Occurrence of adverse events with arterial catheters and their contributing factors: A cross-sectional study

Calcium homeostasis imbalance is one of the important pathological mechanisms in heart failure. Sarco/endoplasmic reticulum Ca2+-ATPase (SERCA2a), a calcium ATPase on the sarcoplasmic reticulum in cardiac myocytes, is a myocardial systolic-diastolic Ca2 + homeostasis regulating enzyme that is not only involved in cardiac diastole but also indirectly affects cardiac myocyte contraction. SERCA2a expression was found to be decreased in myocardial tissue in heart failure, however, there are few reports on serum SERCA2a expression in patients with heart failure, and this study was designed to investigate whether serum SERCA2a levels are associated with the occurrence of adverse events after discharge in patients hospitalized with heart failure. Patients with heart failure hospitalized in the cardiovascular department of the Second Affiliated Hospital of Guangdong Medical University, China, from July 2018 to July 2019 were included in this study, and serum SERCA2a concentrations were measured; each enrolled patient was followed up by telephone after 6 months (6 ± 1 months) for general post-discharge patient status. The correlation between serum SERCA2a levels and the occurrence of adverse events (death or readmission due to heart failure) after hospital discharge was assessed using multiple analysis and trend analysis. Seventy-one patients with heart failure were finally included in this study, of whom 38 (53.5%) were men and 33 (46.5%) were women (All were postmenopausal women). Multiple analysis revealed no correlation between serum SERCA2a levels and the occurrence of adverse events in the total study population and in male patients, but serum SERCA2a levels were associated with the occurrence of adverse outcome events after hospital discharge in female patients (OR = 1.02, P = .047). Further analysis using a trend analysis yielded a 4.0% increase in the risk of adverse outcomes after hospital discharge for each unit increase in SERCA2a in female patients (OR = 1.04; P = .02), while no significant difference was seen in men. This study suggests that serum SERCA2a levels at admission are associated with the occurrence of post-discharge adverse events in postmenopausal female patients hospitalized with heart failure.

Pakistan ranks 4th among 22 multidrug resistant tuberculosis (MDR-TB) high burden countries. The increasing rate of MDR-TB in Pakistan underscores the importance of effective treatment programs of drug-resistant TB. Clinical management of MDR-TB requires prolonged multidrug regimens that often cause adverse events (AEs). This retrospective case series study include all patients who were enrolled for MDR-TB treatment during January 2014 till April 2015 at Programmatic Management of Drug Resistant TB (PMDT) unit at tertiary care hospital, Lady Reading Hospital (LRH) Peshawar Pakistan. In this study we sought to ascertain the occurrence of treatment related adverse events and factors associated with these events. Here we also examined the frequency of and reasons for changing drug regimens. We further sought to determine whether the occurrence of adverse events negatively impacts the treatment outcome and management of adverse effects without requiring the discontinuation of MDR-TB therapy. At the time of analysis final outcomes of all 200 enrolled patients exist. Among these 52.5% were females and (81.5%) were aged ≤ 44 years. Among study cases 155 (77.2%) experienced at least one adverse event during treatment. The most commonly reported events were psychiatric issues (70%) whereas the less common was skin rashes (7.5%). A change in drug dose due to adverse events occurred in 16.5% cases, while 13.5% cases had at least one drug discontinued temporarily. Younger age and lung cavities at baseline were positive association with occurrence of adverse events. Association was also found between adverse events and treatment outcomes (OR 0.480, 0.236-0.978, p= 0.041). Adverse events were prevalent among MDR-TB patients treated at PMDT-LRH Peshawar. All patients who were younger aged and cavitory lungs should be closely monitored for occurrence of adverse events.

