How to find and use validated blood pressure measuring devices.

Clinically validated, automated arm-cuff blood pressure measuring devices (BPMDs) are recommended for BP measurement. However, most BPMDs available for purchase by consumers globally are not properly validated. This is a problem because non-validated BPMDs are less accurate and precise than validated ones, and therefore if used clinically could lead to misdiagnosis and mismanagement of BP. In response to this problem, several validated device lists have been developed, which can be used by clinicians and consumers to identify devices that have passed clinical validation testing. The purpose of this review is to describe the resources that are available for finding validated BPMDs in different world regions, to identify the differences between validated device lists, and describe current gaps and challenges. How to use validated BPMDs properly is also summarised.

Validation of the blood pressure measurement technology used in the Novacor Diasys 3 (DIS-0001-00) upper arm device for ambulatory blood pressure measurement, according to the requirements of the AAMI/ANSI/ISO 81060-2:2013 standard (for both a general study and a cardiac-stress study in adults) and of the European Society of Hypertension International Protocol revision 2010.

OBJECTIVE: The objective of this study was to determine the accuracy of the oscillometric blood pressure measurement technology of the Novacor Diasys 3 (model number DIS-0001-00) blood pressure monitor, intended for ambulatory blood pressure measurement, when used with the recommended Standard (ACC-0213-00), Large (ACC-0214-00) and Paediatric (ACC-0215-00) cuffs. METHODS: The Novacor Diasys 3 (model number DIS-0001-00) was evaluated according to the requirements of the AAMI/ANSI/ISO 81060-2:2013 standard, including an additional cardiac-stress study, a requirement for ambulatory blood pressure measurement devices. It was also validated according to the requirements of the European Society of Hypertension International Protocol revision 2010. The protocol requirements for all thee studies were followed precisely. RESULTS: The Novacor Diasys 3 (model number DIS-0001-00) fulfilled all of the requirements for a pass in each of the three studies. In the primary AAMI/ANSI/ISO 81060-2:2013 study, the Criterion 1 errors were +3.9 mmHg ± 2.9 mmHg for SBP and +3.4 ± 2.5 mmHg for DBP. CONCLUSION: The Novacor Diasys 3 (model number DIS-0001-00), when used with the recommended cuffs, can be recommended for ambulatory blood pressure measurement in the adult population.

Validation of the blood pressure measurement technology used in the Novacor Diasys 3 Plus (DIP-0001-00) upper-arm device for ambulatory blood pressure measurement, according to AAMI/ANSI/ISO 81060-2: 2013, ESH-IP 2010 and MEDDEV 2.7/1.

OBJECTIVE: The objective of this study was to determine the accuracy of the auscultatory and oscillometric blood pressure (BP) measurement technologies of the Novacor Diasys 3 Plus (model number DIP-0001-00) BP monitor, intended for ambulatory BP measurement when used with the recommended Standard Plus (ACC-0210-00), Large Plus (ACC-0211-00) and Paediatric Plus (ACC-0212-00) cuffs. METHODS: The auscultatory measurement technology Novacor Diasys 3 Plus (model number DIP-0001-00) was evaluated according to the requirements of the AAMI/ANSI/ISO 81060-2:2013 standard, including an additional cardiac-stress study, a requirement for ambulatory BP measurement devices. It was also validated according to the requirements of the European Society of Hypertension International Protocol revision 2010. The oscillometric measurement technology was compared to that of the Novacor Diasys 3 (model number DIS-0001-00) according to the equivalence requirements of MEDDEV 2.7/1 rev 4. The protocol requirements for all three studies and the equivalence were followed precisely. RESULTS: The Novacor Diasys 3 Plus (model number DIP-0001-00) fulfilled all of the requirements for a pass in each of the three studies of the auscultatory measurement technology. In the primary AAMI/ANSI/ISO 81060-2:2013 study, the criterion 1 errors were + 3.6 ± 2.7 mmHg for SBP and + 3.0 ± 2.7 mmHg for DBP. It was also proven to be equivalent to the Novacor Diasys 3 (model number DIS-0001-00) with respect to the oscillometric measurement technology CONCLUSION: The Novacor Diasys 3 Plus (model number DIP-0001-00), when used with the recommended cuffs, can be recommended for ambulatory BP measurement in the adult population.

