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\ud The photopupillary reflex regulates the pupil reaction to changing light conditions. Being controlled by the autonomic nervous system, it is a proxy for brain trauma and for the conditions of patients in critical care. A prompt evaluation of brain traumas can save lives. With a simple penlight, skilled clinicians can do that, whereas less specialized ones have to resort to a digital pupilometer. However, many low-income countries lack both specialized clinicians and digital pupilometers.\ud \ud This paper presents the early results of our study aiming at designing, prototyping and validating an app for testing the photopupillary reflex via Android, following the European Medical Device Regulation and relevant standards.\ud \ud After a manual validation, the prototype underwent a technical validation against a commercial Infrared pupilometer. As a result, the proposed app performed as well as the manual measurements and better than the commercial solution, with lower errors, higher and significant correlations, and significantly better Bland-Altman plots for all the pupillometry-related measures.\ud \ud The design of this medical device was performed based on our expertise in low-resource settings. This kind of environments imposes more stringent design criteria due to contextual challenges, including the lack of specialized clinicians, funds, spare parts and consumables, poor maintenance, and harsh environmental conditions, which may hinder the safe operationalization of medical devices. This paper provides an overview of how these unique contextual characteristics are cascaded into the design of an app in order to contribute to the Sustainable Development Goal 3 of the World Health Organization: Good health and well-being.

Mental stress may cause cognitive dysfunctions, cardiovascular disorders and depression. Mental stress detection via short-term Heart Rate Variability (HRV) analysis has been widely explored in the last years, while ultra-short term (less than 5 minutes) HRV has been not. This study aims to detect mental stress using linear and non-linear HRV features extracted from 3 minutes ECG excerpts recorded from 42 university students, during oral examination (stress) and at rest after a vacation. HRV features were then extracted and analyzed according to the literature using validated software tools. Statistical and data mining analysis were then performed on the extracted HRV features. The best performing machine learning method was the C4.5 tree algorithm, which discriminated between stress and rest with sensitivity, specificity and accuracy rate of 78%, 80% and 79% respectively. Mental stress may cause cognitive dysfunctions, cardiovascular disorders and depression. Mental stress detection via short-term Heart Rate Variability (HRV) analysis has been widely explored in the last years, while ultra-short term (less than 5 minutes) HRV has been not. This study aims to detect mental stress using linear and non-linear HRV features extracted from 3 minutes ECG excerpts recorded from 42 university students, during oral examination (stress) and at rest after a vacation. HRV features were then extracted and analyzed according to the literature using validated software tools. Statistical and data mining analysis were then performed on the extracted HRV features. The best performing machine learning method was the C4.5 tree algorithm, which discriminated between stress and rest with sensitivity, specificity and accuracy rate of 78%, 80% and 79% respectively.

Disease management programs, which use no advanced information and computer technology, are as effective as telemedicine but more efficient because less costly. We proposed a platform to enhance effectiveness and efficiency of home monitoring using data mining for early detection of any worsening in patient's condition. These worsenings could require more complex and expensive care if not recognized. In this letter, we briefly describe the remote health monitoring platform we designed and realized, which supports heart failure (HF) severity assessment offering functions of data mining based on the classification and regression tree method. The system developed achieved accuracy and a precision of 96.39% and 100.00% in detecting HF and of 79.31% and 82.35% in distinguishing severe versus mild HF, respectively. These preliminary results were achieved on public databases of signals to improve their reproducibility. Clinical trials involving local patients are still running and will require longer experimentation.

