Creation and Implementation of a Prospective and Multicentric Database of Patients with Acute Myocardial Infarction: RIAM

Abstract Background Multicenter registries representing the real world can be a significant source of information, but few studies exist describing the methodology to implement these tools. Objective To describe the process of implementing a database of ST-segment elevation acute myocardial infarction (STEMI) at a reference hospital, and the application of this process to other centers by means of an online platform. Methods In 2009, our institution implemented an Registry of Acute Myocardial Infarction (RIAM), with the prospective and consecutive inclusion of every patient admitted to the institution who received a diagnosis of STEMI. From March 2014 to April 2016, the registries were uploaded to a web-based system using the REDCap software and the registry was expanded to other centers. Upon subscription, the REDCap platform is a noncommercial software made available by Vanderbilt University to institutions interested in research. Results The following steps were taken to improve and expand the registry: 1. Standardization of variables; 2. Implementation of institutional REDCap (Research Electronic Data Capture); 3. Development of data collection forms (Case Report Form - CRF); 4. Expansion of registry to other reference centers using the REDCap software; 5. Training of teams and participating centers following an SOP (Standard Operating Procedure). Conclusion The description of the methodology used to implement and expand the RIAM may help other centers and researchers to conduct similar studies, share information between institutions, develop new health technologies, and assist public policies regarding cardiovascular diseases. (Arq Bras Cardiol. 2020; 114(3):446-455)

背景 反映真实临床实践的多中心登记数据库可成为重要的信息来源，但目前鲜有研究阐明搭建此类工具的实施方法。目的 阐述在一家参考医院搭建ST段抬高型急性心肌梗死（ST-segment elevation acute myocardial infarction, STEMI）登记数据库的流程，并通过在线平台将该流程推广至其他中心。方法 2009年，本机构搭建了急性心肌梗死登记库（Registry of Acute Myocardial Infarction, RIAM），前瞻性连续纳入本机构收治的所有确诊ST段抬高型急性心肌梗死的患者。2014年3月至2016年4月，研究团队通过REDCap软件将登记数据上传至基于网页的系统，并将登记库推广至其他中心。REDCap（Research Electronic Data Capture，研究电子数据采集系统）是范德堡大学（Vanderbilt University）为有科研需求的机构提供的非商用软件，完成注册即可使用。结果 为优化并推广该登记库，研究团队完成了以下步骤：1. 变量标准化；2. 搭建机构版REDCap系统；3. 研发数据采集表单（病例报告表，Case Report Form, CRF）；4. 借助REDCap软件将登记库推广至其他参考中心；5. 依据标准操作规程（Standard Operating Procedure, SOP）对各参与中心的研究团队开展培训。结论 本研究阐述的急性心肌梗死登记库搭建与推广方法，可为其他机构及研究者开展同类研究、实现跨机构信息共享、研发新型卫生技术，以及制定心血管疾病相关公共卫生政策提供参考依据。（Arq Bras Cardiol. 2020; 114(3):446-455）