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With the COVID-19 pandemic, documenting whether health care workers (HCWs) are at increased risk of SARS-CoV-2 contamination and identifying risk factors is of major concern. In this multicenter prospective cohort study, HCWs from frontline departments were included in March and April 2020 and followed for 3 months. SARS-CoV-2 serology was performed at month 0 (M0), M1, and M3 and RT-PCR in case of symptoms. The primary outcome was laboratory-confirmed SARS-CoV-2 infection at M3. Risk factors of laboratory-confirmed SARS-CoV-2 infection at M3 were identified by multivariate logistic regression. Among 1062 HCWs (median [interquartile range] age, 33 [28-42] years; 758 [71.4%] women; 321 [30.2%] physicians), the cumulative incidence of SARS-CoV-2 infection at M3 was 14.6% (95% confidence interval [CI] [12.5; 16.9]). Risk factors were the working department specialty, with increased risk for intensive care units (odds ratio 1.80, 95% CI [0.38; 8.58]), emergency departments (3.91 [0.83; 18.43]) and infectious diseases departments (4.22 [0.92; 18.28]); current smoking was associated with reduced risk (0.36 [0.21; 0.63]). Age, sex, professional category, number of years of experience in the job or department, and public transportation use were not significantly associated with laboratory-confirmed SARS-CoV-2 infection at M3. The rate of SARS-CoV-2 infection in frontline HCWs was 14.6% at the end of the first COVID-19 wave in Paris and occurred mainly early. The study argues for an origin of professional in addition to private life contamination and therefore including HCWs in the first-line vaccination target population. It also highlights that smokers were at lower risk.Trial registration The study has been registered on ClinicalTrials.gov: NCT04304690 first registered on 11/03/2020.
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COVID-19 , Adulto , Femenino , Humanos , Masculino , Estudios de Cohortes , COVID-19/epidemiología , Personal de Salud , Incidencia , Pandemias , Paris/epidemiología , Estudios Prospectivos , Factores de Riesgo , SARS-CoV-2RESUMEN
OBJECTIVES: It is critical to assess competency of medical students and residents in emergency medicine (EM) during undergraduate and graduate medical education. However, very few valid tools exist to assess both technical and nontechnical skills in the specific context of EM. Three Acute Care Assessment Tools (ACAT 1, 2, and 3) have been previously developed for three acute care conditions: cardiac arrest (1), coma (2), and acute respiratory failure (3). This study aimed to evaluate the reproducibility of the tools. METHODS: The tool was tested using recorded videos of simulation sessions of fourth year medical students and first year residents in EM. Raters independently reviewed the videos two times in a 3-month interval, and interrater and intrarater reliability using intraclass correlation (ICC) was calculated. Secondary endpoints included the completeness rate and relevance of the ACAT. RESULTS: Sixty-two sessions were recorded and 48 videos analyzed (18 for CA and 15 for both respiratory failure and coma. The learners were residents in 32 (66%) of videos. Interrater reliability was excellent (ICC >0.9 for all three contexts) and so was the intrarater reliability (>0.88), both upon first review (month 0, M0) and at 3 months (M3). The usability of the ACAT was good, with a completeness of the items that ranged from 96% to 100%. Only one item of the ACAT 1 had a relevance of 27%, as it could not be completed in 13 scenarios out of 18. CONCLUSIONS: The results demonstrate educators can evaluate students similarly utilizing video recordings of simulated medical scenario. The excellent completeness of the rated items advocated for good usability. The three ACATs can be utilized to assess for completeness of predefined tasks in three acute care broad scenario in a competency-based medical education framework.
