European Society Of Hypertension International Protocol Research Articles

Are portable ankle brachial pressure index measurement devices suitable for hypertension screening?

In a large-scale population cardiovascular screening programme, peripheral artery disease (PAD) and hypertension would ideally be rapidly assessed using a single device. The ankle-brachial pressure index (ABPI) is calculated by comparing the ankle and brachial blood pressure (BP). However, it is currently unclear whether brachial BP measurements provided by automated PAD screening systems are sufficiently accurate for simultaneous hypertension screening. Two portable PAD screening devices, the MESI ABPI MD and Huntleigh's Dopplex ABIlity, were evaluated following the European Society of Hypertension International Protocol (ESH-IP) Revision 2010 using a mercury-free sphygmomanometer as a reference device. On average, the MESI slightly underestimated brachial systolic blood pressure (BP) with a bias and standard deviation (SD) of -3.5 (SD: 3.3) mmHg and diastolic BP with a bias of -1.5 (SD: 2.3) mmHg. For systolic BP estimates, the Dopplex was more accurate than the MESI with a lower bias of -0.5 (SD: 4.2) mmHg but less precise. The MESI successfully fulfilled all the requirements of the ESH-IP for hypertension screening. The Dopplex device failed the ESH-IP due to the absence of DBP measurements. The MESI device appears to be suitable for simultaneous PAD and hypertension screening as part of a preventative care programme. Huntleigh's Dopplex ABIlity failed to pass the ESH-IP validation test. Further clinical trials are underway to assess the use of the MESI for simultaneous screening for hypertension and PAD in a population screening setting.

Validation of Blood Pressure Devices as per 2020 World Health Organization Technical Specifications: A Scoping Review of Global Literature.

To identify and summarize the global research literature on validation of automated noninvasive blood pressure measurement devices (BPMDs) with upper arm cuff, develop a repository of validated BPMDs in compliance with the 2020 World Health Organization technical specifications, and identify challenges and gaps in evidence base on validated BPMDs. A scoping review was conducted. Primary research validating BPMDs complying with the 2020 World Health Organization technical specifications (ie, semiautomated/automated noninvasive devices with upper arm cuff), published in English between January 2000 and December 2021, was included. We searched MEDLINE, Web of Science, Scopus, EMBASE, CINAHL, CENTRAL, ProQuest and the dabl website. We included 269 studies validating 251 BPMDs across 89 manufacturers. Omron (29%), Microlife (10%), and A&D Company (8%) were the top 3 manufacturers. The 3 most frequently used validation protocols were the European Society of Hypertension-international protocol 2002 (27%), European Society of Hypertension-international protocol 2010 (25%), and modified British Hypertension Society protocol 1993 (16%), respectively. Nearly 45% of the validated BPMDs were intended for use in clinical settings, 38% were for home or self-measurement use, and 48% were for general adults. Most studies reported that BPMDs passed the validation criteria. There was inadequate reporting across studies, especially pertaining to validation settings. Most BPMDs fulfilled the validation criteria. However, there are considerable gaps in BPMD research in terms of geographical representation, including specific target populations and diseases/conditions, and a range of arm circumferences. Additionally, a potential strategy is required to accelerate the adoption of the Association for the Advancement of Medical Instrumentation (AAMI)/European Society of Hypertension/International Organization for Standardization Universal Standard (International Organization for Standardization 81060-2:2018) for BPMD validation.