[Lancet Commission on Hypertension Group position statement on the global improvement of accuracy standards for devices that measure blood pressurePosicionamento do Grupo da Lancet Commission on Hypertension sobre a melhoria global dos padrões de acurácia para aparelhos que medem a pressão arterial]. / Declaración de posición del Grupo de la Comisión Lancet de Hipertensión con respecto a la mejora mundial de las normas de exactitud para los dispositivos de medición de la presión arterial.

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.

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.

Declaración de posición del Grupo de la Comisión Lancet de Hipertensión con respecto a la mejora mundial de las normas de exactitud para los dispositivos de medición de la presión arterial

[RESUMEN]. 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.

[ABSTRACT]. 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.

[RESUMO]. 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.

Lancet Commission on Hypertension group position statement on the global improvement of accuracy standards for devices that measure blood pressure.

: 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 3000 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 Organisation 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.

Declaración de posición del Grupo de la Comisión Lancet de Hipertensión con respecto a la mejora mundial de las normas de exactitud para los dispositivos de medición de la presión arterial / Lancet Commission on Hypertension Group position statement on the global improvement of accuracy standards for devices that measure blood pressure / Posicionamento do Grupo da Lancet Commission on Hypertension sobre a melhoria global dos padrões de acurácia para aparelhos que medem a pressão arterial

Objetivos. El boletín de notas de México correspondiente al 2018 evalúa las oportunidades a disposición de la población infantil y joven mexicana para que puedan desarrollar niveles adecuados de actividad física y sueño, y disminuyan el sedentarismo.Métodos. El boletín es un sistema de vigilancia que recopila los datos obtenidos en las encuestas nacionales, censos, documentos gubernamentales, sitios web, literatura gris y estudios publicados con respecto al análisis de 16 indicadores en 4 categorías: comportamientos diarios, estado físico, entornos y fuentes influyentes, y estrategias e inversión. Los datos fueron cotejados con los puntos de referencia establecidos. A cada indicador se le asignó una calificación entre 1 y 10 (< 6 significa reprobado) o fue marcado como "incompleto" si los datos eran nulos o insuficientes. Resultados. Las calificaciones obtenidas para los comportamientos diarios fueron: actividad física en general: 4; participación en actividades deportivas organizadas: 5; juego activo: 3; modalidades de transporte activas: 5; sueño: 7; y sedentarismo: 3. El estado físico obtuvo un 7. Las calificaciones para los entornos y fuentes influyentes fueron: familiares y pares: "incompleto"; escuela: 3; comunidad y entorno: 4. Para las estrategias e inversión: estrategias gubernamentales: 6; entidades no gubernamentales: 2.Conclusiones. Las bajas calificaciones obtenidas en 11 de los 16 indicadores demuestran que las escuelas, las familias, las comunidades y el gobierno tienen que aunar esfuerzos para mejorar las oportunidades que tiene la población infantil y joven en México para desarrollar niveles de actividad física satisfactorios.(AU)

ABSTRACT 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.(AU)

RESUMO 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.(AU)

A Universal Standard for the Validation of Blood Pressure Measuring Devices: Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Collaboration Statement.

In the past 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 the 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.

A universal standard for the validation of blood pressure measuring devices: Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Collaboration Statement.

: 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.

High-fidelity digital recording and playback sphygmomanometry system: device description and proof of concept.

OBJECTIVES: This study describes the development of a new digital sphygmocorder (DS-II), which allows the digital recording and playback of the Korotkoff sounds, together with cuff pressure waveform, and its performance in a pilot validation study. MATERIALS AND METHODS: A condenser microphone and stethoscope head detect Korotkoff sounds and an electronic chip, dedicated to audio-signal processing, is used to record high-quality sounds. Systolic and diastolic blood pressure (SBP/DBP) are determined from the recorded signals with an automatic beat detection algorithm that displays the cuff pressure at each beat on the monitor. Recordings of Korotkoff sounds, with the cuff pressure waveforms, and the simultaneous on-site assessments of SBP/DBP were performed during 100 measurements in 10 individuals. The observers reassessed the recorded signals to verify their accuracy and differences were calculated. RESULTS: The features of the high-fidelity DS-II, the technical specifications and the assessment procedures utilizing the playback software are described. Interobserver absolute differences (mean±SD) in measurements were 0.7±1.1/1.3±1.3 mmHg (SBP/DBP) with a mercury sphygmomanometer and 0.3±0.9/0.8±1.2 mmHg with the DS-II. The absolute DS-II mercury sphygmomanometer differences were 1.3±1.9/1.5±1.3 mmHg (SBP/DBP). CONCLUSION: The high-fidelity DS-II device presents satisfactory agreement with simultaneous measurements of blood pressure with a mercury sphygmomanometer. The device will be a valuable methodology for validating new blood pressure measurement technologies and devices.

