临床研究相关电子数据采集系统的研究与比较

Research and comparison of electronic data capture systems used in clinical researches

目的通过对几种电子数据采集系统在功能和性能方面的阐述与比较,为医务工作者选择合适的临床研究工具软件提供参考。方法以REDCap、Commcare、OpenEDC等3种可免费使用的系统作为研究对象,通过介绍它们在使用许可获取途径、数据采集相关功能、信息安全保障措施等方面的概况并进行比较,阐述上述工具软件在保证数据隐私性、科学性方面的特点及其在系统安全性、可及性方面的考量。结果REDCap是3种系统中发展最为成熟的,在功能完整性、数据安全性、用户友好性、系统延展性等方面均有较为全面的设计。Commcare系统以移动采集为特色,所能支持的采集数据类型是最为丰富的,而OpenEDC系统则具有使用门槛低、部署灵活性强的特点。结论REDCap系统可广泛适用于中小型临床试验、回顾性研究、队列研究、转化研究等多种医学科研项目,Commcare系统是以流调项目为代表的医学调查类研究的首选工具软件,而OpenEDC系统则尤其适用于研究者发起研究。

Objective To provide a reference for the choice of electronic data capture system used in clinical research,the function and performance of some tool software were expounded and compared.Methods We selected three freely available systems of REDCap,Commcare,and OpenEDC as research objects,describing and comparing their user license acquisition path,data capture related functions,and information security assurance measures.This article reflected how the three kinds of tool software ensure research data privacy and scientificity,and presented the consideration of system security and accessibility.Results REDCap was the most mature system of the three,which had a fairly comprehensive design in functional integrity,data security,user friendliness,and system scalability.Commcare system featured in the mobile collection,and supported the most abundant types of collected data,while OpenEDC was characteristic of low threshold and flexible deployment.Conclusions REDCap system is widely applicable to small and medium scale medical research,including clinical trials,retrospective studies,cohort studies,and translational research.Commcare system is the preferred option for medical investigations represented by epidemiologic surveys,while OpenEDC is particularly suitable for investigator initiated studies.