The comprehensive seven-step set of essential information, co-led by the National Institute for Health and Care Research (NIHR) Bristol Biomedical Research Centre (BRC) and the University of Bristol, was published today in the British Journal of Surgery.
It sets out clearly what patients must be told by their surgeon or clinician before undergoing innovative procedures and coincides with the fifth anniversary of the UK Government’s ‘First Do No Harm’ Independent Medicines and Medical Devices Safety Review, which highlighted unacceptable harm experienced by patients and families due to various medical devices and medications.
Co-lead author Angus McNair, Professor in Colorectal Surgery at the University of Bristol Medical School, said: “This is a vital step forward in learning from past mistakes and could be a game changer for improved patient safety and communication. It establishes robust, consistent, and fully transparent processes to make sure patients are given all the important and relevant information they need, including possible associated risks and other available alternatives, before deciding whether to proceed with a new procedure.
“We engaged with a wide range of medical experts, lawyers, ethicists, regulatory and policy bodies, and most crucially patients themselves globally as well as the wider public. Combining their skills, insights and experience with evidence-based research, we have produced core standards which – if adopted internationally – will mean surgical innovation can still advance without potentially compromising safety or transparency for anyone.”
While new surgical techniques and devices are constantly being developed to improve treatment options for patients, unlike medicines, they are not required to undergo a rigorous approval process before being used on patients.
Establishing a Core Information Set (CIS), as presented in this study, was a key recommendation of the UK inquiry’s report which considered various controversial medical interventions, including pelvic mesh implants used to treat conditions like pelvic organ prolapse and stress urinary incontinence.
The CIS states that surgeons must discuss:
- What’s new and different about the procedure
- Possible conflicts of interest
- Reasons for the innovation, including why it’s being recommended for the patient
- Alternative treatments
- Unknowns, including uncertainties about safety, how effective it is, and that the surgeon might abandon or modify the procedure during surgery
- The surgeon’s level of expertise and experience with the innovation
- Governance, oversight and accountability, including how safety will be monitored and how the patient will be compensated if anything goes wrong.
The study analysed more than 200 research publications and involved dozens of global surgeons, anaesthetists, medical directors, regulators, lawyers, and policy makers as well as more than 130 patients.
Its findings highlighted systemic failures to obtain informed consent before patients agreed to be operated on using new surgical techniques and medical devices, such as implanted pelvic mesh which resulted in complications, in some cases life-altering, for scores of women.
The UK inquiry, prompted by public and patient outcry, quoted a woman directly affected by the procedure, who said:
“I feel as though I am an unsuspecting, unwilling participant in a cruel experiment that has gone wrong.”
Professor McNair, who is also a Consultant Colorectal Surgeon at North Bristol NHS Trust, explained:
“Research shows surgeons often don’t tell patients they are using a pioneering technique, leaving them unaware that the procedure isn’t yet fully tried and tested. When surgeons do say it’s new, findings also show they may overstate its benefits or patients can assume that it must be better simply because it’s new.”
“The study aims to address these shortcomings by providing surgeons and clinicians with a step-by-step guide of the specific conversations they must have with patients before and after any new surgical procedure. It captures all the different areas of discussion they need to cover so their patients can make informed choices and, if necessary, know how to seek help and support should anything subsequently go wrong.”
The study, funded by the NIHR Bristol Biomedical Research Centre (BRC) at the at University Hospitals Bristol and Weston NHS Foundation Trust and the University of Bristol, has been submitted to MP Sharon Hodgson, Chair of the cross-party All Parliamentary Group (APPG) First Do No Harm – Mesh, Promodos, Valproate.
Next steps for the study include exploring how to implement the CIS most effectively and integrate it into the Shared Decision Making (SDM) process. This could entail making health service leaders accountable and responsible for embedding it into their organisation in addition to ensuring surgeons and clinicians skills are supported through continual professional development.
