Search

BACKGROUND The purpose of this document is to provide clinicians with guidance, using expert consensus, to help summarize evidence and offer practical recommendations. METHODS Expert Consensus Documents are intended to provide guidance for clinicians in areas in which there are no clinical practice guidelines, especially for new and evolving tests such as arterial stiffness measurements, until any formal guidelines are released. RESULTS This expert consensus document is intended as a source of information for decision-making and to guide clinician–patient discussions in various clinical scenarios. CONCLUSIONS The goal is to help clinicians and patients make a more informed decision together.

OBJECTIVE The objective of this study was to compare the systolic (S) and diastolic (D) blood pressure (BP) estimations from a new optical device at the wrist with invasive measurements performed on patients scheduled for radial arterial catheterization in the ICU. Optical signals were automatically processed by a library of algorithms from Aktiia SA (OBPM - optical blood pressure monitoring algorithms). METHODS A total of 31 participants from both sexes, aged 32-87 years, were enrolled in the study (NCT03837769). The measurement protocol consisted of the simultaneous recording of reflective photoplethysmographic signals (PPG) from the cuffless optical device and the reference BP values recorded by a contralateral radial arterial catheter. From the 31 participants, 23 subjects whose reference data quality requirements were adequate were retained for further analysis. The PPG signals from these patients were then automatically processed by the Aktiia OBPM library of algorithms, which generated uncalibrated estimates of SBP and DBP. After the automatic assessment of optical signal quality, 326 pairs of uncalibrated SBP and DBP determinations from 16 patients were available for analysis. These values were finally transformed into calibrated estimations (in mmHg) using arterial catheter SBP and DBP values, respectively. RESULTS For SBP, a mean difference (±SD) of 0.0 ± 7.1 mmHg between the arterial catheter and the optical device values was found, with 95% limits of agreement in the Bland-Altman method of -11.9 to + 12.2 mmHg (correlation of r = 0.87, P < 0.001). For DBP, a mean difference (±SD) of 0.0 ± 2.9 mmHg between arterial catheter and the optical device values was found, with 95% limits of agreement in the Bland-Altman method of -4.8 to + 5.5 mmHg (correlation of r = 0.98, P < 0.001). CONCLUSION SBP and DBP values obtained by radial artery catheterization and those obtained from optical measurements at the wrist were compared. The new optical technique appears to be capable of replacing more traditional methods of BP estimation.

Objectives Assess the accuracy of the Midmark IQvitals Zone Vital Signs Monitor STEP deflation algorithm according to the ANSI/AAMI/ISO 81060-2 Standard. Methods A total of 85 subjects completed the testing protocol. All standard requirements for gender, blood pressure (BP) values, and arm circumferences were met. Manual auscultation was performed by testers blinded to the device; the manual BP values were compared to the device readings. Results The Standard Criterion 1 data analyses showed mean ± SD device minus manual BP values of 1.22 ± 6.3 mmHg for SBP and -1.67 ± 6.09 mmHg for DBP. The SD values for criterion 2 were 5.06 mmHg (SBP) and 4.98 mmHg (DBP). Conclusions The device passed all Standard requirements. The Midmark IQvitals Zone device has features to improve accuracy and reduce or eliminate transcription errors and inaccuracy from improper patient positioning.

The diagnosis and management of hypertension usually requires the estimation of blood pressure (BP) by means of an inflatable cuff. This procedure generates discomfort and limits patient compliance. Cuffless devices capture BP readings without performing any arterial occlusion. We believe that comfortable and cuffless BP monitoring devices can significantly aid in the fight against hypertension and support the expansion of ambulatory and remote patient monitoring programs, provided that these devices provide reliable BP readings. The purpose of this study was to compare the systolic (S) and diastolic (D) blood pressure (BP) estimations from a new optical device at the wrist (figure) against invasive measurements performed on patients scheduled for radial arterial catheterization. The first results from this study were recently published and demonstrated good agreement for the overall study population. Here we report expanded statistical analyses for different population subgroups such as gender, age, body mass index (BMI) and skin color. The study protocol consisted of the simultaneous recording of reflective photo-plethysmographic signals (PPG) from the optical device, and BP values recorded by a contralateral radial arterial catheter. The PPG signals were processed to generate estimates of SBP and DBP. Agreement of paired BP estimations was further calculated in terms of standard deviation (SD) of differences. The mean of differences were systematically zero because BP estimations from the optical device were calibrated for each patient. The table shows that, for the overall population, both SBP and DBP differences SDs were smaller than 8 mmHg (as already published). Furthermore, across different population groups, both genders, all BMIs and all skin colors also resulted in SDs smaller than 8 mmHg. Only patients whose age was above 65 years were associated with a higher SD. For the overall population and most subgroups the new optical technique appears to be capable of replacing more traditional methods of BP estimation. Only the SBP differences for the subgroup of older patients were larger. Additional studies are needed to confirm and expand these very encouraging results. Table 1. SD of measured BP differences Population N SD of SBP differences SD of DBP differences (mmHg) (mmHg) All 16 7.1 2.9 Gender Male 10 6.4 2.8 Female 6 8.0 3.1 Age (years) 65 9 *9.3 3.4 BMI (kg/m2) 26 6 5.7 2.8 Skin Color (Fitzpatrick) 2 13 7.7 3.0 3 3 4.5 2.6 *Only subgroup with a SD larger than 8mmHg. Figure 1. The investigational device Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Aktiia SA

