19 research outputs found

    Extracorporeal Membrane Oxygenation for Severe Acute Respiratory Distress Syndrome associated with COVID-19: An Emulated Target Trial Analysis.

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    RATIONALE: Whether COVID patients may benefit from extracorporeal membrane oxygenation (ECMO) compared with conventional invasive mechanical ventilation (IMV) remains unknown. OBJECTIVES: To estimate the effect of ECMO on 90-Day mortality vs IMV only Methods: Among 4,244 critically ill adult patients with COVID-19 included in a multicenter cohort study, we emulated a target trial comparing the treatment strategies of initiating ECMO vs. no ECMO within 7 days of IMV in patients with severe acute respiratory distress syndrome (PaO2/FiO2 <80 or PaCO2 ≥60 mmHg). We controlled for confounding using a multivariable Cox model based on predefined variables. MAIN RESULTS: 1,235 patients met the full eligibility criteria for the emulated trial, among whom 164 patients initiated ECMO. The ECMO strategy had a higher survival probability at Day-7 from the onset of eligibility criteria (87% vs 83%, risk difference: 4%, 95% CI 0;9%) which decreased during follow-up (survival at Day-90: 63% vs 65%, risk difference: -2%, 95% CI -10;5%). However, ECMO was associated with higher survival when performed in high-volume ECMO centers or in regions where a specific ECMO network organization was set up to handle high demand, and when initiated within the first 4 days of MV and in profoundly hypoxemic patients. CONCLUSIONS: In an emulated trial based on a nationwide COVID-19 cohort, we found differential survival over time of an ECMO compared with a no-ECMO strategy. However, ECMO was consistently associated with better outcomes when performed in high-volume centers and in regions with ECMO capacities specifically organized to handle high demand. This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives License 4.0 (http://creativecommons.org/licenses/by-nc-nd/4.0/)

    Étude et mise en oeuvre d'une plate-forme de développement applicatif et suivi de sa réalisation

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    IGN wants to streamline its development processes to adapt to the rapidly-changing market. Delays in provision of tools and computing resources are the primary causes identified delays. The establishment of an application development platform, such as a software foundry provides a significant improvement in this regard by providing more autonomy to the development teams. Cloud Computing technology provides high flexibility in the operation of these tools and allows the developers to focus on their missions.This report presents the methodology and resources used for the study and implementation of this solution.l’IGN souhaite rationaliser ses processus de développement pour s’adapter à l’évolution constante et rapide du marché. Les délais de mises à disposition d’outils et de ressources informatiques sont la première cause identifiée de retard. La mise en place d’une plate-forme de développement applicatif, notamment sous forme de forge logicielle apporte une amélioration significative sur ce point en offrant plus d’autonomie aux équipes dedéveloppement. Les technologies de Cloud Computing apportent une grande flexibilité dans l’exploitation de ces outils et permet de laisser les développeurs se concentrer sur leurs missions.Ce rapport présente la méthodologie utilisée et les moyens mis en oeuvre pour l’étude et la réalisation de cette solution

    Excess mortality after hip fracture during COVID-19 pandemic: More about disruption, less about virulence-Lesson from a trauma center

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    International audienceTo date, literature has depicted an increase in mortality among patients with hip fractures, directly related to acute coronavirus disease 2019 (COVID-19) infection and not due to underlying comorbidities. Usual orthogeriatric pathway in our Department was disrupted during the pandemic. This study aimed to evaluate early mortality within 30 days, in 2019 and 2020 in our Level 1 trauma-center. We compared two groups of patients aged &gt;60 years, with osteoporotic upper hip fractures, in February/March/April 2020 and February/March/April 2019, in our level 1 trauma center. A total of 102 and 79 patients met the eligibility criteria in 2019 and 2020, respectively. Mortality was evaluated, merging our database with the French open database for death from the INSEE, which is prospectively updated each month. Causes of death were recorded. Charlson Comorbidity Index was evaluated for comorbidities, Instrumental Activity of Daily Living (IADL), and Activity of Daily Living (ADL) scores were assessed for autonomy. There were no differences in age, sex, fracture type, Charlson Comorbidity Index, IADL, and ADL. 19 patients developed COVID-19 infection. The 30-day survival was 97% (95% CI, 94%-100%) in 2019 and 86% (95% CI, 79%-94%) in 2020 (HR = 5, 95%CI, 1.4-18.2, p = 0.013). In multivariable Cox’PH model, the period (2019/2020) was significantly associated to the 30-day mortality (HR = 6.4, 95%CI, 1.7-23, p = 0.005) and 6-month mortality (HR = 3.4, 95%CI, 1.2-9.2, p = 0.01). COVID infection did not modify significantly the 30-day and 6-month mortality. This series brought new important information, early mortality significantly increased because of underlying disease decompensation. Minimal comprehensive care should be maintained in all circumstances in order to avoid excess of mortality among elderly population with hip fractures

    Challenges for quality and utilization of real-world data for diffuse large B-cell lymphoma in REALYSA, a LYSA cohort

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    International audienceReal-world data (RWD) are essential to complement clinical trial (CT) data, but major challenges remain, such as data quality. REal world dAta in LYmphoma and Survival in Adults (REALYSA) is a prospective noninterventional multicentric cohort started in 2018 that included patients newly diagnosed with lymphoma in France. Herein is a proof-of-concept analysis on patients with first-line diffuse large B-cell lymphoma (DLBCL) to (1) evaluate the capacity of the cohort to provide robust data through a multistep validation process; (2) assess the consistency of the results; and (3) conduct an exploratory transportability assessment of 2 recent phase 3 CTs (POLARIX and SENIOR). The analysis population comprised 645 patients with DLBCL included before 31 March 2021 who received immunochemotherapy and for whom 3589 queries were generated, resulting in high data completeness (<4% missing data). Median age was 66 years, with mostly advanced-stage disease and high international prognostic index (IPI) score. Treatments were mostly rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP 75%) and reduced dose R-CHOP (13%). Estimated 1-year event-free survival (EFS) and overall survival rates were 77.9% and 90.0%, respectively (median follow-up, 9.9 months). Regarding transportability, when applying the CT's main inclusion criteria (age, performance status, and IPI), outcomes seemed comparable between patients in REALYSA and standard arms of POLARIX (1-year progression-free survival 79.8% vs 79.8%) and SENIOR (1-year EFS, 64.5% vs 60.0%). With its rigorous data validation process, REALYSA provides high-quality RWD, thus constituting a platform for numerous scientific purposes. The REALYSA study was registered at www.clinicaltrials.gov as #NCT03869619

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    Extracorporeal Membrane Oxygenation for Severe Acute Respiratory Distress Syndrome Associated with COVID-19: An Emulated Target Trial Analysis

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    International audienc
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