Literature DB >> 36197850

ECG performance in simultaneous recordings of five wearable devices using a new morphological noise-to-signal index and Smith-Waterman-based RR interval comparisons.

Dominic Bläsing1,2, Anja Buder3, Julian Elias Reiser4, Maria Nisser3, Steffen Derlien3, Marcus Vollmer5,6.   

Abstract

BACKGROUND: Numerous wearables are used in a research context to record cardiac activity although their validity and usability has not been fully investigated. The objectives of this study is the cross-model comparison of data quality at different realistic use cases (cognitive and physical tasks). The recording quality is expressed by the ability to accurately detect the QRS complex, the amount of noise in the data, and the quality of RR intervals.
METHODS: Five ECG devices (eMotion Faros 360°, Hexoskin Hx1, NeXus-10 MKII, Polar RS800 Multi and SOMNOtouch NIBP) were attached and simultaneously tested in 13 participants. Used test conditions included: measurements during rest, treadmill walking/running, and a cognitive 2-back task. Signal quality was assessed by a new local morphological quality parameter morphSQ which is defined as a weighted peak noise-to-signal ratio on percentage scale. The QRS detection performance was evaluated with eplimited on synchronized data by comparison to ground truth annotations. A modification of the Smith-Waterman algorithm has been used to assess the RR interval quality and to classify incorrect beat annotations. Evaluation metrics includes the positive predictive value, false negative rates, and F1 scores for beat detection performance.
RESULTS: All used devices achieved sufficient signal quality in non-movement conditions. Over all experimental phases, insufficient quality expressed by morphSQ values below 10% was only found in 1.22% of the recorded beats using eMotion Faros 360°whereas the rate was 8.67% with Hexoskin Hx1. Nevertheless, QRS detection performed well across all used devices with positive predictive values between 0.985 and 1.000. False negative rates are ranging between 0.003 and 0.017. eMotion Faros 360°achieved the most stable results among the tested devices with only 5 false positive and 19 misplaced beats across all recordings identified by the Smith-Waterman approach.
CONCLUSION: Data quality was assessed by two new approaches: analyzing the noise-to-signal ratio using morphSQ, and RR interval quality using Smith-Waterman. Both methods deliver comparable results. However the Smith-Waterman approach allows the direct comparison of RR intervals without the need for signal synchronization whereas morphSQ can be computed locally.

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Year:  2022        PMID: 36197850      PMCID: PMC9534432          DOI: 10.1371/journal.pone.0274994

Source DB:  PubMed          Journal:  PLoS One        ISSN: 1932-6203            Impact factor:   3.752


Introduction

Miniaturization and commercialism of physiological measurement in combination with the ongoing trend for self-quantification of personal health and fitness lead to a new variety of professional or semi-professional measurement devices [1-4]. Fitness trackers, smart watches, and even clothing with bio-physiological sensors were developed to help people gather data for health related aspects such as physical activity, sleep phases, heart rate (HR), cardiac arrhythmias, or to measure stress [2, 5]. A rising number of those devices are also used in the research area [6], with an appropriate methodology to verify their validity and suitability in those contexts still missing [7].

ECG fundamentals

HR and heart rate variability (HRV) analyses deduced from ECG signals have become important in many scientific research areas (psychology, occupational science, telemedicine, sports science) as well as in the public domain. To obtain reliable and valid results for HR and HRV analysis, high signal quality and heart beat detection accuracy are indispensable. In medicine, the 12-lead ECG is the diagnostic gold standard for a comprehensive and meaningful diagnosis in a stationary setting [8]. As an alternative approach, Norman J. Holter invented a method to measure ECGs in an ambulatory setting for time spans up to 24 hours [9]. Compared to a 12-lead ECG, the Holter ECG normally corresponds closest to the V5 or V1 leads [10]. The biggest advantage is the ability to measure an ECG in field trials and during everyday life. For a non-clinical use case in field or laboratory, the ambulant setting allows the participants to move freely and interact naturally with their surroundings. At the moment most commercially available wearable devices rely on the usage of photoplethysmography (PPG) rather than writing a real ECG. Modern mobile ECG measurement solutions are often limited due to their reduced sampling frequency (below 1000 Hz) or their decreased ability for continuous measurement and free movement (restricted to resting measurement or momentary assessment). Future developments, especially in the area of wireless ECG technology, seem to be promising [11, 12]. Using an ECG, it is possible to record the accumulated changes over time in electrical cell potentials over different heart muscle cells that results in the typical PQRST morphology of a heartbeat. A normal cardiac cycle can be seen as a sequence of polarization and depolarization of different involved cells starting before the P wave and ending after the T/U wave with the R peak as the highest spot and most prominent ECG feature. For clinicians, the whole PQRST sequence is important to detect insufficiency of heart muscle activity itself [10]. In sports, occupational science, psychology, or ergonomics, the intervals between two successive R peaks (RR intervals) are needed to analyze or quantify HR and HRV. Using those interbeat-intervals for further calculations, it is possible to detect changes in physical and/or cognitive workload [13, 14], to quantify training load or general fitness [15, 16], or to obtain clinically relevant information about the functionality of the autonomic nervous system [17]. For most athletes and private users, the ECG signal itself is not of interest. The derived HR or a pre-calculated stress index (some sort of HRV measurement) is what they are interested in. Beyond clinical applications, ECG measurement techniques using 1 or 2-channel Holter systems, chest straps, or similar non-invasive methods became popular. A variety of devices is used in mobile medicine ranging from watches and in-ear-systems to smart shirts [2, 5]. For future large-scale clinical studies, the vision is to replace standard ECG techniques by mobile technologies benefiting from the ease of use, faster application, and handling [5].

Aim of this study

High signal quality is necessary in scientific research contexts to guarantee the correctness of the drawn conclusions and derived measures. With an increasing scope of application, the number (and age) of used ECG devices increases, and so does the range of experience in analyzing ECG data. To support the data analysis, many processes can be automatized, e.g, heart beat classification, and RR interval determination. The accuracy of the resulting data highly depends on the ECG signal quality. The aim of this study is to compare usability and data quality of different consumer and professional ECG devices in research and leisure scenarios. Therefore two new approaches to compare data quality are developed. These include a method to assess the amount of noise at a very local level to quantify local disturbances in the waveform of the ECG. The other method is developed for the verification and classification of RR intervals.

Related work

There are several signal quality indices (SQI) available to compare multiple ECG signals [18, 19], which can be classified as either detectability- (iSQI, bSQI) or artefact-correction-based (pSQI, sSQI, kSQI, fSQI, baseSQI). Detectability-based SQIs usually focus on several ECG leads (or sensors—iSQI) or beat detection algorithms (bSQI) to calculate single indicators. In contrast, artefact-correction-based indices are lead or sensor specific and take several artefact sources into account like muscle artifacts (sSQI), baseline wander (baseSQI), or high frequency sinusoidal noise (kSQI). While many of the indices above require sufficient data for computation, specific methods deliver the local quality of short ECG segments: Such methods analyze the correlation between successive beat cycles (also known as template matching) [20], use spectral information [21], or calculate continuous signal-to-noise ratios (SNR) that are based on local time windows and noise-free signals, e.g., computed through low-pass filtering or wavelet decomposition [22]. In contrast, Hoog Antink et al. [23] defined a shape-based SNR (SNRs) using cardiac templates for the approximation of noise-free signals. Additional methods are summarized in a review article by Satija et al. [24]. Many applied researchers also use concrete HRV indicators or RR intervals to compare the quality among different devices and focus on the assessment of inter-class correlations or Bland-Altman limits of agreement [25-28]. In contrast to the previous studies, a comparison of HRV indicators among the devices is waived due to the fact that those indicators are the results of mathematical allocations of RR intervals. Thus, the crucial point is the validity of RR interval measurement as the consequence of accurate R peak detection. We therefore focus on the overall noise-to-signal ratio (NSR) and on the verification of annotated beats.

