Adaptive platform trials rather than randomised controlled trials for paediatric sepsis.
Elliot LongAndrew DavidsonKatherine J LeeFranz E BablShane GeorgePublished in: Emergency medicine Australasia : EMA (2024)
Adaptive platform trials (APTs) offer a promising alternative to traditional randomised controlled trials for evaluating treatments for paediatric sepsis. Randomised controlled trials, despite being the gold standard for establishing causality between interventions and outcomes, make many assumptions about disease prevalence, severity and intervention effects, which are often incorrect. As a result, the evidence for most treatments for paediatric sepsis are based on low-quality evidence. APTs use accrued data rather than assumptions to power trial adaptations. They can assess multiple treatments simultaneously with shared research infrastructure. As such, APTs offer a more efficient, flexible and more effective way to identify optimal treatments. The proposed Paediatric Adaptive Sepsis Platform Trial, leveraging the Paediatric Research in Emergency Departments International Collaborative network's infrastructure, will evaluate resuscitation fluids, vasoactive medications, corticosteroids and antimicrobials. This trial has the potential to substantially impact clinical practice and reduce global sepsis mortality in children.
Keyphrases
- intensive care unit
- septic shock
- acute kidney injury
- emergency department
- phase iii
- study protocol
- clinical trial
- clinical practice
- high throughput
- phase ii
- randomized controlled trial
- risk factors
- young adults
- physical activity
- type diabetes
- cardiovascular disease
- electronic health record
- quality improvement
- skeletal muscle
- weight loss
- climate change
- glycemic control