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Informed Consent and Anaesthesia

Paper delivered to the Meeting of Anaesthetists
Auckland, 15 August 2001

Ron Paterson
Health and Disability Commissioner

The concept of informed consent is central to most health procedures. In emergency situations consent is not required. In all other circumstances consent is a prerequisite to treatment. Determining what constitutes consent is therefore of crucial importance to both patients and health professionals. Tonight I would like to suggest to you that the answer to this question is not as complex as many would have us believe. The answer lies in understanding the principle that underpins the concept of informed concept and that provides a guide to decision-making in this context. This principle is, simply, effective communication of sufficient, relevant information to allow a patient to make an informed choice as to his or her treatment options. If you ask yourself three questions and can answer unequivocally "yes" to all three then you should be confident that your patient has made an informed choice and given or withheld consent for treatment.

The first question is: "Has my communication been effective?"

The second question is: "Has my patient been supplied with the information all patients would expect about their proposed treatment and any extra information that they require because of their special circumstances?"

The third question is: "Is my patient competent to understand the information supplied and make an informed choice or is there another person who is legally able to make such a choice for the patient; if not, am I able to make a decision about what is in my patient's best interests?"

Tonight I will concentrate on the guidance the Code provides in answering these three questions to determine whether informed consent has been achieved in any clinical setting.

Informed consent is not a one-off event. A signature on a consent form is not irrefutable proof of informed consent. Rather, informed consent is a process.

Effective communication - right 5

Right 5 provides that every consumer has the right to effective communication in a form, language, and manner that enables the consumer to understand the information provided. This may involve the provision of an interpreter where necessary and reasonably practicable. In addition, right 5 states that every consumer has the right to an environment that enables both consumer and provider to communicate openly, honestly and effectively. Effective communication optimises informed decision-making, and lies at the heart of real understanding of the available options. In giving a patient information, the provider should not see himself or herself as simply meeting legal requirements or institutional standards, or providing value-neutral data. Rather, the provider should enter into a dialogue that is responsive to the needs, capacities and concerns of the particular consumer. The standard of communication between providers and consumers affects not only the validity of the informed consent process, but also the quality of service, and even the likelihood of a complaint being made in the event that things turn out badly. An effective service cannot be delivered if the provider is unaware of the full nature of the consumer's symptoms and the consumer fails to understand the requirements of ongoing treatment.

Case Study - Surgeon in breach of right 5

As the following example demonstrates, the whole clinical environment, not just the immediate consumer - provider relationship, can impact on communication.

During a consultation with an orthopaedic surgeon a consumer witnessed the surgeon's "rude behaviour" and "violent outbursts" towards his nurse and staff. The surgeon said that the cause of the problem was that his staff had not set up the consulting room the way he liked it, and he was experiencing back pain from having to use the wrong type of examination couch. The surgeon's manner resulted in an environment where the consumer was upset, fearful and unable to communicate freely. The surgeon was found in breach of right 5(1) and it was recommended that he attend a professional course in communication.

One criticism of right 5 raised by providers from time to time is that it simply is not always practicable to take the necessary steps to ensure effective communication. An important poi nt to note is that the rules in the Code - unlike traffic laws applied to rural GPs speeding to attend an emergency - are not applied inflexibly, regardless of the circumstances. Clause 3 of the Code, which is an umbrella provision in relation to all the rights, states:

"1) A provider is not in breach of this Code if the provider has taken reasonable actions in the circumstances to give effect to the rights, and comply with the duties, in this Code.

2) The onus is on the provider to prove that it took reasonable actions.

3) For the purposes of this clause, "the circumstances" means all the relevant circumstances, including the consumer's clinical circumstances and the provider's resource constraints."

I take all the relevant surrounding circumstances into account when considering whether a breach of a right has occurred. Clause 3(2) makes clear that the onus is on the provider to prove that he or she took reasonable actions. If the provider can show - by reference to established practice, guidelines, patient notes or the practical realities of an understaffed, busy public hospital setting - the relevant circumstances in which the act or omission by the provider occurred, then I must take this into account.

