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Kidney Failure and the Federal Government 3 Ethical Issues Dialysis and transplantation have raised ethical questions since their introduction to clinical practice in the early 1960s. The questions have changed over time, however, as the patient population, treatment, and financing have changed. In the 1960s, the discussion focused on the criteria for access to treatment as a function of financial resources and other characteristics of patients. The Seattle experience, using medical judgments and "social worth" criteria applied by an anonymous lay committee, is widely known (Alexander, 1962). Other treatment facilities also found it necessary to limit access to care on similar grounds before the 1972 Medicare ESRD entitlement. The 1972 statute, however, provided relief to physicians, federal and state government officials, and members of Congress from the need to ration access on the basis of financial resources of patients. The primary policy concern became making treatment available to those who needed it. Congress obliquely addressed the matter of appropriate use in the 1972 statute when it directed the Secretary of DHHS to include in the reimbursement regulations a requirement for "a medical review board to screen the appropriateness of patients for the proposed treatment procedures." It did not define appropriateness or provide any clarifying legislative history.1 Neither legislators nor physicians wished the government to determine patient selection (Rettig, 1991). When the Medicare entitlement was passed, moreover, the likely beneficiaries were thought to be relatively young, employed, taxpaying members of society, whom treatment would rehabilitate and return to work (Fox and Swazey, 1978). Congress did not foresee a patient population whose average age would increase to 60 years, or one with substantial comorbid conditions other than renal disease. But it did not seek to constrain growth along these lines.
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Kidney Failure and the Federal Government A different set of ethical issues will be raised in the next decade as the ESRD patient population continues to grow and includes a greater proportion of elderly patients and those with comorbid conditions beyond their renal disease. These features of the ESRD population, and its cost, intersect with a general concern for the level and rate of increase of health care expenditures and the now-extensive discussions of the rationing of health care (Aaron and Schwartz, 1984; Callahan, 1987, 1990; Freeman, 1987; OTA, 1987). The committee, conscious of substantial interest in these issues, focused on three major concerns as they apply to ESRD patients: the acceptance of patients for treatment, the termination of treatment, and ethical questions arising for caregivers who deal with problem patients. Its recommendations emphasize patients' wishes and best interests as well as the appropriate use of the expensive, life-sustaining therapies of dialysis and transplantation. The committee believes that the ethical issues addressed here are properly the domain of patients, families, and physicians and other caregivers. They deserve thorough, open, and extended discussion. They are not, however, issues of public policy until and unless the federal government undertakes explicit rationing of beneficial care. The committee sees no role for federal statutory or regulatory action. PATIENT ACCEPTANCE CRITERIA Since the ESRD program began, nephrologists have seen chronic dialysis treatment as a tremendous success (Lowrie and Hampers, 1981). This view is based largely on the personal satisfaction of being able to provide life-sustaining treatment to patients who would otherwise die. The changing composition of the patient population, however, has resulted in a different treatment population in 1990 than existed nearly 20 years ago (see Chapters 4 and 5). The number of new patients has increased steadily, as has the median age of dialysis patients and the number of dialysis patients with a serious, chronic primary diagnosis such as diabetes (USRDS, 1990). This change occurred in part because physicians, as they gained experience treating older patients and patients with greater medical complications, achieved successful outcomes. Concern has been expressed by some observers that patient acceptance criteria have expanded since enactment of the Medicare ESRD entitlement to include an increasing number of patients with limited survival possibilities and relatively poor quality of life. In its deliberations on this matter, the committee concluded that patient acceptance criteria should be based on the medical assessment of the benefits and burdens of treatment and on the best interests of individual patients, not on economic objectives of cost containment.
