The Ohio State University, College of Arts and Sciences, USA.
The Ohio State University, College of Medicine, USA.
Res Social Adm Pharm. 2022 Dec;18(12):4124-4128. doi: 10.1016/j.sapharm.2022.08.003. Epub 2022 Aug 15.
The United States Food & Drug Administration's emergency authorized use, in December 2020, of over-the-counter (OTC) rapid antigen COVID-19 tests was a pandemic control milestone.
To assess health literacy-related characteristics of OTC rapid antigen COVID-19 test materials.
Between September-December 2021, we identified eleven (n = 11) OTC rapid antigen COVID-19 tests available for purchase in the US. We assessed readability (Flesch Reading Ease and Fernández-Huerta), formatting and layout features of English- and Spanish-language step-by-step OTC rapid antigen COVID-19 test package insert instructions. Video-based step-by-step OTC rapid antigen COVID-19 test instructions were evaluated for understandability and actionability (Patient Education Materials Assessment Tool for Audiovisual Materials [PEMAT-A/V]), overall quality (Global Quality Scale [GQS]) and cultural diversity and inclusiveness. Descriptive analyses were performed using IBM® Statistical Package for the Social Sciences.
Nine (81.8%) OTC rapid antigen COVID-19 tests included English-language (≈8th-9th reading grade level) step-by-step instructions, while 4 included Spanish-language (≈10th-12th reading grade level) instructions. On average, instructions were printed on a tabloid sized piece of paper, with text size ranging from 4 to 12 point and including nearly 20 illustrations. English-language step-by-step OTC rapid antigen COVID-19 test video-based instructions (n = 6) ranged from 1:04 to 5:41 min with PEMAT-A/V scores ranging from 80% to 100%. As indicated by GQS scores, English-language videos were of high quality (5 videos scored 5/5; 1 video scored 4/5). One COVID-19 test product manufacturing website included Spanish-language video-based instructions (time = 4:59 min; PEMAT-A/V = 100%; GQS = 5).
OTC COVID-19 test step-by-step instructions-both package inserts and video-based-included features shown to foster patient understanding and facilitate proper use. Moving forward, greater attention needs to be placed on expanding both Spanish-language and video-based OTC COVID-19 test material availability to improve accessibility across diverse populations.
美国食品和药物管理局于 2020 年 12 月紧急授权使用非处方（OTC）快速抗原 COVID-19 检测，这是控制大流行的一个里程碑。
评估 OTC 快速抗原 COVID-19 检测材料与健康素养相关的特征。
在 2021 年 9 月至 12 月期间，我们确定了 11 种（n=11）可在美国购买的 OTC 快速抗原 COVID-19 检测。我们评估了英语和西班牙语分步 OTC 快速抗原 COVID-19 测试试剂盒说明书的可读性（Flesch 阅读舒适度和 Fernández-Huerta）、格式和布局特点。基于视频的分步 OTC 快速抗原 COVID-19 测试说明用于评估可理解性和可操作性（视听材料患者教育材料评估工具[PEMAT-A/V]）、整体质量（全球质量量表[GQS]）以及文化多样性和包容性。使用 IBM®社会科学统计软件包（SPSS）进行描述性分析。
9 种（81.8%）OTC 快速抗原 COVID-19 检测包括英语语言（≈8-9 年级阅读水平）的分步说明，而 4 种检测包括西班牙语语言（≈10-12 年级阅读水平）的说明。平均而言，说明印在对开大小的一张纸上，文本大小从 4 到 12 点不等，包括近 20 个插图。基于视频的英语语言分步 OTC 快速抗原 COVID-19 测试说明（n=6）时长范围为 1:04 至 5:41 分钟，PEMAT-A/V 评分范围为 80%至 100%。根据 GQS 评分，英语语言视频质量较高（5 个视频得分为 5/5；1 个视频得分为 4/5）。一个 COVID-19 测试产品制造网站包含西班牙语语言的基于视频的说明（时间=4:59 分钟；PEMAT-A/V=100%；GQS=5）。
OTC COVID-19 测试的分步说明——包括包装插页和基于视频的说明——都包含了有助于患者理解和促进正确使用的功能。展望未来，需要更加重视扩大西班牙语语言和基于视频的 OTC COVID-19 测试材料的可用性，以改善不同人群的可及性。
