Italian System Research Articles

Managing Tenders in the Procurement of Advanced Medical Devices: An Original Model Based on the Net Monetary Benefit Combined With Three Clinical Endpoints.

In medical devices, recent studies have proposed original approaches for standardizing competitive tenders with the aim of promoting reproducibility, avoiding discretional decisions, and applying value-based principles. In the framework of tenders' standardization, the net monetary benefit (NMB) method has attracted much interest, but its mathematical complexity has prevented a wide application. In the present work, we developed a procurement model that simplifies clinical information management for high-technology devices purchased for our public hospitals. Our objective was to promote the application of NMB in competitive tenders, particularly at the final stage of the procurement process, where the tender scores are determined. Software to facilitate this task in everyday practice has been developed. This software is made available through the present technical report. We surveyed the most relevant literature about NMB to select the main models commonly used in the studies published thus far. Standard equations of cost-effectiveness were identified. A simplified computation model based on three clinical endpoints was developed to estimate the NMB with less mathematical complexity. This model is proposed as an alternative to the standard approach based on a full economic analysis. The model developed herein has been implemented in a web-based software freely available on the Internet. This software is accompanied by a detailed description of the equations by which the NMB is estimated. A detailed application example is reported; a real tender carried out in 2021 has been re-examined for this purpose. In this re-analysis, the new software has been used to calculate the NMB of three devices. To our knowledge, this is the first experience in which an institution of the Italian healthcare system has evaluated the NMB as a tool for determining tender scores. The model is designed to offer performance similar to a full economic analysis. Our preliminary results are encouraging and suggest a wider application of this method. This approach has important implications regarding cost-effectiveness and cost containment because a value-based procurement is known to maximize effectiveness without determining an increase in costs.

The FLURESP European commission project: cost-effectiveness assessment of ten public health measures against influenza in Italy: is there an interest in COVID-19 pandemic?

BackgroundThe FLURESP project is a public health research funded by the European Commission, with the objective to design a methodological framework to assess the cost-effectiveness of existing public health measures against human influenza pandemics. A dataset has been specifically collected in the frame of the Italian health system. As most of interventions against human influenza are relavant against other respiratory diseases pandemics, potential interests in COVID-19 are discussed.MethodsTen public health measures against human influenza pandemics pandemic were selected to be also relevant to other respiratory virus pandemics such as COVID 19: individual (hand washing, using masks), border control (quarantine, fever screening, border closure), community infection (school closure, class dismissal, social distancing, limitation of public transport), reduction of secondary infections (implementation of antibiotic therapy guidelines), pneumococcal vaccination for at-risk people, development of Intensive Care Unit (ICU) capacity, implementation of life support equipments in ICU, screening interventions, vaccination programs targeting health professional and targeting general population.ResultsUsing mortality reduction as effectiveness criteria, the most cost-effective strategies are “reduction of secondary infections” and “implementation of life support equipment in ICU”. The least cost-effective option whatever the level of pandemic events are screening interventions and mass vaccination.ConclusionsA number of intervention strategies against human influenza pandemics appears relevant against every respiratory virus, including the COVID-19 event. Measures against pandemics should be considered according to their expected effectiveness but also their costs for the society because they impose substantial burden to the population, confirming the interest of considering cost-effectiveness of public health measures to enlighten decision making.

Body and milk production traits as indicators of energy requirements and efficiency of purebred Holstein and 3-breed rotational crossbred cows from Viking Red, Montbéliarde, and Holstein sires

