OGBN P42 Surgical innovation in the NHS: the role of local hospitals, NICE and the health research authority

Abstract

Abstract Background Innovation in surgery is key to advancing care. Innovation, however, may carry risk. Oversight of innovation therefore is needed to ensure transparent patient consent, learning from adverse events and efficient decision making for innovation scaling-up, non-adoption or abandonment. In the UK this may be regulated by an ethically approved research protocol or by committees in NHS local hospitals. The National Institute of Clinical Excellent (NICE) makes recommendations for appropriate oversight but little is known about interactions between local NHS hospital committees and NICE. We explored decision-making about surgical innovation in the local NHS committees in relation to NICE guidance. Methods A prospective study of five hospitals in England was undertaken between February 2022 and March 2023. Decisions made by the local new procedures committees and meeting minutes were all reviewed. Where NICE guidance was available this was compared to the local hospital decision about the new procedure. Where no guidance was available decisions were recorded and analysed based on available evidence and practice. Whether hospitals referred the innovation to NICE was also recorded. Results In the 12 month period 38 decisions about innovative surgical procedures were made (range 1 to 22 per hospital) in 30 meetings. For 16 innovations NICE guidance was thought to be available and implemented. Further analyses identified that two sets of guidance did not apply (e.g. application of laparoscopic to robotic procedures). 17 innovations were considered at meetings for which NICE guidance was not available. None were referred to NICE. 15 were approved to be undertaken in the hospital, 2 were recommended to seek research ethics approval and 1 was rejected. Conclusions Local hospital committees make important recommendations about the introduction of innovative surgical procedures in the NHS. NICE guidance was sometimes difficult to find and interpret and new procedures were generally not referred to NICE. Few were rejected or recommended for research ethics approval. This approach means that local hospitals have large governance responsibilities and there may be inconsistencies across organisations and patient risk. A national strategy is needed to make surgical innovation transparent and safe.