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Objective: We aimed to assess the occurrence and characteristics of antibiotic-associated adverse drug reactions (ADRs) in Malawi. Methods: We retrospectively reviewed 304 patient records from medical wards in three hospitals in Southern Malawi. A global trigger tool was applied for the detection of suspected ADRs, and we used the Naranjo scale, the World Health Organization classification and the Schumock and Thornton scale for causality, seriousness and preventability assessment respectively. ADRs were also further characterized according to anatomical systems. Statistical analysis was done in STATA 14.1. The Chi-square test was used to determine the association between categorical variables and logistic regression analysis was used to measure the strength of the association between various independent variables and the occurrence of ADRs. Results: Suspected ADRs were detected in 24% (73/304) of patients, of which 1.4% were definite, 15.1% were probable and 83.6% were possible ADRs. Most of the sADRs were gastrointestinal events (42.5%), followed by: musculoskeletal (26.3%); cardiovascular (16.3%); central nervous system (13.8%; and urinary events (1.3%). About 27% of the sADRs were serious events such as convulsions. The geriatric age group (≥65 years) was more likely to experience sADRs as compared to the younger age group, with an adjusted odds ratio (aOR) of 4.53, 95% CI (2.21-9.28), P<0.001. Patients taking more than one antibiotic medicine had a higher risk of developing sADRs as compared to patients who were administered one type of antibiotic medicine, aOR 2.14, 95% CI (1.18-3.90), p < 0.012. A long hospital stay of >3days was associated with a higher risk of sADRs with aOR of 5.11, 95% CI (2.47-10.55), p < 0.001 than those who stayed ≤ 3 days in the hospital. Conclusion: We found a higher prevalence of serious sADRs associated with antibiotic medicines than reported elsewhere. This may, among others, contribute to high patient mortality, poor treatment adherence, antibiotic resistance and increased cost of care.

What is already known and why we did the study? Most health care workers and patients are less likely to voluntarily report suspected adverse drug reactions in low- and middle-income countries such as Malawi.Studies have revealed a high usage of antibiotic medicines in Malawi, but there is limited data on the associated adverse drug reactions. What did we do? We assessed the occurrence and characteristics of ADRs associated with antibiotics. What are the new findings? We found a higher prevalence (24%) of adverse drug reactions associated with antibiotic therapy than reported elsewhere using the global trigger tool.About 27.4% of the events were serious ADRs such as convulsions, arrhythmia and hypotension.We observed a higher rate of convulsions which could be a potential safety signal. What do the new findings imply? The high prevalence of serious ADRs leads to complicated treatment strategies and contribute to patient mortality, poor treatment adherence and antibiotic resistance.ADR risk factors need to be considered when prescribing and monitoring patients on antibiotic therapy.

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Background: The increasing prevalence of fungal infections necessitates broader use of antifungal medications. However, the prevalence of adverse drug events (ADEs) restricts their clinical application. This study aimed to develop a reliable ADEs trigger for antifungals to enable proactive ADEs monitoring, serving as a reference for ADEs prevention and control. Methods: This investigation comprises two phases. Initially, the trigger was established via a literature review, extraction of relevant items, and refinement through Delphi expert consultation. Subsequently, the validity of the trigger was assessed by analyzing hospital records of antifungal drug users from 1 January 2019 to 31 December 2020. The correlation between each trigger signal and ADEs occurrence was examined, and the sensitivity and specificity of the trigger were evaluated through the spontaneous reporting system (SRS) and Global Trigger Tool (GTT). Additionally, risk factors contributing to adverse drug events (ADEs) resulting from antifungal use were analyzed. Results: Twenty-one preliminary triggers were refined into 21 final triggers after one expert round. In the retrospective analysis, the positive trigger rate was 65.83%, with a positive predictive value (PPV) of 28.75%. The incidence of ADEs in inpatients was 28.75%, equating to 44.58 ADEs per 100 admissions and 33.04 ADEs per 1,000 patient days. Predominant ADEs categories included metabolic disturbances, gastrointestinal damage, and skin rashes. ADEs severity was classified into 36 cases at grade 1, 160 at grade 2, and 18 at grade 3. The likelihood of ADEs increased with longer stays, more positive triggers, and greater comorbidity counts. Conclusion: This study underscores the effectiveness of the GTT in enhancing ADEs detection during antifungal medication use, thereby confirming its value as a monitoring tool.