Materials and methods

Apparatus

For the purpose of investigating the functionality, accuracy, and usability of several ECG-measurement devices, participants were equipped with five sensor systems at the same time. The sensor placement is illustrated in Fig 1. Three clinically certified devices were used, NeXus-10 MKII (Mind Media B.V., NL—NeXus), eMotion Faros 360°(Mega Electronics Ltd., FI—Faros), and SOMNOtouch NIBP (SOMNOmedics GmbH, GER—SOMNOtouch). In parallel, two consumer products (with a wide and increasing usage in scientific research) were attached: Hexoskin Hx1 (Carré Technologies Inc., CA—Hexoskin), and PolarWatch RS800 Multi (Polar Electro Oy, FI—Polar). All included devices were previously used in field and laboratory settings of the facilities involved. The oldest used deives was the Polar watch, which is, by now, outdated. Newer versions might be able to perform even better in the lower HR range, use better algorithms, or combinations of PPG and chest belts to calculate RR intervals even more precisely and close the gap to the other devices. Despite the fact of a missing raw ECG export functionality, the implementation of wearables in scientific research areas is rising [2]. Adding Polar to the comparison enables us to additionally analyze the quality of RR interval exports, a widely used feature even for consumer products.
Fig 1

ECG system configuration for simultaneous measurement (adapted from [34]).

Even with medical certifications available for three other included devices there is not always comprehensible evidence for the signal quality. Validation studies are available for Hexoskin [29-31] and Polar [32] with correlation coefficients between 0.8 to 0.9 for Polar and 0.8 to 0.99 for Hexoskin. For SOMNOtouch a validation of the blood pressure function is available but not for the ECG component [33]. To generate physical workload, the participants had to walk on a treadmill (Woodway PPS Med, Woodway GmbH, GER). During the whole experiment every participant had to wear a safety vest connected to an overhead fixation in order to guarantee fall protection. The electrode placement (Ag/AgCl hydrogel foam electrodes) for ECG measurement was based on the manufacturers’ suggestions. Hexoskin is working with textile electrodes integrated in the fabric of a shirt on chest and abdomen. The chest strap of Polar is used for data acquisition, the watch itself is used to store, pre-process, and display data. Table 1 summarizes different characteristics of the investigated devices. Product weight was mainly dominated by the storage unit. Not only dimension and weight can be a crucial part of usability for different studies, also the placement of the storage unit (see Fig 1). When it comes to expenses, not only acquisition, but also follow up costs should be considered (see Table 1 for acquisition costs and medical supplies). For NeXus, Faros, and SOMNOtouch additional ECG electrodes are needed. Hexoskin’s textile electrodes need conductive gel or glycerin-based cream. While Faros’, Hexoskin’s and Polar’s main focus is ECG measurement, NeXus und SOMNOtouch are built as an integrated solution able to measure different physiological parameters. With regard to Hexoskin, it should also be emphasized that due to the integration of the sensors in a shirt, different sizes are required for the measurements of several subjects. The sampling rate of all devices are in accordance with the necessary parameters suggested by the European Task Force [35] ranging from 256 Hz (Hexoskin) up to 8000 Hz (NeXus). Taking into account the suggestions from Sammito et al. [36], a sampling rate of at least 1000 Hz is considered ideal for the calculation of inter-beat-intervals [36]. Faros, Polar, and NeXus fulfill this requirement. In clinical settings a high sampling rate is prerequisite to detect narrow pacemaker pulses from the resulting ECG [37, 38].
Table 1

General information about the measurement devices.

See S1 Fig for the table with device images.

eMotion Faros 360°Hexoskin Hx1NeXus-10 MKIIPolar RS800 MultiSOMNOtouch NIBP
Manufacturers’ page bittium.com hexoskin.com mindmedia.com polar.com somnomedics.com
Year of production20172015201620072015
Follow-up modelBittium FarosHexoskin Smart ShirtPolar Watch V800 + Polar H10
Device weight15 g42 g591 g47 g85 g
Additional weight16 g(cables)145 g(M sized shirt)80 g(cables)23 g(wearlink)32 g + 21 g(cables+SpO2)
Dimensions48 x 29 x 12 mm40 x 70 x 13 mm120 x 140 x 45 mmwatch: 47 x 60 x 15 mmwearlink: 62 x 37 x 12 mm74 x 54 x 16 mm
Acquisition costs1€€€ (device)€ (device)€ (shirt)€€€€€ (device + accessories)€ (ExG sensor)€ (follow-up model)€ (wearlink)€€€€€ (device)€ (ExG sensor)€ (SpO2 fingerclip)
Medical suppliesECG electrodesSkin preparation gelECG electrodesECG electrodes
Battery runtime24 h (3–channel ECG at 1000 Hz) up to 30 d (RR intervals only)>14 h (recording mode) up to 400 h (sleep mode)>24 h (exchangable battery)>24 h (exchangable battery)up to 24 h
Maximal sampling rate1000 Hz256 Hz8000 Hz1000 Hz512 Hz
ADC precision224 bit12 bit24 bitNA12 bit

1 €: ≤500 €; €€: 500–1000 €; €€€: 1000–1500 €; €€€€: 1500–2000 €; €€€€€: >2000 €.

2 ADC—Analog-to-Digital Converter.

General information about the measurement devices.

See S1 Fig for the table with device images. 1 €: ≤500 €; €€: 500–1000 €; €€€: 1000–1500 €; €€€€: 1500–2000 €; €€€€€: >2000 €. 2 ADC—Analog-to-Digital Converter. Besides sampling rate, additional technical information is necessary to decide whether the device can be applied in a specific use case (see Table 2). In field tests, for example, weight, battery life and freedom of movement are more important than under laboratory conditions. Certified devices are to be used in clinical studies in which Hexoskin and Polar are not certificated as a medical device on the European market (CE marking). For bio-feedback, NeXus, SOMNOtouch, and Hexoskin provided ECG data in real time, while Polar only showed HR. Faros offers a real-time API to export the live data.
Table 2

Special technical information for scientific studies.

eMotion Faros 360°Hexoskin Hx1NeXus-10 MKIIPolar RS800 MultiSOMNOtouch NIBP
Certified medical useyesnoyesnoyes
Data transferBluetooth, USBBluetooth, USBBluetooth, USBInfraredBluetooth, USB
Live feedbackyesyesyesyesyes
Export formats1EDFEDF, WAV, CSVEDF, EDF+txt, hrmEDF+, RIFF-/ASCII, SCP
Raw data1ECG, acceleration, events, temperatureECG, acceleration, respirationECG, acceleration, eventsRR intervalsECG, events

1 Used abbreviations: EDF/EDF+—European Data Format; WAV—Waveform Audio File Format; CSV—Comma-Separated Values; hrm—Polar summary export (structured text file); RIFF – Resource Interchange File Format; ASCII – American Standard Code for Information Interchange; SCP—Standard Communication Protocol for Computer assisted electrocardiography (SCP-ECG EN1064:2007).