The US and European guidelines for the diagnosis and management of hypertension recommend the introduction of systematic home and night Blood Pressure (BP) monitoring. Fully-automated wearable devices can address the needs of patients and clinicians by improving comfort while achieving measurement accuracy. Often located at the wrist and based on indirect BP measurements, these devices must address the challenges of ambulatory scenarios. New validation strategies are needed, but little guidance has been published so far.In this work, we propose an experimental protocol for the validation of cuffless wrist BP monitors that addresses ambulatory environment challenges in a controlled experimental setting. The protocol assesses the robustness of the measurement for different body postures, the ability of the device to track BP changes, and its ability to deal with hydrostatic pressure changes induced by different arm heights.Performance testing using Aktiia Bracelet is provided as an illustration. The results of this pilot study indicate that the Aktiia Bracelet can generate accurate BP estimates for sitting and lying positions and is not affected by hydrostatic pressure perturbations.Clinical Relevance— Automated cuffless BP monitoring is opening a new chapter in the way patients are being diagnosed and managed. This paper provides a guidance on how to assess the clinical utility of such devices when used in different body positions.

Most automated sphygmomanometers use oscillometric algorithms. Motion, either patient-based or environmental, will affect the ability of a device to record an accurate blood pressure (BP). Members of the Association for the Advancement of Medical Instrumentation (AAMI) Sphygmomanometer Committee have been studying this problem for more than a decade. The AAMI TIR44 was the first publication to address the challenges of motion tolerance. The concepts described in TIR44 have led to the development of a draft of ISO 81060-4, a new standard for testing devices for which the manufacturer wishes to claim motion tolerance. The current ISO 81060-2 addresses both stress testing and 24-hour ambulatory BP monitoring. Recent publications have reported on testing of devices in response to voluntary and involuntary patient motion. The ISO 81060-4 will address testing in the presence of patient transport by ground, fixed-wing, and rotary (helicopter) ambulances. The protocol will utilize noise profiles recorded under those three conditions. The profiles will be digitally stored on a library with free access. The proposed testing will be performed using patient simulators introducing the noise library files into known BP oscillometric envelopes. The specifications of the data capture and playback devices are specified, as is the evaluation statistical testing. The authors expect that the final draft will be published in 2020.

Digital, The Lancet Commission on Hypertension identified that a key action to address the worldwide burden of high blood pressure (BP) was to improve the quality of BP measurements by using BP devices that have been validated for accuracy. Currently, there are over 3 000 commercially available BP devices, but many do not have published data on accuracy testing according to established scientific standards. This problem is enabled through weak or absent regulations that allow clearance of devices for commercial use without formal validation. In addition, new BP technologies have emerged (e.g. cuffless sensors) for which there is no scientific consensus regarding BP measurement accuracy standards. Altogether, these issues contribute to the widespread availability of clinic and home BP devices with limited or uncertain accuracy, leading to inappropriate hypertension diagnosis, management and drug treatment on a global scale. The most significant problems relating to the accuracy of BP devices can be resolved by the regulatory requirement for mandatory independent validation of BP devices according to the universally-accepted International Organization for Standardization Standard. This is a primary recommendation for which there is an urgent international need. Other key recommendations are development of validation standards specifically for new BP technologies and online lists of accurate devices that are accessible to consumers and health professionals. Recommendations are aligned with WHO policies on medical devices and universal healthcare. Adherence to recommendations would increase the global availability of accurate BP devices and result in better diagnosis and treatment of hypertension, thus decreasing the worldwide burden from high BP., La Comisión Lancet de Hipertensión determinó que una medida clave para responder a la carga mundial que representa la hipertensión arterial era mejorar la calidad de las mediciones de la presión arterial, mediante la utilización de dispositivos cuya exactitud haya sido validada. En la actualidad existen 3000 dispositivos comercializados, pero muchos no tienen datos publicados sobre pruebas de exactitud conformes a las normas científicas establecidas. La falta de regulación o su ineficiencia, que permiten la autorización de dispositivos para uso comercial sin una validación oficial, posibilitan este problema. Además, han surgido tecnologías nuevas de medición de la presión arterial (por ejemplo, los sensores sin brazalete) sobre las cuales no existe unanimidad en la comunidad científica con respecto a las normas de exactitud de la medición. En conjunto, estos aspectos contribuyen a la disponibilidad generalizada de tensiómetros de consultorio o domiciliarios que ofrecen una exactitud limitada o incierta, que llevan a diagnósticos, manejo y farmacoterapia inapropiados de la hipertensión a escala mundial. Los problemas más importantes relacionados con la exactitud de los dispositivos de medición de la presión arterial se pueden resolver mediante el requisito regulatorio de una validación independiente obligatoria de los dispositivos, en consonancia con la norma ISO universalmente aceptada. Esta es una recomendación básica y constituye una necesidad internacional acuciante. Otras recomendaciones clave son la elaboración de normas de validación específicas para las tecnologías nuevas de medición de la presión arterial y la publicación en línea de listas de los dispositivos nuevos exactos que están a la disposición de los usuarios y los profesionales de salud. Las recomendaciones están en consonancia con las políticas de la Organización Mundial de la Salud sobre los dispositivos médicos y la atención universal de la salud. El cumplimiento de las recomendaciones aumentará la disponibilidad mundial de dispositivos de medición de la presión arterial que sean exactos y tendrá como efecto un mejor diagnóstico y tratamiento, reduciendo así la carga mundial de la hipertensión., A Comissão Lancet sobre Hipertensão Arterial identificou que uma iniciativa central para enfrentar a carga mundial da hipertensão arterial seria a melhoria na qualidade da mensuração da pressão arterial pelo uso aparelhos de pressão arterial validados quanto à acurácia. Atualmente, existem mais de 3 000 aparelhos de pressão arterial disponíveis comercialmente; entretanto, muitos não têm dados publicados sobre testes de acurácia realizados de acordo com padrões científicos estabelecidos. Este problema resulta de regulamentação fraca ou inexistente, o que permite a aprovação para uso comercial de dispositivos sem validação formal. Além disso, surgiram novas tecnologias de mensuração da pressão arterial (por exemplo, sensores sem algemas) sem consenso científico quanto aos padrões de acurácia. No conjunto, essas questões contribuem para a oferta generalizada de dispositivos de pressão arterial clínica e domiciliar com acurácia limitada ou incerta, levando a diagnóstico, gerenciamento e tratamento inadequados da hipertensão em escala global. Os problemas mais significativos relacionados com a acurácia dos dispositivos de pressão arterial podem ser resolvidos por regulamentação que imponha a obrigatoriedade de validação independente dos aparelhos de pressão arterial, de acordo com a norma universalmente aceita pela Organização Internacional de Normalização. Esta é uma recomendação fundamental para a qual existe uma necessidade internacional urgente. Outras recomendações essenciais incluem o desenvolvimento de padrões de validação especificamente para novas tecnologias de mensuração da pressão arterial e listas on-line de aparelhos com acurácia adequada que sejam acessíveis aos consumidores e profissionais de saúde. As recomendações estão alinhadas com as políticas da Organização Mundial da Saúde (OMS) sobre dispositivos médicos e atenção universal à saúde. A adesão às recomendações aumentaria a oferta global de dispositivos de pressão arterial com acurácia adequada e resultaria em melhor diagnóstico e tratamento da hipertensão arterial, diminuindo assim a carga mundial dessa doença., Traducción oficial al español del artículo original en inglés efectuada por la Organización Panamericana de la Salud. En caso de discrepancia, prevalecerá la versión original en inglés. Wolters Kluwer Health, Inc. y sus sociedades no se hacen responsables de la exactitud de la traducción del original inglés ni de los eventuales errores que esta pueda contener. Cita del artículo original: Sharman JE, O'Brien E, Alpert B, Schutte AE, Delles C, Hecht Olsen M et al. Lancet commission on hypertension group position statement on the global improvement of accuracy standards for devices that measure blood pressure. J Hypertens. 2020:38:21-29.doi: https://doi. org/10.1097/HJH.0000000000002246, Ciencias Médicas y de la Salud

