TARGET-EU: Risk of adverse birth and neurodevelopmental outcomes in children born alive to fathers exposed to valproate versus levetiracetam for generalised epilepsy

Data sources

• Data source(s):
  The Valencia Health System Integrated Database
• 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

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, VID was deemed feasible for the study question, with some limitations. The most important ones are the lack of some variables like intention to conceive, female partner-related selection criteria, and some outcomes (stillbirth and spontaneous abortion) which lead to changes in the protocol, such as adaptations of the research question and data analysis. Achieving sufficient sample size was flagged as a potential limitation.