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Kidney Failure and the Federal Government The committee also distinguished between the criteria of age and comorbid conditions. Chronological age was considered and explicitly rejected by the committee as a criterion for patient acceptance, since it does not measure the ability of an individual to benefit from treatment. Comorbidities—at any age—are the primary determinants of quality of life and of survival. The President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research recommended that life-sustaining treatment should be evaluated in terms of both life extension and the quality of the life extended. They concluded that patients are not obligated to undergo life-sustaining treatment (President's Commission, 1983). Others have also observed that the prolongation of life may not always be a benefit that outweighs all burdens (Landau and Gustafson, 1984; McCormick, 1974). The burdens of pain, suffering, loss of body control or integrity, and loss of privacy, independence, and dignity may outweigh the benefit of life prolongation. This view was held In the Matter of Conroy [486 A.2d 1209 (N.J. 1985); Lo et al., 1990]. Virtually all nephrologists recognize that dialysis treatment is not always the best choice for every ESRD patient (Cummings, 1989) and that the expected benefits are marginal for some categories of patients. Virtually all would agree that life-sustaining dialysis treatment should not be used just because it is available or reimbursed, that the existence of a public entitlement does not obligate them to treat all patients who present with kidney failure. The question of the appropriateness of dialysis arises, then, for ESRD patients who have major comorbidities and a limited life expectancy. These include patients with serious comorbidities such as atherosclerotic, cardiac, and peripheral vascular disease, chronic pulmonary disease, cancer, or AIDS, and who are close to death and whose course cannot be interrupted by dialysis treatment. A second group are some patients whose neurologic status renders them unable to relate to others, such as those in a persistent vegetative state or with severe dementia or cerebrovascular disease. These patients are also significantly more likely to withdraw from dialysis than those without these diagnoses (Neu and Kjellstrand, 1986; Port et al., 1989; Rodin et al., 1981). In one major study, neurologic disease (dementia and acute cerebrovascular accident) was the most common complication leading to the withdrawal of dialysis (Neu and Kjellstrand, 1986). In another, 76 percent of dialysis patients and 55 percent of the dialysis staff thought it was reasonable to discontinue dialysis in a patient who became severely demented (Kaye and Lella, 1986). These findings were confirmed in a recent national survey in which internists and nephrologists considered neurologic impairment the most important factor in deciding to limit the use of dialysis (Foulks et al., 1989). Nephrologists have a professional responsibility to deal with the issues of initiation and termination of treatment. Their training and experience
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Kidney Failure and the Federal Government equip them to assess which patients are likely to benefit from dialysis and which from transplantation. They should use this knowledge to make treatment recommendations to patients, including the recommendation that dialysis not be initiated. Coupled with patient and family preferences, a recommendation may indicate that terminal palliative rather than life-extending care be given to allow a peaceful death from uremia (Roy et al., 1990). Thus the choice is not between treatment and abandonment, but rather between different goals of treatment. For a particular patient, the physician should follow a process that involves a careful clinical assessment of the patient and of all treatment options, including no dialysis. The clinical evaluation provides the initial basis for discussion. Decisions about initiating treatment should then result from full, open, and compassionate discussion with the patient and his or her family. The fact that ESRD patients consistently rate their quality of life higher than "objective" observers rate it (Evans et al., 1985) underlines the need to weigh patient preferences very highly in decision making. The patient and family (or guardians, where appropriate), when fully informed of the benefits and burdens of treatment, should evaluate the proposed treatment in terms of their personal values and accept or reject the physician's recommendation. Quality-of-life measures, developed as research tools for assessing populations and individual patients, including ESRD patients, have not been used for decision making about the initiation or termination of treatment. These measures may generate information that helps the physician assess a patient, but they should not be used as the primary basis of a decision to treat. No quantitative measure can fully evaluate the specificity of each patient's situation. Commentators on life-sustaining therapies have called for the development of guidelines to assist patients, families, and physicians who must make decisions