Smart wearable devices in cardiovascular care: Where we are and how to move forward
Open accessAbstract
Technological innovations reach deeply into our daily lives and an emerging trend supports the use of commercial smart wearable devices to manage health. In the era of remote, decentralized and increasingly personalized patient care, catalysed by the COVID-19 pandemic, the cardiovascular community must familiarize itself with the wearable technologies on the market and their wide range of clinical applications. In this Review, we highlight the basic engineering principles of common wearable sensors and where they can be error-prone. We also examine the role of these devices in the remote screening and diagnosis of common cardiovascular diseases, such as arrhythmias, and in the management of patients with established cardiovascular conditions, for example, heart failure. To date, challenges such as device accuracy, clinical validity, a lack of standardized regulatory policies and concerns for patient privacy are still hindering the widespread adoption of smart wearable technologies in clinical practice. We present several recommendations to navigate these challenges and propose a simple and practical ‘ABCD’ guide for clinicians, personalized to their specific practice needs, to accelerate the integration of these devices into the clinical workflow for optimal patient care. In this Review, Elshazly and colleagues summarize the basic engineering principles of common wearable sensors and discuss their broad applications in cardiovascular disease prevention, diagnosis and management. Smart wearables generate a plethora of data through various sensors and software algorithms and understanding their basic engineering principles and limitations can be helpful for clinicians and scientists. Evidence supports the use of wearable devices in cardiovascular risk assessment and cardiovascular disease prevention, diagnosis and management, but large, well-designed trials are needed to establish their advantages. Several challenges still hinder the widespread adoption of wearables in clinical practice, including a concern for device accuracy, patient privacy and cost, and how to separate actionable data from noise. Overcoming these challenges requires that various stakeholders come together to develop comprehensive evaluation frameworks, pragmatic regulatory policies, clinical trials and medical education curricula. A practical ‘ABCD’ guide for clinicians can facilitate the integration of these devices in routine clinical practice.
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Written from the paper’s full text.
TL;DR
This narrative review summarizes engineering principles, clinical applications, and adoption barriers for smart wearable devices in cardiovascular care, including arrhythmia screening, heart failure management, and cardiac rehabilitation. It proposes an “ABCD” guide for clinicians and argues that accuracy, clinical validity, regulatory policy, privacy, and evidence gaps still limit widespread clinical integration.
Key findings
- An estimated 20% of US residents own a smart wearable, and the global market is expected to grow at a compound annual growth rate of 25%, reaching US$70 billion by 2025.
- In validation studies, the Apple Watch 3 had a mean difference of –1.80 beats per minute and 95% agreement versus ECG over 24 h, whereas the Fitbit Charge 2 had a mean difference of 3.47 beats per minute and 91% agreement; chest-strap monitors had the best concordance during cardiac rehabilitation (Lin’s concordance coefficient rc = 0.99), while 5% of wrist-worn HR measurements were substantially inaccurate.
- The Apple Heart study enrolled 419,297 participants and reported a positive predictive value of 84% for the irregular notification algorithm and 71% for individual tachograms; the IPED trial found symptomatic rhythm detection in 55.6% of the intervention group versus 9.5% of controls, with mean time to detection of 9.5 days versus 42.9 days.
- Heart failure telemonitoring trials showed mixed results: TIM-HF2 (1,571 patients) found lower all-cause mortality (HR 0.70, 95% CI 0.50–0.96), TEMA-HF1 (164 patients) found an absolute all-cause mortality reduction of 12.5%, but BEAT-HF (1,457 patients) found no reduction in hospital readmission and had low adherence (61.4% for telephone calls and 55.4% for telemonitoring within 30 days).
Methods
- Narrative review of wearable sensors and cardiovascular applications, covering activity, heart rate/rhythm, blood pressure, biochemical, and biomechanical sensors.
- Synthesizes published literature from the past 15 years, including key clinical outcome studies, and presents tables of commercial devices, PubMed/ClinicalTrials.gov study counts, and FDA status as of October 2020.
- Proposes a practical “ABCD” guide for clinicians; no primary data collection or systematic meta-analysis is reported.
Limitations
- Stated: device accuracy, clinical validity, lack of standardized regulatory policies, and patient privacy concerns hinder widespread adoption; there is a paucity of meaningful use criteria and robust clinical evidence, with very few trials examining superiority of wearables for clinical outcomes.
- Stated: heart failure telemonitoring trials have heterogeneous inclusion criteria, device types, and variables, often lack blinding, and can have low adherence; cuff-less BP studies are limited by small sample sizes and lack of external validation.
- Evident from the text: as a narrative review, it does not use a systematic search or quantitative synthesis, and the device/study counts in Table 1 depend on specified PubMed and ClinicalTrials.gov search terms.
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Integrity signals
Registry
Cites
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Claims the paper makes
0 of 164 cited sources checked · 0 supported · 0 flagged
- Findingnone given
Small proof-of-concept studies of wearables are abundant.
“Small, proof-of-concept studies are abundant but the larger, well-designed randomized trials, such as those examining wearables in peripheral vascular disease or AF, set a worthy example for others to follow.”
Quote in the paperSubstantial claim - Findingnone given
Larger well-designed randomized trials examining wearables in peripheral vascular disease or AF exist.
“Small, proof-of-concept studies are abundant but the larger, well-designed randomized trials, such as those examining wearables in peripheral vascular disease or AF, set a worthy example for others to follow.”
Quote in the paperNot a substantial claim - Premisecitation
Barometric measurements can be error-prone because the device might mistake natural changes in ambient temperature and pressure as a change in altitude.
“However, barometric measurements can be error-prone because the device might mistake natural changes in ambient temperature and pressure as a change in altitude10.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [10] Bolanakis, D. E. MEMS barometers and barometric altimeters in industrial, medical, aerospace, and consumer applications. IEEE Instrum. Meas. Mag. 20, 30–55 (2017). source
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- Premisecitation
Wrist placement has taken precedence over ankle placement in commercial wearables owing to increased compliance and convenience.
“However, wrist placement has taken precedence over ankle placement in commercial wearables owing to increased compliance and convenience8.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [8] Troiano, R. P., McClain, J. J., Brychta, R. J. & Chen, K. Y. Evolution of accelerometer methods for physical activity research. Br. J. Sports Med. 48, 1019–1023 (2014). source
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- Premisecitation
Over 24 h, the Apple Watch 3 had a mean difference of -1.80 beats per minute and a mean agreement of 95% compared with the gold standard ECG.
“Over 24 h, the Apple Watch 3 had a mean difference of –1.80 beats per minute and a mean agreement of 95% compared with the gold standard ECG22;”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [22] Nelson, B. W. & Allen, N. B. Accuracy of consumer wearable heart rate measurement during an ecologically valid 24-hour period: intraindividual validation study. JMIR mHealth uHealth 7, e10828 (2019). source
Not checked in the free run.
- Rests on an assumption: ECG sensors are the gold standard for heart rate and heart rhythm measurement.
- Interpretationreasoning
Subjective reporting of physical activity levels will become obsolete as digital health trends can objectively and accurately assess physical activity and energy expenditure through various sensors.
“Therefore, the subjective reporting of physical activity levels will become obsolete as digital health trends, such as wearables and smartphones, can objectively and accurately assess physical activity and energy expenditure through various sensors.”
Quote in the paperSubstantial claim - Premisecitation
Impaired heart rate recovery after exercise correlates with increased adverse cardiovascular events.
“An impaired HR recovery after exercise correlates with increased adverse cardiovascular events14.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [14] Sydó, N. et al. Prognostic performance of heart rate recovery on an exercise test in a primary prevention population. J. Am. Heart Assoc. 7, e008143 (2018). source
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- Premisecitation
In patients with established heart disease undergoing phase II or phase III cardiac rehabilitation, the chest strap had the best concordance with standard ECG during all activities (Lin's concordance coefficient rc = 0.99).
“The chest strap had the best concordance with the standard ECG during all activities (Lin’s concordance coefficient rc = 0.99);”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [23] Etiwy, M. et al. Accuracy of wearable heart rate monitors in cardiac rehabilitation. Cardiovasc. Diagn. Ther. 9, 262–271 (2019). source
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- Rests on an assumption: ECG sensors are the gold standard for heart rate and heart rhythm measurement.
- Premisecitation
PPG tachograms, especially when augmented by single-lead ECG, can identify arrhythmias.
“PPG tachograms, especially when augmented by single-lead ECG, can also identify arrhythmias19.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [19] Perez, M. V. et al. Large-scale assessment of a smartwatch to identify atrial fibrillation. N. Engl. J. Med. 381, 1909–1917 (2019). source
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- Premisecitation
In a study, the Apple Watch 3 and Fitbit Charge 2 both provided acceptable PPG sensor heart rate accuracy (<10% mean absolute percent error) across 24 h and during various activities including sitting, walking, running and activities of daily living.
“One study that investigated the accuracy of the Apple Watch 3 (Apple, USA) and the Fitbit Charge 2 (Fitbit, USA) showed that both devices provided an acceptable PPG sensor HR accuracy (<10% mean absolute percent error) across 24 h and during various activities22, including sitting, walking, running and activities of daily living (such as chores or brushing the teeth).”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [22] Nelson, B. W. & Allen, N. B. Accuracy of consumer wearable heart rate measurement during an ecologically valid 24-hour period: intraindividual validation study. JMIR mHealth uHealth 7, e10828 (2019). source
Not checked in the free run.
- Premisecitation
Over 24 h, the Fitbit Charge 2 had a mean difference of 3.47 beats per minute and a mean agreement of 91% compared with the gold standard ECG.
“the Fitbit Charge 2 had a mean difference of 3.47 beats per minute and a mean agreement of 91% compared with the gold standard ECG22.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [22] Nelson, B. W. & Allen, N. B. Accuracy of consumer wearable heart rate measurement during an ecologically valid 24-hour period: intraindividual validation study. JMIR mHealth uHealth 7, e10828 (2019). source
Not checked in the free run.
- Rests on an assumption: ECG sensors are the gold standard for heart rate and heart rhythm measurement.
- Premisecitation
A high resting heart rate is a predictor of adverse outcomes in patients with heart failure.
“In healthy populations, a high resting HR has been associated with an increased risk of coronary artery disease and all-cause death12 and is also well recognized as a predictor of adverse outcomes in patients with heart failure (HF)13.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [13] Fox, K. et al. Heart rate as a prognostic risk factor in patients with coronary artery disease and left-ventricular systolic dysfunction (BEAUTIFUL): a subgroup analysis of a randomised controlled trial. Lancet 372, 817–821 (2008). source
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- Premisecitation
Single-lead ECGs are often insufficient for the accurate diagnosis of more complex arrhythmias and other conditions such as myocardial infarction or to detect interval abnormalities unless specific manoeuvres are deployed.
“However, these single-lead ECGs are often insufficient for the accurate diagnosis of more complex arrhythmias and other conditions such as myocardial infarction (MI) or to detect interval abnormalities unless specific manoeuvres are deployed17.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [17] Cobos Gil, M. Á. Standard and precordial leads obtained with an apple watch. Ann. Intern. Med. 172, 436 (2020). source
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- Premisecitation
Heart rate variability is strongly linked to the risk of adverse cardiovascular events in healthy individuals and in patients with heart failure with reduced ejection fraction.
“HR variability (HRV) has also been strongly linked to the risk of adverse cardiovascular events in healthy individuals and in patients with HF with reduced ejection fraction15.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [15] Singh, N. et al. Heart rate variability: an old metric with new meaning in the era of using mHealth technologies for Health and Exercise Training Guidance. Part Two: Prognosis and Training. Arrhythmia Electrophysiol. Rev. 7, 247–255 (2018).
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- Premisecitation
Most studies of other variables for cuff-less BP measurement are limited by small sample sizes and a lack of external validation.
“Several other variables have been considered to measure cuff-less BP such as pulse wave velocity and propagation in combination with deep learning algorithms; however, most of the studies are limited by small sample sizes and a lack of external validation29.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [29] McCombie, D. B., Reisner, A. T. & Asada, H. H. Adaptive blood pressure estimation from wearable PPG sensors using peripheral artery pulse wave velocity measurements and multi-channel blind identification of local arterial dynamics. Conf. Proc. IEEE Eng. Med. Biol. Soc. 2006, 3521–3524 (2006). source
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- Premisecitation
In office-based setting, the mean difference in systolic blood pressure between the HeartGuide wristwatch and an ambulatory BP device was 0.8 ± 12.8 mmHg.
“The mean difference (±s.d.) in systolic BP between both groups was 0.8 ± 12.8 mmHg in the office-based setting and 3.2 ± 17.0 mmHg in the ambulatory setting25.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [25] Kario, K. et al. The first study comparing a wearable watch-type blood pressure monitor with a conventional ambulatory blood pressure monitor on in-office and out-of-office settings. J. Clin. Hypertens. 22, 135–141 (2020). source
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- Premisecitation
Biomechanical sensors incorporated into clothing or shoes have been developed to passively and continuously measure variables such as cardiac output, lung fluid volume and weight, which could be beneficial in managing conditions such as heart failure.
