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.

Cost-effectiveness Analysis of Radiofrequency Ablation in Patients With Barrett Esophagus and High-grade Dysplasia or Low-grade Dysplasia.

Purpose: Clinical guidelines recommend radiofrequency ablation (RFA) for eradication of Barrett esophagus in patients with low-grade dysplasia (LGD) and high-grade dysplasia (HGD), but evidence on whether RFA provides good value for money is still sparse. This study evaluates the cost-effectiveness of RFA in Italy.

Methods: A Markov model was used to estimate lifelong costs and consequences of disease progression with different treatments.

Recommendations for the design and implementation of an Early Feasibility Studies program for medical devices in the European Union.

Introduction: Early Feasibility Studies (EFS) are among the pre-market clinical investigations allowed by the International Standard for Clinical investigation of medical devices (MD) for human subjects. The Food and Drug Administration (FDA) introduced an EFS program in the US in 2013. The European Union (EU) MD Regulation, that entered into force in May 2021, opened the possibility of EFS in the EU.

[GISE (Italian Society of Interventional Cardiology) Position paper: Short-term hospitalization for percutaneous coronary intervention; a helpful tool to manage post-COVID-19 backlogs].

Minimization of hospital lengths of stay has always been a key goal for healthcare systems. More so during the current COVID-19 pandemic. In fact, we have faced a reduction in no-COVID-19 admissions with the generation of huge backlogs.

How to Reduce Inequity of Access to Cardiac Rehabilitation After Surgical Aortic Valve Replacement. Recommendations for the Post-COVID-19 Era From a Real-World, Population-Based Study.

Purpose: Cardiac rehabilitation (CR) is a class I recommendation after valvular surgery. Few data exist on the level of access to CR after surgical aortic valve replacement (SAVR), and the factors affecting the probability of timely access to CR after SAVR have never been empirically investigated. This study aims at estimating the proportion of SAVR patients who initiated timely CR and understanding to what extent timely access to CR for SAVR patients is influenced by specific characteristics of patients and hospitals.

Establishing a national HTA program for medical devices in Italy: Overhauling a fragmented system to ensure value and equal access to new medical technologies.

Differing contexts have greatly influenced HTA development in various countries, with considerable effort recently made by international HTA networks (e.g., EUnetHTA) and the European Union (EU) to make HTA a more coherent, equal, and efficient process.

Measuring Value in Health Care: A Comparative Analysis of Value-based Frameworks.

Purpose: This paper presents a comparative analysis of value-based frameworks (VBFs) developed in the United States and Europe for both drugs and medical devices.

Methods: The authors relied on a comprehensive literature review to identify relevant dimensions of analysis and available VBFs. Compared to previous studies on this topic, this study focused on the roles and strategic objectives of different institutions and organizations currently orchestrating the debate and development of VBFs and value-based initiatives.

Learning effect and diffusion of innovative medical devices: the case of transcatheter aortic valve implantation in Italy.

Aim: We investigated the diffusion of transcatheter aortic valve implantation (TAVI) since its introduction into the Italian market aimed at identifying the potential drivers of uptake and diffusion at hospital and regional levels.

Materials & Methods: We estimated the determinants of TAVI diffusion in Italy from 2007 to 2015 with a regression analysis based on registry data.

Results: Since 2007, TAVI has shown significant diffusion rates in Italy.

Improving the Methods for the Economic Evaluation of Medical Devices.

Medical devices (MDs) have distinctive features, such as incremental innovation, dynamic pricing, the learning curve and organisational impact, that need to be considered when they are evaluated. This paper investigates how MDs have been assessed in practice, in order to identify methodological gaps that need to be addressed to improve the decision-making process for their adoption. We used the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist supplemented by some additional categories to assess the quality of reporting and consideration of the distinctive features of MDs.

The impact of HTA and procurement practices on the selection and prices of medical devices.

Technological innovation in healthcare yields better health outcomes but also drives healthcare expenditure, and governments are struggling to maintain an appropriate balance between patient access to modern care and the economic sustainability of healthcare systems. Health Technology Assessment (HTA) and centralized procurement are increasingly used to govern the introduction and diffusion of new technologies in an effort to make access to innovation financially sustainable. However, little empirical evidence is available to determine how they affect the selection of new technologies and unit prices.

Overuse of surgery in patients with pancreatic cancer. A nationwide analysis in Italy.

Background: According to current guidelines, pancreatic cancer patients should be strictly selected for surgery, either palliative or resective.

Methods: Population-based study, including all patients undergoing surgery for pancreatic cancer in Italy between 2010 and 2012. Hospitals were divided into five volume groups (quintiles), to search for differences among volume categories.

The role of hospital payments in the adoption of new medical technologies: an international survey of current practice.

This study examined the role of prospective payment systems in the adoption of new medical technologies across different countries. A literature review was conducted to provide background for the study and guide development of a survey instrument. The survey was disseminated to hospital payment systems experts in 15 jurisdictions.

Economic evidence of interventions for acute myocardial infarction: a review of the literature.

Aims: The aims of this review are to identify and evaluate studies exploring the cost-effectiveness of primary angioplasty (PPCI) vs. thrombolysis (TL) for treating acute myocardial infarction (AMI).

Methods And Results: A comprehensive free-text searching identified economic evaluation studies that were reviewed with respect to their effectiveness data, identification, measurement and valuation of resource data, measurement and valuation of health outcomes (clinical and QALYs) and uncertainty analysis.