DARWIN EU® - Characterising the incidence and presentation of myocarditis and/or pericarditis in Europe

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Myocarditis

  Pericarditis

Population studied

• Short description of the study population:
  Objective 1 - General population: ; The study population will include all individuals observed in each of the participating data sources during the study period who have at least 365 days of data visibility before entering the cohort. The index date of cohort entry will be 1st January 2015 or the date each individual fulfils the eligibility criteria (details in Section 8.6.1.).; Objective 2 - Cohort of people with a diagnosis of myocarditis and/or pericarditis; The study population will include all individuals in each of the participating data sources during the study period who have at least 365 days of data visibility when they have a diagnosis of myocarditis and/or pericarditis and at least 90 days without a record of that same event. The index date will be the date of diagnosis of an eligible myocarditis and/or pericarditis event, i.e., the date of diagnosis/recording of a myocarditis and/or pericarditis after 365 days of data visibility and a 90-day washout (see Section 8.6.1.).;
• Age groups:
  • In utero
  • Paediatric Population (< 18 years)

    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Study design details

• Study design:
  A population-based cohort and a cohort characterisation studies will be conducted
• Main study objective:
  1. To estimate the age-standardised incidence rates of myocarditis and/or pericarditis; and the crude incidence rates of myocarditis and/or pericarditis stratified by age and sex, by data source, and by calendar year.; 2. To characterise the signs/symptoms, diagnostic procedures (imaging, laboratory measurements, and biopsy), treatment/s, and outcomes (hospitalisation, Intensive Care Unit [ICU] admission, length of hospital stay, mortality) of myocarditis and/or pericarditis as recorded in Real World Data within the DARWIN EU® network during the month before and up to 1 month after diagnosis (of myocarditis and/or pericarditis).;