对先天性心脏手术中心使用的知情同意文件的描述性评估
Kristal M Hock1,2, Katja Gist3, Pariya L Fazeli1
1School of Nursing, University of Alabama at Birmingham, Birmingham, AL, USA.
Cardiology in the young
|December 4, 2023
概括
对儿科先天性心脏缺陷 (CHD) 手术的知情同意往往缺乏所需的细节. 大多数美国中心使用通用文件,缺少家庭的关键信息. 需要对患者理解进行进一步的研究.
科学领域:
- 儿科手术 儿科手术
- 在知情同意的情况下同意.
- 遗传性心脏病是一种先天性心脏病.
背景情况:
- 儿童手术的知情同意,特别是先天性心脏缺陷 (CHD) 程序,是复杂的.
- 监管机构为必要的知情同意内容提供了指导方针.
- 了解CHD手术知情同意的当前做法至关重要.
研究的目的:
- 评估和描述美国儿科心血管疾病手术中心使用的知情同意内容.
- 评估是否遵守已建立的知情同意标准.
主要方法:
- 在美国的70个心脏病手术中心向125名儿科心脏病临床医生分发了一项调查.
- 该调查评估了遵守联合委员会知情同意标准的情况.
- 数据收集发生在2023年3月14日至4月18日之间.
主要成果:
- 完成了37项调查,揭示了各种文档格式 (纸质,电子或两者兼容).
- 知情同意文件往往缺乏必要的要素,如程序特定的风险,利益,替代方案和结果.
- 虽然大多数中心提供西班牙语版本,但也有只提供英语文档的文档.
结论:
- 儿科心脏病手术中心主要使用通用知情同意文件.
- 这些文件往往不符合联合委员会标准,可能不反映家庭讨论.
- 需要进一步调查父母在知情同意过程中的理解程度.
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