After examining NHS hospital policies for introducing new surgical and other invasive procedures and devices in England and Wales, scientists, as a part of the INTRODUCE study, found that consistency is required in how surgical innovation is overseen.
New innovations by surgeons enhance patient care. The NHS can be benefitted from innovation when more affordable therapies are found. Management and supervision are essential to innovation. It involves risk because it’s impossible to predict every conceivable result of a novel procedure.
The National Institute for Health and Care Excellence (NICE) provides guidance on new surgical procedures not yet generally considered standard clinical practice in the NHS and provides recommendations about the conditions of safe use. NICE may recommend that a procedure is introduced with: “standard arrangements” (as in normal clinical practice), “special (local) arrangements” (with enhanced patient consent and close monitoring of outcomes), or in “(formal) research studies only,” with research ethics committee approval.
The benefit of oversight is that it ensures patients are aware of how innovative their procedure is, which may affect their decision. Additionally, it implies the gathering and sharing of safety data, which will influence whether the procedure is performed on bigger patient populations.
Scientists in this study wanted to determine how hospitals approached this. They studied hospital policies about the level of oversight required to deliver new surgeries and invasive procedures. They investigated the policies to explore when new procedures could be delivered with standard or special arrangements, overseen by the local hospital committee, and when instead, they needed research ethics approval.
They asked 150 NHS trusts in England and seven health boards in Wale to share their policies. The vast majority have a written policy, although 20 did not, and nine did not respond.
Scientists examined 113 policies that stated- when new procedures should be referred to the local hospital committee. However, there was a difference between policies regarding what was within their remit. However, only a few gave guidance for when research oversight was needed.
Only 15 policies explicitly stated that if NICE had categorized the procedure as needing only research oversight, then the procedure should only be delivered with research oversight. Policies frequently emphasized the necessity to comply with NICE recommendations. Guidelines 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.
A follow-up study is undergoing to determine how NHS policies can be clarified and standardized. Experts are working with national stakeholders and NICE to strengthen the implementation of national guidance in local hospitals.
Jane Blazeby, Professor of Surgery at the University of Bristol and INTRODUCE study lead, said: “These new findings will help us improve how surgical innovation takes place in the NHS.”
Dr. Sian Cousins, Research Fellow at the University of Bristol and lead author, added: “Our work adds to findings from the recent report from Baroness Cumberlege, which identified shortcomings in the process around innovation. We hope to work now with stakeholders to improve surgical innovation in the NHS.”
Mrs. Paula Goss, patient representative, said: “I was shocked by these findings. I had expected that all hospitals follow national guidelines and protocols. I hope this work will improve patients’ safety and experience and that all hospitals take action immediately, making it mandatory.”