临床实践指南的制定流程与规范

Development of Clinical practice guidelines:procedure and standard

近10年,我国临床实践指南的制定迅速增长。然而,纵观既往制定的临床实践指南,能与国际接轨的高质量指南为数不多,主要原因是许多临床专家在制定指南之前并不熟悉其相关流程和规则,严重影响了指南的质量。临床实践指南需从临床问题出发,通过凝练化解为目标人群、方案或干预措施、其他备选措施以及可能的结局指标(即PICO问题),利用全面的系统评价、证据分级及推荐强度系统,对评价的措施给予确切的推荐意见。制定过程当中,需要同时考量推荐意见对适用人群的利弊,包括权衡适用人群的偏好和价值观、成本效益、医疗保健系统等。由此,一部高质量临床实践指南的制定需要多维度思考(从临床医生、患者、政策制定者思考)、实施标准流程(确保指南的科学性、真实性与透明性)以及依赖于多方协作(包括本专业领域专家、方法学家和政策制定者)。

In the last decade,the development of clinical practice guidelines in China has grown rapidly.However,with regards to the guidelines that have been established in the past,few were of high quality and in line with international standards.The main reason for this was that many clinical experts were not familiar with the procedures and rules of clinical guidelines before established,which lowered the quality seriously.Clinical practice guidelines are based on a clinical problem that is distilled into populations,interventions,comparison and outcome(PICO).After comprehensive systematic review,recommendations are made through evidence grading and strength of recommendation system.In addition,other issues should be noted such as pros and cons of the recommendation for specific population,preferences and values of the population,cost-effectiveness,and the health care system.A high-quality guideline requires multidimensional thinking(from clinicians,patients and policy makers),the implementation of a standard procedure(to ensure guidelines scientifically sound,honest and transparent),as well as the collaboration of multiple organizations(including experts,methodologists and policy makers).