Rosanna Tarricone

Bocconi University | Bocconi · Division of Government, Health and Non Profit

Digital medical devices (DMDs) present unique opportunities in their regulation and reimbursement. A dynamic landscape of DMD assessment frameworks is emerging within the European Union, with five clusters of prevailing approaches identified. Despite notable gaps in maturity levels, cross-country learning effects are becoming prevalent. We expect m...

In locally advanced (LA) laryngeal/hypopharyngeal squamous cell carcinoma (LHSCC), larynx preservation (LP) strategies aim at the cure of the disease while preserving a functional larynx, thus avoiding total laryngectomy and the associated impact on the quality of life. In the last decades, apart from transoral and open-neck organ preservation appr...

Introduction The treatment of patients with cardiogenic shock (CS) encompasses several health technologies including Impella pumps and venoarterial extracorporeal membrane oxygenation (VA-ECMO). However, while they are widely used in clinical practice, information on resource use and quality of life (QoL) associated with these devices is scarce. Th...

Background Self-management is pivotal in addressing noncommunicable diseases, such as diabetes. The increased availability of digital behaviour change interventions (DBCIs) delivered through mobile health apps offers unprecedented opportunities to enhance self-management and improve health outcomes. However, little is known about the characteristic...

Aim Rectus abdominal diastasis (RAD) can cause mainly incontinence and lower-back pain. Despite its high incidence, there is no consensus regarding surgical indication. We aimed at comparing RAD repair (minimally invasive technique with mesh implant) with no treatment (standard of care – SOC) through cost-effectiveness and budget impact analyses fr...

Introduction The aim of the study was to define a core outcome set (COS) to be measured following cataract surgery for the postoperative evaluation of monofocal intraocular lenses (IOLs). Compared to current COSs, the present work provides updates considering the advances in the technology due to the development of new generation monofocal IOLs, wh...

Population confidence is essential to a well functioning health system. Using data from the People's Voice Survey—a novel population survey conducted in 15 low-income, middle-income, and high-income countries—we report health system confidence among the general population and analyse its associated factors. Across the 15 countries, fewer than half...

The social and behavioural determinants of COVID-19 vaccination have been described previously. However, little is known about how vaccinated people use and rate their health system. We used surveys conducted in 14 countries to study the health system correlates of COVID-19 vaccination. Country-specific logistic regression models were adjusted for...

Background The fact that multimorbid and vulnerable patients need improved care coordination is well known. However, current healthcare system is still mainly single-disease oriented and as a result, coexisting morbidities are often under-evaluated and under managed leading to inappropriate care, inefficiencies, duplication and poor quality of care...

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...

Rotator cuff tear (RCT) is a painful, progressive condition resulting from damage to the rotator cuff tendons and is the leading cause of shoulder-related disability. Surgical repair of rotator cuff is an established standard of care (SOC); however, failure of the procedure can occur. In this context, the use of collagen-based bioinductive implant...

Purpose: The limited evidence available on the cost-effectiveness (CE) of expanded carrier screening (ECS) prevents its widespread use in most countries, including Italy. Herein, we aimed to estimate the CE of three ECS panels (i.e., American College of Medical Genetics and Genomics (ACMG) Tier 1 screening; "Focused Screening", testing 15 severe h...

Time-driven activity-based costing (TDABC) is suggested to assess costs within the value-based healthcare approach, but there is a paucity of applications in chronic diseases such as deep vein thrombosis (DVT) and leg ulcers. In this context, we applied TDABC in a cost-effectiveness analysis comparing venous stenting to compression ± anticoagulatio...

Impella and VA-ECMO are two possible therapeutic courses for the treatment of patients with cardiogenic shock (CS). The study aims to perform a systematic literature review and meta-analyses of a comprehensive set of clinical and socio-economic outcomes observed when using Impella or VA-ECMO with patients under CS. A systematic literature review wa...

Introduction: The new European Union (EU) Regulations for medical devices (MDs) and health technology assessment (HTA) are welcome developments that will hopefully increase the quality of clinical evidence for MDs and reduce fragmentation in the EU market access process. To fully exploit anticipated benefits, their respective assessment processes...

Objectives: Although unexpected conversion during Video-Assisted Thoracic Surgery (VATS) lobectomy is up to 23%, the effects on postoperative outcomes remain debatable. This retrospective study aimed: (i) to identify potential preoperative risk factors of VATS conversion to standard thoracotomy; (ii) to assess the impact of surgical experience in V...

