CHEST

Medical Ethics

Medical Futility Procedures What More Do We Need to Know? Emily Rubin, MD, JD; and Andrew Courtwright, MD, PhD

Unilateral medical futility policies, which allow health-care providers to limit or withdraw lifesustaining treatment over patient or surrogate objections, are increasingly designed around a procedural approach. Medical or ethics committees follow a prespecified process, the culmination of which is a justified decision about whether ongoing treatment should be withheld or withdrawn. These procedures have three stages. First, health-care providers must decide to refer patients for consideration of whether ongoing treatment is futile. Second, the committees involved must decide whether ongoing treatment is actually futile. Third, there is a clinical outcome that often is, but not always, patient death. We review the available data on procedure-based futility policies, arguing that there is limited information on their potential harms and how these harms are distributed. We consider the ethical implications of policy-making under informational uncertainty, invoking the precautionary principle—in the absence of clear data, if a policy has significant risk of significant harm, the burden of proof that it is not harmful falls on those recommending the policy—as the guiding moral standard for hospitals and professional organizations considering whether to adopt a procedural approach to medical futility. On the basis of this principle, we argue that any new futility guideline must include a significant commitment to collecting prospective data on its application. CHEST 2013; 144(5):1707–1711 Abbreviations: CCB 5 Consent and Capacity Board; HEC 5 hospital ethics committee; PP 5 precautionary principle; ROC 5 receiver operating characteristic; TADA 5 Texas Advanced Directives Act

Editor’s Note: To view articles included in the core curriculum of the ongoing Medical Ethics series, visit http://journal.publications.chestnet.org/collection.aspx? categoryid59185. —Constantine A. Manthous, MD, FCCP, Section Editor, Medical Ethics critical care societies—the American ThoTheracicmajor Society, Society for Critical Care Medicine, American College of Chest Physicians, American Asso-

Manuscript received May 28, 2013; revision accepted July 7, 2013. Affiliations: From the Department of Internal Medicine (Dr Rubin), Department of Pediatrics (Dr Rubin), and Institute for Patient Care (Dr Courtwright), Massachusetts General Hospital; and Department of Pulmonary and Critical Care Medicine (Dr Courtwright), Brigham and Women’s Hospital, Boston, MA. Correspondence to: Andrew Courtwright, MD, PhD, Institute for Patient Care, Massachusetts General Hospital, Founders House, Third Floor, 55 Fruit St, Boston, MA 02114; e-mail: [email protected] partners.org © 2013 American College of Chest Physicians. Reproduction of this article is prohibited without written permission from the American College of Chest Physicians. See online for more details. DOI: 10.1378/chest.13-1240

ciation of Critical Care Nurses, and European Society for Intensive Care Medicine—are in the process of producing a new joint guideline on medical futility in the ICU. Relying on some version of primum non nocere (first do no harm), they have argued that it is morally reprehensible to cause suffering without offering meaningful benefit. Focusing, then, on the ethical justification for unilateral decisions to limit or withdraw life-prolonging medical interventions over patient and family objections and the appropriate mechanism for reaching these decisions, the new guidelines are expected to recommend a procedural framework for determining medical futility. In contrast to futility approaches such as the Uniform Health-Care Decisions Act,1 which focus on the substantive judgment of experienced health-care providers in deciding whether ongoing treatment is futile and should be withheld or withdrawn, procedural approaches offer a due process framework that promises to take into consideration a broader array of values, beliefs, and expertise in reaching a justified decision about whether the certain burdens of ongoing or

