摘要
中风病防治一直是全球医学界关注的焦点,针灸治疗中风病的独特优势日益突出,《中国急性缺血性脑卒中指南2018》推荐急性脑梗死患者进行针刺治疗(Ⅱ级推荐,B级证据)。标准化、规范化临床研究数据可以保证临床研究的数据质量,为数据的整理和挖掘提供保障,病例注册登记属于真实世界研究,数据元素的一致性是保证计划实施、数据质量高效、临床研究证据可信的必备要素之一。因此,课题组基于国家重点研发计划课题“针灸治疗中风病的病例注册登记研究”制订了本课题的数据元及定义,以期优化针灸防治中风病临床研究范式。
Stroke prevention and treatment has been the focus of attention in the global medical community,and the unique advantages of acupuncture for stroke treatment are becoming increasingly prominent,Chinese guidelines for acute ischemic stroke 2018 recommend acupuncture for acute cerebral infarction patients(gradeⅡrecommendation,B-level evidence).Standardization and normalization of clinical research data can ensure the data quality of clinical research and provide assurance for data collation and mining.Case registration is a real-world study,and the consistency of data elements is one of the necessary elements to ensure plan implementation,efficient data quality,and credible clinical research evidence.Therefore,the research group developed the data elements and definitions of this project based on the national key research and development project case registration research of acupuncture and moxibustion for the treatment of stroke,in order to optimize the clinical research paradigm of acupuncture and moxibustion for the prevention and treatment of stroke.
作者
杨丽红
张超
李泽芳
杨趁
王飞
杜宇征
史慧妍
YANG Lihong;ZHANG Chao;LI Zefang;YANG Chen;WANG Fei;DU Yuzheng;SHI Huiyan(Acupuncture Department,First Teaching Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300381,China;National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion,Tianjin 300381,China;Department of Rehabilitation Medicine,Changzhi Second People's Hospital,Changzhi 046000,China;Institute of Acupuncture and Moxibustion,First Teaching Hospital of Tianjin University of Traditional Chinese Medicine,Tianjin 300381,China)
出处
《中国全科医学》
CAS
北大核心
2024年第16期2023-2032,共10页
Chinese General Practice
基金
国家重点研发计划(2019YFC0840709)。
关键词
中风病
针灸治疗
注册登记
数据元素
数据质量
研究范式
Stroke
Acupuncture moxibustion therapy
Registration
Data elements
Data quality
Research paradigm