In an anaesthetic setting the practice of obtaining consent just prior to surgery is sometimes an impediment to effective communication. Where the anaesthetist is hurried by the demands of a theatre list, and the patient is distracted by the looming reality of surgery, the situation is hardly conducive to communication. Ideally, there should be sufficient time and privacy to allow for effective communication. In case 98HDC15056, a decision that attracted quite a lot of comment from anaesthetists and hospital management, an employer was found in breach of the Code for failing to allow sufficient time for informed consent to be obtained. I recommended a change in practice to allow sufficient time for consent to be obtained in line with the guidelines set by the Australian and New Zealand College of Anaesthetists: "Guidelines on providing information about anaesthesia" (1994). By not allowing sufficient time the employer was vicariously liable for the employee's failure to obtain informed consent. The service provided was below the standard set by the Guidelines and thus breached right 4(2) of the Code.

Adequate information - right 6

The test in right 6 is whether the consumer has received the information that a reasonable person in the consumer's circumstances would expect to receive. The information that should be given includes an explanation of the consumer's condition and of the options available, including an assessment of the expected risks, side effects, benefits, and costs of each option. In practice, the obligations under right 6 require the provider to make a number of judgements, for example, as to the "expected risks" associated with a proposed medication or treatment, and what the "reasonable consumer in that consumer's circumstances" would want to know. The consensus of medical opinion as to what information should responsibly be given is relevant, but is not the final determining factor in terms of the Code. Equally a provider is not expected to be a mind reader; if there are special concerns that would not be obvious to a provider, the consumer has a responsibility to speak up and state those concerns.

In situations where a practitioner wishes to offer a treatment he or she believes to be effective, even though its efficacy is not yet evidence based, the issue of information provision is crucial. In particular, the consumer needs to be told that the proposed course of treatment has not yet been proven effective, and to receive an explanation as to why the provider nevertheless recommends it.

In setting the standard for what information is to be provided to consumers, the language of right 6(2) focuses on the concept of "choice" as well as the more traditional concept of "consent". This reflects the underlying philosophy of the Code that consumers are to take an active role in decision-making. Armed with sufficient information, they are able to make a positive choice about services, rather than simply acquiescing in decisions made on their behalf by providers.

If consumers are to make genuine choices, it is important that they are advised of all treatment options, not just those that are publicly funded. A provider cannot presume to know a consumer's personal circumstances or needs. The information provided should cover the likelihood of success of the various options; their likely effects and any associated physical, emotional, mental, social or sexual outcomes; the consequences of not accepting the proposed treatment; the costs of treatment; and any financial interest of the provider. Providers should explain which option they recommend and why, and must accept that the consumer also has a right to seek a second opinion.

In addition to the information consumers would expect to receive, they also have the right to ask for information. Consumers can expect honest and accurate answers to questions relating to services, including:

• the identity and qualifications of the provider
  
  
• the provider's recommendations
  
  
• advice on getting a second opinion
  
  
• the results of any research they are involved in.

Consumers may also request a written summary of information.

Case Study - GP in breach of right 6
(www.hdc.org.nz 97HDC7669)

The following case study demonstrates the importance of providing appropriate information before seeking consent for any proposed treatment.

The consumer visited a general practitioner (outside her home town) to have a mole on her neck checked. On examining the mole, the general practitioner noticed that the consumer had a neck problem. He advised her that he was trained in neck and back manipulation techniques and could treat her problem. The general practitioner advised the consumer that if he treated her she would no longer suffer from pain in her neck, back and groin, and commented to the effect that he "could not make it any worse". After some discussion with the consumer, the general practitioner carried out the manipulation. The consumer felt dizzy at the time of the treatment and later developed pain in her neck, lower back and hips, and shooting pains from her groin to knee in both legs. As a consequence, she required drug treatment for severe muscle spasms, and was still experiencing pain and discomfort eighteen months later. The general practitioner was found in breach of right 6(1)(b) of the Code, as he did not provide the consumer with an explanation of the expected risks and side effects of the proposed manipulation, nor did he explain to the consumer her possible treatment options. This matter was referred to the Director of Proceedings, who laid a charge against the medical practitioner with the Medical Practitioners Disciplinary Tribunal. The Tribunal found the practitioner guilty of conduct unbecoming a medical practitioner.

