Annali dell'Istituto Superiore di Sanità
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Ethics committees and research in Italy: seeking new regulatory frameworks (with a look at the past)
Get PDFThe legislation of Italy and the European Union requires a shift in terms of the organisation and national regulation of ethics committees and clinical trials. More generally, this affects the entire sphere of biomedical research. The first part of this article provides a brief review of the history of ethic committees in Italy. We then discuss certain considerations about the current situation and formulate some proposals in terms of the regulatory choices that must be made. There is a vital need for rules that promote efficiency, to guarantee that Italy’s position remains competitive and attractive within the European Union
Considering the microbiota to achieve reduction in the numbers of animals used in scientific studies
Get PDFElimination of pathogens by laboratory rodent commercial vendors has substantially improvedstandardized conditions as well as laboratory animal welfare. However, pathogensare also important for basic activation and functioning of the immune system withconsequential influences on the symbiotic bacteria composition in the individual microbiota.One of the reasons for failures of translating results from preclinical researchto the clinical phase in some studies could be due to unintentional selection processes.Some recommendations are provided to increase researchers’ awareness on this point,together with a practical checklist to optimize information from microbiota knowledge
The evolution of the illegal market of falsified medicines and the experience of the Italian OMCL: from control to research.
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Fresh produce and microbial contamination: persistence during the shelf life and efficacy of domestic washing methods
Get PDFThe transmission of enteric pathogens by fresh produce depends on the survival of the bacteria organisms during the product shelf-life. The removal of any potentially hazardous microorganism from the vegetables is therefore dependent on the washing and sanitizing techniques employed by individual households. For this purpose, in this work we investigated the persistence of enteric bacteria, using as model Salmonella enterica serovar Napoli (S. Napoli) and Yersinia enterocolitica, in vegetables stored at refrigeration temperature (4 °C). The efficiency of tap water and different chlorine solutions for cleaning vegetables experimentally contaminated with Y. enterocolitica were tested. The results showed that in lettuce spiked with different concentrations of S. Napoli and Y. enterocolitica, both microorganisms were still detected after seven days of storage at 4 °C. Lettuce contaminated with low concentrations of Y. enterocolitica was not decontaminated by washing with tap water or with water added with 60 ppm of chlorine. The presence of Y. enterocolitica in lettuce was reduced of about 1-2 logs after washing with water added with 220 ppm of chlorine. The addition of low concentration of chlorine in post arvest washing processes represents a useful tool to reduce the contamination of the vegetables, with consequent reduction of the risks. However, since complete decontamination was not achieved, foodborne infections linked to fresh produce can still be possible, although contamination is avoided during primary production.
Methodological approach towards a Gap Assessment of the Serbian microbiology system in the function of surveillance in line with EU standards and acquis
Get PDFIntroduction. Italian and Serbian Health authorities performed an in-depth Gap Assessment of the Serbian microbiology system in the function of communicable disease surveillance using a methodology adapted to context and information needs. Methods. There were two study phases: a capacity based survey and an equipment mapping survey. Invited participants included national health authorities, heads of national reference laboratories and of public/private diagnostic laboratories in Serbia. Findings were analysed preliminarily and identified gaps were discussed, prioritized and validated through two ad hoc workshops involving all concerned institutions. Results. The Gap Assessment was performed between September and December 2017.The overall response rate was 69% for phase one and 74% for phase two. Identified gaps were assessed as highly relevant during the project workshops. Discussion. Gaps and priorities were highlighted, validated, and studied with a suitable level of detail to develop a concrete action-plan. The same methodological approach
Mesothelioma in Italy: the Casale Monferrato model to a national epidemiological surveillance system
Get PDFThe purpose of the present paper is to review the origin and development of the epidemiology of mesothelioma in Italy, starting with the detection and investigation of the major outbreak of the disease observed in Casale Monferrato, Piedmont Region. Over the last four decades, mortality among the cohort of ex-Eternit workers has been measured at three points in time. More recently, population based case-control studies in the area of Casale Monferrato have provided new light on the dose-response curve of the relationship between asbestos exposure and mesotheliomas. The publication of the first Casale Monferrato study had a major impact in the country and contributed to the decision of the Italian Parliament to ban the use of asbestos. The experience of Casale Monferrato represents a lesson in several terms, from the epidemiological surveillance to the health care of the victims and the relationship between epidemiologists, victims, their relatives and residents in contaminated areas
Pain prevalence, severity, assessment and management in hospitalized adult patients: a result of a multicenter cross-sectional study
Get PDFIntroduction. The measurement of pain prevalence among the patients admitted to hospital, estimated that pain remains a common problem for patients. Methods. This is a multi-center cross sectional study carried out in Italian Hospitals, where data was collected in only one day. All patients aged at least 18 years, hospitalized able or unable to communicate, were eligible to be included in the study. Patients with curarization or quadriplegia (any cause) were excluded. Results. Some hospitals and residential structures took part in our research, 26 centers in total. Pain prevalence has been observed in 268 patients (38%) (95% CI = 34%-41%) (range within wards 31-47%). Women are at higher risk than men (RR = 1.59, 95% CI = 1.29-1.95). Pain prevalence was more observed at 10.9 (+1.46) days after surgery. Severe pain has been observed in 148 (21.2%) cases. Pain was managed in 223 (83.2%) cases, and it was predominantly treated with the administration of paracetamol (n=55; 24.7%) within 30 minutes after having ascertained the presence of pain. Conclusions. Pain is reported by about 4 out of 10 adults, with a higher prevalence of cases in women, and its appearance does not depend on the care setting. In order to assess the prevalence of pain carefully, an Italian study that involves all regions and a large number of the centers, may be necessary.
