Wearables and the Medical Revolution
Open accessAbstract
Wearable sensors are already impacting healthcare and medicine by enabling health monitoring outside of the clinic and prediction of health events. This paper reviews current and prospective wearable technologies and their progress toward clinical application. We describe technologies underlying common, commercially available wearable sensors and early-stage devices and outline research, when available, to support the use of these devices in healthcare. We cover applications in the following health areas: metabolic, cardiovascular and gastrointestinal monitoring; sleep, neurology, movement disorders and mental health; maternal, pre- and neo-natal care; and pulmonary health and environmental exposures. Finally, we discuss challenges associated with the adoption of wearable sensors in the current healthcare ecosystem and discuss areas for future research and development.
AI snapshot
Written from the paper’s full text.
TL;DR
This review surveys wearable sensors for healthcare, covering mechanical, physiological, and biochemical devices and applications from hospital monitoring to chronic disease, maternal, pulmonary, and mental health. It argues wearables can enable continuous longitudinal monitoring and prediction but require validation, standards, integration, and regulatory clarity before broad clinical adoption.
Key findings
- Wearables span mechanical, physiological, and biochemical sensors, with applications including glucose monitoring, arrhythmia detection, sleep, maternal/fetal care, pulmonary health, and environmental exposures.
- In a partnership with the UCSF Health eHeart study, Cardiogram’s DeepHeart platform used data from 14,011 wearable-equipped participants and detected Type II diabetes at 85% accuracy, atrial fibrillation at 97%, sleep apnea at 90%, and hypertension at 82%. A trial comparing AliveCor’s technology with routine care (n = 1001) resulted in a nearly fourfold increase in atrial fibrillation diagnosis.
- Other reported performance examples include Fitbit Charge post-ICU tachycardia detection with 69.5% sensitivity and 98.8% specificity (n = 50); Oura ring sleep detection with 96% sensitivity, 48% wake specificity, and 65/51/61% agreement for light/deep/REM sleep; Empatica Embrace detecting 94% of GTC seizures in 80 pediatric patients with less than one false alarm per 24 h; ADAMM asthma detection accuracy of 71% in 84 teens; and VitalConnect HealthPatch fall detection with 99% sensitivity and 100% specificity (n = 25).
- The global wearable devices market was anticipated to reach $19.5 billion in 2021; replacing one in five outpatient consultations and home health visits with digital visits was estimated to save $40 billion a year, and remote monitoring in patients with implantable cardiovascular devices (n = 43) decreased healthcare costs by 25%.
Methods
- Narrative review of current and prospective wearable technologies and their progress toward clinical application, organized by health areas: metabolic, cardiovascular, and gastrointestinal monitoring; sleep, neurology, movement disorders, and mental health; maternal, pre- and neo-natal care; and pulmonary health and environmental exposures.
- No primary data collection; the paper synthesizes published studies, commercially available devices, early-stage devices, and examples from the literature.
- No systematic search strategy, inclusion criteria, or meta-analysis is stated; the review also discusses regulatory oversight, economic impact, challenges, and future directions.
Limitations
- The paper states limitations including high device cost, cross-platform incompatibility, lack of data standards, setup and charging burden, variable acceptability and stigma, need for large clinical and field trials, unsubstantiated commercial claims, false negatives and false positives, inaccurate activity tracking, need for clinician training, and potential emotional burden or technology addiction.
- Evident from the text: as a narrative review, it lacks a systematic search or formal quality appraisal, and many cited studies are small, early-stage, feasibility, pilot, or not yet peer-reviewed; several device examples are commercial or under development.
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Integrity signals
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Claims the paper makes
0 of 120 cited sources checked · 0 supported · 0 flagged
- Findingcitation
Algorithms have been developed to automatically process and interpret wearables data to present evidence-based health insights such as detection of inflammation or prediction of cardiometabolic health based on activity habits.
“To address this data deluge, we and others have recently developed algorithms to automatically process and interpret wearables data in order to present evidence-based health insights such as detection of inflammation or prediction of cardiometabolic health based on activity habits [40-43].”
Quote in the paperSubstantial claim0 of 4 sources checked- cites [40] Li X, Dunn J, Salins D Digital health: tracking physiomes and activity using wearable biosensors reveals useful health-related information. PLoS Biol. 15(1), e2001402 (2017). 28081144 PMC5230763 •• The first deep phenotyping study that used wearable sensing to detect health events. source
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- cites [41] Ballinger B, Hsieh J, Singh A DeepHeart: semi-supervised sequence learning for cardiovascular risk prediction. arXiv (2018). https://arxiv.org/abs/1802.02511
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- cites [42] Lim WK, Davila S, Teo JX Beyond fitness tracking: The use of consumer-grade wearable data from normal volunteers in cardiovascular and lipidomics research. PLoS Biol. 16(2), e2004285 (2018). 29485983 PMC5828350 source
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- cites [43] Price ND, Magis AT, Earls JC A wellness study of 108 individuals using personal, dense, dynamic data clouds. Nat. Biotechnol 35(8), 747– 756 (2017). 28714965 PMC5568837 source
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- Findingcitation
A semi-supervised method reduces the amount of labeled wearables data needed for training digital biomarker models by tenfold.
“A semi-supervised method that reduces the amount of labeled wearables data needed for training digital biomarker models by tenfold was developed to address this challenge.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [41] Ballinger B, Hsieh J, Singh A DeepHeart: semi-supervised sequence learning for cardiovascular risk prediction. arXiv (2018). https://arxiv.org/abs/1802.02511
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- Findingcitation
Wearables have been successful in detecting obstructive sleep apnea with personalized machine learning algorithms based on similarity to other OSA patients, with detection accuracies between 90 and 93.6%.
“Wearables have been successful in detecting OSA in a variety of ways, including with personalized machine learning algorithms based on similarity to other OSA patients (detection accuracies between 90 and 93.6%) [41,87].”
Quote in the paperNot a substantial claim0 of 2 sources checked- cites [41] Ballinger B, Hsieh J, Singh A DeepHeart: semi-supervised sequence learning for cardiovascular risk prediction. arXiv (2018). https://arxiv.org/abs/1802.02511
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- cites [87] Wu H-T, Wu J-C, Huang P-C Phenotype-based and self-learning inter-individual sleep Apnea screening with a level IV monitoring system. arXiv (2018). https://arxiv.org/abs/1802.09706 PMC6036126 30013479
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- Findingcitation
In a recent feasibility study, Fitbit Charge monitoring of post-ICU convalescence in 50 stable ICU patients over 24 h had tachycardia detection sensitivity 69.5% and specificity 98.8%.
“Tachycardia detection had 69.5% sensitivity and 98.8% specificity [22].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [22] Kroll RR, Mckenzie ED, Boyd JG Use of wearable devices for post-discharge monitoring of ICU patients: a feasibility study. J. Intensive Care 5, 64 (2017). 29201377 PMC5698959 source
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- Findingreasoning
Some digital biomarkers have been found to outperform traditional clinical methods, for example, for arrhythmia detection, because of their ability to continuously monitor patients outside of the clinic.
“Some digital biomarkers have been found to outperform traditional clinical methods, for example, for arrhythmia detection, because of their ability to continuously monitor patients outside of the clinic.”
Quote in the paperNot a substantial claim
- Findingcitation
Specificity of the Oura ring in detecting wake was 48%.
“Specificity in detecting wake was 48%.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [35] De Zambotti M, Rosas L, Colrain IM, Baker FC. The sleep of the ring: comparison of the OURA sleep tracker against polysomnography. Behav. Sleep Med doi: 10.1080/15402002.2017.1300587 (2017) (Epub ahead of print). PMC6095823 28323455 source
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- Findingcitation
Using only measurements from a consumer smart watch, the authors were able to predict clinical measurements of inflammation, infection and insulin sensitivity status.
“Encouragingly, using only measurements from a consumer smart watch, we were able to predict clinical measurements of inflammation, infection and insulin sensitivity status based only on measurements from a consumer smart watch [40].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [40] Li X, Dunn J, Salins D Digital health: tracking physiomes and activity using wearable biosensors reveals useful health-related information. PLoS Biol. 15(1), e2001402 (2017). 28081144 PMC5230763 •• The first deep phenotyping study that used wearable sensing to detect health events. source
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- Findingcitation
In a multisite retrospective study of 172,726 ED visits, e-triage predictions had areas under the receiver operating characteristic curve ranging from 0.73 to 0.92.
“In a multisite retrospective study of 172,726 ED visits, e-triage predictions had areas under the receiver operating characteristic curve ranging from 0.73 to 0.92.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [53] Levin S, Toerper M, Hamrock E Machine-learning-based electronic triage more accurately differentiates patients with respect to clinical outcomes compared with the emergency severity index. Ann. Emerg. Med doi: 10.1016/j.annemergmed.2017.08.005 (2017) (Epub ahead of print). 28888332 source
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- Findingcitation
LifeVest showed comparable outcomes to implantable cardiac devices in a 3-year study (n = 3569) with acute event survival at 99.2%.
“LiveVest showed comparable outcomes to implantable cardiac devices in a 3-year study (n = 3569) with acute event survival at 99.2% [38].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [38] Chung MK, Szymkiewicz SJ, Shao M Aggregate national experience with the wearable cardioverter-defibrillator: event rates, compliance, and survival. J. Am. College Cardiol 56(3), 194– 203 (2010). PMC2962668 20620738 source
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- Findingcitation
Similar to PSG, deep sleep detected with the Oura ring was negatively correlated with advancing age.
