1,720,976 research outputs found
How to reduce inequity of access to cardiac rehabilitation after Surgical Aortic Valve Replacement. Recommendations for the post-COVID era from a real world, population-based study
Little data exist regarding cardiac rehabilitation (CR) access after valve surgery. Moreover, the factors affecting the probability of timely access to CR after surgical aortic valve replacement (SAVR) have never been empirically investigated. The aim of the study is to fill this gap and respond to the following two research questions: (i) How many SAVR patients do access a timely CR program after SAVR in Italy? (ii) To what extent is timely access to CR for SAVR patients influenced by specific characteristics of patients and hospitals
Cost-minimization analysis to support the HTA of Radiofrequency Echographic Multi Spectrometry (REMS) in the diagnosis of osteoporosis
This study aims at evaluating the costs of REMS vs. the conventional ionizing technology (dual-energy X-ray absorptiometry, DXA) for the diagnosis of osteoporosis from the perspective of the Italian National Health Service (NHS) using a cost-minimization analysis (CMA)
Artificial-Intelligence Cloud-Based Platform to Support Shared Decision-Making in the Locoregional Treatment of Breast Cancer: Protocol for a Multidimensional Evaluation Embedded in the CINDERELLA Clinical Trial
Background: Shared decision-making (SDM) plays a crucial role in breast cancer care by empowering patients and reducing decision regret. Patient decision aids (PtDAs) are valuable tools for facilitating SDM, now available in digital and artificial intelligence (AI)-powered formats to offer increasingly personalized contents. The ongoing CINDERELLA clinical trial (ClinicalTrials.gov: NCT05196269) evaluates an innovative AI cloud-based approach using a web platform and a mobile application (CINDERELLA APProach) versus the conventional approach to support SDM in breast cancer patients undergoing locoregional treatment. This protocol outlines a trial-based multidimensional evaluation, encompassing economic, financial, implementability, and environmental considerations associated with the CINDERELLA APProach. Methods: A within-trial cost-consequence and cost-utility analysis from a societal perspective will be performed using patient-level data on outcomes and resource use. The latter will be valued in monetary terms using country-specific unit costs or patient valuations. A budget impact analysis will be performed over 1 and 5 years from the budget holder perspectives. The CINDERELLA APProach implementability will be assessed through an evaluation of its usability, acceptability, organizational impact, and overall feasibility. The environmental impact will be quantitatively assessed across several dimensions, such as quantity, appropriateness, and emissions, supplemented by qualitative insights. Overall, data for the evaluation will be gathered from patient questionnaires, interviews with patients and managers, focus groups with healthcare professionals, and app electronic data. Discussion: A thorough understanding of the broad consequences of the CINDERELLA APProach may foster its successful translation into real-world settings, hopefully benefiting breast cancer patients and clinical practice
Mapping health-related quality of life scores from FACT-G, FAACT, and FACIT-F onto preference-based EQ-5D-5L utilities in non-small cell lung cancer cachexia
Background: Health-related quality of life (HRQoL) measurements from disease-specific tools cannot be directly used in economic evaluations. This study aimed to develop and validate mapping algorithms that predicted EuroQol 5-Dimensions 5-Levels (EQ-5D-5L) utilities from Functional Assessment of Anorexia-Cachexia Therapy (FAACT) and Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and their common component (Functional Assessment of Cancer Therapy-General—FACT-G) in patients with non-small cell lung cancer cachexia.
Methods: Data were collected on five occasions over a 12-week period in two multicenter placebo-controlled trials. EQ-5D-5L utilities were calculated using both English and Dutch value sets. The study sample was divided into development and validation datasets according to patients’ geographical residence. Generalized estimating equations were applied to five different sets of independent variables including overall, Trial Outcome Index (TOI), and individual subscales results. The best performing models were selected based on mean absolute error (MAE) and root-mean square error (RMSE).
Results: EQ-5D-5L and FAACT/FACIT-F results were available for 96 patients. The developed algorithms showed a good predictive performance, with acceptable MAE/RMSE and small differences between mean observed and predicted EQ-5D-5L utilities. In FACT-G models, Physical Well-Being had the highest explanatory value, while Emotional Well-Being did not significantly affect the EQ-5D-5L score; Anorexia-Cachexia and Fatigue subscales were highly statistically significant in FAACT and FACIT-F models, respectively, as well as the TOI scores. The Eastern Cooperative Oncology Group status was included as covariate in all models.
