Context The long-term results of randomized trials have demonstrated equivalent
survival rates for mastectomy and breast-conserving therapy for the treatment
of early stage breast cancer. Consequently, the choice of treatment should
be based on a patient's preferences.
Objective To evaluate the impact of a decision aid regarding the different surgical
treatment options on patient decision making.
Design and Setting A cluster randomized trial for which general surgeons in the communities
of central-west, and eastern Ontario, Canada, were randomly assigned to use
the decision aid or not in the surgical consultation. Patients received the
decision aid or not based on the surgeon seen.
Participants Twenty surgeons participated in the study. Of the 208 eligible women
with newly diagnosed clinical stage I or II breast cancer seen by study surgeons,
201 agreed to be evaluated: 94 were assigned to the decision board and 107
to usual practice. Patients were recruited from November 1999 to April 2002.
Intervention The decision board is a decision aid designed to help physicians inform
their patients about different treatment options and to enable patients to
express a preference for treatment.
Main Outcome Measures Patient knowledge about the surgical treatment of breast cancer; decisional
conflict; satisfaction with decision making; and the treatment decision following
Results Patients in the decision board group had higher knowledge scores about
their treatment options (66.9 vs 58.7; P<.001),
had less decisional conflict (1.40 vs 1.62, P = .02),
and were more satisfied with decision making (4.50 vs 4.32, P = .05) following the consultation. Patients who used the decision
board were more likely to choose BCT (94% vs 76%, P =
Conclusions The decision board was helpful in improving communication and enabling
women to make a choice regarding treatment. Such instruments should be considered
by surgeons when communicating the different surgical options to women with
Breast cancer is common affecting more than 200 000 women per year
in North America. It usually presents at an early stage with disease confined
to the breast and axillary lymph nodes. Prior to 1980, the standard surgical
treatment involved a modified radical mastectomy. In the early 1980s, 2 published
randomized trials from Italy and the United States demonstrated that removal
of the cancer and radiation to the remaining breast called breast conservation
therapy (BCT), resulted in equivalent survival.1,2 Since
then 4 other published randomized trials3-6 and
a number of meta-analyses7,8 confirmed
these findings. Randomized trials have also suggested improved quality of
life and satisfaction for women treated with BCT.9,10
The decision about the different surgical treatment options for early
stage breast cancer is difficult. Information describing the options is complex
and the decision comes at an emotionally charged time when communication can
be difficult. The decision board was developed as an aid to enhance communication
between the physician and patient during the decision-making process and to
help the informed patient decide which treatment she prefers.11 It
consists of a visual aid and written material based on the best available
evidence and is presented by the clinician to the patient during the medical
consultation. The instrument enables patients to discuss different treatment
options with their clinician and to express a preference for treatment. Previous
decision boards were developed for patients and their oncologists working
at comprehensive cancer centers.12,13 The
instruments were shown to improve patient knowledge and facilitate patient
decision making.12-14 Based
on these promising results, we developed a decision board for community general
surgeons and their patients considering the different surgical treatment options
for breast cancer.15 We conducted a randomized
trial to examine whether the decision board could improve communication and
empower patients in the decision-making process.
Women with clinical stage I or II breast cancer newly diagnosed either
by cytology or histological examination who had not received definitive surgical
treatment were eligible for study. Patients were excluded for the following
reasons: serious nonmalignant disease, eg, cardiovascular, respiratory, renal,
that would preclude definitive surgical treatment; breast of insufficient
size to perform a lumpectomy (defined as the surgical excision of the tumor
with a rim of normal tissue); diffusely abnormal mammogram that would preclude
a lumpectomy; not a candidate for breast irradiation, eg, previous breast
irradiation or pregnancy; inability to speak or read English fluently; mental
incompetence including any psychiatric or addictive disorder that would preclude
taking part in the process of shared decision making and adherence to the
protocol; and unwilling to give informed consent to participate in the study.
The institutional review boards at McMaster University and the University
of Ottawa approved the study protocol, and patients gave oral informed consent.
