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Title: Clinical Validation of Heart Rate Apps: Mixed-Methods Evaluation Study
Authors: Vandenberk, Thijs 
Stans, Jelle
Van Schelvergem, Gertjan
Pelckmans, Caroline
Smeets, Christophe J. P. 
Lanssens, Dorien 
De Canniere, Helene 
Storms, Valerie 
Thijs, Inge M. 
Vandervoort, Pieter M. 
Issue Date: 2017
Source: JMIR MHEALTH AND UHEALTH, 5(8), p. 1-15 (Art N° e129)
Abstract: Background: Photoplethysmography (PPG) is a proven way to measure heart rate (HR). This technology is already available in smartphones, which allows measuring HR only by using the smartphone. Given the widespread availability of smartphones, this creates a scalable way to enable mobile HR monitoring. An essential precondition is that these technologies are as reliable and accurate as the current clinical (gold) standards. At this moment, there is no consensus on a gold standard method for the validation of HR apps. This results in different validation processes that do not always reflect the veracious outcome of comparison. Objective: The aim of this paper was to investigate and describe the necessary elements in validating and comparing HR apps versus standard technology. Methods: The FibriCheck (Qompium) app was used in two separate prospective nonrandomized studies. In the first study, the HR of the FibriCheck app was consecutively compared with 2 different Food and Drug Administration (FDA)-cleared HR devices: the Nonin oximeter and the AliveCor Mobile ECG. In the second study, a next step in validation was performed by comparing the beat-to-beat intervals of the FibriCheck app to a synchronized ECG recording. Results: In the first study, the HR (BPM, beats per minute) of 88 random subjects consecutively measured with the 3 devices showed a correlation coefficient of.834 between FibriCheck and Nonin,.88 between FibriCheck and AliveCor, and.897 between Nonin and AliveCor. A single way analysis of variance (ANOVA; P=.61 was executed to test the hypothesis that there were no significant differences between the HRs as measured by the 3 devices. In the second study, 20,298 (ms) R-R intervals (RRI)-peak-to-peak intervals (PPI) from 229 subjects were analyzed. This resulted in a positive correlation (rs=.993, root mean square deviation [RMSE]=23.04 ms, and normalized root mean square error [NRMSE]=0.012) between the PPI from FibriCheck and the RRI from the wearable ECG. There was no significant difference (P=.92) between these intervals. Conclusions: Our findings suggest that the most suitable method for the validation of an HR app is a simultaneous measurement of the HR by the smartphone app and an ECG system, compared on the basis of beat-to-beat analysis. This approach could lead to more correct assessments of the accuracy of HR apps.
Notes: [Vandenberk, Thijs; Stans, Jelle; Van Schelvergem, Gertjan; Pelckmans, Caroline; Smeets, Christophe J. P.; Lanssens, Dorien; De Canniere, Helene; Storms, Valerie; Thijs, Inge M.; Vandervoort, Pieter M.] Hasselt Univ, Mobile Hlth Unit, Fac Med & Life Sci, Martelarenlaan 42, B-3600 Hasselt, Belgium. [Vandenberk, Thijs; Smeets, Christophe J. P.; De Canniere, Helene; Vandervoort, Pieter M.] Ziekenhuis Oost Limburg, Dept Cardiol, Genk, Belgium.
Keywords: heart rate; software validation; remote sensing technology;heart rate; software validation; remote sensing technology
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ISSN: 2291-5222
e-ISSN: 2291-5222
DOI: 10.2196/mhealth.7254
ISI #: 000410033700006
Category: A1
Type: Journal Contribution
Validations: ecoom 2018
Appears in Collections:Research publications

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