Tuscany Region Of Italy Research Articles

PCSK9 Inhibitors' New Users: Analysis of Prescription Patterns and Patients' Characteristics from an Italian Real-world Study.

Cardiovascular (CV) diseases represent a major cause of death and severe medical condition worldwide. Different therapeutic options are available to control low-densitylipoprotein cholesterol (LDL-C) level in order to prevent CV events. In recent years, two new drugs were approved for patients whoare unable to reduce circulating LDL-C with the current therapies: evolocumab and alirocumab (proprotein convertase subtilisin/kexin type nine[PCSK9] inhibitors). This study was aimed to characterise patients who started treatment with PCSK9 inhibitors in the Tuscany region of Italy during the first year of public healthcare service reimbursement and to describe the pattern of PCSK9 inhibitor use in the first 6months of treatment. Patients on PCSK9 inhibitor treatment in Tuscany (3.7 million inhabitants) from 07/2017 to 06/2018 were selected from regional healthcare administrative databases. Concomitant use of lipid-lowering therapies (LLTs), adherence and persistence during the 6months preceding the first PCSK9 inhibitor dispensing, as well as comorbidities since 1996, were described. In the first 6months of PCSK9 inhibitor treatment, adherence, persistence and concomitant LLTs were assessed. There were 269 (176 evolocumab, 93 alirocumab) new users of PCSK9 inhibitors. Patients (mean age of 59.1years) were mainly male (71.0%) in secondary prevention (70.2%) and affected by familial hypercholesterolaemia (53.5%). Sixty-six patients (24.5%) had diabetes mellitusand 12 (4.5%) chronic renal failure. In the 6months prior to the first PCSK9 inhibitor administration, 61.3% of patients received at least one prescription of ezetimibe or high-intensity statins and 45.7% were persistent to these drugs. During follow-up, 79.9% of patients were adherent to PCSK9 inhibitor and 73.3% were persistent. During the first year of availability, the rate of prescription of PCSK9 inhibitors appears below expectations. Patients were mainly in secondary prevention and had been slightly persistent to previous LLTs. During follow-up, the PCSK9 inhibitor monotherapy showed high levels of adherence and persistence. This real-world study sets the stage for future longer-term investigations useful to improve our knowledge on the appropriateness, drug access and public healthcare sustainability of PCSK9 inhibitors.

Chronic disease management: Discussing the perspectives of general practitioners in Italy.

The aim of this paper is to provide an overview of general practitioners’ perspectives across key criteria for effective chronic disease management. The study setting is the Tuscany Region in Italy that implemented the Chronic Care Model in 2010 with multidisciplinary team to assist chronic patients. We used the results of a web-based survey of general practitioners (N = 1136) conducted in 2015 to compare the experiences and satisfaction of general practitioners involved (group 1) and not involved (group 2) in the Chronic Care Model. The analysis included all general practitioners, and compared the two groups’ perspectives of the different core aspects of Chronic Care Model through conducting an ANOVA analysis and Bonferroni test. General practitioners involved in the Chronic Care Model are found to be more favourably disposed toward measurement and benchmarking, and more satisfied in terms of decision support system. Conversely, no significant differences were found in terms of collaboration with specialists, which remains weak and in terms of community collaboration and involvement. This study provides a detailed investigation of the implementation of Disease Management Programs, by considering the professional point of view.

Cystic fibrosis screen positive inconclusive diagnosis (CFSPID): Experience in Tuscany, Italy

