Annali dell'Istituto Superiore di Sanità
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Compassionate drug uses in Italy. Analysis of regional and local diffusion
Get PDFAims. Compassionate drugs are provided to patients with a specific disease and no further treatment option, most frequently via Early (or Expanded) Access Programs. In Italy, it often occurs that compassionate uses concern medicines whose price has not been negotiated yet (and therefore unavailable on the market), although their use has been approved in Europe. Thus, compassionate drug uses turn out to be a way to expedite the access to new innovative drugs with demonstrated efficacy. This study aims to investigate how widespread is the use of compassionate drugs throughout the Country.Methods. We analyzed data from 20 early access programs implemented by 2 pharmaceutical companies in the last few years. Data were analyzed by the number of patients and centers in each Region and province, and a correlation was established between patients and centers in each Region and the resident population. A further analysis was carried out with the same criteria on the subpopulation of oncology patients, including more than 80% of total study population. Results. In our sample, 7529 patients received compassionate drug treatments in 348 centers throughout Italy. A significant correlation exists between the resident population in each Region and the number of requesting centers (r2=0.877) and patients treated (r2=0.844) in the Region. Taking the value of the linear regression slope as the expected one, certain Regions show a better “performance”, in terms of more patients treated than expected, namely Umbria, Emilia-Romagna, Lazio, Lombardy, Tuscany, Liguria and Friuli Venezia-Giulia.Conclusions. In this study we showed that the use of compassionate drugs in Italy is diffused in a manner closely related to the population of each Region. A number of Regions – mostly but not exclusively from the South and Island areas – show a performance below the expectations, in terms of patients treated
Exploring the potential of ChatGPT for clinical reasoning and decision-making: a cross-sectional study on the Italian Medical Residency Exam
Get PDFBackground. This study aimed to assess the performance of ChatGPT, a large language model (LLM), on the Italian State Exam for Medical Residency (SSM) test to determine its potential as a tool for medical education and clinical decision-making support.Materials and methods. A total of 136 questions were obtained from the official SSM test. ChatGPT responses were analyzed and compared to the performance of medical doctors who took the test in 2022. Questions were classified into clinical cases (CC) andnotional questions (NQ).Results. ChatGPT achieved an overall accuracy of 90.44%, with higher performance on clinical cases (92.45%) than on notional questions (89.15%). Compared to medical doctors’ scores, ChatGPT performance was higher than 99.6% of the participants.Conclusions. These results suggest that ChatGPT holds promise as a valuable tool in clinical decision-making, particularly in the context of clinical reasoning. Further research is needed to explore the potential applications and implementation of large language models (LLMs) in medical education and medical practice
Compliance with hand-hygiene guidelines among healthcare workers: a cross-sectional study at the Umberto I teaching hospital of Rome, Italy
Get PDFIntroduction. Healthcare-associated infections are often associated with poor hand hygiene(HH) by healthcare workers (HCWs). The objective of this cross-sectional study at the Umberto I teaching hospital in Rome was to quantify compliance with HH by direct observation following a multimodal strategy devised by the World Health Organisation and to map critical areas for improvement.Methods. Predictors of HH compliance were identified using a multivariable logistic regression model. Adjusted odds ratios (aORs) and 95% confidence intervals (CIs) were calculated.Results. Eighty-four trained observers from 50 wards collected 4,081 observations showingthat overall HH compliance was 71.9%. The multivariable analysis found a positive association with the outcome for midwives compared to physicians (aOR=2.5, 95% CI: 1.5-4.1), and a negative association for healthcare assistants (aOR=0.5, 95% CI: 0.3- 0.8). There was greater compliance during public holidays and weekends (aOR=1.5, 95% CI: 1.1-2.1), but compliance was lower for external staff (aOR=0.7, 95% CI: 0.5-0.9). We found a positive association with all HH indications after interaction with a patient or with patient surroundings compared with the indication “before touching a patient” (all p<0.001); the highest association was with the indication “after contact with biological fluids” (aOR=7.7, 95% CI: 4.7-12.5).Conclusion. Overall, we observed reasonable compliance levels, but it is important toincrease adherence to HH practice and monitor any behaviour change
Diagnosis of Syncytial Respiratory Virus (RSV) infection in children by Respiratory Panel utilized during the Covid-19 pandemic
