Administration Criteria Research Articles

Correct patient identification and matching of adults in an ambulatory care setting: a best practice implementation project.

Ambulatory care settings are at high risk for errors when identifying patients and matching them to their intended care. The objective of this project was to improve correct and consistent patient identification and matching to their intended care by nurses in ambulatory care settings. The seven-phase JBI Evidence Implementation Framework was used to guide this project. JBI tools were used to audit current practices and implement best practices in four ambulatory care units. The implementation plan included a baseline audit and two follow-up audits. Feedback was obtained through interviews with ambulatory care nursing staff, educational sessions were conducted for nursing staff, and unit guidelines were developed. In the baseline audit, compliance with best practice criteria for patient matching and identification was below 62% for 7/13 criteria. After conducting education sessions and other strategies, 1/3 pre- and post-clinical intervention criteria improved in compliance, while 2 were unchanged. For blood product administration criteria, 2/5 improved, 1 was unchanged, and 2 were lower than baseline. Nurses' education in patient identification procedures improved (1/1) and knowing where to access relevant policies remained unchanged at 100%. Criteria for patients knowing the importance of patient identification (2/2) and the identification band following national standards (1/1) improved from baseline. The results support the use of education sessions and infrastructure changes to promote and sustain change in evidence-based practice in ambulatory care units. Not all criteria improved, and the audit team identified strategies to improve the implementation of evidence-based practice in ambulatory care units. http://links.lww.com/IJEBH/A275.

1233P Genomic scarring score as a criterion for PARP inhibitor administration in early-stage NSCLC

1233P Genomic scarring score as a criterion for PARP inhibitor administration in early-stage NSCLC

A pooled analysis of trastuzumab deruxtecan in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer with brain metastases

This exploratory pooled analysis investigated the efficacy and safety of trastuzumab deruxtecan (T-DXd) versus comparator treatment in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (mBC) with brain metastases (BMs) at baseline, categorized according to previous local treatment. T-DXd data were pooled from DESTINY-Breast01/-02/-03. Comparator data, from patients receiving physician's choice therapy and trastuzumab emtansine, were pooled from DESTINY-Breast02 and -03, respectively. Baseline BM status was assessed according to US Food and Drug Administration criteria. The endpoints included intracranial objective response rate (ORR; complete or partial response in the brain) per blinded independent central review (BICR) by RECIST version 1.1, time to intracranial response, intracranial duration of response (DoR), central nervous system progression-free survival (CNS-PFS) by BICR, overall survival (OS), and safety. A total of 148 patients who received T-DXd and 83 patients who received comparator treatment had BMs at baseline. In those treated with T-DXd, the intracranial ORR of patients with treated/stable and untreated/active BMs was 45.2% and 45.5%, respectively. The median (range) time to intracranial response was 2.8 months (1.1-13.9 months) and 1.5 months (1.2-13.7 months) in patients with treated/stable and untreated/active BMs, respectively. For those with treated/stable BMs, the median intracranial DoR was 12.3 [95% confidence interval (CI) 9.1-17.9] months, and for those with untreated/active BMs, it was 17.5 months (95% CI 13.6-31.6 months). The median CNS-PFS and OS were 12.3 months (95% CI 11.1-13.8 months) and not reached (95% CI 22.1 months-not estimable) in those with treated/stable BMs, and 18.5 months (95% CI 13.6-23.3 months) and 30.2 months (95% CI 21.3 months-not estimable) in those with untreated/active BMs, respectively. Drug-related treatment-emergent adverse events grade ≥3 were experienced by 43.2% of patients with BMs and 46.4% without BMs with T-DXd. T-DXd demonstrated meaningful intracranial efficacy and clinical benefit in OS, with an acceptable and manageable safety profile in patients with HER2-positive mBC with treated/stable and untreated/active BMs.

Long-term outcomes of bladder-sparing therapy vs radical cystectomy in BCG-unresponsive non-muscle-invasive bladder cancer.

