Part 2: Making decisions about investigations and treatment
Discussing side effects, complications and other risks
Clear, accurate information about the risks of any proposed investigation or treatment, presented in a way patients can understand, can help them make informed decisions. The amount of information about risk that you should share with patients will depend on the individual patient and what they want or need to know. Your discussions with patients should focus on their individual situation and the risk to them.
In order to have effective discussions with patients about risk, you must identify the adverse outcomes that may result from the proposed options. This includes the potential outcome of taking no action. Risks can take a number of forms, but will usually be:
- side effects
- failure of an intervention to achieve the desired aim.
Risks can vary from common but minor side effects, to rare but serious adverse outcomes possibly resulting in permanent disability or death.
In assessing the risk to an individual patient, you must consider the nature of the patient’s condition, their general health and other circumstances. These are variable factors that may affect the likelihood of adverse outcomes occurring.
You should do your best to understand the patient’s views and preferences about any proposed investigation or treatment, and the adverse outcomes they are most concerned about. You must not make assumptions about a patient’s understanding of risk or the importance they attach to different outcomes. You should discuss these issues with your patient.8
See Explaining the risks and benefits of treatment options, Royal College of Physicians Patient and Carer Involvement Steering Group.
You must tell patients if an investigation or treatment might result in a serious adverse outcome,9 even if the likelihood is very small. You should also tell patients about less serious side effects or complications if they occur frequently, and explain what the patient should do if they experience any of them.
An adverse outcome resulting in death, permanent or long term physical disability or disfigurement, medium or long-term pain, or admission to hospital; or other outcomes with a long-term or permanent effect on a patient’s employment, social or personal life.
You must give information about risk in a balanced way. You should avoid bias, and you should explain the expected benefits as well as the potential burdens and risks of any proposed investigation or treatment.
You must use clear, simple and consistent language when discussing risks with patients. You should be aware that patients may understand information about risk differently from you. You should check that the patient understands the terms that you use, particularly when describing the seriousness, frequency and likelihood of an adverse outcome. You should use simple and accurate written information or visual or other aids to explain risk, if they will help the patient to understand.
If a patient does not want to know about the possible risks of a proposed investigation or treatment, you must follow the guidance in paragraphs 13 - 17.
No one else can make a decision on behalf of an adult who has capacity.5 If a patient asks you to make decisions on their behalf or wants to leave decisions to a relative, partner, friend, carer or another person close to them, you should explain that it is still important that they understand the options open to them, and what the treatment will involve. If they do not want this information, you should try to find out why.
If, after discussion, a patient still does not want to know in detail about their condition or the treatment, you should respect their wishes, as far as possible. But you must still give them the information they need in order to give their consent to a proposed investigation or treatment. This is likely to include what the investigation or treatment aims to achieve and what it will involve, for example: whether the procedure is invasive; what level of pain or discomfort they might experience, and what can be done to minimise it; anything they should do to prepare for the investigation or treatment; and if it involves any serious risks.
If a patient insists that they do not want even this basic information, you must explain the potential consequences of them not having it, particularly if it might mean that their consent is not valid. You must record the fact that the patient has declined this information. You must also make it clear that they can change their mind and have more information at any time.
You should not withhold information necessary for making decisions for any other reason, including when a relative, partner, friend or carer asks you to, unless you believe that giving it would cause the patient serious harm. In this context ‘serious harm’ means more than that the patient might become upset or decide to refuse treatment.
If you withhold information from the patient you must record your reason for doing so in the patient’s medical records, and you must be prepared to explain and justify your decision. You should regularly review your decision, and consider whether you could give information to the patient later, without causing them serious harm.
You must keep up to date with developments in your area of practice, which may affect your knowledge and understanding of the risks associated with the investigations or treatments that you provide.
The scope of decisions
You must explain clearly to patients the scope of any decisions to be made. This will apply particularly if:
- treatment will be provided in stages, with the possibility that changes or adjustments might be needed
- different doctors or healthcare professionals will provide particular parts of an investigation or treatment, such as anaesthesia and surgery
- a number of different investigations or treatments are involved
- uncertainty about the diagnosis or the options might only be resolved when the investigation or treatment has started, when the patient may be unable to make decisions.10
Note for pathologists and radiologists: there may be times when uncertainty about a diagnosis can only be resolved by investigations which were not specifically ordered as part of the original request for testing. If these investigations appear to fall outside the scope of the original consent given by the patient, or there are particular sensitivities around the condition for which the pathologist or radiologist wishes to test, they must contact the treating doctor and establish whether further discussion with, and consent from, the patient is necessary before proceeding.
