INTRODUCTION:Environmental diseases include a wide spectrum of pathologies whose development is influenced by physical, chemical and biological factors external to the individual. Recent WHO estimates show that 24% of global deaths are due to environmental factors as air pollution, climate change, toxic chemicals and poor hygiene. The Province of Alessandria, Piedmont, Italy, has been subjected to contamination due to industrial plants where hazardous materials have been used. To investigate the level of awareness of the population about environmental pathologies, the Research and Innovation Department of the Azienda Ospedaliero-Universitaria of Alessandria and ASL AL distributed a survey to secondary school students and citizens of Alessandria and Casale Monferrato, in two phases between 2022 and 2023. MATERIALS AND METHODS:The sample comprises 230 participants equally divided by gender and with different levels of education. The survey explores knowledge of environmental causes of diseases and their impact on mortality and possible preventive measures. RESULTS:The majority of the sample associate environmental diseases with human pathologies (89.1%), with a higher awareness among students (91% compared to 86.6% of citizens). The main causes identified are air pollution (70.4%) and toxic substances in the air and water (64.8%). 84.8% identify cancer and 69.6% COPD as associated diseases. 56.4% estimate an impact of environmental factors between 10 and 15% on global mortality. The main preventive measures include the use of cleaner fuels (83.9%), improved hygiene measures (70%) and the promotion of sustainable mobility (70%). CONCLUSIONS:This survey reveals a fair degree of awareness of environmental diseases, but also an underestimation of associated mortality. Therefore, it is necessary to improve education and communication on environmental risks through targeted campaigns and educational interventions. Future studies should broaden the sample and analyze percentage differences between subgroups to optimize educational and preventive actions.
Background: emotion regulation plays a key role in adolescent psychological development. Beliefs about emotions and cultural background may significantly influence the regulation process, yet their role in clinical populations remains underexplored. This pilot study aimed to investigate emotion regulation processes in a clinical sample of adolescents, comparing Italian-born participants with peers from diverse cultural backgrounds. Secondary objectives included exploring the relationships between emotion regulation difficulties, beliefs about emotions, and emotional-behavioral symptoms. Materials and Methods: nineteen adolescents (mean age =15.26; 79% female) with International Classification of Diseases, 10th Revision (ICD-10) affective syndromes were recruited from the Psychology Unit of the University Hospital of Alessandria. Participants were categorized into two groups based on nationality. Participants completed three standardized self-report measures: the Youth Self Report (YSR), the Difficulties in Emotion Regulation Scale (DERS-18), and the Emotion Beliefs Questionnaire (EBQ). All participants and their parents provided written informed consent prior to enrollment. Results: no statistically significant differences in emotion regulation or emotional-behavioral symptoms were found between the Italian and non-Italian groups. However, a borderline-significant positive correlation was observed between externalizing problems and emotion regulation difficulties, particularly in the non-Italian group. Further exploratory correlations suggested potential links between depressive symptoms and beliefs about the uselessness of negative emotions. Conclusions: the study highlights the need to consider cultural, relational, and psychological variables in emotion regulation research. Future studies with larger samples are needed to better understand the complex interplay between emotional functioning and cultural context in adolescent mental health.