S-04-3: VALIDATION OF BLOOD PRESSURE DEVICES AS PER 2020 WHO TECHNICAL SPECIFICATIONS: A SCOPING REVIEW OF GLOBAL LITERATURE

Objective: To (1) identify and summarize the global research literature on validation of automated non-invasive blood pressure measurement devices (BPMD) with upper arm cuff, (2) develop a repository of validated BPMD in compliance 2020 WHO technical specifications (3) identify challenges and gaps in evidence base on validated BPMD and develop novel strategies to address them. Design and method: A scoping review was conducted according to the Joanna Briggs Institute methodology using ‘Population, Concept, Context’ concept. Empirical studies validating BPMD complying with the 2020 WHO technical specifications (i.e. semi-automated/automated non-invasive with upper arm cuff), published in English between 2000 and 2022 were eligible for inclusion in the review. We searched MEDLINE, Web of Science, Scopus, EMBASE, CINAHL, CENTRAL, ProQuest and daBL website. We snowballed references from website reports. Title-abstract, full-text screening, and data extraction was conducted in duplicate by four reviewers (PICOPortal, MS Excel). Descriptive data analysis was performed on MS Excel and Tableau. Results: Of 11,825 identified records, we included 269 studies that fulfilled the inclusion criteria. A total of 251 BPMD from 89 manufacturers were assessed for validation methods. Omron (29%), Microlife (10%) and A&D Company (8%) were the top three BPMD manufacturers that underwent validations. China (20%), UK (13%) and USA (12%) were the top three countries where these validations were undertaken. The three most frequently used validation protocols were (Figure1): European Society of Hypertension-International protocol (ESH-IP) 2002 (27%), ESH-IP 2010 (25%) and Modified British Hypertension Society 1993 (16%). Nearly 50%, 40% and 48% of the validated BPMD were intended for use in clinical- and home/self-measurement, and for general adults, respectively. Of the 55% studies that were funded, 72% received support (finances/ BPMD) from device manufacturers. The publications did not reveal details about the following: device manufacturer (13%), country of validation (26%), settings for intended BPMD use (29%), and the target population for BPMD use (22%). Conclusions: While most (89%) of the BPMD included in the review fulfilled the validation criteria, there are considerable gaps in terms of the settings and countries of validation. In designing validation studies, research methods should focus on validating BPMD for specific target population and conditions (e.g. pregnancy or children), and take range of arm circumferences into considerations. Finally, we call for improvement in quality of reporting the validation studies to improve transparency and comparability. This could be best achieved by initiating a dialogue with all stakeholders in blood pressure research and practice.

A model for early failure prediction of blood pressure measurement devices in a stepped validation approach.

Blood pressure monitoring (BPM) devices have to be validated according to strict international validation protocols. Each protocol requests a specific number of participants to be included. All protocols use vast amounts of resources, as three people have to be present for every measurement, making trials costly, especially when the manufacturer has no intention to execute a validation study, reflected in the low share of validated in the commercially available BPM devices. The aim of our study was to develop criteria, which could detect low accuracy devices that could not pass a validation protocol early in the course of the validation process. The 2010 European Society of Hypertension International Protocol (ESH‐IP) and the Universal Standard for Validation of BPM devices (AAMI/ESH/ISO) were scrutinized for criteria which can be used for preclusion of passing. Based on this, we developed a fail model. We found that a BPM device cannot pass the ESH‐IP protocol, if there are ≥27, 13, or 4 single measurements differing more than 5, 10, or 15 mmHg, respectively, from the reference. For the AAMI/ESH/ISO protocol, we developed a model, which calculates best‐case standard deviations (SDs) to detect SDs which would prevent the passing of the protocol before its completion, making a stepwise validation process possible. In conclusion, we found that our model is able to predict failure of low‐accuracy BPM devices early during a validation protocol if used in a stepwise‐approach. This can be useful to keep costs of validation studies low and to enable investigator‐initiated trials.