“Biomechanical sensors incorporated into clothing or shoes, such as ballistocardiograms, seismocardiograms and dielectric sensors, have been developed in an attempt to passively and continuously measure variables such as cardiac output, lung fluid volume and weight1, which could be beneficial in managing conditions such as HF.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [1] Sana, F. et al. Wearable devices for ambulatory cardiac monitoring. J. Am. Coll. Cardiol. 75, 1582–1592 (2020). source
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- Interpretationcitation
Incorporating accurate blood pressure measurement within consumer-grade wearables has the potential to improve screening for hypertension and identify nocturnal or exercise hypertension, which have been linked to worse outcomes.
“Incorporating accurate blood pressure (BP) measurement within consumer-grade wearables has the potential to improve screening for hypertension and identify nocturnal or exercise hypertension, which have been linked to worse outcomes24.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [24] Whelton, P. K. et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation 138, e426–e483 (2018).
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- Premisecitation
Objectively measured physical activity levels, categorized into sedentary behaviour, light PA and MVPA, can be used to assess the risk of cardiovascular and all-cause death.
“Objectively measured PA levels, categorized into sedentary behaviour, light PA and MVPA, can be used to assess the risk of cardiovascular and all-cause death”
Quote in the paperSubstantial claim0 of 6 sources checked- cites [34] Borgundvaag, E. & Janssen, I. Objectively measured physical activity and mortality risk among American adults. Am. J. Prev. Med. 52, e25–e31 (2017). source
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- cites [35] Dohrn, I. M., Sjöström, M., Kwak, L., Oja, P. & Hagströmer, M. Accelerometer-measured sedentary time and physical activity — A 15 year follow-up of mortality in a Swedish population-based cohort. J. Sci. Med. Sport. 21, 702–707 (2018). source
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- cites [36] Klenk, J. et al. Objectively measured walking duration and sedentary behaviour and four-year mortality in older people. PLoS ONE 11, e0153779 (2016). source
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- cites [37] LaMonte, M. J. et al. Accelerometer-measured physical activity and mortality in women aged 63 to 99. J. Am. Geriatr. Soc. 66, 886–894 (2018). source
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- cites [38] Lee, I. M. et al. Accelerometer-measured physical activity and sedentary behavior in relation to all-cause mortality: the women’s health study. Circulation 137, 203–205 (2018). source
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- cites [39] Lee, I.-M. et al. Association of step volume and intensity with all-cause mortality in older women. JAMA Intern. Med. 179, 1105 (2019). source
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- Interpretationcitation
All emerging sensors still require extensive clinical validation.
“However, all these emerging sensors still require extensive clinical validation33.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [33] Digiglio, P., Li, R., Wang, W. & Pan, T. Microflotronic arterial tonometry for continuous wearable non-invasive hemodynamic monitoring. Ann. Biomed. Eng. 42, 2278–2288 (2014). source
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- Premisecitation
In ambulatory setting, the mean difference in systolic blood pressure between the HeartGuide wristwatch and an ambulatory BP device was 3.2 ± 17.0 mmHg.
“The mean difference (±s.d.) in systolic BP between both groups was 0.8 ± 12.8 mmHg in the office-based setting and 3.2 ± 17.0 mmHg in the ambulatory setting25.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [25] Kario, K. et al. The first study comparing a wearable watch-type blood pressure monitor with a conventional ambulatory blood pressure monitor on in-office and out-of-office settings. J. Clin. Hypertens. 22, 135–141 (2020). source
Not checked in the free run.
- Interpretationcitation
These findings are consistent with previously described limitations of wrist-based cuff blood pressure measurements.
“These findings are consistent with previously described limitations of wrist-based cuff BP measurements26.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [26] Zweiker, R., Schumacher, M., Fruhwald, F. M., Watzinger, N. & Klein, W. Comparison of wrist blood pressure measurement with conventional sphygmomanometry at a cardiology outpatient clinic. J. Hypertens. 18, 1013–1018 (2000). source
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- Premisecitation
The IPED trial showed that a single-lead ECG monitor can improve outpatient arrhythmia detection in patients who present to the emergency room with palpitations or presyncope and no clear aetiology.
“The IPED trial58 showed that a single-lead ECG monitor can improve outpatient arrhythmia detection in patients who present to the emergency room with palpitations or presyncope and no clear aetiology”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [58] Reed, M. J. et al. Multi-centre randomised controlled trial of a smartphone-based event recorder alongside standard care versus standard care for patients presenting to the emergency department with palpitations and pre-syncope: the IPED (Investigation of Palpitations in the ED) study. EClinicalMedicine 8, 37–46 (2019). source
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- Interpretationnone given
Rhythm-guided anticoagulation is a feasible approach in some patients with atrial fibrillation.
“Wearables can be used to assess AF burden; rhythm-guided anticoagulation is a feasible approach in some patients with AF; no clinical studies exist but a trial examining smartwatch-guided anticoagulation therapy is under development”
Quote in the paperNot a substantial claim - Premisecitation
Physical activity interventions, including texting, gamification and social or financial incentives, can promote physical activity.
“PA interventions, including texting, gamification and social or financial incentives, can promote PA”
Quote in the paperSubstantial claim0 of 4 sources checked- cites [40] Martin, S. S. et al. mActive: a randomized clinical trial of an automated mHealth intervention for physical activity promotion. J. Am. Heart Assoc. 4, e002239 (2015). source
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- cites [41] Patel, M. S. et al. Effect of a game-based intervention designed to enhance social incentives to increase physical activity among families. JAMA Intern. Med. 177, 1586 (2017). source
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- cites [42] Gremaud, A. L. et al. Gamifying accelerometer use increases physical activity levels of sedentary office workers. J. Am. Heart Assoc. 7, e007735 (2018). source
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- cites [43] Adams, M. A. et al. Adaptive goal setting and financial incentives: a 2 × 2 factorial randomized controlled trial to increase adults’ physical activity. BMC Public Health 17, 286 (2017). source
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- Interpretationnone given
Wearables can be used to assess atrial fibrillation burden.
“Wearables can be used to assess AF burden; rhythm-guided anticoagulation is a feasible approach in some patients with AF; no clinical studies exist but a trial examining smartwatch-guided anticoagulation therapy is under development”
Quote in the paperSubstantial claim - Premisecitation
Single-lead ECG wearables can be manipulated to acquire a 12-lead ECG for acute coronary syndrome diagnosis, as shown in a case report.
“Single-lead ECG wearables can be manipulated to acquire a 12-lead ECG for acute coronary syndrome diagnosis, as shown a in case report17”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [17] Cobos Gil, M. Á. Standard and precordial leads obtained with an apple watch. Ann. Intern. Med. 172, 436 (2020). source
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- Premisecitation
Wearables were used in one study to confirm persistent atrial fibrillation before admission for cardioversion.
“Wearables were used in one study to confirm persistent AF before admission for cardioversion53”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [53] Bumgarner, J. M. et al. Smartwatch algorithm for automated detection of atrial fibrillation. J. Am. Coll. Cardiol. 71, 2381–2388 (2018). source
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- Premisecitation
A machine learning algorithm using heart rate and step count was able to classify cardiovascular risk factors such as high cholesterol levels and hypertension.
“A machine learning algorithm using heart rate and step count was able to classify cardiovascular risk factors such as high cholesterol levels and hypertension”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [59] Ballinger, B. et al. DeepHeart: semi-supervised sequence learning for cardiovascular risk prediction. AAAI Conf. Artif. Intell. 32, 2079–2086 (2018).
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- Premisecitation
Atrial fibrillation screening through PPG has shown variable accuracy depending on the algorithms and devices used.
“AF screening through PPG has shown variable accuracy depending on the algorithms and devices used19,51,52”
Quote in the paperSubstantial claim0 of 3 sources checked- cites [19] Perez, M. V. et al. Large-scale assessment of a smartwatch to identify atrial fibrillation. N. Engl. J. Med. 381, 1909–1917 (2019). source
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- cites [51] Tison, G. H. et al. Passive detection of atrial fibrillation using a commercially available smartwatch. JAMA Cardiol. 3, 409 (2018). source
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- cites [52] Fan, Y. Y. et al. Diagnostic performance of a smart device with photoplethysmography technology for atrial fibrillation detection: pilot study (Pre-mAFA II registry). JMIR Mhealth Uhealth. 7, e11437 (2019). source
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- Premisecitation
In patients with type I myocardial infarction, the MICORE study showed that a mobile app platform (including a smartwatch) improved secondary prevention management by reducing hospital readmissions and cost.
“In patients with type I myocardial infarction, the MICORE study76 showed that a mobile app platform (including a smartwatch) improved secondary prevention management by reducing hospital readmissions and cost”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [76] Marvel, F. A., Spaulding, E. M., Lee, M., Yang, W. & Martin, S. S. Abstract 26: The Corrie Myocardial infarction, COmbined-device, Recovery Enhancement (MiCORE) study: 30-day readmission rates and cost-effectiveness of a novel digital health intervention for acute myocardial infarction patients. Circ. Cardiovasc. Qual. Outcomes 12, (2019). source
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- Premisecitation
Wearable-measured physical activity has an inverse dose-dependent relationship with all-cause mortality.
“Several studies have shown wearable-measured physical activity to have an inverse dose-dependent relationship with all-cause mortality5,34–38.”
Quote in the paperSubstantial claim0 of 6 sources checked- cites [5] Blond, K., Brinkløv, C. F., Ried-Larsen, M., Crippa, A. & Grøntved, A. Association of high amounts of physical activity with mortality risk: a systematic review and meta-analysis. Br. J. Sports Med. 54, 1195–1201 (2020). source
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- cites [34] Borgundvaag, E. & Janssen, I. Objectively measured physical activity and mortality risk among American adults. Am. J. Prev. Med. 52, e25–e31 (2017). source
Not checked in the free run.
- cites [35] Dohrn, I. M., Sjöström, M., Kwak, L., Oja, P. & Hagströmer, M. Accelerometer-measured sedentary time and physical activity — A 15 year follow-up of mortality in a Swedish population-based cohort. J. Sci. Med. Sport. 21, 702–707 (2018). source
Not checked in the free run.
- cites [36] Klenk, J. et al. Objectively measured walking duration and sedentary behaviour and four-year mortality in older people. PLoS ONE 11, e0153779 (2016). source
Not checked in the free run.
- cites [37] LaMonte, M. J. et al. Accelerometer-measured physical activity and mortality in women aged 63 to 99. J. Am. Geriatr. Soc. 66, 886–894 (2018). source
Not checked in the free run.
- cites [38] Lee, I. M. et al. Accelerometer-measured physical activity and sedentary behavior in relation to all-cause mortality: the women’s health study. Circulation 137, 203–205 (2018). source
Not checked in the free run.
- Premisecitation
MVPA measured with triaxial accelerometers is associated with lower mortality than light physical activity or sedentary behaviour in several US cohorts and a Swedish population-based cohort.
“Moderate-to-vigorous physical activity (MVPA), measured with the use of triaxial accelerometers, was associated with a lower mortality than light physical activity or sedentary behaviour in several US cohorts and in a Swedish population-based cohort34–38.”
Quote in the paperSubstantial claim0 of 5 sources checked- cites [34] Borgundvaag, E. & Janssen, I. Objectively measured physical activity and mortality risk among American adults. Am. J. Prev. Med. 52, e25–e31 (2017). source
Not checked in the free run.
- cites [35] Dohrn, I. M., Sjöström, M., Kwak, L., Oja, P. & Hagströmer, M. Accelerometer-measured sedentary time and physical activity — A 15 year follow-up of mortality in a Swedish population-based cohort. J. Sci. Med. Sport. 21, 702–707 (2018). source
Not checked in the free run.
- cites [36] Klenk, J. et al. Objectively measured walking duration and sedentary behaviour and four-year mortality in older people. PLoS ONE 11, e0153779 (2016). source
Not checked in the free run.
- cites [37] LaMonte, M. J. et al. Accelerometer-measured physical activity and mortality in women aged 63 to 99. J. Am. Geriatr. Soc. 66, 886–894 (2018). source
Not checked in the free run.
- cites [38] Lee, I. M. et al. Accelerometer-measured physical activity and sedentary behavior in relation to all-cause mortality: the women’s health study. Circulation 137, 203–205 (2018). source
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- Premisecitation
Stepping intensity was not associated with mortality after adjusting for steps per day.
“Of note, stepping intensity was not associated with mortality after adjusting for steps per day.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [39] Lee, I.-M. et al. Association of step volume and intensity with all-cause mortality in older women. JAMA Intern. Med. 179, 1105 (2019). source
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- Premisecitation
In the BE FIT Framingham trial, the gamification group had a significant increase in mean daily steps from baseline compared with the control group (adjusted difference 953, 95% CI 505-1,401).
