Current management of people with prolonged disorders of consciousness is failing patients, families and society. The causes include a general lack of concern, knowledge and expertise; a legal and professional framework which impedes timely and appropriate decision-making and/or enactment of the decision; and the exclusive focus on the patient, with no legitimate means to consider the broader consequences of healthcare decisions. This article argues that a clinical pathway based on the principles of (a) the English Mental Capacity Act 2005 and (b) using time-limited treatment trials could greatly improve patient management and reduce stress on families. There needs to be early and continuing use of formal best interests meetings, starting between 7 and 21 days after onset of unconsciousness (from any cause, including progressive disorders). The treatment options need to evolve as the clinical state and prognosis becomes more certain. A formal discussion of treatment withdrawal should occur when the upper bound of predicted recovery falls below a level the patient would have considered acceptable, and it should always be discussed when the condition is considered permanent. Any decision to stop treatment should be contingent on a formal second opinion from an independent expert who should review the clinical situation and expected prognosis, but not the best interests decision. The article also asks how, if at all, the adverse effects on the family and the resource implications of long-term care of people left in a prolonged state of unconsciousness should be incorporated in the process.
- health care economics
- living wills/advance directives
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People with a prolonged disorder of consciousness may receive treatments that are not in their best interests, sometimes for years. Three major reasons are a failure to consider their best interests formally, simply assuming professional decisions are best; a reluctance or failure to consider that stopping (or not starting) life-prolonging treatments may be the most appropriate decision; and, in England and Wales at least, a long delay between the decision and its enactment while the legal process is executed. This paper sets the context, clinical and legal (for England and Wales), and discusses how the best interests process should be developed and used to overcome some of the difficulties.
has persisted for >1 week
is caused by brain damage
is not a coma induced for medical reasons.
This paper will consider only adults who had mental capacity to make healthcare decisions beforehand, including both patients who have a progressive disorder and those with an acute onset condition.
The decisions being considered concern interventions that might prolong life. The decisions include but are not restricted to initiation of or withdrawal of clinically assisted nutrition and hydration by gastrostomy feeding.
The legal context is determined by the local jurisdiction. In England and Wales, the Mental Capacity Act 20053 sets out the legal framework for making healthcare decisions in people who lack capacity to do so themselves, including advice on factors relevant to a patient’s best interests.4 5 Best interests are used in court decisions.6–8 The important features are that
best interests are not simply focused on prolongation of life4 8;
evidence from many sources can be used to establish a person’s likely choice;
the decision is made by the healthcare team, not the family (except when there is a valid advance decision or a deputy empowered to make the decision);
the court can consider whether a decision is valid, but cannot suggest a treatment considered clinically inappropriate.9 10
Research suggests that levels of consciousness are on a spectrum, and categorisation into a specific state is often uncertain.11–13 Indeed a systematic review14 concluded ‘From the analysis of several measures comparing VS and MCS, both at the behavioral and at the neurophysiological level, it emerges that there is no combination of variables which reliably and consistently allows discriminating between these two diagnostic categories. This pattern of results questions the empirical validity of the distinction between VS and MCS.’ (Note: VS=vegetative state, MCS=minimally conscious state.) Similarly, although the accuracy of prognosis increases over time, it is rarely absolute. Recovery from unawareness after 6 or 12 months is considered improbable,15 and recovery from a minimally conscious state after between 3 and 5 years is considered improbable.15 However, there are credible although rare reports of isolated brief episodes of complex behaviour,16 and of late improvement into a state of severe disability.17–20 The evidence base does not allow any firm early prognostication and uncertainties persist even after the time of ‘permanence’, but the evidence is no worse than that available for similar decisions in other clinical situations.
