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1.
Artículo en Español | PAHO-IRIS | ID: phr-51862

RESUMEN

[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.


Asunto(s)
Salud Global , Tecnología Biomédica , Estándares de Referencia , Equipo para Diagnóstico , Salud Global , Tecnología Biomédica , Estándares de Referencia , Equipo para Diagnóstico , Salud Global , Tecnología Biomédica , Estándares de Referencia , Equipo para Diagnóstico
2.
J Hypertens ; 38(1): 21-29, 2020 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-31790375

RESUMEN

: 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.

3.
Rev. panam. salud pública ; 44: e21, 2020. tab
Artículo en Español | LILACS-Express | ID: biblio-1101778

RESUMEN

resumen está disponible en el texto completo


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.

4.
Hypertension ; 71(3): 368-374, 2018 03.
Artículo en Inglés | MEDLINE | ID: mdl-29386350

RESUMEN

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.


Asunto(s)
Determinación de la Presión Sanguínea/normas , Monitores de Presión Sanguínea/normas , Consenso , Guías de Práctica Clínica como Asunto/normas , Europa (Continente) , Humanos , Cooperación Internacional , Estándares de Referencia , Reproducibilidad de los Resultados , Sociedades Médicas/normas
5.
J Hypertens ; 36(3): 472-478, 2018 03.
Artículo en Inglés | MEDLINE | ID: mdl-29384983

RESUMEN

: 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.


Asunto(s)
Determinación de la Presión Sanguínea/instrumentación , Hipertensión/diagnóstico , Esfigmomanometros/normas , Estudios de Validación como Asunto , Presión Sanguínea , Consenso , Humanos , Cooperación Internacional , Reproducibilidad de los Resultados , Proyectos de Investigación
6.
Blood Press Monit ; 20(5): 266-72, 2015 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-26075332

RESUMEN

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.


Asunto(s)
Determinación de la Presión Sanguínea/instrumentación , Esfigmomanometros , Algoritmos , Conversión Analogo-Digital , Diástole , Electrónica , Diseño de Equipo , Humanos , Hipertensión/fisiopatología , Variaciones Dependientes del Observador , Oscilometría/instrumentación , Proyectos Piloto , Presión , Procesamiento de Señales Asistido por Computador , Sonido , Estadísticas no Paramétricas , Estetoscopios , Sístole , Grabación en Video/instrumentación
8.
Blood Press Monit ; 16(2): 67-73, 2011 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-21258237

RESUMEN

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.


Asunto(s)
Determinación de la Presión Sanguínea/instrumentación , Determinación de la Presión Sanguínea/normas , Monitores de Presión Sanguínea/normas , Hipertensión/diagnóstico , Humanos , Estudios Retrospectivos , Sociedades Médicas/normas , Estudios de Validación como Asunto
9.
Hypertension ; 56(6): 1047-53, 2010 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-21059998

RESUMEN

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.


Asunto(s)
Determinación de la Presión Sanguínea/instrumentación , Hipertensión/diagnóstico , Energía Solar , Adolescente , Adulto , Anciano , Determinación de la Presión Sanguínea/economía , Determinación de la Presión Sanguínea/normas , Equipo Médico Durable , Diseño de Equipo , Humanos , Masculino , Persona de Mediana Edad , Reproducibilidad de los Resultados , Uganda , Adulto Joven , Zambia
10.
Blood Press Monit ; 15(3): 115-23, 2010 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-20436348

RESUMEN

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.


Asunto(s)
Monitoreo Ambulatorio de la Presión Arterial/normas , Diagnóstico por Computador/métodos , Hipertensión/diagnóstico , Ritmo Circadiano , Humanos , Hipertensión/fisiopatología , Variaciones Dependientes del Observador
12.
Blood Press Monit ; 15(1): 39-48, 2010 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-20087174

RESUMEN

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.


Asunto(s)
Determinación de la Presión Sanguínea/instrumentación , Determinación de la Presión Sanguínea/normas , Hipertensión/diagnóstico , Guías de Práctica Clínica como Asunto/normas , Esfigmomanometros/normas , Europa (Continente) , Adhesión a Directriz/normas , Humanos , Reproducibilidad de los Resultados , Revisiones Sistemáticas como Asunto , Estudios de Validación como Asunto
13.
J Hypertens ; 27(4): 876-85, 2009 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-19516185

RESUMEN

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.


Asunto(s)
Monitoreo Ambulatorio de la Presión Arterial , Hipertensión/tratamiento farmacológico , Anciano , Amlodipino/administración & dosificación , Atenolol/administración & dosificación , Quimioterapia Combinada , Femenino , Humanos , Hipertensión/complicaciones , Hipertensión/fisiopatología , Masculino , Persona de Mediana Edad , Perindopril/administración & dosificación , Estudios Prospectivos , Tiazidas/administración & dosificación
14.
J Hypertens ; 26(7): 1328-35, 2008 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-18551007

RESUMEN

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.


