| 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。 |
| 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 |
| DOI：doi:10.13407/j.cnki.jpp.1672-108X.2024.10.009 |
|
| 基金项目: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。 |
|
| Development of a Trigger Tool for Detection of Adverse Drug Reactions of Antineoplastic Drugs in ChildrenBased on the Delphi Method |
| Shao Miaomiao1,2, Sun Yixin1, Li Yanming1, Yu Yuncui1, Yang Changqing2, Wang Xiaoling1, Li Ying1 |
| ((1. Beijing
Children’s Hospital, Capital Medical University, Beijing 100045, China; 2. School of Basic Medicine and Clinical Pharmacy, China
Pharmaceutical University, Nanjing 210008, China)) |
| Abstract: |
| 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 triggers in the medical records of 600 children, of which 20 triggers had positive predictive
value (PPV) ≥50%, and the overall PPV of trigger tools was 70. 76%. Conclusion: A set of trigger tools for monitoring adverse drug
reactions of antineoplastic drugs in children has been constructed after the Delphi method, and the results of its application in clinical
practice have demonstrated the significant efficacy. |
| Key words: children trigger tool antineoplastic drugs active monitoring the Delphi method adverse drug reactions |
