Annali dell'Istituto superiore di sanita最新文献

{"title":"Live biotherapeutic products and their regulatory framework in Italy and Europe.","authors":"Giovanna Franciosa,&nbsp;Serena Guida,&nbsp;Maria Jesus Gomez Miguel,&nbsp;Christina Von Hunolstein","doi":"10.4415/ANN_23_01_09","DOIUrl":"https://doi.org/10.4415/ANN_23_01_09","url":null,"abstract":"<p><p>In Italy and Europe, live microorganisms-containing products meant to be used by vulnerable or sick people for preventing or curing a disease are defined as live biotherapeutic products and are regulated as biological drugs. As such, they must undergo extensive quality, safety and efficacy testing and evaluation before receiving a marketing authorization. This review describes the regulatory framework of live biotherapeutic products with special focus on the European Pharmacopoeia monograph 3053 that set mandatory requirements for this kind of medicines, including verification of the number of live microorganisms and absence of certain contamination indicator microorganisms. The other product categories that may contain live microorganisms are also described, with brief references to the overlaps possibly occurring between the different categories.</p>","PeriodicalId":8246,"journal":{"name":"Annali dell'Istituto superiore di sanita","volume":"59 1","pages":"56-67"},"PeriodicalIF":2.1,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9567939","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Two years of COVID-19. Impacts on accessibility of a mental health service for immigrants and individuals in socio-economic difficulties.","authors":"Massimiliano Aragona,&nbsp;Gianluca Nicolella,&nbsp;Giovanna Laurendi,&nbsp;Andrea Cavani,&nbsp;Gianfranco Costanzo,&nbsp;Concetta Mirisola","doi":"10.4415/ANN_23_01_02","DOIUrl":"https://doi.org/10.4415/ANN_23_01_02","url":null,"abstract":"<p><strong>Objectives: </strong>Mental health services utilization decreased dramatically during the COVID-19 pandemic. For persons who are highly vulnerable and at risk of health and social care exclusion, restrictions negatively affected the accessibility to treatments and their mental conditions.</p><p><strong>Methods: </strong>All psychiatric and psychological interviews carried out at National Institute for Health, Migration and Poverty (INMP) Italy from January 2018 to February 2022 were included in the study. To measure services use, an interrupted time-series analysis using March 2020 as the starting data of COVID-19 pandemic period was considered, and first visits vs follow-up session numbered.</p><p><strong>Results: </strong>A significant decrease was observed in March 2020 due to the lockdown restrictive measures (p<0.001). Later on, the number of psychological interventions significantly increased (p<0.05), whereas the increment of the psychiatric interventions was not significant. By the end of February 2022 the number of visits returned to pre-COVID-19 levels, although recovery was slower than expected, especially for psychiatric visits.</p><p><strong>Conclusions: </strong>After a dramatic drop during the lockdown, access to mental health out-patient clinics slowly returned to pre-pandemic levels in the next two years. Considering that mental health needs have increased during the pandemic, mental health services should improve their efforts to reduce barriers of access and to implement outreach referral.</p>","PeriodicalId":8246,"journal":{"name":"Annali dell'Istituto superiore di sanita","volume":"59 1","pages":"4-9"},"PeriodicalIF":2.1,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9567937","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Diagnosis of Respiratory Syncytial Virus (RSV) infection in children by Respiratory Panel utilized during the COVID-19 pandemic.","authors":"Paola Alessandra Petrocelli,&nbsp;Veronica Cunsolo,&nbsp;Marianna Melito,&nbsp;Giovanni Scuderi,&nbsp;Rebecca Testa,&nbsp;Stefano Messina,&nbsp;Francesca Tucci,&nbsp;Lorenzo Sardone,&nbsp;Daria Colligiani,&nbsp;Maria Nardone,&nbsp;Stefano Rapi,&nbsp;Elisabetta Stenner","doi":"10.4415/ANN_23_01_05","DOIUrl":"https://doi.org/10.4415/ANN_23_01_05","url":null,"abstract":"<p><strong>Background: </strong>In the months of October and November 2021, there was throughout Italy and in our specific case in the area of Lucca and Versilia, a disturbing increase of SARS-CoV-2 infections and cases of Respiratory Syncytial Virus (RSV) in new-borns. The aim of this paper is to compare the cases of RSV infection diagnosed in recent years to the cases recorded during the SARS-CoV-2 pandemic to November 2022.