摘要
随着中医药临床研究的广泛开展,数据质量成为影响评价临床疗效的核心问题之一,而量表数据在反映中医药临床疗效时有其独特优势。该文章凭借"十三.五"科技部重大科技专项中近20个中医临床试验项目的数据管理经验,对量表数据容易出现的质量问题进行了归类与分析,从数据管理角度系统阐述了如何应用量表和如何提高量表数据质量。该内容按照数据管理的流程分为五个部分:病例报告表(Case Report Form,CRF)设计阶段的量表应用、量表在数据库设计与建立时的注意事项、量表数据采集与录入时的基本要求、量表数据核查时的关键内容、量表数据分析的原则。希望本文能够为中医药领域的临床研究者在应用量表和量表数据时提供有益参考。
With the expanding clinical research in traditional Chinese medicine(TCM),data quality has become one of the core issues affecting the evaluation of clinical efficacy,and scale data has its unique advantages in reflecting the clinical efficacy of TCM.This article is based on the data from nearly 20 major science and technology projects of the13 th Five-Year Plan of the Ministry of Science and Technology Major Project.The article categorizes and analyzes the quality problems of scale data from the perspective of data management,and systematically explains how to apply and improve the quality of scale data from the perspective of data management.The content is divided into five parts according to the process of data management:the application of scale in the design stage of Case Report Form(CRF),considerations for scale in database design and establishment,basic requirements for scale data collection and entry,key elements for scale data verification,and principles of scale data analysis.It is hoped that this paper will provide useful references for clinical researchers in the field of TCM when applying scales and scale data.
作者
吕晓颖
朱燕波
赵若男
刘保延
雒琳
文天才
刘佳
艾艳珂
何丽云
Lyu Xiaoying;Zhu Yanbo;Zhao Ruonan;Liu Baoyan;Luo Lin;Wen Tiancai;Liu Jia;Ai Yanke;He Liyun(School of Traditional Chinese Medicine,Beijing University of Chinese Medicine,Beijing,00029,China;Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China;School of Management,Beijing University of Chinese Medicine,Beijing 100029,China;Shaanxi University of Chinese Medicine,Shanxi 710000,China)
出处
《世界科学技术-中医药现代化》
CSCD
北大核心
2021年第9期3395-3400,共6页
Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology
基金
国家科学技术部国家重大科技专项-子课题任务(2017ZX10106001001003):中医药治疗传染病临床研究支撑平台的应用服务,负责人:吕晓颖
国家自然基金委员会青年基金项目(8170142146):中医临床队列研究中缺失数据的拟合优化路径研究,负责人:吕晓颖
国家自然科学基金委员会青年基金项目(81704189):基于结肠神经-c-kit-ICC通路探讨深刺天枢穴治疗慢传输型便秘的作用机制,负责人:刘佳
关键词
中医药
临床研究
数据质量
数据管理
量表
Traditional Chinese Medicine
Clinical trial
Data quality
Data management
scale
作者简介
通讯作者:何丽云,博士生导师,研究员,主要研究方向:临床评价方法。
