治疗药物监测指南的制订指南

The guideline for therapeutic drug monitoring guideline development

目的规范治疗药物监测(TDM)指南制订的原则、流程和方法,促进TDM指南的公开、透明、科学、可信。方法由中国药理学会治疗药物监测研究专业委员会组建指南工作组,确定和管理利益冲突;由指南工作组采用Delphi法确定指南目的、范围并构建PICO问题,检索与综合证据,结合我国实际情况及TDM特征,初拟推荐意见条目,通过指南制订组内部讨论和外部评审完善指南内容,最终形成适用于指导制订TDM相关指南的制订指南。结果本指南从TDM指南规划阶段、制订阶段、出版与更新阶段需明确和解决的问题给出建议,涵盖组建指南工作组、规划指南、确定和管理利益冲突、构建问题和选择结局指标、准备计划书、检索和合成证据、评价证据、形成推荐意见、撰写指南、外部评审、发布与传播指南、后效评价指南、更新指南。结论本指南可为TDM指南的制订提供方法学指导与参考。

Objective The guideline is formulated to standardize the principles,procedures and methods of developing therapeutic drug monitoring(TDM)guidelines and to promote open,transparent,scientific and credibility of the TDM guidelines.Methods Division of Therapeutic Drug Monitoring,Chinese Pharmacological Society established guideline working groups,declared and managed conflict of interest.The guideline working groups used the Delphi method to formulate the purpose and scope of the guideline and questions in PICO format,searched and synthesized evidence,integrated with Chinese actual situation and TDM characteristics to preliminarily develop recommendations for the guideline for TDM guideline development in China.Through internal discussion of the guideline working groups and external peer review,the content has been improved,and we eventually formulated the guideline suitable for guiding TDM related guidelines development.Results The guideline provide suggestions for problems to be identified and solved in the planning,development,publishing and updating stages of TDM guidelines including forming guideline wording groups,planning guidelines,declaration and management of interests,formulating questions and selecting outcomes,preparing the planning proposal,retrieval and synthesis evidence,evaluating evidence,developing recommendations,drafting guidelines,external review,publishing and spreading guidelines,evaluating guidelines,and updating guidelines.Conclusions This guideline can provide methodological guidance and reference for the development of TDM guidelines.