Performance of the EDACS-ADP incorporating high-sensitivity troponin assay:Do components of major adverse cardiac events matter?

BACKGROUND:The accelerated diagnostic protocol(ADP)using the Emergency Department Assessment of Chest pain Score(EDACS-ADP),a tool to identify patients at low risk of a major adverse cardiac event(MACE)among patients presenting with chest pain to the emergency department,was developed using a contemporary troponin assay.This study was performed to validate and compare the performance of the EDACS-ADP incorporating high-sensitivity cardiac troponin I between patients who had a 30-day MACE with and without unstable angina(MACE I and II,respectively).METHODS:A single-center prospective observational study of adult patients presenting with chest pain suggestive of acute coronary syndrome was performed.The performance of EDACS-ADP in predicting MACE was assessed by calculating the sensitivity and negative predictive value.RESULTS:Of the 1,304 patients prospectively enrolled,399(30.6%;95%confidence interval[95%CI]:27.7%–33.8%)were considered low-risk using the EDACS-ADP.Among them,the rates of MACE I and II were 1.3%(5/399)and 1.0%(4/399),respectively.The EDACS-ADP showed sensitivities and negative predictive values of 98.8%(95%CI:97.2%–99.6%)and 98.7%(95%CI:97.0%–99.5%)for MACE I and 98.7%(95%CI:96.8%–99.7%)and 99.0%(95%CI:97.4%–99.6%)for MACE II,respectively.CONCLUSION:EDACS-ADP could help identify patients as safe for early discharge.However,when unstable angina was added to the outcome,the 30-day MACE rate among the designated lowrisk patients remained above the level acceptable for early discharge without further evaluation.

Impact of body mass index on adverse kidney events in diabetes mellitus patients: A systematic-review and meta-analysis

BACKGROUND The incidence of chronic kidney disease among patients with diabetes mellitus(DM)remains a global concern.Long-term obesity is known to possibly influence the development of type 2 diabetes mellitus.However,no previous meta-analysis has assessed the effects of body mass index(BMI)on adverse kidney events in patients with DM.AIM To determine the impact of BMI on adverse kidney events in patients with DM.METHODS A systematic literature search was performed on the PubMed,ISI Web of Science,Scopus,Ovid,Google Scholar,EMBASE,and BMJ databases.We included trials with the following characteristics:(1)Type of study:Prospective,retrospective,randomized,and non-randomized in design;(2)participants:Restricted to patients with DM aged≥18 years;(3)intervention:No intervention;and(4)kidney adverse events:Onset of diabetic kidney disease[estimated glomerular filtration rate(eGFR)of<60 mL/min/1.73 m2 and/or microalbuminuria value of≥30 mg/g Cr],serum creatinine increase of more than double the baseline or end-stage renal disease(eGFR<15 mL/min/1.73 m2 or dialysis),or death.RESULTS Overall,11 studies involving 801 patients with DM were included.High BMI(≥25 kg/m2)was significantly associated with higher blood pressure(BP)[systolic BP by 0.20,95%confidence interval(CI):0.15–0.25,P<0.00001;diastolic BP by 0.21 mmHg,95%CI:0.04–0.37,P=0.010],serum albumin,triglycerides[standard mean difference(SMD)=0.35,95%CI:0.29–0.41,P<0.00001],low-density lipoprotein(SMD=0.12,95%CI:0.04–0.20,P=0.030),and lower high-density lipoprotein(SMD=–0.36,95%CI:–0.51 to–0.21,P<0.00001)in patients with DM compared with those with low BMIs(<25 kg/m2).Our analysis showed that high BMI was associated with a higher risk ratio of adverse kidney events than low BMI(RR:1.22,95%CI:1.01–1.43,P=0.036).CONCLUSION The present analysis suggested that high BMI was a risk factor for adverse kidney events in patients with DM.

Neutrophil-to-lymphocyte ratio and platelet-to-lymphocyte ratio:Markers predicting immune-checkpoint inhibitor efficacy and immune-related adverse events

We conducted a comprehensive review of existing prediction models pertaining to the efficacy of immune-checkpoint inhibitor(ICI)and the occurrence of immune-related adverse events(irAEs).The predictive potential of neutrophil-to-lymphocyte ratio(NLR)and platelet-to-lymphocyte ratio(PLR)in determining ICI effectiveness has been extensively investigated,while limited research has been conducted on predicting irAEs.Furthermore,the combined model incor-porating NLR and PLR,either with each other or in conjunction with additional markers such as carcinoembryonic antigen,exhibits superior predictive capabilities compared to individual markers alone.NLR and PLR are promising markers for clinical applications.Forthcoming models ought to incorporate established efficacious models and newly identified ones,thereby constituting a multifactor composite model.Furthermore,efforts should be made to explore effective clinical application approaches that enhance the predictive accuracy and efficiency.

