The aim of this study was to assess the blood pressure (BP) measurement accuracy of the Kinetik Blood Pressure Monitor—Series 1 (BPM-1) for use in home or clinical settings according to the 2002 European Society of Hypertension International Protocol (ESH-IP). Forty-two participants were recruited to fulfil the required number of systolic and diastolic BP measurements according to the ESH-IP. Nine sequential same-arm BP readings were measured and analysed for each participant using the test device and observer mercury standard readings according to the 2002 ESH-IP. Forty one participants were used to obtain 33 sets of systolic and diastolic BP readings and were included in the analysis. Mean difference between the device measurements and the observer (mercury standard) measurements was 1.1 ± 7.2/1.1 ± 6.8 mmHg (mean ± standard deviation; systolic/diastolic). The number of systolic BP differences between the test and observer measurements that fell within 5, 10 and 15 mmHg was 65, 86 and 92. For diastolic readings, the number of test—observer measurement differences within 5, 10 and 15 mmHg was 77, 91 and 94. The number of participants with at least two out of three differences within 5 mmHg was 28 for systolic and 40 for diastolic BP readings. Three participants had no differences between the test and observer measurements within 5 mmHg in both the systolic and diastolic measurement categories. The Kinetik BPM-1 device fulfilled the requirements of the ESH-IP validation procedure and can be recommended for clinical use and self-measurement within the home

