Forum.
Sedation. The clinical issues. Counselling and consent.
A. ThornsIntroduction
This section focuses on information giving and decision-making between patients, their families and the healthcare team. There are blurred boundaries between decision-making within the health care team.
Where possible the literature has been explored but by the nature of this topic a large proportion is taken up by moral and legal review. There are, however, very useful research themes that come from this review and are discussed in the conclusion. It has to recognised that moral, legal and cultural influences have a strong bearing on this subject area and I have written mainly from a United Kingdom (UK) perspective.
Table
Factors affecting capacity towards the end of life
- Spread of disease to brain or meninges
- Drug side effects
- Anxiety
- Depression
- Emotional adjustment to condition
- Fears of increase pressure on family and friends
Health professionals have a responsibility to take every step to enhance capacity. This may include the following
- Adjusting the environment to ensure most effective communication and patient safety
- Symptom management
- Adjusting medication with euphoric or sedative properties
- Treating depression or anxiety
- Addressing communication issues
This raises questions in dealing with patients who may benefit or are benefiting from sedation. Presuming the above steps have been covered; it would be difficult to justify withdrawing sedation or other medication in order to try to achieve increased capacity for consent.
A patient lacking capacity offers a challenge to a health care team as to how to approach decision-making. In the UK the legal responsibility lies with the doctor in charge of the patient’s care. The British Medical Association suggests the following issues are considered when making decisions for patients who lack capacity.
- Liberty. The least restrictive of all options should be employed, with appropriate justification, and enabling maximum enjoyment of life. This would mean using the lowest dose of sedation possible and excluding other treatable conditions.
- Autonomy should be promoted as far as possible.
- Dignity should be preserved as far as possible. This would include social and cultural views as well as respect and courtesy. It is debatable as to whether sedation promotes or impairs dignity.
- Patient views should be taken into account as far as possible
- Privacy. No interventions should be undertaken on sedated patients unless there are good reasons why they are needed.
- Health needs need to be met as far as resources will allow. This does put a responsibility on professionals to ensure appropriate interventions are still taken according to need even when patients may not be aware.
- Free from unfair discrimination
- Having views of those close to them taken into account although not asking them to make the decision. Consider the role of proxy decision makers.
- Consider a second opinion
- Involve the team in any decisions
- Consider any anticipatory statements made by the patient
Generally refusing an advised course of action will have more serious consequences for a patient as health care teams will want to advance their best interests. Refusals are therefore considered in more detail, though the same level of capacity is required to both accept and decline treatment.
The role of proxy decision makers
In some countries proxy decision makers are recognised. It is important to ensure the following criteria are met (BMA 2004)
- The patient has agreed to the choice and that the proxy is acting on the basis of what the patient would have wanted and not what they themselves want for the patient.
- The treatment benefits the patient
- The decision takes into account the patient’s wishes
- The decision takes into account the views of relevant others
- The decision restricts the freedom of the adult as little as possible
The risks of proxy decision makers include the possibility of disagreement between professionals and proxy and the balance between respecting an advance directive against the proxy.
Even when not nominated formally as proxies discussions with relatives may be helpful in clarifying what a patient would have wanted however both with relatives and, to an extent, a nominated proxy raise the following concerns may arise:
- There is a risk of relatives stating what they would want themselves.
- Relatives views may well differ from the views of the patient.
- Relatives may not wish to see themselves as the person responsible for withdrawing a treatment or instituting a potentially life shortening treatment and so may be more proactive.
- A patient's "off the cuff" remarks may be seen as a genuine wish.
- Conflicts within a family can be hard to resolve and may influence decision making.
- Concerns could occur that decisions are made on motives other than the best interests of the patient.
The pressure on family and proxies in being involved in such decisions will be an issue and support may well be required during the process of making such decisions.
The role of advance statements
Advance statements regarding treatment decisions are recognised in many countries and can help professionals be guided to appropriate decision making when patients lack capacity.
In relation to sedation at the end of life there may difficulties. For example it may be very difficult to discuss these issues in advance. To raise sedation at an earlier stage may result in misinterpretation and only impair later decision-making. It is not clear whether people can fully comprehend the issues around sedation or know what their experience is going to be. It would be misleading to just make advance planning regarding sedation, all possible decisions after the patient loses capacity would need to be included.
