Obtaining Consent for Treatment – OSCE Guide

If you'd like to support us, check out our awesome products:

This article provides background information on consent and a step-by-step guide to obtaining consent for treatment in an OSCE setting, including how to structure the consultation.

This article follows the guidance from the General Medical Council and relates to the medicolegal position in the United Kingdom.


What is consent?

Consent to treatment is the agreement (usually by a patient) to a treatment, investigation or examination and is a key element of care. It impacts the quality of shared decision-making, experiences of patient-centred care, and medico-legal risk.

Consent to treatment is one type of consent that may be discussed within a medical context. Others include research consent and consent to data sharing.

In this article, we will discuss an adult giving consent for their treatment (i.e. consent form 1) and cover special circumstances in the last section.

Consent validity

For consent to be valid, it must be informed and voluntary.

Informed consent

Informed consent is when the patient has received, or had the opportunity to receive, sufficient information and had the appropriate time to consider it. This should include an opportunity to discuss the decision, options, and any questions they have (i.e. they have had a consent conversation with a clinician).

In the above paragraph, we said β€˜or had the opportunity to receive’. This is because a patient has the right to decline detailed information and, in most cases, can still give informed consent. The way to understand this is that they are as informed as they wish to be to make the decision.

Understanding why they do not wish to receive the information is important, as this will often reveal reasonable concerns. Examples include previous experiences of consent conversations which led to significant anxiety or difficulties in coming to terms with a diagnosis. In these cases, empathetic exploration often leads to a valuable consent conversation and shared decision-making process.

Otherwise, the patient should still be reassured that more information and a consent conversation with a clinician can be provided if they change their mind, and you should explain that you need to convey basic information about the treatment. This basic information includes whether it is an invasive treatment, the level of discomfort to expect, what to do to prepare, and serious risks.

When a patient refuses to receive this basic information, seek advice from your medical defence union. They will support you in considering whether consent is still valid, which will often be the case when the treatment is well-evidenced for the diagnosis but may not be the case in other situations (e.g. an innovative treatment option is being proposed).Β 

Mental capacity

In the context of an adult giving consent for their treatment, there must be no reason to doubt their mental capacity to consent. Otherwise, a mental capacity assessment should be performed. It is important to remember that capacity isΒ decision specific.Β 

A patient with mental capacity can consent to, or refuse, any proposed treatment. This includes a refusal of treatment where a clinician feels that doing so is not in the patient’s best interests.

Clinicians are not required to agree to a patient’s request for a treatment that the clinician does not feel would be in their best interests. A second opinion can be offered in this scenario.

Voluntary

Voluntary means that the decision is the individual’s own and is not influenced by pressure from medical staff, friends or family. If you believe a patient is being pressured, consult your safeguarding team.

Withholding information

Historically it was commonplace for clinicians to withhold information from patients with the rationale that knowing this information would be psychologically harmful to the patient. This approach is not generally supported by now, except in rare circumstances where sharing the information would convincingly cause serious harm to the individual.

This is termed a β€˜limited exception’ in the GMC guidance and should be used only following legal advice and having followed the required legal process.

The legal landscape

The consent process has sometimes been seen as paternalistic, with clinicians recommending their preferred option and patients following this as instructed.

In 2015, a landmark decision by the UK Supreme Court in the Montgomery v Lanarkshire Health Board case prompted a change in the law. The court ruled that doctors must now take β€œreasonable 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.”

Previously, it was at the doctor’s discretion what to tell patients regarding the risks and benefits of treatment, and their actions would have been judged only against other doctors’ opinions of what information should be shared with the patient (known as ‘The Bolam Test’).

With the Montgomery ruling, the requirements regarding consent information changed to being what β€œa reasonable person in the patient’s position would be likely to attach significance to”. This includes a requirement for doctors not to make assumptions about which risks are important to patients, and they must fully disclose any risks that may be of particular importance or relevance to that patient (e.g. a professional pianist undergoing a hand operation).

You might also be interested in our collection of 800+ OSCE Stations that cover clinical examination, procedures, communication skills and data interpretation.

Demonstrating consent

Explicit consent is when a person shows their agreement verbally or in writing.

For some treatments, consent can be implied non-verbally. Implied consent can be expressed by behaviour, such as extending an arm for a blood test or opening the mouth to enable a throat examination.

