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1. Large-Scale Postmarketing Surveillance of Biological Drugs for Immune-Mediated Inflammatory Diseases Through an Italian Distributed Multi-Database Healthcare Network: The VALORE Project

Author

Trifiro, G., Isgro, V., Ingrasciotta, Y., Ientile, V., L'Abbate, L., Foti, S. S., Belleudi, V., Poggi, F., Fontana, A., Moretti, U., Lora, R., Sabaini, A., Senesi, I., Sorrentino, C., Puzo, M. R., Padula, A., Fusco, M., Giordana, R., Solfrini, V., Puccini, A., Rossi, P., Del Zotto, S., Leoni, O., Zanforlini, M., Ancona, D., Bavaro, V., Garau, D., Ledda, S., Scondotto, S., Allotta, A., Tuccori, M., Gini, R., Bucaneve, G., Franchini, D., Cavazzana, A., Biasi, V., Spila Alegiani, S., Massari, M., Andretta, I., Tanaglia, M., Carriero, A., Sassano, S., De Sarro, G., Mirarchi, S., Palleria, C., Sarro, C., Balestrieri, M., Rostan, S., Capuano, A., Bernardi, F. F., Trama, U., Russo, A., Fumo, M. G., Addis, A., Musicco, F., Sapigni, E., Mazzetti, I., Podetti, D., Potenza, A. M., Nikitina, V., Ricciardelli, R., Mogheiseh, N., Croce, S., Pettinelli, A., Ejlli, L., Fortino, I., Ercolanoni, M., Mazzone, A., Nisic, A., Schiatti, S., Ludergnani, M., Mancini, M., Patregnani, L., Fabbietti, P., Antonicelli, E., Mangano, A., Campomori, A., Urru, S. A., Costa, G., Guarrera, G. M., Stella, P., Serra, E., Carta, P., Vannacci, A., Lucenteforte, E., Parrilli, M., Convertino, I., De Giorgi, M., Rocchi, R. E., Rossi, M., Scroccaro, G., Deambrosis, P., Grindelli, G., Ferroni, E., Trifiro, G., Isgro, V., Ingrasciotta, Y., Ientile, V., L'Abbate, L., Foti, S. S., Belleudi, V., Poggi, F., Fontana, A., Moretti, U., Lora, R., Sabaini, A., Senesi, I., Sorrentino, C., Puzo, M. R., Padula, A., Fusco, M., Giordana, R., Solfrini, V., Puccini, A., Rossi, P., Del Zotto, S., Leoni, O., Zanforlini, M., Ancona, D., Bavaro, V., Garau, D., Ledda, S., Scondotto, S., Allotta, A., Tuccori, M., Gini, R., Bucaneve, G., Franchini, D., Cavazzana, A., Biasi, V., Spila Alegiani, S., Massari, M., Andretta, I., Tanaglia, M., Carriero, A., Sassano, S., De Sarro, G., Mirarchi, S., Palleria, C., Sarro, C., Balestrieri, M., Rostan, S., Capuano, A., Bernardi, F. F., Trama, U., Russo, A., Fumo, M. G., Addis, A., Musicco, F., Sapigni, E., Mazzetti, I., Podetti, D., Potenza, A. M., Nikitina, V., Ricciardelli, R., Mogheiseh, N., Croce, S., Pettinelli, A., Ejlli, L., Fortino, I., Ercolanoni, M., Mazzone, A., Nisic, A., Schiatti, S., Ludergnani, M., Mancini, M., Patregnani, L., Fabbietti, P., Antonicelli, E., Mangano, A., Campomori, A., Urru, S. A., Costa, G., Guarrera, G. M., Stella, P., Serra, E., Carta, P., Vannacci, A., Lucenteforte, E., Parrilli, M., Convertino, I., De Giorgi, M., Rocchi, R. E., Rossi, M., Scroccaro, G., Deambrosis, P., Grindelli, G., and Ferroni, E.

Subjects
Male, medicine.medical_specialty, Population, Postmarketing surveillance, Rate ratio, REGISTRIES, Retrospective Studie, Internal medicine, BIOSIMILARS, medicine, Adalimumab, Humans, Pharmacology (medical), Original Research Article, education, Adverse effect, ANTI-TNF THERAPY, RHEUMATOID-ARTHRITIS, RISK, PHARMACOVIGILANCE, BIOSIMILARS, EXPERIENCE, REGISTRIES, PSORIASIS, MEDICINES, ACCESS, Biosimilar Pharmaceuticals, Retrospective Studies, RISK, Delivery of Health Care, Female, Infliximab, Italy, SARS-CoV-2, COVID-19, Pharmacology, education.field_of_study, PSORIASIS, business.industry, Biosimilar, ANTI-TNF THERAPY, General Medicine, medicine.disease, RHEUMATOID-ARTHRITIS, PHARMACOVIGILANCE, MEDICINES, EXPERIENCE, Immune-mediated inflammatory diseases, ACCESS, business, Human, Biosimilar Pharmaceutical, Biotechnology, medicine.drug
Abstract

Background Biological drugs have improved the management of immune-mediated inflammatory diseases (IMIDs) despite being associated with important safety issues such as immunogenicity, infections, and malignancies in real-world settings. Objective The aim of this study was to explore the potential of a large Italian multi-database distributed network for use in the postmarketing surveillance of biological drugs, including biosimilars, in patients with IMID. Methods A retrospective cohort study was conducted using 13 Italian regional claims databases during 2010–2019. A tailor-made R-based tool developed for distributed analysis of claims data using a study-specific common data model was customized for this study. We measured the yearly prevalence of biological drug users and the frequency of switches between originator and biosimilars for infliximab, etanercept, and adalimumab separately and stratified them by calendar year and region. We then calculated the cumulative number of users and person-years (PYs) of exposure to individual biological drugs approved for IMIDs. For a number of safety outcomes (e.g., severe acute respiratory syndrome coronavirus 2 [SARS-COV-2] infection), we conducted a sample power calculation to estimate the PYs of exposure required to investigate their association with individual biological drugs approved for IMIDs, considering different strengths of association. Results From a total underlying population of almost 50 million inhabitants from 13 Italian regions, we identified 143,602 (0.3%) biological drug users, with a cumulative exposure of 507,745 PYs during the entire follow-up. The mean age ± standard deviation of biological drug users was 49.3 ± 16.3, with a female-to-male ratio of 1.2. The age-adjusted yearly prevalence of biological drug users increased threefold from 0.7 per 1000 in 2010 to 2.1 per 1000 in 2019. Overall, we identified 40,996 users of biosimilars of tumor necrosis factor (TNF)-α inhibitors (i.e., etanercept, adalimumab, and infliximab) in the years 2015–2019. Of these, 46% (N = 18,845) switched at any time between originator and biosimilars or vice versa. To investigate a moderate association (incidence rate ratio 2) between biological drugs approved for IMIDs and safety events of interest, such as optic neuritis (lowest background incidence rate 10.4/100,000 PYs) or severe infection (highest background incidence rate 4312/100,000 PYs), a total of 43,311 PYs and 104 PYs of exposure to individual biological drugs, respectively, would be required. As such, using this network, of 15 individual biological drugs approved for IMIDs, the association with those adverse events could be investigated for four (27%) and 14 (93%), respectively. Conclusion The VALORE project multi-database network has access to data on more than 140,000 biological drug users (and > 0.5 million PYs) from 13 Italian regions during the years 2010–2019, which will be further expanded with the inclusion of data from other regions and more recent calendar years. Overall, the cumulated amount of person-time of exposure to biological drugs approved for IMIDs provides enough statistical power to investigate weak/moderate associations of almost all individual compounds and the most relevant safety outcomes. Moreover, this network may offer the opportunity to investigate the interchangeability of originator and biosimilars of several TNFα inhibitors in different therapeutic areas in real-world settings. Supplementary Information The online version contains supplementary material available at 10.1007/s40259-021-00498-3.

