Active Monitoring Of ADE In Inpatients Based On GTT Method

BackgroundAdverse Drug Event(ADE)is an adverse clinical event that occurs during the use of a drug for treatment.According to incomplete statistics,about 10%-30% of patients in China experience ADEs every year,and nearly 190,000 patients die due to ADEs;in the United States,drug-related injuries can cause about 100,000 deaths,and ADEs have become the fifth leading cause of human death.Therefore,effective means of monitoring ADE have become a matter of close concern for our health authorities.The number of ADEs reported is much lower than the actual occurrence,resulting in a lack of accurate,realistic,and valuable information on ADEs to provide a basis for clinical drug treatment.Therefore,healthcare institutions need to further improve the surveillance system and develop new ADE surveillance tools/tools to improve ADE’s detection rate and accuracy.In recent years,with the incidence of fungal infections increasing year by year,the use of antifungal drugs has become more widespread.It has been shown that most antifungal drugs are not very specific and are prone to toxic effects on host cells while acting on the fungus,and their high ADE incidence is an important factor limiting the clinical use of antifungal drugs.The Global trigger tool(GTT)is an active ADE surveillance tool introduced by the Institute for Healthcare Improvement(IHI)in 2003,which is more specific than traditional surveillance methods and has been shown in several studies to have It is more specific than traditional monitoring methods and has been shown in several studies to have high ADE detection efficacy.Although the GTT method has been applied to ADE monitoring in the population and for certain drugs in recent years,it has not been applied to active ADE monitoring for antifungal drugs in China.Based on the above reasons,this study proposed constructing an antifungal drug ADE trigger for inpatients using the GTT as a framework and optimizing the established trigger using the Delphi method.By retrospectively reviewing cases discharged from our hospital who received antifungal medication between 1 January 2019 and 31 December 2020,and comparing them with the spontaneous presentation of ADEs in our hospital during the same period,the established trigger will be evaluated methodologically,and the findings will be sorted out to provide reference suggestions for guiding rational clinical use and improving quality of care.Methods1: Establishment of ADE triggers for antifungal drugs(1)Referring to the trigger framework introduced by IHI and GTT application studies,we reviewed the literature related to ADE of antifungal drugs,drug instructions,ADE databases,and reference books,etc.to extract common ADE information of antifungal drugs and initially established ADE triggers(trigger entries)for antifungal drugs;(2)Optimize the established triggers using the Delphi method.2: Validation of the triggers(1)Through a retrospective cross-sectional study,cases discharged from our hospital between 1 January 2019 and 31 December 2020 who received antifungal medication were randomly selected using stratified sampling.The established ADE trigger was used to trigger the sampled cases,and the Positive Predictive Value(PPV),ADE detection rate,false negative rate,and related authenticity indicators of the trigger were calculated and the results were compared with the spontaneous presentation results of our hospital during the same period;(2)The number of detected ADEs,correlation,severity grading,organs and systems involved,and risk factors were analyzed to summarize the risk factors for antifungal ADE in hospitalized patients and to propose clinical reference recommendations.Results1: Basic information about the trigger(1)The initially established antifungal drug ADE trigger contained 21 trigger entries,including 7 laboratory test indicators(L),10 clinical symptoms(S),2 antidotes(A),and 2 clinical interventions(T);(2)A questionnaire survey of these 21 initial trigger entries was conducted using the Delphi method,consulting a total of 15 experts in the field of anti-infection,including 8 experts in pharmacology and 7 experts in clinical medicine.The recall rate of the questionnaire was 100% and the opinion rate was 20%;the authority coefficient(Cr)of the experts’ opinions was 0.82 ± 0.08;the mean importance rating of the experts’ opinions(Mj)was 3.79 ± 0.88 and the frequency of full scores(Kj)was 0.23 ± 0.18;the coefficient of variation(Vj)of the experts’ opinions was 0.22 ± 0.05 and the coordination coefficient(W)was 0.165(p < 0.001).The results show that the ADE trigger for antifungal drugs established based on the GTT method is reliable.2: Analysis of trigger detection efficacy and ADE-related risk factors(1)Of the 480 patients included in the study,316 were positively triggered and214 antifungal drug ADEs were confirmed,involving 138 patients,with a trigger PPV of 26.92%(214/795)and a detected ADE incidence of 28.75%(138/480).Among the164 patients who were not triggered,four patients had ADEs without positive trigger detection,with a false negative rate of 2.82%(4/142),a sensitivity of 97.2%,a specificity of 47.3%,and a correctness index of 0.45.and a kappa value of 0.33;the spontaneous reporting rate of ADEs with antifungal drugs presented in our hospital during the same period was 0.77%(33/4282),a statistically significant difference(p <0.05)compared to the trigger detection rate of 28.75%(138/480)for ADE in this study.(2)Analysis of the 214 ADEs that occurred showed that the number of ADEs in1000 days was 33.04 and the number of ADEs in 100 patients was 44.58;in terms of correlation analysis,193 cases(90.19%,193/214)were "probably correlated" and 21cases(9.81%,21/214)were "probably correlated".9.81%(21/214)were "likely to be related";in terms of severity: "Grade 1 injury" in 36 cases(16.82%,36/214),"Grade 2injury In terms of severity: "Grade 1 injuries" in 36 cases(16.82%,36/214),"Grade 2injuries" in 160 cases(74.77%,160/214)and "Grade 3 injuries" in 18 cases(8.41%,18/214).In terms of involvement of organs and systems: the metabolic and nutritional system had the most damage,with 60 cases(28.04%,60/214);followed by the gastrointestinal system with 38 cases(17.76%,38/214);and in third place,the skin and adnexal system with 32 cases(14.95%,32/214);logistic regression analysis of the factors associated with the occurrence of ADE(OR=2.004,95% CI: 1.183-3.394)),the number of positive triggers 3-5(OR=7.644,95% CI: 4.288-13.625),the number of positive triggers ≥6(OR=27.327,95% CI: 7.443-100.330),the number of combined diseases 4-6(OR=2.593,95% CI: 2.593(1.417 to 4.747)were significantly associated with the development of ADE.ConclusionThe ADE trigger for antifungal drugs constructed using the GTT method and optimized by the Delphi method is well-designed and feasible.It was validated that the ADE trigger established in this study has high sensitivity and specificity,a higher ADE detection rate compared with the spontaneous presentation,and better monitoring of serious and rare ADEs,and can be recommended for active monitoring of antifungal drug ADEs.