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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.
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.
Recruitment in research can be challenging in Australian Aboriginal contexts. We aimed to evaluate the SToP (See, Treat, Prevent skin infections) trial recruitment approach for Aboriginal families to identify barriers and facilitators and understand the utility of the visual resource used.
Staphylococcus aureus bloodstream (SAB) infection is a common and severe infectious disease, with a 90-day mortality of 15%-30%. Despite this, <3000 people have been randomized into clinical trials of treatments for SAB infection.
Impetigo or skin sores are estimated to affect >162 million people worldwide. Detailed descriptions of the anatomical location of skin sores are lacking.
Acute rheumatic fever and rheumatic heart disease disproportionately affect Aboriginal and Torres Strait Islander people in Australia, with devastating impacts on morbidity, mortality and community wellbeing. Research suggests that general practitioners and primary care staff perceive insurmountable barriers to improving clinical outcomes, including the need for systemic change outside their scope of practice.
A high burden of bacterial skin infections is well documented in remote-living Indigenous children and young people in high-income countries.
Achieving healthy skin requires the prevention of infectious diseases that affect the skin. Prevention activities range from environmental health improvements to address inequities in living situations, through to community-wide treatment programs to reduce transmission and improve skin health.
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.
Vaccine development and implementation decisions need to be guided by accurate and robust burden of disease data. We developed an innovative systematic framework outlining the properties of such data that are needed to advance vaccine development and evaluation, and prioritize research and surveillance activities.