Development of a pre-processing workflow for real world data derived from multicenter clinical laboratories
10.3760/cma.j.cn112338-20240620-00364
- VernacularTitle:多中心临床实验室来源的真实世界数据预处理流程构建
- Author:
Chang LIU
1
;
Xiaoxia PENG
;
Siyu CAI
;
Yali LIU
;
Chao ZHANG
;
Fang HU
Author Information
1. 国家儿童医学中心，首都医科大学附属北京儿童医院，临床流行病与循证医学中心，北京 100045
- Publication Type:Journal Article
- Keywords:
Real world data;
Clinical laboratory;
Multi-center;
Qualitative research
- From:
Chinese Journal of Epidemiology
2025;46(2):296-306
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To develop a pre-processing workflow of real world data (RWD) derived from multicenter clinical laboratories so that the level of data standardization can be improved, and subsequently to produce more robust real world evidence (RWE).Methods:Purpose sampling was used to invite senior experts with experience in clinical research utilizing RWD, covering the fields of clinical laboratory, epidemiology, biostatistics, and clinical medicine. In-depth, semi-structured individual interviews were conducted and thematic analysis was used to analyze the collected data.Results:The in-depth interviews were completed in 16 experts. The experts unanimously agreed that pre-processing RWD derived from multicenter clinical laboratories is necessary prior to its application in research. Based on experts' insights, a comprehensive pre-processing workflow for RWD was constructed, comprising six key steps: ①developing a variable list based on research questions and distributing it to each clinical laboratory; ②conducting an initial quality assessment of RWD based on existing quality control results in clinical laboratories; ③cleaning the data; ④determining whether RWD (including categorical and continuous variables) is heterogeneity among different clinical laboratories; ⑤exploring potential sources of heterogeneity;⑥pre-processing RWD based on identified causes contributing to heterogeneity.Conclusion:The pre-processing workflow of RWD was established, to provide a methodological reference for controlling systematic errors in RWD derived from multicenter clinical laboratories, thereby enhancing the validity of RWE.
