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OBJECTIVE: Biochemical markers are commonly used in medicine to guide diagnostic investigation or therapy duration and/or monitor treatment efficacy. Due to the emergence and spread of antimicrobial resistance, markers able to prompt a more rational use of antimicrobial therapy are regarded with the greatest attention. Procalcitonin (PCT) certainly stands out among others, yet its role must be better established especially outside of the critical care area. Data about PCT utilization in non-critical patients, optimal negativity cut-offs as well as a protocol for measurement timing are all lacking. MATERIALS AND METHODS: To address these issues, a focus group was set up to propose and endorse shared statements regarding the most beneficial use of PCT in real life as infection marker for non-critical patients, based on the authors' experience and a review of recent literature. RESULTS: A group of nine experts in the fields of Infectious Diseases, Internal Medicine, Microbiology, Clinical Chemistry, Surgery and Medical Economics participated in the discussion of nine pre-specified statements. CONCLUSIONS: The potential role for PCT in differentiating infectious and non-infectious clinical syndromes and guiding antimicrobial therapy discontinuation was acknowledged. Moreover, a shared measurement protocol and desirable cut-offs for the non-critical area were proposed. Finally, observations were made about a reasonable selection of the patient population to be tested. [ABSTRACT FROM AUTHOR]

Purpose: The study aimed to present the results of a Delphi consensus involving Italian experts focusing on the management of hypophosphatemia in adults., Methods: A multidisciplinary advisory board of nine physicians, experts in hypophosphatemia management, was established. Next, a literature search was performed to identify international guidelines, consensus, and clinical pathways, which were later presented to the advisory board. Collaboratively, the advisory board and authoring team selected key statements for the consensus process and focused on areas of uncertainty related to the management of hypophosphatemia. The advisory board also indicated the experts to be invited to participate in the consensus process. The Delphi method was employed to reach a consensus., Results: The literature search yielded one guideline, five consensus documents, and one clinical pathway. While our search strategy aimed to identify documents on the management of all types of hypophosphatemia, most of the guidelines and consensus documents retrieved focused on X-linked hypophosphatemia. The consensus process focused on 11 key issues, achieving strong convergence (over 70% consensus) in the first Delphi round for 8 out of the 11 statements. Three statements proceeded to the second round, with strong agreement reached for two. Notably, consensus was not reached for the statement concerning the measurement of fibroblast growth factor 23 for diagnostic purposes., Conclusion: The study revealed that the community of clinical experts is well-informed and in agreement regarding hypophosphatemia management. It emphasized the importance of developing clear national guidance documents to support clinicians and multidisciplinary teams in patient management. These documents are crucial not only for healthcare professionals but also for those responsible for defining pathways and services, facilitating a more accurate management of hypophosphatemic patients., Competing Interests: Declarations. Research involving human participants and/or animals: This article does not contain any studies with human participants or animals performed by any of the authors. Informed consent: For this type of study, formal consent is not required. Conflict of interest: Iacopo Chiodini: no competing interests to declare that are relevant to the content of this article. Daniela d’Angela: no competing interests to declare that are relevant to the content of this article. Alberto Falchetti: no competing interests to declare that are relevant to the content of this article. Luigi Gennari: no competing interests to declare that are relevant to the content of this article. Nazzarena Malavolta: no competing interests to declare that are relevant to the content of this article. Laura Masi: no competing interests to declare that are relevant to the content of this article. Antonio Migliore: no competing interests to declare that are relevant to the content of this article. Massimiliano Orso: no competing interests to declare that are relevant to the content of this article. Barbara Polistena declares to have received in the last 5 years payments or honoraria for lectures, presentations, speaker bureaus, manuscript writing or educational events from the following commercial sources: Amicus, Amgen, UCB. Domenico Rendina declares to have received in the last 5 years payments or honoraria for manuscript writing from the following commercial sources: Kyowa Kirin. Alfredo Scillitani: no competing interests to declare that are relevant to the content of this article. Federico Spandonaro declares to have received in the last 5 years payments or honoraria for lectures, presentations, speaker bureaus, manuscript writing or educational events from the following commercial sources: Allergan, Amgen, Astellas, Baxter, BMS, Boehringer-Ingelheim, Celgene, Eli Lilly, Janssen Cilag, Jazzpharma, Mylan, Nestle´ HS, Novartis, Novo Nordisk, Pfizer, Roche, Sanofi, Servier, Shire, Takeda, Teva; in addition, he received consulting fees from Amgen. Giuseppe Vezzoli declares to have participated in an advisory board of Kiowa Kirin and to have received two honoraria for lectures from Kiowa Kirin. Fabio Vescini: no competing interests to declare that are relevant to the content of this article., (© 2024. The Author(s).)

Objective: Our study's objective was to assess the incidence trends and healthcare resource utilization of hospitalizations for Tick-Borne Encephalitis (TBE) and associated costs in Italy in order to improve public awareness and preventive measures., Methods: This retrospective observational study was based on the Italian Ministry of Health's Hospital Discharge Record (HDR) database. Data were gathered across Italy from 2015 to 2019, selecting hospitalizations with ICD-9 code 063 related to TBE, both in primary and secondary diagnoses. For each year, we collected the following variables: number of hospitalizations, hospitalization rate, mortality rate, mean length of hospital stay, hospital ward, and cost of hospitalization., Results: There were a total of 237 hospitalizations from 2015 to 2019; 62 % of those were male. The lowest number of TBE hospitalizations was in 2015 (21 cases, corresponding to 0.35 per million inhabitants), the highest in 2019 (64 cases, 1.04 per million inhabitants). The summer months saw a greater than average number of hospitalizations. For the years analyzed, the cumulative number of cases peaked in June (54 cases), July (46 cases), and August (35 cases). There were only two deaths registered in our study sample. TBE cases were mostly localized in the North-Eastern regions of Italy. TBE incidence during the study period in the most affected areas were: Autonomous Province of Trento, ranging from 11.2 to 42.3 per million inhabitants, Autonomous Province of South Tyrol, from 0 to 21.1 per million inhabitants, and Veneto Region, from 2.6 to 4.5 per million inhabitants. In the study period, the average length of hospital stay was largely stable ranging from 10.6 days to 12.8 days, with related costs ranging from 5,813.7 € to 7,352.5 €., Conclusions: According to our data, the majority of TBE hospitalizations occur in North-East Italy with an increasing trend over the analyzed period. Even though Italy has fewer TBE cases than other neighboring European countries, the health and economic impact can be high in the affected areas., Competing Interests: Competing interests RS was paid consultant to Pfizer in connection with the development of this manuscript. RI, IB, KS and AP are employees of Pfizer and may hold Pfizer stocks or stock options. CC, DA, LG, MO, BP, and FS are employees of C.R.E.A. Sanità, which received funding from Pfizer in connection with the development of this manuscript., (Copyright © 2024. Published by Elsevier GmbH.)

