Co-Design as Enabling Factor for Patient-Centred Healthcare: A Bibliometric Literature Review.

Service design and in particular co-design are approaches able to align with the need of healthcare contexts of value-based and patient-centered processing through a participatory design of services. The purpose of this study is to identify the characteristics of co-design and its applicability to the reengineering of healthcare services, as well as to detect the peculiarities of the application of this approach in different geographical contexts. The methodology applied for the review, Systematic Literature Network Analysis (SLNA), combines qualitative and quantitative perspectives. In detail, the analysis applied the paper citation networks and the co-word network analysis to detect the main research trends over time and to identify the most relevant publications. The results of the analysis highlight the backbone of literature on the application of co-design in healthcare as well as the advantages and the critical factors of the approach. Three main literature streams emerged concerning the integration of the approach at meso and micro level, the implementation of co-design at mega and macro level, and the impacts on non-clinical related outcomes. Moreover, the findings underline differences in co-design in terms of impacts and success factors in developed countries and economies in transition or developing countries. The analysis shows the potentially added value of the application of a participatory approach to the design and redesign of healthcare services both at different levels of the healthcare organization and in the contexts of developed countries and economies in transition or developing countries. The evidence also highlights potentialities and critical success factors of the application of co-design in healthcare services redesign.

Cost of illness of Primary Biliary Cholangitis - a population-based study.

BACKGROUND: The economic burden of Primary Biliary Cholangitis (PBC) has not been investigated at population-level. Aim of this study was to estimate the cost of illness of PBC in Lombardy, Italy. METHODS: Individuals with PBC were identified through ICD-9-CM code 571.6 and/or medical exemption code 008.571.6, from the Banca Dati Assistito of Lombardy. Only health services (outpatient, inpatient activities and drugs) related to PBC were considered to estimate direct medical costs in 2017. RESULTS: We identified 970 adult patients (83.5% females) with a mean age of 61 years. Global annual costs were equal to € 913,763 (€ 942 per patient), with € 459,506 (50.3%, € 474 per patient) deriving from hospitalizations (mostly due to liver transplantation, 30.5%, and cirrhosis complications, 20.6%). Costs from outpatient activities were € 109,090 (11.9%, € 112 per patient). CONCLUSIONS: This study provides an overview of the costs attributed to PBC care and management, mainly related to hospitalizations for cirrhosis complications, which is necessary for assuring cost-effective introduction of novel therapies. Additional studies focused on indirect cost, e.g. overall loss of productivity, are warranted.

Organisational and financial consequences of the early discharge of patients treated for acute bacterial skin and skin structure infection and osteomyelitis in infectious disease departments in Greece, Italy and Spain: a scenario analysis.

OBJECTIVE: The aim of the analysis is to assess the organisational and economic consequences of adopting an early discharge strategy for the treatment of acute bacterial skin and skin structure infection (ABSSSI) and osteomyelitis within infectious disease departments. SETTING: Infectious disease departments in Greece, Italy and Spain. PARTICIPANTS: No patients were involved in the analysis performed. INTERVENTIONS: An analytic framework was developed to consider two alternative scenarios: standard hospitalisation care or an early discharge strategy for patients hospitalised due to ABSSSI and osteomyelitis, from the perspective of the National Health Services of Greece, Italy and Spain. The variables considered were: the number of annual hospitalisations eligible for early discharge, the antibiotic treatments considered (ie, oral antibiotics and intravenous long-acting antibiotics), diagnosis-related group (DRG) reimbursements, number of days of hospitalisation, incidence and costs of hospital-acquired infections, additional follow-up visits and intravenous administrations. Data were based on published literature and expert opinions. PRIMARY AND SECONDARY OUTCOME MEASURES: Number of days of hospitalisation avoided and direct medical costs avoided. RESULTS: The total number of days of hospitalisation avoided on a yearly basis would be between 2216 and 5595 in Greece (-8/-21 hospital beds), between 15 848 and 38 444 in Italy (-57/-135 hospital beds) and between 7529 and 23 520 in Spain (-27/-85 hospital beds). From an economic perspective, the impact of the early discharge scenario is a reduction between €45 036 and €149 552 in Greece, a reduction between €182 132 and €437 990 in Italy and a reduction between €292 284 and €884 035 in Spain. CONCLUSIONS: The early discharge strategy presented would have a positive organisational impact on National Health Services, leading to potential savings in beds, and to a reduction of hospital-acquired infections and costs.

