Liverpool Adverse Events Profile: Italian validation and predictive value for dropout from antiepileptic treatment in people with epilepsy

Introduction: Adverse events (AEs) of antiepileptic drugs (AEDs) affect patient compliance and dropout. No questionnaire measuring AEs of AEDs is available for Italian-speaking people with epilepsy. Moreover, no questionnaire has been shown to predict patient dropout. Objective: The aim of this study was to provide a validated Italian version of the Liverpool Adverse Events Profile (iLAEP) and to define iLAEP reliability in AE monitoring and dropout risk prediction. Methods: The original LAEP was translated and tested for internal consistency and reliability. Patients with epilepsy who are on stable AED regimen completed the questionnaire as well as a 3-month follow-up to assess dropouts. Results: Overall, 204 patients with epilepsy were enrolled (mean age: 47.1 ± 21.5). High internal consistency (Cronbach's α = 0.88) was demonstrated, and very quick completion time was registered (mean = 9 min). A 3-month follow-up was performed to assess treatment discontinuation and potential predictive value of the iLAEP score. Treatment was discontinued in 33.3% of the cohort. Moreover, iLAEP scores (mean = 30.71) significantly differed between patients interrupting (39.15 ± 5.66) and those prosecuting treatment (29.4 ± 6.54, p <.001). A cutoff of 36.5 had an 85% accuracy in predicting treatment discontinuation (85% sensitivity, 79% specificity). Scores > 36.5 were associated with a 20.27-fold increase in dropout relative risk (RR), with a 66% positive predictive value. Conclusions: The iLAEP represents a reliable, quick, and inexpensive assessment tool for patient-reported AEs of AEDs. An iLAEP cutoff of 36.5 differentiates patients unlikely to interrupt treatment from those more prone to stop AEDs in the following 3 months. The iLAEP might help clinicians in weighting the risk of dropout and better tailor treatment to patients.