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Using causal directed acyclic graphs (DAGs) to select patient-important outcomes in transplantation trials—interventions to treat polyomavirus infection as an exampleTom Snelling BMBS DTMH GDipClinEpid PhD FRACP Head, Infectious Disease Implementation Research 08 6319 1817 tom.snelling@thekids.org.au Head,
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Transparent reporting of adaptive clinical trials using concurrently randomised cohortsAdaptive clinical trials have designs that evolve over time because of changes to treatments or changes to the chance that participants will receive these treatments. These changes might introduce confounding that biases crude comparisons of the treatment arms and makes the results from standard reporting methods difficult to interpret for adaptive trials. To deal with this shortcoming, a reporting framework for adaptive trials was developed based on concurrently randomised cohort reporting.
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FeBRILe3: Safety Evaluation of Febrile Infant Guidelines Through Prospective Bayesian MonitoringDespite evidence supporting earlier discharge of well-appearing febrile infants at low risk of serious bacterial infection (SBI), admissions for ≥48 hours remain common. Prospective safety monitoring may support broader guideline implementation.
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Bacillus Calmette-Guérin vaccination for protection against recurrent herpes labialis: a nested randomised controlled trialRecurrences of herpes simplex virus (HSV) in the orofacial region (herpes labialis or cold sores) impact quality-of-life. We aimed to study whether the bacille Calmette-Guérin (BCG) vaccine can attenuate cold sore recurrences through off-target immunomodulatory effects.
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Searching for Strep A in the clinical environment during a human challenge trial: a sub-study protocolStreptococcus pyogenes (also known as group A Streptococcus , Strep A) is an obligate human pathogen with significant global morbidity and mortality. Transmission is believed to occur primarily between individuals via respiratory droplets, but knowledge about other potential sources of transmission via aerosols or the environment is limited. Such knowledge is required to design optimal interventions to control transmission, particularly in endemic settings.
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West Australian parents’ views on vaccinating their children against COVID-19: a qualitative studyAustralian children and adolescents were among the last local cohorts offered COVID-19 vaccines. Despite promising initial uptake, coverage subsequently plateaued, requiring further efforts to improve access and build parents’ recognition of the importance of COVID-19 vaccination.
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Getting to grips with invasive group A streptococcal infection surveillance in Australia: are we experiencing an epidemic?Asha Rosemary Jeffrey Bowen Wyber Cannon BA MBBS DCH FRACP PhD GAICD FAHMS OAM MBChB MPH FRACGP PhD BSc(Hons) BBus PhD Head, Healthy Skin and ARF
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Randomised controlled trial of perinatal vitamin D supplementation to prevent early-onset acute respiratory infections among Australian First Nations children: the 'D-Kids' study protocolGlobally, acute respiratory infections (ARIs) are a leading cause of childhood morbidity and mortality. While ARI-related mortality is low in Australia, First Nations infants are hospitalised with ARIs up to nine times more often than their non-First Nations counterparts.
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Safety of BCG vaccination and revaccination in healthcare workersBCG vaccination and revaccination are increasingly being considered for the protection of adolescents and adults against tuberculosis and, more broadly, for the off-target protective immunological effects against other infectious and noninfectious diseases. Within an international randomized controlled trial of BCG vaccination in healthcare workers (the BRACE trial), we evaluated the incidence of local and serious adverse events, as well as the impact of previous BCG vaccination on local injection site reactions (BCG revaccination).
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A phase 3 study of safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, followed by 23-valent pneumococcal polysaccharide vaccine, in children with HIVTo evaluate the safety and immunogenicity of V114 [15-valent pneumococcal conjugate vaccine (PCV) containing serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9 V, 14, 18C, 19A, 19F, 22F, 23F, 33F], followed by 23-valent pneumococcal polysaccharide vaccine (PPSV23) 8 weeks later, in children with HIV.