2 Note: NeXus and SOMNOtouch can output additional parameters as raw data with additional sensors.

1 Used abbreviations: EDF/EDF+—European Data Format; WAV—Waveform Audio File Format; CSV—Comma-Separated Values; hrm—Polar summary export (structured text file); RIFF – Resource Interchange File Format; ASCII – American Standard Code for Information Interchange; SCP—Standard Communication Protocol for Computer assisted electrocardiography (SCP-ECG EN1064:2007). 2 Note: NeXus and SOMNOtouch can output additional parameters as raw data with additional sensors. Especially for clinical and research settings, accessibility to the raw data is an important feature most devices offer. For Polar it was only possible to extract pre-calculated RR intervals and no raw ECG. Most devices offered an EDF or EDF+ (European Data Format) export to allow the ease-of-use import into standard analyzing software. Most devices offer more than a single indicator solution (just ECG/RR) and have, for example, the ability to track additional acceleration data using inertial sensors installed in the storage devices. Optional ExG sensors can be bought for NeXus and SOMNOtouch. Hexoskin was able to measure abdominal and chest breathing and Faros collected additional temperature data. Using the finger clip of SOMNOtouch, it is possible to collect data for pulse oximetry and blood pressure. The subjects has not been equipped with a 12-lead ECG system as a gold standard since the chest leads would have interfered with the textile electrodes of Hexoskin. Clinically validated measuring devices were used in compensation. In addition: The focus of this comparison was not on the application for the detection of clinical abnormalities, but on the application of the devices in ergonomics and sports science, as well as in the leisure context with the focus on the valid and automated detection of R peaks in order to reduce the effort involved in manual follow-up checks.

Subjects

13 healthy participants (six male) in the age range between 21 and 35 years (μ = 28.00, σ = 4.28) took part in the experiment. Due to limited sizes of the biometric Hexoskin shirt, only participants could be included for whom a fitting size was available. Further, participants had to confirm that no prior cardiac problems or diseases are known. For both male and female groups, the BMI was in a healthy average range (μfemale = 22.74, σfemale = 2.40; μmale = 23.66, σmale = 1.58). Additionally, 77% had prior experience with treadmill walking. All participants took part in the study without monetary compensation on a voluntary basis. The study was conducted according to the guidelines of the Declaration of Helsinki, and approved by the ethics committee of University of Greifswald (Identifier: BB 171/17, 30th November 2017). Written informed consent to conduct this research has been obtained from the participants.

Procedure

The experimental setup was divided into four consecutive parts of five minutes each. Task order was identical for each subject to be able to determine time-on-task effects. At first, a baseline resting period was recorded while standing upright on the treadmill (P1). Upon completing P1, participants walked on the treadmillat a moderate speed (1.2 m/s) without treadmill inclination to induce medium, everyday physical workload (P2). The third part consisted of executing a cognitive 2-back task while standing still on the treadmill (P3). During this task a predefined sequence of (randomly generated) numbers between 1 and 6 was presented using a Raspberry Pi 2B (Raspberry Pi Foundation, UK) stored in the backpack and in-ear headphones (QC 2, Bose, USA). All stimuli were of 500 ms length with a 2000 ms inter-stimulus-interval [39]. Participants continuously had to memorize the last two digits and update the information while listening to incoming numbers. After the presentation of each stimulus, participants had to say out loud the number that was heard two stimuli before. Prior to task execution, participants had to pass a one-minute exercise block with at least 70% correctly recalled answers to guarantee right task-execution. As it was the goal to induce a mental state contrary to the correct execution of the task, the correctness of answers was not of interest to the research hypotheses and therefore not quantified. For the final phase (P4), subjects walked uphill on the treadmill with a track inclination of 15% and a speed of 1.2 m/s to induce high physical workload resulting in increased HR, respiratory rate, perceived exertion, and stride length [40, 41]. After each task, participants had to rate their subjective workload on all dimensions of the NASA-TLX [42]. Using the Faros trigger point functionality, timestamps were generated at the beginning of each phase.

Data preprocessing—Alignment and frequency correction

Necessary preprocessing steps for data alignment were performed as described in previous work [34]. This includes the correction for time shifts as a result of asynchronous record starts and requires the correction of inaccurate and unsteady sampling frequencies. Alignment was based on the synchronization of heartbeats from a resting period by finding similar patterns in all devices. Sampling frequency was corrected by non-linear resampling to a target sampling frequency of 256 Hz [34]. To improve the automated signal alignment and to further evaluate the detection accuracy of each device, we generated a manual reference annotation of R peaks (beatref). All aligned ECG-signals were manually screened and corrected for missing, misplaced, and wrongly identified R peaks arising from the automated heartbeat detection. Following a four-eye-principle, all corrected records were screened a second time. Corrections were performed by experienced research staff. Furthermore, we checked for cardiac arrhythmia to allow the exclusion of affected periods from SQI calculation since arrhythmia would bias the SQI rating due to physiologically based morphological changes. Moreover, arrhythmic periods should be also excluded from HRV computations. Based on the procedure postulated in Vollmer 2017 [43], we identified suspicious segments which were then manually screened. One ectopic beat was identified in the 13 participants leading to our decision to not exclude participants or ECG segments. Additionally to the use of synchronized data and its complex process to achieve resynchronization, we have extracted RR intervals from raw unsynchronized ECGs by computing the difference of beat locations annotated by eplimited [44]. R peak locations were refined using spline interpolation to increase the resolution of the interval data. This data was then used in comparisons to ground truth intervals computed from the successive differences of beatref. Raw data from all devices and processed data generated during the analysis of the current study have been published open access on PhysioNet [45, 46] and are freely available on PhysioNet (see https://doi.org/10.13026/zhns-t386). Timestamps for experimental stages were manually inspected and relocated by use of movement sensors and HR increase (for phase 2 and 4).

Statistical analysis

For signal quality analysis, three different approaches were chosen. The first approach focused on the NSR as a general index to quantify the quality of the signal itself (A—Morphological signal quality). The second approach is based on the ability to detect R peaks by comparing identified beat locations with the ground truth annotation (B—Heartbeat detectability). The third approach identifies errors in the automated beat detection process by comparing RR intervals from unsynchronized data (C—Modification of the Smith-Waterman algorithm).

A—Morphological signal quality

ECGs measured during different physical activities usually contain distortions such as muscular artifacts, signal baseline wander, and power line inference. To quantify these disturbances around each single R peak, a new local similarity-based morphological signal quality value (morphSQ) is defined. The method belongs the template-based approaches, such as SNRs [23], but in contrast to the available methods it is based on the median cardiac cycle, neglects QRS distortions, and uses a weighting function to increase locality. A short ECG sequence spanning an uneven number of adjacent R peaks is used to calculate the morphSQ value for the current central R peak as illustrated in Fig 2 and described below:
Fig 2

Illustration of the morphological signal quality process in a sliding window of an ECG (number of cardiac cycles k = 8).

