Key result
An in-house wearable wireless ECG device demonstrated high signal accuracy compared to a Holter monitor, with a mean absolute error of 1.4 bpm and limits of agreement of +3.54 to -4.71.
Why the study?
The study was conducted to investigate patient receptiveness and signal accuracy of an in-house lightweight single-lead wearable wireless ECG device in outpatients suspected of cardiac rhythm issues.
Does an in-house single lead wearable wireless ECG device provide accurate signal monitoring and good patient receptiveness compared to a standard Holter monitor in outpatients suspected of cardiac rhythm issues?
Observational (n=20)
Does an in-house single lead wearable wireless ECG device provide accurate signal monitoring and good patient receptiveness compared to a standard Holter monitor in outpatients suspected of cardiac rhythm issues?
A novel in-house wearable single-lead ECG device demonstrated high signal accuracy and good patient compliance compared to standard Holter monitoring for outpatient rhythm assessment.
May support outpatient wearable ECG monitoring; leaves open larger randomized validation for clinical use.
We have conducted a clinical trial to investigate the receptiveness and signal accuracy of our in-house light-weight single lead wearable wireless ECG device with 20 outpatients, who were suspected of cardiac rhythm issues. The receptiveness was measured via a survey score sheet while the signal accuracy was evaluated by comparing the Holter's hourly heart rate report (the gold-standard) against the ones from our device. In terms of receptiveness, a score of 8.6 indicates good patient compliance. In terms of accuracy, the mean absolute error is 1.4 bpm (beats per minute) with precision of ±1.6 bpm. In addition, measurements from both devices were found to be linearly related with coefficient of determination, r 2 , of 0.97. Furthermore, the limits of agreement were calculated to be +3.54 and -4.71 based on the Altman and Bland technique, which indicated good agreement for most of our measurements against the Holter device. In addition, this paper also discusses the unexpected challenges of conducting a trial on actual outpatients which can be used as a reference for similar subsequent studies.
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Wong et al. (2019) conducted an observational in Suspected cardiac rhythm issues (n=20). In-house light-weight single lead wearable wireless ECG device vs. Holter monitor was evaluated on Signal accuracy (heart rate comparison) (Mean absolute error 1.4 bpm). An in-house wearable wireless ECG device demonstrated high signal accuracy compared to a Holter monitor, with a mean absolute error of 1.4 bpm and limits of agreement of +3.54 to -4.71.
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