Last, the current clinical situation is unsatisfactory. The best interests of patients are often overlooked or not considered.6 8 21–23 The legal process adds delays and costs.21 24 25 Families are distressed by the situation26 and by the process of making decisions.21–23 27 Controversy over the legal influences on the process continues.28 29
Improving the situation
The clinical goals for the patient include
ensuring the patient’s wishes are followed from the outset, in as far as they can be ascertained or estimated;
minimising the risk of harm, pain and distress both in short and long term;
maximising the level of functional and social recovery made, if any.
Clinical management goals for the family and friends of the person include
active involvement of family and friends in the process from the outset;
minimisation of stress on and distress of family and friends.
Last, and more controversially, the process must consider equity and the fair use of scarce healthcare resources.
General guidance on clinical care is given in in the national clinical guideline,15 which also discusses legal aspects of care, and underlies a published pathway.30 Problems persist despite this guidance. The following sections will consider
making the patient’s best interests central to all decisions
managing the changing levels of uncertainty over time
the potential influence of family interests and resource use on decisions.
Focus on the person, not on investigation or treatment
In difficult clinical situations where a good outcome is unlikely, healthcare often focuses on investigating and treating, rather than on the person. Figure 1 shows a person-centred pathway applicable to anyone entering a prolonged state of unconsciousness. There is no definition of when unconsciousness becomes prolonged, but somewhere between 1 and 4 weeks15 seems reasonable.
Once a person loses mental capacity, the healthcare team should establish whether there is an advance decision applicable to the situation or a deputy empowered to make clinical decisions because these take precedence. This check is often overlooked by clinical teams, probably because very few patients have either provision in place.
In the absence of a deputy or advance decision, clinical decisions must be in the person’s best interests. In the acute phase, there is little opportunity to hold a formal discussion. In practice, most clinicians will act to save and prolong life,22 and most families consider this correct22 and would support it if asked. The prognosis is too uncertain to do otherwise. Nonetheless, the team should take any available opportunity to ask family members about the person’s likely wishes and to organise an early meeting to discuss treatment options. In progressive disorders, there is no excuse for not holding a formal meeting once it is clear that the person is unlikely to regain capacity; ideally the issues should have been discussed before the person lost capacity.
Once the acute crises have been managed, usually within 7 days, a more structured formal best interests meeting should be held. It is essential that the meeting is attended by a range of professions and specialists, especially someone familiar with prolonged disorders of consciousness, so that there is the best information available about both longer-term prognosis and local management options, and so that rehabilitation interventions can be started.
An early meeting is often the first opportunity for the clinical team and family to meet with time to share information and to ask and answer questions, which may reveal the presence of an advance decision and/or deputy. In both acute onset and progressive onset conditions, the uncertain prognosis at this early stage allows issues that may become important later to be broached without posing any immediate concern or distress, such as setting a ceiling of care or withdrawing a treatment.
The best interests decision-making meeting
Guidance on undertaking best interest meetings is available.4 5 31 The guidance focuses on establishing the person’s values, wishes, but the meeting must consider a much larger body of evidence and opinion. Thus, the meeting must ensure that all parties share information so that decisions are made on the best available evidence. Practical evidence-based advice on the way to managing this type of meeting exists.32 Table 1 outlines a specific list of items to be covered at any best interests meeting.
The first phase is to present, review and explain all relevant facts. This ensures that everyone has and understands all the information available, and that both the family and the clinical staff present have an opportunity to contribute and to ask questions. Different professions will have different information to give and questions to ask, and the family can inform about the person’s wishes, values and attitudes. All management options should always be given, set in the context of the prognosis, without making any assumptions.