Asunto(s)
Monitoreo Ambulatorio de la Presión Arterial , Hipertensión/diagnóstico , Anciano , Anciano de 80 o más Años , Presión Sanguínea , Determinación de la Presión Sanguínea , Enfermedades Cardiovasculares , Ritmo Circadiano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Reproducibilidad de los Resultados , Sístole , Factores de Tiempo
15.
Blood Press Monit ; 12(4): 246-9, 2007 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-17760216

RESUMEN

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.


Asunto(s)
Determinación de la Presión Sanguínea/métodos , Monitores de Presión Sanguínea/normas , Determinación de la Presión Sanguínea/instrumentación , Guías como Asunto , Humanos , Internet , Reproducibilidad de los Resultados
16.
Blood Press Monit ; 12(6): 377-9, 2007 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-18277314

RESUMEN

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.


Asunto(s)
Monitoreo Ambulatorio de la Presión Arterial/instrumentación , Información de Salud al Consumidor , Internet , Estudios de Validación como Asunto , Monitoreo Ambulatorio de la Presión Arterial/clasificación , Educación Médica Continua/métodos , Educación Continua en Enfermería/métodos , Medicina Basada en la Evidencia , Humanos , Educación del Paciente como Asunto
17.
Hypertension ; 47(3): 365-70, 2006 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-16432047

RESUMEN

We hypothesized that the dynamic relation between diastolic and systolic blood pressure over 24 hours provides a measure of arterial stiffness and might, therefore, predict cardiovascular mortality over and above pulse pressure. At baseline, while not on antihypertensive medication, 11 291 patients (mean age, 54.6 years; 5965 women) underwent ambulatory blood pressure monitoring. Using all of the blood pressure readings, we plotted diastolic against systolic blood pressure from each individual and calculated the regression slope. The ambulatory arterial stiffness index (AASI) was defined as 1 minus this regression slope. Over a median follow-up of 5.3 years, 566 cardiovascular deaths occurred, including 151 from stroke and 358 from cardiac disorders. Before and after adjustment for other cardiovascular risk factors, AASI and pulse pressure significantly predicted total cardiovascular mortality. AASI was a stronger predictor than pulse pressure for stroke (mutually adjusted relative hazard ratios for 1 SD increase, 1.21 versus 1.04; P=0.02 versus 0.66) with the opposite trend for cardiac mortality (relative hazard ratios, 1.03 versus 1.21; P=0.63 versus 0.002). In subjects with normal daytime ambulatory blood pressure (<135/<85 mm Hg), AASI was more predictive than pulse pressure of cardiovascular mortality (1.26 versus 0.96; P=0.04 versus 0.70) and of stroke mortality (1.81 versus 1.12; P=0.007 versus 0.58), whereas neither independently predicted cardiac mortality (1.11 versus 0.89; P=0.47 versus 0.40). AASI is a novel measure of arterial stiffness, which can be readily determined from ambulatory blood pressure recordings and which independently predicts cardiovascular mortality, even in normotensive subjects.


Asunto(s)
Arterias/fisiopatología , Monitoreo Ambulatorio de la Presión Arterial , Presión Sanguínea , Enfermedades Cardiovasculares/mortalidad , Hipertensión/fisiopatología , Modelos Cardiovasculares , Adulto , Anciano , Enfermedades Cardiovasculares/etiología , Adaptabilidad , Diástole , Femenino , Estudios de Seguimiento , Humanos , Hipertensión/complicaciones , Irlanda/epidemiología , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Modelos de Riesgos Proporcionales , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/mortalidad , Sístole
18.
Hypertension ; 46(1): 156-61, 2005 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-15939805

RESUMEN

The purpose of this study was to determine if ambulatory blood pressure measurement predicted total and cardiovascular mortality over and beyond clinic blood pressure measurement and other cardiovascular risk factors; 5292 untreated hypertensive patients referred to a single blood pressure clinic who had clinic and ambulatory blood pressure measurement at baseline were followed up in a prospective study of mortality outcome. Multiple Cox regression was used to model time to total and cause-specific mortality for ambulatory blood pressure measurement while adjusting for clinic blood pressure measurement and other risk factors at baseline. There were 646 deaths (of which 389 were cardiovascular) during a median follow-up period of 8.4 years. With adjustment for gender, age, risk indices, and clinic blood pressure, higher mean values of ambulatory blood pressure were independent predictors for cardiovascular mortality. The relative hazard ratio for each 10-mm Hg increase in systolic blood pressure was 1.12 (1.06 to 1.18; P<0.001) for daytime and 1.21 (1.15 to 1.27; P<0.001) for nighttime systolic blood pressure. The hazard ratios for each 5-mm Hg increase in diastolic blood pressure were 1.02 (0.99 to 1.07; P=NS) for daytime and 1.09 (1.04 to 1.13; P<0.01) for nighttime diastolic pressures. The hazard ratios for nighttime ambulatory blood pressure remained significant after adjustment for daytime ambulatory blood pressure. These results have 2 important clinical messages: ambulatory measurement of blood pressure is superior to clinic measurement in predicting cardiovascular mortality, and nighttime blood pressure is the most potent predictor of outcome.


