Pdf Nature Reviews Disease Primers Volume 3 Article Number 17088 (2017)
Original Paper
Abstract
Background: Hypertension is a global public health issue and is closely related to chronic kidney disorder (CKD). In people with CKD, strict monitoring of claret pressure is an important function of therapy.
Objective: The aim of this enquiry was to validate the iHealth Runway blood force per unit area monitoring device for patients with CKD according to the European Society of Hypertension International Protocol 2010 (ESH-IP2).
Methods: In full, 33 patients who received hemodialysis in Plasencia participated in the study. There were 9 successive measurements fabricated, which conformed to the ESH-IP2. We calculated the differences between the standard reference device (Omron M3 Intellisense) and the test device (iHealth Track) for blood pressure and heart rate values. For 99 total comparisons of paired measurements, we classified differences into diverse categories (≤5 mmHg, ≤10 mmHg, and ≤15 mmHg for blood force per unit area; ≤3, ≤5, and ≤8 beats per infinitesimal for middle rate).
Results: In xc of 99 systolic blood pressure and 89 of 99 diastolic claret pressure comparisons between the devices, measurement differences were inside 5 mmHg. In 81 of 99 heart charge per unit comparisons between the devices, measurement differences were inside iii beats per minute. The hateful differences betwixt the examination and reference standard measurements were 3.27 (SD 2.99) mmHg for systolic blood pressure, iii.59 (SD 4.55) mmHg for diastolic blood pressure, and ii.eighteen (SD two.75) beats per minute for heart rate. Nosotros also observed that for both systolic and diastolic blood pressure, 31 of 33 participants had at to the lowest degree two of three comparisons between the devices with measurement differences less than 5 mmHg. For heart rate, 28 of 33 patients had at least 2 of 3 comparisons betwixt the devices with measurement differences less than 3 beats per infinitesimal.
Conclusions: To our noesis, this is the offset study to show that iHealth Rails meets the requirements of the ESH-IP2 in patients with CKD. Therefore, the iHealth Runway is suitable for use in renal patients.
doi:ten.2196/14702
Keywords
Introduction
Chronic kidney disorder (CKD) is a syndrome defined past persistent alterations in renal office or structure that cause complications in a patient's health. Some of the structural anomalies may be tumors, cysts, malformations, or atrophies. In addition, renal dysfunction can be manifested through alterations in the output or grade of urine, increased risks of intellectual disabilities in children, edema, and hypertension [,].
In fact, the diseases most related with CKD are hypertension and diabetes, especially in high- and middle-income countries [,]. Hypertension may simply be a consequence of CKD [,] or both a cause and result of CKD [,]. Hypertension may exist due to hypervolemia or activation of the renin-angiotensin system or neurohumoral (catecholamine and aldosterone) axis. In improver, sometimes loftier blood pressure level (BP) originates from calcineurin or corticosteroid inhibitors used to treat underlying kidney disorders [].
The interaction between CKD and hypertension is complex and increases the probability of cerebrovascular and cardiovascular bug [-]. In several studies, cardiovascular events and deaths from any cause were reduced when systolic BP was <120 mmHg (compared to <140 mmHg) in patients with CKD and hypertension but not diabetes [-]. Therefore, strict command of BP is of import for CKD therapy [].
Monitoring of BP should exist washed with devices that are easy to use and accurate [,-]. These devices must be tested and validated by contained experts (eg, the British Hypertension Society [], the Clan for the Advancement of Medical Instrumentation [], and the European Society of Hypertension [,]) with protocols validated and designed expressly for BP monitoring []. The purpose of this study was to validate the iHealth Track BP monitoring device for self-measurement in patients with CKD, according to the European Lodge of Hypertension International Protocol 2010 (ESH-IP2). Therefore, the hypothesis of this written report was that iHealth Track would be valid for the self-measurement of BP and heart rate (60 minutes) in renal patients co-ordinate to the ESH-IP2.
Methods
Ethical Information
The study protocol was approved by the Institutional Local Research and Ethical Committee (Universidad de Extremadura, Badajoz, Kingdom of spain; tape number 152/2019). In conducting this written report, we complied with the ethical principles of the Declaration of Helsinki [], including any emendations betwixt 2000 and 2013. All participants provided signed informed consent prior to participating in this study.