Blood pressure (BP) measurement, a technique first described over a century ago, is an essential component of clinical care and critical for the detection and management of hypertension.1 Accordingly, the ramifications of inaccurate BP measurement, which is a per‐ sistent and pervasive problem worldwide, are profound.2 Assuming a global prevalence of hypertension of 1.4 billion,3 a 5‐mmHg error in BP measurement has been estimated to result in the incorrect classification of hypertension status in at least 84 million individ‐ uals worldwide.4 In addition, incorrect classification has important ramifications for individual patients, whether it leads to misdiagno‐ sis and inappropriate prescribing of antihypertensive drugs, or to lack of recognition of an clinical condition that can cause devastat‐ ing cardiovascular consequences. The continued rise in the global prevalence of hypertension has made work related to optimizing BP measurement even more critical, and notwithstanding similar initia‐ tives that have been conducted or are ongoing, additional efforts to improve BP measurement on a global scale are clearly needed.5

Blood pressure (BP) is a vital sign and the essential measurement for the diagnosis of hypertension. Therefore, its accurate measurement is a key element for the evaluation of many medical conditions and for the reliable diagnosis and efficient treatment of hypertension. In the last 3 decades prestigious organizations, such as the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH) Working Group on BP Monitoring, and the International Organization for Standardization (ISO), have developed protocols for clinical validation of BP measuring devices. All these initiatives aim to standardize validation procedures and establish minimum accuracy standards for BP monitors. Unfortunately, only a few of the BP measuring devices available on the market have been subjected to independent validation using one of these protocols. Recently, the AAMI, ESH, and ISO experts agreed to develop a single universally acceptable standard (AAMI/ESH/ISO), which will replace all previous protocols. This major international initiative has been undertaken to best serve the needs of patients with hypertension, a public interested in cardiovascular health, practicing physicians, scientific researchers, regulatory bodies, and manufacturers. There is an urgent need to influence regulatory authorities throughout the world to make it mandatory for all BP measuring devices to have undergone independent validation before approval for marketing. Efforts need to be intensified to improve the accuracy of BP measuring devices, further optimize the validation procedure, and ensure that objective and unbiased validation data become available.

Hypertension is now recognized as a major global cause of morbidity and death. All decisions relating to the epidemiology, diagnosis, and management of hypertension are dependent on being able to measure blood pressure accurately. Scientists have developed protocols to assess the accuracy of blood pressure–measuring devices, but little attention has been given to informing users which devices are accurate and inaccurate. This article identifies a recipient audience of researchers, clinicians, and scientists, the public, healthcare executives and administrators, and consumer and regulatory bodies, and discusses how best to communicate the results of device accuracy to these groups with the aim of improving the accurate measurement of blood pressure.