“Similar to PSG, ‘deep sleep’ detected with the Oura ring was negatively correlated with advancing age [35].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [35] De Zambotti M, Rosas L, Colrain IM, Baker FC. The sleep of the ring: comparison of the OURA sleep tracker against polysomnography. Behav. Sleep Med doi: 10.1080/15402002.2017.1300587 (2017) (Epub ahead of print). PMC6095823 28323455 source
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- Findingnone given
All leading CGMs on market today are wearable but invasive to some extent through a subdermal needle or flexible filament insertion.
“All are wearable but invasive to some extent (through a subdermal needle or flexible filament insertion).”
Quote in the paperNot a substantial claim - Findingcitation
A recent trial comparing AliveCor's technology with routine care (n = 1001) resulted in a nearly fourfold increase in atrial fibrillation diagnosis.
“A recent trial comparing AliveCor’s technology with routine care (n = 1001) resulted in a nearly fourfold increase in atrial fibrillation diagnosis [15].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [15] Halcox JPJ, Wareham K, Cardew A Assessment of remote heart rhythm sampling using the AliveCor heart monitor to screen for atrial fibrillation: the REHEARSE-AF study. Circulation 136(19), 1784– 1794 (2017). 28851729 source
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- Findingcitation
In a study of 80 pediatric patients with varying degrees of epilepsy, Empatica Embrace detected 94% of GTC seizures with less than one false alarm per 24-h period.
“In a study of 80 pediatric patients with varying degrees of epilepsy, Embrace detected 94% of GTC seizures with less than one false alarm per 24-h period [20].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [20] Poh MZ, Loddenkemper T, Reinsberger C Convulsive seizure detection using a wrist-worn electrodermal activity and accelerometry biosensor. Epilepsia 53(5), e93– e97 (2012). 22432935 source
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- Findingcitation
In a pilot study (n = 10), a single-channel electroencephalogram and IMU sensor detected five different levels of drowsiness with an average of 95.2% accuracy.
“To explore the use of wearable devices to detect drowsiness, one recent pilot study (n = 10) used a single-channel electroencephalogram and IMU sensor to detect five different levels of drowsiness with an average of 95.2% accuracy [91].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [91] Kartsch VJ, Benatti S, Schiavone PD, Rossi D, Benini L. A sensor fusion approach for drowsiness detection in wearable ultra-low-power systems. Inform. Fusion 43, 66– 76 (2018). source
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- Findingcitation
The SurroGait Rx device has been successful for pressure-offloading alerts to prevent diabetic foot ulcers.
“This device has also been successful for pressure-offloading alerts to prevent diabetic foot ulcers, which cost the US$81.7 billion in 2012 [104,105].”
Quote in the paperNot a substantial claim0 of 2 sources checked- cites [104] Rice JB, Desai U, Cummings AKG, Birnbaum HG, Skornicki M, Parsons NB. Burden of diabetic foot ulcers for medicare and private insurers. Diabetes Care 37(3), 651– 658 (2014). 24186882 source
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- Findingcitation
A study on the relationship between mood and physical activity using wearable actigraphs (n = 85) showed that distinct activity patterns correspond with worsening depressive symptoms.
“A study on the relationship between mood and physical activity using wearable actigraphs (n = 85) showed that distinct activity patterns correspond with worsening depressive symptoms [96].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [96] Kim J, Nakamura T, Kikuchi H, Sasaki T, Yamamoto Y. Co-variation of depressive mood and locomotor dynamics evaluated by ecological momentary assessment in healthy humans. PLoS ONE 8(9), e74979 (2013). 24058642 PMC3773004 source
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- Findingcitation
By tracking additional metrics like diurnal activity and circadian amplitude and dysregulation using wearable sensors, researchers could distinguish BD and non-BD conditions, such as ADHD, with 83% accuracy (92% specificity and 64% sensitivity).
“By tracking additional metrics like diurnal activity and circadian amplitude and dysregulation using wearable sensors, researchers could distinguish BD and non-BD conditions, such as ADHD, with 83% accuracy (92% specificity and 64% sensitivity) [98].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [98] Faedda GL, Ohashi K, Hernandez M Actigraph measures discriminate pediatric bipolar disorder from attention-deficit/hyperactivity disorder and typically developing controls. J. Child Psychol. Psychiatry. 57(6), 706– 716 (2016). 26799153 PMC4873411 source
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- Findingcitation
Bipolar Disorder mood states including depression, mixed, mania and euthymia were accurately classified (68-85%) using a support vector machine trained on features of heart rate variability and previous mood (n = 8).
“Bipolar Disorder (BD) mood states including depression, mixed, mania and euthymia were accurately classified (68–85%) using a support vector machine trained on features of heart rate variability and previous mood (n = 8) [97].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [97] Gentili C, Valenza G, Nardelli M Longitudinal monitoring of heartbeat dynamics predicts mood changes in bipolar patients: a pilot study. J. Affect. Disord 209, 30– 38 (2017). 27870943 source
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- Findingcitation
In the authors' recent study monitoring physiological changes using wearables during flight, SpO2 directly corresponds to drowsiness level.
“In our recent study monitoring physiological changes using wearables during flight, we found that SpO2 directly corresponds to drowsiness level [40].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [40] Li X, Dunn J, Salins D Digital health: tracking physiomes and activity using wearable biosensors reveals useful health-related information. PLoS Biol. 15(1), e2001402 (2017). 28081144 PMC5230763 •• The first deep phenotyping study that used wearable sensing to detect health events. source
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- Findingcitation
New devices that promise to change the current paradigm of hypertension monitoring use either inflating wristband cuffs or optical pulse wave-based metrics of BP.
“New devices that promise to change the current paradigm of hypertension monitoring use either inflating wristband cuffs (e.g., Omron HeartGuide, currently undergoing clinical testing) or optical pulse wave-based metrics of BP [75,76].”
Quote in the paperNot a substantial claim0 of 2 sources checked- cites [75] Solà J, Proença M, Braun F Continuous non-invasive monitoring of blood pressure in the operating room: a cuffless optical technology at the fingertip. Curr. Dir. Biomed. Eng 2(1), 267– 271 (2016). source
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- cites [76] Mukkamala R, Hahn J-O, Inan OT Toward ubiquitous blood pressure monitoring via pulse transit time: theory and practice. IEEE Transact. Biomed. Eng 62(8), 1879– 1901 (2015). PMC4515215 26057530 source
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- Findingcitation
G-tech monitors gastric myoelectric activity via electrodes that measure motor activity of the stomach, small intestine and colon.
“G-tech (Mountain View, CA, USA) takes a different approach to gastric myoelectric activity monitoring via electrodes that measure motor activity of the stomach, small intestine and colon [24,25].”
Quote in the paperNot a substantial claim0 of 2 sources checked- cites [24] G-Tech Medical. Current Studies (2018). www.gtechmedical.com/clinical-studies.php
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- cites [25] Dua MM, Malhotra L, Navalgund AR, Axelrod S, Triadafilopoulos G, Visser B. Monitoring of gastric myoelectric activity after pancreaticoduodenectomy. Gastroenterology 152(5), S1293– S1294 (2017). 30048596 source
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- Findingcitation
The Gastrointestinal Logic AbStats system provides real-time digestive telemetry via noninvasive vibration and sound sensing to assess postsurgery GI tract re-engagement.
“The Gastrointestinal Logic AbStats system (CA, USA) provides real-time digestive telemetry via noninvasive vibration and sound sensing to assess postsurgery GI tract re-engagement [23].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [23] Spiegel BM, Kaneshiro M, Russell MM Validation of an acoustic gastrointestinal surveillance biosensor for postoperative ileus. J. Gastrointest. Surg 18(10), 1795– 1803 (2014). 25091837 source
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- Findingcitation
The SurroGait Rx system senses and converts pressure produced on the insole during walking to the vest with a built-in vibrotactile array to re-teach multiple sclerosis patients to walk (n = 7, 16 weeks).
“The system senses and converts pressure produced on the insole during walking to the vest with a built-in vibrotactile array to re-teach multiple sclerosis patients to walk (n = 7, 16 weeks) [33].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [33] Vienneau J, Bauman J, Nigg S, Nigg BM, Jarvis SE. Investigating the effects of the SurroGait Rx™ device on postural stability, gait, and MSIS-29 outcomes in people with multiple sclerosis. Biomed. Open Access J. Med. Clin. Res 2(1) (2018).
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- Findingcitation
Using physiological and movement metrics from a smartwatch to infer outburst patterns, real-time, self-regulation exercises are sent as smartwatch notifications as a just-in-time intervention.
“Using physiological and movement metrics from a smartwatch to infer outburst patterns, real-time, self-regulation exercises are sent as smartwatch notifications as a just-in-time intervention.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [99] Torrado JC, Gomez J, Montoro G. Emotional self-regulation of individuals with autism spectrum disorders: smartwatches for monitoring and interaction. Sensors (Basel) 17(6), 1359 (2017). 28604607 PMC5492838 source
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- Interpretationnone given
Integration of wearables data in clinical decision support can improve their utility and outcomes.
“Integration of wearables data in CDS can improve their utility and outcomes.”
Quote in the paperSubstantial claim - Premisecitation
Chronic sleep deprivation is linked to chronic illness such as heart disease, obesity, diabetes and depression.
“Diminished motor-skill coordination from lack of sleep leads to accidents and injury, and chronic sleep deprivation is linked to chronic illness such as heart disease, obesity, diabetes and depression [85].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [85] Centers for Disease Control and Prevention. Sleep and sleep disorders (2017). www.cdc.gov/sleep/aboutus.html
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- Interpretationcitation
Wearable sensors show promise for monitoring sleep and related outcomes.
