Brennan Orlaith C, Moore John E, Nutt Thomas W, Moore Peter Ja, Millar Beverley C
School of Medicine, Dentistry and Biomedical Sciences, The Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, Belfast, Northern Ireland, UK.
Laboratory for Disinfection and Pathogen Elimination Studies, Northern Ireland Public Health Laboratory, Nightingale (Belfast City) Hospital, Belfast, Northern Ireland, UK.
J Clin Pharm Ther. 2021 Aug;46(4):1109-1116. doi: 10.1111/jcpt.13405. Epub 2021 Mar 25.
Patient information leaflets (PILs) or Patient Leaflets (PLs) formally accompany dispensed medicines and are intended to provide the patient with information on how to use the medicine safely. To date, there have been no studies that have examined the readability of meningococcal vaccine patient-facing information, including information contained within the vaccine PIL. Given the role of pharmacists in presenting PILs to patients, it was, therefore, the aim of this study to quantitatively analyse the readability of Patient Leaflets, which accompany licensed meningococcal vaccines in the UK and US and to compare PILs to vaccine pharmaceutical manufacturers' summary of product characteristics (SPC), as well as other patient-facing vaccine-related information.
Five sources of meningococcal vaccine information were examined for the licensed meningococcal vaccines in the UK (Bexsero, Menveo, Menitorix, Trumenba, Nimenrix & NeisVac-C) and in the United States (Bexsero, Menveo, Trumenba, Menactra, Menomune-A/C/Y/W-135, Menquadfi), including as follows: (i) SPC (Electronic Medicines Compendium, UK), (ii) Package Insert (FDA; USA), (iii) Patient Leaflet (Electronic Medicines Compendium, UK), (iv) Vaccine pharmaceutical websites and (v) government web resources. Readability was examined employing 10 readability metrics, including the Flesch Reading Ease and the Flesch-Kincaid Grade level.
The information source with the greatest readability scores was the UK Patient Leaflet, which had a mean Flesch Reading Ease score of 58.1 and a mean Flesch-Kincaid Grade score of 7.3, followed by the US Department of Health & Human Services patient-facing website for vaccines (55.9 & 8, respectively), followed by the US Centers for Disease Control and Prevention Vaccine Information Statement (47.3 & 9.4, respectively). Pharmaceutical patient-facing websites for meningococcal vaccines had mean scores of 44.6 and 9.9, respectively. When compared with UK Patient Leaflets, pharmaceutical websites were statistically different with poorer readability with both Flesch Reading Ease and Flesch-Kincaid Grade Level indices (p = 0.02 & p = 0.04, respectively).
Pharmaceutical meningococcal vaccine PILs were easily read and had statistically significant good readability scores in comparison with vaccine SPCs and US Package Inserts, pharmaceutical product websites and other government patient-facing meningococcal vaccine information. Preparation of patient-facing materials of a complex topic, such as describing meningococcal vaccines, is difficult to accomplish. Although there is a plurality of sources of information through websites and social media, PILs are one of the few sources that are provided directly to patients. This underpins the potential importance of PILs and the importance of their readability. Adoption of readability calculators and scrutiny of materials for their readability will help authors develop materials with improved understanding for vaccine recipients, potentially leading to improved health literacy and vaccine uptake. Renewed efforts should be sought to promote the information within the PIL, thereby maximizing the value of this resource with vaccine recipients, their carers and family.
患者信息传单（PILs）或患者传单（PLs）会正式随配药一同提供，旨在向患者提供有关如何安全用药的信息。迄今为止，尚无研究对脑膜炎球菌疫苗面向患者的信息（包括疫苗患者信息传单中包含的信息）的可读性进行考察。鉴于药剂师在向患者提供患者信息传单方面所发挥的作用，因此，本研究的目的是对英国和美国已获许可的脑膜炎球菌疫苗所附带的患者传单的可读性进行定量分析，并将患者信息传单与疫苗制药商的产品特性摘要（SPC）以及其他面向患者的疫苗相关信息进行比较。
对英国（Bexsero、Menveo、Menitorix、Trumenba、Nimenrix和NeisVac-C）和美国（Bexsero、Menveo、Trumenba、Menactra、Menomune - A/C/Y/W - 135、Menquadfi）已获许可的脑膜炎球菌疫苗的五种信息来源进行了考察，具体如下：（i）产品特性摘要（英国电子药品目录），（ii）包装说明书（美国食品药品监督管理局），（iii）患者传单（英国电子药品目录），（iv）疫苗制药网站，以及（v）政府网络资源。采用10种可读性指标对可读性进行考察，包括弗莱什易读性指数和弗莱什 - 金凯德年级水平指数。
可读性得分最高的信息来源是英国患者传单，其弗莱什易读性指数平均得分为58.1，弗莱什 - 金凯德年级水平指数平均得分为7.3，其次是美国卫生与公众服务部面向患者的疫苗网站（分别为55.9和8），接着是美国疾病控制与预防中心疫苗信息声明（分别为47.3和9.4）。脑膜炎球菌疫苗面向患者的制药网站的平均得分分别为44.6和9.9。与英国患者传单相比，制药网站在弗莱什易读性指数和弗莱什 - 金凯德年级水平指数方面的可读性较差，在统计学上存在差异（分别为p = 0.02和p = 0.04）。
与疫苗产品特性摘要、美国包装说明书、制药产品网站以及其他政府面向患者的脑膜炎球菌疫苗信息相比，制药的脑膜炎球菌疫苗患者信息传单易于阅读，且在统计学上具有显著的良好可读性得分。编写关于复杂主题（如描述脑膜炎球菌疫苗）的面向患者的材料是一项艰巨的任务。尽管通过网站和社交媒体有多种信息来源，但患者信息传单是直接提供给患者的少数来源之一。这突出了患者信息传单的潜在重要性及其可读性的重要性。采用可读性计算器并对材料的可读性进行审查将有助于作者编写更易于疫苗接种者理解的材料，这可能会提高健康素养和疫苗接种率。应重新努力宣传患者信息传单中的信息，从而使该资源对疫苗接种者、其护理人员和家人的价值最大化。
