We often assume that new is better but when things don’t work out as hoped, it’s a different story. This is the culture of surgical innovation. Robots, gadgets, and other novel ways of operating are exciting and they generate attention. Surgeon enthusiasm for improving outcomes sweeps patients along. They agree to undergo new procedures and information about uncertainties and ‘unknown unknowns’ is downplayed. Informed consent is jeopardised by surgeon optimism bias. If a patient is harmed, they may feel hoodwinked, data might not be shared, and lessons might not be learnt.
When this happens, public enquiries have been initiated and, on some occasions, followed by legal proceedings. An independent inquiry in 2020 led by Baroness Cumberlege investigated the introduction of new medical devices, concluding that improvements must be made. This is why it is important to re-consider the way in which surgical innovation occurs. We need to look at patient information, regulatory oversight, and reporting of innovative surgical procedures.
Over the past five years members of the surgical and orthopaedic innovation theme of the National Institute for Health and Care Research Bristol Biomedical Research Centre have explored this. The INTRODUCE study (Cousins et al. 2019 BMJ Open and BJS 2022) retrieved NHS hospital policies from England and Wales and scrutinised them in-depth to understand how local governance is provided for innovative surgical procedures. The LOTUS study (Elliot et al BMJ Open 2020 and Annals of Surgery 2023) interviewed surgeons and patients and recorded their consultations in which surgical innovation was discussed.
The team unearthed that in consultations when patients are asked for informed consent for a new procedure, key information was often lacking. For example, a minority of surgeons communicated the uncertainty about safety or told the patient that they had limited experience with the new procedure. This meant that patients may not realise how new the procedure is and be aware of potential risks. This happens despite surgeons intending to be open and transparent about the novelty of procedure and unknown risks. It was found that surgeon innovators uniformly shared the theoretical benefits of the innovation – optimism bias.
Although the way that surgical innovation occurs in the NHS is currently quite different to the rigorous approach taken for new drugs it is hoped that this will soon change. Members of the Bristol BRC are collaborating with NHS trusts, national bodies and patients and the public to improve things. This will strengthen and tighten the current system and close existing loopholes: it will increase patient safety. One of the people we are working with is Paula Goss, founder of campaign group Rectopexy Mesh Victims and Support. She says: ‘I feel that information for patients about new procedures needs to be more carefully regulated. It needs more oversight. Surgeons need to be transparent and truthful as do the healthcare settings to know what is most important in the care and information provided to their patients.’
Jane Blazeby is Professor of Surgery at University of Bristol, University Hospitals Bristol, and Weston and the NIHR Bristol Biomedical Research Centre.