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摘要: 临床实践指南与专家共识作为医学实践中最重要的指导性文件，近年来受到越来越多的关注和研究。目前，国内部分专家对指南和共识的认识和理解存在一定偏差。本文分析和比较了临床实践指南与专家共识的定义、现状和发展，以及二者之间的区别与联系，并结合实例介绍了良好实践主张及其形成条件；最后，就如何提高临床实践指南和专家共识质量提出5条建议，供国内指南和共识的制订者参考。Abstract: As the most important guiding documents in the medical practice, clinical practice guidelines and expert consensuses have received more and more attention in recent years. However, partial domestic experts also have understanding biases on guidelines and consensus. Thus, we analyzed and compared guidelines and consensuses on their definition, status, development, connection, and difference. Combined with the example, we introduced good practice statement along with its formation conditions. Finally, we proposed five recommendations on how to improve the quality of clinical practice guidelines and expert consensus in China.
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Key words:
- clinical practice guideline /
- expert consensus /
- evidence-based medicine
利益冲突 无陈耀龙、罗旭飞对本文同等贡献 -
表 1 国际临床实践指南和专家共识制订组织对共识的定义
序号 机构 年份 对共识的定义 1 NZGG[7] 2001 制订指南的一组专家在达成一致时最常用的方式 2 EHC[8] 2002 在缺乏直接证据的情况下，专家组制订医疗和卫生决策时的一种方法 3 WHO[9] 2014 理想情况下达成决策的一种方法 4 SIGN[10] 2015 指南制订小组形成推荐意见的正式方法 5 NICE[11] 2015 大多数情况下指南制订小组决策达成统一的方法 6 ESHRE[12] 2017 产生关键临床问题、确定最佳证据以及形成推荐意见的方法 NZGG:新西兰指南小组; EHC:欧洲健康委员会; WHO:世界卫生组织; SIGN:苏格兰校际指南协作网; NICE:英国国家健康与临床优化研究所; ESHRE:欧洲人类生殖及胚胎学会 
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分组(发表时间) 范围和目的 参与人员 制订严谨性 表达清晰性 应用性 编辑独立性 中国(1993—2010年) 19 8 7 26 6 2 国际(1980—2007年) 64 35 43 60 22 30 AGREE:临床指南研究与评价
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表 3 临床实践指南与专家共识的主要区别
比较项目 临床实践指南 专家共识 制订者和发布方 一般为行业学会和协会的分会/学组或政府机构 可为行业学会和协会的分会/学组，也可为在某个领域有一定号召力和影响力的专家构成的专家组 制订周期 1~2年 一般少于1年 制订过程 不同机构有各自的要求和规定，整体较为科学严谨 无统一要求，主要通过会议讨论完成 涵盖范围 一般针对某种疾病的诊断和治疗 可针对疾病的全过程、某个阶段，也可针对某个药物或某个临床问题 证据情况 纳入的证据数量较多，质量较高，一般会对证据质量进行分级 很少纳入证据或纳入的证据质量较低，可对证据质量进行分级，也可不分 推荐意见 一般对推荐意见的强度需要分级 一般不进行分级 资助来源 来源广泛，包括政府/基金会、行业学会/协会、医药公司 来源单一，医药公司居多，也有来自行业学会/协会 数量 整体相对较少 整体偏多，是指南的数倍 质量 相对较高 良莠不齐
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