“Wearable sensors show promise for monitoring sleep and related outcomes.”
Quote in the paperSubstantial claim - Interpretationreasoning
Artificial intelligence platforms can learn and predict effective interventions for an individual using a combination of personal historical data and population-level data to optimize treatment type and timing.
“Artificial intelligence platforms can learn and predict effective interventions for an individual using a combination of personal historical data and population-level data to optimize treatment type and timing.”
Quote in the paperSubstantial claim - Interpretationcitation
Mobile apps provide a means to more accurately record symptoms through real-time assessments that can be administered outside of the clinic and accurate recall and time of recording.
“Mobile apps provide a means to more accurately record symptoms (e.g., depressive mood, anxious mood or fatigue) through real-time assessments that can be administered outside of the clinic and accurate recall and time of recording [94,95].”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [94] Runyan JD, Steenbergh TA, Bainbridge C, Daugherty DA, Oke L, Fry BN. A smartphone ecological momentary assessment/intervention ‘app’ for collecting real-time data and promoting self-awareness. PLoS ONE 8(8), e71325 (2013). 23977016 PMC3743745 source
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- cites [95] Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu. Rev. Clin. Psychol. 4, 1– 32 (2008). 18509902 source
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- Interpretationreasoning
Wearables may differentiate between disorders that have shared symptoms which may cause delays in diagnosis or treatment, imprecise treatment or misdiagnosis.
“Wearables may also differentiate between disorders that have shared symptoms which may cause delays in diagnosis or treatment, imprecise treatment or misdiagnosis (e.g., hyperactivity shared by BD and ADHD).”
Quote in the paperSubstantial claim - Interpretationnone given
There are already several findings to support the use of wearable sensors combined with tailored algorithms for continuous, longitudinal monitoring, for example, for detection of abnormal heart conditions, hypertension, and diabetes.
“As described above, there are already several findings to support the use of wearable sensors combined with tailored algorithms for continuous, longitudinal monitoring, for example, for detection of abnormal heart conditions, hypertension, diabetes, for example (Figure 1C).”
Quote in the paperNot a substantial claim - Premisecitation
Low-power solutions for integrating personal ozone exposure and volatile organic compound measures are beginning to appear.
“Toward the inclusion of multiple sensors to improve the accuracy of pulmonary disease efforts, low-power solutions for integrating personal ozone exposure and volatile organic compound measures are beginning to appear [127].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [127] Dieffenderfer J, Goodell H, Mills S Low-power wearable systems for continuous monitoring of environment and health for chronic respiratory disease. IEEE J. Biomed. Health Inform 20(5), 1251– 1264 (2016). 27249840 PMC5124429 source
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- Premisecitation
Step counts are most accurate at slow walking speeds.
“Leth et al. demonstrated that step counts are most accurate at slow walking speeds [145].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [145] Leth S, Hansen J, Nielsen OW, Dinesen B. Evaluation of commercial self-monitoring devices for clinical purposes: results from the future patient trial, Phase I. Sensors (Basel) 17(1), 211 (2017). 28117736 PMC5298782 source
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- Interpretationcitation
Additional benefits of wearable sensors in the field setting include their applicability in environments where rapid medical care is needed and often not readily available, for example, at the scene of accidents, in military settings, athletics and in resource-constrained environments.
“Additional benefits of wearable sensors in the field setting include their applicability in environments where rapid medical care is needed and often not readily available, for example, at the scene of accidents, in military settings, athletics and in resource-constrained environments (Figure 2) [36,138-140].”
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- Premisecitation
The Bloomlife Smart Pregnancy Tracker was shown to have an 87% success rate in predicting delivery within 24-h using electrohysterography and HR.
“The Bloomlife Smart Pregnancy Tracker (CA, USA), a wearable device for tracking contractions in the third trimester of pregnancy, was shown to have an 87% success rate in predicting delivery within 24-h using electrohysterography and HR [18,120].”
Quote in the paperNot a substantial claim0 of 2 sources checked- cites [18] Altini M, Rossetti E, Rooijakkers M Combining electrohysterography and heart rate data to detect labour. Presented at: Biomedical & Health Informatics (BHI), 2017 IEEE EMBS International Conference Orlando-, FL, USA (16-19 February 2017).
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- cites [120] Altini M, Rossetti E, Rooijakkers M 762: remote labour detection using maternal electrohysterography and heart rate data acquired with a wearable sensor. Am. J. Obstet. Gynecol 216(1), S441– S442 (2017). source
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- Interpretationcitation
Wearable sensors have been highly successful in fall detection.
“Wearable sensors have been highly successful in fall detection [50,106,107].”
Quote in the paperNot a substantial claim0 of 3 sources checked- cites [50] Narasimhan R. Skin-contact sensor for automatic fall detection. Presented at: Engineering in Medicine and Biology Society (EMBC), 2012 Annual International Conference of the IEEE. CA, USA (28 August-1 September 2012). 23366814
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- cites [107] Ojetola O, Gaura EI, Brusey J. Fall detection with wearable sensors–safe (smart fall detection). Presented at: Intelligent Environments (IE), 2011 7th International Conference. Nottingham, UK, (25-28 July 2011).
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- Interpretationcitation
New and extremely novel wearable sensors are being developed that build upon movement, physiological and biochemical sensors to improve disease detection and prognostication through changes in physiology over time or as a result of a specific treatment or intervention.
“New and extremely novel wearable sensors are being developed that build upon movement, physiological and biochemical sensors in existence to improve disease detection and prognostication through changes in physiology over time or as a result of a specific treatment or intervention.”
Quote in the paperSubstantial claim - Premisecitation
A tri-axial accelerometer worn at any location of a participant's body and in any orientation could detect falls with a sensitivity of 99% and specificity of 100% (n = 25).
“A study on VitalConnect’s HealthPatch wearable found that a tri-axial accelerometer worn at any location of a participant’s body, and in any orientation, could detect falls with a sensitivity of 99% and specificity of 100% (n = 25) [50].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [50] Narasimhan R. Skin-contact sensor for automatic fall detection. Presented at: Engineering in Medicine and Biology Society (EMBC), 2012 Annual International Conference of the IEEE. CA, USA (28 August-1 September 2012). 23366814
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- Interpretationcitation
The large number of potentially important environmental exposures makes developing a single 'exposome' device challenging.
“The large number of potentially important environmental exposures makes developing a single ‘exposome’ device challenging [126].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [126] Asimina S, Chapizanis D, Karakitsios S Assessing and enhancing the utility of low-cost activity and location sensors for exposure studies. Environ. Monit. Assess 190(3), 155 (2018). 29464404 source
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- Interpretationreasoning
If wearables replaced even a few costly gold standard tests and services, combined savings could effectively reduce much of the healthcare burden.
“If wearables were to replace even a few of the many costly, gold standard tests and services mentioned in this review, it becomes clear that this kind of combined savings could effectively reduce much of the healthcare burden.”
Quote in the paperSubstantial claim - Premisecitation
In a study of 91 women, fertile-window sleeping pulse rate measured via PPG was significantly increased compared with the menstrual phase, by an average of 2.1 beat-per-minute.
“In a recent study of 91 women, a significant increase of the fertile-window sleeping pulse rate compared with the menstrual phase (an average of 2.1 beat-per-minute) measured via PPG was found [17].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [17] Shilaih M, Clerck V, Falco L, Kubler F, Leeners B. Pulse rate measurement during sleep using wearable sensors, and its correlation with the menstrual cycle phases, a prospective observational study. Sci. Rep 7(1), 1294 (2017). 28465583 PMC5431053 • Demonstrates that traditional methods of clinical measurements are insufficient to capture temporal and cyclical biological variation. source
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- Premisecitation
Replacing one in five outpatient consultations and home health visits with digital visits would save $40 billion a year in healthcare costs.
“Replacing just one in five outpatient consultations and home health visits with digital visits would alone save $40 billion a year in healthcare costs [132].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [132] Atluri V, Cordina J, Mango P, Velamooret S. How tech-enabled consumers are reordering the healthcare landscape. McKinsey & Company, (2016). www.mckinsey.com/industries/healthcare-systems-and-services/our-insights/how-tech-enabled-consumers-are-reordering-the-healthcare-landscape
Not checked in the free run.
- Interpretationreasoning
Several recently FDA-approved or FDA-approval-pending devices have the potential to dramatically change the healthcare landscape given their potential for use in and out of the clinic for health and disease management.
“Several devices that have been recently approved by the FDA or that are currently undergoing FDA approval have the potential to dramatically change healthcare landscape given their potential for use in and out of the clinic for health and disease management.”
Quote in the paperSubstantial claim - Interpretationcitation
Such devices have caused frustration in the pediatric medical community due to unsubstantiated claims that may encourage parents to use these devices to monitor infants for conditions such as sudden infant death syndrome and potentially deliver unnecessary or harmful interventions.
“Such devices have caused frustration in the pediatric medical community due to unsubstantiated claims that may encourage parents to use these devices to monitor infants for medical conditions such as sudden infant death syndrome and potentially deliver unecessary or even harmful interventions [123].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [123] Moon RY, Task Force on Sudden Infant Death S. SIDS and other sleep-related infant deaths: evidence base for 2016 updated recommendations for a safe infant sleeping environment. Pediatrics 138(5) pii: e20162940 (2016). 27940805 source
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- Premisecitation
In a validation study, 84 teens aged 13 to 17 were monitored for 1 week, and ADAMM demonstrated an asthma detection accuracy of 71%.
