Doctors work in an increasingly complex environment: medical knowledge is continually expanding; patients have increased access to medical information via the internet; and there are increasing expectations of clinicians by patients and their families. This makes decision-making more complex and challenging for clinicians and their patients.
There is also a growing awareness of the Code of Health and Disability Services Consumers’ Rights Regulation (Code of Patient Rights), which is reflected in the increasing number of complaints lodged with the Health and Disability Commissioner (HDC) against healthcare providers every year. In 2015, the HDC received 112 complaints related to consent.1
One of those complaints (14HDC00307) involved Mrs A, a 46-year-old woman who was booked for an elective total hysterectomy for adenomyosis. She also suffered from catamenial epilepsy, although Mrs A denied ever being advised of this diagnosis. In theatre, just before anaesthesia, Mrs A was approached by Dr B regarding bilateral salpingo-oophorectomy (BSO) in order to treat catamenial epilepsy. She signed the consent form, but later complained to the HDC. Mrs A explained to the HDC that she felt immense pressure to make a decision. The Commissioner found:
- The manner in which Mrs A’s consent was obtained for the BSO was not appropriate. The operating theatre was not an appropriate environment for the informed consent process to take place, and did not allow for effective communication between Mrs A and Dr B. Accordingly, Dr B breached Right 5(2) of the Code of Patient Rights.
- Furthermore, Mrs A was not given sufficient time to consider whether she wished to have a BSO, and was not in a position to give informed consent to the removal of her ovaries. Accordingly, Dr B breached Right 7(1) of the Code.
- An adverse comment was made that Dr B did not appear to have communicated clearly to Mrs A that he had diagnosed her with catamenial epilepsy.
- No criticism made of Dr B’s clinical care.
This case demonstrates some of the potential pitfalls in consent. In this article, I will explain the three key principles of valid consent, before discussing the model of consent as shared decision-making.
RIGHT 5: Right to Effective Communication
1) Every consumer has the right to effective communication in a form, language, and manner that enables the consumer to understand the information provided. Where necessary and reasonably practical, this includes the right to a competent interpreter.
2) Every consumer has the right to an environment that enables both consumer and provider to communicate openly, honestly, and effectively.
RIGHT 6: Right to be Fully Informed
1) Every consumer has the right to the information that a reasonable consumer, in that consumer’s circumstances, would expect to receive, including:
a) an explanation of their condition; and
b) an explanation of the options available, including an assessment of the expected risks, side effects, benefits, and costs of each option; and
c) advice of the estimated time within which the services will be provided.
2) Before making a choice or giving consent, every consumer has the right to the information that a reasonable consumer, in that consumer’s circumstances, needs to make an informed choice or give informed consent.
RIGHT 7: Right to Make an Informed Choice and Give Informed Consent
1) Services may be provided to a consumer only if that consumer makes an informed choice and gives informed consent, except where any enactment, or the common law, or any other provision of this Code provides otherwise.
2) Every consumer must be presumed competent to make an informed choice and give informed consent, unless there are reasonable grounds for believing that the consumer is not competent.
3) Where a consumer has diminished competence, that consumer retains the right to
make informed choices and give informed consent, to the extent appropriate to their level
Valid consent comprises three key principles:2
- The patient must be competent. Mental capacity is decision specific. Assessment of a person’s capacity should be based on their ability to understand, retain and weigh up the information relevant to a particular decision. The person must also be able to communicate the decision. A patient who is unable to make a decision about a complex proposal is not necessarily incapable of making any decisions at all, and may be perfectly able to consent where the issues are simpler. The starting point in the case of adults is always to presume that the patient has capacity to consent until it is shown otherwise.