Introduction: Adverse events, safety incidents, and medical errors in healthcare can be avoided only by understanding the causes of their occurrence, and by applying the knowledge gained from the analysis of similar previous events. Since it is known that most adverse events do not originate from a single cause, most important is timely identification of numerous contributory states that can give us the opportunity to define a number of possible solutions to correct process errors and deficiencies in the system itself. The aim of this paper is to investigate the association between functional capacity of elderly living with cardiovascular diseases and the occurrence of adverse events during use of health-care services.Methods: Assessment of functional limitations was done using the Groningen Activity Restriction Scale (GARS). The presence of adverse events was evaluated after interviews with subjects and review of medical records. Differences in continuous numerical values between inpatient and outpatient service users were analyzed by the Mann–Whitney U-test. Spearman’s correlation coefficients of the number of actual adverse events with the presence of restrictions in daily activities were calculated. Fisher’s exact test or Fisher-Freeman-Halton test (in cases of table sizes larger than 2 × 2 format) analyzed the differences in category variables.Results: The total number of adverse events was 30 (10.1% of the total number of subjects), while there were 12 actual adverse events (40.0% of the total number of adverse events). No statistically significant correlation was found between the limitations in performing daily activities and the occurrence of actual adverse events (p = 0.173).Conclusion: The research conducted in this paper showed that the functional capacity of the elderly with chronic disease is not exclusively related with the occurrence of adverse events associated with health-care utilization.

Introduction. Adverse events (AE) in the process of pharmacotherapy can have direct consequences on the health and life of a patient. Factors leading to AE are categorized in human and systematic ones. Among the latter ones, the most important are significant shortages of nursing staff as well as stress, fatigue and the Occupational Burnout Syndrome. Reporting of AE is a crucial pillar of prevention of adverse events in drug administration in nursing. Aim. The aim of the study was to identify and analyse the factors leading to adverse events in the pharmocotherapy process and to present methods of prevention AE. Material and Methods. The research was lead among 100 hospital nurses from Pomeranian region. A research and research questionnaire was based on the study “Attitudes and beliefs of health services about the causes and reporting of treatment errors in the British intensive care unit”. The project was conducted between January to April 2020. Results. Detailed analysis showed that the most important factors influencing the occurrence of adverse events in the drug administration are: nurses shortage (14%), stress and burnout syndrome (11%), incorrect labelling (13%). 85% of medical personnel are convinced that it is essential to monitor the situation of adverse events in drug administration. The Kruskal–Wallis test did not confirm the existence of a relationship between the: occurrence of adverse events in the area of pharmacotherapy and age (K – W = 0; p = 1), level of education (K – W = 3.6328; p = 0.3039) and work experience of the surveyed respondents (K – W = 0.3651484; p = 0.5457). Similarly, no significant relationships were found between the occurrence of adverse events and the department profile (K – W = 0.330; p = 0.5652). Conclusions. The level of education, professional experience and age are not significantly related to making mistakes in the area of drug administration; the factors that significantly affect the occurrence of AD in the area of drug administration are: reduced nursing staff on duty, performing one’s duties under stress and time pressure, insufficient variety of labels on medicinal products; the best method of prevention in the area of drug management and administration is the presence of a reporting and monitoring system; the was the majority of nurses reported the occurrence of a drug-related adverse event to the rest of the therapeutic team. (JNNN 2022;11(2):65–73).

To determine the benefits and harms of corticosteroids compared with placebo, no intervention, or any active comparator (including supportive care or alternate non-pharmacological treatment) in adults with cancer-related fatigue.

Right ventricle dilatation (RVD) is a common complication of non-intubated COVID-19 pneumonia caused by pro-thrombotic pneumonitis, intra-pulmonary shunting, and pulmonary vascular dysfunction. In several pulmonary diseases, RVD is routinely measured on computed tomography pulmonary angiogram (CTPA) by the right ventricle-to-left ventricle (LV) diameter ratio > 1 for predicting adverse events. The aim of the study was to evaluate the association between RVD and the occurrence of adverse events in a cohort of critically ill non-intubated COVID-19 patients. Between February 2020 and February 2022, non-intubated patients admitted to the Amiens University Hospital intensive care unit for COVID-19 pneumonia with CTPA performed within 48 h of admission were included. RVD was defined by an RV/LV diameter ratio greater than one measured on CTPA. The primary outcome was the occurrence of an adverse event (renal replacement therapy, extracorporeal membrane oxygenation, 30-day mortality after ICU admission). Among 181 patients, 62% (n = 112/181) presented RVD. The RV/LV ratio was 1.10 [1.05-1.18] in the RVD group and 0.88 [0.84-0.96] in the non-RVD group (p = 0.001). Adverse clinical events were 30% and identical in the two groups (p = 0.73). In Receiving operative curves (ROC) analysis, the RV/LV ratio measurement failed to identify patients with adverse events. On multivariable Cox analysis, RVD was not associated with adverse events to the contrary to chest tomography severity score > 10 (hazards ratio = 1.70, 95% CI [1.03-2.94]; p = 0.04) and cardiovascular component (> 2) of the SOFA score (HR = 2.93, 95% CI [1.44-5.95], p = 0.003). Right ventricle (RV) dilatation assessed by RV/LV ratio was a common CTPA finding in non-intubated critical patients with COVID-19 pneumonia and was not associated with the occurrence of clinical adverse events.