about the use of any life-sustaining therapy (Hastings Center, 1987a; Landau and Gustafson, 1984; Lynn and Childress, 1986; Miles and Gomez, 1989). An open discussion involving the nephrology community and experts in medical ethics could lead to the development of guidelines for the use of dialysis. Criteria for these guidelines should include predicted survival and patient functional status. These guidelines could help make explicit the evaluation of patients for whom dialysis would only prolong the dying process or continue a life in which the burdens of treatment outweigh the benefits. They would support nephrologists in not offering dialysis to patients for whom such an intervention would be disproportionately burdensome. Caring for ESRD patients who are dying because dialysis has been withheld or withdrawn may require an adjustment for some nephrologists. For such patients, the nephrologist, the nurse, and the social worker have to shift from providing life-sustaining dialysis to basically giving hospice care
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Kidney Failure and the Federal Government and allowing death to occur naturally. They should comfort the dying patient, ensure the company of his or her family at the moment of death (Ramsey, 1970), and maintain the continuity of caregivers and familiar surroundings in the patient's final days of life. It should not be necessary to transfer dying patients to another physician or facility such as a hospice, although the same principles for palliative care apply. WITHDRAWAL FROM TREATMENT Guidelines A widespread consensus exists that supports the right of competent, informed patients to choose or forgo life-sustaining treatments [AMA, 1989; Hastings Center, 1987b; Jonsen et al., 1986; President's Commission, 1983; Satz v. Perlmutter, 379 So. 2d 359 (Fla. 1980)]. The termination of treatment of incompetent patients, by contrast, should occur only after full discussion between the patients' family, or other representatives, and the physicians. Withdrawal from dialysis treatment by competent ESRD patients is increasingly reported, especially among the elderly. Such choices may be regarded as rational decisions by autonomous individuals who have concluded that the burdens of continuing treatment outweigh the benefits. Nephrologists should be open to permitting dialysis to stop when it no longer benefits the patient. The discussion of the decision to stop dialysis might be initiated by the patient for whom the burdens have come to outweigh the benefits or by the physician who recognizes that the treatment goals are no longer achievable. The general guidelines discussed above could guide physicians as well as treatment units. Dialysis units, in addition, should adopt their own policies for the withdrawal of dialysis which ensure that the patient has been fully evaluated and counseled before stopping dialysis. A psychiatric evaluation to rule out treatable depression should be part of the process. The guidelines suggested above could also help nephrologists determine that dialysis should be discontinued in some patients. When decisions to withhold or withdraw dialysis are considered in individual patients, there is the potential for disagreement within the health care team, between the health care team and the patient (and family), and within the patient and family circle. There should be a means for conflict resolution available to the health care team, the patient, and the family short of resorting to the court system. Hospital ethics committees serve this function, as well as the usual range of other hospital purposes, and are available to hospital-based dialysis units (Fost and Cranford, 1985). It is appropriate that freestanding dialysis units have access to an ethics committee, perhaps through their ESRD network,
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Kidney Failure and the Federal Government for this purpose. Such committees should be available to review decisions to withhold or withdraw dialysis at the request of the patient, the incompetent patient's family, or any member of the health care team. They could also foster education of all dialysis personnel about the ethical issues in dialysis care and draft policies for units on such issues as withdrawal of dialysis, Do Not Resuscitate status, limited-treatment plans, and time-limited trials. These committees should be composed of members of the health care team: physicians, nurses, social workers, dietitians, and administrators, and other patient advocates, such as clergy, ethicists, and lay representatives. In situations where the expected benefit to the patient is not clear but the patient (and/or family) wants treatment, a time-limited trial of dialysis of I to 3 months satisfies two ethical tenets. First, the patient will have a better understanding of the treatment after the trial and will be able to give consent or refusal that is more informed. Second, the physician will have had a chance to observe the patient's response to dialysis and will be able to evaluate more clearly the benefit to the patient. Prior to the initiation of the trial, there should be carefully delineated parameters of what outcomes of dialysis therapy justify continuation