Objectives: Duchenne muscular dystrophy (DMD) is a heritable disorder that causes a rapid and progressive loss of ambulatory skills. There is no curative therapy for this pathology, that is currently managed with a combination of physiotherapy and pharmacological interventions limiting the progression of the disease (e.g. corticosteroids, cardiac medications). However, a new opportunity is represented by gene therapy, a promising treatment that, however, requires significant expertise during the whole delivery of care and a solid organisational infrastructure. An organisational strategy that could effectively support its delivery to DMD patients in Italy is the hub-and-spoke model. However, an accurate portrait of the present network of DMD centres of expertise in Italy and of their readiness in the delivery of gene therapy is paramount, to facilitate access to this experimental medicine in the future., Methods: In this context, the present study aimed to map the DMD centres of expertise in Italy and later evaluate their preparedness in terms of gene therapy delivery. For this purpose, a series of items was proposed to 30 centres in Italy, of which 20 responded., Results: After assessing the readiness of the involved centres in terms of patient preparation, therapy infusion, close surveillance, and long-term follow-up, we proposed a suitable organizational model, namely a flexible hub-and-spoke model, for the delivery of gene therapy in the Italian DMD network and solutions to tackle the challenges emerged from the survey., Conclusion: Overall, the present study detected an adequate readiness of the Italian DMD centres of expertise, despite observing a significant room for improvement in digital infrastructures, culture, and training., (Copyright © 2024 Gaetano Conte Academy - Mediterranean Society of Myology.)

The Health Technology Assessment (HTA) Working Group of the Emerging Technology Division of International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) aims to develop a methodological approach for producing structured HTA information for laboratory medicine technologies. This approach seeks to support decision-making processes at the country, regional, and/or hospital levels regarding the introduction of specific technologies. The focus of this model will primarily be on defining assessment elements within the domains of 'organizational aspects' and 'costs and economic evaluations', potentially differentiated by the type of diagnostic technology (e.g., genetic tests, molecular tests). To achieve this project's goal, a literature review and examination of websites of international HTA agencies have been conducted. The research aims to identify multidisciplinary methodological approaches used to assess laboratory diagnostic technologies and to pinpoint the domains and assessment elements utilized. We found 7 methodological articles describing methodological approaches adopted to assess laboratory diagnostic technologies. Among the HTA organizations considered, 23 reports were found, of which 7 were produced by the European Network of HTA (EUnetHTA), 4 by the National Institute for Health and Care Excellence Diagnostic Assessment Program (NICE DAP), and 12 by other HTA agencies. The EUnetHTA reports were rapid collaborative assessments covering various domains, while the NICE DAP reports focused on diagnostic guidances, including descriptions of technologies, clinical need and practice, diagnostic tests, accuracy, effectiveness, and cost-effectiveness. Finally, a survey targeting laboratory professionals will be conducted to introduce assessment elements, differentiated by the type of diagnostic technology, primarily for organizational and economic domains., (© 2024 Walter de Gruyter GmbH, Berlin/Boston.)

Introduction: Considering the clinical impact of innovative cancer therapies, policy makers strive to balance timely access and thorough value-assessment. While some European countries promoted early access schemes, Italy does not yet display a consolidated strategy for innovative drugs or for medicines targeting pathologies with a high unmet need., Methods: To better understand the risks and opportunities of early access strategies that could be applied in the Italian setting, we performed a scoping review, searching the PubMed and Web of Science databases and interviewing two field experts. The review results were complemented with an exemplificative quantitative analysis for a subset of innovative oncology drugs, to assess the clinical and economic impact of the price and reimbursement negotiation., Results: Our study suggests that early access schemes developed in Germany and France, combining a free-pricing period, pay-back mechanism, and arbitration, could serve as a basis for developing a feasible strategy in Italy. The quantitative analysis indicated that timely access to innovative drugs could have potentially prevented many cancer progressions, associated with a significant healthcare expenditure., Conclusion: Albeit not allowing to express a conclusive assessment, this study proposes a potential early access strategy for Italy and highlights the need for opening a debate on the opportunities and risks of such schemes., Competing Interests: No potential conflict of interest was reported by the author(s)., (© 2024 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.)

Objective: Growth hormone deficiency (GHD) is the most common pituitary hormone deficiency and is one of the main causes of short stature in children and adolescents. The aim of this study is to evaluate the epidemiology of pediatric GHD worldwide, since no other systematic review has been published so far., Methods: We searched PubMed, Embase, and Web of Science up to July 2023 to find epidemiological studies involving children with GHD. Two review authors independently screened articles, extracted data and performed the quality assessment., Results: We selected 9 epidemiological studies published from 1974 to 2022. The range of prevalence was 1/1107-1/8,646. A study based on a registry of GH users in the Piedmont region (Italy) reported the highest mean prevalence. In the included studies, the mean incidence ranged from 1/28,800 to 1/46,700 cases per year. One study reported a 20-year cumulative incidence of 127/100,000 for boys and 93/100,000 for girls. Studies were heterogeneous in terms of population (age and GHD etiology) and diagnostic criteria. As for the methodological quality of included studies, all but one study satisfied the majority of the checklist items., Conclusions: The included studies are mostly European, so the provided estimates cannot be considered global. International multicentre studies are needed to compare epidemiological estimates of GHD among different ethnical groups. Considering the considerable cost of human recombinant GH, the only available therapy to treat GHD, understanding accurate epidemiological estimates of GHD in each country is fundamental for resource allocation., (© 2024. The Author(s).)

Background: Respiratory syncytial virus (RSV) affects 60-80% of children below 1 year and it's the first cause of acute bronchiolitis. The aim of this study was to assess the trend and characteristics of hospitalizations for RSV infections in Italy., Methods: This is a retrospective study based on the Italian Hospital Discharge Record (HDR) database. We analysed HDRs from June 2015 to May 2019, considering two groups of infants: Group 1 had a confirmed diagnosis of RSV; Group 2 had a diagnosis of acute bronchiolitis not RSV-coded., Results: There were 67,746 overall hospitalizations (40.1% Group 1, and 59.9% Group 2). Hospitalization rate increased for Group 1 from 125 to 178 per 10,000 infants (+ 42.4%), and for Group 2 from 210 to 234 per 10,000 (+ 11.4%). The mean hospitalization length was 6.3 days in Group 1, longer than Group 2 (+ 1.0 day). A further analysis revealed that infants with heart disease or born premature had longer mean hospital stay compared to infants without risk factors (10.7 days versus 6.1 days, p < 0.0001; 34.0 days versus 6.1 days, p < 0.0001, respectively). Group 1 required more critical care (oxygen therapy and/or mechanical ventilation) than Group 2. We found that, in proportion to hospital admissions in pediatric and general hospitals, RSV was more frequently diagnosed in the first ones. The mean hospitalization cost increased for Group 1 (from € 2,483 to € 2,617) and Group 2 (from € 2,007 to € 2,180)., Conclusions: Our results confirmed that RSV pulmonary disease in infants is seasonal and often requires hospitalization. Our study suggested that RSV is responsible for an increasing hospitalization rate and related costs during the study period., (© 2024. The Author(s).)

