An Evaluation of Biometric Monitoring Technologies for Vital Signs in the Era of COVID‐19

The novel coronavirus disease 2019 (COVID‐19) global pandemic has shifted how many patients receive outpatient care. Telehealth and remote monitoring have become more prevalent, and measurements taken in a patient’s home using biometric monitoring technologies (BioMeTs) offer convenient opportunities to collect vital sign data. Healthcare providers may lack prior experience using BioMeTs in remote patient care, and, therefore, may be unfamiliar with the many versions of BioMeTs, novel data collection protocols, and context of the values collected. To make informed patient care decisions based on the biometric data collected remotely, it is important to understand the engineering solutions embedded in the products, data collection protocols, form factors (physical size and shape), data quality considerations, and availability of validation information. This article provides an overview of BioMeTs available for collecting vital signs (temperature, heart rate, blood pressure, oxygen saturation, and respiratory rate) and discusses the strengths and limitations of continuous monitoring. We provide considerations for remote data collection and sources of validation information to guide BioMeT use in the era of COVID‐19 and beyond.

[1]  Shunqing Xu,et al.  Beware of the second wave of COVID-19 , 2020, The Lancet.

[2]  M. Nitzan,et al.  Respiration-induced changes in tissue blood volume distal to occluded artery, measured by photoplethysmography. , 2006, Journal of biomedical optics.

[3]  A. Froehle,et al.  Validating a Commercial Device for Continuous Activity Measurement in the Older Adult Population for Dementia Management. , 2017, Smart health.

[4]  Ali Khademhosseini,et al.  Wearables in Medicine , 2018, Advanced materials.

[5]  Meir Nitzan,et al.  Pulse oximetry: fundamentals and technology update , 2014, Medical devices.

[6]  Carol H. Yan,et al.  Association of chemosensory dysfunction and COVID‐19 in patients presenting with influenza‐like symptoms , 2020, International forum of allergy & rhinology.

[7]  Jennifer C. Goldsack,et al.  Verification, analytical validation, and clinical validation (V3): the foundation of determining fit-for-purpose for Biometric Monitoring Technologies (BioMeTs) , 2020, npj Digital Medicine.

[8]  D. Clifton,et al.  Wearable Sensing and Telehealth Technology with Potential Applications in the Coronavirus Pandemic , 2020, IEEE Reviews in Biomedical Engineering.

[9]  S. S. Man,et al.  Health monitoring through wearable technologies for older adults: Smart wearables acceptance model. , 2019, Applied ergonomics.

[10]  Youssef Ouakrim,et al.  Physiological Data Validation of the Hexoskin Smart Textile , 2018, BIODEVICES.

[11]  Meshari F Alwashmi,et al.  The Use of Digital Health in the Detection and Management of COVID-19 , 2020, International journal of environmental research and public health.

[12]  J. Xiang,et al.  Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study , 2020, The Lancet.

[13]  Floor Sieverink,et al.  Opening the Black Box of Electronic Health: Collecting, Analyzing, and Interpreting Log Data , 2017, JMIR research protocols.

[14]  David A. Clifton,et al.  Probabilistic Estimation of Respiratory Rate from Wearable Sensors , 2015 .

[15]  H. Huikuri,et al.  Electrocardiographic patch devices and contemporary wireless cardiac monitoring , 2015, Front. Physiol..

[16]  D. K. Arvind,et al.  Respiratory Rate and Flow Waveform Estimation from Tri-axial Accelerometer Data , 2010, 2010 International Conference on Body Sensor Networks.

[17]  N. Caputo,et al.  Early Self‐Proning in Awake, Non‐intubated Patients in the Emergency Department: A Single ED’s Experience During the COVID‐19 Pandemic , 2020, Academic emergency medicine : official journal of the Society for Academic Emergency Medicine.

[18]  Iztok Fister,et al.  Sensors and Functionalities of Non-Invasive Wrist-Wearable Devices: A Review , 2018, Sensors.