The Devices
Omron M3 Intellisense
The standard device we used for reference was the Omron M3 Intellisense (Omron Healthcare, Kyoto, Japan), which has been validated co-ordinate to the International Protocol for the full general population [] likewise as CKD patients []. We purchased the Omron M3 Intellisense monitor from a local market place. The Omron M3 Intellisense is an oscillometric and automatic upper-arm device for home BP monitoring. The device'southward standard arm cuff is 22 to 32 cm effectually, and a large cuff is also bachelor for arm circumferences of 32 to 42 cm. The device uses IntelliSense technology to produce comfy, controlled inflation without the need for pressure presetting or reinflation.
iHealth Track
The test device was the iHealth Track automatic appliance with serial number KN-550BT (iHealthLabs Europe, Paris, France), which registers brachial BP with the oscillometric protocol. It detects BP between the range of 0 mmHg to 300 mmHg (measuring precision ±3 mm Hg) and HRs within the range of 40 to 180 beats per min (measurement precision ±5%). The device's arm gage is 22 to 42 cm around.
The device'southward liquid crystal display screen shows the measured systolic (Due south) BP, diastolic (D) BP, and Hr values. The device unit has plenty retentivity for 99 recordings. Additionally, this device unit tin be used with Apple Bluetooth 4.0 devices and sure Android Bluetooth iv.0 cellular phones through an application named Wellness MyVitals. This means that BP and 60 minutes data can be stored on wireless devices connected to iHealth Rails and then displayed graphically.
Patients and Recruitment
We recruited patients with CKD who attended the Fresenius Medical Care dialysis dispensary in Plasencia, Espana. A total of 33 patients who met the selection criteria participated. The inclusion criteria were adults 25 years of age or older that received hemodialysis. We sought at least 10 male person participants and x female participants. The exclusion criteria, which were created according to the ESH-IP2 [,], were sustained arrhythmia, circulatory bug where use of the gage is contraindicated, and pregnancy.
Research Protocol
The professional validation team consisted of 2 nurses with senior experience (more than than 6 years) in BP measurement. The measurement area was correctly conditioned to a suitable temperature, and factors that could affect the records, such equally noise or distractions, were removed [,]. All measurements were fabricated in the aforementioned room. The colour of the room was white.
Afterward dialysis, each patient commencement reported information regarding their sex, age, height, and dry out weight. In add-on, nosotros calculated participants' BMI using Quetelet´s alphabetize in kg/m2. The circumference of the patient'southward arm was measured to ensure that the cuff size was acceptable.
Side by side, patients sat in the measurement room and BP measurements were started subsequently a ten- to 15-minute residuum menstruum. Each patient was seated in a standard-size plastic chair with a backrest and armrests.
In full, 9 consecutive measurements were made on each participant with the Omron M3 Intellisense (5) and the iHealth Rail (4) as follows [,]:
- (BPA): input BP, by the standard device unit
- (BPB): device BP detection past the test device unit
- (BP1): standard device unit
- (BP2): test device unit
- (BP3): standard device unit of measurement
- (BP4): test device unit
- (BP5): standard device unit
- (BP6): test device unit of measurement
- (BP7): standard device unit of measurement
During the measurements, participants remained calm, repose, seated, and still. Participants kept their backs straight and anxiety on the floor in a parallel position (ie, without crossing their legs). They rested their arms on a flat surface with their palms facing upwards and their elbows slightly flexed so that their fists were at the height of their hearts.
BP records were fabricated at heart level on the right arm in 31 participants and on the left arm in 2 participants (because of an arteriovenous fistula on the right arm). The standard cuff size (22-32 cm) for the Omron M3 Intellisense was used for all men (20). For women, the standard cuff (22-32 cm) was used for 11 participants, and the big cuff (32-42 cm) was used for 2 participants. Since the iHealth Track has but one cuff size (22-42 cm), all measurements were taken with it. The interval between one measurement and the adjacent was xxx to sixty seconds [].
All measurements were made for each participant during their hemodialysis appointment, afterward the dialysis was complete. The relative values were then used to calculate the hateful difference betwixt the reference device readings and the test device readings. All participants were receiving hemodialysis in the Fresenius Medical Care dialysis dispensary in Plasencia.
Data Analysis
We analyzed the information with the software SPSS Statistics, version xix.0 (IBM, Armonk, New York). We reported the findings as hateful (SD).
According to the ESH-IP2, the accuracy of a device is based on a comparison betwixt the test device (iHealth Track) and the standard reference device (Omron M3 Intellisense) measurements. For each participant, we first compared measurements BP2, BP4, and BP6 with measurements BP1, BP3, and BP5, respectively, and then compared measurements BP3, BP5, and BP7 with each other. The most favorable comparisons were used.
In our comparisons, nosotros classified differences for both SBP and DBP, separately, by whether paired values were within 5, 10, or fifteen mmHg [], and whether paired values for HR were within 3, v, or 8 beats per minute (BPM). We determined whether the test device passed the ESH-IP validation protocol. Function 1 of the validation process concerns the number of differences allowed in the specified ranges of each measure (SBP, DBP, and Hour) for comparisons of individual measurements between devices (99 measurements) []. Office ii concerns the comparisons between devices of each mensurate for individual participants (33) [].
