特定程序同意表在临床实践中的作用:系统性审查
J Norvill1, C Bent2, J A Mawhinney3
1Royal Chesterfield Hospital NHS Foundation Trust, UK.
Annals of the Royal College of Surgeons of England
|October 3, 2024
概括
程序特定同意表格 (PSCF) 显示了比通用表格 (GCF) 更好的文档. 然而,关于患者理解和法律影响的证据仍然不确,需要进一步研究.
科学领域:
- 医学伦理 医学伦理
- 卫生法 法律 卫生法
- 患者安全 患者安全
背景情况:
- 一般的同意表格 (GCF) 是NHS的标准,但程序特定的同意表格 (PSCF) 正在出现.
- 对于PSCF是否符合知情同意所需的标准存在担忧.
- 进行了一项系统性审查,以评估PSCF的证据,其研究方法和医疗法律方面.
研究的目的:
- 系统审查支持使用程序特定同意表格 (PSCF) 的证据.
- 评估评估PSCF的研究方法.
- 调查与PSCF相关的医疗法律标准和影响.
主要方法:
- 在PROSPERO (CRD42023392693) 登记的系统审查,涵盖了1990-2023.
- 搜索了MEDLINE,Embase,CINAHL,CENTRAL,Emcare,以及灰色文学. 这是一个很大的问题.
- 包括所有在医疗/外科环境中评估PSCF的研究;使用RoB 2和ROBINS-I.评估偏差风险.
主要成果:
- 确定了21项研究;大多数是质量改进项目 (n=10) 或随机研究 (n=5).
- 与GCF相比,PSCF表现出更好的文档 (70-100%) 和可读性 (100%).
- 没有找到关于PSCF在诉讼中的最终法律指导或研究;患者理解/召回结果是不确定的.
结论:
- 有证据表明,与GCF相比,PSCF提供了更优质的文档.
- 目前的研究不足以解决PSCF对知情同意和法律问题的影响.
- 需要进一步的随机试验,重点关注以患者为中心的结果和医疗法律标准.
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