The English law clearly states that the treatment of a competent patient is unlawful unless the patient consents to it (Re T (Adult: Refusal of Treatment) [1992] 4 All ER 649). Consent is the legal expression of the principles of self-determination and autonomy (Feldman, 2000: 67). There is no statute specifically on consent; hence, legal principles have been established through case law (Re C (adult refusal of medical treatment) [1994]; Chester v Ashfar [2004]; Chatterson v Gershon [1981]). Consent must be informed and this is always difficult, especially in emergencies. Jackson (2008) states that informed consent is commonly used to describe two legal duties: the duty to obtain the patient's consent before treatment and the duty to ensure that the patient has been adequately informed about the risks and benefits of their therapeutic options. Del Carman and Joff (2005) structured informed consent into five areas: disclosure, decision, understanding, capacity to give consent and voluntarism. Consent of the patient will prevent a paramedic from being liable for the tort of battery, and Lord Mustill showed this protection in Airedale NHS Trust v Bland when he stated:
‘Bodily invasions in the course of proper medical treatment stand completely outside the criminal law. A competent adult cannot be treated without consent; this protects the patient's autonomy and bodily integrity.’
Valid consent to treatment should be given voluntarily. Even if a sufficient amount of information is disclosed to the patient, their consent will be invalid if anyone has pressurised them into choosing what they do (Re T [1984] 1 All ER 1036). Relatives cannot consent on behalf of patients. Hence, the law is clear that patients must be presumed competent unless proven otherwise and any treatment performed requires valid consent from the patient.
Capacity plays a vital role in determining whether a person can exercise autonomy in making choices in all aspects of life, from simple decisions to far-reaching decisions such as serious medical treatment. In a legal context it refers to a person's ability to make a decision, which may have legal consequences for the person themselves or for other people. The common law ruling to treat incapacitated adults without consent, but in their best interests (Re F v. West Berkshire Health Authority (1989) HL), stated that doctors have the power, and in certain circumstances the duty, to treat incapacitated patients in their best interests.
This case applied Bolam (Bolam v Friern Hospital Management Committee [1957] 1 WLR 582; 2 All ER 118); a treatment fulfils the best interest's criteria if it is in line with current competent medical opinion. The legal definition of incapacity at that time remained ambiguous. Re C, involving a patient with schizophrenia refusing amputation of his gangrenous leg provided a test for assessing whether a patient has the mental capacity to exercise autonomy and established criteria for incapacity. It emphasised that a patient does not have to blindly accept medical evaluation and can make their own decisions with any consequences. Following much debate related to the need to protect incapacitated individuals, The Mental Capacity Act 2005 (MCA) (c.6.) came into force in England and Wales in 2007.
The test for capacity is contained in Section 3 of the MCA, as listed in Table 2.
The principle of respect for autonomy underpins the requirement for valid consent. Respect for autonomy is one of the four key principles developed by Beauchamp and Childress (2001) and acknowledges the right of persons to determine how to live their lives, make their own choices in life and reach self-fulfilment. Scanlon defined autonomy as: ‘To regard himself as autonomous…a person must see himself as sovereign in what to believe and in weighing competing reasons for actions’ (Scanlon, 1972: 215). |
A person is unable to make a decision for himself if he is unable: |
Capacity/competence is assessed in terms of whether the individual is unable to make a decision as a result of an impairment or disturbance in the functioning of the mind or brain. Indeed, Section 2 (1) of the MCA provides:
‘[F]or the purposes of this Act, a person lacks capacity in relation to a matter if at the material time he is unable to make a decision for himself in relation to the matter because of an impairment of, or a disturbance in the functioning of, the mind or brain.’
The MCA fully implemented in England and Wales in October 2007, provides a statutory framework for dealing with individuals who may lack the ability to make decisions regarding their treatment, welfare or finances as detailed by Jones (2005a), who states that:
‘It covers a wide range of protocols pertaining to, among other things, court powers, advance decisions, independent advocacy and powers of attorney. At its heart the legislation is concerned with preserving the autonomy of the individual as far as possible whilst allowing protection and care to be provided in the best interests of those who are unable to make their own decisions.’