The aim of this report is to describe a new device that can validate, by automated auscultation, individual blood pressure (BP) readings taken by automated sphygmomanometers.The Accutension Stetho utilizes a smartphone application in conjunction with a specially designed stethoscope that interfaces directly into the smartphone via the earphone jack. The Korotkoff sounds are recorded by the application and are analyzed by the operator on the screen of the smartphone simultaneously with the images from the sphygmomanometer screen during BP estimation. Current auscultatory validation standards require at least 85 subjects and strict statistical criteria for passage. A device that passes can make no guarantee of accuracy on individual patients. The Accutension Stetho is an inexpensive smartphone/stethoscope kit combination that estimates precise BP values by auscultation to confirm the accuracy of an automated sphygmomanometer’s readings on individual patients. This should be of great value for both professional and, in certain circumstances, self-measurement BP. Patients will avoid both unnecessary treatment and errors of underestimation of BP, in which the patient requires therapy. The Stetho’s software has been validated in an independent ANSI/AAMI/ISO standard study. The Stetho has been shown to perform without difficulty in multiple deflation-based devices by many manufacturers.

The accurate measurement of blood pressure in pregnancy is essential to guide medical decision making that affects both mother and fetus. The aim of this systematic review was to determine the accuracy of ambulatory, home, and clinic blood pressure measurement devices in pregnant women. We searched Ovid MEDLINE, The Cochrane Library, EMBASE, CINAHL EBSCO, Clinicaltrials.gov, International Clinical Trials Registry Platform, and dabl from inception through August 3, 2017 for articles that assessed the validity of an upper arm blood pressure measurement device against a mercury sphygmomanometer in pregnant women. Two independent investigators determined eligibility, extracted data, and adjudicated protocol violations. From 1,798 potential articles identified, 41, that assessed 28 devices, met the inclusion criteria. Most articles (N= 32) followed a standard or modified American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization, British Hypertension Society, or European Society of Hypertension validation protocol. Several articles described the results of validation studies performed on more than one device (N=7) and/or in more than one population of pregnant women (N=12), comprising 64 pairwise validity assessments. The device was validated in 61% (32 of 52) of studies which used a standard or modified protocol. Only 34% (11 of 32) of the studies wherein the device was successfully validated were performed without a protocol violation. Given the implications of inaccurate blood pressure measurement in pregnant women, healthcare providers should be aware of and try to use the blood pressure measurement devices which have been properly validated in this population.

Background Current blood pressure (BP) measurement guidelines specify patient requirements, including being still. Some populations of patients cannot comply. A new International Organization for Standards is being developed to test devices that claim tolerance to transport-induced motion artifacts. This study proposes the first protocol to assess BP device accuracy in the presence of patient-induced motion. Participants and methods Forty healthy volunteers (23 males) participated. The device tested was the Welch Allyn Connex Spot Monitor (CSM) using the SureBP algorithm. A reusable cuff was placed on the left arm. During inflation/deflation cycles the participant performed pronation/supination movements of the left forearm every 5 s. The CSM readings during motion were compared to the average of manual resting auscultatory estimations immediately before and after each motion cycle (bracketing). Results The CSM recorded a BP reading on the first cycle in 37 participants. It displayed a reading in all 40 participants with one repeat cycle in the other three. The mean±SD for the device minus the manual BP values was 0.9±7.3 mmHg for systolic BP and −3.4±7.9 mmHg for diastolic BP. Conclusion This study represents a proposal for an automated BP device assessment in the presence of patient-induced motion. The CSM device, which uses an inflation-based algorithm, routinely produced BP values that closely matched auscultatory values bracketed immediately before and after the motion-associated cycle. The CSM should be of significant clinical value in populations in whom resting ‘still’ readings are not usually feasible, such as pediatric and geriatric patients, and patients in pain from injury or illness.

Blood pressure (BP) measurement is the most common procedure performed in clinical practice. Accurate BP measurement is critical if patient care is to be delivered with the highest quality, as stressed in published guidelines. Physician training in BP measurement is often limited to a brief demonstration during medical school without retraining in residency, fellowship, or clinical practice to maintain skills. One hundred fifty-nine students from medical schools in 37 states attending the American Medical Association's House of Delegates Meeting in June 2015 were assessed on an 11-element skillset on BP measurement. Only one student demonstrated proficiency on all 11 skills. The mean number of elements performed properly was 4.1. The findings suggest that changes in medical school curriculum emphasizing BP measurement are needed for medical students to become, and remain, proficient in BP measurement. Measuring BP correctly should be taught and reinforced throughout medical school, residency, and the entire career of clinicians.

The OMRON HEM-907XL is a commercial oscillometric blood pressure (BP) monitor that was used in the Systolic Blood Pressure Intervention Trial (SPRINT), in which 28% of participants had chronic kidney disease (CKD). This study examined the accuracy of the monitor in nondialytic patients with CKD. Eighty-seven patients met inclusion criteria. The authors used a modified Association for the Advancement of Medical Instrumentation (AAMI) protocol, with one observer recording measurements from the monitor and two blinded physicians obtaining simultaneous aneroid values by auscultation. Using AAMI method 1, there was a 2.5±9.5 mm Hg difference in OMRON and aneroid systolic BP, and a -1.6±6.5 mm Hg difference in diastolic BP. Using AAMI method 2, there was a 5.1±7.4 mm Hg difference in systolic BP and a -0.2±5.4 mm Hg difference in diastolic BP. In patients with CKD, the OMRON HEM-907XL appears to be accurate for measuring diastolic BP, but did not perform as well for systolic BP.

