Hospice research is possible and helpful
Two Duke University Medical Center researchers tackle the question "Is it ethical to conduct clinical trials with patients in a hospice environment?" in the Feb. 4, 2008, "Professional Issues" section of the American Medical News web site.
Thomas W. LeBlanc, MD, resident in the Department of Internal Medicine at Duke University Medical Center in Durham, NC, and Amy P. Abernethy, MD, director of Duke Cancer Care Research Program, address two opposing points of view. "The hospice environment is so different from other clinical settings as to be antithetical to research," is one view and "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," is the second view.
Concerns raised by those who oppose clinical studies on hospice patients are outlined and addressed by the authors:
- Hospice patients are too vulnerable to give consent or be research subjects.
The authors point out that the portrayal of all hospice patients as frail and near death is not accurate. Many hospice patients are functional and autonomous, especially in early enrollment. The authors respond that several studies have shown that hospice patients "are interested and willing to participate in research," that "doing so is an autonomous act, a declaration of life and independence ..."
- The use of placebos is inappropriate in hospice patients.
Placebo-controlled trials are only ethically justifiable when it is not clear which therapy is more efficacious, according to the authors. They explain that a "placebo-controlled trial of a pain medication vs. 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," say the authors.
- Research intrudes into the "circle of care" around the hospice patient.
The authors admit that "this concern is quite legitimate, but not insurmountable" and say that care must be taken to maintain the consent process, but that research "may enhance the experience." The added interaction of occasional visits by a clinical research assistant 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 authors conclude, "The many objections to hospice-based trials are not insurmountable." They point out that well-designed clinical trials can protect research participants, even when they are hospice patients. They add, "Furthermore, the need for data-driven care makes this endeavor ethically desirable, if not obligatory." (Editor's note: The article can be found online by going to www.ama-assn.org/amednews. Under "Listings" on the left navigational bar, select "By date." Scroll down to "Feb. 4" and in the "Professional Issues" section, select "Research in hospice possible, even helpful.")
Two Duke University Medical Center researchers tackle the question "Is it ethical to conduct clinical trials with patients in a hospice environment?" in the Feb. 4, 2008, "Professional Issues" section of the American Medical News web site.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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