Defining innovation in the field of medical devices can be extremely challenging due to the peculiarity of the products within this class. Short life-cycle, incrementality, learning curve effect, impact of the organizational setting, uncertainty of effect and level of evidence are only some of these aspects. A clear set of criteria to define innovation would be of paramount relevance in this field. Twelve criteria to define innovation were proposed to a multistakeholder panel within a consensus process. A Delphi method on two rounds was used to reach consensus. In total, 53 of the 93 (47%) invited panelists responded to the first round of the survey. Among them, 51 (96%) completed also the second round. At the first round, consensus was reached for four of the 12 proposed criteria. Three of the remaining eight criteria reached consensus at the second round. It was not possible to reach consensus for the remaining five criteria. The criteria that collected the highest scores (close to 100%) were from the clinical impact domain, namely the ability of the technology to offer significant advantages over existing alternatives in terms of improving relevant clinical outcomes, and the ability to address an unmet need defined in terms of unavailability of diagnosis/treatment alternatives. High levels of consensus (about 80%) were registered on criteria belonging to non-clinical domains of analysis and, in particular, the ability of the technology to introduce organizational benefits, and the ability of the technology to bring cost reduction providing the same clinical benefit of current alternatives., Competing Interests: The authors declare that they have no competing interests., (Copyright © 2024 D’Angela et al.)

This study analyzed hospital admissions for invasive meningococcal disease (IMD) in epidemiological and economic terms in Italy from 2015 to 2019. The volume of acute admissions for meningococcal diagnosis was analyzed in the period from 2015 to 2019. IMD admissions were identified by ICD-9-CM diagnoses. Costs were assessed using current DRG tariffs. In 2019, a total of 237 admissions for meningococcal disease were recorded in Italy. The mean age of patients was 36.1 years. Lumbar puncture was reported in only 14% of hospital discharge forms. From 2015 to 2019, there was a mean annual reduction of - 1.2% nationally for IMD hospitalizations. For 2019, the total costs for acute inpatient admissions were €2,001,093. Considering annual incidence due to IMD, a significant decrease was noted in the age group from 0 to 1 year (p = 0.010) during 2015-2019. For all years, mortality associated with meningeal syndrome was lower compared to septic shock with or without meningitis. From 2015 to 2019, hospitalizations for IMD appear to be decreasing slightly in Italy, even if mortality remains high. Favorable trends in hospitalizations for IMD were seen in the 0-1-year age group, which may be attributable to increased vaccination. Costs of hospitalizations for IMD remain high., (© 2023. The Author(s).)

Background: The main contribution of this article is establishing a set of behaviors and successful actions experimenting the Ipacs' (Institutional & Public Coaching Services) methodology on implementation of the National Recovery Plan (NRP), approved in Italy in 2021 to overcome the socio-economic impact of the pandemic. This research is aimed at pointing out emotional intelligence (EI) behaviors related to the activities of the NRP with respect to the National Health System (NHS)., Participants and Procedure: Fifty-six professionals were provided with an integrated pathway with coaching, participative art and mentoring from January to June 2022. A "core set" of 5 soft skills - communication, result orientation, teamwork, networking, and emotional intelligence - was measured before and after an integrated coaching pathway. Each soft skill related to the following three systemic objectives through pre-defined, related activities: 1) defining and introducing new roles in the health community houses; 2) implementing a new systemic communication in oncology; 3) facilitating the management of chronicity through a new IT platform. We observed that the Giunti test (Org-EIQ) and Ipacs' test enlighten the same emotional intelligence indicators of behaviors considered by the investigated coaching integrated pathway., Results: Forty-eight percent of them increased in all 5 core skills. Results were measured at least in one of the two tests. These results were possible thanks to the changes in abilities of self- introspection, in communicating and sharing common goals, to achieve high standard results in conditions of uncertainty, to understand non-verbal feedback and give feedback., Conclusions: Emotional intelligence acted as a meta skill to pursue a "new model of man" with a new self-schema, self-image and set of behaviors., Competing Interests: The authors declare no conflict of interest., (Copyright © Institute of Psychology, University of Gdansk.)

The delivery of healthcare services at regional level should be modeled on population needs, stemming from patients' consumption pattern and trying to include unexpressed needs and exclude excesses of demand due to both moral hazard behaviors and inducements from the supply side. We propose a model able to estimate the frequency of access in outpatient care (OC) based on the characteristics of the population. According to empirical evidence, among the determinants of outpatient access we include variables addressing health, socioeconomic status and place of residence, plus variables related to the supply of services. We run generalized linear models for counting data of the Poisson family with the aim of both identifying the determinants of OC utilization and quantifying the related effects. We use the regional administrative database of Basilicata region, year 2019. Results are consistent with literature findings and provide new insights into the analysis of OC, suggesting that our model could easily be implemented by regional policymakers to plan the supply of ambulatory services on population needs., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

We evaluated the efficacy, safety, adherence, quality of life (QoL) and cost-effectiveness of long-acting growth hormone (LAGH) vs daily growth hormone (GH) preparations in the treatment of growth hormone deficiency (GHD) in children. Systematic searches were performed in PubMed, Embase and Web of Science up to July 2022 on randomized and non-randomized studies involving children with GHD receiving LAGH as compared to daily GH. Meta-analyses for efficacy and safety were performed comparing different LAGH/daily GH formulations. From the initial 1393 records, we included 16 studies for efficacy and safety, 8 studies for adherence and 2 studies for QoL. No studies reporting cost-effectiveness were found. Pooled mean differences of mean annualized height velocity (cm/year) showed no difference between LAGH and daily GH: Eutropin Plus® vs Eutropin® [- 0.14 (-0.43, 0.15)], Eutropin Plus® vs Genotropin® [- 0.74 (-1.83, 0.34)], Jintrolong® vs Jintropin AQ® [0.05 (-0.54, 0.65)], Somatrogon vs Genotropin® [- 1.40 (-2.91, 0.10)], TransCon vs Genotropin® [0.93 (0.26, 1.61)]. Also, other efficacy and safety outcomes, QoL and adherence were comparable for LAGH and daily GH. Our results showed that, although most of the included studies had some concerns for risk of bias, regarding efficacy and safety all the LAGH formulations were similar to daily GH. Future high quality studies are needed to confirm these data. Adherence and QoL should be addressed from real-world data studies for both the mid and long term and in a larger population. Cost-effectiveness studies are needed to measure the economic impact of LAGH from the healthcare payer's perspective., Competing Interests: Declaration of Competing Interest MGW is a consultant for Pfizer, Merck, Sandoz and Novonordisk. CM has spoken for Pfizer. TA has consulted for Pfizer, and Sandoz. Barbara Polistena has received payments or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from the following commercial sources: Allergan, Amgen, Astellas, Baxter, BMS, Boehringer-Ingelheim, Celgene, Eli Lilly, Janssen Cilag, Jazzpharma, Mylan, Nestle´ HS, Novartis, Novo Nordisk, Pfizer, Roche, Sanofi, Servier, Shire, Takeda, Teva; in addition, she received consulting fees from UCB. Federico Spandonaro has received payments or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events from the following commercial sources: Allergan, Amgen, Astellas, Baxter, BMS, Boehringer-Ingelheim, Celgene, Eli Lilly, Janssen Cilag, Jazzpharma, Mylan, Nestle´ HS, Novartis, Novo Nordisk, Pfizer, Roche, Sanofi, Servier, Shire, Takeda, Teva; in addition, he received consulting fees from Amgen. Simona Granato and Pietro Bruschini are employees of Pfizer. CM, GZ, VC, TA, MGW were paid consultants to Pfizer in connection with the development of this manuscript., (Copyright © 2023. Published by Elsevier Ltd.)