The Lancet Commission on Hypertension identified that a key action to address the worldwide burden of high blood pressure (BP) was to improve the quality of BP measurements by using BP devices that have been validated for accuracy. Currently, there are over 3 000 commercially available BP devices, but many do not have published data on accuracy testing according to established scientific standards. This problem is enabled through weak or absent regulations that allow clearance of devices for commercial use without formal validation. In addition, new BP technologies have emerged (e.g. cuffless sensors) for which there is no scientific consensus regarding BP measurement accuracy standards. Altogether, these issues contribute to the widespread availability of clinic and home BP devices with limited or uncertain accuracy, leading to inappropriate hypertension diagnosis, management and drug treatment on a global scale. The most significant problems relating to the accuracy of BP devices can be resolved by the regulatory requirement for mandatory independent validation of BP devices according to the universally-accepted International Organization for Standardization Standard. This is a primary recommendation for which there is an urgent international need. Other key recommendations are development of validation standards specifically for new BP technologies and online lists of accurate devices that are accessible to consumers and health professionals. Recommendations are aligned with WHO policies on medical devices and universal healthcare. Adherence to recommendations would increase the global availability of accurate BP devices and result in better diagnosis and treatment of hypertension, thus decreasing the worldwide burden from high BP.

ObjectiveThe aims of this ANSI/AAMI/ISO validation study were to assess the accuracy of the Omron HEM-9210T, developed to utilize a small cuff, a wide-range cuff, and an extra-large cuff in the adult population. If accurate, the wide-range and extra-large cuffs will be of clinical significance in bo

Objective The Welch Allyn Pro BP 2000, an automated sphygmomanometer, was subjected to ANSI/AAMI/ISO testing. Patients and methods The protocol used was the same-arm sequential procedure described in the ANSI/AAMI/ISO 2013 Standard. Eight-eight (53 adults and 35 children aged 3-12 years old) patients completed testing successfully. Arm circumferences ranged from 15 to 49.5 cm. Seven different cuff sizes were used, including two long cuffs. Results All requirements for age, sex, blood pressure (BP), and cuff sizes were fulfilled. The mean±SD was -2.8±6.37 mmHg for systolic BP for criterion 1 and -3.6±6.14 mmHg for diastolic BP. The SD for criterion 2 were 5.29 for systolic BP and 5.75 for diastolic BP. All data passed the Standard's requirements. Conclusion The Pro BP 2000 uses an accurate inflationary algorithm. The time for each inflation/deflation cycle is short, thus improving patient comfort. There is also arrhythmia detection to caution the use of BP values obtained during irregular heart rhythms. The algorithm for the professional-grade Pro BP 2000 is also contained in the Home BP 1700, targeted for home use. This encourages out-of-office self-measurement. The healthcare professional can be confident that the values obtained at different sites are comparable.

Copyright © 2018 Wolters Kluwer Health, Inc., and American Heart Association, Inc. This article has been copublished in Hypertension. In the last 30 years, several organizations, such as the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH) Working Group on Blood Pressure (BP) Monitoring and the International Organization for Standardization (ISO) have developed protocols for clinical validation of BP measuring devices. However, it is recognized that science, as well as patients, consumers and manufacturers would be best served if all BP measuring devices were assessed for accuracy according to an agreed single validation protocol that had global acceptance. Therefore, an international initiative was taken by AAMI, ESH and ISO experts who agreed to develop a universal standard for device validation. This statement presents the key aspects of a validation procedure, which were agreed by the AAMI, ESH and ISO representatives as the basis for a single universal validation protocol. As soon as the AAMI/ESH/ISO standard is fully developed, this will be regarded as the single universal standard and will replace all other previous standards/protocols.

Oscillometric devices for the non-invasive estimation of blood pressure (BP) have become the "clinical standard" because of training requirements for determination of BP by auscultation, cost, and the phasing-out/banning of mercury in many states and countries. Analysis of recent publications reveals a lack of understanding of the "meaning" of oscillometric blood pressure (OBP) measurements by authors, journal editors, and clinicians. We were invited to submit a review of OBP methodology written for clinicians. We hope that the material contained herein will clarify how clinicians should interpret OBP values for their patients.

From the Departments of Medicine, Physiology and Pharmacology and Community Health Sciences, O’Brien Institute for Public Health and Libin Cardiovascular Institute of Alberta, University of Calgary,Calgary, AB; Department of Family Practice, University of British Columbia, Vancouver, BC, Canada; Hypertension Center STRIDE-7, Sotiria Hospital, Third University Department of Medicine, Athens, Greece; AAMI Sphygmomanometer Committee, Pediatric Exercise Science, Memphis, TN, USA; Division of Cardiology, Sunnybrook Health Sciences Centre, Toronto, ON, Canada; Improving Health Outcomes at American Medical Association; Department of Family and Community Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA; Clinical Pharmacology and General Internal Medicine, University of Alberta, Edmonton, AB, Canada; MRC Research Unit on Hypertension and Cardiovascular Disease, Hypertension in Africa Research Team, North-West University, Potchefstroom, South Africa; Molecular Pharmacology, University College Dublin, Dublin, Ireland; Corvallis, Montana, USA; and University of Glasgow, Glasgow, UK

