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Guide on Methodological Standards in Pharmacoepidemiology in China (2nd edition) and their series interpretation (6): data sources classification and selection

Published on Jun. 27, 2025Total Views: 40 times Total Downloads: 12 times Download Mobile

Author: MENG Ruogu 1 YANG Yu 1 SUN Feng 2, 3, 4, 5, 6, 7 ZHAN Siyan 2, 3, 4, 8

Affiliation: 1. National Institute of Health Data Science, Peking University, Beijing 100191, China 2. Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing 100191, China 3. Key Laboratory of Epidemiology of Major Diseases (Peking University), Ministry of Education, Beijing 100191, China 4. Center for Post-Marketing Safety Evaluation of Drugs, Peking University Health Science Center, Beijing 100191, China 5. Department of Ophthalmology, Peking University Third Hospital, Beijing 100191, China 6. College of Traditional Chinese Medicine, Xinjiang Medical University, Urumqi 830017, China 7. School of Medicine, Shihezi University, Shihezi 832000, Xinjiang Uygur Autonomous Region, China 8. Clinical Epidemiology Research Center, Peking University Third Hospital, Beijing 100191, China

Keywords: Pharmacoepidemiology Methodology Data sources Data

DOI: 10.12173/j.issn.1005-0698.202506019

Reference: MENG Ruogu, YANG Yu, SUN Feng, ZHAN Siyan. Guide on Methodological Standards in Pharmacoepidemiology in China (2nd edition) and their series interpretation (6): data sources classification and selection[J]. Yaowu Liuxingbingxue Zazhi, 2025, 34(6): 605-611. DOI: 10.12173/j.issn.1005-0698.202506019.[Article in Chinese]

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Abstract

Appropriate data sources are the cornerstone of pharmacoepidemiological research. Based on the Guide on Methodological Standards in Pharmacoepidemiology in China (2nd edition), hereinafter referred to as "the Guideline (2nd edition)", this article provides an in-depth interpretation of the classification and selection of data sources in pharmacoepidemiological research. It begins with a brief overview of the evolution of data sources in pharmacoepidemiological studies, followed by a detailed analysis of the definitions, applicable scopes, conditions of use, and strengthens and limitations of primary and secondary data sources. It further introduces the characteristics of common data sources and relevant classic domestic and international databases. Subsequently, integrating aspects of the Guideline (2nd edition), including research questions, study design, study population, sample size, exposure or intervention, outcomes, and covariates, the article discusses the criteria and strategies for choosing data sources in pharmacoepidemiological research. Ultimately, a data source selection methodology is established based on clear classification, guided by research questions, tailored to research methods, and supported by data quality, aiming to promote the development of high-quality pharmacoepidemiological research in China.

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