Optimizing Telehealth: Leveraging Key Performance Indicators for Enhanced TeleHealth and Digital Healthcare Outcomes (Telemechron Study).

Over the past decade, the use of telehealth has garnered increasing attention. The focus on quality aspects has seen significant growth in tandem with the telehealth expansion. Having useful indicators in this area is becoming increasingly strategic for fully integrating the technology into the health domain. These indicators can help monitor and evaluate the quality of telehealth services, guiding improvements and ensuring that these digital solutions meet the necessary standards for effective healthcare delivery. The purpose of this study is to analyze Key performance indicators (KPIs) in telehealth within institutional websites and the scientific dissemination world by means of a narrative review. A narrative review was proposed with these two specific points of view based on a standardized checklist and a quality control procedure for including scientific papers in the analysis. Results from scientific studies emphasize KPIs such as patient outcomes, operational efficiency, technical reliability, and cost-effectiveness. These include measures like improvements in condition management, patient satisfaction, consultation numbers, waiting times, and cost savings. Institutional documents from entities like the WHO also show diverse perspectives, focusing on equitable access, clinical excellence, patient prioritization, response times, and patient and staff satisfaction. The findings suggest that adopting a comprehensive set of KPIs and continuously monitoring and evaluating telehealth services can enhance their effectiveness, efficiency, and equity, ultimately improving healthcare outcomes and accessibility.

Nanostructured Medical Devices: Regulatory Perspective and Current Applications.

Nanomaterials (NMs) are having a huge impact in several domains, including the fabrication of medical devices (MDs). Hence, nanostructured MDs are becoming quite common; nevertheless, the associated risks must be carefully considered in order to demonstrate safety prior to their immission on the market. The biological effect of NMs requires the consideration of methodological issues since already established methods for, e.g., cytotoxicity can be subject to a loss of accuracy in the presence of certain NMs. The need for oversight of MDs containing NMs is reflected by the European Regulation 2017/745 on MDs, which states that MDs incorporating or consisting of NMs are in class III, at highest risk, unless the NM is encapsulated or bound in such a manner that the potential for its internal exposure is low or negligible (Rule 19). This study addresses the role of NMs in medical devices, highlighting the current applications and considering the regulatory requirements of such products.

Under the Tech Umbrella: Assessing the Landscape of Telemedicine Innovations (Telemechron Study).

The expanding role of technology assessment in telemedicine is the focus of this study. An umbrella review has been proposed to delve into emerging themes within telemedicine technology assessment by scrutinizing systematic reviews gathered from PubMed and Scopus. The proposed approach was based on a standard narrative checklist and a qualification process. The selection process identified 20 systematic reviews. The main findings underscore the transformative potential of telemedicine, emphasizing technology assessments focused on systematic evaluations, stakeholder engagement, societal impact recognition, targeted interventions, and structured frameworks. While offering valuable insights, the current studies highlight certain limitations that require attention. There is a need for the following: (I) First of all, a more focused approach, primarily centered on a process-centric, multidomain, and generalizable technology assessment (TA). (II) A deeper analysis in specific healthcare areas, including a comprehensive examination of the cost-benefit ratio, peer-to-peer interactions, and a broader inclusion of diagnostic technologies. (III) Greater emphasis on the involved stakeholders, ranging from patients to stakeholders. In conclusion, this study contributes to a comprehensive and nuanced understanding of the continually evolving landscape in telemedicine technology assessment, offering valuable insights for practitioners, researchers, and policymakers alike. Researchers are encouraged to further explore both the established and emerging themes identified in this study.

Enhancing spatial navigation skills in mild cognitive impairment patients: a usability study of a new version of ANTaging software.

