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Emanuela Foglia,1 Federica Asperti,1 Grazia Antonacci,2,3 Yogini H Jani,4 Elisabetta Garagiola,1 Daniele Bellavia,1 Lucrezia Ferrario1 1LIUC - University Cattaneo, Healthcare Datascience LAB, Castellanza, Varese, 21053, Italy; 2Department of Primary Care and Public Health, Imperial College London, National Institute of Health Research (NIHR) Applied Research Collaboration (ARC) Northwest London, London, UK; 3Business School, Centre for Health Economics and Policy Innovation (CHEPI), Imperial College London, London, UK; 4Centre for Medicines Optimisation Research and Education, University College London Hospitals NHS Foundation Trust, London, UKCorrespondence: Elisabetta Garagiola, Healthcare Datascience Laboratory - HD LAB, LIUC-Università Cattaneo, Corso G. Matteotti, 22, Castellanza, VA, 21053, Italy, Tel +39.0331.572.467, Email egaragiola@liuc.itBackground: Automated Drug Dispensing (ADD) systems are considered to be strategic hospital assets used to reduce errors and enhance economic and organizational sustainability. With regards to efficacy and safety, the literature evidence demonstrates the incremental benefits of centralised or decentralised systems compared to manual dispensing. Analyses about organisational and economic sustainability are still lacking and the present study aims to perform a Health Technology Assessment (HTA), producing multidimensional evidence on the use of ADD systems within hospitals.Methods: In 2023, a comprehensive HTA draws insights from healthcare professionals across six European nations: Italy, France, Germany, the Netherlands, the United Kingdom, and Belgium. This appraisal juxtaposed four drug dispensing scenarios: manual methods, centralized ADD systems, decentralized ADD systems, and integrated solutions employing cutting-edge technologies in both central pharmacies and wards. The study deployed an Activity-Based Costing approach that was combined with a cost-effectiveness and Budget Impact Analysis to evaluate economic impacts. Qualitative questionnaires were implemented to assess ethical, legal, organizational, safety, and efficacy aspects.Results: From a multidimensional perspective, healthcare professionals acknowledged ADD manifold advantages of ADD systems. From an organizational perspective and within a 12-month timeframe, transitioning to automation may face initial challenges that are attributed to potential resistance from professionals and significant investments. However, 36 months past its adoption, automation’s superiority over manual methods was recognized. Economically, savings burgeoned from +17.9% in UK to +26.6% in Belgian hospitals that adopted integrated systems in comparison to traditional manual approaches.Conclusion: Compared to traditional methods, implementing ADD systems could improve the logistic management of drug in the hospital setting, thereby enhancing safety and efficacy, streamlining the healthcare professionals’ workflow, and bolstering financial stability.Keywords: automated drug dispensing systems, HTA, economic impact, drug logistic management, efficiency

Lucrezia Ferrario,1 Fabrizio Schettini,1 Elisabetta Garagiola,1 Adriana Cecchi,2 Lucia Lugoboni,3 Paolo Serra,4 Emanuele Porazzi,1 Emanuela Foglia1 1Carlo Cattaneo – LIUC University and LIUC Business School, Castellanza, Italy; 2ARCS – Azienda Regionale di Coordinamento per la Salute, Udine, Italy; 3Bee Care, Lugano, Switzerland; 4Brotzu Hospital, Cagliari, ItalyCorrespondence: Lucrezia FerrarioCarlo Cattaneo – LIUC University and LIUC Business School, Corso Matteotti 22, Castellanza, VA 21053, ItalyTel +39 033 1572504Fax +39 033 1572513Email lferrario@liuc.itPurpose: 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.Keywords: closed-system medical device, chemotherapy agents, safety, economic evaluation, HTA, organisational benefits

