在大多数情况下,电子知情同意:急性缺血性中风临床试验
S Iris Davis1, Abbey Staugaitis2, Ian Rines3
1University of Cincinnati Neurology, OH (S.I.D., A.D.R., P.K., J.P.B.).
Stroke
|April 16, 2025
概括
在急性缺血性中风试验中采用电子同意 (eConsent) 增加了现场招生和远程同意率. 与传统的纸质方法相比,这种方法提高了同意文件的遵守率,显示了未来中风研究的潜力.
科学领域:
- 神经学 神经学
- 临床试验 临床试验
- 医疗信息学 医疗信息学
背景情况:
- 及时知情同意是招募患者参加急性缺血性中风临床试验的一个重大挑战.
- 电子同意 (eConsent) 通过简化知情同意流程的交付和文档提供了一个潜在的解决方案.
- 在急性缺血性中风试验中,eConsent的采用和影响仍未得到充分研究.
研究的目的:
- 分析电子同意 (eConsent) 在中风血栓溶解多臂优化试验 (MOST) 的采用趋势.
- 评估eConsent对临床试验招募和参与者招募的影响.
- 为了比较eConsent的坚持和效率与传统的基于纸张的同意方法.
主要方法:
- 对MOST第三期临床试验数据 (2019年10月 - 2023年7月) 的后期分析,涉及57个地点的514名参与者.
- 同意方式的分类:纸面亲自,纸面远程,eConsent亲自和eConsent远程.
- 统计分析 (chi-squared,Kruskal-Wallis测试) 以比较录取,远程同意率,时间指标,数据澄清和同意组之间的不良事件.
主要成果:
- 33.7%的参与者使用eConsent,其中56.1%的网站至少使用过一次.
- 使用eConsent的网站与非eConsent网站相比,平均入学率显著更高 (7.5对3名参与者).
- 电子同意更频繁地促进了远程同意 (46.2%与1.2%相比),并证明了优越的同意文件遵守,数据澄清和不良事件较少.
结论:
- 在MOST试验中采用eConsent与增加现场招生和更高的远程同意率相关.
- 该研究强调,与纸质方法相比,eConsent的同意文档遵守程度有所改善.
- 对于未来的急性缺血性中风临床试验和中风研究网络来说,eConsent具有显著的优势.
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