Abstract
Background/Objectives: Existing patient information leaflets (ePILs), mandated by the FDA to accompany new prescriptions, are difficult to read and understand due to their complexity and poor visual design, especially for populations with low health literacy and low English proficiency. In this study, we developed infographic-based PILs (iPILs) with a concise question-and-answer format, emphasizing essential information, as specified by the FDA. This study compared iPILs and ePILs using the 5C factors: comprehension, cosmetics, convenience, content, and credibility, as perceived by English-speaking and Spanish-speaking populations. Methods: This multicenter, experimental survey study assessed the 5C factors. English and Spanish-speaking adults on ≥1 chronic medication were recruited from community pharmacies in California (CA) and Illinois (IL). They were stratified to review either an ePIL or an iPIL for one of four common medications. They completed a Medication Knowledge Quiz (MKQ) to show their comprehension using six open-ended questions. Subsequently, they received both PIL versions and answered preference questions about the 4C and media format and, lastly, about demographic and health literacy questions. Results: A total of 235 participants completed the surveys at three sites (CA-English, CA-Spanish, and IL-English), with differing participant characteristics. The CA-Spanish participants scored the lowest on health literacy and the number of health conditions. The MKQ scores for those using the iPILs were significantly higher than for those using the ePILs across all groups. They significantly correlated with health literacy results for the ePILs (r = 0.394, p < 0.001). The participants preferred the iPILs over the ePILs for four of the C factors, barring one content question. Regardless of age, printed formats were preferred (64.7%)-alone or with digital formats (21.3%)-over digital formats alone (3.4%). Overall, 79.1% of the participants preferred iPILs, 11.9% preferred ePILs, and 8.9% preferred either version. Conclusions: The infographic-based patient information leaflets (iPILs) were easier to read, navigate, and understand, making them more accessible to individuals with varying levels of health literacy. Infographic-based leaflets outperformed existing ones in user comprehension and were preferred due to their simple layout, ease of navigation, and helpfulness.