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Aim: To establish significant risk factors for the development of adverse drug effects (ADEs) in children and adolescents with an acute psychotic episode taking antipsychotics. Materials and Methods: The research team randomly selected 15 patient records each month for 3 years (2016-2018). Overall, 450 patient records were included (223 boys and 227 girls, mean age was 14.52 ± 2.21 years). Adverse effects were identified using the standard algorithm of the Global Trigger Tool method. A "trigger" is an indication that an adverse reaction is likely to occur, e.g., an antihistamine prescription on a prescribing list. When a trigger was detected, the case history was studied in further detail to confirm the occurrence of ADEs. We divided patients into two groups: the "children" group (under 12 years old) and the "adolescents" group (13 years and older). Data were analyzed using the statistical package IBM SPSS Statistics 23.0. Results: Of the 450 patient records, 402 (89.3%) had at least one trigger detected. In total, 126 case histories contained evidence of ADE (28%). The total number of ADEs per 1000 patient days was 5.39 and the number of ADEs per 100 admissions was 32.0. Among adolescents, two or more triggers per patient were significantly more frequently identified (61.3% vs. 44.6%; p = 0.001). ADEs were rare in "Children" compared with "Adolescents" (13.8% vs. 30.4%; p = 0.006). The logistic regression analysis confirmed high predictive role of "Adolescence" (odds ratio [OR] = 2.58; 95% confidence interval [CI] 1.22-5.4; p = 0.013), "Polypharmacy" (OR = 1.96; 95% CI 1.23-3.1; p = 0.004), and "First-life hospitalization" (OR = 2.17; 95% CI 1.34-3.48; p = 0.001) for ADE fact in patient records. Conclusion: We found that significant risk factors for ADEs to antipsychotics in patients with acute psychotic episode were adolescence (13 years and older), polypharmacy, and first-life hospitalization. The fact that children (i.e., younger than 13 years of age) are less likely to experience ADEs was not associated with high-risk drugs or higher doses in our study.

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Objective: This study aimed to establish an antineoplastic drugs trigger tool based on Global Trigger Tool (GTT), to examine the performance by detecting adverse drug events (ADEs) in patients with cancer in a Chinese hospital (a retrospective review), and to investigate the factors associating with the occurrence of antineoplastic ADEs. Methods: Based on the triggers recommended by the GTT and those used in domestic and foreign studies and taking into account the scope of biochemical indexes in our hospital, some of them were adjusted. A total of 37 triggers were finally developed. Five hundred medical records of oncology patients discharged in our hospital from 1 June 2020 to 31 May 2021 were randomly selected according to the inclusion and exclusion criteria. These records were reviewed retrospectively by antineoplastic drugs trigger tool. The sensitivity and specificity of the triggers were analyzed, as well as the characteristics and risk factors for the occurrence of ADEs. Results: Thirty-three of the 37 triggers had positive trigger, and the sensitivity rate was 91.8% (459/500). For the specificity, the positive predictive value of overall ADEs was 46.0% (715/1556), the detection rate of ADEs was 63.0% (315/500), the rate of ADEs per 100 admissions was 136.0 (95% CI, 124.1-147.9), and the rate of ADEs per 1,000 patient days was 208.33 (95% CI, 201.2-215.5). The top three antineoplastic drugs related to ADEs were antimetabolic drugs (29.1%), plant sources and derivatives (27.1%), and metal platinum drugs (26.3%). The hematologic system was most frequently involved (507 cases, 74.6%), followed by gastrointestinal system (89 cases, 13.1%). Multivariate logistic regression analysis showed that the number of combined drugs (OR = 1.14; 95% CI, 1.07-1.22; P < 0.001) and the previous history of adverse drug reaction (ADR) (OR = 0.38; 95% CI, 0.23-0.60; P < 0.001) were the risk factors for ADEs. The length of hospital stay (OR = 0.40; 95% CI, 0.14-1.12; P < 0.05) and the previous history of ADR (OR = 2.18; 95% CI, 1.07-4.45; P < 0.05) were the risk factors for serious adverse drug events (SAE). Conclusion: The established trigger tool could be used to monitor antineoplastic drugs adverse events in patients with tumor effectively but still needs to be optimized. This study may provide some references for further research in order to improve the rationality and safety of antineoplastic medications.

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BACKGROUND: Surgical site infections are a major health problem that deteriorates the patients' health and increases health care costs. A reliable method to identify patients with modifiable risk of surgical site infection is necessary to reduce the incidence of them but data are limited. Hence the objective is to assess the predictive validity of a logistic regression model compared to risk indexes to identify patients at risk of surgical site infections. METHODS: In this study, we evaluated the predictive validity of a new model which incorporates important predictors based on logistic regression model compared to three state-of-the-art risk indexes to identify high risk patients, recruited from 2016 to 2020 from a medium size hospital in North Norway, prone to surgical site infection. RESULTS: The logistic regression model demonstrated significantly higher scores, defined as high-risk, in 110 patients with surgical site infections than in 110 patients without surgical site infections (p < 0.001, CI 19-44) compared to risk indexes. The logistic regression model achieved an area under the curve of 80 %, which was better than the risk indexes SSIRS (77 %), NNIS (59 %), and JSS-SSI (52 %) for predicting surgical site infections. The logistic regression model identified operating time and length of stay as the major predictors of surgical site infections. CONCLUSIONS: The logistic regression model demonstrated better performance in predicting surgical site infections compared to three state-of-the-art risk indexes. The model could be further developed into a decision support tool, by incorporating predictors available prior to surgery, to identify patients with modifiable risk prone to surgical site infection.

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BACKGROUND: Interprofessional training wards (ITW) are increasingly being integrated into teaching and training concepts in visceral surgery clinics. OBJECTIVE: How safe is patient care on an ITW in visceral surgery? MATERIAL AND METHODS: Data collection took place from November 2021 to December 2022. In this nonrandomized prospective evaluation study the frequency and severity of adverse events (AE) in 3 groups of 100 patients each in a tertiary referral center hospital for visceral surgery were investigated. The groups consisted of patients on the ITW and on the conventional ward before and after implementation of the ITW. The Global Trigger Tool (GTT) was used to search for AE. Simultaneously, a survey of the treatment was conducted according to the Picker method to measure patient reported outcome. RESULTS: Baseline characteristics and clinical outcome parameters of the patients in the three groups were comparable. The GTT analysis found 74 nonpreventable and 5 preventable AE in 63 (21%) of the patients and 12 AE occurred before the hospital stay. During the hospital stay 50 AE occurred in the operating theater and 17 on the conventional ward. None of the five preventable AE (in 1.7% of the patients) was caused by the treatment on the ITW. Patients rated the safety on the ITW better than in 90% of the hospitals included in the Picker benchmark cohort and as good as on the normal ward. CONCLUSION: The GTT-based data as well as from the patients' point of view show that patient care on a carefully implemented ITW in visceral surgery is safe.

