Guidelines on informed consent in anaesthesia: unrealistic, unethical, untenable….

‘Informed consent’ has become the primary paradigm for protecting the legal rights of patients and guiding the ethical practice of medicine.¹ The Association of Anaesthetists of Great Britain and Ireland (AAGBI) ‘informed consent’ guidelines have recently been updated in response to ‘the changing ethical and legal background against which anaesthetists, intensivists and pain specialists, currently work’.² This guidance aims to advise its members (and others) how to provide information about anaesthesia that respects patient autonomy and stays within the law.³ This raises the question, are we really achieving the key principles of primum non nocere,⁴ respect for patient autonomy,⁵ and the need to provide adequate information?⁶ Current guidance has been almost solely based on medicolegal determinations around inadequate informed consent, focusing on the failure to disclose a ‘material risk’.^7,8 This has led health authorities and many clinicians to interpret the guidelines as a directive, informing patients of an ever-increasing list of potential anaesthesia-related adverse events. Misguided attempts to include every possible ‘material risk’ are leaving patients bombarded with excessive amounts of largely irrelevant and incomprehensible information.^9,10 This practice is also leading to unnecessary alarm and confusion, not to mention exposure of patients to the adverse effects of nocebo communications (negative suggestion).¹¹

Material risk

Our medicolegal colleagues define ‘material risk’ as one that a reasonable person would wish to know in that particular patient’s circumstances.⁷ Despite medicolegal anaesthesia experts proclaiming that the law is clear,³ a widely cited note of the California Supreme Court suggests otherwise, ‘One cannot know with certainty whether a consent is valid until a lawsuit has been filed and resolved’.^12–14 It appears that risks only become ‘material’ after a complication occurs and a retrospective judgement determined. Little wonder then that doctors have been struggling with meeting increasingly impractical and unreasonable medicolegal expectations of 20/20 hindsight!^7,8

The reasonable person

The definition of material risk, as presumed for many patients, is based on at least four assumptions. The first assumption is based on the lack of clarity around the legal definition of a ‘reasonable person’. We question whether it is possible to define a ‘reasonable person’, as this will always be idiosyncratic, and like beauty, will be in the eye of the beholder. Secondly, even if one accepts that a reasonable person can be identified, patients cannot be expected to behave in a reasonable way, or think logically, when ill,¹⁵ stressed, or distressed.^16,17 A ‘reasonable person’ may have little capacity to appreciate future realities until actually presented with the situation; for example, a woman with a documented antenatal birth plan which clearly articulates that she will not accept epidural analgesia under any circumstances and who, once in labour, requests it, or the patient refusing blood products before surgery who is then presented with a likely possibility of death without them. Thirdly, the Montgomery ruling,⁷ which provided the impetus for the latest revised AAGBI guidelines, assumes that the doctor can put him or herself in the patient’s shoes. Individual doctors may have very different realities, understandings, and expectations, not only of their patients but of each other.¹⁸ With the best of intentions, anaesthetists trying to predict every possible piece of information that a particular person might wish to know, given the person’s particular circumstances, is inevitably going to be incomplete in some aspects of the disclosure to both patients and their doctors. Finally, if a complication occurs, the law assumes that a person would know what was important to them before experiencing the complication. We suggest that it is unreasonable to expect patients to return accurately to their pre-intervention mindset regarding the acceptability of risk after they have experienced a complication.

How the threat of medicolegal action adversely affects communication

Key aspects of informed consent are to provide enough information for patients to accept or decline a proposed treatment, and avoid deception or coercion.¹⁵ Observational studies^19,20 and clinician surveys²¹ during the last decade suggest that these goals, in the context of anaesthesia clinical practice, are being compromised by the fear of litigation and the push to provide escalating amounts of risk information. Is there an alternative approach? It seems to be well recognized that good communication is key to informing patients, promoting autonomy, and mitigating litigation.^3,22–25 To optimize communication, the anaesthetist needs, first and foremost, to think of the patient rather than base their interactions on the perceived need to cover themselves, their insurer, or the hospital employer from medicolegal action. There are language structures that can be learned and taught such that building of rapport can be integrated into an explanation of pertinent²⁶ information in a non-threatening and meaningful way.^27,28 In this endeavour, listening to the patient is an essential first step.²⁹

We propose that a consideration of the airline industry rather than the legal system for guidance may be more helpful, both as a means of improving patient safety and as a strategy to decrease the risk of litigation. When passengers walk onto a plane they do not have to sign a consent form stating that they understand that they might burn in a fire, drown if there is a water landing, or die if the landing gear fails to deploy, yet there is an implicit understanding that if they wish to reach their destination in a timely manner, these and many other unnamed risks might occur. This industry has led the way in effective team communication strategies, promoting safe work practices, and is becoming increasingly adept at providing critical safety information.³⁰ For example, ‘At take-off and landing and at other times when requested, please have your seat belt buckled low and tight around your waist. It is there for your safety and comfort’, or, ‘In the event of an emergency, floor lighting will guide you to the exit’. This approach aims to show how people can maximize their safety and comfort rather than be fearful and distressed; the exact opposite to the current health-care paradigm of informed consent.