Introduction: Mild Cognitive Impairment (MCI) often presents challenges related to spatial navigation and retention of spatial information. Navigating space involves intricate integration of bodily and environmental cues. Spatial memory is dependent on two distinct frame of reference systems for organizing this information: egocentric and allocentric frames of reference. Virtual Reality (VR) has emerged as a promising technology for enhancing spatial navigation skills and spatial memory by facilitating the manipulation of bodily, environmental, and cognitive cues. Methods: This usability study was based on a fully within-subjects design in which seven MCI patients underwent two kinds of VR conditions: participants were required to complete the ANTaging demo both in Oculus Rift S (immersive condition) and in Samsung UHD 4K monitor (semi-immersive condition). Participants were seated and they had to use a foot-motion pad to navigate and explore the environment to collect and relocate some objects in the virtual environment. Post-interaction, users provided feedback on their experiences. Additionally, usability, potential side effects, data analysis feasibility, and user preferences with immersive and semi-immersive technologies were assessed through questionnaires. Results: Results indicated higher usability ratings for the semi-immersive setup, with fewer negative effects reported compared to the immersive counterpart. According to qualitative analyses of the interviews, patients do seem to like both VR apparatuses even though the semi-immersive condition was perceived as the most suitable choice because of the size of the screen. Patients generally found it difficult to remember object locations. Participants expressed the need for more practice with the foot-motion pad, despite an overall positive experience. They generally would like to use this system to improve their memory. Discussion: Identifying these key aspects was crucial for refining the system before the upcoming clinical trial. This study sheds light on the potential of semi-immersive VR in aiding individuals with MCI, paving the way for enhanced spatial navigation interventions.

Reference theories and future perspectives on robot-assisted rehabilitation in people with neurological conditions: A scoping review and recommendations from the Italian Consensus Conference on Robotics in Neurorehabilitation (CICERONE).

BACKGROUND: Robot-based treatments are developing in neurorehabilitation settings. Recently, the Italian National Health Systems recognized robot-based rehabilitation as a refundable service. Thus, the Italian neurorehabilitation community promoted a national consensus on this topic. OBJECTIVE: To conceptualize undisclosed perspectives for research and applications of robotics for neurorehabilitation, based on a qualitative synthesis of reference theoretical models. METHODS: A scoping review was carried out based on a specific question from the consensus Jury. A foreground search strategy was developed on theoretical models (context) of robot-based rehabilitation (exposure), in neurological patients (population). PubMed and EMBASE® databases were searched and studies on theoretical models of motor control, neurobiology of recovery, human-robot interaction and economic sustainability were included, while experimental studies not aimed to investigate theoretical frameworks, or considering prosthetics, were excluded. RESULTS: Overall, 3699 records were screened and finally 9 papers included according to inclusion and exclusion criteria. According to the population investigated, structured information on theoretical models and indications for future research was summarized in a synoptic table. CONCLUSION: The main indication from the Italian consensus on robotics in neurorehabilitation is the priority to design research studies aimed to investigate the role of robotic and electromechanical devices in promoting neuroplasticity.

Adapting the World Health Organization rapid Assistive Technology Assessment (rATA) to the Italian context: implementation of a TRAPD-based approach.

BACKGROUND: Measuring access to assistive technology (AT) has become a global priority. Recently, the World Health Organization (WHO) has developed the rapid assistive technology assessment (rATA), a population-based household survey that measures the use, need, unmet need, and barriers to accessing AT. OBJECTIVE: The aim of this paper is to report on the translation and adaptation process undertaken to implement the rATA survey in the Italian context. METHOD: The Translate, Review, Adjudicate, Pretest, and Document (TRAPD) approach was used to translate and adapt the rATA from English to Italian. Eleven independent reviewers and 23 AT users were involved to validate the Italian translation of the rATA and pilot the survey, respectively. RESULTS: The feedback provided by the first users of the rATA indicate that the data collected are reliable and well reflect the state of AT provision in Italy. CONCLUSION: This study confirmed the applicability of the rATA survey to the Italian context. The Italian version of the rATA can be used to support the government, the health system as well as the civil society to monitor the current state of AT access (and abandonment) in the country.

Label-free cell based impedance measurements of ZnO nanoparticles-human lung cell interaction: a comparison with MTT, NR, Trypan blue and cloning efficiency assays.

