ABSTRACT
INTRODUCTION: Chest X-rays are commonly used to assess the severity in patients that present in the emergency department with suspected COVID-19 pneumonia, but in clinical practice quantitative scales are rarely employed. AIMS: To evaluate the reliability and validity of two semi-quantitative radiological scales in patients hospitalized for COVID-19 pneumonia (BRIXIA score and RALE score). METHODS: Patients hospitalized between October 2021 and March 2022 with confirmed COVID-19 pneumonia diagnosis were eligible for inclusion. All included patients had a chest X-ray taken in the ED before admission. Three raters that participated in the treatment and management of patients with COVID-19 during the pandemic independently assessed chest X-rays. RESULTS: Intraclass coefficients for BRIXΙA and RALES was 0.781 (0.729-0.826) and 0.825 (0.781-0.862) respectively, showing good to excellent reliability overall. Pairwise analysis was performed using quadratic weighted kappa showing significant variability in the inter-rater agreement. The prognostic accuracy of the two scores for in-hospital mortality for all raters was between 0.753 and 0.763 for BRIXIA and 0.737 and 0.790 for RALES, demonstrating good to excellent prognostic value. Both radiological scores were significantly associated with inhospital mortality after adjustment for 4C Mortality score. We found a consistent upwards trend with significant differences between severity groups in both radiological scores. CONCLUSION: Our findings suggest that BRIXIA and RALES are reliable and can be used to assess the prognosis of patients with COVID-19 requiring hospitalization. However, the inherent subjectivity of radiological scores might make it difficult to set a cut-off value suitable for all assessors.
ABSTRACT
OBJECTIVE: Randomized controlled trials comparing tocilizumab and baricitinib in patients with coronavirus disease 2019 (COVID-19) are needed. This was an open-label, randomized controlled trial aiming to address this unmet need. METHODS: To determine whether baricitinib was non-inferior to tocilizumab, we assessed whether the upper boundary of the two-sided 95% CI of the hazard ratio (HR) did not exceed 1.50. The primary outcome was mechanical ventilation or death by day 28. Secondary outcomes included time to hospital discharge by day 28 and change in WHO progression scale at day 10. RESULTS: We assigned 251 patients with COVID-19 and a PaO2/FiO2 ratio of <200 to receive either tocilizumab (n = 126) or baricitinib (n = 125) plus standard of care. Baricitinib was non-inferior to tocilizumab for the primary composite outcome of mechanical ventilation or death by day 28 (mechanical ventilation or death for patients who received baricitinib, 39.2% [n = 49/125]; mechanical ventilation or death for patients who received tocilizumab, 44.4% [n = 56/126]; HR, 0.83; 95% CI, 0.56-1.21; p 0.001 for non-inferiority). Baricitinib was non-inferior to tocilizumab for the time to hospital discharge within 28 days (patients who received baricitinib- discharged alive: 58.4% [n = 73/125] vs. patients who received tocilizumab- discharged alive: 52.4% [n = 66/126]; HR, 0.85; 95% CI, 0.61-1.18; p < 0.001 for non-inferiority). There was no significant difference between the baricitinib and tocilizumab arms in the change in WHO scale at day 10 (0.0 [95% CI, 0.0-0.0] vs. 0.0 [95% CI, 0.0-1.0]; p 0.83). DISCUSSION: In the setting of this trial, baricitinib was non-inferior to tocilizumab with regards to the composite outcome of mechanical ventilation or death by day 28 and the time to discharge by day 28 in patients with severe COVID-19.
ABSTRACT
Background: Prognostic scores can be used to facilitate better management of patients suffering from life-threatening diseases, provided that they have been tested in the population of interest. Aim: To perform external validation of the 4C Mortality Score and PRIEST COVID-19 Clinical Severity Score. Study Design: Prospective observational Study. Methods: Patients hospitalized with COVID-19 pneumonia in a tertiary hospital in Greece were enrolled in the study. The prognostic scores were calculated based on hospital admission data and ROC curve analysis was performed. We assessed a composite outcome of either in-hospital death or need for invasive ventilation. Results: Both 4C and PRIEST scores showed good discriminative ability with an AUC value of 0.826 (CI 95%: 0.765-0.887) and 0.852 (CI 95%: 0.793-0.910) respectively. Based on the Youden Index the optimal cut-off for the 4C score was 11 (Sensitivity 75%, Specificity 75.5%) and 10 for the PRIEST score (Sensitivity 83% and Specificity 69.4%). Calibration was adequate for both scores, except for the low and very high risk groups in the PRIEST score. Conclusion: The 4C Mortality Score and PRIEST COVID-19 Clinical Severity Score can be used for early identification of patients with poor prognosis in a Greek population cohort hospitalized with COVID-19.