Nonlinear heart rate variability features for real-life stress detection. Case study : students under stress due to university examination

Background: This study investigates the variations of Heart Rate Variability (HRV) due to a real-life stressor and proposes a classifier based on nonlinear features of HRV for automatic stress detection. Methods: 42 students volunteered to participate to the study about HRV and stress. For each student, two recordings were performed: one during an on-going university examination, assumed as a real-life stressor, and one after holidays. Nonlinear analysis of HRV was performed by using Poincaré Plot, Approximate Entropy, Correlation dimension, Detrended Fluctuation Analysis, Recurrence Plot. For statistical comparison, we adopted the Wilcoxon Signed Rank test and for development of a classifier we adopted the Linear Discriminant Analysis (LDA). Results: Almost all HRV features measuring heart rate complexity were significantly decreased in the stress session. LDA generated a simple classifier based on the two Poincaré Plot parameters and Approximate Entropy, which enables stress detection with a total classification accuracy, a sensitivity and a specificity rate of 90%, 86%, and 95% respectively. Conclusions: The results of the current study suggest that nonlinear HRV analysis using short term ECG recording could be effective in automatically detecting real-life stress condition, such as a university examination

Precision medicine and artificial intelligence : a pilot study on deep learning for hypoglycemic events detection based on ECG

Tracking the fluctuations in blood glucose levels is important for healthy subjects and crucial diabetic patients. Tight glucose monitoring reduces the risk of hypoglycemia, which can result in a series of complications, especially in diabetic patients, such as confusion, irritability, seizure and can even be fatal in specific conditions. Hypoglycemia affects the electrophysiology of the heart. However, due to strong inter-subject heterogeneity, previous studies based on a cohort of subjects failed to deploy electrocardiogram (ECG)-based hypoglycemic detection systems reliably. The current study used personalised medicine approach and Artificial Intelligence (AI) to automatically detect nocturnal hypoglycemia using a few heartbeats of raw ECG signal recorded with non-invasive, wearable devices, in healthy individuals, monitored 24 hours for 14 consecutive days. Additionally, we present a visualisation method enabling clinicians to visualise which part of the ECG signal (e.g., T-wave, ST-interval) is significantly associated with the hypoglycemic event in each subject, overcoming the intelligibility problem of deep-learning methods. These results advance the feasibility of a real-time, non-invasive hypoglycemia alarming system using short excerpts of ECG signal

Precision medicine and artificial intelligence : a pilot study on deep learning for hypoglycemic events detection based on ECG

Tracking the fluctuations in blood glucose levels is important for healthy subjects and crucial diabetic patients. Tight glucose monitoring reduces the risk of hypoglycemia, which can result in a series of complications, especially in diabetic patients, such as confusion, irritability, seizure and can even be fatal in specific conditions. Hypoglycemia affects the electrophysiology of the heart. However, due to strong inter-subject heterogeneity, previous studies based on a cohort of subjects failed to deploy electrocardiogram (ECG)-based hypoglycemic detection systems reliably. The current study used personalised medicine approach and Artificial Intelligence (AI) to automatically detect nocturnal hypoglycemia using a few heartbeats of raw ECG signal recorded with non-invasive, wearable devices, in healthy individuals, monitored 24 hours for 14 consecutive days. Additionally, we present a visualisation method enabling clinicians to visualise which part of the ECG signal (e.g., T-wave, ST-interval) is significantly associated with the hypoglycemic event in each subject, overcoming the intelligibility problem of deep-learning methods. These results advance the feasibility of a real-time, non-invasive hypoglycemia alarming system using short excerpts of ECG signal

Heart Rate Variability (HRV) analysis : a methodology for organizational neuroscience

Recently, the application of neuroscience methods and findings to the study of organizational phenomena has gained significant interest and converged in the emerging field of organizational neuroscience. Yet, this body of research has principally focused on the brain, often overlooking fuller analysis of the activities of the human nervous system and associated methods available to assess them. In this paper, we aim to narrow this gap by reviewing heart rate variability (HRV) analysis, which is that set of methods assessing beat-to-beat changes in the heart rhythm over time, used to draw inference on the outflow of the autonomic nervous system (ANS). In addition to anatomo- physiological and detailed methodological considerations, we discuss related theoretical, ethical, and practical implications. Overall, we argue that this methodology offers the opportunity not only to inform on a wealth of constructs relevant for management inquiries, but also to advance the organizational neuroscience research agenda and its ecological validity

The inadequacy of regulatory frameworks in time of crisis and in low-resource settings : personal protective equipment and COVID-19

COVID-19 pandemic is plaguing the world and representing the most significant stress test for many national healthcare systems and services, since their foundation. The supply-chain disruption and the unprecedented request for intensive care unit (ICU) beds have created in Europe conditions typical of low-resources settings. This generated a remarkable race to find solutions for the prevention, treatment and management of this disease which is involving a large amount of people. Every day, new Do-It-Yourself (DIY) solutions regarding personal protective equipment and medical devices populate social media feeds. Many companies (e.g., automotive or textile) are converting their traditional production to manufacture the most needed equipment (e.g., respirators, face shields, ventilators etc.). In this chaotic scenario, policy makers, international and national standards bodies, along with the World Health Organization (WHO) and scientific societies are making a joint effort to increase global awareness and knowledge about the importance of respecting the relevant requirements to guarantee appropriate quality and safety for patients and healthcare workers. Nonetheless, ordinary procedures for testing and certification are currently questioned and empowered with fast-track pathways in order to speed-up the deployment of new solutions for COVID-19. This paper shares critical reflections on the current regulatory framework for the certification of personal protective equipment. We hope that these reflections may help readers in navigating the framework of regulations, norms and international standards relevant for key personal protective equipment, sharing a subset of tests that should be deemed essential even in a period of crisis