In either case, the clinician should be confident that the patient understands what is involved and that they can refuse treatment.

Consent forms

Consent forms are operationally required for most invasive treatments, and serve as a prompt to share key information, including material risks, document the consent information shared, and record that written consent has been given. They include consent statements from the patient and clinician to state that an appropriate process has been followed. Historically, these have been completed on paper consent forms, but digital consent is being introduced in some areas.

Minor bedside procedures (e.g. intravenous cannulation and venepuncture) do not usually require a consent form to be completed.

It is important to note that completing a consent form does not replace meaningful dialogue between the patient and the clinician. A consent form in isolation does not demonstrate that an appropriate, medicolegally robust, consent process has been followed.


Preparing for the consent discussion

An effective, shared decision-making consent conversation depends on two experts in the conversation:

  • A clinician who is an expert in the medicine, including what may be particularly relevant in the clinical context
  • A patient who is an expert in themselves and what matters to them

For this reason, you should ensure that you appropriately understand the individual clinical contextΒ before undertaking a consent conversation (e.g. by reading the medical notes).Β 

The consent conversation with the patient should usually involve a clinician trained to perform the procedure or prescribe the treatment. However, the process may be delegated to another member of the team.

If you are obtaining consent for treatment on behalf of another clinician (i.e. delegated consent), you must be sufficiently qualified, knowledgeable and competent to do so. If you do not meet these criteria, you should not proceed to have the consent conversation and should communicate this to the responsible clinician and/or person performing the procedure.

Ensure you have enough time for an effective consent conversation, with time to discuss the details, explore patient preferences and priorities, and answer their questions. Try to minimise the risk that you will be disturbed during the conversation.

Timing of a consent conversation

Giving consent to treatment should be a process rather than a one-off event, ensuring that the patient has time to consider the decision in their own time.

The initial consent conversation should occurΒ well beforeΒ treatment commences, be confirmed on the day of treatment, and may involve further consent conversations in between.

There remains a challenge in the UK of consent conversations happening and consent being documented on the day of treatment. In some cases, this is necessary (e.g. before emergency surgery). However, in most cases, it should be avoided as it is not best practice, and new information shared on the day may be disregarded in terms of a medicolegal defence.


Opening the consultation

Wash your hands and don PPE if appropriate.

Introduce yourself to the patient including your name and role.

Confirm the patient’s name and date of birth.

Discuss the diagnosisΒ and establishΒ prior understanding:

  • Check the patient’s understanding of their diagnosis, the findings that have led you to this diagnosis, and their prognosis if left untreated
  • Gauge what the patient already knows about their condition to clarify any misunderstandings

Explain the purpose of the conversation: β€œI’d like to discuss your treatment, is now a good time?”

Understand the patient’s wishes, needs, views and expectations:

  • Ask the patient what matters to them, and do not make assumptions about what is a good outcome for them
  • Everyone has different priorities and perspectives about what constitutes a material risk and what risks are acceptable

Consent for treatment

Discussing the options

Explain the indication for treatment, various treatment options and what they would involve (including anaesthetic options if relevant), and the key risks and benefits of each, including the option of no treatment.

Discuss any preparation needed before the procedure and the expected follow-up.

Explaining risks

When discussing risks, you should establish the patient context and what matters to the patient to ensure that you cover all material risks of the treatment for that individual and assess the significance the patient attaches to them. Do not assume what a patient might want to know, as evidence shows our assumptions are often incorrect.

Information should be presented in an understandable way to the patient, avoiding medical jargon (or, where not possible, explaining terms in lay language). The use of diagrams is often helpful.

Explain the risks of treatment, ideally in the context of when they may occur and how likely they are for that individual. Individual patient risk profiles will be based on patient factors (e.g. cardiovascular health, obesity, age). They should utilise verified risk calculators such as the Surgical Outcome Risk Tool (SORT) where available.

There is no simple explanation or rule as to what risks need to be discussed or how likely a risk needs to be to meet the threshold of being discussed.

In general, common complications should always be discussed. As a risk becomes rarer, then the severity of the complication and whether it may have particular relevance to an individual (i.e. it is a material risk) will determine whether it should be discussed. Risks of serious harm should usually be discussed, however unlikely they are to occur.

