基于既有医疗数据构建研究型数据库的方法学探讨及实例解读(一):变量清单和数据库架构的确定

Methodological Discussion and Case Interpretation of Constructing Research Database Based on Existing Medical Data(I):Determination of Variable List and Database Structure

基于既有医疗数据所形成的真实世界证据对医疗卫生决策产生重要影响。真实世界数据向真实世界证据转化过程中的关键点之一在于研究型数据库的建立。由于真实世界数据库的来源、结构不同及真实世界数据的复杂性、多样化等问题,研究型数据库建设在具体实施过程中仍面临各种挑战。建立研究型数据库需先确定变量清单及数据库架构,包括确定变量清单、评估既有数据、明确数据集结构及制定变量字典4个步骤。首先确定变量清单,其重点在于准确提出临床问题并对临床问题进行解构,再根据解构结果确定研究所需的关键变量;其次评估既有数据,应重点关注既有数据的可靠性,以及关键变量的数据来源;接着选择恰当的数据集结构存储数据,通常使用横断面数据结构或纵向数据结构;最后,将数据库中每个变量的信息记录在变量字典中,以实现对众多变量的管理。以“中西医结合治疗新型冠状病毒感染研究型数据库”为例,对研究中变量清单及数据库架构的确定方法进行介绍,以供相关研究人员参考。

Real-world evidence based on existing medical data has an important impact on medical and health decision-making.One of the key points in the process of converting real-world data into real-world evidence is the establishment of research-based databases.Due to the different sources and structures of real-world databases,as well as the complexity and diversity of real-world data,the construction of research-based databases still faces various challenges in the specific implementation process.To establish a research database,it is necessary to determine the variable list and database structure,including four steps:determining the list of variables,evaluating the existing data,clarifying the structure of the data set,and formulating a variable dictionary.Firstly,determination of the list of variables focuses on accurately raising the clinical questions and deconstructing the clinical questions,and then the key variables required for the study were determined according to the deconstruction results.Secondly,evaluating the existing data should focus on the reliability of the existing data and the data sources of key variables,choosing the appropriate dataset structure to store the data,usually using a cross-sectional data structure or a longitudinal data structure.Finally,the information of each variable should be recorded in the database in the variable dictionary to realize the management of many variables.This article took the“Integrated Traditional Chinese and Western Medicine Treatment of COVID-19 Research Database”as an example to introduce the determination method of variable list and database structure in this study for the reference of relevant researchers.