Assessment of the feasibility of an ultra-low power, wireless digital patch for the continuous ambulatory monitoring of vital signs.

BACKGROUND AND OBJECTIVES: Vital signs are usually recorded at 4–8 h intervals in hospital patients, and deterioration between measurements can have serious consequences. The primary study objective was to assess agreement between a new ultra-low power, wireless and wearable surveillance system for continuous ambulatory monitoring of vital signs and a widely used clinical vital signs monitor. The secondary objective was to examine the system's ability to automatically identify and reject invalid physiological data. SETTING: Single hospital centre. PARTICIPANTS: Heart and respiratory rate were recorded over 2 h in 20 patients undergoing elective surgery and a second group of 41 patients with comorbid conditions, in the general ward. OUTCOME MEASURES: Primary outcome measures were limits of agreement and bias. The secondary outcome measure was proportion of data rejected. RESULTS: The digital patch provided reliable heart rate values in the majority of patients (about 80%) with normal sinus rhythm, and in the presence of abnormal ECG recordings (excluding aperiodic arrhythmias such as atrial fibrillation). The mean difference between systems was less than ±1 bpm in all patient groups studied. Although respiratory data were more frequently rejected as invalid because of the high sensitivity of impedance pneumography to motion artefacts, valid rates were reported for 50% of recordings with a mean difference of less than ±1 brpm compared with the bedside monitor. Correlation between systems was statistically significant (p<0.0001) for heart and respiratory rate, apart from respiratory rate in patients with atrial fibrillation (p=0.02). CONCLUSIONS: Overall agreement between digital patch and clinical monitor was satisfactory, as was the efficacy of the system for automatic rejection of invalid data. Wireless monitoring technologies, such as the one tested, may offer clinical value when implemented as part of wider hospital systems that integrate and support existing clinical protocols and workflows

Verification, Analytical Validation, and Clinical Validation (V3): The Foundation of Determining Fit-for-Purpose for Biometric Monitoring Technologies (BioMeTs)

Digital medicine is an interdisciplinary field, drawing together stakeholders with expertize in engineering, manufacturing, clinical science, data science, biostatistics, regulatory science, ethics, patient advocacy, and healthcare policy, to name a few. Although this diversity is undoubtedly valuable, it can lead to confusion regarding terminology and best practices. There are many instances, as we detail in this paper, where a single term is used by different groups to mean different things, as well as cases where multiple terms are used to describe essentially the same concept. Our intent is to clarify core terminology and best practices for the evaluation of Biometric Monitoring Technologies (BioMeTs), without unnecessarily introducing new terms. We focus on the evaluation of BioMeTs as fit-for-purpose for use in clinical trials. However, our intent is for this framework to be instructional to all users of digital measurement tools, regardless of setting or intended use. We propose and describe a three-component framework intended to provide a foundational evaluation framework for BioMeTs. This framework includes (1) verification, (2) analytical validation, and (3) clinical validation. We aim for this common vocabulary to enable more effective communication and collaboration, generate a common and meaningful evidence base for BioMeTs, and improve the accessibility of the digital medicine field

Deep Learning in Cardiology

The medical field is creating large amount of data that physicians are unable to decipher and use efficiently. Moreover, rule-based expert systems are inefficient in solving complicated medical tasks or for creating insights using big data. Deep learning has emerged as a more accurate and effective technology in a wide range of medical problems such as diagnosis, prediction and intervention. Deep learning is a representation learning method that consists of layers that transform the data non-linearly, thus, revealing hierarchical relationships and structures. In this review we survey deep learning application papers that use structured data, signal and imaging modalities from cardiology. We discuss the advantages and limitations of applying deep learning in cardiology that also apply in medicine in general, while proposing certain directions as the most viable for clinical use.Comment: 27 pages, 2 figures, 10 table

Debatable issues in automated ECG reporting

Although automated ECG analysis has been available for many years, there are some aspects which require to be re-assessed with respect to their value while newer techniques which are worthy of review are beginning to find their way into routine use. At the annual International Society of Computerized Electrocardiology conference held in April 2017, four areas in particular were debated. These were a) automated 12 lead resting ECG analysis; b) real time out of hospital ECG monitoring; c) ECG imaging; and d) single channel ECG rhythm interpretation. One speaker presented the positive aspects of each technique and another outlined the more negative aspects. Debate ensued. There were many positives set out for each technique but equally, more negative features were not in short supply, particularly for out of hospital ECG monitoring

Real-time human ambulation, activity, and physiological monitoring:taxonomy of issues, techniques, applications, challenges and limitations

