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目的 对现有临床实践指南基层版(下文简称“基层指南”)的制订方法进行分析，为未来制订高质量基层指南提供参考和借鉴。 方法 系统检索中英文数据库和指南网站，获取2019年1月1日—2021年12月31日发表的基层指南，并通过参考文献追溯和谷歌学术进行补充检索。筛选符合纳入标准的基层指南，提取其基本信息和制订方法等相关内容进行分析。 结果 最终纳入2019—2021年发表的基层指南20部，其中95%来源于发达国家，最常见的制订机构类型为大学/科研机构(8部，40%)，关注较多的学科是护理学(4部，20%)、传染病学(3部，15%)和消化病学(3部，15%)，关注领域主要集中于管理(4部，20%)、治疗(4部，20%)和护理(3部，15%)方面。20部基层指南均未注册，其中11部(55%)使用了证据分级和推荐强度标准。基层指南对指南2.0清单中18个主题的平均报告率为40%，对指南小组成员(85%)、利益冲突注意事项(75%)、证据检索和纳入(75%)等主题的报告相对较好，对组织、预算、规划和培训(15%)、综合证据并考虑其他信息(15%)两个主题的报告率较低。 结论 明确报告制订方法和制订过程的基层指南数量较少，现有基层指南的制订过程对于指南2.0清单中相关内容的考量不够充分，建议未来研究应重视基层指南的报告规范，同时开发针对基层指南制订的方法学指导手册。 Abstract:Objective To analyze the development method of existing clinical practice guidelines in primary care to inform the future development of high-quality clinical practice guidelines in primary care. Methods Chinese and English databases and guideline websites were systematically searched for clinical practice guidelines in primary care published from January 1, 2019 to December 31, 2021, with additional searches conducted by reference tracing and Google Scholar. After screening was completed, basic information on included studies and information related to the development methodology was extracted and analyzed. Results Twenty primary guidelines published between 2019 and 2021 were finally included, 95% of which originated from developed countries. The most common developing institutions were universities/research institutes (8, 40%), the disciplines with the most attention were nursing (4, 20%), infectious diseases (3, 15%), and gastroenterology (3, 15%), and the areas of the guidelines were mainly focused on management (4, 20%), treatment (4, 20%) and nursing (3, 15%).None of the guidelines were registered, and 11 (55%) guidelines used evidence grading and strength of recommendation criteria. Mean reporting on the 18 topics in the Guideline 2.0 inventory was 40%, with relatively good reporting on the topics of guideline panelists (85%), conflict of interest considerations (75%), and evidence retrieval and incorporation (75%), and low reporting on the topics of organizing-budgeting-planning-training (15%), and summarizing the evidence and considering other information (15%). Conclusions The number of clinical practice guidelines in primary care that explicitly report on the methodology and process of development is low, and there is insufficient consideration of the relevant topics in the Guideline 2.0 checklist. It is recommended that future research focus on standardizing the reporting of clinical practice guidelines in primary care and developing the methodological guidebook for guideline development. 作者贡献：王玲、陈耀龙负责论文设计与构思、资料收集、整理和分析，并撰写论文初稿；王平、苏仁凤、赵俊贤、朱迪、李哲玮、贺洪峰、罗旭飞、刘辉、张海绒、王晓辉负责资料收集和论文初稿修订；陈耀龙负责论文选题、团队组建、质量控制及审校。利益冲突：所有作者均声明不存在利益冲突 -