As orthopaedic surgery moves toward bundled payments, there is growing interest in identifying patients at high risk of early postoperative adverse events. The purpose of this study was to develop and validate a risk-stratification system for the occurrence of early adverse events among patients treated with open reduction and internal fixation (ORIF) for a closed fracture of the ankle. Patients undergoing ORIF for a closed ankle fracture during the period of 2006 to 2017, as documented by the American College of Surgeons National Surgical Quality Improvement Program, were identified. For the 60% of patients randomly selected as the development cohort, multivariate Cox proportional hazards modeling was used to identify factors that were independently associated with the occurrence of adverse events (including events such as reoperation, surgical site infection, and pulmonary embolism). On the basis of these results, a nomogram analysis was used to generate a point-based risk-stratification system. To evaluate the validity of the point-based system, the system was applied to the remaining 40% of patients constituting the validation cohort and tested for its ability to predict adverse events. Of the 7,582 patients in the development cohort, 455 developed an adverse event (estimated adverse event risk of 6%). On the basis of Cox proportional-hazards regression, patients were assigned points for each of the following significant risk factors: +1 point for age of 40 to 59 years, +3 points for age of 60 to 79 years, +5 points for age of ≥80 years, +1 point for female sex, +2 points for chronic obstructive pulmonary disease (COPD), +2 points for insulin-dependent diabetes, +3 points for anemia, and +4 points for end-stage renal disease. The validation cohort included 5,263 patients. Among this second cohort, the risk-stratification system predicted the risk of early adverse events (p < 0.001; Harrell C = 0.697). The occurrence of early adverse events following ORIF for closed ankle fractures was associated with greater age, female sex, COPD, insulin-dependent diabetes, anemia, and end-stage renal disease. We present and validate a simple point-based risk-stratification system to predict the risk of early adverse events. Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Azathioprine is widely used in the treatment of children with inflammatory bowel disease. The occurrence and type of adverse events to azathioprine may be related to thiopurine S-methyltransferase (TPMT) enzyme activity and to inosine triphophate pyrophosphatase (ITPase) deficiency. Investigate frequencies of functional TPMT polymorphisms and ITPA polymorphisms and their association with the occurrence of adverse events during azathioprine therapy in a paediatric inflammatory bowel disease population. Seventy-two azathioprine treated paediatric inflammatory bowel disease patients, 47% girls, mean age 12.5 years (range 6.5-17.5), were assessed for TPMT and ITPA polymorphisms and for adverse events. The relation between polymorphisms and adverse events is evaluated. Of all azathioprine treated patients, 11 experienced an adverse event for which azathioprine was stopped: pancreatitis (n = 4), leucopenia (n = 2) and 'general malaise' (n = 5). Of the 11 patients who stopped azathioprine because of adverse events, 10 had wild-type alleles for all investigated genotypes. Genotyping of ITPA 94C>A polymorphisms showed that two patients were homozygous, both tolerated azathioprine well. No association of functional ITPA and TPMT polymorphisms and the occurrence of azathioprine related adverse events could be detected. Pharmacogenetic assessment prior to thiopurine therapy does not seem warranted.

