Denise Lee Publication

Toward Ethically Responsible Choice Architecture
in Prostate Cancer Treatment Decision-Making
J. S. Blumenthal-Barby, PhD1
*; Denise Lee2
; Robert J. Volk, PhD3
Medicine operates under an assumption that “patients will
naturally gather evidence about the risks and benefits of
each medical choice, apply their values to that evidence, and
reach a considered decision.”1
In other words, that patients
will generally make “autonomous” decisions, meaning deci-
sions that are 1) intentional rather than habitual, impulsive,
accidental, or forced; 2) involve substantial understanding of
the nature of the decision, the foreseeable consequences,
and possible outcomes; and 3) are not subject to controlling
influences.2
Although this assumption has been challenged in other
areas of medical decision-making,1
herein we want to chal-
lenge it within the context of treatment decision-making
regarding localized, low-risk prostate cancer. Many men
will face this decision given that there are 220,800 new cases
of prostate cancer diagnosed each year in the United States.3
Yet there is alarming evidence to indicate that patients may
not be properly informed about their options, particularly
expectant management options such as watchful waiting or
active surveillance. In addition, there is further evidence that
men may be especially prone to using intuition, impulse,
and “heuristics” or mental shortcuts in their decision-mak-
ing,4
all of which threaten autonomous decision-making.
Two recent articles in this journal have highlighted the
complexities of treatment decision-making in patients with
low-risk prostate cancer.5,6
As Filson et al note in their arti-
cle,5
men with a new diagnosis of localized prostate cancer
face an array of treatment options, each associated with high
disease-specific survival given the slow-growing nature of
many prostate cancers. Radical prostatectomy and radiation
therapy are the most commonly used treatments for localized
prostate cancer, and each has associated treatment-related
complications that impact men’s quality of life. Increasingly,
active surveillance is being recommended by clinical guide-
lines as a treatment option for men with low-risk disease.4
Unlike watchful waiting, active surveillance involves careful
monitoring of the disease with an expectation of curative
treatment if there is progression. Although active surveillance
has disadvantages of periodic testing and associated anxiety,
its major advantage is the preservation of current health and
the avoidance of treatment-related complications, including
impotence and urinary and rectal incontinence.
Despite the appropriateness of expectant management strat-
egies such as active surveillance for patients with early-stage
prostate cancer, as highlighted by Filson et al in their article,5
men who might benefit from expectant management are not
routinely offered the option. Other studies have reported simi-
lar findings. One report found that only 10 of 25 patients with
early-stage prostate cancer were offered a treatment choice,7
whereas another found that of 21 men (19 of whom chose sur-
gery or radiation), few remembered active surveillance being
presented as a viable option8
and another study found that
health professionals were less likely to discuss active surveil-
lance for localized prostate cancer with Hispanic patients com-
pared with white patients.9
Furthermore, studies have found
biases and heuristics at work in patients’ decision-making (all
favoring surgery or radiation) such as the “commission bias”
(doing something is better than “doing nothing” even if the
“something” causes more harm)8
and the “availability bias”
(reliance on anecdotal stories),10-12
in addition to fear,10-13
heavy reliance on physician recommendation,4,8,10,12
reported
pressure from family,4,8
and lack of awareness that treatment
does not guarantee improved survival.10,11
These findings regarding prostate cancer decision-
making are ethically significant given that they imply that
prostate cancer decision-makers may not be as autonomous
as we would assume. They also raise concerns about patient
well-being given the risk of harm associated with surgery
and radiation. An 8-year follow-up study of 272 men
showed that men who underwent surgery consistently
reported more urinary leakage and impaired erection and
libido.14
Findings from the Prostate Cancer Intervention
Versus Observation Trial (PIVOT) showed higher rates of
urinary leakage and erectile dysfunction among men
1
Associate Professor of Medicine and Medical Ethics, Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, TX; 2
Depart-
ment of Sociology, Rice University, Houston, TX; 3
Professor, Division of Cancer Prevention and Population Sciences, Department of Health Services
Research, The University of Texas MD Anderson Cancer Center, Houston, TX.
Corresponding author: J. S. Blumenthal-Barby, PhD, Center for Medical Ethics and Health Policy, Baylor College of Medicine, One Baylor Plaza, MS 420, Hous-
ton, TX 77030; Jennifer.blumenthal-barby@bcm.edu
See referenced original articles in CA Cancer J Clin. 2015;65:239-251 and pages 264-282, this issue.
DISCLOSURES: This research was supported by a grant from the Greenwall Foundation (Principal Investigator: Dr. Blumenthal-Barby; Co-Investigator: Dr. Volk).
VC 2015 American Cancer Society, Inc. doi: 10.3322/caac.21283. Available online at cacancerjournal.com
VOLUME 65 _ NUMBER 4 _ JULY/AUGUST 2015 257
COMMENTARY

