Futile or non-beneficial treatment in the ICU

The question of futile or non-beneficial care is a constant feature of day-to-day work in the ICU, and it is surprising that it receives so little attention in any forum (be it the media, the college exams, or even in the core business of most hospital specialties). Unfortunately "futile" is a term loaded with unnecessary emotional content which lacks any standard medical definition, and in any given scenario a group of clinicians will disagree as to what futile care is. However, it is widely acknowledged that often we use "considerable resources without a reasonable hope that the patient would recover to a state of relative independence", with death being viewed as treatment failure.

Historically, this issue has been explored  in the following SAQs:

• Question 13 from the first paper of 2022, where the ICU physician’s responsibilities in the process of decisionmaking are outlined
• Question 1a from the first paper of 2003, where a MND quadriplegic's family disagree with you about ventilation
• Question 1c from the second paper of 2002, where a palliative cancer patient is referred to the ICU
• Question 1e from the first paper of 2001, where a severe COPD patient's family disagree with you about ventilation
• Question 1e from the first paper of 2000, where a traumatic C4-5 quadriplegic himself requests withdrawal of care (the college answer for this SAQ was particularly good).

How does one answer these? An exam-oriented approach to a situation where ICU-level care appears to be futile needs to be focused on the examiner's perception of what a safe practitioner might to in a given situation. Most of the abovementioned SAQs are about a clearly unsuitable patient being referred to the ICU for some therapy which will impose a significant level of discomfort upon the patient without offering them a significant chance of recovery. The following generic answer template should help the candidate find something to write about any given ethical quagmire.

• Consider beneficence: is the therapy in the patient's best interest? 
• Consider non-maleficience: is the therapy going to burden the patient?
• Consider fidelity: the patient or their surrogate decisionmaker need to be given a honest breakdown of exactly what the therapy will require, and what the goals of it will be. 
  • Consider utility (rather than futility): is the therapy going to be helpful? As far as what "helpful" means, one needs to defer to the values of the patient and their family as well as to the objective physiological effectiveness of the therapy.
  • Invoke the principle of autonomy. The outcome achieved by this therapy: is this outcome one which the patient would find satisfactory?
• Consider social justice as the last and least important consideration; are the needs of the community served best if this treatment is to go ahead? It is important to note that the responsibilities of the intensivist to the individual patient are usually though to outweigh the responsibilities towards the community.
• Decisions can then be made to limit or withdraw the therapy if any of the following conditions are satisfied
  • The therapy is considered unlikely to succeed on grounds of basic physiology (i.e. it would be scientifically impossible for it to achieve the intended goals)
  • The therapy is known to fail in the vast majority of attempts under these conditions, and the attempt has known and serious adverse consequences
  • The therapy would (if successful) lead to a quality of life which is unacceptable to the patient, or (if the patient or family cannot comment) which would lead to a quality of life which "falls well below the threshold considered minimal by general professional judgment"
  • The therapy leads to the preservation of a state which is unacceptable for the patient, eg. the therapy merely preserves unconsciousness and dependence on intensive medical care.
  • There are parties (including other medical professionals and important figures from the patient's family) who agree that the cost or outcome of the therapy would be unacceptable to the patient. 

That is probably enough to answer the futility questions in the SAQs. These are generally SAQs from a distant bygone era when the college seemed to welcome various forms of flowing long-form essay as an answer. In this cynical age, such difficult-to-mark SAQs have been promoted into vivas. It is much easier for an examiner to subjectively determine that you're an unethical monster from listening to ten minutes of conversation, than to objectively determine this from the quality of your written response. Ergo, this chapter can be viewed as a preliminary step to preparing for the communication viva.

Regional variations in legislation and culture make the content of this chapter impossible to export across national borders; in the sense that nothing can be written about this subject that would remain equally valid in both Saudi Arabia and America. Abandoning all hope of writing something generalisable, the author has decided to write this chapter with an unashamedly Australia-centric bias. Thus, the ANZICS Statement on Care and Decision-Making at the End of Life for the Critically Ill Patient is the definitive reference document here, with the rest of this chapter basically acting as a series of elaborate footnotes. The other essential memorandum is the CICM IC-14, Statement on Witholding and Withdrawing Treatment. Further canonical reading regarding end-of-life decisionmaking can be found in Oh's Manual, Ch 7 ("Ethics in intensive care" by Raper and Fisher, p. 55) and Ch 11 ("Palliative Care" by Cox and Soni, p. 85) from the 7th edition. Another excellent resource would have to be the 2006 article by Danbury and Waldmann "Ethics and law in the intensive care unit". The ANZICS paper from Myburgh et al (2016) is also worth looking at, mainly because ANZICS and Myburgh. The excellent LITFL chapter on medical futility draws its inspiration from an article by Michael Ardagh (2000), which could serve as a stand-alone reading resource for this topic when time is short.