To quantify the oncological risks of bladder-sparing therapy (BST) in patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) compared to upfront radical cystectomy (RC). Pre-specified data elements were collected from retrospective cohorts of patients with BCG-unresponsive NMIBC from 10 international sites. After Institutional Review Board approval, patients were included if they had BCG-unresponsive NMIBC meeting United States Food and Drug Administration criteria. Oncological outcomes were collected following upfront RC or BST. BST regimens included re-resection or surveillance only, repeat BCG, intravesical chemotherapy, systemic immunotherapy, and clinical trials. Among 578 patients, 28% underwent upfront RC and 72% received BST. The median (interquartile range) follow-up was 50 (20-69) months. There were no statistically significant differences in metastasis-free survival, cancer-specific survival, or overall survival between treatment groups. In the BST group, high-grade recurrence rates were 37% and 52% at 12 and 24 months and progression to MIBC was observed in 7% and 13% at 12 and 24 months, respectively. RC was performed in 31.7% in the BST group and nodal disease was found in 13% compared with 4% in upfront RC (P = 0.030). In a selected cohort of patients, initial BST offers comparable survival outcomes to upfront RC in the intermediate term. Rates of recurrence and progression increase over time especially in patients treated with additional lines of BST.

Advancing Tau PET Quantification in Alzheimer Disease with Machine Learning: Introducing THETA, a Novel Tau Summary Measure.

Alzheimer disease (AD) exhibits spatially heterogeneous 3- or 4-repeat tau deposition across participants. Our overall goal was to develop an automated method to quantify the heterogeneous burden of tau deposition into a single number that would be clinically useful. Methods: We used tau PET scans from 3 independent cohorts: the Mayo Clinic Study of Aging and Alzheimer's Disease Research Center (Mayo, n = 1,290), the Alzheimer's Disease Neuroimaging Initiative (ADNI, n = 831), and the Open Access Series of Imaging Studies (OASIS-3, n = 430). A machine learning binary classification model was trained on Mayo data and validated on ADNI and OASIS-3 with the goal of predicting visual tau positivity (as determined by 3 raters following Food and Drug Administration criteria for 18F-flortaucipir). The machine learning model used region-specific SUV ratios scaled to cerebellar crus uptake. We estimated feature contributions based on an artificial intelligence-explainable method (Shapley additive explanations) and formulated a global tau summary measure, Tau Heterogeneity Evaluation in Alzheimer's Disease (THETA) score, using SUV ratios and Shapley additive explanations for each participant. We compared the performance of THETA with that of commonly used meta-regions of interest (ROIs) using the Mini-Mental State Examination, the Clinical Dementia Rating-Sum of Boxes, clinical diagnosis, and histopathologic staging. Results: The model achieved a balanced accuracy of 95% on the Mayo test set and at least 87% on the validation sets. It classified tau-positive and -negative participants with an AUC of 1.00, 0.96, and 0.94 on the Mayo, ADNI, and OASIS-3 cohorts, respectively. Across all cohorts, THETA showed a better correlation with the Mini-Mental State Examination and the Clinical Dementia Rating-Sum of Boxes (ρ ≥ 0.45, P < 0.05) than did meta-ROIs (ρ < 0.44, P < 0.05) and discriminated between participants who were cognitively unimpaired and those who had mild cognitive impairment with an effect size of 10.09, compared with an effect size of 3.08 for meta-ROIs. Conclusion: Our proposed approach identifies positive tau PET scans and provides a quantitative summary measure, THETA, that effectively captures heterogeneous tau deposition observed in AD. The application of THETA for quantifying tau PET in AD exhibits great potential.

