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).