Published
2021
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2. Cost-effectiveness of the adherence with recommendations for clinical monitoring of patients with diabetes

Author

Corrao, G, Rea, F, Mancia, G, Perseghin, G, Merlino, L, Martini, N, Carbone, S, Carle, F, Bucci, A, Dajko, M, Arca, S, Bellentani, D, Bruno, V, Ceccolini, C, De Feo, A, Lispi, L, Mariniello, R, Masullo, M, Medici, F, Pisanti, P, Visca, M, Zanini, R, Di Fiandra, T, Magliocchetti, N, Romano, G, Cantarutti, A, Pugni, P, Davoli, M, Di Martino, M, Lallo, A, Vittori, P, Vuillermin, G, Bernardo, A, Fusciante, A, Belotti, L, De Palma, R, Di Felice, E, Chiandetti, R, Clagnan, E, Del Zotto, S, Di Lenarda, A, Mariotto, A, Prezza, M, Zanier, L, Fusco, D, Marinacci, C, Lora, A, Spazzafumo, L, Pizzi, S, Simiele, M, Massaro, G, Attolini, E, Lepore, V, Petrarolo, V, De Luca, G, Fantaci, G, Pollina Addario, S, Scondotto, S, Bellomo, F, Braga, M, Di Fabrizio, V, Forni, S, Francesconi, P, Profili, F, Avossa, F, Corradin, M, Vigna, S, Dondi, L, Pedrini, A, Piccinni, C, Cosentino, M, Marvulli, M, Maggioni, A, Corrao G., Rea F., Mancia G., Perseghin G., Merlino L., Martini N., Carbone S., Carle F., Bucci A., Dajko M., Arca S., Bellentani D., Bruno V., Ceccolini C., De Feo A., Lispi L., Mariniello R., Masullo M., Medici F., Pisanti P., Visca M., Zanini R., Di Fiandra T., Magliocchetti N., Romano G., Cantarutti A., Pugni P., Davoli M., Di Martino M., Lallo A., Vittori P., Vuillermin G., Bernardo A., Fusciante A., Belotti L., De Palma R., Di Felice E., Chiandetti R., Clagnan E., Del Zotto S., Di Lenarda A., Mariotto A., Prezza M., Zanier L., Fusco D., Marinacci C., Lora A., Spazzafumo L., Pizzi S., Simiele M., Massaro G., Attolini E., Lepore V., Petrarolo V., De Luca G., Fantaci G., Pollina Addario S., Scondotto S., Bellomo F., Braga M., Di Fabrizio V., Forni S., Francesconi P., Profili F., Avossa F., Corradin M., Vigna S., Dondi L., Pedrini A., Piccinni C., Cosentino M., Marvulli M. G., Maggioni A., Corrao, G, Rea, F, Mancia, G, Perseghin, G, Merlino, L, Martini, N, Carbone, S, Carle, F, Bucci, A, Dajko, M, Arca, S, Bellentani, D, Bruno, V, Ceccolini, C, De Feo, A, Lispi, L, Mariniello, R, Masullo, M, Medici, F, Pisanti, P, Visca, M, Zanini, R, Di Fiandra, T, Magliocchetti, N, Romano, G, Cantarutti, A, Pugni, P, Davoli, M, Di Martino, M, Lallo, A, Vittori, P, Vuillermin, G, Bernardo, A, Fusciante, A, Belotti, L, De Palma, R, Di Felice, E, Chiandetti, R, Clagnan, E, Del Zotto, S, Di Lenarda, A, Mariotto, A, Prezza, M, Zanier, L, Fusco, D, Marinacci, C, Lora, A, Spazzafumo, L, Pizzi, S, Simiele, M, Massaro, G, Attolini, E, Lepore, V, Petrarolo, V, De Luca, G, Fantaci, G, Pollina Addario, S, Scondotto, S, Bellomo, F, Braga, M, Di Fabrizio, V, Forni, S, Francesconi, P, Profili, F, Avossa, F, Corradin, M, Vigna, S, Dondi, L, Pedrini, A, Piccinni, C, Cosentino, M, Marvulli, M, Maggioni, A, Corrao G., Rea F., Mancia G., Perseghin G., Merlino L., Martini N., Carbone S., Carle F., Bucci A., Dajko M., Arca S., Bellentani D., Bruno V., Ceccolini C., De Feo A., Lispi L., Mariniello R., Masullo M., Medici F., Pisanti P., Visca M., Zanini R., Di Fiandra T., Magliocchetti N., Romano G., Cantarutti A., Pugni P., Davoli M., Di Martino M., Lallo A., Vittori P., Vuillermin G., Bernardo A., Fusciante A., Belotti L., De Palma R., Di Felice E., Chiandetti R., Clagnan E., Del Zotto S., Di Lenarda A., Mariotto A., Prezza M., Zanier L., Fusco D., Marinacci C., Lora A., Spazzafumo L., Pizzi S., Simiele M., Massaro G., Attolini E., Lepore V., Petrarolo V., De Luca G., Fantaci G., Pollina Addario S., Scondotto S., Bellomo F., Braga M., Di Fabrizio V., Forni S., Francesconi P., Profili F., Avossa F., Corradin M., Vigna S., Dondi L., Pedrini A., Piccinni C., Cosentino M., Marvulli M. G., and Maggioni A.

Abstract

Background and aims: To validate a set of indicators for monitoring the quality of care of patients with diabetes in ‘real-life’ practice through its relationship with measurable clinical outcomes and healthcare costs. Methods and results: A population-based cohort study was carried out by including the 20,635 patients, residents in the Lombardy Region (Italy), who in the year 2012 were newly taken-in-care for diabetes. Adherence with clinical recommendations (i.e., controls for glycated haemoglobin, lipid profile, urine albumin excretion and serum creatinine) was recorded during the first year after the patient was taken-in-care, and categorized according whether he/she complied with none or almost none (0 or 1), just some (2) or all or almost all (3 or 4) the recommendations, respectively denoted as poor, intermediate and high adherence. Short- and long-term complications of diabetes, and healthcare cost incurred by the National Health Service, were assessed during follow-up. Compared with patients with poor adherence, those with intermediate and high adherence respectively showed (i) a delay in outcome occurrence of 13 days (95% CI, −2 to 27) and 23 days (9–38), and (ii) a lower healthcare cost of 54 € and 77 €. In average, a gain of 18 Euros and 15 Euros for each day free from diabetic complication by increasing adherence respectively from poor to intermediate and from poor to high were observed. Conclusion: Close control of patients with diabetes through regular clinical examinations must be considered the cornerstone of national guidance, national audits, and quality improvement incentive schemes.

Published
2021

4. Increased cancer risk in patients undergoing dialysis: A population-based cohort study in North-Eastern Italy

Author

Taborelli, M., Toffolutti, F., Del Zotto, S., Clagnan, E., Furian, L., Piselli, P., Citterio, Franco, Zanier, L., Boscutti, G., Serraino, D., Shalaby, S., Petrara, R., Burra, P., Zanus, G., Zanini, S., Rigotti, P., Rendina, M., Di Leo, A., Schena, F. P., Grandaliano, Giuseppe, Fiorentino, M., Lauro, A., Pinna, A. D., Di Gioia, P., Pellegrini, S., Zanfi, C., Scolari, M. P., Stefoni, S., Todeschini, P., Panicali, L., Valentini, C., Baccarani, U., Risaliti, A., Adani, G. L., Lorenzin, D., Ettorre, G. M., Vennarecci, G., Colasanti, M., Coco, M., Ettorre, F., Santoro, R., Miglioresi, L., Nudo, F., Rossi, M., Mennini, G., Toti, L., Tisone, G., Casella, A., Fazzolari, L., Sforza, D., Iaria, G., Gazia, C., Belardi, C., Cimaglia, C., Agresta, A., D'Offizi, G., Comandini, U. V., Lionetti, R., Montalbano, M., Taibi, C., Fantola, G., Zamboni, F., Piredda, G. B., Michittu, M. B., Murgia, M. G., Onano, B., Fratino, L., Maso, L. D., De Paoli, P., Verdirosi, D., Vaccher, E., Pisani, F., Famulari, A., Delreno, F., Iesari, S., De Luca, L., Iaria, M., Capocasale, E., Cremaschi, E., Sandrini, S., Valerio, F., Mazzucotelli, V., Bossini, N., Setti, G., Veroux, M., Veroux, P., Giaquinta, A., Zerbo, D., Busnach, G., Di Leo, L., Perrino, M. L., Querques, M., Colombo, V., Sghirlanzoni, M. C., Messa, P., Leoni, A., Galatioto, L., Gruttadauria, S., Sparacino, V., Caputo, F., Buscemi, B., Spagnoletti, Gionata, Salerno, Maria Paola, Favi, E., Segoloni, G. P., Biancone, L., Lavacca, A., Maresca, M. C., Cascone, C., Virgilio, B., Donati, D., Dossi, F., Fontanella, A., Ambrosini, A., Di Cicco, M., Citterio F. (ORCID:0000-0003-0489-6337), Grandaliano G. (ORCID:0000-0003-1213-2177), Spagnoletti G. (ORCID:0000-0003-2626-8147), Salerno M. P., Taborelli, M., Toffolutti, F., Del Zotto, S., Clagnan, E., Furian, L., Piselli, P., Citterio, Franco, Zanier, L., Boscutti, G., Serraino, D., Shalaby, S., Petrara, R., Burra, P., Zanus, G., Zanini, S., Rigotti, P., Rendina, M., Di Leo, A., Schena, F. P., Grandaliano, Giuseppe, Fiorentino, M., Lauro, A., Pinna, A. D., Di Gioia, P., Pellegrini, S., Zanfi, C., Scolari, M. P., Stefoni, S., Todeschini, P., Panicali, L., Valentini, C., Baccarani, U., Risaliti, A., Adani, G. L., Lorenzin, D., Ettorre, G. M., Vennarecci, G., Colasanti, M., Coco, M., Ettorre, F., Santoro, R., Miglioresi, L., Nudo, F., Rossi, M., Mennini, G., Toti, L., Tisone, G., Casella, A., Fazzolari, L., Sforza, D., Iaria, G., Gazia, C., Belardi, C., Cimaglia, C., Agresta, A., D'Offizi, G., Comandini, U. V., Lionetti, R., Montalbano, M., Taibi, C., Fantola, G., Zamboni, F., Piredda, G. B., Michittu, M. B., Murgia, M. G., Onano, B., Fratino, L., Maso, L. D., De Paoli, P., Verdirosi, D., Vaccher, E., Pisani, F., Famulari, A., Delreno, F., Iesari, S., De Luca, L., Iaria, M., Capocasale, E., Cremaschi, E., Sandrini, S., Valerio, F., Mazzucotelli, V., Bossini, N., Setti, G., Veroux, M., Veroux, P., Giaquinta, A., Zerbo, D., Busnach, G., Di Leo, L., Perrino, M. L., Querques, M., Colombo, V., Sghirlanzoni, M. C., Messa, P., Leoni, A., Galatioto, L., Gruttadauria, S., Sparacino, V., Caputo, F., Buscemi, B., Spagnoletti, Gionata, Salerno, Maria Paola, Favi, E., Segoloni, G. P., Biancone, L., Lavacca, A., Maresca, M. C., Cascone, C., Virgilio, B., Donati, D., Dossi, F., Fontanella, A., Ambrosini, A., Di Cicco, M., Citterio F. (ORCID:0000-0003-0489-6337), Grandaliano G. (ORCID:0000-0003-1213-2177), Spagnoletti G. (ORCID:0000-0003-2626-8147), and Salerno M. P.

