National stakeholders got together on 4 July 2022 at a workshop organised by the Bristol Biomedical Research Centre (Bristol BRC) to talk about standards for shared decision making and informed consent in surgical innovation. They also discussed how to implement this into the wider health service.
Attendees took part in a lively discussion inspired by presentations they had listened to throughout the day. They shared ideas and expert opinions on how the routine use of information standards such as the core information set for surgical innovation could be encouraged and implemented. They created an action plan for change, as well as setting out key challenges and potential strategies for putting information standards into practice.
The team at the Bristol BRC are now working on summarising the key points from the day. This summary will inform further research to improve shared decision making and informed consent for NHS patients being offered innovative surgical options.
Sir Cyril Chantler (Vice Chair of the Independent Medicines and Medical Devices Safety Review) and Professor Jane Blazeby (Professor of Surgery) talked about key issues in current practice, how patients have been harmed because of innovative procedures and a lack of appropriate informed consent.
Paula Goss (founder of Rectopexy Mesh Victims and Support) gave a moving account of her experience of receiving innovative mesh surgery. Attendees were particularly affected by her testimony:
“It was really powerful to hear Paula’s personal story. I think the reminder that these are people’s actual lives we are talking about is key. This is not a theoretical discussion.”
Dr Daisy Elliott (Research Fellow) and Mr Angus McNair (Consultant Senior Lecturer and NIHR Clinician Scientist) showcased Bristol BRC research in their presentations.
Dr Elliott described how the LOTUS Study explored how innovative procedures have been introduced in NHS hospitals. She explained that many patients were not informed about the novel status of a procedure, nor the possibility of uncertainty or potential risks. They were, however, all optimistically informed about potential benefits.
Mr McNair talked about how the team at the Bristol BRC developed information standards to improve what patients are told during consultation discussions. He described a proposed core information set for surgical innovation — co-designed with patients, clinicians and professional stakeholders. This work is freely available for clinicians and patients to use when talking about innovative invasive and surgical procedures and devices.
The workshop brought together 31 experts in shared decision making and consent, including representatives from the General Medical Council, the Medicines and Healthcare products Regulatory Agency, the National Institute for Health and Care Excellence, the National Institute for Health and Care Research, the Mesh UK Charitable Trust, as well as surgeon innovators, allied health professionals, academics, policy experts, lawyers, ethicists and patients with lived experience of surgical innovation.
This is what patient representatives said about the stakeholder workshop:
“I felt people were genuine in making changes, […] a start in the right direction.”
“I feel the mix of attendees worked very well. I like to think I made very valuable contributions.”
“I think the patient viewpoint is critical. You can’t figure out how to make shared decisions without viewpoints from both sides of the conversation.”