In such cases, you should discuss and agree with the patient how decisions will be made about whether to make changes to the investigation or treatment plan. You should establish whether the patient agrees to all or only parts of the proposed plan. If they agree only to parts of it, you should make sure that there is a clear process through which they can be involved in making decisions at a later stage.
You must not exceed the scope of the authority given by a patient, except in an emergency. If an emergency arises, you must follow the guidance in paragraph 79.
When an emergency arises in a clinical setting21 and it is not possible to find out a patient’s wishes, you can treat them without their consent, provided the treatment is immediately necessary to save their life or to prevent a serious deterioration of their condition. The treatment you provide must be the least restrictive of the patient’s future choices. For as long as the patient lacks capacity, you should provide ongoing care on the basis of the guidance in paragraphs 75–76. If the patient regains capacity while in your care, you should tell them what has been done, and why, as soon as they are sufficiently recovered to understand.
Making decisions about potential future events
You should discuss with patients the possibility of additional problems coming to light during an investigation or treatment when they might not be in a position to make a decision about how to proceed. If there is a significant risk of a particular problem arising, you should ask in advance what the patient would like you to do if it does arise. You should also ask if there are any procedures they object to, or which they would like more time to think about.
Ensuring that decisions are voluntary
Patients may be put under pressure by employers, insurers, relatives or others, to accept a particular investigation or treatment. You should be aware of this and of other situations in which patients may be vulnerable. Such situations may be, for example, if they are resident in a care home, subject to mental health legislation, detained by the police or immigration services, or in prison.
You should do your best to make sure that such patients have considered the available options and reached their own decision. If they have a right to refuse treatment, you should make sure that they know this and are able to refuse if they want to.
Respecting a patient's decisions
You must respect a patient’s decision to refuse an investigation or treatment, even if you think their decision is wrong or irrational.11 You should explain your concerns clearly to the patient and outline the possible consequences of their decision. You must not, however, put pressure on a patient to accept your advice. If you are unsure about the patient’s capacity to make a decision, you must follow the guidance in Part 3.
If the patient has a mental disorder, you should note the exceptions in the Mental Health Act 1983 (as amended by the Mental Health Act 2007), the Mental Health (NI) Order 1986, and the Mental Health (Care and Treatment) (Scotland) Act 2003. They allow compulsory treatment for mental disorder in certain circumstances, without consent, even if the patient has capacity. See the legal annex for more information.
Expressions of consent
Before accepting a patient’s consent, you must consider whether they have been given the information they want or need, and how well they understand the details and implications of what is proposed. This is more important than how their consent is expressed or recorded.
Patients can give consent orally or in writing, or they may imply consent by complying with the proposed examination or treatment, for example, by rolling up their sleeve to have their blood pressure taken.
In the case of minor or routine investigations or treatments, if you are satisfied that the patient understands what you propose to do and why, it is usually enough to have oral or implied consent.
In cases that involve higher risk, it is important that you get the patient’s written consent. This is so that everyone involved understands what was explained and agreed.
By law you must get written consent for certain treatments, such as fertility treatment. You must follow the laws and codes of practice that govern these situations.
You should also get written consent from a patient if:
- the investigation or treatment is complex or involves significant risks
- there may be significant consequences for the patient’s employment, or social or personal life
- providing clinical care is not the primary purpose of the investigation or treatment
- the treatment is part of a research programme or is an innovative treatment designed specifically for their benefit.
If it is not possible to get written consent, for example, in an emergency or if the patient needs the treatment to relieve serious pain or distress, you can rely on oral consent. But you must still give the patient the information they want or need to make a decision. You must record the fact that they have given consent, in their medical records.
You must use the patient’s medical records or a consent form to record the key elements of your discussion with the patient. This should include the information you discussed, any specific requests by the patient, any written, visual or audio information given to the patient, and details of any decisions that were made.
Before beginning treatment, you or a member of the healthcare team should check that the patient still wants to go ahead; and you must respond to any new or repeated concerns or questions they raise. This is particularly important if:
- significant time has passed since the initial decision was made
- there have been material changes in the patient’s condition, or in any aspect of the proposed investigation or treatment
- new information has become available, for example about the risks of treatment or about other treatment options.
