IV. HEALTHCARE AND RESEARCH ISSUES

What is so different about the ethics of healthcare and research in older people that would render a general discussion of these topics insufficient? Basic principles, such as autonomy, beneficence, and justice, are no different and no less important because the individuals involved in healthcare or research are older. Many factors associated with aging, however, do alter substantially the facts of clinical and research encounters with older people.

Healthcare of Older People

The nature of illness in older people greatly influences the ethical issues in their healthcare. Older people have a higher burden of illness than younger people. On average, they are likely to have several chronic medical conditions, be on multiple medications, and have frequent encounters with the healthcare system, including more hospitalizations. Because older people are closer to the end of their life expectancy, they have a greater chance of being involved in situations where difficult healthcare decisions must be made. Decisions about the appropriate use of life-sustaining medical treatment for older patients are commonplace. These range from Do-Not-Resuscitate (DNR) orders, to decisions to discontinue dialysis, to decisions about withholding or withdrawing artificial nutrition and hydration. Many, if not most, deaths in healthcare institutions in the United States are preceded by explicit decisions to limit treatment. These treatment limitation decisions, more properly viewed as decisions to change to a palliative care plan from lifesustaining or death-delaying efforts, are generally more common in the care of older people.

While any individual may become incompetent during a critical illness, older people are at greater risk of impaired decision-making capacity because of either a transient delirium or a chronic dementing illness, such as Alzheimer's disease, which results in permanent cognitive impairment. Thus, older people are not only at risk of having end-of-life decisions made in the healthcare setting; they frequently are not capable of making those decisions themselves at the time required. In such situations, physicians routinely turn to the family of an older person to serve as a surrogate decision maker or proxy. Several studies of the treatment preferences of older patients and their potential proxies (spouses, children, and physicians), like that of Allison Seckler and her colleagues in 1991, have uncovered serious discord between the choices that would be made by patients and by their proxies. While this raises concerns about the validity of proxy decision making vis-à-vis its accuracy as a substituted judgment, one can argue that family members are still appropriate surrogates and that many older people care more about who makes decisions for them than about the exact decisions being made.

The foreseeability of both serious illness and the loss of competency for older people, as well as questions about proxy decision making, have created a strong interest in the use of advance directives in the care of older people. Advance directives include instructional documents, such as living wills, and proxy appointment documents, such as the durable power of attorney for healthcare. Interestingly, most of the empirical studies done on both proxy decision making and advance directives have focused on older people. Advance directives have received increasing attention in the United States with the 1991 enactment of the Patient Self-Determination Act, a federal law requiring healthcare institutions to educate patients about the availability and use of these instruments. While it is hoped that these efforts will increase the number of older people giving advance instructions for their healthcare, it remains to be seen if older people will execute advance directives in significant numbers, and if physicians will respect the preferences outlined in these documents. Data from the 1997 SUPPORT study cast doubt on the effectiveness of advance directives.

Because of its effects on the competency of older individuals, dementia occasions significant ethical dilemmas as discussed by Greg Sachs and Christine Cassel in their article on the subject. Dementia affects perhaps as high a proportion as 10.3 percent of individuals over age sixty-five and 47 percent of those over age eighty-five, and raises ethical concerns for several reasons. First, rather than presuming competence and working within the bounds of confidentiality, truth telling, and patient autonomy expected in the normal doctor-patient dyad, when the patient has dementia, the doctor-patient relationship is altered in a fundamental fashion. A physician caring for an older person with dementia must reassess decision-making capacity frequently, carefully evaluate what the patient says for useful information, weigh what can be shared with the patient, and rely on others for information and assistance in executing a care plan. Second, the progressive and irreversible nature of the most prevalent kinds of dementia alters the goals of medical care of the patient with dementia. While promising research on dementia continues, existing treatments provide only modest benefits and there are no therapies that will either arrest or cure progressive dementias. As with hospice care or rehabilitation medicine, many, including Nicholas Rango, argue that the medical care of a patient with dementia properly focuses on maximizing function, including socialization, palliation of symptoms, maintaining hygiene, and preserving dignity. Third, the family members of an older person with dementia are not only proxies for decision making, they also usually provide the bulk of their relative's daily care needs. The great burden of caregiving places family members at risk of depression and other illness, causing health professionals to consider the psychosocial needs of the family as well as the patient.

