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Introduction: The COVID-19 pandemic highlighted that surges in critical care demand can overwhelm existing healthcare infrastructures, most evident in the acute shortage of mechanical ventilators across the globe. Despite efforts to encourage urgent authorization of newly developed emergency ventilators, the currently available testing protocols are not internationally accepted, standardized and none address testing in clinical settings. The aim of this study was to compile and perform a comprehensive clinical testing protocol for a newly developed emergency ventilator. Methods: Using previously available guidance, we compiled a sequential testing protocol with a: 1. preclinical, 2. safety testing, 3. clinician usability test and 4. clinical stage involving respiratory failure patients. The protocol was then tested on the Luca ventilator, a mechanical ventilator capable of sophisticated ventilator settings rapidly developed specifically in response to the COVID-19 pandemic. Results: During the pre-clinical/safety stages, the ventilator produced pressure and volume changes deemed acceptable by the Rapidly Manufactured Ventilator System guideline. Furthermore, our protocol allowed the identification of a number of issues that were easily resolved with minor software adjustments. Usability was excellent (overall System Usability Scale score = 90.5). Clinical testing revealed that a sampling frame of 15 critically ill patients was sufficiently powered to detect any significant, clinically relevant differences between the Luca ventilator and a standard ICU ventilator. Conclusions: The ventilator was accurate, reliable, safe, and user-friendly. The implementation of a comprehensive, standardized pre-clinical/clinical testing protocol is feasible, potentially enabling the safe and timely emergency authorization of rapidly developed mechanical ventilators crucial in pandemic situations. Resumen: Introducción: La pandemia de COVID-19 ha puesto de manifiesto que las sobrecargas en los cuidados intensivos pueden desbordar las infraestructuras sanitarias existentes, que fue evidente en la escasez inmediata de respiradores mecánicos observada en todo el mundo. A pesar de las tentativas de alentar la autorización urgente de respiradores de emergencia recién desarrollados, los protocolos de ensayos existentes no están aceptados en todo el mundo, no están normalizados y ninguno trata los ensayos en entornos clínicos. El objetivo de este estudio fue recopilar y ejecutar un protocolo de ensayos clínicos exhaustivo para un respirador de emergencia recién desarrollado. Métodos: Aplicando las directrices previas recopilamos un protocolo secuencial de ensayos con: 1. estudio preclínico, 2. estudio de seguridad, 3. ensayo de operabilidad por los facultativos y 4. fase clínica con participación de pacientes con insuficiencia respiratoria. Se analizó el protocolo con el respirador Luca, un respirador mecánico con configuraciones sofisticadas desarrollado rápida y específicamente para responder a la pandemia de la COVID-19. Resultados: Durante las fases preclínicas/de seguridad, los cambios de presión y volumen que produjo el respirador se consideraron aceptables, según la directriz Rapidly Manufactured Ventilator System. Asimismo, nuestro protocolo permitió identificar varios problemas que se resolvieron fácilmente con mínimos ajustes de software. La operabilidad resultó excelente (puntuación total de la escala de operabilidad del sistema = 90,5). Los ensayos clínicos revelaron que una muestra de 15 pacientes graves presentaba suficiente potencia estadística para detectar todas las diferencias significativas de interés clínico entre el respirador Luca y uno de Unidad de Cuidados Intensivos ordinario. Conclusiones: El respirador resultó exacto, fiable, seguro y fácil de usar. La implantación de un protocolo de ensayos preclínicos y clínicos exhaustivo y normalizado es factible y puede habilitar la autorización de emergencia oportuna de respiradores mecánicos de desarrollo rápido, cruciales en situaciones pandémicas.

Introduction: Mild hypertension is a common asymptomatic condition present in people at low risk of future cardiovascular events. These people represent approximately two-thirds of those diagnosed with hypertension. The best available evidence does not support pharmacological treatment for mild hypertension to reduce cardiovascular mortality. Additionally, overdetection of hypertension also occurs, and this practice is supported by public awareness campaigns, screening, easy access to testing, and poor clinical practice, enhancing the overdiagnosis potential. Moreover, sparse qualitative patient-oriented evidence that diagnosing hypertension has harmful consequences is observed. Therefore, evidence regarding the potential for unintended psychosocial effects of diagnosing mild hypertension is required. Objective: The aim of this study was to investigate if diagnosing low-risk people with mild hypertension has unintended psychosocial consequences. Methods: Eleven semi-structured single interviews and four focus groups were conducted in São Paulo, Brazil, among people diagnosed with mild hypertension without comorbidities. Informants were selected among the general population from a list of patients, a primary healthcare clinic, or a social network. The informants had a broad range of characteristics, including sex, age, education level, race/skin colour, and time from diagnosis. Data were subjected to qualitative thematic content analysis by three of the authors independently, followed by discussions, to generate categories and themes. Results: The informants confirmed that the hypertension diagnosis was a label for psychosomatic reactions to stress, medicalised illness experiences, and set a biographical milestone. We observed unintended consequences of the diagnosis in a broad range of psychosocial dimensions, for example, fear of death, disabilities, or ageing; pressure and control from significant others; and guilt, shame, and anxiety regarding work and leisure. Although informants had a broad range of characteristics, they shared similar stories, understandings, and labelling effects of the diagnosis. Conclusion: The diagnosis of hypertension is a significant event and affects daily life. Most of the impact is regarded as negative psychosocial consequences or harm; however, sometimes the impact might be ambiguous. Patients’ explanatory models are key elements in understanding and changing the psychosocial consequences of the diagnosis, and healthcare providers must be aware of explanatory models and psychosocial consequences when evaluating blood pressure elevations.

El propósito fue analizar la influencia de expresiones ideológicas conservadoras, como el autoritarismo de derecha (RWA) y la orientación hacia la dominancia social (SDO), en las percepciones sobre el sistema normativo y el sistema político en el Perú en una muestra accidental de 201 peruanos. Se aplicaron las escalas RWA, SDO, percepción del sistema normativo y cinismo político. Por medio de análisis de varianza, t de Student, análisis factorial exploratorio, correlaciones de Pearson, regresión lineal múltiple y path analysis, los resultados muestran, a nivel descriptivo, que las percepciones sobre los sistemas normativo y político son mayoritariamente negativas. En general, se observan relaciones directas entre los indicadores de autoritarismo y dominancia, con una evaluación positiva del sistema normativo y con una mayor tolerancia hacia prácticas corruptas en el sistema político y sus instituciones. Se parte de una definición del cinismo político como una expresión de desconfianza generalizada hacia el sistema político, que se enriquece con 2 nuevas dimensiones conceptuales relevantes para la comprensión del fenómeno en sociedades latinoamericanas como la peruana: posibilidad de cambio del sistema político y laxitud moral política.