There are k [k = 8] full cardiac cycles in the short ECG sequence spanning k + 1 R peaks [k + 1 = 9] Calculate the midpoints between consecutive R peaks (R, i = 0, …, k) to define the start (s, i = 1, …, k) and end (e, i = 0, …, k − 1) of k cardiac cycles. The start of the new cardiac cycle i + 1 is equal to the end of the previous cycle i (s + 1 = e). Cut each of the cardiac cycles into two sets of segments: The first set (set l) contains cycle segments starting at s till R(i = 1, …, k), which includes the P waves. The second set (set r) contains cycle segments starting at R till e(i = 0, …, k − 1), which includes the T waves. Scale all segments of set l to span the range from -1 to 0. Scale all segments of set r to span the range from 0 to 1. Interpolate each segment linearly to generate values at query points from −1 to 1 with 0.002 increment (−1.00, −0.998, −0.996, …, 1.00). This allows the direct comparison of the different cardiac cycles at each query point. Optional: Plot all re-scaled segments from −1 to 1 to visualize the periodicity of the ECG cycles. QRS templates are pooled around 0. Compute the median cardiac cycle from the overlaid cycles as a robust representative for the observed cardiac cycles and compute the amplitude a of the fit (maximum-minimum). Compute differences d between the observations and the median cycle. Each single difference d will be assigned with a weight ω. More weight is put on cardiac cycles near the central R peak and less weight at the edges of the ECG sequence. We have used weights derived from a normal probability density function from −2 to 2. Set weights at the QRS complex (lqrs = 100 ms around the R peak) to 0, to not quantify those differences caused by respiration-related modulations of the R peak amplitude [47]. morphSQ is defined as the weighted sum of squared differences normalized by the local amplitude of the ECG (Eq 1): The used specifications for the parameters k, ω, lqrs, as well as the used cut-off-value of 10% for morphSQ were chosen based on theoretical assumptions and mathematical necessities. Setting k = 8 and weights ω taken from notched Gaussian distribution function were necessary to reinforce the locality of morphSQ. Increasing k or making ω constant would lead to an reduced influence of the momentarily centered beat (R peak). Considering the physiology basis of the QRS complex a notching length of 100 ms was chosen for lqrs to prevent the effect of respiration-related modulations of the R peak on morphSQ calculation. The quantification of the signal quality as defined in step 11 can be perceived as a weighted peak NSR on percentage scale. Defining morphSQ as a NSR rather than a SNR increases the ease of use and interpretability. Lower values indicate a smaller amount of noise with a minimum of 0%, while at the same time the usage of the percentage scale is easier to interpret (even for inexperienced users) than the usual decibel/db scale for SNR. For a better understanding of morphSQ, Fig 3 shows different ECG samples and the corresponding morphSQ (additional cases are illustrated in S2 Fig). Using clean ECG recordings and realistic noise measurements from PhysioNet [45, 48, 49] we investigated the performance of beat detection and morphSQ in relation to signal noise. S3 Fig shows an example ECG from the Noise Stress Test database, where realistic noise was added to a clean record. morphSQ has been computed at each beat and the performance of beat detection in clean and noisy ECG sections was evaluated. The relation of average morphSQ with increasing SNR ratios was investigated using the methodology as described in [48]. S4 Fig summarizes the results and shows the direct relation to NSR. The similarity-based signal quality expressed by morphSQ is sensitive to beat misplacements and therefore requires accurate, complete, and verified beat annotations.
Fig 3

Examples of ECG segments with different signal quality measured by quantifying the similarity of ECG templates.

Very clean segments have a morphSQ near to zero, noisy segments have values larger than 0.1.

Examples of ECG segments with different signal quality measured by quantifying the similarity of ECG templates.

Very clean segments have a morphSQ near to zero, noisy segments have values larger than 0.1.

B—Heartbeat detectability

First, bandpass-filtering (3 Hz to 20 Hz) was applied on all signals to remove high frequency noise and baseline wandering but keeping the QRS complex. We applied several algorithms for beat detection (methods from WFDB toolbox [45, 50], HRVTool [51], RDECO [52], py-ecg-detectors [53], ECG2RR [54], and eplimited [44]) to search for the most accurate method and for the best channel in each device to detect heart beat locations. The open source algorithm eplimited [44], which is known to be less sensitive to noise [19], performed best in comparison to the screened methods on our experimental data and was further used to define the detected R peaks (beatdetected). If the signal quality is insufficient, the R peak detection either introduces false beat locations (FP—false positives) or some beat locations are missing (FN—false negatives).

C—Modification of the Smith-Waterman algorithm

Polar RR interval sequences were generated by the manufacturer’s in-house algorithm, with no ability to export the underlying ECG. In this case, the pairwise comparisons of beatref with the exported data (query) is the direct way to assess the signal and export quality. For a fair comparison to the other ECG devices, eplimited was applied to the unsynchronized raw data (without correcting the sampling frequencies) to compute RR intervals. Since the interval data were not synchronized, a matching process had to be performed in order classify wrong or inaccurate RR intervals. In bioinformatics, the Smith-Waterman algorithm (SW) [55] is a well-known algorithm to perform local sequence alignment of nucleic acid sequences or protein sequences. We therefore decided to use a variation of SW to align sequences of numeric data types (RR intervals). A scoring matrix will be build that is based on gaps and individual ratings of matched pairs. The latter depends on the difference of matched RR intervals. Using dynamic programming and a traceback procedure, an optimal alignment can be derived. Thus, an open source implementation for global alignments (https://github.com/hiraethus/Needleman-Wunsch) was modified by redefinition of a match/mismatch and its respective reward or penalty values. A modifiable reward function was defined according to our needs to perform an alignment of RR interval sequences. Eqs 2 and 3 shows the definition of the scoring matrix H based on two interval sequences a and b having m and n values respectively. Function s of Eq 4 defines the reward of matched RR interval a from the reference sequence to the RR intervals b from the query sequence. Here we use a quadratic function based on the difference of both intervals in milliseconds. This defines the scoring for matched RR intervals allowing for minor deviations (reward = 1 if difference is 0 ms, reward = 0.9 if absolute difference is 10 ms, reward = 0.6 if absolute difference is 20 ms). The minimum value is capped by 0 and the maximum value is 1. Defining gap penalties as denoted in following Equations and in Fig 4, it was possible to find an optimal alignment of non-synchronized interval data. Interestingly, we have rewarded a gap in the reference sequence (an insertion) by 0.9 instead of penalizing it, since in our case this is always accompanied by a mismatch, which is already scored with 0. In this way, it was beneficial for the matching process and a better alignment could be obtained.
Fig 4

Illustration of a Smith-Waterman-like algorithm for RR interval sequences to identify incorrect RR intervals in a query sequence.

An optimal alignment to maximize the overall score was found by the common traceback procedure. Using the resulting alignments of the ground truth RR intervals with the query sequences, we were to count and classify errors: gaps can be classified as either insertions (RR intervals broken up into smaller subintervals, usually treated as FP) or deletions (due to a missing beat location, usually treated as FN). Moreover, inaccurate RR intervals (due to misplaced beat locations) can be classified. Fig 4 illustrates possible findings by the matching process.

Evaluation methodology

The total amount of reference beats were computed based on the the reference annotation file (beatref) for the full experimental duration. For each experimental phase, total amount of beats, avgerage peak HR and median breathing rate (taken from Hexoskin) over all participant were computed. The morphological signal quality index (morphSQI) was created by computing the mean and standard deviation (SD) of all morphSQ values as well as the rate of morphSQ < 10% for each ECG, participant, and experimental phase. For the summary of the complete experiment, we computed the mean over all participants along with the average SD. The choice of morphSQ values <10% to binary classify the overall signal quality is based on the descending performance of standard heart beat detection algorithms around this cut-off-value (see S3 Fig). For heartbeat detectability the reference annotation was used in combination with a permitted deviation of 50 ms, to rate each beat that has been detected by eplimited either as positive (beatdetected can be matched to the beatref) or negative (no reference beat location in the range of ±50 ms). The performance was expressed as positive predictive value (PPV) and false negative rate (FNR) [56]. Here, PPV is defined as the number of true positives (TP) divided by the total number of beats detected by eplimited. FNR is calculated as the number of FN divided by the sum of TP and FN. A time-window of 50 ms was regarded sufficient in heartbeat detection to allow post-processing algorithms for refinement which is stricter than the current gold standard of 150 ms [57]. Further, F1 scores were computed from PPV and sensitivity (true positive rate) in each of the probands’ ECGs [58, 59]. The number of records with an F1 score below 0.90, between 0.90 and 0.99, and excellent scores greater than 0.99 were determined. In case of an F1 score lower than 0.90 the beat detection was regarded as insufficient which was caused by severe noise and artefacts. Insufficient beat detection may lead to the exclusion of participant data to answer the intended research question. The accuracy was computed for the entire experimental period and each phase separately. The SW process was performed with all extracted intervals from all used devices and all experimental phases separately to count deviations in the RR interval data. Again a 50 ms tolerance window was used. The summary table is showing the accumulated counts across all 13 participants.

