Abstract
OBJECTIVE
The Patient Information Leaflet (PIL) is an authoritative document that all people with epilepsy (PWE) in the European Union receive when prescribed anti-seizure medication (ASM). We undertook the first independent, comprehensive assessment to determine how understandable they are. Regulators state that when patients are asked comprehension questions about them, ≥80% should answer correctly. Also recommended PILs have a maximum reading requirement of US Grade 8.
Methods:
Study 1:
Obtained 140 current ASM PILs written in English. ‘Readability’ assessed using 4 tests, with and without adjustment for influence of familiar, polysyllabic words. 179 online materials on epilepsy also assessed.
Study 2:
Two PILs from Study 1 randomly selected (Pregabalin Focus; Inovelon) and shown to 35 people from UK epilepsy population. Their comprehension was assessed.
Study 3:
To understand whether student population provides accessible alternative population for future examination of ASM PILs, Study 3 was completed. Used same methods as Study 2 but participants were 262 UK university students.
Results:
Study 1:
No PIL had a reading level of Grade 8. Median was 11. Adjusting for context, the PILs were still at Grade 10.5. PILs for branded ASMs were most readable. PILs were no more readable than (unregulated) online materials.
Study 2:
Users struggled to comprehend the PILs key messages. The 8 questions asked about pregabalin were typically answered correctly by 54%. For Inovelon it was 62%.
Study 3:
Most student participants comprehend the PILs key messages. The questions about Inovelon were answered correctly by 90%; for pregabalin it was 86%.
Significance
This is the first independent and comprehensive examination of ASM PILs. Found PILs being used fail to meet recommendations and regulatory requirements and risk not being understandable to substantial proportion of users. In finding that people from epilepsy population differ markedly in comprehension of PILs compared to students, study highlights importance of completing user testing with the target population.
MAY