Multidimensional Impact of Dupilumab on Chronic Rhinosinusitis with Nasal Polyps: A Complete Health Technology Assessment of Clinical, Economic, and Non-Clinical Domains.

Chronic RhinoSinusitis with Nasal Polyps (CRSwNP) represents a condition mainly caused by the type 2 inflammation presence and marked by the existence of polyps within the nasal and paranasal sinuses. The standard of care includes intranasal steroids, additional burst of systemic steroids, if needed, and surgery. However, recurrence is common, especially among patients with comorbid type 2 inflammatory diseases. Recently, biological drugs, addressing the underlying cause of the disease, have been approved in Italy (dupilumab, omalizumab, and mepolizumab). A Health Technology Assessment was conducted to define multidimensional impact, assuming Italian NHS perspective and a 12-month time horizon. The EUnetHTA Core Model was deployed, using the following methods to analyze the domains: (i) literature evidence; (ii) administration of semi-structured questionnaires to 17 healthcare professionals; (iii) health economics tools to define the economic sustainability for the system. Evidence from NMA and ITC showed a more favorable safety profile and better efficacy for dupilumab compared with alternative biologics. All the analyses, synthesizing cost and efficacy measures, showed that dupilumab is the preferable alternative. Specifically, the cost per responder analysis for dupilumab, exhibiting a 67.0% response rate at Week 52, is notably economical at 14,209EUR per responder. This presents a more economical profile compared with the cost per responder for omalizumab (36.2% response rate) at 24,999EUR and mepolizumab (28.5% response rate) at 31,863EUR. These results underscore dupilumab's potential, not merely in terms of clinical outcomes, but also in terms of economic rationality, thereby solidifying its status as a valid and preferrable alternative in the management of CRSwNP, in the context of the Italian NHS.

Barbed sutures and skin adhesives improve wound closure in hip and knee arthroplasty.

PURPOSE: This study aimed to formulate evidence-based recommendations for optimising wound management in hip and knee arthroplasty by exploring alternative methods such as barbed sutures and skin adhesives. METHODS: A Delphi panel, comprising seven orthopaedic surgeons, one musculoskeletal infectious disease specialist, and one health economics expert, was convened to evaluate the use of barbed sutures and skin adhesives for wound closure in hip and knee arthroplasty. Two systematic reviews informed the development of questionnaires, with panelists ranking their agreement on statements using a 5-point Likert scale. Consensus was achieved if ≥75% agreement. Unresolved statements were revisited in a second round. RESULTS: Consensus was reached on 11 statements, providing evidence-based recommendations. The expert panel advocates for a multilayer watertight technique using barbed sutures to prevent surgical site infections (SSI), reduce complications, shorten surgical times, optimise resources and improve cosmetic appearance. For skin closure, the panel recommends topical adhesives to decrease wound dehiscence, enhance cosmetic appearance, promote patient compliance, prevent SSIs, and optimise resources. CONCLUSION: The Delphi consensus by Italian total joint arthroplasty experts underscores the pivotal role of barbed sutures and skin adhesives in optimising outcomes. While guiding clinical decision-making, these recommendations are not prescriptive and should be adapted to local practices. The study encourages further research to enhance current evidence. LEVEL OF EVIDENCE: Level III.

[Cystic fibrosis carrier screening: a Health technology assessment.] / Lo screening del portatore di fibrosi cistica: una valutazione di Health technology assessment.

This project of Health technology assessment was aimed at defining the impacts of offering a cystic fibrosis (CF) carrier screening to the general population, compared to the current situation, where the test is offered to individuals at high-risk to give birth to a child with CF. Results revealed: i) a lack of robust and updated data; ii) a return on investment up to six years from the screening's introduction, despite important economic and organizational efforts; iii) a general positive attitude of healthcare professionals, people with CF, families and general population; iv) possible issues related to the social impact.

Optimising Radioligand Therapy for Patients with Gastro-Entero-Pancreatic Neuroendocrine Tumours: Expert Opinion from an Italian Multidisciplinary Group.

