Guide on Methodological Standards in Pharmacoepidemiology(2nd edition)and their series interpretation(10):an overview and case study of quality assessment tools
10.12173/j.issn.1005-0698.202509141
- VernacularTitle:《药物流行病学研究方法学指南(第2版)》系列解读(10):质量评估工具介绍与案例分析
- Author:
Qingyong ZHENG
1
;
Caihua XU
;
Yongjia ZHOU
;
Xiao TANG
;
Mengjun ZHANG
;
Jinzhi QI
;
Ming LIU
;
Ya GAO
;
Feng SUN
;
Jinhui TIAN
Author Information
1. 兰州大学循证医学中心,兰州大学基础医学院(兰州 730000);甘肃省循证医学重点实验室(兰州 730000)
- Publication Type:Journal Article
- Keywords:
Pharmacoepidemiology;
Methodology;
Guildelines;
Quality assessment tools;
Risk of bias
- From:
Chinese Journal of Pharmacoepidemiology
2025;34(10):1113-1126
- CountryChina
- Language:Chinese
-
Abstract:
Methodological quality assessment is a pivotal link between primary studies and reliable evidence-based practice,and an essential pathway for operationalizing the core principles of the Guide on Methodological Standards in Pharmacoepidemiology(2nd edition).A prevalent challenge in practice,however,is the conflation of appraising methodological robustness(risk of bias assessment)with verifying reporting transparency(adherence to reporting guidelines).This paper systematically addresses this fundamental challenge,beginning with a clear distinction between the essence and boundaries of these two concepts.On this basis,the article provides a comprehensive review of mainstream quality assessment tools,covering the methodological features and evolutionary trajectory of numerous instruments for interventional(e.g.,RoB 2,ROBINS-I),observational(e.g.,NOS,the JBI/SIGN/NIH series),secondary(e.g.,AMSTAR 2),and other specific types of studies such as health economic evaluations.Furthermore,a complete case study is used to illustrate the practical application of the ROBINS-I tool.The paper's central thesis advocates for an"appraisal-informed design"philosophy,urging a conceptual shift from the retrospective critique of existing literature to the prospective quality control of new research by internalizing appraisal standards as design principles,while also exploring the emerging paradigm of artificial intelligence in assisting assessment.This paper provides a comprehensive methodological reference for researchers and practitioners to prudently select appropriate assessment tools and to conduct rigorous critical appraisals of pharmacoepidemiological evidence.