Data handling

Data processing and statistical analysis was done in Matlab (MATLAB versions 9.6.0 to 9.9.0 (R2019a–R2020b), Natick, Massachusetts: The MathWorks Inc.), in R (v3.6.3 to v4.1.3 [60]), and in Python (v3.9.7).

Results

The analysis of morphSQI was conducted with the complete dataset and in each of the four distinct phases (Table 3). Polar had to be excluded from the analysis, since no raw ECG was available. Overall, the differences between the four remaining devices are modest with morphSQI ranging between 0.023 (Faros) and 0.048 (Hexoskin). During the phases P2 and P4, participants were actively moving with elevated average peak HR of 103.3 bpm and 153.7 bpm respectively, and average median breathing rates of 24.1 and 27.1 cycles per minute (see Table 4). This resulted in a rise of morphSQI in all devices—with the smallest incline for NeXus and Faros while participants walked (P2). During the uphill phase (P4), morphSQI values for NeXus increased drastically to 0.072 with a high standard deviation among the different participants. Only the ECG recordings of Hexoskin achieved higher values (0.082).
Table 3

Morphological Signal Quality Index (morphSQI) expressed as mean over all participants (average SD) and proportion of sufficient morphological signal quality (morphSQ < 10%).

OverallP1—RestP2—WalkingP3—2-backP4—Uphill
Mean (SD) morphological signal quality index (morphSQI)
 eMotion Faros 360°.023 (.011).018 (.006).026 (.006).016 (.006).016 (.006)
 Hexoskin Hx1.048 (.036).024 (.008).070 (.016).022 (.008).082 (.025)
 NeXus-10 MKII.035 (.035).019 (.006).025 (.006).023 (.015).072 (.021)
 SOMNOtouch NIBP.028 (.020).016 (.006).042 (.009).016 (.006).038 (.009)
Proportion of sufficient signal quality (morphSQ < 10%)
 eMotion Faros 360°98.78%100.00%99.95%100.00%95.38%
 Hexoskin Hx191.33%99.61%86.82%99.15%77.60%
 NeXus-10 MKII96.48%100.00%98.88%97.51%89.10%
 SOMNOtouch NIBP97.45%100.00%94.77%99.87%93.25%
Table 4

QRS detection performance expressed by false positive (FP) and false negative (FN) counts and positive predictive values (PPV) and false negative rates (FNR) from bandpass-filtered (3–20 Hz) ECGs (heartbeats annotated by eplimited).

OverallP1—RestP2—WalkingP3—2-backP4—Uphill
total reference beats423645623623561069222
avg. peak heart rate93.6 bpm103.3 bpm105.2 bpm153.7 bpm
avg. median breathing rate14.5 min-124.1 min-124.3 min-1 *27.1 min-1
FP|FN using eplimited
 eMotion Faros 360°10|1230|01|00|03|1
 Hexoskin Hx1393|2816|1171|4216|0128|97
 NeXus-10 MKII678|7580|01|034|21506|491
 SOMNOtouch NIBP117|2230|040|151|011|49
 Polar RS800 Multi532|53514|1740|34201|2031|1
PPV|FNR using eplimited
 eMotion Faros 360°1.000|0.0031.000|0.0001.000|0.0001.000|0.0001.000|0.000
 Hexoskin Hx10.989|0.0080.999|0.0000.977|0.0070.997|0.0000.986|0.011
 NeXus-10 MKII0.985|0.0171.000|0.0001.000|0.0000.994|0.0040.944|0.055
 SOMNOtouch NIBP0.998|0.0051.000|0.0000.995|0.0021.000|0.0000.999|0.005
 Polar RS800 Multi0.988|0.0120.997|0.0030.992|0.0070.970|0.0301.000|0.000

* Respiration rate as measured by Hexoskin might be biased by speaking during the 2-back task.

Looking at the morphological signal quality, it is possible to gain insight into the noisiness on a single beat level. Table 3 displays the percentage of beats with a NSR below 10%. Faros had the lowest noise proportion over all phases, followed by SOMNOtouch. During P4 only 77.6% of all beats recorded using Hexoskin had a morphSQ below 10%. Besides Nexus, an increase in signal quality can be seen from P2 to P3 for all devices. To rate the QRS detection performance, beat annotations for each device derived from eplimited (applied to bandpass-filtered signals) are compared to the reference annotation (beatsref) with a permitted deviation of 50 ms. During the entire measurement period and over all participants, 42, 364 beats are observed. Within the relevant experimental phases, 27, 186 beats are recorded with small differences between P1 to P3 and more beats in P4 caused by increased HR through the moderate activity. The most FP and FN beats are detected using NeXus’ ECG (678|758). These FPs and FNs can mostly be found in the uphill phase P4 (506|491). NeXus is followed by Polar and Hexoskin regarding detection accuracy. Best results could be observed using Faros. All devices achieve excellent results in resting state, missing no beats (Faros, NeXus, SOMNOtouch) or up to 0.6% (Polar). During movement phases, Faros keeps a low inaccuracy rate, SOMNOtouch shows a slight increase and NeXus had only significant deterioration during the uphill phase (P4) (10.8% misclassification rate = ). Polar has the highest percentage of missed beats during P3 (2-back) with 6.6% misclassification, but also the best result in P4 (0.02% misclassification) (see Table 4 for details). * Respiration rate as measured by Hexoskin might be biased by speaking during the 2-back task. PPV and FNR were used as a more intuitive approach for data comparison (Table 4). All devices achieved sufficient scores ranging from 0.985 (NeXus) to 1.000 (Faros). The comparatively low value for NeXus results from P4 (.944|.055). Faros is gaining best scores in all phases, SOMNOtouch is missing a few beats during movement phases. Polar scores better in phases with higher HR. Further, F1 scores are used to describe accuracy of detected heartbeats on the participant level. Thus, the influence of single participants can be shown (Fig 5). An F1 score below 90% is considered as an insufficient ECG quality that results in increased error probability during automated beat annotation processes. This is the case for one participant measured with NeXus during P4 and in one participant measured with Hexoskin during walking (P2) but but not while running (P4). Overall, Polar had the most scores low or insufficient quality (below 99%: 7 participants), mainly attributable to the 2-back task, but achieves very high scores during the running phase. Using SOMNOtouch and Hexoskin one respectively three participants had low F1 scores.
Fig 5

QRS detection performance expressed by F1 scores of the used devices per experimental phase with individual curve progression.

For a better understanding and fair comparison to the Polar (RR interval) recordings, a modified SW algorithm was used to identify FPs, FNs, as well as misplaced beats from interval data that has also been extracted from unsynchronized raw ECGs computed from beat locations using eplimited. While for the results presented in Table 4 misplaced beats are usually counted both as one FP and one FN if the beat location differs by more than 50 ms, the following analysis enables the distinction between misplaced beats, and FPs or FNs (Table 5). Insertions (respectively FP) and deletions (respectively FN) are less frequent than the number of misplaced beats, caused by noise around the QRS complexes. In resting conditions satisfying annotations were achieved in all recordings. The high numbers of misplaced beat especially in Hexoskin and NeXus were mainly caused by noise in data of a few participants as depicted in Fig 5 (please see S5 Fig including participant labels for a deeper insight).
Table 5

QRS detection performance through RR interval alignment using the modified Smith-Waterman algorithm for numericals.

Errors are expressed by false positive counts (FP), false negative counts (FN), and the number of misplaced annotations from unsynchronized data (50 ms tolerance).