Abstract

Background: In southern Europe, the risk of cancer in patients with end-stage kidney disease receiving dialysis has not been well quantified. The aim of this study was to assess the overall pattern of risk for de novo malignancies (DNMs) among dialysis patients in the Friuli Venezia Giulia region, north-eastern Italy. Methods: A population-based cohort study among 3407 dialysis patients was conducted through a record linkage between local healthcare databases and the cancer registry (1998-2013). Person-years (PYs) were calculated from 30 days after the date of first dialysis to the date of DNM diagnosis, kidney transplant, death, last follow-up or December 31, 2013, whichever came first. The risk of DNM, as compared to the general population, was estimated using standardized incidence ratios (SIRs) and 95% confidence intervals (CIs). Results: During 10,798 PYs, 357 DNMs were diagnosed in 330 dialysis patients. A higher than expected risk of 1.3-fold was found for all DNMs combined (95% CI: 1.15-1.43). The risk was particularly high in younger dialysis patients (SIR = 1.88, 95% CI: 1.42-2.45 for age 40-59 years), and it decreased with age. Moreover, significantly increased DNM risks emerged during the first 3 years since dialysis initiation, especially within the first year (SIR = 8.52, 95% CI: 6.89-10.41). Elevated excess risks were observed for kidney (SIR = 3.18; 95% CI: 2.06-4.69), skin non-melanoma (SIR = 1.81, 95% CI: 1.46-2.22), oral cavity (SIR = 2.42, 95% CI: 1.36-4.00), and Kaposi's sarcoma (SIR = 10.29, 95% CI: 1.25-37.16). Conclusions: The elevated risk for DNM herein documented suggest the need to implement a targeted approach to cancer prevention and control in dialysis patients.

Published
2019

7. A rapid method for detection of fumonisins B1 and B2 in corn meal using Fourier transform near infrared (FT-NIR) spectroscopy implemented with integrating sphere

Author

Gaspardo, B., Del Zotto, S., Torelli, E., Cividino, S.R., Firrao, G., Della Riccia, G., and Stefanon, B.

Subjects
*CORN meal, *FUMONISINS, *FOOD composition, *NEAR infrared spectroscopy, *ORGANIC compounds, *PRINCIPAL components analysis
Abstract

Abstract: Fourier transform near infrared (FT-NIR) spectroscopy is an analytical procedure generally used to detect organic compounds in food. In this work the ability to predict fumonisin B1 +B2 contents in corn meal using an FT-NIR spectrophotometer, equipped with an integration sphere, was assessed. A total of 143 corn meal samples were collected in Friuli Venezia Giulia Region (Italy) and used to define a 15 principal components regression model, applying partial least square regression algorithm with full cross validation as internal validation. External validation was performed to 25 unknown samples. Coefficients of correlation, root mean square error and standard error of calibration were 0.964, 0.630 and 0.632, respectively and the external validation confirmed a fair potential of the model in predicting FB1 +FB2 concentration. Results suggest that FT-NIR analysis is a suitable method to detect FB1 +FB2 in corn meal and to discriminate safe meals from those contaminated. [Copyright &y& Elsevier]

Published
2012
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8. Cost-effectiveness of the adherence with recommendations for clinical monitoring of patients with diabetes

Author

Giovanni Corrao, Federico Rea, Giuseppe Mancia, Gianluca Perseghin, Luca Merlino, Nello Martini, Simona Carbone, Flavia Carle, Andrea Bucci, Marianxhela Dajko, Silvia Arcà, Donata Bellentani, Velia Bruno, Carla Ceccolini, Angela De Feo, Lucia Lispi, Rosanna Mariniello, Maurizio Masullo, Federica Medici, Paola Pisanti, Modesta Visca, Rinaldo Zanini, Teresa Di Fiandra, Natalia Magliocchetti, Giovanna Romano, Anna Cantarutti, Pietro Pugni, Marina Davoli, Mirko Di Martino, Adele Lallo, Patrizia Vittori, Giuliana Vuillermin, Alfonso Bernardo, Anna Fusciante, Laura Belotti, Rossana De Palma, Enza Di Felice, Roberta Chiandetti, Elena Clagnan, Stefania Del Zotto, Andrea Di Lenarda, Aldo Mariotto, Marisa Prezza, Loris Zanier, Danilo Fusco, Chiara Marinacci, Antonio Lora, Liana Spazzafumo, Simone Pizzi, Maria Simiele, Giuseppe Massaro, Ettore Attolini, Vito Lepore, Vito Petrarolo, Giovanni De Luca, Giovanna Fantaci, Sebastiano Pollina Addario, Salvatore Scondotto, Francesco Bellomo, Mario Braga, Valeria Di Fabrizio, Silvia Forni, Paolo Francesconi, Francesco Profili, Francesco Avossa, Matteo Corradin, Silvia Vigna, Letizia Dondi, Antonella Pedrini, Carlo Piccinni, Mimma Cosentino, Maria G. Marvulli, Aldo Maggioni, Corrao, G, Rea, F, Mancia, G, Perseghin, G, Merlino, L, Martini, N, Carbone, S, Carle, F, Bucci, A, Dajko, M, Arca, S, Bellentani, D, Bruno, V, Ceccolini, C, De Feo, A, Lispi, L, Mariniello, R, Masullo, M, Medici, F, Pisanti, P, Visca, M, Zanini, R, Di Fiandra, T, Magliocchetti, N, Romano, G, Cantarutti, A, Pugni, P, Davoli, M, Di Martino, M, Lallo, A, Vittori, P, Vuillermin, G, Bernardo, A, Fusciante, A, Belotti, L, De Palma, R, Di Felice, E, Chiandetti, R, Clagnan, E, Del Zotto, S, Di Lenarda, A, Mariotto, A, Prezza, M, Zanier, L, Fusco, D, Marinacci, C, Lora, A, Spazzafumo, L, Pizzi, S, Simiele, M, Massaro, G, Attolini, E, Lepore, V, Petrarolo, V, De Luca, G, Fantaci, G, Pollina Addario, S, Scondotto, S, Bellomo, F, Braga, M, Di Fabrizio, V, Forni, S, Francesconi, P, Profili, F, Avossa, F, Corradin, M, Vigna, S, Dondi, L, Pedrini, A, Piccinni, C, Cosentino, M, Marvulli, M, and Maggioni, A

Subjects
Diagnostic Screening Programs, Male, medicine.medical_specialty, Time Factors, Databases, Factual, National Health Programs, Cost effectiveness, Endocrinology, Diabetes and Metabolism, Cost-Benefit Analysis, Population, Medicine (miscellaneous), Audit, Diagnostic Techniques, Ophthalmological, Diabete, Kidney Function Tests, Cost Savings, Predictive Value of Tests, Diabetes mellitus, Health care, medicine, Diabetes Mellitus, Healthcare cost, Humans, education, Aged, Incremental cost-effectiveness ratio, education.field_of_study, Nutrition and Dietetics, medicine.diagnostic_test, business.industry, Periodic examination, Health Care Costs, Middle Aged, medicine.disease, Prognosis, Population-based cohort study, Real-world, Italy, Cost-effectivene, Emergency medicine, Patient Compliance, Female, Cardiology and Cardiovascular Medicine, business, Lipid profile, Complication, Blood Chemical Analysis, Cohort study
Abstract

Background and aims To validate a set of indicators for monitoring the quality of care of patients with diabetes in ‘real-life’ practice through its relationship with measurable clinical outcomes and healthcare costs. Methods and results A population-based cohort study was carried out by including the 20,635 patients, residents in the Lombardy Region (Italy), who in the year 2012 were newly taken-in-care for diabetes. Adherence with clinical recommendations (i.e., controls for glycated haemoglobin, lipid profile, urine albumin excretion and serum creatinine) was recorded during the first year after the patient was taken-in-care, and categorized according whether he/she complied with none or almost none (0 or 1), just some (2) or all or almost all (3 or 4) the recommendations, respectively denoted as poor, intermediate and high adherence. Short- and long-term complications of diabetes, and healthcare cost incurred by the National Health Service, were assessed during follow-up. Compared with patients with poor adherence, those with intermediate and high adherence respectively showed (i) a delay in outcome occurrence of 13 days (95% CI, -2 to 27) and 23 days (9 to 38), and (ii) a lower healthcare cost of 54 € and 77 €. In average, a gain of 18 Euros and 15 Euros for each day free from diabetic complication by increasing adherence respectively from poor to intermediate and from poor to high were observed. Conclusion Close control of patients with diabetes through regular clinical examinations must be considered the cornerstone of national guidance, national audits, and quality improvement incentive schemes.

