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Characteristics, treatment and lung function outcomes of pulmonary exacerbations in cystic fibrosis: insights from the BEAT-CF cohort

Pulmonary exacerbations pose a significant clinical burden on people with cystic fibrosis (pwCF). Whether management of exacerbations should change in the context of modulator therapy is unclear. We describe the characteristics, treatment and lung function outcomes of pulmonary exacerbations requiring intravenous antibiotic therapy (PERITs) in a contemporary Australian cohort of pwCF, in an era of rapidly broadening access to modulator therapy.

Research Priorities for Inpatient General Paediatrics in Australia and New Zealand: A Modified Delphi Study

To develop consensus on the priorities for multi-centre, inpatient general paediatrics research in Australia and New Zealand.

BEAT-BK: An Adaptive, Randomized Controlled Trial to Treat Polyomavirus Infections (BKPyV) in Kidney and Kidney-pancreas Transplantation Recipients (BEAT-BK) Study Protocol

BK polyomavirus (BKPyV) is a common opportunistic infection in kidney transplant recipients, typically reactivating in the context of immunosuppression. Although asymptomatic in immunocompetent individuals, reactivation in transplant recipients can cause BKPyV-associated nephropathy (BKPyVAN), a leading cause of graft dysfunction and loss. BKPyV viremia affects approximately 10%-15% of transplant recipients, and once BKPyVAN is established, the risk of graft failure can exceed 50%.

A Pragmatic Bayesian Adaptive Trial Design Based on the Value of Information: The Value-Driven Adaptive Design

Clinical trial designs are typically narrowly focused on error control in hypothesis testing, but this approach is inadequate in many contexts, particularly when a decision maker intends to, or must, consider multiple relevant clinical and health economic outcomes under uncertainty. Value-of-information (VoI) metrics can be used to estimate the monetary value of data collection to the decision maker. 

Short-Term Safety and Adverse Event Risk Profiles for SARS-CoV-2 Booster Vaccine Doses in Australian Adults: A Survey Study

This study quantifies the short-term risk profiles of seven severe acute respiratory syndrome coronavirus 2 virus (SARS-CoV-2) vaccines-Comirnaty Bivalent BA.1, Comirnaty Bivalent BA.4-5, Comirnaty XBB.1.5, Spikevax Bivalent BA.1, Spikevax Bivalent BA.4-5, Spikevax XBB.1.5 and Nuvaxovid-administered as booster doses in Australia.

Protocol for establishing a core outcome set for evaluation in studies of pulmonary exacerbations in people with cystic fibrosis

Pulmonary exacerbations are associated with increased morbidity and mortality in people with cystic fibrosis (CF). There is no consensus about which outcomes should be evaluated in studies of pulmonary exacerbations or how these outcomes should be measured.

The short term safety of COVID-19 vaccines in Australia: AusVaxSafety active surveillance, February – August 2021

To assess the short term safety of the COVID-19 vaccines Comirnaty (Pfizer–BioNTech BNT162b2) and Vaxzevria (AstraZeneca ChAdOx1) in Australia.

Short- versus standard-course intravenous antibiotics for peri-prosthetic joint infections managed with debridement and implant retention: a randomised pilot trial using a desirability of outcome ranking (DOOR) endpoint

Peri-prosthetic joint infection (PJI) is a devastating complication of joint replacement surgery. Determining the optimal duration of intravenous (IV) antibiotics for PJI managed with debridement and implant retention (DAIR) is a research priority.

Off-target effects of bacillus Calmette-Guerin vaccination on immune responses to SARS-CoV-2: implications for protection against severe COVID-19

Because of its beneficial off-target effects against non-mycobacterial infectious diseases, bacillus Calmette-Guérin vaccination might be an accessible early intervention to boost protection against novel pathogens. Multiple epidemiological studies and randomised controlled trials are investigating the protective effect of BCG against coronavirus disease 2019 (COVID-19).

Statistical analysis plan for the OPTIMUM study: optimising immunisation using mixed schedules, an adaptive randomised controlled trial of a mixed whole-cell/acellular pertussis vaccine schedule

The purpose of this double-blind, randomised, controlled trial is to compare allergic outcomes in children following vaccination with acellular pertussis (aP) antigen (standard of care in Australia) given at 2 months of age versus whole cell pertussis (wP) in the infant vaccine schedule.