Conclusion: The developed algorithms enable the estimation of EQ-5D-5L utilities from three cancer-specific instruments when preference-based HRQoL data are missing
La spesa sanitaria: composizione ed evoluzione nella prospettiva nazionale, regionale ed aziendale
Il capitolo illustra i dati di spesa, finanziamento e performance economica del SSN secondo diversi livelli di rappresentazione e comparazione. Innanzitutto, si analizza l’andamento macroeconomico della spesa sanitaria, inteso come confronto tra l’entità della spesa sanitaria in rapporto al PIL (e altre misure) del nostro Paese con quella di altri Paesi Europei e degli Stati Uniti. A seguire l’analisi approfondisce il livello nazionale, analizzando le dinamiche di finanziamento, l’entità e il ruolo delle diverse componenti della spesa del SSN. Il livello regionale è poi analizzato con l’obiettivo di apprezzare le differenze dei modelli regionali esistenti nei livelli di spesa, verificando anche le performance finanziarie delle singole regioni in termini di avanzo e disavanzo e approfondendo cinque casi studio (riferiti a Campania, Emilia Romagna, Piemonte, Puglia, Veneto) che consentono di avviare una prima riflessione sulle politiche attivate a livello regionale per limitare il rischio del mancato equilibrio economico-finanziario nel 2022. L’ultimo livello di analisi si concentra sulle performance economiche delle aziende del sistema, analizzate con riferimento ai cinque casi di studio, che consente di approfondire il legame tra le dinamiche regionali ed aziendali e di esplorare il ruolo di entrambi rispetto al contenimento dei disequilibri. Se fino allo scorso anno si osservava una condizione di sostanziale disallineamento tra quanto osservato a livello aggregato e a livello locale (da un lato, l’equilibrio complessivo del SSN, osservato attraverso gli aggregati regionali e nazionali, dall’altro la difficoltà crescente delle aziende sanitarie a raggiungere l’equilibrio economico), quest’anno gli interventi di riprogettazione e riorganizzazione dei sistemi sanitari regionali sollevano alcuni interrogativi sostanziali per la tenuta del SSN. I risultati delle analisi evidenziano come il livello di finanziamento per la sanità pubblica del nostro Paese, anche in chiave comparativa con altri Pasi, è stabilmente basso. La situazione di apparente equilibrio complessivo del SSN (osservato attraverso gli aggregati regionali e nazionali) va letta congiuntamente alle crescenti difficoltà riscontrate a livello di SSR e aziende nel raggiungere l’equilibrio economico, sollevando importanti interrogativi per la tenuta del SSN. In un contesto in cui, peraltro, non sono previsti consistenti interventi di aumento strutturale del finanziamento e della spesa sanitaria corrente pubblica
La spesa sanitaria e i costi dei servizi: composizione ed evoluzione nella prospettiva nazionale, regionale ed aziendale
Il capitolo illustra i dati di spesa, finanziamento e performance economica del SSN italiano, integrandoli con un confronto internazionale. L’intento del Capitolo è di illustrare le dinamiche e i trend evolutivi della spesa sanitaria e del relativo finanziamento, articolati in tre livelli di rappresentazione in modo da osservare le dinamiche tra il livello nazionale, regionale e aziendale, in un momento storico in cui la tenuta locale dei conti del SSN è messa a dura prova da fenomeni di natura macroeconomica ma anche da caratteristiche strutturali del sistema
Direct healthcare costs of non-metastatic castration-resistant prostate cancer in Italy
Objectives: The management of non-metastatic castration-resistant prostate cancer (nmCRPC)
is rapidly evolving; however, little is known about the direct healthcare costs of nmCRPC. We
aimed to estimate the cost-of-illness (COI) of nmCRPC from the Italian National Health Service
perspective.
Methods: Structured, individual qualitative interviews were carried out with clinical experts to
identify what healthcare resources are consumed in clinical practice. To collect quantitative
estimates of healthcare resource consumption, a structured expert elicitation was performed
with clinical experts using a modified version of a previously validated interactive Excel-based
tool, EXPLICIT (EXPert eLICItation Tool). For each parameter, experts were asked to provide
the lowest, highest, and most likely value. Deterministic and probabilistic sensitivity analyses
(PSA) were carried out to test the robustness of the results.
Results: Ten clinical experts were interviewed, and six of them participated in the expert
elicitation exercise. According to the most likely estimate, the yearly cost per nmCRPC patient
is €4,710 (range, €2,243 to €8,243). Diagnostic imaging (i.e., number/type of PET scans
performed) had the highest impact on cost. The PSA showed a 50 percent chance for the yearly
cost per nmCRPC patient to be within €5,048 using a triangular distribution for parameters, and
similar results were found using a beta-PERT distribution.
Conclusions: This study estimated the direct healthcare costs of nmCRPC in Italy based on a
mixed-methods approach. Delaying metastases may be a reasonable goal also from an economic
standpoint. These findings can inform decision-making abou
Cost-effectiveness and net monetary benefit of Olaparib maintenance therapy versus no maintenance therapy after first-line platinum-based chemotherapy in newly diagnosed advanced BRCA1/2-mutated ovarian cancer in the Italian National Health Service
Purpose
The aim of this study was to evaluate the cost-effectiveness and net monetary benefit of olaparib maintenance therapy compared with no maintenance therapy after first-line platinum-based chemotherapy in newly diagnosed advanced BRCA1/2-mutated ovarian cancer from the Italian National Health Service (NHS) perspective.
