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分散临床试验的试验特征,方法和报告的挑战:范围审查

Alexandra Cussen^1,2,3, Katherine Littler⁴

¹Adolescent Medicine, The Royal Children's Hospital Melbourne, Parkville, Victoria, Australia Alexandra.Cussen@rch.org.au.

|November 21, 2025

概括

分散临床试验 (DCT) 越来越多地被使用,特别是在心理健康和COVID-19研究中. 本次审查强调了参与者保留和不一致的术语方面的挑战,强调需要标准化报告和监管框架,以有效实施DCT.

科学领域:

临床研究临床研究
医疗卫生技术技术技术
公共卫生公共卫生

背景情况:

分散临床试验 (DCT) 正在获得引力,提供潜在的好处,如降低成本和参与者负担.
发表的DCT在特征,方法和报告的挑战上有所不同,需要全面的概述.

研究的目的:

绘制去中心化临床试验 (DCT) 的地图.
总结已发表的DCT的特征,方法和报告的挑战.

主要方法:

根据PRISMA-ScR检查清单进行了范围审查.
在Ovid MEDLINE和PubMed进行了搜索,截至2024年8月21日.
单个审查员的数据提取包括研究特征,分散的方法和挑战.

主要成果:

53篇论文符合纳入标准,其中大多数研究来自美国.
心理健康和COVID-19是主要的研究领域,研究药物,营养,医疗设备和行为干预.
远程招聘,查和同意是常见的;结果测量使用了不同的方法. 挑战包括参与者保留和招聘偏见,观察到不一致的术语.

结论:

DCT正在迅速增加,在成本和参与者负担方面具有优势.
需要对DCT进行标准化术语,全面报告和强大的监管框架.
正式的道德和报告标准对于有效和负责任地实施DCT至关重要.

关键词:

临床试验临床试验数字技术数字技术数字技术研究设计研究研究设计审查审查审查审查统计学和研究方法.

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