so that at the conclusion of the trial, a decision regarding further dialysis can be made. Advance Directives At some point, dialysis patients may become incompetent as a consequence of kidney failure or dialysis treatment. To protect their values and ensure self-determination in their health care, they should execute advance directives2 (Hastings Center, 1987b; New York State Task Force, 1987). Legal instruments that document the patients' wishes in advance are the living will and the durable power of attorney for health care. Physicians may also document patients' advance directives in patients' charts after a witnessed discussion. Patients should read and sign these chart notes to be sure their physician has understood their preferences. Since there is a presumption in favor of continued life-sustaining treatment for patients who cannot and have not expressed their wishes, the patient's right to forgo dialysis in certain situations is usually difficult to achieve unless patients have explicitly stated their preferences in advance or named a proxy to speak on their behalf (Hackler, 1989). Nephrologists and other health care professionals who work with dialysis patients should discuss the circumstances under which patients would want to stop dialysis and forgo cardiopulmonary resuscitation, and they should encourage their patients to complete advance directives and appoint a proxy so that their wishes can be followed even when they are unable to participate in decision making. The number of elderly people on dialysis is rapidly growing. Two studies have documented that 40 percent and 56 percent of the deaths of patients
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Kidney Failure and the Federal Government over the age of 70 and 85 years, respectively, are due to withdrawal from dialysis (Husebye and Kjellstrand, 1987; Port et al., 1989). It is particularly important, therefore, for health care professionals in dialysis units to discuss with elderly patients and their families their wishes for future care under a variety of contingencies and to encourage them to complete living wills and durable powers of attorney for health care. Patients' wishes regarding dialysis and other life-sustaining therapies may change over time. The review of the dialysis patient care plan every 6 months provides an opportunity to review the patient's wishes and to update advance directives. TREATING THE PROBLEM PATIENT All physicians encounter problem patients. The difficulties these patients present are related to their specific kinds of disorders and treatments. This is particularly true in ESRD practice, and dealing with such patients presents a constant challenge to ESRD providers. Three types of patients raise ethical problems for ESRD caregivers today: the noncompliant, self-destructive dialysis patient; the hostile, abusive dialysis patient; and the self-destructive transplant patient. In all cases, the physician's responsibility is to care for the patient with an understanding of human frailty and the complex psychology of living with chronic illness, to make efforts to develop effective communication, and to ensure continuity of care. Legal contracts between patients and health professionals may be necessary in some cases to specify mutual rights and responsibilities. Courts, of course, remain arbiters of conflicts that can be resolved in no other way. There is substantial literature in internal medicine, family medicine, and psychiatry on dealing with the problem patient, or even the hateful patient (Groves, 1978), which could be productively applied to these problems as they arise in the context of ESRD. In the context of dialysis, noncompliant, self-destructive patients are those who do not routinely keep their dialysis appointments, do not adhere to diet, and do not generally behave in accordance with medical guidelines for their life-threatening disease. They seem to act out a distinct ambivalence about the value of continued life to them and thus do not behave in a way that facilitates the delivery of care. The psychological complexities of living with a chronic disease such as ESRD, of course, put many pressures on people, and every effort must be made to develop effective communication, support, counseling, and even psychiatric treatment when that is indicated (Landsman, 1975). When none of these is effective or possible, however, authorities agree that the responsibility of the physician is to care for the patient and to
