A consistent approach to NHS policies on surgical innovation is urgently needed, a landmark study led by the team at the Bristol Centre for Surgical Research has shown.

Published in the British Journal of Surgery yesterday (3 August), the paper ‘Healthcare organization policy recommendations for the governance of surgical innovation: review of NHS policies’, forms part of the INTRODUCE study, funded by the National Institute for Health and Care Research Bristol Biomedical Research Centre.

The study examined hospital policies across England and Wales for the introduction of new invasive procedures and devices to see what level of oversight was required to deliver new surgeries and invasive procedures. Oversight may be from local NHS hospital committees or by research ethics committees with delivery only permitted within formal research studies. The type of oversight is important because it impacts what patients are told about how innovative their procedure is and whether safety data is collected and shared.

One hundred and fifty NHS trusts in England and seven health boards in Wales were approached to share their policies. The vast majority have a written policy, although 20 did not and nine did not respond. Of the 113 policies examined, most stated when new procedures should be referred to the local hospital committee; however, there was variation between policies in terms of what was within their remit. Few gave guidance for when research oversight was needed. Policies often stressed the need to comply with NICE guidance, but just 15 policies included explicit text stating if NICE had classified the procedure as needing research oversight only, then the procedure should only be delivered with research oversight. Policies were also contradictory. Some said that procedures with uncertain outcomes or insufficient evidence of safety and effectiveness should be referred to the local committee; other policies said that when this was the case procedures should be undertaken in research only.

Researchers from the INTRODUCE study are conducting a follow-up study to look at how NHS policies can be clarified and standardised. They are working with national stakeholders and NICE to strengthen the implementation of national guidance in local hospitals.