VALIDATION OF THE VITA-D1 NONINVASIVE CONTINUOUS BLOOD PRESSURE MONITOR WITH PHOTOPLETHYSMOGRAPHY-ONLY TECHNOLOGY FOR SELF-MEASUREMENT AND CLINIC USE

Objective: Hypertension is still a prevalent health burden without adequate population awareness. As a diagnostic footstone and prognostic indicator, it is of great importance to precisely measure blood pressure (BP). The referenced methods to date for BP measurements are based on inflated cuff. However, stress may contribute to unanticipated BP increasements. Hence, conventional methods limit the efficiency of BP management. A promising BP measuring device with no cuff inflation is clinic practical. Yet, no robust devices with beat-to-beat photoplethysmography (PPG)-only technique have been validated. Design and method: Participants were recruited among out- and inpatients at the Department of Hypertension and Vascular Disease, from May 2019 to November 2019. Exclusive criteria mainly included age below 25 years old, pregnancy, arrythmia and poor quality Korotkoff sounds. Before initiation, an entrance BP measurement based on calibrated mercury sphygmomanometer was needed for each participant for test device calibration. The validation procedure was prospectively conducted following the European Society of Hypertension International Protocol (ESH-IP) revision 2010 in adults. Results: A total of 48 participants were screened and final 33 were enrolled (10 females, mean age 52.1 ± 11.3 years). 99 pairs of comparisons were obtained from 33 enrollees. The number of measurements within a difference range of up to 5 mmHg were 80 for systolic blood pressure (SBP) and 94 for diastolic blood pressure (DBP). All of the 99 SBP and DBP recordings were in a difference range of up to 15 mmHg. Mean observer-test device differences were −1.1 ± 4.2 mmHg for SBP and −1.3 ± 3.0 mmHg for DBP. Meanwhile, 28 and 32 enrollees had at least 2 out of 3 device-observers differences no more than 5 mmHg for SBP and DBP, respectively. Conclusions: The VITA-D1 passed the validation criteria according to the ESH-IP revision 2010 and may be recommended for clinical or self BP monitoring. Being innovative for its cuffless and user-friendly design, VITA-D1 is a promising device for reliable, convenient, and comfortable BP measurements.

Validation of the PHILIPS DL8760 upper arm blood pressure monitor, in oscillometry mode, for self-measurement in a general population, according to the European Society of Hypertension International Protocol revision 2010.

The aim of this study was to determine the accuracy of the PHILIPS DL8760, an oscillometric blood pressure (BP) measuring device designed for self-measurement in the general population according to the European Society of Hypertension International Protocol (ESH-IP) revision 2010. The PHILIPS DL8760 measures BP at the brachial level. The validation was performed in 33 subjects. The mean age of the participants was 55.8 ± 14 years. SBP 146.1 ± 26 mmHg (range: 103-193), DBP was 86.8 ± 17.0 mmHg (range: 47-123), and arm circumference was 28.3 ± 4.0 cm (range: 22-39). The PHILIPS DL8760 fulfilled the criteria of the ESH-IP by passing phases one and two for both SBP measurements and DBP measurements. The device overestimated SBP by 1.5 ± 5.0 mmHg and underestimated DBP by 0.7 ± 3.9 mmHg. The PHILIPS DL8760 BP device, with its specially designed cuff covering a broad range of arm circumferences, fulfilled the requirements of the International Protocol Revision 2010.

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.

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.

Validation of the Globalcare GCE603 automated blood pressure monitor for self-measurement according to the European Society of Hypertension International Protocol revision 2010.

To evaluate the accuracy of the automated oscillometric upper-arm blood pressure (BP) monitor Globalcare GCE603 for home BP monitoring according to the International Protocol of the European Society of Hypertension (ESH) revision 2010. BP was sequentially measured in 33 adult participants and compared with a standard mercury sphygmomanometer. A total of 99 comparison pairs were obtained and analyzed according to the ESH international protocol. For the 33 eligible participants, the device achieved 80/99, 98/99 and 99/99 measurements of absolute differences between device and observers within 5, 10 and 15 mmHg for systolic BP (SBP) and 87/99, 98/99 and 99/99 for diastolic BP (DBP), respectively. The average device-observer difference was 1.01 ± 4.11 mmHg for SBP and -0.69 ± 3.56 mmHg for DBP, respectively. The number of participants with two or three of the device-observer difference within 5 mmHg was 28 for SBP and 30 for DBP, and there was no subject with none of the device-observer difference within 5 mmHg. According to the validation results on the basis of the ESH international protocol revision 2010, the Globalcare GCE603 automated upper-arm BP monitor can be recommended for home measurement in general population.