Auxological Status of Modern Primary School Students of Nizhny Novgorod Region

The article describes the characteristics of the resulting effector auxological morpho-functional status of primary school students, differentiated by gender and administrative-territorial characteristics. The objectives of the study included studying the auxological status of children adolescents, and primary school students in the Nizhny Novgorod region in the context of the peculiarities of the exoenvironment of residence in urban and rural areas. Materials and methods: Own data served as a source of anthropometry and physiometry indicators of the objective population of the region. The analysis of anthropological indicators was carried out by discretizing data sets that state an objective picture of auxological indicators at the regional level, taking into account the peculiarities of anthropogenic loads characteristic of the place of residence of the observed population groups. To quantify the values ​​and statistical differences in indicators by age, gender, and administrative characteristics, the median, standard deviation, and criteria were used: Fisher, Wilks, and Mahalanobis, with an error of differences at p &lt; 0.05. Results: The stability of the age-sex evolution of auxological indicators is shown; the age-sex and territorial dimorphism of total body sizes is shown at 7-10 years of age, with residents of rural areas lagging in the observed indicators. Hemodynamic indicators in both boys and girls significantly prevail among students living in the metropolis relative to their rural counterparts, except diastolic blood pressure. Variance analytics shows differences in the distributions of anthropometry and hemodynamics, both by age and by the urbanization factor at p &lt; 0.001. In the observed age period, at the initial stage, hemodynamic indicators act primarily as modifiers of the metropolis and rural groups. From the age of ten, according to the standardized coefficients of discriminant functions, according to the first canonical variable, the division of series also occurs according to anthropometric characteristics, among which the greatest contribution to the division of groups is made by body weight and body length, and the hemodynamic characteristic - diastolic blood pressure - has also proven to be decisive. Conclusion: Primary school students living in rural areas and in the metropolis of the Nizhny Novgorod region determine the observed indicators ambiguously; if residents of the metropolis state greater results for all observed auxological indicators, then rural peers demonstrate, while lagging in all observed indicators, greater indicators of diastolic blood pressure, which suggests a strain on adaptation mechanisms central character.

Eligibility for vericiguat in a real-world, contemporary heart failure population.

Vericiguat is a soluble guanylate cyclase stimulator and improves survival in patients with heart failure (HF) with reduced ejection fraction (HFrEF) and an increased risk of decompensation. As real-world data on how many patients could be eligible for vericiguat therapy derive from outdated registries, we aimed to assess eligibility in a prospective cohort of patients with HF. Data from consecutive HF patients undergoing an elective ambulatory visit at five university hospitals from 3 July to 28 July 2023 were collected. Independent investigators assessed which patients (i) met the eligibility criteria of the VICTORIA trial, (ii) complied with HF guideline recommendations, (iii) met regulatory agency criteria, or (iv) met criteria for refundability according to the Italian regulatory agency. Patients (n=346, 72% men, median age 69years) had HFrEF in 57% of cases, left ventricular ejection fraction<45% in 68%, and New York Heart Association class II-IV symptoms in 76%. Patients meeting the eligibility criteria of the VICTORIA trial or European and American HF Guideline recommendations were 9% and 13%, respectively. Patients meeting Food and Drug Administration (FDA) or European Medicines Agency (EMA) label criteria were 19% and 17%, respectively. Drug costs would be covered by the Italian National Health System in 10% of patients [if a sodium-glucose cotransporter-2 inhibitor (SGLT2i) is not mandatory] or in 8% (if an SGLT2i is requested). In a real-world study, 9% of patients met the eligibility criteria of the VICTORIA trial, but up to 13% complied with guideline recommendations and up to 19% met FDA or EMA criteria. In Italy, drug costs would be covered by up to 10% of patients.