Details on the design, development, and preliminary evaluation of the
decision board for the surgical treatment of breast cancer are described elsewhere.15 The decision board was based on a systematic review
of randomized trials comparing mastectomy to BCT and qualitative interviews
and focus groups with women with breast cancer and their surgeons regarding
informational needs for decision making. The decision board is an aid that
presents written and visual information from clinical trials to patients regarding
their treatment options; the acute and long-term adverse effects associated
with treatment; and the effects of treatment on a patient's breast, long-term
survival, and quality of life. It is composed of foam core and measures 26
× 20 in (64 × 51 cm). The board has 4 subtitles: "Treatment Choice,"
"Side Effects," "Results of Treatment Choice for the Breast," and "Results
of Treatment Choice for Survival." Below each heading are 2 informational
panels (1 for mastectomy and 1 for lumpectomy plus radiation) resulting in
8 separate panels. The instrument is presented by the surgeon. Initially,
each panel is covered by a sliding door. The panels are opened to reveal information
in a sequential fashion. Each panel contains written information in bullet
points with a diagram (in some instances) describing the option, associated
adverse effects, or outcomes. Each panel is read together by the patient and
the surgeon. The patient is encouraged to ask questions during the presentation
and afterward. In addition to the board, there are 3 separate informational
cards, which provide background information about breast cancer and the purpose
of the decision board, details about breast reconstruction, and questions
for the patient to reflect on how the treatment will affect her as an individual.
At the end of the presentation, the patient is faced with an overall visual
representation of her 2 options and the possible outcomes associated with
each choice. The patient is given a take-home version to review and discuss
with others if she so desires. In a previous pilot study, the instrument was
timed to take an average of 21 minutes to complete and did not increase the
length of the consultation.
Study Design and Procedures
A paired cluster randomization process was used.16 General
surgeons in the cities of Hamilton, Ottawa, and surrounding communities in
Ontario who treated women with breast cancer were approached to participate
in the study. Surgeons were pair-matched according to sex and age as surrogates
for style of information giving. They were then randomly assigned in a concealed
fashion either to use the decision board in their surgical consultation or
to retain their routine consultation style. Eligible patients received the
decision board or not depending on the surgeon they saw in consultation. Patients
were recruited from November 1999 to April 2002.
Surgeons randomly assigned to the decision board group were trained
to use the instrument. An instructional video was developed outlining how
the instrument should be administered. The video was viewed by the surgeon
with 1 of the investigators (T.W. and D.M.)and the research assistant and
any questions were answered. The surgeon was asked to practice presenting
the instrument on a volunteer, often the research assistant. The research
assistant was available throughout the study to address any concerns of the
After providing her medical history and undergoing a physical examination,
eligibility for the study was confirmed and the patient was approached to
participate in the study. In the experimental group, the surgeon explained
the patient's surgical treatment options using the decision board. In the
control group, the surgeon discussed the treatment in his/her usual fashion
without using the decision board. The research assistant contacted patients
by telephone a few days following their consultation to collect information
on the study outcomes.
Surgeons were randomly assigned after being paired in a sequential fashion.
During the course of the study, 7 surgeons were withdrawn because they did
not see any eligible patients in the first 3 months. These surgeons either
worked part-time or were close to retirement. Four of them belonged to the
same pairs respectively and 3 were part of different pairs. This left 3 unpaired
surgeons who continued to recruit patients. Two of these surgeons who were
similar in sex and age were paired. The remaining surgeon was grouped with
another surgeon by randomly selecting a surgeon from a pool of 5 surgeons
yet to be randomized. The remaining 4 surgeons were paired and randomized.
Ultimately 20 surgeons contributed patients to the study. The study groups
were balanced for surgeon characteristics and community size. Ninety percent
of surgeons were men, the mean age was 47.7 years, the mean number of years
since graduation from medical school was 22.4, and the mean community population
was 230 000.
