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Abstract

Medical futility has been used increasingly by physicians to refer to the inappropriate application of medical intervention that is unlikely to produce any signiﬁcant beneﬁt for the patient. However, the concept of medical futility is controversial not only in its deﬁnition but also in its application. Decisions regarding end-of-life care in general and medical futility in particular are shaped by the inevitability of human death, limitations of medical sciences, scarcity of health resources, and various sociocultural issues.

In everyday clinical practice, physicians are under pressure to make decision about futile treatment and in some cases, there are disagreements between healthcare providers and patients’ family about the course of treatment deemed futile. The issue has divided experts in the relevant ﬁelds into two groups. The proponents of medical futility defend the physician’s exclusive right to determine the futility of treatment and decide whether treatment should be withheld or withdrawn. On the other hand, opponents believe that a discourse of power lies at the heart of the futility debate.

By elaborating the concept and controversy over medical futility, this entry presents a global review of the current approaches to the futility debate. It also examines different futility policy options and explains how futility policy can help healthcare professionals as well as family members to decide how aggressively to treat patients and when it is morally permissible to withhold or withdraw futile treatments.

Introduction

Medical futility is an old concept, but a continuing concern. Bibliography : to medical futility have a long history in the medical profession. Plato and Hippocrates commented on the proper response of physicians and patients in the face of medical limitations, and Hippocrates advised physicians to refuse to treat those who are overmastered by their diseases, realizing that in such cases medicine is powerless. In fact, to know the limits of medicine was regarded as an important measure of physician’s skill in integrating the art of medicine and the power of nature (Shneiderman and Jecker 2011).

The controversial concept of medical futility generally refers to the inappropriate application of medical intervention that is unlikely to produce any signiﬁcant beneﬁt for the patient. For healthcare professionals, in clinical practice, it can be an ethical dilemma to determine when to withdraw or withhold treatments deemed futile. Conﬂicts may arise when physicians and patients differ on the goals of treatment. There can also be tension when care providers do not agree with patients or their families that requested therapies are beneﬁcial and resist such requests on the basis of medical futility. In some cases, it is patients or their families who believe that the treatment suggested by physician is futile and may request to withdraw or withhold the treatment. Medical futility is an acknowledgment that there is a point in a patient’s treatment when medicine is powerless. As Edmund Pellegrino (2005) observes, “there is a time when medical interventions are no longer serving the good of the patient, when the good is no longer attainable, the intervention in question is futile; i.e., it cannot attain the desired goal. This is when physician, patient, and/or family must confront the universal fact of human ﬁnitude.”

The inevitability of human death, limitations of medical sciences, scarcity of health resources, and various sociocultural issues mean that decisions regarding end-of-life care in general and medical futility in particular are an inescapable reality in clinical settings.

In an era with an aging population and escalating healthcare costs, the futility debate has become the object of extended critical attention. However, the relevance of medical futility might differ from country to country. While, in industrial countries, medical futility is an important issue because of their relatively aged populations, in developing countries, it is an important issue because of the scarcity of health resources.

Medical Futility: Concept And Controversy

Medical futility, once called “a problem without a name” (Callahan 1991), is still a controversial issue and viewed very differently by various commentators. The discussion on medical futility has divided experts in the relevant ﬁelds into two groups. The proponents of medical futility defend the physicians’ exclusive right to determine the futility of treatment and decide whether treatment should be withheld or withdrawn. On the other hand, opponents argue that medical futility is a construct intended in part to give physicians more power in a context in which medical authority is threatened. Although different approaches have been taken to address the problem and numerous deﬁnitions of futility have been proposed, none have been universally accepted.

In an approach mostly taken by physicians, medical futility has formulated in a way that authorizes physicians to determine whether a treatment is futile and whether it should be withheld or withdrawn. They describe the concept of futility as any effort to achieve a result that is unreasonable or impossible. This deﬁnition is intended to cover treatments that (1) will not serve any useful purpose, (2) cause needless pain and suffering, or (3) do not achieve the goal of restoring the patient to an acceptable quality of life. They argue that physicians should be given sole authority to make decisions to withhold or withdraw treatment.