Tiziana Galli,1 Paolo Mirata,2 Emanuela Foglia,3 Davide Croce,3,4 Emanuele Porazzi,3 Lucrezia Ferrario,3 Elena Ricci,5 Elisabetta Garagiola,3 Roberta Pagani,3 Giuseppe Banfi6,7 1Department of Functional Recovery and Re-education, Hospital of Saronno, Hospital Authority “ASST Valle Olona”, Saronno, Italy; 2Department of Functional Recovery and Re-education, Hospital of Busto Arsizio, Hospital Authority “ASST Valle Olona”, Busto Arsizio, Italy; 3Centre for Research on Health Economics Social and Health Care Management (CREMS), LIUC - Università Cattaneo, Castellanza, Italy; 4School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; 5Department of Infectious Diseases, Fatebenefratelli Sacco Hospital, Milan, Italy; 6Orthopaedics Institute, IRCCS Galeazzi, Milan, Italy; 7San Raffaele Scientific Institute, Milan, Italy Purpose: The aim of the present study was to compare 2 clinical assessment tools, the Modified Barthel Index (currently administered to patients admitted into inpatient rehabilitation units after elective hip or knee arthroplasty) with the World Health Organization Disability Assessment Schedule (WHODAS) 2.0 scale, in order to identify which tool is more suitable for assessing the disability and the “recovery rate”.Patients and methods: A perspective multicenter observational study was developed, involving 2 hospital authorities in Italy. Eighty consecutive cases of inpatients were enrolled. Patient’s disability was evaluated using both of the aforementioned tools, before and after the rehabilitation program.Results: The WHODAS 2.0 score was, on average, 12.21% higher than the Modified Barthel Index, before the surgical intervention. Modified Barthel Index measures could be considered as a determinant and a predictor of length of stay.Conclusion: The Modified Barthel Index is limited, since it does not consider a patient’s perspective. The WHODAS 2.0 scale fully considers a patient’s perception of disability. Therefore, both assessment scales should be administered in clinical practice, in order to provide integration of clinical information with a patient’s reported outcome measures. Keywords: disability, Modified Barthel Index, WHODAS 2.0, orthopedics, rehabilitation

Emanuela Foglia,1 Lucrezia Ferrario,1 Elisabetta Garagiola,1 Giuseppe Signoriello,2 Gianluca Pellino,3 Davide Croce,1,4 Silvestro Canonico3 1Centre for Health Economics, Social and Health Care Management - LIUC University, Castellanza, Italy; 2Department of Mental Health and Preventive Medicine, University of Campania “Luigi Vanvitelli”, Naples, Italy; 3School of Medicine, University of Campania “Luigi Vanvitelli”, Naples, Italy; 4School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa Purpose: Surgical-site complications (SSCs) affect patients’ clinical pathway, prolonging their hospitalization and incrementing their management costs. The present study aimed to assess the economic and organizational implications of a portable device for negative-pressure wound therapy (NPWT) implementation, compared with the administration of pharmacological therapies alone for preventing surgical complications in patients undergoing general, cardiac, obstetrical–gynecological, or orthopedic surgical procedures.Patients and methods: A total of 8,566 hospital procedures, related to the year 2015 from one hospital, were evaluated considering infection risk index, occurrence rates of SSCs, drug therapies, and surgical, diagnostic, and specialist procedures and hematological exams. Activity-based costing and budget impact analyses were implemented for the economic assessment.Results: Patients developing an SSC absorbed i) 64.27% more economic resources considering the length of stay (€ 8,269±2,096 versus € 5,034±2,901, p

