在临床研究中测试和实践实施用户友好的个性化和长期电子知情同意原型:混合方法研究研究
Evelien De Sutter1, David Geerts2, Koen Yskout3
1Clinical Pharmacology and Pharmacotherapy, Department of Pharmaceutical and Pharmacological Sciences, Catholic University (KU) Leuven, Leuven, Belgium.
Journal of medical Internet research
|December 19, 2023
概括
电子知情同意 (eIC) 应用程序需要用户友好的设计,以成功实施临床研究. 可用性测试至关重要,但低数字素养需要额外的支持或替代系统以实现更广泛的可访问性.
科学领域:
- 临床研究 临床研究
- 人与计算机的交互
- 医疗信息学 医疗信息学
背景情况:
- 对临床研究的电子知情同意 (eIC) 越来越感兴趣.
- 用户友好和利益相关者的接受对于eIC成功实施至关重要.
研究的目的:
- 为设计和实施一个用户友好的,个性化的,长期的eIC应用程序收集见解.
- 通过可用性研究和利益相关者采访,评估整合到日常实践中.
主要方法:
- 用比利时公民进行eIC原型的代可用性测试,包括那些数字素养较低的比利时公民.
- 与参与者和利益相关者 (道德委员会成员,医疗保健专业人员,制药行业代表) 进行系统可用性量表问卷和半结构化访谈.
- 使用NVivo软件对定性数据进行主题分析.
主要成果:
- 个性化和长期互动的可用性得分在3次代中得到改善,这表明可用性高于平均水平.
- 利益相关者发现需要简单的设置功能,如内容库,但发现一些功能,如新研究通知,不那么有用.
- 低数字素养是一个挑战,表明需要量身定制的支持.
结论:
- 可用性测试对于提高eIC应用程序的用户友好性至关重要.
- 虽然eIC系统显示出潜力,但对于数字素养较低的人来说,需要额外的支持或替代方案.
- 实际实施需要简单的设置和与现有系统的互操作性.
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