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基于注册表的随机对照试验的用例-对注册表的贡献和约束进行审查

Nadine Kubesch¹, Sneha Gaitonde^2,3, Uarda Petriti⁴

¹Cognizant Technology Solutions, Barcelona, Spain.

Clinical and translational science

|November 19, 2024

概括

基于注册表的随机对照试验 (RRCTs) 越来越多地用于医疗器械,程序和药物. 需要进一步的指导方针来优化卫生当局的使用和报告.

科学领域:

临床试验方法论临床试验方法论
医疗保健服务研究医疗服务研究
在医疗保健中的数据科学.

背景情况:

基于注册表的随机对照试验 (RRCT) 将注册表数据与随机化集成为增强的研究设计.
目前关于RRCT利用和实施的知识需要通过全面的概述来扩展.

研究的目的:

提供基于注册表的随机对照试验 (RRCTs) 使用案例的全面概述.
在RRCTs中识别特征,利用模式,注册表贡献和约束.

主要方法:

到2023年7月进行了有针对性的文献搜索,以确定相关的RRCT出版物.
用描述性统计数据分析了关于RRCT特征和注册表角色的提取数据.

主要成果:

确定了102个RRCT,主要评估医疗器械/程序 (45) 和药物 (30).
大多数RRCT发生在北欧国家 (58),利用卫生服务 (63) 或疾病登记册 (46).
注册表主要对数据收集,随访,患者招募和随机化做出贡献,报告透明度各不相同.

结论:

基于注册表的随机对照试验 (RRCTs) 在各种领域和地区都得到了应用.
需要对RRCT方法制定结构化,透明的报告准则,以告知卫生当局并最大限度地发挥其潜力.

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