背景:医疗知情同意是任何医疗干预之前的道德和法律必要条件。住院患者在处理知情同意书(ICF)时面临功能健康素养(FHL)挑战。ICF和知情同意程序在中国的合法性仍未披露。该研究的目的是调查中国患者在提供医疗同意之前是否有足够的FHL被真正告知。
方法:在此横截面中,结构化访谈为基础的研究,在汕头大学医学院附属的两家教学医院(1500张病床的综合三级医院和700张病床的癌症医院)的知情同意情况下评估了FHL。跨临床科室收治的27名患者,连同他们的亲戚(n=59),在获得知情同意后被纳入研究。参与者进行了三步评估,包括两个选定的ICF-背授技能,感知理解(感知),和知情知识(认知),每个组件的最大分数为10。用SPSS(22.0版)对数据进行描述性和推断性统计分析,考虑到显著的P值<0.05。
结果:参与者的中位年龄(IQR和范围)为35.5岁(28-49岁和13-74岁)。大多数参与者只有高中文化程度(24.4%,21/86)或高中以下学历(47.7%,41/86)。FHL评估-回教的中位数得分(IQR),感知,和认知-为4.0(2.5,5.8),8.0(6.8,8.8),和6.5(5.5,8.0)的10,分别。认知得分与回授得分(r=0.359,P=0.002)或感知得分(r=0.437,P<0.001)之间存在中等相关性。多元线性回归分析预测患者和受教育程度较低是FHL不足的独立危险因素(Ps=0.001)。ICF中缺乏以患者为中心的观点,时间限制,不良的临床沟通被认为是阻碍知情同意的障碍.
结论:这项研究表明个人FHL和受损的组织HL不足,导致中国教学医院知情同意受损。作为一种补救措施,我们建议提高ICFs的质量,并在所有相关临床医生的知情同意方面进行机构授权的以结果为重点的培训,以提高医学伦理学,确保高质量的医疗保健,解决患者价值,缓解潜在的医疗冲突。
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.