Pupillometric analysis for assessment of gene therapy in Leber Congenital Amaurosis patients

Background: Objective techniques to assess the amelioration of vision in patients with impaired visual function are needed to standardize efficacy assessment in gene therapy trials for ocular diseases. Pupillometry has been investigated in several diseases in order to provide objective information about the visual reflex pathway and has been adopted to quantify visual impairment in patients with Leber Congenital Amaurosis (LCA). In this paper, we describe detailed methods of pupillometric analysis and a case study on three Italian patients affected by Leber Congenital Amaurosis (LCA) involved in a gene therapy clinical trial at two follow-up time-points: 1 year and 3 years after therapy administration. Methods: Pupillary light reflexes (PLR) were measured in patients who had received a unilateral subretinal injection in a clinical gene therapy trial. Pupil images were recorded simultaneously in both eyes with a commercial pupillometer and related software. A program was generated with MATLAB software in order to enable enhanced pupil detection with revision of the acquired images (correcting aberrations due to the inability of these severely visually impaired patients to fixate), and computation of the pupillometric parameters for each stimulus. Pupil detection was performed through Hough Transform and a non-parametric paired statistical test was adopted for comparison. Results: The developed program provided correct pupil detection also for frames in which the pupil is not totally visible. Moreover, it provided an automatic computation of the pupillometric parameters for each stimulus and enabled semi-automatic revision of computerized detection, eliminating the need for the user to manually check frame by frame. With reference to the case study, the amplitude of pupillary constriction and the constriction velocity were increased in the right (treated eye) compared to the left (untreated) eye at both follow-up time-points, showing stability of the improved PLR in the treated eye. Conclusions: Our method streamlined the pupillometric analyses and allowed rapid statistical analysis of a range of parameters associated with PLR. The results confirm that pupillometry is a useful objective measure for the assessment of therapeutic effect of gene therapy in patients with LCA

Health Technology Assessment and Biomedical Engineering : global trends, gaps and opportunities

The diffusion of medical devices is expanding at an astonishing rate. The increasing number of novel patents per year suggests this growth will continue. In contrast to drugs, medical devices are intrinsically dependent on the environment in which they are used and how they are maintained. This created an unprecedented global need for well-trained biomedical engineers who can help healthcare systems to assess them. The International Federation for Medical and Biological Engineering (IFMBE) is the global scientific society of biomedical engineers in official relations with the United Nations World Health Organisation (WHO) and has been very active in promoting the role of the biomedical engineer in Health Technology Assessment (HTA). The IFMBE Health Technology Assessment Division (HTAD) is the IFMBE operative branch in this field, promoting studies, projects and activities to foster the growth of this specific and very important science sector, including summer schools, training material, an HTA eLearning platform, HTA guidelines, awards and more. This article describes the vision, the mission and the strategy of the HTAD, with a focus on the results achieved and the impact this is having on global policymaking

A convolutional neural network approach to detect congestive heart failure

Congestive Heart Failure (CHF) is a severe pathophysiological condition associated with high prevalence, high mortality rates, and sustained healthcare costs, therefore demanding efficient methods for its detection. Despite recent research has provided methods focused on advanced signal processing and machine learning, the potential of applying Convolutional Neural Network (CNN) approaches to the automatic detection of CHF has been largely overlooked thus far. This study addresses this important gap by presenting a CNN model that accurately identifies CHF on the basis of one raw electrocardiogram (ECG) heartbeat only, also juxtaposing existing methods typically grounded on Heart Rate Variability. We trained and tested the model on publicly available ECG datasets, comprising a total of 490,505 heartbeats, to achieve 100% CHF detection accuracy. Importantly, the model also identifies those heartbeat sequences and ECG’s morphological characteristics which are class-discriminative and thus prominent for CHF detection. Overall, our contribution substantially advances the current methodology for detecting CHF and caters to clinical practitioners’ needs by providing an accurate and fully transparent tool to support decisions concerning CHF detection

New intelligent network approach for monitoring physiological parameters : the case of Benin

Benin health system is facing many challenges as: (i) affordable high-quality health care to a growing population providing need, (ii) patients’ hospitalization time reduction, (iii) and presence time of the nursing staff optimization. Such challenges can be solved by remote monitoring of patients. To achieve this, five steps were followed. 1) Identification of the Wireless Body Area Network (WBAN) systems’ characteristics and the patient physiological parameters’ monitoring. 2) The national Integrated Patient Monitoring Network (RIMP) architecture modeling in a cloud of Technocenters. 3) Cross-analysis between the characteristics and the functional requirements identified. 4) Each Technocenter’s functionality simulation through: a) the design approach choice inspired by the life cycle of V systems; b) functional modeling through SysML Language; c) the communication technology and different architectures of sensor networks choice studying. 5) An estimate of the material resources of the national RIMP according to physiological parameters. A National Integrated Network for Patient Monitoring (RNIMP) remotely, ambulatory or not, was designed for Beninese health system. The implementation of the RNIMP will contribute to improve patients’ care in Benin. The proposed network is supported by a repository that can be used for its implementation, monitoring and evaluation. It is a table of 36 characteristic elements each of which must satisfy 5 requirements relating to: medical application, design factors, safety, performance indicators and materiovigilance