“In the BE FIT Framingham trial41, involving 200 participants from 94 families, participants in the gamification group were more likely to achieve step goals and had a significant increase in mean daily steps from baseline compared with the control group (1,661 versus 636 increase; adjusted difference 953, 95% CI 505–1,401)41.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [41] Patel, M. S. et al. Effect of a game-based intervention designed to enhance social incentives to increase physical activity among families. JAMA Intern. Med. 177, 1586 (2017). source
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- Interpretationcitation
Oscillometric or cuff-less wearables that accurately measure BP and are continuously worn on the wrist might be more convenient than traditional upper arm BP devices for hypertension screening, self-monitoring, and titration of antihypertensive drugs.
“Oscillometric or cuff-less wearables that accurately measure BP and are continuously worn on the wrist might be more convenient in the ambulatory setting than traditional upper arm BP devices for the screening of hypertension, the self-monitoring of BP and the titration of antihypertensive drugs48.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [48] Kuwabara, M., Harada, K., Hishiki, Y. & Kario, K. Validation of two watch-type wearable blood pressure monitors according to the ANSI/AAMI/ISO81060-2:2013 guidelines: Omron HEM-6410T-ZM and HEM-6410T-ZL. J. Clin. Hypertens. 21, 853–858 (2019). source
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- Premisecitation
A deep neural network using Apple Watch-based PPG sensor data showed excellent prediction of AF (C-statistic 0.97) against the gold standard 12-lead ECG.
“In a proof-of-concept study involving the use of Apple Watch-based PPG sensor data, a deep neural network (DNN) algorithm trained with heuristic pretraining showed excellent prediction of AF (C-statistic 0.97) against the gold standard 12-lead ECG51.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [51] Tison, G. H. et al. Passive detection of atrial fibrillation using a commercially available smartwatch. JAMA Cardiol. 3, 409 (2018). source
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- Interpretationcitation
Wearables might be a convenient tool to diagnose asymptomatic or symptomatic AF.
“Wearables might be a convenient tool to diagnose asymptomatic or symptomatic AF20.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [20] Dagher, L., Shi, H., Zhao, Y. & Marrouche, N. F. Wearables in cardiology: here to stay. Heart Rhythm 17, 889–895 (2020). source
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- Premisecitation
Small, immediate rewards outperformed larger, delayed rewards in a 2 × 2 factorial randomized trial.
“The trial showed that adaptive goals outperformed static goals and small, immediate rewards outperformed larger, delayed rewards, suggesting that adaptive goals with immediate rewards should be preferred to promote physical activity.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [43] Adams, M. A. et al. Adaptive goal setting and financial incentives: a 2 × 2 factorial randomized controlled trial to increase adults’ physical activity. BMC Public Health 17, 286 (2017). source
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- Premisecitation
Adaptive goals outperformed static goals in a 2 × 2 factorial randomized trial.
“The trial showed that adaptive goals outperformed static goals and small, immediate rewards outperformed larger, delayed rewards, suggesting that adaptive goals with immediate rewards should be preferred to promote physical activity.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [43] Adams, M. A. et al. Adaptive goal setting and financial incentives: a 2 × 2 factorial randomized controlled trial to increase adults’ physical activity. BMC Public Health 17, 286 (2017). source
Not checked in the free run.
- Premisecitation
KardiaBand coupled with the SmartRhythm 2.0 DNN showed a sensitivity of >97% for detecting AF episodes lasting ≥1 h.
“KardiaBand (AliveCor, USA), now commercially discontinued, coupled with the SmartRhythm 2.0 DNN was compared with implantable cardiac monitors in a study that collected >31,000 h of continuous heart rhythm data and showed a sensitivity of >97% for detecting AF episodes lasting ≥1 h (ref.53).”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [53] Bumgarner, J. M. et al. Smartwatch algorithm for automated detection of atrial fibrillation. J. Am. Coll. Cardiol. 71, 2381–2388 (2018). source
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- Premisecitation
The two-level classification system achieved a clinically relevant accuracy of 90% for classifying MI on SmartCardia INYU devices.
“The algorithm was tested on SmartCardia INYU devices (SmartCardia, Switzerland) and achieved a clinically relevant accuracy of 90% for classifying MI61.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [61] Sopic, D., Aminifar, A., Aminifar, A. & Atienza, D. Real-time event-driven classification technique for early detection and prevention of myocardial infarction on wearable systems. IEEE Trans. Biomed. Circuits Syst. 12, 982–992 (2018). source
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- Premisecitation
HRV in patients with mildly symptomatic HF can help to identify individuals with limited benefit from cardiac resynchronization therapy.
“HRV in patients with mildly symptomatic HF can help to identify individuals with limited benefit from cardiac resynchronization therapy63.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [63] Sherazi, S. et al. Prognostic significance of heart rate variability among patients treated with cardiac resynchronization therapy. JACC Clin. Electrophysiol. 1, 74–80 (2015). source
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- Interpretationcitation
Wearable monitors can be as effective or even exceed conventional Holter monitoring to detect arrhythmias owing to their convenient usability over longer periods of time.
“Although most of these devices are only single lead, they can be as effective or even exceed the ability of conventional Holter monitoring to detect arrhythmias owing to their convenient usability over longer periods of time55,56.”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [55] Barrett, P. M. et al. Comparison of 24-hour Holter monitoring with 14-day novel adhesive patch electrocardiographic monitoring. Am. J. Med. 127, 95.e11–95.e17 (2014). source
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- cites [56] Turakhia, M. P. et al. Diagnostic utility of a novel leadless arrhythmia monitoring device. Am. J. Cardiol. 112, 520–524 (2013). source
Not checked in the free run.
- Interpretationcitation
In patients with HF, common wearable data such as physical activity levels, HR, HR recovery and HRV can be used for risk stratification.
“In patients with HF, common wearable data, such as physical activity levels, HR, HR recovery and HRV, can be used for risk stratification.”
Quote in the paperSubstantial claim - Premisecitation
A convolutional neural network developed with 12-lead ECGs classified ventricular dysfunction with good accuracy.
“In another study, a convolutional neural network developed with a training dataset of 35,970, 12-lead ECGs and validated in an independent dataset of 52,870 ECGs classified ventricular dysfunction with good accuracy60.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [60] Attia, Z. I. et al. Screening for cardiac contractile dysfunction using an artificial intelligence–enabled electrocardiogram. Nat. Med. 25, 70–74 (2019). source
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- Premisecitation
In the IPED study, the mean time to symptomatic rhythm detection was 9.5 days in the intervention group compared with 42.9 days in the control group.
“The mean time to symptomatic rhythm detection in the intervention group was 9.5 days compared with 42.9 days in the control group58.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [58] Reed, M. J. et al. Multi-centre randomised controlled trial of a smartphone-based event recorder alongside standard care versus standard care for patients presenting to the emergency department with palpitations and pre-syncope: the IPED (Investigation of Palpitations in the ED) study. EClinicalMedicine 8, 37–46 (2019). source
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- Premisecitation
A semi-supervised learning algorithm using Fitbit, Apple Watch and Wear OS data classified high cholesterol levels and hypertension with AUC 0.7441 and 0.8086, respectively.
“For risk factor screening, a semi-supervised learning algorithm, developed from >57,000 person-weeks of data from Fitbit, Apple Watch and Wear OS (Google, USA), classified high cholesterol levels and hypertension with high accuracy (area under the curve (AUC) 0.7441 and 0.8086, respectively) using HR and step count data available from these commercial wearables59.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [59] Ballinger, B. et al. DeepHeart: semi-supervised sequence learning for cardiovascular risk prediction. AAAI Conf. Artif. Intell. 32, 2079–2086 (2018).
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- Premisecitation
KardiaBand experienced difficulty in interpreting up to 33.3% of recordings in another analysis.
“However, the KardiaBand experienced difficulty in interpreting up to 33.3% of recordings in another analysis53.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [53] Bumgarner, J. M. et al. Smartwatch algorithm for automated detection of atrial fibrillation. J. Am. Coll. Cardiol. 71, 2381–2388 (2018). source
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- Premisecitation
A DNN using single-lead ambulatory ECG data classified 12 rhythm classes with high diagnostic performance similar to, and perhaps exceeding, practicing cardiologists.
“A DNN that used single-lead, ambulatory ECG data was able to classify 12 rhythm classes with a high diagnostic performance similar to, and perhaps exceeding, practicing cardiologists57.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [57] Hannun, A. Y. et al. Cardiologist-level arrhythmia detection and classification in ambulatory electrocardiograms using a deep neural network. Nat. Med. 25, 65–69 (2019). source
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- Premisecitation
In the IPED study, at 90 days a symptomatic rhythm was detected in 55.6% of participants in the intervention group compared with 9.5% in the control group.
“At 90 days, a symptomatic rhythm was detected in 55.6% of participants in the intervention group compared with only 9.5% in the control group.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [58] Reed, M. J. et al. Multi-centre randomised controlled trial of a smartphone-based event recorder alongside standard care versus standard care for patients presenting to the emergency department with palpitations and pre-syncope: the IPED (Investigation of Palpitations in the ED) study. EClinicalMedicine 8, 37–46 (2019). source
Not checked in the free run.
- Premisecitation
In a landmark telemonitoring trial, the telemonitoring group had a 39% reduction in HF-related hospitalization compared with the control group.
“After a mean follow-up of 15 months, the telemonitoring group had a 39% reduction in HF-related hospitalization compared with the control group65.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [65] Abraham, W. T. et al. Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: a randomised controlled trial. Lancet 377, 658–666 (2011). source
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- Study design and conductnone given
Most HF telemonitoring trials had a risk of bias due to the lack of blinding.
“In addition, most trials had a risk of bias due to the lack of blinding.”
Quote in the paperNot a substantial claim - Premisecitation
Two randomized trials of more than 100 patients with peripheral vascular disease using the StepWatch 3 accelerometer showed that wearable-guided exercise prescriptions were associated with significant improvement in peak oxygen consumption.
“Two randomized trials of >100 patients with peripheral vascular disease, each utilizing the ankle-based accelerometer StepWatch 3 (Modus, USA), showed that wearable-guided exercise prescriptions were associated with a significant improvement in walking ability, speed and peak oxygen consumption88,89.”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [88] Gardner, A. W., Parker, D. E., Montgomery, P. S. & Blevins, S. M. Step-monitored home exercise improves ambulation, vascular function, and inflammation in symptomatic patients with peripheral artery disease: a randomized controlled trial. J. Am. Heart Assoc. 3, e001107 (2014). source
Not checked in the free run.
- cites [89] Gardner, A. W., Parker, D. E., Montgomery, P. S., Scott, K. J. & Blevins, S. M. Efficacy of quantified home-based exercise and supervised exercise in patients with intermittent claudication: a randomized controlled trial. Circulation 123, 491–498 (2011). source
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- Premisecitation
The REACT.COM pilot study showed a 94% reduction in anticoagulation use compared with chronic anticoagulation treatment.
“This study showed a 94% reduction in anticoagulation use compared with chronic anticoagulation treatment73, with a saving of approximately US$800 per patient over 3 years74.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [73] Passman, R. et al. Targeted anticoagulation for atrial fibrillation guided by continuous rhythm assessment with an insertable cardiac monitor: the Rhythm Evaluation for Anticoagulation with Continuous Monitoring (REACT.COM) Pilot Study. J. Cardiovasc. Electrophysiol. 27, 264–270 (2016). source
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- Premisecitation
In the MiCORE study, preliminary results from 164 patients showed a 43% lower likelihood of hospital readmission at 30 days among participants receiving a guideline-driven, self-management programme than among participants in a propensity-matched, historical comparison group.
“Preliminary results from 164 patients showed a 43% lower likelihood of hospital readmission at 30 days among participants receiving a guideline-driven, self-management programme than among participants in a propensity-matched, historical comparison group (n = 695)76.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [76] Marvel, F. A., Spaulding, E. M., Lee, M., Yang, W. & Martin, S. S. Abstract 26: The Corrie Myocardial infarction, COmbined-device, Recovery Enhancement (MiCORE) study: 30-day readmission rates and cost-effectiveness of a novel digital health intervention for acute myocardial infarction patients. Circ. Cardiovasc. Qual. Outcomes 12, (2019). source
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- Premisecitation
In a study of hyperkalaemia detection, the sensitivity by duration of hyperkalaemia was 94% and the specificity was 74%.
“The sensitivity by duration of hyperkalaemia was 94% and the specificity was 74%, suggesting that this AI algorithm is a viable and non-invasive option for the screening of hyperkalaemia at home83.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [83] Galloway, C. D. et al. Non-invasive detection of hyperkalemia with a smartphone electrocardiogram and artificial intelligence. J. Am. Coll. Cardiol. 71, A272 (2018). source
Not checked in the free run.
- Premisecitation
In a pilot study of 37 patients with peripheral vascular disease, a feedback-enabled Nike FuelBand plus supervised exercise programme significantly increased maximum walking distance compared with supervised exercise alone, sustained over 12 months.