“In a recent validation study, 84 teens between the ages of 13 and 17 were monitored for 1 week during which the ADAMM device collected audio data to assess the number of cough events, ultimately demonstrating an asthma detection accuracy of 71% [26].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [26] Rhee H, Belyea MJ, Sterling M, Bocko MF. Evaluating the validity of an automated device for asthma monitoring for adolescents: correlational design. J. Med. Internet Res 17(10), e234 (2015). 26475634 PMC4704980 source
Not checked in the free run.
- Premisecitation
Mechanical properties of soft tissues were recently monitored via wearables to determine spatiotemporal changes in viscoelasticity of basal cell carcinoma lesions.
“Mechanical properties of soft tissues were recently monitored via wearables to determine spatiotemporal changes in viscoelasticity of basal cell carcinoma lesions [147].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [147] Dagdeviren C, Shi Y, Joe P Conformal piezoelectric systems for clinical and experimental characterization of soft tissue biomechanics. Nat. Mater 14(7), 728– 736 (2015). 25985458 source
Not checked in the free run.
- Interpretationcitation
Inaccuracy of activity trackers may lead individuals to overestimate their level of physical activity, limiting their effectiveness for lifestyle interventions.
“Inaccuracy of activity trackers may also lead individuals to overestimate their level of physical activity, limiting their effectiveness for lifestyle interventions [142,143].”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [142] Wallen MP, Gomersall SR, Keating SE, Wisloff U, Coombes JS. Accuracy of heart rate watches: implications for weight management. PLoS ONE 11(5), e0154420 (2016). 27232714 PMC4883747 source
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- cites [143] Dooley EE, Golaszewski NM, Bartholomew JB. Estimating accuracy at exercise intensities: a comparative study of self-monitoring heart rate and physical activity wearable devices. JMIR Mhealth Uhealth 5(3), e34 (2017). 28302596 PMC5374271 source
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- Premisecitation
The global wearable devices market is anticipated to reach $19.5 billion in 2021.
“With the global wearable devices market anticipated to reach $19.5 billion in 2021 [131], wearable technology has the momentum to dramatically alter our current healthcare economics landscape.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [131] Dangi RT. Wearable medical devices: technologies and global markets 2018. (2017) www.reportlinker.com/p05285115/Wearable-Medical-Devices-Technologies-and-Global-Markets.html
Not checked in the free run.
- Interpretationreasoning
There are several limitations to the use of wearable technology in healthcare.
“There are several limitations to the use of wearable technology in healthcare (Figure 2D).”
Quote in the paperNot a substantial claim - Premisecitation
In a study of patients with implantable cardiovascular devices (n = 43), remote monitoring decreased healthcare costs by 25%.
“In a study involving patients with implantable cardiovascular devices (n = 43), remote monitoring decreased healthcare costs for those patients by 25% [133].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [133] Costa PD, Reis AH, Rodrigues PP. Clinical and economic impact of remote monitoring on the follow-up of patients with implantable electronic cardiovascular devices: an observational study. Telemed. J E Health 19(2), 71– 80 (2013). 23336734 source
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- Premisecitation
Remote monitoring and telemedicine-based approaches greatly improve care access for women with newborns.
“studies show that remote monitoring and telemedicine-based approaches greatly improve care access for women with newborns [116-118].”
Quote in the paperSubstantial claim0 of 3 sources checked- cites [116] Dietz PM, Vesco KK, Callaghan WM Postpartum screening for diabetes after a gestational diabetes mellitus–affected pregnancy. Obstet. Gynecol 112(4), 868– 874 (2008). 18827130 source
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- cites [117] Vesco KK, Dietz PM, Bulkley J A system-based intervention to improve postpartum diabetes screening among women with gestational diabetes. Am. J. Obstet. Gynecol 207(4), 283. e281– 283. e286 (2012). 23021689 source
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- cites [118] Nicklas JM, Zera CA, Seely EW, Abdul-Rahim ZS, Rudloff ND, Levkoff SE. Identifying postpartum intervention approaches to prevent Type 2 diabetes in women with a history of gestational diabetes. BMC Pregnancy Childbirth 11, 23 (2011). 21435246 PMC3076295 source
Not checked in the free run.
- Premisecitation
Studies demonstrate that the wearable chest device ADAMM can be used to track adolescent asthma.
“Studies demonstrate that the wearable chest device, ADAMM, can be used to track adolescent asthma [26-28].”
Quote in the paperSubstantial claim0 of 3 sources checked- cites [26] Rhee H, Belyea MJ, Sterling M, Bocko MF. Evaluating the validity of an automated device for asthma monitoring for adolescents: correlational design. J. Med. Internet Res 17(10), e234 (2015). 26475634 PMC4704980 source
Not checked in the free run.
- cites [27] Rhee H, Miner S, Sterling M, Halterman JS, Fairbanks E. The development of an automated device for asthma monitoring for adolescents: methodologic approach and user acceptability. JMIR Mhealth Uhealth 2(2), e27 (2014). 25100184 PMC4114416 source
Not checked in the free run.
- cites [28] Sterling M, Rhee H, Bocko M. Automated cough assessment on a mobile platform. J. Med. Eng (2014). www.hindawi.com/journals/jme/2014/951621/cta/ PMC4264627 25506590 source
Not checked in the free run.
- Premisecitation
Several research groups have recently developed mechanically flexible and fully integrated wearable sweat sensors for analysis of biofluid metabolites and electrolytes and pH sensing.
“Several research groups have recently developed mechanically flexible and fully integrated wearable sweat sensors (in wristband, temporary tattoo, eyeglasses, mouthguard) for analysis of biofluid metabolites and electrolytes (e.g., glucose, lactate, sodium, potassium) and pH sensing [156-160].”
Quote in the paperNot a substantial claim0 of 5 sources checked- cites [156] Gao W, Emaminejad S, Nyein HYY Fully integrated wearable sensor arrays for multiplexed in situ perspiration analysis. Nature 529(7587), 509– 514 (2016). 26819044 PMC4996079 source
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- cites [157] Dang W, Manjakkal L, Navaraj WT, Lorenzelli L, Vinciguerra V, Dahiya R. Stretchable wireless system for sweat pH monitoring. Biosens. Bioelectron. 107, 192– 202 (2018). 29471280 source
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- cites [158] Sempionatto JR, Nakagawa T, Pavinatto A Eyeglasses based wireless electrolyte and metabolite sensor platform. Lab Chip 17(10), 1834– 1842 (2017). 28470263 PMC5507201 source
Not checked in the free run.
- cites [159] Jia W, Bandodkar AJ, ValdéS-Ramırez G Electrochemical tattoo biosensors for real-time noninvasive lactate monitoring in human perspiration. Analytical Chemistry 85(14), 6553– 6560 (2013). 23815621 source
Not checked in the free run.
- cites [160] Kim J, Imani S, De Araujo WR Wearable salivary uric acid mouthguard biosensor with integrated wireless electronics. Biosens. Bioelectron 74, 1061– 1068 (2015). 26276541 PMC4718709 source
Not checked in the free run.
- Premisecitation
Kulkarni et al. developed a rapid (down to 0.1 s) and sensitive (down to 1 part per billion) nanoelectric graphene vapor sensor that can continuously monitor a wide range of vapor analytes from breath or the environment.
“Kulkarni et al. developed a rapid (down to 0.1 s) and sensitive (down to 1 part per billion) nanoelectric graphene vapor sensor that can continuously monitor a wide range of vapor analytes (e.g., nitric oxide, oxygen) from breath or the environment to monitor for illness or harmful environmental exposures [150,151].”
Quote in the paperNot a substantial claim0 of 2 sources checked- cites [150] Kulkarni GS, Zang W, Zhong Z. Nanoelectronic heterodyne sensor: a new electronic sensing paradigm. Acc. Chem. Res 49(11), 2578– 2586 (2016). 27668314 source
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- cites [151] Kulkarni GS, Reddy K, Zhong Z, Fan X. Graphene nanoelectronic heterodyne sensor for rapid and sensitive vapour detection. Nat. Commun 5, 4376 (2014). 24999712 source
Not checked in the free run.
- Interpretationreasoning
The need for off-site analysis and replacement devices or device cartridges has posed a limitation for longitudinal studies using exposome devices.
“The need for off-site analysis and replacement devices or device cartridges has posed a limitation for longitudinal studies using exposome devices.”
Quote in the paperNot a substantial claim - Premisecitation
Wearable systems enabling stimulus-induced drug delivery that enable dose- and spatiotemporally controlled sustained release of therapeutics have been recently explored.
“Wearable systems enabling stimulus-induced drug delivery (with the stimulus being mechanical changes or signals based on biosensor data analysis) that enable a dose- and spatiotemporally controlled sustained release of therapeutics have been recently explored [163].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [163] Lu Y, Sun W, Gu Z. Stimuli-responsive nanomaterials for therapeutic protein delivery. J. Control. Release 194, 1– 19 (2014). 25151983 PMC4330094 source
Not checked in the free run.
- Interpretationnone given
The lack of publicly available evidence supporting the safety, accuracy, effectiveness or role of these monitors hinders their use in clinical and healthcare settings.
“The lack of publicly available evidence supporting the safety, accuracy, effectiveness or role of these monitors hinders their use in clinical and healthcare settings.”
Quote in the paperSubstantial claim - Premisecitation
Some exposome devices are beginning to address the need for off-site analysis and replacement.
“There are some exposome devices, however, that are beginning to address that [155].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [155] National Institute on Alcohol Abuse and Alcoholism. Director’s report on institute activities to the 142nd meeting of the National Advisory Council on Alcohol Abuse and Alcoholism (2018). www.niaaa.nih.gov/about-niaaa/our-work/advisory-council/directors-reports-council/niaaa-directors-report-institute-12
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- Classified as probably not a substantial claim. 31
- May combine two claims. 42
Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).
