针对功能性便秘症状的参与者进行完全分散的临床试验的可行性研究
Ki Young Huh1, Woo Kyung Chung1, Jiyeon Park1
1Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Korea.
Clinical and translational science
|August 26, 2023
概括
分散临床试验 (DCT) 对功能性便秘有希望,改善了可访问性. 然而,确保数据可靠性对于成功实现远程研究至关重要.
科学领域:
- 胃肠病学 胃肠病学
- 临床研究方法论 临床研究方法论
- 数字健康数字健康
背景情况:
- 分散临床试验 (DCT) 使用数字工具,尽量减少对实体研究场所的依赖.
- 为DCT平衡可访问性,数据完整性和监管合规性是必不可少的.
- 功能性便秘影响着大量人群,需要创新的试验设计.
研究的目的:
- 评估功能性便秘的完全远程,分散的临床试验的可行性.
- 为了评估乳酸菌和维生素C补充剂的疗效,与单独的维生素C相比.
- 调查用于在DCT环境中收集数据的数字工具的可用性和可靠性.
主要方法:
- 进行了一项开放标签,完全远程,随机的临床试验.
- 参与者提供了电子同意,并完成了基于网络的选.
- 干预涉及直接向参与者输送乳酸菌和维生素C或仅维生素C,每天基于移动应用程序的肠道日记.
主要成果:
- 30名参与者完成了这项研究,其中26.7%的参与者居住在大都市地区之外,证明了地理可访问性提高.
- 与对照组相比,乳酸菌治疗导致每周排便的增加 (+0.80 vs +0.46) 和排便时间的减少 (-3.94小时 vs -1.62小时).
- 完成肠道日记的遵守率为67.1%,其中32.9%的记录显示与日程规划的偏差.
结论:
- 分散的临床试验可以显著提高功能性便秘的参与者的地理可访问性.
- 虽然DCT提供了好处,但需要强大的策略来确保数据的可靠性和准确性.
- 未来的DCT实施需要使用客观指标快速检测错误和响应机制.
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