Published
2021

9. Acute Appendicitis After COVID-19 Vaccines in Italy: A Self-Controlled Case Series Study.

Author

Morciano C, Massari M, Cutillo M, Belleudi V, Trifirò G, Mores N, Sapigni E, Puccini A, Zanoni G, Zorzi M, Monaco G, Leoni O, Del Zotto S, Samez S, Mayer F, Marano G, Menniti Ippolito F, Da Cas R, Traversa G, and Spila Alegiani S

Subjects
Humans, Male, Italy epidemiology, Female, Adult, Middle Aged, Young Adult, Adolescent, Aged, ChAdOx1 nCoV-19 adverse effects, Child, Acute Disease, SARS-CoV-2, Ad26COVS1 adverse effects, Appendicitis epidemiology, BNT162 Vaccine adverse effects, 2019-nCoV Vaccine mRNA-1273 adverse effects, COVID-19 Vaccines adverse effects, COVID-19 Vaccines administration & dosage, COVID-19 prevention & control, COVID-19 epidemiology
Abstract

Background and Objective: Cases of appendicitis were identified in the pivotal randomized clinical trial on BNT162b2 mRNA vaccine and reported from coronavirus disease 2019 (COVID-19) vaccine pharmacovigilance systems. Three cohort studies and two self-controlled case series (SCCS) studies evaluating the association between mRNA vaccines and appendicitis reported discordant results. To address this uncertainty, the present study examines in a large population, with a SCCS design, the association between mRNA (BNT162b2 and mRNA-1273) and, for the first time, viral vector (ChAdOx1-S and Ad26.COV2-S) COVID-19 vaccines and acute appendicitis., Methods: The SCCS study design was used to evaluate the association between COVID-19 vaccination and subsequent onset of acute appendicitis. The study was based on record linkage of health archives through TheShinISS application, a statistical tool that locally processes data from regional health care databases according to ad hoc, study-tailored and common data model. The study population included all vaccinated subjects ≥ 12 years old between 27 December 2020 and 30 September 2021. The acute appendicitis was identified through discharge diagnoses of hospital admissions or emergency department visits. Incident cases were defined as those who experienced a first event of acute appendicitis in the study period, excluding subjects with a diagnosis of appendicitis in the previous 5 years. Exposure was defined as the first or second dose of BNT162b2, mRNA-1273 and ChAdOx1-S and the single dose of Ad26.COV2-S. The risk interval was defined as 42 days from the first or second vaccination dose and divided into pre-specified risk subperiods; the reference period was the observation time outside the risk interval. Relative incidences (RI) and 95% confidence intervals (95% CI) were estimated with the SCCS method 'modified for event-dependent exposures', through unbiased estimating equations. The seasonal component was considered as a time-dependent covariate., Results: In the 42-day risk interval 1285 incident cases of acute appendicitis occurred: 727 cases after the first dose and 558 cases after the second dose. In the main analysis, no increased risks of acute appendicitis were observed in subjects vaccinated with BNT162b, mRNA-1273, ChAdOx1-S and Ad26.COV2-S. The subgroup analyses by sex showed an increased risk in the 14-27 day risk interval, in males after the first dose of mRNA-1273 (RI of 1.71; 95% CI 1.08-2.70, p = 0.02) and in females after the single dose of Ad26.COV2-S (RI of 4.40; 95% CI 1.29-15.01, p = 0.02)., Conclusions: There was no evidence of association of BNT162b, ChAdOx1-S, mRNA-1273 and Ad26.COV2-S with acute appendicitis in the general population. The results of the subgroup analyses by sex needs to be considered with caution. The multiplicity issue cannot be excluded being these hypotheses two of several hypotheses tested. In addition, relevant literature on the biological mechanism of the disease and evidence of similar effects with other vaccines or with the same vaccines are still lacking to provide strong support for a conclusion that there is an harmful effect in males and females with mRNA-1273 and Ad26.COV2-S., (© 2024. The Author(s).)

Published
2024
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10. SARS-CoV-2 Infection, Vaccination and Risk of Death in People with An Oncological Disease in Northeast Italy.

Author

Mangone L, Giorgi Rossi P, Taborelli M, Toffolutti F, Mancuso P, Dal Maso L, Gobbato M, Clagnan E, Del Zotto S, Ottone M, Bisceglia I, Neri A, and Serraino D

Abstract

People with a history of cancer have a higher risk of death when infected with SARS-CoV-2. COVID-19 vaccines in cancer patients proved safe and effective, even if efficacy may be lower than in the general population. In this population-based study, we compare the risk of dying of cancer patients diagnosed with COVID-19 in 2021, vaccinated or non-vaccinated against SARS-CoV-2 and residing in Friuli Venezia Giulia or in the province of Reggio Emilia. An amount of 800 deaths occurred among 6583 patients; the risk of death was more than three times higher among unvaccinated compared to vaccinated ones [HR 3.4; 95% CI 2.9-4.1]. The excess risk of death was stronger in those aged 70-79 years [HR 4.6; 95% CI 3.2-6.8], in patients with diagnosis made <1 year [HR 8.5; 95% CI 7.3-10.5] and in all cancer sites, including hematological malignancies. The study results indicate that vaccination against SARS-CoV-2 infection is a necessary tool to be included in the complex of oncological therapies aimed at reducing the risk of death., Competing Interests: The authors declare that the research was conducted without any commercial or financial relationships construed as a potential conflict of interest.

Published
2023
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11. The use of PSA testing over more than 20 years: A population-based study in North-Eastern Italy.

Author

Taborelli M, Toffolutti F, Bidoli E, Dal Maso L, Del Zotto S, Clagnan E, Gobbato M, Serraino D, and Franceschi S

Subjects
Humans, Male, Aged, Middle Aged, Prostate pathology, Italy epidemiology, Biopsy, Prostate-Specific Antigen, Prostatic Neoplasms diagnosis, Prostatic Neoplasms epidemiology, Prostatic Neoplasms pathology
Abstract

Objective: To describe the practice of prostate-specific antigen (PSA) testing over more than 20 years in Friuli Venezia Giulia (FVG), North-Eastern Italy., Methods: A population-based, ecological study was conducted using information derived from regional administrative health-related databases. Data on PSA and prostate biopsies performed on resident men aged ⩾45 years from 1998 to 2019 were retrieved. PSA and biopsy rates were calculated as the number of men who had at least one such procedure in each calendar year over the mean resident male population of the same year. Temporal trends were analyzed using joinpoint regression (annual percentage change -APC)., Results: A total of 2,502,670 PSA were made between 1998 to 2019 in men aged ⩾45 years. The number of PSA steadily increased from 51,055 in 1998-1999 to 134,504 in 2010-2011, then dropped to 122,080 in 2018-2019. Significant changes in the slopes of PSA rates emerged in 2002 and 2009: the largest increase occurred during 1998-2002 (APC 18.4), followed by a smaller increase in 2002-2009 (APC 3.4) and a subsequent reduction (APC -2.5). Similar patterns emerged for all ages, but the decrease since 2009 was smaller for men aged ⩾65 years. An upward trend emerged in biopsy rate from 1998 to 2001 (APC 13.0), followed by a smaller increase until 2007 (APC 5.7) and a subsequent decrease. Biopsies as percentage of PSA decreased from 3.2% to 2.2%, particularly in those aged ⩾75 years., Conclusions: Although overall declining PSA rates have been observed in FVG since 2009, rates remained higher in the ⩾65-year-old group than in the 45-64-year-old group.

Published
2023
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12. Outcomes of SARS-CoV-2 infection in cancer versus non-cancer-patients: a population-based study in northeastern Italy.

