The bio-social revolution and end-of-life care
Medicine has not always been the craft that is practiced today in highly developed countries. On the contrary, until a few decades ago (and still today for the majority of people in the world who have no, or only limited, access to high-technology medicine), medicine was much less effective. There were no means to support a failing heart, or to restart it once it had stopped. Neither was there any efficient tool to replace failing respiratory function. In these situations, dying was an unalterable process. Every illness or dysfunction that could sufficiently limit the efficiency of a single vital organ/system caused the death of the patient in a short time.
In such situations, death was a holistic event. There was a close and clear link between the biological aspects of life (the life or the death of the organism, the functioning of different organs and systems) and the biographical ones (the life/death of the individual, the presence/loss of conscience, feelings, memories, projects, relationships). Supporting and maintaining the biological dimension of life meant supporting the whole person.
Over the last 50 years, artificial organ support technology has been introduced into clinical practice. Such support has different aspects, some of which are of interest to the topic of this paper.
First of all, such technology can effectively sustain and/or replace many of the functions of vital organs (from the heart to the lungs to the kidney, and so on). For this reason, it can prevent - at least temporarily - the death of the critical patient. In this sense, it can be considered life-saving.
A second aspect, which is related to the use of biologically efficacious drugs/tools/procedures, is that their effectiveness is usually measured only by the specific effects on the single organ function or phase of disease for which it is used. The effectiveness of respiratory support is measured by improvement in arterial gas exchange; that of renal replacement therapies is measured by net removal of fluids and toxins; and that of antibiotics by the disappearance of signs of inflammation and infection. Since these biological end-points are considered perhaps the sole indices of adequacy of therapy, diseases are viewed only as biological derangements. Consequently, hospitals and healthcare institutions tend to be considered places where therapies are delivered to cure specific diseases, and healthcare workers (HCW) are viewed as the expert deliverers of those therapies. Yet, the idea that the cure of diseases is the sole objective of the healthcare system is potentially wrong, dangerous and unacceptable.
Actually, if the mission of the healthcare system were to treat diseases, it would be impossible to manage any diagnostic or therapeutic limitation even in desperately terminal situations. Even worse, the patient should be considered just an accident of the illness, the biological substrate necessary for the disease to occur and within which the disease can be fought. In reality, the mission of the healthcare system should be to care for ill human beings according to their interests and wishes.
Another aspect of organ support technology is the fact that it separates biology and biography. This fact is particularly evident in some specific situations. Such situations are so new that naming them was necessary in order to describe, understand and recognize them. Hence, terms such as brain death (1968), vegetative state (1972) and dissociated cardiac death (1998) had to be created and officially put to use [1-3].
Though particularly evident in these specific and well-defined situations, the dissociation of biology and biography is present in many other conditions, which are quite common in everyday clinical practice (especially in critical patients), even if in less-defined terms. This fact is particularly insidious and dangerous because artificial organ support technology (and modern medicine in general) is usually able to support/replace many biological functions but cannot always do very much about biography. When applied to terminal patients, such support is not always able to prevent death, nor can it always restore an acceptable quality of life. Nevertheless, technology always allows for the manipulation of virtually every aspect of the process of dying, often just prolonging and fragmenting it. In this sense, if not carefully managed, such advanced technology risks become just an agony-prolonging intervention.
As for published data, ICUs appear to be largely used in the management of end-of-life care: 30-50% of people in the US spend time in an ICU during their final year of life [4,5] and 20% die there [6,7]. These figures are incredibly high, especially if one considers the fact that a fixed number of deaths exists that cannot be included in this number, i.e. all those people who die because of sudden death outside hospital. Road accidents, homicides and sudden cardiac death are the most common causes of these deaths.
It would be comforting to think that - even if expensive and clinically disproportionate for this aim - ICUs could be, at the very least, adequate locations for the management of good end-of-life care: places where personalized assistance, maximum care and adequate sedation are assured, for the best comfort of patients and satisfaction of relatives. Unfortunately, suffering and discomfort are common among ICU patients [8-10]. Dissatisfaction is also frequent among relatives and friends of such patients [11,12].
These facts are particularly important if the enormous costs of high-technology medicine are considered . Actually, 1 day in an ICU costs up to $3000 [14,15], which implies that ICUs account for about 20% of the total inpatient expenditure [16,17]. Critical care medicine alone consumes more than 1% of gross domestic product (GDP) in the USA .