Objectives: To evaluate the efficacy, safety and efficiency performances related to the introduction of innovative traceability platforms and integrated blood collection systems, for the improvement of a total testing process, thus also assessing the economic and organizational sustainability of these innovative technologies., Methods: A mixed-method approach was utilized. A key-performance indicators dashboard was created based on a narrative literature review and expert consensus and was assessed through a real-life data collection from the University Hospital of Padova, Italy, comparing three scenarios over time (2013, 2016, 2019) with varying levels of technological integration. The economic and organizational sustainability was determined considering all the activities performed from the tube check-in to the validation of the results, with the integration of the management of the prevalent errors occurred during the process., Results: The introduction of integrated venous blood collection and full sample traceability systems resulted in significant improvements in laboratory performance. Errors in samples collected in inappropriate tubes decreased by 42 %, mislabelled samples by 47 %, and samples with irregularities by 100 %. Economic analysis revealed a cost saving of 12.7 % per tube, equating to a total saving of 447,263.80 € over a 12-month period. Organizational efficiency improved with a reduction of 13,061.95 h in time spent on sample management, allowing for increased laboratory capacity and throughput., Conclusions: Results revealed the strategic relevance of introducing integrated venous blood collection and full sample traceability systems, within the Laboratory setting, with a real-life demonstration of TLA economic and organizational sustainability, generating an overall improvement of the process efficiency., (© 2024 the author(s), published by De Gruyter, Berlin/Boston.)

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., (© 2023. BioMed Central Ltd., part of Springer Nature.)

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., (© 2023. The Author(s).)

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., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Rossetto, Borgnis, Isernia, Foglia, Garagiola, Realdon and Baglio.)

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.

Primary care represents an answer to the growing demand of an ageing population for healthcare services outside the hospital. As a support mechanism of primary care, the distribution of health technologies to chronic patients plays an important role, but it has been investigated from the operational viewpoint only, ignoring the patient's perspective. We explored patient's satisfaction in relation to the distribution processes of incontinence health technologies, investigating its antecedents and isolating the factors driving the satisfaction of patients - which could be leveraged to design better distribution processes for better primary care services. We performed a survey study on 650 patients in primary care services affected by incontinence in Italy, building on the ServQual and Kano models. Partial Least Square Structural Equation Modelling (PLS-SEM) with Multi-Group Analysis (MGA) was adopted to analyse the data. Results show that interaction of patients with the personnel delivering the service is the key driver of patient satisfaction: this is an element more important than the operational features of distribution services (such as punctuality/reliability of the service or its flexibility)., Competing Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article., (© The Author(s) 2022.)

Background: The crowding of emergency departments (EDs) is one of the major poor-quality factors for patients. Because of this, measuring ED performance in Healthcare Systems is a difficult but an important task needed to enhance quality and efficiency., Purpose: (i) Development of a tool to observe and evaluate performance measurement, analysing two critical variables (quality and efficiency), verifying the change in performance due to the implementation of a new organizational model; (ii) the implementation of the tool in two EDs with comparable annual volumes of activity in the Italian context., Methods: A literature review on ED performance was conducted in order to identify acknowledged performance measurements used in this context that can be used in the development of a tool for the evaluation of EDs' performance. The goal is to have a matrix that is easily understood and that shows a simple relationship between quality and efficiency. This was possible by setting up a method that translates the ED annual performance data (in this case the data related to year 2018) into a graph with benchmarking purposes, also including an actual situation (AS-IS) view as compared to a TO-BE situation (i.e., before and after an organizational change occurred)., Results: Two real EDs were compared and their results depicted; they can be easily related with each other to benchmark healthcare organisations. More precisely, a comparison can be used for two main tasks: - identifying different strategic areas and observing the positioning of a health organization at any given moment in time, seeing where it stands among its competitors in a matrix; - knowing how to best allocate available resources and where to divert investment. Results show that the tool depicts the situation of EDs, with a clear indication of how performance increases or decreases in the case of AS-IS and TO-BE evaluation, and also offers a quick understanding of the benchmarked EDs' situations., Practice Implications: The results can be shown on a graph that summarises the performance change for the AS-IS versus TO-BE conditions. This can be a useful tool for the ED and for the hospital decision makers, as it allows for an observation of performance by analysing two critical variables: the quality and the efficiency of the service provided. The former represents customer satisfaction, which in this work is the combination of two factors (i.e., appropriateness of assigning the triage code and patient satisfaction), and the latter represents the ED's efficiency in providing emergency care. The tool also helps the organizational changes to be easily evaluated., (© 2022 John Wiley & Sons Ltd.)

