健康结局指标效应量决策阈值制定方法指南  

A guideline for determining the effect size decision threshold of health outcomes

作　　者：刘雅菲 朱鸿飞 李颖 赖鸿皓 周奇[6] 罗旭飞 陈耀龙[6,7,8,9,10] 邓宏勇 杜亮[12] 靳英辉[13] 孔德昭 黎国威[15] 李江 李玲 廖星[17] 刘杰[18] 史楠楠[17,19] 商洪才[20] 田金徽 王晓辉[1] 吴大嵘[21] 杨丰文 杨克虎[6,7,8,9,10] 于长禾[20] 张家兴 赵晨[17] 葛龙 LIU Yafei;ZHU Hongfei;LI Ying;LAI Honghao;ZHOU Qi;LUO Xufei;CHEN Yaolong;DENG Hongyong;DU Liang;JIN Yinghui;KONG Dezhao;LI Guowei;LI Jiang;LI Ling;LIAO Xing;LIU Jie;SHI Nannan;SHANG Hongcai;TIAN Jinhui;WANG Xiaohui;WU Darong;YANG Fengwen;YANG Kehu;YU Changhe;ZHANG Jiaxing;ZHAO Chen;GE Long(Department of Social Science and Health Management,School of Public Health,Lanzhou University,Lanzhou 730000,P.R.China;Evidence-Based Social Science Research Center,School of Public Health,Lanzhou University,Lanzhou 730000,P.R.China;School of Public Health,Fudan University,Shanghai 200032,P.R.China;Key Laboratory of Public Health Safety,Fudan University,Shanghai 200032,P.R.China;National Health Commission Key Laboratory of Health Technology Assessment,Fudan University,Shanghai 200032,P.R.China;Evidence-Based Medicine Center,School of Basic Medical Sciences,Lanzhou University,Lanzhou 730000,P.R.China;Institute of Health Data Science,Lanzhou University,Lanzhou 730000,P.R.China;Key Laboratory of Evidence Based Medicine and Knowledge Translation of Gansu Province,Lanzhou 730000,P.R.China;WHO Collaborating Center for Guideline Implementation and Knowledge Translation,Lanzhou 730000,P.R.China;Chinese GRADE Center,Lanzhou 73000,P.R.China;TCM Health Collaborative Innovation Center,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,P.R.China;Chinese Evidence-Based Medicine Center,West China Hospital,Sichuan University,Chengdu 610041,P.R.China;Center for Evidence-Based and Translational Medicine,Zhongnan Hospital of Wuhan University,Wuhan 430071,P.R.China;Affiliated Hospital of Liaoning University of Traditional Chinese Medicine,Shenyang 110032,P.R.China;Guangdong Second Provincial General Hospital Affiliated to Jinan University,Guangzhou 510317,P.R.China;Cancer Hospital Chinese Academy of Medical Sciences,Beijing 100021,P.R.China;Institute of Basic Research in Clinical,China Academy of Chinese Medical Sciences,Beijing 100700,P.R.China;Guang'anmen Hospital,China Academy of Chinese Medical Sciences,Beijing 100700,P.R.Chin

机构地区：[1]兰州大学公共卫生学院社会医学与卫生事业管理研究所,兰州730000 [2]兰州大学公共卫生学院循证社会科学研究中心,兰州730000 [3]复旦大学公共卫生学院,上海200032 [4]复旦大学公共卫生安全教育部重点实验室,上海200032 [5]复旦大学国家卫生健康委员会卫生技术评估重点实验室,上海200032 [6]兰州大学基础医学院循证医学中心,兰州730000 [7]兰州大学健康数据科学研究院,兰州730000 [8]甘肃省循证医学与临床转化重点实验室,兰州730000 [9]世界卫生组织指南实施与知识转化合作中心,兰州730000 [10]GRADE中国中心,兰州730000 [11]上海中医药大学中医健康协同创新中心,上海201203 [12]四川大学华西医院中国循证医学中心,成都610041 [13]武汉大学中南医院循证与转化医学中心,武汉430071 [14]辽宁中医药大学附属医院,沈阳110032 [15]暨南大学附属广东省第二人民医院,广州510317 [16]中国医学科学院肿瘤医院,北京100021 [17]中国中医科学院临床与基础医学研究所,北京100700 [18]中国中医科学院广安门医院,北京100700 [19]中国中医药循证医学中心,北京100700 [20]北京中医药大学东直门医院,北京100700 [21]广州中医药大学第二附属医院(广东省中医院),广州510120 [22]天津中医药大学循证医学中心,天津301617 [23]贵州省人民医院药剂科,贵阳550002

出　　处：《中国循证医学杂志》2024年第4期405-413,共9页Chinese Journal of Evidence-based Medicine

基　　金：国家自然科学基金项目(编号:82204931);中央级公益性科研院所基本科研业务费(编号:ZZ15-WT-05);中国中医科学院科技创新工程(编号:CI2021A05502);甘肃省科技计划资助(编号:22JR5RA733)。

摘　　要：临床循证决策过程中需要基于最佳证据,综合考虑干预措施利弊大小、证据确信度、成本与可行性等因素。通过制定患者健康结局指标效应量决策阈值(decision threshold of effect size,DTES),能够帮助利益相关者理解干预措施利弊大小、评估证据确信度和解读研究结果。MERGE工作组充分借鉴国际经验,通过小组讨论、半结构化访谈、专家共识和试点应用,开发了一套包括8个步骤的健康结局指标DTES制定方法指南,包括:必要性评估、组建工作组、遴选患者重要结局、基于最佳证据制作情景示例、设计专家函询问卷、分析专家涵询结果、面对面专家共识以及推广应用与后效评价。DTES指南的开发,以期为利益相关者制定不同领域健康结局指标的DTES提供方法指导。In the clinical evidence-based decision-making process,factors including benefits and harms,evidence certainty,cost and feasibility of interventions should be considered based on the best evidence.The development of decision threshold of effect size(DTES)for patient health outcomes can help stakeholders understand the benefits and harms of interventions,assess evidence certainty,and interpret research results.Based on international experience,the MERGE Working Group through group discussions,semi-structured interviews,expert consensus,and pilot application developed a set of 8-step guidelines for the development of DTES for health outcomes.These steps included necessity assessment,formation of working groups,selection of patient important outcomes,creation of scenarios based on the best evidence,design of expert consultation questionnaires,analysis of expert consultation results,face-to-face expert consensus,dissemination of the application and reevaluation.The DTES guideline development is intended to provide methodological guidance for stakeholders to develop DTES for health outcome indicators in different domains.

关 键 词：效应决策阈值 核心结局指标 MERGE 方法学 

分 类 号：R-03[医药卫生]