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Background: Global trigger tool (GTT) was developed for identification of patient harm. In palliative patients deterioration can be expected, and there are no data on whether cases classified as "patient harm" actually represents a potential for improved patient safety. Objectives: The primary aim was to test the performance and suitability of GTT in palliative care patients. The secondary aim was to pilot triggers for substandard palliative care. Design and Measurements: GTT was applied in 113 consecutive patients at a palliative ward at a Norwegian university hospital. Cases of patient harm were further evaluated to decide if the case was (a) a natural part of the disease trajectory or (b) a foreseeable consequence of treatment decisions. Potential triggers for substandard palliative care were tested. Results: Two hundred twelve triggers (1.9 per hospitalization) and 26 cases of patient harm were identified. The positive predictive value (PPV) for identifying patient harm was 0.12. The most prevalent harm was pressure ulcers (8.8%). Of the 26 cases of patient harm, 6 cases were a natural part of the disease trajectory and 10 consequences of treatment decisions. In 21 (18%) patients triggers being piloted for substandard palliative care were present, identifying 9 cases of substandard palliative care. The highest PPV (0.67) was observed for "Cessation of antibiotics less than 5 days before death." Conclusions: With the exception of pressure ulcers, GTT triggers were infrequent or had a very poor PPV for patient harm. Triggers related to overtreatment might be suitable for identifying substandard palliative care.

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BACKGROUND: Pregnant women belong to the special population of drug therapy, and their physiological state, pharmacokinetics and pharmacodynamics are significantly different from the general population. Drug safety during pregnancy involves two generations, which is a hot issue widely concerned in the whole society. Global Trigger Tool (GTT) of the Institute for Healthcare Improvement (IHI) has been wildly used as a patient safety measurement strategy by several institutions and national programs, and the effectiveness had been demonstrated. But only one study reports the use of GTT in obstetric delivery until now. The aim of the study is to establish triggers detecting adverse drug events (ADEs) suitable for obstetric inpatients on the basis of the GTT, to examine the performance of the obstetric triggers in detecting ADEs experienced by obstetric units compared with the spontaneous reporting system and GTT, and to assess the utility and value of the obstetric trigger tool in identifying ADEs of obstetric inpatients. METHODS: Based on a literature review searched in PubMed and CNKI from January of 1997 to October of 2023, retrospective local obstetric ADEs investigations, relevant obstetric guidelines and the common adverse reactions of obstetric therapeutic drugs were involved to establish the initial obstetric triggers. According to the Delphi method, two rounds of expert questionnaire survey were conducted among 16 obstetric and neonatological physicians and pharmacists until an agreement was reached. A retrospective study was conducted to identity ADEs in 300 obstetric inpatient records at the Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital from June 1 to September 30, 2018. Two trained junior pharmacists analyzed the first eligible records independently, and the included records reviewed by trained pharmacist and physician to identify ADEs. Sensitivity and specificity of the established obstetric triggers were assessed by the number of ADEs/100 patients and positive predictive value with the spontaneous reporting system (SRS) and GTT. Excel 2010 and SPSS22 were used for data analysis. RESULTS: Through two rounds of expert investigation, 39 preliminary triggers were established that comprised four modules (12 laboratory tests, 9 medications, 14 symptoms, and 4 outcomes). A total of 300 medical records were reviewed through the obstetric triggers, of which 48 cases of ADEs were detected, with an incidence of ADEs of 16%. Among the 39 obstetric triggers, 22 (56.41%) were positive and 11 of them detected ADEs. The positive predictive value (PPV) was 36.36%, and the number of ADEs/100 patients was 16.33 (95% CI, 4.19-17.81). The ADE detection rate, positive trigger rate, and PPV for the obstetric triggers were significantly augmented, confirming that the obstetric triggers were more specific and sensitive than SRS and GTT. CONCLUSION: The obstetric triggers were proven to be sensitive and specific in the active monitoring of ADE for obstetric inpatients, which might serve as a reference for ADE detection of obstetric inpatients at medical institutions.

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INTRODUCTION: The Global Trigger Tool (GTT) is a tool that accurately identifies adverse events that represent a significant problem in hospitals. METHODS: Cross-sectional study based on retrospective review of randomized medical records using the GTT tool. RESULTS: A total of 161 adverse events (AEs) were detected: 51 events per 100 admissions, 66 per 1000 patient-days, and 30% of admissions with AEs. The most frequent triggers were from the care module, with 25% complications associated with the use of procedures, 10% pressure ulcers, and 9% care-associated infections. The presence of AEs had a statistically significant association with a stay of more than 5 days, and a moderate association with age and number of triggers. Regarding the damage, 78% of the patients presented mild events and 4% fatal events. The ROC curves analysis showed that the triggers with the greatest area under the curve were: procedural complication (0.70), pressure ulcers (0.61) and rapid response code (0.60). DISCUSSION: The number of events per 100 admissions was higher than that reported in the literature, but there were no differences in events per 1000 patientdays. Fatal cases were caused by respiratory infectious diseases in patients with comorbidities, nasogastric tube needs and cognitive decline. The study highlights the scarce use of the tool in public hospitals and the implementation of trigger analysis with ROC curves. Knowing the frequency and the most frequent type of event will allow the implementation of measures that improve patient safety.