This study aimed to compare rotational 3-breed crossbred cows of Viking Red, Montbéliarde, and Holstein breeds with purebred Holstein cows for a range of body measurements, as well as different metrics of the cows' productivity and production efficiency. The study involved 791 cows (440 crossbreds and 351 purebreds), that were managed across 2 herds. Within each herd, crossbreds and purebreds were reared and milked together, fed the same diets, and managed as one group. The heart girth, height at withers, and body length were measured, and body condition score (BCS) was determined on all the cows on a single test day. The body weight (BW) of 225 cows were used to develop an equation to predict BW from body size traits, parity, and days in milk, which was then used to estimate the BW of all the cows. Equations from the literature were used to estimate body protein and lipid contents using the predicted BW and BCS. Evidence suggests that maintenance energy requirements may be closely related to body protein mass, and Holstein and crossbred cows may be different in body composition. Therefore, we computed the requirements of net energy for maintenance (NEM) on the basis either of the metabolic weight (NEM-MW: 0.418 MJ/kg of metabolic BW) or of the estimated body protein mass according to a coefficient (NEM-PM: 0.631 MJ/kg body protein mass) computed on the subset comprising the purebred Holstein. On the same day when body measurements were collected, individual test-day milk yield and fat and protein contents were retrieved once from the official Italian milk recording system, and milk was sampled to determine fresh cheese yield. Measures of NEM were used to scale the production traits. Statistical analyses of all variables included the fixed effects of herd, days in milk, parity, and genetic group (purebred Holstein and crossbred), and the herd × genetic group interaction. External validation of the equation predicting BW yielded a correlation coefficient of 0.94 and an average bias of -4.95 ± 36.81 kg. The crossbreds had similar predicted BW and NEM-MW compared with the Holsteins. However, NEM-PM of crossbreds was 3.8% lower than that of the Holsteins, due to their 11% greater BCS and different estimated body composition. The crossbred cows yielded 4.8% less milk and 3.4% less milk energy than the purebred Holsteins. However, the differences between genetic groups were no longer significant when the production traits were scaled on NEM-PM, suggesting that the crossbreds and purebreds have the same productive ability and efficiency per unit of body protein mass. In conclusion, measures of productivity and efficiency that combine the cows' production capability with traits related to body composition and the energy cost of production seem to be more effective criteria for comparing crossbred and purebred Holstein cows than just milk, fat, and protein yields.

The Italian Right-Wing Government and the EU: an Interesting Case Study

Abstract The Italian general elections of September 2022 introduced several interesting novelties in Italian politics. Indeed, the election’s results – which marked the victory of a new governing coalition led by Brothers of Italy, a far-right party, together with the League, Forza Italia, and Noi Moderati – represent a turning point in Italian politics, a significant shift in the political spectrum. In this brief essay, I will tackle the implications of such a shift: after a quick overview of the constitutional guarantees of the Italian system, which, I argue, can protect Italian democracy from illiberal shifts, I will focus on one of the most interesting aspects of the new government, the attitude towards the EU and international law.

The Oxymoron of the Italian Legal System: The Administrative-Law: From the Collapse of the Genoa Bridge to a Ruling of the Italian Constitutional Court

The tragic collapse of the Genoa bridge – an event that hit the world headlines few years ago, also for the huge number of casualties caused – has engendered in Italy, more recently, multifarious legal controversies. In addition to whether the Italian Government was legally entitled to terminate the long-term service concession arrangements with the private entity in charge of the maintenance of the bridge, further subtle legal issues, of a public law nature, have followed up too. As to the latter, the contribution discusses the one relating to the legal characterisation of the piece of legislation (the obscure and opaque “administrative-law”) which the Italian Government has adopted in order to rule out, apparently within any legal-contractual justification, from the public contest of the Genoa bridge re-construction, an Italian company. This entity was the one in charge of the maintenance of the Italian motorway network, including the infamous bridge. The same Italian Constitutional Law has been recently required to enter the heated debate, with an ensuing decision which, as dissected in the article, has ascertained whether the different acts of the Italian Government, promoted and implemented in the aftermath of the Genoa Bridge, were legitimate. In this very complex scenario, the contribution is also aimed, from a more theoretical perspective, at shedding a light on the myriad of laws (administrative, executive, proper laws) that in the Italian legal system have blossomed in the last decades. Genoa bridge collapse, Italian motorways and service concession arrangements, right of termination, administrative-laws, constitutional legitimacy, rule of law, due process of law, concessionaire’s rights, European Union Law, competition law

