SAFETY-VAC: Phenotype proposal and rates of immunocompromised populations in real-world data sources.

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Method development or testing
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Population studied

• Short description of the study population:
  Electronic health records of people from 10 data sources in 7 countries in Europe from January 1st, 2017, until the last data availability were selected. ; Persons were included in the study population when they had:; - Information on age and gender available,; - At least one day of follow in the study period (1/1/2017- latest availability).; Follow-up started at the latest date of any of the following dates: day that one year of lookback is available during the study period, or at 1/1/2017 when the person is born in the data base.; Follow-up finished at the earliest of the following dates: death, disenrollment, end of study period, or recommended end date.
• Age groups:
  • Paediatric Population (< 18 years)
  • Adult and elderly population (≥18 years)

Study design details

• Study design:
  - Scoping review aimed at describing and identifying immunocompromised populations in epidemiological studies using EHRs.; - Retrospective cohort study from January 1, 2017, to the last available data aimed at identifying and characterizing these populations using RWD.
• Main study objective:
  - To describe what operational definitions are used to identify immunocompromised populations when conducting epidemiological research in EHR databases and propose a phenotype to identify immunocompromised individuals in database studies correctly.; - To estimate the incidence and one-year prevalence rates of immunocompromised status based on the agreed phenotype and different durations of episodes.; - To assess the contribution of different provenances of data and durations to the prevalence of the immunocompromised status.;
• Setting:
  The study will use data from 10 secondary electronic health record databases that are population-based in 7 countries in Europe (UK, Spain, Denmark, Finland, Norway, Italy and France). ; The study will be conducted during the period from January 1st, 2017, to the last data availability, specific for each data source.; The source population comprises all persons in the data sources who can be potentially included in the study.