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Odette Dawkins

Clinical Trial Manager

I am the Trial Manager for the FORENSIC-UK trial, looking at the clinical and cost-effectiveness of lumbar fusion surgery for patients with persistent, severe low back pain:

FORENSIC-UK is a  multicentre, two arm, randomised controlled superiority trial considering lumber fusion surgery vs best conservative care. The trial has an internal pilot, integrated Quintet Recruitment Intervention (QRI) & health economic analysis.  

Lumbar fusion is an operation in which vertebrae are fixed together to reduce or alleviate chronic low back pain (LBP). Uncertainty exists over its effectiveness, especially compared to conservative care. Some previous and larger trials have led to the National Institute for Clinical Excellence (NICE) stating that fusion surgery should only be used in a randomised controlled trial (RCT).

Because of these guidelines the frequency of surgery has reduced substantially in the UK. However, there is a concern that in specific situations, i.e., when patients have failed non-surgical treatments, spinal fusion may still be useful and provide a beneficial option in appropriate patients.

The aim of FORENSIC-UK is:

1) To test for superiority of lumbar fusion surgery versus continued best conservative (non-surgical) care on disability (physical function) in patients with severe persistent LBP and lumbar degenerative disease.

2) To investigate the cost-effectiveness of lumbar fusion surgery compared with continued best conservative care.

 

I joined the University of Oxford in 2018 initially working with the Nuffield Department of Tropical Medicine then with the Nuffield Department of Surgical Sciences where my career pathway moved completely into clinical trials and joined the Surgical Interventional Trials Unit (SITU).

I have worked on a number of trials including TRANSLATE: A randomised controlled trial comparing Transrectal biopsy vs local anaesthetic Transperineal biopsy in evaluation of men with potentially clinically significant prostate cancer.

 

I am a Mental Health 1st Aider and have worked with the Equality, Diversity, and Inclusion Committee