Most healthcare professionals feel considerable pressure to follow guidelines (and respond to other performance metrics) to the letter. This can hinder their ability to make genuinely appropriate decisions with an individual, for whom sticking exactly to the guideline may not be the best thing.
Using information on this website may open up the possibility of deviating from guidelines (or what might be defined as standard “best” practice by other sources).
In this section, we highlight key statements from authorities on this issue, to support your decision making.
The bottom line is that:
What does NICE say?
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.
General Medical Council Guidance on Decision Making and Consent
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.
The Montgomery Judgement
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:
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.
Individualised, person-centred care underpinned by good quality evidence, clinical judgement and shared decision-making has always been the aim of evidence-based practice.
Clinical guidelines are an important part of this, but were never intended to rigidly enforce treatments for individuals. “Guidelines, not tramlines” was a recurring message from the former Chair of NICE, Professor Sir David Haslam.
The threat of complaints, litigation or censure from external bodies can loom large in the minds of people working in healthcare. However, the fear of this is probably out of proportion to the likelihood of a successful case against them.
A clinician practising good quality shared-decision making, supported by the best evidence available to them, and who adequately documents this process, has the law on their side.
References and resources
1)Making Decisions Using NICE Guidance. Accessed December 2022.
2)NICE Shared Decision Making. Accessed December 2022.
3)GMC Guidance on Decision Making and Consent. Accessed December 2022.
4)Montgomery and Informed Consent. Medical Defence Union Guidance and Advice. Online publication Nov 2020. Accessed December 2022.
5)The Relationship Between Realistic Medicine and Consent. Blog. Michael Stewart, Head of Litigation, NHS Scotland Central Legal Office. Accessed December 2022
This website is designed for use by General Practitioners and other healthcare professionals. The content is not exhaustive and assumes a standard level of GP professional knowledge. The information here is intended to support clinical judgement and shared decision making alongside clinical guidelines and standard practice.
If you are a patient/member of the public, do feel free to look around, but please don’t make any changes to your treatments based on information here. If you find something which seems relevant to you, you could show this website to your healthcare professional to help a discussion.