Edwards, K

Gamble, W

Howarth, J

Kirkham, A

Lacy, P

Lewis, P

McDonagh, STJ

Peers, C

Schwartz, CL

Sheppard, JP

Swales, P

Williams, B

English

UCL Discovery

1  Validation of the Kinetik Blood Pressure Monitor – Series 1 for use in adults at home and in clinical 1 settings, according to the 2002 European Society of Hypertension International Protocol on the 2 validation of blood pressure devices 3  4 Schwartz CL1, Edwards K2, Gamble W2, Kirkham A2, Lacy P3, Lewis P4, McDonagh STJ5, Peers C2, 5 Sheppard JP1, Swales P2, Howarth J,6 Williams B3  6 1 Nuffield Department of Primary Care Health Sciences, NIHR School for Primary Care Research, 7 University of Oxford, Radclife Observatory Quarter, Oxford OX2 6GG, UK; 8 2 University Hospitals of Leicester, Glenfield Hospital, Leicester LE3 9QP 9 3 Institute of Cardiovascular Sciences, NIHR UCL Hospitals Biomedical Research Centre, University 10 College London, 170 Tottenham Court Road, London, W1T 7HA, UK 11 4 Stockport NHS Foundation Trust, Stepping Hill Hospital, Stockport, SK2 7JE 12 5 Primary Care Research Group, University of Exeter Medical 13 School, College of Medicine and Health, Smeall Building, St Luke’s Campus, Exeter, UK  14 6 British and Irish Hypertension Society, UK 15  16 Correspondence to: 17 Dr James Sheppard email: james.sheppard@phc.ox.ac.uk   18 2  Abstract 19 The aim of this study was to assess the blood pressure (BP) measurement accuracy of the Kinetik 20 Blood Pressure Monitor – Series 1 (BPM-1) for use in home or clinical settings according to the 2002 21 European Society of Hypertension International Protocol (ESH-IP). Forty-two participants were 22 recruited to fulfil the required number of systolic and diastolic BP measurements according to the 23 ESH-IP. Nine sequential same-arm BP readings were measured and analysed for each participant 24 using the test device and observer mercury standard readings according to the 2002 ESH-IP. The 41 25 participants were used to obtain 33 sets of systolic and diastolic BP readings and were included in 26 the analysis. Mean difference between the device measurements and the observer (mercury 27 standard) measurements was 1.1±7.2/1.1±6.8 mmHg (mean ± standard deviation; systolic/diastolic). 28 The number of systolic BP differences between the test and observer measurements that fell within 29 5, 10 and 15 mmHg was 65, 86 and 92. For diastolic readings, the number of test - observer 30 measurement differences within 5, 10 and 15 mmHg was 77, 91 and 94. The number of participants 31 with at least two out of three differences within 5 mmHg was 28 for systolic and 40 for diastolic BP 32 readings. Three participants had no differences between the test and observer measurements within 33 5 mmHg in both the systolic and diastolic measurement categories. The Kinetik BPM series 1 device 34 fulfilled the requirements of the ESH-IP validation procedure and can be recommended for clinical 35 use and self-measurement within the home. 36 Abstract word count: 247  37 3  What is known about this topic 38 • Clinical validation of blood pressure monitors is important to ensure they are accurate for 39 use at home and in routine clinical practice. 40 • The consistency of the validation process is ensured by the use of standardised protocols 41 such as that developed by the European Society of Hypertension in 2002.  42 What this study adds 43 • The present study examined the accuracy of the Kinetik BPM series 1 electronic monitor 44 using the European Society of Hypertension International protocol. 45 • In 41 subjects, the mean blood pressure difference between the device measurements and 46 the observer (mercury standard) measurements was 1.1±7.2/1.1±6.8 mmHg (mean ± 47 standard deviation; systolic/diastolic). In a total of 99 measurements, the number of systolic 48 differences that fell within 5, 10 and 15 mmHg was 65, 86 and 92. 49 The Kinetik BPM series 1 device fulfilled all of the requirements of the ESH-IP validation 50 procedure and can be recommended for clinical use and self-measurement within the home.51 4  Introduction 52 The Kinetik BPM series 1 electronic monitor is a simple, automatic, lightweight, portable monitor 53 that was developed to be an accurate and affordable method of measuring blood pressure (BP). The 54 device is intended for home use by adults and in clinical settings by health professionals. The 55 popularity of patients self-monitoring their BP is increasing,(1) particularly as self-monitoring can lead 56 to more effective BP control.(2) Due to ease of use and portability, electronic BP monitor usage has 57 also increased within general practice.(3) It is important that health professionals and patients have 58 confidence in the accuracy of the BP measurements. A monitor that has been independently 59 validated against a well-established set of criteria is a vital factor when considering, or 60 recommending, a monitor to purchase. The aim of this study was to assess the BP measurement 61 accuracy of the device in adults using the European Society of Hypertension International Protocol 62 (ESH-IP) for the validation of BP measuring devices in adults from 2002.(4) 63 Participants and Methods 64 Test Device 65 The Kinetik BPM series 1 (produced by Kinetik Medical Devices Ltd, Elstree, Herts, UK) is an 66 automated, electronic, digital, upper arm BP monitor. The device operates using the oscillometric(5) 67 method and is designed for use at home and in clinical practice. It is powered by four AAA batteries 68 or an external 6V, 600mA DC adapter (not included as standard). The device has a BP measurement 69 range of 0 to 300 mmHg and a heart rate detection range of 40 to 180 beats per minute. The 70 measuring accuracy is stated to be within ± 3 mmHg for BP and within ± 5 % for heart rate. The 71 device, which has memory capacity for 60 sets of BP readings, comes with three cuff sizes; a 72 standard cuff, supplied with the monitor (22 – 30 cm arm circumference), a large cuff (30 – 42 cm 73 arm circumference) and an extra-large cuff (42 – 48 cm arm circumference). The manufacturer 74 states that periodic re-calibration is not required if the BP monitor is used according to instructions. 