The field of medical devices has attracted considerable interest from scholarly research in health economics in recent years. Medical devices are indispensable tools for quality health care delivery, but their assessment and appropriate use pose significant challenges to healthcare systems. More research is needed to overcome existing gaps associat...

Aims To perform a cost-effectiveness analysis (CEA) comparing personalised dosimetry with standard dosimetry in the context of selective internal radiation therapy (SIRT) with TheraSphere for the management of adult patients with locally advanced hepatocellular carcinoma (HCC) from the Italian Healthcare Service perspective. Materials and methods...

BACKGROUND mHealth importance has been growing over time due to recent demographic and epidemiological trends and the rise of chronic conditions, enhanced smartphone hardware and software functionalities, and the need to contain healthcare spending. Yet, even when beneficial to improve patient outcomes, sustained mHealth app usage is not necessaril...

Background: Mobile health (mHealth) solutions have proven to be effective in a wide range of patient outcomes and have proliferated over time. However, a persistent challenge of digital health technologies, including mHealth, is that they are characterized by early dropouts in clinical practice and struggle to be used outside experimental settings...

Efficiency in healthcare is crucial since available resources are scarce, and the opportunity cost of an inefficient allocation is measured in health outcomes foregone. This is particularly relevant for cancer. The aim of this paper was to gain a comprehensive overview of how efficiency in cancer care is defined, and what the indicators, different...

Study question Would reimbursement of expanded carrier screening (ECS) panels of different gene content be cost-effective in a universal healthcare system? Summary answer Both tested ECS panels would be cost-effective if reimbursed by the Italian national healthcare system for a population without personal/familiar or racial/ethnic preconception g...

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 forc...

Digital health and mobile medical apps (MMAs) have shown great promise in transforming health care, but their adoption in clinical care has been unsatisfactory, and regulatory guidance and coverage decisions have been lacking or incomplete. A multidimensional assessment framework for regulatory, policymaking, health technology assessment, and cover...

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...

Background: A prospective, observational, US-based study (PROVe) used three questionnaires (Pruritus-VAS, Skindex-29, MF/SS-CTCL QoL) to assess quality of life in patients diagnosed with mycosis fungoides cutaneous T-cell lymphoma (MF-CTCL); however, none of these studies was provided with a preference-based algorithm yielding health state utility...

COVID-19 pandemic challenges have accelerated the reliance on digital health fuelling the expanded incorporation of mobile apps into healthcare services, particularly for the management of long-term conditions such as chronic diseases (CDs). However, the impact of health apps on outcomes for CD remains unclear, potentially owing to both the poor ad...

40 years ago, Italy saw the birth of a national, universal health-care system (Servizio Sanitario Nazionale [SSN]), which provides a full range of health-care services with a free choice of providers. The SSN is consistently rated within the Organisation for Economic Co-operation and Development among the highest countries for life expectancy and a...

Integrated Care (IC) is a perfect fit for people with diabetes. Fundus examination (FE) is a disease marker for diabetologists and identifies potentially blinding complications (Diabetic Retinopathy, DR). In our Diabetes Clinic (DC) in Pescara, Italy, FE is possibly provided with telemedicine in same day as other exams, avoiding it to be a standalo...

Policymakers everywhere struggle to introduce therapeutic innovation while controlling costs, a particular challenge for the universal Italian National Healthcare System (SSN), which spends only 8.8% of GDP to care for one of the world’s oldest populations. Oncology provides a telling example, where innovation has dramatically improved care and sur...

Objective There is limited evidence regarding the economic effects of nutrition support in cancer patients. This study aims at investigating the cost-effectiveness profile of systematic oral nutritional supplementation (ONS) in head and neck cancer (HNC) patients undergoing radiotherapy (RT) and receiving nutritional counseling. Methods A cost-eff...

There is limited evidence on the scope and overall benefit of patient-centred drug development decisions. The present study assessed patients' preferences for the characteristics of an ideal migraine treatment through a discrete choice experiment in order to inform decision-making and drug development processes. We investigated the preferences acco...

Aim: Technological and computational advancements offer new tools for the collection and analysis of real-world data (RWD). Considering the substantial effort and resources devoted to collecting RWD, a greater return would be achieved if real-world evidence (RWE) was effectively used to support Health Technology Assessment (HTA) and decision makin...

Introduction: The unparalleled surge in digital health adoption during the COVID-19 pandemic has emphasized the potential of mHealth apps. However, the quality of available evidence is generally low, and regulatory frameworks have focused on apps with medical purposes only, overlooking apps with significant interactions with patients that may requi...

