中医随机对照试验临床证据元数据研究  

Metadata of Evidence from Traditional Chinese Medicine Randomized Controlled Trials

作　　者：马琳 邓宏勇[1] MA Lin;DENG Hongyong(Sci&Tech Information Center,Shanghai University of Traditional Chinese Medicine,Shanghai201203,China)

机构地区：[1]上海中医药大学科技信息中心,上海201203

出　　处：《中国实验方剂学杂志》2024年第11期129-138,共10页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：中华中医药学会团体标准项目(20210707-BZ-CACM)。

摘　　要：目的:建立《中医随机对照试验临床证据元数据》标准草案,以规范中医系统评价数据采集、存储、传输、交换、分析和评价等。该草案除应用于传统系统评价和Meta分析外,更将有力支撑自动系统评价技术发展,推动中医临床证据高效利用,为中医循证快速科学决策奠定基础。方法:本研究共分3个阶段进行。第一阶段为预研阶段,采用文献调研与专家访谈的方法,在充分研究和论证的基础上,对新标准制定研究提出建议。第二阶段为标准起草,主要任务是形成标准征求意见稿,分为成立工作组、起草元数据标准征求意见稿2个步骤。第三阶段为征求意见,即通过邮件、信函等方式向课题组以外相关组织机构及专家学者广泛征求意见,形成标准草案。结果:预研阶段,对国内外临床研究元数据标准的特点及现状进行了初步整理,确定了制定该标准对中医临床证据资源规范化的意义、元数据制定原则、可参考的资料、元数据子集设置等。成立工作组、形成标准征求意见稿后,通过邮件形式向外部专家征求意见,完成第三轮修订,形成标准草案。最终版本的元数据标准草案共12部分,分别为前言、引言、范围、规范性引用文件、术语与缩略语、原则和构成、元数据的描述方法、元数据摘要表示、元数据字典描述、可扩展标记语言(XML)置标示例、JavaScript对象表示法(JSON)置标示例、参考文献。其中,“元数据摘要表示/字典描述”部分共包含6个元数据子集,总计20个元数据实体、141个元数据元素。结论:本研究采用文献调研、专家访谈、标准起草、征求意见等方法,形成的《中医随机对照试验临床证据元数据》标准草案,对于规范中医药临床研究、促进中医药临床疗效的客观科学评价和有效利用具有重要推动作用。Objective:To draft the Metadata of Evidence from Traditional Chinese Medicine Randomized Controlled Trials for standardizing thedata collection,storage,transmission,exchange,analysis,and evaluation of traditional Chinese medicine(TCM)studies.In addition to the application of conventional systematic review and meta-analysis,this draft will provide strong support for the development of automated systematic review,facilitate the efficient utilization of TCM clinical evidence,and underpin the evidence-based rapid decision-making in TCM.Method:This study was structured into three stages.During the first stage(preresearch),suggestions for formulating new standards were proposed based on comprehensive research and demonstration of views obtained from literature investigation and expert interviews.The second stage concentrated on drafting the standard by assembling a working group and crafting a draft solicitation document for metadata standards.At the third stage,feedback was sought from relevant institutions,organizations,and experts and scholars outside the research group via mail or other means to finalize the draft standard.Result:During the pre-research stage,a preliminary examination was conducted to assess the characteristics and current status of clinical research metadata standards,and the information was identified regarding the significance of formulating the standard,principles guiding metadata formulation,reference materials,and suggestions for metadata subset establishment.After establishing a working group and drafting the initial version of the standard,opinions from external experts were sought via email.Based on the comments,a third round of revisions was conducted,resulting in the finalization of a draft for the standard.The finalized version of the standard draft comprised 12 sections:preface,introduction,scope,normative reference documents,terms and abbreviations,principles and composition,metadata description method,metadata summary representation,metadata dictionary description,Extensible Markup L

关 键 词：中医临床证据 随机对照试验 元数据标准 标准制订 

分 类 号：R242[医药卫生—中医临床基础] R2-031[医药卫生—中医学] R-3R4R-05R24R856.2