Italian National Health System Research Articles

Reducing healthcare costs by timely diagnosis and management in functional motor disorders.

Functional motor disorders (FMDs) are prevalent and highly disabling conditions among young adults, leading to reduced independence. Despite advancements in diagnosis and treatment, the economic burden of FMDs remains largely unknown. This study evaluates the impact of accurate FMDs diagnosis on direct healthcare costs within the Italian National Health System by comparing healthcare utilization and costs before and after diagnosis. This before-after study included 40 patients with a definite diagnosis of FMDs. Retrospective data on healthcare utilization, including diagnostic tests, specialist visits, hospitalizations, Emergency Room (ER) visits, and rehabilitation services, were collected from diaries and documents two years before and after diagnosis. Healthcare direct costs decreased by 67%, from an average of €4,467 [95% CI 3,604-5,329] to €1,461 [95% CI 945-1,976] after diagnosis. Hospitalization costs fell from €2,618 [95% CI 1,899-3,336] to €492 [95% CI 162-821], and ER costs dropped from €403 [95% CI 177-628] to €43 [95% CI 6-78]. Diagnostic procedure costs decreased significantly, from €403 [95% CI 177-628] to €43 [95% CI 6-78]. Specialist visit costs remained unchanged. Rehabilitation costs increased from €371 [95% CI 194-547] to €635 [95% CI 318-915], but this rise was not statistically significant. Accurate diagnosis of FMDs significantly reduces healthcare costs by minimizing unnecessary tests, hospitalizations, and ER visits while emphasizing rehabilitation. This highlights the economic and clinical benefits of improved diagnostic accuracy and specific multidisciplinary intervention. Investing in cost-effective diagnostic tools is crucial for earlier diagnosis and reducing delays.

The minimally clinically important difference in the 2-minute walk test for people in the subacute phase after a stroke

ABSTRACT Background The 2-Minute Walk Test (2MWT) is a simple and reliable test used by clinicians to assess gait function in people with stroke (pwST). No studies established the minimal clinically important difference (MCID) of the 2MWT. Objective To determine the MCID of the 2MWT in subacute pwST using data from a longitudinal cohort study. Methods PwST within 180 days of stroke onset were recruited from the Italian National Health System (NHS) rehabilitation services across the country. Participants underwent physical therapy to improve balance and gait according to their specific needs. The 2MWT was used to assess gait performance at the beginning (T0) and after a minimum of 10 rehabilitation sessions (T1). The Global Perceived Effect (GPE), Activities-specific Balance Confidence Scale (ABC) and the ABC_gait were used to assess balance confidence and the perceived effect of the intervention at T1. Results 51 pwST (69 ± 12 years; 66.7% males) were included in the analysis. Statistically significant improvements were observed in 2MWT, ABC, and ABC_gait scores after rehabilitation using the Wilcoxon signed-rank test. Using an anchor-based approach the receiver operating characteristic (ROC) curves were calculated to establish the MCID. The MCID of the 2MWT was 31 meters with an Area under the curve (AUC) = 0.74 [0.60–0.89], a specificity of 71% and a sensitivity of 63%. Conclusions An improvement of 31 meters on the 2MWT can be considered clinically significant in subacute pwST undergoing rehabilitation. This study provides valuable insights for clinicians to assess walking performance in pwST and determine clinically meaningful changes post-rehabilitation.

How Avoidable Mortality is influenced by health expenditure: an Italian 14-year panel data analysis