Impact of choosing the closest rather than the mean auscultatory blood pressure value on the European Society of Hypertension International Protocol device validation results.

When calculating the difference between alternating auscultatory reference standard (ARS) and the automated device-under-test (DUT) blood pressure (BP) measurements, the European Society of Hypertension International Protocol (ESH-IP) allows investigators to choose the closest ARS value to the DUT value, rather than using the mean of the ARS readings [which is mandated by the International Organization for Standardization (ISO)]. The impact of this rule on ESH-IP validation study results is unknown and was assessed. Nine alternating BP measurements performed according to the ISO protocol were obtained in 94 subjects. The impact of using the closest rather than the mean ARS reading on mean error, SD of the difference, and proportion of readings with DUT-ARS differences within 5, 10, and 15 mmHg was determined. Mean age was 58.6 ± 18.3 years, screening BP was 126.4/77.7 mmHg, and arm circumference was 32.0 ± 4.7 cm. DUT-ARS difference was 0.0 ± 5.3/-0.5 ± 5.0 mmHg using the closest ARS and -0.2 ± 6.5/-0.7 ± 5.9 mmHg using the mean ARS. When using the closest rather than the mean ARS value, the proportion of systolic readings with absolute DUT-ARS differences ≤5 mmHg was 73% (vs. 60% for the mean ARS method), ≤10 mmHg was 93% (vs. 88%), and ≤15 mmHg was 99% (vs. 98%). Corresponding values for diastolic BP were 73% (vs. 62%) for differences ≤5 mmHg, 94% (vs. 91%) for ≤10 mmHg, and 99% (vs. 99%) for ≤15 mmHg. Using the closest rather than the mean ARS value results in more favourable validation study results and increases likelihood of passing.

Reproducibility of the European Society of Hypertension - International Protocol for validation of blood pressure measuring devices in obese patients.

Electronic devices for blood pressure (BP) measurements need to go through independent clinical validation as recommended by different authorities, both in general and special populations. Reproducibility of such validation protocols is unknown. The aim of this study was to assess the inter-centre reproducibility of the European Society of Hypertension-International protocol (ESH-IP) in patients with large arm circumference at least 32 cm or obesity. Two independent validation studies were performed in parallel according to the ESH-IP protocol in two centres (Serbia and Armenia). The two studies were performed blindly and independently. The ESH-IP criteria were applied for the analysis. The OMRON RS7 wrist oscillometric devices were used in both studies. The distribution of the mean differences values of 5 or less, 10 or less and 15 mmHg or less between the observers and the device were for the Serbia team: 74, 95 and 98 for SBP and 78, 95 and 99 for DBP; and for the Armenia team: 86, 95 and 99 for SBP and 90, 99 and 99 for DBP. The mean differences (SD) of BP values between the observers and the device were for the Serbia team of 1.7 ± 4.8 mmHg for SBP and 1.2 ± 4.6 mmHg for DBP and for the Armenia team of -1.1 ± 4.2 mmHg for SBP and -0.3 ± 3.5 mmHg for DBP. This study showed that the ESH-IP validation protocol presents a good inter-centre reproducibility. The OMRON RS7 device showed similar results, fulfilling the validation criteria in two independent studies in patients with arm circumference at least 32 cm.