Objectives: Combinations of on-patent therapies (CTs) are increasingly common in oncology. They cause challenges for funding and affordability, and hence patient access, especially when constituent therapies are owned by different manufacturers. The aim of our study was to develop policy proposals for the assessment, pricing, and funding of CTs and identify which might be relevant in different European countries., Methods: Following a review of available literature, seven hypothetical policy proposals were developed and subsequently assessed through 19 semi-structured interviews with health policy, pricing, technology assessment and legal experts in seven European countries to identify those most likely to gain traction., Results: Experts saw a need for agreed approaches within a country to manage affordability and funding challenges for CTs. Changes to health technology assessment (HTA) and funding models were considered unlikely, but other policy proposals were seen as mostly useful, with country-specific adaptations. Bilateral discussions between manufacturers and payers were deemed important, and less challenging and protracted than arbitrated dialogue between manufacturers. Usage-specific pricing, possibly using weighted average prices, was considered a prerequisite for the financial management of CTs., Conclusions: There is a growing need to ensure that CTs are affordable to health systems. It would appear that there is no one set of policies that is appropriate for all countries in Europe, so countries wishing to ensure that patients have (or continue to have) access to CTs of value to them must explore and implement the policies that are best suited to their general approach to funding health care and to the assessment and reimbursement of medicines., (© 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)

Objective: This systematic review aims to update the evidence on Duchenne muscular dystrophy (DMD) in Italy, describing the epidemiology, quality of life (QoL) of patients and caregivers, treatment adherence, and economic impact of DMD., Methods: Systematic searches were conducted in PubMed, Embase and Web of Science up to January 2023. Literature selection process, data extraction and quality assessment were performed by two independent reviewers. Study protocol was registered in PROSPERO (CRD42021245196)., Results: Thirteen studies were included. The prevalence of DMD in the general population is 1.7-3.4 cases per 100,000, while the birth prevalence is 21.7-28.2 per 100,000 live male births. The QoL of DMD patients and caregivers is lower than that of healthy subjects, and the burden for caregivers of DMD children is higher than that of caregivers of children with other neuromuscular disorders. The compliance of real-world DMD care to clinical guidelines recommendations in Italy is lower than in other European countries. The annual cost of illness for DMD in Italy is € 35,000-46,000 per capita while, adding intangible costs, the total cost amounts to € 70,000., Conclusion: Although it is a rare disease, DMD represents a significant burden in terms of quality of life of patients and their caregivers, and economic impact., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: Barbara Polistena declares to have received in the last 5 years payments or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from the following commercial sources: Allergan, Amgen, Astellas, BMS, Boehringer-Ingelheim, Celgene, Eli Lilly, Janssen Cilag, Nestle´ HS, Novartis, Novo Nordisk, Pfizer, Roche, Sanofi, Servier, Shire, Takeda, Teva; in addition, she received consulting fees from UCB. Federico Spandonaro declares to have received in the last 5 years payments or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from the following commercial sources: Allergan, Amgen, Astellas, Baxter, BMS, Boehringer-Ingelheim, Celgene, Eli Lilly, Janssen Cilag, Jazzpharma, Mylan, Nestle´ HS, Novartis, Novo Nordisk, Pfizer, Roche, Sanofi, Servier, Shire, Takeda, Teva; in addition, he received consulting fees from Amgen. Marika Pane declares to have received consulting fees for this paper from Pfizer. Eleonora Russo, Francesca Gatto, and Mauro Monterubbianesi are employees of Pfizer. All other authors declare that they have no competing interests., (Copyright: © 2023 Orso et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Acid sphingomyelinase deficiency (ASMD) is an ultra-rare disease, and several gaps of knowledge on various issues remain, particularly at a regional/national level. Expert opinions collected through well-defined consensus methodologies are increasingly used to make available reliable information in the context of rare/ultra-rare diseases. With the aim to provide indications on infantile neurovisceral ASMD (also formerly known as Niemann-Pick disease type A), chronic neurovisceral ASMD (formerly known as Niemann-Pick disease type A/B) and chronic visceral ASMD (formerly known as Niemann-Pick disease type B) in Italy, we conducted a Delphi consensus of experts focused on five main areas: (i) patients and disease characteristics; (ii) unmet needs and quality of life; (iii) diagnostic issues; (iv) treatment-related aspects; and (v) patient journey. Pre-specified, objective criteria were used to outline the multidisciplinary panel, based on 19 Italian experts in ASMD in paediatric and adult patients from different Italian Regions, including both clinicians (n = 16) and ASMD patients' advocacy or payors with expertise in rare diseases (n = 3). During two Delphi rounds, a high ratio of agreement was found on several topics related to ASMD characteristics, diagnosis, management and disease burden. Our findings may provide valuable indications for management of ASMD at a public health level in Italy., (© 2023. The Author(s), under exclusive licence to Società Italiana di Medicina Interna (SIMI).)

Spasticity is a well-known motor dysfunction occurring after a stroke. A group of Italian physicians' experts in treating post-stroke spasticity (PSS) reviewed the current scientific evidence concerning the state-of-the-art clinical management of PSS management and the appropriate use of botulinum toxin, aiming to identify issues, possible actions, and effective management of the patient affected by spasticity. The participants were clinicians specifically selected to cover the range of multidisciplinary clinical and research expertise needed to diagnose and manage PSS. When evidence was not available, the panel discussed and agreed on the best way to manage and treat PSS. To address the barriers identified, the panel provides a series of consensus recommendations. This systematic review provides a focused guide in the evaluation and management of patients with PSS and its complications. The recommendations reached by this panel of experts should be used by less-experienced doctors in real life and should be used as a guide on how to best use botulinum toxin injection in treating spasticity after a stroke.