Value of improved nursing measures and enhanced nursing management to reduce the occurrence of adverse events in pediatric infusion

BACKGROUND Intravenous infusion is a common method of drug administration in clinical practice.Errors in any aspect of the infusion process,from the verification of medical orders,preparation of the drug solution,to infusion by nursing staff,may cause adverse infusion events.AIM To analyzed the value of improving nursing measures and enhancing nursing management to reduce the occurrence of adverse events in pediatric infusion.METHODS The clinical data of 130 children who received an infusion in the pediatric department of our hospital from May 2020 to May 2021 were analyzed and divided into two groups according to the differences in nursing measures and nursing management:65 patients in the control group received conventional nursing and nursing management interventions,while 65 patients in the observation group received improved nursing measure interventions and enhanced nursing management.The occurrence of adverse events,compliance of children,satisfaction of children’s families,and complaints regarding the transfusion treatment were recorded in both groups.RESULTS The incidence of fluid extravasation and infusion set dislodgement in the observation group were 3.08%and 1.54%,respectively,which were significantly lower than 12.31%and 13.85%in the control group(P<0.05),while repeated punctures and medication addition errors in the observation group were 3.08%and 0.00%,respectively,which were lower than 9.23%and 3.08%in the control group,but there was no significant difference(P>0.05).The compliance rate of children in the observation group was 98.46%(64/65),which was significantly higher than 87.69%(57/65)in the control group,and the satisfaction rate of children’s families was 96.92%(63/65),which was significantly higher than 86.15%(56/65)in the control group(P<0.05).The observation group did not receive any complaints from the child’s family,whereas the control group received four complaints,two of which were due to the crying of the child caused by repeated punctures,one due to the poor attitude of the nurse,and one due to medication addition errors,with a cumulative complaint rate of 6.15%.The cumulative complaint rate of the observation group was significantly lower than that of the control group(P<0.05).CONCLUSION Improving nursing measures and enhancing nursing management can reduce the incidence of fluid extravasation and infusion set dislodgement in pediatric patients,improve children’s compliance and satisfaction of their families,and reduce family complaints.

Prediabetes: An overlooked risk factor for major adverse cardiac and cerebrovascular events in atrial fibrillation patients

BACKGROUND Prediabetes is a well-established risk factor for major adverse cardiac and cerebrovascular events(MACCE).However,the relationship between prediabetes and MACCE in atrial fibrillation(AF)patients has not been extensively studied.Therefore,this study aimed to establish a link between prediabetes and MACCE in AF patients.AIM To investigate a link between prediabetes and MACCE in AF patients.METHODS We used the National Inpatient Sample(2019)and relevant ICD-10 CM codes to identify hospitalizations with AF and categorized them into groups with and without prediabetes,excluding diabetics.The primary outcome was MACCE(all-cause inpatient mortality,cardiac arrest including ventricular fibrillation,and stroke)in AF-related hospitalizations.RESULTS Of the 2965875 AF-related hospitalizations for MACCE,47505(1.6%)were among patients with prediabetes.The prediabetes cohort was relatively younger(median 75 vs 78 years),and often consisted of males(56.3%vs 51.4%),blacks(9.8%vs 7.9%),Hispanics(7.3%vs 4.3%),and Asians(4.7%vs 1.6%)than the non-prediabetic cohort(P<0.001).The prediabetes group had significantly higher rates of hypertension,hyperlipidemia,smoking,obesity,drug abuse,prior myocardial infarction,peripheral vascular disease,and hyperthyroidism(all P<0.05).The prediabetes cohort was often discharged routinely(51.1%vs 41.1%),but more frequently required home health care(23.6%vs 21.0%)and had higher costs.After adjusting for baseline characteristics or comorbidities,the prediabetes cohort with AF admissions showed a higher rate and significantly higher odds of MACCE compared to the non-prediabetic cohort[18.6%vs 14.7%,odds ratio(OR)1.34,95%confidence interval 1.26-1.42,P<0.001].On subgroup analyses,males had a stronger association(aOR 1.43)compared to females(aOR 1.22),whereas on the race-wise comparison,Hispanics(aOR 1.43)and Asians(aOR 1.36)had a stronger association with MACCE with prediabetes vs whites(aOR 1.33)and blacks(aOR 1.21).CONCLUSION This population-based study found a significant association between prediabetes and MACCE in AF patients.Therefore,there is a need for further research to actively screen and manage prediabetes in AF to prevent MACCE.

