Spring, 2004
This is an edited and updated transcript of a forum presented by the Harvard Medical School, Division of Medical Ethics, in November 2004. It was moderated by Walter M. Robinson, MD, MPH, Assistant Professor of Pediatrics and Social Medicine, and Associate Director of the Division of Medical Ethics, Harvard Medical School.
Worries over the expense of providing dialysis to those with chronic renal failure ignited a prominent and early public debate in American medical ethics. Publicity regarding the Seattle "God Committee," which attempted to provide social criteria for the rationing of dialysis, eventually led to the remarkable decision by Congress to provide full funding for the End Stage Renal Disease (ESRD) program in the early 1970s. In the eyes of some, our government stepped in to buy our way out of an ethical dilemma. At present, it is clear that the ESRD program bought us time, but could not erase the ethical issues. In the mid 1990s, a series of reports demonstrated that for 10 percent to 20 percent of those who died with ESRD, a conscious decision had been made to discontinue dialysis prior to death; the news was greeted with shock by some and relief by others. 1 These reports, and the subsequent debate over the place of palliative care in chronic renal disease, signaled that dialysis had at last entered the "real world" of life-prolonging therapies in which the most difficult issues of withdrawing and withholding therapy, quality of life, and palliative care cannot be solved by an uninterrupted funding stream. 2 Surveys and clinical experience have suggested that discontinuation of dialysis often produces a "good" death, one that is pain-free and peaceful. In this light, our forum today will explore this "new" issue in the withdrawal of life-prolonging treatment, and draw comparisons to other examples of end-of-life decisions.
Lewis M. Cohen, MD,
PDIA Faculty Scholar and Psychiatrist, and Medical Director of the Renal Palliative Care Initiative at Baystate Medical Center, Springfield MA
I offer this case as an illustrative example of many of the issues that we might consider in this Forum. The patient is a 49-year-old woman, who has had diabetes for the past 20 years, and has been on dialysis for the last eight months. She has had a stroke, coronary artery disease and a myocardial infarction. She suffers from a degree of blindness, several neuropathies, and lately her hands have been giving her difficulty. She is also having trouble swallowing. I first saw this woman after she had skipped dialysis for three weeks. Apparently, one of the nephrologists led her to believe that if she refrained from dialysis for a length of time, she would be dead. Her living presence at our first meeting suggested that she obviously had some residual kidney function. At this point, she confessed to her family her intentions to die.
During the course of the hospitalization, she was very clear with me and with the nephrologists that she really wanted to stop this treatment. The family, which included three adult children, stood firmly opposed to it. Unfortunately, they were equally unprepared to hear what we had to tell them. Despite their mother's sad condition, she was clearly competent to make her own treatment decisions. She had the capacity to weigh her options and judge likely outcomes. Moreover, when it came to treatment, this was her decision and not the family's. I will never forget these adult children turning to me and saying, "You call yourself a psychiatrist? You are absolutely crazy. She is depressed. She is out of her mind. She cannot make a decision for herself and you of all people should be able to understand that." From her family's perspective, her decision to end treatment was clear evidence of her mental incompetence. Yet, from our best measures she was fully competent, even if her choice conflicted with her family's wishes. Their mother was discharged from the hospital with the understanding that the treatment team would not force her to undergo dialysis against her wishes. I can't remember if we called on hospice at that point, and to be honest, the lack of coordination with hospice in these cases remained a true shortcoming until recent years. The woman returned home and died within 10 days.
With this case digest in mind, let me outline a few of the broader considerations and goals of the Renal Palliative Care Initiative. I will begin with the most fundamental one and then report on some of the research that we have conducted. Many years ago, one of my mentors at Massachusetts General Hospital told me: "A good death is the kind of death one would want, if one had the choice." This principle seems to most of us nearly incontestable and it has guided much of our effort to define criteria which dialysis physicians and nephrologists could employ when discussing a choice to end dialysis.
Two factors, which often lead to withdrawal of treatment, are a heavy symptom burden and a limited life expectancy. ESRD patients comprise a population that typically suffers under a tremendous symptom burden, rendering daily life rather unpleasant. Insomnia is extraordinarily common and many experience severe muscle cramping and pains of different sorts. Itching is an equally common phenomenon, along with nausea, vomiting and poor spirits. Our data indicates that among the roughly 300,000 patients undergoing dialysis in any given year, about 65,000, or 23 percent, will die. This mortality rate might at first seem discouraging, until you consider that nearly all of these 300,000 would die without this treatment.
