临床实践指南基层版制订方法分析

Analysis of Development Method of Clinical Practice Guidelines in Primary Care

  • 摘要:
      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.

     

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