75 The manufacturer provided three samples of the monitor and all three sizes of cuff to test. 76 5  Recruitment and Participant Selection 77 At least 33 participants are needed to fulfil the BP monitor validation requirements, 15 for phase 1 78 and a total of 33 for phase 2. Forty-two participant and staff volunteers were recruited from the 79 outpatient hypertension clinic at Glenfield Hospital, Leicester, UK. As specified by the ESH-IP, all 80 participants were over the age of 30 years and special groups, such as pregnant women, were not 81 included.(4)  Written, informed consent was obtained from all study participants. Twenty-one were 82 recruited for phase 1, based on inclusion of five systolic and five diastolic readings for each BP 83 category (low, medium and high), and at least five male and five female subjects across the BP 84 categories. Participants had their arm circumference recorded to ensure that the appropriate cuff 85 (standard, large or extra-large) was used according to the participant’s measurement. This was not 86 needed for the selection process as the ESH-IP assumes that there will be a representative spread 87 based on the BP selection criteria.(4) An additional 20 participants were recruited for phase 2 to 88 achieve the required 11 systolic and 11 diastolic BP readings in each BP category (low, medium and 89 high).  90 Procedure 91 The study was conducted in one of the consulting rooms in the Glenfield Hospital, Leicester, UK, by 92 an experienced supervisor and member of the British Hypertension Society (BHS) Blood Pressure 93 Measurement Working Party, and three trained observers, overseen by a principal investigator. 94 Observers were fully trained in accurate BP measurement according to the test requirements of the 95 BHS DVD specified in the ESH-IP(4) and were familiarised with the device prior to the study. 96 Participants were instructed not to eat, smoke or drink caffeinated drinks or alcohol for one hour 97 before the first BP measurement. The participant was seated comfortably for 10 minutes prior to BP 98 measurement. The participant’s arm was supported and the cuff placed at heart level whilst the BP 99 measurement was taken; talking and moving was avoided. 100 6  Reference BP 101  102 One cuff was connected to two mercury sphygmomanometers via a Y-tube connector (calibrated 103 before the study initiation) and this was used for simultaneous, reference auscultatory BP 104 measurements by two observers using the manual and then the test BP monitor cuff. The observers 105 were blinded from each other’s readings and there had to be agreement between the readings 106 within +/- 4 mmHg. The appropriate cuff was used for each participant to ensure that the bladder 107 covered at least 80 % of their arm circumference but not more than 100 %. 108  109 Test BP 110  111 Nine sequential same arm measurements were taken at 30-60 s intervals using the test monitor and 112 the standard mercury device, with separate cuffs. The appropriate cuff size was used for each 113 participant following measurement of arm circumference. Two initial BP readings were taken, one 114 with the reference standard to determine the systolic and diastolic BP category for the participant 115 (high, medium or low) and the other taken with the test device. This was followed by seven BP 116 measurements, alternating the mercury standard (BP1, BP3, BP5 and BP7) with the test device (BP2, 117 BP4 and BP6). 118 Analysis 119 The analysis was carried out as specified in the 2002 ESH-IP(4). Each test BP measurement (BP2, BP4, 120 and BP6) was paired with the mercury reference reading (BP1, BP3, BP5 and BP7) taken immediately 121 before and immediately after. The measurements with the smaller absolute difference (device - 122 mercury BP) were used for analysis (or, if the difference was equal, the first of the mercury reference 123 values was used). The BP differences were then categorised as within 5 mmHg, 10 mmHg or 15 124 mmHg. This was performed separately for systolic and diastolic BP values. The criteria for the device 125 passing the validation was based on two phases: Phase 2.1 representing the absolute number of 126 7  comparisons falling between 5, 10 and 15 mmHg for the 33 participants (99 comparisons) and Phase 127 2.2 representing the number of comparisons per participant which fell within 5 mmHg.     128  129 Results 130 Participants 131 Forty-two participants were recruited of whom 41 were needed to fulfil the required number of 132 systolic and diastolic BP readings for analysis. One recruited participant’s data was in excess of 133 requirements and therefore not included in the analysis. Participants’ characteristics are presented 134 in Table 1. Requirements in the protocol for gender, age and BP ranges were fulfilled.  135 Validation 136 As per the ESH-IP, phase 1 validation was carried out on 15 participants, 5 in each BP category.(4) The 137 Kinetik BPM series 1 device successfully passed the requirements for this phase for both systolic and 138 diastolic BP (Table 2) and, therefore, validation continued to the second phase. Standardised Bland-139 Altman plots are presented in Figures 1 and 2 and display the differences in BP between the device 140 and the observer (mercury standard) for phase 2 measurements. Paired comparisons for mean 141 device BP readings and mean observer BP readings in each BP category are shown in Table 3. 142 Overall, the device-observer difference was 1.1 ± 7.2/1.1 ± 6.8 mmHg in the phase 2 participants (n = 143 33). The validation analysis, based on classifying the differences between the BP measurements 144 from the tested device and the measurements from the mercury standard, fulfilled the requirements 145 to pass parts 2.1 and 2.2 of the phase 2 analysis (Table 4). 