Validação psicométrica da versão português-Brasil do Liverpool Adverse Events Profile (LAEP) em pacientes com epilepsia parcial sintomática e epilepsia generalizada idiopática. / Psychometric Validation of the Portuguese-Brazilian Version of the Liverpool Adverse Events Profile in Patients with Symptomatic Partial and Idiopathic Generalized Epilepsies

Heloise Helena Martins

Purpose: To report the translation, cultural adaptation and validation of the Liverpool Adverse Events Profile (LAEP) into a PortugueseBrazilian version and evaluate its reliability and validity in patients with symptomatic partial (SPE) and idiopathic generalized epilepsies (IGE) (ILAE, 1989). LAEP is a scale to measure patients perception about adverse effects (AEs) of antiepileptic drugs (AEDs). Methods: Patients (literate, >18yrs.) who were taking AEDs at a stable dose for at least one month were recruited for LAEP (19 questions). This version was administered to a group of consecutive outpatients in the Epilepsy Section of Hospital São Paulo. Testretest reliability was determined through intra-class coefficient (ICC) after 2 weeks and internal consistency by Cronbachs alpha coefficient (CAC). Construct validity was accessed by sociodemographic/clinical evaluation, The Hospital Anxiety and Depression Scale (HADS) and Quality of Life in Epilepsy-31 Inventory (QOLIE-31), both validated previously to Portuguese. Pearsons correlation coefficient was used to analyse the association between LAEP and other instruments. Analyses of variance, t-Students for independent samples, Fishers exact, Mann-Whitneys tests were used for sociodemographic/clinical variables. P values less than 0.050 were considered statistically significant. Results: 100 patients were included: 61 (61.0%) with SPE and 39 (39.0%) with IGE (mean age 34.5; SD=12.12yrs), 56 females. Polytherapy (2 or more AEDs) were used by 69 (69,0%) patients. Carbamazepine (CBZ) was the most commonly used AED (43%). LAEP mean score was 37.6 (SD=13.35), and the most common AEs were Sleepiness (35.0%), Memory problems (35.0%) and Difficulty in concentrating (25.0%). The internal consistency was high (CAC=0.903; 0.872- 0.928). The reliability was satisfactory in general and ICC ranged from 0.370 (Unsteadiness) to 0.737 (Dizziness). The items with lower ICC (Unsteadiness, Problems with mouth and gums, Weight gain) were those which are better confirmed during medical physical examination. Correlation between LAEP and QOLIE-31 was high (r=-0.804, p>0.001) and occurrence of AEs were associated with worse QOLIE-31 and HADS results. Higher LAEP scores were associated to number of AEDs (p=0.005), female gender (p<0.001), older age (34.5-70yrs.) (p<0,001) and the presence of uncontrolled seizures (p=0.045). LAEP total scores in the two epilepsy groups were similar. Variables that influenced global LAEP in IGE were seizure frequency (p=0.050), generalized tonic-clonic seizures in the last month (p=0.031) and polytherapy with 3 or more AEDs (p=0.003); in SPE, only polytherapy (p=0.003). Higher CBZ doses (>800mg) showed lower scores in: Nervousness and or/agitation (p=0.006), Hair Loss (p=0.045), Difficulty in concentrating (p=0.003), Problems with mouth and gums (p=0.001), Depression (p=0.042), and overall score (p=0.025). Regarding higher valproic acid doses (>1000mg), Unsteadiness (p=0.005) and Feelings of aggression (p=0.037) were more frequently reported. Conclusion: The Portuguese-Brazilian version of LAEP was confirmed as a reliable and valid instrument for assessing AEs in patients with epilepsy with important restraints in physical symptoms. This study demonstrated that LAEP items were associated to specific AEs of AEDs without a clear dose dependent pattern. Although LAEP overall score was not helpful for differentiating AEs in distinct epilepsies such EPS and EGI this subjective questionnaire may be useful for continued screening of patients in clinical trials with AEDs that affect the items studied by this scale.

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