BACKGROUND: There is a huge body of literature data on ZnOnanoparticles (ZnO NPs) toxicity. However, the reported results are seen to be increasingly discrepant, and deep comprehension of the ZnO NPs behaviour in relation to the different experimental conditions is still lacking. A recent literature overview emphasizes the screening of the ZnO NPs toxicity with more than one assay, checking the experimental reproducibility also versus time, which is a key factor for the robustness of the results. In this paper we compared high-throughput real-time measurements through Electric Cell-substrate Impedance-Sensing (ECIS®) with endpoint measurements of multiple independent assays. RESULTS: ECIS-measurements were compared with traditional cytotoxicity tests such as MTT, Neutral red, Trypan blue, and cloning efficiency assays. ECIS could follow the cell behavior continuously and noninvasively for days, so that certain long-term characteristics of cell proliferation under treatment with ZnO NPs were accessible. This was particularly important in the case of pro-mitogenic activity exerted by low-dose ZnO NPs, an effect not revealed by endpoint independent assays. This result opens new worrisome questions about the potential mitogenic activity exerted by ZnO NPs, or more generally by NPs, on transformed cells. Of importance, impedance curve trends (morphology) allowed to discriminate between different cell death mechanisms (apoptosis vs autophagy) in the absence of specific reagents, as confirmed by cell structural and functional studies by high-resolution microscopy. This could be advantageous in terms of costs and time spent. ZnO NPs-exposed A549 cells showed an unusual pattern of actin and tubulin distribution which might trigger mitotic aberrations leading to genomic instability. CONCLUSIONS: ZnO NPs toxicity can be determined not only by the intrinsic NPs characteristics, but also by the external conditions like the experimental setting, and this could account for discrepant data from different assays. ECIS has the potential to recapitulate the needs required in the evaluation of nanomaterials by contributing to the reliability of cytotoxicity tests. Moreover, it can overcome some false results and discrepancies in the results obtained by endpoint measurements. Finally, we strongly recommend the comparison of cytotoxicity tests (ECIS, MTT, Trypan Blue, Cloning efficiency) with the ultrastructural cell pathology studies.

Controlled Release of 18-ß-Glycyrrhetinic Acid from Core-Shell Nanoparticles: Effects on Cytotoxicity and Intracellular Concentration in HepG2 Cell Line.

18ß-glycyrrhetinic acid (GA) is a pentacyclic triterpene with promising hepatoprotective and anti-Hepatocellular carcinoma effects. GA low water solubility however reduces its biodistribution and bioavailability, limiting its applications in biomedicine. In this work we used core-shell NPs made of PolyD-L-lactide-co-glycolide (PLGA) coated with chitosan (CS), prepared through an osmosis-based methodology, to efficiently entrap GA. NPs morphology was investigated with SEM and TEM and their GA payload was evaluated with a spectrophotometric method. GA-loaded NPs were administered to HepG2 cells and their efficiency in reducing cell viability was compared with that induced by the free drug in in vitro tests. Cell viability was evaluated by the MTT assay, as well as with Electric Cells-Substrate Impedance Sensing (ECIS), that provided a real-time continuous monitoring. It was possible to correlate the toxic effect of the different forms of GA with the bioavailability of the drug, evidencing the importance of real-time tests for studying the effects of bioactive substances on cell cultures.

Patient-specific three-dimensional aortic arch modeling for automatic measurements: clinical validation in aortic coarctation.

AIM: A validated algorithm for automatic aortic arch measurements in aortic coarctation (CoA) patients could standardize procedures for clinical planning. METHODS: The model-based assessment of the aortic arch anatomy consisted of three steps: first, machine-learning-based algorithms were trained on 212 three-dimensional magnetic resonance (MR) data to automatically allocate the aortic arch position in patients and segment the aortic arch; second, for each CoA patient (N = 33), the min/max aortic arch diameters were measured using the proposed software, manually and automatically, from noncontrast-enhanced three-dimensional steady-state free precession MRI sequence at five selected sites and compared ('internal comparison' referring to the same environment); third, moreover, the same min/max aortic arch diameters were compared, obtaining them independently, manually from common MR management software (MR Viewforum) and automatically from the model (external comparison). The measured sites were: aortic sinus, sino-tubular junction, mid-ascending aorta, transverse arch and thoracoabdominal aorta at the level of the diaphragm. RESULTS: Manual and software-assisted measurements showed a good agreement: the difference between diameter measurements was not statistically significant (at α = 0.05), with only one exception, for both internal and external comparison. A high coefficient of correlation was attained for both maximum and minimum diameters in each site (for internal comparison, R > 0.73 for every site, with P < 2 × 10). Notably, in tricuspid aortic valve patients external comparison showed no statistically significant difference at any measurement sites. CONCLUSION: The automatically derived aortic arch model, starting from three-dimensional MR images, could be a support to take the measurements in CoA patients and to quickly provide a patient-specific model of aortic arch anomalies.