Introducción: El Global Trigger Tool (GTT) es una herramienta que identifica con precisión los eventos adversos, estos representan un problema relevante y prevenible en los hospitales. Métodos: Estudio de corte transversal basado en la revisión retrospectiva de historias clínicas aleatorizadas utilizando el GTT. Resultados: Se detectaron 161 eventos adversos (EA): 51 por cada 100 admisiones, 66 por cada 1000 días paciente y 30% de admisiones con EA. Los disparadores más frecuentes fueron del módulo cuidados, 25% complicaciones asociadas al uso de procedimientos, 10% úlceras por presión y 9% infecciones asociadas a la atención. La presencia de EA tuvo asociación estadísticamente significativa con estancia mayor a 5 días, y asociación moderada con edad y número de disparadores. En cuanto al daño, 78% de los pacientes presentaron eventos leves y 4% eventos fatales. En el análisis con curvas ROC, los disparadores con mayor área bajo la curva fueron: complicación de procedimientos (0.70), úlceras por presión (0.61) y código de respuesta rápida (0.60). Discusión: Los eventos por 100 admisiones fueron superiores a la bibliografía pero no hubo diferencias en eventos por cada 1000 días paciente. Los casos fatales se produjeron por enfermedades infecciosas respiratorias en pacientes con comorbilidades, necesidad de sonda nasogástrica y deterioro cognitivo. Se destaca la escasa aplicación de la herramienta en hospitales públicos, y la implementación de análisis de disparadores con curvas ROC. Conocer la frecuencia y el tipo de evento más frecuente permitirá implementar medidas que mejoren la seguridad de los pacientes.

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Resumen Introducción : El Global Trigger Tool (GTT) es una herramienta que identifica con precisión los eventos adversos, estos representan un problema relevante y prevenible en los hospitales. Métodos : Estudio de corte transversal basado en la revisión retrospectiva de historias clínicas aleatorizadas utilizando el GTT. Resultados : Se detectaron 161 eventos adversos (EA): 51 por cada 100 admisiones, 66 por cada 1000 días pa ciente y 30% de admisiones con EA. Los disparadores más frecuentes fueron del módulo cuidados, 25% com plicaciones asociadas al uso de procedimientos, 10% úlceras por presión y 9% infecciones asociadas a la atención. La presencia de EA tuvo asociación estadís ticamente significativa con estancia mayor a 5 días, y asociación moderada con edad y número de disparado res. En cuanto al daño, 78% de los pacientes presentaron eventos leves y 4% eventos fatales. En el análisis con cur vas ROC, los disparadores con mayor área bajo la curva fueron: complicación de procedimientos (0.70), úlceras por presión (0.61) y código de respuesta rápida (0.60). Discusión : Los eventos por 100 admisiones fueron superiores a la bibliografía pero no hubo diferencias en eventos por cada 1000 días paciente. Los casos fatales se produjeron por enfermedades infecciosas respiratorias en pacientes con comorbilidades, necesidad de sonda nasogástrica y deterioro cognitivo. Se destaca la escasa aplicación de la herramienta en hospitales públicos, y la implementación de análisis de disparadores con cur vas ROC. Conocer la frecuencia y el tipo de evento más frecuente permitirá implementar medidas que mejoren la seguridad de los pacientes.

Abstract Introduction : The Global Trigger Tool (GTT) is a tool that accurately identifies adverse events that represent a significant problem in hospitals. Methods : Cross-sectional study based on retrospec tive review of randomized medical records using the GTT tool. Results : A total of 161 adverse events (AEs) were detected: 51 events per 100 admissions, 66 per 1000 patient-days, and 30% of admissions with AEs. The most frequent triggers were from the care module, with 25% complications associated with the use of procedures, 10% pressure ulcers, and 9% care-associated infections. The presence of AEs had a statistically significant asso ciation with a stay of more than 5 days, and a moderate association with age and number of triggers. Regarding the damage, 78% of the patients presented mild events and 4% fatal events. The ROC curves analysis showed that the triggers with the greatest area under the curve were: procedural complication (0.70), pressure ulcers (0.61) and rapid response code (0.60). Discussion : The number of events per 100 admis sions was higher than that reported in the literature, but there were no differences in events per 1000 patient-days. Fatal cases were caused by respiratory infectious diseases in patients with comorbidities, nasogastric tube needs and cognitive decline. The study highlights the scarce use of the tool in public hospitals and the implementation of trigger analysis with ROC curves. Knowing the frequency and the most frequent type of event will allow the implementation of measures that improve patient safety.