In another proposed deﬁnition, futile treatments are those that fail to provide beneﬁt – comfort, well-being, and general health – to a patient, even though they may produce a measurable effect (Scneiderman et al. 1990). In supporting physicians’ unilateral decision-making, Howard Brody (1992) notes that: “The physician must decide unilaterally whether a treatment possibility comes up to the mark as proper scientiﬁc medical practice… when an intervention is futile, the physician may and indeed should withhold it regardless of the patient’s request. Someone who calls himself a physician, but who is constantly willing to compromise on valid modes of treatment in order to satisfy the wishes of the patient, is a fraud.”

Empirical surveys show how in clinical settings physicians are in favor of unilateral decision-making and also conﬁrm that most medical futility judgments are not communicated directly to patients or their surrogates. For instance, a study by the American Thoracic Society (1991) revealed that 83 % of interviewed physicians had unilaterally withheld treatment on the basis of a futility determination and often without informing the patient and/or his or her surrogate. Furthermore, in Europe, a study in the Netherlands shows that patients’ involvement in decision-making regarding a Do Not Resuscitate order is very limited. In that study, the decision was discussed only with 14 % of all cases, and out of 86 % of cases in which the decision was not discussed, 30 % of those patients were competent to make a decision, and in cases of incompetent patients, the family was consulted in only 37 % of cases (van Delden 1993).

In contrast, the second group, mostly bioethicists and philosophers, has formulated medical futility based on patient’s autonomy. In their approach, in dealing with medical futility, priority should be given to the patient’s values. They believe that medical futility was constructed, in part, as a means of enhancing a physician’s domination and physician’s unilateral decision-making on the basis of futility is a problematic and misguided approach to the challenge of setting appropriate limits in medicine (Rubin 1998). For instance, in reference to the fact-value distinction, Susan Rubin distinguishes two types of futility: evaluative futility and factual futility. Evaluative futility refers to treatment that is inappropriate to provide because it would simply not be worth it, based on an evaluative judgment. Factual futility refers to a situation in which futility operates as a primarily factual judgment and it is understood to mean that a treatment is ineffective because it would not work in practice. Rubin suggests, however, that even so-called factual judgment of futility has evaluative components. She argues that the issue detracts from the meaningful debate about the underlying ethical conﬂict concerning fundamental differences in the views and interests of patients, their families, and their physicians by mistakenly turning to the concept of futility. It should be noted that in an attempt to classify futile treatment, Robert Veatch (2013) has grouped it in two kinds of futility: physiological and normative futility.

Opponents are also concerned that futility will become a powerful tool for relieving physicians of the requirement to talk to their patients. The proponents’ argument also is supported by several empirical surveys. For instance, in a study in Japan, 70 % of the respondents expressed concerns about the consequences of granting physicians wide latitude in formulating medical futility based on their personal values and called it “paternalism.” Of the respondent, 60 % believe that physician’s unilateral decision-making may cause greater distrust in medical professionals (Bagheri et al. 2006).

A review of different proposed deﬁnitions of medical futility shows that physician-oriented deﬁnition – supported by scientiﬁc rationality – emphasizes the professional integrity that allows physicians to decide whether to initiate or maintain a treatment (Brody 1994). However, the patient-oriented deﬁnition – backed by sociocultural values – emphasizes the patient’s values and right to self-determination; accordingly, it is the patient who can decide on the course of treatment.

Key Factors In Futility Decision-Making

In dealing with medical futility, there are several key factors which have great impact on decision about futile treatment.

Sociocultural Issues: As we will see in the global review of the current futility practices and policies, in many countries, religious teachings, sociocultural belief, and public attitudes toward death have inﬂuenced end-of-life decision-making. For instance, public attitudes toward human death, the deﬁnition of death, and social acceptance of the deﬁnition of brain death in many societies have shaped terminal patients’ care and inﬂuenced end-of-life decision-making.

Ends of Medicine: The existing controversy over the ends of medicine can be cited as an obstacle in regulating medical futility. Many commentators have argued that the controversy about medical futility, in its deﬁnition and application, refers partly to the controversy over the proper goals of medicine (Pellegrino 2005). In clinical practice, there are futility cases in which physicians believe that they have no professional obligation to deliver a service that is outside the ends of medicine. The ends of medicine, if deﬁned clearly, would determine when medical intervention is meaningful and when further treatment is beyond the powers of medicine. This would guide healthcare professionals on how vigorously to treat and about when it is morally permissible to withhold or withdraw life-sustaining treatment (Bagheri 2014).