Systems Biology-Driven Hypotheses Tested In Vivo: The Need to Advancing Molecular Imaging Tools.

Processing and interpretation of biological images may provide invaluable insights on complex, living systems because images capture the overall dynamics as a "whole." Therefore, "extraction" of key, quantitative morphological parameters could be, at least in principle, helpful in building a reliable systems biology approach in understanding living objects. Molecular imaging tools for system biology models have attained widespread usage in modern experimental laboratories. Here, we provide an overview on advances in the computational technology and different instrumentations focused on molecular image processing and analysis. Quantitative data analysis through various open source software and algorithmic protocols will provide a novel approach for modeling the experimental research program. Besides this, we also highlight the predictable future trends regarding methods for automatically analyzing biological data. Such tools will be very useful to understand the detailed biological and mathematical expressions under in-silico system biology processes with modeling properties.

A new genotyping scheme based on MLVA for inter-laboratory surveillance of Streptococcus pyogenes.

A newly developed MLVA seven-loci scheme for Streptococcus pyogenes is described. The method can be successfully applied by using both agarose gel with visual inspections of bands and Lab on Chip technology. The potential of the present MLVA has been tested on a collection of 100 clinical GAS strains representing the most common emm types found in high-income countries plus 18 published gap-free genomes, in comparison to PFGE and MLST. The MLVA analysis defined 30 MLVA types with ten out of the considered 15 emm types exhibiting multiple and specific MLVA types. In only one occasion the same MLVA profile was shared between isolates belonging to two different emm types. A robust congruency between the methods was observed, with MLVA discriminating within clonal complexes as defined by PFGE or MLST. This new MLVA scheme can be adopted as a quick, low-cost and reliable typing method to track the short-term diffusion of GAS clones in inter-laboratory-based surveillance.

Mechanically Assisted Total Cavopulmonary Connection With an Axial Flow Pump: Computational and In Vivo Study.

A relevant number of patients undergoing total cavopulmonary connection (TCPC) experience heart failure (HF). Heart transplant is then the final option when all other treatments fail. The axial flow blood pumps are now the state of the art; however, there is little experience in low-pressure circuits, such as support of the right ventricle or even a TCPC circulation. A new T-shaped model of mechanically assisted TCPC using the "Jarvik Child 2000" axial pump, (flow rates between 1 and 3 L/m in a range of 5000-9000 rpm) was designed, simulated numerically, and then tested in animals. Eight sheep (42-45 kg) were studied: two pilot studies, four pump-supported (PS) TCPC for 3 h, and two not pump-supported (NPS) TCPC. In the PS, the axial pump was set to maintain the baseline cardiac output (CO). Pressures, CO, systemic and pulmonary vascular resistance, lactate levels, and blood gases were recorded for 3 h. Computational fluid dynamics (CFD) study allows us to set the feasible operating condition and the safety margins to minimize the venous collapse risk. In the NPS animals, a circulatory deterioration, with increasing lactate level, occurred rapidly. In the PS animals, there was a stable cardiac index of 2.7 ± 1.4 L/min/m(2), central venous pressure of 12.3 ± 1 mm Hg, and a mean pulmonary artery pressure (PAP) of 18.1 ± 6 after 3 h of support up to 9000 rpm. systemic vascular resistance (SVR), pulmonary vascular resistance (PVR), blood gasses, and arterial lactate levels remained stable to baseline values. No caval collapse occurred. A new pediatric axial flow pump provides normal CO and physiologic stability in a new T-shaped model of TCPC in sheep, in vivo. CFD and in vivo data showed that this experimental arrangement will allow us to evaluate the potential for mechanical support in patients with Fontan failure avoiding major adverse events.