Trauma is one of the leading causes of death in Western countries and results in severe health, economic, and social consequences due to residual disabilities. To improve the management of major trauma cases, integrated trauma care systems (SIAT) have been implemented in Italy, inspired by North American models. The goal is to centralize severe cases in the most equipped facilities (trauma centers), thereby reducing avoidable mortality [1]. These systems are based on a “Hub and Spoke” network, which includes a Hub center with a Level II Emergency Department (DEA) and several Spoke centers (with Level I DEAs), such as peripheral hospital facilities. In the Province of Alessandria, in Piedmont region, the Hub center is the hospital of Azienda Ospedaliero-Universitaria of Alessandria (AOU AL), and there are four Spoke centers representing the hospitals of the Local Health Authority of Alessandria (ASL AL), located in the cities of Acqui Terme, Casale Monferrato, Novi Ligure, and Tortona. Despite the public health relevance, epidemiological data on trauma in the Italian territory are scarce and inconsistent in the literature. Objective This study aims to give an epidemiological description of hospitalized severe trauma cases in the Spoke and Hub centers of the Province of Alessandria during the period 2017–2021, also analyzing potential differences between the pre-pandemic and pandemic periods. Additionally, the study aims to assess in-hospital and 30-day mortality for this patient category in both Spoke and Hub centers. Methods Subjects admitted to the Hub and Spoke centers were identified based on hospitalizations (ICD9-CM codes: 800.xx–904.xx; 925.xx–939.xx; 950.xx–959.xx) with discharge dates between 01/01/2017 and 31/12/2021.Trauma severity was assessed using the Injury Severity Score (ISS), based on ICD9-CM codes for principal and secondary diagnosis [2,3,4]: only admissions with ISS >15 (severe trauma) were included. In cases of multiple hospitalizations for the same patient, only the first was considered. Mann-Whitney and Chi-square tests were used to evaluate associations between variables. In order to find determinants of in-hospital and 30-day mortality, Odds Ratios (ORs) with 95% Confidence Interval (95% CI), estimated from multivariate logistic regression models, were used; gender, age, ISS, length of stay, access via Emergency Department, being hospitalized in Intensive Care Unit, being hospitalized during Covid-19 pandemic period (after 01/03/2020) and being hospitalized in Hub/Spoke center were put as covariates. The probability of in-hospital death for each subject was also calculated using the Trauma Mortality Prediction Model (TMPM) [5,6,7]. The predictive capacity of the model was tested on the study sample using ROC (Receiver Operating Characteristic) curves and the corresponding area under the curve (AUC) [8]. Results In this study, a total of 1,337 patients were included: 705 hospitalized in the Hub center and 632 in the Spoke centers. Most patients in the whole sample were male (59.6%) and the median age was 76 (IQR: 60-85) years. The median length of hospital stay was 8 (IQR: 4–14) days, significantly longer in the Hub center: 9 (IQR: 5-16) days in the Hub center, 7 (IQR: 4-12) days in the Spoke center (p<0.001). In-hospital mortality was 10.3% in ASL AL centers and 6.4% in AOU AL (p=0.01). The emergency department was the primary point of access (79.4%) for these hospitalizations. The median ISS was 16 (IQR: 16–22). There were no significant differences in ISS between the hospitalizations during Covid-19 pandemic period and the ones that occurred before (p=0.95), nor in the distribution of in-hospital (p=0.48) and 30-day (p=0.90) deaths. TMPM ROC curves showed an AUC of 0.74 for in-hospital mortality and 0.71 for 30-day mortality. The results of the multivariate logistic regressions indicate that increasing of age (OR=1.08; 95% CI: 1.07–1.10), being male (OR=1.50; 95% CI: 1.06–2.14), higher ISS (OR=1.03; 95% CI: 1.02–1.05), and admission to Intensive Care Unit (OR=3.17; 95% CI: 1.74–5.70) are associated with increased odds of 30-day mortality. Furthermore, increasing of age (OR=1.06; 95% CI: 1.04–1.09), shorter length of hospital stay (OR=0.96; 95% CI: 0.94–0.99), higher ISS (OR=1.02; 95% CI: 1.00–1.03), admission to Intensive Care Unit (OR=5.72; 95% CI: 2.93–11.10), and being hospitalized in Spoke centers (OR=1.74; 95% CI: 1.10–2.80) are associated with increased odds of in-hospital mortality. Being hospitalized during the Covid-19 pandemic period was not significantly associated with increased odds of either in-hospital mortality (OR=0.83; 95% CI: 0.52–1.29) or 30-day mortality (OR=0.96; 95% CI: 0.66–1.37). Conclusions The TMPMs showed good discriminatory power in predicting mortality, supporting their reliability in clinical and operational settings. The absence of statistically significant differences in outcomes between the pre-pandemic and pandemic periods suggests that the Covid-19 pandemic had a limited impact on the care of polytrauma patients. The analysis of in-hospital mortality highlights the need to optimize the management of severely injured patients within the "Hub and Spoke" network. In 2024, the urgent transfer protocol for patients from ASL AL centers to the AOU AL center was revised; a future perspective will therefore be the evaluation of in-hospital mortality in the coming years.
