Which risks should patients be warned about?

In order to make a properly informed choice about their care, patients must be aware of any important risks relating to that treatment or procedure.

The HPCSA Guidelines

The HPCSA Guidelines[1] state that patients have a right to information about the health care services available to them, and that the information must be presented in a way that is easy to follow and use.

In addition The National Health Act provides that practitioners must inform patients of the following:

The risks and consequences generally associated with each option

The leading case on informed consent in South African law[1].[2]

In that case, the court held that “… a doctor is obliged to warn a patient so consenting of a material risk inherent in the proposed procedure ….”

Discussion

Material risks and informed consent

Patients have a right to self-determination. This means that they must make their own informed choices about whether to undergo a particular medical treatment or procedure.

Many medical treatments and procedures contain risk. In order to make a properly informed choice about their care, patients must be aware of any important risks relating to that treatment or procedure. Patients cannot agree to treatment or (as importantly), make a proper choice between two or more treatment options, unless they are properly informed of the risks of the treatment which they are considering.

Which information must patients be given about risks?

Practitioners should provide patients with appropriate information, which should include an explanation of any risks to which they may attach particular significance.

Read together, the National Health Act[3] and the HPCSA Guidelines[4] provide that the information which patients must be given regarding risks includes:

  • the material risks associated with the treatment or procedure;
  • common and serious side effects of the relevant treatment or procedure;
  • the likely benefits and the probabilities of success for each option;
  • any serious or frequently occurring risks; and
  • and lifestyle changes which may be caused or necessitated by the treatment.

However, advising of the details of all risks may take time. This is particularly the case in complex procedures. Practitioners often simply do not have the time to spend on overly- complicated explanations of every conceivable risk of a proposed treatment.

A balance should therefore be found between providing information to patients so that they can make a properly informed choice, and not setting unrealistic demands on medical practitioners.

The question then arises as to how practitioners must decide which risks the patient should be warned of, and how much detail should be provided in respect of those risks.

This is where the notion of a “material” risk becomes important.

The approach to be adopted

Practitioners should try to provide clear, accurate information about the risks of any proposed treatment or procedure. They should give the information in a way that patients can understand. Patients should be asked whether they have understood the information and whether they would like more information before making a decision.

When providing information, practitioners are required to do their best to find out about patients’ individual needs and priorities. For example, patients’ beliefs, culture, occupation or other factors may have a bearing on the information they need in order to reach a decision.

Healthcare practitioners should not make assumptions about patients’ views, but discuss those matters with them and ask them whether they have any concerns about the treatment or the risks which the treatment may involve.

What are “material risks”?

A question which arises in practice is how much detail should be provided about the treatment and its risk.

In order to decide on which risks the patient must be advised of, practitioners must ask themselves two questions:

Would the reasonable person in the patient’s position, if warned of the risk, be likely to attach significance to the risk in question?

or

Would the particular patient, if warned of the risk, be likely to attach significance to the risk?

If the risk in question falls into either category, then it qualifies as a “material risk”, and the patient must be told about it.

This means that the practitioner need not point out every possible risk that may arise. However, where a risk would be considered significant by either the reasonable patient, or by that particular patient (even if the reasonable patient would not regard the risk as being material), then the risk must be explained to the patient, even though it might be a remote risk.

Would the reasonable patient attach significance to the risk?

The first step in answering the questionof whether the reasonable patient would attach significance to the risk is for the practitioner to identify the adverse outcomes that might result from the proposed treatment or procedure.

Risks can take a number of forms, but will usually be:

  • side-effects;
  • complications; or
  • failure of an intervention to achieve the desired aim.

Risks can vary from common but minor side effects, to rare but serious risks.

Serious risks

A “serious risk” can be regarded as one which would result 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.  

It is accepted that the reasonable person in the patient’s position, if warned of the risk, would be likely to attach significance to a “serious risks”. Therefore, serious risks are material, and any serious risk must be disclosed to the patient, even if the likelihood of the risk is very low.

In summary, therefore, patients should be advised of any risk which could result 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.  

Minor risks

Practitioners should also tell patients about less serious side-effects or complications if they are common.

As part of this assessment, practitioners should also consider the potential outcome of taking no action.

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.

Would the particular patient be likely to attach significance to the risk?

In addressing this question, practitioners should try to understand the patient’s views and preferences about the proposed procedure or treatment, and their attitude to potential adverse outcomes.

Practitioners should guard against making assumptions about a patient’s understanding of risk or the importance they attach to different outcomes. These issues should be specifically discussed with the patient.

Therefore, in undertaking the process of assessing the risk to the particular patient, the practitioner must consider the nature of the patient’s condition, the patient’s general health and any other relevant circumstances. These are, of course, factors which vary in each situation which affect the likelihood of adverse outcomes occurring, and the resultant risk profile.

Shared decision-making and the amount of information to be provided

Practitioners should do their best to find out about the patient’s individual needs and priorities. For example, the patient’s beliefs, culture, occupation or other factors may have a bearing on the information they need in order to reach a decision.

Practitioners must give information about risk in a balanced way. They should avoid bias, and should explain the expected benefits as well as the potential burdens and risks of any proposed investigation or treatment. (For further information, see: ).

Practitioners must try to use clear, simple and consistent language when discussing risks with patients. They should be aware that patients may understand information about risk differently from them. They should check that the patient understands the terms that they use, particularly when describing the seriousness, frequency and likelihood of an adverse outcome.

Practitioners 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, practitioners must follow the guidance in paragraphs

Practitioners must keep up to date with developments in their area of practice, which may affect their knowledge and understanding of the risks associated with the investigations or treatments that they provide.

The exchange of information between practitioner and patient is central to good decision-making. How much information practitioners share with patients will vary, depending on their individual circumstances.

Practitioners are advised to tailor their approach to discussions with patients according to:

  1. their needs, wishes and priorities;
  2. their level of knowledge about, and understanding of, their condition, prognosis and the treatment options;
  3. the nature of their condition;
  4. the complexity of the treatment; and
  5. the nature and level of risk associated with the investigation or treatment.

[1] Castell v De Greeff