Biggs Jessica M, Glasgow Nicole E, Pradel Francoise, Morgan Jill A
J Pediatr Pharmacol Ther. 2018 Sep-Oct;23(5):362-366. doi: 10.5863/1551-6776-23.5.362.
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.
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.
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.
Leaflets designed for pediatric patients resulted in an improvement in the understanding of the indication for levetiracetam.
本研究的目的是确定针对儿童的教育材料是否能提高儿科患者对药物适应症、给药方法及常见副作用的理解。
这项横断面试点研究纳入了一所郊区小学7至11岁的学生。研究参与者分别阅读美国食品药品监督管理局批准的成人用药说明书或为左乙拉西坦（开浦兰，优时比公司，佐治亚州亚特兰大）制作的一年级阅读水平的儿科用药说明书。向学生提出一组标准化调查问题，以评估对副作用、药物适应症、给药频率、给药方法及说明书总体印象的理解。
纳入了58名儿童。50%的儿童为男性，79%为白种人，平均年龄为9岁。成人说明书组与儿科说明书组在人口统计学方面无统计学差异。成人说明书组30%的参与者（9/30）正确说出了药物适应症，儿科说明书组79%的参与者（22/28）正确说出了药物适应症，p = 0.002。儿科说明书组93%（26/28）的参与者正确回答了给药频率问题，而成人说明书组为73%（22/30），p = 0.05。对于关于副作用和如何给药的问题，两组之间没有差异。与成人说明书组相比，儿科说明书组在可读性和对说明书理解方面的回答有显著差异，p分别为0.001和0.001。
为儿科患者设计的说明书可提高对左乙拉西坦适应症的理解。
