Assessing the Understanding of Pediatric-Oriented Medication Education Materials Versus Standard Available Education Materials

Abstract

OBJECTIVES The objective of this study was to determine if education material targeting children would improve understanding of medication indication, administration, and common side effects in pediatric subjects. METHODS This cross-sectional pilot study included students 7 to 11 years old from a suburban elementary school. Study participants were read either the US Food and Drug Administration–approved adult medication leaflet or a pediatric medication leaflet created at a first-grade reading level for levetiracetam (Keppra, UCB, Inc, Atlanta, GA). Students were asked a set of standardized survey questions to evaluate comprehension of side effects, medication indication, dosing frequency, administration, and overall impression of the leaflet. RESULTS Fifty-eight children were included. Fifty percent of the children were male, 79% were Caucasian, and the average age was 9 years. There was no statistical difference for demographics in the adult leaflet versus the pediatric leaflet group. Children correctly stated the indication for the medication in 30% of participants (9/30) in the adult leaflet group and 79% of participants (22/28) in the pediatric leaflet group, p = 0.002. The administration frequency question was answered correctly in 93% of the pediatric leaflet group (26/28) as compared to 73% in the adult leaflet group (22/30), p = 0.05. For questions about side effects and how to administer the medication, there was no difference between the groups. The responses regarding readability and understanding of the leaflets were significantly different in the pediatric leaflet group compared to the adult leaflet group, p = 0.001 and p = 0.001, respectively. CONCLUSIONS Leaflets designed for pediatric patients resulted in an improvement in the understanding of the indication for levetiracetam.

Worth the paper they are printed on? Findings from an independent evaluation of the understandability of patient information leaflets for antiseizure medications

“…A sample size calculation was completed. It was informed by Biggs et al’s 5 estimate that 83% of children without epilepsy can potentially answer comprehension questions correctly having read an ASM PIL. This, together with a required confidence level of 95% and precision of ±5%, indicated 214 participants with complete data were required.…”

“…4 We systematically searched for studies examining ASM PILs. Five [5][6][7][8][9] were identified (File S1). Only one examined European PILs.…”