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针灸真实世界研究的质量影响因素及其控制措施

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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.
Quality Influencing Factors and Quality Control Methods in Real-world Acupuncture and Moxibustion Study
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.

Acupuncture and moxibustionReal-world studyQuality influencing factorsQuality control methodsStudy design typeClinical researchQuality managementBias

张琪、盛煜栋、卢恩仕、赵天易、吕晓颖、李洪皎

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中国中医科学院中医临床基础医学研究所,北京,100700

天津中医药大学,天津,301617

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

国家重点研发计划"中医药现代化"重点专项国家中医药局委托中国中医科学院项目中国中医科学院创新工程"中医临床基础学科"创新团队重点项目

2017YFC1703600zz13-026CI2021B003

2024

10.3969/j.issn.1673-7202.2024.07.002

世界中医药
世界中医药学会联合会

世界中医药

CSTPCDCHSSCD北大核心
影响因子：1.266
ISSN：1673-7202
年,卷(期)：2024.19(7)