The Act is accompanied by a detailed Code of Practice (CoP), designed to assist clinicians and healthcare professionals to ensure that capacity is properly assessed; decisions on behalf of those lacking capacity are made in their best interests; and to provide legal protection for those responsible for such decisions. The tenets of the MCA are based on common law principles established in key landmark legal rulings and several resultant consultation papers by the Law Commission (1991; 1993a; 1993b). In the early 1990s a number of difficult cases arose that highlighted a gap in legislation for determining when an adult was incapacitated and how he or she should be treated if found to be incapable of making a decision. Against the background of the European Convention on Human Rights (ECHR) and an increasing focus on the rights of the individual, respect for personal autonomy has become the predominant governing principle in healthcare law (Gunn, 1994: 8). This is the case so long as the individual retains the capacity to make a decision about his or her treatment. Common law is clear that treating a competent patient involuntarily amounts to the clinician committing a battery (Grubb, 2004: 161).
The common law principle of necessity dictates that there is a duty of care towards incompetent patients to save life, ensure the provision of beneficial medical treatment or prevent deterioration, or to act in the patient's best interests as determined by prevailing medical opinion (Raymont, 2002). The assessment of capacity is thus of crucial importance in medical decision-making and it is essential that the way it is tested sets a standard that strikes a balance. The MCA and its associated Code of Practice in Section 2 (1) describe capacity as functional and its assessment should be based on evaluating the processes a patient uses to arrive at a decision rather than the content of the decision itself: ‘What matters is [the] ability to carry out the processes involved in making the decision—and not the outcome’ (CoP, Section 4.2).
This could result in dilemmas for paramedics who are faced with numerous challenges which include: patients are unknown to them, hence their usual state of mind and treatment is unknown; patients may have had the ambulance called for them, rather than they having initiated the call; it is established that for patients who lack capacity to consent, the paramedic endeavours to treat according to patients best interests under the doctrine of necessity (Eburn, 2005). However, the challenge arises when competent patients refuse treatment, which is potentially lifesaving. Alternatively, a doctor doing a home visit or a relative and not necessarily the patient himself or herself may have called the ambulance. Often, these patients are very ill, yet refuse to be taken to hospital or to accept medical treatment.
This is supported by a number of studies. A study by Evans et al (2007) looked at doctors and nurses working in accident and emergency departments, and at paramedics and ambulance technicians working in the acute ambulance services. These clinicians are often required to make rapid decisions when patients refuse treatment. The findings of this study show that these healthcare workers often do not know how to assess capacity. Only 10% of nurses and none of the ambulance staff knew how to correctly assess capacity. There are also more than three million ‘emergency patient journeys’ undertaken each year by National Health Service (NHS) ambulances (Health and Social Care Information Centre, 2005: 2.3.1). A series of cases in the 1990s had held that none of the other emergency services was duty bound to go to the aid of persons in peril (Alexandrou v Oxford [1993] 4 All ER 328; Capital and Counties plc v Hampshire County Council [1997] QB 1004; OLL Ltd v Secretary of State for Transport [1997] 3 All ER 897. Hence, there is a duty to respond to calls for medical attention. However, paramedics have often encountered on some occasions when they have arrived, patients refuse treatment and this has proven an ethical dilemma, which they have verbalised being unsure of how to deal with.
Stark et al (1990) conducted a retrospective, descriptive and analytical cohort study of pre-hospital patient refusal of care over a six-month period. The study found that paramedics left behind patients with potentially impaired medical capacity, due to legal constraints. Police at the scene told paramedics that they would be arrested if they attempted to restrain or transport a patient against their will. Patients were therefore left at the scene often against medical advice. While none of these cases have resulted in legal action against paramedics, litigation against paramedics has increased over the past decade (Soler et al, 1985). They also identified that further studies are needed to address patient refusal. Since this study, Selden et al (1990) reported that acts or omission, including failure to transport in cases where patients refuse treatment is a common cause of legal action. Other difficulties encountered by paramedics can be seen in Table 3.