The aim of this study was to investigate the discrimination power of standard long-term heart rate variability (HRV) measures for the diagnosis of chronic heart failure (CHF). The authors performed a retrospective analysis on four public Holter databases, analyzing the data of 72 normal subjects and 44 patients suffering from CHF. To assess the discrimination power of HRV measures, an exhaustive search of all possible combinations of HRV measures was adopted and classifiers based on Classification and Regression Tree (CART) method was developed, which is a non-parametric statistical technique. It was found that the best combination of features is: Total spectral power of all NN intervals up to 0.4 Hz (TOTPWR), square root of the mean of the sum of the squares of differences between adjacent NN intervals (RMSSD) and standard deviation of the averages of NN intervals in all 5-min segments of a 24-h recording (SDANN). The classifiers based on this combination achieved a specificity rate and a sensitivity rate of 100.00 and 89.74%, respectively. The results are comparable with other similar studies, but the method used is particularly valuable because it provides an easy to understand description of classification procedures, in terms of intelligible "if aEuro broken vertical bar then aEuro broken vertical bar aEuroe rules. Finally, the rules obtained by CART are consistent with previous clinical studies.

The aim of this paper is to describe an automatic classifier to assess the severity of congestive heart failure (CHF) patients. Disease severity is defined according to the New York Heart Association classification (NYHA). The proposed classified aims to distinguish very mild CHF (NYHA I) from mild (NYHA II) and severe CHF patients (NYHA III), using long-term nonlinear Heart Rate Variability (HRV) measures. 24h Holter ECG recording from 2 public databases was performed, including 44 patients suffering from CHF. One non-linear HRV feature was effective in distinguishing very-mild CHF from mild CHF, by achieving a sensibility and specificity rate of 75% and 100% respectively. Moreover, we combine the results obtained by LDA in a classification tree (previously described) in order to obtain an automatic classifier for CHF severity assessment. © Springer International Publishing Switzerland 2014.

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. Trial registration ClinicalTrials.gov NCT00516477

Biomedical Engineers should be prepared to adapt to existing or forecasted needs. There is a strong pressure on education, training and life long learning programs to continuously adapt their objectives in order to face new requirements and challenges. The main objective of the TEMPUS IV, CRH-BME project is to update existing curricula in the field of Biomedical Engineering (BME) in order to meet recent and future developments in the area, address new emerging inter-disciplinary domains that appear as a result of the R&D progress and respond to the BME job market demands. The first step is to extensively review the curricula in the BME education field. In this paper, a proposal for a generic curriculum in the BME education is presented, in order to meet recent and future developments and respond to the demands of the BME job market. Adoption of the core program structure will facilitate harmonization of studies as well as student and staff exchange across Europe, thus promoting the European Higher Education Area.

Background Through this paper, we present the initial steps for the creation of an integrated platform for the provision of a series of eHealth tools and services to both citizens and travelers in isolated areas of thesoutheast Mediterranean, and on board ships travelling across it. The platform was created through an INTERREG IIIB ARCHIMED project called INTERMED. Methods The support of primary healthcare, home care and the continuous education of physicians are the three major issues that the proposed platform is trying to facilitate. The proposed system is based on state-of-the-art telemedicine systems and is able to provide the following healthcare services: i) Telecollaboration and teleconsultation services between remotely located healthcare providers, ii) telemedicine services in emergencies, iii) home telecare services for "at risk" citizens such as the elderly and patients with chronic diseases, and iv) eLearning services for the continuous training through seminars of both healthcare personnel (physicians, nurses etc) and persons supporting "at risk" citizens. These systems support data transmission over simple phone lines, internet connections, integrated services digital network/digital subscriber lines, satellite links, mobile networks (GPRS/3G), and wireless local area networks. The data corresponds, among others, to voice, vital biosignals, still medical images, video, and data used by eLearning applications. The proposed platform comprises several systems, each supporting different services. These were integrated using a common data storage and exchange scheme in order to achieve system interoperability in terms of software, language and national characteristics. Results The platform has been installed and evaluated in different rural and urban sites in Greece, Cyprus and Italy. The evaluation was mainly related to technical issues and user satisfaction. The selected sites are, among others, rural health centers, ambulances, homes of "at-risk" citizens, and a ferry. Conclusions The results proved the functionality and utilization of the platform in various rural places in Greece, Cyprus and Italy. However, further actions are needed to enable the local healthcare systems and the different population groups to be familiarized with, and use in their everyday lives, mature technological solutions for the provision of healthcare services.