Abstract
INTRODUCTION: 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. METHODS: 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(2) and t-test was used to assess the significance of mean score differences between groups. RESULTS: 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; p < 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). CONCLUSION: 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.