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临床指南和专家共识制定中循证医学证据等级和推荐强度确定方法

Methods for determining the levels of evidence and strength of recommendations in the development of clinical guidelines and expert consensus
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摘要 近年来,随着生物医学技术进步和新药研发的迅猛发展,临床诊疗技术更新和进展十分迅速。为更好地推广新技术、新药物和新方法在临床诊疗过程中的应用,国内外各专业学会(协会)不断制定疾病的临床诊疗指南和专家共识,以指导临床医师更合理地应用最新的诊疗技术和药物。但在制定临床诊疗指南和专家共识时,编写团队经常面临的一个问题是如何确定纳入指南或共识的“药物”“技术”“方法”的循证医学证据等级和专家推荐强度。因此,本文从文献检索入手,基于检索到的不同文献类别详细阐释如何开展文献质量评价,并据此给出循证医学证据等级和专家推荐强度参考标准和确定方法,以供大家开展临床诊疗指南和专家共识制定工作时参考。 In recent years,with the rapid advancement of biomedical technologies and the development of new drugs,clinical diagnostic and therapeutic techniques have been continuously updated and improved.To better promote the application of new technologies,drugs and methods in clinical practice,various professional societies and associations worldwide have been formulating clinical practice guidelines and expert consensus statements to guide clinicians in the rational use of the latest diagnostic and therapeutic approaches.However,during the development of clinical practice guidelines and expert consensus,a common challenge faced by writing groups is how to determine the levels of evidence for the included“drugs”,“technologies”and“methods”,as well as the strength of expert recommendations.Therefore,this article starts with literature retrieval,elaborates on how to conduct literature quality appraisal based on different categories of retrieved studies,and subsequently provides reference standards and methods for determining levels of evidence and the strength of expert recommendations.These are intended to serve as references for future work in the development of clinical practice guidelines and expert consensus.
作者 王瑞平 李斌 WANG Ruiping;LI Bin(Clinical Research&Innovation Center,Shanghai Skin Disease Hospital,Shanghai 200443,China)
出处 《上海医药》 2025年第8期26-31,共6页 Shanghai Medical & Pharmaceutical Journal
基金 上海市卫生健康委员会卫生行业临床研究专项(202240371) 上海申康医院发展中心第二轮促进市级医院临床技能与临床创新三年行动计划——研究型医师创新转化能力培训项目(SHDC2022CRS053) 第二轮促进市级医院临床技能与临床创新三年行动计划(2023—2025年)CRU协同数据质量提升项目(SHDC2024CRX032) 上海市皮肤病医院引进人才科研基金项目(2021KYQD01) 上海人才发展基金项目(2021SHRCFZ01) 上海市卫生健康委员会、上海市中医药管理局2025年度中医药标准化项目(2025BZ004)。
关键词 临床诊疗指南 专家共识 证据等级 推荐强度 德尔菲法 clinical practice guidelines expert consensus evidence level strength of recommendation Delphi method
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