Impact of applying the more stringent validation criteria of the revised European Society of Hypertension International Protocol 2010 on earlier validation studies.

OBJECTIVE: Since 2002 when the European Society of Hypertension International Protocol (ESH-IP) was published it has become the preferred protocol for validating blood pressure monitors worldwide. In 2010, a revised version of the ESH-IP with more stringent criteria was published. This study assesses the impact of applying the revised ESH-IP criteria. METHODS: A systematic literature review of ESH-IP studies reported between 2002 and 2010 was conducted. The impact of applying the ESH-IP 2010 criteria retrospectively on the data reported in these studies was investigated. The performance of the oscillometric devices in the last decade was also investigated on the basis of the ESH-IP criteria. RESULTS: Among 119 published studies, 112 with sufficient data were analyzed. According to ESH-IP 2002, the test device failed in 19 studies, whereas by applying the ESH-IP 2010 criteria in 28 additional studies increased the failure rate from 17 to 42%. Of these 28 studies, in 20 (71%) the test device failed at part 1 (accuracy per measurement) and in 22 (79%) at part 2 (accuracy per subject). Most of the failures involved the '5 mmHg or less' criterion. In the last decade there has been a consistent trend toward improved performance of oscillometric devices assessed on the basis of the ESH-IP criteria. CONCLUSION: This retrospective analysis shows that the stricter revised ESH-IP 2010 criteria will noticeably increase the failure rate of devices being validated. Oscillometric devices are becoming more accurate, and the revised ESH-IP by acknowledging this trend will allow more accurate devices to enter the market.

A new solar-powered blood pressure measuring device for low-resource settings.

The management of high blood pressure (BP) is particularly inadequate in low-income countries, where the unavailability of a reliable, durable, and affordable BP-measurement device is a major obstacle to accurate diagnosis. Recognizing this, a World Health Organization committee was established to correct this deficiency by influencing manufacturers to produce a device according to predetermined criteria and to demonstrate the suitability of the device for low resource settings. A device, which fulfilled stipulated criteria in being inexpensive, semiautomated, and solar powered, was validated according to the International Protocol of the European Society of Hypertension; it was then subjected to field testing in 716 subjects from 2 centers in Uganda and 1 in Zambia. The Omron HEM-SOLAR having previously fulfilled accuracy criteria of the International Protocol for both systolic blood pressure (SBP) and diastolic blood pressure (DBP), fulfilled criteria for SBP, but not for DBP, when revalidated. In field testing, average SBPs and DBPs were 120.5 ± 21.6/74.6 ± 13.8 mm Hg and 122.3 ± 21.8/71.2 ± 14.0 mm Hg, respectively, with the auscultatory technique and the Omron HEM-SOLAR, respectively. Between-device agreement in defining SBP was 93.7%. The Omron HEM-SOLAR was favored over the mercury sphygmomanometer by both patients and investigators. In summary, considering the accuracy, robustness, relatively low cost, operational simplicity, and advantages such as solar power, the Omron HEM-SOLAR is likely to be a valuable device for improving BP measurement in low-resource settings with nonphysician health workers.

Computerized reporting improves the clinical use of ambulatory blood pressure measurement.