Example

A 1 in 200 chance of death will usually be deemed significant enough to be discussed, but a 1 in 200 chance of a temporary nosebleed in a patient without any bleeding disorder may not.

Significant evidence shows that the information traditionally discussed and documented during a paper-based consent process is highly variable, with significant omissions of key risks. For this reason, treatment-specific resources can be used alongside a consent conversation to minimise the risk of omitting key risks through human error.

You should be honest about any uncertainties (e.g. likely outcomes) and honest regarding the experience of the individual performing a procedure, especially in the context of new or innovative treatments.

Checking patient understanding

During the conversation, it is a good idea to summarise what has been discussed so far and check the patient’s understanding. β€˜Teach-back’ is a mechanism that has been shown to improve the quality of a consent conversation, including supporting patient understanding and retention of information. It involves a patient summarising the information in their own words and adding their own context to the information.

Questions and subsequent support

Allow time for questions. In many cases, this can be the most rewarding part of a consent conversation, where your clinical experience can be used to answer patient questions and concerns.

As discussed, in most cases, it is best practice that consent is a process rather than a one-off event, with the patient having time to consider their decision and discuss it with people who are important to them.

Provide personalised written information, including signposting to reputable resources and support from other multidisciplinary team members.

If the patient has understood all of the information and is happy to do so, it may be appropriate for them to sign their consent form during the consultation, or if possible, it may be shared with them to do so remotely once they have had time to consider the information. Depending on local policy, this may be via a digital consent application or paper consent form.

If the patient decides during the consultation that they will not give their consent to proceed with the treatment, they do not need to justify this, but you should ensure that this is not based on patient misunderstanding.


Closing the consultation

Thank the patient for their time.

Reassure the patient that they can change their mind and withdraw their consent at any point.

Dispose of PPE appropriately and wash your hands.

Document the consent discussion and complete the appropriateΒ consent formΒ (if required).Β 


Following the consultation

If a digital consent application has been used, the consent documentation will be automatically stored and should subsequently be viewed digitally to confirm consentΒ (e.g. before treatment or as part of the WHO surgical safety checklist).Β 

If a paper consent form has been used, ensure the consent form is stored correctly. Depending on local policy, this may be within the patient’s paper notes, sent for scanning, or sent to the department responsible for the treatment.

If the initial consent conversation occurs before the day of treatment (often considered more than 24 hours before treatment), then a further confirmation of consent conversation is required.

This should explore any new information or changes in the clinical context or risks, and answer any additional questions the patient may have. The conversation should be documented but does not require a further signature from the patient unless there are changes to the details on the consent form.


Special circumstances

These special circumstances have nuances we will not cover in this article, but the same high-level principles apply.

Consent on behalf of a child/young person (consent form 2)

The default position is that an individual with parental responsibility should give consent to treatment for a child aged 0 – 15. The person(s) with parental responsibility will usually, but not invariably, be the child’s birth parents.

The principles of consent remain the same as in an adult giving consent for their treatment, only that consent is given by the adult on behalf of the child. There are circumstances where the child may be able to give consent to treatment themselves, where they are deemed Gillick competent.

Young people aged 16 or 17 are, like adults, presumed to have the capacity to decide on their medical treatment unless there is significant evidence to suggest otherwise. They should be fully involved in discussions relating to their care. If there is reason to doubt capacity, a mental capacity assessment should be completed, and if it is deemed that they do not have the mental capacity to make the decision, then an individual with parental responsibility becomes the decision maker.

Treatment in best interests (consent form 4)

If an adult patient is demonstrated to lack the mental capacity to decide to proceed with treatment, then a decision in their best interests is made.

Several possible scenarios exist, such as whether an advance directive exists and whether a health and welfare lasting power of attorney or personal welfare duty has been appointed.Β 

This will be documented in the best interests documentation alongside the Mental Capacity Assessment form and consent form 4Β regarding whether to proceed with treatment.

Depending on the circumstances, this may consider any known and relevant patient preferences or wishes, consultation with those close to the patient or an Independent Mental Capacity Advocate (IMCA), and consideration of less restrictive alternatives.


Reviewers

Dr Dafydd Loughran

Urology Registrar & CEO | Concentric Health

Dr Patrick Hart

Founders Associate | Concentric Health


References

  • General Medical Council. 2020. Decision making and consent. Available from: [LINK]

 

Print Friendly, PDF & Email