“The study showed significant increases in maximum walking distance, claudication distance and quality of life, sustained over 12 months, in the intervention group compared with the control group87.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [87] Normahani, P. et al. Wearable Sensor Technology Efficacy in Peripheral Vascular Disease (wSTEP). Ann. Surg. 268, 1113–1118 (2018). source
Not checked in the free run.
- Premisecitation
In a pilot study of 37 patients with peripheral vascular disease, a feedback-enabled Nike FuelBand plus supervised exercise programme significantly increased claudication distance compared with supervised exercise alone, sustained over 12 months.
“The study showed significant increases in maximum walking distance, claudication distance and quality of life, sustained over 12 months, in the intervention group compared with the control group87.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [87] Normahani, P. et al. Wearable Sensor Technology Efficacy in Peripheral Vascular Disease (wSTEP). Ann. Surg. 268, 1113–1118 (2018). source
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- Premisecitation
In the BEAT-HF study, the remote care intervention did not lower the rate of hospital readmission for any cause at 30 days or 180 days after hospital discharge.
“Moreover, the remote care intervention did not lower the rate of hospital readmission for any cause at 30 days or 180 days after hospital discharge70.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [70] Ong, M. K. et al. Effectiveness of remote patient monitoring after discharge of hospitalized patients with heart failure the better effectiveness after transition-heart failure (BEAT-HF) randomized clinical trial. JAMA Intern. Med. 176, 310–318 (2016). source
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- Premisecitation
A meta-analysis of 23 randomized trials showed that home-based cardiac rehabilitation was as effective as centre-based rehabilitation in improving clinical and health-related quality-of-life outcomes.
“A meta-analysis of 23 randomized trials, including a total of 2,890 patients undergoing cardiac rehabilitation after MI, revascularization or HF diagnosis, showed that a home-based form of cardiac rehabilitation was as effective as centre-based rehabilitation in improving clinical and health-related quality-of-life outcomes84.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [84] Anderson, L. et al. Home-based versus centre-based cardiac rehabilitation. Cochrane Database Syst. Rev. 6, CD007130 (2017).
Not checked in the free run.
- Premisecitation
In a pilot study of 37 patients with peripheral vascular disease, a feedback-enabled Nike FuelBand plus supervised exercise programme significantly increased quality of life compared with supervised exercise alone, sustained over 12 months.
“The study showed significant increases in maximum walking distance, claudication distance and quality of life, sustained over 12 months, in the intervention group compared with the control group87.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [87] Normahani, P. et al. Wearable Sensor Technology Efficacy in Peripheral Vascular Disease (wSTEP). Ann. Surg. 268, 1113–1118 (2018). source
Not checked in the free run.
- Premisecitation
Two randomized trials of more than 100 patients with peripheral vascular disease using the StepWatch 3 accelerometer showed that wearable-guided exercise prescriptions were associated with significant improvement in walking speed.
“Two randomized trials of >100 patients with peripheral vascular disease, each utilizing the ankle-based accelerometer StepWatch 3 (Modus, USA), showed that wearable-guided exercise prescriptions were associated with a significant improvement in walking ability, speed and peak oxygen consumption88,89.”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [88] Gardner, A. W., Parker, D. E., Montgomery, P. S. & Blevins, S. M. Step-monitored home exercise improves ambulation, vascular function, and inflammation in symptomatic patients with peripheral artery disease: a randomized controlled trial. J. Am. Heart Assoc. 3, e001107 (2014). source
Not checked in the free run.
- cites [89] Gardner, A. W., Parker, D. E., Montgomery, P. S., Scott, K. J. & Blevins, S. M. Efficacy of quantified home-based exercise and supervised exercise in patients with intermittent claudication: a randomized controlled trial. Circulation 123, 491–498 (2011). source
Not checked in the free run.
- Premisecitation
The single-lead ECG patch BodyGuardian compared with 24-h, 12-lead Holter monitoring had a mean Bland-Altman plot almost 0 with a small standard error (−1.4 ± 1.8 ms).
“The single-lead ECG patch BodyGuardian (Preventice Solutions Group, USA) was compared with 24-h, 12-lead Holter monitoring in 25 patients with congenital long QT and in 20 healthy individuals and the mean of the Bland-Altman plot was almost 0 with a small standard error (−1.4 ± 1.8 ms)78.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [78] Castelletti, S. et al. A wearable remote monitoring system for the identification of subjects with a prolonged QT interval or at risk for drug-induced long QT syndrome. Int. J. Cardiol. 266, 89–94 (2018). source
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- Premisecitation
A systematic review and meta-analysis of nine trials in patients with cardiovascular disease found that wearable monitors of physical activity that included exercise prescription or advice were superior to no device in improving fitness and step count in the maintenance phase of cardiac rehabilitation.
“Furthermore, a systematic review and meta-analysis of nine trials of patients with cardiovascular disease demonstrated that wearable monitors of physical activity that included exercise prescription or advice were superior to no device in improving fitness and step count in the maintenance phase of cardiac rehabilitation86.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [86] Hannan, A. L. et al. Impact of wearable physical activity monitoring devices with exercise prescription or advice in the maintenance phase of cardiac rehabilitation: systematic review and meta-analysis. BMC Sports Sci. Med. Rehabil. 11, 14 (2019). source
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- Premisecitation
Two randomized trials of more than 100 patients with peripheral vascular disease using the StepWatch 3 accelerometer showed that wearable-guided exercise prescriptions were associated with significant improvement in walking ability.
“Two randomized trials of >100 patients with peripheral vascular disease, each utilizing the ankle-based accelerometer StepWatch 3 (Modus, USA), showed that wearable-guided exercise prescriptions were associated with a significant improvement in walking ability, speed and peak oxygen consumption88,89.”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [88] Gardner, A. W., Parker, D. E., Montgomery, P. S. & Blevins, S. M. Step-monitored home exercise improves ambulation, vascular function, and inflammation in symptomatic patients with peripheral artery disease: a randomized controlled trial. J. Am. Heart Assoc. 3, e001107 (2014). source
Not checked in the free run.
- cites [89] Gardner, A. W., Parker, D. E., Montgomery, P. S., Scott, K. J. & Blevins, S. M. Efficacy of quantified home-based exercise and supervised exercise in patients with intermittent claudication: a randomized controlled trial. Circulation 123, 491–498 (2011). source
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- Premisecitation
Coravos et al. developed an evaluation framework to test the accuracy and validity of connected sensor technologies, including wearables.
“At the beginning of 2020, Coravos et al. developed a timely evaluation framework to test the accuracy and validity of connected sensor technologies, which included wearables95.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [95] Coravos, A. et al. Modernizing and designing evaluation frameworks for connected sensor technologies in medicine. NPJ Digit. Med. 3, 37 (2020). source
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- Premisecitation
False negatives in wearable AF screening can have detrimental consequences, especially in symptomatic or high-risk patients, in whom false reassurance can delay anticoagulation therapy and increase the risk of stroke.
“Alternatively, false negatives can have detrimental consequences, especially in symptomatic or high-risk patients in whom false reassurance can delay anticoagulation therapy and increase the risk of stroke101.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [101] Marcus, G. M. The apple watch can detect atrial fibrillation: so what now? Nat. Rev. Cardiol. 17, 135–136 (2020). source
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- Interpretationreasoning
Heterogeneity in wearable data quality can be attributed to the lack of consensus on the development and design of digital health products and the obscurity of regulatory oversight policies.
“The heterogeneity in wearable data quality can be attributed to the lack of consensus on the development and design of digital health products and the obscurity of regulatory oversight policies.”
Quote in the paperSubstantial claim - Premisereasoning
The FDA leverages the International Medical Device Regulators Forum risk categorization framework to help pre-certified companies determine the appropriate premarket pathway.
“The FDA then leverages the International Medical Device Regulators Forum risk categorization framework to help the pre-certified company determine the appropriate premarket pathway for its product.”
Quote in the paperNot a substantial claim - Premisecitation
The lack of transparency and reproducibility of AI computational algorithm methods and code in many published studies threatens scientific progress and discovery.
“In addition, the lack of transparency and reproducibility of AI computational algorithm methods and code in many published studies threatens scientific progress and discovery, which require that independent scientists are able to scrutinize and reproduce results98.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [98] Haibe-Kains, B. et al. Transparency and reproducibility in artificial intelligence. Nature 586, E14–E16 (2020). source
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- Premisecitation
A wearable activity monitor combined with telephone coaching did not improve quality of life in a trial of 200 patients with peripheral vascular disease.
“Conversely, a wearable activity monitor combined with telephone coaching did not improve walking ability or quality of life but improved exercise frequency in a trial of 200 patients with peripheral vascular disease90.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [90] McDermott, M. M. et al. Effect of a home-based exercise intervention of wearable technology and telephone coaching on walking performance in peripheral artery disease. JAMA 319, 1665 (2018). source
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- Interpretationnone given
The absence of clear regulatory oversight policies governing commercial wearable devices has led to numerous products of unknown safety and efficacy on the market.
“The absence of clear regulatory oversight policies governing commercial wearable devices has also led to the emergence on the market of numerous products of unknown safety and efficacy.”
Quote in the paperSubstantial claim - Premisecitation
Many validation studies have questioned the accuracy of raw sensor data and software algorithms.
“Many validation studies have questioned the accuracy of raw sensor data and software algorithms92–94.”
Quote in the paperSubstantial claim0 of 3 sources checked- cites [92] Shcherbina, A. et al. Accuracy in wrist-worn, sensor-based measurements of heart rate and energy expenditure in a diverse cohort. J. Pers. Med. 7, 3 (2017). source
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- cites [93] Vetrovsky, T. et al. Validity of six consumer-level activity monitors for measuring steps in patients with chronic heart failure. PLoS ONE 14, e0222569 (2019). source
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- cites [94] Herkert, C., Kraal, J. J., van Loon, E. M. A., van Hooff, M. & Kemps, H. M. C. Usefulness of modern activity trackers for monitoring exercise behavior in chronic cardiac patients: validation study. JMIR mHealth uHealth 7, e15045 (2019). source
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- Premisecitation
A wearable activity monitor combined with telephone coaching did not improve walking ability in a trial of 200 patients with peripheral vascular disease.
“Conversely, a wearable activity monitor combined with telephone coaching did not improve walking ability or quality of life but improved exercise frequency in a trial of 200 patients with peripheral vascular disease90.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [90] McDermott, M. M. et al. Effect of a home-based exercise intervention of wearable technology and telephone coaching on walking performance in peripheral artery disease. JAMA 319, 1665 (2018). source
Not checked in the free run.
- Premisecitation
A wearable activity monitor combined with telephone coaching improved exercise frequency in a trial of 200 patients with peripheral vascular disease.
“Conversely, a wearable activity monitor combined with telephone coaching did not improve walking ability or quality of life but improved exercise frequency in a trial of 200 patients with peripheral vascular disease90.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [90] McDermott, M. M. et al. Effect of a home-based exercise intervention of wearable technology and telephone coaching on walking performance in peripheral artery disease. JAMA 319, 1665 (2018). source
Not checked in the free run.
- Interpretationreasoning
Owing to FDA regulatory policies, the performance of medical-grade sensors tends to be more consistent across wearable manufacturers compared with non-medical sensors such as activity or PPG sensors, which do not undergo FDA evaluation.
“Owing to these policies, the performance of medical-grade sensors tends to be more consistent across various wearable manufacturers compared with non-medical sensors, such as activity or PPG sensors, which do not undergo FDA evaluation.”
Quote in the paperNot a substantial claim - Premisereasoning
Post-marketing surveillance of real-world data is used to verify software efficacy and safety.
“Finally, post-marketing surveillance of real-world data is used to verify the software’s efficacy and safety.”
Quote in the paperNot a substantial claim - Premisecitation
The FDA often clears medical-grade sensors such as ECG wearables through the accelerated 510(k) pathway if the applicant shows substantial equivalence to a US legally marketed predicate device.
“The FDA often clears these sensors through the accelerated 510(k) pathway if the applicant can show substantial equivalence to a US legally marketed predicate device96.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [96] US Food and Drug Administration. Classify your medical device. FDA http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ (2016).
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- Premisecitation
The FDA new digital health innovation plan promises a pragmatic risk-based approach to regulate software as a medical device through a pre-certification programme that looks first at the software developer rather than the product.
“The FDA new digital health innovation plan promises a pragmatic risk-based approach to regulate software as a medical device through a pre-certification programme that aims to look first at the software developer rather than at the product100.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [100] US Food and Drug Administration. Digital health software precertification (Pre-Cert) program: participate in 2019 test plan. FDA https://www.fda.gov/medical-devices/digital-health-software-precertification-pre-cert-program/digital-health-software-precertification-pre-cert-program-participate-2019-test-plan (2019).
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- Premisecitation
Rarely do these devices receive approval for a new indication label, which requires randomized trials showing clinical efficacy.
