使用人口和疾病登记册作为临床试验的预选工具,进行系统审查
Juliette Foucher1,2, Louisa Azizi3, Linn Öijerstedt3,4
1Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden. Juliette.foucher@ki.se.
Systematic reviews
|April 23, 2024
概括
人口和疾病登记册简化了临床试验前查,降低了成本和时间. 这一系统性审查强调了它们的好处,并呼吁对这些有价值的预选策略进行标准化报告.
科学领域:
- 临床研究 临床研究
- 医疗信息学 医疗信息学
- 生物医学数据科学 生物医学数据科学
背景情况:
- 临床试验招聘在效率和成本方面面临挑战.
- 人口和疾病登记册为患者识别提供了一个潜在的解决方案.
- 系统审查对于评估新的招聘方法至关重要.
研究的目的:
- 系统地审查使用人口和疾病登记册进行临床试验前查的情况.
- 确定临床研究中基于注册表的预选的范围和影响.
- 评估注册表预先选方法的优势和报告趋势.
主要方法:
- 从2014年1月到2022年12月,在MEDLINE,Embase和Web of Science核心集合中进行了全面的文献搜索.
- 研究选择涉及最初的标题/摘要选,然后使用Rayyan软件进行全文审查.
- 质量评估确保了中等到高质量的出版物.
主要成果:
- 报告了24项使用人口和/或疾病登记册进行预查的研究,涵盖了9个疾病领域.
- 大多数研究使用了美国 (54%) 和国家 (62.5%) 的注册.
- 登记处预先选确定了超过478,679名患者,主要用于药物试验,大大减少了财务负担和时间.
结论:
- 注册表预先选可以提高临床试验中的可复制性和质量保证.
- 预先查策略的使用和报告目前没有充分记录.
- 需要标准化的方法指南,以促进更广泛的采用和一致的应用基于注册表的预先选.
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