Introduction to the ArRoWS Tool for Assessing Real-World Observational Studies

ZHANG Qiang; LU Cuncun; WANG Zhifei; XIE Yanming; LEI Chao; CHEN Zijia; QIAO Meng; ZHAO Xiaoxiao

Abstract：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.