Predicting major adverse cardiovascular events after orthotopic liver transplantation using a supervised machine learning model:A cohort study

BACKGROUND Liver transplant(LT)patients have become older and sicker.The rate of post-LT major adverse cardiovascular events(MACE)has increased,and this in turn raises 30-d post-LT mortality.Noninvasive cardiac stress testing loses accuracy when applied to pre-LT cirrhotic patients.AIM To assess the feasibility and accuracy of a machine learning model used to predict post-LT MACE in a regional cohort.METHODS This retrospective cohort study involved 575 LT patients from a Southern Brazilian academic center.We developed a predictive model for post-LT MACE(defined as a composite outcome of stroke,new-onset heart failure,severe arrhythmia,and myocardial infarction)using the extreme gradient boosting(XGBoost)machine learning model.We addressed missing data(below 20%)for relevant variables using the k-nearest neighbor imputation method,calculating the mean from the ten nearest neighbors for each case.The modeling dataset included 83 features,encompassing patient and laboratory data,cirrhosis complications,and pre-LT cardiac assessments.Model performance was assessed using the area under the receiver operating characteristic curve(AUROC).We also employed Shapley additive explanations(SHAP)to interpret feature impacts.The dataset was split into training(75%)and testing(25%)sets.Calibration was evaluated using the Brier score.We followed Transparent Reporting of a Multivariable Prediction Model for Individual Prognosis or Diagnosis guidelines for reporting.Scikit-learn and SHAP in Python 3 were used for all analyses.The supplementary material includes code for model development and a user-friendly online MACE prediction calculator.RESULTS Of the 537 included patients,23(4.46%)developed in-hospital MACE,with a mean age at transplantation of 52.9 years.The majority,66.1%,were male.The XGBoost model achieved an impressive AUROC of 0.89 during the training stage.This model exhibited accuracy,precision,recall,and F1-score values of 0.84,0.85,0.80,and 0.79,respectively.Calibration,as assessed by the Brier score,indicated excellent model calibration with a score of 0.07.Furthermore,SHAP values highlighted the significance of certain variables in predicting postoperative MACE,with negative noninvasive cardiac stress testing,use of nonselective beta-blockers,direct bilirubin levels,blood type O,and dynamic alterations on myocardial perfusion scintigraphy being the most influential factors at the cohort-wide level.These results highlight the predictive capability of our XGBoost model in assessing the risk of post-LT MACE,making it a valuable tool for clinical practice.CONCLUSION Our study successfully assessed the feasibility and accuracy of the XGBoost machine learning model in predicting post-LT MACE,using both cardiovascular and hepatic variables.The model demonstrated impressive performance,aligning with literature findings,and exhibited excellent calibration.Notably,our cautious approach to prevent overfitting and data leakage suggests the stability of results when applied to prospective data,reinforcing the model’s value as a reliable tool for predicting post-LT MACE in clinical practice.

Adverse Events following AstraZeneca COVID-19 Vaccination: A Case Study in Abidjan, Côte d’Ivoire

Introduction: Pharmaceutical companies have boosted vaccine production following the global COVID-19 pandemic. In Côte d’Ivoire, the first vaccination campaign with the AstraZeneca vaccine began on March 1, 2021, as part of the Covax program. Despite the positive benefit/risk balance, the adverse effects of vaccination should not be minimized. Objective: To identify adverse events of AstraZeneca’s COVID-19 vaccination for better management. Materials and Methods: This is a case of a 57-year-old obese (BMI = 39 kg/m2) female health care worker who experienced adverse events in March 2021 after the second dose of AstraZeneca vaccine administered 4 weeks apart. These were subject to mandatory case reporting. Results: Major post-vaccination events occurred in a noisy systemic picture with parameters showing significant disturbances. Biological surveillance remains costly and makes the accountability of the vaccine complex. Conclusion: Vaccination remains the ultimate weapon in the fight against endemic diseases but should not overshadow the reporting of adverse events.