Author

Rugge M, Zorzi M, Guzzinati S, Stocco C, Avossa F, Del Zotto S, Clagnan E, Bricca L, Dal Maso L, and Serraino D

Subjects
Male, Humans, Aged, SARS-CoV-2, COVID-19 Testing, Comorbidity, COVID-19 complications, COVID-19 epidemiology, Neoplasms complications, Neoplasms epidemiology
Abstract

Introduction: This study assesses the risk of infection and clinical outcomes in a large consecutive population of cancer and non-cancer patients tested for SARS-CoV-2 status., Methods: Study patients underwent SARS-CoV-2 molecular-testing between 22 February 2020 and 31 July 2020, and were found infected (CoV2+ ve ) or uninfected. History of malignancy was obtained from regional population-based cancer registries. Cancer-patients were distinguished by time between cancer diagnosis and SARS-CoV-2 testing (<12/⩾12 months). Comorbidities, hospitalization, and death at 15 September 2020 were retrieved from regional population-based databases. The impact of cancer history on SARS-CoV-2 infection and clinical outcomes was calculated by fitting a multivariable logistic regression model, adjusting for sex, age, and comorbidities., Results: Among 552,362 individuals tested for SARS-CoV-2, 55,206 (10.0%) were cancer-patients and 22,564 (4.1%) tested CoV2+ ve . Irrespective of time since cancer diagnosis, SARS-CoV-2 infection was significantly lower among cancer patients (1,787; 3.2%) than non-cancer individuals (20,777; 4.2% - Odds Ratio (OR)=0.60; 0.57-0.63). CoV2+ ve cancer-patients were older than non-cancer individuals (median age: 77 versus 57 years; p<0.0001), were more frequently men and with comorbidities. Hospitalizations (39.9% versus 22.5%; OR=1.61; 1.44-1.80) and deaths (24.3% versus 9.7%; OR=1.51; 1.32-1.72) were more frequent in cancer-patients. CoV2+ ve cancer-patients were at higher risk of death (lung OR=2.90; 1.58-5.24, blood OR=2.73; 1.88-3.93, breast OR=1.77; 1.32-2.35)., Conclusions: The risks of hospitalization and death are significantly higher in CoV2+ ve individuals with past or present cancer (particularly malignancies of the lung, hematologic or breast) than in those with no history of cancer.

Published
2023
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13. Vaccination against SARS-CoV-2 and risk of hospital admission and death among infected cancer patients: A population-based study in northern Italy.

Author

Gobbato M, Clagnan E, Toffolutti F, Del Zotto S, Burba I, Tosolini F, Polimeni J, Serraino D, and Taborelli M

Subjects
Female, Male, Humans, SARS-CoV-2, COVID-19 Vaccines, Cohort Studies, Vaccination, Hospitalization, Italy epidemiology, Hospitals, COVID-19 epidemiology, COVID-19 prevention & control, Neoplasms epidemiology, Neoplasms therapy
Abstract

Background: The risks of hospital admission for COVID-19-related conditions and all-cause death of SARS-CoV-2 infected cancer patients were investigated according to vaccination status., Methods: A population-based cohort study was carried out on 9754 infected cancer patients enrolled from January 1, 2021 to June 30, 2022. Subdistribution hazard ratio (SHRs) or hazard ratios (HRs) with 95 % confidence intervals (CI), adjusted for sex, age, comorbidity index, and time since cancer incidence, were computed to assess the risk of COVID-19 hospital admission or death of unvaccinated vs. patients with at least one dose of vaccine (i.e., vaccinated)., Results: 2485 unvaccinated patients (25.5 %) were at a 2.57 elevated risk of hospital admission (95 % CI: 2.13-2.87) and at a 3.50 elevated risk of death (95 % CI: 3.19-3.85), as compared to vaccinated patients. Significantly elevated hospitalizations and death risks emerged for both sexes, across all age groups and time elapsed since cancer diagnosis. For unvaccinated patients, SHRs for hospitalization were particularly elevated in those with solid tumors (SHR = 2.69 vs. 1.66 in patients with hematologic tumors) while HRs for the risk of death were homogeneously distributed. As compared to boosted patients, SHRs for hospitalization and HRs for death increased with decreasing number of doses., Conclusions: Study findings stress the importance of SARS-CoV-2 vaccines to reduce hospital admission and death risk in cancer patients., Competing Interests: Declaration of interest None., (Copyright © 2022 Elsevier Ltd. All rights reserved.)

Published
2023
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14. Monitoring gestational weight gain: setting up a regional surveillance system in Italy.

Author

Pani P, Carletti C, Giangreco M, Knowles A, Clagnan E, Gobbato M, Del Zotto S, Cattaneo A, and Ronfani L

Subjects
Infant, Newborn, Pregnancy, Female, Humans, Male, Obesity epidemiology, Weight Gain, Overweight epidemiology, Body Mass Index, Italy epidemiology, Pregnancy Outcome epidemiology, Birth Weight, Gestational Weight Gain, Pregnancy Complications epidemiology
Abstract

Background: In many countries, including Italy, there are few national data on pre-pregnancy Body Mass Index (BMI) and gestational weight gain (GWG), despite these being important predictors of maternal and neonatal health outcomes. This dearth of information makes it difficult to develop and monitor intervention policies to reduce the burden of disease linked to inadequate BMI status and/or GWG in pregnant women. This study describes the setting up and initial implementation of a regional surveillance system on pre-pregnancy BMI and GWG., Methods: Between 1 January 2017 and 31 December 2018, anthropometric data were collected from all pregnant women accessing public health services in the Friuli Venezia Giulia region (Italy) for first ultrasound check (T1) and at delivery (T2). Anthropometric data collected at T1 (self-reported pre-pregnancy weight and measured weight and height) and T2 (measured weight and self-reported pre-pregnancy weight and height) were compared., Results: The system was able to reach 43.8% of all the women who gave birth in the region, and provided complete data for 6400 women of the 7188 who accessed the services at T1. At the beginning of pregnancy 447 (7.0%) women were underweight, 4297 (67.1%) had normal weight, 1131 (17.7%) were overweight and 525 (8.2%) had obesity. At delivery, 2306 (36.0%) women were within the appropriate weight gain range, while for 2021 (31.6%) weight gain was insufficient and for 2073 (32.4%) excessive. Only minor differences were observed between measured and self-reported anthropometric data., Conclusions: The surveillance system offers an overview of the weight status of women during pregnancy. About 1/3 of women entered pregnancy with unsatisfactory BMI and 2/3 did not achieve the recommended weight gain. This surveillance system can be an effective tool to guide public health interventions., (© 2023. The Author(s).)

Published
2023
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15. Risk factors for territorial spreading of SARS-CoV-2 in North-eastern Italy.

Author

Bidoli E, Toffolutti F, Del Zotto S, and Serraino D

Subjects
Bayes Theorem, COVID-19 prevention & control, COVID-19 virology, Cities, Humans, Incidence, Italy epidemiology, Odds Ratio, Risk Factors, SARS-CoV-2 isolation & purification, COVID-19 epidemiology
Abstract

The impact of specific risk factors for SARS-CoV-2 infection spread was investigated among the 215 municipalities in north-eastern Italy. SARS-CoV-2 incidence was gathered fortnightly since April 1, 2020 (21 consecutive periods) to depict three indicators of virus spreading from hierarchical Bayesian maps. Eight explanatory features of the municipalities were obtained from official databases (urbanicity, population density, active population on total, hosting schools or nursing homes, proportion of commuting workers or students, and percent of > 75 years population on total). Multivariate Odds Ratios (ORs), and corresponding 95% Confidence Intervals (CIs), quantified the associations between municipality features and virus spreading. The municipalities hosting nursing homes showed an excess of positive tested cases (OR = 2.61, ever versus never, 95% CI 1.37;4.98), and displayed repeated significant excesses: OR = 5.43, 3-4 times versus 0 (95% CI 1.98;14.87) and OR = 6.10, > 5 times versus 0 (95% CI 1.60;23.30). Municipalities with an active population > 50% were linked to a unique statistical excess of cases (OR = 3.06, 1 time versus 0, 95% CI 1.43;6.57) and were inversely related to repeated statistically significant excesses (OR = 0.25, > 5 times versus 0; 95% CI 0.06;0.98). We highlighted specific municipality features that give clues about SARS-CoV-2 prevention., (© 2022. The Author(s).)

Published
2022
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16. Prevalence, determinants, and outcomes of SARS-COV-2 infection among cancer patients. A population-based study in northern Italy.

