The Australasian COVID-19 Trial (ASCOT) to assess clinical outcomes in hospitalised patients with SARS-CoV-2 infection (COVID-19) treated with lopinavir/ritonavir and/or hydroxychloroquine compared to standard of care: A structured summary of a study protocol for a randomised controlled trial

Objectives: To determine if lopinavir/ritonavir +/- hydroxychloroquine will reduce the proportion of participants who survive without requiring ventilatory support, 15 days after enrolment, in adult participants with non-critically ill SARS-CoV-2 infection. Trial design: ASCOT is an investigator-initiated, multi-centre, open-label, randomised controlled trial. Participants will have been hospitalised with confirmed COVID-19, and will be randomised 1:1:1:1 to receive lopinavir /ritonavir, hydroxychloroquine, both or neither drug in addition to standard of care management. Participants: Participants will be recruited from >80 hospitals across Australia and New Zealand, representing metropolitan and regional centres in both public and private sectors. Admitted patients will be eligible if aged ≥ 18 years, have confirmed SARS-CoV-2 by nucleic acid testing in the past 12 days and are expected to remain an inpatient for at least 48 hours from the time of randomisation. Potentially eligible participants will be excluded if admitted to intensive care or requiring high level respiratory support, are currently receiving study drugs or their use is contraindicated due to allergy, drug interaction or comorbidities (including baseline QTc prolongation of 470ms for women or 480ms for men), or death is anticipated imminently

Mortality from gastrointestinal congenital anomalies at 264 hospitals in 74 low-income, middle-income, and high-income countries: a multicentre, international, prospective cohort study

Summary Background Congenital anomalies are the fifth leading cause of mortality in children younger than 5 years globally. Many gastrointestinal congenital anomalies are fatal without timely access to neonatal surgical care, but few studies have been done on these conditions in low-income and middle-income countries (LMICs). We compared outcomes of the seven most common gastrointestinal congenital anomalies in low-income, middle-income, and high-income countries globally, and identified factors associated with mortality. Methods We did a multicentre, international prospective cohort study of patients younger than 16 years, presenting to hospital for the first time with oesophageal atresia, congenital diaphragmatic hernia, intestinal atresia, gastroschisis, exomphalos, anorectal malformation, and Hirschsprung’s disease. Recruitment was of consecutive patients for a minimum of 1 month between October, 2018, and April, 2019. We collected data on patient demographics, clinical status, interventions, and outcomes using the REDCap platform. Patients were followed up for 30 days after primary intervention, or 30 days after admission if they did not receive an intervention. The primary outcome was all-cause, in-hospital mortality for all conditions combined and each condition individually, stratified by country income status. We did a complete case analysis. Findings We included 3849 patients with 3975 study conditions (560 with oesophageal atresia, 448 with congenital diaphragmatic hernia, 681 with intestinal atresia, 453 with gastroschisis, 325 with exomphalos, 991 with anorectal malformation, and 517 with Hirschsprung’s disease) from 264 hospitals (89 in high-income countries, 166 in middleincome countries, and nine in low-income countries) in 74 countries. Of the 3849 patients, 2231 (58·0%) were male. Median gestational age at birth was 38 weeks (IQR 36–39) and median bodyweight at presentation was 2·8 kg (2·3–3·3). Mortality among all patients was 37 (39·8%) of 93 in low-income countries, 583 (20·4%) of 2860 in middle-income countries, and 50 (5·6%) of 896 in high-income countries (p<0·0001 between all country income groups). Gastroschisis had the greatest difference in mortality between country income strata (nine [90·0%] of ten in lowincome countries, 97 [31·9%] of 304 in middle-income countries, and two [1·4%] of 139 in high-income countries; p≤0·0001 between all country income groups). Factors significantly associated with higher mortality for all patients combined included country income status (low-income vs high-income countries, risk ratio 2·78 [95% CI 1·88–4·11], p<0·0001; middle-income vs high-income countries, 2·11 [1·59–2·79], p<0·0001), sepsis at presentation (1·20 [1·04–1·40], p=0·016), higher American Society of Anesthesiologists (ASA) score at primary intervention (ASA 4–5 vs ASA 1–2, 1·82 [1·40–2·35], p<0·0001; ASA 3 vs ASA 1–2, 1·58, [1·30–1·92], p<0·0001]), surgical safety checklist not used (1·39 [1·02–1·90], p=0·035), and ventilation or parenteral nutrition unavailable when needed (ventilation 1·96, [1·41–2·71], p=0·0001; parenteral nutrition 1·35, [1·05–1·74], p=0·018). Administration of parenteral nutrition (0·61, [0·47–0·79], p=0·0002) and use of a peripherally inserted central catheter (0·65 [0·50–0·86], p=0·0024) or percutaneous central line (0·69 [0·48–1·00], p=0·049) were associated with lower mortality. Interpretation Unacceptable differences in mortality exist for gastrointestinal congenital anomalies between lowincome, middle-income, and high-income countries. Improving access to quality neonatal surgical care in LMICs will be vital to achieve Sustainable Development Goal 3.2 of ending preventable deaths in neonates and children younger than 5 years by 2030

Obstructive Sleep Apnea Confers Lower Mortality Risk in Acute Ischemic Stroke Patients Treated With Endovascular Thrombectomy: National Inpatient Sample Analysis 2010-2018

UNLABELLED: BackgroundObstructive sleep apnea (OSA) portends increased morbidity and mortality following acute ischemic stroke (AIS). Evaluation of OSA in the setting of AIS treated with endovascular mechanical thrombectomy (MT) has not yet been evaluated in the literature. METHODS: The National Inpatient Sample from 2010 to 2018 was utilized to identify adult AIS patients treated with MT. Those with and without OSA were compared for clinical characteristics, complications, and discharge disposition. Multivariable logistic regression analysis and propensity score adjustment (PA) were employed to evaluate independent associations between OSA and clinical outcome. RESULTS: Among 101 093 AIS patients treated with MT, 6412 (6%) had OSA. Those without OSA were older (68.5 vs 65.6 years old, p\u3c0.001), female (50.5% vs 33.5%, p\u3c0.001), and non-caucasian (29.7% vs 23.7%, p\u3c0.001). The OSA group had significantly higher rates of obesity (41.4% vs 10.5%, p\u3c0.001), atrial fibrillation (47.1% vs 42.2%, p=0.001), hypertension (87.4% vs 78.5%, p\u3c0.001), and diabetes mellitus (41.2% vs 26.9%, p\u3c0.001). OSA patients treated with MT demonstrated lower rates of intracranial hemorrhage (19.1% vs 21.8%, p=0.017), treatment of hydrocephalus (0.3% vs 1.1%, p=0.009), and in-hospital mortality (9.7% vs 13.5%, p\u3c0.001). OSA was independently associated with lower rate of in-hospital mortality (aOR 0.76, 95% CI 0.69 to 0.83; p\u3c0.001), intracranial hemorrhage (aOR 0.88, 95% CI 0.83 to 0.95; p\u3c0.001), and hydrocephalus (aOR 0.51, 95% CI 0.37 to 0.71; p\u3c0.001). Results were confirmed by PA. CONCLUSIONS: Our findings suggest that MT is a viable and safe treatment option for AIS patients with OSA

THE IMPACTS AND NON-IMPACTS ON UNIONS OF ENTERPRISE BARGAINING

Griffith Business School, Dept of Employment Relations and Human ResourcesFull Tex