Improving how surgical procedure modifications are reported

The way new surgical procedures are developed and evaluated is very different to how new drugs are developed and evaluated. It is common for surgeon innovators to adjust (modify) a procedure as they perform it more often.

These modifications are often based on a surgeons’ reflections and experiences of performing the procedure and its outcomes. Surgeons may not always document these modifications or share them with colleagues.

This creates a lack of transparency surrounding ‘successful’ and ‘unsuccessful’ modifications. It can:

• Make evaluating a procedure difficult
• Create variation between how surgeons and centres perform a procedure
• Make it difficult to understand when a new procedure has stopped being modified and is ready to be evaluated by being compared with existing treatments
• Have the potential to perpetuate harm to patients – this could be when different surgeons make the same modification that’s detrimental to patients or when they don’t share a modification that could be beneficial to patients

Project aims

To develop and refine a framework for the identification, classification, and reporting of modifications to innovative surgical procedures.

What we hope to achieve

We need to improve how modifications occurring during surgical innovation are understood and reported. This will help surgeons share learning in a transparent way.

It will also improve our understanding of how to we can establish the point at which a new procedure has stopped being modified and is stable enough to be evaluated.

Ultimately, this will lead to improved safety, transparency and efficiency of evaluation.

This research project is being led by James Olivier, with supervision being provided by Rhiannon Macefield, Natalie Blencowe, Daisy Elliott and Kerry Avery.