Background: Understanding trends in pneumonia-associated hospitalizations can help to quantify the burden of disease and identify risk conditions and at-risk populations. This study evaluated characteristics of hospitalizations due to pneumonia that occurred in Italy in a 10-year period from 2010 to 2019. Methods: All hospitalizations with a principal or secondary diagnosis of pneumonia over the 10-year period were included, which were identified by hospital discharges for all-cause pneumonia and pneumococcal pneumonia in the anonymized hospital discharge database of the Italian Health Ministry. Results: A total of 2,481,213 patients were hospitalized for pneumonia between 2010 and 2019; patients aged 75−86 years accounted for 30.1% of hospitalizations. Most hospitalizations (88.1%) had an unspecified pneumonia discharge code. In-hospital death was recorded in 13.0% of cases. The cumulative cost for pneumonia hospitalizations of the 10-year period were EUR 11,303,461,591. Over the observation period, the incidence rate for hospitalized all-cause pneumonia in any ages increased from 100 per 100,000 in 2010 to over 160 cases per 100,000 per year in 2019 (p < 0.001). Overall, there was a significant increase in annual percent changes in hospitalization rates (+3.47 per year), in-hospital death (+4.6% per year), and costs (+3.95% per year) over the 10-year period. Conclusions: Our analysis suggests that hospitalizations for pneumonia are increasing over time in almost all age groups, especially in the elderly. Given the substantial burden of pneumonia in terms of mortality, healthcare resources, and economic costs, greater public health efforts should thus be made to promote vaccinations against influenza and pneumococcus, particularly in high-risk groups.

The availability of a new 20-valent pneumococcal conjugate vaccine (PCV) makes it appropriate to assess its cost-effectiveness. This was evaluated by adopting the Italian National Health Service perspective, using a cost consequences Markovian model. The expected effects of vaccination with 20-valent PCV were compared with the administration of 13-valent PCV and 15-valent PCV. Assuming a 100% vaccination of cohorts aged 65-74 years, in the (lifetime) comparison between 20-valent PCV and 13-valent PCV, the former is dominant (lower cost for a better health outcome). A reduction in disease events was estimated: -1208 deaths; -1171 cases of bacteraemia; -227 of meningitis; -9845 hospitalised all-cause nonbacteremic pneumonia cases (NBP) and -21,058 non-hospitalised. Overall, in the Italian population, a total gain of 6581.6 life years and of 4734.0 QALY was estimated. On the cost side, against an increase in vaccinations costs (EUR +40.568 million), other direct health costs are reduced by EUR 48.032 million, with a net saving of EUR +7.464 million. The comparison between 20-valent PCV and 15-valent PCV results in an Incremental Cost-Effectiveness Ratio (ICER) of EUR 66 per life year gained and EUR 91 per QALY gained. The sensitivity analyses confirm the robustness of the results. We can conclude that the switch to 20-valent PCV is a sustainable and efficient investment.

Competing Interests: Conflict of interest: The authors declare no potential conflict of interest with respect to the research, authorship and/or publication of this article. The authors declare the following competing interests.

Background and Aim: In Italy, the main birthplace is a hospital, and only a few women choose an out-of-hospital setting. This study assessed the costs related to delivery in different birthplaces in Italy., Methods: The cost analysis considered direct and amortizable costs associated with mother-child care in physiological conditions. An analysis of the hospital births considered the Diagnoses-Related Groups 373 and 391. To estimate the cost of the births assisted privately by freelance midwives, an evaluation based on an experts' opinion was carried out., Results: Childbirth hospital care in Italy amounts to € 1832.00, and birth in an out-of-hospital setting accredited with the National Health System has a full cost of € 1345.19 in the 'maternity home' and € 909.60 at home. The average cost of the birth in 'private maternity homes' amounted to € 3260.00, while at-home births amounted to € 2910.00., Conclusions: Any accreditation of out-of-hospital settings by the NHS would considerably reduce the waste of economic resources compared to hospital childbirth.

Background: Obesity is a complex health disorder that significantly increases the risk of several chronic diseases, and it has been associated with a 5-20-year decrease in life expectancy. The prevalence of obesity is increasing steadily worldwide and Italy follows this trend with an increase of almost 30% in the adult obese population in the last 3 decades. Previous studies estimated that 2-4% of the total health expenditure in Europe is attributed to obesity and it is projected to double by 2050. Currently, there is a lack of sufficient knowledge on the burden of obesity in Italy and most relevant estimates are derived from international studies. The aim of this study is to estimate the direct and indirect costs of obesity in Italy, taking 2020 as the reference year., Methods: Based on data collected from the literature, a quantitative cost-of-illness (COI) study was performed from a societal perspective focussing on the adult obese population (Body Mass Index (BMI) ≥ 30 kg/m 2 ) in Italy., Results: The study indicated that the total costs attributable to obesity in Italy amounted to €13.34 billion in 2020 (95% credible interval: €8.99 billion < µ < €17.80 billion). Direct costs were €7.89 billion, with cardiovascular diseases (CVDs) having the highest impact on costs (€6.66 billion), followed by diabetes (€0.65 billion), cancer (€0.33 billion), and bariatric surgery (€0.24 billion). Indirect costs amounted to €5.45 billion, with almost equal contribution of absenteeism (€2.62 billion) and presenteeism (€2.83 billion)., Conclusions: Obesity is associated with high direct and indirect costs, and cost-effective prevention programmes are deemed fundamental to contain this public health threat in Italy., (© 2021. The Author(s).)