Round Table. Implementing the EU Directive on adequate minimum wages in southern Europe: the odd case of Italy

Southern European countries, with their apparently high degree of collective bargaining centralisation and state regulations, may seem to be little affected by the EU Directive on adequate minimum wages. This article looks at the case of Italy, the EU country generally reported to have the highest collective bargaining coverage in Europe, to show how the situation on the ground is more problematic than conventional indicators suggest. Not only does Italy lack a national minimum wage and a legal framework for collective bargaining extension, but its apparent high level of collective bargaining coverage is vulnerable to wage dumping practices. The article identifies the weaknesses of the Italian system and proposes some possible lines of reform.

How ready is the Italian healthcare system regarding the use of genomics in medicine? An application of the Beyond 1 Million Genomes (B1MG) Maturity Level Model (MLM)

How ready is the Italian healthcare system regarding the use of genomics in medicine? An application of the Beyond 1 Million Genomes (B1MG) Maturity Level Model (MLM)

THE RESPONSIBILITY OF THE NURSE IN TEAMWORK

Since the very beginnings of the role of the nurse, this profession has undergone notable changes thanks to a structured framework of normative as well as formative development which has meant that nursing has become an intellectual and autonomous role requiring in-depth subject knowledge and competencies. Within the Italian healthcare system and elsewhere, the nurse is a crucial figure, an integral and integrated part of the professional healthcare teams whose responsibilities require a deeper awareness and knowledge of their role. In order to gain better understanding, it is essential to look at the historical evolution and see how nursing has gone from being considered ‘manual’ work, to what it is today - a highly-skilled, socio-professional role, with all the qualifications, competencies, autonomous decision-making powers and responsibilities that such a role demands - whether dealing with patients, or within the healthcare teams. It follows therefore that such ‘intellectual professionals’ must necessarily be fully aware of their professional responsibilities, and that these must be properly assimilated, also with regards to juridical concepts of responsibility. Although this report is brief, I sincerely trust that such a personal and hermeneutical approach may encourage all within the profession to put into practice and continually improve upon the fundamental principles that are in place to ensure the health and wellbeing of the patient.

National recovery and resilience plan: a framework to strengthen the italian territorial health care system

National recovery and resilience plan: a framework to strengthen the italian territorial health care system

The ‘presidential accordion’ in times of crisis: is it still well tuned?

ABSTRACT The article analyses the role of the President of the Italian Republic (PoR) as it relates to the process of government formation during the political, economic, and pandemic crises of the last three legislatures. The analysis focuses on the political actions of Giorgio Napolitano and Sergio Mattarella, the two Presidents of the Republic elected (and re-elected) as heads of state during those crises. To explain how the PoR operates when forming a government, the article examines the conditions allowing the functioning of the ‘presidential accordion’, i.e. the expansion and contraction of the presidential powers in the process of government formation. The presidential accordion hypothesis has been supported by many empirical studies focussing on the role of the PoR in the Italian parliamentary system. The aim of this study is further empirically to test the hypothesis in order to verify whether profound exogenous crises, such as recent economic and pandemic crises, can be considered as independent or intervening variables strengthening or weakening the PoR in the Italian political system.

Detecting Regional Differences in Italian Health Services during Five COVID-19 Waves

During the waves of the COVID-19 pandemic, both national and/or territorial healthcare systems have been severely stressed in many countries. The availability (and complexity) of data requires proper comparisons for understanding differences in the performance of health services. With this aim, we propose a methodological approach to compare the performance of the Italian healthcare system at the territorial level, i.e., considering NUTS 2 regions. Our approach consists of three steps: the choice of a distance measure between available time series, the application of weighted multidimensional scaling (wMDS) based on this distance, and, finally, a cluster analysis on the MDS coordinates. We separately consider daily time series regarding the deceased, intensive care units, and ordinary hospitalizations of patients affected by COVID-19. The proposed procedure identifies four clusters apart from two outlier regions. Changes between the waves at a regional level emerge from the main results, allowing the pressure on territorial health services to be mapped between 2020 and 2022.