The BMA (2004) questions whether people should be able to decline basic care, defined as interventions with the sole purpose of providing comfort. It could be argued that sedation would come into this category.
However, despite these criticisms of specific advance statements, there would seem to be a good argument for more general wishes or values to be documented. The key considerations for patients to reflect on could be
- Their need for comfort and freedom from distress
- Their wish to avoid any shortening of life
- Their wish to maintain consciousness and clarity of thinking for as long as possible
- The relevance to them of the views and needs of those close and the effect on them of watching any distress
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Safeguarding the incompetent, sedated patient
The final consideration for incompetent patients is the place of routine treatment safeguards that would help to prevent abuses of patients in this vulnerable state. These would be a matter of debate and research but Cherny and Portenoy (1994) put forward a number of suggested safeguards that should be employed:
- Both patient and their family wish for sedation rather than endurance of symptoms and are fully involved in the decisions making
- The decision is made rationally, voluntarily and consistently.
- The intention of all should be the relief of symptoms and not to shorten the patient’s life which comes under the doctrine of double effect
- Diagnostic and prognostic clarity should be established
- Use of a second opinion
- Explicit processes for documentation and review
- The symptom being refractory
Additional points that could be added to this list are:
- Multidisciplinary agreement and review
- Regular training to ensure effective steps are taken to treat any reversible conditions before commencing sedation
- Protocols for the initiation of sedation
Cherny and Portenoy (1994) defined a situation as refractory if any intervention:
- Will not bring adequate relief
- Will be associated with intolerable morbidity
- Will not bring relief within a reasonable time.
They emphasise the need for expert input into this situation and these symptoms should be “refractory” and not “difficult”
Side-effects that impair cognition or run the risk of shortening life become more acceptable when the goals of care of the patient are clearly understood, when the patient’s time is limited and when the clinical situation demands an intervention that will have the desired effect in a prompt and effective manner (Cherny and Portenoy 1994).
No matter how the process proceeds, there are always value judgements for the health care professional involved in assessing competency, which options to discuss, how much info to give. Such decisions are individual to each patient and cannot be determined by guidelines removed from the actual case (Randall and Downie 2004). Similar to consent, it is unlikely that strict criteria for capacity in decisions regarding sedation at the end of life will be achievable. The ongoing knowledge and relationship between patient and professional would be more important. There are certain themes that appear particularly relevant to explore though these need validating. Advance statements or proxies may be useful, but their exact place in this area of healthcare is still to be proven.
The evidence in this section is level IV and V.
Conclusions and moving forward
We have some clear evidence regarding patients’ general wishes at the end of life, the differences that can occur between patients, their families and professionals. We also have a useful theoretical construct of consent and guidance over what might constitute “best interests”. We have some initial ideas regarding advance directives and the use of proxies.
All this information is highly dependant on cultural and local legal interpretation, this needs to be borne in mind and the question raised as to whether research needs to be repeated in different cultures.
Allowing for these factors it does appear that sedation at the end of life fits most closely with the constructed approach to consent alongside a need for advance planning where this fits with the individual needs of the patient.
Future study in this area will have to consider not only research findings but also legal developments.
Future research in this area needs to focus on
- Exploration of the knowledge and perceptions of patients, families and professionals regarding sedation at the end of life across different cultures.
- Exploration of how people make decisions and express their preferences especially across different cultures and the advent of a more choice dominated approach to health care.
- Individualised assessment on patients’ information and decision-making needs and preferences; raising the possibility of setting standards for information giving regarding sedation.
- General methods of improving patient centred decision-making, especially where the patient’s capacity is poor.
- Developing suitable methods of assessing capacity in a palliative care population.
- Exploring the role and effect of advance directives and proxies in end of life decision-making.