The introduction of dialysis is often told as a success story, representing a life-saving treatment that we employ with remarkable outcomes. By all accounts, dialysis has saved hundreds of thousands of ESRD patients from a premature death and given many of them an opportunity to lead very productive and satisfying lives. However, the patient population has changed from what it was 30 years ago, and more and more we are deciding to dialyze very elderly people. In fact, the 65-year-old-and-up group is the fastest growing sector of the dialysis population. As a result of this shift, nephrologists now treat patients with increasing comorbidities, such as diabetes, hypertension and the myriad other conditions common in an aging cohort.
Upon beginning dialysis, the remaining life expectancy of a patient is somewhere between one-eighth to one-third that of a person in the general population without ESRD, matched by age, gender and race. At the onset then, the dialysis patient faces a prognostically shorter survival time than those without ESRD. A few comparisons can make this fact a bit more meaningful: the risk of death for a 45-year-old dialysis patient in any year is 20 times that of person of the same age who does not need dialysis. Average survival time for a 50-year-old male beginning dialysis is five years, and the 75-year-old beginning dialysis could be expected to have two more years before death.
I will now return to the studies we conducted at Baystate Medical Center. We began our research with two working assumptions: first, that a good death is preferable to continued suffering; and second, that patient autonomy should be the cornerstone of end-of-life decisions. Our study targeted several specific questions: Which dialysis patients (or their families) actively choose to end dialysis? Can we define a "good death" or distinguish it from a "bad death?" What are the typical symptoms following dialysis discontinuation? What is the prevalence of depression or even clinical suicide? We carried out our study at eight sites in the United States and Canada, involving 131 patients who died after withdrawing from dialysis. We contacted 79 subjects, and conducted 23 patient interviews and 76 family interviews. We employed multidisciplinary teams to track chronic dialysis patients, whom we interviewed as soon as they made the decision to end treatment, and then every three days until the patient died. Following the death, we made contact with the caretaker - a staff member at the nursing home, a relative or a visiting nurse - in order to gain a deeper understanding of the experience.
In this effort, we also created a measurement tool to distinguish good deaths from bad deaths, a "quality of dying tool" based upon clinician judgments and information we obtained from patient and family interviews. Three dimensions of a "good death" are noteworthy. First is survival time after ending treatment. Most patients want death to come quickly, and on average, ESRD patients will typically be dead by the eighth day, many after only two or three days. (Some, unfortunately, can last a month or more.) The second factor was pain and suffering, and nearly everyone we interviewed defined a good death as one without significant pain. And, finally, we considered psychosocial factors, such as family support of treatment termination.
Our study reached a number of conclusions. 3 For our determination of "who" chooses to terminate dialysis, we employed the data the government collects from every dialysis unit on every patient. Nephrologists are required to complete a fairly extensive form, and issue a death certificate upon nearly every death. In the aggregate, patients who choose to terminate dialysis are white, elderly, diabetic and very ill. However, among our eight clinics, we found a remarkable divergence in the percentage of patients who decided to stop dialysis prior to death, from 8 percent in one clinic to 53 percent in another.
As for the quality of death, we found that seven-eighths of the patients withdrawing from dialysis experienced a good death, with a noticeable portion having a "very good" death. Typically, their discomforts were mild. During the final 24 hours of life, 42 percent of the patients had some pain (with only 5 percent reporting severe pain); 30 percent were agitated; 28 percent had muscle twitching, or myoclonus; and 25 percent had shortness of breath, or agonal breathing, characteristic of terminal breathing in all patients, not just our study group. 4 Nonetheless, it was this collection of symptoms, along with the fact that one-eighth of our patients experienced a "bad death," that prompted me to establish a demonstration project devoted to integrating palliative care within the dialysis population.
In 2002, an End-Stage Renal Disease Workgroup, sponsored by the Robert Wood Johnson Foundation's Program for Promoting Excellence in End-Of-Life Care, published a final report that discusses many of these issues at length. 5 The Workgroup, under the direction of Alvin H. Moss, MD, professor of medicine and director of the West Virginia University Center for Health Ethics and Law, developed instruments for measuring quality of life and quality of death among ESRD patients. Similarly, the Renal Physicians Association and the American Society of Nephrology have adjusted their guidelines for withdrawal of treatment to accommodate many of the ESRD Workgroup's recommendations, including a new attention to palliative care. 6 I had a small role to play in their efforts, and these magnificent guidelines have been widely distributed. I'll end my presentation with this thoughtful quote from Thomas Brown: "Many have studied to exacerbate the ways of death but fewer hours have been spent to soften that necessity." I have been one of the fortunate few to have spent five years studying ways to soften death.
