Introduction: Epilepsy patients not only have to deal with the disease itself but also the side effects of some treatments, fear about sudden occurrence of seizures, stigmatization, and restrictions in activities of daily living. For this reason, it is accepted that seizure control is only one feature of the clinical management of epilepsy, since cognitive, physical and psychological deterioration also affects quality of life. It is essential to have measurement tools that rapidly and accurately evaluate the complex aspects included in the concept of quality of life in persons with epilepsy. This study has aimed to validate the specific Health-Related Quality of Life (HRQoL) questionnaire for epileptic patients, QOLIE-10 (Quality of Life in Epilepsy Inventory-10), a reduced version having easier clinical application than the QOLIE-31 in a Spanish population.
Methods: Naturalistic, prospective, national and multicenter study, in which 21 Spanish neurologists took part. Patients with partial or generalized epilepsy from 18 to 50 years, who were under monotherapy with lamotrigine or valproic acid and clinically stables, were included. Two visits were carried out, one basal visit and a 6, month follow-up visit. Sociodemographic, clinical (ti-me since diagnosis, previous treatment, current treatment and perceived adverse events) and social variables (QOLIE-31, QOLIE-10) were collected.
Results: A total of 107 patients were included. Mean age was 30.4 (deviation standard [DE]: 9.1) years and 61.7% were women. Mean time since epilepsy diagnosis was 8 (SD: 8.1) years. A total of 84.1% of the patients answered all the items correctly (feasibility). The Kaiser- Myer-Olkin measure was 0.822, with an associated pvalue<0.001 (content validity). QOLIE-10 scores did not show any relationship with the type of seizures (p>0.05), either globally or for its different domains (cross-sectional validity). The mean score went from 73.9 (SD: 15.7) to 75.5 (SD: 14.9) between the two visits, equivalent to an increase of HRQoL of 1.6 (SD: 7.6) points (p=0.37) (longitudinal validity). A Cronbach's alpha coefficient of 0.811 was obtained (internal consistency). Interclass correlation coefficients were higher than 0.7 (reliability). In the overall score the effect size obtained was of 0.10 (responsiveness to change).
Conclusions: The Spanish version of the QOLIE-10 has been shown to be feasible, valid, reliable and responsive to changes. The QOLIE-10 is a useful tool to measure HRQoL in usual clinical practice.