Objectives: This systematic review aims to describe 1) the epidemiology of the diseases indicated for treatment with growth hormone (GH) in Italy; 2) the adherence to the GH treatment in Italy and factors associated with non-adherence; 3) the economic impact of GH treatment in Italy; 4) the quality of life of patients treated with GH and their caregivers in Italy., Methods: Systematic literature searches were performed in PubMed, Embase and Web of Science from January 2010 to March 2021. Literature selection process, data extraction and quality assessment were performed by two independent reviewers. Study protocol has been registered in PROSPERO (CRD42021240455)., Results: We included 25 studies in the qualitative synthesis. The estimated prevalence of growth hormone deficiency (GHD) was 1/4,000-10,000 in the general population of children; the prevalence of Short Stature HOmeoboX Containing gene deficiency (SHOX-D) was 1/1,000-2,000 in the general population of children; the birth prevalence of Turner syndrome was 1/2,500; the birth prevalence of Prader-Willi syndrome (PWS) was 1/15,000. Treatment adherence was suboptimal, with a range of non-adherent patients of 10-30%. The main reasons for suboptimal adherence were forgetfulness, being away from home, pain/discomfort caused by the injection. Economic studies reported a total cost for a complete multi-year course of GH treatment of almost 100,000 euros. A study showed that drug wastage can amount up to 15% of consumption, and that in some Italian regions there could be a considerable over- or under-prescribing. In general, patients and caregivers considered the GH treatment acceptable. There was a general satisfaction among patients with regard to social and school life and GH treatment outcomes, while there was a certain level of intolerance to GH treatment among adolescents. Studies on PWS patients and their caregivers showed a lower quality of life compared to the general population, and that social stigma persists., Conclusion: Growth failure conditions with approved GH treatment in Italy constitute a significant burden of disease in clinical, social, and economic terms. GH treatment is generally considered acceptable by patients and caregivers. The total cost of the GH treatment is considerable; there are margins for improving efficiency, by increasing adherence, reducing drug wastage and promoting prescriptive appropriateness., Competing Interests: Simona Granato, Giuseppe Novelli, Roberto Di Virgilio and Daria La Torre are employees of Pfizer. Barbara Polistena declares to have received in the last 5 years payments or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from the following commercial sources: Allergan, Amgen, Astellas, Baxter, BMS, Boehringer-Ingelheim, Celgene, Eli Lilly, Janssen Cilag, Jazzpharma, Mylan, Nestlé HS, Novartis, Novo Nordisk, Pfizer, Roche, Sanofi, Servier, Shire, Takeda, Teva; in addition, she received consulting fees from UCB. Federico Spandonaro declares to have received in the last 5 years payments or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from the following commercial sources: Allergan, Amgen, Astellas, Baxter, BMS, Boehringer-Ingelheim, Celgene, Eli Lilly, Janssen Cilag, Jazzpharma, Mylan, Nestlé HS, Novartis, Novo Nordisk, Pfizer, Roche, Sanofi, Servier, Shire, Takeda, Teva; in addition, he received consulting fees from Amgen. All other authors declare that they have no competing interests. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Minimization of hospital lengths of stay has always been a key goal for healthcare systems. More so during the current COVID-19 pandemic. In fact, we have faced a reduction in no-COVID-19 admissions with the generation of huge backlogs. Low-risk patients undergoing elective percutaneous coronary intervention (PCI) can be candidate for short-term hospitalization, with consequent reduction of waiting lists. Several single-center and multicenter observational studies, multiple randomized trials and some meta-analyses have addressed this topic.In this position paper, we present a proposal for short hospitalization for elective PCI procedures in selected patients who present complications only exceptionally and exclusively immediately after the procedure, if the inclusion and exclusion criteria are met. Each Center can choose between admission in day surgery or one day surgery, extending hospital length of stay only for patients who present complications or who are candidate for urgent surgery. Short-term hospitalization considerably reduces costs even if, with the current model, it generally results in a parallel reduction in reimbursement. Hence, we present an actual model, already tested successfully in an Italian hospital, that warrants sustainability. This approach can then be tailored to single Centers.

Fabry disease (FD) is a genetic disease included in the group of lysosomal storage disorders, caused by X-linked deficiency of the enzyme alpha-galactosidase A. The aim of this study was to evaluate different aspects related to the quality of life (QoL) of a multicentre cohort of Italian patients with FD. An observational survey was conducted to measure health-related quality of life (HR-QoL) in FD patients using the CAPI (Computer-Assisted Personal Interview) method: 106 patients (mostly women) responded to the questionnaire. Geographically, 53.7% of patients lived in northern Italy, 18.9% in central Italy and 27.4% in southern Italy or the Islands. All data were collected through a five-dimensional EuroQoL questionnaire referring to functional aspects (mobility, personal care, routine activities) and perception of physical/mental well-being (pain or discomfort, anxiety or depression). A descriptive analysis of responses was performed; FD patients were compared in terms of QoL with subjects suffering from other chronic diseases, such as Crohn's disease, chronic hepatitis, cirrhosis and multiple sclerosis. Difficulty in normal daily activities was reported by 47.2% of FD patients. About one third of subjects also had mobility difficulties. Feelings of loneliness and isolation were reported by 33.3% of those being 60-69 years old. Anxiety was equally reported in both oldest and youngest patients (66.7%), while depression, relational problems, fear of other people's judgement increased along with age, reaching 66.7% in the over-70-years group. Male patients were largely troubled about the risk of physical disability, particularly those aged 60 years or over. Furthermore, FD patients had a poorer QoL than people suffering from other chronic inflammatory disorders. Our study upholds that FD patients have a poor QoL, as already known, negatively impacting psychic well-being and social activities. Our survey has also found a worse QoL in FD patients compared with other severe chronic disorders.

Competing Interests: Conflict of interest: GA, GA, GB, PC, EC, FD, CLV, MM, WM, AM, AP, WR, FRdM, FS and VT have nothing to declare. AA received personal fees and/or grants from BMS, MSD, Roche, Astra Zeneca, Eli-Lilly, Takeda e Bayer. GWC received personal fees and/or grants from A. Menarini, Alk-Abelló, Allergy Therapeutics, AstraZeneca-Medimmune, Boehringer Ingelheim, Chiesi Farmaceutici, Genentech, Guidotti-Malesci, Glaxo Smith Kline, Hal Allergy, Merck Sharp & Dome, Mundipharma, Novartis, Orion, Sanofi-Aventis, Sanofi Genzyme/Regeneron, Stallergenes-Greer, Uriach Pharma, Teva, Valeas, ViforPharma. GC received personal fees and/or grants from the European Community, AIFA, Ministeri dell’Università e Ricerca (MIUR), Novartis, GSK, Roche, AMGEN, BMS, Roche. APM received personal fees and/or grants from Bayer, Fresenius, Novartis. GM received personal fees and/or grants from Astra Zeneca, Boehringer Ingelheim, Daiichi Sankyo, Medtronic, Menarini, Merck, Novartis, Recordati, Sandoz, Sanofi, Servier. AM received personal fees and/or grants from Ventana, Pierre Fabre, Verily, Abbvie, AstraZeneca, Verseau Therapeutics, Compungen, Myeloid Therapeutics, Third Rock Venture, Imcheck Therapeutics, Ellipses, Novartis, Roche, Macrophage Pharma, Bioveloclta, Merck, Principia, BMS, Johnson & Johnson. Declares commercial interest in Cedarlane Laboratories Ltd, HyCult Biotechnology, eBioscience, Biolegend, ABCAM PIc, Novus Biologicals, Enzo Life, Affymetrix. AR received personal fees and/or grants from Amgen, Pfizer, Sanofi, Novartis, Kite-Gilead, Celgene-BMS, Jazz, Omeros.

