Key Points
Patients’ autonomy appears to trump other considerations. Their wishes of refusing treatment are determining irrespective of their rationale or lack of rationale and medical consequences.
A doctor is legally required to apprise a patient about any material risks to ensure consent for any procedure is fully informed. Materiality refers to relevance and significance of a complication to a particular patient rather than the likelihood of that complication.
A doctor may withhold information from the patient only in exceptional, clearly defined circumstances, including the patient’s refusal, in an emergency or when such information would result in the patient’s harm. Harm is defined as a serious consequence to a patient’s physical or mental health and the patient’s distress alone is insufficient ground for omitting consultation.
Not only outcomes but also processes are increasingly legally challenged. This means that not exercising due care to discuss treatment options with the patient can be a basis for litigation, notwithstanding that the same may be subsequently agreed and consented.
Capacity relates to the ability to make an independent decision in relation to a particular treatment and its assessment is based on the Mental Capacity Act (MCA) 2005.
Best interest is determined by looking at the patient’s welfare and taking into account a wide range of factors far beyond medical consideration. These can be guided by the patient’s known or perceived views of quality of life and can be supported by those closest to the patient or by a legal representative.
Patients’ anticipatory decisions as formulated in valid and applicable advance directives are legally binding and it is anticipated that their use will increase.
In preoperative assessment, methodical evaluation of combined surgical risk and the patient’s medical fitness largely determines whether the proposed surgery will go ahead. This chapter considers how non-medical factors influence this process.
Within non-medical factors, great relevance is given to the recent legal shifts focusing on patients’ right to relevant and accurate information as well as establishing a central and leading role for patients in their treatment decisions.
While signing surgical consent is a single event, this agreement is an end result of a process during which a patient acquires comprehensive information and develops full understanding of the proposed treatment and any alternative treatment options. While emphasis of surgical consent is on medical benefits and risks, the role of a preoperative clinician is to elicit social, cultural and other relevant circumstances to help to fully understand the individual requirements, needs and preferences.
In the instance of patients lacking capacity, anticipatory decisions substitute contemporaneous consent and if such legal documentation is not available, decisions are made in the best interest of the patient.
Common law cases cited here serve to illustrate the application of some legal principles in medical practice and are not intended to give a comprehensive account of law on the subject. Such cases are not always concerned with the preoperative setting, yet legal principles are valid and will apply to patients awaiting surgery. In this context, contemplating legal cases is a relevant exercise, but it is also important to keep in mind that resorting to courts in medical negligence matters is relatively rare and the vast majority of matters are agreed through the Trusts internal compensation system and any ensuing professional shortcomings through the professional regulatory bodies.
While most patients attending preoperative clinic have full capacity, nonetheless there will be patients who have no ability to make their own decisions. The first part of this chapter will analyse issues related to consent for surgery and will cover legal interpretation of patients’ autonomy including the right to refuse treatment and the right to sufficient information. The second part will provide guidelines for less common events when assessment of capacity is required and address standards of care for patients unable to make decisions for themselves.
Consent
The principle of consent is founded on a patient’s right to autonomous choice. Individual autonomy applied to the medical setting ‘encompasses at a minimum, self rule that is free from controlling interference by others and from certain limitations as an inadequate understanding that prevents meaningful choice’ (Beauchamp, 2009).
Legal rights derived of these two core elements of autonomy, considered in the context of a patient’s consent, are freedom of choice and the right to information.
Right to Refuse Clinically Indicated Treatment
Freedom from controlling interference of others denotes that the autonomous patient has a right to refuse clinically indicated medical treatment (or intervention) even if such refusal is to his/her clinical detriment. This principle stating that ‘A person is not to be treated as unable to make a decision merely because he makes an unwise decision’ is set out in the MCA 2005 (section 1(4)). Equally, common law is clear in protecting competent patients’ right to decide irrespective of how ‘rational, irrational, unknown or even non-existent’ their rationale may be (Re T (Adult: Refusal of Treatment) [1992] 3 W.L.R. 782 at 786, CA; Airedale NHS Trust v. Bland [1993] 1 All E.R. 821 at 860). Essentially, this right guarantees patients’ choice to accept or refuse treatment, but is also linked to a competent adult’s responsibility for his/her own decisions and the consequences of his/her choices.
While a competent adult does not require his doctor to agree that he refuses treatment, an individual should not expect to receive treatment on demand. ‘Autonomy and the right to self determination do not entitle the patient to insist on receiving a particular medical treatment regardless of the nature of the treatment.’ (R (On the Application of Oliver Leslie Burke) vs The General Medical Council [2005] EWCA Civ 1003). Recent legal developments confirm that a patient cannot demand a particular treatment; however, healthcare professionals must take into account the patient’s wishes when making treatment decisions (Aintree University NHS Trust v James [2013] EWCA Civ 65).
Shift from Doctors’ Duties to Patients’ Rights
Historically, the legal standard of care was determined by the Bolam test, which measured quality of treatment, including information disclosed with the patient’s consent, in relation to practice recognised by other doctors (Bolam v Friern Hospital Management Committee [1957]2 All ER 118). The Bolam test states that a doctor who acted in accordance with practice accepted at the time as proper by a ‘responsible body of medical opinion’ (skilled in the particular form of treatment in question) was not guilty of negligence, placing such practice merely as a different technique. The Bolam test was subsequently modified by Bolitho, which added a requirement to sustain logical analysis to the Bolam standard (Bolitho v Hackney Health Authority [1998] AC 232).
