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癌症治疗知情同意方面有何进展?综合癌症中心的横断面分析结果。

Any progress in informed consenting for cancer treatment? Results from a cross sectional analysis at a comprehensive cancer center.

机构信息

Department of Internal Medicine III, Comprehensive Cancer Center, University Medical Center of the Johannes Gutenberg University, Mainz, Germany.

Institute of Medical Biostatistics, Epidemiology and Informatics, University Medical Center of the Johannes Gutenberg University, Mainz, Germany.

出版信息

J Cancer Res Clin Oncol. 2021 Jul;147(7):2117-2126. doi: 10.1007/s00432-020-03495-1. Epub 2021 Jan 9.

Abstract

PURPOSE

Informed consent is required prior to any medical procedure. In the context of cancer treatment, special efforts are needed to inform cancer patients properly about treatment, potential sequelae and alternative therapies. Little is known about the effectiveness of current informed consent strategies and patients' individual satisfaction. Given the heterogeneity in terms of age, education, sex and other factors, detailed understanding of patients' comprehension and perception is the basis for further optimization of the informed consent process, which was the aim of the current investigation.

METHODS

Patients with a new cancer diagnosis and recent informed consent were asked to complete a questionnaire about satisfaction, comprehension, time management, physician-patient relationship and other items of the informed consent process. Patients were followed for 6 months and invited to complete a follow-up questionnaire.

RESULTS

In total, 89 patients completed the first questionnaire and 52 the follow-up questionnaire. Subjective understanding was assumed high, however, this did not correlate with objective understanding. Age and education were identified as influencing factors for comprehension. 85% of the patients were satisfied with the information provided. A major gap was the information on alternative therapies. Moreover, not all patients perceived the consent dialog as such, and particularly the individual treatment intention partially remained unclear for some patients.

CONCLUSIONS

To ensure that informed consent is based on solid understanding, informed consenting must be patient-centered and consider the individual expectations, needs and abilities of cancer patients. Further studies are required to develop tailored informed consent strategies.

摘要

目的

在进行任何医疗程序之前,都需要获得知情同意。在癌症治疗的背景下,需要特别努力向癌症患者正确告知治疗、潜在后果和替代疗法。目前对于现行知情同意策略的有效性以及患者的个体满意度知之甚少。鉴于年龄、教育、性别和其他因素的异质性,详细了解患者的理解和感知是进一步优化知情同意过程的基础,这也是当前研究的目的。

方法

新诊断出癌症且最近获得知情同意的患者被要求完成一份关于满意度、理解程度、时间管理、医患关系和知情同意过程的其他方面的问卷。患者随访 6 个月,并邀请他们完成一份随访问卷。

结果

共有 89 名患者完成了第一份问卷,52 名患者完成了随访问卷。患者主观上认为自己理解程度高,但这与客观理解程度没有相关性。年龄和教育程度被确定为影响理解程度的因素。85%的患者对提供的信息感到满意。一个主要的差距是关于替代疗法的信息。此外,并非所有患者都将同意对话视为如此,并且对于一些患者来说,个别治疗意图部分仍不清楚。

结论

为了确保知情同意是基于充分理解的,知情同意必须以患者为中心,并考虑癌症患者的个体期望、需求和能力。需要进一步的研究来制定有针对性的知情同意策略。

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