The QardioArm Blood Pressure App for Self-Measurement in an Obese Population: Validation Study Using the European Society of Hypertension International Protocol Revision 2010

BackgroundObesity and high blood pressure (HBP) pose high cardiovascular risks, and they are frequent causes of cardiovascular disease.ObjectiveThe aim of this study was to validate the mobile app QardioArm for high blood pressure monitoring in obese subjects (body mass index ≥30 kg/m2) according to guidelines in the European Society of Hypertension-International Protocol 2 (ESH-IP2).MethodsWe recruited 33 obese subjects and measured their blood pressure using QardioArm (test device) and Omron M3 Intellisense (Omron Healthcare, Kyoto, Japan; standard device). We compared systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate (HR) according to the ESH-IP2.ResultsA total of 95 of 99 differences for SBP and 91 of 99 for DBP displayed absolute differences within 10 mm Hg. A total of 98 of 99 differences for SBP and 98 of 99 for DBP exhibited absolute differences within 15 mm Hg. This result satisfied requirements for part 1 of the ESH-IP2. A total of 27 out of 33 individuals for SBP and 30 out of 33 individuals for DBP had a minimum of 2 of 3 comparisons within 5 mm Hg difference. None of the subjects had 3 differences outside 5 mm Hg for SBP and DBP, satisfying part 2 of the ESH-IP2. For HR measurements, a total of 90 of 99 differences had absolute differences within 3 beats per minute (bpm), and a total of 94 or 99 differences had absolute differences within 5 bpm. A total of 98 of 99 differences had absolute differences within 8 bpm. Therefore, the test device satisfied part 1 of ESH-IP2 criteria for HR. For part 2 of ESH-IP2, 31 of 33 individuals had a minimum of 2 of 3 comparisons within 3 bpm difference for HR. Only 1 of 33 subjects had 3 differences outside 3 bpm.ConclusionsTo the best of our knowledge, this was the first study to show that an app that measures blood pressure and HR meets the requirements of the ESH-IP2 in an obese population. We believe the ESH-IP2 should publish explicit criteria for validation of blood pressure devices in specific populations.

Validation of the Beneware model ABP-021 ambulatory blood pressure monitor according to the revised 2010 European Society of hypertension international protocol.

This study aimed to evaluate the accuracy of the Beneware model ABP-021 oscillometric blood pressure monitor in the general population according to the European Society of Hypertension International Protocol (ESH-IP). The accuracy of the device was assessed in relation to various clinical variables, including age, sex, BMI, and arm circumference. Thirty-three individuals (18 men and 15 women), with a mean age of 36±14 years (age range: 20-68 years), were studied according to the recommendations of the ESH-IP. Sequential same-arm blood pressure measurements were performed, alternating between a mercury standard and the automatic device. The differences among the test-control measurements were assessed and divided into categorization zones of 5, 10, and 15 mmHg discrepancy. The device complied with the quality requirements of the ESH-IP. The device-observer disagreement was -1.2±4.7 mmHg for systolic blood pressure (SBP) and -1.7±4.3 mmHg for diastolic blood pressure (DBP). The device produced 77, 93, and 98 measurements, respectively, within the 5, 10, and 15 mmHg discrepancy limits for SBP. For DBP, 80, 97, and 99 measurements were observed within the 5, 10, and 15 mmHg discrepancy limits. The number of participants with two or three of the device-observer differences within 5 mmHg was 26 for SBP and 29 for DBP, whereas there were only two participants with no device-observer differences within 5 mmHg for DBP. These data show that the Beneware model ABP-021 monitor meets the requirements of the ESH-IP, in static conditions, indicating its suitability for measuring blood pressure in the general adult population.

Improving the accuracy of blood pressure measurement

The European Society of Hypertension (ESH) International Protocol (ESH-IP) for the validation of blood pressure (BP) measuring devices was published in 2002, with the main objective of simplifying the validation procedures, so that more BP monitors would be subjected to independent validation. This article provides an overview of the international impact of the ESH-IP and of the lessons learned from its use, to be able to justify further developments in validation protocols. A review of published (PubMed) validation studies from 2002 to 2017 was performed. One hundred and seventy-seven validation studies using the ESH-IP, 59 using the British Hypertension Society protocol, 46 using the Association for the Advancement of Medical Instrumentation (AAMI) standard and 23 using the International Organization for Standardization (ISO) standard were identified. Lists of validated office-clinic, home and ambulatory BP monitors are provided. Of the ESH-IP studies, 93% tested oscillometric devices, 80% upper arm, 71% home, 25% office and 7% ambulatory monitors (some had more than one function). The original goal of the ESH-IP has been fulfilled in that in the last decade the number of published validation studies has more than doubled. It is now recognized that the provision of accurate devices would be best served by having a universal protocol. An international initiative has been put in place by AAMI, ESH and ISO experts aiming to reach consensus for a universal validation protocol to be accepted worldwide, which will allow a more thorough evaluation of the accuracy and performance of future BP monitors.

