COMMENTARY

Medical Futility and Nonbeneficial Interventions: An Algorithm to Aid Clinicians Matthew H. Armstrong, MD, MA; Joseph K. Poku, MD, JD; and Christopher M. Burkle, MD, JD

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edical futility is a clinically relevant and controversial issue. In 2005, 87% of Canadian intensivists surveyed1 believed that they had provided futile medical interventions during the past year. A 2013 study2 of 5 academic intensive care units found that physicians considered nearly 20% of all interventions provided over a 3-month period to be futile. The duration of futile interventions ranged from 1 to 58 days, with an estimated cost of $2.6 million during the 3-month study. More than half of the cases were considered futile because even with intervention the physician believed that the patient’s goals were unreachable. In 31% of the futile intervention cases, the physicians believed that the patient would never survive outside of the intensive care unit.2,3 Despite some authors describing the “rise and fall of the futility movement,” the challenge of intervening in these scenarios remains difficult and clinically prevalent.4 The term medical futility has been widely discussed in the literature and in the clinical setting. Despite evading definition, it has become integral to the modern medical lexicon. Any scenario involving a potentially nonbeneficial intervention (NBI) is dynamic, variable, and value laden. Family members and clinicians, however, often lack the skills to comfortably navigate these very difficult issues. The associated discomfort may stem from treatments or scenarios that transgress the family’s or physician’s ethical limits, and both groups need to be apprised of their rights to withdraw from, in the case of providers, or open a discussion, in the case of families, regarding the particular interventions they perceive as nonbeneficial. Multiple sources have independently offered techniques intended to assist during NBI scenarios. We first briefly review the legal and clinical history of the futility literature, noting the difficulty surrounding its precise definition and use in clinical arenas. We argue

that incorporating the concept of NBIs offers several advantages when discussing futility disputes. Given this reframed perspective, a novel algorithm is advanced, synthesized from previously published techniques that have been shown to assist clinicians struggling with potentially NBIs.

From the Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA (M.H.A.); Department of Anesthesiology, University of Rochester Medical Center, Rochester, MN (J.K.P.); and Department of Anesthesiology, Mayo Clinic, Rochester, MN (C.M.B.).

Definition and Clinical Evolution The words futile and medical futility are not present in Stedman’s Medical Dictionary.5 MerriamWebster Dictionary defines futile as having “no result or effect, pointless or useless.”6 Clinically, interventions labeled as medically futile refer to the unfortunate situation in which continued therapy will not benefit the patient and, therefore, ought not be used. Expanding this definition is difficult, particularly when applied to complex patient situations. Some classifications use the term strictly to refer only to the absence of physiologic effectda situation rarely encountered in clinical medicine. The second, loose classification acknowledges that interventions may have some physiologic action but do not promote the patient’s goals. Individual goals, inaccurate statements regarding prognosis, or a miscalculation of the burden to benefit ratio can cause nearly any therapy to seem futile in the loose sense. Because the definition is relative to the goals of each stakeholder, the patient prognosis, the burden to benefit ratio perceived by each stakeholder (patient, family, physician, hospital), and the limits of medical technology, clarity among involved parties is paramount. Because what is considered futile is relative to many factors, a universal definition has been elusive, keeping futility at the forefront of ethical medical practice for centuries. The Edwin Smith surgical teaching papyrus references ancient Egyptian notions of futility regarding high spinal cord injuries.7 Without ventilators or vasopressors, treatment was largely ineffective, and

