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. This is the first attempt to provide an overview of SRs (OoSRs) focusing on secondary studies reporting clinical outcomes/process indicators. This research aims to summarize the findings of extant literature on the performance of TAVI over time. METHODS: A literature search took place from inception to April 2024. We searched MEDLINE and the Cochrane Library for SLRs. SLRs reporting at least one review of clinical indicators were included. Subsequently, a two-step inclusion process was conducted: [1] screening based on title and abstracts and [2] screening based on full-text papers. Relevant data were extracted and the quality of the reviews was assessed. RESULTS: We included 33 SLRs with different risks assessed via the Society of Thoracic Surgeons (STS) score. Mortality rates were comparable between TAVI and Surgical Aortic Valve Replacement (SAVR) groups. TAVI is associated with lower rates of major bleeding, acute kidney injury (AKI) incidence, and new-onset atrial fibrillation. Vascular complications, pacemaker implantation, and residual aortic regurgitation were more frequent in TAVI patients. CONCLUSION: This study summarizes TAVI performance findings over a decade, revealing a shift to include both high and low-risk patients since 2020. Overall, TAVI continues to evolve, emphasizing improved outcomes, broader indications, and addressing challenges.

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. These technological innovations can lead to better patient outcomes and support for healthcare professionals, also considering resource scarcity. As these digital technologies continue to evolve, the healthcare field must be ready to integrate them into processes to take advantage of their benefits. This study aims to develop a framework for the development and assessment of Digital Therapeutics. METHODS: The study was conducted relying on a mixed methodology. 338 studies about Digital Therapeutics resulting from a systematic literature review were analyzed using descriptive statistics through RStudio. Machine learning algorithms were applied to analyze variables and find patterns in the data. The results of these analytical analyses were summarized in a framework qualitatively tested and validated through expert opinion elicitation. RESULTS: The research provides M-LEAD, a Machine Learning-Enhanced Assessment and Development framework that recommends best practices for developing and assessing Digital Therapeutics. The framework takes as input Digital Therapeutics characteristics, regulatory aspects, study purpose, and assessment domains. The framework produces as outputs recommendations to design the Digital Therapeutics study characteristics. CONCLUSIONS: The framework constitutes the first step toward standardized guidelines for the development and assessment of Digital Therapeutics. The results may support manufacturers and inform decision-makers of the relevant results of the Digital Therapeutics assessment.

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. A sample of 22 European and US selected companies (13 SEs and 9 LEs) then reached a consensus on a list of key themes through a robust Delphi process (stage 2). Finally, we constructed (stage 3) and validated (stage 4) the checklist for SEs and LEs. The checklist for SEs and LEs included 21 and 15 items (i.e., fundamental Yes/No questions) with nine overlapping criteria for both SEs and LEs. In both groups, MD success was driven by three major item categories: (i) R&D assessment strategy; (ii) device-outcome measures; (iii) company profiling. Alongside the retrospective validation study, we collected 40 case studies on MDs (23 successes and 17 failures) across the selected enterprises. The retrospective validation provided the proportion of successful and failed case studies that met the 'MeDKET' criteria. We discovered that early HTA plays a pivotal role in MD industry success with different implications based on enterprise size. This study is the first of its kind to provide a holistic picture of the perceived role of early-stage HTA in MD industry 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. Developed by a team of researchers at Politecnico di Milano, AGREE is an exoskeleton for upper limb rehabilitation at the stage gate between translational research and clinical validation. Since the cost of this device is particularly high, the present study aimed to provide a framework for assessing its value. The Social Return on Investment (SROI) method, able to grasp the economic, social and environmental impact of an activity, was applied, using expert opinions of a pool of clinical engineers and healthcare professionals from different Italian hospitals to obtain information. Environmental impacts were estimated through Life Cycle Assessment in terms of CO2 emissions and incorporated in the analysis. Considering a 5-year period, the SROI for a single exoskeleton was 3.75:1, and the SROI for the number of exoskeletons projected to be sold was 2.868:1, thus resulting largely in value for money. This study provides a model for combining economic, social and environmental outcomes that, besides contributing to theory, could be useful for decision-making.

