世界中医药
文章摘要
引用本文:张琪1,盛煜栋1,卢恩仕1,赵天易2,吕晓颖1,李洪皎1.针灸真实世界研究的质量影响因素及其控制措施[J].世界中医药,2024,(07):.  
针灸真实世界研究的质量影响因素及其控制措施
Quality Influencing Factors and Quality Control Methods in Real-world Acupuncture and Moxibustion Study
投稿时间:2023-11-28  
DOI:10.3969/j.issn.1673-7202.2024.07.002
中文关键词:  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
English Keywords:Acupuncture and moxibustion  Real-world study  Quality influencing factors  Quality control methods  Study design type  Clinical research  Quality management  Bias
基金项目:国家重点研发计划“中医药现代化”重点专项(2017YFC1703600)——针灸优势病种疗效评价国际合作研究;国家中医药管理局委托中国中医科学院课题(zz13-026)——“一招鲜”诊疗技术规范和评价方法与策略研究;中国中医科学院创新工程“中医临床基础学科”创新团队项目重点项目(CI2021B003)——基于真实世界诊疗数据的辨证论治有效方药发现与疗效评价的研究
作者单位
张琪1,盛煜栋1,卢恩仕1,赵天易2,吕晓颖1,李洪皎1 1 中国中医科学院中医临床基础医学研究所北京100700 2 天津中医药大学天津301617 
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中文摘要:
      与传统随机对照试验(RCT)相比,真实世界研究(RWS)以真实的临床研究环境为基础,基于临床真实数据,围绕“效果”研究开展,与针灸学的理论体系和临床实践特点表现出较好的相适性。赫尔辛基宣言、国家药监局发布的药物临床试验质量管理规范(GCP)、国际人用药品注册技术协调会发布的药物临床试验管理规范(ICH E6)等为临床研究质量控制提供了指导法则,RCT可通过对人群、干预、对照、结局的严格控制产生高质量临床研究证据,而RWS由于开放、非盲的研究设计,在研究过程中容易产生偏倚,为提升真实世界数据(RWD)质量,故从研究设计角度分析RWS质量影响因素,并从研究者操作标准质量控制、基于受试者相关风险的质量控制、结局指标质量控制等3个方面探讨RWS质量控制措施;从原始数据采集管理规范、原始数据预处理及质量控制、科学数据质量评估、RWD核查等4个方面探讨RWD质量控制措施,以提升RWD质量,产出高可信度的真实世界证据,推动RWS在针灸领域的应用与发展。
English Summary:
      Compared with traditional randomized controlled trails(RCTs),real-world study(RWS) is based on actual clinical research environments and utilize real clinical data to investigate “effectiveness”.It demonstrates better compatibility with the theoretical framework and clinical practice characteristics of acupuncture and moxibustion.Guidelines such as the Declaration of Helsinki,Good Clinical Practice(GCP) regulations issued by national drug regulatory agencies,and the International Conference on Harmonisation 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,control,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 perspective 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 collection 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.
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