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WHAT IS KNOWN ON THE SUBJECT: Most health professionals working in psychiatric care will experience adverse events (AE) such as service user suicide or violence, during their career Norway lacks measures to capture potential iatrogenic injuries, such as risk assessment measures, to evaluate patient records for AEs in both inpatient and outpatient psychiatric clinics in hospitals WHAT THE PAPER ADDS TO EXISTING KNOWLEDGE: We have described an approach to the validation of a research tool between different national contexts; a process that went beyond language translation We have incorporated the understanding of health professionals and service users; to bring together the lifeworld of the patient with the professional definition of AEs, triggers and risk areas of AEs in a psychiatric context. The service users' experiences resulted in modifications to the tool. WHAT ARE THE IMPLICATIONS FOR NURSES: Applying the 'Global Trigger Tool-Psychiatry' in Norway and Sweden can help mental health nurses to prevent iatrogenic harm and reduce the occurrence of AEs through the identification of potential triggers. Implementing 'Global Trigger Tool-Psychiatry' might help mental health nurses to improve patient safety in Norway and Sweden. ABSTRACT: INTRODUCTION: There is little consensus on cross-cultural and cross-national adaptation of research instruments. AIM/QUESTION: To translate and validate a Swedish research tool (GTT-P) to detect iatrogenic adverse events in psychiatric health care by involving service users and health professionals in the process. METHOD: The GTT-P, designed to identify events in patient records that were triggers for adverse events, was translated to Norwegian using a cross-cultural adaptation approach. This involved two focus groups with clinical staff, one of which involved service users, and a joint discussion at a Dialogue Conference to generate consensus on the definition of the triggers of potential adverse events identifiable in patient records. RESULTS: We highlight both the differences and commonalities in defining the nature of risks, the adverse events and the triggers of such events. The Dialogue Conference resulted in three modifications of the tool, based on service users' experiences. Service user involvement and co-production was essential for both the translation and adaptation of the research instrument. DISCUSSION: We have described an approach to the validation of a research tool between different national contexts; a process that went beyond language translation. This approach enables a more nuanced understanding of potential risks within a psychiatric context as it engages differences in the care delivery. Applying the GTT-P in hospital-based psychiatric care might help to identify processes that need to be changed in order to promote patient safety and a safer work environment for mental health nurses. IMPLICATIONS FOR PRACTICE: When translating and validating the GTT-P from Swedish to Norwegian, we have considered the knowledge and experiences of both service users and health professionals. The application of the GTT-P can promote greater patient safety in hospital settings.

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Clinical record (CR) is a tool for recording details about the patient and the most commonly used source of information for detecting adverse events (AEs). Its completeness is an indicator of the quality of care provided and may provide clues for improving professional practice. The primary aim of this study was to estimate the prevalence of AEs. The secondary aims were to determine the completeness of CRs and to examine the relationship between the two variables. We retrospectively reviewed randomly selected CRs of patients discharged from the Academic Hospital of Udine (Italy) in the departments of general surgery, internal medicine, and obstetrics between July and September 2020. Evaluation was performed using the Global Trigger Tool and a checklist to evaluate the completeness of CRs. The relationship between the occurrence of AEs and the completeness of CRs was analyzed using nonparametric tests. A binomial logistic regression analysis was also performed. We reviewed 291 CRs and identified 368 triggers and 56 AEs. Among them, 16.2% of hospitalizations were affected by at least one AE, with a higher percentage in general surgery. The most common AEs were surgical injuries (42.6%; 24) and care related (26.8%; 15). A significant positive correlation was found between the length of hospital stay and the number of AEs. The average completeness of CRs was 72.9% and was lower in general surgery. The decrease in CR completeness correlated with the increase in the total number of AEs (R = -0.14; P = .017), although this was not confirmed by regression analysis by individual departments. Our results seem to suggest that completeness of CRs may benefit patient safety, so ongoing education and involvement of health professionals are needed to maintain professional adherence to CRs.

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Background: Elderly patients frequently experience a high incidence of adverse drug events (ADEs) due to the coexistence of multiple diseases, the combination of various medications, poor medication compliance, and other factors. Global Trigger Tool (GTT) is a new method for identifying ADEs, introducing the concept of a trigger, that is, clues including abnormal laboratory values, reversal drugs, and clinical symptoms that may suggest ADEs, and specifically locating information related to ADEs in the medical record to identify ADEs. The aim of this study was to establish a GTT-based trigger tool for adverse medication events in elderly patients and to investigate the risk variables associated with such events. Methods: The triggers were identified by reviewing the frequency of ADEs in elderly patients in Sichuan, China, retrieving relevant literature, and consulting experts. A retrospective analysis was carried out to identify adverse medication occurrences among 480 elderly inpatients in Sichuan People's Hospital. Results: A total of 56 ADEs were detected in 51 patients (10.62%), 13.04 per 1,000 patient days, and 11.67 per 100 admissions. The overall positive predictive value (PPV) of the triggers was 23.84, and 94.64% of ADEs caused temporary injury. Gastrointestinal system injury (27.87%) and metabolic and nutritional disorders (24.53%) were the primary organ-systems affected by ADEs. The majority of ADEs were caused by drugs used to treat cardiovascular diseases. 71.43% of ADE occurred within 2 days of administration and the risk factor analysis of ADE revealed that the number of medicines had a significant correlation. Conclusion: This study demonstrated GTT's value as a tool for ADEs detection in elderly inpatients in China. It enhances the level of medication management and comprehensively reflects the situation of ADE of the elderly.

