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

Background: There is a growing enthusiasm for machine learning (ML) among academics and health care practitioners. Despite the transformative potential of ML-based applications for patient care, their uptake and implementation in health care organizations are sporadic. Numerous challenges currently impede or delay the widespread implementation of ML in clinical practice, and limited knowledge is available regarding how these challenges have been addressed.

Breast-cancer specific comprehensive archive of Patient-Reported Outcome Measures (PROMs) for clinical research and clinical practice in oncology: Results from the PRO4All project.

Background: Inclusion of patient-reported outcomes (PROs) in oncology clinical trials is strongly recommended. However, selecting the most appropriate patient-reported outcome measures (PROMs) is not easy. This study aimed to develop a breast cancer (BC) specific comprehensive archive of PROMs.

The development of an archive of patient-reported outcome measures (PROMs) in oncology: The Italian PRO4All project.

Background: Choosing the most adequate measure of patient-reported outcomes (PROs) for a specific medical condition is not straightforward. This study aimed to develop a comprehensive archive of patient-reported outcome measures (PROMs), observer-reported outcome measures (ObsROMs) and caregiver-reported outcome measures (CROMs) in oncology and identify their main characteristics and target outcome domains.

Materials And Methods: As part of the Italian PRO4All Project, we retrieved questionnaires through an extensive search of online databases.

Mapping Payment and Pricing Schemes for Health Innovation: Protocol of a Scoping Literature Review.

Introduction: Innovative pricing and payment/reimbursement schemes have been proposed as one part of the solution to the problem of patient access to new health technologies or to the uncertainty about their long-term effectiveness. As part of a Horizon Europe research project on health innovation next generation pricing and payment models (HI-PRIX), this protocol illustrates the conceptual and methodological steps related to a scoping review aiming at investigating nature and scope of pricing and payment/reimbursement schemes applied to, or proposed for, existing or new health technologies.

Methods: A scoping review of literature will be performed according to the PRISMA guidelines for scoping reviews (PRISMA-ScR) guidelines.

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.

Evaluating the ability of an artificial-intelligence cloud-based platform designed to provide information prior to locoregional therapy for breast cancer in improving patient's satisfaction with therapy: The CINDERELLA trial.

Background: Breast cancer therapy improved significantly, allowing for different surgical approaches for the same disease stage, therefore offering patients different aesthetic outcomes with similar locoregional control. The purpose of the CINDERELLA trial is to evaluate an artificial-intelligence (AI) cloud-based platform (CINDERELLA platform) vs the standard approach for patient education prior to therapy.

Methods: A prospective randomized international multicentre trial comparing two methods for patient education prior to therapy.

Implementing preconception expanded carrier screening in a universal health care system: A model-based cost-effectiveness analysis.

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 3 ECS panels (ie, American College of Medical Genetics and Genomics [ACMG] Tier 1 screening, "Focused Screening," testing 15 severe, highly penetrant conditions, and ACMG Tier 3 screening) compared with no screening, the health care model currently adopted in Italy.

Methods: The reference population consisted of Italian couples seeking pregnancy with no increased personal/familial genetic risk.

Exploring key-stakeholder perceptions on non-communicable disease care during the COVID-19 pandemic in Kenya.

Introduction: over one third of total Disability-Adjusted-Life-Years lost in Kenya are due to non-communicable diseases (NCD). In response, the Government declared significant commitment towards improving NCD care. The COVID-19 pandemic increased the burden on the already overstretched health systems in Kenya.

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.

Divergent COVID-19 vaccine policies: Policy mapping of ten European countries.

Background: The COVID-19 pandemic highlighted the fragmented nature of governmental policy decisions in Europe. However, the extent to which COVID-19 vaccination policies differed between European countries remains unclear. Here, we mapped the COVID-19 vaccination policies that were in effect in January 2022 as well as booster regulations in April 2022 in Austria, Denmark, England, France, Germany, Ireland, Italy, the Netherlands, Poland, and Spain.

1000 Days: The "WeCare Generation" Program-The Ultimate Model for Improving Human Mental Health and Economics: The Study Protocol.

Introduction: The COVID-19 pandemic stressed the necessity of a new resilience of the human population and health system. The "WeCare Generation" program is a new proposal of territorial intervention, with a new paradigm, on the diseases of the human body and mind.

Background: In recent decades, the independent strands of investigation on brain plasticity and early trauma consequences have demonstrated that traumatic experiences in the period from pregnancy to the age of 3 years have an enormous impact on an individual's future development, and both physical and mental health.

Spillover effects and other determinants of medical device uptake in the presence of a medical guideline: An analysis of drug-eluting stents in Germany and Italy.

We investigated the role of spillover effects among hospitals in the diffusion of drug-eluting stents (DES) in Germany and Italy during a period in which the relevant medical guideline clearly recommended their use over bare-metal stents. We used administrative data of hospitalized patients treated with ST-elevation myocardial infarction from 2012 to 2016 to estimate spatial panel models allowing for global spillover effects. We used an inverse-distance weights matrix to capture the geographical proximity between neighboring hospitals and assigned a lower weight to more distant neighbors.

"Immuni" and the National Health System: Lessons Learnt from the COVID-19 Digital Contact Tracing in Italy.

Since the early stage of the current pandemic, digital contact tracing (DCT) through mobile phone apps, called "Immuni", has been introduced to complement manual contact tracing in Italy. Until 31 December 2021, Immuni identified 44,880 COVID-19 cases, which corresponds to less than 1% of total COVID-19 cases reported in Italy in the same period (5,886,411). Overall, Immuni generated 143,956 notifications.

Regulatory and HTA early dialogues in medical devices.

Introduction: Specific guidance and examples for health technology assessment (HTA) of medical devices are scarce in medical device development. A more intense dialogue of competent authorities, HTA agencies, and manufactures may improve evidence base on clinical and cost-effectiveness. Especially as the new Medical Device Regulation requires more clinical evidence.

The Traffic Light Approach: Indicators and Algorithms to Identify Covid-19 Epidemic Risk Across Italian Regions.

With the beginning of the autumn-winter season, Italy experienced an increase of SARS-CoV-2 cases, requiring the Government to adopt new restrictive measures. The national surveillance system in place defines 21 key process and performance indicators addressing for each Region/Autonomous Province: (i) the monitoring capacity, (ii) the degree of diagnostic capability, investigation and contact tracing, and (iii) the characteristics of the transmission dynamics as well as the resilience of health services. Overall, the traffic light approach shows a collective effort by the Italian Government to define strategies to both contain the spread of COVID-19 and to minimize the economic and social impact of the epidemic.

Hazard Prevention, Death and Dignity During COVID-19 Pandemic in Italy.

On 9 March 2020, Italy passed the Prime Minister's Decree n. 648, establishing urgent measures to contain the transmission of COVID-19 and prevent biological hazards, including very restrictive interventions on public Holy Masses and funerals. Italy banned burial procedures based (i) on the recent acknowledgment about the virus environmental stability as well as (ii) its national civil contingency plan.

Surrogate Endpoints in Health Technology Assessment: An International Review of Methodological Guidelines.

In the drive towards faster patient access to treatments, health technology assessment (HTA) agencies are increasingly faced with reliance on evidence from surrogate endpoints, leading to increased decision uncertainty. This study undertook an updated survey of methodological guidance for using surrogate endpoints across international HTA agencies. We reviewed HTA and economic evaluation methods guidance from European, Australian and Canadian HTA agencies.