Findingnone givenWearables most commonly related to clinical applications include biochemical sensors.
“Wearables that are most commonly related to clinical applications include biochemical sensors.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing), S4 (based).
Findingnone givenThe first continuous glucose monitor for retrospective patient analysis (MiniMed) earned FDA approval in 1999.
“The first continuous glucose monitor (CGM) for retrospective patient analysis (MiniMed) earned FDA approval in 1999.”
Quote in the paperNot a substantial claimMay combine two claims.
FindingcitationThe Oura ring compared with polysomnography had 96% sensitivity to detect sleep, and agreement of 65, 51 and 61% in detecting light sleep, deep sleep and REM sleep, respectively.
“The Oura ring (FIN) compared with polysomnography had a 96% sensitivity to detect sleep, and agreement of 65, 51 and 61%, in detecting ‘light sleep’, ‘deep sleep’ and REM sleep, respectively.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [35] De Zambotti M, Rosas L, Colrain IM, Baker FC. The sleep of the ring: comparison of the OURA sleep tracker against polysomnography. Behav. Sleep Med doi: 10.1080/15402002.2017.1300587 (2017) (Epub ahead of print). PMC6095823 28323455
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Probably not a substantial claim: may not pass S3 (load-bearing).
FindingcitationThe leading CGMs on market today are Dexcom, Medtronic and Abbott devices.
“The leading CGMs on market today are Dexcom (CA, USA), Medtronic (MN, USA) and Abbott (IL, USA) devices [2-5,19,31].”
Quote in the paperNot a substantial claim0 of 6 sources checked- cites [2] Boscari F, Galasso S, Acciaroli G Head-to-head comparison of the accuracy of Abbott FreeStyle Libre and Dexcom G5 mobile. Nutr. Metab. Cardiovasc. Dis 28(4), 425– 427 (2018). 29502924
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- cites [3] Thompson H, Lunt H, Fleckney C, Soule S. Insulin degludec overdose in an adolescent with Type 1 diabetes: proactive management including monitoring using the Freestyle Libre flash glucose monitoring system. Endocrinol. Diabetes Metab. Case Rep doi: 10.1530/EDM-18-0044 (2018) (Epub ahead of print). PMC5987182 29887987
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- cites [4] Massa GG, Gys I, Op ‘t Eyndt A Evaluation of the FreeStyle® Libre Flash Glucose Monitoring System in children and adolescents with Type 1 diabetes. Horm. Res. Paediatr 89(3), 189– 199 (2018). 29587254
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- cites [5] Matuleviciene V, Joseph JI, Andelin M A clinical trial of the accuracy and treatment experience of the Dexcom G4 sensor (Dexcom G4 system) and Enlite sensor (guardian REAL-time system) tested simultaneously in ambulatory patients with Type 1 diabetes. Diabetes Technol. Ther 16(11), 759– 767 (2014). 25233297 PMC4201312
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- cites [19] Heinemann L, Freckmann G, Ehrmann D Real-time continuous glucose monitoring in adults with Type 1 diabetes and impaired hypoglycaemia awareness or severe hypoglycaemia treated with multiple daily insulin injections (HypoDE): a multicentre, randomised controlled trial. Lancet 391(10128), 1367– 1377 (2018). 29459019 source
Not checked in the free run.
- cites [31] Sinha M, Mckeon KM, Parker S A comparison of time delay in three continuous glucose monitors for adolescents and adults. J. Diabetes Sci. Technol 11(6), 1132– 1137 (2017). 28459159 PMC5951038
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May combine two claims.
FindingcitationVitalConnect has built successful sleep apnea and fall detection algorithms using respiratory rate and accelerometry.
“VitalConnect (CA, USA) has also built successful sleep apnea and fall detection algorithms using respiratory rate and accelerometry [48-51].”
Quote in the paperNot a substantial claim0 of 4 sources checked- cites [48] Selvaraj N, Narasimhan R. Detection of sleep apnea on a per-second basis using respiratory signals. Presented at: Engineering in Medicine and Biology Society (EMBC), 2013 35th Annual International Conference of the IEEE. Osaka, Japan, (3-7 July 2013). 24110140
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- cites [49] Selvaraj N, Narasimhan R. Automated prediction of the apnea-hypopnea index using a wireless patch sensor. Presented at: Engineering in Medicine and Biology Society (EMBC), 2014 36th Annual International Conference of the IEEE. IL, USA (26-30 August 2014). 25570349
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- cites [50] Narasimhan R. Skin-contact sensor for automatic fall detection. Presented at: Engineering in Medicine and Biology Society (EMBC), 2012 Annual International Conference of the IEEE. CA, USA (28 August-1 September 2012). 23366814
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- cites [51] Chan AM, Selvaraj N, Ferdosi N, Narasimhan R. Wireless patch sensor for remote monitoring of heart rate, respiration, activity, and falls. Presented at: Engineering in Medicine and Biology Society (EMBC), 2013 35th Annual International Conference of the IEEE. Osaka, Japan, (3-7 July 2013). 24111135
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Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Findingnone givenData from wearable sensors have been used for tracking gait, detecting atrial fibrillation and monitoring blood glucose.
“Data from these sensors have been used in a wide range of tasks, including, for example, tracking gait, detecting atrial fibrillation and monitoring blood glucose, respectively.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing), S4 (based).
Findingnone givenWearable pressure sensors have become increasingly common to track forces exerted on or by the body.
“Wearable pressure sensors have also become increasingly common to track forces either exerted on or by the body.”
Quote in the paperNot a substantial claimMay combine two claims.
FindingcitationThe Cardiogram DeepHeart team has demonstrated early success in detecting Type II diabetes (85% accuracy), atrial fibrillation (97% accuracy), sleep apnea (90% accuracy), hypertension (82% accuracy) and cardiovascular risk using wearables data.
“This team has demonstrated early success in detecting Type II diabetes (85% accuracy), atrial fibrillation (97% accuracy), sleep apnea (90% accuracy), hypertension (82% accuracy) and more recently, cardiovascular risk using the DeepHeart platform [42,48].”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [42] Lim WK, Davila S, Teo JX Beyond fitness tracking: The use of consumer-grade wearable data from normal volunteers in cardiovascular and lipidomics research. PLoS Biol. 16(2), e2004285 (2018). 29485983 PMC5828350
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- cites [48] Selvaraj N, Narasimhan R. Detection of sleep apnea on a per-second basis using respiratory signals. Presented at: Engineering in Medicine and Biology Society (EMBC), 2013 35th Annual International Conference of the IEEE. Osaka, Japan, (3-7 July 2013). 24110140
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Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).
Findingnone givenAt this time, most integration/interoperability apps aggregate data from hundreds of different wearables with their partnered electronic health record systems.
“At this time, most integration/interoperability apps aggregate data from hundreds of different wearables with their partnered electronic health record systems.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing), S4 (based).
Findingnone givenTechnological limitations include noisy heart rate during periods of high intensity activity.
“Technological limitations include noisy heart rate during periods of high intensity activity.”
Quote in the paperNot a substantial claimMay combine two claims.
FindingcitationAn early-stage ingestible sensor is being explored to diagnose gastrointestinal slowdown or monitor food intake via gastrointestinal movement.
“An early-stage ingestible sensor is being explored to diagnose gastrointestinal slowdown or monitor food intake via gastrointestinal movement [83].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [83] Dagdeviren C, Javid F, Joe P Flexible piezoelectric devices for gastrointestinal motility sensing. Nat. Biomed. Eng 1(10), 807 (2017). 31015594
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May combine two claims.
FindingcitationThe Empatica Embrace can detect seizures using electrodermal activity and accelerometry and can also notify emergency contacts.
“The Empatica Embrace (MA, USA), a smartwatch that evolved out of the MIT Media Lab, can detect seizures using electrodermal activity and accelerometry and can also notify emergency contacts [20,21,103].”
Quote in the paperNot a substantial claim0 of 3 sources checked- cites [20] Poh MZ, Loddenkemper T, Reinsberger C Convulsive seizure detection using a wrist-worn electrodermal activity and accelerometry biosensor. Epilepsia 53(5), e93– e97 (2012). 22432935 source
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- cites [21] Dolgin E. Dressed to detect. Nature 511(Suppl. 7508), S16– S17 (2014). 25019131
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- cites [103] Poh M-Z, Loddenkemper T, Reinsberger C Autonomic changes with seizures correlate with postictal EEG suppression. Neurology 78(23), 1868– 1876 (2012). 22539579 PMC3369522
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May combine two claims.
Findingnone givenStill a challenge is the dependence on active patient participation and the semi-quantitative nature of the measurements.
“Still a challenge is the dependence on active patient participation and the semi-quantitative nature of the measurements.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing), S4 (based).
Findingnone givenWearable technologies to detect, diagnose and manage gastrointestinal conditions are limited.
“Wearable technologies to detect, diagnose and manage gastrointestinal conditions are limited.”
Quote in the paperNot a substantial claimMay combine two claims.
FindingcitationSentio Solutions' Feel wristband is anticipated to deliver personalized interventions to the wearer according to their mood state based on a proprietary neural network model that can accurately detect 70-75% of relaxed, anxious, excited and fun mood states using features of heart rate variability and skin conductance (n = 224).