Theodore I. Steinman, MD
Staff Physician in the Nephrology Division, Beth Israel Deaconess Medical Center, and Clinical Professor of Medicine, Harvard Medical School
At the onset, I should mention that I intend to broaden our discussion today to include considerations of both initiation and withdrawal of dialysis. 7 I also believe that we should look at the role that disparities in healthcare play in this process. ESRD has a disproportionate effect on the minority population in the United States. African Americans make up 12 percent of the total population, yet they represent 33 percent of the ESRD population. Most patients who choose to end dialysis are Caucasian. Therefore, we find racial differences in two aspects of ESRD - prevalence and the decision to discontinue dialysis. The possible reasons for these disparities are multifactorial. With regards to prevalence, the African American population may have a higher frequency of certain gene deletions that lead to severe hypertension. Hence, the disproportionate finding of hypertension as a cause for chronic renal failure in African Americans. Concerning possible socioeconomic issues, there are many potential contributing situations that lead to an increased incidence of ESRD in the black individual. Certain psychosocial factors can influence the course of the disease, including alcohol intake, substance abuse and smoking. All of these topics should be part of our exploration of the initiation and withdraw of dialysis.
In 1973, Congress passed Public Law 92- 603, providing federal funds for all dialysis patients in America. The Act represents the first and only instance of Medicare covering a specific disease. As a result of this law, African Americans, Native Americans, Asians and Hispanics have the same access to dialysis as the Caucasian population. Yet, equal access because of funding support is not the only consideration, and Public Law 92-603 may have actually delayed contemplation of the more difficult decision involving whether dialysis is always the best choice for the individual with chronic kidney disease.
Allow me to offer a brief scenario, one that is familiar to every nephrologist. About 15 years ago, I was called to the intensive care unit with a request to dialyze "Mrs. Jones." When I arrived, I found an 85-yearold woman who had been in a nursing home for the last 10 years. She presented with severe dementia and chronic kidney failure as a consequence of pneumonia, malnutrition and a host of other comorbid conditions. She had just been transferred from the nursing home to the hospital, and the house staff, noting that she was uremic, requested that she be dialyzed. After evaluation of the patient, I told the house staff that dialysis was inappropriate. I told them a dialysis procedure can be accomplished, but it will not improve her quality of life. But they protested: "Her son, Sheldon, wants everything done for his mother. Sheldon insists dialysis be done." I held my ground, and requested to speak to the son.
Sheldon, who had not seen his mother for 10 years, flew up from Miami. I informed him that renal failure represented the culmination of multiple organ failure. If I dialyzed his mother, she might live another few days but it would not change the natural course of her disease. Even so, Sheldon said "Dialyze her, just dialyze her." In my opinion, Sheldon's decision arose from his guilt at not having seen his mother in years and was not a decision based on love and caring. I refused to dialyze her because it simply constituted poor care. Finally, in a moment of frustration I looked at him and asked, "How much do you hate your mother?" When Sheldon stepped back with horror, I said, "you must hate her a lot because you will be torturing her by demanding this procedure." I gathered that our short conversation relieved some of his guilt, and Sheldon agreed with my recommendation. We did not initiate dialysis and she died peacefully.
I give this example in order to illustrate some of the difficulties in weighing the burdens of renal replacement against the possible benefits. We would all agree that patients should be afforded the greatest degree of autonomy possible in making treatment decisions. Nonetheless, we are equally obliged to "do no harm." Before a nephrologist asks a patient, or his or her family, if they would like to initiate dialysis, the nephrologist needs to determine if the procedure is medically appropriate. The key question is whether the patient will derive overall benefit from the procedure. If this is not the case, then dialysis may be doing something to the patient, rather than something for the patient.8 Additionally, if a physician decides against dialysis, he or she has the obligation to carefully explain their reasoning to the patient or the family.
For the nephrologist, patient and family member, there are several factors to weigh. Dr. Cohen already mentioned comorbidities, so I will only echo his sentiments. We should consider whether the primary illness is due to a non-renal cause. For example, if someone has a metastatic cancer with a very limited life expectancy, we might only be prolonging their misery rather than providing relief. Then again, many cancer patients have done quite well on dialysis. Clinical judgment must come into play. We should also determine if the technical process of dialysis can be done safely. Dialyzing someone with severe heart disease or severe malnutrition (as reflected by a very low serum albumin) can lead to many complications that make the procedure extremely difficult. The technical challenges of dialysis can be likewise found in demented patients, who often become agitated and pull out their lines, endangering not only themselves but also the nursing staff or other dialysis patients in close proximity.
