《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

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【关键词】药物流行病学；方法学；指南；质量评估工具；偏倚风险【中图分类号】 【文献标识码】A

【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 inPharmacoepidemiology （2nd edition）.A prevalentchallnge inpractice，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 esence 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-1）， 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，acomplete case study is used to illstrate 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.

【Keywords】Pharmacoepidemiology; Methodology; Guildelines; Quality assessment tools; Risl of bias

高质量的药物流行病学研究是支撑临床决策、药品监管及卫生政策制定的证据基础。（剩余27372字）