Data characterization of population-based data sources: ConcePTION pipeline

Study type

• Study type:
  Non-interventional study

Non-interventional study

• Non-interventional study design:
  Other

Population studied

• Age groups:
  • 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)
• Estimated number of subjects:
  36320000

Study design details

• Main study objective:
  To assess integrity of the ETL and internal consistency of the CDM instance for each DAP. To produce high-level characterization results describing the final outcomes of these checks in terms of missingness in key variables, distributions of key variables, and internal inconsistency. To assess the data quality and determine 'fit for purpose' for studies on drugs safety and utilization.
• Data analysis plan:
  First, we will construct frequency tables based on categorical data and we will plot the distribution of continuous variables and dates. We will use these outputs to identify outlinear, picks, drops, and trends on the data sources. After we will analyzed the missing data pattern, repeated events and incidence rate. Last, we will check the compliance with conception CDM.