Radioligand therapy (RLT) with lutetium (177Lu) oxodotreotide is an approved therapy in combination with somatostatin analogues (SSAs) for patients with advanced, well-differentiated G1-G2, gastro-entero-pancreatic neuroendocrine tumours (GEP-NETs) that progress on SSAs. We conducted a series of round table meetings throughout Italy to identify issues related to RLT delivery to patients with GEP-NETs. Four key issues were identified: (1) the proper definition of tumour progression prior to RLT initiation; (2) the impact of RLT in patients with bone metastases and/or high hepatic tumour burden; (3) the optimal follow-up protocol after RLT; and (4) organisational issues related to RLT use and managerial implications. This article reviews the literature relating to the aforementioned issues and makes recommendations based on available evidence and Italian NET experts' opinions. In particular, the group recommends the development of a diagnostic-therapeutic care pathway (DTCP) for patients undergoing RLT which provides systematic guidance but can still be individualised for each patient's clinical and psychosocial needs. A DTCP may clarify the diagnostic, therapeutic and post-treatment monitoring process, and improve communication and the coordination of care between hub and spoke centres. The DTCP may also contribute to changes in the care process related to the 2013/59/EURATOM Directive and to the definition of costs when planning for future or updated reimbursement of RLT in Italy.

Healthcare professional and manager perceptions on drivers, benefits, and challenges of telemedicine: results from a cross-sectional survey in the Italian NHS.

BACKGROUND: The Covid-19 pandemic provided new challenges and opportunities for patients and healthcare providers while accelerating the trend of digital healthcare transformation. This study explores the perspectives of healthcare professionals and managers on (i) drivers to the implementation of telemedicine services and (ii) perceived benefits and challenges related to the use of telemedicine across the Italian National Health Service. METHODS: An online cross-sectional survey was distributed to professionals working within 308 healthcare organisations in different Italian regions. Quantitative and qualitative data were collected through a self-administered questionnaire (June-September 2021). Responses were analysed using summary statistics and thematic analysis. RESULTS: Key factors driving the adoption of telemedicine have been grouped into (i) organisational drivers (reduce the virus spread-80%; enhance care quality and efficiency-61%), (ii) technological drivers (ease of use-82%; efficacy and reliability-64%; compliance with data governance regulations-64%) and (iii) regulatory drivers (regulations' semplification-84%). Nearly all respondents perceive telemedicine as useful in improving patient care (96%). The main benefits reported by respondents are shorter waiting lists, reduced Emergency Department attendance, decreased patient and clinician travel, and more frequent patient-doctor interactions. However, only 7% of respondents believe that telemedicine services are more effective than traditional care and 66% of the healthcare professionals believe that telemedicine can't completely substitute in-person visits due to challenges with physical examination and patient-doctor relationships. Other reported challenges include poor quality and interoperability of telemedicine platforms and scarce integration of telemedicine with traditional care services. Moreover, healthcare professionals believe that some groups of patients experience difficulties in accessing and using the technologies due to socio-cultural factors, technological and linguistic challenges and the absence of caregivers. CONCLUSIONS: Respondents believe that telemedicine can be useful to complement and augment traditional care. However, many challenges still need to be overcome to fully consider telemedicine a standard of care. Strategies that could help address these challenges include additional regulations on data governance and reimbursements, evidence-based guidelines for the use of telemedicine, greater integration of tools and processes, patient-centred training for clinicians, patient-facing material to assist patients in navigating virtual sessions, different language options, and greater involvement of caregivers in the care process.