OverallP1—RestP2—WalkingP3—2-backP4—Uphill
FP|FN|Misplaced using Smith-Waterman approach *
 eMotion Faros 360°5|0|190|0|00|0|00|0|00|0|6
 Hexoskin Hx185|10|7653|0|5114|0|20411|0|1429|1|270
 NeXus-10 MKII40|5|7650|0|03|0|415|0|400|1|309
 SOMNOtouch NIBP63|0|2020|0|08|5|1340|0|20|0|65
 Polar RS800 Multi28|29|3330|3|186|0|573|3|660|0|11

* Comparison based on exported Polar RR intervals and detected heart beats (eplimited) in raw unsynchronized ECGs.

QRS detection performance through RR interval alignment using the modified Smith-Waterman algorithm for numericals.

Errors are expressed by false positive counts (FP), false negative counts (FN), and the number of misplaced annotations from unsynchronized data (50 ms tolerance). * Comparison based on exported Polar RR intervals and detected heart beats (eplimited) in raw unsynchronized ECGs.

Discussion

Five ECG measurement devices made for specific use cases were tested. Holter ECG systems, chest straps, and biometric shirts all reached acceptable results with use case specific accuracy. This is supported by the low number of insufficient quality periods (see Fig 5). The medical device Faros achieved almost perfect results even during movement phases. Hexoskin’s main problem is the dependency of the shirt size to fit the participant perfectly. Sensor placement may change during body movement and may result in reduced accuracy. NeXus overall accuracy is sufficient with deficits in the uphill condition. There is one participant for whom NeXus produces unusable data (c.f. Fig 5). If this participant is excluded, NeXus reaches signal quality (morphSQI(P3) = 0.015, morphSQI(P4) = 0.028) comparable to Faros and SOMNOtouch. Polar, as the most popular mass-producing sports equipment manufacturer of the devices used, achieved the best results in phases with higher movement and thus higher HR. Nevertheless statistical differences has not been conducted due to the low number of participants. A limitation of this study is the missing usage of a 12-lead ECG system as a gold standard for comparison. Such a system was not applicable due to possible interferences of the chest leads with the textile electrodes of Hexoskin. Clinically validated measuring devices were used in compensation. Additionally, the focus of this comparison was not on the application for the detection of clinical abnormalities, but on the application of the devices in ergonomics and sports science, as well as in the leisure context with the focus on the valid and automated detection of R peaks in order to reduce the effort involved in manual follow-up processing steps. Measuring simultaneously with all devices enables the true comparison of the (morphological) signal quality, but at the same time restricts the perfect electrode placement for each device. Mutual interference was kept minimal by using Ag/AgCl electrodes. Several smaller discrepancies from manufacturer specifications for sampling frequency could be observed (e.g. NeXus using 8000 Hz instead of 8192 Hz) as well as unsteady fluctuations in sampling frequency especially for Faros and Polar. Using a single device, such variation would not be noticed nor corrected, as has been done in our approach [34]. This phenomenon, though, needs further investigation. With some HRV indicators being really sensitive to missing or falsely detected beats it is important to check and correct automatically generated beat annotations. Especially for research purposes a device with accessible raw data should be used. While using devices storing just RR intervals, more robust indicators should be calculated (such as rrHRV [61]). To meet the current gold standard for HRV analysis, even with the best device and QRS detection algorithm, a visual inspection of annotated R peaks should be carried out by a professional to determine possible errors [36]. The accessibility to raw data is not always trivial. Most devices offer EDF format or other commonly used file types and users are able to access them via USB. For Hexoskin special software or skills are needed to extract the raw ECG from WAV format. For non-scientific usage, this can be challenging. Wearables and similar self-quantification technologies are a fast moving and rapidly growing market [6]. With increasing signal quality, lower prices, and improvements in sensor technology, their future potentials are promising as long as they get validated. Healthcare can take advantage of it, especially through telemedical applications in rural areas. Promising approaches are made with ePatch to record data similar to 12-lead ECGs in more field like settings [62] and the Apple Heart Study shows first scientific possibilities to use consumer products for large scale clinical scenarios [63]. While most wearable HR detectors currently rely on PPG, this might change in the future with promising use cases from Apple Watch 4 and Withings Move. Future medical devices and consumer products will influence and enrich each other, but a technically and scientifically valid data acquisition should always be the basis of such development.

Conclusion

Wearable ECG devices can be used as self-monitoring tools in leisure and mass sport, daily life, with special technical requirements for the use in scientific research as well as for the collection of big data sets in ambulatory settings. For work and sports related research, an affordable, valid device is a key aspect to allow for field studies. Although, medical studies in laboratory settings facilitate higher precision. None of the used devices performed insufficiently overall. Most inter-device data-quality differences are only in nuances. A frequent usage in field settings requires the consideration of additional aspects: preparation time, mobility, and scientific usability. Preparation time is always dependent on the users’ experience, but some limiting factors can remain the same. With just a chest belt to put on, Polar has the fastest mounting option, followed by the two devices with three electrodes (Faros and NeXus) and SOMNOtouch with four electrodes and the optional pulse oximeter. Hexoskin might take more time for the application of conductance gel and adjusting chest and abdomen straps afterwards. Nevertheless, all devices can be equipped in under five minutes. For mobility, handing of electrodes and cable placement is of importance, weight and other restrictive factors such as missing comfort or insufficient fit of textiles and strap bands have to be considered. Scientific usability further includes aspects of data handling, data access and interpretability. Sports devices offer a simple user experience and quick and easy interpretability of the data with no need for further raw data access which can be a limitation for research use cases. The remaining devices require experience in sensor placement and ECG data analysis to further interpret the data. Accuracy still might be the most important aspect for research and ease of use in a scientific context. The data recorded during this study suggest that the clinically approved devices are the most accurate. Hexoskin’s data quality relied on the fit of the shirts, with a loose fit causing the electrodes to move during physical activity resulting in an increased susceptibility to noise. With the missing possibility to extract the raw ECG, and compared to the other devices, Polar is the least accurate justified by the higher failure rate. The simultaneous usage of five ECG devices differs from standard ECG use cases, but it offered the chance for a comprehensive comparison of data quality by two new approaches: analyzing the NSR using morphSQ, and RR interval quality using SW. Both methods offer intuitive and fast approaches to estimate data quality of a new device compared to a gold standard. morphSQ uses an intuitively interpretable percentage scale and works perfectly on a local level. It thus shows high correlation to SNR, FNR, and PPV of the detection of R peaks, but requires manually revised annotations of R peaks for reliable values. A future application of the morphSQ algorithm might be the additional analysis of p- and t-wave autocorrelation. Additionally to morphSQ, SW does not require synchronization to summarize and classify beat detection capability. There is also no need to handle incorrect sampling frequencies and signals interruptions during long-term measurements. In future research contexts, this approach can be applied to any sequences of numeric data, as the reward function can be easily adapted to other problems. High scores for both indicators imply low manual postprocessing effort. Based on good signal quality, automated beat detection should lead to sufficient results. Thus, high morphSQ scores and good SW results indicate an increased ease of use/user friendliness during data processing and higher confidence in automatically generated/derived parameters. Integrating a wearable device with ECG features into either leisure time activities or scientific research requires a careful consideration of available devices features and the corresponding task’s demands. Some areas of application require more than a single-channel ECG or just RR intervals per se. Therefore, some devices are unsuitable. Before using new equipment, it is recommended to check the data quality thoroughly.

General information about the measurement devices with images.

(EPS) Click here for additional data file.

Example of signal quality metric morphSQ with performance of beat detection in clean and noisy ECG segments.

(PDF) Click here for additional data file.

Part a) performance of beat-detection-algorithms in a noise stress test, part b) Signal quality metric morphSQ in relation to signal-to-noise ratio.