Cost-effectiveness analysis of the use of daclatasvir + sofosbuvir + ribavirin (16 weeks and 12 weeks) vs sofosbuvir + ribavirin (16 weeks and 24 weeks) for the treatment of cirrhotic patients affected with hepatitis C virus genotype 3 in Italy.

The WHO estimates that more than 185 million people are infected with hepatitis C virus (HCV) worldwide. The aim of the study is to assess the incremental cost-effectiveness ratio (ICER) of the use of daclatasvir (DCV) + sofosbuvir (SOF) + ribavirin (RBV) for 12 and 16 weeks vs SOF + RBV for 16 and 24 weeks for the treatment of genotype 3 HCV infected cirrhotic patients from the Italian National Health Service (NHS) perspective. A published cohort-based Markov model was used to perform the analysis estimating the lifetime direct medical costs associated with the management of the pathology and the quality adjusted life years gained by patients. Deterministic and probabilistic sensitivity analyses were performed to test the robustness of the results. SOF + RBV for 16 weeks was excluded from the analysis due to the significant lower effectiveness, compared with SOF + RBV for 24 weeks (51% vs 79%). DCV + SOF + RBV would increase QALYs and costs in all the comparisons: the ICERs obtained comparing DCV + SOF + RBV for 12 and 16 weeks with SOF + RBV for 24 weeks (reference scenario) are 38,572 €/QALY and 16,436 €/QALY, respectively, both below the 40,000 €/QALY threshold identified by the Italian Health Economics Association. Sensitivity analyses confirmed the robustness of the results. The use of DCV + SOF + RBV is likely to be cost-effective compared with SOF + RBV (for 24 weeks) for the treatment of cirrhotic patients infected with genotype 3 HCV considering a threshold value of 40,000 €/QALY.

Cost-effectiveness analysis of dolutegravir plus backbone compared with raltegravir plus backbone, darunavir+ritonavir plus backbone and efavirenz/tenofovir/emtricitabine in treatment naïve and experienced HIV-positive patients.

BACKGROUND: In January 2014, the European Medicines Agency issued a marketing authorization for dolutegravir (DTG), a second-generation integrase strand transfer inhibitor for HIV treatment. The study aimed at determining the incremental cost-effectiveness ratio (ICER) of the use of DTG+backbone compared with raltegravir (RAL)+backbone, darunavir (DRV)+ritonavir(r)+backbone and efavirenz/tenofovir/emtricitabine (EFV/TDF/FTC) in HIV-positive treatment-naïve patients and compared with RAL+backbone in treatment-experienced patients, from the Italian National Health Service's point of view. MATERIALS AND METHODS: A published Monte Carlo Individual Simulation Model (ARAMIS-DTG model) was used to perform the analysis. Patients pass through mutually exclusive health states (defined in terms of diagnosis of HIV with or without opportunistic infections [OIs] and cardiovascular disease [CVD]) and successive lines of therapy. The model considers costs (2014) and quality of life per monthly cycle in a lifetime horizon. Costs and quality-adjusted life years (QALYs) are dependent on OI, CVD, AIDS events, adverse events and antiretroviral therapies. RESULTS: In treatment-naïve patients, DTG dominates RAL; compared with DRV/r, the ICER obtained is of 38,586 €/QALY (6,170 €/QALY in patients with high viral load) and over EFV/TDF/FTC, DTG generates an ICER of 33,664 €/QALY. In treatment-experienced patients, DTG compared to RAL leads to an ICER of 12,074 €/QALY. CONCLUSION: The use of DTG+backbone may be cost effective in treatment-naïve and treatment-experienced patients compared with RAL+backbone and in treatment-naïve patients compared with DRV/r+backbone and EFV/TDF/FTC considering a threshold of 40,000 €/QALY.

