Consent and the importance of exploring all possible options with your patient

Obtaining a patient’s informed consent is a fundamental part of clinical practice. Peter J Mordecai, Claims Manager at Medical Protection, and Dr Katie Grant, Medicolegal Consultant at Medical Protection, discuss a case where alternative treatment or investigation options were not explained to the patient, resulting in medicolegal consequences for the doctor.

A patient attended a consultant surgeon with suspected cancer. The surgeon decided to perform a diagnostic laparoscopy that came with the risk of a bowel perforation which the patient was not informed about. The surgeon did not offer alternative investigation strategies which whilst less reliable, were less invasive. Unfortunately, the bowel perforation occurred. The patient required further treatment and commenced a claim. What could the surgeon have done differently?

Generally, the patient should be made aware of all the treatment and investigations options available, even if some are less effective. Without a detailed discussion, informed consent cannot be obtained because a patient cannot truly be informed unless they know of all the options available to them. This will expose the doctor to a claim for trespass to their patient.

In addition, the patient was not made aware of all the significant risks of the specific investigation option that the surgeon was proposing. Whilst it was an infrequently occurring complication, it was a severe outcome if it occurred. The patient should have therefore been made aware of this. The failure to inform the patient of the risks of the procedure exposed the doctor to a claim for negligence.

Key considerations when obtaining the patient’s consent

1.     The various treatment and investigation procedure options should be explained to the patient, including the option of doing nothing. It does not matter if the recommended option has a 75 percent chance of success and the second-best option only has a 25 percent chance of success. The patient still needs to be made aware of the alternatives.

2.     The material risks, benefits and alternatives of the above should be explained to the patient as far as practicable and fall into four broad categories:

 a.     Colleague consideration – what various procedure options along with their associated risks and benefits would the colleagues discuss if this was an average patient?
b.     Risk consideration – what are the standard risks in performing these procedures eg, infection?
c.     Severity consideration – what serious risks are there in performing these procedures eg, a procedure may carry a 1 percent chance of a loss of limb, but this is a serious outcome if it occurs and therefore, should be explained.
d.     Patient consideration – are there any risks that are likely to be material to this patient? The law takes a patient-centric position, and if there is a risk that a reasonable person in the patient’s position would be likely to attach significance to this, then the risk is deemed to be material and should be brought to the patient’s attention eg, the risk of a loss of sight during cataract surgery would be more significant to a patient with sight in only one eye instead of two. Thus, gather what is significant to a patient by considering the risks of information that:

i.     the patient has communicated about – if they have specifically asked, then it would be deemed important to a reasonable person in the patient’s position.
ii.    can be implied to be important to the patient – if the patient’s records contain concern about loss of hair and this is a risk, then it would be deemed important to a reasonable person in the patient’s position.

3.    The timing of consent matters. Obtaining the patient’s consent on the day of a surgical procedure is likely to be deemed inadequate unless the procedure is an emergency. Aim to discuss all of the above key considerations before any procedure, and offer different sources of reliable information about these options and document these steps. This allows the patient time to consider and reflect on the options discussed.

4.     Repeat the information and try to have more than one discussion before the procedure. This will show you have made efforts to obtain the patient’s informed consent and given the patient time to consider their options before they decide. On the day of the procedure, you should reconfirm the procedure option the patient has selected, the risks and benefits of this, along with the alternative procedure options and their associated risks and benefits.

5.     The consent form is not enough. While it is required, it does not show that informed consent has been obtained. There should be a clear record of the discussion between yourself and the patient going through the various procedure options and the material risks and benefits of each of them. Revisiting consent throughout the patient’s journey is important eg, consider asking the patient to review and sign the consent form before the day of the procedure and then reaffirm it on the day.

6.     Documenting the discussion in detail is vital because Medical Protection has seen several cases where doctors could not defend claims against them due to a lack of documentation. While time is limited, a detailed consultation note can be the thing that prevents a protracted litigation or disciplinary process.

7.     Any coercion? Consider whether there are any factors that could be considered to be unduly influencing the patient’s decision and ensure these are removed eg, obtaining a patient’s informed consent for a surgical procedure whilst they are in the operating room could be deemed to be coercing them into having the surgery and this should be avoided.

A doctor can perform the best procedure in the world, but a legal case can still be made if they have not obtained the patient’s informed consent. It is important for doctors to take plenty of time to explore the risks and benefits, and the alternative procedure options, with the patient and to document the discussions.