Consent is changing, and for the better. When I qualified as a doctor in 2006, I remember being asked to consent patients for operations I’d never even seen before. Thankfully this is no longer permitted, neither in law or in our medical culture, but we are still a long way from perfection.
Conversations on consent
Last week I had the privilege of attending ‘Conversations on Consent’ - a learning event run by NHS Resolution (formally the NHS litigation authority). NHS Resolution manages claims and provides indemnity schemes to the NHS in England.
Dr Chaffer, Director of Safety and Learning at NHS Resolution, set the scene for the day by sharing the statistics around litigation and consent. In 2017-18 there was a total of 10,673 clinical claims. Of note, the emergency department (13%) has now overtaken orthopaedic surgery (12%) as the specialty with the greatest number of clinical negligence claims received. The total value of clinical claims received for the year totalled £4,513.2 Million with obstetrics accounting for the large majority of this (48%), despite representing only 10% of the submitted claims.
- Total number of claims in 2017-2018: 10,673
- Total cost of claims in 2017-18: £4.5 billion
- Claims relating to deficiencies in consent (2013-18): 1025
- Cost of claims relating to deficiencies in consent (2013-18): £226 million
Over a 5 years period (2013-18) there were 1025 claims as a direct result of ‘failure to warn,’ or in other words, deficiencies in consent. These consent cases cost £226 million over 5 years.
Hearing from Nadine Montgomery
Whilst startling, these numbers felt removed, and so it was both illuminating and sobering to hear directly from Nadine Montgomery who discussed the details of her case heard by the Supreme Court (Montgomery v Lanarkshire, 2015). Here was a bright, kind, conscientious lady who shared her tragic story of the complications experienced during the birth of her son. Having both type I diabetes and a short stature meant she was at risk of having problems with normal vaginal delivery. However, the alternative of a caesarean section was not adequately discussed. Had she had a caesarean section her son would not have become stuck in her birth canal and would not have developed cerebral palsy.
Nadine Montgomery sharing her sobering story of the events that led toward the Supreme Court judgement.
Previously doctors were judged against the Bolam test (1957) which asks if a group of specialty peers agree with the medical actions in question. The Montgomery verdict has shifted the emphasis away from what a body of medical professionals deem as acceptable to what a reasonable patient would want. The concept of ‘material risk’ was introduced, stating that risks specifically relevant to the patient should be explored and discussed by the doctor with the patient. The point Nadine Montgomery emphasised was not that doctors should be perfect, but that it should not be the doctor who decides whether to withhold discussion of treatment options. The patient has a right to have their risks individualised and available treatment options discussed.
This landmark case has sent shockwaves across the medical community. It has significant implications for how consent should be approached. Nadine summarised Lady Hale’s judgement by saying that this is ”the end of medical paternalism”. It is therefore a requirement that (where capacity exists) we make shared decisions with, but not for, our patients. It was hypothesised that in the future there will be fewer operations performed but with fewer poor outcomes.
Consent on the day of surgery?
Adequate consent is a legal requirement. When asked “What is the legal validity of on the day of surgery consent for elective procedures?” I was interested to hear the views of the expert panel who concluded that risks discussed exclusively on the day of surgery are unlikely to be deemed as valid consent. The supreme court case of Thefaut vs Johnston (2017), highlights the need for there to be “adequate time and space” for valid informed consent.
Panellists: Ian Adams (NHS Resolution), Dr Denise Chaffer (NHS Resolution), Sharon Burton (GMC), Professor Mike McNicholas (Aintree University Hospitals), Vicky Morris (Weightmans), Dr Aron D’Sa (Adenbrooke’s Hospital), and Nadine Montgomery.
It seems clear that we need to move consent forwards in the pathway. A newly appointed Obstetrics & Gynaecology consultant explained how on his first operating list in his new role, he was faced with patients who had not been consented for their procedures. Bravely he refused to proceed with the operations, the manager came down and suggested that he consent them now, but he held his ground, showed the GMC guidance on consent that states for elective procedures a 24-hour cooling off period is required after the discussion of risks. The list was cancelled, the service reconfigured, and the issue hasn’t been repeated now that all patients are consented in clinic in advance of the day of their surgery.
I was surprised to hear of such bravery, but should this not be the norm not the exception? Adequate time allowed for consent is mandatory. It is a legal requirement for the medical practitioner and therefore hospital processes must allow for this. As an audience we were advised that if resource issues prevented this occurring, we should seek senior guidance within the hospital, and could legitimately raise the issue with the GMC.
The usefulness of written information was discussed, and I was reassured to hear that Nadine Montgomery felt that content, written or otherwise, is a valuable aid to support decision making. Furthermore, videos and voice recordings of consent interactions were all felt to be important tools that could be used to aid consent in terms of both understanding and documentation.
What if your patient doesn’t want to know all the information? The answer from the panel was that it is our responsibility to get to know our patients, including an obligation to probe the reasons for not wanting to know. However, with sufficient understanding of such reasons, if a patient chooses that certain information is not shared with them, then it is acceptable to withhold such information.
Towards data-driven shared decision making
Much has occurred in recent years to move the goal-post away from a paternalistic model of decision making towards ensuring adequate discussions of treatment options, including individualised risks and benefits. It is increasingly clear that we will only be able to achieve this with buy in from doctors, hospitals and our patients. The panel expressed hope that emerging technological solutions will help in the quest towards fully informed surgical consent.
Here at Concentric Health we’re building a pan-specialty digital consent platform to support the consent process for the benefit of patients, doctors and hospitals. Our mission is to support truly informed decision, by guiding shared decisions around what matters to the individual, supported by personalised information about the risks and benefits.
The truth is, for each available procedure, clinicians frequently do not know the exact data about what complications occur when and to who. This is not through ignorance but simply that the data does not exist, has not been collected, and is not contemporaneous. Through patient and clinician reported complications and hospital episode statistics we aim to capture this data and present it in a meaningful way so that we help our patients make the right decision for them.
We’re excited about the future, and we’d love to share our journey with you, so get in touch!
We’d like to thank NHS Resolutions for organising an excellent day and for the all the speakers and panel members for their thought-provoking content.