Effectiveness of preconceptional and prenatal cystic fibrosis carrier screening: a systematic review

BACKGROUND: genetic testing for cystic fibrosis (CF) has been offered to people with higher risk of being carrier. OBJECTIVES: to assess the effectiveness of population-based CF carrier screening for adults of reproductive age and its optimal organizational features. DESIGN: systematic review. SETTING AND PARTICIPANTS: MedLine, Embase, Cochrane Library, CINAHL and LILACS (1990-2022) were searched to retrieve primary and secondary studies on adults (16 years and older), with no clinical indication or genetic risk, eligible for genetic testing for CF carrier status. MAIN OUTCOMES MEASURES: attitude to screening, uptake of screening offered, informed reproductive choices. RESULTS: a total of 3,326 records were screened and 292 potentially eligible full-text publications assessed. The review included 71 publications, corresponding to 3 reviews, 40 cohort studies (11 comparative, 29 single-arm), and 6 model studies, published between 1992 and 2021 (median 1998). Only one study compared screening or no screening. This study suggested an association between carrier screening and a lower incidence of CF. Comparative studies examined different approaches for invitation and testing, i.e., settings, target population (individuals/couples, prenatal/preconceptional), how invitations are organized (primary care/maternal hospitals), and format and content of the pre-test information. However, no firm conclusions can be drawn on the impact of these features on informed reproductive choices, uptake, and attitude, because of the limitations of the evidence collected. CONCLUSIONS: the broad heterogeneity of the studies, methodological weaknesses, and the limited transferability of the results mean there is still uncertainty about the effectiveness of preconceptional and prenatal CF carrier screening in the general population.

Embedding the Patient-Citizen Perspective into an Operational Framework for the Development and the Introduction of New Technologies in Rehabilitation Care: The Smart&Touch-ID Model.

To date, at least 2.41 billion people with Non-Communicable Diseases (NCDs) are in need of rehabilitation. Rehabilitation care through innovative technologies is the ideal candidate to reach all people with NCDs in need. To obtain these innovative solutions available in the public health system calls for a rigorous multidimensional evaluation that, with an articulated approach, is carried out through the Health Technology Assessment (HTA) methodology. In this context, the aim of the present paper is to illustrate how the Smart&TouchID (STID) model addresses the need to incorporate patients' evaluations into a multidimensional technology assessment framework by presenting a feasibility study of model application with regard to the rehabilitation experiences of people living with NCDs. After sketching out the STID model's vision and operational process, preliminary evidence on the experiences and attitudes of patients and citizens on rehabilitation care will be described and discussed, showing how they operate, enabling the co-design of technological solutions with a multi-stakeholder approach. Implications for public health are discussed including the view on the STID model as a tool to be integrated into public health governance strategies aimed at tuning the agenda-setting of innovation in rehabilitation care through a participatory methodology.

System Integrated Digital Empowering and teleRehabilitation to promote patient Activation and well-Being in chronic disabilities: A usability and acceptability study.

Introduction: Telerehabilitation systems represent a promising way for the management of chronic disability, delivering technology-enabled rehabilitation outside the hospital setting. However, usability and acceptability assessment with users represents a critical starting point when using digital healthcare solutions. This study aims at evaluating the user experience with a Telerehabilitation system (SIDERA∧B) from the end-user side. Methods: SIDERA∧B consists of an asynchronous delivery of rehabilitation activities through multimedia digital contents and tele-monitoring of vital parameters with technological devices for individualized, home-based management of chronic conditions. Usability (with the System Usability Scale, SUS) and acceptability (using the Technology Acceptance Model, TAM - and The Service User Technology Acceptance Questionnaire, SUTAQ) data were analyzed from the dataset of the SIDERA∧B project (N = 112 patients with Chronic Heart Failure, Parkinson's Disease and Chronic Obstructive Pulmonary Disease). The possible influence of five external factors (i.e., technological expertise, education, sex, age, and level of disability) on TAM domains was tested using Spearman's Correlation analysis. Results: Results showed a satisfactory level of technological usability (SUS Median = 77.5) and good scores in usability and learnability SUS subdomains (mean scores > 2.5). Regarding technological acceptability, participants showed high scores (Median > 4) in "Behavioral Intention", "Perceived Usefulness", and "Perceived Ease of Use" TAM domains. Finally, results from the SUTAQ scale highlighted that the SIDERA∧B system obtained optimal scores in all domains, especially in "Increased accessibility," "Care personnel concerns," and "Satisfaction." Age (rho = -0.291, p = 0.002) and disability level (WHODAS Total score: rho = -0.218, p = 0.021) were the two external factors inversely associated with the Perceived Ease of Use. Discussion: The age of digital transformation requires everyone to understand, accept and master the changes affecting modern-day healthcare. The usability and acceptability of the SIDERA∧B system were high across all end-users, despite the medium-low level of the technological expertise of the sample. These findings support the efficiency and the suitability of these digital solutions in the modern digital age transition of rehabilitation from inside to outside the clinic.