Knowledge,perceptions,and practice towards adverse events following immunization surveillance among vaccination workers in Zhejiang province,China

Objective:To access the level of knowledge,perceptions,and practice towards adverse events following immunization(AEFI)surveillance among vaccination workers in Zhejiang province,China.Methods:This was a cross-sectional survey involving 768 vaccination workers.Data were collected using self-administered questionnaires and analyzed by using SAS 9.3 software.Knowledge,perceptions,and practice on AEFI surveillance were summarized using frequency tables.The mean±SD value was used as the cut-off for defining good(values≥mean)and poor(values<mean)knowledge,perceptions or practice.Binary logistic regression analysis was used to determine sociodemographic variables associated with knowledge,perceptions,and practice towards AEFI.Results:The proportions of good knowledge,perceptions and practice on AEFI surveillance were 78.13%,57.81%and 66.15%,respectively.Having a higher education background,longer years of experience,previous training on AEFI and≥30 years of age were factors associated with good knowledge,perceptions and practice on AEFI surveillance among vaccination workers.Conclusions:Over half of the respondents had good knowledge,perceptions and practice on AEFI surveillance work.Interventions on improving the vaccination workers’knowledge,perceptions and practice on AEFI surveillance should be considered in order to develop a more effective surveillance system.

Application of traditional indexes and adverse events in the ophthalmologic perioperative medical quality evaluation during 2010-2012

AIM: To evaluate the medical quality of ophthalmologic perioperative period during 2010-2012 in our hospital. METHODS: The relevant data of perioperative period were collected in our hospital during 2010-2012, and the medical quality of perioperative period was evaluated by using the traditional evaluation indexes and adverse events. Whereby, the traditional indicators include vision changes, improving of intraocular pressure, diagnostic accordance rate before and after operation, cure improvement rate, successful rescue rate, and incidence of surgical complications, etc Adverse events are associated with ophthalmologic perioperative events including pressure sores, postoperative wound infection, drug adverse events, and equipment related adverse events. RESULTS: There were 1483, 1662 and 1931 ophthalmic operations in our hospital in the year 2010, 2011 and 2012, respectively. From traditional index analysis, the proportions of vision improvement for each year were 96.43%, 96.76% and 97.32%, respectively; the rates of intraocular pressure improvement were 87.50%, 85.72% and 90.17%, respectively ( P <0.05); the diagnostic accordance rates before and after operation were 99.86%, 99.94% and 99.90%, respectively; cure improvement rates were 99.73%, 99.93% and 99.84%, respectively; the successful rescue rates were 82.98%, 81.46% and 76.66%, respectively; the complications incidence rates were 18.44%, 17.52% and 17.97%, respectively. The negative factor analysis results showed that: among all the patients of ophthalmic surgeries in our hospital during 2010 and 2012, only one case of postoperative wound infection was found in 2011, and also only one case of tumbling in 2010. The adverse drug events for each year were 1 case (0.07%), 2 cases (0.12%), and 4 cases (0.21%), respectively; the medical device adverse events for each year were 3 cases (0.20%), 5 cases (0.30%), and 6 cases (0.31%), respectively. Noticeably, only one case with postoperative infection of endophthalmitis was found in 2011. Moreover, no pulmonary infection or pulmonary embolism occurred during the three years. The perioperative adverse event rates for each year were 0.34% (5/1483), 0.48% (8/1662) and 0.52% (10/1931), respectively. Though incidence was rising during the three years, no statistical significance was observed (P>0.05). It is the same case with drugs and medical devices adverse events (P>0.05). CONCLUSION: Traditional indicators reflect an excellent operation of the perioperative ophthalmologic quality, whereas adverse events analysis indicates some underlying problems. Compared with the traditional indexes for medical quality evaluation, the index of adverse events is more reasonable and easier to make an objective evaluation for medical quality of ophthalmologic perioperation, facilitating further refine analysis. Reasonable application of the adverse events indicators helps hospital to make the detailed quality control measures.