Validation of the Pangao PG-800A36 automatic wrist blood pressure monitor according to the European Society of Hypertension and the British Hypertension Society protocols.

The aim of this study was to validate the PG-800A36 automatic wrist blood pressure monitor according to the European Society of Hypertension International Protocol (ESH-IP) revision 2010 and the British Hypertension Society (BHS) protocols. A total of 33 participants were initially included on the basis of the ESH-IP, followed by examination of 85 participants according to the BHS protocol. The procedures and analysis methods of the protocols were followed precisely with left arm/wrist sequential measurements by two trained observers using a mercury sphygmomanometer and one supervisor using the device. The device passed the ESH-IP with an average difference of 1.45±6.46 mmHg for systolic blood pressure and 1.25±5.10 mmHg for diastolic blood pressure. Furthermore, the A/A grade of the BHS protocol was achieved with an average difference of 1.84±6.94 mmHg for systolic blood pressure and 1.15±6.49 mmHg for diastolic blood pressure, and thus, the device also fulfilled the requirements of the Association for the Advancement of Medical Instrumentation. The Pangao PG-800A36 passed the requirements of the ESH-IP revision 2010 and achieved the A/A grade of the BHS protocol, which can be recommended for self-measurement in the general population.

Validation of the Pangao PG-800B26 upper arm blood pressure monitor in the general population according to the European Society of Hypertension and the British Hypertension Society protocols.

This study aimed to evaluate the accuracy of the automated oscillometric upper arm blood pressure monitor Pangao PG-800B26 for home blood pressure monitoring according to the European Society of Hypertension International Protocol (ESH-IP) revision 2010 and the British Hypertension Society (BHS) protocols. Systolic and diastolic blood pressures were measured sequentially in 33 and 85 adults, respectively, on the basis of the ESH-IP and BHS protocols using a mercury sphygmomanometer (two observers) and the device (one supervisor). The procedures and analysis methods of the protocols were followed precisely. The device fulfilled the criteria of the ESH-IP, with device-observer differences of 1.01±5.16 and -0.58±4.17 mmHg for systolic and diastolic blood pressure, respectively. Furthermore, the A/A grade of the BHS protocol was also achieved for overall grading and for the three pressure levels, with average differences of 0.85±6.35 and -0.15±5.65 mmHg for systolic and diastolic blood pressure, respectively, which also fulfilled the requirements of the Association for the Advancement of Medical Instrumentation. The Pangao PG-800B26 fulfilled the criteria of the ESH-IP 2010 and achieved the A/A grade of the BHS protocol, and hence can be recommended for home use in adults.

Validation of BP devices QardioArm® in the general population and Omron M6 Comfort® in type II diabetic patients according to the European Society of Hypertension International Protocol (ESH-IP).

