Algabbani Aljoharah M, Alzahrani Khalid A, Sayed Sarah K, Alrasheed Meshael, Sorani Deema, Almohammed Omar A, Alqahtani Amani S
Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
Department of Clinical Pharmacy, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia.
Saudi Pharm J. 2022 May;30(5):544-554. doi: 10.1016/j.jsps.2022.02.017. Epub 2022 Mar 4.
Patient information leaflets (PILs) are one of the main sources of information for over-the-counter medications (OTCs). This study aimed to assess caregivers' understanding of instructions in PILs provided with paracetamol medications and the impact of pictograms use.
A quasi-experimental study was conducted among caregivers of children aged < 13 years recruited in pediatric outpatient clinics at University Medical City in Riyadh. The calculated sample size was 128; at least 64 participants were needed in each group (the text-only group and the text-plus pictograms group). Caregivers' health literacy was assessed using a validated Arabic version of the Newest Vital Sign scale. Participants' understanding of PILs instructions was assessed using eight questions on the route of administration, minimal hours between doses, max daily dose, shake medication before use, storage, and reporting adverse events; and was rated based on the number of questions correctly understood. Characteristics of participants were compared by Pearson X and -test was used to assess the significance of mean score differences between groups.
A total of 130 caregivers participated in the study; almost half of them were mothers (47%, [n = 61]) and 43% (n = 56) have "a possibility of limited health literacy". The mean number of correct answers to questions assessing the understanding of PILs instructions was significantly higher among the text-plus pictograms group compared to the text-only group (5.25 ± 1.85 vs. 4.38 ± 1.27; < 0.001). When results were controlled for age and gender, better health literacy was found to be associated with a better understanding of instructions (B = 0.39, 95 %CI 0.23-0.54).
Limited comprehension of medications instructions was observed; adding pictorial aids to PILs might enhance the comprehension. Differences in health literacy levels of caregivers should be considered when designing PILs.
患者信息单页（PILs）是非处方药（OTCs）的主要信息来源之一。本研究旨在评估护理人员对扑热息痛药物所附患者信息单页中说明的理解以及使用象形图的影响。
在利雅得大学医学城儿科门诊招募的13岁以下儿童的护理人员中进行了一项准实验研究。计算出的样本量为128；每组（纯文本组和文本加象形图组）至少需要64名参与者。使用经过验证的阿拉伯语版本的最新生命体征量表评估护理人员的健康素养。通过关于给药途径、剂量之间的最短时间、最大日剂量、使用前摇晃药物、储存以及报告不良事件的八个问题来评估参与者对患者信息单页说明的理解；并根据正确理解的问题数量进行评分。通过Pearson X比较参与者的特征，并使用t检验评估组间平均得分差异的显著性。
共有130名护理人员参与了该研究；其中近一半是母亲（47%，[n = 61]），43%（n = 56）的人“健康素养可能有限”。与纯文本组相比，文本加象形图组中评估对患者信息单页说明理解的问题的正确答案平均数显著更高（5.25±1.85对4.38±1.27；P<0.001）。在对年龄和性别进行控制后，发现更好的健康素养与对说明的更好理解相关（B = 0.39，95%CI 0.23 - 0.54）。
观察到对药物说明的理解有限；在患者信息单页中添加图片辅助可能会提高理解。在设计患者信息单页时应考虑护理人员健康素养水平的差异。
