TARGET-EU: Comparison of single-device vilanterol/fluticasone furoate with other single-device inhaled corticosteroid and long-acting beta agonist combinations in the risk of pneumonia in adolescents with asthma

ENCePP Code of conduct

Yes

Data sources

• Data source(s):
  Clinical Practice Research Datalink

  Terveydenhuollon hoitoilmoitusrekisteri (Finland Care Register for Health Care)
• Data source(s), other:
  Finnish national registers (population information system, KANTA electronic dispensings, causes of death, special reimbursements, Care Register for Health Care)
• Data sources (types):
  Electronic healthcare records (EHR)

  Population registry

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 moment:
  after data extraction

  after extract-transform-load to a common data model

  after creation of study variables
• 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.; Finnish national registers and CPRD were selected as data sources for this study because they offer large, high-quality, population-based electronic health records with national coverage in Finland and the UK, respectively. Both sources provide the required data elements to operationalise the study design and have been used in regulatory studies and are known to support the emulation of clinical trial eligibility criteria and endpoints. Data extraction and feasibility assessments confirm that the study variables are available with sufficient completeness and temporal coverage to support the research objectives.

Data characterisation details

CS5_Feasibility Assessment.pdf