The role of INTERCheckWEB digital innovation in supporting polytherapy management.

The study aims at defining the factors affecting the clinicians' decision of changing or confirming the treatment options for frail patients in polytherapy, supporting prescribing patterns, thus also figuring out if the inclination of the clinicians towards digital solutions (INTERCheckWEB) and specific guidelines, could play a role in their decision. A literature review was performed, revealing the main individual, organizational and decisional factors, impacting on the clinicians' propensity to change the current patients' therapy: the clinician perceptions of support in case of clinical guidelines use or INTERCheckWEB use were studied. A qualitative approach was implemented, and thirty-five clinicians completed a questionnaire, aimed at evaluating fifteen different clinical cases, defining if they would change the patient's current therapy depending on the level of information received. Three methodological approaches were implemented. (1) Bivariate correlations to test the relationships between variables. (2) Hierarchical sequential linear regression model to define the predictors of the clinician propensity to change therapy. (3) Fuzzy Qualitative Comparative Analysis-fsQCA, to figure out the combination of variables leading to the outcome. Patient's age and autonomy (p value = 0.000), as well as clinician's perception regarding IT ease of use (p value = 0.043) and seniority (p value = 0.009), number of drugs assumed by the patients (p value = 0.000) and number of concomitant diseases (p value = 0.000) are factors influencing a potential change in the current therapy. The fsQCA-crisp confirms that the clinical conditions of the patients are the driving factors that prompt the clinicians towards a therapy change.

In-hospital cost-effectiveness analysis of open versus staged fenestrated/branched endovascular elective repair of thoracoabdominal aneurysms.

OBJECTIVE: To compare costs and effectiveness of elective open (OR) vs fenestrated/branched endovascular (ER) repair of thoracoabdominal aneurysms (TAAAs) in a high-volume center. METHODS: This single-center retrospective observational study (PRO-ENDO TAAA Study, NCT05266781) was designed as part of a larger health technology assessment analysis. All electively treated TAAAs between 2013 and 2021 were analyzed and propensity-matched. End points were clinical success, major adverse events (MAEs), hospital direct costs, and freedom from all causes and aneurysm-related mortality and reinterventions. Risk factors and outcomes were homogeneously classified according to the Society of Vascular Surgery reporting standards. Cost-effectiveness value and incremental cost-effectiveness ratio were calculated, considering the absence of MAEs as a measure of effectiveness. RESULTS: Propensity matching identified 102 pairs of patients out of 789 TAAAs. Mortality, MAE, permanent spinal cord ischemia rates, respiratory complications, cardiac complications, and renal injury were higher for OR (13% vs 5%, P = .048; 60% vs 17%, P < .001; 10% vs 3%, P = .045; 91% vs 18%, P < .001; 16% vs 6%, P = .024; 27% vs 6%, P < .001, respectively). Access complication rate (6% vs 27%; P < .001) was higher in the ER group. Intensive care unit stay was longer (P < .001) for OR, and ER patients were discharged home more frequently (3% vs 94%; P < .001). No differences in midterm end points were observed at 2 years. Despite ER reducing all the hospital cost items (-42% to -88%, P < .001), the higher expenses (P < .001) of the endovascular devices increased the overall cost of ER by 80%. Cost-effectiveness value for ER was favorable to OR (56,365 vs 64,903 €/patient) with an incremental cost-effectiveness ratio of 48,409 € per MAE saved. CONCLUSIONS: ER of TAAA reduces perioperative mortality and morbidity compared with OR, with no differences in reinterventions and survival rates at midterm follow-up. Despite the expenses for endovascular grafts, ER was found to be more cost-effective in preventing MAEs.

