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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. 

Searching for Strep A in the clinical environment during a human challenge trial: a sub-study protocol

Streptococcus 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.

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

Defining research priorities and needs in cancer symptoms for adults diagnosed with cancer: an Australian/New Zealand modified Delphi study

This study asked consumers (patients, carers) and healthcare professionals (HCPs) to identify the most important symptoms for adults with cancer and potential treatment interventions.

Evaluating the role of asymptomatic throat carriage of Streptococcus pyogenes in impetigo transmission in remote Aboriginal communities in Northern Territory, Australia: a retrospective genomic analysis

Streptococcus pyogenes, or group A Streptococcus (GAS), infections contribute to a high burden of disease in Aboriginal Australians, causing skin infections and immune sequelae such as rheumatic heart disease. Controlling skin infections in these populations has proven difficult, with transmission dynamics being poorly understood. We aimed to identify the relative contributions of impetigo and asymptomatic throat carriage to GAS transmission.

Qualitative assessment of healthy volunteer experience receiving subcutaneous infusions of high-dose benzathine penicillin G (SCIP) provides insights into design of late phase clinical studies

Secondary prophylaxis to prevent rheumatic heart disease (RHD) progression, in the form of four-weekly intramuscular benzathine benzylpenicillin G (BPG) injections, has remained unchanged since 1955. Qualitative investigations into patient preference have highlighted the need for long-acting penicillins to be delivered less frequently, ideally with reduced pain.

Walking the walk to include pregnant participants in non-obstetric clinical trials: Insights from the SNAP Trial

Despite several calls for greater inclusion of pregnant people in non-obstetric clinical trials, their systematic exclusion remains common practice. Excluding pregnant individuals from clinical trials may result in unintended consequences such as inadequate treatment of medical conditions in pregnancy, inappropriate dosing of medications, and investigational therapies being used off-label outside of the context of a clinical trial, risking adverse events in the absence of demonstrated efficacy.

Culturally supported health promotion to See, Treat, Prevent (SToP) skin infections in Aboriginal children living in the Kimberley region of Western Australia: a qualitative analysis

While there are many skin infections, reducing the burden of scabies and impetigo for remote living Aboriginal people, particularly children remains challenging. Aboriginal children living in remote communities have experienced the highest reported rate of impetigo in the world and are 15 times more likely to be admitted to hospital with a skin infection compared to non-Aboriginal children.

Impact of mitral regurgitation on left ventricular remodeling and function in children with rheumatic heart disease

The impact of mitral regurgitation from pediatric rheumatic heart disease and its effect on left ventricular remodeling and function following surgical intervention is uncertain. The objective is to explore the impact of mitral valve surgeries on myocardial mechanics, remodeling and function and identify pre-operative predictors of post-operative dysfunction which may contribute to the optimal timing of intervention.

Consumer perspectives on simplified, layered consent for a low risk, but complex pragmatic trial

For decades, the research community has called for participant information sheets/consent forms (PICFs) to be improved. Recommendations include simplifying content, reducing length, presenting information in layers and using multimedia. However, there are relatively few studies that have evaluated health consumers' (patients/carers) perspectives on the type and organisation of information, and the level of detail to be included in a PICF to optimise an informed decision to enter a trial.