3D velocity field characterization of prosthetic heart valve with two different valve testers by means of stereo-PIV.

BACKGROUND: Prosthetic heart valves can be associated to mechanical loading of blood, potentially linked to complications (hemolysis and thrombogenicity) which can be clinically relevant. In order to test such devices in pulsatile mode, pulse duplicators (PDs) have been designed and built according to different concepts. This study was carried out to compare anemometric measurements made on the same prosthetic device, with two widely used PDs. METHODS: The valve (a 27-mm bileaflet valve) was mounted in the aortic section of the PD. The Sheffield University PD and the RWTH Aachen PD were selected as physical models of the circulation. These two PDs differ mainly in the vertical vs horizontal realization, and in the ventricular section, which in the RWTH PD allows for storage of potential energy in the elastic walls of the ventricle. A glassblown aorta, realized according to the geometric data of the same anatomical district in healthy individuals, was positioned downstream of the valve, obtaining 1:1 geometric similarity conditions. A NaI-glycerol-water solution of suitable kinematic viscosity and, at the same time, the proper refractive index, was selected. The flow field downstream of the valve was measured by means of the stereo-PIV (Particle Image Velocimetry) technique, capable of providing the complete 3D velocity field as well as the entire Reynolds stress tensor. The measurements were carried out at the plane intersecting the valve axis. RESULTS: A three-jet profile was clearly found in the plane crossing the leaflets, with both PDs. The extent of the typical recirculation zone in the Valsalva sinus was much larger in the RWTH PD, on account of the different duration of the swirling motion in the ventricular chamber, caused by the elasticity of the ventricle and its geometry. CONCLUSION: The comparison of the hemodynamical behaviour of the same bileaflet valve tested in two PDs demonstrated the role of the mock loop in affecting the valve performance.

Molecular characterization of HIV-1 subtype C gp-120 regions potentially involved in virus adaptive mechanisms.

The role of variable regions of HIV-1 gp120 in immune escape of HIV has been investigated. However, there is scant information on how conserved gp120 regions contribute to virus escaping. Here we have studied how molecular sequence characteristics of conserved C3, C4 and V3 regions of clade C HIV-1 gp120 that are involved in HIV entry and are target of the immune response, are modulated during the disease course. We found an increase of "shifting" putative N-glycosylation sites (PNGSs) in the α2 helix (in C3) and in C4 and an increase of sites under positive selection pressure in the α2 helix during the chronic stage of disease. These sites are close to CD4 and to co-receptor binding sites. We also found a negative correlation between electric charges of C3 and V4 during the late stage of disease counteracted by a positive correlation of electric charges of α2 helix and V5 during the same stage. These data allow us to hypothesize possible mechanisms of virus escape involving constant and variable regions of gp120. In particular, new mutations, including new PNGSs occurring near the CD4 and CCR5 binding sites could potentially affect receptor binding affinity and shield the virus from the immune response.

A software tool for the selection of tandem repeats for MLVA analysis.

DNA fingerprinting is a reliable tool for identifying, tracing and characterizing bacterial clonal population structure. A recent technique is given by the Multiple Loci VNTR Analysis (MLVA), where VNTR denotes Variable Number of Tandem Repeats, that meets the need for fast and reliable typing methods by combining the polymorphic nature of tandem repeats (TR) and the use of Polymerase Chain Reaction (PCR) methodology. The key point in the MLVA technique is the selection of a set of TRs which have a sufficient variability (polymorphism) across strains, in order to allow easy strain typing. In this work, we present a program which analyses a set of N genomes and outputs the list of shared TRs and associated information. The program compares the TRs for each possible genome pair, and finds the sets of TRs that are shared by at least M genomes. The subsequent determination of "virtual amplicons" enables the user to consider the actual polymorphism exhibited by the different strains with regards to each given TR, which is the critical parameter for the experimental strain typing.