Recommended standards for assessing blood pressure in human research where blood pressure or hypertension is a major focus

It is important to note the opportunity that validated public-use kiosks offer the U.S. healthcare system in terms of ease of public access, reduced cost of screening/monitoring, and the opportunity to support coordinated care between physicians, pharmacists, and patients. It is equally important to recognize that all public-use BP kiosks are not equivalent. Members of the AAMI Sphygmomanometer Committee and other ‘‘concerned citizens’’ are working with FDA officials to try to improve both device validation and cuff range performance of these devices. In reality, regulatory changes will be slow to take effect, and for the foreseeable future, the burden of device accuracy assessment lies with the private sector and the public. There is a device currently available that has undergone full validation testing and offers a wide-range cuff validated for almost all US adult arms. We recognize the importance of innovation in out-of-office BP measurement. Therefore, in the interest of public health, we strongly urge those business professionals buying such devices, and those health professionals advising patients on their use, to become better informed and more discriminant in their device selection.

The current ISO Standard is accepted as the National Standard in almost every industrialized nation. An overview of the most recently adopted standards is provided. Standards writing groups including the Advancement of Medical Instrumentation Sphygmomanometer Committee and ISO JWG7 are working to expand standardized evaluation methods to include the evaluation of devices intended for use in environments where motion artifact is common. An Association for the Advancement of Medical Instrumentation task group on noninvasive blood pressure measurement in the presence of motion artifact has published a technical information report containing research and standardized methods for the evaluation of blood pressure device performance in the presence of motion artifact.

A Forum For Our Readers Sportsmedicine Forum is intended to provide a sounding board for our readers. Perhaps you have a special way to treat a common medical problem, or you may want to air your views on a controversial topic. You may object to an article that we have published, or you may want to support one. You may have a new trend to report, Identified through an interesting case or a series of patients. Whatever your ideas, we invite you to send them to us. Illustrative figures are welcomed. Address correspondence to Sportsmediclne Forum, The Physician And Sportsmedicine, 4530 W 77th St, Minneapolis 55435.

Little information exists regarding pediatric contrast-enhanced US. To assess the safety and feasibility of contrast-enhanced US of pediatric abdominal and pelvic tumors. This prospective study included eight boys and five girls (mean age, 10.8 years) with abdominal or pelvic tumors. Cohorts of three subjects underwent US with perflutren contrast agent at escalating dose levels. Neurological and funduscopic examination, electrocardiography and continuous pulse oximetry were performed before and after contrast administration. Three radiologists independently scored six imaging parameters on pre- and postcontrast sonography. Inter-reviewer agreement was measured by the Kappa statistic. No neurological, retinal, electrocardiographical or pulse oximetry changes were attributable to the contrast agent. Two subjects reported minor, transient symptoms. Postcontrast US parameter scores improved slightly in 8 of 12 subjects. Postcontrast ultrasound inter-reviewer agreement improved slightly for detection of tumor margins (precontrast = 0.20, postcontrast = 0.26), local tumor invasion (precontrast = -0.01, postcontrast = 0.10) and adenopathy (precontrast = 0.35, postcontrast = 0.44). Although our sample size is small, perflutren contrast agents appear to be safe and well tolerated in children. Contrast-enhanced sonography of pediatric abdominal and pelvic tumors is feasible, but larger studies are needed to define their safety and efficacy in children.

Cardiovascular reactivity to stress and beta-adrenergic receptor (beta-AR) function may contribute to the development of hypertension. As Black Americans have an increased risk of hypertension, we evaluated associations between beta(1)-AR (Arg389Gly) and beta(2)-AR (Arg16Gly, Gln27Glu) gene variants and cardiovascular reactivity in 500 Black youth. Heart rate, preejection period, total peripheral resistance, and blood pressure reactivity were measured during cold and psychological stress. The Arg389Gly polymorphism in the beta(1)-AR was associated with preejection period reactivity in males but not in females. The Arg16Gly polymorphism in the beta(2)-AR was associated with diastolic blood pressure reactivity only during video game stress. An association between the Gln27Glu polymorphism in the beta(2)-AR and vascular reactivity depended on sex. Thus, specific patterns of associations emerged between genetic variations in beta-ARs and cardiovascular reactivity in young Blacks.

Athleticism is often associated with optimal health; however, some athletes have high blood pressure (BP) despite being physically active. Using proper guidelines to determine a BP diagnosis is essential when working with both children and adults who are physically active because basal BP levels rise during physical activity. Once a physician has determined an athlete is hypertensive, a full clinical assessment may be required to identify possible etiologies for the condition and furthermore to establish appropriate BP management. Special recommendations for sport participation can follow. Sport participation is dependent on, but is not limited to, coexisting cardiovascular risk factors and associated clinical conditions, BP condition, and evidence of end-organ damage. This article reviews the available research literature on the diagnosis of hypertension, recommendations for clinical assessments, and special considerations of BP management and sport participation to ensure the safety of hypertensive patients/athletes.