While only about 5 percent of people over the age of sixty-five are in a nursing home at any one time, in 1991 Peter Kemper and Christopher Murtaugh estimated that the lifetime risk of spending time in a nursing home in the United States is as high as 40 percent. Thus, many older people do receive medical care in a nursing home for some portion of their lives and it is the location of death for an increasing number of older Americans, as noted by Joan Teno in 2002. At least in the United States, nursing home care frequently has been cited more for its deficiencies: unwarranted mechanical restraint of residents, inattention to treatable conditions such as urinary incontinence, and inappropriate and excessive use of psychotropic medications. At least part of the problem of poor nursing home care has been the lack of continuity in medical care of older people once they enter a nursing home. A minority of physicians in the United States visits their older patients once the patients enter a nursing home (as few as 28% in one U.S. nationwide study), according to research by Janet Mitchell and Helene Hewes. Subspecialty care, including psychiatry, is even less available to older people residing in nursing homes. On a more positive note, in 1997 Catherine Hawes and her colleagues noted that changes in nursing home regulations do appear to be having beneficial effects on many aspects of the quality of nursing home care.

Problems with access to good medical care for nursing home residents are actually a subset of the larger problem of the level of expertise in the medical care of all older people. While geriatrics is an established specialty in the United Kingdom, a subspecialty certifying exam in geriatric medicine in the United States was offered for the first time only in 1988. Very few physicians enter fellowship programs that provide postresidency training in geriatric medicine. In his study of these programs, David Reuben contends that the shortage of fellowship-trained geriatricians remains a significant challenge despite changes made in the late 1990s to shorten the duration of training required for certification (Reuben).

Research on Older People

As with the relationship between healthcare of older people and healthcare in general, research involving older people emphasizes different ethical issues because of the history of research on older people and specific healthcare attributes of older populations. As geriatrics has been late in being recognized as a specialty in American medicine, so too has serious research on older people been a relatively recent phenomenon in the United States. The National Institute on Aging (NIA) was established within the National Institutes of Health (NIH) in 1974 to promote research on aging. That the creation of NIA was necessary is supported by the dearth of research on the problems of older people in earlier years. People over the age of sixty-five were frequently excluded from clinical studies, even from trials examining cancer, heart disease, diabetes, and hypertension, all conditions more prevalent in older populations. Older people have remained under represented in clinical trials even after investigators stopped employing arbitrary age cutoffs as documented in a 1999 study by Laura Hutchins and her fellow researchers.

While it is not clear why older people were excluded from research in the past, conducting research on older people is more difficult than working with younger subjects. Surveys have shown that older people tend to be less willing than younger people to become research subjects. As noted earlier, they are likely to have multiple medical conditions and to be taking several medications, factors that may cause them to be excluded from research projects that are trying to study single illnesses and the unadulterated effects of single medications. Because of these factors, older people also have a higher attrition rate, necessitating larger numbers of older subjects when the study begins in order to compensate for dropouts over time. Impairments in vision, hearing, or cognition may make efforts to obtain informed consent and enroll older subjects more time consuming and labor intensive. These factors together may make research on older people more expensive to complete. For all of the above reasons, it is clear that under representation of older people in clinical research will remain a persistent challenge. Specific, targeted initiatives from funding agencies and clinical trial consortia, however, can facilitate important studies with adequate numbers of older subjects.

