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改善手术知情同意:未解答的问题
Steven E Raper1, Justin T Clapp2, Lee A Fleisher2
1From the Department of Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.
概括
这次对随机试验的审查发现,虽然干预措施可以提高患者的理解和满意度,但很少有人解决知情同意的社会正义方面. 未来的研究应该集中在语言,识字和成本上,以确保公平的知情同意.
科学领域:
- 医学伦理 医学伦理
- 临床试验方法论 临床试验方法论
- 患者的自主权 患者的自主权
背景情况:
- 知情同意是道德医疗实践的基石,随着患者护理的发展而发展.
- 定义和衡量改善手术知情同意的干预措施的有效性仍然是一个挑战.
- 自主,公益和社会正义的伦理要求指导知情同意过程.
研究的目的:
- 审查随机临床试验 (RCT),评估旨在改善知情同意过程的干预措施.
- 评估各种干预措施对患者理解,满意度和心理状态的影响.
- 发现有关知情同意的社会正义维度的研究缺口.
主要方法:
- 一项文献搜索确定了70个关于知情同意干预的RCT.
- 对人口统计,干预和评估的数据进行了表格化.
- 干预措施分为印刷物,视听工具和交互式多媒体.
主要成果:
- 在65项试验中,有46项试验记录了患者理解能力的改善.
- 在33项试验中,有13项观察到更高的满意度;在30项试验中,有3项观察到更低的焦虑度.
- 很少有研究评估初级语言,识字能力,学习需求或成本,这凸显了社会正义方面的差距.
结论:
- 没有任何单一的干预措施有效地改善了知情同意的三个伦理原则 (自主,公益,社会正义).
- 经过验证的干预措施和评估表明对结果的影响更大.
- 未来的研究应该优先考虑社会正义方面,包括语言,识字,学习需求和成本,以确保公平的知情同意.
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