Psychothérapie assistée par psychédéliques (PAP) : le modèle genevois

BackgroundIn this article, we aim to describe an interdisciplinary model for psychedelic assisted psychotherapy (PAP) that we have developed at the Geneva University Hospitals, in an institutional setting. Our model integrates the collaborative efforts of psychiatrists, psychologists, and nurses establishing a structured framework for administering PAP in a safe, controlled, and standardized manner. IntroductionPsychedelic assisted psychotherapy (PAP) is a psychotherapeutic approach that utilizes the profound alteration of the state of consciousness induced by psychedelic substances to enhance therapeutic outcomes. This innovative approach, which has been neglected due to historical biases rather than empirical evidence, is now experiencing a renewed interest among clinicians. Contemporary research, equipped with advanced methodologies and a rigorous scientific approach, is showing significant therapeutic potential for a range of mental health disorders. In Switzerland, the legal framework authorizes the medicinal use since 2014 for exceptional authorizations for the medicinal use of LSD and psilocybin for therapeutic purposes, under strict regulations. MethodWe provide a comprehensive description of the PAP protocol implemented at the Geneva University Hospitals, beginning with its inception in September 2020. Our methodological outline includes the administrative and clinical selection criteria for patient eligibility; the preparatory sessions designed to introduce the patients with psychoeducation interventions and the analysis of intention and therapeutical objectives; the controlled administration of psychedelics in a supportive environment; and the integration sessions that follow psychedelic experiences. Our protocol emphasizes safety, ethical considerations, and the importance of a supportive therapeutic relationship throughout the process. We also describe questionnaires we use to qualify and assess the alteration in the state of consciousness, namely The Five Dimension Altered States of Consciousness (5AD-ASC) and the Mystical Experience Questionnaire (MEQ). Since the start of the program in September 2020 and up to February 2024, a total of 224 personal authorizations (114 LSD, 110 Psilocybin) have been issued to the Geneva University Hospital PAP team, for a total of 396 individual sessions. DiscussionThe core argument presented in this article is that the psychedelic-induced alteration of consciousness is a novel therapeutic tool, which works as a potent catalyst that can be synergistically combined with traditional dialogue-based psychotherapy. This combination has the potential to support the psychotherapeutic processes and enable breakthroughs in cases where conventional therapy has reached its limits. We discuss the implications of this approach, reflecting on both its challenges and its transformative potential within its clinical application. ConclusionThe conclusion of our article is an endorsement of the continued basic and clinical research on PAP. By presenting a detailed framework of the PAP process, including its preparatory, experiential, and integrative phases, we advocate for a structured and scientifically grounded exploration of its therapeutic efficacy. Our conclusion calls for a broader acceptance and integration of PAP within clinical practice, provided it is underpinned by ongoing research, ethical practice, and institutional support.

Navigating the future of Alzheimer’s care in Ireland - a service model for disease-modifying therapies in small and medium-sized healthcare systems

BackgroundA new class of antibody-based drug therapy with the potential for disease modification is now available for Alzheimer’s disease (AD). However, the complexity of drug eligibility, administration, cost, and safety of such disease modifying therapies (DMTs) necessitates adopting new treatment and care pathways. A working group was convened in Ireland to consider the implications of, and health system readiness for, DMTs for AD, and to describe a service model for the detection, diagnosis, and management of early AD in the Irish context, providing a template for similar small-medium sized healthcare systems.MethodsA series of facilitated workshops with a multidisciplinary working group, including Patient and Public Involvement (PPI) members, were undertaken. This informed a series of recommendations for the implementation of new DMTs using an evidence-based conceptual framework for health system readiness based on [1] material resources and structures and [2] human and institutional relationships, values, and norms.ResultsWe describe a hub-and-spoke model, which utilises the existing dementia care ecosystem as outlined in Ireland’s Model of Care for Dementia, with Regional Specialist Memory Services (RSMS) acting as central hubs and Memory Assessment and Support Services (MASS) functioning as spokes for less central areas. We provide criteria for DMT referral, eligibility, administration, and ongoing monitoring.ConclusionsHealthcare systems worldwide are acknowledging the need for advanced clinical pathways for AD, driven by better diagnostics and the emergence of DMTs. Despite facing significant challenges in integrating DMTs into existing care models, the potential for overcoming challenges exists through increased funding, resources, and the development of a structured national treatment network, as proposed in Ireland’s Model of Care for Dementia. This approach offers a replicable blueprint for other healthcare systems with similar scale and complexity.

