紧急部门的广泛同意:一个横截面研究
Antje Fischer-Rosinský1, Larissa Eienbröker2, Martin Möckel1
1Health Services Research in Emergency and Acute Medicine, Charité - Universitätsmedizin Berlin, Berlin, Germany.
Archives of public health = Archives belges de sante publique
|February 19, 2025
概括
在紧急部门 (ED) 实施广泛的同意是可行的,同意率为27.5%. 解决语言和理解障碍是包容性患者参与研究的关键.
科学领域:
- 医疗信息学 医疗信息学
- 临床研究 临床研究
- 患者参与 患者参与
背景情况:
- 医疗信息化倡议 (MII) 开发了一个广泛的同意表格 (MII-BC) 用于临床,保险和生物材料数据.
- 急诊室 (ED) 设置对患者同意提出了独特的挑战,因为患者人群和敏度不同.
- 在BC-ED项目中,评估了MII-BC在德国ED的实施情况.
研究的目的:
- 评估在紧急部门实施广泛同意表的可行性.
- 调查患者对自愿,信息回忆,动机和对广泛同意过程的满意度的看法.
- 识别ED环境中广泛同意的障碍和促进者.
主要方法:
- 在四个德国大学医院的ED中使用了一种系统的抽样方法 (每第5名/第30名患者).
- 患者招募和同意程序适应当地场地条件.
- 数据收集涉及患者问卷,研究护士调查和常规临床数据,并使用SPSS进行描述性分析.
主要成果:
- 在被接触的1,138名患者中,有553名 (48.6%) 能够同意;有313名 (58.5%的接触合格患者) 同意接受MII-BC.
- 拒绝同意的主要原因包括语言障碍 (35.4%) 和难以理解研究细节 (21.5%).
- 患者报告了高度的理解 (89.8%) 和满意度,但同意的选择和患者回忆之间存在差异.
结论:
- 在ED中实施广泛的同意是可以实现的,表明患者愿意参与研究.
- 语言障碍和医疗状况显著影响同意率,需要针对性的包容性战略.
- 虽然患者通常理解同意过程,但需要改进理解策略,以解决回忆差异.
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