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Research in hospice possible, even helpful

A column that answers questions on ethical issues in medical practice

The Ethics Group provides discussions on questions of ethics and professionalism in medical practice. Readers are encouraged to submit questions and comments to [email protected], or to Ethics Group, AMA, 515 N. State St., Chicago, IL 60654. Opinions in Ethics Forum reflect the views of the authors and do not constitute official policy of the AMA. Posted Feb. 4, 2008.

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The vulnerability of this special group of patients, intrusion into their care and the questionable ethics of placebo use all must be considered.

Response

As medicine becomes increasingly data-driven, this question is raised ever more frequently. Responses are divided.

To some, the hospice environment is so different from other clinical settings as to be antithetical to research. For others, palliative care seems woefully behind other medical specialties in its use of research-derived evidence and is thus in dire need of high-quality clinical research. In the spirit of working toward a resolution of these divergent points of view, we examine the goals of clinical trials and the hospice movement and explore the possibility for an intersection of the two.

Clinical trials aim to improve the quality of care for patients and to advance medical science by testing newly developed therapies in a safe, controlled and ethical manner. The goal of hospice is to provide medical services and care to patients with advanced, incurable illnesses.

Moreover, hospice cares for the whole family unit, not just the patient, using a biopsychosocial model in offering social, emotional and spiritual support for patients and families, in addition to respite for caregivers. Finally, hospice therapies emphasize symptom management and the maintenance of quality of life, either as the sole focus of care or delivered concurrently with curative treatments.

At first glance, these statements seem to describe radically different goals and activities: clinical trials operating within the biomedical realm to advance treatment and cures and to improve medical science in general; hospice working within a biopsychosocial model of care to alleviate suffering within the confines of the family unit.

One thread unites these seemingly disparate endeavors, however: the desire to provide the best care possible. The goal may be more immediate for hospice and more distal for research, but it is indeed shared.

One often does not know what "the best possible care" is without research and comparison.

Indeed, the history of medicine demonstrates the folly of our assumptions about what is truly "best."

For example, beta-blockers were long thought to be detrimental to patients with cardiac disease. Why, after all, would one want to decrease the rate and pumping function of an already damaged heart? But several clinical studies have now revealed the complex neurochemical mechanism by which beta-blockers help in managing cardiac disease, often lengthening survival and mitigating symptoms. This is but one of many examples that attest to the ability of clinical trials to improve the daily practice of medicine.

Generally, the hospice environment is driven more by historical precedent and expert opinion than by data. For example, hospice lore and expert opinion long taught that the optimal method of opioid titration was the simple escalation of short-acting oral morphine solution at four-hour dosing intervals. Yet when this standard was put to the test in a randomized trial, the results proved the opposite: titration of a more long-acting morphine preparation in pill form yielded more rapid and more significant lowering of pain scores. Clearly, symptom management and its contribution to improved quality of life, demonstrated by this clinical research, are goals of hospice.

Though the need for more data-driven practice in hospice seems clear, there are objections to such an endeavor that span concern for the vulnerability of hospice patients, the special nature of death and dying, and worry over intrusion into the "circle of care," to the ethical problems of placebo use and the potential for harm that research entails.

Many hospice patients are near the end of their days; they may be frail, somnolent and confused. How could consent be obtained from such patients? It seems patently inappropriate to turn these vulnerable persons into research subjects, "guinea pigs" as some might say, at such a difficult time in their lives. Moreover, there is an intimacy and sacredness to the dying process that the research process would intrude upon and, in the views of some, defile.

The first argument in response to these objections is that the description paints a skewed and unrealistic picture of the typical hospice patient. Some patients are indeed frail and very near death, but the great majority of hospice patients are more functional than this. They often are autonomous, especially early in their enrollments. Survey studies show that hospice patients often are interested and willing to participate in research; doing so is an autonomous act, a declaration of life and independence, a way to give something back and help others. Besides, all research subjects are vulnerable and subject to harm, and all deserve to be protected to a very high standard, regardless of life stage. If they are appropriate research participants, hospice patients should be treated no differently than any research participant.

The problem of placebo use in clinical research is an interesting one. Placebo-controlled trials are only ethically justifiable when there is "equipoise"; in other words, when it is not clear which therapy is more efficacious. In this sense, hospice research is no different than other clinical research. A placebo-controlled trial of a pain medication versus placebo would be ethically indefensible in any patient, in hospice or not. Such an experiment contradicts the physician's pledge not to let a patient's pain go intentionally untreated when an effective option -- the standard of care -- exists. Similarly, it is unethical to design a study comparing several anti-nausea drugs to placebos, whether patients are enrolled in hospice or not.

That said, there are several instances where placebos are easily and rightfully incorporated into research to ensure that the study result will be helpful in application to other patients and not skewed by confounding variables.

In the study of morphine preparations described previously, patients in one arm of the research received the shorter-acting morphine solution plus a placebo in pill form, while patients in the other arm got the longer-acting pill plus a placebo in solution form. This way, participants and providers were adequately blinded to the intervention, ensuring that the data obtained was unbiased and applicable to future patients. One could argue that it would be unethical not to use placebo in this case, as doing so would put patients at risk of participating in research for which there was not likely to be a useful result.

Finally, there is concern about the hospice care unit, often called the "circle of care." Research threatens to disturb this therapeutic unit, wherein family, caregivers and clinicians are allied in the patient's interest. The introduction of research into the unit creates the possibility for harm and incorporates outside interests that may conflict with those of the circle of care and ultimately the patient.

This concern is quite legitimate, but not insurmountable. When integrated into the "hospice bundle," clinical trials can be a tool of empowerment and can serve the hospice mission of providing the best symptom relief. As long as the consent process is maintained, so that there is no coercion by staff or family members, an autonomous hospice patient can safely participate in research without disruption of circle of care. If anything, research may enhance the experience. A clinical research assistant may visit the patient's home to ask questions and assess the relevant clinical response or outcome. This occasional added interaction for some period may foster a sense of meaning for the patient and a feeling of accomplishment in helping to improve the quality of future care for others.

The many objections to hospice-based trials are not insurmountable. Designed well, clinical trials can protect research participants, even when they are hospice patients. Furthermore, the need for data-driven care makes this endeavor ethically desirable, if not obligatory. A great deal is known about the optimal management of patients with heart disease, yet very little is known about the optimal management of the most common symptoms in hospice patients, including nausea and vomiting, constipation, or "death rattles."

As the newly minted medical subspecialty of palliative care gains acceptance and becomes widespread throughout the country, new opportunities will be presented to coordinate research efforts in this special patient population. Patients increasingly are encouraged to enroll earlier in the course of their diseases, and there is a movement to better integrate palliative measures into the daily care of patients with oncologic and other advanced illnesses.

With this paradigm shift, more research will be carried out and data-driven modalities will be more readily available.

The next step is making sure they translate into advances at the bedside.

Thomas W. LeBlanc, MD, second-year resident, Dept. of Internal Medicine, Duke University Medical Center, Durham, N.C.

Amy P. Abernethy, MD, director of the Duke Cancer Care Research Program and assistant professor of medicine in the Division of Medical Oncology, Dept. of Medicine, Duke University Medical Center

The Ethics Group provides discussions on questions of ethics and professionalism in medical practice. Readers are encouraged to submit questions and comments to [email protected], or to Ethics Group, AMA, 515 N. State St., Chicago, IL 60654. Opinions in Ethics Forum reflect the views of the authors and do not constitute official policy of the AMA.

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