The Safety Profile of COVID-19 Vaccines in Patients Diagnosed with Multiple Sclerosis: A Retrospective Observational Study.

In the current COVID-19 pandemic, patients diagnosed with multiple sclerosis (MS) are considered to be one of the highest priority categories, being recognized as extremely vulnerable people. For this reason, mRNA-based COVID-19 vaccines are strongly recommended for these patients. Despite encouraging results on the efficacy and safety profile of mRNA-based COVID-19 vaccines, to date, in frail populations, including patients diagnosed with MS, this information is rather limited. We carried out a retrospective observational study with the aim to evaluate the safety profile of mRNA-based COVID-19 vaccines by retrieving real-life data of MS patients who were treated and vaccinated at the Multiple Sclerosis Center of the Hospital A.O.R.N. A. Cardarelli. Three-hundred and ten medical records of MS patients who received the first dose of the mRNA-based COVID-19 vaccine were retrieved (63% female; mean age: 45.9 years). Of these patients, 288 also received the second dose. All patients received the Pfizer-BioNTech vaccine. Relapsing-Remitting Multiple Sclerosis (RRSM) was the most common form of MS. The Expanded Disability Status Scale (EDSS) values were <3.0 in 70% of patients. The majority of patients received a Disease Modifying Therapy (DMT) during the study period, mainly interferon beta 1-a, dimethyl fumarate, and natalizumab and fingolimod. Overall, 913 AEFIs were identified, of which 539 were after the first dose of the vaccine and 374 after the second dose. The majority of these AEFIs were classified as short-term since they occurred within the first 72 h. The most common identified adverse events were pain at injection site, flu-like symptoms, and headache. Fever was reported more frequently after the second dose than after the first dose. SARS-CoV-2 infection occurred in 3 patients after the first dose. Using historical data of previous years (2017−2020), the relapses' rate during 2021 was found to be lower. Lastly, the results of the multivariable analysis that assessed factors associated with the occurrence of AEFIs revealed a statistical significance for age, sex, and therapy with ocrelizumab (p < 0.05). In conclusion, our results indicated that Pfizer-BioNTech vaccine was safe for MS patients, being associated with AEFIs already detected in the general population. Larger observational studies with longer follow-up and epidemiological studies are strongly needed.

A case study to investigate the impact of overcrowding indices in emergency departments.

BACKGROUND: Emergency department (ED) overcrowding is widespread in hospitals in many countries, causing severe consequences to patient outcomes, staff work and the system, with an overall increase in costs. Therefore, health managers are constantly looking for new preventive and corrective measures to counter this phenomenon. To do this, however, it is necessary to be able to characterize the problem objectively. For this reason, various indices are used in the literature to assess ED crowding. In this work, we explore the use of two of the most widespread crowding indices in an ED of an Italian national hospital, investigate their relationships and discuss their effectiveness. METHODS: In this study, two of the most widely used indices in the literature, the National Emergency Department Overcrowding Scale (NEDOCS) and the Emergency Department Working Index (EDWIN), were analysed to characterize overcrowding in the ED of A.O.R.N. "A. Cardarelli" of Naples, which included 1678 clinical cases. The measurement was taken every 15 minutes for a period of 7 days. RESULTS: The results showed consistency in the use of EDWIN and NEDOCS indices as measures of overcrowding, especially in severe overcrowding conditions. Indeed, in the examined case study, both EDWIN and NEDOCS showed very low rates of occurrence of severe overcrowding (2-3%). In contrast, regarding differences in the estimation of busy to overcrowded ED rates, the EDWIN index proved to be less sensitive in distinguishing these variations in the occupancy of the ED. Furthermore, within the target week considered in the study, the results show that, according to both EDWIN and NEDOCS, higher overcrowding rates occurred during the middle week rather than during the weekend. Finally, a low degree of correlation between the two indices was found. CONCLUSIONS: The effectiveness of both EDWIN and NEDOCS in measuring ED crowding and overcrowding was investigated, and the main differences and relationships in the use of the indices are highlighted. While both indices are useful ED performance metrics, they are not always interchangeable, and their combined use could provide more details in understanding ED dynamics and possibly predicting future critical conditions, thus enhancing ED management.

Physiologic Range of Myocardial Mechano-Energetic Efficiency among Healthy Subjects: Impact of Gender and Age.

