Responding to patient requests for nonbeneficial interventions may be one of the most challenging and emotionally taxing issues that physicians face. These requests can run the gamut from a patient asking for antibiotics to treat a viral URI, inquiries about surgery to treat an advanced cancer, or refusal to stop life-sustaining interventions, such as hemodialysis, when the patient’s likelihood of recovery is poor. These requests are often framed in terms of conflicts between patient autonomy and physician autonomy. They can lead to deterioration of the relationship between patients, their families, and the physician. Tensions can also arise and lead to an adversarial relationship. A few high profile cases, particularly those involving life-sustaining interventions, have required the courts to get involved. Several states, most notably Texas and Virginia, have passed “futility laws,” which set in place a system for discontinuing an intervention that is determined to be nonbeneficial.
At ProNobis Health, we understand the distress that requests for nonbeneficial care can cause in a physician’s relationship with a patient. We also understand the time and energy it takes to explain to patients why their request will not be beneficial. It can be particularly difficult if you believe that an intervention is nonbeneficial but the patient finds a colleague who disagrees, or is nonetheless willing to perform the intervention. In some instances, it can be easier to go along with the patient’s request rather than refuse and create tension in the relationship. We want to help you understand the art and the science of responding to requests for nonbeneficial interventions. Having knowledge of the historic framework, definitions of futility, and an understanding of process approaches and legal implications can empower you to better respond to patient requests. We also hope that this leads to less distress on your part and more harmonious relationships with your patients and their families.
Historic Perspective: The Cruzan and Quinlan Cases
On January 11, 1983, 25-year-old Nancy Cruzan was in a motor vehicle collision and was thrown from her car. When paramedics arrived, she did not have vital signs, but she was successfully resuscitated en route to the hospital. After three weeks in a coma, it was decided that she was in a persistent vegetative state, and a feeding tube was surgically inserted. After five years, the family asked the physicians to remove the feeding tube so that Nancy could die. Her parents believed that the burden of the feeding tube was greater than the benefit, since it seemed unlikely that she would recover. They believed that the feeding tube was nonbeneficial. The physicians and hospital refused, arguing that removing the feeding tube would be murder. From the perspective of physicians and the hospital, life was an absolute value, regardless of its condition, or the means necessary to sustain it. In order to grant the family’s petition to remove Nancy’s feeding tube, the state of Missouri required clear and convincing evidence of what Nancy would want.
The case ultimately made it to the United States Supreme Court because of the level of evidence the state of Missouri required in order to decisions to be made on the part of a patient lacking capacity. While the Supreme Court recognized the rights of patients with decision-making capacity to refuse treatments, it ruled in favor of the standard required by the state of Missouri for patients lacking capacity. In order to satisfy the state’s requirements, the Cruzan family gathered additional evidence to support their claim that Nancy would want the feeding tube removed. With the additional evidence, a judge ruled that the feeding tube could be removed.
A similar case is that of Karen Ann Quinlan, who—on April 15, 1975, at the age of 21—suffered a respiratory arrest after consuming alcohol and valium and remained in a persistent vegetative state. Her parents asked to have her disconnected from the ventilator but doctors and the hospital disagreed, believing that doing so would be equivalent to homicide. Like the Cruzans, the Quinlans believed that the ventilator was a nonbeneficial treatment and was a greater burden than benefit. The case was also taken to court, and the final ruling allowed Karen to be disconnected from the ventilator.
Although these cases have several technical legal dimensions, the important points for our discussion are (1) consideration of benefit and burden in any medical intervention, (2) the recognition that a patient can refuse any treatment, including life-sustaining treatments, nutrition, and hydration, and (3) when the patient is not able to make known his or her wishes regarding treatments, a surrogate who knows the patient can act as his or her decision maker. It is also important to note that these cases set an important legal and ethical precedent in recognizing that patients can refuse life-sustaining treatments.
These cases set the historic context for discussions about nonbeneficial treatments. Because the measurement of a treatment based on benefit and burden is value laden, there can be differing perspectives about what is a benefit and what is a burden. Up until the time these cases were debated, many physicians viewed their role as preserving life by whatever means necessary. The Cruzan and Quinlan cases were challenges to traditional ways of thinking and illustrate the shifting perspective of physicians about what is ethical care, particularly around life-sustaining treatments. There can be multiple reasons for these shifts. Judgments about quality of life, human suffering, and the limitations of medicine all play into what physicians believe is ethical. Personal religious beliefs can also affect a physician’s judgment. It is important to recognize the shift in medical ethical thinking that began with cases like these.