Multidimensional Results and Reflections on CAR-T: The Italian Evidence.

The present study aims at defining the economic and organizational impacts of the introduction of chimeric antigen receptor T-cell therapy (CAR-T) in Italy, for the management of diffuse large B-cell lymphoma (DLBCL) patients in third-line therapy, defining the overall level of sustainability for both hospitals and the National Healthcare System (NHS). The analysis focused on CAR-T and Best Salvage Care (in the following BSC), assuming the Italian hospital and NHS perspectives, over a 36-month time horizon. Process mapping and activity-based costing methodologies were applied to collect the hospital costs related to the BSC and CAR-T pathways, including adverse event management. Anonymous administrative data on services provided (diagnostic and laboratory examinations, hospitalizations, outpatient procedures, and therapies) to 47 third-line patients with lymphoma, as well as any organizational investments required, were collected, in two different Italian Hospitals. The economic results showed that the BSC clinical pathway required less resources in comparison with CAR-T (excluding the cost related to the therapy) (BSC: 29,558.41 vs. CAR-T: EUR 71,220.84, -58.5%). The budget impact analysis depicts that the introduction of CAR-T would generate an increase in costs ranging from 15% to 23%, without considering treatment costs. The assessment of the organizational impact reveals that the introduction of CAR-T therapy would require additional investments equal to a minimum of EUR 15,500 to a maximum of EUR 100,897.49, from the hospital perspective. Results show new economic evidence for healthcare decision makers, to optimize the appropriateness of resource allocation. The present analysis suggests the need to introduce a specific reimbursement tariff, both at the hospital and at NHS levels, since no consensus exists, at least in the Italian setting, concerning the proper remuneration for the hospitals who guarantee this innovative pathway, assuming high risks related to timely management of adverse events.

High-energy devices in different surgical settings: lessons learnt from a full health technology assessment report developed by SICE (Società Italiana di Chirurgia Endoscopica).

BACKGROUND: The present paper aims at evaluating the potential benefits of high-energy devices (HEDs) in the Italian surgical practice, defining the comparative efficacy and safety profiles, as well as the potential economic and organizational advantages for hospitals and patients, with respect to standard monopolar or bipolar devices. METHODS: A Health Technology Assessment was conducted in 2021 assuming the hospital perspective, comparing HEDs and standard monopolar/bipolar devices, within eleven surgical settings: appendectomy, hepatic resections, colorectal resections, cholecystectomy, splenectomy, hemorrhoidectomy, thyroidectomy, esophago-gastrectomy, breast surgery, adrenalectomy, and pancreatectomy. The nine EUnetHTA Core Model dimensions were deployed considering a multi-methods approach. Both qualitative and quantitative methods were used: (1) a systematic literature review for the definition of the comparative efficacy and safety data; (2) administration of qualitative questionnaires, completed by 23 healthcare professionals (according to 7-item Likert scale, ranging from - 3 to + 3); and (3) health-economics tools, useful for the economic evaluation of the clinical pathway and budget impact analysis, and for the definition of the organizational and accessibility advantages, in terms of time or procedures' savings. RESULTS: The literature declared a decrease in operating time and length of stay in using HEDs in most surgical settings. While HEDs would lead to a marginal investment for the conduction of 178,619 surgeries on annual basis, their routinely implementation would generate significant organizational savings. A decrease equal to - 5.25/-9.02% of operating room time and to - 5.03/-30.73% of length of stay emerged. An advantage in accessibility to surgery could be hypothesized in a 9% of increase, due to the gaining in operatory slots. Professionals' perceptions crystallized and confirmed literature evidence, declaring a better safety and effectiveness profile. An improvement in both patients and caregivers' quality-of-life emerged. CONCLUSIONS: The results have demonstrated the strategic relevance related to HEDs introduction, their economic sustainability, and feasibility, as well as the potentialities in process improvement.

Determination of costs for the CSRwNP pathway. A time-driven activity-based costing experiment.

