Medico-legal considerations

At the start of every NICE guideline it says (emphasis added):

‘The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals and practitioners are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or the people using their service. It is not mandatory to apply the recommendations, and the guideline does not override the responsibility to make decisions appropriate to the circumstances of the individual, in consultation with them and their families and carers or guardian.’

NICE uses wording to differentiate the strength of recommendations¹:

‘Where there is clear and strong evidence of benefit, we will use the word “offer”.’

‘Where the benefit is less certain we use the word “consider”.’

NICE strongly supports the principle of Shared Decision Making and provides a number of resources and guidance².

In 2020 the GMC published new guidance on decision making and consent. This contains a new, strong emphasis on the importance of patient’s values and preferences, advice on how to share decisions, what information should be shared, and how to discuss the benefits and harms of treatments.

Interestingly, the guidance steers clear of defining exactly what information should be provided (e.g., how big a treatment risk should be to require discussion), emphasising proportionality and finding out what matters to a patient.

It is worth reading and is well structured and easy to read and navigate online³.

This landmark case in 2015 changed the standard by which the law judges a doctor’s behaviour. Replacing the previous standard (the Bolam test) which asks whether a decision would be supported by ‘a responsible body of medical opinion’, Montgomery requires a doctor to take ‘reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments.’

Though the case revolved around the disclosure of a specific potential risk and the need for discussion of treatment options, the change in law represented a general shift away from a paternalistic standard, to one which places much more emphasis on information giving and patients’ priorities. It aligns better with GMC guidance and the principles of shared decision making, and can inform our thinking about offering patients treatments for long-term conditions.

The Medical Defence Union highlight two key passages of the judgement relating to “material risks”⁴:

‘The doctor is therefore under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments.

‘The test of materiality is 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 reasonably be aware that the particular patient would be likely to attach significance to it.’

Importantly, there is no defined number, or amount of risk which defines “material risk”. This would be down to the judgement of a court and would be likely to vary depending on the severity of the risk and characteristics of an individual person or the clinical decision.

To be clear, the definition of material risk is with regard to what the patient should be made aware of, rather than what risk they are “allowed” to take – this is entirely up to the individual.

There are no universally agreed criteria for what should be included in the clinical record regarding a treatment decision which does not align with a guideline recommendation.

In the case of a treatment contraindication or side effect, it is relatively straightforward to document this reasoning.

Where a shared decision has been made based on a patient’s circumstances and preferences, documentation of the elements of good shared decision making should provide evidence of practice compatible with the Montgomery judgement⁵. This might include:

• a record of the patients preferences and priorities
• a record of which treatment options were offered and discussed
  • The BRAN formula (Benefits, Risks, Alternatives, do Nothing – see the Shared Decision Making section) provides a useful framework.
• reference to a trustworthy data source or a decision aid if used to support the conversation
• plans for follow-up or revisiting the decision where appropriate

The detail of note keeping should be proportionate to the degree of clinical importance or level of risk of the decision.

Additional sources of documentation such as consent forms, follow-up letters or electronic communications to patients may provide supportive evidence of good quality consent, but are not compulsory. Neither are they a total guarantee of medico-legal security.