国内外卫生健康标准管理体系及制订现状的循证评价  

Management and Development of Health-related Standards in Nations and Organizations:An Evidence-based Review

作　　者：贺洪峰 田倩男 周奇[2] 赵俊贤 苏仁凤 李哲玮 刘辉 杨楠 陈耀龙 伍丽群[3] 王晓辉 HE Hongfeng;TIAN Qiannan;ZHOU Qi;ZHAO Junxian;SU Renfeng;LI Zhewei;LIU Hui;YANG Nan;CHEN Yaolong;WU Liqun;WANG Xiaohui(School of Public Health,Lanzhou University,Lanzhou 730000,China;Evidence-based Medicine Center,School of Basic Medical Sciences,Lanzhou University,Lanzhou 730000,China;Shenzhen Health Development Research and Data Management Center,Shenzhen 518028,China;Research Unit of Evidence-based Evaluation and Guidelines,Chinese Academy of Medical Sciences,School of Basic Medical Sciences,Lanzhou University,Lanzhou 730000,China;WHO Collaborating Center for Guideline Implementation and Knowledge Translation,Lanzhou 730000,China;Institute of Health Data Science,Lanzhou University,Lanzhou 730000,China)

机构地区：[1]兰州大学公共卫生学院,兰州730000 [2]兰州大学基础医学院循证医学中心,兰州730000 [3]深圳市卫生健康发展研究和数据管理中心,深圳518028 [4]中国医学科学院循证评价与指南研究创新单元兰州大学基础医学院,兰州730000 [5]世界卫生组织指南实施与知识转化合作中心,兰州730000 [6]兰州大学健康数据科学研究院,兰州730000

出　　处：《协和医学杂志》2024年第1期202-210,共9页Medical Journal of Peking Union Medical College Hospital

基　　金：深圳市“医疗卫生三名工程”项目(SZSM202111001)。

摘　　要：目的了解全球卫生健康标准管理体系及制订现状,为促进我国卫生健康标准高质量发展提供科学依据。方法系统检索相关数据库和标准化机构网站,对目标国家和组织的标准管理体系及制订现状进行分析。结果纳入研究的国家和组织在标准管理体系方面主要实行自愿型标准,仅中国和欧洲的标准化委员会发布了强制型标准。各国卫生健康标准均包含国家、团体、企业三级层面。中、日两国的标准主管机构隶属于政府,其余国家和组织的标准主管机构为独立民间团体组织。在标准研制程序方面,各国家/组织卫生健康标准的制订流程/程序均遵循“立项/提案→起草→征求意见→审查→发布”5个阶段,而具体步骤不尽相同。标准制订现状数据显示,中国发布的标准总数和卫生健康标准总数均位居前列,但卫生健康标准占比仅为2.06%。结论中国与其他国家和组织在卫生健康标准管理体系及制订现状方面存在较大差别,可考虑通过推进标准制订协作机制、加大标准宣贯和实施效果评估力度、强化卫生健康标准研制人才队伍建设、优化标准研制效率和提升卫生健康标准国际化水平等措施,促进我国高质量卫生健康标准的管理与发展。Objective To promote the development of high-quality health standards in China and summarize the characteristics of global health standards management systems and development processes.Methods We conducted a systematic search of relevant databases and the websites of standardization institutions.A descriptive method was used to analyze the basic characteristics of the standard management systems and development processes.Results The majority of the investigated countries and organizations primarily implement voluntary standards,with the exception of Chinese and the European Committee for Standardization that enforce compulsory standards.All countries and organizations have health standards at the national,group,and enterprise levels.In China and Japan,standards authorities are subordinate to the government,while in other countries or organizations,they operate as independent civil societies.The development process for health standards generally involves five stages:“Project/Proposal→Draft→Enquiry→Review→Publication”.However,the specific steps in the development of health standards vary across different countries and organizations.Furthermore,China ranks high in the number of both standards and health standards issued,but the proportion of health standards is only 2.06%.Conclusions There are significant differences between China and other countries in terms of the management system and development process of health standards.To promote the management and development of high-quality health standards in China,we recommend promoting the coordination mechanism for standard development,increasing efforts to publicize standards and evaluate the implementation effect,strengthening the construction of personnel for the development of health standards,optimizing the efficiency of standard development and improving the internationalization level of health standards.

关 键 词：卫生健康标准 标准体系 标准制订 概况性评价 

分 类 号：R194[医药卫生—卫生事业管理] R-1[医药卫生—公共卫生与预防医学]