“One example is Sentio Solutions’ Feel wristband (San Francisco, CA, USA), which is anticipated to deliver personalized interventions to the wearer according to their mood state based on their proprietary neural network model that can accurately detect 70–75% of relaxed, anxious, excited and fun mood states using features of heart rate variability and skin conductance (n = 224) [37].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [37] Martinez HP, Bengio Y, Yannakakis GN. Learning deep physiological models of affect. IEEE Comput. Intel. Mag 8(2), 20– 33 (2013).
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FindingcitationIn a recent study, 33 and 43% of the alerts successfully engaged the participant in the self-regulation exercise and resulted in de-escalation of a potential episode, respectively.
“In a recent study, 33 and 43% of the alerts successfully engaged the participant in the self-regulation exercise and resulted in de-escalation of a potential episode, respectively [99].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [99] Torrado JC, Gomez J, Montoro G. Emotional self-regulation of individuals with autism spectrum disorders: smartwatches for monitoring and interaction. Sensors (Basel) 17(6), 1359 (2017). 28604607 PMC5492838
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May combine two claims.
FindingcitationIMUs affixed to shoes were recently found to result in comparable diagnoses with gold standard video-based assessments to distinguish gait differences between PD and unaffected patients and for longitudinal tracking of gait changes in PD (n = 291).
“IMUs affixed to shoes were recently found to result in comparable diagnoses with gold standard video-based assessments to distinguish gait differences between PD and unaffected patients and for longitudinal tracking of gait changes in PD (n = 291) [78].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [78] Watanabe S, Hojo M, Nagahara A. Metabolic syndrome and gastrointestinal diseases. J. Gastroenterol 42(4), 267– 274 (2007). 17464454
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Probably not a substantial claim: may not pass S4 (based).
Interpretationnone givenWearable sensors are already impacting healthcare and medicine by enabling health monitoring outside of the clinic and prediction of health events.
“Wearable sensors are already impacting healthcare and medicine by enabling health monitoring outside of the clinic and prediction of health events.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
PremisecitationAccelerometers are most common in wearables, but gyroscopes are appropriate when it is necessary to differentiate acceleration due to gravity versus acceleration due to movement.
“Accelerometers are most common in wearables, but gyroscopes are appropriate when it is necessary to differentiate acceleration due to gravity versus acceleration due to movement [39].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [39] Casson AJ, Galvez AV, Jarchi D. Gyroscope vs. accelerometer measurements of motion from wrist PPG during physical exercise. ICT Express 2(4), 175– 179 (2016). source
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Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).
Premisenone givenBioimpedance sensors are thought to be useful for detecting stress and emotion through changes in electrical resistance of tissues related to neural activity.
“Bioimpedance sensors are thought to be useful for detecting stress and emotion through changes in electrical resistance of tissues related to neural activity.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S4 (based).
Interpretationnone givenWearables facilitate algorithm development for automated health event prediction, prevention and intervention.
“Wearables also facilitate algorithm development for automated health event prediction, prevention and intervention.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim.
Premisenone givenOne major challenge in wide adoption of wearable biosensor technologies for healthcare is extraction of useful and actionable health-related information from the large volume of data.
“One of the major challenges in the wide adoption of wearable biosensor technologies for healthcare is the extraction of useful and actionable health-related information from the large volume of data.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S4 (based).
InterpretationreasoningNew wearables-based analytic platforms are transforming quality and accessibility of healthcare from hospital ICUs to in-home chronic disease management to resource-limited field settings.
“New wearables-based analytic platforms are coming online at an unprecedented rate and are transforming quality and accessibility of healthcare everywhere from hospital intensive care units (ICUs) to in-home chronic disease management to resource-limited field settings.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S4 (based).
Interpretationnone givenWearable devices provide opportunities to improve healthcare in settings from in-hospital and in-clinic care to ambulatory care in the home and remote geographical settings.
“Wearable devices provide opportunities to improve healthcare in a variety of settings, from in-hospital and in-clinic care, to ambulatory care in the home and in remote geographical settings including rural areas and low-resource environments (Figure 2A).”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationNonimplantable wearable sensors can generally be classified into three main categories: mechanical, physiological and biochemical.
“These sensors can generally be classified into three main categories: mechanical, physiological and biochemical (Figure 1B) [1].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [1] Tamsin M. Wearable biosensor technologies. Int. J. Innov. Sci. Res 13, 697– 703 (2015).
Not checked in the free run.
Probably not a substantial claim: may not pass S4 (based).
Interpretationnone givenHealthcare practitioners are now beginning to adopt wearables for patient monitoring.
“Previously geared toward consumer health enthusiasts, healthcare practitioners are now beginning to adopt wearables for patient monitoring.”
Quote in the paperNot a substantial claimMay combine two claims.
PremisecitationDiagnosis and monitoring of hypertension and treatment efficacy is difficult because a single blood pressure measurement in the clinic often does not capture true average BP, BP fluctuates throughout the day based on circadian rhythms and daily activity, and white coat syndrome can lead to higher BP measurements in the clinic.
“Diagnosis and monitoring of hypertension and treatment efficacy is difficult for a few reasons: a single blood pressure (BP) measurement in the clinic often does not capture true average BP, BP fluctuates throughout the day based on circadian rhythms and daily activity, and the ‘white coat syndrome’ can lead to higher BP measurements in the clinic [68-73].”
Quote in the paperSubstantial claim0 of 6 sources checked- cites [68] Wexler R. Ambulatory blood pressure monitoring in primary care. South Med. J 103(5), 447– 452 (2010). 20375938
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- cites [69] Hermida RC, Ayala DE, Mojon A, Fernandez JR. Decreasing sleep-time blood pressure determined by ambulatory monitoring reduces cardiovascular risk. J. Am. Coll. Cardiol 58(11), 1165– 1173 (2011). 21884956
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- cites [70] Burkard T, Mayr M, Winterhalder C, Leonardi L, Eckstein J, Vischer AS. Reliability of single office blood pressure measurements. Heart doi: 10.1136/heartjnl-2017-312523 (2018) (Epub ahead of print). 29530989
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- cites [71] Asayama K, Thijs L, Brguljan-Hitij J Risk stratification by self-measured home blood pressure across categories of conventional blood pressure: a participant-level meta-analysis. PLoS Med 11(1), e1001591 (2014). 24465187 PMC3897370 source
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- cites [72] Pickering TG. The clinical significance of diurnal blood pressure variations. Dippers and nondippers. Circulation 81(2), 700– 702 (1990). 2137050
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- cites [73] Mahabala C, Kamath P, Bhaskaran U, Pai ND, Pai AU. Antihypertensive therapy: nocturnal dippers and nondippers. Do we treat them differently? Vasc. Health Risk Manag. 9, 125– 133 (2013). 23569382 PMC3616131
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PremisecitationPolysomnography, the current gold standard for sleep monitoring, often conflicts with subjective self-reports of sleep and is difficult to monitor longitudinally.
“Polysomnography, the current gold standard for sleep monitoring, often conflicts with subjective self-reports of sleep and is difficult to monitor longitudinally [84].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [84] Kaplan KA, Hirshman J, Hernandez B When a gold standard isn’t so golden: lack of prediction of subjective sleep quality from sleep polysomnography. Biol. Psychol 123, 37– 46 (2017). 27889439 PMC5292065
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InterpretationreasoningWith the ability to more accurately track acute and chronic neurologic and mental health symptoms, the opportunity for real-time intervention follows.
“With the ability to more accurately track acute and chronic neurologic and mental health symptoms, the opportunity for real-time intervention follows.”
Quote in the paperSubstantial claimClassified as probably not a substantial claim. May combine two claims.
InterpretationreasoningThe devices described provide new sensing and potential therapeutic modalities and are expected to dramatically improve gastrointestinal care.
“The devices described above provide new sensing and potential therapeutic modalities and are expected to dramatically improve gastrointestinal care.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing), S4 (based).
Interpretationnone givenIf FDA approved, these devices will pioneer the field of continuous BP monitoring.
“If FDA approved, these devices will pioneer the field of continuous BP monitoring.”
Quote in the paperNot a substantial claimMay combine two claims.
InterpretationreasoningContinuous, passive wearables monitoring can lower dependence on participant interaction and increase the volume of data that can be collected over time.
“Continuous, passive wearables monitoring can lower dependence on participant interaction and increase the volume of data that can be collected over time.”
Quote in the paperSubstantial claimMay combine two claims.
PremisecitationSleep impacts chronic illness, neurological conditions and acute cognitive function including memory and mood.
“Sleep impacts chronic illness, neurological conditions and acute cognitive function including memory and mood [22,88-90].”
Quote in the paperNot a substantial claim0 of 4 sources checked- cites [22] Kroll RR, Mckenzie ED, Boyd JG Use of wearable devices for post-discharge monitoring of ICU patients: a feasibility study. J. Intensive Care 5, 64 (2017). 29201377 PMC5698959
Not checked in the free run.
- cites [88] Horvath K, Aschermann Z, Acs P Is the MDS-UPDRS a good screening tool for detecting sleep problems and daytime sleepiness in Parkinson’s disease? Parkinsons Dis. 2014, 806169 (2014). 25506041 PMC4251816
Not checked in the free run.
- cites [89] Walker MP. The role of sleep in cognition and emotion. Ann. NY Acad. Sci 1156, 168– 197 (2009). 19338508
Not checked in the free run.
- cites [90] Bianchi MT. Sleep devices: wearables and nearables, informational and interventional, consumer and clinical. Metabolism 84 99– 108 (2017). 29080814
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
PremisecitationGait analysis is used to assess Parkinson's Disease patients and generally requires video-based motion-capture in a specialized laboratory.