Author

Serraino D, Zucchetto A, Dal Maso L, Del Zotto S, Taboga F, Clagnan E, Fratino L, Tosolini F, and Burba I

Subjects
Aged, Aged, 80 and over, COVID-19 mortality, Female, Humans, Intensive Care Units statistics & numerical data, Italy epidemiology, Male, Middle Aged, Mortality, Neoplasms epidemiology, Prevalence, Retrospective Studies, COVID-19 epidemiology, Neoplasms virology
Abstract

Background: It is well established that cancer patients infected with SARS-CoV-2 are at particularly elevated risk of adverse outcomes, but the comparison of SARS-CoV-2 infection risk between cancer patients and cancer-free individuals has been poorly investigated on a population-basis., Methods: A population-based study was thus conducted in Friuli Venezia Giulia region, northeastern Italy, to estimate prevalence and determinants of SARS-CoV-2 infection among cancer patients, as compared to cancer-free individuals, and to evaluate adverse outcomes of SARS-CoV-2 infection. The study included 263,042 individuals tested for SARS-CoV-2 in February-December 2020 with cancer history retrieved through the regional cancer registry. Odds ratios (ORs) of SARS-CoV-2 positivity, with corresponding 95% confidence intervals (CIs), were calculated using multivariable logistic regression models, adjusted for sex and age. Hazard ratios (HRs) adjusted for sex and age for intensive care unit (ICU) admission and all-cause death were estimated using Cox models., Results: Among 26,394 cancer patients tested for SARS-CoV-2, the prevalence of infection was 11.7% versus 16.2% among 236,648 cancer-free individuals, with a corresponding OR = 0.59 (95% CI: 0.57-0.62). The prevalence was much higher (29% in both groups) during the second pandemic wave (October-December 2020). Among cancer patients, age ≥80 years and cancer diagnosis ≥13 months before SARS-CoV-2 testing were the major risk factors of infection. Among 3098 infected cancer patients, the fatality rate was 17.4% versus 15.8% among 23,296 negative ones (HR = 1.63, 95% CI: 1.49-1.78), and versus 5.0% among 38,268 infected cancer-free individuals (HR = 1.23, 95% CI: 1.12-1.36). No significant differences emerged when considering ICU admission risk., Conclusion: Albeit cancer patients reported reduced SARS-CoV-2 infection risk, those infected showed higher mortality than uninfected ones and infected cancer-free population. Study findings claim for continuing to protect cancer patients from SARS-CoV-2, without reducing the level of oncologic care., (© 2021 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.)

Published
2021
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17. COVID-19 infections in the Friuli Venezia Giulia Region (Northern Italy): a population-based retrospective analysis.

Author

Calagnan E, Gobbato M, Burba I, Del Zotto S, Toffolutti F, Serraino D, and Tonutti G

Subjects
Adolescent, Adult, Age Distribution, Aged, Aged, 80 and over, Angiotensin II Type 1 Receptor Blockers therapeutic use, Angiotensin Receptor Antagonists therapeutic use, COVID-19 diagnosis, COVID-19 Testing statistics & numerical data, Child, Child, Preschool, Comorbidity, Databases, Factual, Female, Geography, Medical, Homes for the Aged statistics & numerical data, Hospitalization statistics & numerical data, Humans, Incidence, Infant, Infant, Newborn, Italy epidemiology, Male, Middle Aged, Procedures and Techniques Utilization, Retrospective Studies, Sex Distribution, Young Adult, COVID-19 epidemiology, Pandemics, SARS-CoV-2
Abstract

Objectives: to study the cumulative incidence, the demographics and health conditions of the population tested for COVID-19, and to map the evolving distribution of individual cases in the population of the Friuli Venezia Giulia Region (North-Eastern Italy)., Design: population-based observational study based on a record linkage procedure of databases included in the electronic health information system of the Friuli Venezia Giulia Region., Setting and Participants: the study group consisted of individuals who resided in the Friuli Venezia Giulia Region and who underwent COVID-19 testing from 01.03 to 24.04.2020. The study group was identified from the laboratory database, which contains all the microbiological testing performed in regional facilities. Tested people were categorized into positive or negative cases, based on test results., Main Outcome Measures: probability of being tested for and cumulative incidence of COVID-19., Results: the cumulative probability of being tested for COVID-19 was 278/10,000 inhabitants, while the cumulative incidence was 22 cases/10,000. Out of 33,853 tested people, 2,744 (8.1%) turned out to be positive for COVID-19. Women were tested more often than men (337 vs 216/10,000), and they showed a higher incidence of infection than men (25 and 19 infected cases/10,000 residents, respectively). Both cumulative incidence and cumulative probability of being tested were higher in the elderly population. About 25% of infected people was hosted in retirement homes and 9% was represented by healthcare workers. Thirty seven percent of positive cases had hypertension, 15% cardiologic diseases, while diabetes and cancer characterized 11.7% and 10% of the infected population, respectively. The geographic distribution of positive cases showed a faster spread of the infection in the city of Trieste, an urban area with the highest regional population density., Conclusions: the COVID-19 pandemic did not hit the Friuli Venezia Giulia Region as hard as other Northern Italian Regions. In the early phase, as documented in this study, the COVID-19 pandemic particularly affected women and elderly people, especially those living in retirement homes in Trieste.

Published
2020
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18. Clinical, demographical characteristics and hospitalisation of 3,010 patients with Covid-19 in Friuli Venezia Giulia Region (Northern Italy). A multivariate, population-based, statistical analysis.

Author

Gobbato M, Clagnan E, Burba I, Rizzi L, Grassetti L, Del Zotto S, Dal Maso L, Serraino D, and Tonutti G

Subjects
Age Distribution, Aged, Angiotensin II Type 1 Receptor Blockers pharmacology, Angiotensin Receptor Antagonists pharmacology, Catchment Area, Health, Comorbidity, Databases, Factual, Female, Homes for the Aged statistics & numerical data, Hospital Mortality, Hospitalization statistics & numerical data, Humans, Italy epidemiology, Male, Medical Record Linkage, Middle Aged, Multivariate Analysis, Pneumococcal Vaccines, Residence Characteristics, Retrospective Studies, Sex Distribution, Vaccination statistics & numerical data, COVID-19 epidemiology, Pandemics
Abstract

Objectives: to describe the clinical and demographical characteristics of COVID-19 infected people in the Friuli Venezia Giulia Region (FVG, Northern Italy)., Design: retrospective cohort study with an individual level record linkage procedure of different administrative databases., Setting and Participants: the cohort included 3,010 patients residing in FVG who tested positive for COVID-19 between 1 March and 15 May 2020, 2020. Regional hospital admissions and deaths without hospital admissions up to June 1st, 2020 were analysed. Determinants of the probability of a highly severe illness were investigated in terms of hospitalisations or death without hospital admission., Main Outcome Measures: COVID-19 patients were identified from regional epidemiological data warehouse. Demographical and clinical variables such as gender, age, patient's comorbidities, vaccinations, ARBs/sartans prescriptions, and geographical residence variables were collected by linking different databases. Descriptive analyses were performed. Logistic multivariate regressions were used to estimate the probability of hospitalisation or death, whichever came first. Model coefficients and odds ratios (OR) were reported., Results: COVID-19 population in FVG had a mean age of 60 years and 59% were females. The study found that 37% had hypertension while patients with cardiologic diseases, diabetes, and cancer were around 15%; 22% of the cases were residing in retirement homes. Approximately 30% received flu or pneumococcal vaccination and a similar proportion of patients had at least one prescription of ARBs /sartans in the previous 6 months. Statistical models showed a higher probability of a worst course of disease for males, elderly, highly complicated (in terms of resource use) subjects, in the presence of cardiologic diseases, diabetes, and pneumococcal vaccination. People living in retirement homes had a lower probability of hospitalisation/death without hospital admission. The cohort was divided into two groups: COVID-19 patients infected in the territory and infected in retirement homes. Among COVID-19 patients infected in the territory, the probability of hospitalisation/death was higher for males, for older individuals, and for those with comorbidities. Diabetes resulted to be a risk factor (OR 1.79; 95%CI 1.23-2.62), as well as pneumococcal vaccination (OR 1.64; 95%CI: 1.18-2.29), which is a likely proxy of fragile patients with pulmonary disease. The flu vaccination showed a potential protective effect with a 40% lower probability of hospitalisation or death (OR 0.62; 95%CI 0.44-0.85). Among the retirement homes cohort group, a higher probability of a bad course of disease emerged for males and for more complex patients., Conclusions: the greatest risk of hospitalisation/death as a measure of more severe illness was confirmed for males, elderly, and for individuals with comorbidities. Flu vaccination seemed to have had a protective effect while pneumococcal vaccination likely identified a group of high-risk patients to be actively monitored. For patients infected in the territory, different hospitalisation strategies were implemented by the regional health districts.

Published
2020
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19. Preventing the Risk of Hospitalization for Respiratory Complications of Influenza among the Elderly: Is There a Better Influenza Vaccination Strategy? A Retrospective Population Study.