Currently, the Bolam standard is regarded as a reflection of an out-of-date patriarchal doctor–patient relationship and has been replaced by an approach centred on patients’ autonomy. Accordingly, while previously consent-related information disclosure focussed on doctors’ duties (expressed by the courts by what a ‘reasonable doctor’ would reveal), current emphasis has moved beyond doctors’ duties and shifted towards patients’ rights. Consequently, a doctor is required to disclose what a ‘reasonable patient’ would want to know (Sidaway v Board of Governors of the Bethlem Royal Hospital [1985] AC 871, Pearce v United Bristol Healthcare NHS Trust [1998] EWCA Civ 865 and Chester v Afshar [2005] 1 AC 134).
Patients’ Right to Receive All ‘Material Information’
Respect for patients’ autonomy determines that a patient has the right to know all the facts that may affect his/her decision. This principle, which determines the validity of consent, was asserted in Montgomery (Montgomery v Lanarkshire Health Board [2015] UKSC11). In law, a doctor is under a duty to take reasonable care to ensure that the patient is aware of any ‘material risks’ involved in any recommended treatment, and of any reasonable alternative treatments. The ‘test of materiality’ is whether ‘in the circumstances of the particular case, a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it’ ((Sidaway), p. 889, para 87; (Montgomery)).
These developments in law are reflected in the guidelines for professional practice. One of the documents currently in force (Good Medical Practice, General Medical Council, 2013) states, under the heading ‘The duties of a doctor registered with the General Medical Council’: ‘Work in partnership with patients. Listen to, and respond to, their concerns and preferences. Give patients the information they want or need in a way they can understand. Respect patients’ right to reach decisions with you about their treatment and care’ (para 78).
GMC Consent Guidance: patients and doctors making decisions together (2008) highlights an individualised approach to information disclosure: ‘The amount of information about risk that [a doctor] should share with patients will depend on the individual patient and what they want or need to know. [Doctors’] discussions with patients should focus on their individual situation and the risk to them’ (para 8). ‘[Doctors] should do [their] best to understand the patient’s views and preferences about any proposed investigation or treatment, and the adverse outcomes they are most concerned about. [The clinician] must not make assumptions about a patient’s understanding of risk or the importance they attach to different outcomes’ (para 31).
Additionally, a doctor must appreciate that, from a legal standpoint, risk is not about ‘percentages’ and that he/she is obliged to discuss even numerically very low risks, if deemed ‘material’ to the patient (Chester v Afshar [2005] 1 AC 134). Accordingly, GMC guidelines (2008) make it a professional obligation that: ‘[a doctor] should tell patients if an investigation or treatment might result in a serious adverse outcome, even if the likelihood is very small’ (para 32).
Significance of a given risk is likely to reflect a variety of factors besides magnitude, including the nature of the risk, the effect on the patient’s life, the importance to the patient of perceived treatment benefits, and any alternatives and risk involved in those alternatives. Assessment of the risk is therefore fact-sensitive and sensitive to the characteristics of the patient (Sidaway). Doctors’ advisory role involves a dialogue, the aim of which is to ensure that the patient understands the seriousness of his or her condition, the anticipated benefits and risks of the proposed treatment and any alternative treatment options. The aim of this discussion is to ensure that all information given to the patient is clear and comprehensive so that the patient is able to make an informed decision.
Withholding information from the patient. There are only three exceptions when a doctor may withhold information from a patient: firstly, when the patient does not wish to receive it, secondly, when a doctor reasonably considers that the disclosure would be seriously detrimental to a patient’s health (causing a patient’s upset is not sufficient), lastly, in an emergency situation rendering the patient unconscious or unable to make a decision.
The second exception relies on a doctor’s clinical judgment to assess the likelihood of a harmful effect of information disclosure on the patient. This reason for withholding material information has been established in common law so that ‘Even if the risk is material, the doctor will not be liable if upon a reasonable assessment of his patient’s condition he takes the view that a warning would be detrimental to his patient’s health’ (Sidaway: 889–90). GMC guidelines (2008) emphasise that being detrimental in this context ‘means more than that the patient might become upset or decide to refuse treatment’ (para 16).
The almost inevitable consequence derived from these considerations is the need to provide patients, particularly in an increasingly litigious society, with large amounts of information. However, information verges on infinite and it is not possible to offer all information that exists. Besides, large amounts of information may be confusing and detrimental to the patient and one must be respectful of the patient’s wishes regarding the amount of detail he/she wishes to know. Essentially it is suggested that truly autonomous patients should decide what information they need (O’Neill, 2003) and that they may choose to access more detailed information via a variety of sources such as patients’ information leaflets, guides and the Internet. Similarly, Beauchamp highlights that ‘A fundamental obligation exists to ensure that patients have the right to choose and the right to accept or decline information. Forced information and forced choice are inconsistent with this obligation’ (2009: 107).
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