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Patient involvement in decision making
It has been demonstrated that the majority of cancer patients fail to achieve their desired level of participation during treatment decision-making (Gatellari 2001). A UK study looking at information and decision-making needs in hospice patients showed that two-thirds desired some form of collaborative decision-making (Murtagh 2003) rather than the medical team making decisions on their behalf. However this conflicts with a Fainsinger’s (2003) findings when comparing populations in Spain and Canada. Spanish patients were less likely to want to be involved in decision-making compared with Canadian patients and families who rated openness and involvement in decision-making highly and were keen to avoid treatments that may result in sedation. Review articles in the UK have highlighted the challenges for doctors in including patient preferences in making treatment decisions (Say 2003) These related to
- Time pressures
- Difficulties in building relations
- Eliciting patients’ preferences in decision making
- Giving the information in the right way and at the right time
- Presenting risk and likely outcomes
- Expressing uncertainty
- Dealing with alternative information sources
- Negotiating a decision in partnership with a patient
- Discrimination influencing patient choice
Specific issues that might impair full patient involvement in decision-making regarding sedation at the end of life might include:
- Impaired cognition and so understanding and capacity
- As an emotionally charged time of life, uncoerced decision-making is likely to be more difficult.
- Divisions among the health care team over the ethical situation
- Different perspectives between patients and their families
- Misperceptions over the intentions over the use of sedation by patients and families
Guidance from a number of areas call for the need for informed consent when sedation is used at the end of life (Quill 1997, Morita 1999, Cherny and Portenoy 1994). A survey of Canadian palliative care experts showed that 78% involved the patient to some degree in decisions on sedation at the end of life, whilst 96% involved families to some degree. Fifty-seven per cent of respondents found the decision “somewhat difficult” or “very difficult” (Chater 1998)
Morita’s Japanese study (1996) showed that in all but 4% of 69 patients who received sedation an explanation was provided either to themselves or their family. The extent of this explanation varied. In 7% both family and the patient were informed of both the possibility of shortening life and somnolence, in 48% family members were fully informed but patients were told of somnolence and in 41% family members were fully informed but patients were not told of either the risk of somnolence or shortening life.
Examples of phrases used in this study included: “To relieve your discomfort, you might be a little drowsy” or “Do you have anything you want to say before you fall asleep?”. The authors also suggested that the atmosphere and non-verbal communication that occurred at the time of decision-making helped to inform the patient of the implications of their decision.
Chiu (2001), in a study from Taiwan of 70 patients receiving sedation, reported that consent was gained in 42.9% of cases from both patient and family and in 50% consent was gained only from the family. The exact content of the informed consent is not documented.
In analysing such data we need to be clear as to the definition of consent we are using and where the border is between informing and consenting to sedation. We should also consider whether family or those close to the patient are able to consent both morally and legally.
Patients and families knowledge and wishes on sedation
Morita (2003) studied both Japanese Oncologists and Palliative care physicians alongside members of the public. In a secondary analysis of two earlier studies it appeared that although physicians differentiated between deep-continuous sedation and Physician Assisted Suicide (PAS) / Euthanasia the public were more likely to link the two more closely. This, it is suggested, indicates the public are more influenced by outcomes rather than intentions.
Muller-Busch (2003) retrospectively reviewed the notes of patients dying in a German unit. Of the 80 patients (14.6%) receiving sedation at the end of life there appeared to be a trend for an increasing number of patients to either include a desire for sedation in advance directives or to request sedation themselves from 18% in 1995 to 34% in 2002, although these numbers are quite small and their statistical significance questioned.
In a US survey of patients, bereaved relatives and physicians looking at patient preferences at the end of life, Steinhauser (2000) found that decision making in terms of trust and a physician comfortable in talking about dying, knowledge of what to expect, a named proxy decision maker and written wishes regarding future treatment were rated highly by patients. Patients rated being mentally aware much more highly than health care professionals which the authors suggests demonstrates physicians may be more willing to sacrifice lucidity for analgesia. Although being pain free was more important than being mentally aware the difference was only small (93% against 92%).
Chiu (2001) found that 90% of families thought sedation to be acceptable, although only just over two thirds were satisfied with the outcome of the sedation. These terms were not defined.
Morita (1996) asked physicians what their interpretation of patients’ and families’ wishes were as regards sedation at the end of life. Of the 69 patients it was felt 4% wanted to be alert even if suffering continued, compared with 2% of families. 50% of patients were thought to want to be alert as far as they could endure suffering, compared with 38% of families. Finally 46% of patients wanted to be free from suffering even if they became drowsy, compared with 61% of families. This demonstrating the difference between patients and their families in decision-making over sedation. Tschann (2003) demonstrated that the presence of a family member at the time of the death can affect the approach of the health care professionals and the treatment offered by increasing the use of comfort care and decreasing the technology. This was a retrospective review of 370 patients dying in a community hospital.