Application of the acquis in the case-law of a non-member state of the European Union - the case of the Republic of Moldova

Accession to the European Union implies respect for democracy, human rights and European values, as well as meeting political, economic and administrative criteria. The European Council approved the opening of accession negotiations with the Republic of Moldova in December 2023, and the latter must implement far-reaching reforms and legislative changes to align with European standards and the Union acquis. In this article, the national case-law developed by the Constitutional Court and the Supreme Court of Justice in the field of application of European Union law and accession to her values is reflected and analysed. Although the application of the acquis was not an obligation of the state, formally speaking, given that it is not yet a member of the European Union, this fact shows, however, the clear direction of European integration of the Republic of Moldova.

A Guide to the Clinical Management of Vipera Snakebite in Italy.

The genus Vipera encompasses most species of medically significant venomous snakes of Europe, with Italy harbouring four of them. Envenomation by European vipers can result in severe consequences, but underreporting and the absence of standardised clinical protocols hinder effective snakebite management. This study provides an updated, detailed set of guidelines for the management and treatment of Vipera snakebite tailored for Italian clinicians. It includes taxonomic keys for snake identification, insights into viper venom composition, and recommendations for clinical management. Emphasis is placed on quick and reliable identification of medically relevant snake species, along with appropriate first aid measures. Criteria for antivenom administration are outlined, as well as indications on managing potential side effects. While the protocol is specific to Italy, its methodology can potentially be adapted for other European countries, depending on local resources. The promotion of comprehensive data collection and collaboration among Poison Control Centres is advocated to optimise envenomation management protocols and improve the reporting of epidemiological data concerning snakebite at the country level.

Simultaneous Quantification of Vancomycin, Linezolid and Voriconazole in Human Plasma by UHPLC-MS/MS: Application in Therapeutic Drug Monitoring.

Individual differences challenge the treatment of vancomycin, linezolid and voriconazole in severe infections. This study aimed to build a simple and economical method for simultaneous determination of the three antibiotics in human plasma by ultra-high performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS) and provided a reference for therapeutic drug monitoring (TDM) of infected patients. The plasma samples were precipitated by acetonitrile and detected and separated on a shim-pack GIST C18 column following the gradient elution within 5min. Mass quantification was performed on multiple reaction monitoring mode under positive electrospray ionization. The linear ranges of vancomycin, linezolid and voriconazole were 1.00-100.00, 0.10-15.00 and 0.10-20.00μg·mL-1, respectively, with good linearity (R2 > 0.99). The accuracy and precision, matrix effect, extraction recovery and stability were validated, and the results all meet the acceptance criteria of China Food and Drug Administration (CFDA) guidelines. The UHPLC-MS/MS method was established and validated for the simultaneous determination of vancomycin, linezolid and voriconazole in human plasma and successfully applied to routine TDM for individualized treatment.

Extensive Macular Atrophy with Pseudodrusen-like appearance: Progression Kinetics and Late-Stage Findings