Two additional attributes of older people that most affect research ethics were mentioned in discussing their healthcare: the prevalence of dementia and the frequent use of nursing homes. Dementing illnesses fundamentally change the investigator-subject relationship, as well as the doctor-patient relationship. Far less is known empirically about issues in the research setting, such as the ability of subjects with dementia to give informed consent, the reliability of proxies in giving consent for experiments, or the practices of investigators in safeguarding vulnerable, cognitively impaired subjects. The assessment of decision-making capacity for research consent, for example, is best characterized as a growing but still quite immature field. Serious concerns were raised by a 1991 study, conducted by John Warren and others, of relatives who gave proxy consent for their cognitively impaired older family members residing in nursing homes. Many of these proxies gave consent for a study on urinary catheters despite saying that they thought the older person would not have wanted to participate and that they themselves would not want to be in such a study.

Over the 1980s and 1990s, various organizations and authorities have published guidelines for research involving subjects with dementia. In the first decade of the twenty-first century, the National Bioethics Advisory Commission (NBAC) and state commissions in New York and Maryland weighed in on these issues. Most authorities endorse the practice of proxy consent, as long as the subject assents when the particular study commences. Some explicitly prohibit the participation of subjects with dementia if it is known that the older person would not have wanted to participate in a study. Others worry, however, that excessive safeguards may end up serving as barriers to research that might benefit people with dementia.

The ethics of research on older people in nursing homes also focuses on consent issues because of the high prevalence of dementia in nursing homes, but there are other ethical concerns as discussed in an article edited by Brian Hofland in Gerontologist. On the one hand, access to research may mean access to improved care and increased socialization for an older nursing home resident. On the other hand, limited freedom and the existence of less than optimal care in many nursing homes may create a coercive environment for enrolling subjects. Another concern is that although much nursing home research is conducted in large, academically affiliated, well-staffed nursing homes, these conditions do not exist in many nursing homes, raising the question of how much one can generalize the research findings to more typical nursing homes.

Finally, all of these research ethics issues regarding older people have been playing out on a background that changed significantly in the United States in the late 1990s. Articles in the New York Times and Washington Post have reported on the concerns about safety and research oversight, prompted by deaths of research subjects, which led to the temporary suspension of clinical research at many prestigious academic centers. Clinical research is under greater scrutiny. In addition, serious questions have been raised about the relationship between academic investigators and industry.

Additional Ethical Issues

Unfortunately, many of the issues that affect younger individuals with regard to access to healthcare and research do not disappear when people get older. While this is not a great concern in countries with a national health service or national health insurance, it remains a major issue in the United States. Many people, including a surprising number of older people, assume that Medicare, the federal health insurance program for older people, covers most healthcare needs. While Medicare pays a substantial portion of hospital and physician fees for acute care, it does not cover the cost of medications, many preventive services, and important items for older people such as eyeglasses and hearing aids; most important, Medicare pays for very few long-term care services. Older people who are poor, female, or minority, especially African Americans, are disproportionately affected by problems with access to care. In the United States, as noted by David Barton Smith, the difference between African Americans and whites in terms of access to hospitals and nursing homes narrowed from the 1960s to the 1980s. However, studies in the late 1980s and 1990s, such as that by Kenneth Goldberg and others, continued to uncover less utilization of aggressive and expensive treatments for cardiac disease, for example, in African Americans and women compared with white men, even when insurance status was taken into account.

greg a. sachs (1995)

revised by author

SEE ALSO: Access to Healthcare; Dementia; Grief and Bereavement; Life Sustaining Treatment and Euthanasia; Long-Term Care; Medicaid; Medicare; Research, Human; Research Policy; and other Aging and the Aged subentries

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INTERNET RESOURCES

National Bioethics Advisory Commission. "Ethical and Policy Issues in Research Involving Human Participants. Final Recommendations, May 18, 2001." Available from <http://bioethics.gov/pubs.html#final>.

Teno, Joan M. "Facts on Dying: Policy Relevant Data on Care at the End of Life." Available from <http://www.chcr.brown.edu/dying/factsondying.htm>.