在儿科临床试验中进行敏感的同意过程:从患者的角度进行定性研究
Mirian Luengo1, Ana Minguez-Garrido2, Alberto Bellido-Esteban1
1Universidad Europea de Madrid, Madrid, Spain.
European journal of pediatrics
|November 14, 2025
概括
青少年 青少年 青少年
科学领域:
- 儿科临床试验儿童临床试验
- 青少年健康研究 青少年健康研究
- 研究中的生物伦理学.
背景情况:
- 儿科患者往往缺乏知情同意的法律能力,使得知情同意在道德上至关重要.
- 适当地传达复杂的健康信息,以便为儿科同意提供重大挑战.
研究的目的:
- 探索青少年在儿科临床试验中的知情同意过程中的经验和观点.
- 确定影响青少年在研究决策中的有意义参与的因素.
- 为改进审批工具和沟通策略的开发提供信息.
主要方法:
- 定性构造主义设计利用与青少年 (15-19岁) 进行半结构化的焦点小组.
- 转录的焦点组数据的诱导性内容分析,采用开放编码和研究人员三角化.
- 涉及来自KIDS马德里青年咨询小组的11名青少年,具有不同之前的医院经验.
主要成果:
- 五个主要主题出现了:沟通,坚持,格式,生活质量影响和决策.
- 来自值得信赖的专业人士的清晰,富有同情心的沟通显著提升了青少年的信心和对话.
- 青少年更喜欢青少年友好的格式 (视频,图形),而不是冗长的技术文件,并重视对生活中断的透明度.
结论:
- 将同意视为一个有意义的过程可以提高青少年在临床试验中的参与和坚持.
- 有效的同意依赖于清晰,同情,适合年龄的沟通,培养信任,情感安全和自主权.
- 通过参与决策来赋予青少年权力,可以建立对护理的信心和伙伴关系感.
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