It has long been recognized that ‘Maintaining good relationships with patient(s) often works better than the best informed consent’.¹³ This view is consistent with listening to patients and developing a therapeutic relationship so as to provide meaningful risk information in a way that enhances rather than hinders the patient experience. For example, patients are frequently ‘informed’ before injection that local anaesthetic ‘stings’ or feels like a ‘bee sting’.³¹ The operator with the best of intentions believes that this is truth telling when, in fact, this statement fails to recognize the possibility that the perception experienced by the patient may not sting. In addition, this nocebo communication can introduce or exacerbate a negative perceptual experience that has been shown to increase pain.³² An alternative communication giving meaningful information, such as, ‘The local anaesthetic will numb the skin so as to allow us to perform the procedure as comfortably as possible for you’, provides both meaningful and truthful information that is more likely to decrease pain and anxiety.³² Of course, patients must be given every opportunity to have concerns addressed and questions responded to. However, it might be helpful to question the necessity of repeating negative risk information verbally on the day of surgery unless the patient asks specifically for clarification. This is particularly relevant when suggesting symptoms such as pain, nausea, and itch, given that patients are particularly vulnerable to the effects of nocebo communications when anxious, and anxiety tends to escalate as the time to anaesthesia induction approaches.^11,33 It is frequently possible to provide risk information in a way that is reassuring rather than anxiety provoking. For example, rather than tell a parent that their asthmatic child might have an ‘asthma attack’ during their surgery, one could say, ‘as asthma is a concern, we will give some of the asthma medicine before their surgery to ensure the lungs are relaxed so as to make the anaesthesia as safe and comfortable as possible’. Likewise, rather than tell patients that they might have nausea and vomiting, we could just as truthfully inform them that, ‘most patients find that they can eat and drink as soon as they feel like it’.

Effective communication after a complication to reduce litigation risk

Trying to identify and predict a material risk as part of the informed consent process is likely to be less effective as a strategy to reduce litigation risk than clinicians behaving professionally as a caring doctor in good faith. Equally important is to communicate with the patient both effectively and with compassion should a complication occur. This includes listening to patient concerns,²⁷ expressing an apology for what has happened, having a plan of what steps should now be taken, and being there for the patient through their recovery.

The uncritical acceptance of legal precedent

The recent updated AAGBI guideline on ‘informed consent’ appears to have been revised in a way that leads to an uncritical acceptance of legal precedent based on cases outside the context of providing anaesthesia care.^7,8 This approach largely ignores the fact that anaesthetists are rarely sued for failure to provide adequate informed consent, which probably reflects differences between the anaesthesia context and that of surgeons and obstetricians. Consistent with the AAGBI guidance, where anaesthesia is being conducted as part of another procedure (e.g. surgery), ‘informed consent’ in its current form is frequently not worth the paper it is written on.¹⁴ An awareness of nocebo effects and carefully listening to the patient are likely to be the most effective strategy of informing patients in a way that respects their autonomy,⁵ avoids inadvertent harms,^9,15 and decreases unwarranted litigation.^22,34 The current provision of anaesthesia informed consent, especially on the day of surgery, is becoming increasingly inconsistent with the principle of primum non nocere.⁴

Conclusions

In clinical practice, the physician’s primary responsibility must come down to acting and interacting in the best interests of the individual patient in front of them. The inevitable failure to meet unrealistic expectations of recent legal rulings on informed consent will probably continue to impair communication with patients and cause inadvertent patient harms. It is becoming increasingly clear that the disconnect between legal expectations and the reality of communicating with patients in difficult and highly stressful situations is having the opposite effect to what is intended. Is it not time to change the paradigm of informed consent from legal-centred to patient-centred anaesthesia care?

Authors’ contributions

First draft: A.M.C.

Subsequent drafting, ethical analysis, conceiving the idea for the manuscript, critical revisions, approval of submission of the manuscript, and guarantors: A.M.C., S.W.S.

Declaration of interest

None declared.

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