冠心病患者诊疗过程及临床结局中关键数据标准字段集:基于CardiaCare多中心临床科研创新平台

Key data elements for clinical management and outcomes of patients with coronary artery disease:definitions from Coronary Artery Disease and Creative Antithrombotic Clinical Research Collaboration(CardiaCare)

目的建立冠心病与抗栓临床研究创新网络平台(CardiaCare)的标准化数据字段定义,以期促进国内外数据平台的互认互通,增强平台对多中心临床研究的支持,进而保证平台数据得以规范化的使用。方法通过对国内外重要指南、临床研究文献、数据库、标准术语集等进行回顾和分析,结合我国特色的临床诊疗实践信息及本平台主要研究方向,制定CardiaCare标准字段集及定义,并根据患者住院诊治、转归直至进行长期随访的时间顺序进行数据类别划分。结果CardiaCare字段集涵盖了冠心病患者从入院之时起整个诊疗过程产生的常见字段以及随访期间相关的字段共计864个。字段集共由8个部分组成,分别为人口学和入院信息、病史和风险因素、临床表现及诊断、检验和检查、介入诊疗信息、用药信息、临床结局、特殊人群。其中,人口学和入院信息23个字段;病史和风险因素102个字段;临床表现及诊断22个字段;检验和检查111个字段;介入诊疗信息118个字段;用药信息213个字段;临床结局161个字段;特殊人群114个字段(其中经导管瓣膜置换术人群87个字段、心脏康复人群27个字段)。结论基于CardiaCare多中心临床科研创新平台建立的冠心病患者诊疗过程及临床结局中关键数据标准字段集可为真实世界临床研究的连续数据采集和深度利用提供支持。该字段集在更多场景中的应用值得进一步探索。

Objective To develop a set of data elements and standardized definitions of Coronary Artery Disease and Creative Antithrombotic Clinical Research Collaboration(CardiaCare),aiming to facilitate the exchange of disparate data sources,enhance the abilities to support multicenter researches,and subsequently ensure the databases use under standardized process and criteria.Methods The Cardiacare writing committee members reviewed data elements and definitions from published guidelines,clinical trials,databases,and standardized documents,then determined the data elements and standardized definitions,which should be included in CardiaCare.The writing committee also considered the specific domestic clinical management strategies during the establishment of Cardiacare.The resulting documents provide a series of key data elements and standardized definitions used in the management of coronary artery disease patients.Key data elements from CardiaCare could be sorted by clinical management flowsheet and outcome from hospitalization to long-term follow-up.Results The Cardiacare standardized set comprised 864 data elements from admission to post-hospital follow-up visit.There were 8 tables in the documents,including demographic and admission information(23 elements),medical history and risk factors(102 elements),clinical presentations and diagnosis(22 elements),diagnostic and laboratory tests(111 elements),interventional diagnosis and treatment(118 elements),pharmacological therapy(213 elements),clinical outcomes(161 elements),and special subpopulations(114 elements:87 elements for transcatheter valve replacement and 27 elements with cardiac rehabilitation).Conclusions The Cardiacare standardized data elements set could provide support for real-world clinical research in consecutive data collection and databases mining.A wider applicability in various settings of CardiaCare needs to be explored further.