BY-COVID - WP5 - Baseline Use Case: COVID-19 vaccine effectiveness assessment - Data Management Plan
Contributors
Researchers:
- Francisco Estupiñán Romero (orcid:0000-0002-6285-8120)1
- Javier González Galindo (orcid:0000-0002-8783-5478)1
- Nina Van Goethem (orcid:0000-0001-7316-6990)1
- Santiago Royo-Sierra (orcid:0000-0002-0048-4370)1
- Marjan Meurisse (orcid:0000-0002-4409-0664)1
- ENRIQUE BERNAL-DELGADO (orcid:0000-0002-0961-3298)1
- Ramón Launa Garces (orcid:0000-0003-2922-8749)1
- Natalia Martínez-Lizaga (orcid:0000-0002-9586-7955)1
- Perola, Markus2
- Paajanen, Teemu3, 2
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.
Below is a brief structured description of the research question, the proposed study design, and the cohort definition.
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.
Version 1.0.0 changelog
- DMP updated to include comments from expert external ethical review and add the latest changes in the procedures for data access in the participant institutions
Version 2.0.0 changelog
- DMP updated adding THL datasets management plan
Files
DMP_Beyond_COVID_2.pdf
Additional details
Related works
- Is identical to
- Output management plan: https://argos.openaire.eu/explore-plans/publicOverview/2a2b1e3e-39ef-4916-9431-c644dbe43f19 (URL)
- Is new version of
- Output management plan: https://argos.openaire.eu//external/zenodo/a44aef9a-5cb0-4aa6-af2b-43ea6c037768 (URL)
- Is referenced by
- Journal article: 10.1186/s12874-023-02068-3 (DOI)