在药物流行病学研究中描述现实世界数据源的多样性:DIVERSE范围审查
Rosa Gini1, Romin Pajouheshnia2,3, Helga Gardarsdottir2,4,5
1ARS Toscana, Florence, Italy.
了解现实世界数据源 (RWDS) 的多样性是可复制医学研究的关键. 本研究确定了改善现实世界证据 (RWE) 质量和有效性的维度和机会.
科学领域:
- 药理流行病学 药理流行病学
- 医疗信息学 医疗信息学
- 数据科学数据科学数据科学
背景情况:
- 现实世界证据 (RWE) 对于监管决策至关重要,但其可复制性受到现实世界数据源 (RWDS) 的多样性阻碍.
- 解决收集和报告RWDS多样性的挑战对于提高RWE的有效性至关重要.
- 利用数据多样性可能会提高从二次数据使用中获得的证据质量.
研究的目的:
- 识别,描述和描述实践,建议和工具,以收集和报告RWDS的多样性.
- 探索如何利用RWDS多样性可以提高药物流行病学研究的质量和有效性.
- 建立一个关于报告RWDS多样性的正式指导的基础.
主要方法:
- 在2021年12月之前进行了系统的文献搜索.
- 文件进行了选和审查,以提取有关RWDS多样性的信息.
- 用内容分析来确定与数据多样性相关的主题.
主要成果:
- 91份文件产生了12个主题,包括描述RWDS的9个维度 (例如数据来源者,内容,数据质量).
- 在这些维度内确定了36个主题,突出挑战和机遇.
- 确定了诸如多重归因和标准化等机会,以利用数据多样性.
结论:
- 确定的维度为报告RWDS多样性的正式指导提供了基础.
- 对数据源多样性的标准化报告将提高RWE的解释和可复制性.
- 改进的报告实践将在监管决策中加强现实世界的证据的有效性和可信性.
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