The conclusion from all these data is that quality of care - especially the quality of end-of-life care - is not always related to the amount of expensive resources applied, but more probably to the careful commitment of HCW and to a dedicated working organization that has the patient's best interest as a priority.
Managing end-of-life care
The consequence of what is discussed above is that the management of end-of-life care should depend on the fact that the patient is the centre and the subject of the curing/caring activity. This means that whatever is done or forgone should be exclusively in the interest of the patient.
In this sense, a first step is making the right decision. Such a goal is best achieved by continuously and thoughtfully involving the patient in every decision regarding the management of her/his own health status. This involvement is mandatory for all those patients with chronic degenerative or neoplastic diseases with sufficiently long and usually defined progress, in which the reality of the end-of-life condition can be anticipated. In all these cases, the patient should be adequately informed of the course of her/his disease and of all possible clinically indicated interventions. A suitable course of care should be planned and respected until the end. Better, together with specific decisions, the patient should clarify her/his values and view of life so that a decision is possible even in unexpected emergency situations. Relatives should be involved in the whole decision process, or at least informed of it, so that every difficult decision should be anticipated. This should be done when the patient is relatively well and has time for reflection.
As for the incompetent patient, the goal (and the great real problem) is to ascertain the patient's wishes.
Once a decision has been taken, adequate actions should follow, again taking into account primarily the patient's interests and well-being.
Throughout this process, following the rule of the five Cs (competence, collegiality, communication, continuity of care and compassion) could prove helpful.
Competence is paramount to any aspect of medical care, but is essential in end-of-life care. It assumes two different meanings. The first one refers to the clinical capacity to understand the patient's condition, making a correct diagnosis and, consequently, a reliable prognosis. In the absence of a reasonably certain diagnosis and prognosis, every subsequent decision and action will be inadequate and very likely wrong, as it is quite impossible to reach a sound and tenable decision based on wrong clinical assumptions.
The second aspect includes the professional and relational abilities necessary to accompany the patients and her/his family through the dying process. Healthcare professionals are usually expert in obtaining and managing haemodynamic, microbiological and metabolic data. This is the result of a process of continuous education and training. The same passion must be exerted in fostering all the skills, which are necessary for adequate palliative care.
Collegiality is extremely important, as it is one of the best ways to reach the best decision for the incompetent patient. Such a decision should be reached by taking into account the position of all the subjects involved in the care process (and possibly shared by all of them). Clearly, the final decision rests with the clinicians, and so, consequently, does responsibility. The patient's family should never be overburdened with the final decision. However, the decision process should be as open and inclusive as possible. The relatives' role to clarify the patient's wishes and values for the terminal incompetent patient is essential. Also the nurses' point of view is paramount in this step, as they are the HCW who spend more time with the patient and her/his relatives and are in a unique position to interact with the family.
Communication has different aspects. One of them is that the best decision can be made only with adequate involvement of all the HCWs involved in the care of the patients. In this sense, communication borders on collegiality. Yet, communication also means that everybody involved in the care process should know, at every moment, what is being done (or not) and why. As for this step, verbal and non-verbal communicative skills are indispensable. At the same time, communication demands that the decision should be reported, explained and substantiated in the patient's charts. Especially in the case of forgoing artificial organ support, this is the only way to give the decision a degree of clinical, moral and legal adequacy.
Continuity of care is another essential factor. The decision to forgo any intensive support should not be a sudden change. Difficult as it can be, it should be a part of an adequate and continuous course of care, possibly planned in advance with the competent patient in her/his own best interest. On the other hand, forgoing support should never mean forgoing patient care. On the contrary, when artificial organ support is judged to be against the patient's interests, forgoing it is the best form of care. Notably, palliation is not a separate form of care, which is applied ex novo after the forgoing of supportive measures. There are neither different times nor different workers for restoration and for palliation. On the contrary, intensive attention and palliation are always present together in the process of care and their respective intensity depends on the patient's condition. In the end, when artificial organ support has no more meaning, palliation alone remains the best care for the patient.
Compassion is the last C. The word derives from the Latin cum-patio (suffering with); deriving it from the Greek, it sounds like sympathy (syn-pathos). In this sense, compassion includes some aspects of palliation. Yet, it is also something more. It is not just a technique but rather a state of mind and heart. Furthermore, it is not to be reserved only for the dying patient but also for her/his relatives, in order to help them understand the situation, accompanying their loved one during the dying process and overcome their loss. The work of a careful and compassionate healthcare team is not just to give back a corpse to a family, but to help them live through what is usually one of the saddest and most difficult moments of their life.
