Efficacy and safety of dupilumab in patients with severe chronic rhinosinusitis with nasal polyps (LIBERTY NP SINUS-24 and LIBERTY NP SINUS-52): results from two multicentre, randomised, double-blind, placebo-controlled, parallel-group phase 3 trials.

Background: Patients with chronic rhinosinusitis with nasal polyps (CRSwNP) generally have a high symptom burden and poor health-related quality of life, often requiring recurring systemic corticosteroid use and repeated sinus surgery. Dupilumab is a fully human monoclonal antibody that inhibits signalling of interleukin (IL)-4 and IL-13, key drivers of type 2 inflammation, and has been approved for use in atopic dermatitis and asthma. In these two studies, we aimed to assess efficacy and safety of dupilumab in patients with CRSwNP despite previous treatment with systemic corticosteroids, surgery, or both.

Using a knowledge translation framework to identify barriers and supports to effective nursing handover: A focus group study.

The aims of this study were to systematically assess the barriers and facilitators to evidence-based nursing handover in a clinical environment, and to identify potential adopters and attributes of evidence-based nursing handover for translation into practice. The study was conducted in the medical wards of a major tertiary referral hospital in Brisbane, Australia. Participants comprised registered and enrolled nurses permanently employed in the participating wards for at least three months prior to the commencement of study.

Cost-Effectiveness of Erythropoietin in Traumatic Brain Injury: A Multinational Trial-Based Economic Analysis.

The EPO-TBI multi-national randomized controlled trial found that erythropoietin (EPO), when compared to placebo, did not affect 6-month neurological outcome, but reduced illness severity-adjusted mortality in patients with traumatic brain injury (TBI), making the cost-effectiveness of EPO in TBI uncertain. The current study uses patient-level data from the EPO-TBI trial to evaluate the cost-effectiveness of EPO in patients with moderate or severe TBI from the healthcare payers' perspective. We addressed the issue of transferability in multi-national trials by estimating costs and effects for specific geographical regions of the study (Australia/New Zealand, Europe, and Saudi Arabia).

PREDICTING ATTENDANCE OF A PREVENTIVE PARENTING INTERVENTION FOR VERY PRETERM INFANTS.

Preventive parenting interventions can experience challenges in maximizing dosage, or the amount of intervention received by parents. This study examined the associations of baseline mother, father, and very preterm infant (VPT; <32 weeks) characteristics with satisfactory intervention attendance of the family within a randomized controlled trial of Baby Triple P for Preterm Infants (Colditz et al., 2015).

Effect of Delayed Cord Clamping on Cerebral Oxygenation in Very Preterm Infants.

Background And Objective: The mechanism of reported benefits of delayed cord clamping (DCC) are unclear. We aimed to determine whether DCC compared to immediate cord clamping (ICC) in very preterm infants improves cerebral oxygenation in the first 24 h.

Study Design: This is a prospective study of a subset of infants at < 30 weeks of gestation who were randomised to DCC (≥60 s) or ICC (< 10 s) and required an indwelling arterial catheter.

Audit of ten years of donation after circulatory death experience in Queensland: observations of agonal physiology following withdrawal of cardiorespiratory support.

An audit of ten years' experience in all patients undergoing withdrawal of cardiorespiratory support (WCRS) in the context of donation after circulatory death (DCD) was conducted in Queensland, Australia (2008 to 2017). One hundred and seventy-one patients proceeded to donation after declaration of death by circulatory criteria with loss of pulsatile arterial blood pressure (circulatory arrest) for five minutes. The demographics, times and haemodynamic observations were abstracted, de-identified and collated.

The availability of probiotics and donor human milk is associated with improved survival in very preterm infants.

Background: To determine whether the introduction of pasteurized donor human milk and probiotics for infants born < 32 weeks gestational age or < 1500 g birthweight is associated with a reduction in mortality and the incidence of necrotising enterocolitis (NEC) and sepsis.

Methods: We performed a retrospective analysis of two cohorts: before and after the introduction of probiotics and pasteurised donor human milk. Univariate analysis of primary and secondary outcomes was performed; variables impacting outcomes were assessed using multivariate logistic regression.

PD-1 Blockade with Cemiplimab in Advanced Cutaneous Squamous-Cell Carcinoma.

Background: No systemic therapies have been approved for the treatment of advanced cutaneous squamous-cell carcinoma. This cancer may be responsive to immune therapy, because the mutation burden of the tumor is high and the disease risk is strongly associated with immunosuppression. In the dose-escalation portion of the phase 1 study of cemiplimab, a deep and durable response was observed in a patient with metastatic cutaneous squamous-cell carcinoma.

Gout, Hyperuricemia, and Crystal-Associated Disease Network Consensus Statement Regarding Labels and Definitions for Disease Elements in Gout.

Objective: The language currently used to describe gout lacks standardization. The aim of this project was to develop a consensus statement on the labels and definitions used to describe the basic disease elements of gout.

Methods: Experts in gout (n = 130) were invited to participate in a Delphi exercise and face-to-face consensus meeting to reach consensus on the labeling and definitions for the basic disease elements of gout.

Infusion-fill method versus standard auto-fill trial of void protocol following a TVT-exact procedure: A randomised controlled trial.