Abstract Background Avoidable Mortality is a widely used public health indicator to assess the quality of healthcare systems. The aim of this study was to investigate how the allocation of private and public health expenditure (PHE) could influence avoidable mortality (AM), treatable mortality (TM) and preventable mortality (PM) of Italian citizens. Methods A pooled cross-sectional time series study was conducted. Italian healthcare data from 2009 to 2019 was extracted from ‘Health for All’, a WHO-related database released periodically by the Italian National Institute of Statistics. PHE was divided by providers area (directly provided services (DPS), general and specialist medicine, pharmaceutical, rehabilitation). Data about private health expenditure, gross domestic product per capita (GDPPC), level of education, medical drug consumption per capita (MDCPC), general practitioners per capita (GPPC), physical exercise, tobacco use, and obesity were collected. AM was divided into TM and PM using OECD/Eurostat lists of causes of death (2022). A fixed-effects regression was used to assess the effects of economic and social variables on AM, TM and PM. Results Higher spending on DPS (-0.027), higher MDCPC (-0.859) and higher GDPPC (-0.001) were associated with lower rates of AM. Higher sport activity (c -0.673) was associated with lower rates of TM. Higher levels of private health expenditure (0.022) and higher number of GPPC (0.023) were associated with higher rates of PM; these counterintuitive results could be caused by the inappropriateness of medical treatment directly requested by patients. Other variables were not significantly associated with AM, TM or PM. Conclusions The results highlight the importance of medical DPS by NHS (emergency departments, hospital care, specialized care, primary care, etc.). Analyzing health data divided by areas of NHS we could help policy makers to allocate human and economic resources more efficiently. Key messages • The allocation of public health resources could influence the health status of the polulazion. • Italian National Health System could reduce avoidable mortality through the use of directly provided services.

Cost-Effectiveness Analysis of Topical Treatments for Actinic Keratosis in Italian National Health System.

Introduction: Actinic keratosis (AK) is a widespread pre-cancerous skin condition that may evolve to squamous cell carcinoma, a non-melanoma skin cancer, which is able to become locally invasive and metastatic. Thus, it is important to treat AK. Methods: We conducted a cost-effectiveness analysis for the field-directed therapeutic approaches: local application of drugs containing 5-fluorouracil, both alone at a 4% concentration and associated to 10% salicylic acid at a 0.5% concentration (0.5% 5-FU + 10% SA cut. sol.); diclofenac-hyaluronic acid gel; imiquimod, both at 3.75% and 5% (5% IMQ cream) concentrations; and tirbanibulin ointment. The effectiveness data were abstracted from the literature. The cost-effectiveness analysis was performed by considering the prices reported by Agenzia Italiana del Farmaco (AIFA) for each medicine. Results: We obtained the total cost for each treatment by computing the cost of a single treatment for its duration. Application of 0.5% 5-FU + 10% SA cut. sol. appeared as the most convenient approach, as it was more effective and less expensive than all treatments except for 5% IMQ cream. For this last option, the incremental cost/effectiveness ratio analysis showed that a modest gain in effectiveness has a cost of EUR 7.94, therefore making it less cost effective.

Advanced Therapy Medicinal Products: Availability, Access and Expenditure in Italy.

Advanced therapy medicinal products (ATMPs) are an innovative output of biomedical research, characterized by a high level of uncertainty on long-term efficacy and safety, elevated price tags and often complex administration. All these elements compounded make their European authorization, national price negotiation for reimbursement and subsequent dispensation and administration to the patient less straightforward and often less successful than for less innovative drugs. To assess if these hurdles have affected patient access and how are ATMPs used in Italy, we have analysed availability, access and expenditure of ATMPs in the period spanning from 2016 to 2023. We have analysed real world data on the duration of ATMP regulatory evaluations for authorisation and reimbursement, time to first patient access and expenditure for ATMPs through the Italian National Health System (INHS) expenditure data flow, as well as information on patient mobility and availability of health facilities specialized in administering ATMPs. Of the 18 ATMPs currently authorized in Europe, 9 are reimbursed by the INHS, but only 6 were actually used, generating a cumulative expenditure of roughly 300 Mln€ from 2016 to 2023, largely owing to CAR-T therapies. Time to patient access reaches an average of 340.6 days from the day publication in the official Gazette of the reimbursement decision to first patient treatment in one of the 107 health facilities authorized for ATMP administration, after an even longer evaluation time by regulatory agencies. Since the first reimbursement decision for an ATMP in Italy, back in 2016, these innovative drugs became progressively more and more available, both in terms of numbers and in terms of coverage across the country. Almost all Italian regions have at least one centre for ATMP administration and has performed a treatment in 2023. Notwithstanding their high per-treatment prices, ATMPs currently have a rather contained expenditure, however it is bound to keep growing in the next few years.

Cost per responder analysis of abrocitinib versus dupilumab in moderate to severe atopic dermatitis.