BACKGROUND: Ambulatory blood pressure measurement (ABPM) is being used increasingly in clinical practice. One previous study has shown that there can be considerable variance between expert observers in the interpretation of ABPM data. The purpose of this study was to show whether computer-generated reports with the dablABPM system would provide more consistency in the interpretation of data than reports from expert observers. METHODS: Twenty-six international experts in hypertension were invited to participate and 17 agreed to do so. Twelve ABPMs generated by the Spacelabs device that were considered representative of the patterns likely to be seen in practice were sent to each participant for reporting. The corresponding dabl reports with an automatic interpretation were generated according to the European Society of Hypertension guideline for comparison with the observer reports. Each of the observer-interpreted Spacelabs reports for the 12 ABPM patterns were coded, analysed and compared with the automatically interpreted dablABPM reports. Both sets of data were analysed for interobserver variability, observer v dablABPM consistency and the time taken for observer reportage. The main analysis determined issues of definite disagreement, namely the presence or absence of nocturnal dipping. Further analysis determined the presence or absence of white-coat phenomena and the severity of hypertension. RESULTS: Incorrect diagnoses were made in 13 instances. White-coat hypertension and white-coat effect, although obvious in many instances, were not identified in five ABPMs; the severity of hypertension was not reported in four ABPMs; the severity of nocturnal hypertension was not diagnosed in one ABPM by nine experts and isolated diastolic hypertension was not identified by six experts in two ABPMs. CONCLUSION: This study provides evidence to show that observer variance in reporting ABPMs is common even among experts and that computer-generated interpretative reports of ABPM data improve the diagnostic decisions based on the data generated by 24-h blood pressure recording.

European Society of Hypertension International Protocol for the validation of blood pressure monitors: a critical review of its application and rationale for revision.

OBJECTIVE: To perform a systematic review of validation studies of blood pressure measuring devices done using the European Society of Hypertension International Protocol (ESH-IP) since its publication in 2002. METHODS: Major aspects of ESH-IP studies are described. A review of the ESH-IP performance, problems and violations in its application, and the effect of applying several more stringent validation criteria in an ESH-IP revision is carried out. RESULTS: From January 2002 to June 2009, 104 validation studies had been conducted using the ESH-IP, 36 using the British Hypertension Society protocol and 28 using the US Association for the Advancement of Medical Instrumentation protocol. Among 78 studies reported up to June 2008, in 66 (85%) the tested device has passed the ESH-IP. In 19 validations a modification of the ESH-IP was performed to adapt for specific study needs (population or device). Protocol violations of the ESH-IP were identified in 23 studies (eight major violations). A test of several arbitrarily chosen changes in the ESH-IP validation criteria applied in the published studies showed the phase 2.1 criterion (BP differences < or =15 mmHg) and the phase 2.2 criteria to be the more stringent. CONCLUSION: The ESH-IP has succeeded in expanding the validation procedure worldwide by three to four-fold compared with the period before its publication. There is a need for protocol revision aiming to address issues that appeared in published studies, prevent protocol violations, and ensure complete data reporting. Standardization of the ESH-IP validation studies' report and application of more stringent criteria should be considered.

Ambulatory blood pressure monitoring predicts cardiovascular events in treated hypertensive patients--an Anglo-Scandinavian cardiac outcomes trial substudy.

BACKGROUND: Results of the Anglo-Scandinavian cardiac outcomes trial-blood pressure lowering arm (ASCOT-BPLA) showed significantly lower rates of coronary and stroke events in individuals allocated an amlodipine-perindopril combination drug regimen than in those allocated an atenolol-thiazide combination drug regimen. The aims of the ambulatory blood pressure (ABP) substudy of ASCOT were to examine the impact of the two blood pressure (BP)- lowering regimens on ambulatory pressures, test to what extent the between-treatment differences in cardiovascular outcome could be attributed to differences in ABP and assess whether ABP provides predictive information additional to that of clinic blood pressure (CBP) in treated hypertensive patients. METHODS AND RESULTS: One thousand, nine hundred and five patients from four ASCOT centres had repeated ABPs performed over a median follow-up period of 5.5 years. As in the whole ASCOT population, CBP values were lower in amlodipine-perindopril-treated patients compared with those treated with atenolol-thiazide [between-regimen difference [95% confidence intervals (CIs)]]: [-1.5 (-2.4 to -0.5)/-1.2 (-1.8 to +0.5) mmHg]. Daytime BP during follow-up was higher in patients treated with amlodipine-perindopril therapy [+1.1 (0.1-2.1)/+1.6 (0.8-2.3) mmHg]; night-time systolic, but not diastolic BP, was lower in patients treated with amlodipine-perindopril therapy [-2.2 (-3.4 to +0.9)/+0.8 (0.0-1.6) mmHg]. The relative risk of a cardiovascular event associated with a 1 SD increment in accumulated mean BP was 1.35 (1.18-1.53) for clinic systolic BP, 1.30 (1.14-1.49) for daytime systolic BP and 1.42 (1.24-1.62) for night-time systolic BP. With adjustment for baseline variables, treatment regimen and clinic systolic BP, the hazard ratios were 1.17 (1.00-1.36) and 1.25 (1.08-1.47) for daytime and night-time systolic BP, respectively. The between-regimen adjusted hazard ratio for cardiovascular events (amlodipine-perindopril therapy versus atenolol-thiazide therapy) was 0.74 (0.55-1.01) and increased to 0.81 (0.60-1.10) after further adjustment for clinic systolic BP. Further, adjustment for night-time systolic BP increased the hazard ratio to 0.85 (0.62-1.16). CONCLUSION: The amlodipine-perindopril and atenolol-thiazide regimens had different effects on daytime and night-time ABP, which may have contributed to the lower rates of events in patients treated with amlodipine-perindopril therapy. Both CBP and ABP were significantly associated with rates of cardiovascular events. ABP nocturnal pressures provided complimentary and incremental utility over CBP in the prediction of cardiovascular risk in treated hypertensive patients. These data support the use of ABP to assess the effect of antihypertensive treatment in clinical practice.