Purpose: Follow-up of automated peritoneal dialysis (APD) has been improved by data transmission by cellular modem and internet cloud. With the new remote patient monitoring (RPM) technology, clinical control and prescription of dialysis are performed by software (Baxter Claria-Sharesource), which allows the center to access home operational data. The objective of this pilot study was to determine the impact of RPM compared to traditional technology, in clinical, organizational, social, and economic terms in a single center., Methods: We studied 21 prevalent APD patients aged 69 ± 13 years, on dialysis for a median of 9 months, for a period of 6 months with the traditional technology and 6 months with the new technology. A relevant portion of patients lived in mountainous or hilly areas., Results: Our study shows more proactive calls from the center to patients after the consultation of RPM software, reduction of calls from patients and caregivers, early detection of clinical problems, a significant reduction of unscheduled visits, and a not significant reduction of hospitalizations. The analysis also highlighted how the RPM system lead to relevant economic savings, which for the health system have been calculated € 335 (mean per patient-month). With the social costs represented by the waste of time of the patient and the caregiver, we calculated € 685 (mean per patient-month)., Conclusion: In our pilot report, the RPM system allowed the accurate assessment of daily APD sessions to suggest significative organizational and economic advantages, and both patients and healthcare providers reported good subjective experiences in terms of safety and quality of follow-up., (© 2021. The Author(s), under exclusive licence to Springer Nature B.V. part of Springer Nature.)

Background: Immunotherapies have revolutionized oncology, but their rapid expansion may potentially put healthcare budgets under strain. We developed an approach to reduce demand uncertainty and inform decision makers and payers of the potential health outcomes and budget impact of the anti-PD-1/PD-L1 class of immuno-oncology (IO) treatments., Methods: We used partitioned survival modelling and budget impact analysis to estimate overall survival, progression-free survival, life years gained (LYG), and number of adverse events (AEs), comparing "worlds with and without" anti-PD-1/PD-L1s over five years. The cancer types initially included melanoma, first and second line non-small cell lung cancer (NSCLC), bladder, head and neck, renal cell carcinoma, and triple negative breast cancer [1]. Inputs were based on publicly available data, literature, and expert advice., Results: The model [2] estimated budget and health impact of the anti-PD-1/PD-L1s and projected that between 2018-2022 the class [3] would have a manageable economic impact per year, compared to the current standard of care (SOC). The first country adaptations showed that for that period Belgium would save around 11,100 additional life years and avoid 6,100 AEs. Slovenia - 1,470 LYGs and 870 AEs avoided; Austria - respectively 4,200, 3,000; Italy - 19,800, 6,800. For Austria, the class had a projected share of about 4.5 % of the cancer care budget and 0.4 % of the total 2020 healthcare budget. For Belgium, Slovenia, and Italy - respectively 15.1 % and 1.1 %, 12.6 %, 0.6 %, and 6.5 %, 0.5 %., Conclusion: The Health Impact Projection (HIP) is a horizon scanning model designed to estimate the potential budget and health impact of the PD-(L)1 inhibitor class at a country level for the next five years. It provides valuable data to payers which they can use to support their reimbursement plans., Policy Summary: The model is a strategic tool which allows decisionmakers to assess the implications of policy decisions, such as additional investment, or accelerated access to IOs. It can drive tangible population health benefits by eliminating the questions around PD-(L)1 inhibitor spending and its related outcomes., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Introduction: Viscosupplementation with hyaluronic acid (HA) is indicated for non-responders to non-pharmacological therapy, to analgesics or when non-steroidal anti-inflammatory drugs (NSAIDs) are contraindicated. The aim of this study is to compare the efficacy, safety and costs of three different HA treatments ( Sinovial® Forte , sinovial one and hyalgan)., Patients and Methods: Ninety patients with grade I/II Kellgren-Lawrence knee osteoarthritis were included in three groups, the first was treated with hyalgan (weekly for 5 weeks), the second with Sinovial® Forte (weekly for 3 weeks) and the third group with a single injection of sinovial one., Results: All three treatments were effective, with an average reduction in the Western Ontario and McMaster Universities osteoarthritis index (WOMAC) score of 18.9 points for hyalgan, 18.04 points for Sinovial® Forte and 17.92 points for sinovial one. The comparison of the three groups did not show any statistical difference in terms of efficacy. National health system (NHS) and social costs are, respectively, €419.12 and €853.43 for hyalgan, €338.64 and €599.22 for Sinovial® Forte , €221.56 and €308.42 for sinovial one., Conclusion: All three treatments were equally effective with no statistically significant differences; thus, the treatment with sinovial one may be considered as clinically effective as the other two regimens, but with a very efficient cost profile in early symptomatic knee osteoarthritis., Competing Interests: Conflict of interest: The authors declare that there is no conflict of interest., (© The Author(s), 2021.)

Understanding the distribution of prostate cancer (PC) at various clinical stages of disease is of utmost importance to quantify the cancer care needs of patients and to adequately plan health services. The aim of this analysis is thus to provide a model-based estimation of the number of prevalent PC patients at different clinical stages in the Italian setting. A simulation model of patient transitions was constructed on a yearly basis using data obtained through a literature review on the incidence, prevalence, progression and mortality of PC, with specific focus on disease stage. A total of 462,570 prevalent PC patients were estimated at 1 January 2019. According to the model, 94.8% of them had non-metastatic PC and 5.2% had metastatic disease. Among the non-metastatic patients, most had T1/T2 PC (85.6%), followed by T3/T4 (10.9%) and T0/Tx PC (3.6%). About 20% of the T3/T4 patients had biochemically recurrent PC. Among the metastatic PC patients, 66.1% had castration-resistant PC and 33.9% had hormone-sensitive PC. This study provided original information on the distribution of PC according to different clinical stages that may be useful to define strategies, understand the PC disease pathway, estimate treatment-related needs and, possibly, plan targeted interventions for public health management of prostate cancer in Italy.

Background: Enteropathic spondyloarthritis (ESpA) and inflammatory bowel diseases (IBD) have high impact on physical and psychological health but health-related quality of life (HRQoL) has never been evaluated in ESpA patients., Purpose: Cross-sectional multidisciplinary study was performed to evaluate HRQoL, state of health, and well-being in IBD and ESpA patients., Methods: Consecutive IBD and ESpA outpatients were enrolled. Disease activity, inflammatory parameters, function, and quality of life (EuroQol questionnaire) were assessed at visit time and compared with 12 months ago., Results: Two hundred fifty-three IBD patients were evaluated. Ninety-five patients met inclusion criteria. ESpA was established in 65.3% IBD patients. Most ESpA patients had discreet or good health perception (65.3% and 22.5%, respectively), similar to IBD group (64.6% and 20.7%, respectively). In both groups, no patients had exceptional state of general well-being. Compared with previous 12 months, ESpA group showed improved state of health in 12% of patients, worsening in 28% and stable state of health in 60%. Similar results were obtained in IBD group. Emotional and psychological problems (anxiety, depression, and feeling of loneliness and isolation) were reported: In ESpA patients, these feelings were observed in 58.1%, 40.57%, and 29% of cases, respectively; IBD patients showed slightly lower percentage. More than half of ESpA and IBD patients reported an embarrassment about their condition and worry about disease's future progression and physical pain., Conclusions: Well-being, quality of life, and psychological problems were described in ESpA and IBD patients. Disease management should include also social, mental, and psychological impacts, in terms of QoL., (© 2020 John Wiley & Sons Ltd.)

