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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 a trigger for children’s adverse drug reactions (ADEs) in hospitalized patients by Delphi method, and to provide a reference for clinical active monitoring of ADE based on comprehensive triggering tool (GTT). Methods Refer to the triggers in the GTT white paper and related literature for pre-investigation by experts to form initial triggers, and based on this, design an expert consultation questionnaire. Twenty-seven experts from Beijing, Shanghai and other provinces and cities were selected to conduct two rounds of expert consultation using the Delphi method to screen and modify trigger entries. Results The questionnaire recovery rate was 92.6% and 100% respectively. After two rounds of consultation, the expert authority coefficient (Cr) was 0.81 ± 0.05, the expert opinion coefficient of variation (CV) was 0.29 ± 0.13 and the expert opinion coordination coefficient (W) was 0.346 , The test was statistically significant (P <0.001). The final trigger 36, including laboratory indicators 20, antidote 9, 4 clinical symptoms, 3 interventions. Conclusion The ADE trigger built by Delphi method is reasonable and feasible, which lays the foundation for the implementation of GTT method.