Correlation between immune-related adverse events and long-term outcomes in pembrolizumab-treated patients with unresectable hepatocellular carcinoma:A retrospective study

BACKGROUND Although immune checkpoint inhibitor(ICI)therapy has improved the prognosis of unresectable hepatocellular carcinoma(HCC),it has also resulted in unique immune-related adverse events(irAEs).The relationship between irAE and treatment outcomes in ICI-treated unresectable HCC patients remains unknown.AIM To elucidate the correlation between immune-related toxic effects and prognosis in patients with unresectable HCC treated with pembrolizumab.METHODS From March 2019 to February 2021,a total of 190 unresectable HCC(Barcelona Clinic Liver Cancer C)patients receiving pembrolizumab treatment were retrospectively reviewed.Overall survival(OS)was the primary endpoint,while objective response rate(ORR),disease control rate(DCR),and time to progression(TTP)were secondary evaluation indexes.We assessed demographics,irAEs,and outcomes by retrospective review.RESULTS One hundred and forty-three males and 47 females were included in the study.The ORR and DCR were 12.1%(23/190)and 52.1%(99/190),respectively.The median OS was 376 d[95%confidence interval(CI):340-411 d]and the median TTP was 98 d(95%CI:75-124 d).The overall incidence of treatment-related adverse events was 72.6%(138/190)and 10.0%of them were severe irAEs(grade≥3).Child-Pugh B class,portal vein tumor thrombus,extrahepatic metastasis,and hypothyroidism were the independent risk factors for survival.Patients with hypothyroidism showed a longer OS[517 d(95%CI:423-562)vs 431 d(95%CI:412-485),P=0.011]and TTP[125 d(95%CI:89-154)vs 87 d(95%CI:61-98),P=0.004]than those without irAEs.CONCLUSION Pembrolizumab-treated patients with unresectable HCC who experienced hypothyroidism have promising ORR and durable response.Hypothyroidism,an irAE,may be used as a clinical evaluation parameter of response to ICIs in unresectable HCC.

Immune-related adverse events induced by programmed death protein-1 inhibitors from the perspective of lymphoma immunotherapy

Lymphoma,which is highly malignant,stems from lymph nodes and lymphoid tissue.Lymphoma cells express programmed death-ligand 1/2(PD-L1/PD-L2),which binds with programmed cell death 1 protein(PD-1)to establish inhibitory signaling that impedes the normal function of T cells and allows tumor cells to escape immune system surveillance.Recently,immune checkpoint inhibitor immunotherapies such as PD-1 inhibitors(nivolumab and pembrolizumab)have been introduced into the lymphoma treatment algorithm and have shown remarkable clinical efficacy and greatly improve prognosis in lymphoma patients.Accordingly,the number of lymphoma patients who are seeking treatment with PD-1 inhibitors is growing annually,which results in an increasing number of patients developing immune-related adverse events(irAEs).The occurrence of irAEs inevitably affects the benefits provided by immunotherapy,particularly when PD-1 inhibitors are applied.However,the mechanisms and characteristics of irAEs induced by PD-1 inhibitors in lymphoma need further investigation.This review article summarizes the latest research advances in irAEs during treatment of lymphoma with PD-1 inhibitors.A comprehensive understanding of irAEs incurred in immunotherapy can help to achieve better efficacy with PD-1 inhibitors in lymphoma.

Maternal Hospital Mortality in Cotonou: Incidence, Care-Associated Adverse Events and Causes

Introduction: Despite the many efforts made to combat preventable maternal deaths, these still remain high in Benin. It was therefore important to revisit the causes but especially the adverse events associated with care (EIS) in maternity. Objective: Determine the incidence, adverse events associated with care and causes of intra hospital maternal mortality in cotonou. Methods: This was a cross-sectional maternal mortality review study with retrospective data collection. It covered all cases of maternal death recorded between 2017 and 2021 in two (2) reference university maternities in Cotonou. Adverse events associated with care and the patient were analyzed using the maternal death audit grid validated for Benin. SPSS.26 software was used for data analysis. Results: The in-hospital maternal mortality ratio in Cotonou was 2028 maternal deaths per 100,000 live births in 2021. Only 7.2% (n = 36) of deaths were audited. The deceased mothers were 29.8 ± 7.4 years old, with no fixed monthly income in 82.7% (n = 420). Serious adverse events associated with care were: delay in decision to refer in 37% (n = 188), non-medical referral in 85.8% (n = 436) of cases, inadequate pre-referral treatment in 25.7% of cases. In receiving maternities, delay in diagnosis and inappropriate treatment at the receiving maternity were noted respectively in 22.9% and 28.6% of cases of maternal death. The direct causes of maternal death were dominated by serious obstetric hemorrhage in 43.9% (n = 223). As for the indirect causes, they were dominated by anemia excluding obstetric hemorrhages in 21.5% (n = 109). Conclusion: The in-hospital maternal mortality ratio was very high in Cotonou. The main cause was severe obstetric hemorrhage. There were several serious healthcare-associated adverse events whose correct management would significantly reduce the incidence of maternal deaths.