Refusal and Request
The Cruzan and Quinlan cases represent instances in which families have refused what they saw as nonbeneficial life-sustaining treatments. When properly informed and made by a patient with capacity, or a rightful surrogate, most ethics committees and courts would uphold these refusals. Requests by families to continue life-sustaining treatments when they have been determined by physicians and the treatment team to be nonbeneficial can be more challenging to address, both ethically and legally. While these conflicts can be framed as competing interests between physician and patient autonomy, they also illustrate very well the difficulty defining what a nonbeneficial treatment is.
Definitions of Nonbeneficial Treatment
Attempts to define nonbeneficial treatments ask on what basis “benefit” is being measured. Furthermore, implied in some assessments of benefit is a determination of the burden of the treatment. Burden can be similarly complicated to measure, and like benefit, can be viewed from the perspective of different stakeholders. For instance, a mother may consider a beneficial treatment one that keeps her young child alive, even if the child does not have a reasonable chance of long-term survival, because the pain of the child’s death is too great for the mother to face. For the mother, there is a benefit in preserving the child’s life. Similarly, one may believe that even if there is a slim chance of some recovery, there is a benefit to continuing life-sustaining treatments. These instances, and the definitions below, illustrate the difficulty in determining what is meant by benefit.
One attempt at defining benefit has been disease based. Some have proposed a list of clinical conditions in which treatment should not be provided. For instance, it was at one time proposed that HIV infection with greater than two episodes of pneumocystis carinii pneumonia (PCP) not be treated because it was nonbeneficial. The reasoning was that the patient’s prognosis was so poor that any further treatment would not result in improved survival. One can immediately see one difficulty with a canonical definition of diseases or conditions in which treatment would not be beneficial; prognoses are constantly shifting, and hopefully improving, with improved treatments. HIV is an excellent example. There has been a significant improvement in survival during the last 20 years. Another problem with listing diseases or conditions in which treatment is never beneficial is that the determination is made based on the disease, not the patient. Every physician knows that two different patients can respond to the same disease in very different ways.
Another proposed structure for defining nonbeneficial treatment is the 100 case rule, sometimes called the <1% rule. According to this standard, if in the last 100 cases that a physician has seen, the treatment has not provided a benefit, then it is considered nonbeneficial. This relies very narrowly on a physician’s own experience. Similar proposals have used other success rates ranging from 1% to 13% to define treatments that are nonbeneficial. Other definitions have used criteria such as “permanent preservation of unconsciousness” and “failure to end dependence on intensive medical care” to define treatments which are nonbeneficial.
These definitions are largely quantitative in that they focus on the probability of success defined in terms of percentage. A similar, and perhaps more narrow quantitative definition is based on probability of physiologic success—the likelihood that treatment is going to be able to achieve a narrow physiologic goal. For instance, hemodialysis may be successful at removing fluid and toxins from a patient in a persistent vegetative state from an anoxic brain injury, but it is unlikely to reverse the effects of the anoxic injury. It is physiologically beneficial, but how beneficial is it to the patient’s recovery?
Qualitative assessments of benefit, in contrast, consider a subjective assessment of the quality of benefit produced. Although somewhat circular, a treatment is qualitatively beneficial if it produces an effect that a patient appreciates as beneficial. The degree of benefit is often measured in terms of quality of life such that a qualitatively beneficial treatment improves a patient’s quality of life. This is not the same as whether the treatment is in keeping with a patient’s values. In the latter, a physician would be compelled to perform any treatment that a patient requested as long as it was consistent with the patient’s values.
The futility definitions in many ways seek to balance patient and professional autonomy. They are driven in part by recognition that in some clinical settings, patients will either request or refuse to terminate a treatment that the physician judges to be nonbeneficial. The physician is making a clinical judgment based on education and experience, as well as a moral judgment based on the principles of doing good and avoiding harm. The patient or surrogate is making a value judgment based on beliefs and morals. No one definition can adequately account for opposing perspectives on what is beneficial for an individual patient. Because of this, the focus has shifted from attempts to define nonbeneficial and decide who is right and who is wrong, to procedural solutions when there is disagreement.
