Liu Yi, Yan Junfeng, Xie Yunfei, Bian Yuan
Clinical Medical College & Affiliated Hospital of Chengdu University, Chengdu, China.
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Affiliated Hospital of University of Electronic Science and Technology of China, Chengdu, China.
BMC Pediatr. 2020 Sep 29;20(1):454. doi: 10.1186/s12887-020-02354-9.
The Global Trigger Tool (GTT),which is a method using "triggers" to review medical record retrospectively to identify possible adverse events. Several studies showed that the GTT was effective. However, there were only a few localized trigger tools that had been established to detect pediatric adverse drug events (ADEs) in China. This study aimed to establish a pediatric trigger tool based on GTT, to examine the performance by detecting pediatric inpatients ADEs in a Chinese hospital (a retrospective review), and to investigate the factors associating with the occurrence of ADEs.
The triggers were established by three steps including literature search, triggers extraction and revision, and experts investigation. A retrospective cohort study was conducted to detect ADEs by using 200 pediatric inpatient records of Sichuan Provincial People's Hospital.
Thirty-three preliminary triggers were established, and 2 rounds of experts investigation were conducted. Finally, 33 triggers were established. In the retrospective review, the positive trigger rate was 64.0%, while the positive predictive value (PPV) was 24.9%. The occurrence of inpatients with ADEs was 20.5%. ADEs/100 admissions were 49.0. ADEs/1000 patient days were 46.89. The most common ADE categories were leukocyte disorders, skin disorders and platelet disorders. The severity of 39 ADEs was grade 1, 55 ADEs was grade 2, 4 ADEs was grade 3. The highest frequency of ADE-related drugs was antineoplastic, followed by antibacterial. The length of stay and the leukemia in the diagnosed diseases were positively correlated with ADEs.
The 33 pediatric triggers may detect ADEs effectively, but still need to be optimized. This study may provide some references for further research in order to improve the rationality and safety of medication.
全球触发工具（GTT）是一种利用“触发因素”对病历进行回顾性审查以识别可能的不良事件的方法。多项研究表明GTT是有效的。然而，在中国，仅有少数局部触发工具用于检测儿科药物不良事件（ADEs）。本研究旨在基于GTT建立儿科触发工具，通过对一家中国医院儿科住院患者的ADEs进行检测（回顾性审查）来检验其性能，并调查与ADEs发生相关的因素。
通过文献检索、触发因素提取与修订以及专家调查三个步骤建立触发因素。采用回顾性队列研究，利用四川省人民医院200份儿科住院病历检测ADEs。
建立了33个初步触发因素，并进行了两轮专家调查。最终确定了33个触发因素。在回顾性审查中，阳性触发率为64.0%，而阳性预测值（PPV）为24.9%。住院患者中ADEs的发生率为20.5%。每100次入院的ADEs为49.0。每1000患者日的ADEs为46.89。最常见的ADE类别为白细胞疾病、皮肤疾病和血小板疾病。39例ADEs的严重程度为1级，55例为2级，4例为3级。与ADE相关药物的最高使用频率是抗肿瘤药物，其次是抗菌药物。住院时间和确诊疾病中的白血病与ADEs呈正相关。
33个儿科触发因素可能有效检测ADEs，但仍需优化。本研究可为进一步研究提供一些参考，以提高用药的合理性和安全性。
