The Application Of Global Trigger Tool (GTT) For Adverse Drug Events In Obstetric Inpatients

Objective:Survey the adverse drug events(ADE)of local pregnancy patients,adopt Delphi method to construct the triggers for actively monitoring the obstetric inpatients with ADE,retrospectively analyze the medical records and compare with the spontaneous reporting system data,verify the validity and adaptability of the established local triggers.Provide a reference for the drug safety and the quality of hospital management improvement.Research methods:1.Relevant literatures on the application of global trigger tool(GTT)in PubMed,CNKI and other databases were searched to screen the triggers used in various studies,and preliminarily establish the triggers that were suitable for obstetric inpatients.By summarizing the adverse reactions of commonly used obstetric drugs,investigating the occurrence of ADE in local patients during pregnancy,consulting domestic and foreign obstetrics and gynecology specialist guidelines,and pre-investigating the obstetrics and gynecology experts,the triggers initially established were revised to be more applicable to the actual situation of local obstetric inpatients.2.By conducting two rounds of expert questionnaire of the initial established triggers using the Delphi survey method,evaluation and revision suggestion were collected from 16 experts to form a local obstetric inpatients ADE triggers.3.A total of 300 medical records of the hospital in the third quarter of 2018 were randomly selected and retrospectively reviewed according to the established GTT,the positive condition of triggers and the detection of ADE were recorded,the causality and severity of ADEs was judged,and the validity of triggers was analyzed and verified.Research results:1.Retrospective study on ADR reports of local pregnancy patients.A total of 1309patients with adverse drug reactions in Sichuan province were reported between November 2016 and November 2017,serious adverse reaction was 4.43%(58/1309),mainly involving the system of skin and its accessories,gastrointestinal system,the whole body damage,and the central and peripheral nervous system and cardiovascular system,the main drugs were tromethamine,cefazolin,oxytocin,misoprostol,magnesium sulfate injection.Twenty-eight GTT studies on general adult patients and perioperative patients were collected as a reference.According to physiological changes during pregnancy and ADR characteristics of local patients during pregnancy,41 initial triggers were established for local obstetric patients.2.Establishment of local obstetric inpatient triggers.Delphi method was used to conduct a two-round questionnaire survey on 41 initial triggers.The recovery rate of the first round of questionnaire survey was 88.89%,the suggestion rate was 18.75%,the expert authority coefficient Cr was 0.73±0.07,the degree of the opinion concentration M_j(the mean)and K_j(full frequency)were 3.89±0.28 and 0.33±0.12 respectively,the degree of the expert opinion coordination V_j(the coefficient of variation)and W(the coordination coefficient)were 0.36±0.13 and 0.427(P<0.001).The recovery rate of the second round of questionnaire survey was 100%,the suggestion rate was 12.5%,the degree of the opinion concentration M_j(the mean)and K_j(full frequency)were4.30±0.24 and 0.51±0.15 respectively,the degree of the expert opinion coordination V_j(the coefficient of variation)and W(the coordination coefficient)were 0.32±0.15 and0.326(P<0.001).Reliable 39 ADE triggers for obstetric inpatients were established by two rounds of expert questionnaire,including 12 triggers of laboratory indicators,9triggers of drug use,14 triggers of clinical manifestations and 4 triggers of results.Compared with the white paper and the previous general adult patient GTT,the thresholds of triggers were modified,triggers of special ADR for obstetric patients and fetal/neonatal ADR were added,the triggers of ADR of obstetric drugs were added,and triggers irrelevant to obstetrics were deleted.3.Empirical study on local obstetric inpatient triggers.300 medical records were reviewed by using the 39 triggers established,49 cases of ADE were detected,and the ADE incidence was 16.33%.Among them,22 triggers were positive(56.41%),and 11of them detected ADE.A total of 154 positive triggers were detected,and the detection frequency of ADE was 54 cases and PPV was 35.71%.The number of ADEs/100patients was 16.33(4.19~17.81,95%CI),and the number of ADEs/1,000patients*days was 36.89(32.72~41.07,95%CI).Compared with the spontaneous reporting system and the 13 triggers in the white paper,the ADE detecting rate,positive trigger rate and PPV value were significantly increased,confirming the specificity and sensitivity of the 39triggers.The detected ADEs mainly involved the cardiovascular system(17 cases,34.69%),gastrointestinal system(12 cases,24.49%),the female reproductive system(8cases,16.33%)and fetal(7 cases,14.29%).ADE severity:level 1,17 cases(34.69%),level 2,27 cases(55.10%),level 3,5 cases(10.20%),no level 4 and level 5 severity were found.Conclusion:The trigger design method established in this study was reasonable and had been proved to be sensitive and specific in the active monitoring of ADE in obstetric inpatients.Compared with the self-report reporting system and white paper,ADE could be accurately detected,which had significant advantages and could provide a reference for ADE monitoring of obstetric inpatients in medical institutions.