(PDF) Click here for additional data file.

Correlation of signal quality metric morphSQ with beat detection performance in noise stress test recordings.

(PDF) Click here for additional data file.

QRS detection performance expressed by F1 scores of the used devices per experimental phase with individual curve progression and participant labels.

(PDF) Click here for additional data file. 17 Dec 2021
PONE-D-21-31227
Comparison of ECG signal quality, QRS detection performance, and device usability based on simultaneous recordings
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Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Yes Reviewer #2: Yes Reviewer #3: Yes ********** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: N/A Reviewer #2: Yes Reviewer #3: Yes ********** 3. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). 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You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: The authors present results of a study comparing signal quality of ECG recordings acquired using five commercially-available devices of which three are medical grade. Data was acquired in parallel as the devices employ different sensors technologies (e.g. conventional skin electrodes, textile sensors, chest strap) while the subjects (N=13) were performing different cognitive and physical activities. The dataset was already published within PhysioNet and preprocessing is described in a CinC 2019 contribution. The topic is of high interest due to the increasing availability of (non-)medical grade ECG hardware - not only for interested individuals but also researchers - as it could enable ECG acquisition in scenarios that were not possible before. Evidently, the signal quality of these devices in different scenarios is a crucial point. The evaluation is based on a novel signal quality index that is proposed in this work. In conclusion, this work addresses an important topic and fits to PLOS ONE due to its multidisciplinary nature. The language of the paper is fine and the figures provided are of high-quality. However, I have concerns regarding i) the fact that this work introduces a novel signal quality measures without evaluating it or comparing it to other algorithms; ii) the cited references as important up-to-date literature is not considered; iii) the document content and structure being sometimes chaotic and not following IMRAD. Moreover, iv) at multiple points in the work the wording is not uniform, the title requires changes and v) the level of detail is too superficial at some points. However, I am optimistic that all issues can be addressed in an extensive revision, leading to acceptance. i) The authors propose a new heuristic algorithm for ECG signal quality estimation. I am completely fine with that but this requires to evaluate its performance w.r.t. state-of-the-art methods in this field and/or test/synthetic signals with a pre-defined signal quality. Unfortunately, both are missing which prevents to assess the quality of the proposed method in any way. I suggest the authors to either i) apply a state-of-the-art method to their data and compare the results to the results achieved with the proposed method or ii) apply their method to synthetic signals with manually added noise (e.g. baseline wander, muscle twitches) at pre-defined signal-to-noise levels (as done in [23]). Ideally, both experiments are conducted. This would lead the reader to appreciate the many open parameters (e.g. k=8, w=[-2,2], l_qrs=100ms, morphSQ < 10%) because at the moment the reader cannot assess how robust the proposed algorithm and results are. Moreover, the reader cannot get "a feeling" for the proposed morphSQ values. Fig. 3 shows four ideal ECG signals and their corresponding morphSQ values but what about the special cases? What influence does baseline wander, motion artifacts etc. have on the accuracy of morphSQ? ii) I strongly miss a "Related work" chapter in this work giving an overview of the state-of-the-art in ECG signal quality estimation. In the Introduction only two references are given which are from 2012 and 2007, respectively. I am absolutely not an expert in that field but I know some recent works that definitively have to be considered (e.g. https://doi.org/10.1109/tbme.2020.2969719 , https://doi.org/10.1109/rbme.2018.2810957) just by reading the relevant journals in that field. iii) The document structure is chaotic at various points, especially in the first chapter: ll. 1-14: Introduction and first mention of HR and HRV ll. 15-23: "The aim of this study is to compare usability and data quality ..." ll. 24-41: Fundamentals of ECG (clinical vs. Holter systems, PQRST etc) ll. 42-50: The role of HR and HRV w.r.t. different user groups ll. 51-60: Information on the devices used ll. 60-68: "In this study, the ECG device comparison is based on..." ll. 69-73: Information why a high signal quality is important in research ll. 74-80: Short summary of ECG signal quality indices ll. 81-85: "In this paper, a new signal quality index was developed" As I try to underline, it is very hard for the reader to follow. I highly suggest to split the introduction into i) ECG fundamentals, ii) related work, iii) the aims of this work (or research questions), iv) and which methods will be used to reach these aims (answer the research questions). At some other instances of the document, the authors do not follow IMRAD. For example: - ll. 137-143: This should be raised in the introduction or discussed at the end of the work as a limitation. - ll. 256-284: This chapter is hard to read as it mixes description of the algorithm and evaluation. I suggest to add a new subchapter "Evaluation methodology" (or similar). - Conclusion: All the information on usability should be part of the main body of the text (method & results). The information how long a device needs to be equipped or how the authors assess the experience needed for sensor placement is not a "Conclusion" but a result. iv) At multiple instances the wording is not uniform. Some examples are (this list is not complete): - l. 22: "RR intervals" vs. l. 55: "RR-intervals" - l. 54: "PPG" (not introduced) - l. 10: "Heart Rate (HR)" vs. l. 49: "heart rate" (abbreviation not used) - l. 129: "EDF or EDF+" (written in italics; also not introduced) vs. Table 2: "EDF" (no italics) - l. 210: "PQT analysis" (what is that?) vs. l. 42: "PQRST" - l. 259: "FP - false positive" vs. l. 312: "false positive (FP)" Furthermore, the title does not contain the key information that in this work i) multiple, wearable ECG devices are compared and that ii) a novel method for signal quality estimation is proposed. v) The description of the "Smith-Waterman-like algorithm" is too superficial. I cannot understand it from the 6 lines of text and the figure provided. Minor issues: - Please provide information how many annotators at what level of expertise provided beat_ref. Moreover, you report that arrhythmia periods were removed. Please report how this decision was made and how much data was removed. - Table 1: That is a strange Euro symbol? Additionally, I think it would be good to report on the bit depth of the ECG signals. - Table 2: Please define all abbreviations. What is EDF/SDC/ASC...? - ll. 154-177: How long are P3 and P4? - l. 202: I suggest to not use the wording "Statistical analysis" as no statistical testing is performed but only mean and SD values are reported. - Abstract: "The results allow conclusions to be drawn..." -> I suggest to actually name the conclusions. Reviewer #2: Summary The authors compare five different ECG devices to evaluate these devices regarding QRS detection and usability. The research question is relevant. It is also important that the authors make the recorded data publicly available. However, it exists already many papers which compare different ECG devices. Before the publication, the method should be described sufficiently detailed, as some of the reasons for the selected approach are lacking. In addition, the limitations of the method should be discussed more intensively in the discussion. Major Issues • Introduction o 1-4: The first reference should support this statement “[…] ongoing trend for self-quantification of personal health and fitness lead to […]” and is from 2012. o 7-8: “A rising number of those devices are […]” here you need to add more than one reference. o 23-41: It is more important to address wearable devices instead of the Holter ECG systems. o 51-60: The selection of the different ECG devices belongs to the chapter “Material and Methods” and in the chapter “Introduction”. • Material and Methods o The authors need to address the time synchronization of the different devices. They need to explain how they can ensure that the recorded signals are the signals for the same time interval. o Subjects: Please add the inclusion and exclusion criteria for the subjects. o Statistical analysis: Please add the explanation why you chose the algorithm eplimited and did not choose another state-of-the-art algorithm (e.g., template matching or deep learning approach). o 278: It is important to use the same algorithms to make the results comparable. • Conclusion o 401 „Fig 6. Authors' ordinal ranking of used recording devices.“: This ranking depends on the author's opinion and is not scientific. The authors need to exclude this figure. Minor Issues • Figures and tables o Table 1: You should replace the euro signs with numbers. o Figure 5: It is important to differentiate between the different use cases and to explain the results. Reviewer #3: The authors present a study in which they compare several ECG devices for ambulatory monitoring in terms of their signal quality. The paper is very well written and the topic is of interest to the community. There are some points I would like to see addressed before publication. - The authors introduce a novel signal quality index. I think it would make a lot of sense to either evaluate this signal quality index on existing benchmark problems first or to evaluate their data using also other signal quality indices and see whether or not there are any differences, if their new metric correlates with other metrics, etc. (as a side note, I find it somewhat unintuitive that the signal quality index has to assume low values for the signal to be of good quality. In Figure 3, the authors even write “quantify similarity”, so why not something like “1 – SQI”? Then, the authors also don’t need to talk about “Noise to Signal” in their manuscript but rather SNR...) - The SQI cannot be applied to the Polar-device for obvious reasons. However, this makes the analysis somewhat inconsistent. Thus, I believe the authors should make a much stronger point on why to include this device (other than because it was there) or think about leaving it out. - Along the same lines, the authors make an argument as to why they are not using a 12-lead ECG as reference (which is plausible) while, at the same time, argue that their SQI might be useful in the context of “further PQT analysis”. This seems like an ambiguity to me. - I find the presentation of results in the large tables somewhat confusing. The authors could think about, for example, highlighting the best values, etc. Also, is there a way to perform some sort of statistical test to see whether or not the results of the different devices and test scenarios are significantly different? - The conclusion section is rather long and also introduces a new figure, I would consider rearranging the content between discussion and conclusion. - The paper could benefit from another round of proof reading from a native speaker ”differences in usability and practicability between all devices ARE characterized”, “As it was the goal to induce a mental state” (?). Also, it seems to me that punctuation could be improved. - “During a first check of the recorded data from all five devices, several problems occurred that needed to be solved.” I am not sure this is a good sentence to start the paragraph as this should be a result-oriented (and not a progress-oriented) report. ********** 6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: No Reviewer #2: No Reviewer #3: No [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step. 16 Jun 2022 Dear Reviewers, thank you all for taking your time and providing us with your thoughtful comments. We are confident that our revised manuscript benefited from your input. Please find our detailed response in the added PDF. Supplemental figures A1-A4 are only for this response letter and should not be published with the manuscript. Yours sincerely Submitted filename: Response_to_Reviewers.pdf Click here for additional data file. 16 Aug 2022
PONE-D-21-31227R1
ECG performance in simultaneous recordings of five wearable devices using a new morphological Noise-to-Signal index and Smith-Waterman-based RR interval comparisons
PLOS ONE Dear Dr. Blaesing, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. Please submit your revised manuscript by Sep 30 2022 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. Please include the following items when submitting your revised manuscript:
If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter. A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'. A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'. An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'. If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols. We look forward to receiving your revised manuscript. Kind regards, Thomas Martin Deserno, Ph.D. Academic Editor PLOS ONE Journal Requirements: Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice. Additional Editor Comments (if provided): I suggest to consider the paper metioned by reviewer 2 [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation. Reviewer #1: All comments have been addressed Reviewer #3: All comments have been addressed ********** 2. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: (No Response) Reviewer #3: Yes ********** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: (No Response) Reviewer #3: N/A ********** 4. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: (No Response) Reviewer #3: Yes ********** 5. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: (No Response) Reviewer #3: Yes ********** 6. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: Dear authors, thank you very much for the thorough revision of your manuscript. I congratulate you to this effort and suggest to highlight this work on the PLOS ONE website. Reviewer #3: The authors addressed all my comments (and I believe those of the other reviewers as well) sufficiently and have improved the manuscript significantly in the process. I now find the manuscript acceptable for publication. Looking at the not super-recent literature, this paper [https://doi.org/10.3390/s18010038] introduces a “shape-based signal-to-noise ratio SNR_S” for cardiorespiratory signals that, to me, seems to have some obvious connections to the “morphological signal quality index” presented here. Thus, the authors might want to think about discussing it in the related work section. ********** 7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: Yes: Nicolai Spicher Reviewer #3: No ********** [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step.
26 Aug 2022 Dear Reviewers, thank you for taking the time to review our revised version of the manuscript. We are pleased that our changes have met your expectations and that you now consider the article worthy of publication. @Reviewer 3: Please find our answer to your suggestion in the "Response to Reviewers" File. We read the suggested reference and included it in our manuscript. Submitted filename: Response to Reviewers.pdf Click here for additional data file. 9 Sep 2022 ECG performance in simultaneous recordings of five wearable devices using a new morphological Noise-to-Signal index and Smith-Waterman-based RR interval comparisons PONE-D-21-31227R2 Dear Dr. Blaesing, We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements. Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication. An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org. If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. Kind regards, Thomas Martin Deserno, Ph.D. Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: 26 Sep 2022 PONE-D-21-31227R2 ECG performance in simultaneous recordings of five wearable devices using a new morphological Noise-to-Signal index and Smith-Waterman-based RR interval comparisons Dear Dr. Blaesing: I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org. If we can help with anything else, please email us at plosone@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. Thomas Martin Deserno Academic Editor PLOS ONE
  39 in total