Scarcity of Healthcare Resources: Currently, scarcity of health resources is a great concern in all societies; however, resource limitation is more critical problem in developing countries and it shapes end-of-life decisions. Due to scarcity of health resources, for instance, ICU beds and artiﬁcial ventilators, the main questions are how to limit their inefﬁcient use and whether providing the limited resources to a patient would jeopardize the welfare of those who have just claims on these resources? However, in terms of priority setting on scarce resources, the main question is how and who should set the limits? To answer the question, Robert Veatch (2013) suggests that, “.. .there is reason to hold that someone other than the patient’s physician should set limits on the use of medical resources on grounds of responsible use of resources.”

It should be noted that in societies, which family should bear some of the medical costs, the end-of-life decision is also shaped by this ﬁnancial burden.

Payment Model, Fee for Service vs Capitation: The model of healthcare payment inﬂuences decision about futile treatment. It also shapes the dialogue between healthcare providers and patient/family. For instance, in a fee-for-service payment system which the hospital can gain more if the patients stay alive under care, physicians may communicate to the patient’s family by saying: “your loved one is under ventilator, he is alive, his heart pumps, and his body is warm, do you want to withdraw the ventilator and let him die?” The answer is usually, no.

In contrast, in a capitation or a ﬂat rate payment in which the healthcare facility can beneﬁt more if they withdraw treatments, the dialogue might be different and physicians may say to the patient’s family that: “your loved one is unconscious and is suffering, his no longer alive, do you want him to suffer more?” And the answer would be no. This is an area in which we can see how healthcare professionals’ conﬂict of interest may jeopardize futility decisions and in result the patient’s best interest will be compromised.

Physician-Patient Relationship, the Issue of Trust: As Pellegrino observes, medical ethics begins and ends in the doctor-patient relationship; and in every clinical situation, the conception we hold of that relationship shapes the decision we make. The sociocultural changes as well as increasing attention to “patient autonomy” have inﬂuenced and reshaped doctor-patient relationships in recent years. However, existing distrust in this relationship makes the recognition and acceptance of medical futility increasingly difﬁcult.

Decision-Making Model: Three decades ago, most major medical decisions were left exclusively in the hands of physicians. They were usually made with beneﬁcent intent but without open discussion, much less the full participation of the patient. However, increased recognition of the value of patient autonomy in many Western countries, along with a new generation of physicians being trained in a patient-centered approach, has changed the decision-making process in clinical settings.

In futility decision, based on traditional paternalism in doctor-patient relationship, there is a strong desire among physicians for a unilateral decision-making. For instance, it has been argued that “.. .physicians must decide unilaterally, when an intervention is futile, and they may and indeed should withhold it regardless of the patient’s request” (Brody 1994). However, based on a shared decision-making model, a patient-oriented deﬁnition emphasizes the patient’s values and right to self-determination.

Health Insurance: Some commentators have argued that in some cases patients may be entitled to get access to a treatment deemed futile if the funding of the treatment come from sources for which the patient has a just claim (Veatch 2013). For example, the patient may have bought special insurance to cover the cost of the treatment deemed futile and not consuming social resources to which the patient is not entitled to use.

Medical Futility Policies In End-Of-Life Care: A Global Review

As mentioned earlier, socioeconomic cultural issues have a great impact on futility decision-making and different countries deal with this issue differently. Based on a cross-national study on this topic, following section elaborates on how these thirteen countries deal with medical futility in their healthcare system (Bagheri 2013).

In Chinese society, the traditional Chinese view of death, the idea of “cherishing life but dreading death,” has inﬂuenced the attitudes of the public and healthcare providers in decision-making about medical futility. In clinical settings, request for prolonging patient’s life by applying modern medical technology explains how overtreatment is relatively common in China. However, due to the absence of the terminology of medical futility in China, the issue of futile medicine is dealt under the issue of hospice care.

