Following high profile cases on consent, most notably Montgomery vs Lanarkshire (2015) and Chester vs Afshar (2014), the importance of the consent process has been brought into considerable focus. Many clinicians are ensuring that they advise about potential risks and benefits of a procedure, and understanding whether a risk is material to a patient. Clinicians are also understanding the importance of consent as a journey - as opposed to a “one-stop” process - where patients are given increased opportunity to discuss their treatment option, receive more detailed information, and have time to consider their options.
However, recent Medical Protection data has shown an increasing number of claims relating to an alleged failure to explain alternative treatment options, including the option of no treatment.
Consent has been debated in courts since Bolam vs Friern Hospital Management Committee (1957) and has moved forward considerably from a paternalistic, doctor-centred process, to a patient-focused consent process.
The case of Montgomery vs Lanarkshire Health Board (2015) was pivotal in changing how consent is viewed by the courts and highlighted the importance of material risk from a patient perspective. The case highlighted the importance of a failure to discuss the treatment option of caesarean section in a diabetic patient where shoulder dystocia was a foreseeable risk, but the chance of serious harm (including hypoxic brain injury) was thought to be negligible. This is despite Mrs Montgomery having concerns over the size of her baby but not asking about the specific complications.
The court accepted that if Mrs Montgomery had been told about the risk of dystocia, she would have chosen to have a caesarean. Her appeal was successful, and the judgment held that the assessment of whether consent was adequate in a clinical negligence claim would not be assessed by the Bolam test. Instead, doctors must provide information about all material risks; they must disclose any risk to which a reasonable person in the patient's position would attach significance.
Alternative options were highlighted some years earlier in the case of Birch vs UCL NHS Foundation Trust (2008), a case which was referenced in the verdict for Montgomery, but with which few clinicians may be familiar.
In this case, Mrs Birch, a type 1 diabetic, was admitted to hospital with blurred vision, headache and nausea and vomiting. The consultant neurologist felt, due to the atypical presentation for a vascular cause of her painful, pupil-sparing third nerve palsy, that an MRI scan should be done to exclude aneurysm or cavernous sinus pathology. Due to lack of availability of MRI scan at the admitting centre, Mrs Birch was transferred, and the receiving neurosurgical team felt that angiography was required. She subsequently underwent catheter angiogram and suffered a dense hemiplegia. Despite having consented for a 1% risk of stroke associated with the angiography, Mrs Birch was successful in her claim. The judge found that the decision to undertake angiography was not negligent, but the failure to discuss alternative options, including MRI scan, was a breach of duty.
The more recent case of Bayley vs George Eliot NHS Hospital Trust (2017) clarified that reasonable treatment depends on the patient, their treatment and prognosis, but more importantly, that a reasonable treatment must be accepted practice and more than “experimental,” and which would work for the condition in question.
GMC position and medicolegal advice on consent
Medical Protection has provided guidance on consent in line with the GMC guidance on Decision Making and Consent1. A key principle is that respect for patients’ autonomy is expressed in consent law; to impose care or treatment on people without respecting their wishes and right to self-determination is not only unethical, but illegal.
For consent to be valid:
- The patient must be competent – mental capacity is decision-specific. Assessment of a person’s capacity should be based on their ability to understand, retain and weigh up the information relevant to a particular decision. The person must also be able to communicate the decision.
- The patient must have sufficient information to make achoice – without adequate information, patients are unable to make decisions about their treatment. Patients should be given time to ask questions and consider their options. The GMC and the courts expect patients to be given all information material to their decision, with the proviso that it would not cause the patient serious harm. This is the key point in consent and the alternative treatment options not being discussed would be considered as insufficient information.
- The patient must be able to give their consent freely – pressuring patients into consenting to treatment invalidates the consent.
The GMC guidance on consent was updated on 9 November 2020.2. It remains clear that doctors should provide information about ‘options for treating or managing the condition, including the option not to treat’ (paragraph 10c), and inform patients of the risks associated with each of these options, including the option of doing nothing (paragraph 10e).
The guidance also reiterates that clinicians should not rely on assumptions about the information a patient might want or need; the factors a patient might consider significant, or the importance a patient might attach to different outcomes.
What does this mean in practice?
Historically consent was often a single process, undertaken at the bedside, or as a brief discussion in clinic. However, to be valid, unless there is therapeutic exception, it should now be considered as a journey where patients are given sufficient information and have a period of opportunity to consider their options. Often clinicians express concern that patients should not be overloaded with information, or will not read leaflets or information provided. However, unless it is specifically stated by a patient and documented that they do not wish for further information, it should not be presumed.
It is recognised that consent forms often lack specific areas to record discussion about alternative treatment options, hence it is sometimes omitted or not documented. In other clinical scenarios, doctors only discuss those treatments which they themselves perform when other alternatives may be suitable for a patient. In clinical negligence law, on the basis of Montgomery, it would be difficult to defend this practice. Medical records can be used to record discussions, and patient information leaflets can also be used to outline other treatment options, provided they are kept regularly updated to reflect changing practice. Where a patient information leaflet is given, this should be made clear in the records or on the consent form. Claims have been successfully defended where a copy of the information given has been included in the patient record, as when claims arise further down the line, it may be difficult to obtain a copy of the exact information that was given to a patient.
Alternative therapeutic options are available in all clinical scenarios of consent, as doing nothing is always an option for a patient. Even when the decision is not considered to be in the best interest of the patient, provided they have capacity, this does not mean the consent is not valid. Clinicians should not presume that a patient is aware of the option of doing nothing, nor presume that their attendance in seeking a therapeutic solution is indicative that this must be the only outcome for them.
If a clinician is unable to provide a specific alternative option, either through skillset or clinical restrictions, this does not mean a patient should not be made aware of that option, providing it is reasonable for the clinician to be aware of the procedure. If necessary, referral to an alternative clinician or centre may be required to ensure the patient is consenting to the treatment option they want.
If possible, patients should be informed of the available avenues to return should they have further questions regarding the proposed treatment.
Consent needs to consider not only the risks involved in the proposed treatment but, to be valid, should discuss other options for the patient, including the option of doing nothing. Patients should be aware of the risks associated with alternate options and if a practitioner is unable to offer an option, appropriate offer of referral should be made. The scope of reasonable alternative treatment options can be summarised below:
- alternative treatment option must be within knowledge of reasonably competent clinician
- alternative treatment must be accepted practice
- alternative treatment should be appropriate and not just a “possible” treatment
While this may not be routine practice for all clinicians, the legal and ethical position on consent is clear that options should be discussed routinely, unless considered to be detrimental to a patient (therapeutic exception) or in emergency situations.