Investigating adverse events in long-term care facilities:a systematized review

Objective:This systematized review aimed to synthesize the results of empirical studies focused on the types and factors of adverse events(AEs)that contribute to them in long-term care(LTC)settings.Methods:The search was conducted in Pro Quest,Scopus,and Pub Med in January 2021 and resulted in 1057 records.The content analysis method was used in the data analysis.Results:In all,35 studies were identified as relevant for the review.The analysis revealed 133 different types of AEs and 60 factors that contributed to them.Conclusions:In LTC,various AEs occur,most of which are preventable,while many factors that influence their occurrence could be significantly modifiable.Through an effective analysis of AEs in LTC,it is possible to minimize their occurrence and,at the same time,minimize their negative impact on all par ties concerned.

Why Don’t We Adequately Identify and Manage Adverse Drug Reactions despite Having the Needed Information?

Importance/Objective: Adverse Drug Reactions (ADRs) are unavoidable, but recognizing and addressing ADRs early can improve wellness and prevent permanent injury. We suggest that available medical information and digital/electronic methods could be used to manage this major healthcare problem for individual patients in real time. Methods: We searched the available digital applications and three literature databases using the medical subject heading terms, adverse drug reaction reporting systems or management, filtered by clinical trial or systemic reviews, to detect publications with data about ADR identification and management approaches. We reviewed the reports that had abstract or summary data or proposed or implemented methods or systems with potential to identify or manage ADRs in clinical settings. Results: The vast majority of the 481 reports used retrospectively collected data for groups of patients or were limited to surveying one population group or class of medication. The reports showed potential and definite associations of ADRs for specific drugs and problems, mostly, but not exclusively, for patients in hospitals and nursing homes. No reports described complete methods to collect comprehensive data on ADRs for individual patients in a healthcare system. The digital applications have ADR information, but all are too cumbersome or incomplete for use in active clinical settings. Several studies suggested that providing information about potential ADRs to clinicians can reduce these problems. Conclusion and Relevance: Although investigators and government agencies agree with the need, there is no comprehensive ADR management program in current use. Informing the patient’s healthcare practitioners of potential ADRs at the point of service has the potential for reduction of these complications, which should improve healthcare and reduce unneeded costs.

An Evaluation of the Adverse Events Following Voluntary Medical Male Circumcision Surveillance System in Zvimba District, Zimbabwe, 2020

Background: The Adverse Events following Voluntary Medical Male Circumcision Surveillance System (VMMC AESS) serves to identify adverse events (AEs) for safe provision of VMMC. In 2019, Zvimba District reported two adverse events out of 542 circumcisions translating to a 0.4% AE rate against an acceptable threshold of 2% and this is suggestive of underreporting. We evaluated the system to verify existence of underreporting of AEs, assess the surveillance system attributes and evaluate data quality. Methods: A descriptive cross-sectional study was conducted using the updated Center for Disease Control (CDC) guidelines for surveillance system evaluation. We proportionately sampled VMMC client intake records and purposively selected health workers involved in the VMMC programme into the study. An interviewer-administered questionnaire was used to collect data from 14 - 30 December 2020 on knowledge of the VMMC AESS among health care workers and surveillance system attributes. We used a checklist to check for data quality. Data were analysed using Epi Info 7 statistical software. Results: Of the 31 health workers that participated in the study, 21 (68%) had fair knowledge of the surveillance system. Out of 384 records reviewed, 104 had missing data on AE monitoring days 7 and 42. Sixteen (52%) of participants regarded filling AE reporting forms as difficult and the process as time-consuming. The surveillance system was not representative as only two out of eight facilities were conducting outreaches in hard-to-reach areas. Conclusion: There was possible underreporting of adverse events as about a quarter of reviewed records had missing data on AE monitoring days and the system’s performance was threatened by poor data quality and unavailability of reporting forms. The system was rendered acceptable though unstable, not representative and not simple and the health workers were not making use of the surveillance system. We recommended retraining on the surveillance system for all health care workers involved in VMMC in Zvimba District.