Bioethics, laws and societies
Problems related to end-of-life care are obviously different all over the world, as situations differ. In many developing countries, as in sub-Saharan Africa for instance, end-of-life care problems are usually related to lack of effective intervention because of lack of resources. Triage of patients for scarce and limited life-saving interventions (anti-malarial drugs, antibiotics, sterile gauzes for surgery) is a dramatic but common necessity.
Situations are quite different in developed countries, where intensive care support is rarely limited because of scarcity. Yet, even though in these circumstances problems are quite similar, accepted solutions are quite different in different countries and can even differ over time and/or location in the same country.
The case of adequate care for patients in permanent vegetative state (PVS) well illustrates this concept. In the US, the case of Karen Ann Quinlan led to the acknowledgement of the principle that a competent patient (or surrogate) may refuse any medical intervention, including life-saving ones . After some years, the US Supreme Court established that tube-administered artificial nutrition and hydration (ANH) are medical interventions, which can be consequently refused . In 2005, deciding about the case of Terri Schiavo, the Court negated the patient's parents the permission to hydrate their daughter by mouth (even if feeding and hydration by mouth are not medical actions). According to Truog and Cochrane , such a decision relates more to the right to die than the right to refuse medical treatments: ‘… a right to refuse nutrition and hydration is not because they are provided medically or artificially. Rather, the right to refuse stems from a right to refuse any unwanted intervention, medical or otherwise, and is grounded in the fundamental rights to self-determination and bodily integrity that are deeply rooted in the American legal tradition, which prohibits any unwanted touching as battery' .
In Italy a similar case was taking a different course. The parents of a young woman in vegetative state had asked to forgo ANH considering that their daughter would never accept to be maintained in PVS. Their request has not been granted so far because of the still incomplete legal acknowledgement of the Oviedo convention, because of the present lack of clear legal value of advance directives and because of the uncertain nature of ANH (medical therapy or inalienable care) in Italy . After this verdict, the majority of members of the Italian National Committee for Bioethics recently endorsed the opinion that ANH constitutes ‘inalienable care' .
Also, the management of terminal patients is highly variable. The practice of limiting artificial support during the terminal phase of a patient's illness is variable [24,25].
Prendergast and colleagues  collected data from 131 ICUs in 38 states of the USA in which all the patients who had died (5910) were divided into five classes: full ICU care (I, 23%), full ICU care excluding cardiopulmonary resuscitation (CPR) (II, 22%), withholding of life supports (III, 10%) and withdrawing of life support (IV, 38%). Brain-dead patients were in a separate class (V). The interesting finding is the wide variability of classes in different ICU: 4-79% class I, 0-83% class II, 0-67% class III, and 0-79% class IV. This probably means that, in different ICUs, the rate of patients receiving full ICU care before death ranges from 4% to 79%. Furthermore, the forgoing of life support in dying patients ranges from 0 to 67-79% .
Cook and colleagues  used a cross-sectional survey, submitting 12 hypothetical scenarios to clinicians and nurses working in the ICUs of 37 Canadian university-affiliated hospitals, in order to examine their attitudes regarding the management of intensive support. The result was that ‘in only one of the 12 scenarios did more than 50% of the responders make the same treatment choice. In eight of the 12 scenarios, more than 10% of the respondents chose the opposite extreme. The same patient may thus receive full aggressive intensive care treatment from one healthcare provider and only comfort measures from another' .
Again, Sprung and Eidelman  demonstrated an extreme variability among physicians in defining a patient's prognosis and in deciding about withdrawing life-sustaining therapies. Pochard and colleagues  demonstrated that, in France, many end-of-life decisions are taken without regard for one or more factors identified as relevant in the US guidelines.
Not only do practices differ, but also consideration of what is good and permitted is different. In Israel, for instance, the law prohibits stopping continuous life-sustaining therapies (which is viewed as active shortening of life). Nonetheless, it allows stopping intermittent life-sustaining therapies (which is viewed as omitting treatments that prolong suffering rather than committing an act of withdrawal). In order to respect the law, clinicians can change the ventilator from a continuous to an intermittent form of treatment by connecting a timer and allowing the ventilator to stop intermittently, which defines the interruption as an omission rather than commission .
On the contrary, in a recent paper, JL Vincent not only admits stopping continuous life-sustaining therapies but, in addition, does not condemn active shortening of the dying process (which is legally forbidden and punished in most countries): ‘A recent European inquiry [Vincent JL, Crit Care Med 1999] revealed that some 40% of respondents admitted that they sometimes administered high doses of sedatives to hasten death in hopeless patients. However, because the end-result is the same, it is hypocritical to consider the withdrawal of life support as acceptable but drug injection as unacceptable. In our department of intensive care, we never perform prolonged terminal weaning process.' .