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Many hospitals continue to use incident reporting systems (IRSs) as their primary patient safety data source. The information IRSs collect on the frequency of harm to patients [adverse events (AEs)] is generally of poor quality, and some incident types (e.g. diagnostic errors) are under-reported. Other methods of collecting patient safety information using medical record review, such as the Global Trigger Tool (GTT), have been developed. The aim of this study was to undertake a systematic review to empirically quantify the gap between the percentage of AEs detected using the GTT to those that are also detected via IRSs. The review was conducted in adherence to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Studies published in English, which collected AE data using the GTT and IRSs, were included. In total, 14 studies met the inclusion criteria. All studies were undertaken in hospitals and were published between 2006 and 2022. The studies were conducted in six countries, mainly in the USA (nine studies). Studies reviewed 22 589 medical records using the GTT across 107 institutions finding 7166 AEs. The percentage of AEs detected using the GTT that were also detected in corresponding IRSs ranged from 0% to 37.4% with an average of 7.0% (SD 9.1; median 3.9 and IQR 5.2). Twelve of the fourteen studies found <10% of the AEs detected using the GTT were also found in corresponding IRSs. The >10-fold gap between the detection rates of the GTT and IRSs is strong evidence that the rate of AEs collected in IRSs in hospitals should not be used to measure or as a proxy for the level of safety of a hospital. IRSs should be recognized for their strengths which are to detect rare, serious, and new incident types and to enable analysis of contributing and contextual factors to develop preventive and corrective strategies. Health systems should use multiple patient safety data sources to prioritize interventions and promote a cycle of action and improvement based on data rather than merely just collecting and analysing information.

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The objective of this study is to describe and analyze adverse drug events (ADE) identified using the Global trigger tool (GTT) in a Finnish tertiary hospital during a 5-year period and also to evaluate whether the medication module of the GTT is a useful tool for ADE detection and management or if modification of the medication module is needed. A cross-sectional study of retrospective record review in a 450-bed tertiary hospital in Finland. Ten randomly selected patients from electronic medical records were reviewed bimonthly from 2017 to 2021. The GTT team reviewed a total of 834 records with modified GTT method, which includes the evaluation of possible polypharmacy, National Early Warning Score (NEWS), highest nursing intensity raw score (NI), and pain triggers. The data set contained 366 records with triggers in medication module and 601 records with the polypharmacy trigger that were analyzed in this study. With the GTT, a total of 53 ADEs were detected in the 834 medical records, which corresponds to 13 ADEs/1000 patient-days and 6% of the patients. Altogether, 44% of the patients had at least one trigger found with the GTT medication module. As the number of medication module triggers increased per patient, it was more likely that the patient had also experienced an ADE. The number of triggers found with the GTT medication module in patients' records seems to correlate with the risk of ADEs. Modification of the GTT could provide even more reliable data for ADE prevention.

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Global Trigger Tool (GTT) of the Institute for Healthcare Improvement (IHI) has been used as a measurement strategy for patient safety by several institutions and national programs. Although the greater ability of the GTT to identify adverse events (AEs) compared to other methods has already been demonstrated, there are few data on its accuracy, and studies suggest lower sensitivity for minor AEs. This study aimed to assess the accuracy of the GTT for identifying AEs in adult inpatients for all AEs and for the subgroup of AEs with greater harm to the patient, classified as F-I on the IHI-GTT adapted version of the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP) Index for Categorizing Errors. In this diagnostic test study, GTT is the index test and identification of AEs (yes/no) represents the condition of interest. Due to the lack of a gold standard test, a composite reference standard method was developed. Reference standard method combined real-time (during hospitalizations) and retrospective search of medical records and administrative data for screening criteria and AEs. Both tests were applied to a random sample of 211 hospitalizations of adult inpatients during October-November 2016 in a large public hospital in Belo Horizonte, Brazil. The accuracy of the GTT was evaluated using sensitivity, specificity, and global accuracy. A total of 176 AEs were identified in 67 admissions using reference standard method and 129 AEs in 76 admissions using GTT, resulting in rates of 126 and 93 AEs/1000 patient-days, respectively. Sensitivity, specificity, and global accuracy of the GTT for the identification of individual AEs were, respectively, 0.41 (95% confidence interval [CI] 0.34; 0.49), 0.68 (95% CI 0.60; 0.74), and 0.54 (95% CI 0.49; 0.60) for all AEs, regardless of the harm categorization, and 0.85 (95% CI 0.72; 0.93), 0.88 (95% CI 0.82; 0.92), and 0.87 (95% CI 0.82; 0.91) for the subgroup of AEs categorized as harm F-I. Among the main AEs missed by the GTT are AEs related to nursing care, such as those related to peripheral venous access and gastric/enteric catheters. GTT proved to be a valid method for identifying AEs in adult inpatients. Its accuracy increases when minor harm AEs are not counted. Among the main AEs missed by the GTT are those related to nursing care. Therefore, the GTT should be used in conjunction with other measurement strategies to achieve results that are representative of the quality profile of the care provided and, thus, guide the best improvement strategies.