When I speak with patients who have ESRD, I often try to explain their predicted mortality and life expectancy rates. For example, according to the US Renal Data System, if an ESRD patient has recently had an acute myocardial infarction, they have a 60 percent one-year mortality. One with an above-knee amputation faces a 73 percent one-year mortality rate. Accurate data aid the patient's ability to make an informed choice.
It is our role to try to quantify the factors that can lead to severe or poor outcomes with dialysis. Using the Charlson Comorbidity Index, 9 an increase of 1 in the index increases the relative risk of death by 1.5 times. Fortunately, the index is not difficult for most patients and their families to understand. For example, a history of cardiovascular disease (e.g., myocardial infarction, congestive heart failure, peripheral vascular disease, prior stroke) yields a score of 1. Evidence of pulmonary disease, connective tissue disease, peptic ulcer and liver impairment also adds 1 to the score. Diabetes without end-stage renal disease, and without other organ damage, and also a tumor without metastasis and some forms of lymphoma scores a 2. With the number of comorbid conditions common to severe liver disease or AIDS (not simply HIV), it is not difficult to reach a score of 8, or a 12-fold increase in the relative risk of death. And, for each decade over 40 years of age, you add a score of 1. Assuming you are able to engage in a dialogue with the patient or family, this information can be invaluable.
Before we become too confident about our prognosticative powers, I will admit that the longer that I have been in the field of dialysis, the less able I am to accurately predict outcomes, even with the Charlson Comorbidity Index. As a result, I have taken to the practice of developing a contract with the patient and family when it is unknown if the patient will derive benefit from dialysis. One month of dialysis, or 13 treatments, will usually determine patient benefit (or lack thereof) from the procedure. If, at the end of the month, the patient is still unable to participate in activities of daily living feed, dress oneself, or use toilet facilities unassisted) we can be pretty sure that the quality of life will not improve beyond that. These contracts include specific endpoints and movement toward particular goals. The contract allows the patient and the family to realize that continuing dialysis will bring little benefit.
Walter M. Robinson, MD, MPH
(Moderator) Assistant Professor of Pediatrics and Social Medicine, and Associate Director of the Division of Medical Ethics, Harvard Medical School
In our consideration of these issues, it might be helpful to reflect on a few of the broader historical and ethical aspects of dialysis. Initially, we should note the remarkable nature of the ESRD Program. Dialysis represented the first working organ replacement, one that proved extremely difficult to ration. Moreover, the kinds of prognostic criteria that Dr. Steinman mentioned were not yet available. As a result, physicians could not assign this scarce recourse based on any sound medical criteria. In Seattle, individual doctors ceded this rationing authority to what was deemed the "God Committee." 10 This body, comprised of community leaders, clergy members, hospital administrators and physicians, developed a scoring system to evaluate deserving ESRD patients. Given the absence of any sound medical criteria, however, the Committee resorted to such factors as church attendance or family support to make their decisions.
As some of you may remember from the late 1960s, Shana Alexander, a reporter for Life Magazine, published a widely read account of the "God Committee" and its work. 11 The publicity from this article produced a near revolution in medical ethics, one that initiated many of our contemporary debates about medical treatments. It also so unnerved members of Congress that they attempted to buy their way out of the predicament by requiring Medicare to cover the cost of dialysis. In retrospect, we know that Congress grossly underestimated the scope and price of this policy. They envisioned a limited program, one that would provide dialysis for young and reasonably healthy people. As a patient grew older, their access to dialysis would be removed in favor of a younger person. Yet, because Congress included the dialysis provision in Medicare, and only the dialysis provision, they effectively avoided the frightening specter of medical rationing. In countries with closed or national healthcare systems, ESRD patients confront a full set of rules governing dialysis. By contrast, in America we have no shortage of dialysis machines or beds.