Objective: To establish whether the infusion method trial of void (TOV) after a mid-urethral sling procedure, in contrast to the standard auto-fill TOV, permits discharge home from recovery, as these procedures are eminently suited to same day discharge, and the delay in achieving a successful TOV often keeps the patient in hospital overnight.

Method: A randomised controlled trial performed between December 2014 and April 2016 at the University Hospital, enrolling 40 women undergoing a mid-urethral sling procedure for stress urinary incontinence. The women were randomised to infusion method or auto-fill method TOV.

Pharmacokinetics of meropenem in septic patients on sustained low-efficiency dialysis: a population pharmacokinetic study.

Background: The aim of the study was to describe the population pharmacokinetics (PK) of meropenem in critically ill patients receiving sustained low-efficiency dialysis (SLED).

Methods: Prospective population PK study on 19 septic patients treated with meropenem and receiving SLED for acute kidney injury. Serial blood samples for determination of meropenem concentrations were taken before, during and after SLED in up to three sessions per patient.

Adjunctive Glucocorticoid Therapy in Patients with Septic Shock.

Background: Whether hydrocortisone reduces mortality among patients with septic shock is unclear.

Methods: We randomly assigned patients with septic shock who were undergoing mechanical ventilation to receive hydrocortisone (at a dose of 200 mg per day) or placebo for 7 days or until death or discharge from the intensive care unit (ICU), whichever came first. The primary outcome was death from any cause at 90 days.

Tissue adhesive for vascular access devices: who, what, where and when?

Despite vascular access devices (VADs) being vital for patient care, device failure rates are unacceptably high with around 25% of central venous devices, and 30-40% of peripheral venous devices, developing complications that result in VAD failure. The use of tissue adhesive is a novel method of securing VADs and is gaining popularity, however the evidence base guiding its clinical use is still emerging. This article aims to review the types and properties of tissue adhesives, provide an overview of the existing evidence base, and discuss how tissue adhesives may be used in clinical practice.

Building psychosocial capacity through training of front-line health professionals to provide brief therapy: lessons learned from the PROMPT study.

Purpose: This report describes the views of front-line health professionals who participated in a randomised controlled trial examining a model of care in which depressed cancer patients received a brief psychosocial intervention. Health professionals from four cancer centres received focused training, skill development and clinical supervision in order to deliver the intervention.

Methods: We interviewed 20 health professionals asking them about their perceptions of participation in the study and their views about more widespread implementation of this model of care.

Patterns in use and costs of conventional and biologic disease-modifying anti-rheumatic drugs in Australia.

Objectives: The aim of this study was to characterise the use and costs of subsidising conventional disease-modifying anti-rheumatic drugs (DMARDs) and biologic DMARDs in Australia from 2004-2014 through pharmaceutical benefits schemes.

Methods: Dispensing and expenditure data on conventional and biologic DMARDs were extracted from Medicare Australia and temporal trends were analysed. Medicine use was standardised in terms of the defined daily dose (DDD) per 1,000 population per day (DDD/1,000 population/day).

Rapid Rule-out of Acute Myocardial Infarction With a Single High-Sensitivity Cardiac Troponin T Measurement Below the Limit of Detection: A Collaborative Meta-analysis.

Background: High-sensitivity assays for cardiac troponin T (hs-cTnT) are sometimes used to rapidly rule out acute myocardial infarction (AMI).

Purpose: To estimate the ability of a single hs-cTnT concentration below the limit of detection (<0.005 µg/L) and a nonischemic electrocardiogram (ECG) to rule out AMI in adults presenting to the emergency department (ED) with chest pain.

Fatigue Self-Management Behaviors in Patients With Advanced Cancer: A Prospective Longitudinal Survey.

Purpose/objectives: To explore the fatigue self-management behaviors and factors associated with effectiveness of these behaviors in patients with advanced cancer.
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Design: Prospective longitudinal interviewer-administered survey.

Identification and outcomes of clinical phenotypes in amyotrophic lateral sclerosis/motor neuron disease: Australian National Motor Neuron Disease observational cohort.

Objective: To capture the clinical patterns, timing of key milestones and survival of patients presenting with amyotrophic lateral sclerosis/motor neuron disease (ALS/MND) within Australia.

Methods: Data were prospectively collected and were timed to normal clinical assessments. An initial registration clinical report form (CRF) and subsequent ongoing assessment CRFs were submitted with a completion CRF at the time of death.

A tiered multidisciplinary approach to the psychosocial care of adult cancer patients integrated into routine care: the PROMPT study (a cluster-randomised controlled trial).

Purpose: A stepped-wedge cluster-randomised controlled trial was conducted to evaluate the feasibility and effectiveness of a brief psychosocial intervention for depressed cancer patients, delivered by trained front-line health professionals in routine clinical care.

Methods: Nine hundred two patients were assessed across four treatment centres which were allocated in random order from control epoch to intervention epoch. Eligible patients had Hospital Anxiety and Depression Scale (HADS) scores of 8 or greater.

A Prospective Study of Sudden Cardiac Death among Children and Young Adults.

Background: Sudden cardiac death among children and young adults is a devastating event. We performed a prospective, population-based, clinical and genetic study of sudden cardiac death among children and young adults.

Methods: We prospectively collected clinical, demographic, and autopsy information on all cases of sudden cardiac death among children and young adults 1 to 35 years of age in Australia and New Zealand from 2010 through 2012.