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Published February 9, 2023 | Version 0.0.1
Output management plan Open

BY-COVID - WP5 - Baseline Use Case: COVID-19 vaccine effectiveness assessment - Data Management Plan

  • 1. Health Sciences Institute in Aragon (IACS)
  • 2. Sciensano
  • 1. Sciensano
  • 2. Aragon Health Sciences Institute (IACS)

Description

This publication corresponds to the Data Management Plan (DMP) for 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.”

This use case aims to investigate the real-world effectiveness of SARS-CoV-2 primary vaccination compared to partial or no vaccination in preventing SARS-CoV-2 infection in virtually all resident populations spanning different countries. The study will be conducted in two sequential stages, expanding the exercise to several countries/regions:

  • Stage I (pilot): Aragon (Spain) and Belgium.
  • Stage II: Aragon (Spain), Belgium, Austria, Finland, Norway, Estonia and The Netherlands. The participation of these countries/regions is conditional on data access.

A brief structured description of the research question, the proposed study design, and the cohort definition is provided below. 

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

Subgroup analysis: 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.

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 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.

This DMP follows the guidelines and principles of the BY-COVID - Deliverable 8.2.2 Project Data Management Plan

 

Notes

The contents of this document are the sole responsibility of their authors. All rights reserved. Copying and distribution by any means are permitted provided that the authors are acknowledged, that no commercial use is made of the works and that no modifications are made (CC-BY NC INT 4.0.).

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DMP_Beyond COVID_0.pdf

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Additional details

Related works

Is supplemented by
Proposal: 10.5281/zenodo.7551181 (DOI)
Other: 10.5281/zenodo.6913045 (DOI)

Funding

BY-COVID – Beyond COVID 101046203
European Commission