1. Extreme time pressure, where minutes can make a difference between life and death. The time taken to inform patients, gather information or to check for competency may actually compromise patient welfare (Iserson et al, 1995) |
2. Extreme emotion by anyone at a scene, e.g. at a traumatic cardiac arrest, affecting the ability to make well-balanced judgements |
3. Informational deprivation, e.g. being unable to determine the age or medical history of a patient, or being unable to come to an accurate diagnosis, again making informed choices very difficult (Beauchamp and Childress, 2001) |
4. Resource limitations and demands, where excessive time spent at the scene ties up crews, increases response times and removes paramedics from the pool of resources (Deschamp, 2000) |
5. Conflict at scene, e.g. between the patient and relatives or callers and paramedics (Deschamp, 2000) |
6. Impaired judgement on the part of the paramedic due to dangers, inexperience, stress or fatigue from shift work (Robinson, 2002). |
In some cases it is reasonably clear that a prima facie refusal can be ignored. If, for example, a person is assessed as having a significant distortion of perception, mood, thought or memory, and is a danger to self, others or property, then the MCA allows paramedics to use reasonable restraint to treat and transport these patients to hospital for treatment. In these instances patients are considered to lack capacity to provide informed consent. If a patient passes all the tests for informed consent, and refuses, then the paramedic has to balance a respect for the patient's autonomy with a duty to protect life. One way through this difficulty is for paramedics to refer decisions and thus responsibility to emergency physicians via consultation. However, in a study by Stuhlmiller et al (2005) this strategy was found to be inadequate in increasing the reliability of either accurately recognising or documenting competency, or more accurately determining if the elements of informed consent had been met—the disadvantages of not being at the scene outweighed any advantages gained from expert involvement. Aside from this, referring to online medical command does little to help gain expertise in decision making or advance the move of paramedics into professional ranks, where autonomy is one essential trait (Wyatt, 1998). Hence, ensuring paramedics understand how to assess capacity is vital to their role.
The case studies in Clinical Vignette 1 and 2 explores the principles of capacity as set out in the guiding principles in Section 2 (3) of the MCA, which clarifies that a lack of capacity cannot be established by reference to a person's age, appearance, and aspect of behaviour or merely by the fact that they have made a decision that is deemed unwise, as considered in the clinical vignettes.
The principles for assessing capacity as outlined in the MCA are detailed in Table 4 below.
Principle 1: Capacity should always be assumed. A patient's diagnosis, behaviour, or appearance should not lead you to presume capacity is absent |
Principle 2: A person's ability to make decisions must be optimised before concluding that capacity is absent. All practicable steps must be taken, such as giving sufficient time for assessments; repeating assessments if capacity is fluctuating; and, if relevant, using interpreters, sign language, or pictures |
Principle 3: Patients are entitled to make unwise decisions. It is not the decision but the process by which it is reached that determines if capacity is absent |
Principle 4: Such decisions must also be the least restrictive option(s) for their basic rights and freedoms |
Principle 5: Best interests—anything done for or on behalf of a person who lacks capacity must be done in their best interest. |
Hence, treatment provided to patients who lack capacity must be given in their best interests, as determined by the treating clinician. This is to reinforce to paramedics the importance of understanding the guiding principles of the MCA and that if, despite this, a patient who has been determined as having capacity still refuses treatment, then his or her decision should be respected (General Medical Council, 1998). In English law there is no mechanism by which a relative or friend can make the decision lawfully on an adult's behalf (Hornett, 1998).
Sections 2 and 3 of the Act set out a two-stage process for testing capacity. The first stage checks the inclusion criterion that the person must be suffering from an impairment or disturbance to his mental functioning, whether this is temporary or permanent (CoP, Section 4.11). Only if this criterion is fulfilled does assessment proceed to the second stage, which stipulates that for a person to come under the powers of the Act, the impairment of mental functioning must be causing an inability to make the relevant decision. Examples of such impairment include delirium, coma, severe brain damage, dementia and severe learning difficulties. These are discussed in Table 5.
Delirium, which is a common source of incapacity in hospitalised patients, conspicuously affects a person‘s decision-making ability by altering cognition and disrupting thought processes to render the actions and utterances of the person incomprehensible (Raymont, 2002). The severe cognitive impairment typical of advanced dementia is perhaps the classic example of a clear indication that a patient may lack capacity (Nygaard et al, 2000; Kim et al, 2002). Capacity may also be impaired by external factors that have only a temporary effect. Shock, confusion, sedation, fatigue, panic, pain and medication may all potentially undermine capacity by diminishing the person‘s ability to take in information or engage in a coherent process of decision making (Grubb and Laing, 2004). |
The above problems are commonly encountered by paramedics in clinical practice, as mentioned in the studies highlighted earlier.
A necessary requirement for capacity is that one understands and retains the information relevant to the decision. This includes having an awareness of the purpose of the treatment, an idea of what it will involve and the consequences of deciding to receive or refuse the treatment, or of not making a decision at all (Ashton et al, 2006). Every appropriate effort must be made to assist in communicating this information to the patient. These criteria aim to minimise the gap between potential and actual understanding so that the patient is able to participate in the decision-making process to the best of their abilities (Gunn, 1994).