“Rarely do these devices receive approval for a new indication label, which requires randomized trials showing clinical efficacy (Table 1).”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites Table 1
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- Premisecitation
A study examining low-cost fitness trackers (defined as less than US$105) on the market showed no correlation between the cost of the device and the number of BCTs incorporated.
“Interestingly, a study examining low-cost fitness trackers (defined as <US$105) on the market showed no correlation between the cost of the device and the number of BCTs incorporated.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [108] Chia, G. L. C., Anderson, A. & McLean, L. A. Behavior change techniques incorporated in fitness trackers: content analysis. JMIR mHealth uHealth 7, e12768 (2019). source
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- Premisecitation
A trial with 800 participants questioned the value of wearables in sustaining long-term behavioural changes and improving clinical outcomes.
“As mentioned previously, a trial with 800 participants questioned the value of wearables in sustaining long-term behavioural changes and improving clinical outcomes44.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [44] Finkelstein, E. A. et al. Effectiveness of activity trackers with and without incentives to increase physical activity (TRIPPA): a randomised controlled trial. Lancet Diabetes Endocrinol. 4, 983–995 (2016). source
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- Premisecitation
In a small study of 67 participants with overweight or obesity, the group receiving text message prompts showed an increase in number of steps.
“The group receiving the text message intervention showed an increase in the number of steps. However, this effect was not sustained over the 6-week study period.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [45] Wang, J. B. et al. Wearable sensor/device (Fitbit One) and SMS text-messaging prompts to increase physical activity in overweight and obese adults: a randomized controlled trial. Telemed. e-Health 21, 782–792 (2015). source
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- Premisecitation
The increase in steps from text message prompts was not sustained over the 6-week study period.
“The group receiving the text message intervention showed an increase in the number of steps. However, this effect was not sustained over the 6-week study period.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [45] Wang, J. B. et al. Wearable sensor/device (Fitbit One) and SMS text-messaging prompts to increase physical activity in overweight and obese adults: a randomized controlled trial. Telemed. e-Health 21, 782–792 (2015). source
Not checked in the free run.
- Interpretationreasoning
Cardiology society guidelines have not yet endorsed the use of the Apple Watch for AF screening.
“Therefore, cardiology society guidelines have not yet endorsed the use of the Apple Watch for AF screening.”
Quote in the paperSubstantial claim - Interpretationcitation
The use of behavioural economics and cognitive psychology to develop novel social and financial incentives can potentially sustain good habits, especially when initiated at a very young age.
“Therefore, the use of behavioural economics and cognitive psychology to develop novel social and financial incentives can potentially sustain good habits, especially when initiated at a very young age44.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [44] Finkelstein, E. A. et al. Effectiveness of activity trackers with and without incentives to increase physical activity (TRIPPA): a randomised controlled trial. Lancet Diabetes Endocrinol. 4, 983–995 (2016). source
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- Premisecitation
Heterogeneity in the design and implementation of BCTs has been a considerable challenge.
“Heterogeneity in the design and implementation of BCTs has been a considerable challenge and efforts have been made to standardize the methods to create these tools103.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [103] Yardley, L., Choudhury, T., Patrick, K. & Michie, S. Current issues and future directions for research into digital behavior change interventions. Am. J. Prev. Med. 51, 814–815 (2016). source
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- Premisecitation
A survey among 4,272 US adults reported a threefold difference in wearable use between individuals earning at least US$75,000 and those earning less than US$30,000.
“A survey among 4,272 US adults reported a threefold difference in wearable use between individuals earning ≥US$75,000 and those earning <US$30,000 (ref.107).”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [107] Vogels, E. A. About one-in-five Americans use a smart watch or fitness tracker. Pew Research Center https://www.pewresearch.org/fact-tank/2020/01/09/about-one-in-five-americans-use-a-smart-watch-or-fitness-tracker (2020).
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- Premisecitation
In one survey, two-thirds of millennials agreed to share their wearable data with insurance companies.
“Although two-thirds of millennials in one survey agreed to share their wearable data with insurance companies1, applying financial and non-financial rewards with penalties raises several ethical questions.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [1] Sana, F. et al. Wearable devices for ambulatory cardiac monitoring. J. Am. Coll. Cardiol. 75, 1582–1592 (2020). source
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- Premisecitation
Zhou et al. produced a tool to pre-empt non-adherence using a Discontinuation Prediction Score.
“Zhou et al. produced a tool to pre-empt the problem of non-adherence with use of a Discontinuation Prediction Score105.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [105] Zhou, M., Fukuoka, Y., Goldberg, K., Vittinghoff, E. & Aswani, A. Applying machine learning to predict future adherence to physical activity programs. BMC Med. Inform. Decis. Mak. 19, 169 (2019). source
Not checked in the free run.
- Premisecitation
A simulation allocating financial incentives based on predicted exercise adherence resulted in theoretically greater adherence compared with random incentivization.
“A simulation was then performed in which financial incentives were allocated based on an individual’s predicted exercise adherence, resulting in a theoretically greater adherence compared with a random incentivization scheme.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [105] Zhou, M., Fukuoka, Y., Goldberg, K., Vittinghoff, E. & Aswani, A. Applying machine learning to predict future adherence to physical activity programs. BMC Med. Inform. Decis. Mak. 19, 169 (2019). source
Not checked in the free run.
- Interpretationcitation
The use of wearables in standard clinical practice might emerge as a new health disparity, with individuals unable to afford the device being subject to substandard health care.
“Therefore, the use of wearables in standard clinical practice might emerge as a new health disparity, with individuals unable to afford the device being subject to substandard health care.”
Quote in the paperSubstantial claim - Interpretationreasoning
Data breaches of wearable data are expected as an eventuality rather than a mere possibility.
“Given the sensitivity of wearable data, next-generation cybersecurity tools, such as blockchain111, should be considered because data breaches are expected as an eventuality rather than a mere possibility and because the data constantly move from one platform to another.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [111] Hasselgren, A., Kralevska, K., Gligoroski, D., Pedersen, S. A. & Faxvaag, A. Blockchain in healthcare and health sciences—a scoping review. Int. J. Med. Inf. 134, 104040 (2020). source
Not checked in the free run.
- Premisecitation
De-identification of wearable data may be insufficient because meta-data associated with the user can theoretically be used to re-identify them.
“Although de-identification is a possibility, the meta-data associated with the user can be theoretically used to re-identify them110.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [110] Cohen, I. G. & Mello, M. M. Big data, big tech, and protecting patient privacy. JAMA 322, 1141 (2019). source
Not checked in the free run.
- May combine two claims. 46
- Classified as probably not a substantial claim. 24
May combine two claims.
PremisecitationPhysical activity is inversely correlated with adverse cardiovascular outcomes and all-cause mortality.
“Physical activity is inversely correlated to adverse cardiovascular outcomes5 and all-cause mortality and is recommended by the AHA as one of the ‘Life’s Simple 7’ lifestyle recommendations to promote heart health6.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [5] Blond, K., Brinkløv, C. F., Ried-Larsen, M., Crippa, A. & Grøntved, A. Association of high amounts of physical activity with mortality risk: a systematic review and meta-analysis. Br. J. Sports Med. 54, 1195–1201 (2020). source
Not checked in the free run.
May combine two claims.
PremisecitationIn healthy populations, a high resting heart rate is associated with an increased risk of coronary artery disease and all-cause death.
“In healthy populations, a high resting HR has been associated with an increased risk of coronary artery disease and all-cause death12 and is also well recognized as a predictor of adverse outcomes in patients with heart failure (HF)13.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [12] Zhang, D., Wang, W. & Li, F. Association between resting heart rate and coronary artery disease, stroke, sudden death and noncardiovascular diseases: a meta-analysis. Can. Med. Assoc. J. 188, E384–E392 (2016). source
Not checked in the free run.
May combine two claims.
PremisecitationIn patients with established heart disease undergoing phase II or phase III cardiac rehabilitation, the accuracy of wrist-worn devices varied substantially by the type of activity and 5% of heart rate measurements were substantially inaccurate.
“the accuracy of wrist-worn devices varied substantially by the type of activity and 5% of HR measurements were substantially inaccurate23.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [23] Etiwy, M. et al. Accuracy of wearable heart rate monitors in cardiac rehabilitation. Cardiovasc. Diagn. Ther. 9, 262–271 (2019). source
Not checked in the free run.
May combine two claims.
PremisecitationA centrally located sensor on the torso is best suited for detecting posture, acceleration and whole-body movements and offers the least errors compared with other body locations.
“A centrally located sensor on the torso (embedded into vests, mounted by straps or attached to the skin) is best suited for detecting posture, acceleration and whole-body movements and offers the least errors compared with other body locations7.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [7] Yang, C. C. & Hsu, Y. L. A review of accelerometry-based wearable motion detectors for physical activity monitoring. Sensors 10, 7772–7788 (2010). source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationSkin colour, moisture and tattoos have been postulated to affect PPG accuracy.
“Skin colour, moisture and even tattoos have also been postulated to affect PPG accuracy20”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [20] Dagher, L., Shi, H., Zhao, Y. & Marrouche, N. F. Wearables in cardiology: here to stay. Heart Rhythm 17, 889–895 (2020). source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationOne study showed similar device performance across a full range of skin tones.
“although one study showed similar device performance across a full range of skin tones21.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [21] Bent, B., Goldstein, B. A., Kibbe, W. A. & Dunn, J. P. Investigating sources of inaccuracy in wearable optical heart rate sensors. NPJ Digit. Med. 3, 18 (2020). source
Not checked in the free run.
May combine two claims.
PremisecitationUsing more sensors leads to better estimation of physical activity and energy expenditure but can put further strain on battery life.
“Although the use of more sensors leads to better estimation of physical activity and energy expenditure, this approach can also put further strain on battery life11.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [11] Muralidharan, K., Khan, A. J., Misra, A., Balan, R. K. & Agarwal, S. Barometric phone sensors: more hype than hope! Proc. Workshop Mob. Comput. Syst. Appl. 14, 1–6 (2014).
Not checked in the free run.
May combine two claims.
PremisereasoningSubjective reporting of physical activity levels is limited by a lack of sufficient detail, recall bias, and a failure to objectively assess physical activity in a real-life environment.
“This approach is limited by a lack of sufficient detail, recall bias and a failure to objectively assess physical activity in a real-life environment.”
Quote in the paperSubstantial claimMay combine two claims.
PremisecitationIn a small study, mean biases between cuff-less wearable and ambulatory devices over 24 h were 0.5 mmHg for systolic BP and 2.24 mmHg for diastolic BP, with mean bias widening over 7 days to -12.7 mmHg for systolic BP and -5.6 mmHg for diastolic BP.
“Mean biases between the wearable and ambulatory devices over 24 h were 0.5 mmHg (–10.1 mmHg to 11.1 mmHg) for systolic BP and 2.24 mmHg (–17.6 mmHg to 13.1 mmHg) for diastolic BP, with the mean bias widening over 7 days to –12.7 mmHg for systolic BP and –5.6 mmHg for diastolic BP.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [28] Islam, S. M. S. et al. Validation and acceptability of a cuffless wrist-worn wearable blood pressure monitoring device among users and health care professionals: mixed methods study. JMIR mHealth uHealth 7, e14706 (2019). source
Not checked in the free run.
May combine two claims.
InterpretationcitationPPG heart rate readings from wrist-worn devices during activity should be interpreted with caution, whereas less convenient chest-strap monitors are more accurate.
“These studies highlight that PPG HR readings from wrist-worn devices during activity should be interpreted with caution20, whereas less convenient, chest-strap monitors are more accurate.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [20] Dagher, L., Shi, H., Zhao, Y. & Marrouche, N. F. Wearables in cardiology: here to stay. Heart Rhythm 17, 889–895 (2020). source
Not checked in the free run.
May combine two claims.
Interpretationnone givenBlood pressure can now be measured without a cuff, increasing the feasibility and ease of monitoring BP throughout the day.
“BP can now be measured without a cuff, increasing the feasibility and ease of monitoring BP throughout the day.”
Quote in the paperNot a substantial claimMay combine two claims.
PremisecitationMinimally invasive continuous glucose monitors have been clinically validated but are difficult to embed in consumer-grade wearables and mostly function as a stand-alone product.
“One example of biochemical sensors are the minimally invasive continuous glucose monitors that have been clinically validated but are difficult to embed in consumer-grade wearables and mostly function as a stand-alone product31.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [31] Bailey, T. S. Clinical implications of accuracy measurements of continuous glucose sensors. Diabetes Technol. Ther. 19 (Suppl. 2), S51–S54 (2017). source
Not checked in the free run.
May combine two claims.
InterpretationreasoningCuff-less blood pressure monitoring is still in its infancy and requires further scrutiny.
“Although encouraging, cuff-less BP monitoring is still in its infancy and requires further scrutiny.”
Quote in the paperSubstantial claimMay combine two claims.
PremisecitationBiochemical sensors can measure body fluid electrolytes with electrochemical transducers, offering valuable information about plasma volume status and analyte concentrations.