表 1 纳入基层指南的基本特征
第一作者 发表年份 国家 制订机构性质 指南领域 关注疾病或症状 所属学科 指南版本 证据分级和推荐强度标准 Thompson [16] 2021 美国 学会/协会 综合 HIV感染 感染病学 原版 未使用 You[17] 2021 韩国 大学/研究机构 管理 虚弱 消化病学 改编版 韩国医学科学院推荐的证据分级和推荐强度标准 Sisó-Almirall[18] 2021 西班牙 学会/协会 管理 COVID-19 感染病学 原版 未使用 Moore[19] 2021 加拿大 大学/研究机构 筛查 淋病 感染病学 原版 GRADE Anderson[20] 2021 美国 医药公司 诊断 急性肝卟啉病 消化病学 原版 未使用 Wharton[21] 2020 加拿大 大学/研究机构 综合 肥胖 内分泌病学 更新版 其他[22] Verhestraeten[23] 2020 比利时 医药公司 诊断、治疗、随访 心力衰竭 心血管病学 原版 未使用 Turakhia[24] 2020 印度 学会/协会 预防 COVID-19 传染病学 改编版 未使用 Tsou[25] 2020 美国 基金会 护理 成人唐氏综合征 护理学 原版 GRADE Thaçi[26] 2020 德国 医院 治疗 银屑病 皮肤病学 原版 未使用 Scheepmans[27] 2020 比利时 医院 护理 / 护理学 原版 GRADE Jacobs[28] 2020 美国 学会/协会 技术 慢性阻塞性肺疾病和间质性肺病 呼吸病学 改编版 GRADE Hurtado[29] 2020 西班牙 医院 治疗 广泛性焦虑症 神经精神病学 改编版 GRADE Gamble[30] 2020 美国 大学/研究机构 护理 / 护理学 原版 未使用 Covington[31] 2020 英国 基金会 治疗 / 麻醉学 原版 未使用 Groulx[32] 2020 加拿大 大学/研究机构 筛查 慢性胃食管反流病 消化病学 原版 GRADE Martel-Pelletier[33] 2020 加拿大 大学/研究机构 诊断 骨关节炎 骨科学 原版 未使用 Korownyk[34] 2019 加拿大 大学/研究机构 管理 鸦片依赖 临床药学 原版 GRADE Birtwhistle[35] 2019 加拿大 大学/研究机构 筛查 无症状甲状腺功能不良 内分泌病学 原版 GRADE Auclair[36] 2019 加拿大 学会/协会 治疗 子宫内膜增生 妇产科学 原版 GRADE HIV: 人类免疫缺陷病毒；GRADE: 推荐分级的评估、制订与评价；/该指南未关注疾病或症状 
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表 2 基层指南对指南2.0清单的报告情况
指南制订需考虑的主题 未报告(部) 报告(部) 报告率(%) 1.组织、预算、规划和培训 17 3 15.0 2.设置优先领域 16 4 20.0 3.指南小组成员 3 17 85.0 4.组建指南小组的过程 12 8 40.0 5.确定目标用户和主题 8 12 60.0 6.用户和利益相关者的参与 13 7 35.0 7.利益冲突注意事项 5 15 75.0 8.形成问题 13 7 35.0 9.考虑结局指标和干预措施的重要性、价值观、偏好及效用 16 4 20.0 10.确定纳入的证据类型并检索证据 5 15 75.0 11.综合证据并考虑其他信息 17 3 15.0 12.评价证据体的质量、强度或可信度 9 11 55.0 13.制订推荐意见并确定推荐强度 9 11 55.0 14.对推荐意见和实施、可行性、公平性的注意事项的撰写 15 5 25.0 15.报告与同行评审 10 10 50.0 16.传播与实施 16 4 20.0 17.评价与应用 18 2 10.0 18.更新 14 6 30.0
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表 3 基层指南小组成员及分布情况
第一作者 发表年份 临床专家 基层人员 患者代表 方法学家 专家人数 Thompson[16] 2021 √ √ / You[17] 2021 √ √ 6 Sisó-Almirall[18] 2021 √ √ / Anderson[20] 2021 √ √ 10 Wharton[21] 2020 √ √ 6 Verhestraeten[23] 2020 √ √ 22 Turakhia[24] 2020 √ / Tsou[25] 2020 √ √ √ 29 Thaçi[26] 2020 √ 7 Scheepmans[27] 2020 √ √ √ 7 Jacobs [28] 2020 √ √ 22 Hurtado[29] 2020 √ √ / Covington[31] 2020 √ √ / Groulx[32] 2020 √ √ 5 Martel-Pelletier[33] 2019 √ / Korownyk[34] 2019 √ √ 13 Birtwhistle[35] 2019 √ √ / √该指南包含列标题相应的人员；/该指南未说明相关数据
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