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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

黄猛

中国食品药品监管Issue(6):92-101,10.
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中国食品药品监管Issue(6):92-101,10.DOI:10.3969/j.issn.1673-5390.2026.06.009

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

Meta-Analysis Method for Integrating Evidence from Randomized Controlled Trials and Real-World Studies from the Perspective of Target Validity

黄猛1

作者信息

  • 1. 国家医疗保障局医药价格和招标采购指导中心
  • 折叠

摘要

Abstract

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.

关键词

目标效度/随机对照试验/真实世界研究/Meta分析/证据整合

Key words

target validity/randomized controlled trials/real-world studies/meta-analysis/evidence integration

分类

医药卫生

引用本文复制引用

黄猛..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[J].中国食品药品监管,2026,(6):92-101,10.

中国食品药品监管

1673-5390

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