In Japan, because of aging population and an increase of national health expenditure, medical futility became an important topic for researchers as well as healthcare policy makers. The issues such as excessive medical examinations, lengthy hospitalizations, and overtreatment of the elderly patients are just a few practical problems in their current healthcare system. Several studies in Japan have shown that most end-of-life decisions have been left to individual physicians based on the existing paternalism (Bagheri et al. 2006). While a public survey by the Ministry of Health conﬁrmed that the majority of the population is not in favor of aggressive life-prolonging treatments deemed futile, physicians are hesitant to forgo life-prolonging treatments for terminally ill patients. Empirical surveys show how, in deciding to withdraw life-prolonging treatments for terminally ill patients, many Japanese physicians confront legal, emotional, and cultural barriers.

However, in a neighboring country, Korea, the situation is slightly different. In Korea, withdrawing futile treatment from dying patients is understood as “death with dignity,” which in Korean context means facing death in harmony with the natural order. Based on the cultural reality, in end-of-life decision-making, the patient’s wishes may sometimes be overridden by the wishes of family members. However, end-of-life decisions are sometimes inﬂuenced by the economic burden faced by patient’s family.

In Turkey, like many other countries, medical futility is not a subject in medical curriculum, and also, there is a lack of studies examining how physicians make end-of-life decisions and whether social factors affect these decisions. According to the Patients’ Rights Act of 1998, physicians have the right not to offer medically futile interventions. This right is also based on considerations of fair resource allocation.

In the United Arab Emirates, like other Islamic countries, end-of-life decision-making is inﬂuenced by the Islamic teachings. Due to the lack of understanding about the prognosis of terminal illnesses, patients’ families usually request futile treatments. However, the idea of limiting futile treatment is gaining more public and professional attention.

In Iran, an empirical survey shows that scarcity of medical resources, patient’s suffering, family’s opinion, and religious concerns are four inﬂuential factors in futility decisions. Currently, there is a lack of regulation or policy to address the issue; however, physicians and health policy makers have focused on developing guidelines regarding medical futility (Bagheri 2013).

In Belgium, having both legalized physician assisted dying and one of the most developed palliative care program in Europe has made the situation in Belgium different. Jan Bernheim and his colleagues (2013) suggest that these factors could reduce instances of medically futile treatments at the end of life. In this country, euthanasia has been widely integrated into comprehensive palliative care, thus reducing demand for futile treatments. However, the question whether the approach taken in Belgium can be adopted by other countries remains unanswered.

Like some other countries, such as Japan and China, in Russian Federation, the term “futile medicine” is absent from the vocabulary of healthcare professionals, and therefore, all ethical, social, legal, and medical aspects associated with end-of-life treatment and medical futility are expressed through the concept of palliative medicine. In Russia, availability of health resources determines the reasonable limits of treatments.

In Switzerland, futility decisions are based on societal and economic elements with a strong reliance on risk-beneﬁt assessments by physicians. Medical futility has been addressed by the Health Insurance Law, and interestingly, there have been cases in which insurers or the state refused to pay for interventions deemed medically futile. Even in one case, the Federal Supreme Court ruled that the insurer was not obliged to cover the costs of the futile treatment because it did not offer a substantial therapeutic beneﬁt and cost-effectiveness could not be demonstrated.

In Australia, as observed by Dominique Martin (2013), recently, there is more attention regarding the role of medical futility in end-of-life care. The health policy makers have tried to address this issue through related legislations and policy such as advance directives. However, despite the absence of a formal deﬁnition of medical futility in Australia, there is a broad consensus on the key elements of the concept and the role they play in guiding ethical practice in clinical settings.

In Venezuela, cultural issues as well as available resources shaped healthcare providers’ approach to medical futility. However, the lack of uniﬁed medical protocol causes great variations in the way that physicians decide about futile treatment.

In Brazil, healthcare professionals are concern about legal action against them, which may force them to provide futile treatment against their professional judgment that a particular treatment is futile. However, there is a challenge of harmonizing judicial rulings with ethical standards in Brazilian healthcare system.

In the United States, there is a long-lasting debate on medical futility. It started with concern about “a problem without a name” as called by Daniel Callahan in 1991 to the current legislative and regulatory approach in dealing with medical futility. Currently, there are two states, Texas and Virginia, that have addressed the issue in legal terms. This approach, as Robert Veatch (2013) explains, tries to allow a physician to unilaterally withhold or withdraw life-sustaining treatments against the wishes of the patient or surrogate. Since last two decades, in the United States, there have been several court cases in which almost all court cases regarding futile treatment advocate patients’ rights to access futile treatments, if speciﬁed conditions are met.