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., Competing Interests: The authors have declared that no competing interests exist.

The aim of this study is to analyze the potential advantages of emtricitabine/tenofovir alafenamide (FTC/TAF) introduction, creating evidence-based information to orient strategies to reduce costs, thus preserving effectiveness and appropriateness. An Health Technology Assessment (HTA) was implemented in the years 2017-2018 comparing the dual backbones available in the Italian market: FTC/TAF, FTC/TDF (tenofovir disoproxil fumarate/emtricitabine) and ABC/3TC (abacavir/lamivudine). From an efficacy point of view, FTC/TAF ensured a higher percentage of virologic control and a better safety impact than FTC/TDF (improving the renal and bone safety profile, as well as the lipid picture). From an economic point of view, the results revealed a 4% cost saving for the Italian National Healthcare Service NHS with FTC/TAF introduction compared with the baseline scenario. Qualitative perceptions' results showed that FTC/TAF would decrease the burden of adverse events management, increasing the accessibility of patients to healthcare providers (FTC/TAF: 0.95, FTC/TDF: 0.10, ABC/3TC: 0.28; p -value: 0.016) and social costs (FTC/TDF: -0.23, FTC/TAF: 1.04, ABC/3TC: 0.23; p -value < 0.001), improving patient quality of life (FTC/TDF: 0.31, FTC/TAF: 1.85, ABC/3TC: 0.38; p -value < 0.001). Healthcare services may consider the evidence provided by the present study as an opportunity to include HIV patients in a more adequate antiretroviral treatment arm, guaranteeing a personalized clinical pathway, thus becoming more efficient and effective over time., Competing Interests: The authors declare no conflict of interest. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results.

Introduction: The use of oral tenofovir/emtricitabine (FTC/TDF) for pre-exposure prophylaxis (PrEP) among high-risk people without Human Immunodeficiency Virus (HIV), is emerging as an innovative strategy to decrease HIV epidemic. The study aims at evaluating the implications related to PrEP introduction, from a multidimensional point of view, as required by Health Technology Assessment (HTA) approach, with a particular attention on sustainability and social factors, influencing PrEP implementation., Methods: An analysis was conducted involving 35 Italian Infectious Disease Departments. The introduction of PrEP (applied both as "add-on" and "substitute" prevention strategy) into the clinical practice was compared with a baseline scenario, consisting of condoms among men who have sex with men, and serodiscordant couples, and the use of Needle Syringe Programme among injection drugs users The above scenarios were analysed by means of a Health Technology Assessment (HTA) approach. The 9 EUnetHTA Core Model domains were assessed through comparative information, retrieved from literature evidence, and collection of qualitative and quantitative information, derived from real-world evidence, in particular from 35 Infectious Disease Departments and potential PrEP' users involved. A final multi-criteria decision analysis approach (MCDA) was implemented to simulate the appraisal phase and providing evidence-based information with regard to the preferable technology., Results: Despite the improvement in patients' quality of life, PrEP would generate the development of other sexually transmitted and blood-borne diseases, with a consequent decrease of patients' safety in case of PrEP applied as a "substitute" prevention strategy. In addition, PrEP would generate an increase in staff workflow, with investment in medical supplies and training courses. PrEP would lead to significant economic investments both for the NHS (+40%), and for citizens (+2,377%) if used as an add-on strategy, assuming FTC/TDF patent cost. With the off-patent drug, the NHS would benefit from an advantage (37%), and a shrink of the patients' expenditure emerged (+682%). More economic resources are required if PrEP is applied as a substitute strategy, considering both the patent (NHS: 212%; citizens: 3,423%) and the off-patent drug (NHS: 73%; citizens: 1,077%). Conclusions. The most cost-containing strategy would be the use of PrEP, as an add-on strategy, with a consequent improvement in patients' safety, even if drug-related adverse events would be considered. The implementation of the off-patent drug would decrease the economic burden of the innovative prevention strategy. Hence, the organizational aspects related to its adoption would be deeply investigated, with the potential opportunity to create specific ambulatories devoted to PrEP users' especially for medium and big size hospitals., (©2020 Pacini Editore SRL, Pisa, Italy.)