146 Discussion 147 The Kinetik BPM series 1 electronic monitor has been tested using the 2002 ESH-IP validation 148 protocol. The device tends to overestimate low systolic BP and underestimate high systolic BP 149 relative to measurements obtained using a mercury standard. On two occasions, the monitor failed 150 8  to give a measurement, both of which involved different subjects with systolic pressures in the 151 “high” BP category. The monitor is more accurate at determining diastolic BP.  152 The device was able to meet the minimum criteria required for passing the validation test for systolic 153 and diastolic BP (phase 2.1 and 2.2). Therefore, the device can be recommended for home and 154 clinical use. 155 The “standard” cuff size (22-30 cm) used with this monitor is smaller than specified for many 156 automated BP devices (22-32 cm) and may account for reports from some study subjects that 157 repeated measurements were uncomfortable due to the tightness of the cuff, particularly at high BP 158 levels. The discrepancy in cuff size may result in an inappropriate cuff being used for some subjects 159 by operators not fully familiar with the cuff size range specified for this device.  160  161 Acknowledgements 162 The British and Irish Hypertension Society, Blood Pressure Measurement Working Party 163  164 Conflicts of Interest 165 Funding 166 Future Legends 167 Table 1 – Characteristics of the included participants, BP – blood pressure, * In order to get the 168 required number of systolic and diastolic BP readings for the low, medium and high categories 21 169 participants were included overall. 170 Table 2 – Validation results for phase 1. Device passed therefore phase 2 validation recommended. 171 SBP – systolic blood pressure, DBP – diastolic blood pressure. 172 Table 3 – Paired comparisons between the device and mercury/observer systolic and diastolic blood 173 pressure for each blood pressure diagnostic group, BP – blood pressure. 174 Table 4 – Validation results for Phase 2. Completion of analysis produces differences between test 175 and observer measurements for all 33 participants in phase 2 (99 in total). Part 1 requires the 176 number of these comparisons that fall within 5, 10 and 15 mmHg to be determined. The comparisons 177 are then analysed per subject to determine the number that fall within 5 mmHg. The Kinetik BPM1 178 device passed both parts 1 and 2. SBP – Systolic blood pressure and DBP – Diastolic blood pressure. 179  180 9  Figure 1 – Bland-Altman plot showing the difference between the observer (mercury) systolic BP and 181 the device systolic BP against the mean value 182 Figure 2 - Bland-Altman plot showing the difference between the observer (mercury) diastolic BP and 183 the device diastolic BP against the mean value.  184 10  References 185 1. McManus RJ, Wood S, Bray EP, Glasziou P, Hayen A, Heneghan C et al. Self-monitoring in 186 hypertension: a web-based survey of primary care physicians. Journal of human hypertension. 187 2014;28(2):123-7. 188 2. Tucker KL, Sheppard JP, Stevens R, Bosworth HB, Bove A, Bray EP et al. Self-monitoring of 189 blood pressure in hypertension: A systematic review and individual patient data meta-analysis. PLoS 190 medicine. 2017;14(9):e1002389. 191 3. Medicines, Healthcare Products Regulatory A. Blood Pressure Measurement Devices 192 London: Medicines and Healthcare Products Regulatory Agency 2013 [Available from: 193 https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file194 /403448/Blood_pressure_measurement_devices.pdf. 195 4. O'Brien E, Pickering T, Asmar C, Myers M, Parati G, Staessen J et al. Working Group on Blood 196 Pressure Monitoring of the European Society of Hypertension International Protocol for validation of 197 blood pressure measuring devices in adults. Blood Press Monit. 2002;7(1):3-17. 198 5. Lewis PS, Chapman N, Chowienczyk P, Clark C, Denver E, Lacy P et al. on behalf of the British 199 and Irish Hypertension Society’s Blood Pressure Measurement Working Party Oscillometric 200 measurement of blood pressure: a simplified explanation. A technical note on behalf of the British 201 and Irish Hypertension Society. Journal of Human Hypertension volume 33, pages 349–351(2019) 202 Phase 2 participants (n= 41)Age, Mean (SD), years 53.6 (13.1) 54.0 (11.6)Range, years 30 - 80 30 -80Men, No. (%) 11 (52.4) 21 (51.2)Arm Circumference, Mean (SD), cm (N=40)28.2 (3.8) 30.6 (5.8)Range, cm 23 - 36 23 - 54Recruitment Systolic BP, Mean (SD), mmHg143.6 (29.2) 147.7 (28.4)Range, mmHg 99 - 199 99 - 199Recruitment Diastolic BP, Mean (SD), mmHg90.0 (17.4) 89.8 (16.3)Range, mmHg  58 - 122 58 - 122Participants in each recruitment  range Systolic BP Low (<130) 5 11Medium (130–160) 5 11High (>160) 5 11Diastolic BP Low (<80) 5 11Medium (80–100) 5 11High (>100) 5 11Phase 1 participants (n=21)*SBP 28 38 41DBP 40 44 44Required to pass Validation25 5 40Within 5 mmHg       Within 10 mmHgWithin 15 mmHgGroup Mercury Kinetik Difference NumberLow 113 118 5 33Medium 140.9 141.7 0.76 33High 161.1 158.6 -2.5 32Diastolic BPGroup Mercury Kinetik Difference NumberLow 71 74.1 3.1 32Medium 87.5 87.5 0 33High 110.6 110.7 0.1 32Difference - Device - Mercury mean (SD) mmHgNumberSystolic 1.1 (7.12) 33Diastolic 1.1 (6.77) 33Systolic BP Part 1Within 5 mmHg          Within 10 mmHg           Within 15 mmHgValidation ResultTwo required 65 80 95All r equired 60 75 90AchievedSBP                     65 86 92 PassDBP                     77 91 94 PassPart 2Diff’ within 5mmHg       “at least 2/3”              “none”Required ≥22 ≤3AchievedSBP                       22 3 PassDBP                      27 3 Pass

Validation of the Kinetik Blood Pressure Monitor-Series 1 for use in adults at home and in clinical settings, according to the 2002 European Society of Hypertension International Protocol on the validation of blood pressure devices

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Validation of the Kinetik Blood Pressure Monitor-Series 1 for use in adults at home and in clinical settings, according to the 2002 European Society of Hypertension International Protocol on the validation of blood pressure devices

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