Oxygen permeability measurements of contact lenses: a proposal for accuracy improvement.

Contact lens are a widespread medical device. In view of the importance of a proper oxygenation of the cornea, new materials are continuously being tested, with a high permeability to oxygen. Taking into account the limitations of the methods for testing soft contact lenses, as presented in the relevant international standards, this paper focuses on the polarographic method and on the approach of measuring oxygen permeability of stacked contact lenses. The effect of the interspersed saline solution layers on the measurable permeability of the stack is considered, using Fick's law of diffusive flux, and a proposal for accuracy improvement in oxygen permeability measurements is presented.

Virtual microscopy and digital cytology: state of the art.

The paper approaches a new technological scenario relevant for the introduction of the digital cytology (D-CYT) in the health service. A detailed analysis of the state of the art on the status of the introduction of D-CYT in the hospital and more in general in the dispersed territory has been conducted. The analysis was conducted in a form of review and was arranged into two parts: the first part focused on the technological tools needed to carry out a successful service (client server architectures, e-learning, quality assurance issues); the second part focused on issues oriented to help the introduction and evaluation of the technology (specific training in D-CYT, health technology assessment in-routine application, data format standards and picture archiving computerized systems (PACS) implementation, image quality assessment, strategies of navigation, 3D-virtual-reality potentialities). The work enlightens future scenarios of actions relevant for the introduction of the technology.

Improved management of systemic venous anomalies in a single ventricle: New rationale.

OBJECTIVES: Two innovative surgical approaches addressing systemic venous anomalies in single-ventricle patients are evaluated. METHODS: Between 2003 and 2007, 7 patients underwent a unifocal bilateral bidirectional cavopulmonary anastomosis, and 5 patients underwent a hepatoazygos venous connection associated with a previous (n = 4) or concomitant (n = 1) Kawashima operation. Computational fluid dynamics simulations allowed investigation of 2 sets of comparative models: (1) bifocal versus unifocal bilateral bidirectional cavopulmonary anastomosis and (2) classic hepatic vein-pulmonary artery channel versus hepatoazygos direct anastomosis for Fontan completion after or combined with the Kawashima operation. RESULTS: There was 1 hospital death in the unifocal bilateral bidirectional cavopulmonary anastomosis group. At a mean follow-up of 15.6 +/- 7.40 months after a unifocal bilateral bidirectional cavopulmonary anastomosis and of 38.7 +/- 13.2 months after direct hepatoazygos venous connection, respectively, all 11 survivors are in New York Heart Association class I with functional anastomoses. Computational assessment of bifocal bilateral bidirectional cavopulmonary anastomosis demonstrated weak perfusion between caval veins against symmetric and steady bilateral flow fields in the unifocal arrangement. In the classic post-Kawashima Fontan completion model, the hepatic venous flow to the pulmonary artery was held back by means of preponderant opposite flow, whereas in the direct hepatoazygos venous connection model, the hepatic venous flow merged smoothly into the azygos vein. Power-loss calculation showed no significant difference between bifocal and unifocal bilateral bidirectional cavopulmonary anastomosis topology, whereas the hepatoazygos connection clearly had better energy preservation than the classical connection. CONCLUSIONS: This limited clinical and computational fluid dynamics assessment suggests the efficacy of this new rationale to reduce the additional thrombotic risks produced by systemic venous anomalies in single-ventricle patients.

Fluid dynamics studies of cardiovascular medical devices and blood damage prediction.

The implantation of cardiovascular devices such as prosthetic heart valves, even though very common in the clinical domain, is still not free from complications. Thromboembolic events and hemolysis are the major clinical problems that can occur, upon implantation. In this paper, we analyze the role of the particular fluid dynamics associated to such devices, in relation to the clinical outcome. A major issue, still debated, is the way to correlate the experimental findings with blood damage. The availability of advanced techniques such as LDA or PIV is necessary to evaluate the hemodynamical performance of a given implantable device at the local level and to draw reliable conclusions about potentially adverse clinical effects.