基于云架构的慢病患者随访穿戴设备数据采集平台的构建  

Construction of Data Capture Platform for Chronic Patient Follow-up Wearable Devices Based on Cloud Architecture

作　　者：王登 郑园园 陈露露 朱伟明 李晓晖 WANG Deng;ZHENG Yuan-yuan;CHEN Lu-lu;ZHU Wei-ming;LI Xiao-hui(Changsha Phamark Data Technology Co.Ltd.;Changsha Duxact Biotechnology Co.,Ltd.;Changsha Duxact Biotechnology Co.,Ltd.Hunan Key Laboratory for Bioanalysis of Complex Matrix Samples)

机构地区：[1]长沙砝码柯数据科技有限责任公司 [2]长沙都正生物科技股份有限公司,复杂基质样本生物分析湖南省重点实验室

出　　处：《中国食品药品监管》2023年第10期106-113,共8页China Food & Drug Administration Magazine

基　　金：湖南省科技人才托举工程(2023TJ-N20);复杂基质样本生物分析湖南省重点实验室(2017TP1037);湖南省科技创新计划(2023RC3232)。

摘　　要：真实世界数据收集是开展真实世界研究的关键环节,为提高真实世界研究的数据质量,推动真实世界数据研究及应用,构建信息化的数据采集手段尤为必要。本文按照“数字医疗”概念进行设计,融入真实世界研究方法,基于云架构搭建了慢病患者随访穿戴设备数据采集平台,实现慢病患者居家监测数据与电子数据采集系统实时对接,保障数据从产生、传输到存储全过程自动化。该电子平台已实现睡眠障碍患者睡眠监测仪与电子采集系统之间直接的数据交换,有效避免了人工录入所产生的错误,确保真实世界数据真实、准确、完整、可溯源、合规。基于云架构的真实世界数据电子采集平台推动了源数据电子化发展,为慢病真实世界研究提供了新的思路和方法。Real world data(RWD)collection is a crucial link in real world study(RWS).To improve the quality of RWD and advance its application,it is particularly necessary to build information-based data capture means.This paper is designed according to the concept of"digital medical treatment",incorporates RWS methods,and builds a data capture platform for patients'follow-up wearable devices based on cloud architecture,which realizes the real-time docking between home monitoring data of chronic patients and electronic data capture(EDC)system,ensuring the automation of the entire process of data generation,transmission,and storage.This electronic platform has realized direct data exchange between sleep monitors and the electronic data capture for patients with sleep disorders,effectively avoiding errors caused by manual entry and ensuring that RWD is true,accurate,complete,traceable,and compliant.The electronic data capture platform based on cloud architecture promotes the electronic development of source data and provides new ideas and methods for RWS on chronic diseases.

关 键 词：云架构 真实世界数据 慢病患者 电子数据采集平台 居家监测 院外数据 数字医疗 

分 类 号：TP311.1[自动化与计算机技术—计算机软件与理论]