The role of a data manager at a clinical trial center: the experience of the Alessandria hospital, Italy

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

Fatality rate and predictors of mortality in an Italian cohort of hospitalized COVID-19 patients

Clinical features and natural history of coronavirus disease 2019 (COVID-19) differ widely among different countries and during different phases of the pandemia. Here, we aimed to evaluate the case fatality rate (CFR) and to identify predictors of mortality in a cohort of COVID-19 patients admitted to three hospitals of Northern Italy between March 1 and April 28, 2020. All these patients had a confirmed diagnosis of SARS-CoV-2 infection by molecular methods. During the study period 504/1697 patients died; thus, overall CFR was 29.7%. We looked for predictors of mortality in a subgroup of 486 patients (239 males, 59%; median age 71 years) for whom sufficient clinical data were available at data cut-off. Among the demographic and clinical variables considered, age, a diagnosis of cancer, obesity and current smoking independently predicted mortality. When laboratory data were added to the model in a further subgroup of patients, age, the diagnosis of cancer, and the baseline PaO2/FiO2 ratio were identified as independent predictors of mortality. In conclusion, the CFR of hospitalized patients in Northern Italy during the ascending phase of the COVID-19 pandemic approached 30%. The identification of mortality predictors might contribute to better stratification of individual patient risk

Mesotelioma pleurico da inusuale esposizione ad amianto. Tre casi clinici

Finalità: Richiamare l’attenzione sull’importanza dell’anamnesi lavorativa e ambientale per il corretto inquadramento eziologico del mesotelioma pleurico, neoplasia assai aggressiva che riconosce come principale fattore di rischio l’inalazione di fibre d’amianto. Casi clinici: Sono presentati tre casi, esemplificativi delle diverse modalità attraverso le quali si può realizzare un’esposizione inusuale (non strettamente professionale) all’amianto. Essi provengono da Casale Monferrato (Alessandria), dove dal 1907 al 1986 operò la principale industria italiana produttrice di manufatti in cemento-amianto e dove tuttora si registra un’alta incidenza di mesotelioma maligno. Il primo caso (donna di 81 anni) è un mesotelioma pleurico da esposizione “professionale passiva”, legato alla presenza di fibre nell’ambiente di lavoro (e di vita). Il secondo (uomo di 85 anni) è un mesotelioma da vicinanza, mentre il terzo (donna di 77 anni) è un mesotelioma da esposizione domestica, per contatto con abiti di lavoro del coniuge. Conclusioni: Il mesotelioma pleurico può insorgere come conseguenza di inusuali (e lontane nel tempo) esposizioni all’amianto. In tali casi, un’accurata anamnesi lavorativa e ambientale è fondamentale ai fini della corretta diagnosi eziologica, alla quale conseguono complesse ricadute medico-legali

Supportare la ricerca e l’innovazione in sanità tramite i modelli organizzativi: il caso dell’Azienda Ospedaliera “SS. Antonio e Biagio e Cesare Arrigo” di Alessandria

Working Paper Ircres-CNR 09/2017. Research and innovation is broadly recognized as a key factor to contain public expenditure and to enhance human resources. However, there are not models to support this key activity. In other words, there are not organizational models which can support physicians’ research activity. Obviously, considering the current age of austerity, this model becomes essential to be competitive on the research market. This paper proposes the case study of the General Hospital "SS. Antonio e Biagio e Cesare Arrigo" of Alessandria, and the decision of adopting a structure aimed at supporting and coordinating scientific research and innovation. An organizational model which might be adopted by other hospitals and/or medical centers.     

Cancer risk after cessation of asbestos exposure. a cohort study of italian asbestos cement workers

OBJECTIVES: We aimed to study mortality for asbestos related diseases and the incidence of mesothelioma in a cohort of Italian asbestos cement workers after cessation of asbestos exposure. METHODS: The Eternit factory operated from 1907 to 1986. The cohort included 3434 subjects active in 1950 or hired in 1950-86, ascertained from company records, without selections. Local reference rates were used for both mortality and mesothelioma incidence. RESULTS: Mortality was increased in both sexes for all causes (overall 1809 observed (obs) vs 1312.3 expected (exp); p<0.01), pleural (135 obs vs 3.6 exp; p<0.01) and peritoneal (52 vs 1.9; p<0.01) malignancies and lung cancer (249 vs 103.1; p<0.01). In women, ovarian (9 vs 4.0; p<0.05) and uterine (15 vs 5.8; p<0.01) malignancies were also in excess. No statistically significant increase was found for laryngeal cancer (16 obs vs 12.2 exp). In Poisson regression analyses, the RR of death from pleural neoplasm linearly increased with duration of exposure, while it showed a curvilinear increase with latency and time since cessation of exposure. RR for peritoneal neoplasm continued to increase by latency, duration and time since cessation of exposure. RR for lung cancer showed a reduction after 15 years since cessation of exposure and levelled off after 40 years of latency. CONCLUSION: This study of a cohort of asbestos exposed workers with very long follow-up confirmed the reduction in risk of death from lung cancer after the end of exposure. It also suggested a reduction in risk for pleural mesothelioma with over 40 years of latency, while risk for peritoneal mesothelioma showed a continuing increase

Asbestos Fibers and Ferruginous Bodies Detected by VP-SEM/EDS in Colon Tissues of a Patient Affected by Colon-Rectum Cancer: A Case Study

The aim of this work was to inspect the presence of asbestos fibers in colon tissue from a patient, with history of indirect exposure to asbestos and affected by colon cancer, who underwent surgery. Variable pressure scanning electron microscopy, coupled with energy dispersive spectroscopy (VP-SEM/EDS), was used for identification of inorganic fibers and for their morphological—chemical characterization. Fresh tissue samples from both, healthy area close to the neoplasia and from the neoplastic regions, were separately digested to eliminate the biological matrix. The precipitate was analyzed by VP-SEM/EDS, identifying in samples from healthy tissue asbestos bodies and small asbestos fibers, and in samples from neoplastic tissue long fibers of asbestos, free from covering. A quantification of the asbestos bodies and the free fibers in the two type of specimens is proposed. Moreover, to locate the fibers in the biological medium, histological sections from the colon of the same patient were also examined. Free asbestos fibers appeared concentrated in the tissue bridge between the healthy and the neoplastic areas. Immuno-histochemical investigation performed on the neoplasia seems to exclude a role of microsatellite instability in the carcinogenesis process, suggesting an influence of the fibers

Georeferencing of COVID-19 Positive Nasopharyngeal Swabs to Support Emergency Management in an Area of Northern Italy

Spatial distribution heterogeneity of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been observed in several countries. While previous studies have covered vast geographic areas, detailed analyses on smaller territories are not available to date. The aim of our study was to understand the spatial spread of SARS-CoV-2 in a province of Northern Italy through the analysis of positive nasopharyngeal (NP) swabs. The study was conducted on subjects who lived in the province of Alessandria with at least one positive NP swab between 2 March and 22 December 2020. To investigate if clustering occurred, the proportion of SARS-CoV-2 positive subjects over the total number of residents in each small administrative subregion was calculated and then mapped. A total of 17,260 subjects with at least one positive NP swab were included; the median age was 54 years (Interquartile range 38–72) and 54.9% (n = 9478) of our study population were female. Among the 192 towns scanned, 26 showed a prevalence between 5% and 7.5%, one between 7.5% and 10% and two with more than 10% positive swabs. The territories with a higher prevalence of positive subjects were located in areas with at least one nursing home and potential clusters were observed within these structures. The maps produced may be considered a useful and important monitoring system to identify areas with a significant and relevant diffusion of SARS-CoV-2