Objectives: The study aims to define the economic resources needed to manage chronic rhinosinusitis with nasal polyposis (CRSwNP), assuming the hospital perspective, based on different patient characteristics, within a 24-month time horizon. Methods: Real-world data were collected in 3 Italian hospitals. A time-driven activity-based costing approach was implemented to map and assess the pathways for CRSwNP. The following drivers were considered: diagnostic services, drugs, consumables, human resources, equipment and overhead costs based on the length of stay. Costs related to management of comorbidities and adverse events were evaluated. Three main groups of patients were identified: ineligible for surgery; having 1 intervention; having more than 1 intervention. The economic absorption of patients who continued corticosteroid treatment was analysed. Results: Patients experiencing 1 intervention had a cost of 3,453.31 € that increased to 4,705.03 € for those who required additional surgery. The cost of intranasal corticosteroids was 649.20 €, whereas the cost of oral corticosteroids was 37.60 € per patient. Conclusions: The results demonstrate the strategic relevance of analytical cost definitions of the clinical pathway for CRSwNP, which can help to support decision makers in the review of internal procedures and in the definition of proper reimbursement tariffs.

COVID-19 and hospital management costs: the Italian experience.

BACKGROUND: This article investigates the hospital costs related to the management of COVID-19 positive patients, requiring a hospitalization (from the positivity confirmation to discharge, including rehabilitation activities). METHODS: A time-driven activity-based costing analysis, grounding on administrative and accounting flows provided by the management control, was implemented to define costs related to the hospital management of COVID-19 positive patients, according to real-word data, derived from six public Italian Hospitals, in 2020. RESULTS: Results reported that the higher the complexity of care, the higher the hospitalization cost per day (low-complexity = €475.86; medium-complexity = €700.20; high-complexity = €1,401.65). Focusing on the entire clinical pathway, the overall resources absorption, with the inclusion of rehabilitation costs, ranged from 6,198.02€ to 32,141.20€, dependent from the patient's clinical condition. CONCLUSIONS: Data could represent the baseline cost for COVID-19 hospital management, thus being useful for the further development of proper reimbursement tariffs devoted to hospitalized infected patients.

Suture-Mediated Patent Foramen Ovale Closure Using the NobleStitch EL: Results from a Hospital-Based HTA.

(1) Background: Patent foramen ovale (PFO) is a congenital abnormality present in up to 25% of the general population, and it is a relevant cause of cryptogenic stroke. We applied the hospital-based HTA model (AdHopHTA) to conduct a multidimensional assessment of NobleStitch EL, an innovative suture-mediated PFO closure device. We compared it to Amplatzer PFO Occluder (APO) to provide evidence to inform technologies' governance in hospital settings. (2) Methods: For each AdHopHTA dimension we: systematically retrieved available evidence from the literature applying the PRISMA guidelines and then analyzed original clinical and cost data of a NobleStitch EL device at San Raffaele research hospital in Milan (Italy). The economic dimension was analyzed through activity-based costing and a cost analysis. We conducted semi-structured interviews with selected healthcare professionals to explore the organizational, legal, social, and ethical impact. (3) Results: A single study was included for the NobleStitch EL, with 10 for APO. Both literature data and original data showed comparable safety. Efficacy data analysis found that the PFO closure was at 89% for NobleStitch EL vs. 89-97% for APO. APO has a better impact on the budget and minor process costs. Consulted experts reported that the organizational impact of NobleStitch EL in the short and the long run as null, albeit a better impact under the social and the ethical aspects. (4) Conclusion: We suggest that there is inadequate evidence to conclude the relative efficacy of NobleStitch EL as compared to APO. Nevertheless, this report shows a good safety profile and higher costs for NobleStitch EL, with no organizational or legal impact. Further studies in selected population are recommended.

Tools supporting polypharmacy management in Italy: Factors determining digital technologies' intention to use in clinical practice.