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attempts would have been futile in both the strict and looser senses. Identifying futile interventions in the Hippocratic tradition meant finding patients whose prognosis was so poor that they were “overmastered” by their disease. Identification of these patients was central to the physician’s duty to do no harm by incurring the risk of intervention only when there was reasonable certainty that the benefit of the intervention could be realized.8 “It appears to me a most excellent thing for the physician to cultivate Prognosis . [so] he will be the more readily believed to be acquainted with the circumstances of the sick; so that men will have confidence to intrust themselves to such a physician .. For it is impossible to make all the sick well; this, indeed, would have been better than to be able to foretell what is going to happen; . [It] therefore becomes necessary to know the nature of such affections, [and] how far they are above the powers of the constitution.”9,p42 Hippocrates understood well the physician’s duty to benefit his or her patients (beneficence) by selecting interventions that would truly help. He does not recognize in this particular passage that benefit is more than physiologic improvement or that patients deserve input into which benefits are sought. More recently, the ethical principle of autonomy, which protects patients’ personal values from infringement by others, was underscored in the medical sphere by Justice Cardozo in 1914 when he wrote that “[e] very human being of adult years and sound mind has a right to determine what shall be done with his own body.”10 This entrenched protection of personal goals and values has clearly and consistently been interpreted to show that the desirability of any given intervention is also relative to the goals of the individual who it is intended to benefit. The 1976 case of Karen Ann Quinlan is a prominent example of a request (by the patient’s family) that noncurative interventions be withheld because according to Ms Quinlan’s value system there was little benefit to the patient from prolonging her physiologic life without significant mental recovery.11-13 In re Cruzan,12 the US Supreme Court underscored a patient’s right to refuse treatment, a decision 1600

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that later helped ground legislation promoting patient autonomy.14 Although the Quinlan and Cruzan cases do not speak directly to the matter of what futile medical care is, they provide legal insight and guidance regarding patient autonomy and solidify the preeminent place of patient values in determining the benefit or burden imposed by medical interventions. Early clinical efforts to define medically futile interventions were based on the empirical success rate of a given intervention and quickly fell victim to the omission of the patient’s value system. Some ethicists and clinicians proposed success rates between 0% and 13% as a threshold for the definition of medically futile interventions.15 Others thought that “when physicians conclude (either through personal experience, experiences shared with colleagues, or consideration of reported empiric data) that in the last 100 cases, a medical treatment has been useless, they should also regard the treatment as futile.”16,p951 The procedural details and difficulty associated with personal recollection, case matching, and ascertainment of accurate prognosis, along with challenges in defining the term useless, made these absolute approaches clinically untenable. Youngner17 and Schneiderman16 separated the quantitative (percentage success rate), qualitative (can any treatment goals be met), and physiologic aspects of futility. Increasing the fidelity with which futility could be defined brought the debate out of the statistical trenches and helped create a less paternalistic concept by placing subjective individual value alongside physiologic effect and medical success rate. The 1986 case of Elizabeth Bouvia18 underscored the importance of qualitative metrics in autonomous decision making, holding that the quality of a patient’s life was of equal if not superior import relative to quantity when considering various interventions. Although this approach moved clinical and ethical practice forward, a precise definition and consistent application remained elusive, leaving clinicians and researchers only slightly better equipped to battle the seemingly indefinable yet readily identifiable foe.19 The difficulty of finding a precise definition to easily encompass the broad scope of the concept, and a general disease facilitating these difficult clinical discussions, seem to

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have led to a clinical preference for procedural solutions. These methods involved a period of conflict resolution, followed by involvement of an institution’s ethics committee. The process could be initiated by a patient, the family, or the medical staff (any stakeholder) in response to any treatment they felt was of greater burden than benefit to the patient. A contingency pathway for physician withdrawal in deference to a colleague willing to perform the disputed intervention, transferring the patient to another facility, or withdrawing the disputed intervention was created for unfortunate cases of intractable conflict. This type of procedural resolution was useful in a broad range of circumstances and offered a means to resolve difficult situations without precisely defining futility. As such, procedural solutions were rapidly assimilated into societal guidelines and hospital policies.20-22 One frequently referenced policy used at Boston Children’s Hospital (BCH) is exemplary of the procedural nature of futility resolution. The BCH policy, although formally unproven and never tested in court, focuses on exhaustive dispute resolution.23-25 Any

stakeholder (patient, family, nurse, or physician) who perceives that the burdens of therapy may outweigh the benefits or that the active intervention is not moving toward the goals of care can initiate this policy. Discussion between medical staff and patients (or their surrogates) attempts to address any misunderstanding or miscommunication of a patient’s values, prognosis, options, and wishes. This discussion is intended to clarify the values of the care team and patient so that the manner in which a given intervention may align or conflict with those values and goals can be discussed and a decision about how to manage the questioned intervention can be made. The style with which this exhaustive resolution is performed is left to the attending physician. Strategies to aid clinicians in this effort are not directly offered under the BCH policy. If agreement cannot be reached after these initial efforts, institutional or legal recourse may follow (Table).24,25 The state of Texas has taken the procedural resolution of futility disputes further by adopting the Texas Advance Directives Act (TADA) into legislation.26 The law stipulates that if

TABLE. Boston Children’s Hospital and Texas Advance Directives Act Medical Futility Policies Boston Children’s Hospital Futility Policy

Texas Advance Directives Act

Request for help: any party (clinicians or family). Exhaustive dispute resolution involving ethics, pastoral care, social work, palliative care, etc. Case is referred to ethics committee. Verbal notification of surrogates.