Ethical framework which informs medical decision-making:

Ethical problems in ICU tend to arise as the consequence of competing values or ethical principles. Those principles in some detail are as follows:

• Beneficence: We are obliged to always act in the patient's best interest.
• Non-maleficence: "First, do no harm".
• Fidelity: the principle which governs integrity in the management of patient information, and which covers confidentiality as well as a healthy respect for fact (which includes always telling the patient the truth).
• Social justice: The principle of ensuring equitable access to scarce medical resources 
• Utility: principle of doing most good for the most number of people 
• Consequentialism: Literally, motivation by consequences; the concept that whether  decision is "right" or "wrong" is determined by the outcome of that decision. This Machiavellian approach to medical ethics is often viewed as the opposite of a moral-based or rights-based approach. According to Raper and Fisher, this is the sort of thinking we can expect from healthcare administrators and broad policy decisions.

For instance, in Question 1c from the second paper of 2002 a patient is referred to the ICU after a palliative procedure results in lifethreatening complications. On one hand, beneficence recommends we take this patient to the ICU and resuscitate her. On the other hand, utility and social justice recommend we reserve those resources for salvageable patients. Autonomy would be the major decider in this case, as the patient herself may have strong views about what she might want happen in this scenario. Some of this needs to be reflected thoughtfully in the frenzied scribble of a ten-minute SAQ answer.

Definiting futility: what is non-beneficial treatment?

LITFL's Chris Nickson makes an excellent effort to define this otherwise undefinable term by quoting several sources and classifying medical futility by levels of "obviousness", using systems  quoted in an article by Michael Ardagh (2000). In short, one can classify the futility of a treatment according to how patently ridiculous the treatment appears, and how many people agree that this is so. 

Physiological futility

The therapy, though probably well-intentioned, cannot bring about the intended results because that would violate the laws of physics, or something equally fundamental. Into this category fall such things as prayer and the use of homeopathic remedies.

The advantage of this definition is the near-total separation of the clinician's values from the decision. I'm not making a value judgement, you might argue; science itself dictates that the therapy is clearly pointless. However, others might argue that to take this stance is itself a value judgement. You decide that objective measurement of physiological organ function is an important goal; you make that value choice, and you choose that goal as more important than the value of the outcome for the patient as the patient might perceive it. This could give rise to conflict with hippies and the religious. 

Another issue with physiological futility is the near-insurmountable problem of authoritarian disregard patient autonomy. This is discussed very well in a paper by Waisel and Truog (1995). Essentially, the underlying concept is that doctors have no obligation to undertake a medical therapy that does not offer achievable and appropriate goals. Thus, unilateral decisionmaking regarding therapy can take place, where the clinician knows what's best. This approach fails to take into account the possibility that the patient themselves might want some input into the process, particularly into helping define what goals are appropriate and what steps might be tolerable to achieve them.

Latly, one could argue that physiological futility is a matter which separates the effect of a treatment from its benefit. A treatment may achieve the effect it is prescribed for, eg. increase the cardiac output in the case of levosimendan, and is therefore not physiologically futile, but it may still be non-beneficial. 

Quantitative and qualitative futility

 Schneiderman et al (1994) proposed we define futility in terms of quantitative treatment effect estimates and qualitiative estimates of the predicted effect size. The quantitative estimate is pure numbers, i.e. the therapy is futile if it has "failed in the last defined number of times attempted" with 100 successful attempts suggested by the authors as a (totally arbitrary) threshold for this definition. The qualitative estimate involves making a prediction about the patient's quality of life which might result from the proposed therapy: the therapy is futile if the quality of life "falls well below the threshold considered minimal by general professional judgment"

One hardly knows where even begin to discuss the problems with this definition. For one, it would be extremely paternalistic for an intensivist to make a judgement call as to what quality of life is "well below the threshold considered minimal ". Sure, for all doctors and generally for most sane people "treatments which merely preserve unconsciousness or cannot end dependence on intensive medical care" would appear as qualitatively futile. However, that's our values we are using, and some might argue that any imposition of the physician's values on the patient is a violation of their right to self-determination.