The person chairing the meeting needs to be aware of and alert to some potential difficulties. Everybody enters the meeting with pre-existing attitudes, beliefs and expectations. These are rarely discussed but the chair should ‘be mindful of potential decision-making biases’.32 Some people question the veracity of evidence given by family members—as happened in the Briggs case.8 In my view and experience, families give truthful evidence. Unfortunately, professional carers may report observations, suggesting a higher level of awareness than is true.33 34
Two common beliefs are that survival and prolongation of life is always in the person’s best interests, and that the surviving person will not suffer. Neither is necessarily true. A study of people with capacity asked what values would influence future healthcare choices found that prolongation of life was rated as most important by only 4% of people, and that only 32%–42% of people rated it of some or great importance compared with pain relief, dignity and independence.35
Pain may be experienced by people in the minimally conscious state and possibly by people in a vegetative state.36 37 Many survivors who regain awareness will remain severely disabled, often in residential care. Many will have muscle spasticity and poor posture, both of which are painful. Many are unable to exercise any real autonomy in their life and need regular assistance with very personal activities, which may be demeaning to them. Usually friends stop visiting and most family members also withdraw, so that the person is socially isolated, with only carers and people in the same home for company. Depression is not uncommon. Some people develop aggressive behaviour as a response and need long-term medication and secure care. The frequency of these outcomes is unknown, but they occur.
It is also commonly thought that intervening is always better than not; futile treatment is not uncommonly given at the end of life.38 In practice, many unconscious patients are on a cocktail of harmful drugs, reasonably started by someone else, but never reviewed; this follows from changing responsibility for medical care and a lack of relevant clinical expertise. In several cases known to me, reducing and stopping medication has been associated with further emergence from a minimally conscious state, once to full awareness. Surgical interventions, such as inserting a ventriculo-peritoneal shunt ‘just in case there is hydrocephalus’, are also not risk free. Rehabilitation interventions such as splints may cause skin breakdown, and stretching muscles is often painful.
Respect for and the dignity of the patient may be lost. Receiving total care includes many demeaning activities—bowel care, having one’s mouth cleaned, exposure of the whole body to the sight of strangers—which no one likes. Care tasks are often intrinsically painful or distressing, for example, tracheal suction, changing a urethral catheter and stretching spastic muscles. Care standards may be unintentionally poor: talking over a person is easily done; making comments that might be hurtful or distressing is not that uncommon; at times care will be rushed and less careful. Intentional abuse may arise such as making spiteful or discriminatory remarks, causing physical harm and even rape has been reported.39 Families are often distressed by (perceived) substandard care.
Four actions can reduce the risks identified above:
Never assume that people who survive and regain awareness will necessarily be happy; some will suffer ongoing pain and distress that cannot be overcome.
Ensure that there is a full documented justification for every proposed action, investigations as well as treatments, considering the benefits and risks. Undertake a critical review of all ongoing treatments at each meeting, to include rehabilitation treatments.
Use time-limited trials (of a treatment); they reduce the risk of continuing unnecessary treatments and help families (and probably professional staff) to come to terms with the situation.
The principles of time-limited trials are simple.32 40 The medical team and family agree that a specific treatment will be tried for an agreed length of time, when agreed criteria will be applied to determine future actions and what those actions might be. The choices are usually to continue treatment(s), trying an alternative treatment or stopping treatment except supportive and palliative care.
Considering families and resources
The best interests framework is focused entirely on the patient, and this is usually entirely appropriate, including in the acute phase of any illness causing unconsciousness. Nevertheless, healthcare decisions always have an impact on others, and this needs consideration.
The impact of a prolonged disorder of consciousness in one person on family members is obviously great. Families may break up and/or experience financial loss, friendships wither, the emotional strain is great and some family members simply stop being involved. Given that a person may survive for about 10 years,41 the cumulative burden on family members is substantial. Sometimes there may be compensatory benefits, such as forming a satisfying relationship with the new person, even if the relationship cannot be reciprocated. Nonetheless, at each meeting the impact on family should be considered, including family members who are not present (eg, children and those too distressed to attend). Although this information may not influence decisions made about the patient, it may precipitate actions to help family members directly or through referral to other agencies. It may also stimulate a higher standard of care.