The JADE COMPARE was a multicenter, phase 3 randomized, double-blind, placebo-controlled trial with the objective of comparing the 16-week efficacy and safety of oral abrocitinib 100 or 200 mg once daily, dupilumab 300 mg subcutaneous injection every 2 weeks, or placebo in adults with moderate-to-severe atopic dermatitis (AD). Pharmacoeconomic evaluation of these new drugs for AD is lacking. The objective of our study was to compare the cost per responder of abrocitinib versus dupilumab in patients with AD using the data from the JADE COMPARE trial. The cost per responder was calculated by multiplying the cost of treatment by the number needed to treat for each therapy, as obtained from the JADE COMPARE trial. The 12-week primary endpoint was the Investigator global assessment (IGA) 0/1 and eczema area and severity index improvement of at least 75% (EASI75) response rate. The key secondary end points were itch response (defined as an improvement of ≥4 points in the score on the Peak Pruritus Numerical Rating Scale [PP-NRS; scores range from 0 to 10]) at week 2 and IGA and EASI-75 responses at week 16. The cost per responder model was based on the perspective of the Italian National Health System. Regarding the costs of drugs, ex-factory wholesale purchase prices were used, including the mandatory discounts according to the national legislation (5% discount, plus a further 5% reduction on the discount result). Abrocitinib 100 mg and 200 mg have flat price in Italy. The 12-week IGA 0/1 cost per responder was € 3955.77 and € 2984.94 for abrocitinib 100 mg and 200 mg, respectively, versus € 7467.96 for dupilumab; as for 12-week EASI75 the cost were € 2463.30 and € 2057.58 vs. € 4705.09, respectively. As far as the secondary end points, the costs per responder were always lower for abrocitinib 100 and 200 mg compared to dupilumab, including the PP-NRS (€ 3791.55 and € 2451.22, vs. € 6462.65), the IGA 0/1 at week 16 (€ 6931.05 and € 4854.15 vs. € 8787.85) and the EASI75 at week 16 (€ 3984.75 and € 3381.00 vs. € 5197.45). According to JADE COMPARE trial data, the costs per responder of abrocitinib were considerably lower than dupilumab. The results of the study are limited to the short time frame of JADE COMPARE trial.

Cost-effectiveness analysis comparing single-pill combination of perindopril/amlodipine/indapamide to the free equivalent combination in patients with hypertension from an Italian national health system perspective

ABSTRACT Objective To evaluate the cost-effectiveness of a single-pill combination (SPC) of perindopril/amlodipine/indapamide versus its free equivalent combination (FEC) in adults with hypertension in Italy. Methods A Markov model was developed to perform a cost-utility analysis with a lifetime horizon and an Italian healthcare payer’s perspective. In the model, the additional effect of the SPC on blood pressure level compared with the FEC was translated into a decreased risk of cardiovascular events and CKD, which was modeled via Framingham risk algorithms. Difference in persistence rates of SPC and FEC were modeled via discontinuation rates. Results A perindopril/amlodipine/indapamide SPC is associated with lower cost and better health outcomes compared to its FEC. Over a lifetime horizon, it is associated with a 0.050 QALY gain and cost savings of €376, resulting from lower cardiovascular event rates. In the alternative scenario, where different approach for modeling impact of adherence was considered, incremental gain of 0.069 QALY and savings of €1,004 were observed. Results were robust to sensitivity and scenario analyses, indicating that use of this SPC is a cost-effective strategy. Conclusions The findings indicate that a perindopril/amlodipine/indapamide SPC is a cost-saving treatment option for hypertension in Italy, compared to its FEC.

Psychological interventions in the Italian national health system: appropriateness and accountability.

In the field of clinical governance, the search for progressive high-quality health interventions is accompanied by the different health values they assume for the different stakeholders involved. With increasing frequency, the value of clinical psychology and psychotherapy interventions in the public service is also supported by their ability to be appropriate and measurable in terms of their effectiveness. As such, their expected future is one of systematic inclusion within increasingly defined and specific care pathways. The challenge that this evolution poses is complex from an epistemologicalmethodological point of view because it must include the various perspectives from which one looks at the nature of these interventions. Clinical appropriateness, as a meta-level variable, and accountability go beyond the simplistic/generic cost-benefit assessment of services and are proposed as a necessary conceptual framework for an adequate determination of outcomes.

