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).;
• Setting:
  This study will be conducted using routinely collected data from 10 data sources in the DARWIN EU® network of data partners from eight European countries, of which six are EU member states. The proposed data covers Northern Europe/Scandinavia (DK, FI, NO, SE), Western Europe (DE, NL, UK), and Southern Europe (ES).
• Outcomes:
  Objective 1 ; The outcomes for this objective are as follows: ; 1. Myocarditis (without a diagnosis of pericarditis on the same date) ; 2. Pericarditis (without a diagnosis of myocarditis on the same date) ; 3. Myo-pericarditis (concomitant diagnosis of myocarditis and pericarditis within 7 days of the first diagnosis of myocarditis or pericarditis) ; ; Three additional outcomes will be studied based on the combination of diagnosis and hospitalisation, ; named as: 4) Hospitalised myocarditis, 5) Hospitalised pericarditis, and 6) Hospitalised myo-pericarditis ; ; Objective 2 ; Key variables for the characterisation planned in Objective 2 include: ; • Signs and symptoms of myocarditis and/or pericarditis: chest pain, palpitations/arrhythmia, dyspnoea in the 30 days before index date ; • Diagnostic work-up: echocardiogram, chest ultrasound scan, thorax CT, cardiac MRI, cardiac/myocardial biopsy, laboratory measurement of troponin/s in the 30 days before and up to 30 days after index date ; • Treatments: aspirin, colchicine, non-steroidal anti-inflammatory drugs, other painkillers in the 30 days after index date ; • Outcomes: all-cause hospitalisation, all-cause ICU admission, length of hospital stay per admission record, and all-cause mortality from day 1 to 30 after index date