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Applying causal inference and Bayesian statistics to understanding vaccine safety signals using a simulation study

Community perception of vaccine safety influences vaccine uptake. Our objective was to assess current vaccine safety monitoring by examining factors that may influence the availability of post-vaccination survey data, and thereby the specificity and sensitivity of existing signal detection methods.

Platform trial in COVID-19 priming and BOOsting (PICOBOO): The immunogenicity, reactogenicity and safety of seven licensed COVID-19 vaccines delivered as fifth dose or subsequent boosters

PICOBOO is a randomised, adaptive trial evaluating the immunogenicity and reactogenicity of licensed COVID-19 booster vaccines in immunocompetent individuals >12 years old. Here, we present data for seven different vaccines among three pre-specified participant strata defined by age and primary vaccine schedule.

Evaluating the impact of the ‘Blow, Breathe, Cough’ health promotion intervention in resolving otitis media with effusion in children: An adaptive randomized-controlled trial protocol

Otitis media with effusion (OME) affects hearing, speech development, and quality of life (QoL) in children. The 'Blow, Breathe, Cough' (BBC) intervention promotes nasal, respiratory, and middle ear clearance through nose blowing, deep breathing, coughing, and hand hygiene. It shows promise in resolving OME but lacks randomized-controlled trial (RCT) evaluation. This paper presents a RCT protocol evaluating BBC's effect on OME resolution, hearing, speech, and QoL in children aged two to seven years.

Yarning with a remote Aboriginal community about the next steps for achieving healthy skin

Skin health is widely recognised as being important for overall good health and well-being, yet the burden of skin infections in remote Aboriginal communities remains high. This project aimed to explore if virtual support for skin health could be a strategy to reduce community barriers to skin health engagement. 

What is the quality of evidence informing vaccine clinical practice recommendations in Australia?

Vaccine policy and guideline recommendations require high quality evidence. A review of the evidence quality used to inform vaccine clinical practice guidelines could help guide researchers on how to improve the design of their clinical studies to produce evidence of greater value to decision-makers.

among children with pneumonia using a causal Bayesian network

Pneumonia remains a leading cause of hospitalization and death among young children worldwide, and the diagnostic challenge of differentiating bacterial from non-bacterial pneumonia is the main driver of antibiotic use for treating pneumonia in children. Causal Bayesian networks (BNs) serve as powerful tools for this problem as they provide clear maps of probabilistic relationships between variables and produce results in an explainable way by incorporating both domain expert knowledge and numerical data.

Core protocol for the adaptive Platform Trial In COVID-19 Vaccine priming and BOOsting (PICOBOO)

The need for coronavirus 2019 (COVID-19) vaccination in different age groups and populations is a subject of great uncertainty and an ongoing global debate. Critical knowledge gaps regarding COVID-19 vaccination include the duration of protection offered by different priming and booster vaccination regimens in different populations, including homologous or heterologous schedules.

BEAT CF pulmonary exacerbations core protocol for evaluating the management of pulmonary exacerbations in people with cystic fibrosis

Cystic fibrosis (CF) is a rare, inherited, life-limiting condition predominantly affecting the lungs, for which there is no cure. The disease is characterized by recurrent pulmonary exacerbations (PEx), which are thought to drive progressive lung damage. Management of these episodes is complex and generally involves multiple interventions targeting different aspects of disease. The emergence of innovative trials and use of Bayesian statistical methods has created renewed opportunities for studying heterogeneous populations in rare diseases.

FeBRILe3: Caregiver Satisfaction With Early Discharge of Febrile Infants Under 3 Months Old

Although evidence supports clinicians to "safely do less" for febrile infants assessed as low risk of serious bacterial infection (SBI), early discharge may increase caregiver concern and reduce satisfaction with care. We captured the self-reported satisfaction and concerns for families enrolled in the study of fever, blood cultures and readiness for discharge in infants less than 3 months old (FeBRILe3), a prospective safety assessment of early discharge of low-risk febrile infants, to aid evaluation of this practice. 

Does adjunctive clindamycin have a role in Staphylococcus aureus bacteremia? A protocol for the adjunctive treatment domain of the S. aureus Network Adaptive Platform (SNAP) randomized controlled trial

The use of adjunctive antibiotics directed against exotoxin production in Staphylococcus aureus bacteremia (SAB) is widespread, and is recommended in many guidelines, but there is limited evidence underpinning this.