[19]  T. Hastie,et al.  Accuracy in Wrist-Worn, Sensor-Based Measurements of Heart Rate and Energy Expenditure in a Diverse Cohort , 2016, bioRxiv.

[20]  Märtha Sund-Levander,et al.  Normal oral, rectal, tympanic and axillary body temperature in adult men and women: a systematic literature review. , 2002, Scandinavian journal of caring sciences.

[21]  Elena S. Izmailova,et al.  Evaluation of Wearable Digital Devices in a Phase I Clinical Trial , 2019, Clinical and translational science.

[22]  T. Greenhalgh,et al.  Covid-19: a remote assessment in primary care , 2020, BMJ.

[23]  Xiao Li,et al.  Digital Health: Tracking Physiomes and Activity Using Wearable Biosensors Reveals Useful Health-Related Information , 2017, PLoS biology.

[24]  Toshiyo Tamura,et al.  Current Developments in Wearable Thermometers , 2018 .

[25]  Yutaka Imai,et al.  European Society of Hypertension International Protocol revision 2010 for the validation of blood pressure measuring devices in adults , 2010, Blood pressure monitoring.

[26]  Tsair Kao,et al.  Respiratory Rate Estimation by Using ECG, Impedance, and Motion Sensing in Smart Clothing , 2017, Journal of Medical and Biological Engineering.

[27]  Jessilyn Dunn,et al.  Wearables and the medical revolution. , 2018, Personalized medicine.

[28]  Harry Hemingway,et al.  Blood pressure and incidence of twelve cardiovascular diseases: lifetime risks, healthy life-years lost, and age-specific associations in 1·25 million people , 2014, The Lancet.

[29]  N. Bello,et al.  An Update on Masked Hypertension , 2017, Current Hypertension Reports.

[30]  Beverly B. Green,et al.  History and Justification of a National Blood Pressure Measurement Validated Device Listing , 2019, Hypertension.

[31]  Brennan E. Yamamoto,et al.  Nail polish does not significantly affect pulse oximetry measurements in mildly hypoxic subjects. , 2008, Respiratory care.

[32]  J. Aerts,et al.  Wearable Finger Pulse Oximetry for Continuous Oxygen Saturation Measurements During Daily Home Routines of Patients With Chronic Obstructive Pulmonary Disease (COPD) Over One Week: Observational Study , 2019, JMIR mHealth and uHealth.

[33]  Marco V Perez,et al.  Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation. , 2019, The New England journal of medicine.

[34]  G. Patijn,et al.  Current Evidence for Continuous Vital Signs Monitoring by Wearable Wireless Devices in Hospitalized Adults: Systematic Review , 2020, Journal of medical Internet research.

[35]  Zacharias E. Andreadakis,et al.  The COVID-19 vaccine development landscape , 2020, Nature Reviews Drug Discovery.

[36]  V. Wright,et al.  An objective clinical study of chest expansion. , 1972, Annals of the rheumatic diseases.

[37]  T. Pickering.  Principles and techniques of blood pressure measurement. , 2002, Cardiology clinics.

[38]  Elena S. Izmailova,et al.  Wearable Devices in Clinical Trials: Hype and Hypothesis , 2018, Clinical pharmacology and therapeutics.

[39]  J. Hollander,et al.  Virtually Perfect? Telemedicine for Covid-19. , 2020, The New England journal of medicine.

[40]  Cinna Soltanpur,et al.  A review on wearable photoplethysmography sensors and their potential future applications in health care , 2018, International journal of biosensors & bioelectronics.

[41]  A. Seely,et al.  Comparison of the heart and breathing rate of acutely ill medical patients recorded by nursing staff with those measured over 5 min by a piezoelectric belt and ECG monitor at the time of admission to hospital. , 2011, Resuscitation.

[42]  Andrea Coravos,et al.  Modernizing and designing evaluation frameworks for connected sensor technologies in medicine , 2020, npj Digital Medicine.