TECHNOLOGY ASSESSMENT IN HOSPITALS: LESSONS LEARNED FROM AN EMPIRICAL EXPERIMENT.

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.

Financial and feasibility implications of the treatment of hepatitis C virus in Italy: scenarios and perspectives.

BACKGROUND: Hepatitis C virus (HCV) affects an estimated number of people between 130 million and 210 million worldwide. In the next few years, the Italian National Health Service will face a growing trend of patients requiring HCV antiviral treatments. The aim of the analysis was to estimate the time horizon in which it would be possible to treat HCV-infected patients and the related direct medical costs (antiviral treatment and monitoring activities) from the Italian National Health Service point of view. METHODOLOGY: In order to estimate the number of HCV-infected patients in Italy, we considered a top-down (considering published data) and a bottom-up approach. The number of years needed for treatment and related direct costs were estimated through the development of a static deterministic model. RESULTS: The estimated number of HCV-infected patients in Italy varies from 2.7 (estimated through a top-down approach) to 0.6 million (estimated through a bottom-up approach) and 0.3 million (measured through a bottom-up approach). Considering the last two scenarios and the use of interferon-free therapies for 50,000 patients per year, treatment for HCV-infected patients could be at a cost of €13.7 billion and €7.0 billion by 2030 and 2023, respectively. CONCLUSION: The treatment for HCV-infected patients in Italy is a challenging target for the financial implications of patient care. HCV infection could be controlled or eliminated in a 10- to 15-year time horizon. The cost of treatment can hardly be dealt with using the traditional economic tools but should be faced through multiyear investments, as health benefits are expected in the long period. National Health Service stakeholders (industry, government, insurance, and also patients) will have to identify suitable financial instruments to face the new expenditure required.

Budget impact analysis of antiretroviral less drug regimen simplification in HIV-positive patients on the Italian National Health Service.

BACKGROUND: Deintensification and less drug regimen (LDR) antiretroviral therapy (ART) strategies have proved to be effective in terms of maintaining viral suppression in human immunodeficiency virus (HIV)-positive patients, increasing tolerability, and reducing toxicity of antiretroviral drugs administered to patients. However, the economic impact of these strategies have not been widely investigated. The aim of the study is to evaluate the economic impact that ART LDR could have on the Italian National Health Service (INHS) budget. METHODS: A budget impact model was structured to assess the potential savings for the INHS by the use of ART LDR for HIV-positive patients with a 3 year perspective. Data concerning ART cost, patient distribution within different ARTs, and probabilities for patients to change ART on a yearly basis were collected within four Italian infectious diseases departments, providing ART to 13.7% of the total number of patients receiving ART in Italy. RESULTS: The LDR investigated (protease inhibitor-based dual and monotherapies) led to savings for the hospitals involved when compared to the "do nothing" scenario on a 3 year basis, between 6.7% (23.11 million €) and 12.8% (44.32 million €) of the total ART expenditures. The mean yearly cost per patient is reduced from 9,875 € in the do nothing scenario to a range between 9,218 € and 8,615 €. The use of these strategies within the four departments involved would have led to a reduction of ART expenditures for the INHS of between 1.1% and 2.1% in 3 years. CONCLUSION: ART LDR simplification would have a significant impact in the reduction of ART-related costs within the hospitals involved in the study. These strategies could therefore be addressed as a sustainable answer to the public financing reduction observed within the INHS in the last year, allowing therapies to be dispensed without affecting the quality of the services provided.

Health technology assessment in the HIV setting: the case of monotherapy.