Automated methods of real-time, unobtrusive, human ambulation, activity, and wellness monitoring and data analysis using various algorithmic techniques have been subjects of intense research. The general aim is to devise effective means of addressing the demands of assisted living, rehabilitation, and clinical observation and assessment through sensor-based monitoring. The research studies have resulted in a large amount of literature. This paper presents a holistic articulation of the research studies and offers comprehensive insights along four main axes: distribution of existing studies; monitoring device framework and sensor types; data collection, processing and analysis; and applications, limitations and challenges. The aim is to present a systematic and most complete study of literature in the area in order to identify research gaps and prioritize future research directions

CardioCam: Leveraging Camera on Mobile Devices to Verify Users While Their Heart is Pumping

With the increasing prevalence of mobile and IoT devices (e.g., smartphones, tablets, smart-home appliances), massive private and sensitive information are stored on these devices. To prevent unauthorized access on these devices, existing user verification solutions either rely on the complexity of user-defined secrets (e.g., password) or resort to specialized biometric sensors (e.g., fingerprint reader), but the users may still suffer from various attacks, such as password theft, shoulder surfing, smudge, and forged biometrics attacks. In this paper, we propose, CardioCam, a low-cost, general, hard-to-forge user verification system leveraging the unique cardiac biometrics extracted from the readily available built-in cameras in mobile and IoT devices. We demonstrate that the unique cardiac features can be extracted from the cardiac motion patterns in fingertips, by pressing on the built-in camera. To mitigate the impacts of various ambient lighting conditions and human movements under practical scenarios, CardioCam develops a gradient-based technique to optimize the camera configuration, and dynamically selects the most sensitive pixels in a camera frame to extract reliable cardiac motion patterns. Furthermore, the morphological characteristic analysis is deployed to derive user-specific cardiac features, and a feature transformation scheme grounded on Principle Component Analysis (PCA) is developed to enhance the robustness of cardiac biometrics for effective user verification. With the prototyped system, extensive experiments involving 25 subjects are conducted to demonstrate that CardioCam can achieve effective and reliable user verification with over 99% average true positive rate (TPR) while maintaining the false positive rate (FPR) as low as 4%

Novel hybrid extraction systems for fetal heart rate variability monitoring based on non-invasive fetal electrocardiogram

This study focuses on the design, implementation and subsequent verification of a new type of hybrid extraction system for noninvasive fetal electrocardiogram (NI-fECG) processing. The system designed combines the advantages of individual adaptive and non-adaptive algorithms. The pilot study reviews two innovative hybrid systems called ICA-ANFIS-WT and ICA-RLS-WT. This is a combination of independent component analysis (ICA), adaptive neuro-fuzzy inference system (ANFIS) algorithm or recursive least squares (RLS) algorithm and wavelet transform (WT) algorithm. The study was conducted on clinical practice data (extended ADFECGDB database and Physionet Challenge 2013 database) from the perspective of non-invasive fetal heart rate variability monitoring based on the determination of the overall probability of correct detection (ACC), sensitivity (SE), positive predictive value (PPV) and harmonic mean between SE and PPV (F1). System functionality was verified against a relevant reference obtained by an invasive way using a scalp electrode (ADFECGDB database), or relevant reference obtained by annotations (Physionet Challenge 2013 database). The study showed that ICA-RLS-WT hybrid system achieve better results than ICA-ANFIS-WT. During experiment on ADFECGDB database, the ICA-RLS-WT hybrid system reached ACC > 80 % on 9 recordings out of 12 and the ICA-ANFIS-WT hybrid system reached ACC > 80 % only on 6 recordings out of 12. During experiment on Physionet Challenge 2013 database the ICA-RLS-WT hybrid system reached ACC > 80 % on 13 recordings out of 25 and the ICA-ANFIS-WT hybrid system reached ACC > 80 % only on 7 recordings out of 25. Both hybrid systems achieve provably better results than the individual algorithms tested in previous studies.Web of Science713178413175

A review of machine learning techniques in photoplethysmography for the non-invasive cuff-less measurement of blood pressure

Hypertension or high blood pressure is a leading cause of death throughout the world and a critical factor for increasing the risk of serious diseases, including cardiovascular diseases such as stroke and heart failure. Blood pressure is a primary vital sign that must be monitored regularly for the early detection, prevention and treatment of cardiovascular diseases. Traditional blood pressure measurement techniques are either invasive or cuff-based, which are impractical, intermittent, and uncomfortable for patients. Over the past few decades, several indirect approaches using photoplethysmogram (PPG) have been investigated, namely, pulse transit time, pulse wave velocity, pulse arrival time and pulse wave analysis, in an effort to utilise PPG for estimating blood pressure. Recent advancements in signal processing techniques, including machine learning and artificial intelligence, have also opened up exciting new horizons for PPG-based cuff less and continuous monitoring of blood pressure. Such a device will have a significant and transformative impact in monitoring patients’ vital signs, especially those at risk of cardiovascular disease. This paper provides a comprehensive review for non-invasive cuff-less blood pressure estimation using the PPG approach along with their challenges and limitations