《单臂试验中目标值选择的方法学质量评价清单及其说明》的形成  

Formation of the list of methodological quality evaluation and explanation for the selection of objective performance criteria in single arm trial

作　　者：曹蕊 柴倩云[1,2] 王瀚东 罗慜婧 李贺 李姝颖 刘芷含 陶立元 刘建平[1] 费宇彤[1] CAO Rui;CHAI Qianyun;WANG Handong;LUO Minjing;LI He;LI Shuying;LIU Zhihan;TAO Liyuan;LIU Jianping;FEI Yutong(Center for Evidence-based Medicine,Beijing University of Traditional Chinese Medicine,Beijing 100029,P.R.China;Journal of Traditional Chinese Medicine,Beijing 100700,P.R.China;Guangdong Provincial Hospital of Traditional Chinese Medicine,Guangzhou 511400,P.R.China;Guangdong Academy of Traditional Chinese Medicine,Guangzhou 511400,P.R.China;The First Clinical College,Beijing University of Traditional Chinese Medicine,Beijing 100027,P.R.China;Clinical Epidemiology Research Center of Peking University Third Hospital,Beijing 100191,P.R.China)

机构地区：[1]北京中医药大学循证医学中心,北京100029 [2]中医杂志社,北京100700 [3]广东省中医院,广州511400 [4]广东省中医药科学院,广州511400 [5]北京中医药大学第一临床学院,北京100027 [6]北京大学第三医院临床流行病研究中心,北京100191

出　　处：《中国循证医学杂志》2025年第4期447-453,共7页Chinese Journal of Evidence-based Medicine

基　　金：国家自然科学基金项目(编号:82074282)。

摘　　要：目的形成《单臂试验中目标值选择的方法学质量评价清单及其说明》,初步构建有关目标值选择与评价的方法学引导性工具,为完善目标值法单臂试验方法学质量评价体系提供研究基础。方法结合观察性研究与干预性试验的偏倚风险评价方法学工具以及国内外政策性文件,系统搜集了临床研究方法学质量评价中的常见偏倚和评价要点等,初步拟定了单臂试验中目标值选择的评价方法清单,运用名义群体法进行两轮专家共识投票,最终结合投票结果和专家意见拟定该清单。结果研究人员通过两轮讨论、排序,综合确定专家修改意见并对该清单中相应条目加以完善,最终形成《单臂试验中目标值选择的方法学质量评价清单及其说明》,包括4个领域:权威性、溯源性、可比性、可靠性,共包含10个条目。每个领域的条目综合考虑了设计和实施两个环节,贯穿临床试验始终。结论本研究制定的方法学清单为目标值的选择以及质量评价提供方法学引导,为建立完整的目标值法单臂试验质量评价方法学体系提供了扎实的理论基础。Objective To form the list of methodological quality evaluation and explanation for the selection of objective performance criteria in single arm trial,and initially construct a methodological guiding tool for the selection and evaluation of target value,so as far to provide a research basis for improving the system of single-arm trial quality evaluation by objective performance criteria method.Methods Combining the bias risk assessment method of observational study,interventional trails,domestic and foreign policy documents,and systematically collecting the common bias and evaluation key points,preliminarily proposing the list of methodological quality evaluation and explanation for the selection of objective performance criteria in single-arm trial,via two rounds of expert consensus voting using nominal group method,finally formulating the list based on the voting results and expert opinions.Results Through two rounds of discussion,sorting,comprehensive expert opinions,we improved the corresponding items in the list and finally formed the list of methodological quality evaluation and explanation for the selection of objective performance criteria in single-arm trial,which included four areas:authority,traceability,comparability,and reliability,including 10 items.The entries in each field considered both design and implementation throughout the clinical trial.Conclusion The methodology list developed in this study provides methodological guidance for the selection of objective performance criteria and quality evaluation,and provides a solid theoretical basis for the establishment of a complete methodological system of quality evaluation for objective performance criteria single arm trails.

关 键 词：单臂试验 目标值 名义群体法 专家共识 方法学 

分 类 号：R-3[医药卫生]