Background: Since HIV+ treatment has become more effective, the average age of people living with HIV (PLWHIV) has increased, and consequently the incidence of developing comorbidities, making the clinical and economic management of HIV+ patients more complex. Limited literature exists regarding the management of comorbidities costs. This study is aimed at defining and comparing the total annual costs of comorbidities, in an Italian cohort of HIV and HIV/HCV patients, from the National Healthcare Service perspective. The authors hypothesised that there are higher costs, for patients with multiple comorbidities, and a greater consumption of resources for HIV/HCV co-infected patients versus HIV mono-infected patients., Methods: An observational retrospective multi-centre health-economics study, enrolling HIV+ and HIV/HCV consecutive patients with at least one comorbidity, was conducted. The consecutive cases, provided by three Italian infectious diseases centres, were related to the year 2016. The enrolled patients were on a stable antiviral therapy for at least six months. Demographic and clinical information was recorded. Costs related to HIV and HCV therapies, other treatments, medical examinations, hospitalizations and outpatient visits were evaluated. Data from mono-infected and co-infected groups of patients were compared, and the statistical analysis was performed by t-tests, chi-square and ANOVA. A sub-analysis excluding HCV therapy costs, was also conducted. The hierarchical sequential linear regression model was used to explore the determinants of costs, considering the investigated comorbidities. All analyses were conducted with a significant level of 0.05., Results: A total of 676 patients, 82% male, mean age 52, were identified and divided into groups (338 mono-infected HIV+ and 338 co-infected HIV/HCV patients), comparable in terms of age, gender, and demographic characteristics. A trend towards higher annual costs, for patients with multiple comorbidities was observed in HIV mono-infected patients (respectively € 8272.18 for patients without comorbidities and € 12,532.49 for patients with three or more comorbidities, p-value: 0.001). Excluding anti-HCV therapies costs, HIV/HCV co-infected patients generally required more resources, with statistically significant differences related to cardiovascular events (€10,116.58 vs €11,004.28, p-value: 0.001), and neurocognitive impairments events (€7706.43 vs €11,641.29 p- value: < 0.001)., Conclusions: This study provides a differentiated and comprehensive analysis of the healthcare resources needed by HIV and HIV/HCV patients with comorbidities and may contribute to the decision process of resources allocation, in the clinical management of different HIV+ patient populations.

Purpose: This study aims to analyze the managerial levers previously considered in literature in the setting of the provision of primary care and community services (in particular for patients with long-term conditions being treated also at home) as well as those scarcely explored that could potentially be adopted in the future., Design/methodology/approach: This study was a structured literature review. The authors retrieved papers, published from 2005-2020, from electronic databases (i.e. ABI/INFORM Complete, Jstor, PubMed and Scopus). Each selected paper was assigned to a framework category, and a thematic analysis was performed., Findings: Topics scarcely explored in literature were related to logistics/supply chain, economic evaluations, performance management and customer satisfaction. Some papers embraced more than one management topic, confirming the multidisciplinary nature of territorial healthcare services. The majority of research, however, focused on only one aspect of primary care services, and a lack of an integrated view regarding the provision of those services emerged., Originality/value: This study represents a first attempt to rationalize the fragmented body of knowledge on the topic of the provision of primary and community care services. This study enabled some light to be shed on the managerial levers already explored previously in literature and also identifies a number of trajectories for future research., (© Emerald Publishing Limited.)

