Il Registro Tumori Infantili della Regione Campania: qualità dei dati e incidenza oncologica nei bambini

Introduzione Il Registro Tumori Infantili della Campania (RTIC) fa parte della Rete di Registrazione Oncologica Regionale istituita dalla LR 19/2012 e dal DCA 104/2012 insieme ad altri sette Registri Tumori di popolazione provinciali e subprovinciali, tanti quanti le Aziende Sanitarie Locali, ma a differenza di questi ultimi è unico per l’intero territorio regionale ed è allocato presso l’AORN “Santobono-Pausilipon“ in base alla LR 9/2014. Si tratta, innanzitutto, di un importante strumento di sorveglianza epidemiologica della salute dei bambini e degli adolescenti campani; inoltre, i dati raccolti dal registro possono essere utili per scopi di ricerca, per la programmazione sanitaria, nonchè per studi di epidemiologia valutativa volti ad indagare i percorsi diagnostico-terapeutici ed eventuali diseguaglianze nell’accesso alle cure. É, dunque, evidente la sua valenza strategica in ambito di health policy. Per le funzioni che è deputato a svolgere, il RTIC non può prescindere dalla raccolta dei casi secondo procedure riconosciute e validate dalla comunità scientifica internazionale, deputate al raggiungimento di elevati standard di completezza e accuratezza. Il presente lavoro è volto all’analisi dei dati raccolti nel RTIC in termini di qualità della registrazione dei casi e di incidenza della patologia oncologica nei bambini campani nell’intervallo temporale 2008-2014. Materiali e metodi La casistica eleggibile è rappresentata da tutti i tumori maligni e dai tumori maligni e non maligni del sistema nervoso centrale inclusi nell’International Classification of Childhood Cancer (ICCC-3), insorti nel periodo 2008-2014 nella popolazione pediatrica 0-14 anni residente in Campania. Il Registro codifica i casi raccogliendo e integrando diverse fonti informative principali (anagrafi comunale e sanitaria, archivi delle schede di dimissione ospedaliera e dei referti dei servizi di anatomia patologica, Registro Nominativo delle Cause di Morte) e secondarie (cartelle cliniche, referti degli esami di citometria a flusso dei reparti di oncoematologia, referti degli esami di biologia molecolare, archivi di radioterapia). Per la verifica della qualità della registrazione sono stati adoperati indicatori “classici” per i registri tumori di popolazione, quali: la percentuale di casi con conferma microscopica (MV), con il solo certificato di morte (DCO), con diagnosi clinica o base sconosciuta (PSD), con un sito generico o non specificato (IDS) e il rapporto mortalità/incidenza (M/I), calcolandoli per le 12 classi ICCC-3. Per l’analisi di incidenza nell’intera regione e nei territori di pertinenza delle singole ASL sono stati calcolati, sia in maniera aggregata che suddivisi per genere e per le 12 classi ICCC-3: i tassi specifici per fasce di età (0-1, 1-4, 5-9, 10-14 anni); i tassi standardizzati per età 0-14 anni (ASR)con intervalli di confidenza al 95%, applicando il metodo della standardizzazione diretta; i rapporti di incidenza standardizzati (SIR) con intervalli di confidenza del 95%. Gli indicatori di qualità e i tassi di incidenza calcolati dal RTIC sono stati confrontati con i dati osservati dai Registri generali di popolazione nel periodo 2008-2012 in Italia e nel solo Sud Italia. Tutte le analisi sono state effettuate utilizzando il software Stata in versione 13.1. Risultati Nel periodo 2008-2014 sono stati registrati 1099 casi incidenti di tumori maligni nei bambini, 1291 se si includono anche i tumori non maligni del sistema nervoso centrale. Il 97% delle diagnosi di neoplasia maligna sono state supportate da una diagnosi microscopica (MV), contro il 92% del pool dati nazionale e il 91% del solo pool Sud Italia. Non sono stati rilevati DCO e PSD. L’ASR dei tumori maligni è risultato di 167,8 casi per milione, 179,7 per i maschi e 155,3 per le femmine, con un rapporto maschi/femmine di 1,2. Le più alte incidenze sono state osservate per le leucemie (55,4/106), i linfomi (24,5/106) e i tumori del sistema nervoso centrale (22,4/106). I SIR regionali per tutti i tumori maligni si sono attestati su valori di 1,0 (IC 95% 0,94;1,06), applicando i tassi di incidenza nazionali, e di 0,99 (IC 95% 0,94;1,05), utilizzando i tassi di incidenza del solo Sud Italia. Sia nel confronto con il pool nazionale che con il pool Sud Italia sono state riscontrate differenze statisticamente significative per i tumori germinali (1,4 con IC 95% 1,01;1,9 e 1,72 con IC 95% 1,24;2,34 rispettivamente), che rappresentano il 4% dei tumori maligni, e per le neoplasie epiteliali e i melanomi (1,31 con IC 95% 1,03;1,65 e 1,26 con IC 95% 0,99;1,58 rispettivamente), che concorrono per il 7% al totale dei tumori maligni. Nel confronto tra ASL, il tasso di incidenza varia tra 184,7/106 di Caserta e 123,9/106 di Benevento; tuttavia in nessuna ASL è stata riscontrata una differenza statisticamente significativa rispetto al dato regionale. Conclusioni Il RTIC ha prodotto dati di qualità soddisfacente, mostrando un’accuratezza maggiore rispetto ai benchmark. Sembra ragionevole ritenere che la creazione di un archivio di casi prevalenti, grazie a flussi informativi che precedono di otto anni il periodo analizzato, consente al registro di essere protetto da rilevanti errori di sovranotifica. L’incidenza dei tumori maligni è risultata per larga parte sovrapponibile a quella nazionale e del Sud Italia, ma è stato rilevato un profilo di rischio maggiore per i tumori a cellule germinali e per i tumori epiteliali e i melanomi. I risultati invitano, comunque, a un monitoraggio costante e ad ulteriori approfondimenti

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

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

DMAIC Approach for the Reduction of Healthcare-Associated Infections in the Neonatal Intensive Care Unit of the University Hospital of Naples ‘Federico II’

Improvements in the obstetrical and neonatal management have allowed children to survive. These enhancements have showed, anyway, a general increased incidence of healthcare-associated infections, one of the most influent causes of morbidity and mortality in neonatal intensive care units. The aim of this paper is to suggest corrective measures to reduce sentinel germs colonization and identify the relationships between bacteria colonization with the number of procedures and the length of hospital stay. The Lean Six Sigma methodology was used to tackle this issue using a tailored Define, Measure, Analyze, Improve, and Control problem-solving strategy. An increased number of procedures and an extended length of hospital stay demonstrated a statistically significant influence on newborns’ possibility to be infected by sentinel germs. These findings could guide the clinical staff to improve the management of neonates in neonatal intensive care units reducing the number of infected patients, their length of hospital stay and the costs for the hospital. © 2021, Springer Nature Switzerland AG

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

Rationale, Aims, and ObjectivesThe 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) MethodsThe 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. ResultsThe 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). ConclusionsThe 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

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

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

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

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

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