Process-based approaches move beyond definitions and instead seek mediation and dispute resolution, stressing good communication. Recognizing that some disagreements will be based on misunderstandings, process-based approaches seek to clarify the values of both the patient and the treatment team and work together to formulate an agreeable plan. This model is also collaborative, identifying and involving all stakeholders. Hospital ethics committees are often involved, as are professional mediators who can facilitate the conversation. If mediation fails, attempts are made to identify either a different physician or a different facility willing to provide, or not to discontinue, the disputed treatment. Another option that has been tested is to change the surrogate when there is disagreement. The burden on the physician and hospital is to prove that the surrogate is either not acting according to the patient’s wishes, or is acting in a way that is not in the patient’s best interest, such as inflicting ongoing suffering. Attempts at removing surrogate decision makers when they disagree with medical team recommendations have largely not withstood legal challenges.
Finally, when all else fails, some have advocated a unilateral decision to withhold or withdraw a nonbeneficial treatment. In general, this is an ill-advised approach and should only be undertaken after thorough and broad collaboration with an ethics committee, legal team, risk team, and hospital administration. From a legal perspective, most attempts at withdrawing or withholding a life-sustaining treatment have been blocked by the court. In the absence of specific legislation, the judiciary tends to side with patients and surrogates over physicians and hospitals when it comes to life-sustaining treatments. Additionally, physicians could be vulnerable to civil litigation and possibly criminal charges for unilaterally withdrawing or withholding life-sustaining treatments against the wishes of a patient or surrogate.
Texas Advance Directives Act of 1999
One example of legislation that attempts to systematize the process-based approach and keep cases involving nonbeneficial treatment out of the courts is the Texas Advance Directives Act of 1999 (TADA). Once the medical team advises withholding or withdrawing a nonbeneficial life-sustaining treatment, and the patient or surrogate disagrees, the ethics committee is consulted and the family is given 48 hours to participate. If the ethics committee agrees that the disputed treatment is nonbeneficial, the hospital must make an attempt to transfer the patient to a facility or physician that will perform the treatment. If after 10 days a good faith effort at transfer is unsuccessful, the treatment can be withdrawn or continue to be withheld. The family can request an extension, but if it is not sought or granted, the treatment can be withdrawn without civil or criminal persecution.
TADA was tested in 2005 by the family of Sun Hudson, an infant born with fatal congenital dwarfism. Because of his prognosis, the medical team judged that ongoing ventilatory support was nonbeneficial, a decision with which the ethics committee at Texas Children’s Hospital agreed, despite requests from his mother to continue life-sustaining treatment. Unsuccessful attempts were made to transfer Sun to a different hospital, and ultimately the medical team disconnected him from the ventilator and he died shortly after. The hospital’s decision was upheld by an appellate court, the first time a US judge sided with the medical team over a parent in withdrawing life-sustaining treatment. Some have argued that TADA is flawed because of biases that may exist in hospital ethics committees and within the institution’s own bureaucracy, therefore these cases should be adjudicated individually in the courts. Regardless of the outcome, these cases are always emotionally challenging for everyone involved.
Moral Courage and Professional Autonomy
It can be very hard to say no to a patient, especially when responding to a request for a life-sustaining treatment. In some cases it is easier to say yes than to have a difficult interaction. Doing what you believe is right, exercising your professional autonomy, can take a lot of moral courage. Your training and experience, guided by the moral standards to do good and avoid doing harm, form the basis of professional autonomy. That is not to dispute the moral foundation of patient autonomy, but rather to affirm that in some cases, you have an ethical obligation to withhold or withdraw nonbeneficial treatments. This preserves your professional and personal integrity. Disagreements are best addressed through a process-based approach. Many hospitals have teams who can support you. At the minimum, the ethics committee is a place to start in resolving conflicts over nonbeneficial treatments. It is very important to recognize that you don’t have to be both the mediator and one of the major stakeholders. Getting the ethics committee and a professional negotiator or ombudsman involved will often help to resolve disagreements. While as physicians we should be good, empathic communicators, an unbiased third party can often help find an acceptable resolution. In the end, trust your judgment, act with empathy and integrity. You are not alone.
As Uncle Ben said to Peter Parker (Spiderman), “With great power comes great responsibility.”