Objective: To develop a risk-scoring tool to predict multidrug-resistant (MDR) etiology in patients with bloodstream infections (BSI) caused by Gram-negative bacilli (GNB)., Methods: A prospective multicenter study analyzed patients with BSI hospitalized in 31 Internal Medicine wards in Italy from March 2012 to December 2012. Patients with BSI caused by MDR-GNB (non-susceptible to at least one agent in three antimicrobial categories) were compared to those with BSI due to susceptible GNB. A logistic regression to identify predictive factors of MDR-GNB was performed and the odds ratio (OR) were calculated. A score to predict the risk of MDR was developed., Results: Of 533 BSI episodes, 253 (47.5%) were caused by GNB. Among GNB-BSI, 122 (48.2%) were caused by MDR-GNB while 131 (51.8%) by non-MDR GNB. At multivariate analysis transfer from long-term care facility (OR 9.013, 95% CI 1.089-74.579, p = 0.041), hospitalization in the last 3 months (OR 2.882, 95% CI 1.580-5.259, p = 0.001), urinary catheter (OR 2.315, 95% CI 1.202-4.459, p = 0.012), antibiotic therapy in the last 3 months (OR 1.882, 95% CI 1.041-3.405, p = 0.036), age ≥ 75 years (OR 1.866, 95% CI 1.076-3.237, p = 0.026) were factors independently associated with MDR etiology. A score ranging from 0 to 10 was useful to recognize patients at lowest risk (0 points: Negative Likelihood Ratio 0.10) and those at highest risk (>6 points, Positive Likelihood Ratio 11.8) of GNB bacteremia due to a MDR strain., Conclusions: Specific predictors of MDR etiology are useful to calculate probabilities of MDR etiology among hospitalized patients with blood cultures positive for GNB., (Copyright © 2018 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.)

Objectives: Hospital Based Health Technology Assessment (HBHTA) practices, to inform decision making at the hospital level, emerged as urgent priority for policy makers, hospital managers, and professionals. The present study crystallized the results achieved by the testing of an original framework for HBHTA, developed within Lombardy Region: the IMPlementation of A Quick hospital-based HTA (IMPAQHTA). The study tested: (i) the HBHTA framework efficiency, (ii) feasibility, (iii) the tool utility and completeness, considering dimensions and sub-dimensions., Methods: The IMPAQHTA framework deployed the Regional HTA program, activated in 2008 in Lombardy, at the hospital level. The relevance and feasibility of the framework were tested over a 3-year period through a large-scale empirical experiment, involving seventy-four healthcare professionals organized in different HBHTA teams for assessing thirty-two different technologies within twenty-two different hospitals. Semi-structured interviews and self-reported questionnaires were used to collect data regarding the relevance and feasibility of the IMPAQHTA framework., Results: The proposed HBHTA framework proved to be suitable for application at the hospital level, in the Italian context, permitting a quick assessment (11 working days) and providing hospital decision makers with relevant and quantitative information. Performances in terms of feasibility, utility, completeness, and easiness proved to be satisfactory., Conclusions: The IMPAQHTA was considered to be a complete and feasible HBHTA framework, as well as being replicable to different technologies within any hospital settings, thus demonstrating the capability of a hospital to develop a complete HTA, if supported by adequate and well defined tools and quantitative metrics.