Health needs and perception of health care quality among Asylum Seekers and Refugees in an Italian local health authority: A qualitative study.

Migrants, Asylum Seekers and Refugees (ASRs) represent a vulnerable diversified population with increased risks of developing health problems, and in the hosting countries several barriers often hamper their access to the health services. Gathering information about ASRs' experiences and perceptions of host country health care systems may contribute to improve the quality of health care provided. The aim of this study was to explore the health needs in their bio-psycho-social meaning, and the quality of health care as perceived from the ASRs' perspective. The qualitative descriptive study was conducted as part of the Project "G-START - testing a governance model of receiving and taking care of the Asylum Seekers and Refugees." Through purposeful and snowball sampling, four Focus Groups conducted in English, Italian and French were carried out between July and August 2019, involving 50 ASRs hosted by four reception centers located on the territory pertaining to an Italian Local Health Authority covering a general population of 500.000 people. The analysis of data was categorical, and was performed using N-Vivo software. The macro-categories emerged were the ASRs' bio-psycho-social health needs, including mental health, sexual and reproductive health, food and nutrition, knowledge of the health care system, need for inclusion; healthcare services access, including barriers before and after the access and the ability of the local health system to respond to existing and evolving demands; strengths of the healthcare and reception systems, and suggestions for improving them in the future. ASRs present vulnerabilities and specific health needs, and the health care system is not always able to guarantee access or to respond to these needs. Several obstacles have been highlighted, such as linguistic barriers and lack of cultural mediation, bureaucratic and administrative barriers, lack of knowledge of the Italian health care system. An effective reorganization of services driven by a more detailed output analysis of the target population needs, together with the use of cultural mediation, peer to peer education and support, and the training of health professionals are recommended to ensure a more accessible, equitable and effective health care system at local level.

Optimization and public transport tendering: a case study in Southern Italy

This article presents a multi-start heuristic approach to a design problem motivated by a real-world application in the Italian transport system. Specifically, it focuses on the problem of designing optimal lots in the public transport organization. In defining lots (in terms of number, size, and boundaries) both cost and service level have to be considered. Under certain assumptions, we model the problem as a graph partitioning problem and consider the same performance measure indicated by the relevant decree-law enacted by the Italian Ministry of Transport. The multi-start algorithm proposed for individuating high-quality solutions for the problem uses adaptive large neighbourhood search. The results of a computational study based on real data from a region in Southern Italy are reported.

Do more targets allow more cancer treatments, or not?

The three current oncology models (histological, agnostic and mutational) mainly differ in clinical, technological and organisational aspects, leading to different regulatory procedures and implications in antineoplastic therapy access by patients. Within the histological and agnostic models, Regulatory Agencies authorise target therapies and define their price, reimbursement, prescription and access based on results from clinical trials including patients affected by the same tumour (histological) or subjects with specific genetic mutations regardless of the tumour site or the histology (agnostic). The mutational model has been developed to identify specific actionable molecular alterations found by next-generation sequencing test-based large platforms on solid and liquid biopsies. Nevertheless, due to the highly uncertain efficacy and possible toxicity of drugs tested within this model, regulatory procedures based on histological or agnostic oncology cannot be followed. Multidisciplinary skills are required (e.g. the molecular tumour board’s (MTB) representatives) to identify the best association between the genomic profile and the drug planned to be used, but quality requirements, practices and procedures of these discussions still need to be standardised. Real-world evidence from clinical practice (i.e. genomic findings, clinical data and MTBs’ choices) lacks, therefore, it is urgently needed as opposed to limited findings from clinical trials. A potential solution for an appropriate access to the therapy chosen by the mutational model can be the indication-value-based sub iudice procedure of authorisation. The access to therapies suggested by extensive molecular profiling could be easily implementable within the Italian national health system, thanks to the existing regulatory procedures, i.e. the managed-entry agreements and the antineoplastic drug monitoring registries, alongside those granted by conventional studies (phase I, II, III, IV) conducted according to the histological and agnostic models.