This global review shows the lack of consensus on the deﬁnition and application of medical futility, and it also conﬁrms that “there is no common universal standard for the concept of futility or its proper use” (Callahan 2013).

Futility Policy: Benefits And Options

Except in some hospitals in the United States, there is a lack of policy or regulation in dealing with medical futility. However, the question is whether and what would be the beneﬁts of addressing medical futility through legislation, policy, or regulations. As Edmund Pellegrino (2005) suggested, “Where deﬁnition is difﬁcult to come by, or consider subjective, there is a turn to procedures and policies.”

Making decisions about futile treatment is medically complex and morally stressful. It has been suggested that futility policy which can guide the withholding and withdrawal of futile care seems to offer a way out of morally distressing clinical situations (Taylor 1995). By establishing a policy and procedure to identify and decide about futile treatment, physicians will have a framework for making decisions and justifying the proposed course of treatment. With no policy in place, physicians have no choice but to refer to their own evaluations, perspectives, and opinions as well as their own judgment about a patient’s quality and value of life. In such cases, a patient’s family may feel that they have no choice but to surrender themselves to the physician’s personal opinions. The family may be left with a feeling that the patient’s physician has imposed his own personal opinions about the value and quality of life and has decided not to extent their loved one’s life. It has been suggested that one of the advantages of referring to a futility policy, while deciding about and communicating futility decisions, is avoiding a perception that physicians are biased by their own personal opinions on the value of life at its marginal level (Bagheri 2014).

In practice, a procedural framework would also reassure patients and their families that the decision has been made through a balanced and fair process which is supported by a thoughtful policy. Futility policies can further ensure that all involved parties hear the family’s narrative about their loved one and why they want treatments to be continued. Such guidelines can also help family members better understand the decision-making framework and become more active participants in the decision-making process. In addition, decision-making based on an established policy ensures family that someone besides the physician in charge – such as an ethics committee – carefully reviews the case and provides input on the decision-making. Therefore, with a policy in place, one can expect that it is more likely to avoid disagreements or to reach agreement if conﬂict occurs. Therefore, in dealing with futile treatments, it is crucial to develop a futility policy which guides healthcare professionals on the process of decision-making and when it is morally permissible to withhold or withdraw life-sustaining treatment. It is expected that such policies would be very instrumental in decreasing disagreement between physicians and family members about futile treatment.

In terms of policy development on medical futility, current discussions have focused on two options, one is “hospital policy” and the second is to address the issue in a legislative language by developing a national or state law:

Hospital Futility Policy: Based on this due process policy which has been applied in several large hospitals in the United States, physician’s judgment on futile treatment should be evaluated by the hospital ethics committee to ensure that physician’s futility decision is not based on physician’s personal view and has taken patient’s best interest into account. In support of hospital futility policy, Troug and Mitchell (2006) have argued that “… the ethical and legal burdens associated with the withdrawal of life-sustaining treatments against the wishes of the family should not be borne solely by the clinicians at the bedside, but should be known and supported by the hospital ethics committee as well.” When the ethics committee concurs with clinicians’ judgment of futility, the result will be provided to the family; if they agree, then physicians would act accordingly, and if they disagree, there are three possible outcomes depending on the case: (1) to transfer the patient to another institution, (2) to seek a court order to have the family replaced by a “guardian” for medical decision-making, and (3) to withdraw the life support unilateral against the wishes of the family, after informing them and allowing a time to seek legal advice or other alternatives.

National or State Laws: The second policy option is to address medical futility through a legislative approach, by adopting a national or state law. In the United States, this has been implemented in the states of Texas and Virginia for more than a decade. As observed by Robert Veatch (2013), “.. .these two states appear to have carved out a set of circumstances under which a physician could unilaterally withhold or withdraw life sustaining treatments even though the patient or family object to such action.” However, in recent years, these two states’ laws have been subject to critical bioethical analysis. For instance, in comparing these two futility policies, it has been suggested that, “.. .a due process approach is an excellent way to address the concerns of caregivers while equally respecting the views of patients and families.. .and when applied through state laws, however, we believe there may be an unjustiﬁed imposition of the caregivers’ perspective on that of the patient and family” (Truog and Mitchell 2006).

