Remote patient monitoring should reduce mortality rates, improve care, and reduce costs. We present an overview of the available technologies for the remote monitoring of chronic obstructive pulmonary disease (COPD) patients, together with the most important medical information regarding COPD in a language that is adapted for engineers. Our aim is to bridge the gap between the technical and medical worlds and to facilitate and motivate future research in the field. We also present a justification, motivation, and explanation of how to monitor the most important parameters for COPD patients, together with pointers for the challenges that remain. Additionally, we propose and justify the importance of electrocardiograms (ECGs) and the arterial carbon dioxide partial pressure (PaCO2) as two crucial physiological parameters that have not been used so far to any great extent in the monitoring of COPD patients. We cover four possibilities for the remote monitoring of COPD patients: continuous monitoring during normal daily activities for the prediction and early detection of exacerbations and life-threatening events, monitoring during the home treatment of mild exacerbations, monitoring oxygen therapy applications, and monitoring exercise. We also present and discuss the current approaches to decision support at remote locations and list the normal and pathological values/ranges for all the relevant physiological parameters. The paper concludes with our insights into the future developments and remaining challenges for improvements to continuous remote monitoring systems. Graphical abstract ᅟ.

/pdf/continuous-remote-monitoring-of-copd-patients-justification-4fffmgftb3.pdf

Continuous remote monitoring of COPD patients—justification and explanation of the requirements and a survey of the available technologies

Walking impairments are highly prevalent in persons with multiple sclerosis (PwMS) and are associated with reduced quality of life. Walking is traditionally quantified with various measures, including patient self-reports, clinical rating scales, performance measures, and advanced lab-based movement analysis techniques. Yet, the majority of these measures do not fully characterize walking (i.e., gait quality) nor adequately reflect walking in the real world (i.e., community ambulation) and have limited timescale (only measure walking at a single point in time). We discuss the potential of wearable sensors to provide sensitive, objective, and easy-to-use assessment of community ambulation in PwMS. Wearable technology has the ability to measure all aspects of gait in PwMS yet is under-studied in comparison with other populations (e.g., older adults). Within the studies focusing on PwMS, half that measure pace collected free-living data, while only one study explored gait variability in free-living conditions. No studies explore gait asymmetry or complexity in free-living conditions. Wearable technology has the ability to provide objective, comprehensive, and sensitive measures of gait in PwMS. Future research should investigate this technology’s ability to accurately assess free-living measures of gait quality, specifically gait asymmetry and complexity.

Next Steps in Wearable Technology and Community Ambulation in Multiple Sclerosis.

https://spiral.imperial.ac.uk/bitstream/10044/1/79504/9/1-s2.0-S1201971220303933-main%20%281%29.pdf

Continuous physiological monitoring using wearable technology to inform individual management of infectious diseases, public health and outbreak responses.

Wearable devices emerged from the advancement of communication technology and the miniaturization of electronic components. These devices periodically monitor the user’s vital signs and generally have a short battery life. This work introduces ODIN, a model for optimized vital signs collection based on adaptive rules. Analyzing vital sign values requires preciseness, so the adaption of these collected data allows a personalized analysis of the user’s health condition. The comparison with related works indicates that ODIN is the only model that presents context-aware-adaptive vital signs collection. The implementation of a prototype allowed to perform three evaluations of ODIN. The first evaluation used simulations in different scenarios, with the adaptive approach increasing battery life by 119% through the analysis of input data compared to data collection without adaptivity. The second evaluation applied the prototype to a database of real physiologic data, which allowed reduced data collection when the user has regular vital signs. This reduction optimized battery consumption by 66% compared to collection without adaptivity. Finally, the third evaluation applied ODIN through an Arduino and a heart rate monitor (Polar H7). The average power saved across mobile devices was 21%. Consequently, the adaptive strategy presented in this work allows the optimization of computational resources during the collection and analysis of vital signs. This optimization occurs because of the reduction in energy expenditure and the reduction in the amount of data that needs to be collected and stored.