Request for help: any party (clinicians or family). Exhaustive dispute resolution involving ethics, pastoral care, social work, palliative care, etc. Case is referred to medical review committee or ethics committee. Written or verbal notification of surrogates with information regarding other rights under the policy or law. Included is written notification of the potential for withdrawal of medically inappropriate treatment if no alternative provider is found during a 10-d search and the family does not seek court intervention. If futility is endorsed by the ethics committee, the surrogates are informed If futility is endorsed by the appropriate institutional committee, the in writing. Hospital leadership must endorse the decision. surrogates are informed in writing. Attempts must be made to transfer treatment to another physician and Attempts to transfer treatment to another physician and facility willing to provide the disputed medical intervention can be made for 10 d. facility willing to provide the disputed medical intervention. The length of this period is not specified. Hospital may consider judicial challenge to the decisions of the surrogate decision maker. Notify the family of the intention to unilaterally withdraw futile therapy. Inform the family of their option to seek a court order to continue Surrogates have been previously notified of their option to ask a judge to treatment. extend the time frame for the search for an alternative provider of the disputed medical intervention, which should be granted only if transfer is “reasonably likely.” Withdraw medically inappropriate or futile interventions. Withdraw medically inappropriate or futile interventions. Clinicians are not legally immune, but their decisions are endorsed by the Clinicians are legally immune from civil and criminal prosecutions. hospital leadership.

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physicians or surrogate decision makers decide that an intervention cannot reach a reasonable physiologic or qualitative goal, the hospital’s ethics committee can be asked to help facilitate a process of discussion and deliberation. Ultimately, if the committee agrees that a treatment will not benefit the patient, the patient’s surrogates must be informed in writing and provided 10 days to secure another physician or facility willing to offer the disputed intervention. Although the patient’s surrogates may seek a court-granted extension of the transfer period, withdrawal of the futile intervention is legally protected if no physician or facility is found. The hallmark of TADA is that the ethics committee’s decision protects the involved clinicians from future civil and criminal prosecution as well as medical license review. Unlike the policies at BCH, disputes involving TADA have been brought before the courts. Sun Hudson was born with a fatal congenital dwarfism at Texas Children’s Hospital in 2005. His condition required that he be placed on a ventilator while physicians determined his final diagnoses. The hospital’s ethics committee agreed with clinicians that continued ventilator support was futile in the loose sense of the definition discussed previously, yet his mother requested that the ventilator support be continued. After no other medical facility was willing to accept the transfer of the child, the breathing tube was removed, and the child died shortly after. The probate court and an appellate court later upheld the process and the ethics committee’s decision. This case marked the first time a US judge allowed a hospital to discontinue an infant’s life-sustaining care against a parent’s wishes.23,27 Fine and Mayo28 published a description of the Baylor Medical Center experience 12 months before and 24 months after the passage of TADA. They reported that under the new law, 37 of 47 futility cases were resolved with ethics committee counseling alone. Of the remaining 10 cases, the committee affirmed the clinical decision in 6 and disagreed in 4. A report to the Texas state legislature25 regarding 2922 ethics consultations performed in 2005 showed that only 974 (33%) were judged to involve futile interventions. Of those 974 consultations, 65 “10day letters” were issued. Eleven of 65 patients were transferred within 10 days, 22 died while 1602

