Gohil Jaydipsinh B, Desai Chetna K, Panchal Jigar R, Patel Rajnish R, Rathod Gunvant H
Department of Pharmacology, B.J. Medical College, Ahmedabad, Gujarat, India.
Department of Surgery, B.J. Medical College and Civil Hospital, Ahmedabad, Gujarat, India.
Indian J Pharmacol. 2022 Jan-Feb;54(1):19-23. doi: 10.4103/ijp.ijp_764_20.
Trigger tool method (TTM) is an active surveillance method for adverse drug reaction (ADR) monitoring. The study aimed to evaluate TTM for ADR monitoring in indoor patients of the surgery department.
This prospective, observational study was conducted at the Department of Surgery of a Tertiary Care Teaching Hospital in Gujarat. Patients of either gender and more than 18 years of age admitted to two selected surgery units were enrolled with prior informed consent. Preliminary trigger tool list (PTTL) comprising 13 drug triggers (DTs), 13 patient triggers (PTs), 9 laboratory triggers (LTs), and 12 surgical module triggers (STs) were used. Patients were followed up till discharge to monitor the occurrence of triggers and adverse events.
A total of 400 patients were included (male: female ratio of 2.3:1; mean age: 43.07 ± 16.4 years; and mean length of hospital stay: 5.75 ± 3.12 days). Of 400 patients, triggers were present in 359 patients (89.75%) and no trigger was observed in 41 patients (10.25%). Of the 47 triggers in PTTL, 24 triggers were observed 1155 times, of these 14 triggers lead to the detection of 49 ADRs in 43 patients. The rate of adverse drug events was 12.25/100 patients. DT was the most common trigger identified (81.64%). Positive predictive values (PPV) for PTs, STs, DTs, LTs were 26.88%, 23.07%, 10.3%, and 5.55%, respectively. The comprehensive PPV of PTTL was 11.97%. Modified trigger tool list consists of 14 triggers.
TTM is an effective method of ADR monitoring in the surgery department. An awareness of TT helps better detection of ADRs.
触发工具法（TTM）是一种用于监测药物不良反应（ADR）的主动监测方法。本研究旨在评估TTM在外科住院患者中监测ADR的效果。
本前瞻性观察性研究在古吉拉特邦一家三级医疗教学医院的外科进行。入选两个选定外科病房的18岁以上男女患者，均获得事先知情同意。使用了包含13种药物触发因素（DTs）、13种患者触发因素（PTs）、9种实验室触发因素（LTs）和12种手术模块触发因素（STs）的初步触发工具清单（PTTL）。对患者进行随访直至出院，以监测触发因素和不良事件的发生情况。
共纳入400例患者（男女比例为2.3:1；平均年龄：43.07±16.4岁；平均住院时间：5.75±3.12天）。400例患者中，359例（89.75%）存在触发因素，41例（10.25%）未观察到触发因素。在PTTL的47种触发因素中，观察到24种触发因素1155次，其中14种触发因素导致在43例患者中检测到49例ADR。药物不良事件发生率为12.25/100例患者。DT是最常见的已识别触发因素（81.64%）。PTs、STs、DTs、LTs的阳性预测值（PPV）分别为26.88%、23.07%、10.3%和5.55%。PTTL的综合PPV为11.97%。改良触发工具清单由14种触发因素组成。
TTM是外科ADR监测的有效方法。了解TT有助于更好地检测ADR。
