采用德尔菲法构建基于全面触发工具法的儿童药品不良事件触发器

The Established of Pediatric-Focused Adverse Drug Event Triggers based on GTT by using Delphi Method

目的采用德尔菲(Delphi)法构建儿童住院患者药品不良事件(ADE)的触发器,为临床开展基于全面触发工具(GTT)的ADE主动监测提供参考。方法参考GTT白皮书和相关文献中的触发器,通过专家预调查,形成触发器初始条目,并在此基础上设计专家咨询问卷。选取北京、上海等省市的27名专家,采用Delphi法进行两轮专家咨询,对触发器条目进行筛选、修改。结果问卷回收率为92.6%、100%,两轮咨询后专家权威程度系数(Cr)为0.81±0.05,专家意见的变异系数(CV)为0.29±0.13,专家意见的协调系数(W)为0.346,经检验具有统计学意义(P<0.001)。最终确定触发器36个,包括实验室指标20个,解毒剂9个,临床症状4个,干预措施3个。结论采用Delphi法构建的儿童ADE触发器合理可行,为GTT法的实施奠定了基础。

OBJECTIVE To establish pediatric-focused trigger of adverse drug event using Delphi expert consensus method,and provide a reference for clinical to develop ADE active monitoring based on GTT. METHODS The formed trigger items were adopted to design an expert consultation questionnaire based on GTT white paper,related literatures and by expert pre investigation. Twenty-seven experts from Beijing、Shanghai and so on were chosen to do a two-round Delphi consultation. Trigger items were screened and modified.RESULTS THE recovery rate of questionnaire were 92.6%、100%. After two rounds of consultation the authority coefficient （Cr） was 0.81±0.05. The coefficient of variation （CV） was 0.29±0.13. The KendallW was 0.346, respectively（P〈0.001）. Finally 36 trigger items were formulated,including 20 laboratory index, 9 antidotes, 4 clinical symptoms and 3 intervention measures.CONCLUSION It is reasonable, feasible to adopt Delphi expert consensus method as pediatric-focused trigger of adverse drug events,which lays the foundation for the implementation of GTT.