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waiting for transfer, 27 had interventions withdrawn, and 5 were granted judicial extension pending transfer. Proponents of TADA argue that this rate of resolution before an ethics committee’s formal affirmation of futility is excellent. Also, when the mechanism of adjudication is contained in the health system, the decision process moves at the pace of clinical medicine, not bureaucracy. These policies are intended to help protect the rights and values of both physicians and patients, but each has their detractors. Those who advocate BCH-like policies have argued that TADA creates an inherent conflict of interest by placing too much authority in the hands of the hospital’s ethics committee, an intrainstitutional body. To avoid this potential bias, Truog24 argues that the final authority ought to reside with the judiciary. He notes that futility policies rarely deny or question treatments requested by patients themselves; the issue surfaces much more commonly when surrogate decision makers are involved. The judiciary was created to balance the rights and obligations of conflicted stakeholders, and being divorced from the institution makes conflicts of interest less apparent. Most important, a judicial route allows institutions to challenge the root of the problemddysfunctional surrogate decision makingdrather than skirting the central issue by attacking its end resultdinappropriate intervention. Other potential advantages of directing disputed cases to the judiciary exist. Decisions made by clinical ethics committees are not routinely published, which arguably fails to promote conceptual review or the sharing of ideas and arguments outside institutional walls. Directing medical futility cases to the judiciary could create a repository of decisions from which clinicians and ethicists could draw clinical guidance and information regarding the legal limits of medical liability. Most clinicians, however, believe that these decisions belong in a clinical sphere. With guidance from ethics committees, clinicians and families can discuss the goals of care, and the adequacy of surrogate decisions can be gently addressed. Shapiro29 argued that the court may be misinterpreting surrogate decisionmaking standards and “threatening individual’s decision making rights by creating serious roadblocks”29,p45 to appropriate care. Furthermore,

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creating a repository of cases in the academic literature may be the responsibility of the professional ethicist, not the barrister. Finally, some courts have made it clear that these decisions are best handled at the bedside, among patients, surrogates, and health care providers.13,30 We assume that all stakeholders intervene with beneficent intentions at all times. Even in this idealistic scenario, individuals may choose to support certain values in different hierarchies. This ability to choose actions that align with a patient’s value system deserves ethical protection. It follows, however, that there will be instances in which 2 teams working to protect the same person will choose different interventions to achieve their beneficent aims. When discussion and resolution of the differences is possible, interventions respecting both value systems may be identified and performed. There are practices that can facilitate this understanding. Unfortunately, there will always be situations in which this mutual understanding is not possible and recourse to arbitrated judgment is necessary (BCH Futility Policy, TADA, etc). Early Identification and Resolution of Futility and NBIs End-of-life conflicts often stem from inadequate communication among stakeholders; therefore, most effective resolution strategies aim to improve communication, clarify values, and align goals, values, and prognosis.31 Avoiding these conflicts with proactive, open, honest, and sensitive communication about the values of the patient and the family, the prognosis of the patient, and the way in which these entities interact is ideal.17,32-34 However, open and clear communication at the end of life can be difficult, and clinicians often lack the training for these types of discussions.35 We believe that a combination of preventive communication strategies, early detection and discussion of potentially inappropriate treatment, and conflict resolution skills must be used to help minimize the number of cases that require difficult procedural and legal resolution. Previous attempts to aid clinicians confronted with potentially futile interventionsddefining the concept, analysis of qualitative vs quantitative futility, exhaustive dispute resolution, or procedurally protected withdrawaldhave been Mayo Clin Proc. n December 2014;89(12):1599-1607 www.mayoclinicproceedings.org

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largely reactive strategies. Regardless of the procedure followed, a preventive approach is best, and any policy (or law) should promote this from the outset.36,37 We propose an algorithm (Figure)38 to help clinicians conceptualize the intricate concept of NBIs and understand the role that excellent and proactive communication, early identification, and conflict resolution can play in minimizing the need for reactive interventions. One strategy advocated for promoting communication is represented by the mnemonic VALUE (value comments made by the family, acknowledge family emotions, listen, understand the patient as a person, elicit family questions).39 If agreement on prognosis, values, and treatment goals can be reached in discussion, there is a higher likelihood that surrogate decisions will fulfill the criteria for substituted judgment and autonomous decisions.40 If a family’s values are understood when communication comes to an impasse around a particular issue, discussing the source of conflict as part of the patient’s or surrogate’s value system can be effective and compassionate, allowing for tailored intervention and mutual understanding. For example, conflict of a religious nature may be more readily resolved by requesting help from a clergy member rather than from the institution’s ethics committee. Likewise, a second opinion from a physician chosen by the family may help resolve issues surrounding a difficult prognosis.41 These strategies all facilitate meaningful communication with the intent to prevent disputes going forward. Huynh et al2 suggested that early detection and discussion of potentially futile interventions or NBIs is a valuable way to minimize the time the intervention is used, thereby minimizing the time a patient is subjected to the harms of an intervention without any prospect of its benefit (ie, overmastered). Early detection also helps physicians respect their own moral compass and the principles of beneficence and nonmaleficence. After communicating with stakeholders about the patient’s values, preferences and wishes, and prognosis, it is possible to formulate the patient’s treatment goals. These goals are necessarily wide in range and should represent the patient’s values in a given clinical circumstance, understanding that certain prognostic factors limit what may be possible given technological or physiologic