How to Implement Pressurized Intraperitoneal Aerosol Chemotherapy into a National Health System Scenario: A Single-Center Retrospective Analysis of Costs and Economic Sustainability at a High-Volume Italian Hospital.

PIPAC is a new surgical procedure and a viable treatment option for PSM patients, due to promising therapeutic outcomes, minimal invasiveness, limited surgical morbidity, and systemic toxicity side effects. However, its implementation throughout hospitals is hard to obtain due to its fragile economical sustainability. A retrospective health economic analysis was conducted in order to evaluate the cost of hospitalization for patients undergoing PIPAC treatment at Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, in Rome. The average cost of a PIPAC procedure was defined based on the cost of surgery (cost of surgical material, operating room, intraperitoneal chemotherapy), hospital stay, diagnostic examinations, and drugs used during the stay. A total of 493 PIPAC procedures were performed on 222 patients with peritoneal metastases or primary peritoneal cancer from 2017 to 2023. Since the mean remuneration for each PIPAC hospitalization is €5916 and the mean expenditure per hospitalization is €6538, this results in an operating profit per PIPAC hospitalization of -€622. The reimbursement of PIPAC treatment by the Italian National Health System currently only partially covers the hospital's costs. Development of specific codes and adequate reimbursement for PIPAC by recognizing this procedure as a proper treatment for peritoneal carcinomatosis is essential.

A Comparative Study to Assess the Energy Efficiency of Temporary Structures to Guarantee Emergency Basic Healthcare in Italy

During emergencies, healthcare is generally provided by tents and temporary shelters, without considering the environmental and social impact of the structures as a priority, in favor of swift response. The resultant constructions intended as a temporary solution often persist for a long time. This paper aims to analyze an alternative and innovative modular structure designed as a transitory solution in emergencies and everyday life. The aim of this study is to assess and compare the energetic performance of a modular adaptive model for basic healthcare for people who are not subscribed to the Italian National Health System. The main goal is to challenge standard models by proposing a new model able to diminish the weaknesses of the current sanitary models, to improve the social conditions, flexibility and energy efficiency, and the thermal comfort of the occupants. In the first part of the paper, the conceptual framework and the preliminary design of the model are described by investigating the benefits of a safe space as a generator space for care services and the community. In the second part, the technological requirements of the system are defined by comparing the use of different panel structures and low-impact technologies. The energy efficiency and environmental impact of the model are assessed by comparing several panel structures in two different climatic areas in Italy (northern and Mediterranean areas) using SketchUp and EnergyPlus simulation. As a result, different configurations of the model are proposed according to the different climatic areas in order to optimize the model, from both an architectural and a technological point of view (box and panel composition).

Eligibility for vericiguat in a real-world, contemporary heart failure population.

Vericiguat is a soluble guanylate cyclase stimulator and improves survival in patients with heart failure (HF) with reduced ejection fraction (HFrEF) and an increased risk of decompensation. As real-world data on how many patients could be eligible for vericiguat therapy derive from outdated registries, we aimed to assess eligibility in a prospective cohort of patients with HF. Data from consecutive HF patients undergoing an elective ambulatory visit at five university hospitals from 3 July to 28 July 2023 were collected. Independent investigators assessed which patients (i) met the eligibility criteria of the VICTORIA trial, (ii) complied with HF guideline recommendations, (iii) met regulatory agency criteria, or (iv) met criteria for refundability according to the Italian regulatory agency. Patients (n=346, 72% men, median age 69years) had HFrEF in 57% of cases, left ventricular ejection fraction<45% in 68%, and New York Heart Association class II-IV symptoms in 76%. Patients meeting the eligibility criteria of the VICTORIA trial or European and American HF Guideline recommendations were 9% and 13%, respectively. Patients meeting Food and Drug Administration (FDA) or European Medicines Agency (EMA) label criteria were 19% and 17%, respectively. Drug costs would be covered by the Italian National Health System in 10% of patients [if a sodium-glucose cotransporter-2 inhibitor (SGLT2i) is not mandatory] or in 8% (if an SGLT2i is requested). In a real-world study, 9% of patients met the eligibility criteria of the VICTORIA trial, but up to 13% complied with guideline recommendations and up to 19% met FDA or EMA criteria. In Italy, drug costs would be covered by up to 10% of patients.

