2.1 Patients and study design
This study is a randomized, controlled, study with pre-test and
post-test design to examine the efficacy of clinical pharmacist-led
education on pediatric patients with epilepsy. It was conducted in two
large hospitals in Jordan, over a period of six months from June 2020 to
November 2020. Follow up was done eight-week after enrolment. The study
was approved by the Institutional Review Boards (IRB) at both hospitals
(No.80/2020/1007). Sample size was determined as 35 patients in each
group based on effect size = 0.68 for difference in adherence as one of
the endpoints measured (16), power = 80% and alpha = 0.05 were
determined for this study.
Inclusion criteria were pediatric patients aged < 18 years
old, with physician diagnosis of epilepsy and treated with AEDs. And the
exclusion criteria were the presence of a neurological congenital
disease or comorbid neurodevelopmental disability. Since the patients
did not reach the legal age to consent for participation in the study,
parent or caregiver written consent and patient verbal assent was taken
if age is applicable after the aims and voluntary participation in the
study was explained. No compensation was offered to patients or
families.
Out of 1393 patients evaluated for suitability, 81 patients were
enrolled in the study. Patients enrolled were randomly assigned into
either the control or intervention group. Randomization was done using
Research Randomizer® and allocation sequence was not shared with
participants (Concealed). Follow-up was done after eight weeks (Figure
1).