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To determine the safety and efficacy of ruxolitinib (RUX) and fostamatinib (FOS) compared with standard of care (SOC) in patients requiring hospital admission for the treatment of COVID-19 pneumonia.
Adaptive multiarm, multistage, randomised, open-label trial (three arm, two stage).
Five hospitals in England between October 2020 and September 2022.
Hospitalised patients (≥18 years) with COVID-19 pneumonia defined by a modified WHO COVID-19 severity grade of 3 or 4.
Participants were randomly assigned 1:1:1 to receive RUX (10 mg two times per day for 7 days then 5 mg two times per day for 7 days), FOS (150 mg two times per day for 7 days then 100 mg two times per day for 7 days) or SOC.
Primary outcome was development of severe COVID-19 pneumonia (modified WHO severity grade≥5) within 14 days of randomisation. Secondary outcomes included mortality, invasive and non-invasive ventilation, venous thromboembolism, duration of hospital stay, readmissions, inflammatory markers and serious adverse events (SAEs).
At stage 1, 181 patients were randomised, with 4 assessed as ineligible post randomisation. FOS was stopped early for futility with 16 participants (27.6%, n=58) developing severe COVID-19 pneumonia compared with 15 (25.0%, n=60) in the SOC arm (adjusted odds ratio (aOR) compared with SOC: 1.12; 95% CI 0.49 to 2.58; p=0.608). RUX progressed to stage 2 but the trial was stopped early due to slow recruitment. At the final analysis, 10 participants (16.1%, n=62) developed severe COVID-19 pneumonia in the RUX arm compared with 15 (24.6%, n=61) in the SOC arm (aOR: 0.63; 95% CI 0.25 to 1.57; p=0.161). Four (7.4%) participants in the FOS arm, none in the RUX arm and three (5.5%) in the SOC arm died within 14 days of randomisation. Infections were the most frequently reported SAE and were numerically higher in the FOS (10, 17.2%) and RUX (10, 16.1%) arms compared with SOC (7, 11.5%). Two unexpected serious adverse reactions occurred in the RUX arm only.
We found no evidence that FOS was superior to SOC for the treatment of COVID-19 pneumonia in patients requiring hospital admission. Due to early stopping, the trial was underpowered to establish RUX’s effect in this population. Further study is needed.
NCT04581954; EUDRA-CT:
Diagnosing pulmonary tuberculosis (PTB) in children is challenging owing to paucibacillary disease, non-specific symptoms and signs and challenges in microbiological confirmation. Chest X-ray (CXR) interpretation is fundamental for diagnosis and classifying disease as severe or non-severe. In adults with PTB, there is substantial evidence showing the usefulness of artificial intelligence (AI) in CXR interpretation, but very limited data exist in children.
A prospective two-stage study of children with presumed PTB in three sites (one in South Africa and two in Pakistan) will be conducted. In stage I, eligible children will be enrolled and comprehensively investigated for PTB. A CXR radiological reference standard (RRS) will be established by an expert panel of blinded radiologists. CXRs will be classified into those with findings consistent with PTB or not based on RRS. Cases will be classified as confirmed, unconfirmed or unlikely PTB according to National Institutes of Health definitions. Data from 300 confirmed and unconfirmed PTB cases and 250 unlikely PTB cases will be collected. An AI-CXR algorithm (qXR) will be used to process CXRs. The primary endpoint will be sensitivity and specificity of AI to detect confirmed and unconfirmed PTB cases (composite reference standard); a secondary endpoint will be evaluated for confirmed PTB cases (microbiological reference standard). In stage II, a multi-reader multi-case study using a cross-over design will be conducted with 16 readers and 350 CXRs to assess the usefulness of AI-assisted CXR interpretation for readers (clinicians and radiologists). The primary endpoint will be the difference in the area under the receiver operating characteristic curve of readers with and without AI assistance in correctly classifying CXRs as per RRS.
The study has been approved by a local institutional ethics committee at each site. Results will be published in academic journals and presented at conferences. Data will be made available as an open-source database.
PACTR202502517486411
Introducción: La identidad e imagen de las enfermeras son conceptos interrelacionados que reflejan el sentido de uno mismo y las percepciones sociales sobre la profesión. Ambos son esenciales para el desarrollo de una práctica confiada y respetada. Objetivo: Develar el marco conceptual asociado a la imagen e identidad profesional de enfermería desde la perspectiva de enfermeras jubiladas. Materiales y Métodos: Estudio cualitativo basado en el paradigma constructivista y Teoría Fundamentada según Morse, que explora la identidad e imagen profesional de enfermería en Chile mediante entrevistas y grupos focales con enfermeras jubiladas. Para el análisis de los datos, se siguió la metodología propuesta por Charmaz. Sobre el rigor ético del estudio, se contó con la evaluación y aprobación de un Comité de Ética Científica independiente. Resultados: Participaron de este estudio 20 enfermeras jubiladas con una edad promedio de 74 años. Se establecieron 4 categorías que construyen la imagen social de las enfermeras y 3 categorías que construyen su identidad profesional. Discusión: Este estudio explora la imagen e identidad profesional de las enfermeras jubiladas, destacando cómo la pandemia mejoró la percepción pública de la profesión, de acuerdo con estudios internacionales. Han disminuido estereotipos como la feminización de la enfermería y su subordinación a la medicina, ampliamente descritos en la literatura. Las participantes se ven como líderes naturales, pero señalan deshumanización debido al agotamiento, tareas administrativas y los avances tecnológicos. Conclusiones: Resaltar una imagen auténtica y una identidad profesional coherente de la profesión fortalece su valor, estatus y reconocimiento social, lo que, a su vez, impacta positivamente en la calidad de los cuidados prestados a los pacientes.
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