BackgroundFollowing the European Society of Hypertension International Protocol (ESH-IP) Revision 2010, QardioArm® and Omron M6 Comfort IT® oscillometric devices were evaluated in the general population and in patients with type II diabetes, respectively, for self-blood pressure (BP) measurement.MethodsBoth devices, QardioArm® and Omron M6 Comfort®, measure BP at the brachial level. The ESH-IP Revision 2010 includes a total number of 33 subjects. For each measure, the difference between observer and device BP values was calculated. In all, 99 pairs of BP differences are classified into three categories (≤5, ≤10, and ≤15 mmHg). The protocol procedures were followed precisely.Results: QardioArm® and Omron M6 Comfort® fulfilled the requirements of the ESH-IP and passed the validation process successfully. For QardioArm®, a total of 69 out of 99 comparisons for systolic blood pressure (SBP) showed an absolute difference within 5 mmHg and 82 out of 99 for diastolic blood pressure (DBP). As for Omron M6 Comfort®, a total of 83 out of 99 comparisons for SBP showed an absolute difference within 5 mmHg and 77 out of 99 for DBP. The mean differences between the device and mercury readings were 0.7±5.9 mmHg for SBP and 0.3±4.1 mmHg for DBP for QardioArm® and −1.4±4.7 mmHg for SBP and −2.1±4.3 mmHg for DBP for Omron M6 Comfort®. With regard to part 2 of ESH-IP 2010, 27 out of 33 subjects had a minimum of two out of three measurements within 5 mmHg difference for SBP and 31 out of 33 subjects for DBP for the QardioArm®, and 29 out of 33 patients had a minimum of two out of three measurements within 5 mmHg difference for SBP and 26 out of 33 patients for DBP for Omron M6 Comfort®.Conclusion: QardioArm® and Omron M6 Comfort® readings differing from the mercury standard by <5, 10, and 15 mmHg fulfill the ESH-IP Revision 2010 requirements. Consequently, these two devices are suitable for use in the general population and non-insulin-dependent type II diabetic patients, respectively.

Validation of the G.LAB MD2680 digital automatic blood pressure monitor according to international protocols.

The aim of this study was to validate the G.LAB MD2680 digital automatic blood pressure (BP) monitor according to major international protocols. The device was evaluated against auscultatory sphygmomanometry according to the European Society of Hypertension International Protocol (ESH-IP) revision 2010, the British Hypertension Society (BHS), and the International Organization for Standardization (ISO) 81060-2:2013 protocols. Bland-Altman plots were completed for systolic (SBP) and diastolic blood pressures (DBP), and the mean differences and SDs between the test device and the reference device were computed for all BP values. The G.LAB MD2680 passed the ESH-IP revision 2010 on 33 participants with a mean device-observer difference of 0.89±4.97 mmHg for SBP and 0.72±4.91 mmHg for DBP, respectively. The device achieved A/A grading for the BHS protocol among 85 participants with a device-observer difference of 0.70±6.35 mmHg for SBP and 0.62±6.41 mmHg for DBP, respectively. Furthermore, it also fulfilled the two criteria of the ISO 81060-2:2013 protocol. The G.LAB MD2680 digital automatic BP monitor fulfilled the accuracy requirements of the ESH-IP revision 2010 and the ISO 81060-2:2013 protocols, and achieved A/A grade of the BHS protocol, and it can be recommended for self-measurement in adults.

Validation of the G.LAB MD2231 digital automatic wrist blood pressure monitor according to multiple protocols.

The objective of this study was to validate the G.LAB MD2231 digital automatic wrist BP monitor according to multiple protocols, which included the European Society of Hypertension International Protocol (ESH-IP) revision 2010, the British Hypertension Society (BHS), and the Association for the Advancement of Medical Instrumentation (AAMI)/the International Organization for Standardization (ISO) protocols. A total of 33 participants were initially included for validation on the basis of the ESH-IP revision 2010, and then the device was further assessed on 85 participants according to the BHS and AAMI/ISO protocols. The validation procedures of the protocols were followed precisely. The G.LAB MD2231 achieved the requirements of the ESH-IP revision 2010 with mean differences of 1.99±5.13 and -0.85±4.83 mmHg for systolic and diastolic BP, respectively. Furthermore, the A/A grade was obtained according to the BHS protocol with mean differences of 2.19±6.89 and -1.03±6.56 mmHg for systolic and diastolic BP, respectively, and the two criteria of the AAMI/ISO were also fulfilled. The G.LAB MD2231 digital automatic wrist BP monitor fulfilled the ESH-IP revision 2010, the BHS, and the AAMI/ISO protocols, which can be recommended for BP measurement in the general population.