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Kidney Failure and the Federal Government continue patiently to try to deal with him or her in a nonjudgmental fashion. It is not enjoyable or particularly gratifying to care for those who reject one's help (Groves, 1978), yet that is not an ethical justification for withdrawing from the care of such patients (Papper, 1970). If the physician and the patient develop differences that prevent a successful relationship, the physician (with the patient's agreement) should arrange for the transfer of the patient's care to another physician (ACP, 1989). Continuity of care must be ensured because of the life-sustaining nature of the therapy. When the hostile, abusive patient's actions are destructive to others, the balancing of moral responsibilities becomes more complex. In the event that a patient poses a threat to other patients in a dialysis unit (for example, by hostile behavior of any sort), the physician's or nurse's responsibility to the other patients may outweigh their responsibility to that patient. Hostile, abusive dialysis patients have been found by the courts not to have a right to demand treatment from nephrologists if the nephrologists take care to avoid abandonment. However, dialysis units, because of the scarce and life-saving nature of the treatment they provide, have been found to have a collective responsibility, if not an individual one, to provide dialysis to these patients. The sharing of such a disruptive patient by a network of dialysis units has been the proposed solution in one case [Payton v. Weaver, 182 Cal. Rptr. 225 (Calif. 1981)]. If a patient is abusive only to staff and not to other patients, then every effort should be made to understand and deal effectively with the underlying psychosocial determinants of that patient's behavior (Groves, 1978). A contract between such a patient and the health care team can be very helpful if it outlines the rights and responsibilities of each, sets limits, and describes consequences of unacceptable behavior. This approach may improve the relationship of the patient to the treating nephrologists and the dialysis unit personnel. Although the complexity and frailty of human existence must be acknowledged, and physicians cannot insist that patients adhere to strict rules in order to be eligible for care, a different consideration occurs in the case of a transplant patient than for a dialysis patient. Transplanted kidneys have to be viewed as absolutely scarce resources for which there is a substantial waiting list. Thus, a patient who receives a kidney transplant and then engages repeatedly in behavior that threatens the survival of that kidney may disqualify himself or herself as a candidate for a subsequent transplant if the current one fails. This area has not been well described in the ethics literature, although surgeons often report it informally as a difficult issue. CONCLUSIONS AND RECOMMENDATIONS. The growing public and professional discourse about ethical issues in health care creates an atmosphere in which the special issues in ESRD
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Kidney Failure and the Federal Government treatment can be addressed openly. Advances in medical technology and the ensuing health policy debates ensure that value conflicts and ethical dilemmas will continue to arise in all areas of health care, including ESRD. Thus, our recommendations address current and specific issues as well as the need for ongoing education in ethics to provide the language and conceptual framework necessary to ensure the optimal approach to patient care in the future. The committee recommends that patients, professionals in adult and pediatric nephrology, and bioethicists develop guidelines for evaluation of patients for whom the burdens of renal replacement therapy may substantially outweigh the benefits. These guidelines should be flexible and should encourage the physician to use discretion in the assessment of the individual patient. Any guidelines for children should be child-specific and should describe the role of the parents in the decision-making process. Renal professionals should discuss with ESRD patients their wishes for dialysis, cardiopulmonary resuscitation, and other life-sustaining treatments and encourage documented advance directives. ESRD health care professionals should be encouraged to participate in continuing education in medical ethics and health law. There is a need for some specialists in the medical ethics of renal disease to educate health care providers, to train members of ethics committees, and to do research on ethical issues in dialysis and transplantation. NOTES 1. Congress, in 1978, directed the ESRD networks to ''evaluate the procedure'' by which appropriateness was assessed but did not clarify the basic term. 2. In the Omnibus Budget Reconciliation Act of 1990, Pub. L. No. 101–508, Congress enacted advance directives legislation. Section 4206 applies to Medicare and Section 4751 to Medicaid. As a condition of participation in the Medicare program, hospitals, skilled nursing facilities, home health agencies, and hospice programs are required to establish and maintain written policies regarding advance directives for all adult individuals receiving medical care from such organizations; to provide written information to each such individual regarding their rights to accept or refuse treatment and to formulate advance directives; to document in the individual's medical record whether or not an advance directive has been executed; and "not to condition the provision of care or otherwise discriminate against an individual based on whether or not the individual has executed an advance directive." Outpatient dialysis units were not specifically included among the organizations to which this legislation pertains, an apparent legislative oversight. Nevertheless, the legislation