Cost-effectiveness of outpatient adherence to recommendations for monitoring of patients hospitalized for heart failure.

A set of indicators to assess the quality of care for patients hospitalized for heart failure was developed by an expert working group of the Italian Health Ministry. Because a better performance profile measured using these indicators does not necessarily translate to better outcomes, a study to validate these indicators through their relationship with measurable clinical outcomes and healthcare costs supported by the Italian National Health System was carried out. Residents of four Italian regions (Lombardy, Marche, Lazio, and Sicily) who were newly hospitalized for heart failure (irrespective of stage and New York Heart Association class) during 2014-2015 entered in the cohort and followed up until 2019. Adherence to evidence-based recommendations [i.e. renin-angiotensin-aldosterone system (RAS) inhibitors, beta-blockers, mineralocorticoid receptor antagonists (MRAs), and echocardiograms (ECCs)] experienced during the first year after index discharge was assessed. Composite clinical outcomes (cardiovascular hospital admissions and all-cause mortality) and healthcare costs (hospitalizations, drugs, and outpatient services) were assessed during the follow-up. The restricted mean survival time at 5years (denoted as the number of months free from clinical outcomes), the hazard of clinical outcomes (according to the Cox model), and average annual healthcare cost (expressed in euros per person-year) were compared between adherent and non-adherent patients. A non-parametric bootstrap method based on 1000 resamples was used to account for uncertainty in cost-effectiveness estimates. A total of 41406 patients were included in this study (46.3% males, mean age 76.9±9.4years). Adherence to RAS inhibitors, beta-blockers, MRAs, and ECCs were 64%, 57%, 62%, and 20% among the cohort members, respectively. Compared with non-adherent patients, those who adhered to ECCs, RAS inhibitors, beta-blockers, and MRAs experienced (i) a delay in the composite outcome of 1.6, 1.9, 1.6, and 0.6months and reduced risks of 9% (95% confidence interval, 2-14%), 11% (7-14%), 8% (5-11%), and 4% (-1-8%), respectively; and (ii) lower (€262, €92, and €571 per year for RAS inhibitors, beta-blockers, and MRAs, respectively) and higher costs (€511 per year for ECC). Adherence to RAS inhibitors, beta-blockers, and MRAs showed a delay in the composite outcome and a saving of costs in 98%, 84%, and 93% of the 1000 bootstrap replications, respectively. Strict monitoring of patients with heart failure through regular clinical examinations and drug therapies should be considered the cornerstone of national guidelines and audits.

Remote Check as a tele-health instrument for cochlear implant recipients: Analysis of impact and feasibility of application.

PurposeThe number of cochlear implant (CI) surgeries is growing over time, with the risk of overloading CI centers in the post-surgical management. Telemedicine is a possible solution to address this phenomenon. Remote Check (RC) is an application that is specific for CI recipients monitoring. The aim of this study is to evaluate the feasibility of application, potential economic impact and patients' acceptance of RC. MethodsThe study is retrospective investigation, data on clinical, audiological features (from remote and on-site evaluation), and satisfaction surveys of 66 consecutive patients were collected; costs required for RC and for on-site evaluations were recorded as well. ResultsOne hundred and ninety RC sessions were completed by the patients (2.88 sessions per patient). RC and on-site audiometry significantly correlated except for the 500 Hz frequency.Estimated costs for the Italian National Health System for RC review and on-site evaluations were 1.32€ and 3.49€ per minute, respectively. High satisfaction for RC was reached in 91 % of patients. ConclusionRC revealed to be a reliable, cost-effective and well accepted tool in CI monitoring. This study preliminarily supports the hypothesis that RC could be a valid instrument to reduce CI management overload in the outpatient clinic.

Co-payment exemption and healthcare consumption: quasi-experimental evidence from Italy

This paper investigates the causal effect of co-payment exemption on the number of specialist visits in the Italian National Health System. Exploiting a discontinuity in the multiple eligibility criteria, we apply multiple regression discontinuity in a quasi-experimental setting, considering both age and income requirements. Differently from the standard regression discontinuity, this twofold discontinuity allows to identify the effect of co-payment on a particularly needy sub-population of less wealthy people and how it changes according to the eligibility criteria. We find positive effects of co-payment exemption and the effects are stronger for less wealthy and older individuals. The result may be useful to the policy maker to tailor ad-hoc policies aimed at disadvantaged sub-populations.