Moreover, nosotros produced Bland-Altman plots [,] to display the understanding between the ii devices (the iHealth Track and the Omron M3 Intellisense). These plots evidence the difference betwixt each pair of measurements on the y-axis confronting the hateful of each pair of measurements on the x-centrality (for SBP, DBP, and 60 minutes).
Results
Participants
Of the 34 participants we recruited, 33 completed the study successfully (one was excluded for device failure). The 33 participants included 20 men and 13 women. shows a summary of their biometric characteristics.
| Variables | Total sample (N=33) | Males (N=20) | Females (N=13) | ||||
| | Mean (SD) | Range | Hateful (SD) | Range | Mean (SD) | Range | |
| Age (years) | 71.24 (xi.76) | 47.0-88.0 | 70.25 (11.42) | 47.0-85.0 | 72.77 (12.57) | 47.0-88.0 | |
| Weight (kg) | 70.48 (fifteen.87) | 46.0-101.0 | 70.18 (12.95) | 47-100.0 | seventy.94 (xx.16) | 46.0-101.0 | |
| Elevation (cm) | 162.24 (9.87) | 141.0-180.0 | 167.10 (4.58) | 160.0-180.0 | 154.77 (11.24) | 141.0-174.0 | |
| BMI (kg/mii) | 26.95 (6.72) | eighteen.0-44.0 | 25.07 (4.08) | 18.0-33.0 | 29.84 (8.ninety) | xix.0-44.0 | |
| Arm circumference (mm) | 265.0 (33.12) | 220.0-350.0 | 264.75 (26.13) | 220.0-320.0 | 265.0 (33.12) | 220.0-350.0 | |
Blood Pressure Measurements
The iHealth Track BP device validation results were taken in accordance with the ESH-IP2. The mean differences betwixt the reference standard and test devices were 3.27 (SD 2.99) mmHg for SBP and 3.59 (SD 5.28) mmHg for DBP. In 90 out of 99 SBP and 89 out of 99 DBP comparisons between the devices, measurement differences were inside 5 mmHg, exceeding the ESH-IP thresholds (>72 comparisons for SBP and >64 comparisons for DBP). Additionally, in 95 out of 99 SBP and 94 out of 99 DBP comparisons between the devices, measurement differences were within 10 mmHg, also exceeding the ESH-IP thresholds (>86 comparisons for SBP and >fourscore comparisons for DBP). Moreover, in 98 out of 99 SBP and 94 out of 99 DBP comparisons between the devices, measurement differences were inside 15 mmHg, which over again surpasses the ESH-IP thresholds (>95 comparisons for SBP and >92 comparisons for DBP). Therefore, the iHealth Track passed function 1 of the validation protocol for BP monitoring.
Regarding role ii of the ESH-IP2, 31 out of 33 participants had at least two of the three comparisons between devices with measurement differences within 5 mmHg for both SBP and DBP, exceeding the ESH-IP threshold (>23 participants). One participant had all three comparisons for both SBP and DBP with measurement differences greater than v mmHg, which is less than the ESH-IP maximum of 3 participants. Given these results, the iHealth Track also passed part 2 of the validation protocol for BP. Thus, considering the iHealth Track passed parts i and 2 of the BP validation protocol, it passed part 3 of the protocol, overall validation.
Heart Rate Measurements
The validation findings for the iHealth Track 60 minutes monitoring device were taken according to the ESH-IP2. The mean difference between the reference standard and examination devices was 2.xviii BPM (SD 2.75). In comparisons between devices, 81 out of 99 pairs of measurements were within 3 BPM, 91 out of 99 were within v BPM, and 96 out of 99 were within eight BPM. These results point that the iHealth Runway passed role ane of the validation protocol for HR.
Regarding part 2 of the ESH-IP2, 28 out of 33 patients had at to the lowest degree two of three comparisons between devices with measurement differences within iii BPM, which exceeds the ESH-IP threshold (>23 participants). Only 2 participants had all three Hour comparisons with measurement differences greater than 3 BPM, which is less than the ESH-IP maximum of 3 participants. Therefore, the iHealth Rail passed part 2 of the HR validation protocol and, consequently, part three (overall validation) equally well.
The Bland-Altman graphs (-) give farther information on the performance of the iHealth Track device. The graphs show that the measurement differences betwixt the devices were adequately constant across the ranges of SBP, DBP, and HR.
Word
This study is the get-go to validate the accurateness of the iHealth Track device for BP and HR recordings in patients with CKD. The results indicate that the iHealth Track, equally used in renal patients, passed the ESH-IP2 validation requirements. We previously validated the iHealth Track device for the general population following ESH-IP2 [].