A study of Canadian intensive care specialists and coroners highlighted the joint, yet conflicting, concerns of families that sedation may be a form of physician assisted death, but also a fear that a patient may experience pain or suffering (Hawryluck 2002)
It appears that families are more commonly involved in the decision-making process than patients, yet have different views than patients and are torn between a need to see their relative comfortable and their wish to avoid drowsiness and perceived shortening of life. This is also supported by qualitative work in Israel looking at relatives’ perceptions of terminal restlessness (Brajtman 2003).
Further exploration of public and professional views would be useful in order to set the context for any guidance on information giving and counselling.
Issues to consider in discussing sedation
The UK General Medical Council guidance (1998 p8) provides the following, generic, guidance regarding issues to raise with patients about potential treatments:
- Any consent cannot be an isolated event but part of a continuing dialogue
- Written, visual and other aids should be employed where appropriate
- Arrangements should be made to overcome specific language or communication difficulties
- Where appropriate, discuss with patients the possibility of involving a friend or relative or possibly recording the conversation.
- Explain the probabilities of success, or the risk of failure or harm.
- Ensure that information which patients may find distressing is given to them in a considerate way
- Allow time for patients to reflect and come to a conclusion. In complex situations information may be communicated over a period of time.
- Involve other members of the health care team in the discussions
- Ensure the patient is given a clear route for reviewing the decision
The guidance goes on to state that sufficient information should be supplied and only withheld if “serious harm” would result. “This does not mean the patient would become upset, or decide to refuse treatment”.
Recognition is also given to a patient’s right to not want to be involved in decision-making but stresses the need for the health professional to ensure they fully understand the implications of this decision. (GMC 1998)
The ways of communicating delicate information should be a basic skill in palliative care and will not be expanded on further here except to highlight the role of non-verbal communication in these situations although as Morita (1996) points out this may vary between different cultures.
A number of authors (Morita 1996, Quill 1997, Chan KS 2004, Cherny and Portenoy 1994) have suggested an approach to discussing sedation at the end of life. It is suggested that the following points be included in any discussion
- The poor chance of recovery, that death is inevitable and the severity of present suffering whether this is physical or existential.
- The need to establish that all palliative methods have been applied before coming to a decision on sedation
- That the side effects of sedation may include: life shortening potential and decreased conscious level; though the exact content of this discussion depends on the physician’s judgement.
- That the opinion of the multidisciplinary team is that the benefits of sedation should outweigh the burdens
- That the intention of sedation is to relieve the distressing symptom and not to cause sedation directly or to end life.
- That continuous review will be undertaken and there is the possibility to discontinue sedation if necessary
- Discussion around other end of life issues that may also be appropriate at this time
Cherny and Portenoy (1994) sum this up with the guidance: “In this situation the clinician should explain that by virtue of the severity of the problems and the limitations of the available techniques the goal of providing the needed relief without the use of drugs that may impair the conscious state is probably not achievable. The offer of sedation as an available therapeutic option is often received as an empathic acknowledgement of the severity of the degree of patient suffering”.
Such guidance is helpful but does leave a number of unanswered questions and dilemmas. Suffering and distress are subjective symptoms and so can only really be judged by the patient. It is therefore debatable as to whether the patient or the professional should decide when the symptoms become refractory and whether all palliative treatments need to have been “applied” or just “offered”.
Quill reviewed the anaesthetic literature and found conflicting evidence as to whether sedation relieves suffering or just makes people unable to report it. What are the implications of this in our discussions with patients? Do we say to people that sedation will relieve their suffering or that they will be unaware or unable to report their suffering? (Quill 1997).
Cherny and Portenoy’s (1994) further summary seems highly pertinent: “No patient should have to ask to be killed for persistently unrelieved pain, and contra wise, no patient should be sedated without appropriate consideration of other options and informed consent by the patient or proxy”.