Hypertrophic growth of the heart is a response to ventricular wall stress, and has been associated with athletic training, neurohormonal activation, or chronically increased hemodynamic load.1 Left ventricular hypertrophy (LVH) is the most commonly assessed target organ effect of hypertension among children and adolescents. While the future impact of LVH detected during childhood is not known, LVH is associated with significantly increased cardiac risk among adults.2 The LV mass of children with hypertension (HTN) is greater than that of children with normal blood pressure (BP). In a cross sectional study of children with primary hypertension, the prevalence of LVH was 15.5 and 41.1% based upon adult and pediatric criteria, respectively.3 Several recent studies have emphasized the increased risk for LVH among children with hypertension and/or obesity.4-6 Hemodynamic loading by increased pressure (afterload) or volume (preload) results in changes in LV geometry. The former stimulates a concentric pattern characterized by the parallel addition of myofibrils that create LV wall thickening, whereas an eccentric pattern is characterized by the series addition of sarcomeres creating myofibril elongation and LV chamber enlargement.7, 8 Classification of these responses, in conjunction with the evaluation of relative wall thickness (LV wall thickness to internal chamber dimension ratio), has been extensively examined for prognostic importance in the diagnosis and treatment of hypertension and its related co-morbidities. Four geometric patterns have emerged.9, 10 Normal LV geometry is characterized by normal LV mass with normal relative wall thickness (RWT); concentric remodeling describes a pattern of normal LV mass in the presence of elevated RWT; concentric hypertrophy is identified by LVH in the presence of elevated RWT; and eccentric hypertrophy displays LVH with normal RWT (dilated LV chamber). Daniels et al. reported that 47% of children with primary hypertension had LVMI >95th percentile; within that cohort of 130 hypertensive children, 30% had eccentric hypertrophy and 17% had concentric hypertrophy, while an additional 9% displayed concentric remodeling.11 The aim of the current study was to assess LV geometry in a clinical cohort of untreated children with primary hypertension who underwent ambulatory blood pressure monitoring (ABPM) as part of their evaluation.

Cardiovascular disease is increased in US groups versus Japanese counterparts. Increased arterial stiffness is an important predictor of cardiovascular risk. Pulse wave velocity correlates well with arterial stiffness. Gender and ethnic differences in biracial US adolescent groups have been described. No data are available evaluating differences in arterial stiffness between US and Japanese subjects. Previously published data from an adolescent (12-17 years of age) Japanese cohort were used as an historical control and were compared to an adolescent cohort from the United States. The same simple noninvasive oscillometric technique was used in each cohort to measure brachial-ankle pulse wave velocity (baPWV) as an index of arterial stiffness. The US group was a cross-sectional, biracial (64% African American, 56% female) sample of 162 subjects. The Japanese group was a cross-sectional (48% female) sample of 820 Japanese subjects. All subjects in both cohorts were normotensive (BP < 95% for gender, height, and age) adolescents (12-17 years of age). Subjects were analyzed in four groups on the basis of gender and age (12-14 and 15-17 years of age). In both individual cohorts, the mean baPWV was higher in males versus females and the baPWV increased with age. The mean baPWV was higher in all US groups versus Japanese counterparts (p < 0.0001). The mean systolic and diastolic blood pressures were higher in all Japanese groups versus US counterparts (p < 0.005). Differences in arterial stiffness are present and detectable between normotensive US and Japanese adolescent subjects. Increased arterial stiffness among these adolescent groups correlates with known adult risk for cardiovascular events among the same ethnic and gender groups.

Hyperuricemia is associated with primary hypertension (HTN) in adults and children. Furthermore, uric acid levels during childhood are associated with blood pressure (BP) levels in adulthood. We measured 24-h ambulatory BP and serum uric acid (SUA) in 104 children referred for possible hypertension. Mean age was 13.7 +/- 2.6 y (range, 7-18 y) with 67 males and 37 females; 74 were African-American, 29 Caucasian and one Asian. SUA was associated with age (r = 0.38, p = 0.0001) and BMI Z-score (r = 0.23, p = 0.021). SUA was significantly associated with mean ambulatory systolic (S) and diastolic (D) BP. Mean ambulatory BP was normalized to gender- and height-specific reference standards using BP index. SUA was significantly associated with 24-h DBP index and nocturnal DBP index after adjusting for age, gender, race, BMI Z-score and urinary sodium excretion. SUA was also significantly associated with 24-h DBP load and nocturnal DBP load. Uric acid was significantly associated with increased likelihood for diastolic HTN (OR = 2.1, CI = 1.2, 3.7; p = 0.0063) after adjusting for other co-variables. Among children at risk for HTN, the likelihood for diastolic HTN (as defined by ambulatory blood pressure monitoring) increases significantly as SUA increases. SUA may be associated with increased severity of HTN during youth.

OBJECTIVE—Compared with Caucasians, obese African-American adolescents have a higher risk for type 2 diabetes. Subclinical inflammation and reduced glucagon-like peptide 1 (GLP-1) concentration are linked to the pathogenesis of the disease. We determined the relationship between insulin resistance, β-cell activity, and subclinical inflammation with GLP-1 concentrations and whether racial disparities in GLP-1 response were present in 49 obese adolescents (14 ± 3 years; 76% African American; 71% female). RESEARCH DESIGN AND METHODS—Subjects underwent physical examination and an oral glucose tolerance test. We measured levels of high-sensitivity CRP (CRPhs), fibrinogen, glucose, GLP-1total, GLP-1active, and insulin. Insulin and glucose area under the curve (AUC), insulinogenic index (ΔI30/ΔG30), and composite insulin sensitivity index (CISI) were computed. Subjects were categorized by race and as inflammation positive (INF+) if CRPhs or fibrinogen were elevated. RESULTS—No racial differences were seen in mean or relative BMI. Thirty-five percent of subjects had altered fasting or 2-h glucose levels (African American vs. Caucasian, NS), and 75% were INF+ (African American vs. Caucasian, P = 0.046). Glucose and insulin, CISI, and ΔI30/ΔG30 values were similar; African Americans had lower GLP-1total AUC (P = 0.01), GLP-1active at 15 min (P = 0.03), and GLP-1active AUC (P = 0.06) and higher fibrinogen (P = 0.01) and CRPhs (NS) compared with Caucasians. CONCLUSIONS—African Americans exhibited lower GLP-1 concentrations and increased inflammatory response. Both mechanisms may act synergistically to enhance the predisposition of obese African Americans to type 2 diabetes. Our findings might be relevant to effective deployment of emerging GLP-1–based treatments across ethnicities.