Background and Aims: INTERCheckWEB is one of the most outstanding digital technologies, that could be implemented at the hospital level, supporting the clinicians in the evaluation of the therapy appropriateness, reducing the potentially inappropriate prescriptions, for the improvement of the clinical decision-making process. The paper aims at investigating the relationship between clinicians' behaviors towards digital decision support system in therapy appropriateness for elderly patients in polytherapy in medical departments, defining the factors that could influence clinicians to use INTERCheckWEB, for supporting drugs' prescription. Methods: A questionnaire was administered to 70 clinicians referring to Internal Medicine wards, of four Italian hospitals. The authors assessed how perceived usefulness, perceived ease of use, image, and output quality, would affect INTERCheckWeb intention to use. Inferential statistics, by means of a regression analysis, were conducted to define the main aspects useful to understand the factors impacting on such digital technology adoption in clinical practice. Results: The regression analysis reported that image, perceived ease of use and perceived usefulness, as well as the moderator effect of the voluntary use between the perceived usefulness and the intention to use, are the factors that most influence the use of INTERCheckWEB (adjusted R 2 = 0.870). Conclusions: Results demonstrated that clinicians would use INTERCheckWEB, when available, to identify all the information on situations that could be dangerous for the patients, thus limiting the drug-drug interactions, optimizing the overall patient's clinical pathway. Furthermore, the implementation of INTERCheckWEB could also contribute to the proper management of COVID-19 patients, since both hospitalized and symptomatic COVID-19 patients are frequently older, with comorbidities.

Care pathways production and review checklist: results from an HTA evaluation.

INTRODUCTION: The study aims to assess the implications of using a specific checklist in the production and review of care pathways. Care pathways have been developed to plan and standardize clinical practice, although the way they are designed remains unclear. METHODS: This study was implemented through a Health Technology Assessment model, assuming the hospital perspective. The checklist consists of 7 different domains, subdivided into 14 subdomains and 77 items. RESULTS: After a prioritization phase, our analysis reported a better performance of the checklist in terms of safety [2.00 vs -0.04; p<0.001], effectiveness [1.33 vs 0.00; p<0.001], social and ethical impact [1.15 vs 0.33; p<0.001], and legal perception from healthcare professionals [1.23 vs 0.25; p<0.001]. The Cost-Effectiveness Analysis and Budget Impact Analysis showed an advantage of the checklist (5.75% annual economic saving). CONCLUSIONS: A dedicated checklist may lead to potential benefits in terms of quality of care pathway processes.

The implementation of a standardized optimal procedure for peripheral venous catheters' management: Results from a multi-dimensional assessment.

Peripheral Venous Catheter (PVC) is a widely used device in the hospital setting and is often associated with significant adverse events that may impair treatment administration and patient health. The aim of the present study is to define the incremental benefits related to the implementation and the standardized and simultaneous use of three disposable devices for skin antisepsis, infusion, and cleaning, assuming the hospital's point of view, from an effectiveness, efficiency, and organizational perspective. For the achievement of the above objective, real-life data were collected by means of an observational prospective study, involving two hospitals in the Liguria Region (Northern Italy). Consecutive cases were enrolled and placed into two different scenarios: 1) use of all the three disposable devices, thus representing the scenario related to the implementation of a standardized optimal procedure (Scenario 1); 2) use of only one or two disposable devices, representing the scenario related to not being in a standardized optimal procedure (Scenario 2). For the definition of effectiveness indicators, the reason for PVC removal and the PVC-related adverse events occurrence were collected for each patient enrolled. In addition, an activity-based costing analysis grounded on a process-mapping technique was conducted to define the overall economic absorption sustained by hospitals when taking in charge patients requiring a PVC. Among the 380 patients enrolled in the study, 18% were treated with the standardized optimal procedure (Scenario 1). The two Scenarios differed in terms of number of patients for whom the PCV was removed due to the end of therapy (86.8% versus 39.40%, p-value = 0.000), with a consequent decrease in the adverse events occurrence rate. The economic evaluation demonstrated the sustainability and feasibility of implementing the standardized optimal procedure specifically related to the need for lower economic resources for the hospital management of adverse events occurred (€19.60 versus €21.71, p-value = 0.0019). An organizational advantage also emerged concerning an overall lower time to execute all the PVC-related activities (4.39 versus 5.72 minutes, p-value = 0.00). Results demonstrate the feasibility in the adoption of the standardized optimal procedure for PVC management, with significant advantages not only from a clinical point of view, but also from an organizational and economic perspective, thus being able to increase the overall operational efficiency of the hospitals.

