Pan Xin, Kim Eunhee, Zamora Jose, Hata Micah, Wooley Andrea, Devraj Radhika, Gogineni Hyma P, Law Anandi V
College of Pharmacy, Western University of Health Sciences, Pomona, CA 91766, USA.
Department of Pharmaceutical Sciences, School of Pharmacy, Southern Illinois University Edwardsville, Edwardsville, IL 62025, USA.
Healthcare (Basel). 2025 May 23;13(11):1227. doi: 10.3390/healthcare13111227.
: 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. : 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. : 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, < 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. : 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.
美国食品药品监督管理局（FDA）规定，新处方必须附带现有的患者信息单页（ePIL），但由于其内容复杂且视觉设计不佳，尤其是对于健康素养低和英语水平有限的人群而言，这些信息单页难以阅读和理解。在本研究中，我们按照FDA的规定，以简洁的问答形式开发了基于信息图的患者信息单页（iPIL），突出重要信息。本研究使用5C因素，即理解性、美观性、便利性、内容和可信度，对说英语和西班牙语的人群对iPIL和ePIL的看法进行了比较。
这项多中心实验性调查研究评估了5C因素。从加利福尼亚州（CA）和伊利诺伊州（IL）的社区药房招募了正在服用≥1种慢性药物的讲英语和西班牙语的成年人。他们被分层，以便对四种常见药物之一的ePIL或iPIL进行审查。他们完成了一份用药知识测验（MKQ），通过六个开放式问题来展示他们的理解程度。随后，他们收到了两种版本的患者信息单页，并回答了关于4C和媒体格式以及最后关于人口统计学和健康素养的偏好问题。
共有235名参与者在三个地点（CA英语组、CA西班牙语组和IL英语组）完成了调查，参与者特征各不相同。CA西班牙语组的参与者在健康素养和健康状况数量方面得分最低。在所有组中，使用iPIL的参与者的MKQ得分显著高于使用ePIL的参与者。这些得分与ePIL的健康素养结果显著相关（r = 0.394，P < 0.001）。除了一个内容问题外，参与者在四个C因素方面更喜欢iPIL而不是ePIL。无论年龄如何，印刷格式（64.7%）单独或与数字格式（21.3%）一起比单独的数字格式（3.4%）更受青睐。总体而言，79.1%的参与者更喜欢iPIL，11.9%更喜欢ePIL，8.9%对两种版本都无偏好。
基于信息图的患者信息单页（iPIL）更易于阅读、浏览和理解，使不同健康素养水平的人都更容易获取。基于信息图的单页在用户理解方面优于现有单页，并且由于其简单的布局、易于浏览和实用性而更受青睐。
