Economic Evaluation of a Bioinductive Implant for the Repair of Rotator Cuff Tears Compared with Standard Surgery in Italy.

Introduction: 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 REGENETEN showed long-term improvements in clinical scores.

Promoting the systematic use of real-world data and real-world evidence for digital health technologies across Europe: a consensus framework.

Despite the acceleration in the use of digital health technologies across different aspects of the healthcare system, the full potential of real-world data (RWD) and real-world evidence (RWE) arising from the technologies is not being utilised in decision-making. We examine current national efforts and future opportunities to systematically use RWD and RWE in decision-making in five countries (Estonia, Finland, Germany, Italy and the United Kingdom), and then develop a framework for promotion of the systematic use of RWD and RWE. A review assesses current national efforts, complemented with a three-round consensus-building exercise among an international group of experts (1 = 44, 2 = 24, 3 = 24) to derive key principles.

Implementation of Machine Learning Applications in Health Care Organizations: Protocol for a Systematic Review of Empirical Studies.

Background: An increasing interest in machine learning (ML) has been observed among scholars and health care professionals. However, while ML-based applications have been shown to be effective and have the potential to change the delivery of patient care, their implementation in health care organizations is complex. There are several challenges that currently hamper the uptake of ML in daily practice, and there is currently limited knowledge on how these challenges have been addressed in empirical studies on implemented ML-based applications.

Using big data and Population Health Management to assess care and costs for patients with severe mental disorders and move toward a value-based payment system.

Background: Mental health (MH) care often exhibits uneven quality and poor coordination of physical and MH needs, especially for patients with severe mental disorders. This study tests a Population Health Management (PHM) approach to identify patients with severe mental disorders using administrative health databases in Italy and evaluate, manage and monitor care pathways and costs. A second objective explores the feasibility of changing the payment system from fee-for-service to a value-based system (e.

The Assessment of Patient-Reported Outcomes for the Authorisation of Medicines in Europe: A Review of European Public Assessment Reports from 2017 to 2022.

Objectives: Health regulators have progressively increased their attention and focus on patient-reported outcomes (PROs), driven by the diffusion of a patient-centred approach to the drug development process. This study investigates the consideration of PROs and their measures (PROMs) in the authorisation of medicines in Europe.

Methods: All medicines for human use authorised or refused by the European Medicines Agency (EMA) in the period 2017-2022 were identified, and corresponding European Public Assessment Reports (EPARs) were downloaded for review.

Implementing shared decision-making interventions in breast cancer clinical practice: a scoping review.

Background: Shared decision-making (SDM) is a collaborative process whereby patients and clinicians jointly deliberate on the best treatment option that takes into account patients' preferences and values. In breast cancer care, different treatment options have become available to patients in the last decade. Various interventions, including patient decision aids (PtDAs), have been designed to promote SDM in this disease area.

Cost-effectiveness analysis of pressure-controlled intermittent coronary sinus occlusion in elective percutaneous coronary intervention.

Objectives: Percutaneous coronary intervention (PCI) represents the standard treatment for ST-elevated myocardial infarction, nevertheless, mortality and heart failures are frequent. Pressure-controlled intermittent coronary sinus occlusion (PiCSO) might reduce infarct size showing better patients' outcomes. We evaluated the cost-effectiveness of PCI+PiCSO compared to PCI from the National Healthcare Service (NHS) perspective in Italy.

Prioritizing COVID-19 vaccine allocation in resource poor settings: Towards an Artificial Intelligence-enabled and Geospatial-assisted decision support framework.

Objectives: To propose a novel framework for COVID-19 vaccine allocation based on three components of Vulnerability, Vaccination, and Values (3Vs).

Methods: A combination of geospatial data analysis and artificial intelligence methods for evaluating vulnerability factors at the local level and allocate vaccines according to a dynamic mechanism for updating vulnerability and vaccine uptake.

