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
"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
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
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
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
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
"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."