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additional interventions outweigh the possibility of any significant benefit.2,3 The appeal of a process-based approach is not surprising partly because these policies have survived legal challenges4 and partly because they address concerns about health-care provider paternalism and loss of patient autonomy that were at the center of the 1990s debate on substantive medical futility policies.5,6 We review the available empirical literature on how procedure-based futility policies operate, focusing on the kinds of patients for whom physicians request futility evaluations, the composition of the committees making these decisions, and what is known about clinical outcomes after futility judgments. We argue that there are very limited data on the potential harms of these policies and consider the ethical implications of policy-making under informational uncertainty, invoking the precautionary principle (PP) as a guiding moral standard. The Futility Process The most widely discussed procedural futility model is the Texas Advanced Directives Act (TADA), although other examples, some of which do not explicitly use the term “futile,” preferring “nonbeneficial” or “not in the patient’s best interest,” include Ontario’s Consent and Capacity Board (CCB), Boston Children Hospital’s limitation of life-sustaining treatment policy, and the American Medical Association Council on Ethical and Judicial Affairs process for resolving conflict at the end of life.7 In each case, there are three distinct procedural stages. First, health-care providers must decide to refer a patient for judgment of whether ongoing treatment is futile. Second, the committees or third parties involved in the process must decide whether ongoing treatment actually is futile. Third, there is a clinical outcome that often is, but not always, patient death. Referral The first step in a medical futility procedure is for a health-care provider to refer his or her patient for consideration of whether ongoing treatment is futile. There are limited published data on why some patients rather than others are referred to the committees that implement futility procedures. For example, a survey study of physicians who referred cases to the Ontario CCB found that moral distress among healthcare providers and impasse with the family were among the main reasons that the medical futility process was initiated.8 This suggests, as Truog9 has argued, that futility referrals may, in part, be a way to address difficult surrogates rather than reflect actual medical prognosis.

This should not be surprising given that health-care providers are notoriously unreliable in predicting general clinical outcomes, including death. For example, Meadow et al10 found that 16% of patients in the ICU who every member of the care team agreed would die during their hospitalization survived to discharge. The receiver operating characteristic (ROC) for unanimous prediction of death in this cohort was only 0.79, about the same as the old CHADS2 (congestive heart failure, hypertension, age ⱖ 75 years, diabetes mellitus, and prior stroke or transient ischemic attack or thromboembolism) score, which was recently replaced with a more accurate system for assessing anticoagulation in atrial fibrillation. Although there are no studies specifically addressing the ROC for invocation of medical futility, Frick et al11 found substantial variability among individual health-care provider assessments of whether ongoing treatment was futile, suggesting that whether a patient is referred to a medical futility process depends as much on individual provider factors as the patient’s medical condition. Furthermore, there are no data on whether specific sociodemographic factors make futility evaluation requests more likely, particularly regarding race, sex, ethnicity, or functional status. Given, however, that race and cultural background are strong predictors of conflict between health-care providers and surrogates over intensity of medical care at the end of life, it is likely that racial minorities are overrepresented in procedural medical futility cases.12-15 Without further data on the factors that lead providers to invoke medical futility procedures, we do not know whether the use of these procedures is arbitrary; unrelated to actual medical prognosis; or, more seriously, inappropriately biased by patient or surrogate sociodemographic characteristics.

Determination of Futility Once the decision has been made to refer a patient for consideration of whether his or her ongoing treatment is medically futile, procedure-based policies rely on a third party to make that judgment. Under TADA, a hospital’s medical or ethics committee plays this role. There are, however, few data on the composition of these groups. Empirical studies of hospital ethics committees (HECs) consistently demonstrate substantial heterogeneity in membership and training requirements, length of appointment, and institutional support.16,17 For example, a 2007 national survey suggested that the majority of HEC members had no formal education in bioethics or clinical ethics, only about one-half of HECs usually or always see the patients for whom they were consulted, and one-fourth never made specific recommendations about the best course of action.18

