Application And Evaluation Of Global Trigger Tool For Monitoring Adverse Drug Events In The Elderly Patients

Adverse drug event refers to adverse clinical event that occurs during drug treatment.ADEs is a danger to drug safety of patients.At present,China's medical institutions mainly rely on Spontaneous Reporting System(SRS)to monitor ADRs,which have problems such as underreporting and reporting bias,and cannot reflect the real situation of clinical drug safety.In 2003,the United States introduced the Global Trigger Tool(GTT)method.The"triggers"cited in the method can locate information about adverse events in medical records.Several countries have improved and applied the trigger,and it has been proved to be an efficient and practical ADEs active monitoring method.China has not developed a standard GTT method for the monitoring ADEs in the elderly patients.Based on the original triggers from the United States,the study adjusted triggers for the elderly.By retrospective review of medical records,the GTT method was evaluated and the ADEs results in elderly patients were analyzed.Objectives:1.To establish GTT method for monitoring ADEs in the elderly patients based on the GTT method introduced by the United States.2.To evaluate GTT method for monitoring ADEs in the elderly patients.3.To analysis the ADEs results such as severity classification,drugs classification,involved organ-systems and related risk factors monitored by using GTT method in the elderly patients.Methods:1.Based on the triggers recommended in IHI Global Trigger Tool for Measuring Adverse Events and the triggers used in domestic studies,and combining the scope of biochemical indexes,drug catalogue and prescription habits in the hospital,the triggers were adjusted.31 triggers were finally developed.2.The information of discharged patients in geriatrics aged above 65years old from January to December 2016 was collected.After sorting by discharged date,15 eligible records were selected each half month by the Microsoft Excel 2010 software,which were 360 records totally.Records were reviewed by GTT and the ADEs was determined by the Naranjo method.All ADEs were evaluated for severity classification,drugs classification and involved organ-systems.3.Measurement data was described by Mean±Std.Deviation.Enumeration data was described by frequency(percentage)and compared by?~2 test.GTT method was evaluated by sensitivity,specificity,Youden's index,reliability,Kappa value and PPV.Whether ADEs occur as a dependent variable,Logistic regression analysis were applied to assess the risk factors of ADEs.A backward selection approach was used to choose the best model.ROC curve was used to evaluate the model.All statistical analysis were conducted by SPSS software,version 21.0,for window.The test level?=0.05(bilateral).Results:1.Among the 360 elderly patients,there were 216 males and 144females.The average age was 79.98±7.23,the mean length of hospital stay was 13.94±7.22,the mean number of drugs was 15.44±7.19,and the mean number of basic diseases was 12.49±5.04.2.169 records were positive according to the GTT method,the positive rate was 46.67%.19 triggers were positive among 31 triggers.3.There are 98 ADEs indentified involving 75 patients.The incidence of ADEs was 20.83%.The number of ADEs in 100 patients was 27.22,and the number of ADEs in 1000 patients was 19.53.97 cases were category E and1 case was category F.A total of 9 classes of drugs were involved in ADEs,in which the incidence of ADEs induced by cardiovascular drugs was the highest,58.16%.11 organ-systems were included,among which the proportion of metabolism and nutrition was 42.86%.4.The Naranjo method was used as a standard to evaluate the GTT.Authenticity index:sensitivity was 100.00%,specificity was 67.02%,and Youden's index was 0.67.Reliability index:consistency rate was 73.89%,Kappa value was 0.46.PPV was 44.38%.5.Logistic regression analysis found that age(OR=1.68,95%CI:1.14-2.46),length of stay in hospital(OR=2.14,95%CI:1.42-3.24),the number of medications(OR=3.10,95%CI:2.03-4.74),the number of positive triggers(OR=117.89,95%CI:15.56-893.44)and the number of basic diseases(OR=1.81,95%CI:1.08-3.04)had a significant association with ADEs among the elderly patients.The risk factors that finally entered the model were the number of medications(OR=2.29,95%CI:1.43-3.67)and the number of positive triggers(OR=71.82,95%CI:9.31-553.86),and Area Under the Cur(AUC)of ROC curve was 0.734(P<0.001).Conclusions:1.The validity and reliability of GTT for monitoring ADEs in the elderly patients were good,and PPV was high,but some triggers need to be improved.2.GTT found that all ADEs in the elderly patients were temporary harm.The proportion of ADEs caused by cardiovascular drugs was the highest.ADEs had the highest harmful effect on metabolism and nutrition.3.Age,length of stay in hospital,the number of medications,the number of positive triggers and the number of basic diseases were risk factors for ADEs in the elderly patients.The number of medications and the number of positive triggers were more significant to predict the occurrence of ADEs.