Validity of Chronic Venous Disease Diagnoses and Epidemiology Using Validated Electronic Health Records From Primary Care: A Real-World Data Analysis.

PURPOSE: The aim of this study was to evaluate the validity of lower limb chronic venous disease (CVD) diagnoses entered in a large electronic health record database in primary care in Catalonia, Spain; to investigate the reliability of these data for research purposes; and to estimate the prevalence and incidence of CVD, chronic venous insufficiency (CVI), and venous leg ulcer (VLU).

DESIGN

Real-world data analysis based on a large electronic health record database in primary care in Catalonia, Spain.

METHODS

We used a primary care research database (Information System for the Development of Research in Primary Care [SIDIAP]), which contains anonymous data on some 5.8 million people from 279 primary care centers, accounting for more than 80% of the Catalonian population and 15% of the Spanish population. We evaluated the validity of the ICD-10 codes for CVD in SIDIAP for 200 adult patients through the responses of 20 primary care physicians to a questionnaire.

FINDINGS: The positive predictive value of CVD in SIDIAP was 89.95% (95% confidence interval [CI] 84.99-93.40). The prevalence rates for CVD, CVI, and VLU were 9.54% (95% CI 9.51-9.56), 3.87%, and 0.33%, respectively. The incidence rates for CVD, CVI, and VLU were 7.91/1,000 person-years (95% CI 7.82-8.00), 3.37/1,000 person-years (95% CI 3.31-3.43), and 0.23/1,000 person-years (95% CI 0.21-0.24), respectively.

CONCLUSIONS

The Catalonian SIDIAP database contains valid CVD diagnoses. The prevalence and incidence rates found using real-world data are low compared with those in the literature, possibly because CVD is an underdiagnosed entity.

CLINICAL RELEVANCE: Real-world data can inform clinicians on lower limb venous health in a population, show changes as individuals age, and reveal aspects where healthcare can be improved.