The Use of Routine Outcome Monitoring (ROM) Among the Psychotherapists of the Italian National Health Service.

Routine outcome monitoring (ROM) is one of the most important methodologies for evaluating client progress and improving the efficiency and quality of psychological assistance. Despite this, the culture of ROM use is struggling to establish itself in the Italian National Health System, shaping up as a sporadic and unevenly used practice. The main objective of the present study was to assess the frequency of use of different outcome monitoring measures and the attitudes toward ROM within psychological services of the Italian National Health System. The study involved 184 psychotherapist (75% female and 25% male) employed in the Italian Health System structures. Participants completed an anonymous questionnaire composed by Outcome monitoring use and Attitudes to ROM. The data reveal a general low-frequency in ROM use, with the exception of the symptom monitoring measures. In our sample, the variables that significantly affect the level of ROM use are psychological capability and physical and social opportunity. The present study provides some empirical evidence to reflect on the importance of increasing the use of ROM within psychological services and to promote interventions to improve clinicians' positive attitudes toward ROM.

The economic burden of pediatric growth hormone deficiency in Italy: a cost of illness study

PurposeGrowth hormone deficiency (GHD) is a rare condition with a worldwide prevalence of 1 patient in 4000 to 10,000 live births, placing a significant economic burden on healthcare systems. The aim of this study is to generate evidence on the economic burden of children and adolescents with GHD treated with rhGH and their parents in Italy.MethodsA cost of illness analysis, adopting the prevalence approach, has been developed, producing evidence on the total annual cost sustained by the Italian National Health System (NHS) and by the society. The study is based on original data collected from a survey conducted among Italian children and adolescents with GHD and their parents.Results143 children/adolescents with GHD and their parents participated to the survey, conducted from May to October 2021. Patients had a mean age of 12.2 years (SD: 3.1) and were mostly males (68.5%).The average direct healthcare cost sustained by the NHS was € 8,497.2 per patient/year; adding the out-of-pocket expenses (co-payments and expenses for private healthcare service), the total expense was € 8,568.6. The indirect costs, assessed with the human capital approach, were € 847.9 per patient/year. The total of direct and indirect cost is € 9,345.1 from the NHS perspective, and € 9,416.5 from a social perspective. The total cost incurred by the Italian NHS for children with GHD (range: 5,708–8,354) was estimated in € 48.5–71.0 million, corresponding to 0.04–0.06% of the total Italian public health expense in the year 2020.ConclusionsThe total annual cost for GHD children is close to € 10,000, and is mainly due to the cost of rhGH treatment. This cost is almost entirely sustained by the NHS, with negligible out-of-pocket expenses.The economic burden on the Italian NHS for the health care of established GHD children is fourfold higher than the prevalence of the disease in the overall Italian population.

Feasibility and Safety of Performing Day-Surgery Medial Unicompartmental Robotic Prostheses in the Italian Health Care System