- The patient must have sufficient information to make a choice. Without adequate information, patients are unable to make decisions about their treatment. The information provided should, for example, include: an explanation of the investigation, diagnosis or treatment; an explanation of the probabilities of success, or the risk of failure; or harm associated3. The patient must have sufficient information to make a choice. Without adequate information, patients are unable to make decisions about their treatment. The information provided should, for example, include: an explanation of the investigation, diagnosis or treatment; an explanation of the probabilities of success, or the risk of failure; or harm associated with options for treatment. The patient should be given time to ask questions. The Medical Council of New Zealand (MCNZ) and the HDC (Right 5) expect patients to be given all information material to their decision, with the proviso that it would not cause the patient serious harm.
- The patient must be able to give their consent freely. Pressuring patients into consenting to treatment invalidates the consent. To ensure that consent is freely given, patients should, where possible, be given time to consider their options before deciding to proceed with a proposed treatment. Be aware, too, that patients’ friends and relatives may also try to exert their influence and that this can be subtle, but nevertheless powerful.
The MCNZ states, ‘Informed consent is an interactive process between a doctor and patient where the patient gains an understanding of their condition and receives an explanation of the options available including an assessment of the expected risks, side effects, benefits and costs of each option and thus is able to make an informed choice and give their informed consent.’4
Consent as shared decision-making
The best approach to consent is one of shared decision-making. Neither the paternalistic model of care where ‘doctor knows best’ or a purely informative approach of, ‘here’s all the information, you decide’ are appropriate to informed consent. A better model is shared decision-making. Shared decision-making is a process in which clinicians and patients work together to select tests, treatments, management or support packages, based on clinical evidence and the patient’s informed preferences. It involves the provision of evidence-based information about options, outcomes and uncertainties, together with decision support counselling and a system for recording and implementing patients’ informed preferences.5
- Increases patient involvement in the decision-making process
- Increases patient knowledge and understanding
- Shares some responsibility for the decision with the patient
- Leads to more realistic expectations from treatment
- Ensures decisions and choices that align with patients’ preferences and values
- Leads to, in some cases, better health outcomes
- Helps reduce geographical variations in care
- Improves patient satisfaction
- Improves adherence to treatment
- Increases the accuracy of patients’ risk perceptions and makes them better informed
- Helps identify the high-risk decision
Consent is a process
Shared decision-making places the individual patient at the centre of the process. The goal is to arrive at a decision that is right for the individual patient, from their perspective, which may not be the treatment option that the clinician believes to be the best.
Often clinicians approach consent as an event when the patient signs the completed consent form. Completed consent forms provide some evidence that consent was obtained, but mean little beyond that – it is important to realise that they do not constitute proof that the consent was valid. If there is any dispute over whether valid consent was obtained, the key issue will not be whether the patient signed a form or not, but whether they were given all the information they needed to make a considered decision.7
Consent is more accurately viewed as a process. Patients need time to absorb information, ask questions and weigh up the benefits of a procedure against the potential adverse outcomes. The circumstances surrounding the procedure will affect the degree to which patients wish to be involved. In the acute setting, the patient is more likely to place the responsibility for the majority of the decision-making with the clinician. In situations where a procedure is elective and not mandatory, it is advisable to take the time to ensure that all the information that the patient needs to make the decision is carefully explained. This includes the possible adverse outcomes that may be rare, but of high importance to that specific patient. Be aware that should the patient experience an adverse outcome from their treatment, their preference about how much they should have been told and involved may well be different in retrospect and so can change over time.8
Verbal or written consent?
The Code of Patient Rights requires written consent in the following situations: Right 7 (6) Where informed consent to a healthcare procedure is required, it must be in writing if:
a) The consumer is to participate in any research; or
b) The procedure is experimental; or
c) The consumer will be under general anaesthetic; or
d) There is a significant risk of adverse effects on the consumer.
Outside these situations, whether verbal or written consent is given, it is crucial that the key points of the discussions with the patient are documented in the medical record.
Consent is not always a straightforward process. Organisations, such as District Health Boards, have policies on consent that ensure the patient and clinicians are protected. Following a robust process will help to avoid a later complaint. It is also advisable to contact your medical defence organisation if you have any concerns regarding consent and wish to discuss them further.