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.

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)

Short report: long-term serum antibody isotype responses to Strongyloides stercoralis filariform antigens in eight patients treated with ivermectin

The enzyme-linked immunosorbant assay was used to investigate long term changes in serum immunoglobulin G1 (IgG1), IgG4, IgE, and IgA against Strongyloides stercoralis phosphate-buffered saline-soluble filariform larval antigens in eight Jamaican patients treated with ivermectin. Patients were followed for periods of between 170 and 542 days. Based on repeated formalin-ether concentration and agar plate culture, all patients were found to be uninfected up to 18 months following chemotherapy. Generally, all antibody isotype levels decreased following treatment, although there was considerable heterogeneity among patients. In a single patient with hyperinfection, the decrease in IgG4 was marginal and may represent a treatment failure. Reduction in serum antibody isotype responses to S. stercoralis following treatment may be used to assess the effectiveness of ivermectin in treating endemic strongyloides (AU)

Serum isotype responses in patients infected with Strongyloides stercoralis following treatment with ivermectin - abstract

Infections with Strongyloides stercoralis occur worldwide and can cause significant morbidity and mortality in man. They are often refractory to conventional chemotherapy especially in immunocompromised individuals. Recent studies have shown that Ivermectin is a safe and effective drug for use in uncomplicated infections. In this study, the profiles of parasite-specific IgG1, IgG4, IgE and IgA against a PBS soluble S. stercoralis filariform extract following treatment with ivermectin were investigated using the enzyme-linked immunosorbant assay (ELISA) technique. A series of 8 patients with parasitologically proven strongyloidiasis were treated with ivermectin and followed up for periods of 5 to 18 months. The predominant isotype found in the sera of patients from this series was IgG. High levels of IgG1 were recorded in young individuals while IgG4 was predominant in older persons. Levels of all isotypes declined following treatment and remained low up to eighteen months. Furthermore, no parasitological evidence of S. stercoralis infection was found after treatment, using agar plate and formalin-ether concentration methods. The reduction in antibody levels of post-treatment may be used as an indicator of adequate treatment and also demonstrate that patients are not exposed to drug-induced antigens following treatment. The study of S. stercoralis specific isotype profile will be useful in immuno-epidemiological studies in communities (AU)

Treatment of patients infected with Strongyloides stercoralis using ivermectin: assessment of efficacy and safety - abstract

Infections with Strongyloides stercoralis are often refractory to thiabendazole therapy in certain patients. Ivermectin is being used increasingly for treatment of uncomplicated infections; however, possible immunopathological changes associated with drug-induced release of antigens as observed with use of the drug in filariasis has not been studied in strongyloidiasis. In this study we used the enzyme linked immunosorbant assay (ELISA) technique to examine the profiles of S. stercoralis-specific IgG4, IgE and IgA against saline soluble filariform extracts in 8 patients treated for the parasite. All patients were found to be negative for the parasite by stool examination following treatment. Isotype levels fell in concert following treatment although there was considerable heterogeneity among patients. Levels remained low following treatment response but were still measurable for up to eighteen months post-treatment. There appeared to be no rapid release of parasite antigens following treatment. One patient exhibited a transient increase in levels of IgA after which there was a decline in this and all other isotypes. The single patient with proven chronic infection and a history of gastrointestinal symptoms exhibited almost ablated IgG1, IgE and IgA responses prior to treatment but had a significant IgG4 response which remained high following treatment. The reduction in antibody levels post-treatment may be used as confirmation of parasitological cure. The study showed that there was no rapid release of S. stercoralis antigens as seen in filarial infections and that Ivermectin is safe and effective against the parasite (AU)

Prospective evaluation of enzyme-linked immunosorbent assay and immunoblot methods for the diagnosis of endemic Strongyloides stercoralis infection

Recently described enzyme-linked immunosorbent assay (ELISA) and immunoblot methods for the detection of serum IgG against Strongyloides stercoralis larval antigens were prospectively evaluated for the diagnosis of endemic strongyloidiasis. A modification of the ELISA involved preincubation of sera with Onchocerca gutturosa phosphate-buffered saline-soluble extract to remove cross-reactivity with other helminths. The sensitivity of the ELISA increased from 80 percent and 85 percent following preincubation. Similarly, there was an increase in specifity from 94 percent to 97 percent. The IgG recognition of 41-, 31-, and 28-kD filariform larval components showed sensitivities of 100 percent, 85 percent and 65 percent, respectively. Both the ELISA following incubation of sera with O. gutturosa extract and serum IgG reactivity to a 41-kD larval component using immunoblotting are sensitive and specific techniques for diagnosing endemic strongyloidiasis.(AU)

Immunodiagnosis of Strongyloides stercoralis infection: a method for increasing the specificity of the indirect ELISA

Indirect enzyme-linked immunosorbent (ELISA) allows sensitive detection of serum immunoglobulin (Ig) G against a soluble extract of Strongyloides stercoralis infective larvae. In this study, 40/40 (100 percent) human strongyloidiasis sera had high levels of anti-S. stercoralis IgG, but 30/40 (75 percent) filariasis sera, and 12/40 (30 percent) necartoriasis sera also had higher levels than control sera from UK residents. In attempts to increase the assay specificity by absorption of cross-reactive IgG, the effectiveness of pre-incubation of sera with extracts of different parasitic nematodes was investigated. One hour of incubation with 20 æ/ml aqueous extract of Onchocerca gutturosa absorbed cross-reactive IgG in most filariasis and necatoriasis sera, reducing the proportion with IgG levels above the positivity threshold by more one-half. Preliminary results suggest that absorption with extracts of other filarial nematodes is equally effective, and that some cross-reactive IgG is directed against phosphorylcholine. Cross-reactive IgG in most necatoriasis sera was effectively absorbed with an extract of Ascaris lumbricoides. Absorption of cross-reactive IgG is an effective means of increasing the specificity of the indirect ELISA, for use in the immunodiagnosis and immuno-epidemiology of S. stercoralis infection.

Prospective evaluation of an ELISA and Western Blot for the diagnosis of endemic strongyloides stercoralis infection - abstract

Strongyloides stercoralis is the most serious intestinal nematode infecting humans in the Caribbean. The parasite is, however, difficult to diagnose using standard laboratory techniques, especially in sub-clinical cases. An ELISA, using PBS extracts of filariform larvae as antigen, and a Western Blot method were evaluated in the Jamaican community. Sensitivity and specificity of the ELISA were 73 per cent and 93 per cent (n=135) respectively. Pre-incubation of sera with Onchocerca gutterosa (Filariata) antigen increased sensitivity and specificity of the ELISA to 82 per cent and 97 per cent, respectively. Similarly, The Western Blot which was based on IgG recognition of proteins of 41kD and one of 31kD or 28kD detected 82 per cent of infected individuals and 97 per cent of true negatives. There was no notable cross-reactivity by either ELISA or Western Blot with Ascaris, Trichuris or hookworm, also common to the Region. ELISA proved to be a sensitive and specific test for diagnosing S. stercoralis infection in Jamaica. Western Blotting had no significant merits over those of ELISA although it confirmed the presence of 3 immunodominant bands which may play a role in future immunodiagnosis. Furthermore, it adds to the battery of sensitive serological tests available to clinicians who have to decide on the infection status of potential S. stercoralis patients who are about to receive immuno-suppressive therapy (AU)