Impact of circular economy on the decarbonization of the Italian residential sector

Circular economy is a new economic model that aims at overcoming today's linear “take, make, dispose” pattern, decoupling global economic development from finite resource consumption. Household appliances are a promising field for the adoption of Circular Economy, being one of the most resource-intensive industries and due to the global e-waste problem. The aim of this work is to quantify the potential contribution of making the household appliances sector more circular to the decarbonization of the Italian energy system, using the TIMES-RSE model. First, a literature review of the available circular measures was performed and used as a basis for modeling assumptions. The following circular measures were considered: extending the lifetime of appliances, increased adoption of remanufactured appliances, growing importance of leasing, lower average washing temperature for washing machines, and lower usage of tumble dryers. Second, each circular practice was modeled either as a new technology available for the optimization of the system or as a change in demand for a certain commodity. The reference scenario is the Italian Long Term Strategy. It is shown that the modeled circular practices can reduce the energy consumption of household appliances in 2050 by 0,327 Mtoe (−16%) and cut in half their costs through the 2020–2050 period, saving 96 billion euros (−47%). Moreover, savings could be even higher if efforts are taken to remove barriers to their diffusion, including consumers' habits and manufacturers' inertia. As the energy weight of appliances is low within the overall residential sector, energy savings of these circular practices are negligible at the sectoral level, however, economic savings of 107 billion euros are achieved over 2020–2050 (−22%).

Ground-Return Parameters of Submarine Cables Buried in the Seabed

The computation of sea/seabed-return distributed parameters of subsea cables is a relevant topic due to the growing importance of submarine connections. This article presents for the first time new formulas for the computation of self and mutual ground impedances and admittances for submarine cables buried in the seabed. The original theory developed by Sunde is applied to a three-media model with air, sea, and seabed. Referring to the practical installation practice of the Italian transmission system operator Terna S.p.A., we compare the prediction of the available models and assess the effect of the different approximations on the computation of the per unit length ground parameters. Finally, we define the limits of applicability of the available models that differ in accuracy and complexity.

Labour Law: New Workplaces in the Metaverse and Opportunities for Cultural and Heritage Professions

The authoress will analyse the impact that the metaverse has and will have on the labour market, with a focus on the employment relationship, in the scenario of transitional (labour) markets that face several issues closely related to technology and digital. Microsoft's investment of nearly $70 billion in 2022 on the metaverse, along with investments by Google and Epic Games and large groups such as Gucci, Nike and Walmart - to name a few - represent the tip of the iceberg of a process that is already well underway and in which we are all involved. On the one hand, the interaction of different elements of cyberspace – used to generate immersive experiences in augmented reality through the combination of physical and digital aspects of life, three-dimensional technology, the Internet of Things, and personal avatars – may represent a form of welfare. On the other hand, the legal issues are different both with respect to aspects that are more typical of digital/technology platform property law (to give an immediate example) and with respect to the issue of blockchain-supported platforms and the impact of the metaverse on the "workplace," which we are specifically interested in. It is necessary to delve into the different issues that arise in the Italian legal system. Such issues include both the status of the worker with the applicable discipline (whether framed under the discipline of transnational posting or falling under the discipline of the relationship with elements of internationality set forth in the Regulation (ec) no 593/2008 of the European Parliament and of the Council of 17 June 2008 of the Rome Convention on the law applicable to contractual obligations (Rome I)) and labour control. Moreover, issues related to the protections provided in the Italian Workers' Statute (Statuto dei Lavoratori), not excluding psychosocial risks, must also be investigated. Another issue to focus on is contractual distancing. The status of the worker in the Metaverse is that of one who sits at a virtual desk in front of a virtual keyboard and screen for completely virtual work performance. Likewise, effects of social dumping arise in light of a possible labour crowdsourcing problem in Countries where labour costs are low. On the labour front, the questions that will arise are: what employment regulations and contracts will have to be applied to such professional activities? And what kind of new job profiles will emerge? Lastly, ethical questions also surface regarding the system of rules as well as the algorithms that will have to administer the labour market in a scenario in which human and artificial intelligence will have to coexist and contaminate each other. Further enquiry will be presented on the need to manage human capital and its strictly related impact on human resources to avoid social inequalities and discrimination. Finally, the impact on new job profiles and opportunities for cultural and heritage professions will be analysed. Keywords: Labour law; Labour market; Metaverse; Health & safety; Heritage professions.

