Abstract
Potential adverse drug events can be signaled in Clinical Decision Support Systems (CDSSs). This study validated a Swedish CDSS (Janusmed Risk Profile) by investigating associations between calculated risk classifications of drugs with QT-prolonging potential and registered related clinical outcomes. Subjects living in Kalmar County, Sweden, between 2011 and 2020 exposed to risk drugs (risk level I: somewhat increased risk, II: moderate increased risk, III: significant increased risk) were extracted from regional electronic health records and matched to controls (risk level 0: no known increased risk) by age, sex, and index date. Ventricular arrhythmia (VA), Torsade de Pointes, cardiac arrest and death were outcomes followed for one year. Logistic regression analysis was performed adjusted for age, sex, number of drugs, days in hospital and previous diagnosis. Among the 188,453 subjects, a higher proportion of those classified by the CDSS as having a risk of QT prolongation experienced VA compared to controls (risk level I = 0.26%, II = 0.34%, III = 0.71% vs risk level 0 = 0.17%). When adjusting for other risk factors, the association decreased, but risk level III remained significant with OR 2.1 (95% CI 1.6-2.9) compared to controls. Similar results were seen for the other outcomes. Although there was an association between CDSS risk classifications and clinical outcomes, only a few subjects are affected, and other factors, such as previous diagnosis, play an important role. The need for multifactorial CDSS algorithms is thus crucial to better guide prescribers in finding high-risk patients.