Study Purpose: Our study analyzes the feasibility and safety of robotic-assisted medial unicompartmental prostheses performed in day surgery compared to the current standard for a minimum of two nights in the rules of the Italian National Health System, which is mandatory for Diagnosis Related Groups reimbursement of ordinary hospitalization. Two groups of patients undergoing robotic-assisted medial unicompartmental prostheses were compared, of which one group in ordinary hospitalization and one group in day surgery. All patients from both groups underwent Robot-assisted medial unicompartmental prosthesis surgery (RIO® MAKO Stryker surgical corporation). The terms of comparison between the two groups regarding feasibility and safety were: any complications, any transfusions, hospital readmissions, and ER accesses for prosthesis-related reasons within 7 days and within 3 months after surgery. Pain preoperatively, at discharge, 3 months and 1 year after surgery was quantified by Verbal Rating Scale (0 to 4). Method: At the ASL Toscana Sudest in Arezzo, a total of 280 robot-assisted Unicompartmental Knee Arthroplasty (UKA) surgeries were performed during the study period (2014-2018), 259 of which were medial surgeries. The surgical team was always the same with oversight by two experienced senior surgeons. In this study, 259 cases of medial UKA were taken into consideration, while lateral or patellofemoral types were left out. Of the 259 medial UKA, 30 patients were consecutively operated on in day surgery by waiting list progression without any exclusion. The other 229 were all operated on as inpatients. We collected the ASA (American Society of Anesthesiologists) value data of the 30 patients under study namely 9 patients with ASA 1, 19 patients with ASA 2, and 2 patients with ASA 3. The average time for robotic surgery between the first 30 patients operated in 2014 and the last 30 operated in 2018 was studied to evaluate the trend in reduction of operational time by showing improvement in the learning curve of robotic technique with statistically significant result of P&lt;0.01. We assessed patient satisfaction with the surgical course and outcomes of the 30 patients operated for UKA in day surgery, 3 and 12 months after surgery with Likert scale quantifying satisfaction from 1 to 5: 1 totally dissatisfied, 2 dissatisfied, 3 neutral, 4 satisfied, 5 completely satisfied. Results: No readmission to the emergency room or ward occurred within 7 and 90 days after surgery for minor or major complications in the two groups. In view of the pain treatment protocol adopted for all UKA operated patients, the results regarding pain were not statistically significant between the two groups. Therefore, there were no differences according to the two types of hospitalization. After 3 and 12 months, 80% and 76% of patients, respectively, in the day-surgery operated group expressed themselves with value 4 and 5 on the Likert scale of satisfaction. Conclusions: In our study, we found no differences between the two groups of 30 patients operated in day surgery and the 229 operated in ordinary hospitalization in terms of transfusions, complications or hospital readmissions within 7 days, nor minor or major complications within 90 days after surgery. We found no statistically significant differences in the VRS pain scale by comparing the two groups; we found a high satisfaction index of the 30 patients undergoing day surgery. The pain scale, compared with values between the same group of 30 patients before surgery and after 3 and 12 months, showed a decrease such that it was statistically significant for P&lt;0.05; an analogous result was obtained by comparing values between the same group of 229 patients for P&lt;0.05. Our study demonstrates that robotic medial UKA can be safely performed in day surgery. Being able to perform this surgery under the assumptions and characteristics of day surgery organization means reduction of surgery costs, of waiting lists, of hospitalization risks, and of patient stress. The resulting organizational proposal is to authorize Italian health facilities to perform partial prosthesis surgery in day surgery with equal DRG reimbursement. Economic savings would result from this opportunity by offsetting the higher cost of the same robotic surgery.

How ready is the Italian healthcare system in the use of genomics? The B1MG Maturity Level Model

Abstract Background The integration of genomics into healthcare systems allows to fulfilling the potential of Personalised Medicine for patients and citizens. This demands countries to make extensive adjustments in key areas, such as technical infrastructure, health professional competencies, or ethical and legal frameworks. Effective identification of current challenges and barriers to integrating genomics in the healthcare system is crucial to define a path toward sustainable implementation. Methods We applied the B1MG Maturity Level Model framework to assess the maturity of the Italian national health system (NHS) in key aspects of genomics implementation. From March to June 2022, 18 experts from academic and non-academic institutions that participate in the B1MG activities rated on a 5-point scale (from ad hoc to fully implemented) the level of maturity of 49 indicators grouped into eight domains: governance (I), economic aspects (II), ethics and legislation (III), public awareness (IV), workforce skills (V), clinical organization (VI), clinical genomics guidelines (VII), and data infrastructure (VIII). From July to September 2022, consensus procedures were carried out within each domain. Results Italy stands at a local level of genomics implementation in most indicators, but several regional and/or national initiatives are ongoing. Genomic medicine is considered a priority but still lacks updated strategies, governance, and investment plans. The highest maturity is reached for ethical and legal aspects, followed by domain VII. There is a strong need to invest in workforce training for some health professionals, citizen engagement, and literacy. Infrastructures to improve data security and fairification are still under development. Conclusions We defined the status of genomics implementation in the Italian NHS, drawing a comprehensive picture of all key domains and identifying areas for investment. Regional and national initiatives currently ongoing need to be monitored. Key messages • Italy stands at a local level of genomics implementation in most indicators, but several regional and/or national initiatives are ongoing. • Genomic medicine is considered a priority but lacks updated strategies, governance, and investment plans.

