瓣膜性心脏病临床研究数据采集规范和变量标准——基于“老年瓣膜性心脏病标准评估体系及优化治疗路径研究”大数据平台  

Key Data Collection Specifications and Variable Standards for Measuring the Clinical Management and Outcomes of Patients With Valvular Heart Disease in China:Based on the Multi-center Clinical Research Innovation Platform of"China-DVD2 Study"

作　　者：李喆 许海燕 吴永健 老年瓣膜性心脏病项目研究组 LI Zhe;XU Haiyan;WU Yongjian;China-DVDStudy Group(Structure Heart Disease Center,National Center for Cardiovascular Diseases and Fuwai Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100037,China)

机构地区：[1]中国医学科学院、北京协和医学院、国家心血管病中心、阜外医院结构性心脏病中心,北京100037

出　　处：《中国循环杂志》2025年第3期219-226,共8页Chinese Circulation Journal

基　　金：国家重点研发计划(2020YFC2008100,2020YFC2008101)。

摘　　要：目的:基于高标准大容量的老年瓣膜性心脏病数据采集系统,建立瓣膜性心脏病临床研究大数据平台的标准数据采集规范和变量集定义,基于以临床治疗决策为导向的标准化、同质化瓣膜性心脏病的评估流程,创建首个涵盖临床信息、功能学、多模态影像、治疗以及随访完整的老年瓣膜性心脏病数据库。方法:依据分析既往国内外临床研究、文献数据,参照相关重要指南和标准,结合瓣膜性心脏病新的发展和中国特色的临床实践以及专家经验,遴选变量,制定数据变量的标准和定义、精细化影像评估技术和数据采集规范、多道数据核查和质量控制方案;根据变量的属性以及产生时间进行归类。结果:本变量集涵盖了瓣膜性心脏病患者从接诊之时起整个诊疗过程产生以及临床研究所需的相关变量共567个。变量集共由6个部分组成,分别为临床信息(包括人口学特征和就诊信息、临床表现和体格检查、合并疾病和既往病史、实验室检查和辅助检查、衰弱在内的老年综合评估)、超声心动图、心脏计算机断层摄影术(CT)、治疗(包括外科手术、瓣膜与非瓣膜介入治疗、药物治疗)、临床结局、随访。其中,人口学特征和就诊信息包含14个变量;临床表现和体格检查包含22个变量;合并疾病和既往病史包含63个变量;实验室检查与辅助检查包含49个变量;老年综合评估包含15个变量;超声心动图包含55个变量及基线、术中、术后上传完整动态影像(包括采集各个时间节点、每个节点6个切面及相应多普勒频谱图);心脏CT包含131个变量及基线、术后上传原始影像[包括心电门控非增强CT扫描、心电门控全期相CT血管成像(CTA)扫描、大范围非心电门控螺旋CTA扫描];外科手术诊疗包含51个变量;瓣膜介入治疗包含72个变量;非瓣膜介入治疗包含33个变量;药物治疗包含27个变量;临床结局包含35个Objectives:Utilizing an advanced and high-capacity data acquisition system tailored for elderly patients with valvular heart disease,we aimed to establish standardized data acquisition protocols and define variable sets for a clinical research big data platform dedicated to this condition.Guided by clinical treatment decisions,we implemented a standardized and uniform evaluation process for valvular heart disease.This initiative might culminate in the creation of the first comprehensive database for elderly valvular heart disease,encompassing clinical information,functional assessments,multimodal imaging,treatment modalities,and follow-up data.Methods:Variables were selected based on past clinical studies and literature,both domestic and international,and considering key guidelines,advancements in valvular heart disease,and China's clinical practices.Standards for data variables,imaging techniques,data acquisition,multi-channel verification,and quality control were established.Variables are then classified by their properties and generation time.Results:This comprehensive set of variables encompassed a total of 567 relevant variables,which were generated throughout the entire diagnosis and treatment process of patients with valvular heart disease,starting from admission and extending to those required for clinical research.The variable set was divided into six distinct parts:clinical information(encompassing demographics,admission details,clinical manifestations,comorbidities,medical history,physical examination,auxiliary examinations,and comprehensive assessment of frailty in the elderly),echocardiography,cardiac computed tomography(CT),treatment(including surgery,valve intervention therapy,non-valve intervention therapy,and medication therapy),clinical outcomes,and follow-up.Specifically,it included 14 variables related to demographic and admission information;22 variables encompassing clinical manifestations and physical examination;63 variables concerning medical history and comorbidities;49 variables for ins

关 键 词：瓣膜性心脏病 标准化变量集 临床研究 信息化数据平台 影像数据 

分 类 号：R541.4[医药卫生—心血管疾病]