</p><p><strong>Materials and methods: </strong>The study consisted of evaluating the results of requests for RSV diagnosis from 2015 to November 2022, using molecular biology techniques.</p><p><strong>Results: </strong>The data obtained show that the number of cases of RSV infection in children during the winter season had a constant trend from 2015 to 2019. From November 2020 to February 2021 there were no cases of RSV respiratory infections. Starting from September 2021, on the other hand, there was a resumption of cases of RSV infections in conjunction with an increase in the number of children affected by COVID-19. From January 2022, after a peak in cases of SARS-CoV-2 infection, there has been a decrease in RSV infections. From September 2022 to November 2022, there was no increase of cases of RSV infections in new-borns but on the contrary, there was a trend in respiratory infections comparable to the pre-pandemic period.</p><p><strong>Conclusion: </strong>The data that emerged from the study conducted, show the onset of an outbreak of RSV in new-borns. This incidence is linked to the implementation of rigorous non-pharmacological public health interventions in 2020, aimed at combating COVID-19 infection. The use of the molecular panel made it possible to identifying the responsible agent and highlighting the most suitable clinical and therapeutic path.</p>","PeriodicalId":8246,"journal":{"name":"Annali dell'Istituto superiore di sanita","volume":"59 1","pages":"31-36"},"PeriodicalIF":2.1,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9567942","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Neurorehabilitation of severe acquired brain injury in the time of COVID-19: impact of the absence of caregivers.","authors":"Maria De Luca,&nbsp;Valentina Bandiera,&nbsp;Elena D'Aviero,&nbsp;Benedetta Onofri,&nbsp;Fabiana Mungiello,&nbsp;Giulia Ferri,&nbsp;Manuela Iannetti,&nbsp;Susanna Lucatello,&nbsp;Rita Formisano,&nbsp;Umberto Bivona","doi":"10.4415/ANN_22_04_03","DOIUrl":"https://doi.org/10.4415/ANN_22_04_03","url":null,"abstract":"<p><strong>Introduction: </strong>During the COVID-19 pandemic, several restrictions were imposed to limit the circulation of the infection within communities. Hospitals denied access to the family and friends of inpatients, and thus to caregivers. This observational study evaluated the impact of the physical absence of caregivers during the lockdown period due to the COVID-19 emergency on the rehabilitation of inpatients with severe acquired brain injury (sABI).</p><p><strong>Methods: </strong>The functional outcome at discharge was measured in 25 inpatients with sABI through the Disability Rating Scale (DRS), Glasgow Outcome Scale (GOS), and Levels of Cognitive Functioning scale (LCF) after neuropsychological rehabilitation in an Adult Inpatient Neurorehabilitation Unit for Patients with sABI. Fourteen patients were directly assisted by their informal caregivers physically present in the neurorehabilitation ward. Eleven patients were indirectly supported via remote connection because during the lockdown period (from March to July 2020) caregivers could not be admitted to the rehabilitation hospital. The Caregiving Impact on Neuro-Rehabilitation Scale (CINRS) was also used to evaluate both the change since the admission and the impact of the caregiver from the perspective of the cognitive therapist. Demographic characteristics, time since injury, injury severity (duration of impaired consciousness measured by the time to follow commands), level of functioning at the beginning of the rehabilitation, and duration of the rehabilitation treatment were comparable between the groups.