Health technology assessment (HTA) and performance management (PM): a scoping review on the intersecting realms.

Background: Both Health Technology Assessment (HTA) and Performance Management (PM) are clinical governance disciplines that aim to improve the quality, equity, and financial sustainability of health organizations and systems. Although HTA and PM share many features, to the authors' knowledge, few studies have investigated their interplay. This study attempts to fill this gap by analysing how the literature has explored and developed the integration between HTA and PM concepts and tolls within healthcare sector.

A systematic literature review of real-world evidence (RWE) on post-market assessment of medical devices.

The increasing use of real-world evidence (RWE) and real-world data (RWD) to assess post-market medical devices (MDs) might satisfy the urgent need for data sharing and traceability. This study sought to (i) get an overview of current practice in post-market assessments of MDs reporting on RWE/RWD; (ii) draw policy recommendations for governments and health organisations and identify a research agenda for scholars.A systematic review was undertaken until February 2024 following the PRISMA guidelines.

The evolution of TAVI performance overtime: an overview of systematic reviews.

Background: Transcatheter aortic valve implantation (TAVI) is a well-established treatment for high and intermediate-risk patients with severe aortic stenosis (AS). Recent studies have demonstrated non-inferiority of TAVI compared to surgery in low-risk patients. In the past decade, numerous literature reviews (SLRs) have assessed the use of TAVI in different risk groups.

Rewiring care delivery through Digital Therapeutics (DTx): a machine learning-enhanced assessment and development (M-LEAD) framework.

Background: Digital transformation has sparked profound change in the healthcare sector through the development of innovative digital technologies. Digital Therapeutics offer an innovative approach to disease management and treatment. Care delivery is increasingly patient-centered, data-driven, and based on real-time information.

Development and validation of Medical Device Key Evidence Tool ('MeDKET'): An evidence-based framework to explain success in selected European and US companies.

Innovating in Medical Device (MD) industry is challenging. This study aims to develop and validate an evidence-based framework that helps innovators of small and large enterprises (SEs and LEs) assess their readiness for successful MD development and deployment. We conducted a key-informant process (stage 1) where 25 international experts identified a list of emergent Health Technology Assessment (HTA) themes they believed were essential to company success.

Assessing the Social and Environmental Impact of Healthcare Technologies: Towards an Extended Social Return on Investment.

Stroke is the third leading cause of death and disability overall worldwide. Upper limb impairment is a common consequence for stroke survivors, having negative impact on their quality of life. Robotic rehabilitation, through repetitive and monitored movements, can improve their status.

Adoption of novel biomarker test parameters with machine learning-based algorithms for the early detection of sepsis in hospital practice.

Aims: We aim (i) to redesign sepsis's clinical pathway and fit the organizational requirements of a novel machine-learning algorithm incorporating a novel biomarker test and (ii) to assess adoption drivers of the new combined technology.

Background: There is an urgent need to achieve sepsis' early detection and diagnostic excellence.

Methods: A qualitative study based on semi-structured interviews conducted at the target site and across other Italian hospitals.

Research protocol for the validation of a new portable technology for real-time continuous monitoring of Early Warning Score (EWS) in hospital practice and for an early-stage multistakeholder assessment.

Introduction: The real-time continuous monitoring of vital parameters in patients affected by multiple chronic conditions and/or COVID-19 can lead to several benefits to the Italian National Healthcare System (IT-NHS). The UBiquitous Integrated CARE (UBICARE) technology is a novel health digital platform at the validation stage in hospital setting. UBICARE might support the urgent need for digitalisation and early intervention, as well as minimise the face-to-face delivery of care in both hospital and community-based care settings.

Determining the cost-effectiveness requirements of an exoskeleton preventing second hip fractures using value of information.

Background: Falls may lead to hip fractures, which have a detrimental effect on the prognosis of patients as well as a considerable impact on healthcare expenditures. Since a secondary hip fracture (SHF) may lead to even higher costs than primary fractures, the development of innovative services is crucial to limit falls and curb costs in high-risk patients. An early economic evaluation assessed which patients with a second hip fracture could benefit most from an exoskeleton preventing falls and whether its development is feasible.

Correction to: The Impact of Hospital Costing Methods on Cost-Effectiveness Analysis: A Case Study.

The Open Access license, which previously read.

Dialogic reading in the rehabilitation of Children with Hearing Loss and the "Born to Read" Project: A pilot study.

The "born to read" initiative entails a dialogic reading to children in poor socio-economical conditions aimed at fostering cognitive and relational skills. Reading is professionally delivered by experts to promote psycho-social development of children and their parents. In this study the project was extended to include children positive at early screening for hearing impairment.

The Impact of Hospital Costing Methods on Cost-Effectiveness Analysis: A Case Study.

Background: Several methods exist to cost hospital contacts when estimating the cost effectiveness of a new intervention. However, the implications of choosing a particular approach remain unclear. We compare the use of the three main diagnosis-related group (DRG)-based national unit costs in England to determine whether choice of approach can impact on economic evaluation results.

Comparative health technology assessment of robotic-assisted, direct manual laparoscopic and open surgery: a prospective study.

Background: Despite many publications reporting on the increased hospital cost of robotic-assisted surgery (RAS) compared to direct manual laparoscopic surgery (DMLS) and open surgery (OS), the reported health economic studies lack details on clinical outcome, precluding valid health technology assessment (HTA).

Methods: The present prospective study reports total cost analysis on 699 patients undergoing general surgical, gynecological and thoracic operations between 2011 and 2014 in the Italian Public Health Service, during which period eight major teaching hospitals treated the patients. The study compared total healthcare costs of RAS, DMLS and OS based on prospectively collected data on patient outcome in addition to healthcare costs incurred by the three approaches.

Effects of a new device to guide venous puncture in elderly critically ill patients: results of a pilot randomized study.

Background: Novel devices based on the emission of near-infrared electromagnetic radiation (NIR) have been developed to minimize venous puncture failures. These instruments produce an "augmented reality" image, in which subcutaneous veins are depicted on a LCD display. We compared the new technique with standard venipuncture in a population of elderly patients.

Psychological effects of treatment with new oral anticoagulants in elderly patients with atrial fibrillation: a preliminary report.

Background And Aims: Atrial fibrillation (AF) is the most common arrhythmia in elderly people, yet oral anticoagulation is underused in the aged. We tried to determine whether new oral anticoagulants (NOA) have greater psychological tolerability than warfarin.

Methods: Age-, gender-matched groups of AF patients receiving NOA (N = 15) or warfarin (N = 15) were assessed with the Anti-Clot Treatment Scale (ACTS) and the Perceived Stress Scale (PSS).