中国全科医学 ›› 2024, Vol. 27 ›› Issue (16): 2023-2032.DOI: 10.12114/j.issn.1007-9572.2022.0839

• 论著·基层中医药服务研究 • 上一篇    下一篇

针灸治疗中风病的病例注册登记研究——数据元及定义

杨丽红1,2, 张超1,2, 李泽芳3, 杨趁2,4, 王飞2,4, 杜宇征1,2, 史慧妍2,4,*()   

  1. 1.300381 天津市,天津中医药大学第一附属医院针灸部
    2.300381 天津市,国家中医针灸临床医学研究中心
    3.046000 山西省长治市第二人民医院康复医学科
    4.300381 天津市,天津中医药大学第一附属医院针灸研究所
  • 收稿日期:2023-01-31 修回日期:2023-04-30 出版日期:2024-06-05 发布日期:2024-04-08
  • 通讯作者: 史慧妍

  • 作者贡献:

    杨丽红、张超提出主要研究目标,负责研究的构思与设计,研究的实施,撰写论文;李泽芳进行数据元及定义的收集与整理;杨趁、王飞进行数据元及定义的修订;杜宇征、史慧妍负责文章的质量控制与审查,对文章整体负责,监督管理。

  • 基金资助:
    国家重点研发计划(2019YFC0840709)

A Case Registry Study of Acupuncture Treatment for Stroke: Data Elements and Definitions

YANG Lihong1,2, ZHANG Chao1,2, LI Zefang3, YANG Chen2,4, WANG Fei2,4, DU Yuzheng1,2, SHI Huiyan2,4,*()   

  1. 1. Acupuncture Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
    2. National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin 300381, China
    3. Department of Rehabilitation Medicine, Changzhi Second People's Hospital, Changzhi 046000, China
    4. Institute of Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300381, China
  • Received:2023-01-31 Revised:2023-04-30 Published:2024-06-05 Online:2024-04-08
  • Contact: SHI Huiyan

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。

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

Abstract:

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.

Key words: Stroke, Acupuncture moxibustion therapy, Registration, Data elements, Data quality, Research paradigm