</p><p><strong>Results: </strong>Both groups improved after the treatment; however, the improvement was consistently greater in the group directly assisted by the caregivers. The results showed that although the caregivers ensured their virtual presence at distance, their physical absence played a role in hindering the functional outcome of the patients.</p><p><strong>Conclusions: </strong>The role of the caregiver of patients with sABI is underlined in being not only a person handing out generic aid, cares, and affection, but also an integral part of the rehabilitation process.</p>","PeriodicalId":8246,"journal":{"name":"Annali dell'Istituto superiore di sanita","volume":"58 4","pages":"236-243"},"PeriodicalIF":2.1,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10342987","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Characteristics of COVID-19 cases in Italy from a sex/gender perspective.","authors":"Massimo D'Archivio,&nbsp;Claudia Cataldo,&nbsp;Martina Del Manso,&nbsp;Daniele Petrone,&nbsp;Chiara Sacco,&nbsp;Maria Fenicia Vescio,&nbsp;Matteo Spuri,&nbsp;Maria Cristina Rota,&nbsp;Marco Bressi,&nbsp;Massimo Fabiani,&nbsp;Stefano Boros,&nbsp;Alberto Mateo Urdiales,&nbsp;Flavia Riccardo,&nbsp;Antonino Bella,&nbsp;Roberta Masella,&nbsp;Patrizio Pezzotti,&nbsp;Luca Busani","doi":"10.4415/ANN_22_04_02","DOIUrl":"https://doi.org/10.4415/ANN_22_04_02","url":null,"abstract":"<p><strong>Introduction: </strong>Coronavirus disease 19 (COVID-19) is an infectious disease caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). To date, few data on clinical features and risk factors for disease severity and death by gender are available.</p><p><strong>Aim: </strong>The current study aims to describe from a sex/gender perspective the characteristics of the SARS-CoV-2 cases occurred in the Italian population from February 2020 until October 2021.</p><p><strong>Method and results: </strong>We used routinely collected data retrieved from the Italian National Surveillance System. The highest number of cases occurred among women between 40 and 59 years, followed by men in the same age groups. The proportion of deaths due to COVID-19 was higher in men (56.46%) compared to women (43.54%). Most of the observed deaths occurred in the elderly. Considering the age groups, the clinical outcomes differed between women and men in particular in cases over 80 years of age; with serious or critical conditions more frequent in men than in women.</p><p><strong>Conclusions: </strong>Our data clearly demonstrate a similar number of cases in women and men, but with more severe disease and outcome in men, thus confirming the importance to analyse the impact of sex and gender in new and emerging diseases.</p>","PeriodicalId":8246,"journal":{"name":"Annali dell'Istituto superiore di sanita","volume":"58 4","pages":"227-235"},"PeriodicalIF":2.1,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10342988","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A case of medicine in disguise: motion sickness patches sold as medical devices containing active pharmaceutical substances.","authors":"Maria Cristina Gaudiano,&nbsp;Paola Bertocchi,&nbsp;Daniela De Orsi,&nbsp;Livia Manna,&nbsp;Eleonora Antoniella,&nbsp;Andrea Rodomonte,&nbsp;Angela Sorbo,&nbsp;Federica Aureli,&nbsp;Monica Bartolomei","doi":"10.4415/ANN_22_04_05","DOIUrl":"https://doi.org/10.4415/ANN_22_04_05","url":null,"abstract":"<p><strong>Introduction: </strong>A case study is reported on anti-motion sickness transdermal patches sold in the Internet, claiming to contain only natural ingredients but, actually, containing undeclared medicinal active substances. The visual inspection of the samples evidenced many inconsistencies in secondary and primary packaging, missing of various legal information and a non-compliant \"CE\" mark.</p><p><strong>Methods: </strong>The qualitative analysis was performed by liquid chromatography - high resolution mass spectrometry and the quantitative by liquid chromatography with diode array detector.