Making decisions more patient centred
A patient centred discussion should help to most closely match a patient’s wishes. In their Cochrane review article Lewin et al (2001) found that the effectiveness of interventions to improve patient centredness was only partly proven. Interventions varied, but included training for the providers in communication skills, problem defining skills training, humanistic and empathic behaviour, consultation structuring and recognition of psychological issues, materials for patients and patient centred training. None of the interventions involved palliative care patients or patients with impaired capacity. Whist it is useful for our discussion to know such interventions could be effective further evidence is necessary for palliative care patients and in particular to validate interventions or tools to use in discussing sedation at the end of life.
Consent
Consent is defined by Gillon (1985 p113) as being a “voluntary, uncoerced decision, made by a sufficiently competent or autonomous person on the basis of adequate information and deliberation, to accept rather than reject some proposed course of action that will affect him or her”. As a concept in healthcare its importance is unquestioned, for example the General Medical Council (1998) in the UK states: “Successful relationships between doctors and their patients depend on trust. To establish that trust you must respect patients’ autonomy – their right to decide whether or not to undergo any medical intervention (para1 page 2). Randall and Downie (2004) suggest consent should be seen as a continuous process of joint decision making involving exploration of patient wishes and goals that is “absolutely essential” in order to provide treatment that is best for the individual patient.
Harris (2003) describes consent as being a central theme in health care owing to its close allegiance to respect for autonomy. It is this informed decision making that makes an individual what they are.
However the approach to consent needs more careful exploration than an initial glance at the Gillon quote may indicate. Theories of consent have evolved, as has the approach in law, so that consent should no longer be “a burden or hurdle that has to be vaulted rather than a standard of communicatory excellence to which we ought to aspire” (Marks 2003).
Theories of consent
Alderson and Goodey (1998) provide an excellent review of the different theories of consent and how they pertain to current healthcare.
“Real consent” is described as a positivist approach based on factual concepts defined through either achieving a certain level or not. It allows standards to be set and for consent to be researched in a scientific or systematic way.
However the standards are high for patients to reach the expected levels of knowledge and for professionals to pass on the information in an effective manner. It is therefore particularly unhelpful in borderline cases such as sedation at the end of life.
“Constructed consent” looks at consent from a range of social constructs. They suggest that understanding is put forward as the most predominant factor in modern health care, but that voluntariness needs much more consideration. Complex desires and resistances may either confuse or enrich understanding. Patients may initially be anxious over the thought of invasive or risky treatments as an immediate reaction but in time balance this against the anxieties over the situation they will remain with if they decline the intervention. Increasing trust in their health care team helps such a process.
In addition, if we consider the individual identities and experiences that make up the person then consent moves further away from the emotionless “real” approach. Abilities to understand are not fixed personal attributes but instead “responses in relationships partly influenced by the professional’s ability to explain, respect and support”. This may allow both to move towards a position where patients are regarded as competent to make certain treatment decisions whilst sharing or deferring other aspects. An ability to decide is different to wanting to be the responsible decider.
Coercion traditionally is seen as a bad thing with the “real” approach trying to limit the interference of outside influences. In this social construct it is recognised that such outside influences cannot be excluded and patients may want to include them as part of their decision-making. For example a patient considering sedation at the end of life might state: “She wouldn’t want to see me agitated, she always said she wouldn’t want to see me suffering so I want to use high doses of sedation”. In this situation the patient may be seen to have undue influence indirectly exerted by his partner, alternatively this could be part of his reasoned and autonomous decision-making.
By this method consent becomes a process rather than an event. The influences in the patients’ life can be varied including family, professionals, past memories, media, friends and all these help to produce the final outcome.
“Functionalist consent” is described by the authors as a “polite ceremony” where consent is a routine process whereby the smooth running of healthcare is unaffected and responsibility for the consequences of a decision pass from the professional to the patient.
Conversely “critical theory” sees consent as a “necessary protection for patients against useless, harmful and unwanted interventions”. This promotes medical accountability and rather than being a one way passing of medical information, consent is seen as an exchange of knowledge so that informed decisions can be made together.
Finally the authors consider “postmodernism” and its influence on consent. They describe the increasingly frequent approach to patients as consumers and the need to offer choice. Individuals who are used to extensive choices in the day to day consumer market expect the same in health care, but the values and decision-making processes people utilise when buying a new television or choosing clothes cannot be the same as when making important healthcare decisions. The authors raise the question as to how patients do approach such decisions. They suggest choice can be too onerous when people are uncertain how to make autonomous decisions or balance their values and rules in the process.