To describe the clinical outcome and late-stage findings of extensive macular atrophy with pseudodrusen-like appearance (EMAP). Retrospective cohort study. Seventy-eight patients (156 eyes) affected by EMAP. We collected data on best-corrected visual acuity, kinetic perimetry, OCT, short-wavelength autofluorescence, and near-infrared autofluorescence findings. Genetic testing for the TIMP3 and C1QTNF5 genes was performed via Sanger sequencing for 58 patients, with no pathogenic variants identified. The primary outcomes were best-corrected visual acuity at the last examination, visual field at the last examination, and incidence rates and time-to-event curves for blindness with the United States Social Security Administration and World Health Organization (WHO) criteria, foveal involvement, and atrophy enlargement beyond the 30° and 55° field of view. Imaging findings at the last examination were secondary outcomes. At the most recent visit, mean age was 70.9 ± 5.2 years. Using United States criteria, 58.1% of the patients were blind, and 25.8% were blind according to WHO criteria. All eyes showed large central scotomas, which were associated with visual field constriction in 22.2% of eyes. We detected focal openings or large dehiscences of Bruch's membrane (BM) in 25.4% of eyes. Near-infrared autofluorescence showed increased visibility of the choroidal vessels beyond the atrophy in 87.2% of eyes. The incidence rates for blindness were 3.95 per 100 patient-years with United States criteria and 1.54 per 100 patient-years according to WHO criteria. The incidence rates were 22.8 per 100 eye-years for foveal involvement, 12.0 per 100 eye-years for atrophy enlargement beyond 30°, and 6.6 per 100 eye-years for atrophy enlargement beyond 55°. The estimates were not influenced by the age at onset. We identified characteristic imaging findings, including BM ruptures, in elder patients with EMAP and calculated incidence rates for different functional and anatomic outcomes. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Statistical estimation of noise induced hearing loss among the drivers in one of the most polluted cities of India

In the present study, an attempt has been made to assess the impact of vehicular noise upon the 3-wheeler tempo drivers and to know whether there is any relationship between hearing loss and cumulative noise exposure. For this purpose, 3-wheeler tempo drivers (Exposed group) and non-commercial light motor vehicle car drivers (Unexposed group) were chosen as study subjects. Three traffic routes were selected to assess the noise level during waiting and running time in the exposed and unexposed groups. Among all three routes, the highest mean noise level (Leq) was observed on the Chowk to Dubagga route for waiting and en-route noise measurement. It was measured as 84.13 dB(A) and 86.36 dB(A) for waiting and en-route periods of 7.68 ± 3.46 and 31.05 ± 6.6 min, respectively. Cumulative noise exposure was found to be significantly different (p < 0.001) in all age groups of exposed and unexposed drivers. Audiometric tests have been performed over both exposed and unexposed groups. The regression analysis has been done keeping hearing loss among tempo drivers as the dependent variable and age (years) and Energy (Pa2 Hrs) as the independent variable using three different criteria of hearing loss definitions, i.e., World Health Organization, National Institute for Occupational Safety and Health (NIOSH), Occupational Safety and Health Administration criteria. Among these three criteria, the NIOSH criterion of hearing loss best explained the independent variables. It could explain the total variation in dependent variable by independent variable quite well, i.e., 68.1%. The finding showed a linear relationship between cumulative noise exposures (Pa2 Hrs) and the exposed group's hearing loss (dB), i.e., hearing loss increases with increasing noise dose. Based on the findings, two model equations were developed to identify the safe and unsafe noise levels with exposure time.

Adapting prescribing criteria for amyloid-targeted antibodies for adults with Down syndrome.

Prior authorization criteria for Federal Drug Administration (FDA) approved immunotherapeutics, among the class of anti-amyloid monoclonal antibodies (mAbs), established by state drug formulary committees, are tailored for adults with late-onset Alzheimer's disease. This overlooks adults with Down syndrome (DS), who often experience dementia at a younger age and with different diagnostic assessment outcomes. This exclusion may deny DS adults access to potential disease-modifying treatments. To address this issue, an international expert panel convened to establish adaptations of prescribing criteria suitable for DS patients and parameters for access to Centers for Medicare & Medicaid Services (CMS) registries. The panel proposed mitigating disparities by modifying CMS and payer criteria to account for younger onset age, using alternative language and assessment instruments validated for cognitive decline in the DS population. The panel also recommended enhancing prescribing clinicians' diagnostic capabilities for DS and initiated awareness-raising activities within healthcare organizations. These efforts facilitated discussions with federal officials, aimed at achieving equity in access to anti-amyloid immunotherapeutics, with implications for national authorities worldwide evaluating these and other new disease-modifying therapeutics for Alzheimer's disease.