randomized to undergo radical prostatectomy compared
with men who were observed.15
Higher rates of urinary
leakage among men assigned to radical prostatectomy ver-
sus watchful waiting were observed in the Scandinavian
Prostate Cancer Group Trial Number 4.16-18
Although
randomized trials comparing radiation therapy with
expectant management are lacking, evidence from obser-
vational studies has demonstrated an increased risk of
erectile dysfunction in patients treated with radiation
therapy compared with those treated with watchful wait-
ing.19-21
Finally, these findings have important implica-
tions for societal costs as well. It has been estimated that if
one-half of patients recently diagnosed with low-risk
prostate cancer opted for observation, the health care sav-
ings would surpass $1 billion in the United States per
year.22
Moreover, according to current UK National Insti-
tute for Health and Care Excellence guidelines issued in
2008, active surveillance should be the preferred treatment
for patients with low-risk disease.23
In addition, both the
American Urological Association and the National Com-
prehensive Cancer Network have issued guidelines that
stress the importance of assessing life expectancy in the
decision-making process given that the survival benefits of
immediate treatment may not be realized for many years,
if ever.24,25
Despite all this, only 20% to 30%26,27
of eligi-
ble men are currently on active surveillance protocols.
In their conclusion, Filson et al argued for a shared
decision-making process in which patients are presented
with information regarding the risks and benefits of expect-
ant management, including the use of patient decision
aids.5
Also in this journal, Violette et al reported a system-
atic review of randomized trials of patient decision aids for
the treatment of localized prostate cancer.6
It is important
to note that the aids included in their review did not define
or distinguish active surveillance or watchful waiting
because they were developed before the publication of large
trials such as PIVOT.15
Among the 14 trials reviewed by
Violette et al, the use of patient decision aids was found to
have no impact on treatment choices.6
Decision aids have
long been viewed as adjuncts to clinical encounters, prepar-
ing patients to participate in clinical decision-making with
the health care providers with the goal of making decisions
that are congruent with the patient’s values.28
Clearly, the
use of patient decision aids alone will not be sufficient to
raise the profile of expectant management for prostate can-
cer treatment for patients who might benefit from it.
Furthermore, their use among specialists treating patients
with prostate cancer is relatively low.29
Ethically Responsible Choice Architecture
We propose that a beginning solution to the current situa-
tion in prostate cancer decision-making is for clinicians
to engage in what we call “ethically responsible choice
architecture.” Choice architecture is a term coined by Thaler
and Sunstein30
to refer to the organization of the context in
which people make decisions. Thaler and Sunstein stress
that the design of the choice context is important and
unavoidable such that, “If you are a doctor and must
describe the alternative treatments available to a patient,
you are a choice architect.”30
The question then becomes
how clinicians can engage in choice architecture around
prostate cancer decision-making in a way that is ethically
responsible given what we know about how patients make
decisions in this context. The current context is one that
heavily favors immediate intervention. Thus, ethically
responsible choice architecture would encourage men to
seriously consider the harms/cons of immediate intervention
and also the pros/benefits of active surveillance.31
This
applies not only to clinicians but also to developers of
decision aids for localized prostate cancer treatment (see
Violette et al6
for a systematic review and meta-analysis of
prostate cancer decision aids). This could be accomplished
using several techniques: 1) framing insights; 2) social
norms; and 3) narratives.
Framing of Options
When clinicians deliver options and information to men
about how to deal with their newly diagnosed prostate can-
cer, they have to make several decisions regarding how to
frame that information (eg, the order in which to deliver it,
whether to frame numbers in terms of frequencies vs per-
centages, whether to frame risk in absolute or relative
terms, whether to frame information in terms of gains such
as survival rates or losses such as mortality rates, etc). How-
ever, at a very basic level, they have to make a decision con-
cerning how to frame the initial decision: they can frame
the decision as an immediate intervention versus active
surveillance or as open surgery versus laparoscopic surgery
versus robot-assisted surgery versus 3-dimensional radia-
tion versus intensity-modulated radiation versus proton
radiation versus brachytherapy versus cryoablation versus
active surveillance. The former framing is preferable both
because it simplifies the initial decision for patients and
avoids tipping the scales heavily toward immediate treat-
ment as the latter framing does. Another important tech-
nique that clinicians can use to frame the options in an
ethically responsible manner is to avoid presuming inter-
vention as the default by asking men which treatment
intervention they prefer (eg, surgery or radiation). Instead,
active surveillance could be framed as the default, commu-
nicating to appropriately selected men that they could begin
an active surveillance protocol and that they have time to
decide whether and when to opt for more invasive manage-
ment. Default options are so powerful that they even
Choice Architecture in Prostate Cancer Treatment Decision-Making
COMMENTARY
258 CA: A Cancer Journal for Clinicians