Abstract Background/aims In order to make the centers more attractive to trial sponsors, in recent years, some research institutions around the world have pursued projects to reorganize the pathway of trial activation, developing new organizational models to improve the activation process and reduce its times. This study aims at analyzing and reorganizing the start-up phase of trials conducted at the Research and Innovation Department (DAIRI) of the Public Hospital of Alessandria (Italy). Methods A project was carried out to reorganize the trial authorization process at DAIRI by involving the three facilities responsible for this pathway: clinical trial center (CTC), ethics committee secretariat (ESC), and administrative coordination (AC). Lean Thinking methodology was used with the A3 report tool, and the analysis was carried out by monitoring specific key performance indicators, derived from variables representing highlights of the trials’ activation pathway. The project involved phases of analysis, implementation of identified countermeasures, and monitoring of timelines in eight 4-month periods. The overall mean and median values of studies activation times were calculated as well as the average times for each facility involved in the process. Results In this study, 298 studies both sponsored by research associations and industry with both observational and interventional study design were monitored. The mean trial activation time was reduced from 218 days before the project to 56 days in the last period monitored. From the first to the last monitoring period, each facility involved achieved at least a halving of the average time required to carry out its activities in the clinical trials’ activation pathway (CTC: 55 days vs 23, ECS: 25 days vs 8, AC 29 days vs 10). Average activation time for studies with agreement remains longer than those without agreement (100 days vs. 46). Conclusions The reorganization project emphasized the importance of having clinical and administrative staff specifically trained on the trial activation process. This reorganization led to the development of a standard operating procedure and a tool to monitor the time (KPIs of the process) that can also be implemented in other clinical centers.
Aims: prognostic impact of mutations in BRAF and KRAS genes in patients with colorectal cancer was evaluated to detect variations in survival among patients with these mutations, in relation to different morphologic features identified at diagnosis and the expression of mismatch repair proteins. The final purpose of the project will be to establish models to predict variations in survival in different subsets of patients with colorectal cancer. Materials and Methods: partial survival analyses were conducted on 32 subjects in relation to three different variables: mutation in BRAF or KRAS genes, expression of mismatch repair system and morphological features of the tumor. Results: preliminary results of this study provide evidence that survival in different subsets of patients with colorectal cancer can be influenced by several factors, which include, in addition to immunohistochemical and molecular investigations, the assessment of different morphological features. Conclusions: Integrating different characteristics may reveal which factors have a more significant impact on survival in these subgroups. More patients will be needed to design different survival models and to check these preliminary results more effectively.
Background: one under-researched line of investigation is gliomas, which are a group of malignant brain tumours with highly poor prognoses. Despite efforts to identify environmental risk factors for gliomas, their etiology still remains unclear. It turns out that several future developments are needed in order to understand other potential risk factors. To this end, the primary objective of the present pilot study is to conduct an assessment of the spatial distribution of high-grade brain tumor cases in the province of Alessandria, where possible risk factors such as the presence of chemical industries and asbestiform fibers are found. Materials and Methods: the study sample consisted of all patients diagnosed with high-grade glioma between January 2018 and April 2023, residents in the province of Alessandria at the time of diagnosis and referred to the health facilities of the "Azienda Sanitaria Locale di Alessandria" and the "Azienda Universitario-Ospedaliera di Alessandria". Biographical and pathological history variables were collected, and finally, data were processed in aggregate and anonymized form. A total of 103 deceased patients were enrolled, stratified by age and type of diagnosis. Results: it was seen that the city with the most cases was Alessandria, with 27 diagnoses found during the period under review (26.2%), followed by cities of Acqui Terme, Casale Monferrato, and Novi Ligure with seven diagnoses (6.8%). Preliminary results presented in this paper were compared with data already published. Conclusions: analyses performed to arrive at an initial geographical distribution of high-grade glioma diagnoses are consistent relative to the population density of each municipality considered.