In summary these theories show the complexities of consent and the need for more than just one approach. Constructed theory of consent appears most relevant to the decisions regarding sedation at the end of life, though other theories also have some role. For example, There is a need to maintain some idea of the “real” approach in order to have some validity and generalisability.
The information in this section is level IV or V.
Legal Position on Consent
The legal position on consent continues to evolve. In the UK the Bolam principle established the justification for disclosure based on a body of medical opinion. However this has been increasingly questioned and a move towards the balance of power being with the patient (Marks 2003). In the case of Canterbury v Spence in the USA, the right to self-determination for patients was described as the most pre-eminent factor. This was based on the following points:
- Each patient has the right to determine what is done with his or her body
- Proficiency in diagnosis and therapy is not a full measure of a physician’s responsibility, the wider skills in communication and decision-making need to be recognised.
- It is the prerogative of the patient (not the physician) to determine in which direction his interests seem to lie.
- Elucidating the patients’ “perils and options” is a prerequisite before obtaining consent.
- The physician’s duty to inform is not dependent on the patient’s request for disclosure. A physician has a duty to inform when a reasonable patient in the patient’s position, if warned of the risk, would be likely to attach significance to it.
Mayberry (2002) studied groups of patients and lawyers views on what constituted sufficient information in making a decision about healthcare. Lawyers required more information. In particular the essential information should include:
- Why is the intervention needed?
- What are the common dangers?
- How is it done?
Bridson (2003) calls for the recognition of the movement in law from the medical opinion to the reasonable patient. This process needs a change from disclosing information to sharing, and instead of focussing on disclosure to focus on patient objectives first. The Bristol Enquiry held in the UK looked at the process of consent leading up to cardio thoracic operations in children, one finding was that: healthcare professionals should adopt the notion of partnership between themselves and the patient, whereby the patient and the professional meet as equals with different expertise.
The move to a reasonable patient approach to consent helps to overcome the risk of paternalism in decision-making. However faults in this approach also exist. The patient approach is hypothetical and only truly respects the patient’s autonomy when they meet the criteria of a “typical” patient. What the typical patient would want to know is as much a topic of a debate. For example, in Louisiana, the Medical Disclosure Panel defines risks that must be disclosed for any given procedure (Mayberry 2002). We need to be careful that by trying to respect the full autonomy of all we don’t cause to harm to those who would rather not be fully informed.
The evidence in this section is level IV / V.
Theories and assessment of capacity
Capacity and competency refer to the ability of an individual to make a decision. They are terms that can be used interchangeably although capacity is more commonly used in law (BMA 2004). This is ultimately a legal requirement, and is defined in terms of the law. It is essential that all health care professionals are confident that their patients have made decisions competently and are able assess this. This section considers the factors important in making assessments of capacity and in making decisions when the patient lacks capacity.
To have the capacity to make fully informed decisions a patient should fulfil the following criteria
- The ability to understand in simple language of the purpose of the treatment, its nature and why it has been proposed.
- The ability to understand principal benefits, risks and alternatives of the intervention
- The ability to understand broadly the consequences of not receiving the intervention
- The ability to retain this information to deliberate on it
- The ability to understand the necessary facts and probabilities
- The ability to make voluntary, uncoerced choice
- The ability to make reasoned choice
- The ability to communicate that choice
(GMC 1998; Randall and Downie 2004; BMA 2004)
A patient cannot be found lacking capacity on the basis of knowledge or experience.
In the UK there is a requirement on the healthcare team to assume a patient competent unless proven otherwise (GMC 1998).
However this assessment is specific to the decision faced and when considered alongside the shared approach to decision-making described above it is likely that, when considering sedation at the end of life, such strict criteria cannot always be applied.
Capacity is intrinsically linked to the decision being made (BMA 2004). So, relatively minor decisions need less capacity than more important ones. In considering sedation at the end of life it could be argued that the depth and length of sedation alters the stringency of any tests of capacity applied. A short acting, light sedative may require less stringency than permanent, deeper sedation.
For a patient with capacity, decision making with their involvement is relatively straightforward. In the periods approaching death it is common that patients are unable to maintain full capacity. The indication for sedation is likely to interfere with cognition for example delirium, anxiety, depression or intractable symptoms. The sedation itself will also impair decision-making.