1.  Levels of agreement for RR intervals and short-term heart rate variability obtained from the Polar S810 and an alternative system.

Authors:  David Nunan; Djordje G Jakovljevic; Gay Donovan; Lynette D Hodges; Gavin R H Sandercock; David A Brodie
Journal:  Eur J Appl Physiol       Date:  2008-04-22       Impact factor: 3.078

2.  Heart rate variability. Standards of measurement, physiological interpretation, and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology.

Authors: 
Journal:  Eur Heart J       Date:  1996-03       Impact factor: 29.983

3.  A pilot study on quantification of training load: The use of HRV in training practice.

Authors:  Damien Saboul; Pascal Balducci; Grégoire Millet; Vincent Pialoux; Christophe Hautier
Journal:  Eur J Sport Sci       Date:  2015-02-06       Impact factor: 4.050

4.  Diagnostic tests 2: Predictive values.

Authors:  D G Altman; J M Bland
Journal:  BMJ       Date:  1994-07-09

5.  Robust heart rate estimation from multiple asynchronous noisy sources using signal quality indices and a Kalman filter.

Authors:  Q Li; R G Mark; G D Clifford
Journal:  Physiol Meas       Date:  2007-12-10       Impact factor: 2.833

6.  Comparable Cerebral Oxygenation Patterns in Younger and Older Adults during Dual-Task Walking with Increasing Load.

Authors:  Sarah A Fraser; Olivier Dupuy; Philippe Pouliot; Frédéric Lesage; Louis Bherer
Journal:  Front Aging Neurosci       Date:  2016-10-20       Impact factor: 5.750

7.  Validity of the Polar V800 heart rate monitor to measure RR intervals at rest.

Authors:  David Giles; Nick Draper; William Neil
Journal:  Eur J Appl Physiol       Date:  2015-12-26       Impact factor: 3.078

Review 8.  The Rise of Consumer Health Wearables: Promises and Barriers.

Authors:  Lukasz Piwek; David A Ellis; Sally Andrews; Adam Joinson
Journal:  PLoS Med       Date:  2016-02-02       Impact factor: 11.069

9.  An Open-source Toolbox for Analysing and Processing PhysioNet Databases in MATLAB and Octave.

Authors:  Ikaro Silva; George B Moody
Journal:  J Open Res Softw       Date:  2014-09-24

10.  Current State of Commercial Wearable Technology in Physical Activity Monitoring 2015-2017.

Authors:  Jennifer A Bunn; James W Navalta; Charles J Fountaine; Joel D Reece
Journal:  Int J Exerc Sci       Date:  2018-01-02
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