Objectives To clinically evaluate an inflation-based algorithm incorporated into a new automated blood pressure monitor manufactured by Welch Allyn, Inc. Methods Device evaluation was performed according to the Association for the Advancement of Medical Instrumentation standard. An overabundance of patients with hypertension (32) were part of the 110 total participants. The data were also analyzed as described in the British Hypertension Society protocol. Results The mean error and standard deviation for systolic blood pressure were -0.9 mmHg+/-7.2; for diastolic blood pressure -2.2 mmHg+/-6.7. These passed the Association for the Advancement of Medical Instrumentation standard requirements. By British Hypertension Society data analysis, the device achieved an AA grading. Over 90% of the cycles' blood pressure values were obtained during inflation. Conclusions The SureBP inflation-based algorithm successfully passed the Association for the Advancement of Medical Instrumentation standard requirements and achieved an AA rating by British Hypertension Society data analysis. The monitor has great advantages for patient comfort and speed of readings (average 15 s per reading). As the population studied was skewed by including a much larger than needed number of patients with hypertension, clinicians can have added confidence in this new technology.

Objective To investigate whether parental hypertension (HTN) affects children’s body mass index (BMI) and cardiovascular reactivity (CVR) over time. Study design A longitudinal study of 315 students (black: 23 females, 19 males; white: 142 females, 131 males) was conducted in the public schools of Obion County, Tennessee, between 1987 and 1992. BMI and BMI z scores were calculated. The CVR task was a series of video games (taking ∼10 minutes to play) given to the same students in their third-, fourth-, fifth-, seventh-, and eighth-grade years. CVR was defined as the change in blood pressure (Δ_BP) or heart rate (Δ_HR) between before playing and while playing the video game. Positive parental history of HTN (27.6%) was defined as at least 1 parent with HTN. Multivariable regression analyses were performed to estimate the effects of parental HTN on children’s BMI and CVR over time. Results Children with parental HTN had significant higher BMI, BMI z score, and R_BP than did children without parental HTN (BMI: 21.6 vs 19.9, P = .001; BMI z score: 1.6 vs 1.1, P = .003; R_SBP: 112.6 vs 110.4 mm Hg, P = .01; R_DBP 62.7 vs 60.6 mm Hg, P = .003) after adjustment for covariates. Increased CVR was observed in children with parental HTN compared with children without parental HTN but was statistically significant only for SBP (Δ_SBP: 17.2 vs 14.9 mm Hg; P = .01) after adjustment for covariates. Conclusions Parental HTN independently predicted children’s BMI, BMI z score, resting BP, and BP reactivity.

Research on the reliability of cardiovascular reactivity has focused on temporal stability and intertask consistency with only modest results. The present study evaluated the internal consistency reliability of cardiovascular reactivity in three large samples of adolescents and young adults (N=326, 136, and 142). Impedance cardiographic and blood pressure measures were recorded at rest and during standard laboratory stress tasks (math, video game, cold pressor). The reliability of cardiovascular reactivity within tasks, as assessed by Cronbach's alpha coefficient of internal consistency, ranged from alpha=.83 to .96 for 4-min to 5-min math tasks, and alpha=.65 to .94 for 3-min video game and cold pressor tasks. Although highly reliable within tasks, cardiovascular reactivity was less reliable across tasks, even within a single testing session. Possible reasons for the discrepancy between internal consistency and intertask consistency are discussed.

Objective To test the Pharma-Smart Model PS-2000 public use blood pressure monitor for compliance with the Association for the Advancement of Medical Instrumentation's Standard (AAMI) and to a modified British Hypertension Society (BHS) Protocol. Methods Subjects tested ranged in age from 18–74, with the average age of 40. Arm circumference ranged from 22–38 cm. Resting systolic blood pressure (BP) ranged from 91–252 mmHg, and resting diastolic pressure ranged from 57–160 mmHg. There were 44 males, and 41 females. For each subject the readings obtained by the PS-2000 were compared with auscultatory readings obtained by two clinicians, blinded to the results of each other and the device. The manual reference measurements were alternated with the readings obtained by the device. Results The average differences between the reference readings (average of the two clinicians) using the AAMI analysis and the automated readings were 0.07±7.0 mmHg (Mean±SD) for systolic BP, and −0.3±6.6 mmHg for diastolic BP. Conclusions The device met the accuracy requirements of the AAMI standard. In addition, when the data were analyzed to assess the compliance with the current British Hypertension Society Protocol (BHS), the device earned the highest rating of ‘A’ for both systolic and diastolic pressure. We believe that the Pharma-Smart PS-2000 will provide valid readings when placed in non-medical public use sites.