中医随机对照试验元数据完整性的评价  

Data integrity of randomized controlled trial in TCM

作　　者：黄忠营 孙卫强[1] 邓宏勇[2] 赖佳琪 刘少南[3] 杨丽虹[3] 郭新峰[3] 吴大嵘[3] 商洪才[4] HUANG Zhongying;SUN Weiqiang;DENG Hongyong;LAI Jiaqi;LIU Shaonan;YANG Lihong;GUO Xinfeng;WU Darong;SHANG Hongcai(Shanghai Jiao Tong University,Shanghai 200240,P.R.China;Shanghai University of Traditional Chinese Medicine,Shanghai 201203,P.R.China;Guangdong Provincial Hospital of Chinese Medicine,Guangzhou 510120,P.R.China;Dongzhimen Hospital of Beijing University of Chinese Medicine,Beijing 100700,P.R.China)

机构地区：[1]上海交通大学,上海200240 [2]上海中医药大学,上海201203 [3]广东省中医院,广州510120 [4]北京中医药大学东直门医院,北京100700

出　　处：《中国循证医学杂志》2021年第10期1211-1218,共8页Chinese Journal of Evidence-based Medicine

基　　金：国家重点研发计划项目(编号:2019YFC1709803)。

摘　　要：目的提出中医随机对照试验(RCT)元数据完整性客观评价模型,并对在我国中医期刊发表的中医药RCT报告数据完整性进行评价。方法计算机检索主要中英文数据库中中医RCT文献并提取所报告的数据,采用"中医药优势病种证据系统的智能化构建和应用示范"项目定义的元数据接口规范和数据完整性评价模型,对当前中医药期刊发表的中医药RCT数据完整性进行评价。结果提出元数据接口规范和中医药RCT元数据完整性客观评价模型。评估1986~2020年10个病种共37 361篇文献,其中6 743篇研究报告不符合元数据接口规范基本要求。关键条目无缺失的报告数目比例在73%~97%之间,"中医诊断"和"脱落例数"对关键条目完整程度影响较大。"分组情况"部分的"年龄标准差"和"病程标准差"、"干预措施"部分的"剂量"、"剂型"、"治疗频率"条目报告率较低。RCT报告平均得分为71.39分。结论当前中医药RCT元数据完整性有较大提升空间,数据报告亟需标准化、规范化。本研究提出的元数据接口规范和完整性客观评价模型可为提高中医药临床试验报告数据完整性提供参考和依据。Objective To define an objective evaluation model for metadata integrity of randomized controlled trials(RCTs) in traditional Chinese medicine(TCM), and to evaluate the data integrity of RCT reports published in TCM journals. Methods Retrieving Chinese medicine RCT literature and extracting data, using the metadata specification list and customized evaluation model defined in the project "Intelligent Construction and Application Demonstration of the Evidence System of Chinese Medicine Dominant Diseases" to analyze RCTs from the perspective of data integrity.Results A metadata interface specification and an objective evaluation model for RCT metadata integrity were proposed. A total of 37 361 articles of 10 diseases from 1986 to 2020 were evaluated. Among them, 6 743 reports failed to meet the basic requirements of metadata specifications. The proportion of reports with no missing required items was between 73% and 97%. "tcmdisease" and "numdroptotal" had a greater impact on completeness for the required items.The reporting rates of the items in the "agesd" and "historysd" in the "group" section, and "dosage", "dosageform" and "dosagefreq" in the "interventions" section were low. The average score of RCT report was 71.39 points. Conclusions There is room for improvement in the integrity of RCT data in TCM, and data reporting is urgently required to be standardized. The metadata specification and completeness objective evaluation model proposed in this study can provide references for improving the data integrity of clinical trial reports of TCM.

关 键 词：中医药 随机对照试验 数据完整性 元数据接口规范 

分 类 号：R-3[医药卫生]