Abstracts

Rationale: Background: Adverse event profile (AEP) scale has been proved to be a useful tool to detect and quantify adverse effects of antiepileptic drugs (AEDs) in clinical practice. Administration of this simple questionnaire helps to manage adverse effects and improve quality of life of patients with epilepsy. The objective of the study was to elaborate and validate a version of the AEP in Spanish. Methods: The cultural adapatation of the AEP scale was performed according to the usual procedure: translation, retroversion, inspection for lexical equivalence and content validaty; preliminary validity was tested in 10 patients. The questionnaire was later administered to 237 patients with epilepsy, treated with one or more AEDs, recruited in outpatient epilepsy clinics of Spain. Three months after first visit, it was readministered to a subgroup of 50 patients in whom no changes in medications were done for test-retest reliability. Patients were administered also the QUOLIE-31 and the Hospital Anxiety and Depression Scale (HADS). The viability of the questionnaire was measured by means of the lost answers, together with the time needed to complete it. The patient and doctor perception about the easiness and possible usefulness of the scale in clinical daily practice were also described. Percentages of patients with minimum and maximum scores were also evaluated. Internal consistency was measured obtaining the Cronbach alfa for all the items and test retest reliability was calculated with the intraclass correlation coefficient. Convergent validity was estimated by the correlation between the Spanish version of AEP and the score in the QOLIE-31, mainly with the dimension of QUOLIE related to antiepileptic drugs adverse effects. Results: Ninety percent of questionnaires administered on the first visit were valid. Seventy nine per cent of patients considered the questionnaire very easy or reasonably easy to complete. Only 3 patients (1.1%) had the lowest possible score on the scale; No patients had the highest score. Median time to fill in the questionnaire was 6.5 minutes Chronbach alpha for the totality of items in AEP was 0.84. Intraclass correlation coefficient was 0.81. Score in AEP correlated with patient perception of medication adverse effects and with score in medication dimension of QOLIE-31. Patients with AEP score indicative of toxicity (>45) had significantly worse quality of life as evidenced by scores in QUOLIE-31 than patients with scores not indicative of toxicity (<45). Score in AEP also correlated with score in HADS. Conclusions: The Spanish version of the AEP seems to be a valid, reliable and consistent tool to evaluate adverse effects of AEDs in people with epilepsy (the study was supported by UCB Pharma)