在临床试验中观察到的数字解决方案:形成性可行性范围审查
Taylor M Harrison1,2, Sungrim Moon1, Liwei Wang1
1Department of Artificial Intelligence and Informatics, Mayo Clinic, Rochester, MN, USA.
AMIA ... Annual Symposium proceedings. AMIA Symposium
|January 15, 2024
概括
数字解决方案 (DSs) 正在改变临床试验,但报告标准和最佳实践尚不清楚. 本次审查确定了DS质量和可重复性方面的差距,为未来的研究提供了信息,以获得更好的试验结果.
科学领域:
- 数字健康数字健康
- 临床试验方法论 临床试验方法论
- 医疗信息学 医疗信息学
背景情况:
- 数字化转型在临床试验中正在加速,数字化解决方案 (DSs) 的广泛采用.
- 诸如技术障碍,隐私和用户参与等因素显著影响了DS的成功.
- 目前的文献缺乏关于如何考虑和报告这些因素的清晰度,影响DS质量和可重复性.
研究的目的:
- 进行形成性的可行性范围审查,以确定临床试验中关于数字解决方案的文献上的差距.
- 了解临床研究中数字解决方案的当前趋势和报告实践.
- 为制定一项大型研究提供信息,该研究的重点是报告DSs的标准化和最佳实践.
主要方法:
- 从2009年到2022年收集了4167篇包含数字术语的文章,这些文章以英语出版.
- 随机选择了2016年至2022年间发表的130篇文章进行全文审查.
- 分析了100篇符合条件的文章,将它们分类为教育,干预,患者和治疗领域.
主要成果:
- 确定了影响数字解决方案成功的关键因素,包括技术障碍,隐私问题和用户参与.
- 分类符合条件的文章: 16% 教育,59% 干预,8% 患者,17% 治疗.
- 揭示了临床试验中数字解决方案相关的趋势和报告实践,突出了需要改进的领域.
结论:
- 临床试验中数字解决方案的报告标准和评估方法存在重大差距.
- 需要进一步的研究,以建立关于报告标准化和最佳实践的基本知识.
- 这项研究的结果将指导对数字解决方案质量和可重复性进行大规模调查的协议开发.
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