In patients with diabetes intending to fast, Ramadan, risk assessment, and stratification are essential for an individualized treatment plan. It seems that the new IDF-DAR risk stratification tool (International Diabetes Federation - Diabetes and Ramadan Alliance) has become the primary tool in this setting. This study aims to validate this tool in the Abu Dhabi population. The assessment was performed before Ramadan, followed by an evaluation of any significant outcome after Ramadan through tele-interview and an electronic medical records review. Patients were included if the attending physicians used the tool in the risk assessment of the patients within 6 weeks before Ramadan 1,444 (CE 2022) in the AHS healthcare center. The study included 435 patients. Half (51.7%) were in the low-risk category of the IDF-DAR risk stratification tool, 28.5% were in the moderate-risk category, and 19.8% were in the higher-risk category. Of the total patients, 81.3% fasted during the entire Ramadan period and 18.7% attempted to fast. A total of 14 (3.8%) patients were admitted at least once, and 56 (12.9%) had at least one significant event, including admission to the hospital. Using univariable logistic regression, the occurrence of adverse events was significantly associated with more days not fasted, B = -0.126, p < 0.001, OR = 0.88 (0.839-0.927). Using multivariable logistic regression, and after controlling for all variables studied, other risk factors identified with the occurrence of adverse events in this study were as follows: being in the low-risk category of the DAR risk assessment tool, B = -1.1, OR = 0.34 (0.157-0.744), p = 0.0072; being in the frail category compared to the reference category, the robust category, B = 1.54, OR = 4.6 (1.3-16.6), p = 0.018; and older age B = -0.034, OR = 0.966 (0.938-0.995). There was no significant difference between moderate- and high-risk categories in the occurrence of significant adverse events (SAEs). Similar determinants of fasting were identified during the entire Ramadan period using multivariable logistic regression. According to the IDF-DAR risk assessment, patients with diabetes in the low-risk category had a better outcome than those in the moderate- or high-risk categories regarding SAEs. Another independent risk factor is if the patient is frail, according to the FRAIL scoring.

In long-term treatments or in treatments associated with frequent severe adverse events (AEs) such as those for oncology, it is important to know the probability of occurrence of AEs over time and their severity. However, some patients discontinue treatment and drop out of the clinical trial. Assumption that the drop-outs are non-informative is not always true and are not validated by data. We propose a method of applying competing risk analysis by defining events of 'occurrence of AE' and 'drop-out prior to AE'. We focus on one AE at a time. We distinguish obvious non-informative censoring from other censorings that may not be non-informative. Therefore, our approach does not need an independent assumption for drop-outs. The cumulative incidence function estimator (CIFE) for the AE by severity can be obtained by treating the degree of severity as a competing risk within the AE. We also propose a non-parametric estimator of CIF for sequential occurrence of the same AE by forming a subset of subjects with prior occurrence(s) of the same AE and by applying Wang and Wells' estimator. We give a very simple formulation of the cumulative joint incidence function estimator (CJIFE) for subjects who drop out of the clinical trial after having suffered from the AE at least one time. We evaluate the performance of Pepe's variance estimator for CJIFE with small samples by simulations. We find that it works well with a sample size more than 100. A useful graphical presentation for CIFEs and CJIFE is shown.

Task. The article aims to propose a methodology for risk management through internal control of risks that appear in connection with unfavorable events in the activities of the organization. Managing risk factors associated with the occurrence of events that negatively affect the organization's performance is of great importance in achieving business success. The problem is the lack of a detailed methodology for internal control of risks associated with the occurrence of adverse events. The purpose of this article is to reflect the research conducted on the impact of risks associated with the occurrence of adverse events on the financial condition and solvency of the organization. Model. Based on the research conducted, a methodology for internal control of risks associated with the occurrence of unfavorable events for the organization is proposed. Conclusions. The presented methodology gives an idea of the objects, subjects of internal control and its subject within the framework of the study of risks associated with the occurrence of unfavorable events for the organization. The stages and directions of internal control, as well as tools to manage risks associated with uncertainty, have been developed. Practical significance. The methodology for internal control of risks associated with the occurrence of unfavorable events for the organization will allow in practice to manage risks associated with uncertainty. Originality. New knowledge has been generated about internal control of risks associated with the occurrence of unfavorable events for the organization.