ObjectiveThe implementation of cystic fibrosis (CF) newborn screening (NBS) has led to identification of infants with a positive NBS test but inconclusive diagnosis classified as “CF screen positive, inconclusive diagnosis” (CFSPID). We retrospectively evaluated the prevalence and clinical outcome of CFSPID infants diagnosed by 2 NBS algorithms in the period from 2011 to 2016 in the Tuscany region of Italy. MethodsIn 2011–2016, we assessed the diagnostic impact of DNA analysis on the NBS 4-tier algorithm [immunoreactive trypsin (IRT) – meconium lactase – IRT2 – sweat chloride (SC)]. All CFSPID patients repeated SC testing every 6 months, and CFTR gene analysis was performed (detection rate 98%). We reclassified children as: CF diagnosis in presence of at least 2 pathological SC results; healthy carrier or healthy in presence of at least 2 normal SC results for age and either 1 or 0 CF-causing mutations, respectively. ResultsWe identified 32 CF and 50 CFSPID cases: 20/50 (40%) were diagnosed only by the IRT-DNA-SC algorithm and 16/50 (32%) only by IRT-meconium lactase-IRT2-SC. Both protocols identified the remaining 14 cases (28%). Thirty-seven of 50 (74%) CFSPID patients had a conclusive diagnosis on December 31, 2017:5 (10%) CF, 17 (34%) healthy and 15 (30%) healthy carriers; 13/50 (26%) cases were asymptomatic with persistent intermediate SC and followed as CFSPID (CF:CFSPID ratio 2.85:1). ConclusionsIn 6 years, the CF:CFSPID ratio modified from 0.64:1 to 2.85:1, and 10% of CFSPID cases progressed to CF. Genetic analysis improved positive predictive value and identified a higher number of CFSPID infants progressing to CF.

S737F is a new CFTR mutation typical of patients originally from the Tuscany region in Italy

BackgroundAn increasing number of patients have been described as having a number of Cystic Fibrosis Transmembrane conductance Regulator (CFTR) variants for which it lacks a clear genotype–phenotype correlation. We assesses the clinical features of patients bearing the S737F (p.Ser737Phe) CFTR missense variant and evaluated the residual function of CFTR protein on nasal epithelial cells (NEC).MethodsA retrospective database was performed from individuals homozygous or compound heterozygous for the S737F variant followed in the Cystic Fibrosis (CF) Centre of Florence. We performed a nasal brushing in cooperating patients and compared the results with those of patients followed in the pediatric CF Centre of Naples.Results9/295 (3%) subjects carrying at least S737F CFTR variant on one allele were identified. Patients were diagnosed in 7/9 cases by newborn screening and in two cases for dehydration with hypochloremic metabolic alkalosis; at diagnosis sweat chloride levels (SCL) were in the pathological range in only one case. After a mean follow up of 8,6 years (range 0,5–15,8), SCL were in the pathological range in 8/9 cases (mean age at CF diagnosis: 1,5 years), all patients were pancreatic sufficiency and respiratory function was normal. The gating activity on NEC was 15.6% and 12.7% in two patients compound heterozygous for W1282X and DelE22_24, while it was ranged between 6,2% and 9,8% in CF patients.ConclusionsS737F is a CFTR mutation associated to hypochloremic alkalosis in childhood, mild CF phenotype in teenage years and a residual function of CFTR protein.

Psoriatic arthritis prevalence in the clinical practice of dermatologists in North-West Tuscany centers of excellence: a screening experience.

Psoriasis arthritis will develop during cutaneous psoriasis in a significant percentage. The aim of this study was to improve assistance to patients and to provide the most individualized care possible. Patients: all consecutive subjects with psoriasis accessing the outpatients facilities of five dermatologic centers of excellence in the Tuscany region of Italy between December 2014 and February 2015. All subjects were screened for the presence of a previous diagnosis of arthritis and symptoms affecting the articular system, using some questions chosen and shared by dermatologists in charge of the centers. In the chosen three months period, 134 patients affected with psoriasis had been observed, 32 (24%) of which answered "yes" to the question "Have you ever been diagnosed with arthritis?". There have been differences in the characteristics of patients in the two groups, with and without arthritis. In particular, in the arthritis patients a statistically significant higher mean age, more ungueal psoriasis, less body surface cutaneous psoriasis extension, and a statistically significant higher percentage of patients treated with biological drugs (57% vs. 24.5%) have been observed. The results were consistent with the scientific literature in the field. The experience seems to confirm the opportunity of screening programs on arthropathy in cutaneous psoriasis patients. About a quarter of psoriasis patients had relevant arthropathic features, and more than half of these required challenging therapies like biologics.

