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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. 

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%.

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.

Immune impacts of infant whole-cell and acellular pertussis vaccination on co-administered vaccines

We compared the effect of a heterologous wP/aP/aP primary series (hereafter mixed wP/aP) versus a homologous aP/aP/aP primary schedule (hereafter aP-only) on antibody responses to co-administered vaccine antigens in infants and toddlers.

FeBRILe3: Risk-Stratification and Diagnosis of Serious Bacterial Infections in Febrile Infants Less Than 3 Months Old

Evidence-based recommendations exist for early discharge (before 48 h) of young infants with fever without source (FWS) at low risk of serious bacterial infections (SBIs). However, concerns regarding the applicability of international data to local contexts may hinder implementation. We aimed to describe the local epidemiology of FWS and evaluate a newly implemented risk-stratification guideline to support practice change.

Establishing the lowest penicillin concentration to prevent pharyngitis due to Streptococcus pyogenes using a human challenge model (CHIPS)

The in-vivo plasma concentration of penicillin needed to prevent Streptococcus pyogenes pharyngitis, recurrent acute rheumatic fever, and progressive rheumatic heart disease is not known. We used a human challenge model to assess the minimum penicillin concentration required to prevent streptococcal pharyngitis.

Short term safety profile of respiratory syncytial virus vaccine in adults aged ≥ 60 years in Australia

Australia's active vaccine safety surveillance system AusVaxSafety monitors a number of vaccines, including Arexvy, by reporting on solicited adverse events following immunisation (AEFI) through an online survey sent to vaccinees 3 days post-vaccination as previously described.3 Here we report on survey responses from adults aged ≥60 years receiving Arexvy at primary healthcare practices or pharmacies, who responded to the survey by day 7 post-vaccination.

Transparent reporting of adaptive clinical trials using concurrently randomised cohorts

Adaptive 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. 

The Unintended Impact of COVID-19 Associated Non-Pharmaceutical Interventions on Paediatric Hospital Admissions: An Interrupted Time Series Analysis

COVID-19 related non-pharmaceutical interventions (NPIs) disrupted global healthcare utilisation, with notable declines in infection related paediatric hospitalisations. We aimed to identify non-infectious paediatric conditions for which the incidence of hospital admissions increased during the introduction and alleviation of NPIs in 2020.

Immunogenicity of a Third Scheduled Dose of Rotarix in Australian Indigenous Infants: A Phase IV, Double-blind, Randomized, Placebo-Controlled Clinical Trial

Jonathan Lea-Ann Tom Carapetis AM Kirkham Snelling AM MBBS FRACP FAFPHM PhD FAHMS PhD BMBS DTMH GDipClinEpid PhD FRACP Executive Director; Co-Head,