Compared with traditional randomized controlled trails(RCTs),real-world study(RWS)is based on actual clinical re-search environments and utilize real clinical data to investigate"effectiveness".It demonstrates better compatibility with the theo-retical framework and clinical practice characteristics of acupuncture and moxibustion.Guidelines such as the Declaration of Helsin-ki,Good Clinical Practice(GCP)regulations issued by national drug regulatory agencies,and the International Conference on Har-monisation of Technical Requirements for Registration of Pharmaceuticals for Human Use(ICH E6)provide guidance for controlling the quality of clinical research.RCTs produce high-quality clinical evidence through strict control of population,intervention,con-trol,and outcomes.However,RWS,due to its open and non-blinded study design,is prone to bias during the research process.To improve the quality of real-world data(RWD),it is necessary to analyze the factors in fluencing thequality of RWS from the perspec-tive of study design.Quality control measures for RWS were discussed from three aspects:research eroperational standards,quality control based on participant-related risks,and outcome indicator quality control.Furthermore,to enhance the quality of RWD,produce real-world evidence(RWE)with high reliability,quality control measures for RWD were explored from four aspects:raw data collec-tion management standards,preprocessing and quality control of raw data,scientific data quality assessment,and RWD verification.This study is expected to promote the application and development of RWS in the field of acupuncture and moxibustion.
关键词
针灸/真实世界研究/质量影响因素/质量控制内容/研究设计类型/临床研究/质量管理/偏倚
Key words
Acupuncture and moxibustion/Real-world study/Quality influencing factors/Quality control methods/Study design type/Clinical research/Quality management/Bias
维普
万方数据