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Although the TADA process requires transparency of decision-making and written documentation of recommendations, there are no specific restrictions on the membership of these committees, and there is little information on how often hospital administrators, representatives of the legal department, the colleagues of referring health-care providers, or other individuals with a potential of conflict of interest sit on the HECs that decide TADA cases.19 Given that there are no widely accepted accreditation or credentialing requirements that regulate HEC practices, there is a real possibility that medical futility judgments may be made by committees that are untrained and unprepared to do so with any degree of sophistication.20 Even for futility procedures where committee membership is more clearly defined (eg, the CCB in Ontario), there is limited information on the evidentiary standards these committees use to reach their decisions. For example, in reviewing a case series from the CCB, Chidwick et al21 found that the board did not allow surrogates to invoke life itself as a sufficient reason for ongoing medical intervention. A particularly challenging issue for the CCB was how to weigh surrogate perceptions that loved ones were communicating against physician judgments that these efforts were reflexes or myoclonic jerks. To our knowledge, there have been no published consensus guidelines on evidentiary standards for use in medical futility procedures. Finally, just as we do not know what characteristics predict which patients are referred to futility committees, we do not know what factors predict the outcome of the procedure, specifically regarding race, sex, functional status before hospitalization, and ethnicity.22,23 Given that age and functional status are strong predictors of whether patients will be declined ICU admission under the category too sick to benefit, a different kind of unilateral medical futility decision, it seems likely that similar demographic characteristics would predict the outcome of unilateral medical futility procedures.24 To our knowledge, the only relevant published study in this area is a small cohort (n 5 31) where neither race nor sex predicted the recommendation of a unilateral do not attempt resuscitation order, but that study was not powered to meaningfully detect these differences, nor did it adjust for relevant confounders.25 Clinical Outcomes Of the three available studies on the outcomes of futility procedures taken to completion, committees recommended limiting or withdrawing life-sustaining treatment in 70%, 79%, and 91% of cases.19,21,26 Once a committee has made this determination, however, there are still a number of possible clinical outcomes. Health-care providers may elect not to follow the com-

mittee’s recommendations; patients may get better, may die, or may be transferred to another facility; or surrogates may change their mind and decide to limit treatment on their own accord. What little we know about the clinical consequences of procedural futility policies comes from a retrospective survey study of Texas hospitals regarding their use of TADA.19 Under the TADA statute, if the medical or ethics committee recommends withdrawing or withholding medical treatment, surrogates are given 10 days to transfer to another hospital before the recommendation is implemented. Smith et al19 found that by the end of the 10-day waiting period, 44% of patients died, 17% were transferred to another institution, and 5% improved to the point that ongoing treatment was no longer deemed futile. For patients who were not transferred and whose surrogates insisted on continuing treatment even after the 10-day waiting period, life-sustaining treatment was actually withdrawn in only 42% of cases. In the other 58%, there were no data on whether any of the patients improved. Thus, what little we know about unilateral futility policies suggests that some percentage of patients in whom medical futility is invoked improve to the point that ongoing treatment is deemed appropriate and that we do not know the clinical outcomes among patients for whom treatment is declared futile but who nonetheless—for legal or public relations reasons—continue to receive such care. In summary, we lack information on the factors that influence health-care providers’ decisions to refer patients for judgment about the futility of ongoing treatment, we know little about the composition and evidentiary standards of the committees that make these judgments, and we have limited data on the outcomes of these decisions, except that in some number of cases, these committees were wrong that ongoing intervention was futile. We now turn to the ethical implications of these informational gaps. Precaution Ahead How does uncertainty or absence of information affect our moral obligations when considering whether to implement a policy? The most commonly cited guide in these circumstances is the PP, which comes from environmental and research ethics: Precautionary principle: In the absence of clear data, if a policy has significant risk of significant harm, the burden of proof that it is not harmful falls on those recommending the policy.

The PP formalizes the sentiment behind the sayings look before you leap or better safe than sorry.27,28 It contains an epistemic standard (“clear data”), a prediction under uncertainty (“significant risk”), a

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normative outcome (“significant harm”), an evidentiary standard (“burden of proof”), and a criterion of agency (“those recommending”). In health-care policy, the PP can be specified as follows: Clear data are evidence that could not be reasonably rejected by a group of unbiased reviewers, also known as peer-reviewed evidence; significant risk is a nontrivial chance of an outcome; and significant harm is patient death or loss of function, the prevention of which are among the goals of medicine. Burden of proof identifies who is responsible for producing peer-reviewed evidence. Those recommending refers to the professional society, hospital administration, or legislative body promulgating a specific health-care policy. With these definitions in mind, we can further specify the PP: Health-care policy precautionary principle: In the absence of peer-reviewed evidence, if there is a nontrivial chance that a health-care policy will result in patient death or loss of function, the professional society, hospital administration, or legislative body recommending the policy is responsible for producing peer-reviewed evidence that it does not have these results.