Consent - right 7

Under right 7 of the Code consumers have the right to make an informed choice and give informed consent. This right is subject to other legal standards, such as the common law doctrine of necessity, which allows treatment to proceed in emergency situations without the need for informed consent. However, apart from the exceptional situations provided for in right 7(1), the consumer's consent is always required before services can be provided.

The Code also makes clear that every consumer has the right to refuse services and to withdraw consent to services (right 7(7)). This is consistent with s 11 of the New Zealand Bill of Rights Act 1990, which provides that everyone has the right to refuse to undergo any medical treatment.

One issue that may prevent a consumer from giving legally effective consent is his or her competence. The Code makes a presumption in right 7(2) that all consumers are competent unless there are reasonable grounds for believing otherwise.

Right 7(3) states that even when a consumer has diminished competence the consumer retains the right to make informed choices and give informed consent to the extent appropriate to his or her level of competence. A 12-year-old child may be perfectly capable of giving consent to having a wound stitched up, but may not be able to withhold consent to intravenous feeding for treatment of anorexia.

If a consumer lacks the competence to consent, right 7(4) states that services can still be provided to that consumer even if no person can consent on his or her behalf, as long as the proposed treatment is in the best interests of the consumer, and an attempt has been made to ascertain the consumer's views (eg, expressed in an advance directive), or the views of other people who are interested in the welfare of the consumer have been taken into account. The phrase "best interests" should not be interpreted narrowly. It refers to best interests not only in a clinical sense but also having regard to the consumer's overall life situation.

Right 7(6) requires consent to be recorded in writing for participation in any research or experimental procedure, for a general anaesthetic, and where there is significant risk of adverse effects on the consumer.

Right 7(7) makes it clear that every consumer has the right to refuse consent to services or to change their mind and withdraw consent. Providers may ask the consumer why he or she has had a change of mind, and may provide more information, but should be careful not to harass the consumer.

Case Study - Anaesthetist in breach of right 7
( Gisborne Report)

My recently released report on Gisborne Hospital makes it quite clear that a practitioner's sincere belief that treatment would be in the patient's best interest is no excuse for treating a patient without informed consent. The following case study is based on one of the incidents discussed in the Gisborne Hospital Report.

A patient booked for surgery at Gisborne Hospital advised her anaesthetist that she had experienced a serious adverse reaction to the anaesthetic drug fentanyl in 1981. She specifically requested that she not be administered fentanyl again. The consultant believed that her previous reaction to fentanyl had been due to an overdose, and not a true allergic reaction. He decided to re-expose her to fentanyl in a closely controlled environment in order to establish whether she was in fact truly allergic to it because he believed that "it was not in the patient's best interests to spend the rest of her life not having fentanyl available to her". The anaesthetist administered fentanyl and the patient did not show any signs of allergy. The anaesthetist was found to have breached right 7 of the Code by administering fentanyl to a patient in the face of her specific refusal to consent to such administration.

Case Study - Surgeon in breach of rights 6(1)(b), 7(1)
98HDC19009

This case demonstrates the danger of using a risk rating of 1% as a strict basis for disclosing risk factors. The probability of a risk eventuating must be weighed against the magnitude of the potential harm and the availability of other options.

A patient was admitted to hospital one month after giving birth. She had experienced a number of complications prior to and following the birth. The patient had shown signs of infection and had had antibiotic treatment. The obstetrician, who was aware of this history, decided to perform a D&C. He met with the patient prior to the surgery to discuss the risks of anaesthesia and surgery. The risk of uterine perforation was not mentioned, as the chance of it occurring is less than 1%. My obstetric advisor noted that "most obstetricians would not include discussion of this during preoperative counselling unless the risk was deemed to be considerably elevated". The patient was left with the impression that the operation was simple and that nothing could go wrong. She said she would not have consented had she known the risks. During the surgery the patient's uterus was perforated necessitating a laparotomy with oversewing to correct it. Expert advice showed that the uterus is rendered more susceptible to perforation following infection and antibiotic treatment. It was reasonable for the consumer to expect to be informed of this slight but well-recognised risk. The surgeon was found in breach of right 6(1)(b) in failing to provide adequate information. This meant that the patient was unable to give informed consent, and that a breach of 7(1) also occurred.