The major outcome measures for the study were patient knowledge; decisional
conflict; satisfaction with decision making; and the treatment decision following
the consultation. Patient knowledge was assessed using a 44-item questionnaire
that covered various content areas including general information about breast
cancer, details regarding mastectomy and BCT, and the associated adverse effects
and benefits of the respective treatments. Thirty-six items consisted of a
statement followed by a true, false, or unsure response and the 4 items inquiring
about numerical risk had a multiple-choice format with 4 options each. The
instrument was scored out of 100; each correct true or false statement received
a score of 2 and each correct multiple-choice question received a score of
5. We have shown this approach to be valid and reliable.12-15
Patient decisional conflict was assessed using the decisional conflict
scale, which assesses how well-informed patients feel about their choices
and the associated benefits and risks; the clarity of their values; the support
they have in the decision-making process; and their level of uncertainty.17 It consists of 16 items followed by a Likert response
of 1, strongly agree, to 5, strongly disagree. A mean score was obtained for
each patient. Patient satisfaction with decision making was assessed using
the effective decision-making subscale of the decisional conflict scale.17 The subscale consists of 4 items on satisfaction
with decision making. Scores for patient satisfaction with decision making
were reversed so that the higher scores reflected higher levels of satisfaction
(ie, a reversed Likert scale in which 5 is the highest score). Patient knowledge
and her treatment decision were assessed following the consultation. Patient
decisional conflict and satisfaction with decision making were assessed following
the consultation and at 6 and 12 months after surgery.
Other important outcomes assessed included whether patients perceived
that they were offered a choice, how strongly they preferred their decision,
and levels of anxiety and depression. Anxiety was assessed by the Spielberger
State Anxiety Inventory, which consists of 20 items—each with a 4-point
Likert scale from 1 to 4.18 The inventory yielded
total scores of 20 to 80. Depression was assessed by the Centre for Epidemiologic
Studies Depression scale, which consists of a 20-item scale—each with
a 4-point Likert scale from 0 to 3 yielding total scores of 0 to 60.19 Levels of anxiety and depression were measured following
the consultation and at 6 and 12 months after surgery.
The study was designed to enrol 200 patients to detect an effect size
of 0.3 in decisional conflict with a 2-sided α of .05 and a power of
90%.20 For a conservative sample-size calculation,
a within-physician correlation of 0.3 was assumed. Treatment-arm comparisons
were performed using methods appropriate for a cluster randomized trial.21 Using a meta-analysis approach, usually used for
summarizing data across several trials, each surgeon-pair was considered a
separate "trial." A treatment effect with corresponding variance was calculated
for each pair, and a random effects model was used to summarize the data over
pairs to arrive at an overall estimate of the treatment effect and corresponding
variance. Weighted averages were used to estimate central tendency for the
different scales by treatment group. It should be noted that due to the nonlinearity
of the statistical methods used, the estimated difference between groups is
not the straight arithmetic difference between the estimates for each group.
All statistical tests were 2-sided. P<.05 was
considered statistically significant. All analyses were performed using SAS
statistical software Version 8.2 (Carey, NC).
The trial profile is shown in Figure
1. Two hundred eight eligible patients were approached to participate:
98 patients by surgeons randomly assigned to the decision board and 110 patients
by surgeons randomly assigned to the control group. Seven patients refused
to provide consent to participate in the study: 4 in the decision board group
and 3 in the control group. The analysis is based on 201 patients. Age, marital
status, educational level, employment status, and preference for role in decision
making were similar between the 2 treatment groups (Table 1).
Patients in the decision board group had higher knowledge scores than
patients in the control group (66.9 vs 58.7; difference, 9.34; SE, 2.64, P<.001). One of the greatest improvements in knowledge
was observed for understanding that survival was the same with mastectomy
or BCT (73 [77.7%] of 94 correct in the decision board group vs 62 [57.9%]
of 107 correct in the control group; P = .006]. Patients
in the decision board group also had lower decisional conflict scores (1.40
vs 1.62; difference,−0.223; SE, 0.0958; P =
.02) and higher satisfaction with decision-making scores (4.50 vs 4.32; difference,
0.215; SE, 0.110; P = .05) following the consultation.
No differences were seen between groups in decisional conflict and patient
satisfaction at 6 and 12 months after surgery (Table 2).
