DARWIN EU® Age specific incidence rates of RSV related disease in Europe

Study type

• Study type:
  Non-interventional study

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Respiratory syncytial virus infection

  Respiratory syncytial virus bronchiolitis

  Respiratory syncytial virus bronchitis

  Influenza

  H1N1 influenza

  Pneumonia

  Upper respiratory tract infection
• Additional medical condition(s):
  Acute bronchiolitis due to respiratory syncytial virus, Pneumonia due to respiratory syncytial virus, Acute respiratory syncytial virus bronchitis, Bronchopneumonia due to respiratory syncytial virus, Healthcare associated respiratory syncytial virus disease, Positive sputum culture for hRSV (Human respiratory syncytial virus), Respiratory syncytial virus laryngotracheobronchitis, Respiratory syncytial virus pharyngitis, Bronchiolitis caused by influenza virus

Population studied

• Age groups:
  • Paediatric Population (< 18 years)

    • 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)
• Estimated number of subjects:
  22700000

Study design details

• Study design:
  A cohort study will be conducted using routinely collected health data from 6 databases.
• Main study objective:
  To estimate the incidence of RSV related hospitalizations and the prevalence of RSV co infections with other respiratory pathogens specifically Influenza Viruses Rhinoviruses SARS CoV 2 Parainfluenza Viruses Adenoviruses Metapneumovirus and Enteroviruses in the general population stratified by year and age groups.
• Outcomes:
  RSV related hospitalization ICU admission mortality rate and co infection with a range of other respiratory pathogens including Influenza Viruses Rhinoviruses SARS CoV 2 Parainfluenza Viruses Adenoviruses Metapneumovirus and Enteroviruses.
• Data analysis plan:
  Analyses will be conducted separately for each database. Before study initiation test runs of the analytics are performed on a subset of the data sources or on a simulated set of patients and quality control checks are performed. Once all the tests are passed the final package is released in the version controlled Study Repository for execution against all the participating data sources. The data partners locally execute the analytics against the OMOP CDM in R Studio and review and approve the by default aggregated results before returning them to the Coordination Centre. Sometimes multiple execution iterations are performed and additional fine tuning of the code base is needed. A service desk will be available during the study execution for support. The study results of all data sources are checked after which they are made available to the team and the Study Dissemination Phase can start. All results are locked and timestamped for reproducibility and transparency.