Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, New South Wales, Australia.
Department of Cardiology, Sunshine Coast University Hospital, University of the Sunshine Coast, Birtinya, Australia.
Patient Educ Couns. 2022 May;105(5):1254-1260. doi: 10.1016/j.pec.2021.08.027. Epub 2021 Sep 14.
Consent forms that are difficult to understand may jeopardize informed consent. The aim of this study was to determine whether consent documents for cardiology-related procedures could be easily read and understood by patients with low health literacy.
All 37 cardiology-related consent forms with patient information material were retrieved from a publicly available suite of documents from one state in Australia. Two raters independently assessed documents and resolved discrepancies through discussion. Understandability was assessed using the Patient Education Materials Assessment Tool for Printed materials (PEMAT-P). Readability was assessed using the Gunning Fog Index, SMOG and Flesch Reading Ease formulas. Images were assessed using the 5C Image checklist. Results were analyzed descriptively.
Only 1 of 37 forms met the general PEMAT-P threshold (70%) for being 'understandable'. The average readability score was high, requiring a grade 10-12 level of education to understand. Most images lacked useful captions, had low visual clarity, and were not purpose-designed for the material.
The current format for cardiology consent forms does not meet recommended standards for understandability and readability.
Development of consent forms would benefit from taking health literacy principles into account with patient input, and purpose-designed images should be included in all forms to reinforce text.
难以理解的知情同意书可能会危及知情同意。本研究旨在确定低健康素养的患者是否能够轻松阅读和理解与心脏病学相关的程序的知情同意书。
从澳大利亚一个州的公开可用文档套件中检索了所有 37 份与心脏病学相关的同意书和患者信息材料。两名评估者独立评估文件，并通过讨论解决差异。使用印刷材料患者教育材料评估工具（PEMAT-P）评估理解性。使用 Gunning Fog 指数、SMOG 和 Flesch 阅读舒适度公式评估可读性。使用 5C 图像清单评估图像。结果以描述性方式进行分析。
只有 37 份表格中的 1 份符合“可理解”的一般 PEMAT-P 标准（70%）。平均可读性得分较高，需要 10-12 年级的教育程度才能理解。大多数图像缺乏有用的标题，视觉清晰度低，并且不是为该材料专门设计的。
目前心脏病学同意书的格式不符合可理解性和可读性的推荐标准。
在制定同意书时，考虑到健康素养原则并征求患者的意见，将受益于患者的投入，并且应该在所有表格中包含专门设计的图像，以加强文本。