“Biochemical sensors can measure body fluid electrolytes with the use of electrochemical transducers, offering valuable information about plasma volume status and analyte concentrations30.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [30] Kim, J., Campbell, A. S., de Ávila, B. E.-F. & Wang, J. Wearable biosensors for healthcare monitoring. Nat. Biotechnol. 37, 389–406 (2019). source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
PremisecitationNon-invasive sensors of sweat and saliva might be more practical to integrate into wearables but still need to be carefully evaluated.
“Non-invasive sensors of sweat and saliva might be more practical to integrate into wearables but still need to be carefully evaluated32.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [32] Seshadri, D. R. et al. Wearable sensors for monitoring the physiological and biochemical profile of the athlete. NPJ Digit. Med. 2, 72 (2019). source
Not checked in the free run.
May combine two claims.
PremisecitationThe TEN-HMS, TIM-HF and BEAT-HF trials showed that a remote telemonitoring intervention did not reduce heart failure hospitalizations and all-cause mortality.
“TEN-HMS, TIM-HF and BEAT-HF trials showed that a remote telemonitoring intervention did not reduce HF hospitalizations and all-cause mortality68–70”
Quote in the paperSubstantial claim0 of 3 sources checked- cites [68] Cleland, J. G. F., Louis, A. A., Rigby, A. S., Janssens, U. & Balk, A. H. M. M. Noninvasive home telemonitoring for patients with heart failure at high risk of recurrent admission and death: the trans-European network-home-care management system (TEN-HMS) study. J. Am. Coll. Cardiol. 45, 1654–1664 (2005). source
Not checked in the free run.
- cites [69] Koehler, F. et al. Impact of remote telemedical management on mortality and hospitalizations in ambulatory patients with chronic heart failure: the telemedical interventional monitoring in heart failure study. Circulation 123, 1873–1880 (2011). source
Not checked in the free run.
- cites [70] Ong, M. K. et al. Effectiveness of remote patient monitoring after discharge of hospitalized patients with heart failure the better effectiveness after transition-heart failure (BEAT-HF) randomized clinical trial. JAMA Intern. Med. 176, 310–318 (2016). source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).
Interpretationnone givenWearables can be used to guide β-blocker titration in patients with chronic coronary syndrome.
“Wearables can be used to guide β-blocker titration in patients with chronic coronary syndrome; no available clinical studies”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing), S4 (based).
Interpretationnone givenWearables can be used to guide rate control in patients with permanent atrial fibrillation.
“Wearables can be used to guide rate control in patients with permanent AF; no clinical studies available”
Quote in the paperNot a substantial claimMay combine two claims.
PremisecitationThe TEMA-HF1 and TIM-HF-2 trials showed that telemonitoring reduced days lost owing to heart failure hospitalizations and reduced all-cause mortality.
“The TEMA-HF1 and TIM-HF-2 trial showed that telemonitoring reduced days lost owing to HF hospitalizations and reduced all-cause mortality66,67”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [66] Koehler, F. et al. Efficacy of telemedical interventional management in patients with heart failure (TIM-HF2): a randomised, controlled, parallel-group, unmasked trial. Lancet 392, 1047–1057 (2018). source
Not checked in the free run.
- cites [67] Dendale, P. et al. Effect of a telemonitoring-facilitated collaboration between general practitioner and heart failure clinic on mortality and rehospitalization rates in severe heart failure: the TEMA-HF 1 (telemonitoring in the management of heart failure) study. Eur. J. Heart Fail. 14, 333–340 (2012). source
Not checked in the free run.
May combine two claims.
PremisecitationAtrial fibrillation screening via ECG patches in selected high-risk individuals is feasible and clinically valuable.
“AF screening via ECG patches in selected high-risk individuals is feasible and clinically valuable50”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [50] Steinhubl, S. R. et al. Effect of a home-based wearable continuous ECG monitoring patch on detection of undiagnosed atrial fibrillation. JAMA 320, 146 (2018). source
Not checked in the free run.
May combine two claims.
PremisecitationPhysical activity interventions did not show long-term behavioural changes or did not improve clinical outcomes.
“PA interventions did not show long-term behavioural changes or did not improve clinical outcomes”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [44] Finkelstein, E. A. et al. Effectiveness of activity trackers with and without incentives to increase physical activity (TRIPPA): a randomised controlled trial. Lancet Diabetes Endocrinol. 4, 983–995 (2016). source
Not checked in the free run.
- cites [45] Wang, J. B. et al. Wearable sensor/device (Fitbit One) and SMS text-messaging prompts to increase physical activity in overweight and obese adults: a randomized controlled trial. Telemed. e-Health 21, 782–792 (2015). source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing), S4 (based).
Interpretationnone givenWearables can be used to objectively and frequently assess heart failure prognosis via 6-minute walk tests or measuring heart rate variables such as heart rate recovery or variability.
“wearables can be used to objectively and frequently assess HF prognosis via 6-minute walk tests or measuring heart rate variables such as heart rate recovery or variability; no clinical studies available”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S4 (based). May combine two claims.
Interpretationnone givenAtrial fibrillation screening through PPG coupled with ECG is feasible and practical.
“AF screening through PPG coupled with ECG is feasible and practical; no clinical studies available; the HEARTLINE study aims54 to examine this application and its effect on clinical outcomes”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationAdoption of smart wearables accelerated after the COVID-19 pandemic and the explosive growth of telehealth.
“its adoption has further accelerated after the coronavirus disease 2019 (COVID-19) pandemic and the explosive growth of telehealth4.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [4] Varma, N. et al. HRS/EHRA/APHRS/LAHRS/ACC/AHA worldwide practice update for telehealth and arrhythmia monitoring during and after a Pandemic. Circ. Arrhythm. Electrophysiol. 13, 1048–1059 (2020).
Not checked in the free run.
May combine two claims.
PremisecitationOther trials showed no improvement in walking ability or quality of life but improvement in exercise frequency.
“Other trials showed no improvement in walking ability or quality of life but improvement in exercise frequency90,91”
Quote in the paperNot a substantial claim0 of 2 sources checked- cites [90] McDermott, M. M. et al. Effect of a home-based exercise intervention of wearable technology and telephone coaching on walking performance in peripheral artery disease. JAMA 319, 1665 (2018). source
Not checked in the free run.
- cites [91] Chan, C. et al. The role of wearable technologies and telemonitoring in managing vascular disease. Vasc. Endovasc. Rev. https://doi.org/10.15420/ver.2019.11 (2020). source
Not checked in the free run.
May combine two claims.
InterpretationcitationHome-based cardiac telerehabilitation using wearable sensors is equivalent or better than centre-based rehabilitation and can increase access to cardiac rehabilitation and reduce the cost.
“Home-based cardiac telerehabilitation using wearable sensors is equivalent or better than centre-based rehabilitation and can increase access to cardiac rehabilitation and reduce the cost”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [85] Maddison, R. et al. Effects and costs of real-time cardiac telerehabilitation: randomised controlled non-inferiority trial. Heart 105, 122–129 (2019). source
Not checked in the free run.
- cites [86] Hannan, A. L. et al. Impact of wearable physical activity monitoring devices with exercise prescription or advice in the maintenance phase of cardiac rehabilitation: systematic review and meta-analysis. BMC Sports Sci. Med. Rehabil. 11, 14 (2019). source
Not checked in the free run.
May combine two claims.
InterpretationcitationSingle-lead or 6-lead ECG can reasonably measure the QTc interval but with clinically significant variability.
“Single-lead or 6-lead ECG was able to reasonably measure the QTc interval but with clinically significant variability”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [78] Castelletti, S. et al. A wearable remote monitoring system for the identification of subjects with a prolonged QT interval or at risk for drug-induced long QT syndrome. Int. J. Cardiol. 266, 89–94 (2018). source
Not checked in the free run.
- cites [79] Schram, M. et al. Prediction of the heart rate corrected QT interval (QTc) from a novel, multilead smartphone-enabled ECG using a deep neural network. J. Am. Coll. Cardiol. 73, 368 (2019). source
Not checked in the free run.
May combine two claims.
InterpretationreasoningChallenges such as device accuracy, clinical validity, a lack of standardized regulatory policies and concerns for patient privacy are still hindering the widespread adoption of smart wearable technologies in clinical practice.
“To date, challenges such as device accuracy, clinical validity, a lack of standardized regulatory policies and concerns for patient privacy are still hindering the widespread adoption of smart wearable technologies in clinical practice.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing), S4 (based). May combine two claims.
Interpretationnone givenWearables can be used to detect high-risk arrhythmias and stratify patients who might need a defibrillator.
“Wearables can be used to detect high-risk arrhythmias and stratify patients who might need a defibrillator; no clinical studies available”
Quote in the paperNot a substantial claimMay combine two claims.
PremisecitationRandomized trials showed that wearable-guided exercise prescriptions improve walking ability, speed and oxygen consumption.
“Randomized trials showed that wearable-guided exercise prescriptions improve walking ability, speed and oxygen consumption88,89”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [88] Gardner, A. W., Parker, D. E., Montgomery, P. S. & Blevins, S. M. Step-monitored home exercise improves ambulation, vascular function, and inflammation in symptomatic patients with peripheral artery disease: a randomized controlled trial. J. Am. Heart Assoc. 3, e001107 (2014). source
Not checked in the free run.
- cites [89] Gardner, A. W., Parker, D. E., Montgomery, P. S., Scott, K. J. & Blevins, S. M. Efficacy of quantified home-based exercise and supervised exercise in patients with intermittent claudication: a randomized controlled trial. Circulation 123, 491–498 (2011). source
Not checked in the free run.
May combine two claims.
InterpretationcitationHyperkalaemia detection via wearable ECG is feasible but has high false-positive rates.
“Hyperkalaemia detection via wearable ECG is feasible but has high false-positive rates”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [82] Galloway, C. D. et al. Development and validation of a deep-learning model to screen for hyperkalemia from the electrocardiogram. JAMA Cardiol. 4, 428 (2019). source
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- cites [83] Galloway, C. D. et al. Non-invasive detection of hyperkalemia with a smartphone electrocardiogram and artificial intelligence. J. Am. Coll. Cardiol. 71, A272 (2018). source
Not checked in the free run.
May combine two claims.
InterpretationcitationLongitudinal HR data can establish what is normal for an individual and recognize important deviations earlier, before cardiovascular disease develops.
“Moreover, longitudinal HR data can establish what is normal for an individual and, subsequently, recognize important deviations in lifestyle earlier, before cardiovascular disease develops46.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [46] Quer, G., Gouda, P., Galarnyk, M., Topol, E. J. & Steinhubl, S. R. Inter- and intraindividual variability in daily resting heart rate and its associations with age, sex, sleep, BMI, and time of year: retrospective, longitudinal cohort study of 92,457 adults. PLoS ONE 15, e0227709 (2020). source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationInitiating hypertension screening in young adulthood is widely recommended to prevent cardiovascular disease.
“Initiating hypertension screening in young adulthood is widely recommended to prevent cardiovascular disease24.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [24] Whelton, P. K. et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation 138, e426–e483 (2018).
Not checked in the free run.
May combine two claims.
PremisecitationIn another gamification study, participants with MapTrek had an average of 1,455 more steps per day and 89.6 additional active minutes per week than the Fitbit-only group.
“Participants with MapTrek had an average of 1,455 more steps per day and 89.6 additional active minutes per week than the Fitbit-only group42.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [42] Gremaud, A. L. et al. Gamifying accelerometer use increases physical activity levels of sedentary office workers. J. Am. Heart Assoc. 7, e007735 (2018). source
Not checked in the free run.
Classified as probably not a substantial claim.
InterpretationreasoningContinuous wearable BP measurements using novel sensors will potentially facilitate BP measurement during sleep or exercise when oscillometric measurements are not practical.
“Continuous wearable BP measurements using novel sensors will potentially facilitate the measurement of BP during sleep or activities such as exercise when oscillometric measurements are not practical.”
Quote in the paperSubstantial claimMay combine two claims.
PremisecitationIn the mActive trial, the text messaging group increased daily steps by 2,534 compared with the no-texting unblinded group and by 3,376 compared with blinded controls.
“The text messaging group increased their daily steps by 2,534 compared with the no-texting unblinded group and by 3,376 steps compared with blinded controls40.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [40] Martin, S. S. et al. mActive: a randomized clinical trial of an automated mHealth intervention for physical activity promotion. J. Am. Heart Assoc. 4, e002239 (2015). source
Not checked in the free run.
May combine two claims.
PremisecitationDespite improvement in MVPA at 12 months with activity tracking, with or without incentives, there was no improvement in health outcomes such as weight and BP reduction at 12 months.
“Moreover, despite the improvement in MVPA at 12 months with activity tracking, with or without incentives, these findings did not translate into an improvement in health outcomes, such as weight and BP reduction, at 12 months.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [44] Finkelstein, E. A. et al. Effectiveness of activity trackers with and without incentives to increase physical activity (TRIPPA): a randomised controlled trial. Lancet Diabetes Endocrinol. 4, 983–995 (2016). source
Not checked in the free run.
