摘要
目的:建立适用于监测儿童抗肿瘤药物不良反应的触发工具,衡量患儿肿瘤用药风险,并为保障其安全用药提供参考。方法:使用文献研究和德尔菲法完成触发工具的构建。首先,以“全面触发工具”“global trigger tool”等为检索词,全面检索触发工具相关中英文文献,根据纳入标准和排除标准筛选并纳入文献,提取其中的触发器条目,形成初版触发工具。其次,采用德尔菲法开展专家咨询,共邀请6个省市的15名多学科专家,逐条评价触发器条目对识别药物不良事件的重要性,并根据专家打分结果及修改建议调整触发器条目,得到趋于一致的结果。最后,使用建立的触发工具回顾性审查肿瘤患儿病历以评估其效能。结果:共纳入18篇文献,通过整合和删除文献中提取的触发器条目,得到包含49个条目的初版触发工具。经过两轮德尔菲专家咨询,最终确定39个条目,包括实验室检查19项、解毒剂8项、临床症状9项和干预措施3项。两轮专家咨询问卷平均回收率为96.67%,第一轮意见提出率为66.67%,专家的积极性较高。两轮专家咨询的权威系数均>0.80,变异系数均<0.25,第一轮和第二轮肯德尔协调系数(Kendall’s W)分别为0.11和0.12(P<0.05)。建立的39项触发器在600例患儿病历审查中,94.87%(37/39)有阳性触发,其中20个触发器的阳性预测值(PPV)≥50%,触发工具总体PPV为70.76%。结论:通过德尔菲法构建了一组用于监测儿童抗肿瘤药物不良反应的触发工具,并且在临床实际中应用的结果表明该触发工具具有良好的效能。
Objective:To establish a trigger tool for monitoring adverse drug reactions of antineoplastic drugs in children,to measure the application risk of antineoplastic drugs in children,so as to provide reference for safe medication.Methods:The establishment of trigger tool was completed by using literature research and the Delphi method.Firstly,the terms“global trigger tool”were used to comprehensively retrieve the Chinese and English literature related to trigger tools.The initial version of trigger tool was formed by screen the literature according to the inclusion criteria and exclusion criteria and extracting the trigger items.Secondly,the Delphi method was used to carry out expert consultation,a total of 15 multidisciplinary experts from 6 provinces and cities were invited to evaluate the importance of trigger entries for identifying adverse drug events one by one,and the trigger entries were adjusted according to the expert scoring results and modification suggestions,and a convergent result was obtained.Finally,the established trigger tool was used to retrospectively review the medical records of children with tumors to assess its efficacy.Results:A total of 18 articles were included,the initial version of trigger tool containing 49 entries was obtained by integrating and removing the trigger entries extracted from the literature.After two rounds of the Delphi expert consultation,39 entries were finalized,including 19 laboratory tests,8 antidotes,9 clinical symptoms and 3 interventions.The average return rate of two rounds of expert consultation questionnaires was 96.67%.The rate of submission of opinions in the first round was 66.67%,with a high level of motivation among experts.The authority coefficient for both rounds of expert consultation was greater than 0.80,the coefficient of variation was less than 0.25,and the Kendall’s coefficient of coordination(Kendall’s W)was respectively 0.11 and 0.12 for the first and second rounds(P<0.05).Among the 39 triggers established,94.87%(37/39)had positive trigg
作者
邵苗苗
孙一鑫
李雁铭
尉耘翠
杨长青
王晓玲
李英
Shao Miaomiao;Sun Yixin;Li Yanming;Yu Yuncui;Yang Changqing;Wang Xiaoling;Li Ying(Beijing Children’s Hospital,Capital Medical University,Beijing 100045,China;School of Basic Medicine and Clinical Pharmacy,China Pharmaceutical University,Nanjing 210008,China)
出处
《儿科药学杂志》
CAS
2024年第10期34-41,共8页
Journal of Pediatric Pharmacy
基金
2022白求恩·求索-药学科研能力建设项目,编号Z04JKM2021005
医院药物警戒研究协作组医院药学科研专项,编号DRM2022013。
关键词
儿童
触发器
抗肿瘤药物
主动监测
德尔菲法
药物不良反应
children
trigger tool
antineoplastic drugs
active monitoring
the Delphi method
adverse drug reactions
