Significant variability
My research focuses on decision aids for
prostate cancer testing and treatment (for men)
and reproductive care (for women). In reviewing
dozens of decision aids, I have found dramatic
variability in both the content and presentation of
information, some of which is traceable to the issues
described above. Decision aids for prostate-specific
antigen screening, for example, range widely in
the rate of false negatives they report—from 1-2
percent in one to 15 percent in another. Though
some studies have shown up to a 36 percent rate of
false negatives, no decision aid I have reviewed has
cited figures that high. Decision aids for women of
childbearing age routinely report that women who
have had abortions have an increased risk of breast
cancer and suicide; however, scientific studies have
concluded that no such correlation exists.
Beyond factual inaccuracies, the manner
in which information is presented may have a
biasing effect. The International Patient Decision
Aids Standards Collaboration, a leader in ensuring
decision aid quality, has recognized the impact
of presentation bias on patient decision making,
noting that“even a ‘balanced’presentation of views
can potentially give false impressions that there is
an equal split in opinion about treatment,”when in
fact that is not the case. As an example, consider a
prostate cancer decision aid featuring testimonials
from two patients, one who chose chemotherapy
and surgery, and another who chose“watchful
waiting.”Given that over 90 percent of men
diagnosed with prostate cancer choose immediate
treatment, readers may be misled by even this
seemingly neutral approach. Many abortion
decision aids suffer from similar problems: although
they present accurate statistics about the risks
resulting from abortion, their textual descriptions
often highlight abortion’s complications, while
describing pregnancy as“usually a safe, natural
process”—despite the fact that pregnancy and
childbirth pose a higher risk of death in 98.5 percent
of cases.
What can the law do to ensure the quality
of patient decision aids? One option is an
administrative solution similar to the one proposed
in PPACA, establishing a quasi-governmental
agency to review and certify decision aids. A second
option is to use tort liability to fill in the gaps of the
regulatory approach— allowing patients who have
suffered injury as a result of faulty decision aids to
bring suit against the creators of these decision
aids, in much the same way as patients can bring
informed consent claims against their physicians.
In a forthcoming article in
Arizona Law Review,
I conclude that regulation in the absence of a tort
complement may not be sufficient to guarantee
decision aid quality. While the current tort system is
not well-suited to accommodate claims against the
creators of faulty decision aids, I argue that shifting
trends in tort law’s approach to privity and causation
will facilitate such claims, in turn providing a strong
foundation for patient protection.
■
Regulating patient
decision aids
Administrative and
tort law can protect
patients from medical
misinformation
FACULTY RESEARCH
»
Bioethicist Nadia Sawicki is studying the ways the law can help patients receive more reliable information for making medical decisions.
B Y
P R O F E S S O R
N A D I A S A W I C K I
W
hen you are faced with a
medical decision, where
do you get your health
information? If you’re like
the average American
consumer, you no longer rely exclusively on a
doctor’s opinion—you probably consult a variety
of other sources, including websites, information
provided by your employer or insurance plan, or
pharmaceutical advertisements. And increasingly, a
patient choosing between treatment options may
be offered an additional tool by her physician—a
brochure or video, known as a patient decision aid,
which walks through the risks and benefits of each
alternative and helps the patient make the decision
that is right for her.
The Patient Protection and Affordable Care
Act (PPACA) highlights the use of decision aids
as one of the most promising innovations in
medical practice. Many critics have argued that the
modern informed consent process has become
overlegalized and has lost its focus on patient
education and understanding. Decision aids, in
contrast, provide health information in easy-to-
understand and culturally appropriate language,
including graphical representations of risk that
may be more accessible to patients with low health
literacy. More importantly, decision aids, which are
typically used when choosing between multiple
clinically viable options, encourage patients to
think about the values and preferences that are
important to them before making a decision.
More facts for patients—
but greater risk
Consider a patient diagnosed with prostate
cancer, which is typically slow-growing and rarely
fatal. The patient is deciding whether to seek
immediate treatment (surgery or chemotherapy)
to eliminate the tumor, or instead take a “watchful
waiting” approach until the cancer becomes
problematic. A decision aid would provide the
patient with relevant facts, including that less than
15 percent of men diagnosed with prostate cancer
die as a result of the cancer; and that more than
half of men who pursue treatment suffer serious
side effects, including incontinence and
impotence. The brochure might explicitly prompt
the patient with a question: “Which is more
important to me? Getting rid of the cancer so I
can have peace of mind, or avoiding side effects
for as long as possible?”
Both patients and providers care about
ensuring the quality of medical information,
and decision aids are no exception. Unfortunately,
as compared to other materials provided by
physicians during informed consent, decision
aids pose a greater risk. They are published
by third parties outside the physician-patient
relationship—insurance companies, professional
associations, and for-profit corporations, among
others—which are not bound by fiduciary duties to
act in patients’ best interests, and may suffer from
conflicts of interest. Evidence demonstrates that
the information presented in decision aids
can vary widely depending on their source. A
prostate cancer brochure published by a radiology
society, for example, is likely to send a different
message than one published by an organization of
urologic surgeons.
A member of the Loyola law faculty since 2009, Professor Nadia Sawicki focuses on bioethics and health law. Her scholarship evaluates recent developments in health law
from two perspectives: one through the lens of legal academic inquiry, and the other grounded in ethical theory generally with particular focus on bioethics.
Evidence demonstrates that
the information presented in
decision aids can vary widely
depending on their source.
A prostate cancer brochure
published by a radiology society,
for example, is likely to send
a different message than one
published by an organization
of urologic surgeons.
EMPOWERING CONSUMERS
SPRING 2012
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LOYOLA LAW