May combine two claims.
PremisecitationIn the Apple Heart study, the positive predictive value for AF detection was 84% for the irregular notification algorithm and 71% for individual tachograms.
“The positive predictive value for AF detection was 84% and 71% for the irregular notification algorithm and individual tachograms, respectively19.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [19] Perez, M. V. et al. Large-scale assessment of a smartwatch to identify atrial fibrillation. N. Engl. J. Med. 381, 1909–1917 (2019). source
Not checked in the free run.
May combine two claims.
PremisecitationIn women with mean age 72, as few as 4,400 steps per day were associated with a 41% reduction in mortality compared with 2,700 steps per day, but benefits levelled at 7,500 steps per day.
“Another study of women with a mean (s.d.) age of 72 (5.7) years showed that as few as 4,400 steps per day were significantly associated with a 41% reduction in mortality compared with 2,700 steps per day, but the benefits levelled at 7,500 steps per day39.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [39] Lee, I.-M. et al. Association of step volume and intensity with all-cause mortality in older women. JAMA Intern. Med. 179, 1105 (2019). source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
PremisecitationThe global burden of AF and its association with stroke, HF and mortality are well established.
“The global burden of AF and its association with stroke, HF and mortality have been well established49.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [49] Kirchhof, P. et al. 2016 ESC guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur. Heart J. 37, 2893–2962 (2016). source
Not checked in the free run.
May combine two claims.
PremisecitationIn the mSToPS study, ECG monitoring led to a higher rate of new AF diagnosis at 4 months and 1 year and was associated with increased initiation of anticoagulation therapy and outpatient cardiology and primary care visits in patients without previously known AF.
“The study showed that ECG monitoring led to a higher rate of new AF diagnosis at 4 months and 1 year and was associated with the increased initiation of anticoagulation therapy and outpatient cardiology and primary care visits in patients without previously known AF50.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [50] Steinhubl, S. R. et al. Effect of a home-based wearable continuous ECG monitoring patch on detection of undiagnosed atrial fibrillation. JAMA 320, 146 (2018). source
Not checked in the free run.
May combine two claims.
PremisecitationIn a four-arm Singapore trial, a cash incentive was most effective at increasing MVPA at 6 months, but this effect was not sustained 6 months after removal of incentives.
“The trial showed that a cash incentive was most effective at increasing MVPA at 6 months, but this effect was not sustained 6 months after the removal of incentives.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [44] Finkelstein, E. A. et al. Effectiveness of activity trackers with and without incentives to increase physical activity (TRIPPA): a randomised controlled trial. Lancet Diabetes Endocrinol. 4, 983–995 (2016). source
Not checked in the free run.
May combine two claims.
PremisecitationThe Huawei Band 2 PRO AF algorithm showed a positive predictive value of 99.6% and a negative predictive value of 96.2%.
“Another study that assessed the use of the Huawei Band 2 (Huawei, China) PRO AF algorithm showed a positive predictive value of 99.6% and a negative predictive value of 96.2%52.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [52] Fan, Y. Y. et al. Diagnostic performance of a smart device with photoplethysmography technology for atrial fibrillation detection: pilot study (Pre-mAFA II registry). JMIR Mhealth Uhealth. 7, e11437 (2019). source
Not checked in the free run.
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PremisecitationAdministering the 6-minute walk test through a pedometer is feasible and can be used to predict HF severity and death.
“For example, one study showed that administering the 6-minute walk test through a pedometer is feasible and can be used to predict HF severity and death62.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [62] Werhahn, S. M. et al. Designing meaningful outcome parameters using mobile technology: a new mobile application for telemonitoring of patients with heart failure. ESC Heart Fail. 6, 516–525 (2019). source
Not checked in the free run.
May combine two claims.
PremisecitationIn the TIM-HF2 trial, the intervention was associated with a smaller proportion of days lost from unplanned HF-related hospital admissions and lower all-cause mortality (HR 0.70, 95% CI 0.50-0.96).
“The intervention, compared with usual care, was associated with a smaller proportion of days lost from unplanned HF-related hospital admissions and had a lower all-cause mortality (HR 0.70, 95% CI 0.50–0.96) after 393 days of follow-up66.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [66] Koehler, F. et al. Efficacy of telemedical interventional management in patients with heart failure (TIM-HF2): a randomised, controlled, parallel-group, unmasked trial. Lancet 392, 1047–1057 (2018). source
Not checked in the free run.
May combine two claims.
PremisecitationIn the TEN-HMS trial, there were no significant differences in days lost owing to hospitalization or death compared with nurse telephone support or usual care at 240 days, although the telemonitoring group had a lower mean duration of hospital admission by 6 days.
“The TEN-HMS home telemonitoring trial68 used wearable and non-wearable non-invasive monitors (home BP monitor, weigh scale and single-lead ECG on a wrist band) in patients with an LVEF of <40% and a recent hospital admission for HF and showed no significant differences in days lost owing to hospitalization or death compared with nurse telephone support or usual care at 240 days, although the tele”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [68] Cleland, J. G. F., Louis, A. A., Rigby, A. S., Janssens, U. & Balk, A. H. M. M. Noninvasive home telemonitoring for patients with heart failure at high risk of recurrent admission and death: the trans-European network-home-care management system (TEN-HMS) study. J. Am. Coll. Cardiol. 45, 1654–1664 (2005). source
Not checked in the free run.
May combine two claims.
PremisecitationIn the TEMA-HF1 trial, the intervention group had significantly lower all-cause mortality (absolute reduction of 12.5%) and a lower number of follow-up days lost to death, hospitalization or dialysis.
“The intervention group had a significantly lower all-cause mortality (absolute reduction of 12.5%) and a lower number of follow-up days lost to death, hospitalization or dialysis.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [67] Dendale, P. et al. Effect of a telemonitoring-facilitated collaboration between general practitioner and heart failure clinic on mortality and rehospitalization rates in severe heart failure: the TEMA-HF 1 (telemonitoring in the management of heart failure) study. Eur. J. Heart Fail. 14, 333–340 (2012). source
Not checked in the free run.
May combine two claims.
PremisecitationIn the TIM-HF trial, there were no differences between groups in cardiovascular and all-cause mortality or in hospitalizations at a median follow-up of 26 months.
“The TIM-HF trial69 randomly assigned 710 patients with an LVEF of ≤35%, NYHA class II–III and a history of HF decompensation within the previous 2 years to telemonitoring (weight, BP and heart rhythm data transmission) compared with usual care and found no differences between the groups in cardiovascular and all-cause mortality or in hospitalizations at a median follow-up of 26 months.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [69] Koehler, F. et al. Impact of remote telemedical management on mortality and hospitalizations in ambulatory patients with chronic heart failure: the telemedical interventional monitoring in heart failure study. Circulation 123, 1873–1880 (2011). source
Not checked in the free run.
May combine two claims.
PremisecitationREMOTE-CR was associated with less sedentary time at 24 weeks and was more cost-effective than the centre-based programme.
“A non-inferiority, randomized trial comparing REMOTE-CR — a real-time, remote telerehabilitation platform that includes the use of a chest-worn wearable sensor (BioHarness 3, Zephyr Technology, USA) — with a centre-based programme showed that REMOTE-CR was associated with less sedentary time at 24 weeks and was more cost-effective than the centre-based programme85.”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [85] Maddison, R. et al. Effects and costs of real-time cardiac telerehabilitation: randomised controlled non-inferiority trial. Heart 105, 122–129 (2019). source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationThe US National Academy of Medicine issued a reference document for responsible development and maintenance of AI in clinical settings that provides a guiding framework for stakeholders.
“The US National Academy of Medicine issued a reference document for the responsible development and maintenance of AI in the clinical setting that provides a guiding framework for all stakeholders, including AI developers and the medical community99.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [99] Matheny, M., Israni, S. T., Ahmed, M., Whicher, D. & Edu, N. Artificial intelligence in health care: the hope, the hype, the promise, the peril (National Academy of Medicine, 2019). source
Not checked in the free run.
Classified as probably not a substantial claim.
InterpretationcitationA small false-positive rate in wearable AF screening can increase downstream medical testing and costs if screening is applied to the entire general population.
“For example, the Apple Heart Study sparked a debate on how a small false-positive rate can increase downstream medical testing and costs if screening is applied to the entire general population.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S2 (checkable).
InterpretationcitationMeticulous scrutiny of wearable devices through structured frameworks ensures they are worthy of clinician and patient trust by the time they reach the market.
“Meticulous scrutiny of these devices through such structured frameworks ensures that they are worthy of clinician and patient trust by the time they reach the market.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
PremisecitationThe Coravos et al. framework covers hardware and software and outlines resources, evaluation criteria and target thresholds for five dimensions: V3; data security and privacy; data rights and governance; utility and usability; and economic feasibility.
“In this comprehensive framework covering both the hardware and software components of these technologies, the authors outline the potential resources, evaluation criteria and target thresholds for five dimensions: verification, analytical validation and clinical validation (V3); data security and privacy; data rights and governance; utility and usability; and economic feasibility95.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [95] Coravos, A. et al. Modernizing and designing evaluation frameworks for connected sensor technologies in medicine. NPJ Digit. Med. 3, 37 (2020). source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationThe Hekler et al. framework highlights the importance of the state-space, the readiness to respond to an intervention according to intrinsic factors (state) and contextual factors (space).
“This framework highlights the importance of the ‘state-space’, essentially the readiness to respond to an intervention according to intrinsic factors (state) and contextual factors (space).”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [104] Hekler, E. B. et al. Advancing models and theories for digital behavior change interventions. Am. J. Prev. Med. 51, 825–832 (2016). source
Not checked in the free run.
May combine two claims.
PremisecitationThe Discontinuation Prediction Score had an AUC of 0.9 with high accuracy (>80%) and specificity (>80%).
“The score had an AUC of 0.9 with high accuracy (>80%) and specificity (>80%).”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [105] Zhou, M., Fukuoka, Y., Goldberg, K., Vittinghoff, E. & Aswani, A. Applying machine learning to predict future adherence to physical activity programs. BMC Med. Inform. Decis. Mak. 19, 169 (2019). source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationHekler et al. proposed a framework for the use of digital BCTs, such as just-in-time adaptive interventions, to encourage and maintain health.
“Hekler et al. proposed a framework for the use of digital BCTs, such as just-in-time adaptive interventions, to encourage and maintain health104.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [104] Hekler, E. B. et al. Advancing models and theories for digital behavior change interventions. Am. J. Prev. Med. 51, 825–832 (2016). source
Not checked in the free run.
May combine two claims.
InterpretationcitationSome behavioural intervention strategies might not be cost-prohibitive for individuals or unprofitable for the manufacturer.
“Some of these behavioural intervention strategies might not be cost-prohibitive for individuals or unprofitable for the manufacturer, which is encouraging108.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [108] Chia, G. L. C., Anderson, A. & McLean, L. A. Behavior change techniques incorporated in fitness trackers: content analysis. JMIR mHealth uHealth 7, e12768 (2019). source
Not checked in the free run.
May combine two claims.
PremisecitationDigital models often require programming for a strict definition of the desired outcome and the type and amount of intervention proposed and are in constant flux to tailor interventions.
“However, digital models often require programming for a strict definition of the desired outcome and the type and amount of intervention proposed and are in constant flux to tailor interventions104.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [104] Hekler, E. B. et al. Advancing models and theories for digital behavior change interventions. Am. J. Prev. Med. 51, 825–832 (2016). source
Not checked in the free run.
Probably not a substantial claim: may not pass S2 (checkable), S4 (based).
Interpretationnone givenA practical ABCD clinician's guide can facilitate the integration of wearable devices into the clinical workplace.
“Moreover, a practical ABCD clinician’s guide can facilitate the integration of these devices into the clinical workplace.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable), S4 (based).
Interpretationnone givenA new age of consumer-driven health has arrived.
“A new age of consumer-driven health has arrived, with great future benefits in cardiovascular disease prevention, diagnosis and management.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
PremisecitationIn the USA, CPT codes 99453, 99454, 99457 and 99091 can be used to bill for remote monitoring set up and data review.
“in the USA, CPT codes 99453, 99454, 99457 and 99091 can be used”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [115] mTelehealth. CMS guidance for remote patient monitoring (RPM) during COVID-19 (CPT Code 99453). mTelehealth https://mtelehealth.com/cms-guidance-for-remote-patient-monitoring-rpm-during-covid-19-cpt-code-99453/ (2020).
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
PremisecitationHIPAA/HITECH privacy and security bureaucratic requirements in the USA are considered outdated and might need to be amended to cope with increasing availability and heterogeneity of technologies that personalize and promote patient engagement.