Asunto(s)
Determinación de la Presión Sanguínea/métodos , Monitoreo Ambulatorio de la Presión Arterial , Enfermedades Cardiovasculares/mortalidad , Visita a Consultorio Médico , Adulto , Anciano , Presión Sanguínea , Determinación de la Presión Sanguínea/normas , Monitoreo Ambulatorio de la Presión Arterial/normas , Ritmo Circadiano , Diástole , Femenino , Humanos , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Modelos de Riesgos Proporcionales , Medición de Riesgo , Sístole
19.
Blood Press Monit ; 9(5): 237-41, 2004 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-15472495

RESUMEN

BACKGROUND: 24-h ambulatory blood pressure measurement (ABPM) is now recognized as being indispensable in the diagnosis and management of hypertension. The technique must, therefore, be made available in primary care, but in doing so it must be recognized that unfamiliarity with the technique may lead to misinterpretation of data. OBJECTIVE: To facilitate the wider application of ABPM, especially in primary care, we examined the features that would facilitate the development of a standardized user-friendly software program for the presentation, analysis and interpretation of data. METHODS AND RESULTS: The following features were considered essential to any software program for ABPM: standardized plots of 24-h profiles; computer interpretation of ABPM data and patterns; a user-friendly one-page report, flexible statistical analysis, and the facility to group data and to export data for audit and research analysis. The dabl ABPM program incorporating these features was introduced into the Blood Pressure Unit, Beaumont Hospital in 2000 and has been used in over 15 000 ABPM recordings. The program is now being used widely in general practice and specialized centres. CONCLUSIONS: It is feasible to design a software program to provide a standardized plotting format for ABPM, a basic analysis of data for day-to-day clinical work, or elaborate analyses for research, and an interpretative report to assist diagnosis and to provide an educational process for doctors and nurses not familiar with the technique.


Asunto(s)
Monitoreo Ambulatorio de la Presión Arterial/normas , Hipertensión/diagnóstico , Programas Informáticos , Ritmo Circadiano , Interpretación Estadística de Datos , Diagnóstico por Computador , Humanos , Estándares de Referencia
20.
Blood Press Monit ; 8(6): 255-60, 2003 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-14688556

RESUMEN

BACKGROUND: It is now accepted that blood pressure measuring devices should be subjected to an independent evaluation of their accuracy before they are marketed for clinical use. The results of validation of the TONOPORT V blood pressure monitor for the measurement of ambulatory blood pressure according to the European Society of Hypertension International Protocol for Validation of Blood Pressure Measuring Devices in Adults are presented in this paper. POPULATION: Thirty-three subjects were recruited from among staff and patients at Beaumont Hospital, Dublin, Ireland. METHODS: The TONOPORT V monitor was connected to the Sphygmocorder, an audiovisual system for validation, which records blood pressure on tape and video for later analysis. Nine sequential same-arm measurements between the device and a standard mercury sphygmomanometer were recorded using the Sphygmocorder. RESULTS: In phase 1, the TONOPORT V monitor produced 28 measurements within 5 mmHg, 37 within 10 mmHg and 40 within 15 mmHg for systolic blood pressure (SBP), and 26 within 5 mmHg, 38 within 10 mmHg and 44 within 15 mmHg for diastolic blood pressure (DBP). The mean differences were -2.2 (8.6) [mean (SD)] mmHg for SBP and +0.5 (7.2) mmHg for DBP. The TONOPORT V monitor passed all the criteria for both SBP and DBP. In phase 2.1, the TONOPORT V monitor had 56 measurements within 5 mmHg, 78 within 10 mmHg and 88 within 15 mmHg for SBP, and 60 measurements within 5 mmHg, 83 within 10 mmHg and 97 within 15 mmHg for DBP. The mean differences were -1.4 (8.7) mmHg for SBP and -0.2 (6.8) mmHg for DBP. The TONOPORT V monitor passed the criteria for DBP but failed to meet any of the criteria for SBP. In phase 2.2, 19 subjects had at least two of the differences within 5 mmHg and six subjects had no differences within 5 mmHg for SBP, and 22 subjects had at least two of the differences within 5 mmHg and six subjects no differences within 5 mmHg for DBP. The TONOPORT V monitor failed to meet the criteria for SBP and for DBP. CONCLUSIONS: The TONOPORT V monitor cannot be recommended for clinical use in an adult population because it records SBP inaccurately and because it records DBP inaccurately in an unacceptably high proportion of people.


Asunto(s)
Monitoreo Ambulatorio de la Presión Arterial/instrumentación , Hipertensión/rehabilitación , Adulto , Anciano , Monitoreo Ambulatorio de la Presión Arterial/métodos , Monitoreo Ambulatorio de la Presión Arterial/normas , Tamaño Corporal , Diástole/fisiología , Europa (Continente) , Femenino , Humanos , Irlanda , Masculino , Persona de Mediana Edad , Reproducibilidad de los Resultados , Autocuidado , Sístole/fisiología
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