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limits. Goals can range from maintenance of physiologic functions while family arrives to complete cure. As discussed earlier, these realistic and patient-centered goals are pivotally important because they serve as the end against which the means are measured. Provided the medical intervention can move toward at least 1 goal, the intervention should be used if the risks to the patient do not outweigh the benefit expected. A lack of realistic or patient-centered treatment goals and a poor estimation of medical prognosis or the risks of available interventions greatly increase the likelihood that the resulting steps will be incompatible with ethical standards for autonomous decisions. Early recognition of this imbalance is difficult and requires in-depth knowledge of all aspects of clinical care but may help minimize the initiation of NBIs. It will, in turn, help clinicians identify and address interventions early in the clinical course.38 Discussing an intervention that is physiologically effective but fails to move toward a treatment goal is futile in the loose sense, although not futile in the physiologic and strict senses. This distinction is difficult for many clinicians let alone for family members who perceive maintained physiology as signs of effective medical treatment. In this scenario, the concept of NBIs can be particularly powerful. The term nonbeneficial treatment or care has been used in the ethics literature since at least the late 1980s to stratify interventional outcomes ordinally (ie, nonbeneficial, marginally beneficial, etc).42 The term nonbeneficial care remains in the literature today describing similar clinical situations.43 We disagree with the idea that caring or treating is ever useless and have, therefore, chosen the term nonbeneficial intervention. From a semantic perspective, futile actions should not be pursued because they are by definition “pointless . or useless.”6 It is implicit that useless actions represent wasted resources and, therefore, wrong decisions. The invested parties, however, can see the effect of a given intervention and may perceive its benefit differently depending on the type of futility they are using to justify the intervention. Considering a family member’s choice as wasteful, or incorrect, places a wedge between clinicians and families, hindering communication. 1604

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Using the NBI concept may help remove impediments to open, VALUE-style communication. First, the benefit of an intervention is always relative to the patient. Any infringement on a patient’s person is not intended to benefit the family, or the hospital, or the clinical staff: the needs of the patient come first. Furthermore, the outcomes of a given intervention are benefits only if they align with the patient’s values, further strengthening this patientcentered model. Second, the connotation of families or physicians pursuing pointless or useless actions is obviated. Finally, with the discussion framed around benefit relative to the patient, the difficulty of breaking apart strict and loose futility is minimized. Interventions that were previously effective in the physiologic or strict sense may now be discussed with increased clarity relative to the patient’s wishes and benefit. Persistent stalemate regarding the treatment goals or the alignment of those goals with available clinical options and the patient’s values will require further discussion. The Four Steps of Principled Negotiation were advanced by Fischer and Ury to help facilitate this discussion.44 The 4 steps are (1) separating the people from the problem, (2) focusing on interests rather than positions, (3) generating a variety of options before deciding on one, and (4) insisting that agreement be based on objective criteria. Using this strategy will help focus the discussion on the difficult scenario at hand and minimize feelings of personal animosity. Also, NBIs may help focus discussion on the interests of the patient by using the goals of care as the benefits any given interventions are seeking, again hoping to extend open and clear VALUE-style communication. If an impasse remains despite extensive communication and good-faith attempts at resolution, outside assistance will likely be necessary. Policies should allow either the physicians or family members to request assistance from the hospital ethics committee or a patient affairs group. This practice allows for early and targeted interventions by any involved group. It combines aspects of both the BCH and TADA pathways and has been retrospectively validated by the Texas experience.25,28 Despite these efforts, a small percentage of cases25 will remain in conflict and

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Suggestions for clear communication: Value statements made by family members Acknowledge emotions Listen Understand the patient as a person (goals, values, etc) Elicit and answer questions from family (options, prognosis, etc) Consider using the term Nonbeneficial Intervention (NBI)

After discussing the patient’s values and prognosis, formulate treatment goals (eg, surviving the night or return to full function). Do the treatment goals benefit the patient?

