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在妇科瘤学临床试验中使用远程医疗
Leslie Andriani1, Jinhee Oh2, Erin McMinn3
1Division of Gynecologic Oncology at Penn Medicine, University of Pennsylvania, Philadelphia, PA, United States of America.
Gynecologic oncology
|September 2, 2023
概括
在COVID-19大流行期间,妇科瘤学临床试验中的远程医疗和远程操作是安全的. 这些方法没有损害患者安全或试验完整性,这表明未来的实用性.
科学领域:
- 妇科瘤学 妇科瘤学
- 临床试验操作 临床试验操作
- 数字健康数字健康
背景情况:
- 在COVID-19大流行之前,远程医疗和远程临床试验操作的利用率不足.
- 对于这些操作变化,患者级安全数据有限.
研究的目的:
- 评估远程医疗和远程临床试验操作的安全性和可行性.
- 评估这些变化对在疫情期间的妇科瘤学临床试验的影响.
主要方法:
- 在临床试验中对妇科瘤患者的回顾性审查.
- 在一个学术机构内比较远程医疗和远程医疗前期.
- 分析患者的人口统计,接触,不良事件和协议偏差.
主要成果:
- 在远程医疗期间增加了虚拟提供者访问和现场实验室测试.
- 访问,成像或实验室检测的延迟没有显著差异.
- 与远程医疗文档相关的小协议偏差增加;主要事件仍然很低且没有变化.
结论:
- 在妇科瘤学临床试验中,远程医疗和远程手术似乎是安全的.
- 这些调整并没有影响本研究中的试验方案.
- 需要进行更大规模的研究来证实这些试验适应后流行病的有用性.
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