A modified self-controlled case series method for event-dependent exposures and high event-related mortality, with application to COVID-19 vaccine safety
© 2022 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd..
We propose a modified self-controlled case series (SCCS) method to handle both event-dependent exposures and high event-related mortality. This development is motivated by an epidemiological study undertaken in France to quantify potential risks of cardiovascular events associated with COVID-19 vaccines. Event-dependence of vaccinations, and high event-related mortality, are likely to arise in other SCCS studies of COVID-19 vaccine safety. Using this case study and simulations to broaden its scope, we explore these features and the biases they may generate, implement the modified SCCS model, illustrate some of the properties of this model, and develop a new test for presence of a dose effect. The model we propose has wider application, notably when the event of interest is death.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:41 |
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| Enthalten in: |
Statistics in medicine - 41(2022), 10 vom: 10. Mai, Seite 1735-1750 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Ghebremichael-Weldeselassie, Yonas [VerfasserIn] |
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| Links: |
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| Themen: |
COVID-19 |
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| Anmerkungen: |
Date Completed 12.04.2022 Date Revised 29.07.2022 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1002/sim.9325 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM336263260 |
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| 520 | |a © 2022 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd. | ||
| 520 | |a We propose a modified self-controlled case series (SCCS) method to handle both event-dependent exposures and high event-related mortality. This development is motivated by an epidemiological study undertaken in France to quantify potential risks of cardiovascular events associated with COVID-19 vaccines. Event-dependence of vaccinations, and high event-related mortality, are likely to arise in other SCCS studies of COVID-19 vaccine safety. Using this case study and simulations to broaden its scope, we explore these features and the biases they may generate, implement the modified SCCS model, illustrate some of the properties of this model, and develop a new test for presence of a dose effect. The model we propose has wider application, notably when the event of interest is death | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a COVID-19 | |
| 650 | 4 | |a cardiovascular events | |
| 650 | 4 | |a epidemiological methods | |
| 650 | 4 | |a self-controlled case series | |
| 650 | 4 | |a vaccines | |
| 650 | 7 | |a COVID-19 Vaccines |2 NLM | |
| 700 | 1 | |a Jabagi, Marie Joëlle |e verfasserin |4 aut | |
| 700 | 1 | |a Botton, Jérémie |e verfasserin |4 aut | |
| 700 | 1 | |a Bertrand, Marion |e verfasserin |4 aut | |
| 700 | 1 | |a Baricault, Bérangère |e verfasserin |4 aut | |
| 700 | 1 | |a Drouin, Jérôme |e verfasserin |4 aut | |
| 700 | 1 | |a Weill, Alain |e verfasserin |4 aut | |
| 700 | 1 | |a Zureik, Mahmoud |e verfasserin |4 aut | |
| 700 | 1 | |a Dray-Spira, Rosemary |e verfasserin |4 aut | |
| 700 | 1 | |a Farrington, Paddy |e verfasserin |4 aut | |
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