[43]  S. Oparil,et al.  Accuracy of Blood Pressure Measurement Devices in Pregnancy: A Systematic Review of Validation Studies , 2018, Hypertension.

[44]  R. Collins,et al.  Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies , 2002, The Lancet.

[45]  Eric J Topol,et al.  Harnessing wearable device data to improve state-level real-time surveillance of influenza-like illness in the USA: a population-based study. , 2020, The Lancet. Digital health.

[46]  João Paulo Silva Cunha,et al.  Wearable Health Devices—Vital Sign Monitoring, Systems and Technologies , 2018, Sensors.

[47]  E. O’Brien,et al.  An outline of the revised British Hypertension Society protocol for the evaluation of blood pressure measuring devices. , 1993, Journal of hypertension.

[48]  Luciano Gattinoni,et al.  Mechanical Ventilation in Adults with Acute Respiratory Distress Syndrome. Summary of the Experimental Evidence for the Clinical Practice Guideline , 2017, Annals of the American Thoracic Society.

[49]  David A. Clifton,et al.  Breathing Rate Estimation From the Electrocardiogram and Photoplethysmogram: A Review , 2017, IEEE Reviews in Biomedical Engineering.

[50]  L. Schultheis,et al.  Clinical Interpretation of Peripheral Pulse Oximeters Labeled “Not for Medical Use” , 2018, The Annals of Family Medicine.

[51]  Santanu Guha,et al.  Digital healthcare: The only solution for better healthcare during COVID-19 pandemic? , 2020, Indian Heart Journal.

[52]  Abi Berger,et al.  Oscillatory Blood Pressure Monitoring Devices , 2001, BMJ : British Medical Journal.

[53]  Neema Moraveji,et al.  Ambulatory monitoring of respiratory effort using a clothing-adhered biosensor , 2018, 2018 IEEE International Symposium on Medical Measurements and Applications (MeMeA).

[54]  H. Maibach,et al.  Allergic Contact Dermatitis to Components of Wearable Adhesive Health Devices. , 2020, Dermatitis : contact, atopic, occupational, drug.

[55]  Elena S. Izmailova,et al.  Continuous Monitoring Using a Wearable Device Detects Activity‐Induced Heart Rate Changes After Administration of Amphetamine , 2019, Clinical and translational science.

[56]  L. Tarassenko,et al.  Protocol for a prospective, controlled, cross-sectional, diagnostic accuracy study to evaluate the specificity and sensitivity of ambulatory monitoring systems in the prompt detection of hypoxia and during movement , 2020, BMJ Open.

[57]  Sarah Kohn,et al.  Wrist-Sensor Pulse Oximeter Enables Prolonged Patient Monitoring in Chronic Lung Diseases , 2019, Journal of Medical Systems.

[58]  D C Hoaglin,et al.  The Effect of Nail Polish on Pulse Oximetry , 1988, Anesthesia and analgesia.

[59]  Nathaniel Hupert,et al.  Clinical Characteristics of Covid-19 in New York City , 2020, The New England journal of medicine.

[60]  N. Marjanovic,et al.  An easy and accurate respiratory rate monitor is necessary , 2019, Journal of Clinical Monitoring and Computing.

[61]  Ramesh Jain,et al.  Respiration rate and volume measurements using wearable strain sensors , 2019, npj Digital Medicine.

[62]  Brinnae Bent,et al.  Investigating sources of inaccuracy in wearable optical heart rate sensors , 2020, npj Digital Medicine.

[63]  Peter J Watkinson,et al.  Wearable monitors for patients following discharge from an intensive care unit: practical lessons learnt from an observational study. , 2016, Journal of advanced nursing.

[64]  H. van Goor,et al.  Continuous Monitoring of Vital Signs Using Wearable Devices on the General Ward: Pilot Study , 2017, JMIR mHealth and uHealth.

[65]  Claire M. Lochner,et al.  Monitoring of Vital Signs with Flexible and Wearable Medical Devices , 2016, Advanced materials.

