TARGET EU: The risk of angiooedema and other safety events in heart failure patients treated with sacubitril/valsartan compared to angiotensin-converting enzyme inhibitors

ENCePP Code of conduct

Yes

Data sources

• Data source(s):
  Clinical Practice Research Datalink

  PHARMO Data Network
• 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, both CPRD and PHARMO were deemed feasible data sources for studying SV and the risk of angioedema, with achievable sample sizes and reasonably up-to-date data. Both data sources provide data of good recency but certain limitations were identified. For CPRD these were that it lacks dispensing information and may have incomplete diagnostic coding in some settings, while for PHARMO this was that it has 70%-100% completeness in most of the variables.

Data characterisation details

CS6_Feasibility Assessment.pdf