“Gait analysis is also used to assess Parkinson’s Disease (PD) patients and generally requires video-based motion-capture in a specialized laboratory [34].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [34] Schlachetzki JC, Barth J, Marxreiter F Wearable sensors objectively measure gait parameters in Parkinson’s disease. PLoS ONE 12(10), e0183989 (2017). 29020012 PMC5636070
Not checked in the free run.
May combine two claims.
Study design and conductcitationThe Bloomlife labor risk score was developed based on in-hospital data from 55 pregnant women and evaluated on recordings from 142 pregnant women in free-living conditions.
“Their labor risk score was developed based on in-hospital data from 55 pregnant women and was evaluated on recordings from 142 pregnant women in free-living conditions.”
Quote in the paperNot a substantial claim0 of 2 sources checked- cites [18] Altini M, Rossetti E, Rooijakkers M Combining electrohysterography and heart rate data to detect labour. Presented at: Biomedical & Health Informatics (BHI), 2017 IEEE EMBS International Conference Orlando-, FL, USA (16-19 February 2017).
Not checked in the free run.
- cites [120] Altini M, Rossetti E, Rooijakkers M 762: remote labour detection using maternal electrohysterography and heart rate data acquired with a wearable sensor. Am. J. Obstet. Gynecol 216(1), S441– S442 (2017).
Not checked in the free run.
Probably not a substantial claim: may not pass S4 (based).
Interpretationnone givenCommercially available motion sensing, physiological and biochemical wearable sensors have been adopted for use in both consumer and clinical healthcare.
“Commercially available motion sensing, physiological and biochemical wearable sensors have been adopted for use in both consumer and clinical healthcare.”
Quote in the paperNot a substantial claimMay combine two claims.
Interpretationnone givenWearable and environmental sensors promise to improve information collection and transfer rapidly, potentially to off-site experts, and specially designed algorithms enable automated and real-time medical decision support in time- and resource-constrained environments.
“Wearable and environmental sensors promise to improve information collection and transfer rapidly, potentially to off-site experts and specially designed algorithms enable automated and real-time medical decision support in time- and resource-constrained environments (Figure 2B).”
Quote in the paperSubstantial claimMay combine two claims.
Interpretationown dataThe ADAMM study established the device's utility for detection and a modest potential to predict near-future disease progression.
“This study established the device’s utility for detection and a modest potential to predict near-future disease progression.”
Quote in the paperSubstantial claimMay combine two claims.
PremisecitationMost wrist-worn devices adequately measure heart rate in laboratory-based activities, but poorly estimate energy expenditure.
“Shcherbina et al. demonstrated that most wrist-worn devices adequately measure HR in laboratory-based activities, but poorly estimate energy expenditure and caution the use of those measurements as part of health improvement programs [144].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [144] Shcherbina A, Mattsson CM, Waggott D Accuracy in wrist-worn, sensor-based measurements of heart rate and energy expenditure in a diverse cohort. J. Pers. Med 7(2), 3 (2017). 28538708 PMC5491979 source
Not checked in the free run.
May combine two claims.
InterpretationcitationWearable tools can be used in specific settings to target extreme healthcare costs, for example, by reducing emergency room visits and hospital readmission rates, improving postsurgical and rehabilitation outcomes, assisting with aging in-home, and preventing serious, preventable and costly medical events.
“Further, these tools can be used in specific settings to target extreme healthcare costs, for example, by reducing emergency room visits and hospital readmission rates, improving postsurgical and rehabilitation outcomes, assisting with aging in-home, and preventing serious, preventable and costly medical events (deemed ‘never events’ by CMS) (Figure 2A) [137].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [137] Centers for Medicare & Medicaid Services. Eliminating serious, preventable, and costly medical errors – never events (2013). www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2006-Fact-sheets-items/2006-2005-2018.html
Not checked in the free run.
May combine two claims.
InterpretationcitationThe acceptability of wearable devices and potential stigma associated with them varies by community and may be a factor in dividing who benefits from these technologies.
“The acceptability of these devices and potential stigma associated with them varies by community and may also be a factor in dividing who benefits from these technologies [141].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [141] Farrington C. Wearable technologies and stigma in diabetes: the role of medical aesthetics. Lancet Diabetes Endocrinol. 4(7), 566 (2016). 26923941
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).
Premisenone givenSeveral neurologic disorders include motor control dysregulation.
“Several neurologic disorders include motor control dysregulation.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Interpretationnone givenThere is a wide effort to integrate information from wearable devices into electronic health records.
“Currently, there is a wide effort to integrate information from these devices into electronic health records.”
Quote in the paperNot a substantial claimMay combine two claims.
Interpretationnone givenWearable sensors have an extremely broad variety of applications to specific areas of medicine, enabling monitoring of acute and chronic conditions and overall health both in and outside of the clinical setting.
“Wearable sensors have an extremely broad variety of applications to specific areas of medicine, enabling monitoring of acute and chronic conditions and overall health both in and outside of the clinical setting.”
Quote in the paperSubstantial claimMay combine two claims.
Interpretationnone givenAlthough consumer-grade research devices have been primarily adopted for fitness, medical professionals are beginning to find utility in information collected by these devices.
“Although consumer-grade research devices have been primarily adopted for fitness, medical professionals are beginning to find utility in information collected by these devices.”
Quote in the paperNot a substantial claimMay combine two claims.
PremisecitationBased on collective results of 16 studies, wheeze event classification had accuracies between 75.78-100% and crackle event classification had accuracies between 89-98.15%.
“Based on collective results of 16 studies, wheeze and crackle event classification had accuracies between 75.78–100% and 89–98.15%, respectively [124].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [124] Pramono RXA, Bowyer S, Rodriguez-Villegas E. Automatic adventitious respiratory sound analysis: a systematic review. PLoS ONE 12(5), e0177926 (2017). 28552969 PMC5446130
Not checked in the free run.
May combine two claims.
Interpretationnone givenMany devices are not compatible across platforms and there is a lack of data standards, which limits their broad use and ubiquity.
“Further, many devices are not compatible across platforms (e.g., iOS and Android smart phone operating systems) and there is a lack of data standards which limits their broad use and ubiquity.”
Quote in the paperNot a substantial claimMay combine two claims.
PremisecitationWheezing is linked to both asthma and chronic obstructive pulmonary disease, while fine crackling is linked with pneumonia, congestive heart failure and lung fibrosis.
“Wheezing, characterized by narrowing airway and limited airflow, is linked to both asthma and chronic obstructive pulmonary disease while fine crackling, caused by ‘explosive opening of small airways,’ is linked with pneumonia, congestive heart failure and lung fibrosis [124].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [124] Pramono RXA, Bowyer S, Rodriguez-Villegas E. Automatic adventitious respiratory sound analysis: a systematic review. PLoS ONE 12(5), e0177926 (2017). 28552969 PMC5446130
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Interpretationnone givenThe time needed to choose and properly set up a device, and remembering to charge the device, are potential barriers to proper use.
“The time needed to choose and properly set up a device, and remembering to charge the device are also potential barriers to proper use.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim. May combine two claims.
Interpretationnone givenFalse negatives from wearable devices can cause a potentially fatal condition to be missed, while false positives can lead to overtreatment and/or anxiety.
“False negatives can cause a potentially fatal condition to be missed while false positives can lead to overtreatment and/or anxiety.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S4 (based).
Interpretationnone givenIt is common to find unsubstantiated scientific claims with no reference to peer-reviewed studies on commercial wearable device company websites and advertising materials.
“It is common to find unsubstantiated scientific claims with no reference to peer-reviewed studies on commercial wearable device company websites and advertising materials that can set a dangerous precedent if inaccurate or misinterpreted data is factored into medical decision making.”
Quote in the paperNot a substantial claimMay combine two claims.
Interpretationnone givenWearables can inform ongoing or new symptoms, such as medication side effects or interactions, and may be able to provide automated just-in-time interventions.
“Wearables can inform ongoing or new symptoms, such as medication side effects or interactions, and may be able to provide automated just-in-time interventions.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Interpretationnone givenHigh device cost is a concern that may hinder the accessibility of wearable healthcare technology to benefit only those who can afford the devices.
“High device cost is a concern that may hinder the accessibility of this consumer healthcare technology to benefit only those who can afford the devices.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing), S4 (based).
Interpretationnone givenThe tripartite regulation of wearable devices by the FDA, FCC and CMS creates challenges for device manufacturers and vendors because regulations can be difficult to adhere to due to different, sometimes divergent, objectives of these agencies.
“The tripartite regulation of wearable devices by the federal government through the FDA, Federal Communications Commission and CMS creates challenges for device manufacturers and vendors whereby regulations can be difficult to adhere to due to the different, and sometimes divergent, objectives of these agencies.”
Quote in the paperNot a substantial claimMay combine two claims.
PremisecitationPantelopoulos and Bourbakis created a scoring system from the perspective of patient/wearer, manufacturer and supervising physician for wearables and found that many systems score low on wearability because sensor, battery and on-body hardware size tends to be too bulky in weight and size.
“Pantelopoulos and Bourbakis created a scoring system from the perspective of the patient/wearer, the manufacturer and supervising physician for wearables found that many systems score low on wearability, because sensor, battery and on-body hardware size tends to be too bulky in weight and size [165].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [165] Pantelopoulos A, Bourbakis N. A survey on wearable biosensor systems for health monitoring. Conf. Proc. IEEE Eng. Med. Biol. Soc. 2008, 4887– 4890 (2008). 19163812
Not checked in the free run.
May combine two claims.
PremisecitationWristbands to detect environmental exposures have been successful but require off-site analysis using gas chromatography on returned wristbands.
