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Viability Of Using Electronic Medical Records From European Countries As Data In Novelty (A Novel Observational Longitudinal Study Of Patients With Asthma And/Or Copd)

      Objectives

      NOVELTY is an observational, global 3-year study in nearly 15 000 patients with asthma and/or COPD to identify patient characteristics, treatment patterns, disease burden and phenotypes/endotypes associated with differential outcomes. An electronic medical record (EMR) feasibility study was conducted to optimise NOVELTY design. Data from 6 countries (UK, France, Germany, Italy, Spain, Sweden) are presented.

      Methods

      EMRs from patients with asthma and/or COPD and ≥1 year of data from most recent diagnosis were identified over a 1-year period using diagnostic codes and compared with available national data. EMR variable coverage and completeness relative to the desired NOVELTY protocol were also assessed. Disease severity was classified by an algorithm based on clinical guidelines (drug treatment for asthma; treatment and airflow limitation for COPD).

      Results

      The EMR sample identified 8 401–57 741 patients with asthma and 4 245–67 591 with COPD in the various countries; 3–10% had both diagnoses. EMRs were generally representative of national data for age and gender, and routinely captured demographics, first diagnosis and treatment information. Spirometry, haematology and imaging were not routinely captured. Proportions of patients with insufficient information to classify disease severity were lowest in the UK (23% for asthma and 7% for COPD) and highest in Italy (45% and 48%, respectively).

      Conclusions

      EMRs provide information regarding current clinical practice, diagnosis and disease severity, and insight into the potential patient population for NOVELTY. Many EMR variables important for NOVELTY are not routinely captured.