IgA肾病信息化标准数据集和质控标准  

IgA nephropathy standard dataset and quality control

作　　者：谢静远 欧阳彦 陈靖[2] 丁峰[3] 顾乐怡[4] 朱立峰[5] 冯东雷 宋艳艳 俞章盛 任红 陈楠[1] Xie Jingyuan;Ouyang Yan;Chen Jing;Ding Feng;Gu Leyi;Zhu Lifeng;Feng Donglei;Song Yanyan;Yu Zhangsheng;Ren Hong;Chen Nan(Department of Nephrology,Ruijin Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai 200025,China;Department of Nephrology,Huashan Hospital,Fudan University,Shanghai 200040,China;Department of Nephrology,Ninth People′s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine,Shanghai 200011,China;Department of Nephrology,Renji Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai 200001,China;Computer Center,Ruijin Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai 200025,China;Shanghai Xinyi Technology Co.,Ltd.,Shanghai 200072,China;Biostatistics Teaching and Research Group,Clinical Research Center,Shanghai Jiao Tong University School of Medicine,Shanghai 200025,China;Clinical Research Center,Shanghai Jiao Tong University School of Medicine,Shanghai 200025,China)

机构地区：[1]上海交通大学医学院附属瑞金医院肾脏科,上海交通大学医学院附属肾脏病研究所,上海200025 [2]复旦大学附属华山医院肾脏科,上海200040 [3]上海交通大学医学院附属第九人民医院肾脏科,上海200011 [4]上海交通大学医学院附属仁济医院肾脏科,上海200001 [5]上海交通大学医学院附属瑞金医院计算机中心,上海200025 [6]上海信医科技有限公司,上海200072 [7]上海交通大学医学院临床研究中心生物统计教研组,上海200025 [8]上海交通大学医学院临床研究中心,上海200025

出　　处：《中华肾脏病杂志》2022年第6期543-549,共7页Chinese Journal of Nephrology

基　　金：国家自然科学基金重点国际(地区)合作研究项目(8211001014);国家自然科学基金(81870460、81570598、81370015、81900656);上海市临床重点专科建设项目(shslczdzk02502);上海科委"优秀学术带头人"(21XD1402000);上海市教委高原高峰临床医学基金(20152207);上海申康医院发展中心"促进市级医院临床技能与临床创新三年行动计划"(SHDC2020CR6017);上海交通大学医学院多中心临床研究项目(DLY201510);上海交通大学"交大之星"计划医工交叉研究基金重点项目(YG2019ZDA18、YG2019QNA37)。

摘　　要：目的建立IgA肾病(IgA nephropathy,IgAN)标准数据集是实现IgAN临床信息结构化和标准化的前提,将有利于不同医疗机构间临床信息的整合利用。为此,上海IgAN专家协作组编写了这部《IgA肾病标准数据集》。方法参考国内信息标准,结合相关领域内的指南、数据规范及专家共识,以电子病史档案为基础,将患者身份标识号作为系统主键进行信息收集。通过对数据集中各个数据元进行规范,确保管理系统在数据与信息交换、数据协同与共享上的标准化,并制定相应的质量控制体系。结果本标准数据集共包括607个数据元,8个模块,分为患者信息、病史信息、体格检查、实验室检查、辅助检查、肾脏病理、药物治疗、随访。各模块又由子模块名称、数据元名称、英文名称、定义、值域、参考标准等组成。同时,质量控制体系被制定,从完整性、规范性、准确性、及时性及安全性等多维度对数据质量进行评估,确保数据的高质量与安全。结论本研究建立了IgAN标准数据集,将有助于国内IgAN临床信息的结构化和标准化。Objective To establish a IgA nephropathy(IgAN)standard dataset for the structured and standardization of IgAN clinical information,which will be beneficial to the integration and utilization of clinical information among different medical institutions.Therefore,the IgAN Expert Collaboration Group composed the"IgA Nephropathy Standard Dataset".Methods Referring to the domestic information standards,guidelines,data standard and consensus of related fields,based on electronic medical history,the patient identification number was used as the primary key of the system to collect information.By standardizing each data element in the data set,the standardization of the management system in data and information exchange,data collaboration and sharing was ensured,and a quality control system was developed.Results This standard dataset included 607 data elements and 8 business domains,which were patient information,medical history information,physical examination,laboratory examination,assistant examination,renal pathology,drug treatment,and follow⁃up,respectively.Each module was composed of module name,data element name,English name,definition,range,reference standard,etc.At the same time,a corresponding quality control system was formulated to evaluate data quality from multiple dimensions such as completeness,standardization,accuracy,timeliness,and security for ensuring the high quality and security of the data.Conclusion The IgAN standard dataset is established,which will contribute to the structuration and standardization of clinical information of IgAN patients.

关 键 词：肾小球肾炎 IGA 标准数据集 医学大数据 医院信息系统 数据整合 

分 类 号：R692.31[医药卫生—泌尿科学]