/pdf/a-computational-model-for-adaptive-recording-of-vital-signs-1pz4q11eg5.pdf

A computational model for adaptive recording of vital signs through context histories

Biointerfaced sensors have emerged as a new paradigm for medical applications that require an interface and/or intimate contact with biological components/systems such as cells, tissues, and whole organs. This article provides a review of the concept, design, and device characteristics of biointerfaced sensors needed for successful implementation of biodiagnostics and monitoring. It begins by presenting and discussing the different considerations that arise from artificial interfaces with different biological environments. It then explores the main strategies for sensor and material design, while highlighting the required chemistry, structure, and mechanical properties needed to maintain an unperturbed interface with the surrounding biological environment. Finally, the review discusses successful state‐of‐the‐art demonstrations of body monitoring and biodiagnostics, focusing on the brain, heart, muscles, skin, teeth, and other tissues for medical purposes. Insights, perspectives, and recommendations for future research are presented.

https://onlinelibrary.wiley.com/doi/pdf/10.1002/VIW.20200172

Biointerfaced sensors for biodiagnostics

Background: Increasingly, drug and device clinical trials are tracking activity levels and other quality of life indices as endpoints for therapeutic efficacy. Trials have traditionally required intermittent subject visits to the clinic that are artificial, activity-intensive, and infrequent, making trend and event detection between visits difficult. Thus, there is an unmet need for wearable sensors that produce clinical quality and medical grade physiological data from subjects in the home. The current study was designed to validate the BioStamp nPoint® system (MC10 Inc., Lexington, MA, USA), a new technology designed to meet this need. Objective: To evaluate the accuracy, performance, and ease of use of an end-to-end system called the BioStamp nPoint. The system consists of an investigator portal for design of trials and data review, conformal, low-profile, wearable biosensors that adhere to the skin, a companion technology for wireless data transfer to a proprietary cloud, and algorithms for analyzing physiological, biometric, and contextual data for clinical research. Methods: A prospective, nonrandomized clinical trial was conducted on 30 healthy adult volunteers over the course of two continuous days and nights. Supervised and unsupervised study activities enabled performance validation in clinical and remote (simulated “at home”) environments. System outputs for heart rate (HR), heart rate variability (HRV) (including root mean square of successive differences [RMSSD] and low frequency/high frequency ratio), activity classification during prescribed activities (lying, sitting, standing, walking, stationary biking, and sleep), step count during walking, posture characterization, and sleep metrics including onset/wake times, sleep duration, and respiration rate (RR) during sleep were evaluated. Outputs were compared to FDA-cleared comparator devices for HR, HRV, and RR and to ground truth investigator observations for activity and posture classifications, step count, and sleep events. Results: Thirty participants (77% male, 23% female; mean age 35.9 ± 10.1 years; mean BMI 28.1 ± 3.6) were enrolled in the study. The BioStamp nPoint system accurately measured HR and HRV (correlations: HR = 0.957, HRV RMSSD = 0.965, HRV ratio = 0.861) when compared to ActiheartTM. The system accurately monitored RR (mean absolute error [MAE] = 1.3 breaths/min) during sleep when compared to a Capnostream35TM end-tidal CO2 monitor. When compared with investigator observations, the system correctly classified activities and posture (agreement = 98.7 and 92.9%, respectively), step count (MAE = 14.7, < 3% of actual steps during a 6-min walk), and sleep events (MAE: sleep onset = 6.8 min, wake = 11.5 min, sleep duration = 13.7 min) with high accuracy. Participants indicated “good” to “excellent” usability (average System Usability Scale score of 81.3) and preferred the BioStamp nPoint system over both the Actiheart (86%) and Capnostream (97%) devices. Conclusions: The present study validated the BioStamp nPoint system’s performance and ease of use compared to FDA-cleared comparator devices in both the clinic and remote (home) environments.

/pdf/a-pivotal-study-to-validate-the-performance-of-a-novel-4fzo8rkyp8.pdf

James P. Maynard

Papers

A Pivotal Study to Validate the Performance of a Novel Wearable Sensor and System for Biometric Monitoring in Clinical and Remote Environments.