Adverse events related to colonoscopy: Global trends and future challenges

Colonoscopy is a widely used method for diagnosing and treating colonic disease. The number of colonoscopies is increasing worldwide, and concerns about associated adverse events are growing. Large-scale studies using big data for post-colonoscopy complications have been reported. A colon perforation is a severe complication with a relatively high mortality rate. The perforation rate, as reported in large studies(≥ 50,000 colonoscopies) published since 2000, ranges from 0.005-0.085%. The trend in the overall perforation rate in the past 15 years has not changed significantly. Bleeding is a more common adverse event than perforation. Recent large studies(≥ 50,000 colonoscopies) have reported postcolonoscopy bleeding occurring in 0.001-0.687% of cases. Most studies about adverse events related to colonoscopy were performed in the West, and relatively few studies have been conducted in the East. The incidence of post-colonoscopy complications increases in elderly patients or patients with inflammatory bowel diseases. It is important to use a unified definition and refined data to overcome the limitations of previous studies. In addition, a structured training program for endoscopists and a systematic national management program are needed to reduce post-colonoscopy complications. In this review, we discuss the current trends in colonoscopy related to adverse events, as well as the challenges to be addressed through future research.

Severe adverse events during antiviral therapy in hepatitis C virus cirrhotic patients: A systematic review

AIM: To identify severe adverse events (SAEs) leading to treatment discontinuation that occur during antiviral therapy in hepatitis C virus (HCV)-infected cirrhotic patients. METHODS: We identified all the articles published prior to December 2011 in the PubMed, Medline, Lilacs, Scopus, Ovid, EMBASE, Cochrane and Medscape databases that presented these data in cirrhotic patients. These studies evaluated the rate of SAEs leading to discontinuation of standard care treatment: Pegylated interferon (PegIFN) alpha 2a (135-180 μg/wk) or PegIFN alpha 2b (1 or 1.5 μg/kg per week) and ribavirin (800-1200 mg/d). Patients with genotype 1 + 4 underwent treatment for 48 wk, whereas those with genotypes 2 + 3 were treated for 24 wk.RESULTS: We included 17 papers in this review, comprising of 1133 patients. Treatment was discontinued due to SAEs in 14.5% of the patients. The most common SAEs were: severe thrombocytopenia and/or neutropenia (23.2%), psychiatric disorders (15.5%), decompensation of liver cirrhosis (12.1%) and severe anemia (11.2%). The proportion of patients who needed to discontinue their therapy due to SAEs was significantly higher in patients with Child-Pugh class B and Cvs those with Child-Pugh class A: 22%vs 11.4% (P = 0.003). A similar discontinuation rate was found in cirrhotic patients treated with PegIFN alpha 2a and those treated with PegIFN alpha 2b, in combination with ribavirin: 14.2%vs 13.7% (P = 0.96). The overall sustained virological response rate in cirrhotic patients was 37% (95%CI: 33.5-43.1) but was significantly lower in patients with genotype 1 + 4 than in those with genotype 2 + 3: 20.5% (95%CI: 17.9-24.8) vs 56.5% (95%CI: 51.5-63.2), (P < 0.0001). CONCLUSION: Fourteen point five percent of HCV cirrhotic patients treated with PegIFN and ribavirin needed early discontinuation of therapy due to SAEs, the most common cause being hematological disorders.

Endoscopic retrograde cholangiopancreatography in cirrhosis-a systematic review and meta-analysis focused on adverse events

AIM To investigate indications and outcomes of endoscopic retrograde cholangiopancreatography(ERCP) in cirrhotics, especially adverse events. Patients with cirrhosis undergoing ERCP are believed to have increased risk. However, there is a paucity of literature describing the indications and outcomes of ERCP procedures in patients with cirrhosis, especially focusing on adverse events.METHODS We performed a systematic appraisal of major literature databases, including PubMed and EMBASE, with a manual search of literature from their inception until April 2017.RESULTS A total of 6,505 patients from 15 studies were analyzed(male ratio 59%, mean age 59 years), 11% with alcoholic and 89% with non-alcoholic cirrhosis, with 56.2% Child-Pugh class A, and 43.8% class B or C. Indications for ERCP included choledocholithiasis 60.9%, biliary strictures 26.2%, gallstone pancreatitis 21.1% and cholangitis 15.5%. Types of interventions included endoscopic sphincterotomy 52.7%, biliary stenting 16.7% and biliary dilation 4.6%. Individual adverse events included hemorrhage in 4.58%(95%CI: 2.77-6.75%, I^2 = 85.9%), post-ERCP pancreatitis(PEP) in 3.68%(95%CI: 1.83-6.00%, I^2 = 89.5%), cholangitis in 1.93%(95%CI: 0.63-3.71%, I^2 = 87.1%) and perforation in 0.00%(95%CI: 0.00-0.23%, I^2 = 37.8%). Six studies were used for comparison of ERCPrelated complications in cirrhosis vs non-cirrhosis, which showed higher overall rates of complications in cirrhosis patients with pooled OR of 1.63(95%CI: 1.27-2.09, I2 = 65%): higher rates of hemorrhage with OR of 2.05(95%CI: 1.62-2.58, I^2 = 2.1%) and PEP with OR of 1.33(95%CI: 1.04-1.70, I2=65%), but similar cholangitis rates with OR of 1.23(95%CI: 0.67-2.26, I^2 = 44.3%).CONCLUSION There is an overall higher rate of adverse events related to ERCP in patients with cirrhosis, especially hemorrhage and PEP. A thorough risk/benefit assessment should be performed prior to undertaking ERCP in patients with cirrhosis.