My second point involves the place of emotions and professional roles in medical ethics. The choice to dialyze or not to dialyze a person's elderly mother draws upon the emotional realm of not only the relatives, but also of the physician. Regarding the use and discontinuance of high-technology interventions, physicians will typically go to great lengths to avoid a feeling of moral agency, to avoid the sense that their actions resulted in death. Instead, they look to ensure that the patient was "allowed to die" after the treatment ended, not because they ended it, even if the two events are nearly simultaneous. A physician will say: "I removed the ventilator and allowed him to die." But for many of us, we assume a moral responsibility for making these kinds of decisions. In initiating dialysis we may feel that we have made a promise to a patient about what is going to happen, and it is very difficult to avoid feeling guilty when we persuade families to discontinue that treatment.
The guilt derives from both our unarticulated feeling that we were unable to rescue them and from the unease that our decision was at the very least a proximate cause of death, if not the actual cause of death. The third issue is one that I will only mention briefly, and it refers to the remarkable economic or structural externalities of dialysis. It is the single therapy with a continuous funding stream; there is simply no question that dialysis pays for itself. As a result, we have created not only a whole set of specialized physicians, but also a set of equipment manufacturers, a set of nurses and a set of freestanding facilities. There is an entire social structure to support the continuation of this practice, and we should be careful to judge if this system might influence our decisions to either use or not use dialysis. Off hand, I am in no position to say that we use more dialysis because there is a continuous system of reimbursement. It could equally be the case that our freedom from economic concerns enables us to make truly rational decisions. However, we do know that when a hospital buys a new CT scanner, CT scanning increases, and when it buys a new MRI scanner, the number of MRIs increase. "If you build it, they will come."
My final point is actually a question: Is this a new debate or an old one? Upon listening to Drs. Cohen and Steinman, I couldn't help but feeling that we have already discussed this issue. Substitute the word ventilators for dialysis machines and we can return to the hot debates of the late 1980s and early 1990s. In these earlier debates, there was a lot of discussion about the meaning of futility. Superficially, futility was defined as that state when the provision of care was no longer beneficial to the patient. Unfortunately, no one could define that state. It was like pornography; you knew it when you saw it but it defied simple definition. Some sought to construct numerical scales for futility with much of the same goals as the Charlson Index that Dr. Steinman mentioned. Yet, even these tools seemed arbitrary. Futility is in the eye of the beholder. Family members might not think it is futile to keep mom alive. Her presence means something to them, and no amount of evidence from the past 100 patients under similar conditions is persuasive. As a result, dialysis physicians and nephrologists will likely move away from a series of prognostic equations and towards a process for discussing with patients when to initiate and when not to initiate dialysis in the first place.
Footnotes
1 Cohen LM, Germain MJ, Poppel DM. Practical considerations in dialysis withdrawal: "To have that option is a blessing." JAMA 2003; 290 6):815.
2 Kjellstrand CM. Duration and adequacy of dialysis: Overview: the science is easy, the ethic is difficult. ASAIO J 1997;43(3):220-4.
3 Poppel DM, Cohen LM, Germain MJ. The Renal Palliative Care Initiative. J Palliat Med 2003 Apr;6(2):321-6.
4 Cohen LM, Germain MJ, Poppel DM, Woods AL, Pekow PS, Kjellstrand CM. Dying well after discontinuing the life-support treatment of dialysis. Arch Intern Med 2000;160(16):2513-8.
5 Moss AH, et al. End-Stage Renal Disease Workgroup Full Report. Promoting Excellence in End-of- Life Care. Missoula: University of Montana Press, 2002.
6 Moss AH. Shared decision-making in dialysis: the new RPA/ASN guideline on appropriate initiation and withdrawal of treatment. Am J Kidney Dis 2001;37(5):1081-91.
7 Moss AH. Too many patients who are too sick to benefit start chronic dialysis; nephrologists need to learn to "just say no." Am J Kidney Dis 2003;41(4):723-7.
8 Keating RF, Moss AH, Sorkin MI, Paris JJ. Stopping dialysis of an incompetent patient over the family's objection: is it ever ethical and legal? J Am Soc Nephrol 1994;4(11):1879-83.
9 Hemmelgarn BR, Manns BJ, Quan H, Ghali WA. Adapting the Charlson Comorbidity Index for use in patients with ESRD. Am J Kidney Dis 2003;42:125-32.
10 Steinman TL. ESRD in the geriatric population: the crisis of managed care and the opportunity of disease management. Semin Dial 2002;15(2):84-7.
11 Alexander S. They decide who lives, who dies. Life 1962 Nov 9;102-25.
The Medical Ethics Forums are edited by Eric D. Kupferberg, PhD, Assistant Director of Public Programs, Division of Medical Ethics, Harvard Medical School. Publication is made possible by a generous grant from the Pettus-Crowe Foundation.
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