How does the PP apply when considering whether to adopt unilateral medical futility guidelines more broadly? The potential harms of unilateral futility policies include both withdrawing life-sustaining treatment from patients who might otherwise survive with reasonable functional status (a direct harm) and denying care to patients on the basis of factors unrelated to the underlying severity of their disease (an injustice). Furthermore, what little we know about unilateral futility policies suggests that in some number of cases, patients improve to the point where medical interventions are restarted, suggesting a risk of at least one of these harms. Thus, the PP requires that hospitals and professional organizations endorsing a unilateral futility policy also be responsible for collecting evidence that the policy does not actually result in significant harms. It does not, however, specify exactly what incidence of harm requires a revision of the procedure, only assigning the onus for identifying the extent and frequency of a policy’s potential harms. A strict interpretation of the PP would require the collection of such evidence before broadly adopting a unilateral medical futility policy, demonstrating in advance of adoption that the policies would not result in patient death or loss of function and would not be applied in a biased or unfair manner by an unprepared committee. A strict application of the PP, however, is only appropriate where the status quo is benign and the proposed policy would be a significant departure from that state. As we have emphasized, however, the current state of medical futility decision-making is not benign. In the face of intractable conflicts of values between medical teams and surrogates over what quan-

tity and quality of life is sufficient to justify initiating or continuing a given life-sustaining treatment, these decisions currently are being made opaquely, arbitrarily, or not at all. This approach in which healthcare providers are called on to provide interventions that cause pain and suffering without materially altering the patient’s clinical outcome is not benign, so the PP does not demand that a policy be vetted for potential harms before it is fully enacted. What the PP does require is that as hospitals and professional societies construct and implement processes for unilaterally limiting medically futile interventions, the burden of proof is on them to establish prospectively whether such a process causes additional, significant harms. This is not a requirement to show that physicians and ethics committees are infallible, unbiased predictors of medical futility; rather, as these procedures are adopted and implemented, we must demonstrate that they are not poor, biased predictors of medical futility. In many respects, this idea is similar to postmarketing surveillance requirements that both manufacturers and the organizations that approve drugs are responsible for monitoring for adverse events.29

What Do We Need to Know? Merely calling for or suggesting additional research is not sufficient to meet the PP burden of proof. Given the number of open-ended questions and potential harms associated with unilateral futility policies, it is morally imperative that hospitals and professional organizations endorsing and applying them finance and undertake prospective empirical efforts to study their effects. They should especially prioritize research to identify patient and surrogate predictors of why health-care providers invoke medical futility procedures and the ROCs of these predictions. They should collect or make possible the collection of data on the composition, training, and membership requirements of the third parties called on to make futility judgments and provide guidelines on evidentiary standards for these procedures. Finally, they should fund the collection of prospective data on cases in which the policy is invoked. These data should include, at a minimum, basic demographic information; case characteristics that predict recommendation of limiting or withholding life-sustaining treatment; and outcomes after the process is completed, including long-term survival and functional status and resumption of medical treatment, if that occurs. Ultimately, proponents of unilateral medical futility procedures must be cognizant of what may happen when further information is incidentally uncovered about a policy after it is enacted. If it turns out that

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biases exist, particularly racial biases, in the way a futility policy is applied or that physicians are worse at predicting medical futility than expected, it is hard to imagine a positive outcome for these policies. Considering the response to the Admissions and Policies Committee of the Seattle Artificial Kidney Center (the so-called God Committee) after its criteria for selecting dialysis patients was divulged or to the recent political obsession with death panels, the negative consequences of an imperfectly understood unilateral futility policy go beyond patient harm. It is hard to imagine these policies weathering such a discovery, threatening any benefit that proponents may have hoped for in their implementation. As such, it is essential that the endorsing organizations collect the necessary data to identify and correct any significant harms from unilateral medical futility policies.

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Acknowledgments Financial/nonfinancial disclosures: The authors have reported to CHEST that no potential conflicts of interest exist with any companies/organizations whose products or services may be discussed in this article.

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Medical futility procedures: what more do we need to know?

Unilateral medical futility policies, which allow health-care providers to limit or withdraw life-sustaining treatment over patient or surrogate objec...
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