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Importance: Uncontrolled studies suggest that pulmonary embolism (PE) can be safely ruled out using the YEARS rule, a diagnostic strategy that uses varying D-dimer thresholds. Objective: To prospectively validate the safety of a strategy that combines the YEARS rule with the pulmonary embolism rule-out criteria (PERC) rule and an age-adjusted D-dimer threshold. Design, Settings, and Participants: A cluster-randomized, crossover, noninferiority trial in 18 emergency departments (EDs) in France and Spain. Patients (N = 1414) who had a low clinical risk of PE not excluded by the PERC rule or a subjective clinical intermediate risk of PE were included from October 2019 to June 2020, and followed up until October 2020. Interventions: Each center was randomized for the sequence of intervention periods. In the intervention period (726 patients), PE was excluded without chest imaging in patients with no YEARS criteria and a D-dimer level less than 1000 ng/mL and in patients with 1 or more YEARS criteria and a D-dimer level less than the age-adjusted threshold (500 ng/mL if age <50 years or age in years × 10 in patients ≥50 years). In the control period (688 patients), PE was excluded without chest imaging if the D-dimer level was less than the age-adjusted threshold. Main Outcomes and Measures: The primary end point was venous thromboembolism (VTE) at 3 months. The noninferiority margin was set at 1.35%. There were 8 secondary end points, including chest imaging, ED length of stay, hospital admission, nonindicated anticoagulation treatment, all-cause death, and all-cause readmission at 3 months. Results: Of the 1414 included patients (mean age, 55 years; 58% female), 1217 (86%) were analyzed in the per-protocol analysis. PE was diagnosed in the ED in 100 patients (7.1%). At 3 months, VTE was diagnosed in 1 patient in the intervention group (0.15% [95% CI, 0.0% to 0.86%]) vs 5 patients in the control group (0.80% [95% CI, 0.26% to 1.86%]) (adjusted difference, -0.64% [1-sided 97.5% CI, -∞ to 0.21%], within the noninferiority margin). Of the 6 analyzed secondary end points, only 2 showed a statistically significant difference in the intervention group compared with the control group: chest imaging (30.4% vs 40.0%; adjusted difference, -8.7% [95% CI, -13.8% to -3.5%]) and ED median length of stay (6 hours [IQR, 4 to 8 hours] vs 6 hours [IQR, 5 to 9 hours]; adjusted difference, -1.6 hours [95% CI, -2.3 to -0.9]). Conclusions and Relevance: Among ED patients with suspected PE, the use of the YEARS rule combined with the age-adjusted D-dimer threshold in PERC-positive patients, compared with a conventional diagnostic strategy, did not result in an inferior rate of thromboembolic events. Trial Registration: ClinicalTrials.gov Identifier: NCT04032769.
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Productos de Degradación de Fibrina-Fibrinógeno/análisis , Embolia Pulmonar/diagnóstico , Tromboembolia Venosa/diagnóstico , Adulto , Factores de Edad , Anciano , Anciano de 80 o más Años , Anticoagulantes/uso terapéutico , Causas de Muerte , Intervalos de Confianza , Estudios Cruzados , Servicio de Urgencia en Hospital , Femenino , Francia , Hospitalización/estadística & datos numéricos , Humanos , Tiempo de Internación , Masculino , Persona de Mediana Edad , Readmisión del Paciente/estadística & datos numéricos , Estudios Prospectivos , Embolia Pulmonar/sangre , Embolia Pulmonar/diagnóstico por imagen , Embolia Pulmonar/mortalidad , Reproducibilidad de los Resultados , España , Tromboembolia Venosa/sangre , Adulto JovenRESUMEN
INTRODUCTION: In the work-up strategy for pulmonary embolism (PE) in the ED, the recently introduced YEARS rule allows the raising of the D-dimer threshold to 1000 ng/ml in patients with no signs of deep venous thrombosis and no hemoptysis and in whom PE is not the most likely diagnosis. However, this decision rule has never been prospectively compared to the usual strategy. Furthermore, it is unclear if the YEARS rule can be used on top of the Pulmonary Embolism Rule-out Criteria (PERC). We aim to assess the non-inferiority of YEARS compared to current guidelines to rule out PE among PERC-positive ED patients with suspicion of PE. METHODS/DESIGN: The MODIGLIANI study is a multicenter, European, non-inferiority, cluster-randomized, two periods cross-over, controlled trial. Each center will be randomized for the sequence of two 4-month periods: intervention (MOdified Diagnostic Strategy: MODS) followed by control (usual care), or control followed by intervention with 1 month of "wash-out" between the two periods. In the control period, the threshold will be as usual (500 ng/ml for patients aged 50 years or younger and age × 10 for older patients). In the MODS period, the threshold of D-dimers to rule out PE will be raised to 1000 ng/ml if no item of the YEARS score is present or will remain unchanged otherwise. Patients will be included if they have a suspicion of PE, defined as chest pain, dyspnea, or syncope. Non-inclusion criteria comprise a high clinical probability of PE or PERC-negative patients with low clinical probability. ETHICS AND DISSEMINATION: The study has received the following approvals: Comité de protection des personnes Ile de France XI (France) and Comité de Ética de la Investigación con medicamentos del Hospital Clínic de Barcelona (Spain). Results will be made available to all included participants and other researchers. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04032769. Registered on 24 July 2019.