Attitudes towards physician–nurse collaboration in a primary care team-based setting: Survey-based research conducted in the chronic care units of the Tuscany region of Italy

ABSTRACTAcross the world, multidisciplinary teamwork has become an essential component in the care of patients with chronic conditions—the Chronic Care Units (CCUs) in the Italian region of Tuscany are no exception to this new era of collaboration. We sought to explore the attitudes towards collaboration of general practitioners (GPs) and nurses within the CCUs using the Jefferson Scale of Attitudes towards Physician–Nurse Collaboration (JSAPNC). The survey was sent electronically to 218 GPs and 46 nurses of 23 CCUs in two Local Health Authorities of Tuscany. A higher JSAPNC score is indicative of a more positive attitude towards physician–nurse collaboration. JSAPNC scores were calculated for both totals and by three factors: “shared education and collaboration,” “caring versus curing,” and “physician authority.” A total of 133 healthcare professionals (94 GPs and 39 nurses) responded (response rate = 51.5%). Nurses reported significantly more positive attitudes towards collaboration than GPs (52.5 vs. 44.0, p < 0.01). This trend was also found in each of the three factors. This information adds to the scarce literature on nurse–physician collaboration in the primary care setting and highlights the need for considerable improvement given the rise of team-based outpatient care models.

Local Comparisons of Small Area Estimates of Poverty: An Application Within the Tuscany Region in Italy

The aim of this paper is to highlight some key issues and challenges in the analysis of poverty at the local level using survey data. In the last years there was a worldwide increase in the demand for poverty and living conditions estimates at the local level, since these quantities can help in planning local policies aimed at decreasing poverty and social exclusion. In many countries various sample surveys on income and living conditions are currently conducted, but their sample size is not enough to obtain reliable estimates at local level. When this happens, small area estimation (SAE) methods can be used. In this paper, a SAE model is used to compute the mean household equivalised income and the head count ratio for the 57 Labor Local Systems of the Tuscany region in Italy for the year 2011. The caveats of the analysis of poverty at the local level using small area methods are many, and some are still not so well explored in the literature, starting from the definition of the target indicators to the relevant dimensions of their measurement. We suggest in this paper that together with the universally recognized multidimensional, longitudinal and local dimensions of poverty, a new dimension must be considered: the price dimension, which should take into account local purchasing power parities to correctly compare the poverty indicators based on income measures.

Public Organizations Between Old Public Administration, New Public Management and Public Governance: the Case of the Tuscany Region

This paper analyzes the presence of different managerial approaches in a public organization, the Tuscany Region of Italy. In particular, it highlights the phenomenon of the plurality of frameworks working in the organization, namely Old Public Administration (OPA), New Public Management (NPM) and Public Governance (PG). The transformation and coexistence of the above-mentioned models is tested with a content analysis based on the perspectives of policy makers and top-level managers expressed in interviews and on the context of administration planning and control systems found in documents. Each managerial logic has a different relevance in the organization.

Lack of usutu virus RNA in cerebrospinal fluid of patients with encephalitis of unknown etiology, Tuscany, Italy.

Usutu virus (USUV) is an African mosquito-borne flavivirus associated with human neurological disorders in Europe. Recently, USUV introduction in Europe has been traced back to Eurasian blackbirds deaths in the Tuscany region of Italy in 1996. Ninety-six cerebrospinal fluid (CSF) samples from patients with encephalitis of unknown etiology diagnosed in 2010-2013 were screened to determine whether USUV circulates in humans in Tuscany. Using real-time polymerase chain reaction, no positive patient was found. USUV does not seem to cause neuroinvasive disorders in humans in Tuscany.