Results: A novel approach is introduced including (I) Vulnerability data collection (including country-specific data on demographic, socioeconomic, epidemiological, healthcare, and environmental factors), (II) Vaccination prioritization through estimation of a unique Vulnerability Index composed of a range of factors selected and weighed through an Artificial Intelligence (AI-enabled) expert elicitation survey and scientific literature screening, and (III) Values consideration by identification of the most effective GIS-assisted allocation of vaccines at the local level, considering context-specific constraints and objectives.

A repeated cross-sectional analysis on the economic impact of SARS-CoV-2 pandemic at the hospital level in Italy.

Italy was the first country in Europe to be hit by the Severe Acute Respiratory Syndrome Coronavirus 2. Little research has been conducted to understand the economic impact of providing care for SARS-CoV-2 patients during the pandemic. Our study aims to quantify the incremental healthcare costs for hospitalizations associated to being discharged before or after the first SARS-CoV-2 case was notified in Italy, and to a positive or negative SARS-CoV-2 notified infection.

Assessment of a SARS-CoV-2 population-wide rapid antigen testing in Italy: a modeling and economic analysis study.

Background: This study aimed to compare the cost-effectiveness of coronavirus disease 2019 (COVID-19) mass testing, carried out in November 2020 in the Italian Bolzano/Südtirol province, to scenarios without mass testing in terms of hospitalizations averted and quality-adjusted life-year (QALYs) saved.

Methods: We applied branching processes to estimate the effective reproduction number (Rt) and model scenarios with and without mass testing, assuming Rt = 0.9 and Rt = 0.

The quality of mental health care for people with bipolar disorders in the Italian mental health system: the QUADIM project.

Background: The assessment of the quality of care pathways delivered to people with severe mental disorders in a community-based system remains uncommon, especially using healthcare utilization databases. The aim of the study was to evaluate the quality of care provided to people with bipolar disorders taken-in-care by mental health services of four Italian areas (Lombardy, Emilia-Romagna, Lazio, province of Palermo).

Methods: Thirty-six quality indicators were implemented to assess quality of mental health care for patients with bipolar disorders, according to three dimensions (accessibility and appropriateness, continuity, and safety).

Early access programs for medicines: comparative analysis among France, Italy, Spain, and UK and focus on the Italian case.

Early access programs (EAPs) generally refer to patient access to medicines/indications before marketing authorization, possibly extended to price and reimbursement approval. These programs include compassionate use, which is usually covered by pharmaceutical companies, and EAPs reimbursed by third-party payers. This paper aims at comparing EAPs in four European countries (France, Italy, Spain, UK) and providing empirical evidence on EAPs in Italy.

Assessment and Monitoring of the Quality of Clinical Pathways in Patients with Depressive Disorders: Results from a Multiregional Italian Investigation on Mental Health Care Quality (the QUADIM Project).

Ensuring adequate quality of care to patients with severe mental disorders remains a challenge. The implementation of clinical indicators aimed at assessing the quality of health care pathways delivered is crucial for the improvement of mental health services (MHS). This study aims to evaluate the quality of care delivered to patients who are taken-into-care with depressive disorders by MHS.

Patient-reported outcome measures in drugs for neurological conditions approved by European Medicines Agency 2017-2022.

Background: Regulatory agencies have been responsive to public demand for inclusion of the patient experience in evaluating and approving therapies. Over the years, patient-reported outcome measures (PROMs) have become increasingly prevalent in clinical trial protocols; however, their influence on regulators, payers, clinicians, and patients' decision-making is not always clear. We recently conducted a cross-sectional study aimed at investigating the use of PROMs in new regulatory approvals of drugs for neurological conditions between 2017 and 2022 in Europe.

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.

Impella Versus VA-ECMO for Patients with Cardiogenic Shock: Comprehensive Systematic Literature Review and Meta-Analyses.

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 was performed in Medline, and Web of Science databases on 21 February 2022.

Evaluating Barriers and Facilitators to the Uptake of mHealth Apps in Cancer Care Using the Consolidated Framework for Implementation Research: Scoping Literature Review.

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 or on larger scales.

Objective: This study aimed to explore barriers and enablers to the uptake of mHealth solutions used by patients with cancer undergoing treatment, using a theory-guided implementation science model, that is, the Consolidated Framework for Implementation Research (CFIR).