024.03.002","DOIUrl":null,"url":null,"abstract":"<div><h3>Introduction</h3><div>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 (IC<sub>0.25</sub>) 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 IC<sub>0.25</sub> from Vigilyze and thus illustrate with a concrete example the competition bias.</div></div><div><h3>Methods</h3><div>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). IC<sub>0.25</sub> was recomputed for the group V− and we compared the positive signal evolution in the two settings of selection (V+ and V− groups).</div></div><div><h3>Results</h3><div>The number of positive potential signals was significantly different in the groups V+ and V− for IC<sub>0.25</sub>. 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.</div></div><div><h3>Discussion</h3><div>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 IC<sub>0.25</sub> 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.</div></div><div><h3>Conclusion</h3><div>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).</div></div>","PeriodicalId":23147,"journal":{"name":"Therapie","volume":"79 6","pages":"Pages 680-691"},"PeriodicalIF":2.2000,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"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\",\"authors\":\"Francis Adjaï , Dorine Fournier , Charles Dolladille , Bénédicte Lebrun-Vignes , Kevin Bihan\",\"doi\":\"10.1016/j.therap.2024.03.002\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Introduction</h3><div>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 (IC<sub>0.25</sub>) 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 IC<sub>0.25</sub> from Vigilyze and thus illustrate with a concrete example the competition bias.</div></div><div><h3>Methods</h3><div>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). IC<sub>0.25</sub> was recomputed for the group V− and we compared the positive signal evolution in the two settings of selection (V+ and V− groups).</div></div><div><h3>Results</h3><div>The number of positive potential signals was significantly different in the groups V+ and V− for IC<sub>0.25</sub>. 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.</div></div><div><h3>Discussion</h3><div>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 IC<sub>0.25</sub> 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.</div></div><div><h3>Conclusion</h3><div>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).</div></div>\",\"PeriodicalId\":23147,\"journal\":{\"name\":\"Therapie\",\"volume\":\"79 6\",\"pages\":\"Pages 680-691\"},\"PeriodicalIF\":2.2000,\"publicationDate\":\"2024-11-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Therapie\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0040595724000398\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"PHARMACOLOGY & PHARMACY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Therapie","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0040595724000398","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
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).
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.