“Wristbands to detect environmental exposures have been successful but require off-site analysis using gas chromatography on returned wristbands [154].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [154] Donald CE, Scott RP, Blaustein KL Silicone wristbands detect individuals’ pesticide exposures in West Africa. R. Soc. Open Sci 3(8), 160433 (2016). 27853621 PMC5108971
Not checked in the free run.
Probably not a substantial claim: may not pass S2 (checkable). May combine two claims.
Interpretationnone givenAlthough immense progress has been made in wearable sensing technologies and their healthcare applications, significant limitations must be addressed for wearable biosensing to achieve its full potential of seamless integration into healthcare.
“Although immense progress has been made over the past several decades in wearable sensing technologies and even more recently toward their applications in healthcare, significant limitations must be addressed for wearable biosensing to achieve its full potential of seamless integration into healthcare.”
Quote in the paperNot a substantial claimMay combine two claims.
PremisecitationThe wristband sweat sensor also measures skin temperature for calibration, and that data is useful in analyzing health.
“The wristband device also measures skin temperature for calibration, and that data is also useful in analyzing health as described earlier [126,156].”
Quote in the paperNot a substantial claim0 of 2 sources checked- cites [126] Asimina S, Chapizanis D, Karakitsios S Assessing and enhancing the utility of low-cost activity and location sensors for exposure studies. Environ. Monit. Assess 190(3), 155 (2018). 29464404
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- cites [156] Gao W, Emaminejad S, Nyein HYY Fully integrated wearable sensor arrays for multiplexed in situ perspiration analysis. Nature 529(7587), 509– 514 (2016). 26819044 PMC4996079 source
Not checked in the free run.
Classified as probably not a substantial claim.
Interpretationnone givenThere are often conflicting technological constraints in device design.
“There are often conflicting technological constraints in device design.”
Quote in the paperSubstantial claimMay combine two claims.
PremisecitationThe wristband sweat sensor was recently tested for cystic fibrosis diagnosis and preliminary investigation of the blood/sweat glucose correlation.
“This device was recently tested for cystic fibrosis diagnosis and preliminary investigation of the blood/sweat glucose correlation [161].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [161] Emaminejad S, Gao W, Wu E Autonomous sweat extraction and analysis applied to cystic fibrosis and glucose monitoring using a fully integrated wearable platform. Proc. Natl Acad. Sci. USA 114(18), 4625– 4630 (2017). 28416667 PMC5422810 •• A seminal demonstration of how fully integrated wearable platforms with multimodal measurement capabilities can dramatically improve monitoring and intervention capabilities. source
Not checked in the free run.
Probably not a substantial claim: may not pass S4 (based).
Interpretationnone givenUnsubstantiated claims that overstate the testing accuracy and indications for the device are commonly made by wearable device companies to improve sales.
“Unsubstantiated claims that overstate the testing accuracy and indications for the device are commonly made by wearable device companies to improve sales, and further regulations are needed to ensure their appropriate use and to evaluate the potential harm that may result from medical interventions or overdiagnosis based on the use of these devices.”
Quote in the paperNot a substantial claimMay combine two claims.
Interpretationnone givenFDA-regulated devices like CGMs have substantially more clinical trials establishing their safety and efficacy in healthcare, but consumer-grade FDA devices have limited evidence of their utility in healthcare.
“FDA-regulated devices like CGMs have substantially more clinical trials establishing the safety and efficacy of these devices in healthcare (only the most recent/impactful studies are referenced for brevity), but consumer-grade FDA devices have limited evidence of their utility in healthcare.”
Quote in the paperSubstantial claimMay combine two claims.
PremisecitationBreathLink is a breath analysis technology to identify women with breast cancer and pulmonary tuberculosis, but it is not yet in a wearable form factor.
“BreathLink is another breath analysis technology to identify women with breast cancer and pulmonary tuberculosis, but this technology is not yet in a wearable form factor [152,153].”
Quote in the paperNot a substantial claim0 of 2 sources checked- cites [152] Phillips M, Beatty JD, Cataneo RN Rapid point-of-care breath test for biomarkers of breast cancer and abnormal mammograms. PLoS ONE 9(3), e90226 (2014). 24599224 PMC3943910
Not checked in the free run.
- cites [153] Phillips M, Basa-Dalay V, Blais J Point-of-care breath test for biomarkers of active pulmonary tuberculosis. Tuberculosis (Edinb.) 92(4), 314– 320 (2012). 22647661
Not checked in the free run.
May combine two claims.
PremisecitationThis type of integrated device has been explored most recently through closed-loop insulin delivery systems for Type 1 diabetics, and broader applications are forthcoming.
“This type of device has been explored most recently through closed-loop insulin delivery systems for Type 1 diabetics, and broader applications are forthcoming [162].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [162] Stone JY, Haviland N, Bailey TS. Review of a commercially available hybrid closed-loop insulin-delivery system in the treatment of Type 1 diabetes. Ther. Deliv 9(2), 77– 87 (2018). 29235423
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May combine two claims.
InterpretationreasoningChallenges to improving algorithms for wearable data include the wide range of device and system architectures and the proprietary nature of many analytic platforms, which limit their generalizability.
“Challenges to addressing this include the wide range of device and system architectures and the proprietary nature of many analytic platforms which limit their generalizability.”
Quote in the paperSubstantial claimMay combine two claims.
PremisecitationWearable oxygen diffusion sensors have been used to track wound healing, and moisture sensors can inform better timing of wound dressing changes.
“Wearable oxygen diffusion sensors have been used to track wound healing, and moisture sensors can inform better timing of wound dressing changes [148,149].”
Quote in the paperNot a substantial claim0 of 2 sources checked- cites [148] Niederauer MQ, Michalek JE, Armstrong DG. A prospective, randomized, double-blind multicenter study comparing continuous diffusion of oxygen therapy to sham therapy in the treatment of diabetic foot ulcers. J. Diabetes Sci. Technol 11(5), 883– 891 (2017). 28654304 PMC5950983
Not checked in the free run.
- cites [149] Milne SD, Seoudi I, Al Hamad H A wearable wound moisture sensor as an indicator for wound dressing change: an observational study of wound moisture and status. Int. Wound J 13(6), 1309– 1314 (2016). 26561281 PMC7950073
Not checked in the free run.
The paper relies on this without support.
Most airway abnormalities can be characterized by abnormal sounds (adventitious sounds).
“Pulmonary disease wearables take advantage of the fact that most airway abnormalities can be characterized by the abnormal sounds (adventitious sounds).”
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
In recent years, wearables have resulted in more clinically approved certifications.
“In recent years, the quality and accuracy of wearables have improved [7,8], resulting in more clinically approved certifications [9].”
From The impact of wearable technologies in health research: scoping review (2022) · cites this paper as [9]
The literature underlines the potential for wearable-based research in low-resource settings to generate data and improve health care, based on low cost and ease of use.
“The literature underlines the potential for wearable-based research in low-resource settings to generate data and improve health care [9], based on their low cost and ease of use (data acquisition, hardware, and software handling) [233].”
From The impact of wearable technologies in health research: scoping review (2022) · cites this paper as [9]
The included studies did not show the full range of possible wearables and measured vital signs.
“We have provided a wide overview of wearable devices; however, the included studies did not show the full range of possible wearables and measured vital signs [9,37].”
From The impact of wearable technologies in health research: scoping review (2022) · cites this paper as [9]
Most studies using wearable sensors have been conducted in high-income settings like the US and Europe.
“However, most studies were conducted in high-income settings, like the US and Europe [19, 25, 35].”
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
Each contradiction between two passages listed here was confirmed by an independent check.
Five initiatives are called four
MinorThe sentence names five initiatives but says there are four.
“are four large-scale initiatives to collect longitudinal wearable device data”
“The Precision Medicine Initiative, the Google Baseline Project, MyHeartCounts, the Stanford Azumio Activity Inequality study and the Health ePeople study”
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- Authors
- Dunn, J., Runge, R., & Snyder, M.
- Affiliations
- Stanford University (US)
- Corresponding author
- Snyder, Michael
- Venue
- Personalized Medicine
- Publisher
- Informa UK Limited
- Published
- 2018-09
- Volume
- 15
- Issue
- 5
- Pages
- 429-448
- ISSN
- 1741-0541 (ISSN-L)
- 1744-828X
- PMC
- PMC12294383
- OpenAlex
- W2893814198
- Semantic Scholar
- 10a52258659a025213707790354a6cc13482bade
- Cited by
- 654
- References
- 154
- Citations by year
- 2026: 99 · 2025: 88 · 2024: 101 · 2023: 94 · 2022: 94 · 2021: 95 · 2020: 56 · 2019: 22 · 2018: 5
- FWCI
- 3.64
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Personalized Medicine (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Funders
- Mobilize Center (U54 EB020405)
- Topics
- Physical Sciences › Engineering › Biomedical Engineering › Non-Invasive Vital Sign Monitoring
- Physical Sciences › Computer Science › Computer Vision and Pattern Recognition › Context-Aware Activity Recognition Systems
- Physical Sciences › Engineering › Biomedical Engineering › Wireless Body Area Networks
- Keywords
- wearable sensors, remote patient monitoring, clinical translation, metabolic monitoring, cardiovascular monitoring, gastrointestinal monitoring, sleep monitoring, neurology, movement disorders, mental health, maternal and newborn care, respiratory health, environmental exposure monitoring
- MeSH terms
- Wearable Electronic Devices, Delivery of Health Care, Humans, Monitoring, Physiologic, Telemetry, Monitoring, Ambulatory, Wireless Technology
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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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