Exploring the impact of spatial correlations and uncertainties for portfolio analysis in probabilistic seismic loss estimation

The significant potential for human and economic losses arising from earthquakes affecting urban infrastructure has been demonstrated by many recent events such as, for example, L’Aquila (2009), Christchurch (2011) and Tohoku (2012). Within the current practice of seismic loss estimation in both academic and industry models, the modelling of spatial variability of the earthquake ground motion input across a region, and its corresponding influence upon portfolios of heterogeneous building types, may be oversimplified. In particular, the correlation properties that are well-known in observations of ground motion intensity measures (IMs) may not always be fully represented within the probabilistic modelling of seismic loss. Using a case study based on the Tuscany region of Italy, the impacts of including spatially cross-correlated random fields of different ground motion IMs are appraised at varying spatial resolutions. This case study illustrates the impact on the resulting seismic loss when considering synthetic aggregated portfolios over different spatial scales. Inclusion of spatial cross-correlation of IMs into the seismic risk analysis may often result in the likelihood of observing larger (and in certain cases smaller) losses for a portfolio distributed over a typical city scale, when compared against simulations in which the cross-correlation is neglected. It can also be seen that the degree to which the spatial correlations and cross-correlations can impact upon the loss estimates is sensitive to the conditions of the portfolio, particularly with respect to the spatial scale, the engineering properties of the different building types within the portfolio and the heterogeneity of the portfolio with respect to the types.

Applying discrete choice modelling in a priority setting: an investigation of public preferences for primary care models

ObjectivesThe shift toward more innovative and sustainable primary care models in Italy leads policy makers and clinicians to face difficult decisions between options that are all regarded as potentially beneficial. In this study, patient preferences for different primary care models in the Tuscany region of Italy were elicited. The relative importance of different attributes to the surveyed respondents was then examined, as well as the rate at which individuals trade between attributes and the relative value of different service configurations.MethodsA discrete choice experiment survey explored the following attributes in a stratified random sample of 6,970 adults: primary care provider, diagnostic facilities and waiting time for the visit.ResultsRespondents (3,263) were likely to prefer a consultation by their own general practitioner (GP) and a practice with many diagnostic facilities. The predicted utilities of different service configurations have shown that a “primary care centre” with many diagnostic facilities was preferable to a “solo GP” model or a “group general practice”.ConclusionsThe study demonstrated how a patient choice model could be used by decision makers for developing successful policies that takes into account different healthcare needs, balancing responsiveness with care continuity, equity and appropriateness. Considering that a primary care centre would perform better than a “solo GP”, especially for younger respondents and for those with minor healthcare needs, for a more rapid diffusion of this model policymakers and managers could direct the care of primary care centres towards these targeted subgroups, at least in the first phase.

The equity lens in the health care performance evaluation system

The main objective of this paper is to describe how indicators of the equity of access to health care according to socioeconomic conditions may be included in a performance evaluation system (PES) in the regional context level and in the planning and strategic control system of healthcare organisations. In particular, the paper investigates how the PES adopted, in the experience of the Tuscany region in Italy, indicators of vertical equity over time. Studies that testify inequality of access to health services often remain just a research output and are not used as targets and measurements in planning and control systems. After a brief introduction to the concept of horizontal and vertical equity in health care systems and equity measures in PES, the paper describes the 'equity process' by which selected health indicators declined by socioeconomic conditions were shared and used in the evaluation of health care institutions and in the CEOs' rewarding system, and subsequently analyses the initial results. Results on the maternal and child path and the chronicity care path not only show improvements in addressing health care inequalities, but also verify whether the health system responds appropriately to different population groups.