What is the meaning of all these apparently conflicting data? And what is the role of bioethics? One might think that the moral principles of respect for autonomy (the patient's right to self-determination), beneficence (the promotion of the patient's welfare), non-maleficence (the avoidance of harm to the patient) and justice (the promotion of fair access to treatment for every patient) are sufficiently recognized to assure universally homogeneous solutions. In reality, the definition of every principle in a specific situation can be problematic. Who decides what is beneficial for an incompetent patient whose relatives (parents, spouse, children) disagree with each other and with the HCW regarding the course of care? What does autonomy mean for patients coming from a culture in which the decision-making unit may be the (extended) family, the tribe or the clan, when the ‘patient's decision' is taken by the head of the family or the clan leader? What if such a decision - even when accepted by the patient - seems in contrast not only with the patient's best interests but perhaps also with the patient's real wishes?
On the other hand, respecting and promoting moral principles is not the goal. Neither are such principles goals in themselves. The goal of care is promoting the patients' dignity, true wishes and interest, the principles are the means we use to achieve such a goal. Consequently, moral principles are not absolute. In the case of conflict between two or more of them - the one that allows us to best promote the patient's dignity, interests and real wishes in that specific situation must be privileged.
Unfortunately, even though dignity has now become a fundamental right (see Appendix), the problem of defining its real meaning remains.
Dignity has at least three dimensions. The first is the universal agreement (at least in Western cultures) of the value of every human being. This is most important for the cultural recognition of dignity, but has little relevance for operational decision-making.
The second dimension refers to the different interpretation of dignity in different communities. End-of-life care and even active euthanasia have wide-ranging social and legal appreciations in different societies [31-33]. Such differences are founded on the respect of human dignity, which nonetheless becomes manifest through uneven specific weight given to every moral principle.
The third dimension applies to the real meaning of dignity for that very patient in that specific situation, as perceived by the patient and bystanders. Consequently, dignity is quite a universal value but its definitions (and its practical consequences) are - at least in part - a personal and community issue.
A consequent problem becomes evident, i.e. the validity and universality of the solution, which is achieved using moral principles in an attempt to promote the patients' dignity and interests. Decisions based on these premises can be different because of different circumstances, different cultures and different people involved in the decision process. There is no single correct (‘ethical') answer to any given moral problem. The specific facts of the case, the personal values of involved subjects, professional customs, existing ethical guidelines and the law can all influence the final decision.
In this sense, Ross  distinguishes two kinds of moral sense. The first one is the general moral sense (prima facie), which makes people sensitive to the general moral duties (moral rules): everybody knows that she/he must behave responsibly and respect human dignity. More important is the particular moral sense (‘the individual sense of particular duties in particular circumstances') . This can be different for every single subject and is the one determining every subject's final decision .
It is evident, in this sense, that different persons - and even the same person in different circumstances - can make different decisions. Consequently, judgements about duties cannot be certain in a scientific sense.
Yet, decisions have to be taken. A reasonable level of ‘moral certainty' can be achieved using a deliberative approach, which has been extensively described elsewhere [36-38]. Such an approach provides for the inclusion of as many as possible of all the views of the different subjects involved in the decision, based on mutual respect, intellectual humility and the desire to enrich one's own comprehension of facts in order to reach the best possible decision in that specific situation.
This is not science. On the other hand, deliberation can be ‘highly fallible, but it is the only guide we have to our duty' . As we move more and more to evidence-based medicine (universal and objective in nature) in the field of scientific practice, paradoxically we may be moving toward community-based applied bioethics (local and personal in nature) in the field of clinical decision-making.
Grant support: No financial funds, including departmental or institutional funding, supported the preparation of this paper.
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The official recognition of human dignity as the foundation of modern morality
‘Whereas recognition of the inherent dignity and of the equal and inalienable rights of all members of the human family is the foundation of freedom, justice and peace in the word, …'.
From the Preamble of the Universal Declaration of Human Rights
‘Human dignity is inviolable. It must be respected and protected.'
Art. 1 of the Charter of Fundamental Rights of the European Union
‘The Union is founded on the values of respect for human dignity, liberty, democracy, equality, the rule of law and respect for human rights, …'
Art. 2 of the Constitution of the European Union