“In the USA, HIPAA/HITECH (The Health Insurance Portability and Accountability Act of 1996/Health Information Technology for Economic and Clinical Health Act) privacy and security bureaucratic requirements are, to an extent, considered outdated and might need to be amended to cope with the increasing availability and heterogeneity of technologies that personalize and promote patient engagement112.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [112] Sarpatwari, A. & Choudhry, N. K. Recalibrating privacy protections to promote patient engagement. N. Engl. J. Med. 377, 1509–1511 (2017). source
Not checked in the free run.
Probably not a substantial claim: may not pass S2 (checkable).
InterpretationcitationOpt-in systems with transparent privacy policies might be better equipped to improve patient engagement while maintaining autonomy.
“Opt-in systems with transparent privacy policies might be better equipped to improve patient engagement while maintaining autonomy112.”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [112] Sarpatwari, A. & Choudhry, N. K. Recalibrating privacy protections to promote patient engagement. N. Engl. J. Med. 377, 1509–1511 (2017). source
Not checked in the free run.
- Rests on an assumption: Some institutions currently allow patients to waive rigid security standards for sharing health information, but this opt-out system involves additional costs and is biased towards the most engaged patients.
Probably not a substantial claim: may not pass S4 (based).
Interpretationnone givenCurrently, several challenges hinder the widespread use of wearable technologies in clinical practice.
“Currently, several challenges hinder the widespread use of wearable technologies in clinical practice.”
Quote in the paperNot a substantial claim
The paper relies on this without support.
ECG sensors are the gold standard for heart rate and heart rhythm measurement.
“ECG sensors come in various forms and are the gold standard for HR and heart rhythm measurement.”
The paper relies on this without support.
PPG sensors work best when in direct contact with the skin, which is not always the case with wearables secured with straps.
“The main drawback is that the sensor works best when in direct contact with the skin, which is not always the case with wearables secured with straps.”
The paper relies on this without support.
The accuracy of biochemical sensors changes with skin temperature, skin contamination with dust, dried sweat or other substances, and hair density.
“However, the accuracy of these sensors changes with skin temperature, skin contamination with dust, dried sweat or other substances, and hair density.”
The paper relies on this without support.
Single-lead ECGs are useful to diagnose simple and common arrhythmias such as atrial fibrillation.
“Single-lead ECGs are useful to diagnose simple and common arrhythmias such as atrial fibrillation (AF).”
The paper relies on this without support.
Most clinical risk scores do not capture the dynamic changes in personalized risk that closely follow lifestyle habits.
“However, most of these scores do not capture the dynamic changes in personalized risk that closely follow lifestyle habits.”
The paper relies on this without support.
The incorporation of subjective lifestyle behaviours in risk assessment has been challenging.
“The incorporation of subjective lifestyle behaviours in risk assessment has been challenging; therefore, objective data derived from wearables provide a renewed opportunity to make the assessment of the risk of cardiovascular disease more accurate, comprehensive and dynamic over a lifetime.”
The paper relies on this without support.
The encouragement of physical activity is a cornerstone of primary and secondary prevention.
“The encouragement of physical activity is a cornerstone of primary and secondary prevention; therefore, cardiovascular specialists should familiarize themselves with BCT platforms that have been proven to work and recommend them to their patients, particularly those who have failed to follow traditional counselling for the promotion of physical activity.”
The paper relies on this without support.
A prolonged QT interval can predispose patients to life-threatening arrhythmias.
“A prolonged QT interval can predispose patients to life-threatening arrhythmias.”
The paper relies on this without support.
Cardiac rehabilitation is a mainstay in the management of many cardiovascular conditions because it provides a structured exercise programme together with comprehensive guideline-directed secondary prevention.
“Cardiac rehabilitation is a mainstay in the management of many cardiovascular conditions because it provides a structured exercise programme together with comprehensive guideline-directed secondary prevention.”
The paper relies on this without support.
In patients with peripheral vascular disease, the first-line treatment for intermittent claudication is a supervised exercise programme of gradually increasing intensity.
“In patients with peripheral vascular disease, the first-line treatment for intermittent claudication is a supervised exercise programme of gradually increasing intensity.”
The paper relies on this without support.
Abnormal PPG heart rate measurements are often error-prone.
“For example, abnormal PPG HR measurements are often error-prone and should be interpreted in the context of device placement, user activities and symptoms.”
The paper relies on this without support.
In 2018, the American Medical Association introduced new CPT codes to incentivize adoption of remote monitoring in clinical practice.
“In 2018, the American Medical Association introduced new CPT (Current Procedural Terminology) codes to incentivize the adoption of remote monitoring in clinical practice.”
The paper relies on this without support.
These CPT codes were included in the 2019 Centers for Medicare and Medicaid Services physician fee schedule and are reimbursed by private insurers.
“These codes were included in the 2019 Centers for Medicare and Medicaid Services physician fee schedule and are reimbursed by private insurers.”
The paper relies on this without support.
In light of COVID-19, insurers have expanded remote monitoring to include acute as well as chronic conditions.
“In light of COVID-19, insurers have even expanded remote monitoring to include acute as well as chronic conditions.”
The paper relies on this without support.
Reimbursement for services such as reviewing vitals is currently more straightforward than reviewing physical activity levels or delivering wearable-guided lifestyle interventions.
“Reimbursement for services, such as reviewing vitals, is currently more straightforward than other services such as reviewing physical activity levels or delivering wearable-guided lifestyle interventions.”
The paper relies on this without support.
Some institutions currently allow patients to waive rigid security standards for sharing health information, but this opt-out system involves additional costs and is biased towards the most engaged patients.
“Some institutions currently allow patients to waive rigid security standards for sharing health information but this opt-out system involves additional costs and is biased towards the most engaged patients.”
The paper relies on this without support.
Patient records are generally dispersed in data silos across multiple platforms and health-care facilities that are not easily accessible, thereby exposing patients to safety concerns.
“Patient records are generally dispersed in data silos across multiple platforms and health-care facilities that are not easily accessible, thereby exposing patients to safety concerns.”
The paper relies on this without support.
COVID-19 has launched us into a new era of remote and decentralized patient care.
“As COVID-19 has launched us at rocket speed into a new era of remote and decentralized patient care”
The paper relies on this without support.
Some smartwatches can share patient ECGs to electronic health records; for example, Apple Watch-derived ECGs can be shared to some electronic health records such as EPIC.
“some smartwatches can share patient ECGs to electronic health records, for example, Apple Watch-derived ECGs can be shared to some electronic health records such as EPIC”
The paper relies on this without support.
Reimbursement for virtual visits and remote monitoring requires patient consent.
“Reimbursement for virtual visits and remote monitoring requires patient consent”
The paper relies on this without support.
Cybersecurity breaches are a possibility, especially if non-secure platforms are used.
“cybersecurity breaches are a possibility, especially if non-secure platforms are used”
The paper relies on this without support.
The patient must consent to the rights for using their data in research or sharing the data with third parties.
“The patient must consent to the rights for using their data in research or sharing the data with third parties”
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?
By examining an individual's activity level, sleep patterns, and heart rate, AI algorithms can forecast the likelihood of heart attacks or strokes.
“For instance, by examining an individual’s activity level, sleep patterns, and heart rate, AI algorithms can forecast the likelihood of heart attacks or strokes, empowering healthcare providers to take proactive measures [8,20].”
From The emergence of AI-based wearable sensors for digital health technology: a review (2023) · cites this paper as [20]
Photoplethysmography enables continuous and non-invasive measurements of heart rate, blood oxygen saturation, and even blood pressure.
“Another optical sensing technique is photoplethysmography for vital sign monitoring, which enables continuous and non-invasive measurements of heart rate, blood oxygen saturation, and even blood pressure [20].”
From The emergence of AI-based wearable sensors for digital health technology: a review (2023) · cites this paper as [20]
Comparing data across a wide range of wearable devices becomes challenging, compromising the efficacy of ML algorithms in classifying health conditions.
“Comparing data across a wide range of wearable devices becomes challenging, compromising the efficacy of ML algorithms in classifying health conditions [20,194].”
From The emergence of AI-based wearable sensors for digital health technology: a review (2023) · cites this paper as [20]
A significant constraint of applying ML algorithms to wearable technology is the lack of standardization in data collection and analysis.
“A significant constraint of applying ML algorithms to wearable technology is the lack of standardization in data collection and analysis.”
From The emergence of AI-based wearable sensors for digital health technology: a review (2023) · cites this paper as [20]
Signal processing algorithms for high-resolution ECG sensors significantly improved the fidelity of ECG measurements, enabling early detection of arrhythmias, ischemic events, and other cardiac abnormalities.
“For instance, signal processing algorithms for high-resolution ECG sensors significantly improved the fidelity of ECG measurements, enabling early detection of arrhythmias, ischemic events, and other cardiac abnormalities [20].”
From The emergence of AI-based wearable sensors for digital health technology: a review (2023) · cites this paper as [20]
There are no systematic reviews addressing the potential of smart wearables for early diagnosis of CVDs.
“To the best of our knowledge, there are no systematic reviews addressing the potential of smart wearables for early diagnosis of CVDs. For example, in [34], the authors investigated the application of AI in smart wearables for cardiovascular disease detection. However, the focus of their research was on smart models rather than hardware; the obstacles that have slowed the development of this field”
From Smart Wearables for the Detection of Cardiovascular Diseases: A Systematic Literature Review (2023) · cites this paper as [35]
Wearable device-enabled detection of cardiovascular-related diseases is likely to become more common as healthcare technology expands.
“Wearable device-enabled detection of cardiovascular-related diseases are likely to become more common as healthcare technology expands.139”
From Artificial intelligence for detection of cardiovascular-related diseases from wearable devices: A systematic review and meta-analysis (2022) · cites this paper as [139]
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.
Heart-failure table says no studies exist for a studied pedometer application
MinorTable 2 says no clinical studies are available for assessing heart-failure prognosis via wearable-administered six-minute walk tests, but the text describes a pedometer study that used such a test to predict heart-failure severity and death.
“wearables can be used to objectively and frequently assess HF prognosis via 6-minute walk tests or measuring heart rate variables such as heart rate recovery or variability; no clinical studies available”
“For example, one study showed that administering the 6-minute walk test through a pedometer is feasible and can be used to predict HF severity and death62.”
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- Fitbit. Fitbit launches Fitbit Care, a powerful new enterprise health platform for wellness and prevention and disease management. Fitbit https://investor.fitbit.com/press/press-releases/press-release-details/2018/Fitbit-Launches-Fitbit-Care-A-Powerful-New-Enterprise-Health-Platform-for-Wellness-and-Prevention-and-Disease-Management/default.aspx (2018).
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Self-citationMedication management initiatives using wearable devices: scoping review
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- Authors
- Bayoumy, K., Gaber, M., Elshafeey, A., Mhaimeed, O., Dineen, E. H., Marvel, F. A., Martin, S. S., Muse, E. D., Turakhia, M. P., Tarakji, K. G., & Elshazly, M. B.
- Affiliations
- NewYork–Presbyterian Brooklyn Methodist Hospital (US)
- National Center for Cancer Care and Research (QA)
- Weill Cornell Medical College in Qatar (QA)
- University of California, Irvine (US)
- Johns Hopkins University (US)
- Scripps Clinic (US)
- VA Palo Alto Health Care System (US)
- Cleveland Clinic (US)
- Corresponding author
- Elshazly, Mohamed B.
- ORCID
- Venue
- Nature Reviews Cardiology
- Published
- 2021-03-04
- Volume
- 18
- Issue
- 8
- Pages
- 581-599
- ISSN
- 1759-5002 (ISSN-L)
- 1759-5010
- PMC
- PMC7931503
- OpenAlex
- W3135128169
- Semantic Scholar
- 8cd5db74e2b338916df16bf7788a92d1df78ee91
- Cited by
- 829
- References
- 112
- Citations by year
- 2026: 121 · 2025: 206 · 2024: 191 · 2023: 159 · 2022: 116 · 2021: 36
- FWCI
- 10.61
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- Nature Reviews Cardiology (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- Funders
- Aetna Foundation
- American Heart Association
- National Institutes of Health
- National Heart, Lung, and Blood Institute (P01HL108800)
- Topics
- Physical Sciences › Engineering › Biomedical Engineering › Non-Invasive Vital Sign Monitoring
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › ECG Monitoring and Analysis
- Health Sciences › Health Professions › General Health Professions › Mobile Health and mHealth Applications
- Keywords
- wearable devices, cardiovascular care, wearable sensors, remote patient monitoring, arrhythmia detection, heart failure treatment, device accuracy, clinical validity, regulatory policy, patient privacy, clinical integration, COVID-19 pandemic
- MeSH terms
- Wearable Electronic Devices, Arrhythmias, Cardiac, Humans, Inventions
About these checks
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.
Claims read by deepseek-v4.1-flash under definition version 3 (extract-v3) on 2026-10-09.
Classified by jev-1.13-20260917 (gold-guideline-v0.2) on 2026-10-09.
Statistics and arithmetic are recomputed, not judged.
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