The present article describes the case study of a "real world" HIV practice within the debate concerning the strategic role of Clinical Governance (CG) tools in the management of a National Healthcare System's sustainability. The study aimed at assessing the impact of a Clinical Pathway (CP) implementation, required by the Regional Healthcare Service, in terms of effectiveness (virological and immunological conditions) and efficiency (economic resources absorption), from the budget holder perspective. Data derived from a multi-centre cohort of patients treated in 6 Hospitals that provided care to approximately 42% of the total HIV+ patients, in Lombardy Region, Italy. Two phases were compared: Pre-CP (2009-2010) vs. Post-CP implementation (2011-2012). All HIV infected adults, observed in the participating hospitals during the study periods, were enrolled and stratified into the 3 categories defined by the Regional CP: first-line, switch for toxicity/other, and switch for failure. The study population was composed of 1,284 patients (Pre-CP phase) and 1,135 patients (Post-CP phase). The results showed that the same level of virological and immunological effectiveness was guaranteed to HIV+ patients: 81.2% of Pre-CP phase population and 83.2% of Post-CP phase population had undetectable HIV-RNA (defined as <50 copies/mL) at 12-month follow up. CD4+ cell counts increased by 28 ± 4 cells/mm3 in Pre-CP Phase and 39 ± 5 cells/mm3 in Post-CP Phase. From an economic point of view, the CP implementation led to a substantial advantage: the mean total costs related to the management of the HIV disease (ART, hospital admission and laboratory tests) decreased (-8.60%) in the Post-CP phase (p-value < 0.0001). Results confirmed that the CP provided appropriateness and quality of care, with a cost reduction for the budget holder., Competing Interests: We confirm that we have read the journal’s policy and the authors of this manuscript had the following competing interests: consulting fees, support for travel to conferences, participation in scientific board for MSD, BMS, Gilead, Abbott, Janssen Cilag, GlaxoSmithline, Pfizer, ViiV Healthcare and AbbVie. Francesca Scolari, Elisabetta Garagiola and Elena Ricci have declared that no competing interests exist. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Background: The advent of new HCV drugs has generated widespread economic concerns, particularly within the Italian setting, characterized by continuous linear cuts and spending review actions. The overall trade-off between investments and savings needs an in depth analysis., Aims: The study aimed to estimate the budget impact of the introduction of the novel drugs approved during the year 2015, compared with the historical situation based on the different treatment options available prior to 2015., Methods: A three-year budget impact model was developed, taking into consideration the Lombardy Region (Northern Italy) Health Service perspective. The degree of liver fibrosis, genotypes, presence of only HCV or HIV/HCV co-infections, presence or absence of sustained virological response, and direct healthcare total costs were the variables of the model., Results: With the introduction of the novel regimens, a higher number of HCV patients achieved a sustained virological response (+20%). Further analysis showed that an investment in innovative technologies would have given the Regional System significant economic savings within the 36-month period (-6.64%/-7.15%)., Conclusions: Treating HCV-infected persons in the Lombardy Region with the new drugs would reduce healthcare expenditure on this specific disease, in each forecast implemented, thus reducing the economic burden of the pathology., (Copyright © 2016 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Only a few studies provided data on the clinical history of sepsis within internal Medicine units. The aim of the study was to assess the short-term mortality and to evaluate the prognostic risk factors in a large cohort of septic patients treated in internal medicine units. Thirty-one internal medicine units participated to the study. Within each participating unit, all admitted patients were screened for the presence of sepsis. A total of 533 patients were included; 78 patients (14.6%, 95%CI 11.9, 18.0%) died during hospitalization; mortality rate was 5.5% (95% CI 3.1, 9.6%) in patients with nonsevere sepsis and 20.1% (95%CI 16.2, 28.8%) in patients with severe sepsis or septic shock. Severe sepsis or septic shock (OR 4.41, 95%CI 1.93, 10.05), immune system weakening (OR 2.10, 95%CI 1.12, 3.94), active solid cancer (OR 2.14, 95% CI 1.16, 3.94), and age (OR 1.03 per year, 95% CI 1.01, 1.06) were significantly associated with an increased mortality risk, whereas blood culture positive for Escherichia coli was significantly associated with a reduced mortality risk (OR 0.46, 95%CI 0.24, 0.88). In-hospital mortality of septic patients treated in internal medicine units appeared similar to the mortality rate obtained in recent studies conducted in the ICU setting., Competing Interests: The authors have no conflicts of interest to disclose.