TARGET-EU: Tolvaptan and risk associated to hepatotoxicity in autosomal dominant polycystic kidney disease

Data sources

• Data source(s):
  Clinical Practice Research Datalink
• 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:
  V2.2

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.; ; CPRD is deemed feasible to use as a data source for studying hepatotoxicity risks involved with tolvaptan use. It is expected that the target sample size for intervention and control groups will be reached. Elements with high criticality are available and fairly reliable with sufficient recency, although dispensing data is unavailable, discontinuation must be inferred from prescription duration, and diagnostic coding may be incomplete in some emergency room settings. Some other limitations are present, but these are manageable within the study design.

Data characterisation details

Feasibility Assessment.pdf