真实世界观察性研究常用于评价某种干预措施或暴露因素对疾病健康的影响.然而,在真实世界观察性数据的采集、处理和分析过程中,由于缺乏严格的质量控制,通常存在数据缺失,或数据标准、数据模型和描述方法不统一等问题,进而影响到真实世界研究证据的质量.现有用于观察性研究的工具并不专用于真实世界研究,也并非用于评价研究质量.为了解决这一问题,国外Coles等研究者研发并测试了一种真实世界观察性研究评估(the Assessment of Real-World Observational Studies,ArRoWS)工具,用于评价基于电子健康记录的真实世界观察性研究的质量.该工具共有16 个条目,包括9 个核心条目和7 个研究设计特定条目,以及条目具体的评价方式及结果.虽然国内也有研究者提出ArRoWS工具可用于评估真实世界观察性研究的质量,但尚未被广泛推广和使用.因此,本文就ArRoWS工具的研发过程、评价条目、评价方式及结果进行介绍,旨在促进该工具在真实世界观察性研究中的应用,从而产出更多高质量的真实世界证据.
Introduction to the ArRoWS Tool for Assessing Real-World Observational Studies
Real-world observational study is commonly used to evaluate the effects of an intervention or exposure on a disease or health condition.However,in the process of collection,processing,and analysis of real-world observational data,due to the lack of strict quality control,there are usually problems such as missing data,inconsistent data standards,data models,and description methods,which further affect the quality of real-world evidence.The existing tools for observational studies are not specific to real-world studies and are not designed to assess the quality of studies.In order to solve this problem,Coles and other researchers developed and tested ArRoWS,an assessment tool for real-world observational studies,to evaluate the quality of real-world observational studies based on electronic health records.The tool had a total of 16 items,including 9 core items and 7 research design-specific items,as well as item-specific evaluation methods and results.Although some domestic researchers have proposed that ArRoWS tool can be used to evaluate the quality of real-world observational studies,it has not been widely promoted and used.Therefore,this paper introduces the development process,evaluation items,evaluation methods and results of ArRoWS tool,aiming to promote the application of ArRoWS tool in real-world observational studies,so as to generate more high-quality real-world evidence.
万方数据
维普