Country Report

After a brief presentation of the Italian education system, the article (a) describes the current situation of the teaching of philosophy in Italy, then (b) it presents the method and the laws that regulate this teaching. Moreover it illustrates the current compulsory philosophical curriculum in grammar schools and the situation of teacher training in philosophy.

CEU 2023 Florence: an appointment with the future of the emergency system

The Academy of Emergency Medicine and Care is one of the more than 20 scientific societies promoting the 3rd National Congress of Emergency/Urgency (CEU2023), planned in Florence from March 30th to April 1st.1
 This will be a fundamental appointment for update on all clinical and organizing aspects of the Italian emergency system. More that 2500 people will participated to the CEU2023 meeting and courses with the possibility to attend more than 50 sessions with approximately 500 national and international speakers. This organization will ensure elevate quality of updating for specific themes by covering the point of view of hospital and pre-hospital medical doctors and nurses, emergency medicine trainees, but other professionals (drivers, rescuers, technicians, and volunteers). [...]

Risk of parenterally transmitted hepatitis following exposure to invasive procedures in Italy: SEIEVA surveillance 2000-2021

Surgical interventions and invasive diagnostic/therapeutic procedures are known routes of transmission of viral hepatitis. Using data from the Italian surveillance system for acute viral hepatitis (SEIEVA), the aim of this study was to investigate the association between specific types of invasive procedures and the risk of acute HBV and HCV infections. Data from SEIEVA (period 2000-2021) were used. The association between acute HBV and HCV infection and potential risk factors, i.e. surgical interventions and diagnostic/therapeutic procedures (given according to the ICD-9-CM classification), was investigated in comparison to age-matched hepatitis A cases, used as controls, by conditional multiple logistic regression analysis. A total of 8,176 cases with acute HBV, 2,179 with acute HCV, and the respective age-matched controls with acute HAV infection were selected for the main analysis. Most of the procedures evaluated were associated with the risk of acquiring HBV or HCV. The strongest associations for HBV infection were: gynaecological surgery (odds ratio [OR] 5.19; 95% CI 1.12-24.05), otorhinolaryngological surgery (OR 3.78; 95% CI 1.76-8.09), and cardiac/thoracic surgery (OR 3.52; 95% CI 1.34-9.23); while for HCV infection, they were: neurosurgery (OR 11.88; 95% CI 2.40-58.85), otorhinolaryngological surgery (OR 11.54; 95% CI 2.55-52.24), and vascular surgery (OR 9.52; 95% CI 3.25-27.87). Hepatitis C was also strongly associated with ophthalmological surgery (OR 8.32; 95% CI 2.24-30.92). Biopsy and/or endoscopic procedures were significantly associated with both HCV (OR 3.84; 95% CI 2.47-5.95) and, to a lesser extent, HBV infection (OR 1.48; 95% CI 1.16-1.90). Despite the progress made in recent years, invasive procedures still represent a significant risk factor for acquiring parenterally transmitted hepatitis viruses, thus explaining the still numerous and unexpected cases diagnosed among the elderly population in Italy. Our results underline the importance of observing universal precautions to control the iatrogenic transmission of hepatitis viruses. Cases of parenterally transmitted acute viral hepatitis in the elderly population, that are difficult to explain based on the most widely recognised risk factors, continue to be diagnosed in Italy. Based on the Italian SEIEVA surveillance of acute viral hepatitis data, this study highlights an increased risk of acquiring hepatitis B and C following exposure to invasive procedures, which might explain the observed cases in elderly individuals. Furthermore, this finding emphasises the need to observe universal precautions strictly, in healthcare settings, including in the case of minor surgical procedures.