Short-term and long-term repeatability of the morning blood pressure in older patients with isolated systolic hypertension.

OBJECTIVE: Using 24-h ambulatory blood pressure monitoring, we studied the repeatability of the morning blood pressure in older (> or =60 years) patients with isolated systolic hypertension. METHODS: The sleep-through morning surge was the morning blood pressure minus the lowest nighttime blood pressure. The preawake morning surge was the morning blood pressure minus the preawake blood pressure. In addition, we determined the cusum plot height of blood pressure from 04:00 to 10:00 h from a plot of cumulative sums. RESULTS: In 173 patients with repeat recordings within 33 days (median), the short-term repeatability coefficients, expressed as percentages of maximal variation, ranged from 35 to 41% for the daytime and nighttime blood pressures and from 50 to 56% for the night-to-day blood pressure ratios. Short-term repeatability ranged from 52 to 75% for the sleep-through and the preawake morning surge, and from 51 to 62% for the cusum plot height. In 219 patients with repeat recordings within 10 months (median), the corresponding long-term estimates ranged from 45 to 64%, from 69 to 71%, from 76 to 83%, and from 50 to 78%, respectively. In categorical analyses of the short-term repeatability of the sleep-through morning surge and the preawake morning surge, using the 75th percentile as arbitrary cut-off, surging status changed in 28.0 and 26.8% of patients (kappa-statistic < or =0.33). In the long-term interval, these proportions were 32.0 and 32.0%, respectively (kappa-statistic < or =0.20). The kappa-statistic threshold for moderate reproducibility is 0.4. CONCLUSION: The morning surge of blood pressure is poorly reproducible, irrespective of whether it is analysed as continuous or categorical variable.

The dabl Educational Trust device equivalence procedure.

Manufacturers of blood pressure measuring devices that have previously been successfully validated for accuracy may make modifications to a device, which do not affect its measurement accuracy and should not require further validation. In this paper the procedure for manufacturers to declare the equivalence of a modified device with a device that has been validated earlier is described.

State-of-the-market from the dableducational.org website.

Inaccurate blood pressure measurement leads inevitably to the inappropriate diagnosis and treatment of hypertension with resultant disadvantages for patients. Despite the serious consequences of inaccurate measurement of blood pressure the fact is that there are many inaccurate devices in the market and many have not been validated independently for accuracy. To overcome this deficiency, state-of-the-market papers have been published over the past decade. These papers, however, are limited in their availability to the wide range of potential purchasers of blood pressure measuring devices and such papers are often out-of-date by the time of publication. The dableducational website was founded in 2003 to provide regularly updated evidence-based information on blood pressure measuring devices on the internet to all would-be purchasers of blood pressure measuring devices. Since its foundation, the dableducational website has received in excess of 2 million visits; it is used by 1200 organizations in more than 105 countries worldwide, and receives an average of 160,000 visits monthly with a high percentage take down rate. In addition, the website provides a library resource with over 450 papers, and a device equivalence procedure for manufacturers.