首页|匹配调整间接比较应用的方法学要点和实践现状分析

匹配调整间接比较应用的方法学要点和实践现状分析

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目的 为匹配调整间接比较(MAIC)的应用提供方法学指导.方法 基于MAIC方法学文献明晰关键步骤和方法学要点,同时系统评价2016年1月至今非小细胞肺癌领域内MAIC应用文献,对比分析MAIC的实践现状和问题.结果 MAIC包括数据来源和样本选择、匹配变量筛选、个体权重计算、匹配效度评估、相对疗效计算5个关键步骤.系统评价纳入的研究主要通过文献综述筛选数据来源;通过统计分析等科学方法筛选匹配变量;借助软件计算个体权重;通过报告有效样本量(ESS)评估匹配效度;通过Cox模型、Logistic模型等计算相对疗效;开展敏感性分析评估不同数据来源、匹配变量组合等造成的不确定性;报告规范性总体良好但各条目间差距较大.在MAIC与药物经济学研究的衔接方面,纳入研究多选择目标药品作为生存数据的拟合外推参照组;使用风险比(HR)拟合外推时会考虑等比例风险(PH)假设.结论 目前MAIC研究在方法应用和报告规范方面存在一定欠缺,如未说明数据来源选择依据和匹配变量筛选依据、未报告权重分布、未考虑PH假设等,建议后续MAIC研究系统筛选数据来源,并对协变量分布评估、协变量状态评估、权重分布、不确定性测量等内容进行报告,计算HR时考虑PH假设.
Analysis of the methodological points and practice status of matching-adjusted indirect comparison application
Objective To provide methodological guidance for the application of matching-adjusted indirect comparison(MAIC).Methods The methodology literature on MAIC was examined to clarify key steps and methodological points,and MAIC application literature in the non-small cell lung cancer field published after January 2016 was systematically reviewed to compare and analyze the current status and problems of MAIC.Results MAIC consisted of five key steps:data source and sample selection,matching variable screening,individual weight calculation,matching validity evaluation,and relative efficacy calculation.The systematic review revealed that studies primarily employed literature reviews to screen data sources,used statistical analysis and other scientific methods to screen matching variables,employed software for individual weight calculation,evaluated matching validity by reporting effective sample size(ESS),calculated relative efficacy using Cox,logistic,and other models,conducted sensitivity analyses to evaluate the uncertainty caused by different data sources and matching variable combinations,and the studies demonstrated good overall reporting standardization but significant differences in particular aspects.Concerning the connection between MAIC and pharmacoeconomic research,studies included mainly used target drugs as the reference group of survival data extrapolation,and proportional hazards(PH)assumptions were considered when utilizing hazard ratios(HR)in extrapolation.Conclusion There are some deficiencies in the method application and reporting standards of MAIC research,such as lack of explanation of data source selection criteria and matching variable screening criteria,insufficient reporting of weight distribution,and inadequate consideration of PH assumptions.It is recommended that future MAIC research systematically screen data sources and report covariate distribution evaluation,covariate status evaluation,weight distribution,uncertainty measurement,etc.Additionally,considering PH assumptions after calculating HR is suggested.

Matching-adjusted indirect comparisonIndirect comparisonMethodologySystematic review

许佳艺、代展菁、卢钰琼、路云、常峰

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中国药科大学国际医药商学院(南京 211198)

匹配调整间接比较 间接比较 方法学 系统评价

江苏省卓越博士后计划江苏省研究生科研与实践创新计划

2023ZB105KYCX23_0885

2024

中国循证医学杂志
四川大学

中国循证医学杂志

CSTPCD北大核心
影响因子:1.761
ISSN:1672-2531
年,卷(期):2024.24(3)
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