ABSTRACT
BACKGROUND: The electronic medical database (EMD) has been increasingly used for clinical research as it reflects a real-world practice with large and heterogeneous samples. However, few studies have reported on the validity of EMD from community hospitals for research purposes. OBJECTIVE: To assess the validity of EMD based on data from patients with atrial fibrillation (AF) receiving care from community hospitals in Phitsanulok Province, Thailand. MATERIAL AND METHOD: The validity of EMD was determined using hand-written out-patient medical records (OPMRs) as a criterion standard. One hundred ninety three records of patient with ICD-10 of AF (148) were retrieved from the EMD of two community hospitals between August 2007 and July 2008. For each patient, data of a randomly selected visit from the EMD was matched to data of the same visit from OPMRs, abstracted by a standardized data collection form. The EMD was cross-validated with OPMRs based on patient's diagnosis of AE co-morbidities (risk factors for stroke) and bleeding events. All data were tabulated in a 2 x 2 format to calculate sensitivity, specificity and the Cohen's Kappa. RESULTS: Out of 193 AF patients retrieved from the EMD, 169 (87.56%) were documented as having a diagnosis of AF in OPMRs. The EMD data on risk factors for stroke showed moderate to high sensitivity (range: 66.67-100%) and high specificity (range: 98.77-100%). The agreement between the two databases was considered good to very good (calculated kappa range: 0.7942-0.9681). The specificity based on major bleeding was 100%; however, sensitivity and the Cohens Kappa could not be determined as the major bleeding diagnosis was found in neither the EMD nor the OPMRs. CONCLUSION: The EMD of AF patients from community hospitals in Phitsanulok was valid and in good agreement with the OPMRs. The EMD from community hospitals appeared suitable for health research in patients with AF