Clinical Presentation and Outcomes of Pregnant Women with COVID-19: A Systematic Review and Meta-Analysis

INTRODUCTION: Descriptions of coronavirus disease-2019 (COVID-19) have focused on the non-pregnant adult population. This study aims to describe the clinical characteristics and perinatal outcomes of COVID-19 in pregnancy. METHODS: We searched databases from December 2019 to April 30th, 2020. Eligible studies reported clinical characteristics, radiological findings and/or laboratory testing of pregnant women during infection. Data were pooled across studies using random-effects model. RESULTS: Twenty-four studies (136 women) were included. Most common symptoms were fever (62.9%) and cough (36.8%). Laboratory findings included elevated C-Reactive Protein (57%) and lymphocytopenia (50%). Ground-glass opacity was the most common radiological finding (81.7%). Preterm birth rate was 37.7% and cesarean delivery rate was 76%. There was one maternal death. There were two fetal COVID-19 cases. CONCLUSION: The clinical picture in pregnant women with COVID-19 did not differ from the non-pregnant population, however, the rate of preterm birth and cesarean delivery are considerably higher than international averages

A Prediction Model to Help with Oncologic Mediastinal Evaluation for Radiation: HOMER

RATIONALE: When stereotactic ablative radiotherapy (SABR) is an option for non-small cell lung cancer (NSCLC) patients, distinguishing between N0, N1 and N2 or N3 (N2|3) disease is important. OBJECTIVES: To develop a prediction model for estimating the probability of N0, N1, and N2|3 disease. METHODS: Consecutive patients with clinical-radiographic stage T1-3/N0-3/M0 NSCLC that underwent endobronchial ultrasound-guided staging from a single center were included. Multivariate ordinal logistic regression analysis was used to predict the presence of N0, N1 or N2|3 disease. Temporal validation used consecutive patients from three years later at the same center. External validation used three other hospitals. RESULTS: In the model development cohort (n=633), younger age, central location, adenocarcinoma and higher PET-CT nodal stage were associated with a higher probability of having advanced nodal disease. Area under the receiver operating characteristic curves (AUC) were 0.84 and 0.86 for predicting N1 or higher (vs. N0) disease and N2|3 (vs. N0|1) disease respectively. Model fit was acceptable (Hosmer-Lemeshow p=0.960; Brier score 0.36). In the temporal validation cohort (n=473) AUCs were 0.86 and 0.88. Model fit was acceptable (Hosmer-Lemeshow p=0.172; Brier score 0.30). In the external validation cohort (n=722), AUCs were 0.86 and 0.88, but required calibration (Hosmer-Lemeshow p CONCLUSIONS: This prediction model can estimate the probability of N0, N1 and N2|3 disease in NSCLC patients. The model has the potential to facilitate decision-making in NSCLC patients when SABR is an option

The Impact of Gravity vs Suction-driven Therapeutic Thoracentesis on Pressure-related Complications: The GRAVITAS Multicenter Randomized Controlled Trial

BACKGROUND: Thoracentesis can be accomplished by active aspiration or drainage with gravity. This article investigated whether gravity drainage could protect against negative pressure-related complications such as chest discomfort, re-expansion pulmonary edema, or pneumothorax compared with active aspiration. METHODS: This prospective, multicenter, single-blind, randomized controlled trial allocated patients with large free-flowing effusions estimated ≥ 500 mL 1:1 to undergo active aspiration or gravity drainage. Patients rated chest discomfort on 100-mm visual analog scales prior to, during, and following drainage. Thoracentesis was halted at complete evacuation or for persistent chest discomfort, intractable cough, or other complication. The primary outcome was overall procedural chest discomfort scored 5 min following the procedure. Secondary outcomes included measures of discomfort and breathlessness through 48 h postprocedure. RESULTS: A total of 142 patients were randomized to undergo treatment, with 140 in the final analysis. Groups did not differ for the primary outcome (mean visual analog scale score difference, 5.3 mm; 95% CI, -2.4 to 13.0; P = .17). Secondary outcomes of discomfort and dyspnea did not differ between groups. Comparable volumes were drained in both groups, but the procedure duration was significantly longer in the gravity arm (mean difference, 7.4 min; 95% CI, 10.2 to 4.6; P \u3c .001). There were no serious complications. CONCLUSIONS: Thoracentesis via active aspiration and gravity drainage both seem safe and result in comparable levels of procedural comfort and dyspnea improvement. Active aspiration requires less total procedural time. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT03591952; URL: www.clinicaltrials.gov

The Impact of Gravity vs Suction-driven Therapeutic Thoracentesis on Pressure-related Complications: The GRAVITAS Multicenter Randomized Controlled Trial.