No full textBackground. 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.Materials and methods. The study consisted of evaluating the results of requests for RSV diagnosis from 2015 to November 2022, using molecular biology techniques.Results. 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.Conclusion. 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- harmacological 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
The role of ecotoxicology in the health impact assessment: an innovative ecosystem approach for the protection of human health in Italy
Get PDFBackground. The Health Impact Assessment (HIA) is a procedure with the aim to protect the populations exposed to the impacts deriving from the establishment or upgrading of large industrial enterprises, i.e. large combustion plants (>300 MWth). In Italy a guideline for the HIA procedure has been published in compliance with the 2014/52/EU Directive on the Environmental Impact Assessment (EIA) requirements.Italian HIA procedure. An ecotoxicological approach has been included for the first time in the HIA procedure with the aim to detect toxic effects caused by unknown not-monitored contaminants or mixtures in the ecosystem components affected by the potential emissions, discharges and releases of large industrial enterprises. Ecotoxicology plays an important bridge role between environment and human health in the scoping and monitoring step of the HIA procedure with a key function of early warning system and screening. The aim of this paper is to present the Italian experience in the first three years of the application of the new approach, proposing recommendations on specific case studies.Conclusion and future perspective. 80% of enterprises, that applied HIA, have delivered a robust, integrated and detailed documentation in relation to the ecotoxicological assessment, this positive feedback will generate environmental and human health benefits to the areas where the plants are established
A preliminary analysis of luspatercept use and expenditure in Italy in the first semester of 2022
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HCV prevalence and treatment outcomes among drug users in an outpatient center for drug addiction in Northern Italy: HCV prevalence and treatment outcomes in drug users
No full textIntroduction. We aimed at evaluating hepatitis C virus (HCV) prevalence and treatment referral outcomes in a large population of drug users in Northern Italy.Material and methods. Each participant underwent a quick capillary blood test. Positive participants underwent HCV RNA quantification. HCV RNA positive subjects were referred to treatment and evaluated immediately at the end of treatment and at 3 and 6 months after treatment.Results. Of the 636 participants tested, 244 were positive. Intravenous drug use was more frequent among subjects who tested positive for HCV antibodies (99%). Among subjects who tested positive, 68% were HCV-RNA positive while 32% were negative.Among people referred to treatment, nearly 30% did not show up while 70% completed the treatment with success. Over 99% of people who started direct-acting antiviral agent (DAA) have a sustained response.Discussion. We observed a significant higher prevalence of HCV positive subjects among people who inject drugs (99%) and we observed a high success rate for HCV treatment engagement.Conclusions. Rapid testing for HCV represents a potential tool for HCV screening among high-risk group
Effects of phthalates on marine organisms: cytotoxicity and genotoxicity of mono-(2-ethylhexyl)-phthalate (MEHP) on European sea bass (Dicentrarchus labrax) embryonic cell line
Get PDFIntroduction. Mono-(2-ethylhexyl) phthalate (MEHP) represents a toxicological risk for marine organisms due to its widespread presence in aquatic environments. Methods. MEHP effects on cell viability, cell death and genotoxicity were investigated on the DLEC cell line, derived from early embryos of the European sea bass Dicentrarchus labrax L.Results. A dose-dependent cytotoxic effect, with no induction of necrotic process, except at its highest concentration, was observed. Moreover, chromosomal instability was detected, both in binucleated and mononucleated cells, coupled with a minor inhibition of cell proliferation, whereas genomic instability was not revealed. To our knowledge, the overall results suggest the first evidence of a possible aneugenic effect of this compound in the DLEC cell line, that is the induction of chromosomal loss events without the induction of primary DNA damage. Conclusions. MEHP should be considered more harmful than its parent compound DEHP, because it induces genomic instability in the DLEC cell line without triggering cell death
Publications from International Organizations on Public Health
Get PDFThe Publications from International Organizations on Public Health section includes a wider selection of the most recent publications edited by the main international organizations active in the field of public health, such as: the European Food Safety Authority (EFSA), the Food and Agriculture Organization of the United Nations (FAO), the International Labour Organization (ILO), the Organisation for Economic Co-operation and Development (OECD), the United Nations Educational, Scientific and Cultural Organization (UNESCO), the United Nations Environment Programme (UNEP), the United Nations Programme on HIV/AIDS (UNAIDS), and the World Health Organization (WHO)