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. A content analysis was undertaken, emergent themes were selected and categorized, and interviews were conducted until saturation was reached. RESULTS: Sixteen nurses (10 at the target site and six across other hospitals) and nine non-nursing professionals (seven at the target site and two across other hospitals) were interviewed. An organizational redesign was identified as the primary adoption driver. Even though nurses perceived workload increase related to the machine-learning component, technology acceptability was relatively high, as the standardization of tasks was perceived as crucial to improving professional satisfaction. CONCLUSIONS: A novel business-oriented solution based on machine learning requires interprofessional integration, new professional roles, infrastructure improvement, and data integration to be effectively implemented. IMPLICATIONS FOR NURSING MANAGEMENT: Lessons learned from this study suggest the need to involve nurses in the early stages of the design of new machine-learning technologies and the importance of training nurses on sepsis management through the support of disruptive technological innovation.

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. This research protocol aims to design an early-stage assessment of the multidimensional impact induced by UBICARE within the IT-NHS alongside technology validation in a hospital ward. METHODS AND ANALYSIS: The targeted patients will be medium/high-risk hypertensive individuals as an illustrative first example of how UBICARE might bring benefits to susceptible patients. A mixed-method study will be applied to incorporate to the validation study a multistakeholder perspective, including perceived patient experiences and preferences, and facilitate technology adoption. First, semistructured interviews will be undertaken with a variety of stakeholders including clinicians, health managers and policy-makers to capture views on the likely technology utility, economic sustainability, impact of adoption in hospital practice and alternative adoption scenarios. Second, a monocentric, non-randomised and non-comparative clinical study, supplemented by the administration of standardised usability questionnaires to patients and health professionals, will validate the use of UBICARE in hospital practice. Finally, the results of the previous stages will be discussed in a multidisciplinary-facilitated workshop with IT-NHS relevant stakeholders to reconcile stakeholders' perspectives. Limitations include a non-random recruitment strategy in the clinical study, small sample size of the key stakeholders and potential stakeholder recruitment bias introduced by the research technique. ETHICS AND DISSEMINATION: The Ethics Committee for Clinical Experimentation of Tuscany Region approved the protocol. Participation in this study is voluntary. Study results will be disseminated through peer-reviewed publications and academic conferences.

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. METHODS: The life-course of hip fractured patients presenting with dementia or cardiovascular diseases was simulated using a Markov model relying on the United Kingdom administrative data and complemented by published literature. A group of experts provided the exoskeleton parameters. Secondary analyses included a threshold analysis to identify the exoskeleton requirements (e.g. minimum impact of the exoskeleton on patients' quality of life) leading to a reimbursable incremental cost-effectiveness ratio. Similarly, the uncertainty around these requirements was modelled by varying their standard errors and represented alongside population Expected Value of Perfect Information (EVPI). RESULTS: Our base-case found the exoskeleton cost-effective when providing a statistically significant reduction in SHF risk. The secondary analyses identified 286 cost-effective combinations of the exoskeleton requirements. The uncertainty around these requirements was explored producing further 22,880 scenarios, which showed that this significant reduction in SHF risk was not necessary to support the exoskeleton adoption in clinical practice. Conversely, a significant improvement in women quality of life was crucial to obtain an acceptable population EVPI regardless of the cost of the exoskeleton. CONCLUSIONS: Our study identified the exoskeleton requisites to be cost-effective and the value of future research. Decision-makers could use our analyses to assess not only whether the exoskeleton could be cost-effective but also how much further research and development of the exoskeleton is worth to be pursued.

