01 Mar Getting Consent Right
When considering improvements in patient safety, one of the first considerations has to be getting consent right.
Getting Consent Right
A patient who is not engaged in the process, who fails to understand the risks, benefits and complications and who is looking for an absolute cure, may well find cause for compliant. Consent is a two-way process. It allows the patient the opportunity to fully understand the illness or injury that they have. Discussions should include the stages of an illness or injury in terms of deterioration and improvement and include the range of treatments available and what those treatments are likely to achieve. It allows the patient an opportunity to question the doctor, to test knowledge and experience and determine if this is a person in whom they trust their medical care. It allows the doctor an opportunity to determine what is important to the patient, impart knowledge and record the decision making process.
The discussions surrounding the range of risks and complications should ascertain the fears and aims of the patient. What is significant for them in terms of their risk profile and what are the aims of the treatment important for getting consent right.
Depending on the illness, many patients will be seeking an absolute cure whilst others will be looking to manage their symptoms. It is the doctor’s duty to manage their expectations about what is achievable against the risk and complication associated with a particular line of treatment. There is a need for a patient ‘buy-in’ to the choice and options available whilst understanding the cost of those options. By understanding the available options and risks thereof, a patient can make a determination and consent to a line of treatment.
What are the elements of full informed consent?
The most important goal of getting consent right is that the patient has an opportunity to be an informed participant in her health care decisions. It is generally accepted that informed consent includes a discussion of the following elements:
- The nature of the decision/procedure
- Reasonable alternatives to the proposed intervention
- The relevant risks, benefits, and uncertainties related to each alternative
- Assessment of patient understanding
- The acceptance of the intervention by the patient
The GMC Guidance has been clear that it is a partnership decision since 2008. The guidance states:
“Whatever the context in which medical decisions are made, you must work in partnership with your patients to ensure good care. In so doing, you must:
- listen to patients and respect their views about their health
- discuss with patients what their diagnosis, prognosis, treatment and care involve
- share with patients the information they want or need in order to make decisions
- maximise patients` opportunities, and their ability, to make decisions for themselves
- respect patients` decisions”.
Montgomery v South Lanarkshire
In the case of Montgomery v Lanarkshire Health Board  UKSC 11 the Supreme Court`s determination, in favour of Nadine Montgomery, marks a significant shift in the test to be applied when considering whether a patient has given consent to medical treatment. It is departure from the Bolam Test and brought the courts in line with the GMC Guidance.
The law now generally requires that a doctor must 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.`
“˜Materiality` is to be judged by reference to the individual circumstances of the case and whether a reasonable person in the patient`s position would be likely to attach significance to the risk, or whether the doctor is or should be aware that the particular patient would be likely to attach significance to it. This requires consideration of the patient as an individual – a risk that is “˜material` for one individual may not be so for another – and thereby requires a bespoke consent process.
It also follows that a doctor`s advisory role is not to be regarded as solely an exercise of medical skill. A patient is entitled to decide the risks that they are willing to run (a decision which may be influenced by non-medical considerations) and responsibility for determining the nature and extent of a person`s rights rests with the courts, not with the medical professions.
In Mrs Montgomery`s case, it is clear that she had the right to be advised of the risk of shoulder dystocia. She had the right to make her own decision on what risks she was prepared to undertake in terms of the delivery of her baby. The court accepted her evidence that she would have opted for a caesarean section if properly advised. Damages of £5.25 million were therefore awarded.
In a scathing reproach of Dr McLellan`s conduct, Lady Hale stated:
“˜Whatever Dr McLellan may have had in mind, this does not look like a purely medical judgment. It looks like a judgment that vaginal delivery is in some way morally preferable to a caesarean section: so much so that it justifies depriving the pregnant woman of the information needed for her to make a free choice in the matter”¦
A patient is entitled to take into account her own values, her own assessment of the comparative merits of giving birth in the “natural” and traditional way and of giving birth by caesarean section, whatever medical opinion may say, alongside the medical evaluation of the risks to herself and her baby”¦
The medical profession must respect her choice, unless she lacks the legal capacity to decide.` 
The Supreme Court has now authoritatively overruled the old clinician-centric approach. It has confirmed that informed consent plays a central role in English law (effectively endorsing the dissenting judgment of Lord Scarman in Sidaway) and reinforcing the professional obligations of all doctors under the GMC.
In giving judgment, Lord Kerr remarked that:
“˜[Since Sidaway] “¦patients are now widely regarded as persons holding rights, rather than as the passive recipients of the care of the medical profession. They are also widely treated as consumers exercising choices”¦ The idea that patients were medically uninformed and incapable of understanding medical matters was always a questionable generalisation”¦` [74-75].
The law of consent now formally treats patients, so far as possible, as adults who are capable of understanding that medical treatment is uncertain of success and may involve risks, accepting responsibility for the taking of risks affecting their own lives, and living with the consequences of their choices.
It is the ‘living with the consequences of their choices’ which concerns patient safety. Well-informed patients are more likely to receive care that reflects their personal preferences and values, and they are better prepared to provide necessary self-care. Well-informed patients tend to be more satisfied with their care and to be more trusting of their caregivers. Conversely, poorly informed
patients are at increased risk of suffering from a medical error or poor-quality care.
Getting consent right is best for patient, hospital and doctor alike. It really is win win for patient safety.
To find out more about getting consent right contact us on 0800 954 2951 or email Dr Victoria Handley at firstname.lastname@example.org