You must make sure that patients are kept informed about the progress of their treatment, and are able to make decisions at all stages, not just in the initial stage. If the treatment is ongoing, you should make sure that there are clear arrangements in place to review decisions and, if necessary, to make new ones.
Involving children and young people in making decisions
You should involve children and young people as much as possible in discussions about their care, even if they are not able to make decisions on their own.
A young person’s ability to make decisions depends more on their ability to understand and weigh up options, than on their age. When assessing a young person’s capacity to make decisions, you should bear in mind that:
- a young person under 16 may have capacity to make decisions, depending on their maturity and ability to understand what is involved
- at 16 a young person can be presumed to have capacity to make most decisions about their treatment and care.
You must follow the guidance in 0–18 years: guidance for all doctors, and in particular the section Making decisions (paragraphs 22 - 41). It gives advice on involving children and young people in decisions, assessing capacity and best interests, and what to do if they refuse treatment. It also explains the different legal requirements across the UK for decision- making involving children and young people.
You can provide medical treatment to a child or young person with their consent if they are competent, or with the consent of a parent or the court.6 You can provide emergency treatment without consent to save the life of, or prevent serious deterioration in the health of, a child or young person.
You should involve children and young people as much as possible in decisions about their care, even when they are not able to make decisions on their own.
You must decide whether a young person is able to understand the nature, purpose and possible consequences of investigations or treatments you propose, as well as the consequences of not having treatment. Only if they are able to understand, retain, use and weigh this information, and communicate their decision to others can they consent to that investigation or treatment.7 That means you must make sure that all relevant information has been provided and thoroughly discussed before deciding whether or not a child or young person has the capacity to consent.
The capacity to consent depends more on young people’s ability to understand and weigh up options than on age. When assessing a young person’s capacity to consent, you should bear in mind that:
- at 16 a young person can be presumed to have the capacity to consent (see paragraphs 30 to 33)
- a young person under 16 may have the capacity to consent, depending on their maturity and ability to understand what is involved.8
It is important that you assess maturity and understanding on an individual basis and with regard to the complexity and importance of the decision to be made. You should remember that a young person who has the capacity to consent to straightforward, relatively risk-free treatment may not necessarily have the capacity to consent to complex treatment involving high risks or serious consequences.9 The capacity to consent can also be affected by their physical and emotional development and by changes in their health and treatment.
If a child lacks the capacity to consent, you should ask for their parent’s consent. It is usually sufficient to have consent from one parent. If parents cannot agree and disputes cannot be resolved informally, you should seek legal advice about whether you should apply to the court.10
The legal framework for the treatment of 16 and 17-year-olds who lack the capacity to consent differs across the UK:
- In England, Wales and Northern Ireland, parents can consent to investigations and treatment that are in the young person’s best interests
- In England and Wales, treatment can also be provided in the young person’s best interests without parental consent, although the views of parents may be important in assessing the young person’s best interests (see paragraphs 12 and 13)11
- In Northern Ireland, treatment can be provided in the young person’s best interests if a parent cannot be contacted, although you should seek legal advice about applying for court approval for significant (other than emergency) interventions
- In Scotland, 16 and 17-year-olds who do not have the capacity to consent are treated as adults who lack capacity and treatment may be given to safeguard or promote their health.12
You should encourage young people to involve their parents in making important decisions, but you should usually abide by any decision they have the capacity to make themselves (see paragraphs 30 to 33 and 46 - 52). You should also consider involving other members of the multi-disciplinary team, an independent advocate or a named or designated doctor for child protection if their involvement would help young people in making decisions.
Respect for young people’s views is important in making decisions about their care. If they refuse treatment, particularly treatment that could save their life or prevent serious deterioration in their health, this presents a challenge that you need to consider carefully.
Parents cannot override the competent consent of a young person to treatment that you consider is in their best interests. But you can rely on parental consent when a child lacks the capacity to consent. In Scotland parents cannot authorise treatment a competent young person has refused.13 In England, Wales and Northern Ireland, the law on parents overriding young people’s competent refusal is complex.14 You should seek legal advice if you think treatment is in the best interests of a competent young person who refuses.15
You must carefully weigh up the harm to the rights of children and young people of overriding their refusal against the benefits of treatment, so that decisions can be taken in their best interests.16 In these circumstances, you should consider involving other members of the multi-disciplinary team, an independent advocate, or a named or designated doctor for child protection. Legal advice may be helpful in deciding whether you should apply to the court to resolve disputes about best interests that cannot be resolved informally.