Glycated Albumin for Glycemic Control in T2DM Population: A Multi-Dimensional Evaluation.

PURPOSE: To investigate the glycated albumin (GA) introduction implications, as an add-on strategy to traditional glycemic control (Hb1Ac and fasting plasma glucose - FPG) instruments, considering insulin-naïve individuals with type 2 diabetes mellitus (T2DM), treated with oral therapies. METHODS: A Health Technology Assessment was conducted in Italy, as a multi-dimensional approach useful to validate any innovative technology. The HTA dimensions, derived from the EUnetHTA Core Model, were deployed by means of literature evidence, health economics tools and qualitative questionnaires, filled-in by 15 professionals. RESULTS: Literature stated that the GA introduction could lead to a higher number of individuals achieving therapeutic success after 3 months of therapy (97.0% vs 71.6% without GA). From an economic point of view, considering a projection of 1,955,447 T2DM insulin-naïve individuals, potentially treated with oral therapy, GA introduction would imply fewer individuals requiring a therapy switch (-89.44%), with a 1.06% in costs reduction, on annual basis, thus being also the preferable solution from a cost-effectiveness perspective (cost-effectiveness value: 237.74 vs 325.53). According to experts opinions, lower perceptions on GA emerged with regard to equity aspects (0.13 vs 0.72, p-value>0.05), whereas it would improve both individuals (2.17 vs 1.33, p-value=0.000) and caregivers quality of life (1.50 vs 0.83, p-value=0.000). Even if in the short term, GA required additional investments in training courses (-0.80 vs 0.10, p-value = 0.036), in the long run, GA could become the preferable technology (0.30 vs 0.01, p-value=0.018) from an organisational perspective. CONCLUSION: Adding GA to traditional glycaemic control instruments could improve the clinical pathway of individuals with T2DM, leading to economic and organisational advantages for both hospitals and National Healthcare Systems.

Advanced Medical Devices for Preparation and Administration of Chemotherapeutic Agents: Results from a Multi-Dimensional Evaluation.

PURPOSE: To evaluate the incremental benefits concerning the implementation of closed-system medical devices for the preparation and administration of chemotherapy agents (integrated or not with traceable workflow), within an Italian clinical practice, in which the use of such technologies is not standardized. METHODOLOGY: Four Scenarios, implying different levels of technologies introduction, were analyzed, based on the presence and/or absence of closed systems and traceable workflow, in the preparation and in the administration phase. A literature review was conducted, in order to retrieve efficacy and safety measures. Economic and organizational benefits, assuming a hospitals perspective, were assessed by means of health-economics tools, considering 27,660 (±695.86) drugs on average prepared, on an annual basis, by 12 hospitals involved. The typology of medical devices and other devices/equipment used, the human resources involved, and the time spent for the preparation and administration phases were collected. RESULTS: Literature stated that the introduction of advanced technologies (CSTDs in the preparation phase, closed-system in the administration phase, both integrated by a traceable workflow) could: i) decrease surface contamination (12.24% vs 26.39%, P<0.001) and ii) improve the capability to identify dosage errors (7% vs 0.096%, P<0.05). The above technologies presented the best trade-off between cost sustained and efficacy gained. Despite marginal investments (ranging from +1% to +6%) being required for their acquisition, an organizational saving equal to more than 1,000 working hours emerged, which could be spent on other hospital activities. CONCLUSION: The implementation of closed systems, integrated with a traceable workflow grounding on gravimetric control, may be considered a valid technological alternative within the investigated setting. The marginal incremental costs could be absorbed already in the first year after their introduction, in particular, because of the potential time saving in using closed systems in both the preparation and administration phases, demonstrating the sustainability and feasibility of such advanced technologies.