基层医疗机构一体化临床指南制定的方法学体系研究：以儿科为例

Primary care is significant carrier of basic medical care and public health service in China. However, the servie system of our primary care is weak so that it can not meet the health care need of the residents and need to be improved. Guideline is an important measurement to promote and solve the weak service capability of our primary care. But there is lack of clinical guidelines for primary care and the current guidelines are not suitable for primary care. Therefore, there is an urgent need for methodology of integrated guideline development for primary care to guide the development of our local clinical guidelines. The applicant proposed the concept and made a clear definition of integrated clinical guideline. Meanwhile, as front-line worker in the area of women and children's health, the applicant pay hight attention to children's health and did a lot of research in this field. This project plans to use systematic review, survey research,comprehensive assessment and health economic evalutions to establish the methodology of integrated clinical guideline development for primary care and to develop a polit guideline in pediatrics. If this project succeed, the methodology can be used to develop local integrated clinical guidelines for primary care and to provide methodological support for solving the poblem in primary care.

基层医疗机构是我国基本医疗和公共卫生服务的重要载体。但我国基层医疗卫生服务体系薄弱，难以满足居民的卫生保健需求，有待规范与指导。指南是规范卫生行为、解决我国基层医疗机构服务能力薄弱的重要手段。然而，我国基层版临床指南极缺且现有临床指南多不适用于基层医疗机构，亟需建立基层版一体化临床指南制定的方法学体系，指导本土一体化临床指南生产。申请人首次提出并明确定义了“一体化”临床指南，同时作为妇幼医疗卫生领域的一线工作者，申请人尤其关注儿童这一脆弱人群的健康问题并一直致力于相关研究。本研究综合运用系统评价、调查研究、综合评价、临床综合干预方案评价、卫生经济学评价等方法，建立基层医疗机构一体化临床指南制定的方法学体系，并以儿科为例建立示范指南。研究若获成功，可用于我国本土化、基层版、一体化临床指南的制定，为解决我国基层医疗机构技术力量薄弱、缺乏全科化人才的现状提供方法学支撑。

针对我国基层版临床指南极缺且现有临床指南多不适用于基层医疗机构的实际需求，本研究综合运用系统评价、横断面调查研究及Delphi专家咨询等方法：抽样调查了全国县级与基层医疗机构医务人员临床指南使用的现状与需求。循证评价了全球制订指南的指南，梳理指南制订的基本流程与方法并描述性分析其方法学异同。深入探讨了基层版指南与普通版指南在制订方法学上的差异，并形成针对基层版指南制订方法学的推荐意见。针对研究过程中发现的尚缺乏供指南用户使用的指南临床适用性评价工具的问题，本项目组团队拓展性建立了适用于包括基层医务人员在内的、可供一线医务人员使用的指南临床适用性评价工具。项目执行期间，项目组受中国药学会医院药学专委会委托，作为牵头单位之一参与国家卫健委药政司短缺药品管理系列指南的制订，负责系列指南的方法学设计与质量控制。通过制订系列指南，验证与完善了项目组所建立的基层版临床指南制订方法学。