Case Study - Anaesthetist in breach of rights 5(1), 6(2) and 7(1); Employer in breach of right 4(2)
98HDC15056

This is a case study where an anaesthetist was found to have breached rights 5(1), 6(2) and 7(1), and the public hospital that employed him was also found to be in breach of the Code because insufficient time was allowed for staff to gain informed consent for anaesthesia. I recommended a change in practice to allow sufficient time for informed consent to be obtained. This is in line with the guidelines set by the Australian and New Zealand College of Anaesthetists: "Guidelines on providing information about anaesthesia" (1994). Specifically the complaint was that the doctor did not allow sufficient time to read a consent form, administered midazolam to the patient without her consent, and was aggressive and rude.

A patient attended a pre-assessment anaesthetic clinic appointment where it was noted that she had a past history of addiction to benzodiazepine and was concerned about the choice of anaesthetic. She did not want drugs from the benzodiazepine family. In the theatre reception just prior to her surgery the consumer met another anaesthetist, who checked her notes, took her medical history and asked her to sign an anaesthetic form. This was the first time the consumer was made aware she had to sign a separate form for anaesthesia. Some discussion of her reluctance to use an oxygen mask occurred and she repeated her concerns about certain drugs being used. The anaesthetist explained the safety record of the drugs in question and the patient was taken into theatre. He reported that the patient appeared extremely anxious and that there was very little time for the consultation to take place. The patient, noticing she was being administered a drug, asked the anaesthetist to tell her what drug she was receiving. The request was initially ignored. The patient became distressed and repeated the request, which was then answered. The drug, midazolam, was a short-acting benzodiazepine that the anaesthetist believed had no risk attached to it and would help to relax an anxious patient. He proceeded to administer it on the basis that it was in her best interests. The anaesthetist was found in breach of rights 5(1), 6(2) and 7(1) by failing to effectively communicate with the consumer, by failing to enable the consumer to make an informed choice, and by administering midazolam without her consent.

The public hospital was found in breach of right 4(2) by not allowing sufficient time for anaesthetists to obtain informed consent. The employer failed to provide services that complied with the legal requirements for informed consent.

One aspect of the woman's complaint was that she had told the anaesthetists that she did not like the feeling of the oxygen mask on her face, to which he replied that she could "suck on the end of a tube for all I care as long as you get some oxygen". During the subsequent investigation, the anaesthetist offered the following explanation:

"I did not intend to be offensive. I was speaking quite light-heartedly, comparing the procedure with scuba-diving."

The incident highlighted the need for sensitivity in discussing anaesthesia with anxious patients. Humour should be used with caution.

My report recommended that the anaesthetist fully document his pre-anaesthetic consultations, ensure that he obtain informed consent before administering any anaesthetic, and apologise for his breaches of the Code. In response he wrote to me:

"I wish to express my extreme disappointment at your opinion. I feel humiliated, powerless, cheated because I had just endeavoured to practise my profession according to the best standards of humanity and safety. However I understand that I should endeavour to at least practise more defensive medicine, spend more time documenting the requests of my patients, even if these are irrelevant to the safe administration of the anaesthetic."

I found his response disappointing. Did this anaesthetist stop to ask himself whether he had effectively communicated with his patient? Whether his patient had all the information she needed? Whether she had consented to administration of a benzodiazepine?

Conclusion

It is not hard to see how difficulties in communication can arise. The challenge is to create a variety of resources and materials that can be used to impart meaningful information. Written and video material may be a useful way of supplying information. As Rob Ebert notes in a forthcoming editorial for Anaesthesia Aotearoa, we need a greater focus on individual educational needs. This may mean two sets of simple educational pamphlets: one for patients who attend a Pre-admission Programme and another for patients who do not. Anaesthetists should not be "stuck with a legal paradigm". Informed consent is not about "securing the future [with] the Health and Disability Commissioner and the Medical Council". It is about three basic principles - effective communication, adequate information and freely given consent from competent patients.