Current progress towards prevention of Nipah and Hendra disease in humans: A scoping review of vaccine and monoclonal antibody candidates being evaluated in clinical trials.

Nipah and Hendra are deadly zoonotic diseases with pandemic potential. To date, no human vaccine or monoclonal antibody (mAb) has been licensed to prevent disease caused by these pathogens. The aim of this scoping review was to identify and describe all Phase I, II, and III clinical trials of vaccine candidates or mAbs candidates designed to prevent Nipah and Hendra in humans and to compare the characteristics of the vaccine candidates to characteristics outlined in the Target Product Profiledrafted by the World Health Organisation as part of the WHO Research & Development Blueprint for Action to Prevent Epidemics. We searched 23 clinical trial registries, the Cochrane Central Register of Clinical Trials, and grey literature up to June 2023 to identify vaccine and mAb candidates being evaluated in registered clinical trials. Vaccine candidate and trial characteristics were double-extracted for evaluation and the vaccine candidate characteristics were compared with the preferred and critical criteria of the World Health Organisation's Target Product Profile for Nipah virus vaccine. Three vaccine candidates (Hendra Virus Soluble Glycoprotein Vaccine [HeV-sG-V], PHV02, and mRNA-1215) and one mAb (m102.4) had a registered human clinical trial by June 2023. All trials were phase 1, dose-ranging trials taking place in the United States of America or Australia and enrolling healthy adults. Although all vaccine candidates meet the dose regimen and route of administration criteria of the Target Product Profile, other criteria such as measures of efficacy and reactogenicity will need to be evaluated in the future as evidence becomes available. Multiple vaccine candidates and one mAb candidate have reached the stage of human clinical trials and are reviewed here. Monitoring progress during evaluation of these candidates and candidates entering clinical trials in the future can help highlight many of the challenges that remain.

Abstract WP20: Hemorrhagic Conversion Patterns After Stroke Thrombolysis With Alteplase versus Tenecteplase Real-World Experience

Importance: Tenecteplase use is more prevalent as the thrombolytic drug of choice for acute ischemic stroke, with results demonstrating its non-inferiority compared to alteplase. However, there is conflicting data regarding intracranial hemorrhage risk. Objective: To determine the rate of symptomatic intracranial hemorrhage in ischemic stroke patients after thrombolysis with either tenecteplase or alteplase. Design: Retrospective cohort study. Setting: 15 Texas stroke centers. Participants: 431 patients that were eligible for thrombolytic therapy, and received either tenecteplase or alteplase. Exposure: Data was collected 90 days before and after the stroke center changed from alteplase to tenecteplase. Main Outcomes: Primary endpoint was to compare the incidence of sICH according to SITS-MOST/ECASS-3 criteria in the alteplase and tenecteplase groups. Secondary endpoint included the radiographic pattern of hemorrhagic conversion according to the Heidelberg bleeding classification (HBC). Results: Median age was 62.94 for alteplase and 64.45 for tenecteplase, females represented half of each cohort:110 for alteplase and 117 for tenecteplase. Half of patients received alteplase (n=216), 174 (81%) received alteplase within 3 hours versus 176 (82%) for tenecteplase. Endovascular thrombectomy was attempted in 34 patients (15%) receiving alteplase versus 26 patients (12%) receiving tenecteplase. 7 patients in the alteplase group (3.2%) and 14 (6.5%) in the tenecteplase group had sICH, with an odds ratio of 1.44 (95% CI 0.60-3.43; P=0.41). A higher NIHSS score on arrival (1.06; 95% CI 1.0004-1.131; P=0.04) was a statistically significant predictor of sICH. A two-sample proportion test on tenecteplase produced a statistically significant increase in HBC class 3 (P=0.040) over alteplase. Conclusions and Relevance: An increased rate of sICH was observed with a statistically significant increase in HBC class 3 with tenecteplase administration compared to alteplase. Suggested mechanisms of bleeding are hemorrhagic conversion in clinically silent infarcts and contusions underlying the lesions. This suggests a potential need to reevaluate the criteria for tenecteplase administration. Larger studies are required to confirm this data.

