ROCHESTER, New York- Although assessing the decision-making capacity of cognitively impaired elderly cancer patients can be challenging, following established guidelines can provide the clinician with knowledge needed to form a more firm opinion, according to Daniel Ari Mendelson, MD. "Determination of decision-making capacity is the ultimate responsibility of the attending physician," said Dr. Mendelson, assistant professor of medicine at University of Rochester Medical Center, Rochester, NY. "Physicians need to be comfortable with that determination." Case Study To illustrate the intricacies of making this determination, Dr. Mendelson presented the case of an 82-yearold woman with Alzheimer's disease (indicated by a score of 14 out of 30 on the Mini-Mental Status Exam). The woman presented to the emergency department with pain in the right hip and groin. A pelvis radiograph revealed a lytic lesion and ramus fracture, and occult blood was found in the stool. The woman refused further workup, much to the chagrin of her daughter, an oncology nurse who demanded further tests. The patient, however, stated that she had "lived long enough" and was an "old lady" who wanted to be left alone. The law upholds the right of the woman to refuse treatment, Dr. Men-delson said, but determining the patient's capacity to refuse is a matter left up to the expert medical opinion of the medical provider. A patient may have decision-making capacity if it can be demonstrated that she has a specific understanding of the situation (ie, does she understand she may have cancer, that further workup is medically indicated, and that her decision may carry increased risk), along with a consistencyof reaction to the situation (ie, an hour later, when presented with the same information again, does she make the same decisions despite the cognitive deficit). The patient does not need to demonstrate exhaustive knowledge to establish that the there is an understanding of the medical condition. "If the patient can repeat back to me in her own words that she has something in her pelvis that's not good, that's good enough," Dr. Mendelson said. "That's a reasonable understanding of her medical condition." Consistency with the way a particular patient made decisions years earlier, before onset of dementia, could also be useful in making a determination of decision-making capacity. "You can put their medical care into context of their life story," Dr. Mendelson explained. Decision-making capacity is specific to each situation. For example, the patient may clearly have the capacity to make a simple decision, such as saying she would like to assign herdaughter to make medical decisions for her. A do not resuscitate (DNR) order is fairly straightforward as well, according to Dr. Mendelson. Consent Form Complexities However, going through a 25-page informed consent form may be too complex for a patient with compromised mental status. "Patients can only give informed consent if they have the decision-making capacity for that particular instance," Dr. Mendelson said. "For this example, yes, I think she does...Does she have the ability to consent to a complex medical procedure? I'm not so sure about that-I would have to talk more with her." The inclusion of cognitively impairedindividuals in clinical trials, according to the American Geriatrics Society, should hinge in part on the issue of decision-making capacity. Specifically, decision-making capacity should be determined for each potential participant and each research protocol. Additionally, trials that do not have a reasonable chance of directly benefiting the participants should not be offered unless the individual retains decision-making capacity or has given advance consent. Dr. Mendelson called for a "reasonable standard" in informed consent processes developed by institutional review boards (IRBs). "I see IRBs coming out with longer and longer consent processes," he said. "It doesn't meet the reasonable standard. The reasonable standard is that we are effectively communicating within the reasonable realm of possibility. It doesn't mean patients have to have a PDR (Physician's Desk Reference) listing of side effects on every possible drug we are going to give them...we, in fact, dishonor our patients by not using a reasonable standard." Clear communication is essential, Dr. Mendelson said, given that "patients drop out or won't participate in a trial because they get befuddled by these complex things that are well beyond a reasonable standard." Referring to himself, he added, "I'm not sure I can sign a 25-page consent and be sure what I'm signing."