BACKGROUND: Myocardial mechano-energetic efficiency (MEE) is the capability of the left ventricle (LV) to convert the chemical energy obtained from the cardiac oxidative metabolism into mechanical work. The aim of present study was to establish normal non-invasive MEE and MEEi reference values. METHODS: In total, 1168 healthy subjects underwent physical examinations, clinical assessment, and standardized transthoracic echocardiographic (TTE) examination. MEE was obtained by TTE as the ratio between stroke volume (SV) and heart rate (HR): MEE = SV/HR [HR expressed in seconds (HR/60)]. Because MEE is highly related to left ventricular mass (LVM), MEE was then divided by LVM with the purpose of obtaining an estimate of energetic expenditure per unit of myocardial mass (i.e., indexed MEE, MEEi, mL/s/g). RESULTS: The mean values of MEE and MEEi in the overall population were 61.09 ± 18.19 mL/s; 0.45 ± 0.14, respectively. In a multivariable analysis, gender, body surface area (BSA), diastolic blood pressure, left atrial volume indexed to BSA, E/e' and tricuspid annular plane systolic excursion (TAPSE) were the independent variables associated with MEE, while age, gender, BSA and TAPSE were the independent variables associated with MEEi. CONCLUSIONS: The knowledge of age- and gender-based MEE and MEEi normal values may improve the global assessment of LV cardiac mechanics and serve as a reference to identify phenotypes at high risk of cardiovascular events.

Lean Management Approach for Reengineering the Hospital Cardiology Consultation Process: A Report from AORN "A. Cardarelli" of Naples.

BACKGROUND: Consultations with specialists are essential for safe and high-quality care for all patients. Cardiology consultations, due to a progressive increase in cardiology comorbidities, are becoming more common in hospitals prior to any type of treatment. The appropriateness and correctness of the request, the waiting time for delivery and the duration of the visit are just a few of the elements that can affect the quality of the process. METHODS: In this work, a Lean approach and Telemedicine are used to optimize the cardiology consultancy process provided by the Cardiology Unit of "Antonio Cardarelli" Hospital of Naples (Italy), the largest hospital in the southern Italy. RESULTS: The application of corrective actions, with the introduction of portable devices and telemedicine, led to a reduction in the percentage of waiting for counseling from 29.6% to 18.3% and an increase in the number of patients treated. CONCLUSIONS: The peculiarity of the study is to apply an innovative methodology such as Lean Thinking in optimizing the cardiology consultancy process, currently little studied in literature, with benefits for both patients and medical staff.

Flu vaccination in multiple sclerosis patients: a monocentric prospective vaccine-vigilance study.

BACKGROUND: In 2020, the Italian Medicines Agency recommended to bring forward the flu vaccination campaign, whose importance was also emphasized for patients with Multiple Sclerosis (MS). We aimed to assess the safety profile of flu vaccines in terms of occurrence of short-term and long-term Adverse Events Following Immunization (AEFIs). METHODS: This is an observational study that enrolled MS patients who were eligible for any of the flu vaccines recommended by the Italian medicines Agency. RESULTS: 194 patients were enrolled. Out of 133 patients who accepted to be vaccinated, 45 experienced not serious short-term AEFIs (pain at the injection site, headache, flu-like symptoms, fatigue). Long-term AEs were detected in 12 vaccinated patients (flu-like symptoms, COVID-19 and MS relapse). No statistically significant differences in terms of infections or MS relapse were found between vaccinated and unvaccinated groups. Using Kaplan-Meier analysis we observed no differences in the cumulative survival rate in both groups. CONCLUSION: Flu vaccines were well tolerated in MS patients, who mainly experienced not serious short term AEFIs. Considering that COVID-19 vaccines campaign is still ongoing among MS patients, our results might bring new knowledge concerning the safety profile of vaccines in this frail population.

Preoperative Assessment and Management of Cardiovascular Risk in Patients Undergoing Non-Cardiac Surgery: Implementing a Systematic Stepwise Approach during the COVID-19 Pandemic Era.