Opioids prescriptions in pain therapy and risk of addiction: a one-year survey in Italy Analysis of national opioids database
Get PDFObjectives. Previous epidemiological studies reported a significantly higher risk of Amyotrophic Lateral Sclerosis (ALS) in Italian male soccer players. As a consequence, sports newspapers and news agencies focused on this issue and spread the news of 51 male soccer players with a reported diagnosis of ALS. Design. We searched news on male Italian national soccer players with a reported diagnosis of ALS quoted from January 1, 1950 to July 31, 2016 in at least two Internet web sites or in books by journalists. Results. A total of 39 male soccer players with a reported diagnosis of ALS were identified. Subjects were born from 1905 to 1973, 32 were currently deceased, 6 were still living, while the status of 1 player was unknown. All gathered information was available for 29 soccer players. The group had a mean age at diagnosis of 45.3 ± 12.2 years, a mean age at onset of symptoms of 46.4 ± 12.1 years, and a mean age at death of 50.9 ± 12.3 years. A significant inverse correlation between year of birth and age at onset of symptoms was observed, with a younger age at onset of symptoms in soccer players born in more recent years (r = -0.65, p < 0.01). Conclusions. Italian male soccer players with a reported diagnosis of ALS have a significantlyyounger age at diagnosis when compared to other European patients with ALS.Results support a possible relationship between soccer and the risk of ALS. We believethat further research is urgently needed in this field.
Amyotrophic Lateral Sclerosis and soccer: an internet survey of 29 Italian players
Get PDFObjectives Some epidemiological studies have shown a very high risk of Amyotrophic Lateral Sclerosis (ALS) in Italian male soccer players. Subsequently, the sports newspapers and news agencies have spread the news of 51 male soccer players with reported ALS. Design We searched for male Italian national soccer players quoted in at least two Internet web sites or in books of journalists from January 1, 1950 to July 31, 2016 with a reported diagnosis of ALS. Results. Thirty nine male soccer players with reported ALS were identified. These subjects were born from 1905 to 1973 (32 deceased 6 living and 1 unknown). In the group of 29 soccer players for which the information was available the mean age at diagnosis was 45.3± 12.2 years; the mean age at onset of symptoms was 46.4± 12.1 years; the mean age at death was 50.9± 12.3 years. An inverse statistically correlation between year of birth and age at onset of symptoms was observed, with a more younger age at onset of symptoms for soccer players born in the recent years (r =-0.65 p<0.01). Conclusions. The ALS Italian male soccer have a clear anticipation of the age of diagnosis respect to European ALS patients. The findings support the possible relation between the soccer and the occurrence of ALS. We believe that an increase in research activity is urgently needed in this field
Are the Italian ethics committees ready for Europe?
Get PDFThe Law of 3 January 2018 established in Italy the “National Centre for the Coordination of Regional Ethics Committees for Clinical Trials of Medicines and Medical Devices for Human Use” and reduced the number of ethics committees in the country to 40. This Act should, amongst other things, facilitate Italy’s compliance with the provisions set forth in European Regulation (EU) 536/2014. Hopefully, in addition to the provisions set forth in the Law, the National Centre will strive to foster the harmonisation of ethics committee procedures, in order to reform Italian legislation on the evaluation of clinical trials and, more generally, biomedical studies. Unfortunately, certain organizational and structural conditions do not bode well for the success of the National Centre