Simulated versus physical bench tests

none8Pierpaolo Mincarone; Antonella Bodini; Saverio Sabina; Riccardo Colella; Maria Rosaria Tumolo; Martin Fawdry; Dimitrios I. Fotiadis; Carlo Giacomo LeoMincarone, Pierpaolo; Bodini, Antonella; Sabina, Saverio; Colella, Riccardo; Tumolo, MARIA ROSARIA; Fawdry, Martin; Fotiadis, Dimitrios I.; Giacomo Leo, Carl

Health Technology Assessment for In Silico Medicine: Social, Ethical and Legal Aspects

The application of in silico medicine is constantly growing in the prevention, diagnosis, and treatment of diseases. These technologies allow us to support medical decisions and self- management and reduce, refine, and partially replace real studies of medical technologies. In silico medicine may challenge some key principles: transparency and fairness of data usage; data privacy and protection across platforms and systems; data availability and quality; data integration and interoperability; intellectual property; data sharing; equal accessibility for persons and populations. Several social, ethical, and legal issues may consequently arise from its adoption. In this work, we provide an overview of these issues along with some practical suggestions for their assessment from a health technology assessment perspective. We performed a narrative review with a search on MEDLINE/Pubmed, ISI Web of Knowledge, Scopus, and Google Scholar. The following key aspects emerge as general reflections with an impact on the operational level: cultural resistance, level of expertise of users, degree of patient involvement, infrastructural requirements, risks for health, respect of several patients’ rights, potential discriminations for access and use of the technology, and intellectual property of innovations. Our analysis shows that several challenges still need to be debated to allow in silico medicine to express all its potential in healthcare processes

Predictive added value of selected plasma lipids to a re-estimated minimal risk tool

Background: Lipidomics is emerging for biomarker discovery in cardiovascular disease, and circulating lipids are increasingly incorporated in risk models to predict cardiovascular events. Moreover, specific classes of lipids, such as sphingomyelins, ceramides, and triglycerides, have been related to coronary artery disease (CAD) severity and plaque characteristics. To avoid unnecessary testing, it is important to identify individuals at low CAD risk. The only pretest model available so far to rule out the presence of coronary atherosclerosis in patients with chest pain, but normal coronary arteries, is the minimal risk tool (MRT).Aim: Using state-of-the-art statistical methods, we aim to verify the additive predictive value of a set of lipids, derived from targeted plasma lipidomics of suspected CAD patients, to a re-estimated version of the MRT for ruling out the presence of coronary atherosclerosis assessed by coronary CT angiography (CCTA).Methods: Two hundred and fifty-six subjects with suspected stable CAD recruited from five European countries within H2020-SMARTool, undergoing CCTA and blood sampling for clinical biochemistry and lipidomics, were selected. The MRT was validated by regression methods and then re-estimated (reMRT). The reMRT was used as a baseline model in a likelihood ratio test approach to assess the added predictive value of each lipid from 13 among ceramides, triglycerides, and sphingomyelins. Except for one lipid, the analysis was carried out on more than 240 subjects for each lipid. A sensitivity analysis was carried out by considering two alternative models developed on the cohort as baseline models.Results: In 205 subjects, coronary atherosclerosis ranged from minimal lesions to overt obstructive CAD, while in 51 subjects (19.9%) the coronary arteries were intact. Four triglycerides and seven sphingomyelins were significantly (p < 0.05) and differentially expressed in the two groups and, at a lesser extent, one ceramide (p = 0.067). The probability of being at minimal risk was significantly better estimated by adding either Cer(d18:1/16:0) (p = 0.01), SM(40:2) (p = 0.04), or SM(41:1) at a lesser extent (p = 0.052) to reMRT than by applying the reMRT alone. The sensitivity analysis confirmed the relevance of these lipids. Furthermore, the addition of SM(34:1), SM(38:2), SM(41:2), and SM(42:4) improved the predictive performance of at least one of the other baseline models. None of the selected triglycerides was found to provide an added value.Conclusions: Plasma lipidomics can be a promising source of diagnostic and prognostic biomarkers in cardiovascular disease, exploitable not only to assess the risk of adverse events but also to identify subjects without coronary atherosclerosis, thus reducing unnecessary further testing in normal subjects.Cardiolog

RARE-Bestpractices: a platform for sharing best practices for the management of rare diseases

No abstract available

RARE-Bestpractices: a platform for sharing best practices for the management of rare diseases

No abstract available

Semi-Passive RFID Electronic Devices With On-Chip Sensor Fusion Capabilities for Motion Capture and Biomechanical Analysis

This article presents the development and testing of a novel electronic device for wireless motion capture (W-MoCap), a technology that allows the reconstruction of movements of objects and body parts with many potential applications in various contexts. The device integrates UHF radio frequency identification (RFID) technology with sensors for low-power backscattering communication. It consists of a battery-assisted passive (BAP) UHF RFID chip, an inertial measurement unit (IMU), an ultralow power microcontroller, and a custom-designed edge-fed body-tolerant antenna operating at 866 MHz. The proper matching between the RFID chip and antenna is ensured through a well-designed L-match unbalanced network, and the separation of RF and dc signals is achieved with a meandered microstrip quarter-wavelength transformer, choke inductor, and decoupling capacitor. The designed and realized RFID W-MoCap sensor tag has been thoroughly evaluated in terms of current consumption, front-end sensitivity, and sensing accuracy. Finally, five prototypes have been applied to specific segments of a human subject and successfully tested in a practical scenario for real-time reconstruction of human movements

Healthcare and Economic Impact of Lung Perfusion Scintigraphy in Patients Affected by Acute Pulmonary Embolism

Acute pulmonary embolism (APE) is a cardiovascular emergency, representing the main cause of mortality, morbidity, and hospitalisation in Europe. We aim to evaluate the economic and healthcare impact of lung perfusion scintigraphy (LPS) used in patients with suspected APE, in the event of non-conclusive or contraindicated computed tomography pulmonary angiography (CTPA). We considered two alternative healthcare processes for APE diagnosis, with and without LPS. We performed a cost analysis with the aim of evaluating the average direct healthcare costs for diagnosis, risk assessment, and treatment of APE. We used data from a monocentric trial. Our economic model showed that the strategy with LPS was preferable in terms of costs. The average per-patient costs for the diagnosis and treatment of the acute phase of PE in low-risk patients with a non-conclusive or not-executable CTPA, with and without LPS, are EUR 2145.25 and EUR 4912.45, respectively. LPS is a simple, quick, and economic examination, useful in this setting of patients not only for an early diagnosis but also to exclude APE, demonstrating an advantage in terms of healthcare resources. To the best of our knowledge, this study is the first to analyse the economic and healthcare impact of the use of LPS in the diagnostic pathway of suspected APE

Additional file 1: of A conceptual framework for rationalized and standardized Universal Newborn Hearing Screening (UNHS) programs

The need of an explanation: what is the target Hearing Loss for UNHS?. (PDF 82 kb