Management of critical limb ischemia: proposal for a multidisciplinary operating network in Tuscany

Introduction: Critical limb ischemia (CLI) is a clinical entity that is not well known to patients or the mass media, and it often receives inadequate attention by medical specialists as well. In most cases, patients with CLI already have advanced disease when they are first seen by physicians, and they frequently arrive on internal medicine wards without having received appropriate treatment. The numerous comorbidities that characterize these cases really require multidisciplinary management. Materials and methods: We sent multiple-choice questionnaires to 26 internal medicine units in hospitals located in the Tuscany region of Italy to learn more about the true incidence and impact of CLI. Results: As expected, in most wards, there is no specific, structured clinical protocols for effective management of CLI patients.Discussion: We analyze the current situation and propose a multidisciplinary network for structured, integrated management of CLI. The network would operate throughout the region and be composed of internist-angiologists and vascular surgeons with greater awareness of CLI and experience in its management. This initiative, if effectively implemented, will help increase awareness of this condition and the fact that CLI patients are suffering from what is unacceptably an ‘‘orphan’’ illness.

Usutu Virus, Italy, 1996

Retrospective analysis of archived tissue samples from bird deaths in the Tuscany region of Italy in 1996 identified Usutu virus. Partial sequencing confirmed identity with the 2001 Vienna strain and provided evidence for a much earlier introduction of this virus into Europe than previously assumed.

Economic evaluation of forest biomass production in central Italy: A scenario assessment based on spatial analysis tool

A spatial analysis tool, a Decision Support (DS) model able to support decision-making processes related to forestry energy planning has been developed using ecological and economic parameters. In this paper, the relative performance of different forest energy chains were compared by using metrics such as net revenue from forest processes, break-even prices of wood fuels, and the price elasticity of the bioenergy supply. Working with different scenarios at a spatial level, the DS model can evaluate innovative technologies and traditional forest harvest and logistical chains across a range of products, such as firewood and woodchips. The spatial analysis lends itself easily to an analysis of the political and administrative constraints with respect to levels of administration and regional variables.As expected, applying the tool to the Tuscany region in Italy shows that local characteristics and the species composition of an area influence the economic outcome of different harvest and logistical chains. In particular, mixed species Mediterranean forests appear to be suitable for the implementation of innovative bioenergy production processes, such as Whole Tree Chipping.

Building China's municipal healthcare performance evaluation system: a Tuscan perspective

Regional healthcare performance evaluation systems can help optimize healthcare resources on regional basis and improve the performance of healthcare services provided. The Tuscany region in Italy is a good example of an institution which meets these requirements. China has yet to build such a system based on international experience. In this paper, based on comparative studies between Tuscany and China, we propose that the managing institutions in China's experimental cities can select and commission a third-party agency to, respectively, evaluate the performance of their affiliated hospitals and community health service centers. Following some features of the Tuscan experience, the Chinese municipal healthcare performance evaluation system can be built by focusing on the selection of an appropriate performance evaluation agency, the design of an adequate performance evaluation mechanism and the formulation of a complete set of laws, rules and regulations. When a performance evaluation system at city level is formed, the provincial government can extend the successful experience to other cities.

A Uniform Procedure for Reimbursing the Off-Label Use of Antineoplastic Drugs According to the Value-for-Money Approach

National healthcare systems as well as local institutions generally reimburse numerous off-label uses of anticancer drugs, but an explicit framework for managing these payments is still lacking. As in the case of on-label uses, an optimal management of off-label uses should be aimed at a direct proportionality between cost and clinical benefit. Within this framework, assessing the incremental cost/effectiveness ratio becomes mandatory, and measuring the magnitude of the clinical benefit (e.g. gain in overall survival or progression-free survival) is essential.This paper discusses how the standard principles of cost-effectiveness and value-for-money can be applied to manage the reimbursement of off-label treatments in oncology. It also describes a detailed operational scheme to appropriately implement this aim. Two separate approaches are considered: a) a trial-based approach, which is designed for situations where enough information is available from clinical studies about the expected effectiveness of the off-label treatment; b) an individualized payment-by-results approach, which is designed for situations in which adequate information on effectiveness is lacking; this latter approach requires that each patient receiving off-label treatment is followed-up to determine individual outcomes and tailor the extent of payment to individual results.Some examples of application of both approaches are presented in detail, which have been extracted from a list of 184 off-label indications approved in 2010 by the Region of Tuscany in Italy. These examples support the feasibility of the two methods proposed.In conclusion, the scheme described in this paper represents an operational solution to an unsettled problem in the area of oncology drugs.

