On 27 October 2016 the Royal College of Surgeons (RCS) published its new guidance on consent on the back of the landmark Supreme Court case in April 2015 of Montgomery v Lanarkshire Health Board, with the warning that “NHS trusts risk facing a dramatic increase in the number of litigation pay-outs made if they do not make changes to the processes they use to gain consent from patients before surgery.
The RCS goes on to state in the same press release that the NHS Litigation Authority, the body which handles clinical negligence claims against NHS trusts, paid out more than £1.4 billion in claims during 2015/16. This is an increase of approximately £320 million over the preceding year, although it is also worth noting that new clinical negligence claims registered with the NHS LA fell by 4.6% over the same period. The RCS explains its concerns that the bill to the NHS could increase significantly if hospitals do not take the Montgomery ruling seriously.
It has been over 18 months since the Montgomery judgment and, from a practical perspective, it has certainly seemed (of some concern) as if it has taken longer than it probably should have for some clinicians at the coalface to recognise and appreciate the importance and significance of the case. The RCS’s guidance is welcome, therefore, as hopefully it will focus surgeons’ minds on the issue of consent going forwards; and not just surgeons but all clinicians, as the impact of the case is wider than just the issue of surgical consent.
The guideline published by the RCS is a very comprehensive document setting out in terms the post-Montgomery requirements to ensure proper and adequate informed consent. It sets out on pages 4-5 six key principles which underpin the process of consent, which in summary are:
- The aim is to ensure the patient has the information they need and want with which to make an informed decision about their treatment.
- The discussion must be tailored to the individual patient.
- The clinician must explain to the patient all reasonable treatment options and their pros and cons.
- The clinician must also discuss all “material” risks with the patient. The RCS quotes from the judgment to define “material”, but in essence the term has an objective element, i.e. whether a reasonable person would be likely to attach significance to the risk, and a subjective element, i.e. the doctor should be aware that this particular patient would attach significance to the risk: this is the “patient-specific” element.
- Consent should be written and recorded, with the patient signing the consent form at the end of the discussion. However, the RCS points out that the signing of the form is merely evidence that the discussion has taken place, not that proper informed consent has occurred.
- Finally, a record of the discussion between doctor and patient should be made, including documenting the important factors discussed and the decisions made.
On page 6 the RCS confirms that, “it is essential that all patients have given valid consent for all treatments and investigation … consent refers to the right of patient to decide what, if any, clinical care they are to receive …” This is an acceptance that the judgment does not just affect consent to surgery but is wider and applies to examinations, investigations, etc. There is helpful discussion on pages 8-11 of the principles underlying supported decision-making, including no treatment as an option and acting in the patient’s best interests.
There is then a detailed section on pages 12-19 of the actual consent discussion, setting out exactly what surgeons should provide patients with information about, namely:
- The patient’s diagnosis and prognosis
- The right of the patient to refuse treatment and make their own decisions about their care
- Alternative options for treatment, including non-operative care and no treatment
- Advice on lifestyle that may moderate the disease process
- The purpose and expected benefit of the treatment
- The nature of the treatment (what it involves)
- The likelihood of success
- The clinicians involved in their treatment
- Potential follow-up treatment
- The material risks inherent in the procedure and in the alternative options discussed
- For private patients, costs of treatment and potential future costs in the event of complications.
The document emphasises (page 13) that a doctor should not make assumptions regarding the wishes of a patient, must give advice regarding the treatment that the doctor recommends in an impartial and factual manner and must not allow the doctor’s personal views and preferences to have an impact on their description or emphasis given for the options given. There are further comments on the potential importance of providing written information (page 14), the relevance of the experience of the doctor who is consenting the patient (page 15), the avoidance of problems occurring because of referrals of patients between different specialities (page 16) and the issue of the timeframe between consent and procedure (page 16).
Both the press release and the consent guidance (page 18) recognise the time pressure on doctors which “can leave little opportunity to discuss at length the diagnoses or available treatment options”, and the latter points out that “this does not change the fundament legal requirement that surgeons and doctors allocate sufficient time for a discussion that will allow them to understand the individual patient and their needs”. The Supreme Court in the Montgomery judgment was unequivocal on this point: lack of time for, skill in or inclination for communication is no defence to inadequate consent.
Page 20 sets out a tabulated overview of the consent process. It is a detailed checklist that sets out 10 points for the consenting doctor to follow (as per the below), with even more detail in the accompanying comments (not reproduced below):
- Explain the diagnosis to the patient.
- Explain the options for treatment.
- Explain the consent and decision-making process so the patient understands what is expected of them.
- Time for deliberation and homework for the patient.
- Discuss the patient’s wishes, needs, views and expectations regarding any treatment they might undertake.
- Discuss trade-offs with the patient in light of their needs, goals and expectations.
- Provide any relevant information not already covered, or any emerging information that may have altered the conditions surrounding the various options for treatment.
- Has the patient understood?
- Respect the patient’s decision.
- The signing of the form and maintaining a decision-making record.
The checklist is certainly a comprehensive list and one which, should it be followed by a clinician, would likely guarantee that proper informed consent had been obtained. However, the practical reality of being able to abide by every single aspect of the list in the busy cut and thrust of frontline medicine is perhaps a little more problematic, and some may feel it is an overly burdensome wish list that cannot always be attainable within an under-resourced and increasingly stretched NHS: but only time will tell.
The guidance concludes (pages 23-39) with a helpful bibliography and list of useful resources for reference, with some commentary to assist including on relevant case law and statute.
In conclusion, there can be no doubt that clinicians are now required to take the Court’s ruling seriously and must understand and put into effect the steps necessary to ensure a patient-centred approach to treatment as envisaged by the Court, and the RCS’s guidance is to be welcomed. The Supreme Court was of the view that the long term effect of Montgomery would be to reduce litigation and, if doctors do follow the RCS’s and other recent guidance on consent, and the Court is right, this ultimately will serve to benefit patients, doctors and the NHS, which can only be good news.