</p><p><strong>Results: </strong>The analyses evidenced the presence of the antihistaminic drug Diphenhydramine and of other active substances (Capsaicin, a transdermal absorption enhancer, and Diclofenac in traces, probably a contaminant from other productions of the same plant). Moreover, the presence of several trace elements, including those potentially toxic to humans, was assessed by ICP-MS analysis.</p><p><strong>Conclusions: </strong>The case discussed is a new case of \"medicines in disguise\" never reported in literature, and shows the presence of tangible risks for public health.</p>","PeriodicalId":8246,"journal":{"name":"Annali dell'Istituto superiore di sanita","volume":"58 4","pages":"254-263"},"PeriodicalIF":2.1,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10342989","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Health Belief Model efficacy in explaining and predicting intention or uptake influenza vaccination during pregnancy.","authors":"Francesca Zambri,&nbsp;Alessia Quattrini,&nbsp;Ilaria Perilli,&nbsp;Stefania Spila Alegiani,&nbsp;Francesca Marchetti,&nbsp;Sofia Colaceci,&nbsp;Angela Giusti","doi":"10.4415/ANN_22_04_09","DOIUrl":"https://doi.org/10.4415/ANN_22_04_09","url":null,"abstract":"<p><strong>Introduction: </strong>The influenza vaccination is a priority during pregnancy due to infection-related-outcomes. The study aim is to assess the acceptance by women of influenza vaccination during pregnancy based on Health Belief Model (HBM).</p><p><strong>Methods: </strong>A multicentre observational study was carried out with a convenience sample of 300 respondents.</p><p><strong>Results: </strong>Most women (53.7%) declared that they worried to contract influenza during pregnancy and 80.7% of them agreed that there is a risk of contracting influenza during the first months of life. Vaccine benefits (adjOR 4.3 CI 95% 1.7-10.9 p <0.01), information on vaccination (adjOR 2.6 CI 95% 1.2-5.5 p <0.01) and trust in guidelines (adjOR 3.5 CI 95% 1.6-7.3 p <0.01) are some factors associated with intent/vaccination during pregnancy.</p><p><strong>Conclusions: </strong>HBM confirms its effectiveness in explaining/predicting health behaviours. It is necessary to create trust in the vaccinations through an integrated work of health professionals to set up training programs and to provide effective health communication.</p>","PeriodicalId":8246,"journal":{"name":"Annali dell'Istituto superiore di sanita","volume":"58 4","pages":"285-292"},"PeriodicalIF":2.1,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10342992","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Key performance indicators of breast cancer screening programmes in Italy, 2011-2019.","authors":"Francesca Battisti,&nbsp;Paola Mantellini,&nbsp;Patrizia Falini,&nbsp;Leonardo Ventura,&nbsp;Livia Giordano,&nbsp;Gianni Saguatti,&nbsp;Marco Zappa,&nbsp;Silvia Deandrea,&nbsp;Giuseppe Gorini","doi":"10.4415/ANN_22_04_04","DOIUrl":"https://doi.org/10.4415/ANN_22_04_04","url":null,"abstract":"<p><strong>Introduction: </strong>Performance indicators for organised breast cancer screening programmes in Italy, 2011-2019, were evaluated.</p><p><strong>Materials and methods: </strong>Aggregated data were gathered by the National Centre for Screening Monitoring from over 150 regional or sub-regional screening programmes in Italy. Invitation and examination coverage, participation rate (PR), recall rate (RR), detection rate, positive predictive value (PPV) for the target population as a whole (women aged 50-69), by 5-year age-class, geographical macro-area (North, Centre, South-Islands with the exception of three Regions for missing/uncomplete data) and Region were estimated.</p><p><strong>Results: </strong>Coverage showed an increasing positive trend, especially in the South-Islands, and PR was stable all over Italy. On the other hand, an increasing RR and decreasing PPV were recorded, especially at the first screening test and in some regions.</p><p><strong>Discussion and conclusions: </strong>The positive increase in coverage is accompanied by a worsening of some performance indicators for which a better resource allocation and staff training are required. For this reason, further and continuous monitoring is mandatory.