Following the Supreme Court ruling of Montgomery v Lanarkshire Health Board  UKSC 11 the Royal College of Surgeons have very recently published updated guidance advising its members on how to appropriately obtain consent from patients for medical treatment.
The impact of Montgomery
As practitioners will know, the Supreme Court’s 2015 judgment in Montgomery resulted in an award of £5.25m in damages due to a failure to adequately explain the relatively small risk of shoulder dystocia to a diabetic mother, whose son developed cerebral palsy when he suffered a lack of oxygen during delivery. The court ruled that a doctor is under a duty to warn a patient of a material risk inherent in their treatment and to discuss this with them.
What constitutes a material risk will vary from patient to patient and consequently consent has to be patient-specific. The test of materiality is two-fold: whether, in the circumstances of the particular case, a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor is or should be reasonably aware that the particular patient would likely attach significance to it.
The RCS Guidance
The 44 page RCS guidance document, called ‘Consent: Supported Decision-Making – A Good Practice Guide’, was published on 27 October 2016, and is essential reading for those involved in cases concerning allegations of inadequate consent prior to surgical treatment. The guidance is a well-expressed document that seems likely to be followed by similar documentation from other relevant organisations such as the BMA.
The Guidance directly addresses the impact of Montgomery and it is observed that, “the recent changes in case law have highlighted even more the need to tailor information to the patient’s individual needs”. It further acknowledged that Montgomery requires a change in attitude from surgeons in discussions about consent as they are no longer the sole arbiter of determining what risks are material to their patients.
It is expressly recognised that a surgeon has a non-delegable responsibility to have the consent discussion with the patient:
“(The) surgeon discussing treatment with the patient should be suitably trained and qualified to provide the treatment in question and have sufficient knowledge of the associated risks and complications, as well as any alternative treatments available for the patient’s condition.”
The key principles identified in the Guidance can be summarised as follows:
- The purpose of the consent discussion is for the surgeon to give the patient the information they need to make a decision about what treatment or procedure (if any) that they want.
- The discussion has to be tailored to the individual patient. This will require an investment of time to build a relationship to understand their views and values. A patient should be given enough time to make an informed decision and for a complex or life changing decision the discussion may need to take place over more than one session.
- All reasonable treatment options and their implications should be presented side by side by the surgeon and discussed. Information about non-operative care and no treatment should be included. Where possible written documentation describing diagnosis and the available treatment options should be provided. A surgeon providing advice on which treatment they believe is the most conducive to the best health of the patient should do so in an impartial and factual manner. The Guidance states that, “this should be aimed at helping the patient make an informed decision and should not influence the patient to take a course of action that is not in keeping with their wishes, even if this course of action has been proposed by the multidisciplinary team”.
- The material risks for each option should be explained.
- The patient’s consent should be written and recorded.
- Additionally, a written record of the discussion should be made that contains a contemporaneous note of the key points discussed. This record and any written information provided should be included in the patient’s notes.
Matters of concern
In the Guidance the RSC rightly acknowledge the changes are required to the current consent process to seek to avoid its members be placed at risk of a dramatic increase in litigation. However the consequences of the changes are that typical consultation times must increase, that record keeping requirements are more onerous and that surgeons must set aside greater time to comply with consent conversation responsibilities. This seems extremely likely to create tension between surgeons and NHS Trusts who will be concerned about the resource implications of the reduction in time available for surgeons to conduct operations. This likely problem is acknowledged in the Guidance which states that, “the time and workload pressures facing clinical teams pose significant challenges in providing the right level of support to patients throughout the consent process”.
There may also be a potential issue about the circumstances in which it is appropriate for a surgeon to proceed without complying with the consent discussion requirements. The Guidance states that the key principles apply to an elective situation where the patient has time to consider their options and that, “in an urgent or emergency situation where it is imperative to save live and limb, or prevent deterioration, the surgeon will have to proceed with limited discussion or even without consent”. In some cases, categorization and/or the extent of justifiable divergence from the principles in the Guidance may be difficult to determine and the surgeon will need to proceed with care.