The Texas policy is part of the Texas Health and Safety Code of 1999. The law elaborates the circumstances under which a physician could unilaterally withhold or withdraw life-sustaining treatments even against the wishes of the patient or surrogates (Chapter 166, Subchapter A, §166.046 and 52).

According to this law, if the physicians consider the requested life-sustaining procedure to be “inappropriate,” the patient or surrogate is to be given 48 h notice saying that a committee will review the case. If the committee concurs that the treatment is inappropriate, the physician, with the help of the facility, must assist the patient to ﬁnd a facility willing to provide the requested treatment. In the meantime, the patient is to be given the requested treatment for up to 10 days. In other words, Texas law authorizes a process whereby physicians may unilaterally withdraw or withhold life support from patients even though the patients or their surrogates desperately want their life to continue. It should be noted that the law in Texas makes clinicians immune from legal prosecution if the requirements of the law are met. Virginia law does not require referral to a committee and allows the patient 10 days to ﬁnd an alternative caregiver. The key sentence of the law reads: “If a provider cannot be found willing to give the requested treatment within 10 days, life-sustaining treatment may be withdrawn unless a court of law has granted an extension” (Code of Virginia, Title 54.1).

These two policies have been compared in several points, for instance, the law in Texas makes clinicians immune from legal prosecution if the requirements of the law are met, but hospital policy does not provide this assurance. Clinicians in Texas may therefore be much more conﬁdent in applying the policy, knowing that they are protected by the law.

In fact, the development of national or state laws has shifted the balance of power so that now physicians and nurses have greater control. There is a concern that regardless of the appropriateness of their goals, such policies “may also contain the seeds of further mistrust and alienation on the part of healthcare seekers and their proxies.” Another concern expressed is that because such policies ultimately leave the ﬁnal decision-making in the hands of the institution and medical professionals, they will either function as or be perceived by care seekers and proxies as functioning as unilateral policies (Wojtasiewicz 2006).

Conclusion

In developing futility policy, regardless of socioeconomic and cultural diversity which exist across nations, there are several important points that should be considered in futility policy development. For instance, a sound policy cannot ignore medical facts, normative values, socioeconomic considerations, and the opinions of patients and families.

In the process of futility decision, if a patient feels that physician’s opinion prevails unilaterally, patient may think that his or her wishes and values are being disrespected by the physicians. On the other hand, if physicians are pressured to comply with whatever their patients ask, they may see this as a violation of their professional integrity.

Therefore, a futility policy should neither legitimize the excessive claims of patients to dictate the course of treatment, nor it should grant physicians the authority to decide exclusively and unilaterally. Granting physicians a unilateral futility decision making power not only would fail to prevent conﬂict between the parties involved, but also it will damage the essential elements of “trust” in the therapeutic relationship.

It is important to take a comprehensive approach that balances patient autonomy and physician authority so that neither party feels they are being undermined. It has been suggested that a futility policy should be based on neither excessive patient autonomy nor physician paternalism. It is important to allow physicians to support and guide patients’ decision-making without surrendering their professional integrity or imposing medical power on their patients. Guidelines should provide the opportunity for all voices to be heard. It is crucial to give an opportunity to patients and their family to exchange information and engage in dialogue with physicians and to help each party understand the other’s concerns. Such approach encourages all parties to understand and accept the limitations of medicine and the inescapable clinical reality in which they should no longer insist only on their personal views. It should require physicians to listen attentively to their patient’s concerns and patients or family should realize the limits of medicine and respect the just claims of others on scarce resources. This provides an opportunity to override a scientiﬁc justiﬁcation for a futility decision by providing morally justiﬁable reasons, if they exist (Veatch 2013).

In addition to guidelines, however, there is a great need for professional and public education about end-of-life decision-making in general and medical futility in particular (Bagheri 2014). To distinguish between medical intervention and patient care, it is important to emphasize what the late Dr. Pellegrino reminded us, “Physicians’ responsibility is to restore health, if that is possible; or to provide comfort care if restoration of health is not possible.” However, care of the patient is never futile.

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