Adverse Respiratory Events Increase Post-anesthesia Care Unit Stay in China:A 2-year Retrospective Matched Cohort Study

Despite growing attention to patients,safety worldwide,no data were available on the impact of adverse respiratory events(AREs)on post-anesthesia care and post-operation care in China.This study evaluated the occurrence of AREs,the impact of AREs on length of stay(LOS)in post-anesthesia care unit(PACU)and postoperative time in hospital,and PACU cost and in patient healthcare costs.A retrospective,matched-cohort study was conducted by prospectively collecting the data of 159 AREs in PACU during 2016-2017 in an university hospital in China.Records were reviewed by pre-trained,qualified nurses and/or anesthesiologists.The incidence and the impact of AREs were analyzed.The LOS in PACU and postoperative time in hospital and the costs in PACU and inpatient healthcare costs were also obtained.Results showed that there were 253 AREs involving 156 patients.Hypoxia(n=141,55.73%)and respiratory depression(n=70,27.67%)were the most common AREs.Measurement data including body mass index(BMI)(22.85±4.36 vs.22.32±3.83),duration of procedure(138.47±77.33 min vs.137.44±72.33 min),duration of anesthesia(176.35±82.66 min vs.174.61±78.08 min),LOS(16.53±10.65 days vs.16.57±9.56 days),inpatient healthcare costs($9465.57±9416.33 vs.$8166.51±5762.01),and postoperative LOS(11.26±8.77 days vs.11.9±8.30 days)showed no significant differences between ARE and matched groups(P<0.05).Duration(81.65±54.79 min vs.38.89±26.09 min)and costs($31.99±17.80 vs.$18.72±8.39)in PACU were significantly different in ARE group from those in matched group(P<0.001).Proportion of patients with prolonged stay in PACU was significantly higher in ARE group than in matched group(18.59%vs.1.28%),with an odds ratio(after matching)of 17.58(95%CI=4.11 to 75.10;P<0.001).The AREs that occurred during the immediate postoperative period in PACU increased the incidence rate of prolonged stay,delayed the PACU stay,and increased the costs in PACU,resulting in the need of higher levels of postoperative care than anticipated,but the postoperative LOS and inpatient healthcare costs were unchanged.

rate of adverse events of gastroduodenal snare polypectomy for non-flat polyp is low: A prospective and multicenter study

AIM To evaluate the rate of adverse events(AEs) during consecutive gastric and duodenal polypectomies in several Spanish centers. METHODS Polypectomies of protruded gastric or duodenal polyps ≥ 5 mm using hot snare were prospectively included. Prophylactic measures of hemorrhage were allowed in predefined cases. AEs were defined and graded according to the lexicon recommended by the American Society for Gastrointestinal Endoscopy. Patients were followed for 48 h, one week and 1 mo after theprocedure. RESULTS308 patients were included and a single polypectomy was performed in 205. Only 36(11.7%) were on prior anticoagulant therapy. Mean polyp size was 15 ± 8.9 mm(5-60) and in 294 cases(95.4%) were located in the stomach. Hemorrhage prophylaxis was performed in 219(71.1%) patients. Nine patients presented AEs(2.9%), and 6 of them were bleeding(n = 6, 1.9%)(in 5 out of 6 AE, different types of endoscopic treatment were performed). Other 24 hemorrhagic episodes could be managed without any change in the outcome of the endoscopy and, consequently, were considered incidents. We did not find any independent risk factor of bleeding.CONCLUSION Gastroduodenal polypectomy using prophylactic measures has a rate of AEs small enough to consider this procedure a safe and effective method for polyp resection independently of the polyp size and location.