目标效度视角下随机对照试验与真实世界研究证据整合的Meta分析方法OA
Meta-Analysis Method for Integrating Evidence from Randomized Controlled Trials and Real-World Studies from the Perspective of Target Validity
随机对照试验与真实世界研究在证据属性上具有互补性,科学整合两类证据已成为卫生技术评估与医保价值评价的核心课题.本文立足于"目标效度"这一视角,将现有 Meta 分析方法划分为描述性整合、内部偏倚调整和目标偏倚调整,后两者统属于定量偏倚调整;并对各类方法在处理内部效度与外部效度方面的考量及优劣进行评价.研究发现,虽然质量加权等方法为量化偏倚提供了有效手段,但其稳健性仍受限于先验设定的主观性与外部偏倚标准框架的缺失.定量偏倚调整方法虽具方法学灵活性,但其稳健性仍受限于偏倚评估的主观性及外部偏倚标准框架的缺失.未来整合研究应遵循"透明报告、多维评价、敏感验证"的原则,并推动外部偏倚评价工具的标准化发展,从而为价值导向的医保与卫生决策提供最具针对性的科学支撑.
Randomized controlled trials(RCTs)and real-world studies(RWSs)provide complementary forms of evidence.The rigorous integration of these two evidence sources has become a key issue in health technology assessment(HTA)and value-based healthcare decision-making.From the perspective of"target validity,"this review classifies existing meta-analytic approaches into three categories:descriptive synthesis,internal bias adjustment,and target bias adjustment,with the latter two collectively referred to as quantitative bias adjustment methods.The strengths and limitations of these approaches in addressing internal and external validity are systematically evaluated.This review indicates that although methods such as quality weighting provide useful tools for quantifying bias,their robustness remains limited by the subjectivity of prior assumptions and the lack of a standardized framework for assessing external bias.While quantitative bias adjustment methods offer substantial methodological flexibility,their performance is likewise constrained by subjective bias assessment and the lack of standardized criteria for evaluating external validity.Future evidence integration studies should adhere to the principles of transparent reporting,multidimensional evaluation,and sensitivity analysis.In addition,efforts should be made to standardize tools for assessing external bias,thereby providing more targeted scientific evidence to support value-based healthcare security and health policy decision-making.
黄猛
国家医疗保障局医药价格和招标采购指导中心
医药卫生
目标效度随机对照试验真实世界研究Meta分析证据整合
target validityrandomized controlled trialsreal-world studiesmeta-analysisevidence integration
《中国食品药品监管》 2026 (6)
92-101,10
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