Patients in the decision board group were more likely to choose BCT
than patients in the control group (88 [94%] vs 81 [76%] ; P = .03]). Patients in the decision board group were also more likely
to perceive that they were offered a clear choice regarding treatment by their
surgeons (82 [87%] vs 74 [69%]; P = .07) and to strongly
prefer the treatment they choose (78 [83%] vs 76[72%]; P = .05).
Patient anxiety scores were high just after the consultation but decreased
at 6 and 12 months after surgery (Table
3). No differences were observed between the decision board or control
groups. Patient depression scores were not increased at any point and no differences
between groups were observed (Table 3).
Results of randomized trials have demonstrated equivalent survival rates
for BCT and mastectomy. Consequently the choice of treatment should be based
on a patient's preferences. Previous studies have suggested that there are
problems with communicating to patients the different surgical options and
with offering women choice. In 1990, Fallowfield et al22 reported
that a significant proportion of women with breast cancer were not offered
a choice in surgical treatment of their breast cancer by their surgeons. More
recent reports continue to suggest that up to 17% to 29% of women in some
areas of the United States do not receive adequate discussion of the different
surgical treatment options for breast cancer.23,24
The decision board was developed to aid surgeons in communicating the
different surgery options for breast cancer and to permit women to express
a preference for treatment. The results of this randomized trial demonstrate
that the decision board not only improved patient knowledge about breast cancer
and its treatment but also decreased their decisional conflict and increased
their satisfaction with decision making following the consultation. The instrument
permitted women to make different treatment decisions consistent with their
preferences: women who used the decision board were more likely to choose
BCT and to more strongly prefer their treatment choice.
These findings are in keeping with the hypothesis that physician-patient
communication and decision making can be improved with the use of decision
aids. Studies have demonstrated that women with breast cancer ideally prefer
to receive information about the disease and its treatment from their physician.25 The surgical consultation about the diagnosis of
breast cancer and its treatment is often understandably an upsetting time
for women. This was evidenced by the level of anxiety observed in women around
the time of consultation in our study. It has been suggested that increased
anxiety may make it difficult to recall and understand complicated information
regarding the treatment of the cancer.26 Presenting
information in different forms—written, oral, and visual—can help
improve patient knowledge.27 The judicious
use of repetition and providing women with a take-home version of the decision
aid to reflect on when they are less distressed may further improve understanding.28 Although we demonstrated that overall patient knowledge
was improved, what most improved was women knowing that survival was the same
between the 2 treatments (BCT and mastectomy). This information is likely
to have an important affect on patient decision making.
A goal of decision aids is to help patients make informed decisions
reflecting their true preference for treatment. The outcomes assessed in this
study included not only patient knowledge and treatment choice but also decisional
conflict and satisfaction. Decisional conflict has been defined as a state
of uncertainty about the course of action to take.17 A
number of factors may contribute to a patient's decisional conflict including
lack of information about choices and their outcomes, unclear values, emotional
distress, and feeling unsupported. The decisional conflict scale measures
important attributes of quality decision making including how well informed
patients feel about their options and associated benefits and risks, the clarity
of their values and the support they have in making a decision. Patient-centered
decision making is an important component of quality of care and is closely
linked to patient satisfaction.29 In this study,
patients who used the decision board had less decisional conflict and were
more satisfied with the decision-making process.
We hypothesized that by providing patients with information in an explicit
fashion, encouraging discussion and consideration of their values, and supporting
them in decision making, patients would be encouraged to express their own
treatment preferences. Consistent with this hypothesis, patients in our trial
made different treatment decisions with the use of the decision aid. By improving
communication, women were empowered to choose the treatment that reflected
their own values. This is supported by the observations that when the decision
board was used more women perceived that they were offered a clear choice
and more strongly preferred the choice they made.
A number of systematic reviews of decision aids have been performed.30-32 In the most comprehensive
review to date investigators identified more than 130 decision aids for health
treatment or screening decisions but only 35 randomized trials to evaluate
their effectiveness.30 These trials evaluated
decision aids for screening and prevention interventions (14), hormone replacement
therapy (7), elective surgical procedures (8), treatments for cardiovascular
disease (3), and cancer treatments (3). The majority of the trials (26) compared
decision aids to usual care. In these studies patient knowledge was significantly
increased in 9 out of 9 trials. Decisional conflict was reduced in 3 of 6
studies. In 5 trials of decision aids for elective surgical procedures, patients
who used the aid were significantly more likely to choose the less intensive
surgical treatment in 1 trial.