Rete gestionale toscana per il trattamento dell’ischemia critica degli arti inferiori: proposta di un network operativo multidisciplinare

Summary Introduction Critical limb ischemia (CLI) is a clinical entity that is not well known to patients or the mass media, and it often receives inadequate attention by medical specialists as well. In most cases, patients with CLI already have advanced disease when they are first seen by physicians, and they frequently arrive on internal medicine wards without having received appropriate treatment. The numerous comorbidities that characterize these cases really require multidisciplinary management. Materials and methods We sent multiple-choice questionnaires to 26 internal medicine units in hospitals located in the Tuscany region of Italy to learn more about the true incidence and impact of CLI. Results As expected, in most wards, there is no specific, structured clinical protocols for effective management of CLI patients. Discussion We analyze the current situation and propose a multidisciplinary network for structured, integrated management of CLI. The network would operate throughout the region and be composed of internist-angiologists and vascular surgeons with greater awareness of CLI and experience in its management. This initiative, if effectively implemented, will help increase awareness of this condition and the fact that CLI patients are suffering from what is unacceptably an “orphan” illness.

Standing-up Vineyards: The Political Relevance of Tuscan Wine Production

This paper investigates the philosophical and political assumptions supporting the commonly held view of ‘place identity’, exemplarily represented by the Tuscany region in Italy and its wine. It focuses on the production process of one of the most expensive and highly rated Italian wines, the Brunello di Montalcino, produced in the southeast of Tuscany. The Brunello di Montalcino wine area in Tuscany has a leading role in Italian wine production, and it represents an enormously successful example of place authenticity protection, promoting high-quality standards of economic solidarity and a fulfilling sense of well-being. This paper puts into question the romantic and fascinating image of Tuscany by offering an alternative portrait of the material-semiotic networks constituting the specificity of this place. The case for the analysis is provided by the diplomatic impasse between Italy and the United States in 2008. Anomalies in the wine production process were detected by a massive use of technological control devices; this put in ‘danger’ the reputation of the Italian wine makers and overturned the tradition, local authenticity, and identity of Tuscan wines—and eventually the identity of the Tuscany region itself. In reconstructing the way in which Brunello di Montalcino wine materially shapes politics, economic relations, social behaviours, landscape, cultural production and international narratives, the paper analyses the related material-semiotic networks. These analyses show that local identity does not naturally grow out of the soil but is generated and preserved by a long retinue of global-based practices and connections. Brunello, a symbol of authentic Tuscany, only exists as Brunello and can be enjoyed as such through the mediation of a large apparatus of very specific scientific knowledge, laboratory practices and protocols, administrative procedures at different geographical scales, and certificates and licences. Paradoxically, we need the global to protect the local.

An Analysis of Regional Policies Promoting Networks for Innovation

The diffusion of system-based innovation policies calls for the development of an appropriate evaluation framework. Such a frame requires a careful definition of the unit of analysis and evaluation, since evaluation based on the sum of individual additional results cannot assess appropriately the emergence of system effects. Moreover, it requires experimenting with new tools for measuring the relational effects of the new policies. The paper aims to contribute to this challenge, proposing an analysis of the inner structure and the organization of regional innovation systems in terms of network relations, and considering its results for their potential contribution to the evaluation of innovation policies in a systemic perspective. The empirical application focuses on a set of policies implemented by the Tuscany Region in Italy. It highlights that the same policy intervention may lead to the emergence of different relational architectures connecting the world of research and that of production, depending on the different relational context (technological/sectoral and territorial) in which they are grounded. These two aspects—the structure of the relations and the context in which they develop—must be carefully combined in order to identify the effects of policies aimed at promoting innovation.