远程医疗与面对面知情同意的有效性:理解和决策的随机研究
Saif Khairat1,2,3,4, Paige Ottmar1, Prabal Chourasia1
1Carolina Health Informatics Program, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.
Journal of medical Internet research
|March 7, 2025
概括
远程同意与面对面的知情同意 (IC) 在参与者理解和参与方面同样有效. 这种数字化方法克服了障碍,改善了研究人员的招聘和可访问性.
科学领域:
- 临床研究 临床研究
- 医疗信息学 医疗信息学
- 患者招募 患者招募
背景情况:
- 传统的面对面的知情同意 (IC) 面临着地理和识字等障碍,影响了研究入学.
- 远程医疗,特别是远程同意,为克服这些障碍提供了一个数字化解决方案.
- 有关远程同意与参与者理解和参与的面对面IC的等价性存在担忧.
研究的目的:
- 为了评估参与者在远程同意中的理解和决策,与传统的面对面IC相比.
- 确定远程同意是否是一种可行的替代方案,保持参与者的理解和决策能力.
主要方法:
- 一项随机比较研究,比较了远程同意 (使用Doxy.me) 和亲自IC.
- 验证的评估包括决策控制工具 (DMCI) 和知情同意质量 (QuIC).
- 医疗素养是使用简短评估健康素养-英语 (SAHL-E) 工具来衡量的.
主要成果:
- 在远程同意和面对面的组之间,QuIC或DMCI得分没有显著差异.
- 与面对面的组 (P=.03) 相比,远程同意组在SAHL-E得分上显示出了统计学上显著的差异.
- 在人口分组之间没有发现理解或决策的显著差异.
结论:
- 基于远程医疗的知情同意 (远程同意) 表明参与者对面方法的理解和参与程度相当.
- 远程同意有效地解决了地理和可访问性障碍,增强了临床研究的招聘和保留.
- 将远程医疗实践纳入法规可以改善获得和健康结果.
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