| 刘畅,彭晓霞,蔡思雨,刘雅莉,张超,胡芳.多中心临床实验室来源的真实世界数据预处理流程构建[J].Chinese journal of Epidemiology,2025,46(2):296-306 |
| 多中心临床实验室来源的真实世界数据预处理流程构建 |
| Development of a pre-processing workflow for real world data derived from multicenter clinical laboratories |
| Received:June 20, 2024 |
| DOI：10.3760/cma.j.cn112338-20240620-00364 |
| KeyWord: 真实世界数据 临床实验室 多中心 定性研究 |
| English Key Word: Real world data Clinical laboratory Multi-center Qualitative research |
| FundProject:海南省博鳌乐城先行区真实世界研究专项计划（HNLC2022RWS010）；高层次公共卫生技术人才培养计划（2022-2-026） |
| Author Name | Affiliation | E-mail | | Liu Chang | Center for Clinical Epidemiology and Evidence-based Medicine, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing 100045, China
Hainan Institute of Real World Data, Qionghai 571400, China | | | Peng Xiaoxia | Center for Clinical Epidemiology and Evidence-based Medicine, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing 100045, China
Hainan Institute of Real World Data, Qionghai 571400, China | pengxiaoxia@bch.com.cn | | Cai Siyu | Center for Clinical Epidemiology and Evidence-based Medicine, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing 100045, China | | | Liu Yali | Center for Clinical Epidemiology and Evidence-based Medicine, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing 100045, China | | | Zhang Chao | Center for Clinical Epidemiology and Evidence-based Medicine, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing 100045, China | | | Hu Fang | Center for Clinical Epidemiology and Evidence-based Medicine, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing 100045, China | |
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| Abstract: |
| 目的 构建一个适用于多中心临床实验室来源真实世界数据（RWD）的预处理流程，以提高数据的标准化水平，控制多中心数据间的系统误差，进而提升真实世界证据（RWE）的真实性和可信度。方法 采用目的抽样，在临床检验诊断学、流行病与卫生统计学、临床医学等领域内邀请曾利用RWD开展临床研究的相关专家作为访谈对象，采用半结构式个人深度访谈法，对其进行一对一深入访谈，然后采用主题分析法对资料进行分析。结果 共完成16位专家的深入访谈，他们均认为在应用RWD之前，对多中心临床实验室来源的数据进行预处理是至关重要的。基于专家知识，构建了多中心临床实验室来源的RWD预处理流程，包括6个关键步骤：①根据研究问题制定拟提取变量的清单并下发给各个临床实验室；②根据各临床实验室已有的质评结果初步评估数据质量；③数据清洗；④判断不同临床实验室之间的RWD（包括分类变量/连续变量）是否存在异质性；⑤探索产生异质性的潜在原因；⑥针对识别的原因进行相应处理。结论 本研究针对多个临床实验室来源的RWD构建了理论上可行的应用前预处理流程，将为控制多中心临床实验室来源RWD的系统误差、提升RWE真实性提供方法学参考。 |
| English 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. |
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