Can clarification of the patient’s values (religious, personal, etc) or medical prognosis help create clear goals?

No

Yes

Yes Is there a medical intervention that can help obtain that benefit?

NBI the risks of interventions may outweigh the benefits in this scenario.

No

No

Is the clinical team comfortable providing the intervention?

No

Continued difficulty may signify ineffective clinical communication, uncertainty of prognosis, misaligned therapeutic goals, or difficulties with surrogate decision making. Consider principled negotiation:

Yes Would/does the patient desire the intervention? (respect for autonomy)

No

1 Separate the people from the problem 2 Focus on interests rather than positions 3 Generate a variety of options before agreeing on a course of action 4 Insist that the agreement be based on objective data

Informed refusal

Contentious objection (withdraw from or transfer care)

Return to top and seek expert consultation

Yes Seek expert consultation and Reinitiate discussion of Patient-Centered goals

Proceed with the intervention (continue to reassess goals and values regularly)

FIGURE. A conceptual framework for discussion of goals, risks and benefits, and common ethical concepts in the clinical setting. Open and clear communication should always be used. When goals are discussed, support from all parties should be sought. Interventions moving toward at least 1 goal should be pursued. Interventions without physiologic or quantitative effect will likely not satisfy criteria for autonomous decisions and should be evaluated critically. Situations without qualitative benefit also fall under the nonbeneficial intervention (NBI) spectrum and should be discussed with care and empathy. Understanding the differences between interventions considered futile (McMath, Baby K, Wangile) and informed refusal cases (Cruzan, Quinlan) as well as contentious objection are illustrated here as well.

require additional interventions, including physician withdrawal, possible transfer of care, or legal arbitration. Inability to resolve a disagreement about the appropriateness of an intervention should not be regarded as a failure of communication or clinical acumen. The opportunity to discuss these very challenging cases in a medically and legally protected sphere is necessary regardless of outcome. Our discussion and subsequent proposal for early and aggressive resolution is designed to serve as a guide to conceptualize, interpret, and navigate medical futility. Mayo Clin Proc. n December 2014;89(12):1599-1607 www.mayoclinicproceedings.org

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We hope that the conceptual addition of NBI to this discussion is helpful to clinicians and families. Advancing a single and specific, allencompassing solution to such a broad ethical, legal, and clinical topic has evaded clinicians for decades and would require hubris absent these authors. Given this reality, the unfortunate scenario where disagreement persists despite attempts at early communication and extensive conflict resolution will occur and the jurisdictional location of the reader becomes very important in

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determining the appropriate action.45 Most states follow the Uniform Health Care Decisions Act for legal arbitration, but this is not universally the case. It is outside the scope of this review to weigh which legislative or procedural approaches merit allegiance as all have significant strengths. Regardless of the path necessitated by law, ethics committee and legal counsel assistance will be invaluable. Help navigating the appropriate proactive stepwise approach, which should be practiced consistently, is critical to the just resolution of disputes involving potentially futile interventions.46 Conclusion Futility’s conceptual complexity makes discussions of NBIs a very difficult and constantly moving ethical and legal target. Communication is perhaps the single most important factor in preventing and resolving disputes. Despite this, most attempts at identification and resolution of futility disputes have been reactive. Herein, we articulated a proactive approach incorporating the concept of NBIs to help clinicians conceptualize medical futility, its very difficult circumstance, and some of the strategies to facilitate open and clear communication among all stakeholders. This deeper understanding and proactive communication will help avoid, or detect very early on, scenarios in which NBIs are likely to occur. To our knowledge, this is the first time that these concepts have been synthesized into a cohesive and inclusive algorithm designed to help ease the discomfort of dealing with NBIs. Abbreviations and Acronyms: BCH = Boston Children’s Hospital; NBI = nonbeneficial intervention; TADA = Texas Advance Directives Act Correspondence: Address to Matthew H. Armstrong, MD, MA, Department of Anesthesiology and Pain Medicine, University of Washington, 1959 NE Pacific St, Box 356540, Seattle, WA 98195.

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Medical futility and nonbeneficial interventions: an algorithm to aid clinicians.

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