Equally importantly, other people are affected. The cost of caring for someone left minimally conscious or totally unaware is between £90 000 and £120 000 each year.42 Given an average life expectancy,41 the total cost for one person after the first year will be about £1.0 million. Health budgets are finite. Choosing to fund one healthcare intervention inevitably leads to no funding of some other treatment for some other person and, if the chosen treatment is high cost and has little benefit (ie, is not cost-effective), then other people will fail to receive more cost-effective treatments.43 Increasing resources will not overcome this fact; it will just alter the boundary.43 Transferring the cost to another organisation such as Social Services only transfers the same problem to another group where other people will not receive support.
The cost consequences of individual healthcare decisions of this magnitude (£1.0 million) for so little benefit (remaining unchanged) should not be ignored. Although many people reject making decisions based on cost, society already makes explicit decisions not to devote resources to some patients who might benefit because the cost is too high for the potential benefit. In the UK (England and Wales), the National Institute for Health and Care Excellence undertakes such decisions. Its charter44 states it has ‘a responsibility to ensure careful and targeted use of finite resources’ and recognises that decisions ‘involve social value judgements’, and it ensures that ‘the judgements we make reflect the values of society’. At present the current National Health Service (NHS) threshold is about £20 000–30 000 per quality-adjusted life-years.45 46
To put it bluntly, the consequences of deciding to continue treatment of one unconscious person for 10 years are that
Each year 10 people with severe hip pain cannot have a total hip arthroplasty and remain with a poor quality of life (NHS cost = £5500 each, private cost £11 000 each).
Each year two people with Band 6 Cystic fibrosis will not get treatment (£40 000 NHS tariff cost).
Over 10 years, five other people will die who would not have and 23 people will lose a year of their life (figures extrapolated from Claxton et al,46 p. xxxiii).
There needs to be some societal discussion about the resources devoted to continuing treatment of people who gain little or no benefit. The numbers may be large, including people who have sustained an acute brain injury, and people in the end stages of progressive disorders such as multiple sclerosis or Alzheimer’s disease.
Stopping treatments already happens. The number of people remaining alive but unaware for many years differs between countries.47 Different hospitals have different practices,48 possibly related to the use of time-limited treatment trials. Doctors are more likely to withhold or withdraw treatment than members of the public, except in the most severely affected patients.49 In the Netherlands, if the doctor decides a treatment is futile then it is stopped, and there is no routine involvement of a legal process.50
Many healthcare staff will not contemplate withdrawal of life-sustaining treatment8 and may refuse to participate in the process. Sometimes healthcare staff may not even discuss stopping treatment, often citing a conscientious objection. The ethical aspects of conscientious objection to legitimate medical management have been debated recently.51–53 Some people feel that death by dehydration following withdrawal of feeding and hydration is unacceptable. The time taken, the change in the person’s appearance with dehydration and the unpredictability of the time of death may all be upsetting to others, but the limited evidence available suggests dehydration does not distress the patient.54 Last, many healthcare teams are also reluctant to be involved in a legal process.
It is neither reasonable nor possible to ban absolutely long-term medical treatment once it has started, even though treatments of proven greater benefit are not funded. It is more difficult to withdraw treatment than it is not to start it. One potential adverse consequence might be a failure to start a beneficial treatment because the potential difficulty of stopping is so great.
A way forward
At present acute clinical services focus on disease and pay little attention to long-term problems.55 If clinical services were to consider the long-term consequences from the outset, these problems might be reduced.56 For people entering a prolonged disorder of unconsciousness, whether acutely or as part of a progressive disorder, establishing a person’s best interests as soon as possible would be an excellent start. This should be accompanied by registering the person on a database, which should collect limited information in order to enhance compliance. Neither of these occur at present, despite recommendations.15 Last, the legal position is ambiguous10 29 and disrupts clinical process25 28 and the apparent legal requirement to involve the court in every case should be removed.27 29
Currently no one takes responsibility for people in a prolonged disorder of consciousness; they are cared for but not actively managed. The commissioners (purchasers, funders) of healthcare services are the people most able to achieve change. If they funded a register and only paid providers if appropriate standards derived from national guidelines15 were met, then the situation could be transformed.
