TARGET-EU: Effectiveness of nirsevimab for RSV-lower respiratory tract infection hospitalization in infants ≤12 months of age

Data sources

• Data source(s):
  Pedianet
• Data sources (types):
  Electronic healthcare records (EHR)

Use of a Common Data Model (CDM)

• CDM mapping:
  Yes

CDM Mappings

• CDM name:
  ConcepTION CDM
• CDM website:
  https://www.imi-conception.eu/
• CDM release frequency:
  6 months

• CDM version:
  v 2.2

Data quality specifications

• Check conformance:
  Yes
• Check completeness:
  Yes
• Check stability:
  Yes
• Check logical consistency:
  Yes

Data characterisation

• Data characterisation conducted:
  Yes
• Data characterisation details:
  The feasibility assessment for this case study, detailed in the appendix of the study protocol, was conducted as part of the broader TARGET-EU feasibility assessment (EUPAS1000000791). Data source suitability was evaluated using a structured framework based on the EMA data quality framework, assessing system characteristics, data quality, and fitness for the research question.; ; Briefly, with an approximate estimated sample size of 7,408 individuals and considering that PEDIANET includes data on 24,572 toddlers aged between 28 days and 23 months, and ~ 30K births every year it offers large, high-quality, population-based electronic health records of the paediatric population in Italy. It provides the required data elements to operationalize the study design, including demographics, diagnoses, prescriptions, immunization registry and hospitalizations.