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. A total of 26 children were included and 14 parents were taught to read aloud and emphatically. Reading session were delivered for at least 10 minutes at least 3 times/week, usually at bedtime, for one year. The Griffiths scale were applied to explore the expressive and receptive language skills (Scale C) and eye and hand coordination (Scale D), as measures of linguistic and neurocognitive skills. Program sustainability and reactions by the parents were also investigated. All 14 families successfully received the training, becoming capable of reading aloud and emphatically and provided reading sessions for the entire duration of the study. Children receiving the intervention performed slightly better than controls and those who were exposed to increased number of sessions, performed even better although the differences with controls were not significant. Parents enjoyed reading to their children. They expressed satisfaction and gratitude for being able to play an active and productive role in children rehabilitation. The results of this pilot study suggest that the born to read initiative may be considered in adjunct to medical and psychological interventions to enhance the benefits of early screening of hearing function.

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. METHODS: A cost-utility model was developed to compare secondary fracture prevention models of care for hip fracture patients, using data from large primary and hospital care administrative datasets in England. A healthcare and personal social services payer perspective was adopted, and utilities were informed by a meta-regression. Hospital resource use was valued using three DRG-based unit costs, and regression-based costing models were developed using data from 13,906 patients to inform the model health states. RESULTS: Finished consultant episode (FCE)-level reference costs resulted in the highest costs on admission (£9075) and in the year of the fracture (£14,440). Relative to FCE-level costs, spell-level tariffs led to the lowest total hospital care costs per patient within 1 year of fracture (- £3691) compared with spell-level reference costs (- £2106). At a £20,000/quality-adjusted life-year threshold, using spell-level reference costs or spell-level tariffs, the introduction of a nurse-led fracture liaison service model of care was the cost-effective alternative. However, using FCE-level reference costs, usual care was the cost-effective option. CONCLUSIONS: Our results show that, conditional on the set of national unit costs adopted, the costs of hip fracture may vary considerably and different decisions may be reached regarding the introduction of new healthcare interventions.

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. METHODS: Patients admitted in Intensive Care Unit were randomized to standard or to NIR assisted procedure. RESULTS: In the 103 enrolled patients (age 74 ± 12 years; standard venipuncture-N = 56; NIR-N = 47), no differences were found in procedure length, number of attempts, and referred pain. With NIR there was a lower incidence of hematomas and fewer anxiety and depressive symptoms. CONCLUSIONS: The use of the novel NIR-based device is safer and more psychologically tolerable, and it is not associated to an increase of procedure length or number of attempts.

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. RESULTS: The cost of RAS operations was significantly higher than that of OS and DMLS for both gynecological and thoracic operations (p < 0.001). The study showed no significant difference in total costs between OS and DMLS. Total costs of general surgery RAS were significantly higher than those of OS (p < 0.001), but not against DMLS general surgery. Indirect costs were significantly lower in RAS compared to both DMLS general surgery and OS gynecological surgery due to the shorter length of hospital stay of RAS approach (p < 0.001). Additionally, in all specialties compared to OS, patients treated by RAS experienced a quicker recovery and significantly less pain during the hospitalization and after discharge. CONCLUSIONS: The present HTA while confirming higher total healthcare costs for RAS operations identified significant clinical benefits which may justify the increased expenditure incurred by this approach.

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). RESULTS: Patients were old (81 ± 9 years). NOA group showed greater psychological satisfaction, with lower therapy-related burden (ACTS burdens: 16.3 ± 4.5 vs. 32.9 ± 10.2, p < 0.001) and higher awareness of benefits (ACTS benefits: 13.0 ± 1.3 vs. 10.8 ± 1.9, p = 0.001). Even stress was lower (PSS: 13.1 ± 4.0 vs. 17.1 ± 4.2, p = 0.013). The multivariate analysis confirmed these findings, showing that higher levels of anxiety and depression could justify more stress in warfarin patients. CONCLUSIONS: The results of this preliminary study show that NOA have an improved psychological impact compared with warfarin in elderly patients.