METHOD
A multicenter observational and descriptive study carried out in
southwestern part of Nigeria among adults PWE after due ethical
clearance has been obtained. The estimation of sample size was done by
using the single population proportional formulation by taking 5%
margin of error, 95% confidence level and proportion of reported
adverse events as 0.5%. Using convenient sampling method, we included
940 consenting participants aged 16 years and above attending epilepsy
clinics for period of 5years with diagnosis confirmed by International
League against Epilepsy(ILAE) criteria and supported by
Electroencephalography(EEG).(Brodie et al., 2018; Fisher, 2017; Hirsch
et al., 2013; Scheffer et al., 2017) The case records of all patients
attending/that attended neurology clinics in the last 5 years with
diagnosis of epilepsy in the selected hospitals was reviewed with the
use of a semi structured questionnaire, to extract information about
clinical and socio demographic characteristics. These include age, age
of onset, seizure characteristics, type, and duration of AEDs.
LEAP, a previously validated instrument was used to assess ADR. It is a
21- item self-reported questionnaire, designed to measure AEDs side
effect which covers both Central Nervous System (CNS) and Non-CNS
related adverse effects. The total score of LAEP ranges from 19 to 76,
with higher score indicating more adverse effects burden. Scores ≤45
indicates mild to moderate adverse effects and reaches the toxic level
if the total score exceeds 45.(Fadare et al., 2018). (Fadare et al.,
2018; Sakuma et al., 2014; Yang et al., 2014). MMAS a previously
validated and extensively used adherence instrument was used to measure
medication adherence. There are five expected responses in MMAS namely;
never, rarely, sometimes, often and always respectively which are scored
as 0, 1, 2, 3, 4 respectively and subsequently subdivided into 0 (high
adherence), 1-2 (medium adherence) and >2 (poor adherence).
These instruments were administered by Neurologist and trainees who are
qualified Doctors at participating Centers. Data were cleaned, coded,
and analyzed using the IBM Statistical Package of Social Sciences
Version 23. Socio-demographic and clinical characteristics of patients
were presented as frequency (percentage). Using Pearson chi square test.
Independent T-test was used to examine the possible association between
ADR with gender, AED therapy (monotherapy and polytherapy) and
medication adherence. One-way ANOVA test was used to assess the
association between type of seizure, duration of epilepsy and
epileptiform pattern. The significance level of statistical measures was
set at p<0.05.