You should also consider involving these same colleagues before seeking legal advice if parents refuse treatment that is clearly in the best interests of a child or young person who lacks capacity, or if both a young person with capacity and their parents refuse such treatment.17 For further guidance on these issues see Communitybaptistpa guidance on consent and treatment and care towards the end of life.
Both the Communitybaptistpa and the law permit doctors to undertake procedures that do not offer immediate or obvious therapeutic benefits for children or young people, so long as they are in their best interests (see paragraphs 12 and 13) and performed with consent (see paragraph 27).
To assess their best interests you should consider the religious and cultural beliefs and values of the child or young person and their parents as well as any social, psychological and emotional benefits. This may be relevant in circumcision of male children for religious or cultural reasons18, or surgical correction19 of physical characteristics that do not endanger the child’s life or health.
Research involving children and young people can benefit all children; but they may be vulnerable because they cannot always recognise their best interests, express their needs or defend their rights.
Children or young people should be involved in research only when research on adults cannot provide the same benefits. They can be involved in research that has either:
- potential benefits for children or young people generally, as long as the research does not go against their best interests or involves only minimal or low risk of harm (this would be research that involves, for example, asking questions or taking blood samples, the assessment of the risk depending on the view of the child or young person), or
- potential therapeutic benefits for them that outweigh any foreseeable risks, which should be kept as low as possible.
Children and young people should not usually be involved in research if they object or appear to object in either words or actions, even if their parents consent. If they are able to consent for themselves, you should still consider involving their parents, depending on the nature of the research.20
You must not put pressure on children, young people or their parents to consent to research in the expectation of therapeutic, financial or any other benefit.
Before involving children or young people in research21 you should seek advice and get the necessary approval from a relevant research ethics committee, the Medical Research Council22 or a medical royal college.23
The Human Tissue Act 2004 and Human Tissue (Scotland) Act 2006 were passed following inquiries into the storage of children’s organs and tissue without the proper consent. The Acts make consent central to the lawful storage and use of children and young people’s organs and tissue, and to the removal of such material after death. The regulates and issues codes of practice on activities covered by the Act in England, Wales and Northern Ireland. Scottish ministers have those powers in Scotland.
Advance care planning
If a patient:
- has a condition that will affect the length or quality of their life, or
- has a condition that will impair their capacity as it progresses, such as dementia, or
- is otherwise facing a situation in which loss or impairment of capacity is a foreseeable possibility
you should encourage them to think about what they might want for themselves in the event that they cannot make their own decisions, and to discuss their wishes and concerns with you and the healthcare team.
Such discussions might cover:
- the patient’s wishes, preferences or fears in relation to their future care, including any treatments they would want to refuse, and under what circumstances
- the feelings, beliefs or values that may be influencing the patient’s preferences and decisions
- the relatives, friends, carers or representatives that the patient would like to be involved in decisions about their care
- interventions that are likely to become necessary in an emergency, such as cardio-pulmonary resuscitation (CPR).
You should approach such discussions sensitively. If the patient agrees, you should consider involving other members of the healthcare team, people who are close to the patient or an advocate.
If a patient wants to nominate someone to make decisions on their behalf if they lose capacity, or if they want to refuse a particular treatment, you should explain that there may be ways to formalise these wishes and recommend that they get independent advice on how to do this.
You must record the discussion and any decisions the patient makes. You should make sure that a record of the plan is made available to the patient and others involved in their care, so that everyone is clear about what has been agreed. This is particularly important if the patient has made an advance decision to refuse treatment.12 You should bear in mind that care plans need to be reviewed and updated as the situation or the patient’s views change.
The Mental Capacity Act 2005 requires advance decisions to refuse life-sustaining treatment to be in writing. Advance decisions to refuse other types of treatment may be written or verbal but, if verbal, they should be recorded in a person’s healthcare record (see Mental Capacity Act 2005 Code of Practice, chapter 9). It may be helpful under the provisions of the Adults with Incapacity (Scotland) Act 2000, for a written record to be made of a person’s advance decision to refuse medical treatment (see Code of Practice for those authorised to carry out medical treatment or research under Part 5 of the Act, chapter 2).