Background Deep Vein Thrombosis (DVT) is one of the major health problems worldwide with potentially serious outcomes related to mortality and morbidity. Objectives We tried to give a current view on how DVT patients are managed in routine practice compared to recommendations of published clinical guidelines. Methods A literature review has been...

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. Medical devices (MDs) present particular challenges for HTA because of frequent, rapid innovatio...

Objectives: Methodological challenges in the evaluation of medical devices (MDs) may be different for early and late technology adopter countries, as well as the potential health technology assessment (HTA) solutions to tackle them. This study aims to provide guidance to Central and Eastern European (CEE) countries on how to address key challenges...

Safety and effectiveness of healthcare innovations must be assessed before entering routine clinical practice. Selection of outcome measures is therefore essential to inform clinical practice and the health-related decision-making process. However, recent studies have demonstrated a largely inconsistent approach to the selection, definition, measur...

In this paper, we use a design science approach to develop a mobile app for lung cancer patients that facilitates their interactions with their clinicians, manages and reports on their health status, and provides them access to medical information/education. This paper contributes to the information systems literature by demonstrating the value of...

BACKGROUND POWER is an observational study that aims at evaluating the relationship between physical activity levels and bleedings in patients with haemophilia A. Self-reported outcomes of the study are registered through an electronic patient-reported outcome (ePRO) app which requires sustained active input by study participants. While mobile tech...

Background There is currently limited evidence on the level and intensity of physical activity in individuals with hemophilia A. Mobile technologies can offer a rigorous and reliable alternative to support data collection processes but they are often associated with poor user retention. The lack of longitudinal continuity in their use can be partly...

Introduction: The new European Union (EU) Regulations on medical devices and on in vitro diagnostics provide manufacturers and Notified Bodies with new tools to improve pre-market and post-market clinical evidence generation especially for high risk products but fail to indicate what type of clinical evidence is appropriate at each stage of the wh...

Background: Chronic conditions have important long-term consequences for patients’ personal and social lives and require patient commitment to their management. In this context, the assessment of patients’ preferences for treatment characteristics would increase the current evidence on the impact of diseases to support decision-making processes in...

Aim: To perform cost–effectiveness analysis (CEA) and budget impact analysis (BIA) comparing stenting to standard medical treatment (SMT) for the management of deep venous outflow obstruction and leg ulcers from the Italian Healthcare Service perspective. Materials & methods: A Markov model was developed to project costs and quality-adjusted life-y...

With the development of newer meshes and approaches to hernia repair, it is currently difficult to evaluate their performances while considering the patients’ perspective. The aim of the study was to assess the clinical outcomes and quality of life consequences of abdominal hernia repairs performed in Italy using Phasix and Phasix ST meshes through...

UNSTRUCTURED A common development during COVID-19 has been renewed reliance on digital health. While prior to the pandemic the uptake of digital health technologies to directly strengthen public health systems had been unsatisfactory, the relentless acceleration during COVID-19 happened within healthcare systems and thus could not prescind from the...

A common development observed during the COVID-19 pandemic is the renewed reliance on digital health technologies. Prior to the pandemic, the uptake of digital health technologies to directly strengthen public health systems had been unsatisfactory; however, a relentless acceleration took place within health care systems during the COVID-19 pandemi...

Healthcare associated infections (HAIs) and antibiotic resistance have high social and economic burdens. Healthcare environments play an important role in the transmission of HAIs. The Probiotic Cleaning Hygiene System (PCHS) has been shown to decrease hospital surface pathogens up to 90% vs. conventional chemical cleaning (CCC). This study compare...

Objectives The aim of the present study was to perform cost-effectiveness and budget impact analyses comparing endovascular arteriovenous fistula creation to surgical arteriovenous fistula creation in hemodialysis patients from the National Healthcare Service (NHS) perspective in Italy. Methods A systematic literature review has been conducted to...

Purpose: The aim of the present study was to assess, by using a cost-benefit analysis, the net monetary benefit (NMB) of bariatric surgery compared with diet (including physical exercise) for obese patients, from both an Italian payer perspective and the broader societal perspective. Methods: The study considered the following groups of patients...

Managing the adoption and diffusion of technological innovation is a key challenge for healthcare systems. In 2015, Italy has started designing and implementing a National Health Technology Assessment (HTA) Programme for Medical Devices (MDs), a network aimed at promoting the use of HTA tools, and safety, effectiveness and cost-effectiveness princi...

Objectives: To investigate whether the use of economic evaluation (EE) in healthcare decision making is influenced by the social values and institutional context in a given country. Methods: We developed and tested a conceptual framework for the 36 Organisation for Economic Co-operation and Development (OECD) countries. The countries were divide...

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...