Vaccination and Trust in the National Health System among HIV+ Patients: An Italian Cross-Sectional Survey.

This study aimed to evaluate the knowledge, attitudes, and practises (KAP) of individuals living with HIV (PLWH) regarding vaccines and their trust in the Italian national health system (NHS). A cross-sectional survey was conducted at Amedeo di Savoia Hospital in Turin, Italy, involving 160 HIV-positive patients. Descriptive statistics were utilised to analyse variables such as vaccination status and intention, perceived risk of infection, and disease severity. The infections were categorised into sexually transmitted diseases and other vaccine-preventable diseases. Except for the perceived severity of infection, there were no significant differences in the percentages between the two infection groups for the variables examined. Concerning patients' perception of the Italian NHS, a high percentage of the sample believed in the information provided by healthcare workers (HCWs) (95.6%) and considered HCWs up-to-date on vaccines (93.1%). However, a considerable proportion expressed concerns about insufficient information on vaccine risks from HCWs (33.3%), perceived judgement by HCWs for vaccine refusal (40.3%), and suspected financial interests of HCWs in vaccination (19.5%). Some HIV+ patients may hesitate to be vaccinated or hold misconceptions about the severity of certain infectious diseases. Additionally, there are concerns about trust in the Italian NHS and communication by HCWs.

Treatment with valacyclovir during pregnancy for prevention of congenital cytomegalovirus infection: a real-life multicenter Italian observational study

Valacyclovir is the only treatment demonstrated to be effective for the prevention of vertical transmission of cytomegalovirus within a clinical randomized, placebo-controlled trial and has been reimbursed by the Italian National Health System since December 2020. This study reported the results of a real-life Italian multicenter observational study on cytomegalovirus infection in pregnancy evaluating the effect of the introduction of valacyclovir in the clinical practice for the prevention of vertical transmission of cytomegalovirus. The outcomes of women who received valacyclovir treatment and their fetuses or newborns were compared with those of a retrospective cohort observed between 2010 and 2020 who did not receive the antiviral treatment. The inclusion criterion was the diagnosis of cytomegalovirus primary infection occurring in the periconceptional period or up to 24 weeks of gestation. The primary outcome was the transmission by the time of amniocentesis. The secondary outcomes were termination of pregnancy, transmission at birth, symptomatic infection at birth, and a composite outcome (termination of pregnancy or transmission at birth). A total of 447 pregnant women from 10 centers were enrolled, 205 women treated with valacyclovir (called the valacyclovir group, including 1 twin pregnancy) and 242 women not treated with valacyclovir (called the no-valacyclovir group, including 2 twin pregnancies). Valacyclovir treatment was significantly associated with a reduction of the diagnosis of congenital cytomegalovirus infection by the time of amniocentesis (weighted odds ratio, 0.39; 90% confidence interval, 0.22-0.68; P=.005; relative reduction of 61%), termination of pregnancy (weighted odds ratio, 0.36; 90% confidence interval, 0.17-0.75; P=.0021; relative reduction of 64%), symptomatic congenital cytomegalovirus infection at birth (weighted odds ratio, 0.17; 90% confidence interval, 0.06-0.49; P=.006; relative reduction of 83%). The treatment had no significant effect on the rate of diagnosis of congenital cytomegalovirus infection at birth (weighted odds ratio, 0.85; 90% confidence interval, 0.57-1.26; P=.500), but the composite outcome (termination of pregnancy or diagnosis of congenital cytomegalovirus infection at birth) occurred more frequently in the no-valacyclovir group (weighted odds ratio, 0.62; 90% confidence interval, 0.44-0.88; P=.024). Of note, the only symptomatic newborns with congenital cytomegalovirus infection in the valacyclovir group (n=3) were among those with positive amniocentesis. Moreover, 19 women (9.3%) reported an adverse reaction to valacyclovir treatment, classified as mild in 17 cases and moderate in 2 cases. Lastly, 4 women (1.9%) presented renal toxicity with a slight increase in creatinine level, which was reversible after treatment suspension. Our real-life data confirm that valacyclovir significantly reduces the rate of congenital cytomegalovirus diagnosis at the time of amniocentesis with a good tolerability profile and show that the treatment is associated with a reduction of termination of pregnancy and symptomatic congenital cytomegalovirus infection at birth.