DARWIN EU® - Descriptive study of tetanus immunoglobulin use and tetanus-prone wounds in Europe

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J06AA02) tetanus antitoxin

  tetanus antitoxin

  (J06BB02) tetanus immunoglobulin

  tetanus immunoglobulin

Population studied

• Short description of the study population:
  All individuals registered in the respective database between 1st of January 2017 and 31st of December 2023 (or latest date available). For estimation of incidence rates, individuals must have at least 1 year of data visibility prior to becoming eligible for study inclusion. However, no such requirement will be applied for prevalence and treatment rate analyses. Children aged <1 year of age will be excluded

Study design details

• Study design:
  A cohort study will be conducted using routinely collected health data from 6 data sources.
• Main study objective:
  Research question; What is the incidence and prevalence of tetanus immunoglobulins use and tetanus-prone wounds over time across Europe?; Study objectives; 1. To estimate incidence, prevalence, and treatment rate of tetanus immunoglobulins use in the general population, overall and stratified by calendar year.; 2. To estimate incidence rate and prevalence of tetanus-prone wounds in the general population, overall and stratified by calendar year and type of wound.;
• Setting:
  The study will be conducted using routinely collected data from 6 data sources in 6 European countries (5 EU countries and the United Kingdom). ; All databases were previously mapped to the OMOP Common Data Model (CDM).