中国医院因功能性健康知识普及困难而导致知情同意受损。

IF 3 1区 哲学 Q1 ETHICS BMC Medical Ethics Pub Date : 2024-08-23 DOI:10.1186/s12910-024-01089-x
Dangui Zhang, Zhilin Hu, Zhuojia Wu, Ting Huang, Tingting Huang, Junhao Liu, Hongkun Sun, William Ba-Thein
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引用次数: 0

摘要

背景:医疗知情同意是任何医疗干预之前的道德和法律要求。住院病人在处理知情同意书(ICF)时面临着功能性健康知识(FHL)方面的挑战。在中国,ICF 和知情同意程序的合法性仍未得到充分披露。本研究旨在调查中国患者是否具备足够的功能性健康素养,以便在提供医疗同意书前获得真正的知情权:在这项以结构化访谈为基础的横断面研究中,在汕头大学医学院附属两所教学医院(拥有 1500 张床位的综合性三级甲等医院和拥有 700 张床位的肿瘤医院)的知情同意情景中对 FHL 进行了评估。在获得知情同意后,27名临床科室住院患者及其亲属(59人)被纳入研究。研究人员通过回授技能、感知理解(感知)和知情知识(认知)这两个选定的 ICF 进行了三步评估,每个部分的最高分均为 10 分。数据采用 SPSS(22.0 版)进行描述性和推论性统计分析,并考虑显著的 P 值作为结果:参与者的中位年龄(IQR 和范围)为 35.5(28 - 49 和 13 - 74)岁。大多数参与者只有高中学历(24.4%,21/86)或高中以下学历(47.7%,41/86)。FHL评估的中位数(IQR)--回授、感知和认知--分别为4.0(2.5,5.8)、8.0(6.8,8.8)和6.5(5.5,8.0)分(满分10分)。认知得分与回授(r = 0.359,P = 0.002)或感知(r = 0.437,P 结论:认知得分与回授(r = 0.359,P = 0.002)或感知(r = 0.437,P = 0.002)之间存在中度相关性:本研究表明,在中国的教学医院中,个人 FHL 的不足和组织 HL 的受损导致知情同意受到影响。作为补救措施,我们建议提高ICF的质量,并对所有相关临床医生进行以结果为中心的知情同意培训,以提高医德水平,确保医疗质量,满足患者价值,并减少潜在的医疗冲突。
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Compromised informed consent due to functional health literacy challenges in Chinese hospitals.

Background: Medical informed consent stands as an ethical and legal requisite preceding any medical intervention. Hospitalized patients face functional health literacy (FHL) challenges when dealing with informed consent forms (ICFs). The legitimacy of ICFs and informed consent procedures in China remains substantially undisclosed. The study's aim was to investigate if Chinese patients have adequate FHL to be truly informed before providing medical consent.

Methods: In this cross-sectional, structured interview-based study, FHL was assessed within the context of the informed consent scenarios in two teaching hospitals (a 1500-bed general tertiary hospital and a 700-bed cancer hospital) affiliated with Shantou University Medical College. Twenty-seven patients admitted across clinical departments, along with their relatives (n = 59), were enrolled in the study after obtaining informed consent. The participants underwent a three-step assessment with two selected ICFs -teach-back skills, perceived understanding (perception), and informed knowledge (cognizance), with each component carrying a maximum score of 10. Data were analyzed with SPSS (version 22.0) for descriptive and inferential statistics, with consideration of significant P values as < 0.05.

Results: The median age (IQR and range) of participants was 35.5 (28 - 49 and 13 - 74) years. Most participants had only high school education (24.4%, 21/86) or below high school education (47.7%, 41/86). The median score (IQR) of FHL assessments-teach-back, perception, and cognizance-was 4.0 (2.5, 5.8), 8.0 (6.8, 8.8), and 6.5 (5.5, 8.0) out of 10, respectively. A moderate correlation was observed between the scores of cognizance and teach-back (r = 0.359, P = 0.002) or perception (r = 0.437, P < 0.001). Multivariate linear regression analysis predicted being a patient and having lower education levels as independent risk factors of inadequate FHL (Ps = 0.001). Lack of patient-centeredness in ICFs, time constraints, and poor clinical communication were identified as barriers impeding informed consent.

Conclusions: This study demonstrates inadequacy in personal FHL and impaired organizational HL, resulting in compromised informed consent in Chinese teaching hospitals. As a remedy, we propose improving the quality of ICFs and institutionally mandated outcome-focused training on informed consent for all concerned clinicians to enhance medical ethics, ensure quality health care, address patient values, and mitigate potential medical conflicts.

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来源期刊
BMC Medical Ethics
BMC Medical Ethics MEDICAL ETHICS-
CiteScore
5.20
自引率
7.40%
发文量
108
审稿时长
>12 weeks
期刊介绍: BMC Medical Ethics is an open access journal publishing original peer-reviewed research articles in relation to the ethical aspects of biomedical research and clinical practice, including professional choices and conduct, medical technologies, healthcare systems and health policies.
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