儿童药品临床综合评价主题的遴选方法初探  

Exploration on Topic Selection Method for Evaluation of Pediatric Medicine in China

作　　者：邱英鹏 赵琨 王晓玲[2] 黄敏[3] 翟晓文[4] 贾露露[2] 赵瑞玲[5] 闫美兴 王刚[7] 孙华君[3] 陈育智[8] 刘克军 尉耘翠 曹旺 赵羽西 肖月 QIU Ying-peng;ZHAO Kun;WANG Xiao-ling;HUANG Min;ZHAI Xiao-wen;JIA Lu-lu;ZHAO Rui-ling;YAN Mei-xing;WANG Gang;SUN Hua-jun;CHEN Yu-zhi;LIU Ke-jun;YU Yun-cui;CAO Wang;ZHAO Yu-xi;XIAO Yue(China National Health Development Research Center,Beijing 100044,China;National Center for Children′s health,China/Beijing Children′s hospital,Capital Medical University,Beijing 100045 China;Children′s hospital of Shanghai/Children′s Hospital of Shanghai Jiaotong University,Shanghai 200062,China;Children′s Hospital of Fudan University,Shanghai 201102,China;Children′s hospital of Shanxi,Shanxi Taiyuan 030013,China;Qingdao Women and Children′s Hospital,Shandong Qingdao 266011,China;Children′s Hospital of Chongqing Medical University,Chongqing 400014,China;Children′s Hospital,Capital Institute of Pediatrics Beijing 100020,China)

机构地区：[1]国家卫生健康委卫生发展研究中心,北京100044 [2]国家儿童医学中心,首都医科大学附属北京儿童医院,北京100045 [3]上海市儿童医院,上海交通大学附属儿童医院,上海200062 [4]复旦大学附属儿科医院,上海201102 [5]山西省儿童医院,山西太原030013 [6]青岛市妇女儿童医院,山东青岛266011 [7]重庆医科大学附属儿童医院,重庆400014 [8]首都儿科研究所附属儿童医院,北京100020

出　　处：《中国药物评价》2021年第3期177-182,共6页Chinese Journal of Drug Evaluation

摘　　要：目的:探索儿童药品临床综合评价主题遴选的路径和方法,为国家出台相关技术指南提供参考。方法:采用系统文献综述,总结国际卫生技术评估主题遴选经验。通过专家咨询,总结提炼主题遴选方法框架。联合6家试点医疗机构开展试点验证。结果:通过对17个卫生技术评估机构主题遴选经验总结,提出儿童药品临床综合评价主题遴选德的5大步骤即确定重点领域、收集主题、制定遴选标准、初步设计和证据收集,主题优先排序和决策。指导6家试点医疗机构完成6大重点疾病领域的主题遴选。结论:本研究提出的儿童药品临床综合评价主体遴选方法具有较好的科学性和操作性,但需在实践中不断完善。Objective:To explore the topic selection method for evaluation of pediatric medicine(EPM)and inform the development of national technical guideline of EPM.Methods:A systematic review was conducted to summarize practices on topic selection in health technology assessment(HTA)agency around the world.Then,a methodical framework of topic selection of EPM were produced by expert consultation and pilots on were implemented by 6 hospitals.Results:A methodical framework with 5 major steps were proposed based on common practices summarized from 17 HTA agencies,which were priority setting on disease area,collection of potential topics,primary design of topic and evidence collection,ranking and decision making.under the guidance of the frameworks.within six prioritized areas,six topics were selected by 6 hospitals respectively.Conclusion:The scientificity and operability of the framework of EPM were shown to be satisfactory in the pilots,while it needs to be further improved in future practices.

关 键 词：儿童药品 药品临床综合评价 主题遴选 

分 类 号：R95[医药卫生—药学]