impact an individual’s end-of-life decisions. One study
found that when life-sustaining treatment was assumed the
default in an advance directive document, 38% of individu-
als favored treatment, and when no intervention was
assumed the default, only 20% favored treatment.32
Engaging Social Norms
A second technique for ethically responsible choice architec-
ture in prostate cancer decision-making is to show patients
that some men (eg, a public role model33
) do choose active
surveillance and this can very well be considered a “normal”
or reasonable choice. For example, one study of 331 survi-
vors of prostate cancer found that a normative message of
“You don’t have to panic. . .you have time to think about
your options” was perceived as believable, accurate, and
important to hear by over 80% of men, and 60.4% believed
that this message would make men more likely to choose
active surveillance. The message rated the highest in terms
of likelihood to impact choice was “As long as I’m keeping a
close eye on it with my doctors, I can possibly prolong this
for a number of years until the treatment options have
improved,” and 77.3% believed that hearing this message
would make a man more likely to choose active surveil-
lance.34
Moreover, because physician recommendations cre-
ate powerful social norms, physicians should avoid
recommending surgery or radiation as the only reasonable
choices for patients with low-risk, localized prostate cancer.
They may even positively recommend active surveillance as
an option to seriously consider.35
Use of Narratives
A third technique for ethically responsible choice architec-
ture in prostate cancer decision-making is to make the
potential harms of surgical intervention or radiation more
realistic and salient to patients. Although men state that
side effects are important, a systematic review of prostate
cancer decision-making found that these same men do not
report that consideration of side effects actually influenced
their ultimate decision.36
Patients may intentionally or
unintentionally minimize side effects, or side effects may be
presented too abstractly.36
Narratives (textual or video) are
ideal for helping patients to imagine health situations that
they have not previously experienced.37
Objections and Replies
There are 2 major objections to our proposal. One is that
individual patient preference and patient autonomy are
important components of prostate cancer decision-making
that our proposal misses or deemphasizes. The second is
that our proposal assumes that avoidance of immediate
treatment is in a patient’s best interest, but there are reasons
to question this. Let us address each in turn. Regarding
the issue of the roles of patient preferences and patient
autonomy, we want to emphasize 2 things. First, our artic-
ulation of ethically responsible choice architecture is just
that: an articulation of choice architecture. The ultimate
choice is the patient’s, within the context of the physician-
patient relationship, and all options need to be presented
to and discussed with the patient. Patients who prefer
surgery or radiation are free to, and will, elect those treat-
ment options. Second, our proposal takes into account that
the current choice architecture heavily favors immediate
treatment and involves several factors in decision-making
that are not conducive to autonomous decision-making (eg,
lack of information regarding all the options, biases and
heuristics heavily favoring immediate treatment, the diag-
nosing physician might also be the treating physician, etc).
Our proposal attempts to counter the existing choice cli-
mate so that expectant management is seriously considered
as an option and the risks and side effects (not only the ben-
efits) of surgery and radiation are understood and appreci-
ated. We believe this is the ethically responsible thing to do
given that the current climate so heavily favors immediate
treatment and given that clinicians are ultimately responsi-
ble for creating and managing choice contexts for patients.
With regard to the issue of what is in a patient’s best inter-
ests, we do not assume that expectant management (or
immediate treatment for that matter) is in the best interest of
all patients because what is best for each patient depends on
their preferences, values, and trade-offs (prostate cancer man-
agement truly is a preference-sensitive decision). Instead, we
recognize that expectant management may be in some men’s
best interests-much more than the small percentage of newly
diagnosed men who are actually on active surveillance proto-
cols. Five-year outcomes reveal that although both immediate
treatment and active surveillance groups experienced equal
amounts of health-related distress, worry, feeling low, and
insomnia, the intervention group (most of whom were
treated with surgery) consistently reported more urine leakage
and impaired erection and libido.38
A recent systematic
review of the impact of active surveillance on quality of life
identified 10 observational studies with follow-up periods
ranging from 9 to 36 months.39
Patients undergoing active
surveillance reported good overall quality of life without neg-
ative psychological impacts. It was also concluded that longer
follow-up data were needed to identify reasons for leaving
active surveillance protocols and long-term impact on quality
of life. Moreover, studies have shown that active surveillance
does not necessarily produce anxiety harms40
or decisional
regret.14
Thus, it is likely that expectant management strat-
egies such as active surveillance may be in the best interests of
some men with low-risk, localized prostate cancer, despite
that fact that they often do not consider it a viable option, or
it is not presented as such. The crux of our proposal is that
ethically responsible choice architecture does not occur in a
CA CANCER J CLIN 2015;65:257–260
VOLUME 65 _ NUMBER 4 _ JULY/AUGUST 2015 259

vacuum and instead needs to account for known facts con-
cerning the current context in which this decision occurs,
both on the clinician end and the patient end. ᭿
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Choice Architecture in Prostate Cancer Treatment Decision-Making
COMMENTARY
260 CA: A Cancer Journal for Clinicians

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