Background and Aims: the main purpose of this paper is analyzing the hourly activities performed by Data Managers (DMs) and Clinical Research Coordinators (CRCs) in a Clinical Trial Center (CTC) of an Italian Public Hospital in order to define and monitor the relevant job descriptions of these professionals Materials and Methods: the CTC of the Research and Innovation Departments (DAIRI) has created a tool to collect the hourly activity of DMs and CRCs. In the period between January 1 and December 31, 2022; the activities were collected and grouped in 24 macro areas. Results: the main activities conducted by staff are found in the macro areas "Study Management" (15.78%); "Briefing/Planning" (12.86%) and “Data Management/Data Entry” (12.42%). A difference was found between the activities carried out by CRCs and those conducted by DMs. Conclusions: the results of this monitoring, compared with data obtained at the national level, confirm the heterogeneity of the tasks performed by these professional figures. These differences increasingly underscore the need to obtain recognition of the figure by the National Health System (NHS) with the definition of a precise “job description”.
Obiettivi: Lo scopo del presente lavoro è stato quello di esplorare l’impatto psicologico a lungo termine della pandemia da COVID-19 negli operatori sanitari e in altri professionisti che lavorano presso l’Azienza Ospedaliera “SS Antonio e Biagio, e Cesare Arrigo” di Alessandria. Materiali e Metodi: È stato condotto uno studio osservazionale prospettico monocentrico su 112 operatori dell’Azienda Ospedaliera attraverso la somministrazione di un questionario on-line. I dati sono stati raccolti a tra l’1 e il 30 aprile 2021. Il questionario comprendeva un’autovalutazione delle informazioni socio-demografiche, cliniche, lavorative e relative al COVID-19 e la percezione del rischio. Inoltre, includeva la versione on-line di questionari psicologici validati in lingua italiana: Scala dell’impatto dell’Evento-Rivista (IES-R), Scala di Depressione, Ansia e Stress (DASS-21), Insomnia Severity Index (ISI), Coping Orientation to the Problems Experienced - Nuova Versione Italiana (COPE-NVI- 25), e Scala della Qualità di Vita Professionale (ProQOL-5). Risultati: L’analisi dei dati mostra che i lavoratori dell’Azienda Ospedaliera partecipanti allo studio, presentano percentuali moderate di sintomatologia da stress post-traumatico (40,2%), depressiva (40.2%), ansiosa (28.6%), da stress (44.6%) e insonnia (16.1%). La categoria dei lavoratori in ambito amministrativo mostra maggiori sintomi ansiosi e di stress post-traumatico. Le strategie di coping maggiormente utilizzate nel nostro campione sono l’attitudine positiva, l’orientamento al problema e il sostegno sociale. Il sottogruppo di lavoratori a diretto contatto con i pazienti mostra livelli moderati di compassion-satisfaction e bassi livelli di stress traumatico secondario e burn-out. Conclusioni: Dai risultati del presente lavoro si è osservato che gli effetti negativi a livello psicologico si possono mantenere anche nel lungo termine dall’insorgenza della pandemia.
Objectives: The aim of the study was to explore the psychological impact of COVID-19 outbreak, during the so-called phase three of the infection in Italy, in healthcare workers and other professionals working in the Public Hospital “SS Antonio e Biagio e Cesare Arrigo” in the Piedmont Region.Methods: A monocentric prospective observational study was conducted on 113 hospital workers by completing an online survey. Data were collected from 29th June to 20th July 2020. The survey assessed self-reported socio-demographic, clinical, work and COVID-19 related information and risk perception. Moreover, it included an online version of validated questionnaires in the Italian language: Impact of Event Scale-Revised (IES-R), Depression, Anxiety and Stress Scale (DASS-21), Insomnia Severity Index (ISI), Coping Orientation to the Problems Experienced: COPE-NVI-25, and the Professional Quality of Life scale (ProQOl-5).Results: The exploratory analysis revealed that hospital workers showed a high percentage of post-traumatic stress symptoms in the months following the beginning of the pandemic. In general, having higher levels of education seems to be associated with less anxiety, stress, depression insomnia e post-traumatic stress symptoms. Those symptoms were reported among those who had higher risk perception, previous psychological problems, or suffered from a chronic disease. Workers with more than 10 years experience and low risk perception reported less insomnia symptoms.Conclusions: The assessment of psychological effects of COVID-19 outbreak might help to create good practices that could be used and improved to implement focused interventions on workers’ well-being, especially during COVID-19 and post COVID-19 periods.