</p>","PeriodicalId":8246,"journal":{"name":"Annali dell'Istituto superiore di sanita","volume":"58 4","pages":"244-253"},"PeriodicalIF":2.1,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10342991","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Italians are still loyal to conventional cigarettes, despite novel tobacco products.","authors":"Giulia Carreras, Valentina Minardi, Alessandra Lugo, Silvano Gallus, Maria Masocco, Lorenzo Spizzichino, Giuseppe Gorini","doi":"10.4415/ANN_22_04_06","DOIUrl":"10.4415/ANN_22_04_06","url":null,"abstract":"<p><strong>Introduction: </strong>Over the last few decades in Italy, we observed a substantial reduction in conventional tobacco cigarette consumption, the introduction of electronic cigarettes (e-cigarette) in 2010, and the launch of heated tobacco products (HTP) in 2015.</p><p><strong>Methods: </strong>We investigated novel products, i.e. e-cigarettes and HTP, use in Italy in 2018-2021 using data from the cross-sectional annual PASSI (Progressi delle Aziende Sanitarie per la Salute in Italia) survey conducted in representative samples of adults aged 18-69 (overall n = 101,458). We compared characteristics of conventional cigarette smokers with those of novel product users.</p><p><strong>Results: </strong>A stall in e-cigarette use at around 2.4% and a three-fold increase in HTP use from 0.5% in 2018 to 2.5% in 2021 were recorded, with around 60% of e-cigarette users and 70% of HTP users who kept on smoking conventional cigarettes. Around 86% of smokers did not use novel products at all. Novel products use among former smokers was more likely in younger e-cigarette with no nicotine users, whereas older users of both novel products were less able to completely shift to an exclusive use.</p><p><strong>Conclusions: </strong>After 10 years from the introduction of e-cigarettes and 5 years from that of HTP, the majority of smokers in Italy were still loyal to conventional tobacco cigarettes, and more than half of novel product users kept on smoking conventional cigarettes.</p>","PeriodicalId":8246,"journal":{"name":"Annali dell'Istituto superiore di sanita","volume":"58 4","pages":"264-268"},"PeriodicalIF":1.1,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10342994","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Knowledge, attitude and barriers of the Italian National Guidelines System for the development of clinical practice guidelines: a cross-sectional survey of registered scientific-technical societies.","authors":"Greta Castellini,&nbsp;Silvia Bargeri,&nbsp;Daniela Coclite,&nbsp;Daniela D'Angelo,&nbsp;Alice Josephine Fauci,&nbsp;Ornella Punzo,&nbsp;Antonello Napoletano,&nbsp;Primiano Iannone,&nbsp;Silvia Gianola","doi":"10.4415/ANN_22_04_07","DOIUrl":"https://doi.org/10.4415/ANN_22_04_07","url":null,"abstract":"<p><strong>Background: </strong>To explore knowledge, attitude, and barriers of the Italian National Guidelines System (SNLG) for the development of clinical practice guidelines (CPG) among scientific-technical societies (STS) of health care professional.</p><p><strong>Methods: </strong>A cross-sectional survey was distributed to the STS registered in the Italian Ministry of Health (n = 336). The questionnaire consisted of three sections: Respondent characteristics; Perception, knowledge, attitude, and use of CPGs; Knowledge of the SNLG.</p><p><strong>Results: </strong>The survey sample was 194 (57.7%) STS: 69% STS members stated they \"often consulted CPGs\". Two out of three STS perceived scientific activities as extremely important. Additionally, 20.6% STS had submitted at least one CPG to the SNLG platform after the Gelli-Bianco Law went into effect (median 1 CPG; interquartile range, IQR, 1-4). The most often cited barrier (62.7%) to CPG submission was limited economic resources.</p><p><strong>Conclusions: </strong>STS members hold a positive attitude towards CPGs despite barriers to CPG development.</p>","PeriodicalId":8246,"journal":{"name":"Annali dell'Istituto superiore di sanita","volume":"58 4","pages":"269-276"},"PeriodicalIF":2.1,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10342990","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}