[66]  Dhruv R. Seshadri,et al.  Wearable Sensors for COVID-19: A Call to Action to Harness Our Digital Infrastructure for Remote Patient Monitoring and Virtual Assessments , 2020, Frontiers in Digital Health.

[67]  Rui-guang Zhang,et al.  Clinical Features of 69 Cases with Coronavirus Disease 2019 in Wuhan, China , 2020, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[68]  Jackson T. Wright,et al.  Measurement of Blood Pressure in Humans: A Scientific Statement From the American Heart Association. , 2019, Hypertension.

[69]  U. Roggenbuck,et al.  [The Stamp of Quality (Prüfsiegel) of the German Hypertension League for the clinical validation of blood pressure measuring devices. Results from the testing of 51 devices]. , 2006, Deutsche Medizinische Wochenschrift.

[70]  N. M. Hettiarachchi,et al.  Clinical Characteristics of COVID-19 , 2020, Journal of the Ceylon College of Physicians.

[71]  M. Seim,et al.  COVID-19 with silent hypoxemia. , 2020, Tidsskrift for den Norske laegeforening : tidsskrift for praktisk medicin, ny raekke.

[72]  Benjamin M. Smith,et al.  Late Breaking Abstract - Validation of Hexoskin biometric technology to monitor ventilatory responses at rest and during exercise in COPD , 2017 .

[73]  L. Masotti,et al.  Respiratory rate assessments using a dual-accelerometer device , 2014, Respiratory Physiology & Neurobiology.

[74]  S. Davies,et al.  Feasibility of continuous temperature monitoring in pediatric immunocompromised patients: A pilot study , 2019, Pediatric blood & cancer.

[75]  Susan DeMeulenaere,et al.  Pulse Oximetry: Uses and Limitations , 2007 .

[76]  Sergio Silvestri,et al.  Contact-Based Methods for Measuring Respiratory Rate , 2019, Sensors.

[77]  S. Steinhubl,et al.  Effect of a Home-Based Wearable Continuous ECG Monitoring Patch on Detection of Undiagnosed Atrial Fibrillation: The mSToPS Randomized Clinical Trial , 2018, JAMA.

[78]  Andrea Aliverti,et al.  Wearable technology: role in respiratory health and disease , 2017, Breathe.

[79]  J. Basile,et al.  Self-Measured Blood Pressure Monitoring at Home: A Joint Policy Statement From the American Heart Association and American Medical Association , 2020, Circulation.

[80]  Jennifer C. Goldsack,et al.  Digital Medicine: A Primer on Measurement , 2019, Digital Biomarkers.

[81]  S. Teerenstra,et al.  Diagnostic accuracy of a single‐lead portable ECG device for measuring QTc prolongation , 2019, Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc.

[82]  S. Lewington.  Prospective studies collaboration. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies (vol 360, pg 1903, 2002) , 2003 .

[83]  V. Tikhonoff,et al.  Poor Reliability of Wrist Blood Pressure Self-Measurement at Home: A Population-Based Study , 2016, Hypertension.

[84]  J. Cacioppo,et al.  Respiratory sinus arrhythmia: autonomic origins, physiological mechanisms, and psychophysiological implications. , 1993, Psychophysiology.

[85]  Ravi Narasimhan,et al.  Ambulatory respiratory rate detection using ECG and a triaxial accelerometer , 2013, 2013 35th Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC).

[86]  L. Tarassenko,et al.  Photoplethysmographic derivation of respiratory rate: a review of relevant physiology , 2012, Journal of medical engineering & technology.

[87]  M. Lipnick,et al.  The Accuracy of 6 Inexpensive Pulse Oximeters Not Cleared by the Food and Drug Administration: The Possible Global Public Health Implications , 2016, Anesthesia and analgesia.

[88]  J. Laragh,et al.  How common is white coat hypertension? , 1988, JAMA.

[89]  Kongqiao Wang,et al.  Learning from Large-Scale Wearable Device Data for Predicting the Epidemic Trend of COVID-19 , 2020, Discrete Dynamics in Nature and Society.