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药品临床综合评价工作流程指南
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| 篇名： | 药品临床综合评价工作流程指南 |
| TITLE： | Guideline for the workflow of clinical comprehensive evaluation of drugs |
| 摘要： | 目的 为规范药品临床综合评价工作的主要流程和相关技术环节，提升综合评价证据的质量和转化应用价值提供指导和参考。方法以世界卫生组织标准指南制定方法为依据，严格遵循美国国家科学院医学研究所关于指南的最新定义，并符合指南研究与评价工具Ⅱ的六大领域要求制定《药品临床综合评价工作流程指南》。该指南采用德尔菲法构建研究问题；应用循证医学研究方法建立研究证据，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，采用牛津大学循证医学中心制定的推荐强度分级标准确定推荐强度，并通过专家共识法形成推荐意见。结果与结论《药品临床综合评价工作流程指南》涵盖主题遴选、评价实施、证据评价和结果应用转化4类研究问题。该指南的制定规范了药品临床综合评价的全流程技术环节，可有效指导该项工作的高质、高效开展，提升评价证据的规范产出和转化应用价值，为卫生决策的科学化和临床用药合理化提供高质量的证据支持。 |
| ABSTRACT： | OBJECTIVE To standardize the main processes and related technical links of the clinical comprehensive evaluation of drugs， and provide guidance and reference for improving the quality of comprehensive evaluation evidence and its transformation and application value. METHODS The construction of Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs was based on the standard guideline formulation method of the World Health Organization （WHO）， strictly followed the latest definition of guidelines by the Institute of Medicine of the National Academy of Sciences of the United States， and conformed to the six major areas of the Guideline Research and Evaluation Tool Ⅱ. Delphi method was adopted to construct the research questions； research evidence was established by applying the research methods of evidence-based medicine. The evidence quality classification system of the Chinese Evidence-Based Medicine Center was adopted for evidence classification and evaluation. The recommendation strength was determined by the recommendation strength classification standard formulated by the Oxford University Evidence-Based Medicine Center， and the recommendation opinions were formed through the expert consensus method. RESULTS & CONCLUSIONS The Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs covers 4 major categories of research questions， including topic selection， evaluation implementation， evidence evaluation， and application and transformation of results. The formulation of this guideline has standardized the technical links of the entire process of clinical comprehensive evaluation of drugs， which can effectively guide the high-quality and high-efficient development of this work， enhance the standardized output and transformation application value of evaluation evidence， and provide high-quality evidence support for the scientific decision-making of health and the rationalization of clinical medication. |
| 期刊： | 2025年第36卷第19期 |
| 作者： | 李正翔；段蓉；史录文；田金徽；左笑丛；张玉；张伶俐；张俊华；郑华林；赵荣生；郭武栋；缪丽燕；翟所迪 |
| AUTHORS： | LI Zhengxiang，DUAN Rong，SHI Luwen，TIAN Jinhui，ZUO Xiaocong，ZHANG Yu， ZHANG Lingli，ZHANG Junhua，ZHENG Hualin，ZHAO Rongsheng，GUO Wudong，MIAO Liyan，ZHAI Suodi |
| 关键字： | 药品临床综合评价；工作流程；指南；团体标准；循证医学 |
| KEYWORDS： | clinical comprehensive evaluation of drugs； workflow； guideline； group standard； evidence-based medicine |
| 阅读数： | 13 次 |
| 本月下载数： | 11 次 |
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