An inaccurate automated device negatively impacts the diagnosis and treatment of gestational hypertension.

Automated blood pressure devices are frequently introduced in maternity care without prior validation for their accuracy in pregnancy. Our objectives were to, firstly, establish the accuracy in pregnancy of a locally used device (Welch Allyn 300) and, secondly, to audit its impact on the diagnosis and treatment of hypertension. Validation study: The device was evaluated using the grading criteria of the European Society of Hypertension International Protocol (ESH-IP) (2010). Two observers took nine same-arm measurements alternating between the Welch Allyn and the mercury sphygmomanometer. Thirty-three women of any gestation were included. Clinical audit: One observer took three same-arm measurements alternating between the Welch Allyn and the mercury sphygmomanometer. One hundred women of any gestation referred with suspected hypertension were included. The main outcome measures were the proportion diagnosed with hypertension or commenced on anti-hypertensive treatment on the presenting visit when using either the manual or the automated device. Grading criteria of the ESH-IP (2010) and proportion of women diagnosed with hypertension or commenced on antihypertensive therapy at the presenting visit when using either manual sphygmomanometry or the Welch Allyn device. The Welch Allyn 300 series failed to meet the criteria of the ESH-IP (2010) for pregnancy. Compared to the mercury device, it under diagnosed hypertension by 48% and need for treatment by 80%. The Welch Allyn 300 cannot be recommended for the measurement of blood pressure in pregnancy. Its use leads to the under-diagnosis and under-treatment of gestational hypertension.

PP.01.08] EUROPEAN SOCIETY OF HYPERTENSION INTERNATIONAL PROTOCOL 2010 FOR THE VALIDATION OF BLOOD PRESSURE MONITORS

Objective: The reliability of blood pressure (BP) monitors is a prerequisite for the accurate evaluation of hypertension. Validation protocols have been developed to evaluate the accuracy of BP monitors, and the European Society of Hypertension International Protocol (ESH-IP) is the most widely used worldwide. A review of published validation studies using the revised ESH-IP 2010 (ESH-IP2) was performed, to identify possible violations, divergences and adaptations. Design and method: Published validation studies that used the ESH-IP2 from its publication (2010) until the end of 2015 were identified. All aspects of the protocol procedure were scrutinized using a standard checklist. Results: 147 validation studies were identified: 92 (63%) used the ESH-IP, 22 (15%) the British Hypertension Society Protocol, 26 (18%) the US AAMI and/or ISO protocol, and 18 (12%) did not follow an established protocol (some studies used two protocols). Of the 92 ESH-IP studies 54 (59%) used the ESH-IP2. The number of ESH-IP2 studies published per year were 7/3/9/16/19 for years 2011/12/13/14/15 respectively. 52 studies reported a ‘pass’ result (96.3%). 93% of the studies tested oscillometric devices, 78% upper-arm devices, 20% clinic, 6% ambulatory and 89% home monitors (some for more than one function). Four studies (7%) included special populations (children, renal disease patients, intensive care unit patients). The ESH-IP2 was adapted for specific device type or population in 5 studies. Protocol violations were identified in 17 studies (some two or more violations), involving sample size, recruitment criteria, simultaneous measurements, or combined use of ESH-IP1 and ESH-IP2 criteria. Most frequent violations were diastolic BP distribution range (19% of studies), BP recruitment range (15%), participants’ age (6%). One study with ESH-IP2 criteria indicating ‘fail’ concluded ‘pass’. Detailed information on cuffs use, and on recruitment and distribution BP ranges was omitted in 29 studies (54%). Conclusions: Five years after its publication, the revised ESH-IP2 remains the preferred protocol for device validation. Protocol violations occur in one third of the studies, suggesting that a more strict standardization of the validation procedure and reporting is necessary. The peer review process of scientific journals often misses important deficiencies of validation studies.