| 于玥琳,卓琳,孟若谷,詹思延,王胜锋.真实世界数据适用性评价方法的研究进展与前景挑战[J].Chinese journal of Epidemiology,2022,43(4):578-585 |
| 真实世界数据适用性评价方法的研究进展与前景挑战 |
| Methodology progress and challenges on assessing the appropriateness of real-world data |
| Received:April 02, 2021 |
| DOI：10.3760/cma.j.cn112338-20210402-00271 |
| KeyWord: 真实世界证据|质量评价|数据适用性|数据质量|真实世界研究 |
| English Key Word: Real-world evidence|Quality assessment|Data appropriateness|Data quality|Real-world study |
| FundProject:国家自然科学基金面上项目（82173616）；北京大学文化传承与创新研究院（抚州）项目（FZICIPKU20200010） |
| Author Name | Affiliation | E-mail | | Yu Yuelin | Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing 100191, China | | | Zhuo Lin | Research Center of Clinical Epidemiology, Peking University Third Hospital, Beijing 100191, China | | | Meng Ruogu | National Institute of Health Data Science, Peking University, Beijing 100191, China | | | Zhan Siyan | Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing 100191, China
Research Center of Clinical Epidemiology, Peking University Third Hospital, Beijing 100191, China | | | Wang Shengfeng | Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing 100191, China | shengfeng1984@126.com |
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| Abstract: |
| 对真实世界数据开展适用性评价是从数据使用角度出发，保证健康医疗大数据质量并确保数据范畴与研究假设紧密相关的重要途径。基于此开展的研究也将具有更好的样本代表性和证据外推性，产出高可信度的真实世界证据。本文总结各国家、国际组织真实世界数据适用性文件，对真实世界数据适用性的概念、范畴、评价维度、指标细则、评价方式及已开展研究进行梳理归纳，探讨我国开展真实世界数据适用性评价所面临的机遇和挑战。 |
| English Abstract: |
| From the perspective of data users, ensuring the relevance and reliability of big data in healthcare and medicine via assessments on data appropriateness is a prerequisite for generating high-quality real-world evidence, which could guarantee good representativeness and generalizability of real-world studies. This review summarized the quality dimensions, definitions, evaluation indexes and calculating methods of assessment on the appropriateness of real-world data (RWD) according to guidance from different countries and international organizations, as well as exploring the opportunities and challenges for better assessing RWD appropriateness. |
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