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Kidney Failure and the Federal Government points to the importance of advance directives for dialysis patients as well and provides a strong reason for nephrologists, other caregivers, and dialysis unit representatives to address this matter. REFERENCES Aaron HJ, Schwartz WB. 1984. The Painful Prescription—Rationing Hospital Care. Washington, D.C.: The Brookings Institution. ACP (American College of Physicians). 1989. American College of Physicians ethics manual. Part 1: History; the patient; other physicians. Ann Intern Med 111:245–252. Alexander S. 1962. They Decide Who Lives, Who Dies. Life 53 (November 9):102–104. AMA (American Medical Association). 1989. Current Opinions: The Council on Ethical and Judicial Affairs of the American Medical Association, Vol. 13. Chicago, Ill. Callahan D. 1987. Setting Limits: Medical Goals in an Aging Society. New York: Simon and Schuster. Callahan D. 1990. What Kind of Life: The Limits of Medical Progress. New York: Simon and Schuster. Cummings NB. 1989. Social, ethical and legal issues involved in chronic maintenance dialysis. In: Maher JF, ed. Replacement of Renal Function by Dialysis, 3d ed. Dordrecht, The Netherlands: Kluwer Academic Publishers, 1141–1158. Evans RW, Mannien DL, Garrison LP, Jr., et al. 1985. The quality of life of patients with end-stage renal disease. N Engl J Med 312:553–559. Fost N, Cranford RE. 1985. Hospital ethics committees. JAMA 253:2687–2692. Foulks C, Holley J, Moss AH. 1989. Unpublished data. Fox RC, Swazey JP. 1978. The Courage to Fail: A Social View of Organ Transplantation and Dialysis, 2d ed. Chicago: University of Chicago Press, 367–375. Freeman RB. 1987. Renal dialysis decision-making. In: Life-Sustaining Technologies and the Elderly Working Papers, vol. 1: The Technologies, Part 1. Washington, D.C.: Office of Technology Assessment, 650–684. Groves J. 1978. Taking care of the hateful patient. N Engl J Med 298:883–887. Hackler C. 1989. Advance directives and the refusal of treatment. Law 7:457–465. Hastings Center. 1987a. Guidelines on the Termination of Life-Sustaining Treatment and the Care of the Dying. Bloomington: Indiana University Press. Hastings Center. 1987b. Part three: Prospective planning. Guidelines on advance directives. In: Guidelines on the Termination of Life-Sustaining Treatment and the Care of the Dying. Bloomington: Indiana University Press, 77–84. Husebye DG, Kjellstrand CM. 1987. Old patients and uremia: Rates of acceptance to and withdrawal from dialysis. Int J Artif Organs 10:166–172. Jonsen AR, Siegler M, Winslade WJ. 1986. Clinical Ethics, 2d ed., New York: MacMillan, 11–12. Kaye M, Lella JW. 1986. Discontinuation of dialysis therapy in the demented patient. Am J Nephrol 6:75–79. Landau RL, Gustafson JM. 1984. Death is not the enemy. JAMA 252:2458. Landsman MK. 1975. The patient with chronic renal failure: A marginal man. Ann Intern Med 82:268–270. Lo B, Rouse P, Dornbrand L. 1990. Family decision making on trial: Who decides for incompetent patients. N Engl J Med 322:1228–1232. Lowrie EG, Hampers CL. 1981. The success of Medicare's end-stage renal disease program. N Engl J Med 305:434–438. Lynn J, Childress JF. 1986. Must patients always be given food and water? In: Part II
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Kidney Failure and the Federal Government Considerations in Formulating a Moral Response. By No Extraordinary Means: The Choice to Forgo Life-Sustaining Food and Water. Bloomington: Indiana University Press, 47–60. McCormick RA. 1974. To save or let die: The dilemma of modern medicine. JAMA 229:172–176. Miles OH, Gomez CF. 1989. Protocols for Elective Use of Life-Sustaining Treatments. New York: Springer. Neu R, Kjellstrand CM. 1986. Stopping long-term dialysis: An empirical study of withdrawal of life-supporting treatment. N Engl J Med 314:14–20. New York State Task Force on Life and Law. 1987. Life-Sustaining Treatment: Making Decisions and Appointing a Health Care Agent. New York: The Task Force. OTA (Office of Technology Assessment, U.S. Congress). 1987. Life-Sustaining Technologies and the Elderly. OTA-BA-306. Washington, D.C.: U.S. Government Printing Office. Papper S. 1970. The undesirable patient. J Chronic Dis 22:777–779. Port FK, Wolfe RA, Hawthorne VM, Ferguson CW. 1989. Discontinuation of dialysis therapy as a cause of death. Am J Nephrol 9:145. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. 1983. Deciding to Forego Life-Sustaining Treatment. Washington, D.C.: U.S. Government Printing Office. Ramsey P. 1970. The Patient as a Person. New Haven, Conn.: Yale University Press, 113–164. Rettig RA. 1991. Origins of the Medicare kidney disease entitlement: The Social Security Amendments of 1972. In Hanna K, ed. Biomedical Politics. Washington, D.C.: National Academy Press, 176–208. Rodin GM, Chmara J, Ennis, J, et al. 1981. Stopping life-sustaining medical treatment: Psychiatric considerations in the termination of renal dialysis. Can J Psychiat 26:540–544. Roy AT, Johnson LE, Lee DBN, Brautbar N, Morley JE. 1990. Renal failure in older people: UCLA Grand Rounds. J Am Geriatr Soc 38:239–253. USRDS (U.S. Renal Data System). 1990. Annual Data Report. National Institute of Diabetes and Digestive and Kidney Diseases. Bethesda, Md.
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