BY-COVID - WP5 - Baseline Use Case: COVID-19 vaccine effectiveness assessment - Common Data Model Specification

TY - GEN

T1 - BY-COVID - WP5 - Baseline Use Case: COVID-19 vaccine effectiveness assessment - Common Data Model Specification

AU - Estupiñán-Romero, Francisco

AU - Van Goethem, Nina

AU - Meurisse, Marjan

AU - González-Galindo, Javier

AU - Bernal-Delgado, Enrique

A2 - Saldner, Simon

A2 - Dolanski-Aghamanoukjan, Lorenz

A2 - Degelsegger-Marquez, Alexander

A2 - Martínez-Lizaga, Natalia

PY - 2022/7/27

Y1 - 2022/7/27

N2 - This publication corresponds to the Common Data Model (CDM) specification of the Baseline Use Case proposed in T.5.2 (WP5) in the BY-COVID project on “COVID-19 Vaccine(s) effectiveness in preventing SARS-CoV-2 infection.”Research Question: “How effective have the SARS-CoV-2 vaccination programmes been in preventing SARS-CoV-2 infections?” Intervention (exposure): COVID-19 vaccine(s) Outcome: SARS-CoV-2 infection Mediator: Vaccination schedule (type of vaccine)Study Design: An observational retrospective longitudinal study to assess the effectiveness of the COVID-19 vaccine(s) in preventing SARS-CoV-2 infections using routinely collected social, health and care data from several countries.A causal model was established using Directed Acyclic Graphs (DAGs) to map domain knowledge, theories and assumptions about the causal relationship between exposure and outcome. The DAG developed for the research question of interest is shown below.Cohort definition: All people, eligible to be vaccinated (from 5 to 115 years old, included) or with, at least, one dose of a SARS-CoV-2 vaccine (any of the available brands) having or not a previous SARS-CoV-2 infection. Inclusion criteria: All people vaccinated with at least one dose of the COVID-19 vaccine (any of the available brands) in an area of residence. Any person eligible to be vaccinated (from 5 to 115 years old, included) with a positive diagnosis (irrespective of the type of test) for SARS-CoV-2 infection (COVID-19) during the period of study. Exclusion criteria: People not eligible for the vaccine (from 0 to 4 years old, included) Study period: From the date of the first documented SARS-CoV-2 infection in each country to the most recent date in which data is available at the time of analysis. Roughly from 01-03-2020 to 30-06-2022, depending on the country.

AB - This publication corresponds to the Common Data Model (CDM) specification of the Baseline Use Case proposed in T.5.2 (WP5) in the BY-COVID project on “COVID-19 Vaccine(s) effectiveness in preventing SARS-CoV-2 infection.”Research Question: “How effective have the SARS-CoV-2 vaccination programmes been in preventing SARS-CoV-2 infections?” Intervention (exposure): COVID-19 vaccine(s) Outcome: SARS-CoV-2 infection Mediator: Vaccination schedule (type of vaccine)Study Design: An observational retrospective longitudinal study to assess the effectiveness of the COVID-19 vaccine(s) in preventing SARS-CoV-2 infections using routinely collected social, health and care data from several countries.A causal model was established using Directed Acyclic Graphs (DAGs) to map domain knowledge, theories and assumptions about the causal relationship between exposure and outcome. The DAG developed for the research question of interest is shown below.Cohort definition: All people, eligible to be vaccinated (from 5 to 115 years old, included) or with, at least, one dose of a SARS-CoV-2 vaccine (any of the available brands) having or not a previous SARS-CoV-2 infection. Inclusion criteria: All people vaccinated with at least one dose of the COVID-19 vaccine (any of the available brands) in an area of residence. Any person eligible to be vaccinated (from 5 to 115 years old, included) with a positive diagnosis (irrespective of the type of test) for SARS-CoV-2 infection (COVID-19) during the period of study. Exclusion criteria: People not eligible for the vaccine (from 0 to 4 years old, included) Study period: From the date of the first documented SARS-CoV-2 infection in each country to the most recent date in which data is available at the time of analysis. Roughly from 01-03-2020 to 30-06-2022, depending on the country.

KW - COVID-19

KW - comparative effectiveness

KW - causal inference

KW - international comparison

KW - SARS-CoV-2

KW - common data model

KW - directed acyclic graph

KW - synthetic data

KW - vaccines

U2 - 10.5281/zenodo.6913046

DO - 10.5281/zenodo.6913046

M3 - Other contribution

PB - Zenodo

ER -