OBJECTIVES: Databases integrating electronic medical records (EMRs) offer great potential for observational research and evidence generation. This study evaluates the population representativeness and external validity of TELOTRON^® as a source for retrospective observational research.

METHODS: An observational-retrospective study was carried out based on the Spanish anonymized database TELOTRON^®. The database, established in 2012, contains longitudinal real-world-data from primary care, specialties and hospital, encompassing approximately 2.2 million Spanish patients. Population representativeness was assessed comparing TELOTRON^®’s demographic distribution with 2022 Spanish population data from the National Institute of Statistics. External validity was evaluated comparing disease prevalences (arterial hypertension, diabetes, dyslipidemia, bronchial asthma, chronic obstructive pulmonary disease, depressive syndrome, hypothyroidism, osteoporosis, ischemic heart disease, cerebrovascular disease and heart failure) with 2022 report of the Spanish National Health System (BDCAP) and drug dispensations by Anatomical Therapeutic Chemical Classification (ATC) with 2023 Ministry of Health data. Descriptive statistics and Pearson's correlation were used to determine concordance.

RESULTS: TELOTRON^® population distribution (age and sex) was comparable to Spanish population (r=0.971), with an average difference of 0.2%. For disease prevalences, the average difference was 0.96%, median 0.46%. Depressive syndrome showed the greatest difference (4.7% BDCAP; 9.8% TELOTRON^®), followed by hypothyroidism (6.4% BDCAP; 4.5% TELOTRON^®). The most prevalent disease was dyslipidemia (21.5% BDCAP; 22.4% TELOTRON^®) and the least prevalent was heart failure (1.2% BDCAP; 1.3% TELOTRON^®). Prescription data showed strong correlation with Ministry of health data, r=0.997 (ATC1), r=0.994 (ATC2) and r=0.982 (ATC3), with an average difference of 0.50%. The biggest difference was observed in the therapeutic group A02 (1.8%).

CONCLUSIONS: The Spanish database TELOTRON^® effectively mirrors the Spanish population in demographic and health-related data with respect to the data sources consulted. TELOTRON^® is shown as a reliable source for real-world evidence research in Spain in terms of representativeness and external validity of its records.