Despite the success of multiple-drug therapy regimens, the idea of treating human immunodeficiency virus (HIV) infection with fewer drugs is captivating due to issues of convenience, long-term toxicities and costs. This study investigated the impact on a local health budget of the introduction of a protease inhibitor (PI)-based antiretroviral monotherapy. An analysis of 23,721 administrative records of HIV-infected patients and a health technology assessment (HTA) were performed to assess cost-effectiveness, budget, organizational, ethics, and equity impact. Data showed that monotherapy had a annual cost of € 7,076 (patient with undetectable viral load) and € 7,860 (patient with detectable viral load), and that its implementation would realise economic savings of between 12 and 24 million euro (between 4.80% and 9.72% of the 2010 total regional budget expenditure for HIV management) in the first year, with cumulated savings of between 48 and 145 million euro over the following five years. Organizational, ethical and equity impact did not indicate any significant differences. The study suggests that for specific categories of patients monotherapy may be an alternative to existing therapies. Its implementation would not result in higher operating costs, and would lead to a reduction in total expenditure.

Intraprocedural contrast-enhanced ultrasound (CEUS) in liver percutaneous radiofrequency ablation: clinical impact and health technology assessment.

OBJECTIVES: To assess the clinical and the economic impacts of intraprocedural use of contrast-enhanced ultrasound (CEUS) in patients undergoing percutaneous radiofrequency ablation for small (<2.5 cm) hepatocellular carcinomas. METHODS: One hundred and forty-eight hepatocellular carcinomas in 93 patients were treated by percutaneous radiofrequency ablation and immediate assessment by intraprocedural CEUS. Clinical impact, cost effectiveness, and budget, organisational and equity impacts were evaluated and compared with standard treatment without intraprocedural CEUS using the health technology assessment approach. RESULTS: Intraprocedural CEUS detected incomplete ablation in 34/93 (36.5 %) patients, who underwent additional treatment during the same session. At 24-h, complete ablation was found in 88/93 (94.6 %) patients. Thus, a second session of treatment was spared in 29/93 (31.1 %) patients. Cost-effectiveness analysis revealed an advantage for the use of intraprocedural CEUS in comparison with standard treatment (4,639 vs 6,592) with a 21.9 % reduction of the costs to treat the whole sample. Cost per patient for complete treatment was  4,609 versus  5,872 respectively. The introduction of intraprocedural CEUS resulted in a low organisational impact, and in a positive impact on equity CONCLUSIONS: Intraprocedural use of CEUS has a relevant clinical impact, reducing the number of re-treatments and the related costs per patient. TEACHING POINTS: • CEUS allows to immediately asses the result of ablation. • Intraprocedural CEUS decreases the number of second ablative sessions. • Intraprocedural CEUS may reduce cost per patient for complete treatment. • Use of intraprocedural CEUS may reduce hospital budget. • Its introduction has low organisational impact, and relevant impact on equity.

Real-world economic burden of venous thromboembolism and antithrombotic prophylaxis in medical inpatients.

INTRODUCTION: Venous thromboembolism (VTE) is a significant cause of morbidity and mortality in medical patients, and the economic burden of this disease is plausibly relevant as well. However, few data from real-world observations are available on this topic. Aim of our study was to assess the costs of VTE management and antithrombotic prophylaxis in patients hospitalized in Internal Medicine (IM) departments. MATERIALS AND METHODS: The in-hospital paths of 160 patients with VTE (VTE group) and 160 patients receiving prophylaxis and without VTE (NO-VTE group) were retrospectively evaluated within 26IM units in Italy. The economic analysis was undertaken by applying a process analysis, the initial phase of the more comprehensive Activity Based Costing technique. Accordingly to this approach, only information closely linked to VTE or its prevention was registered. RESULTS: The total median costs for VTE management were around four-times higher than those for prophylaxis (€ 1,348.68 vs € 373.03). Human resources were the most important cost-driver (55.5% and 65.7% in the VTE and NO-VTE groups), followed by instrumental (24.6% in VTE and 15.5% in NO-VTE) and haematologic tests (12.6% in VTE patients and 13.3% in controls). In the NO-VTE group the direct costs for prophylaxis accounted for 4.5% of total. CONCLUSIONS: The real-world data of this study confirm the economic burden of in-hospital treatment of VTE, and the relatively low costs of thromboprophylaxis. A greater adherence to evidence-based protocols for VTE prevention could probably reduce the current financial burden of VTE on healthcare systems.