Analysis of the Marketing and Claims of Online Pharmacies: A Focus on Administrative, Regulatory and Content Criteria

Analysis of the Marketing and Claims of Online Pharmacies: A Focus on Administrative, Regulatory and Content Criteria

Two-year audit of compliance in the preparation and administration of medications by nursing staff in a mother-and-child university hospital center

ObjectiveAudits are essential for reviewing and improving the medication-use process. Identifying areas for improvement can limit the risk of errors when preparing and administering drugs. Pediatric centers face specific challenges in ensuring the safety of the medication-use process. The objective of this study was to observe and compare compliance with criteria for the preparation and administration of medications by nurses in a mother-and-child university hospital center over two consecutive years. MethodsThis observational cross-sectional study was conducted in a Canadian mother-and-child university hospital center. Audits were conducted over a 1-month period in 16 and 18 nursing care sectors in 2021 and 2022, respectively. The standardized audit evaluated compliance with prespecified criteria related to the preparation and administration of medication by nursing staff (77 criteria for 2021 and 82 criteria for 2022). The auditors comprised nurses and a pharmacist trained by the research team. Compliance was compared between years and assessed through a chi-square test. ResultsThe audit consisted of 522 observations in 2021 and 448 observations in 2022. Overall compliance was 76% in 2021 and 66% in 2022. The compliance rate by criterion ranged from 16% to 100%. In 2021 and 2022, 51 (84%) and 52 (87%) of the criteria, respectively, had compliance rates of more than 75%, and 12 (20%) and eight (13%), respectively, had 100% compliance. There were statistically significant decreases in compliance for nine of the 39 criteria for preparation of medications, notably prior hand hygiene (91%% vs. 84%, p = 0.002), and for six of the 17 criteria for administration of medications, including mentioning possible adverse effects to the patient (41% vs- 30%, p = 0.008). ConclusionIn this study, compliance was over 75% for most of the criteria. However, for a few criteria, we observed a decrease in compliance from 2021 to 2022. Various hypotheses are proposed to explain these decreases, such as the COVID-19 pandemic.

Adverse Events of Peripherally Administered Norepinephrine During Surgery: A Prospective Multicenter Study.

Perioperative treatment of hypotension by intravenous administration of norepinephrine in a peripheral vein can lead to adverse events, for example, tissue necrosis. However, the incidence and severity of adverse events during perioperative administration are unknown. This was a prospective observational study conducted at 3 Swedish hospitals from 2019 to 2022. A total of 1004 patients undergoing surgery, who met the criteria for perioperative peripheral norepinephrine administration, were included. The infusion site was inspected regularly. If swelling or paleness of skin was detected, the infusion site was changed to a different peripheral line. Systolic blood pressure and pulse frequency were monitored during the infusion time and defined as adverse events at >220 mm Hg and <40 beats•min -1 . In case of adverse events, patients were observed for up to 48 hours. The primary outcome was prevalence of extravasation, defined as swelling around the infusion site. Secondary outcomes were all types of adverse events and associations between predefined clinical variables and risk of adverse events. We observed 2.3% (95% confidence interval [CI], 1.4%-3.2%) extravasation of infusion and 0.9% (95% CI, 0.4%-1.7%) bradycardia. No cases of tissue necrosis or severe hypertension were detected. All adverse events had dissipated spontaneously within 48 hours. Proximal catheter placement was associated with more adverse events. Extravasation of peripherally administrated norepinephrine in the perioperative period occurred at similar rates as in previous studies in critically ill patients. In our setting, where we regularly inspected the infusion site and shifted site in case of swelling or paleness of skin, we observed no case of severe adverse events. Given that severe adverse events were absent, the potential benefit of this preventive approach requires confirmation in a larger population.