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The World Hip Trauma Evaluation (WHiTE) platform trial: a framework for randomized comparisons of interventions for
Matthew L Costa1, Juul Achten1, Duncan Appelbe1
1Oxford Trauma and Emergency Care, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Insights
This study introduces a platform trial framework for efficiently comparing hip fracture treatments. It aims to provide evidence to improve patient outcomes and inform clinical guidelines for hip fracture care.
Area of Science:
- Geriatric Medicine
- Orthopedic Surgery
- Clinical Trials Methodology
Background:
- Hip fracture is a significant global health challenge, with incidence projected to increase dramatically.
- Current management strategies require efficient evaluation of diverse interventions.
Purpose of the Study:
- To describe a platform trial framework for evaluating multiple interventions in fragility hip fracture patients.
- To establish a standardized approach for conducting randomized comparisons within a single trial infrastructure.
Main Methods:
- The World Hip Trauma Evaluation (WHiTE) platform trial will enroll patients aged 60+ with hip fractures.
- Eligible patients can participate in multiple, contemporaneous or sequential randomized comparisons.
- A master protocol details core procedures, with specific interventions detailed in appendix protocols.
Main Results:
- The platform trial is designed to generate robust randomized evidence on intervention effectiveness.
- Focus on clinical and cost-effectiveness of interventions for fragility hip fractures.
Conclusions:
- The WHiTE platform trial will yield crucial evidence to guide national and international management guidelines.
- This framework facilitates efficient research into improving outcomes for hip fracture patients.
Aims:
Hip fracture is one of the biggest challenges facing patients and healthcare systems. Worldwide, there are currently 1.3 million hip fractures per year, projected to rise to more than six million by 2050. This protocol describes a platform trial framework, designed to efficiently deliver multiple randomized comparisons of interventions for patients with a fragility hip fracture.
Methods:
All patients aged 60 years and over with a hip fracture presenting to the World Hip Trauma Evaluation (WHiTE) recruitment centres will be considered for eligibility for each of the randomized comparisons appended to the platform at the time of recruitment. They will be offered the opportunity to take part in any or all of the randomized comparisons for which they are eligible. Comparisons may be contemporaneous or distributed throughout the treatment pathway. This master protocol describes the trial procedures, core dataset, and documentation. It describes those components of the research process which will be consistent between randomized comparisons. Where additional procedures are planned, specific to a randomized comparison, these will be described in a separate appendix protocol for that randomized comparison.
Conclusion:
The WHiTE platform trial will provide randomized evidence regarding the clinical and cost-effectiveness of interventions to improve outcomes for patients with fragility hip fracture. Findings will inform national and international policy and practice guidelines for the management of patients with a hip fracture.
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