Boyd Louisa C, Kareh Aurora M, Rodby Katherine A
From the Division of Plastic and Reconstructive Surgery, Saint Louis University School of Medicine, Saint Louis, MO.
Ann Plast Surg. 2023 Dec 1;91(6):651-655. doi: 10.1097/SAP.0000000000003674. Epub 2023 Sep 4.
In October 2021, the US Food and Drug Administration mandated patient decision checklists and new labeling for breast implants with the goal of improving the informed decision-making process for patients considering breast implantation. Given growing concerns over breast implant-associated anaplastic large cell lymphoma, breast implant-associated squamous cell carcinoma, and breast implant illness, patients should be able to easily review these resources to make a fully informed decision when considering surgery. This study seeks to elucidate the accessibility, and therefore the utility of the newly mandated literature for the average breast implant patient.
Patient decision checklists and breast implant boxed warnings were obtained from the most used breast implant manufacturers in the United States-Allergan, Mentor, and Sientra. Readability analysis of all Food and Drug Administration required documents was performed using the Flesch Reading Ease Score, Flesch Kincaid Grade Level, Gunning-Fog Index, Coleman-Liau Index, Simplified Measure of Gobbledygook, and Automated Readability Index.
The overall readability of all Allergan, Mentor, and Sientra patient materials correlates with a college reading level. Documents from all 3 implant manufacturers were of a statistically significantly higher reading level than that recommended by the American Medical Association and US Department of Health and Human Services. No materials were found to be at or below the recommended sixth-grade level.
The newly mandated breast implant patient decision guides are written at a college reading level. These materials should be simplified to improve health literacy shared decision making.
2021年10月，美国食品药品监督管理局强制要求提供患者决策清单并对乳房植入物进行新的标签标注，目的是改善考虑进行乳房植入手术患者的知情决策过程。鉴于对乳房植入物相关间变性大细胞淋巴瘤、乳房植入物相关鳞状细胞癌和乳房植入物疾病的担忧日益增加，患者在考虑手术时应能够轻松查阅这些资源，以便做出充分知情的决策。本研究旨在阐明新强制要求的文献对于普通乳房植入手术患者的可及性及其效用。
从美国使用最多的乳房植入物制造商——艾尔建、美敦力和仙特拉公司获取患者决策清单和乳房植入物盒装警示。使用弗莱什易读性分数、弗莱什-金凯德年级水平指数、冈宁-福格指数、科尔曼-廖指数、简化的晦涩难懂度量表和自动可读性指数，对美国食品药品监督管理局要求的所有文件进行可读性分析。
艾尔建、美敦力和仙特拉公司所有患者材料的总体可读性与大学阅读水平相当。来自所有3家植入物制造商的文件在统计学上显著高于美国医学协会和美国卫生与公众服务部推荐的阅读水平。未发现有材料达到或低于推荐的六年级水平。
新强制要求的乳房植入物患者决策指南的编写水平为大学阅读水平。这些材料应加以简化，以提高健康素养共享决策。
