Patients are not given sufficient information about the novel status of a procedure, possible uncertainties or potential risks when deciding to go ahead with the procedure, research led by the University of Bristol and published in the Annals of Surgery has found.
The study, funded by the National Institute of Health and Care Research Bristol Biomedical Research Centre (NIHR Bristol BRC), is one of the first pieces of work to investigate these issues and examine exactly what patients are told about innovative surgical procedures.
Whilst surgical innovation is crucial to improving outcomes, an independent safety review led by Baroness Cumberlege highlighted that patients may not be getting all the information they need before undergoing new procedures. Current guidance says that patients need to be given enough information to fully consider the risks and benefits of a new procedure.
To investigate current practice, the study team looked at consultations between surgeons and patients in which new procedures were discussed. They focused on seven different procedures that were being introduced in five NHS hospitals. Nine clinicians carrying out innovative procedures were also interviewed about what they wanted to tell patients.
Researchers found that clinicians fully intended to discuss the innovative nature of the procedures but admitted these conversations could be difficult. The team audio-recorded 37 consultations between clinicians and patients during which innovative procedures were discussed.
The recordings revealed only a minority of clinicians talked explicitly about the procedure being innovative, their limited experience with it, the lack of evidence and uncertainty of what the outcome would be. The study also showed that all the clinicians were optimistic about the benefits of a new type of procedure, but often did not discuss the potential risks associated with it.
Thirty post-operative interviews were then conducted with patients. Researchers did this to understand what patients thought about the information they had been given.
Patients reported having a strong sense of trust in their clinicians and described feeling reassured by their confident attitude. They also picked up on the enthusiasm of clinicians towards procedures that they considered 'the future'. Many thought the procedures were more established than they actually were and felt that they were not told about potential disadvantages of undergoing the new procedure.
This study provides important insights into the communication process surrounding innovative surgical procedures and devices. Despite the clinicians' best intentions, many patients weren't fully informed about innovative procedures. Whilst there is often a belief that 'new is better', this research highlights that clinicians can find it difficult to provide neutral and balanced information in this context. A major focus of our work at the Bristol BRC will be to work with clinicians to provide support and training, so that patients can make well informed decisions about undergoing new procedures."
Dr Daisy Elliott, Lead Author and Research Fellow in the Bristol Medical School: Population Health Sciences (PHS)
Paula Goss, founder of Rectopexy mesh victims and support and ambassador for Mesh UK, added: "Fully informed consent discussions are crucial for patient safety for all procedures. Consultants and nurses should speak to patients thoroughly and transparently, allow recording of the consultations for patients to think about the information provided, and patients should be able to continue a dialogue to ask any question before any procedure. This should be a mandatory requirement for all hospitals and healthcare settings. Thorough in-depth patient involvement at every stage is the only way to provide and correct the issue of lack of trust that arises commonly with patients about to undergo any procedure."
Jane Blazeby, Professor of Surgery in the Bristol Medical School: (PHS) and project lead, said: "To our knowledge this is the first time that conversations between clinicians and patients discussing innovative surgical procedures have been investigated. It highlights the need for a standard approach that provides clear and unbiased information for patients. This is our next plan to improve this process to benefit patients, surgeons and the NHS."
Elliott, D., et al. (2023) What Are Patients Told About Innovative Surgical Procedures? A Qualitative Synthesis of 7 Case Studies in the United Kingdom. Annals of Surgery. doi.org/10.1097/SLA.0000000000005714.