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药品临床综合评价主题遴选指南
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| 篇名： | 药品临床综合评价主题遴选指南 |
| TITLE： | Guidelines for topic selection for comprehensive clinical evaluation of drugs |
| 摘要： | 目的 为促进药品临床综合评价工作的规范、高质开展，提升综合评价证据的质量和应用转化价值提供参考。方法遵循美国国家科学院医学研究所关于指南的最新定义，并以世界卫生组织标准指南制定的方法学为依据进行指南制定。采用德尔菲法构建主题遴选评估指标体系，并采用层次分析法对各级指标进行权重赋值；应用循证医学方法建立研究证据，采用中国循证医学中心的证据分级体系进行证据分级评价，通过专家共识法形成推荐意见。结果形成的《药品临床综合评价主题遴选指南》涵盖主题遴选组织管理、主题遴选评审流程、主题遴选评估方法3个部分，其中主题遴选评估指标体系包括5个一级指标、9个二级指标、17个三级指标。结论本指南的制定，为药品临床综合评价拟开展的主题研究工作提供了标准化遴选工具，有助于提升评价质量、促进评价结果转化，支持卫生决策科学化。 |
| ABSTRACT： | OBJECTIVE To promote the standardized and high-quality development of comprehensive clinical drug evaluation， and enhance the quality of comprehensive evaluation evidence and its application transformation value. METHODS The guidelines were formulated in accordance with the latest definition of guidelines provided by the Institute of Medicine of the National Academy of Sciences and based on the methodology established by the World Health Organization standard guidelines. An index system for topic selection was constructed using the Delphi method， and weights for each index were assigned through the analytic hierarchy process. Research evidence was established following the principles of evidence-based medicine. The evidence grading evaluation was conducted using the evidence grading system of the China Evidence-Based Medicine Center， and recommendation opinions were formed via expert consensus. RESULTS Guidelines for Topic Selection for Comprehensive Clinical Evaluation of Drugs （hereinafter referred to as “the Guidelines”） were successfully developed， encompassing the organization and management of topic selection， review processes， and evaluation methods. The evaluation index system for topic selection was established， comprising 5 primary indexes， 9 secondary indexes， and 17 tertiary indexes. CONCLUSIONS The development of the Guidelines provides a standardized topic selection tool for the proposed research work of clinical comprehensive evaluation of drugs， enhances the quality of evaluations， facilitates result transformation， and supports scientific health decision-making. |
| 期刊： | 2025年第36卷第08期 |
| 作者： | 《药品临床综合评价主题遴选指南》项目组 |
| AUTHORS： | Project Team of Guidelines for Topic Selection for Comprehensive Clinical Evaluation of Drugs |
| 关键字： | 药品临床综合评价；主题遴选；指南；评估指标体系 |
| KEYWORDS： | clinical comprehensive evaluation of drugs； topic selection； guideline； evaluation index system |
| 阅读数： | 9 次 |
| 本月下载数： | 2 次 |
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