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Resumen El daño asociado al cuidado de la salud es relevante y altamente prevenible. El Global Trigger Tool es la principal metodología en uso para su cuantificación. Los objetivos del trabajo fueron cuantificar mediante dicha herramienta el daño asociado al cuidado durante la internación, caracterizar los tipos de daño involucrados, identificar los factores asociados y describir la utilización de la información recabada. Se trata de un estudio longitudinal retrospectivo. Se detectaron 266 eventos adversos totales entre los dos hospitales: 138 eventos en el Hospital A, y 128 eventos en el Hospital B. Esto es 61.3 eventos cada 1000 días paciente, y 62.5 eventos cada 1000 días paciente en A y B respectivamente, p = 0.3. En términos generales, construyendo una sola población de los dos hospitales, se hallaron 32 eventos adversos cada 100 admisiones, y 64.3 eventos cada 1000 días/pacientes. Los eventos estaban asociados en orden decreciente de frecuencia a: medicación (45.5%), infecciones (32.4%), procedimientos sin infección (15.2%), tromboembolismo pulmonar (4.8%), úlceras por presión (1.4%), dispositivos (0.7%). Las variables asociadas fueron polimedicación y polimorbilidad. Los factores asociados a la aparición de eventos adversos fueron el sexo femenino (OR: 2.1), la administración de medicamentos de alto riesgo (OR 2.3), la edad ≥ 80 años (OR 2.6) y el registro de ≥ 3 transferencias entre salas durante la internación (OR 2.9). Las tasas de daño observadas son comparables a las tasas evaluadas por el mismo método en estudios internacionales.

Abstract The damage associated with health care is relevant and highly preventable. The Global Trigger Tool is a leading methodology in use for its quantification. Our study aimed to quantify, through this tool, the damage associated with care during hospitalization, characterize the types of damage involved, identify the associated factors and describe the use of the information collected. We conducted a retrospective longitudinal study. A total of 266 adverse events were detected between the two hospitals: 138 events in Hospital A, and 128 in Hospital B, the patient days analyzed in each hospital were 2089 and 2046 respectively. This is 61.3 events every 1000 patient days, and 62.5 events every 1000 patient days in A and B respectively, p = 0.3. In general terms, constructing a single population of the two hospitals, 32 adverse events were found every 100 admis sions, and 64.3 events every 1000 days / patients. The events were associated in decreasing order of frequency with: medication (45.5%), infections (32.4%), procedures without infection (15.2%), pulmonary thromboembolism (4.8%), pressure ulcers (1.4%), devices (0.7%). The associated variables were polypharmacy and polymorbid ity. Factors associated with the occurrence of adverse events were female gender (OR: 2.1), administration of high-risk medications (OR 2.3), age ≥ 80 years (OR 2.6), and registration of ≥ 3 transfers between wards during hospitalization (OR 2.9). The observed damage rates are comparable to the rates evaluated by the same method in international studies.

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The objective of this study was to apply a machine learning method to evaluate the risk factors associated with serious adverse events (SAEs) and predict the occurrence of SAEs in cancer inpatients using antineoplastic drugs. A retrospective review of the medical records of 499 patients diagnosed with cancer admitted between January 1 and December 31, 2017, was performed. First, the Global Trigger Tool (GTT) was used to actively monitor adverse drug events (ADEs) and SAEs caused by antineoplastic drugs and take the number of positive triggers as an intermediate variable. Subsequently, risk factors with statistical significance were selected by univariate analysis and least absolute shrinkage and selection operator (LASSO) analysis. Finally, using the risk factors after the LASSO analysis as covariates, a nomogram based on a logistic model, extreme gradient boosting (XGBoost), categorical boosting (CatBoost), adaptive boosting (AdaBoost), light-gradient-boosting machine (LightGBM), random forest (RF), gradient-boosting decision tree (GBDT), decision tree (DT), and ensemble model based on seven algorithms were used to establish the prediction models. A series of indicators such as the area under the ROC curve (AUROC) and the area under the PR curve (AUPR) was used to evaluate the model performance. A total of 94 SAE patients were identified in our samples. Risk factors of SAEs were the number of triggers, length of stay, age, number of combined drugs, ADEs occurred in previous chemotherapy, and sex. In the test cohort, a nomogram based on the logistic model owns the AUROC of 0.799 and owns the AUPR of 0.527. The GBDT has the best predicting abilities (AUROC = 0.832 and AUPR = 0.557) among the eight machine learning models and was better than the nomogram and was chosen to establish the prediction webpage. This study provides a novel method to accurately predict SAE occurrence in cancer inpatients.

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A pesar del avance que ha supuesto en la supervivencia de los pacientes oncológicos, la aparición de nuevos agentes quimioterápicos y nuevas combinaciones, estos han traído consigo numerosos efectos adversos que pueden llegar a comprometer el tratamiento y, por consiguiente, el pronóstico de la enfermedad.Objetivos: Conocer la incidencia de los eventos adversos asociados a quimioterapia (EA), caracterizarlos y analizar sus implicancias económicas utilizando dos herramientas de detección.Materiales y métodos: Estudio de incidencia de corte longitudinal.Resultados: Se estudiaron 350 pacientes. La media de edad: 56,9, mediana: 43,4, rango: 19-85. El número de pacientes con EA fue: 323 en los cinco años. La incidencia acumulada (IA) fue: 0,923 es decir 92,3% pacientes en 5 años y la densidad de incidencia (DI) fue 0,186 en cinco años es decir 18,6%. El número de ADES en la muestra fue 1.601 con la revisión manual, una media de 4,57 EA/paciente en el total de la muestra. Los indicadores de EA fueron: 457,42 EA/100 altas, y 118,57 EA/1.000 días paciente hospitalizados. Se detectaron 152,47 EA/1.000 dosis de oncológicos administrados. Con la revisión de GTT se hallaron 1.578 EA, una media de 4,50 EA/paciente. Los indicadores de EA fueron: 450,8 EA/100 altas, y 126,64 EA/1.000 días paciente y 141,45 EA/1.000 dosis de medicamentos oncológicos administrados. Los costos facturados con y sin eventos son USD 5.343,75 vs. 15.287,5. Las dos herramientas de detección tienen similar capacidad de detección en cuanto número de EA pero la revisión completa de historia clínica sin gatillos lleva seis veces el tiempo que lleva la herramienta de gatillos. (AU)