Major adverse cardiac events, defined as death or myocardial infarction, are common causes of perioperative mortality and major morbidity in patients undergoing non-cardiac surgery. Reduction of perioperative cardiovascular risk in relation to non-cardiac surgery requires a stepwise patient evaluation that integrates clinical risk factors, functional status and the estimated stress of the planned surgical procedure. Major guidelines on preoperative cardiovascular risk assessment recommend to establish, firstly, the risk of surgery per se (low, moderate, high) and the related timing (elective vs. urgent/emergent), evaluate the presence of unstable cardiac conditions or a recent coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting), assess the functional capacity of the patient (usually expressed in metabolic equivalents), determine the value of non-invasive and/or invasive cardiovascular testing and then combine these data in estimating perioperative risk for major cardiac adverse events using validated scores (Revised Cardiac Risk Index (RCRI) or National Surgical Quality Improvement Program (NSQIP)). This stepwise approach has the potential to guide clinicians in determining which patients could benefit from cardiovascular therapy and/or coronary artery revascularization before non-cardiac surgery towards decreasing the incidence of perioperative morbidity and mortality. Finally, it should be highlighted that there is a need to implement specific strategies in the 2019 Coronavirus disease (COVID-19) pandemic to minimize the risk of transmission of COVID-19 infection during the preoperative risk assessment process.

Cardiac teleconsulting in the time of COVID-19 global pandemic: The "Antonio Cardarelli" Hospital project.

Dear Editor, Teleconsulting - defined as real-time consultation between doctors by exploiting video conferencing technology over the Internet network - is exponentially being implemented through the western world lastly triggered by COVID-19 pandemic...

Improving performances of the knee replacement surgery process by applying DMAIC principles.

RATIONALE, AIMS, AND OBJECTIVES: The work is a part of a project about the application of the Lean Six Sigma to improve health care processes. A previously published work regarding the hip replacement surgery has shown promising results. Here, we propose an application of the DMAIC (Define, Measure, Analyse, Improve, and Control) cycle to improve quality and reduce costs related to the prosthetic knee replacement surgery by decreasing patients' length of hospital stay (LOS) METHODS: The DMAIC cycle has been adopted to decrease the patients' LOS. The University Hospital "Federico II" of Naples, one of the most important university hospitals in Southern Italy, participated in this study. Data on 148 patients who underwent prosthetic knee replacement between 2010 and 2013 were used. Process mapping, statistical measures, brainstorming activities, and comparative analysis were performed to identify factors influencing LOS and improvement strategies. RESULTS: The study allowed the identification of variables influencing the prolongation of the LOS and the implementation of corrective actions to improve the process of care. The adopted actions reduced the LOS by 42%, from a mean value of 14.2 to 8.3 days (standard deviation also decreased from 5.2 to 2.3 days). CONCLUSIONS: The DMAIC approach has proven to be a helpful strategy ensuring a significant decreasing of the LOS. Furthermore, through its implementation, a significant reduction of the average costs of hospital stay can be achieved. Such a versatile approach could be applied to improve a wide range of health care processes.

The application of Lean Six Sigma methodology to reduce the risk of healthcare-associated infections in surgery departments.

RATIONALE: Nowadays, the monitoring and prevention of healthcare-associated infections (HAIs) is a priority for the healthcare sector. AIMS AND OBJECTIVES: In this article, we report on the application of the Lean Six Sigma (LSS) methodology to reduce the number of patients affected by sentinel bacterial infections who are at risk of HAI. METHODS: The LSS methodology was applied in the general surgery department by using a multidisciplinary team of both physicians and academics. Data on more than 20 000 patients who underwent a wide range of surgical procedures between January 2011 and December 2014 were collected to conduct the study using the departmental information system. The most prevalent sentinel bacteria were determined among the infected patients. The preintervention (January 2011 to December 2012) and postintervention (January 2013 to December 2014) phases were compared to analyze the effects of the methodology implemented. The methodology allowed the identification of variables that influenced the risk of HAIs and the implementation of corrective actions to improve the care process, thereby reducing the percentage of infected patients. RESULTS: The improved process resulted in a 20% reduction in the average number of hospitalization days between preintervention and control phases, and a decrease in the mean (SD) number of days of hospitalization amounted to 36 (15.68), with a data distribution around 3 σ. The LSS is a helpful strategy that ensures a significant decrease in the number of HAIs in patients undergoing surgical interventions. The implementation of this intervention in the general surgery departments resulted in a significant reduction in both the number of hospitalization days and the number of patients affected by HAIs. CONCLUSIONS: This approach, together with other tools for reducing the risk of infection (surveillance, epidemiological guidelines, and training of healthcare personnel), could be applied to redesign and improve a wide range of healthcare processes.