中国药物警戒 ›› 2023, Vol. 20 ›› Issue (10): 1081-1089.
DOI: 10.19803/j.1672-8629.20230308

• 上市后监测方法与评估体系研究专栏 • 上一篇    下一篇

真实世界数据在疫苗上市后安全性主动监测中适用性评价分析

吴昀效1,2, 于玥琳1,2, 王胜锋1,2, 孙凤1,2, 孟若谷3,#, 詹思延1,2,4,*   

  1. 1北京大学公共卫生学院流行病与卫生统计学系,北京 100191;
    2重大疾病流行病学教育部重点实验室（北京大学）,北京 100191;
    3北京大学健康医疗大数据国家研究院,北京 100191;
    4北京大学第三医院临床流行病学研究中心,北京 100191
  • 收稿日期:2023-05-18 出版日期:2023-10-15 发布日期:2023-10-16
  • 通讯作者: *詹思延,女,博士,教授,循证医学与药物流行病学。E-mail: siyan-zhan@bjmu.edu.cn。#为共同通信作者。
  • 作者简介:吴昀效,女,本科,循证医学与药物流行病学。
  • 基金资助:
    国家自然科学基金资助项目（81973146、82330107）; 北大医学顶尖学科及学科群发展专项; 比尔及梅琳达盖茨基金（INV-035024）

Suitability assessment of real-world data in active post-marketing surveillance of vaccine safety

WU Yunxiao1,2, YU Yuelin1,2, WANG Shengfeng1,2, SUN Feng1,2, MENG Ruogu3,#, ZHAN Siyan1,2,4,*   

  1. 1Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing 100191, China;
    2Key Laboratory of Epidemiology of Major Diseases (Peking University), Ministry of Education, Beijing 100191, China;
    3National Institute of Health Data Science, Peking University, Beijing 100191, China;
    4Research Center of Clinical Epidemiology, Peking University Third Hospital, Beijing 100191, China
  • Received:2023-05-18 Online:2023-10-15 Published:2023-10-16

PDF (PC)

300

摘要： 目的 梳理真实世界数据（real-world data, RWD）在疫苗上市后安全性主动监测的适用性评价内容和方法,初步搭建符合我国RWD特点的适用性评价指标框架。方法 采用概括性评价方法,检索和筛选RWD在疫苗上市后主动监测中适用性评价的相关研究和指南性文件,提取并标绘适用性评价指标及内容,结合框架整合法初步确定层级化的适用性评价指标结构。结果 纳入文献51篇,中国8篇（15.69%）。共提取出229条评价指标,形成了RWD在疫苗上市后安全性主动监测中适用性评价框架,包括3个一级指标（数据溯源、数据可靠性和数据相关性）、8个二级指标（数据源基本特征、数据收集、数据治理、完整性、准确性、数据内容、数据覆盖范围、数据特征）和31个三级指标。关键变量的准确性（60.78%）、人群覆盖规模（45.10%）、及时性（39.22%）和关键变量的完整性（35.29%）是在纳入文献中出现频率最高的三级指标。三级指标的分布情况根据RWD类型、疫苗种类和医疗体系划分而不同。结论 疫苗主动监测领域尚缺少标准化的RWD适用性评价维度和方法,初步构建的适用性评价指标框架为相关研究提供了参考,未来仍需开展专家论证确保指标体系的科学性,从而推进我国疫苗主动监测系统的建设。

关键词: 真实世界数据, 疫苗, 上市后, 主动监测, 数据, 适用性, 评价

Abstract: Objective To sort out the suitability assessment content and methods of real-world data(RWD) in active post-marketing surveillance of vaccine safety, and preliminarily build a suitability assessment framework that meets the characteristics of RWD in China. Methods The scoping review was used to retrieve and screen studies and guideline documents related to the suitability assessment of RWD in active post-marketing surveillance of vaccine safety, extract and map suitability assessment indicators and content, and combine the framework synthesis to preliminarily determine the hierarchical suitability assessment structure. Results 51 articles were included, including 8(15.7%) in China. 229 assessment indicators were extracted to form a framework for suitability assessment of RWD in active post-marketing surveillance of vaccine safety, including 3 primary indicators(data traceability, data reliability, and data relevance), 8 second-level indicators (basic characteristics of data sources, data collection, data governance, completeness, accuracy, data content, data coverage, and data characteristics), and 31 third-level indicators. Accuracy of key variables(60.8%), population coverage(45.1%), timeliness(39.2%), and completeness of key variables(35.3%) were the third-level indicators with the highest frequency in the included articles. The distribution of the third-level indicators varied according to the type of RWD, vaccine, and health system. Conclusion There is still a lack of standardized RWD suitability assessment dimensions and methods in the active surveillance of vaccine safety. The suitability assessment framework summarized in this study provides a reference for relevant studies, but expert validation is still needed in the future to ensure the scientific nature of the indicator system and thus promotes the construction of the active surveillance system of vaccine safety in China.

Key words: real-world data, vaccine, post-marketing, active surveillance, data, suitability, evaluations

中图分类号: