Methodological Recommendations for Developing Integrative Chinese-Western Medicine Databases Using Electronic Health Records (MERGE)
Author(s)
Jing Tan, PhD, Yulong Jia, MSc, Wengxue Liang, MSc, Ye Xu, MSc, Xuehong Liu, PhD, Yiquan Xiong, PhD, hao jiang, MSc, Kang Zou, BS, Xin Sun, PhD, Yan Ren, PhD.
Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, China.
Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, China.
OBJECTIVES: Electronic health records (EHRs) provide valuable real-world data (RWD) for Traditional Chinese Medicine (TCM) research, yet methodological gaps exist in developing integrative Chinese-Western medicine databases. This study aims to develop a methodological framework for constructing such databases using EHRs.
METHODS: We developed the methodological recommendations through a comprehensive process involving a literature review, empirical experiences, thematic discussions, and a panel of external experts to finally achieve a consensus.
RESULTS: This study proposes a methodological framework for developing ICWM-EHR database, describes their key elements, and illustrates their usage. The methodological framework consisted of six core components: overall design, database framework, data extraction and linkage, data governance, data verification, and data quality evaluation. The key elements of ICWM-EHR database are these variables related to study subjects, treatment /exposure, outcome, and confounding. The databases can support multiple research applications, mostly for effectiveness and safety evaluation. We also develop the fertility preservation ICWM-EHR database as an empirical example to illustrate the usefulness of the methodological framework for researchers. A total of 2,064,482 patients were included in such database. This database covers diseases related to women's health throughout their life cycle, from childbearing age to older.
CONCLUSIONS: The proposed methodological recommendations may serve as an effective tool to guide researchers to develop high-quality ICWM-EHR database and provide a unique opportunity to enhance the quality of TCM real-world research.
METHODS: We developed the methodological recommendations through a comprehensive process involving a literature review, empirical experiences, thematic discussions, and a panel of external experts to finally achieve a consensus.
RESULTS: This study proposes a methodological framework for developing ICWM-EHR database, describes their key elements, and illustrates their usage. The methodological framework consisted of six core components: overall design, database framework, data extraction and linkage, data governance, data verification, and data quality evaluation. The key elements of ICWM-EHR database are these variables related to study subjects, treatment /exposure, outcome, and confounding. The databases can support multiple research applications, mostly for effectiveness and safety evaluation. We also develop the fertility preservation ICWM-EHR database as an empirical example to illustrate the usefulness of the methodological framework for researchers. A total of 2,064,482 patients were included in such database. This database covers diseases related to women's health throughout their life cycle, from childbearing age to older.
CONCLUSIONS: The proposed methodological recommendations may serve as an effective tool to guide researchers to develop high-quality ICWM-EHR database and provide a unique opportunity to enhance the quality of TCM real-world research.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
RWD124
Topic
Methodological & Statistical Research, Real World Data & Information Systems, Study Approaches
Topic Subcategory
Data Protection, Integrity, & Quality Assurance
Disease
Reproductive & Sexual Health