Background Individual differences in susceptibility to SARS-CoV-2 infection, symptomatology and clinical manifestation of COVID-19 have thus far been observed but little is known about the prognostic factors of young patients. Methods A retrospective observational study was conducted on 171 patients aged ≤ 65 years hospitalized in Alessandria’s Hospital from 1st March to 30th April 2020 with laboratory confirmed COVID-19. Epidemiological data, symptoms at onset, clinical manifestations, Charlson Comorbidity Index, laboratory parameters, radiological findings and complications were considered. Patients were divided into two groups on the basis of COVID-19 severity. Multivariable logistic regression analysis was used to establish factors associated with the development of a moderate or severe disease. Findings A total of 171 patients (89 with mild/moderate disease, 82 with severe/critical disease), of which 61% males and a mean age (± SD) of 53.6 (± 9.7) were included. The multivariable logistic model identified age (50–65 vs 18–49; OR = 3.23 CI95% 1.42–7.37), platelet count (per 100 units of increase OR = 0.61 CI95% 0.42–0.89), c-reactive protein (CPR) (per unit of increase OR = 1.12 CI95% 1.06–1.20) as risk factors for severe or critical disease. The multivariable logistic model showed a good discriminating capacity with a C-index value of 0.76. Interpretation Patients aged ≥ 50 years with low platelet count and high CRP are more likely to develop severe or critical illness. These findings might contribute to improved clinical management.
The increasing complexity of clinical research makes it indispensable for an Institution that wants to conduct clinical trials to have an Organisational Structure and a dedicated multidisciplinary team. Since 2013, the public Hospital "SS Antonio and Biagio and C. Arrigo" of Alessandria (AO AL) has established a Clinical Trial Center (CTC), that has now become a centralized inter-company sector of the Research and Innovation Department. The CTC is part of the Research Infrastructure with its head office at AO AL and a further office at the Local Health Authority Territorial Hospital "S. Spirito" of Casale Monferrato (ASL AL). The CTC aims to design high standard clinical trials, ensuring better efficiency in their activation, management and data management according to the Good Clinical Practice (GCP) guidelines. Over the years, the CTC has grown and gained professional skills such as the Clinical Research Coordinator (CRC) and the Clinical Research Nurse (CRN), not yet officially recognized by the National Health System. These are skilled professional figures, that have been adequately trained even with post-graduate education through a 1st level Master in "Data Management and Coordination of Clinical Trials" which was activated by the University of Eastern Piedmont in collaboration with AO AL. The number and diversity of the activities carried out by CRCs and CRNs within the CTC has led them to develop a tool that strategically permits to recollect and record the time needed to perform these tasks with the aim of evaluating the different types of activities undertaken and assessing the needs of new staff. The organizational model adopted by the AO AL and the ASL AL through a centralized inter-company CTC represents a unique organizational model in the regional scenario and a peculiarity within the Public Health Authority not as yet recognized as Scientific Institutes for Research, Hospitalization and Healthcare.
Objective: The aim is to evaluate the speed in the activation of Covid-19 clinical trials at SS. Antonio e Biagio e Cesare Arrigo Hospital of Alessandria during the pandemic. Methods: Data collection related to the activation and the conduction of clinical trials was managed using a database created through a web-based platform REDCap (Research Electronic Data Capture). Results: 32 studies were activated in the period between March 23 and July 31, 2020. An average time of 14 days elapsed between taking charge of the request and the issuance of the authorization act. Conclusions: During the emergency it was possible to activate the trials quickly thanks to fast-track procedures, optimizing COVID-19 clinical research.
Objectives: To define the Data Manager (DM) job description within the Clinical Trial Center (CTC) of the Alessandria Hospital (AO AL). To identify the number of authorized clinical studies after the implementation of three DMs in the CTC of the AO AL. Methods: The activities of the DM within the CTC of the AO AL take place in the activation, management and conclusion of clinical trials. The activities were monitored through specific indicators from June 01st, 2019 to May 31st, 2020. Results: During the reference period, an increased authorized studies were observed. Conclusion: The implementation of DMs in the CTC of AO AL has been demonstrated the importance of the figure itself, which, although it has not professionally recognized yet, is found to be fundamental in clinical research.