Obesity may be a risk factor for transbronchial lung cryobiopsy-related adverse events in Japanese patients with interstitial lung disease

Hemotherapy services play a key role in attracting donors and providing safe blood to the population. The apheresis platelet collection procedure is a relatively simple, safe and important procedure for increasing the stocks of these services. However, the recruitment and retention of these donors still represent a major challenge. Objective: Evaluating the profile of donors of blood components by apheresis in the Transfusion Unit of Professor Alberto Antunes University Hospital - UFAL, as well as knowing the hematological parameters pre- and post-donation, the occurrence of the main adverse events related to the procedure and the difficulties faced by the donor. Method: This was a cross-sectional observational study. We analyzed a total of 160 forms of apheresis donors from March 2017 to June 2018. The data were tabulated using the Excel program, and then analyzed in order to determinethe objectives. Results: Most donors were male (93.13%), aged between 25 and 40 years (48.75%) and brown (25.62%). There was a slight prevalence of singles (49.37%) and 73.75% were from Maceió. The most prevalent ABO and Rh phenotyping was O+ (39.3%). Most of the procedures were simple platelet collection (75.60%) and the occurrence of adverse events during donations was 30.63%. Conclusion: Evaluation of apheresis donor profile and the knowledge of the possible side effects related to the procedure provided a better understanding of this type of donation and may improve the capture and retention processes of these individuals, minimizing the effects of lack of blood for Alagoana population.

Este estudo objetivou identificar a predisposição à ocorrência de eventos adversos em unidades de terapia intensiva. Trata-se de uma pesquisa descritiva com abordagem quantitativa, transversal, do tipo survey. O estudo foi realizado no Centro de Terapia Intensiva de um hospital de referência do estado do Ceará. A população do estudo foi composta pelos enfermeiros que atuavam na assistência das três UTI adulto. A coleta de dados foi realizada por meio de um instrumento que avalia a predisposição da unidade à eventos adversos por meio da percepção de enfermeiros. O domínio Estrutura obteve uma média percepção de aspectos que podem predispor a ocorrência de eventos adversos. Já o domínio Processo obteve uma baixa percepção de aspectos que podem predispor a ocorrência de eventos adversos. Espera-se que em ambos os domínios obtenham uma baixa percepção de aspectos que possam predispor à ocorrência de eventos adversos. A assistência encontra-se comprometida quanto ao domínio Estrutura, tendo como destaque algumas fragilidades específicas, como a capacitação continuada da equipe de enfermagem, que deve ser reforçada, assim como é necessário a comissão de educação continuada se fazer presente no ambiente da assistência, principalmente no CTI. Quanto aos aspectos de processo presentes na assistência, de um modo geral, os enfermeiros mostraram uma baixa percepção da presença de tais aspectos que pudessem predispor à ocorrência de eventos adversos. Desta forma, deve-se fortalecer aspectos de processo.

Although general hospitals receive nearly 60% of all inpatient psychiatric admissions, little is known about the care environment and related adverse events. The purpose of this study was to determine the occurrence of adverse events and examine the extent to which organizing factors of inpatient psychiatric care environments were associated with the occurrence of these events. The events examined were wrong medication, patient falls with injuries, complaints from patients and families, work-related staff injuries, and verbal abuse directed toward nurses. This cross-sectional study used data from a 1999 nurse survey linked with hospital data. Nurse surveys from 353 psychiatric registered nurses working in 67 Pennsylvania general hospitals provided information on nurse characteristics, organizational factors, and the occurrence of adverse events. Linear regression models and robust clustering methods at the hospital level were used to study the relationship of organizational factors of psychiatric care environments and adverse event outcomes. Verbal abuse toward registered nurses (79%), complaints (61%), patient falls with injuries (44%), and work-related injuries (39%) were frequent occurrences. Better management skill was associated with fewer patient falls and fewer work-related injuries to staff. In addition, fewer occurrences of staff injuries were associated with better nurse-physician relationship and lower patient-to-nurse staffing ratios. Adverse events are frequent for inpatient psychiatric care in general hospitals, and organizational factors of care environments are associated with adverse event outcomes. Further development of evidence-based quality and safety monitoring of inpatient psychiatric care in general hospitals is imperative.