Methods
We developed a lifetime Markov model in which a cohort of patients with newly diagnosed advanced BRCA1/2-mutated ovarian cancer was assigned to receive either olaparib maintenance therapy or active surveillance (Italian standard of care) after first-line platinum-based chemotherapy to compare cost-effectiveness and net monetary benefit of the 2 strategies. Data on clinical outcomes were obtained from related clinical trial literature and extrapolated using parametric survival analyses. Data on costs were derived from Italian official sources and relevant real-world studies. The incremental cost-effectiveness ratio (ICER), incremental cost-utility ratio (ICUR), and incremental net monetary benefit (INMB) were computed and compared against an incremental cost per quality-adjusted life-year (QALY) gained of €16,372 willingness-to-pay (WTP) threshold. We used deterministic sensitivity analysis (DSA) and probabilistic sensitivity analysis (PSA) to assess how uncertainty affects results; we also performed scenario analyses to compare results under different pricing settings.
Findings
In the base-case scenario, during a 50-year time horizon, the total costs for patients treated with olaparib therapy and active surveillance were €124,359 and €97,043, respectively, and QALYs gained were 7.29 and 4.88, respectively, with an ICER of €9,515 per life-year gained, an ICUR of €11,345 per QALY gained, and an INMB of €12,104. In scenario analyses, considering maximum selling prices for all other drugs, ICUR decreased to €11,311 per QALY and €7,498 per QALY when a 10% and 20% discount, respectively, was applied to the olaparib official price, and the INMB increased to €12,186 and €21,366, respectively. DSA found that the model results were most sensitive to the proportion of patients with relapsing disease in response to platinum-based chemotherapy, time receiving olaparib first-line maintenance treatment, and subsequent treatments price. According to PSAresults, olaparib was associated with a probability of being cost-effective at a €16,372 per QALY WTP threshold ranging from 70% to 100% in the scenarios examined.
Implications
Our analysis indicates that olaparib maintenance therapy may deliver a significant health benefit with a contained upfront cost during a 50-year time horizon, from the Italian NHS perspective, providing value in a setting with curative intent
Elicitation of societal preferences for chronic lymphocytic leukemia’s treatments: a discrete choice experiment
The overall value of treatments for chronic lymphocytic leukemia (CLL) depends on several factors, including preferences of the general population, who contributes to the financing of health systems. This study investigated societal preferences for attributes of CLL treatments in Italy. An online large-scale survey was designed using a discrete choice experiment (DCE) methodology and delivered to the Italian adult general population. Ten treatment attributes were identified, covering efficacy, safety, operational aspects and (hypothetical) out-of-pocket cost. DCE data were analyzed using a mixed logit regression model, estimating the willingness-to-pay for attribute levels' change. The general population significantly preferred more effective treatments, with shorter duration, administered orally rather than orally + intravenously. Changes in therapy duration, frequency of checkups and organ damage risk had the greatest impact on preferences. The integration of societal preferences in the value judgments of CLL therapies may help health authorities in establishing priority setting and taking pricing-reimbursement decisions
Collecting physicians' preferences on medical devices: are we doing it right? Evidence from Italian orthopedists using 2 different stated preference methods
Objectives. Physician preference items (PPIs) are high-cost medical devices for which clinicians express firm preferences with respect to a particular manufacturer or product. This study aims to identify the most important factors in the choice of new PPIs (hip or knee prosthesis) and infer about the existence of possible response biases in using 2 alternative stated preference techniques. Methods. Six key attributes with 3 levels each were identified based on a literature review and clinical experts' opinions. An online survey was administered to Italian hospital orthopedists using type 1 best-worst scaling (BWS) and binary discrete choice experiment (DCE). BWS data were analyzed through descriptive statistics and conditional logit model. A mixed logit regression model was applied to DCE data, and willingness-to-pay (WTP) was estimated. All analyses were conducted using Stata 16. Results. A sample of 108 orthopedists were enrolled. In BWS, the most important attribute was "clinical evidence," followed by "quality of products," while the least relevant items were "relationship with the sales representative" and "cost." DCE results suggested instead that orthopedists prefer high-quality products with robust clinical evidence, positive health technology assessment recommendation and affordable cost, and for which they have a consolidated experience of use and a good relationship with the sales representative. Conclusions. The elicitation of preferences for PPIs using alternative methods can lead to different results. The BWS of type 1, which is similar to a ranking exercise, seems to be more affected by acquiescent responding and social desirability than the DCE, which introduces tradeoffs in the choice task and is likely to reveal more about true preferences
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