Author

Cocchio S, Gallo T, Del Zotto S, Clagnan E, Iob A, Furlan P, Fonzo M, Bertoncello C, and Baldo V

Abstract

Influenza and its complications are an important public health concern, and vaccination remains the most effective prevention measure. However, the efficacy of vaccination depends on several variables, including the type of strategy adopted. The goal of this study was to assess the impact of different influenza vaccination strategies in preventing hospitalizations for influenza and its related respiratory complications. A retrospective cohort study was conducted on data routinely collected by the health services for six consecutive influenza seasons, considering the population aged 65 years or more at the time of their vaccination and living in northeastern Italy. Our analysis concerns 987,266 individuals vaccinated against influenza during the study period. The sample was a mean 78.0 ± 7.7 years old, and 5681 individuals (0.58%) were hospitalized for potentially influenza-related reasons. The hospitalization rate tended to increase over the years, not-significantly peaking in the 2016-2017 flu season (0.8%). Our main findings revealed that hospitalizations related to seasonal respiratory diseases were reduced as the use of the enhanced vaccine increased ( R 2 = 0.5234; p < 0.001). Multivariate analysis confirmed the significantly greater protective role of the enhanced vaccine over the conventional vaccination strategy, with adjusted Odds Ratio (adj OR) = 0.62 (95% CI: 0.59-0.66). A prior flu vaccination also had a protective role (adj OR: 0.752 (95% CI: 0.70-0.81)). Age, male sex, and H3N2 mismatch were directly associated with a higher risk of hospitalization for pneumonia. In the second part of our analysis, comparing MF59-adjuvanted trivalent inactivated vaccine (MF59-TIV) with conventional vaccines, we considered 479,397 individuals, of which 3176 (0.66%) were admitted to a hospital. The results show that using the former vaccine reduced the risk of hospitalization by 33% (adj OR: 0.67 (95% CI: 0.59-0.75)). This study contributes to the body of evidence of a greater efficacy of enhanced vaccines, and MF59-adjuvanted TIV in particular, over conventional vaccination strategies in the elderly.

Published
2020
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20. Risk of intestinal and extra-intestinal cancers in patients with inflammatory bowel diseases: A population-based cohort study in northeastern Italy.

Author

Taborelli M, Sozzi M, Del Zotto S, Toffolutti F, Montico M, Zanier L, and Serraino D

Subjects
Adolescent, Adult, Aged, Aged, 80 and over, Disease Progression, Humans, Italy, Kaplan-Meier Estimate, Middle Aged, Population Surveillance methods, Retrospective Studies, Risk Assessment methods, Risk Assessment statistics & numerical data, Risk Factors, Young Adult, Colitis, Ulcerative pathology, Colorectal Neoplasms diagnosis, Crohn Disease pathology, Intestinal Neoplasms diagnosis
Abstract

The cancer risk of patients with inflammatory bowel diseases (IBD) has not been well documented in southern Europe. This study aimed to evaluate the overall pattern of cancer risk among patients with IBD in Friuli Venezia Giulia, northeastern Italy. A population-based cohort study was performed through a record linkage between local healthcare databases and the cancer registry (1995-2013). We identified 3664 IBD patients aged 18-84 years, including 2358 with ulcerative colitis (UC) and 1306 with Crohn's disease (CD). Sex- and age-standardized incidence ratios (SIRs) and 95% confidence intervals (CIs) were used to compare the cancer incidence of IBD patients with the general population. The cumulative cancer risk among IBD patients reached about 10% after 10 years of follow-up. A total of 246 cancers occurred among UC patients (SIR = 1.05, 95% CI: 0.92-1.19), and 141 among CD patients (SIR = 1.20, 95% CI: 1.01-1.41). As compared with the general population, no increased risk of colorectal cancers was observed for either UC or CD patients, whereas the risk of anal cancer was significantly elevated among UC patients (SIR = 6.03, 95% CI: 1.24-17.60). Increased risks were seen for specific extra-intestinal cancers, including corpus uteri (SIR = 2.67, 95% CI: 1.07-5.50) and kidney (SIR = 2.06, 95% CI: 1.03-3.69) among UC patients; thyroid (SIR = 5.58, 95% CI: 2.41-11.00) and skin non-melanoma (SIR = 1.86, 95% CI: 1.32-2.55) among CD patients. This population-based study showed that both UC and CD patients had a colorectal cancer risk similar to that of the general population. However, they were at a higher risk of developing certain extra-intestinal cancer types. Although detection biases cannot be excluded, the study findings pointed to a role of long-standing exposures to immunosuppressive therapies, underlying disease status, as well as the interactions with lifestyle factors. Our findings lent additional support to the need for monitoring the cancer burden in this at-risk population., Competing Interests: The authors have declared that no competing interests exist.

Published
2020
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21. [Early effects of attendance to the Friuli Venezia Giulia (Northern Italy) mammography screening programme on the incidence of advanced-stage breast cancer: a cohort study].

Author

Giudici F, Bortul M, Clagnan E, Del Zotto S, Franzo A, Giordano L, Gobbato M, Puliti D, Serraino D, Zucchetto A, Zanier L, Zanconati F, and Bucchi L

Subjects
Adult, Aged, Female, Humans, Incidence, Italy epidemiology, Mammography, Middle Aged, Breast Neoplasms epidemiology, Early Detection of Cancer statistics & numerical data
Abstract

Objectives: to evaluate the incidence of advanced-stage breast cancer (BC) - an early surrogate indicator of effectiveness of mammography screening - among women who attended the Friuli Venezia Giulia (FVG) Region (Northern Italy) screening programme compared to women who did not attend., Design: retrospective cohort study. Women invited to the first screening round (2006-2007) were identified from the database of the programme. The cohort was record-linked to the archive of women invited to the second round (2008-2009). The definition of attendance to screening was based on attendance to at least one of the two rounds. The incidence of BC was assessed through record linkage with the FVG cancer registry using an anonymous univocal identifier (end of follow-up: 31st December 2013). Three distinct definitions of advanced stage were used: pT2 or greater (pT2+), positive lymph nodes (pN+), and TNM stage II or greater (stage II+)., Setting and Participants: organized mammography screening programme for women aged 50-69 years in the five regional healthcare districts., Main Outcome Measures: incidence rate ratio (IRR) between attenders and non-attenders, adjusted for age and deprivation index, with 95% confidence interval (95%CI)., Results: the cohort included 104,488 attenders and 49,839 non-attenders. During follow-up (median duration 84 months), 2,717 invasive BCs were diagnosed among attenders and 1,149 among non-attenders. Total incidence rate was 13% higher among attenders (IRR 1.13; 95%CI 1.05-1.21). These, conversely, had a 36% lower rate of pT2+ BC (IRR 0.64; 95%CI 0.56-0.72), a 13% lower rate of pN+ BC (IRR 0.87; 95%CI 0.78-0.98), a 22% lower rate of stage II+ BC (IRR 0.78; 95%CI 0.70-0.87), and a 32% lower rate of mastectomy (IRR 0.68; 95%CI 0.60-0.78)., Conclusions: attenders had lower incidence rates of advanced-stage BC. This early effect is suggestive of a future impact of the screening programme on BC mortality.

Published
2020
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22. Thyroid cancer in Friuli Venezia Giulia, northeastern Italy: incidence, overdiagnosis, and impact of type of surgery on survival.

Author

Panato C, Serraino D, De Santis E, Forgiarini O, Angelin T, Bidoli E, Zanier L, Del Zotto S, Vaccarella S, Franceschi S, and Dal Maso L

Subjects
Adult, Aged, Aged, 80 and over, Female, Humans, Incidence, Italy epidemiology, Male, Medical Overuse, Middle Aged, Registries, Thyroidectomy methods, Young Adult, Thyroid Neoplasms diagnosis, Thyroid Neoplasms epidemiology
Abstract

Background: Incidence rates of thyroid cancer (TC) increased in the last decades worldwide. This study aimed to describe TC incidence in the Friuli Venezia Giulia (FVG) region, to estimate the quota of overdiagnosis, and to investigate the impact of surgery on long-term survival after TC diagnosis., Methods: TC cases reported to the FVG population-based cancer registry during 2002-2013, aged <85 years, were included. Age standardized rates (ASR) on the European population were computed, while proportion of TC overdiagnosis was estimated in comparison with expected age-specific incidence rates from published time series. Adjusted hazard ratios of death, with 95% confidence intervals, were also estimated., Results: During 2002-2013, 1701 TC cases were reported to the FVG cancer registry, with papillary TC (78.2%) as the most frequent histologic type. ASR increased from 12.4 to 16.5 in women and from 4.3 to 6.2 in men (+33.1% and +44.2%, respectively). Overdiagnosis was estimated as 79% of TC cases in women and 64% in men. Almost all TC cases (97.1%) underwent surgery, including 84.6% of women and 78.9% of men who underwent total thyroidectomy. Up to 10 years after TC diagnosis, the type of surgery did not appear to influence survival., Conclusions: This study documented an increase in TC incidence in FVG in the last decade, with overdiagnosis accounting for a large proportion of TC diagnoses and total thyroidectomy in more than 80% of cases. These findings suggest reconsidering thyroid screening practice and aggressive therapeutic strategies, as recommended by new TC guidelines.

Published
2019
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23. Increased cancer risk in patients undergoing dialysis: a population-based cohort study in North-Eastern Italy.