Operational futility

In an attempt to extract medicine from the ethical swamp into which it constantly threatens to sink, one might create a more pragmatic definition, one which calls upon some sort of joint decision made by society and informed by the wisdom of the clinician. Operational futility is therefore the concept where a therapy is considered futile when a sufficiently large number of people (lay and professional) agree that it is so. The therapy is “so unlikely to succeed that many people... would consider it not worth the cost”. 

This again shifts the decisionmaking away from the patient and family. Except a wise all-knowing authoritarian clinician is no longer imposing their values on you. Now, it's a collective of "many people—professional and lay persons". How that is better, difficult to say. Surely to move decisionmaking power further from the directly involved individuals will degrade the quality of the decisions made. To defer that power to a group not directly involved, and potentially not equipped with all the important information or historical context, might result in a complete disaster. Look what happened when morons took over the Terri Schiavo case. The only potential benefit from this rule by mediocrity is the arse-covering effect of not having to be the only person who makes a decision.

The ICU physician’s responsibilities

Question 13 from the first paper of 2022 asked specifically about this, and worded it in this exact way ("outline the ICU physician’s responsibilities in this process"). The question started with a stem, "the ANZICS statement on care and decision making at the end of life for the critically ill outlines the process for shared decision making about treatment options", suggesting that they expected their answer to be quoting from the ANZICS document. Some burgundy-bordered boxes do exist in that paper (eg. p. 53), representing ANZICS recommendations for this process. So that the trainee does not need to refer to the entire 148-page document during their revision, they have been extracted and listed her, verbatim:

All of these recommendations are valuable in some sense or another, even though some might appear condescending or superfluous (for example, the intensivist is exhorted to be attentive, sincere, compassionate and kind to the family of the dying child, as if without this advice they would revert to being indifferent, dishonest, rude and pitilessly mean). The problem is, even the short recommendation list is overly long, and totally unsuited for answering Question 13. What follows is an attempt to render this thin broth into a concentrated stock:

The responsibilities of the intensivist in the process of shared decision making at the end of life for the critically ill:

• Governance
  • The intensivist should take a leadership position in end-of-life discussions within the ICU
• Key skills and knowledge
  • Ability to assess a patients capacity
  • Skills for communicating effectively with dying patients, their families, and other health professionals
  • Familiarity with the relevant local laws and guidelines
  • Expertise in effective symptom control in the dying ICU patient
• Determining treatment goals
  • Seek, identify and comply with the patients' expressed preferences
  • Discuss the reasons for withholding or withdrawing therapy with the patient or surrogate in specific patient-focused language and in an atmosphere of mutual respect
  • Involve cultural advisers and translators where the cultural or language differences might impede communication and understanding.
  • Seek to prevent and resolve conflict
• Documentation
  • Assist patients and substitute decision-makers to document the decision
  • Formally and clearly document any discussions
  • Audit compliance with documentation
• Management
  • Individually tailor an end-of-life plan for each patient
  • Coordinate pharmacological treatments for symptom control with the sole intention of relieving suffering
  • Recognise and present opportunities for organ and tissue donation
  • Arrange post-bereavement support for the family
  • Carry out follow-up for families whose members die in the ICU

Disagreement about end of life decisions

Chapter 6 of the 2014 ANZICS document (p. 76) deals with managing conflict, and appears relevant to the tiny 20% part of Question 13 from the first paper of 2022 which asked the candidates to outline the steps they would take if the patient or their substitute decision-maker disagrees with the consensus opinion of the treating teams that treatment is futile or non-beneficial. Given what is known about the maximum possible handwriting speed of the average human, these steps would have to be outlined in fifty words or less - something most reasonable people would agree is impossible. What follows is much longer (126 words), but answers the question more thoroughly (suggesting that it should have been worth 40% of 50% of the mark):

• Prevent conflict:
  • Prevent disagreement by early, sensitive and proactive communication
  • Be present for all meetings with other specialities to reduce inconsistent messaging
  • Listen and empathise with the concerns of the other party
  • Explore expectations of treatment and improve their accuracy
• Manage existing conflict
  • Offer more time for ongoing discussions
  • Seek a second medical opinion and present the medical consensus
  • Involve a third party as a mediator during discussions
  • Be willing to negotiate and compromise, including agreeing to a trial of treatment
  • Seek advice from the Guardianship tribunal to give for consent for palliative treatment, eg. where the patient lacks capacity
  • Seek senior institutional advice, including legal and ethical advice, from the hospital administration
  • Seek legal intervention from the Supreme Court to help resolve a disputed decision