Despite the progress it has made in the survival of cancer patients, the appearance of new chemotherapeutic agents and new combinations, these have brought with them numerous adverse effects that can compromise treatment and, consequently, the prognosis of the disease.Objectives: To know the incidence of adverse events associated with chemotherapy (AE), characterize them and analyze their economic implications using two detection tools.Materials and methods: Longitudinal cut incidence study.Results: 350 patients were studied. Mean age: 56.9, median: 43.4, range: 19-85. The number of patients with AD was: 323 in the five years. The cumulative incidence (AI) was: 0.923 that is 92.3% patients in 5 years and the incidence density (DI) was 0.186 in five years that is 18.6%. The number of ADES in the sample was 1,601 with manual review, a mean of 4.57 EA/patient in the total sample. The AE indicators were: 457.42 AE/100 discharges, and 118.57 AE/1,000 hospitalized patient days. 152.47 EA/1,000 doses of oncology administered were detected. With the GTT review, 1,578 AE were found, a mean of 4.50 AE/patient. The AE indicators were: 450.8 AE/100 discharges, and 126.64 AE/1,000 patient days and 141.45 AE/1,000 doses of oncological drugs administered. The costs invoiced with and without events are USD 5,343.75 vs. 15,287.5. The two detection tools have a similar detection capacity in terms of number of AE, but the complete medical history review without triggers takes six times the time that the trigger tool takes.Conclusions: The incidence of adverse cancer events is high, the GTT tool is useful compared to the complete review of medical records to find AE, the costs of hospitalization with events in relation to without events are significantly higher. The most frequent reactions are dermatological, and those that affect the blood system, among others. (AU)

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The damage associated with health care is relevant and highly preventable. The Global Trigger Tool is a leading methodology in use for its quantification. Our study aimed to quantify, through this tool, the damage associated with care during hospitalization, characterize the types of damage involved, identify the associated factors and describe the use of the information collected. We conducted a retrospective longitudinal study. A total of 266 adverse events were detected between the two hospitals: 138 events in Hospital A, and 128 in Hospital B, the patient days analyzed in each hospital were 2089 and 2046 respectively. This is 61.3 events every 1000 patient days, and 62.5 events every 1000 patient days in A and B respectively, p = 0.3. In general terms, constructing a single population of the two hospitals, 32 adverse events were found every 100 admissions, and 64.3 events every 1000 days / patients. The events were associated in decreasing order of frequency with: medication (45.5%), infections (32.4%), procedures without infection (15.2%), pulmonary thromboembolism (4.8%), pressure ulcers (1.4%), devices (0.7%). The associated variables were polypharmacy and polymorbidity. Factors associated with the occurrence of adverse events were female gender (OR: 2.1), administration of high-risk medications (OR 2.3), age = 80 years (OR 2.6), and registration of = 3 transfers between wards during hospitalization (OR 2.9). The observed damage rates are comparable to the rates evaluated by the same method in international studies.

El daño asociado al cuidado de la salud es relevante y altamente prevenible. El Global Trigger Tool es la principal metodología en uso para su cuantificación. Los objetivos del trabajo fueron cuantificar mediante dicha herramienta el daño asociado al cuidado durante la internación, caracterizar los tipos de daño involucrados, identificar los factores asociados y describir la utilización de la información recabada. Se trata de un estudio longitudinal retrospectivo. Se detectaron 266 eventos adversos totales entre los dos hospitales: 138 eventos en el Hospital A, y 128 eventos en el Hospital B. Esto es 61.3 eventos cada 1000 días paciente, y 62.5 eventos cada 1000 días paciente en A y B respectivamente, p = 0.3. En términos generales, construyendo una sola población de los dos hospitales, se hallaron 32 eventos adversos cada 100 admisiones, y 64.3 eventos cada 1000 días/pacientes. Los eventos estaban asociados en orden decreciente de frecuencia a: medicación (45.5%), infecciones (32.4%), procedimientos sin infección (15.2%), tromboembolismo pulmonar (4.8%), úlceras por presión (1.4%), dispositivos (0.7%). Las variables asociadas fueron polimedicación y polimorbilidad. Los factores asociados a la aparición de eventos adversos fueron el sexo femenino (OR: 2.1), la administración de medicamentos de alto riesgo (OR 2.3), la edad = 80 años (OR 2.6) y el registro de = 3 transferencias entre salas durante la internación (OR 2.9). Las tasas de daño observadas son comparables a las tasas evaluadas por el mismo método en estudios internacionales.

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