This report showed 2 limitations. Although the iHealth Rail has been validated in the general population and now in patients with CKD, we cannot necessarily extrapolate our results to other specific populations. In addition, patients with CKD take stiffer arteries than other people [,,]. We did not investigate arterial stiffness, but information technology would be useful to appraise it in future validation studies.
The ESH-IP2 for abode BP monitoring highlights the need for specific validation in patients with end-stage renal disease [,] equally strict control of hypertension is required in these patients [,].
Nonetheless, at that place are few devices that have been validated in patients with renal disease [,-]. Akpolat et al [] validated Omron M3 HEM-7051 in patients with CKD according to the ESH-IP2 revision. They used the mercury sphygmomanometer every bit their standard reference device and included 66 participants, rather than 33. The results were similar to ours, since both studies passed the ESH-IP revision'due south two phases of validation. However, the number of differences included in the category of five mmHg according to the ESH-IP2 were better for the iHealth Track for both SBP and DBP (ie, iHealth Rail accomplished college differences than Omron). The differences obtained with the HRs cannot exist contrasted equally HR was not measured past Akpolat et al. Likewise, our findings cannot exist compared with the residual of the validation studies found [-], since none followed the ESH-IP2 validation requirements. We believe that more validation studies for BP monitoring devices are necessary for patients with CKD.
The purpose of the ESH-IP2 was to simplify the previous protocols of the British Hypertension Gild (BHS) [] and the Association for the Advancement of Medical Instrumentation (AAMI) []. However, the protocol does have some shortcomings. Outset, the major limitation is that information technology is underpowered with only 33 participants (99 measures) required rather than the 85 participants (255 measures) required by the previous AAMI and BHS validation protocols [,]. Second, the ESH-IP2 does non indicate the number of validation studies needed to found the accurateness of a device. According to some experts, at least two validation studies should be performed in different centers and in different populations before accepting the device every bit accurate []. Therefore, it is valuable to evaluate BP devices in diverse specific populations before they are used widely in clinics and homes. Third, the ESH-IP2 imposes certain gender requirements and limits validation studies to individuals older than 25 years who take BPs within specific ranges. Therefore, device accurateness remains unknown in children, adolescents, young adults, and patients with farthermost BP values. Finally, the ESH-IP2 does not mention explicit criteria for validation in specific populations. Following the commencement of our study, in March 2019, the AAMI/ESH/ISO Universal Standard was published as the recommended standard for validation of BP measuring devices. []. This standard includes criteria for the validation of BP devices in specific populations. This volition be considered in our future validations.
Our study is the first to bear witness that the iHealth Track device meets the requirements of ESH-IP2 in patients with CKD. Hereafter versions of the ESH-IP should include explicit criteria for validation in specific populations. Validation of this device would exist valuable in other specific populations such equally pregnant women, older adults, and patients with arrhythmias.
Acknowledgments
Nosotros thank the patients and medical staff from the Fresenius Medical Care dispensary in Plasencia, specially Dr Alejandro Cives, nephrologist.
Conflicts of Involvement
None declared.
Abbreviations
| AAMI: Association for the Advancement of Medical Instrumentation |
| BHS: British Hypertension Society |
| BP: blood pressure |
| BPM: beats per minute |
| CKD: chronic kidney disorder |
| D: diastolic |
| ESH-IP2: Hypertension International in European Society protocol 2010 |
| 60 minutes: eye rate |
| ISO: International Organization for Standardization |
| S: systolic |
Edited past M Eysenbach; submitted 13.05.19; peer-reviewed past E Navarro Flores, I Sanz, H Beltrán Alacreu, Southward Omboni, Due south Melville, J Bayod; comments to author 28.09.19; revised version received 08.10.xix; accustomed 27.01.xx; published 02.04.20
Copyright©Victoria Mazoteras-Pardo, Ricardo Becerro-De-Bengoa-Vallejo, Marta Elena Losa-Iglesias, Daniel López-López, César Calvo-Lobo, David Rodríguez-Sanz, Eva María Martínez-Jiménez, Patricia Palomo-López. Originally published in JMIR mHealth and uHealth (http://mhealth.jmir.org), 02.04.2020.
This is an open-access article distributed nether the terms of the Creative Eatables Attribution License (https://creativecommons.org/licenses/past/4.0/), which permits unrestricted utilize, distribution, and reproduction in any medium, provided the original work, offset published in JMIR mHealth and uHealth, is properly cited. The complete bibliographic information, a link to the original publication on http://mhealth.jmir.org/, as well as this copyright and license information must be included.
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