Author

Taborelli M, Toffolutti F, Del Zotto S, Clagnan E, Furian L, Piselli P, Citterio F, Zanier L, Boscutti G, and Serraino D

Subjects
Adult, Aged, Cohort Studies, Female, Follow-Up Studies, Humans, Italy epidemiology, Kidney Failure, Chronic diagnosis, Male, Middle Aged, Neoplasms diagnosis, Registries, Renal Dialysis trends, Risk Factors, Kidney Failure, Chronic epidemiology, Kidney Failure, Chronic therapy, Neoplasms epidemiology, Population Surveillance methods, Renal Dialysis adverse effects
Abstract

Background: In southern Europe, the risk of cancer in patients with end-stage kidney disease receiving dialysis has not been well quantified. The aim of this study was to assess the overall pattern of risk for de novo malignancies (DNMs) among dialysis patients in the Friuli Venezia Giulia region, north-eastern Italy., Methods: A population-based cohort study among 3407 dialysis patients was conducted through a record linkage between local healthcare databases and the cancer registry (1998-2013). Person-years (PYs) were calculated from 30 days after the date of first dialysis to the date of DNM diagnosis, kidney transplant, death, last follow-up or December 31, 2013, whichever came first. The risk of DNM, as compared to the general population, was estimated using standardized incidence ratios (SIRs) and 95% confidence intervals (CIs)., Results: During 10,798 PYs, 357 DNMs were diagnosed in 330 dialysis patients. A higher than expected risk of 1.3-fold was found for all DNMs combined (95% CI: 1.15-1.43). The risk was particularly high in younger dialysis patients (SIR = 1.88, 95% CI: 1.42-2.45 for age 40-59 years), and it decreased with age. Moreover, significantly increased DNM risks emerged during the first 3 years since dialysis initiation, especially within the first year (SIR = 8.52, 95% CI: 6.89-10.41). Elevated excess risks were observed for kidney (SIR = 3.18; 95% CI: 2.06-4.69), skin non-melanoma (SIR = 1.81, 95% CI: 1.46-2.22), oral cavity (SIR = 2.42, 95% CI: 1.36-4.00), and Kaposi's sarcoma (SIR = 10.29, 95% CI: 1.25-37.16)., Conclusions: The elevated risk for DNM herein documented suggest the need to implement a targeted approach to cancer prevention and control in dialysis patients.

Published
2019
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24. Risk of serious infection among patients receiving biologics for chronic inflammatory diseases: Usefulness of administrative data.

Author

Quartuccio L, Zabotti A, Del Zotto S, Zanier L, De Vita S, and Valent F

Abstract

Risk of hospitalized infections under biologics among patients suffering from chronic inflammatory autoimmune diseases such as rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PSA), or psoriasis was investigated using administrative data. The hospital discharge records database, the medical prescription database, and the database of exemptions from medical charges were linked at the individual patient level. A cohort of patients diagnosed with RA, SA, PSA, and severe psoriasis from 2006 to 2017 was identified and followed-up to either the end of 2017 or hospitalization with the main discharge diagnosis of infection, death, or they moved out of the region. Multiple Cox regression was used to estimate the hazard ratio (HR) of hospitalization associated with bDMARDs and adjusting for age, sex, Charlson's Comorbidity Index, calendar year, prescription of steroids, and use of csDMARDs. Use of bDMARDs was treated as a time-dependent variable. A total of 5596 patients diagnosed with RA, AS, or PSA/severe psoriasis were included in the cohort. Overall, 289 (4.2%) were hospitalized due to infection. Time to first use of biological drugs was significantly associated with a 55% increased risk of hospitalization for infections. Thus, large cohorts from administrative databases are useful to support observations from registries and clinical trials. Patients with chronic autoimmune inflammatory diseases are at risk of serious infections when starting biologics. This risk is higher in the elderly or those with comorbidities. Upper and lower respiratory tract infections are the most common infections. Our findings support prevention policies such as vaccination.

Published
2018
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25. The epidemiology of Parkinson's disease in the Italian region Friuli Venezia Giulia: a population-based study with administrative data.

Author

Valent F, Devigili G, Rinaldo S, Del Zotto S, Tullio A, and Eleopra R

Subjects
Adolescent, Adult, Aged, Aged, 80 and over, Child, Child, Preschool, Female, Humans, Infant, Italy epidemiology, Male, Middle Aged, Parkinson Disease diagnosis, Prevalence, Research Design, Young Adult, Databases, Factual, Incidence, Parkinson Disease epidemiology, Registries statistics & numerical data
Abstract

Parkinson's disease is known to pose a relevant burden to society in industrialized countries. However, not much research has been conducted on the epidemiology of this disease in Italy. Our aim was to estimate the incidence rate and prevalence of Parkinson's disease in the Italian Friuli Venezia Giulia region using administrative health-related databases. Five regional administrative databases (hospitalizations, exemptions from medical charges, drug prescriptions, nursing homes, and home visits) were individually linked with one another through an anonymous stochastic univocal key. Using a pre-defined algorithm, incident and prevalent cases of Parkinson's disease were identified for the year 2016. The estimated regional incidence rate was 0.28 new cases/1000 person-years; prevalence was 3.89/1000 inhabitants. Both increased with increasing age and were higher among males than among females. A considerable proportion of prevalent cases was admitted to the hospital or nursing home in 2016, whereas only a few received home visits by health professionals. The incidence and prevalence of the disease were considerable, especially in the older population, indicating the need to develop multidisciplinary models to care for patients living in the region.

Published
2018
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26. Residence in Proximity of a Coal-Oil-Fired Thermal Power Plant and Risk of Lung and Bladder Cancer in North-Eastern Italy. A Population-Based Study: 1995-2009.

Author

Collarile P, Bidoli E, Barbone F, Zanier L, Del Zotto S, Fuser S, Stel F, Panato C, Gallai I, and Serraino D

Subjects
Aged, Air Pollutants analysis, Benzene analysis, Environmental Monitoring, Female, Humans, Italy epidemiology, Male, Nitrogen Dioxide analysis, Risk Factors, Sulfur Dioxide analysis, Air Pollution analysis, Coal, Fuel Oils, Lung Neoplasms epidemiology, Power Plants, Urinary Bladder Neoplasms epidemiology
Abstract

This study investigated the risk of lung and bladder cancers in people residing in proximity of a coal-oil-fired thermal power plant in an area of north-eastern Italy, covered by a population-based cancer registry. Incidence rate ratios (IRR) by sex, age, and histology were computed according to tertiles of residential exposure to benzene, nitrogen dioxide (NO2), particular matter, and sulfur dioxide (SO2) among 1076 incident cases of lung and 650 cases of bladder cancers. In men of all ages and in women under 75 years of age, no significant associations were observed. Conversely, in women aged ≥75 years significantly increased risks of lung and bladder cancers were related to high exposure to benzene (IRR for highest vs. lowest tertile: 2.00 for lung cancer and 1.94 for bladder cancer) and NO2 (IRR: 1.72 for lung cancer; and 1.94 for bladder cancer). In these women, a 1.71-fold higher risk of lung cancer was also related to a high exposure to SO2. Acknowledging the limitations of our study, in particular that we did not have information regarding cigarette smoking habits, the findings of this study indicate that air pollution exposure may have had a role with regard to the risk of lung and bladder cancers limited to women aged ≥75 years. Such increased risk warrants further analytical investigations., Competing Interests: The Authors declare that they have no conflict of interest.

Published
2017
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27. Impact of pneumococcal conjugate vaccination: a retrospective study of hospitalization for pneumonia in North-East Italy.

Author

Baldo V, Cocchio S, Gallo T, Furlan P, Clagnan E, Del Zotto S, Saia M, Bertoncello C, Buja A, and Baldovin T

Subjects
Adolescent, Adult, Aged, Aged, 80 and over, Child, Child, Preschool, Female, Hospitalization, Humans, Infant, Italy, Male, Middle Aged, Pneumonia prevention & control, Retrospective Studies, Vaccination, Young Adult, Pneumococcal Vaccines therapeutic use, Pneumonia therapy
Abstract

Introduction: Pneumonia remains a common reason for hospitalizing infants and the elderly worldwide, and streptococcal infection is often responsible. The aim of this study was to assess the burden of pneumonia in a large general population., Methods: All pneumonia-related hospitalizations from 2004 to 2013 in north-east Italy were identified from the hospital records with a first-listed diagnosis on discharge of bacterial pneumonia, or a first-listed diagnosis on discharge of meningitis, septicemia or empyema associated with a secondary diagnosis of bacterial pneumonia. We identified major comorbidities, calculated agespecific case-fatality rates (CFR), and estimated the related cost to the health care system., Results: Of the 125,722 hospitalizations identified, 96.9% were cases of pneumonia, 2.4% of septicemia, 0.4% of meningitis, and 0.3% of empyema; 75.3% of hospitalizations involved ≥ 65-yearolds. The overall CFR was 12.4%, and it increased with age, peaking in people over 80 (19.6%). The mean annual pneumonia-associated hospitalization rate was 204.6 per 100,000 population, and it peaked in 0- to 4-year-old children (325.6 per 100,000 in males, 288.9 per 100,000 in females), and adults over 65 (844.9 per 100,000 in males, 605.7 per 100,000 in females). Hospitalization rates dropped over the years for the 0-4 year-olds, and rose for people over 80. The estimated overall annual cost of these pneumonia-related hospitalizations was approximately € 41 million., Conclusions: This study shows that the burden on resources for pneumonia-related hospitalization is an important public health issue. Prevention remains the most valuable tool for containing pneumonia, and vaccination strategies can help in the primary prevention of infection, possibly reducing the number of cases in all age groups.

Published
2016

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