The service standards would include
Early registration of people entering a prolonged disorder of consciousness; ideally at 1 week but realistically up to 4 weeks after onset.
Early involvement of specialist rehabilitation services.
Regular, planned best interest meetings starting no later than 4 weeks after onset (with an incentive to start before 10 days). Full documentation and evidence of family involvement would be required.
Use of the recently established ReSPECT process57 to ensure that ceilings of care are openly discussed.
This would not only improve clinical management, but it would also provide a database which would give the commissioners information to develop better services.
Clinical teams should explicitly record observations on level of awareness made during routine daily care, including observations made by family. More formal serial observations should be made using the Wessex Head Injury Matrix,58 which can be fitted into routine care processes. Last, more specific assessment should be recorded using the Coma Recovery Scale—Revised59 because this is a relatively straightforward assessment taking about 30 min and is probably the best available with much evidence to support its validity and reliability.60 61
Stopping or withdrawing treatment
Stopping treatment, including withdrawal of feeding and hydration, should always be discussed at a best interests meeting in two circumstances. The first, which may arise within a few weeks or months of onset, is when the upper range of possible recovery is below a level that the person would consider acceptable.8 62 The second is when the person’s state is considered permanent and very unlikely to change, currently accepted as being 6 months after metabolic brain injury and 12 months in other cases.15 In the case of progressive disorders, a period of 3 months would seem a reasonable delay before accepting permanence.
Before finally stopping or withdrawing stopping any treatment, such that death will inevitably follow, a second opinion should be obtained to review the clinical evidence and to confirm the clinical conclusion about the state and the prognosis. As far as possible, the second opinion should be given by someone with appropriate expertise and training who is not directly involved with the patient’s management. The person should be provided with a summary of the evidence and informed of any areas of doubt or disagreement, and should be given access to all relevant evidence. The person should see staff and family members, especially if there are any areas of doubt or dispute; they must see anyone reporting disputed observations or with other disagreements. Although they should not normally review the best interests decision, any concerns should be discussed with the decision maker.
One vital legal change is needed—removal of the requirement for the court to review decisions concerning life-sustaining treatment in this group of patients.63 Decisions not to start and to stop life-sustaining treatment are made routinely and frequently in healthcare, without requiring legal review. The current legal position adversely affects care in this group of patients because it disempowers clinical teams from using the best interests process to make a decision. It also prolongs the process and stresses families and clinical teams. The option to go to court should be reserved for cases of disagreement between involved parties, or if there is some other specific reason, as is normal practice for all other clinical situations.
In summary, management of patients with prolonged disorders of consciousness will only improve if
service commissioners, those funding clinical services,
require all services to put all patients entering a prolonged disorder of consciousness on a register
fund such a register
require clinical services to hold regular best interests meetings starting within 3 weeks of entering a prolonged disorder of consciousness using the Mental Capacity Act 2005 guidance and a meeting checklist similar to table 1.
require the routine use of the ReSPECT process.57
the current Practice Direction 9E63 is amended so that there is no requirement or expectation that a court reviews all decisions to stop or withdraw treatment in people suffering any form of prolonged disorder of consciousness.
This article has also argued that there must be discussion of the ethics of providing people who remain unaware or minimally aware with medical treatment and care, once it is obvious that there is very little chance of meaningful improvement, given the large opportunity costs associated with lifelong care. It is not proposing that a fixed rule enforcing treatment withdrawal should be imposed or that any other absolute rules are developed; it intends to stimulate discussion and debate.
I would particularly like to acknowledge all the families and friends of people in a prolonged state of unconsciousness that I have seen over the last 20 years for their insightful questions and discussions; the Kitzinger family for all their support and encouragement; and all the other lawyers, clinicians, friends and my family for all the challenging questions and discussions I have had. All have influenced my thought and my practice—and I hope will continue to do so.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
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