Purpose: Over the last few years, the share of public spending for orphan drugs (ODs) has increased in several western countries, raising concern on the exemptions granted to this sector with respect to the implementation of health technology assessment (HTA) principles. The aim of this paper is to shed light on both the HTA criteria adopted and the international agreements implemented in the OD regulation, given the new challenges imposed on western countries by a growing number of therapies for rare diseases., Methods: We carried out a literature review to analyse the development of the international debate on the adaptability of HTA criteria for the OD assessment and regulation. The time span lies between January 1990 and May 2018, and the policies considered relate to both market authorization and reimbursement decisions within western countries. We focus specifically on HTA criteria in some of the dimensions included in the Core Model of the European net for HTA (EUnetHTA)., Results: OD high prices, the absence of clarity on the possible high revenues realized by the distribution of a new OD outside the national borders, the risk that - once marketed - a new OD can be used to treat common diseases, are all issues that raise concern on OD regulation and have to be carefully monitored by policymakers in the next future., Conclusions: Across western countries, the preferential track granted to ODs in the implementation of HTA principles is not homogeneous, but fragmented and differentiated. The need for common rules at an international level is underlined, with a view to assessing the sustainability of a sector which, due to this regulatory void, can lend itself to producers' strategic and opportunistic behaviours.

Introduction: Three Italian scientific associations of different specialties (AMD, Associazione Medici Diabetologi-for diabetologists; ANMCO,Associazione Nazionale Medici Cardiologi Ospedalieri-for cardiologists; SIMG, Società Italiana di Medicina Generale-for General Practitioners) designed this study to assess whether an integrated care organization comprising three different specialists can improve adherence and can achieve the guidelines targets in a population of individuals with type 2 diabetes, without established cardiovascular disease but at high risk (≥ 20% at 10 years according to the CUORE.ISS risk cards) compared with the current standards of care provided by the Italian National Health Service., Methods: Thirty primary care centers (general practitioners, GPs), 30 cardiology centers and 30 diabetes centers have been selected by the scientific associations, disseminated in the national territory, on the basis of proven previous cooperation in other studies. Each primary care center will enroll 100 type 2 diabetic subjects, > 45 years old, with no established cardiovascular disease, but with a high risk due to the presence of at least one other risk factor besides diabetes over the cutoff [hypertension > 135/80 mmHg, LDL cholesterol > 70 mg/dl, tobacco smoke, first-degree familiarity for CHD (coronary heart disease), central obesity according the WHO criteria]. Fifteen of 30 selected primary care centers, chosen randomly, will continue the treatment of the 100 identified patients according to their "usual care," driven by Good Clinical Practice and by current guidelines (control group or "UC"-usual care), collecting all available clinical and instrumental data and transferring them to the electronic CRF. The remaining 15, after informed consent, will submit their 100 patients each in a specific integrated pathway, which entails the mandatory operational integration and exchange of information with the diabetes specialists and cardiologists pertaining to the same previously identified area. The integrated care path for the patients in the proband group (IC, integrated care) is based on application of the recommendations of the Italian Guidelines aimed at achieving the proposed targets for the main risk factors [LDL < 70 mg/dl; SBP < 130 mmHg; HbA1c (glycated hemoglobin) ≤ 7% (52 mmol/mol]. All the clinical data will be recorded on a shared electronic CRF. The trial will last 3 years: 6 months for the enrollment and randomization of the centers, 6 months for the enrollment of the probands and control subjects, and 2 years of follow-up. The study will be conducted according the Helsinki Declaration on human experimentation ethics., Planned Outcomes: The primary planned outcome is represented by the increase in the percentage of people that achieve the target values of at least two out of three of the considered risk factors [HbA1c, SBP (systolic blood pressure), LDL cholesterol] compared with the percentage actually achieved in the control group. The secondary outcomes are: (1) a MACE (major adverse cardiac event) composite: non-fatal myocardial infarction, non-fatal stroke, mortality from any cause and hospitalization for cardiovascular disease; (2) the number of early diagnoses of new onset complications; (3) evaluation of adverse events and safety of the probands and control patients; (4) comparative cost analysis and cost-effectiveness analysis.

Purpose: To investigate whether the number of nursing diagnoses on hospital admission is an independent predictor of the hospital length of stay., Design: A prospective observational study was carried out. A sample of 2,190 patients consecutively admitted (from July to December 2014) in four inpatient units (two medical, two surgical) of a 1,547-bed university hospital were enrolled for the study., Methods: Data were collected from a clinical nursing information system and the hospital discharge register. Two regression analyses were performed to investigate if the number of nursing diagnoses on hospital admission was an independent predictor of length of stay and length of stay deviation after controlling for patients' sociodemographic characteristics (age, gender), clinical variables (disease groupers, disease severity morbidity indexes), and organizational hospital variables (admitting inpatient unit, modality of admission)., Findings: The number of nursing diagnoses was shown to be an independent predictor of both the length of stay (β = .15; p < .001) and the length of stay deviation (β = .19; p < .001)., Conclusions: The number of nursing diagnoses is a strong independent predictor of an effective hospital length of stay and of a length of stay longer than expected., Clinical Relevance: The systematic inclusion of standard nursing care data in electronic health records can improve the predictive ability on hospital outcomes and describe the patient complexity more comprehensively, improving hospital management efficiency., (© 2018 Sigma Theta Tau International.)

Background: Atrial fibrillation (AF) increases significantly the risk of comorbidities and premature death. This paper aims to estimate: 1) the current prevalence of AF in Italy as a whole and within individual local health authorities (LHA); 2) the proportion of strongly eligible patients receiving oral anticoagulants; 3) the impact of non-vitamin K antagonist oral anticoagulants (NOACs)., Methods: The prevalence of AF and the proportion of patients strongly eligible for anticoagulant treatment (defined by a CHADS2 score ≥2) were obtained by applying the results of a systematic literature search to the Italian population stratified by gender, age and LHA. The consumption of oral anticoagulants in eligible patients within each LHA was derived from Intercontinental Marketing Services data., Results: Altogether, the detected prevalence of AF in Italy is 1.7%, i.e. 1 036 448 cases. Of these, 62.6%, i.e. 648 832 subjects, are estimated to have a CHADS2 ≥2 and therefore strongly eligible for anticoagulant treatment. The estimated percentage of eligible treated patients in 2015 was 43.7%, significantly greater compared to 2014 (31.3%), with local and regional variabilities. In 2015 the estimated use of NOACs for AF was 36.4% of all oral anticoagulants, with marked local and regional variabilities. NOAC prescription appears influenced by financial limitations and by factors related to the network of anticoagulation services., Conclusions: The present analysis shows a prevalence of AF in Italy of 1.7%. The overall rate of anticoagulant use is increasing, but is still insufficient, with marked regional and local variations. In 2015, approximately one third of oral anticoagulation in eligible patients was based on NOACs.