BACKGROUND: Thoracentesis can be accomplished by active aspiration or drainage with gravity. This article investigated whether gravity drainage could protect against negative pressure-related complications such as chest discomfort, re-expansion pulmonary edema, or pneumothorax compared with active aspiration. METHODS: This prospective, multicenter, single-blind, randomized controlled trial allocated patients with large free-flowing effusions estimated ≥ 500 mL 1:1 to undergo active aspiration or gravity drainage. Patients rated chest discomfort on 100-mm visual analog scales prior to, during, and following drainage. Thoracentesis was halted at complete evacuation or for persistent chest discomfort, intractable cough, or other complication. The primary outcome was overall procedural chest discomfort scored 5 min following the procedure. Secondary outcomes included measures of discomfort and breathlessness through 48 h postprocedure. RESULTS: A total of 142 patients were randomized to undergo treatment, with 140 in the final analysis. Groups did not differ for the primary outcome (mean visual analog scale score difference, 5.3 mm; 95% CI, -2.4 to 13.0; P = .17). Secondary outcomes of discomfort and dyspnea did not differ between groups. Comparable volumes were drained in both groups, but the procedure duration was significantly longer in the gravity arm (mean difference, 7.4 min; 95% CI, 10.2 to 4.6; P \u3c .001). There were no serious complications. CONCLUSIONS: Thoracentesis via active aspiration and gravity drainage both seem safe and result in comparable levels of procedural comfort and dyspnea improvement. Active aspiration requires less total procedural time. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT03591952; URL: www.clinicaltrials.gov

Predicting Lymph Node Metastasis in Non-small Cell Lung Cancer: Prospective External and Temporal Validation of the HAL and HOMER Models

BACKGROUND: Two models, the Help with the Assessment of Adenopathy in Lung cancer (HAL) and Help with Oncologic Mediastinal Evaluation for Radiation (HOMER), were recently developed to estimate the probability of nodal disease in patients with non-small cell lung cancer (NSCLC) as determined by endobronchial ultrasound-transbronchial needle aspiration (EBUS-TBNA). The objective of this study was to prospectively externally validate both models at multiple centers. RESEARCH QUESTION: Are the HAL and HOMER models valid across multiple centers? STUDY DESIGN AND METHODS: This multicenter prospective observational cohort study enrolled consecutive patients with PET-CT clinical-radiographic stages T1-3, N0-3, M0 NSCLC undergoing EBUS-TBNA staging. HOMER was used to predict the probability of N0 vs N1 vs N2 or N3 (N2|3) disease, and HAL was used to predict the probability of N2|3 (vs N0 or N1) disease. Model discrimination was assessed using the area under the receiver operating characteristics curve (ROC-AUC), and calibration was assessed using the Brier score, calibration plots, and the Hosmer-Lemeshow test. RESULTS: Thirteen centers enrolled 1,799 patients. HAL and HOMER demonstrated good discrimination: HAL ROC-AUC = 0.873 (95%CI, 0.856-0.891) and HOMER ROC-AUC = 0.837 (95%CI, 0.814-0.859) for predicting N1 disease or higher (N1|2|3) and 0.876 (95%CI, 0.855-0.897) for predicting N2|3 disease. Brier scores were 0.117 and 0.349, respectively. Calibration plots demonstrated good calibration for both models. For HAL, the difference between forecast and observed probability of N2|3 disease was +0.012; for HOMER, the difference for N1|2|3 was -0.018 and for N2|3 was +0.002. The Hosmer-Lemeshow test was significant for both models (P = .034 and .002), indicating a small but statistically significant calibration error. INTERPRETATION: HAL and HOMER demonstrated good discrimination and calibration in multiple centers. Although calibration error was present, the magnitude of the error is small, such that the models are informative