Few decision aids for cancer treatments have been evaluated in randomized
trials.33 We previously reported the results
of a randomized trial of a decision board for women with node negative breast
cancer.14 The instrument was shown to increase
patient knowledge about breast cancer and adjuvant chemotherapy and to improve
patient satisfaction with decision making. In that study, the instrument was
administered by research nurses working with oncologists in comprehensive
cancer centers. The decision board for breast cancer surgery was a departure
from previous work. It was introduced to women of all age groups shortly after
their diagnosis and administered by general surgeons. The positive results
observed in this study are consistent with our previous experience and support
that such instruments are effective when administered by physicians in the
community. Previous randomized trials34,35 of
decision aids for breast cancer patients regarding options for surgery have
failed to demonstrate an effect on patient outcomes. These studies were relatively
small in size, compared the decision aid to another instrument, and evaluated
the administration of the decision aid after patients had met with their surgeon
when many patients had already made a treatment decision.35 It
is unclear whether the lack of benefits observed in these studies relate to
the instruments themselves, the time of application, or the small number of
There are several potential limitations of our study. We used a cluster
design to randomize surgeons rather than patients in this trial. We chose
this design to avoid the contamination that might have occurred if surgeons
were required to use the decision board for some patients and not others.
The data demonstrated that this approach was successful, in that surgeon and
patient groups were well balanced for factors that may affect communication
and decision making. However as surgeons were aware that they were participating
in a study, it is likely that they may have applied their best communication
skills. Despite this potential effect, our results demonstrate that the addition
of the decision board improved patient outcomes. A unique limitation of cluster
randomization is the potential for compensatory bias,36 in
which case, patients might switch surgeons in order to obtain the preferred
intervention. To avoid this possibility the study was not widely advertised.
In our trial, no patient switched surgeons.
One of the main outcomes assessed in this trial was patient knowledge.
The patient-based questionnaire used in this study to assess knowledge was
based on information identified by patients and surgeons as important in making
a decision about breast cancer surgery.15 This
information was also contained in the decision board to some degree. Patients
who used the decision board were thus trained and perhaps better able to answer
the knowledge questionnaire. To avoid this problem questions in the questionnaire
were rephrased in a different frame wherever possible. To further avoid this
limitation other outcomes less likely to be affected by the training were
assessed including patient decisional conflict, satisfaction, and treatment
The outcomes assessed in this study (patient knowledge, decisional conflict,
satisfaction, and treatment choice) are not the typical classical outcomes
of cancer trials such as tumor regression, disease free, or overall survival
and quality of life. Nevertheless, they reflect the potential benefits patients
may accrue from decision aids and are likely to be important with respect
to the clinical management of patients with chronic disease. The use of BCT
and patient-perceived choice have been identified as important indicators
of quality of cancer care.37-39 It
is of considerable interest that both these outcomes were increased with the
use of the decision board. However, physicians should realize that the rate
of BCT may not necessarily be increased with the use of a decision aid. The
decision board will improve patient knowledge and a patient's ability to express
a preference for treatment. However, the use of BCT in any given community
will depend on a number of other important factors including stage of disease,
use of screening mammography, access to radiation therapy facilities, and
Are these results generalizable? In this study, the decision board was
used by community surgeons. In academic or other practices where other formal
educational interventions regarding treatment options are in place, for example
counseling before patients have made their decision, then such an instrument
may be less applicable. However, based on our previous experience, the decision
board may still be beneficial for framing the discussion and actively engaging
patients in decision making. The decision aid used in this study may be useful
for physician counseling for other complex and multimodality treatments in
oncology, such as the use of preoperative radiation and chemotherapy for rectal
cancer and the treatment of early stage prostate cancer. It may also be applicable
for complex treatment decisions for nononcological diseases such as inflammatory
bowel disease. Further research is necessary to investigate the impact of
the decision board in these situations.
Despite the demonstration of effectiveness of decision aids in a number
of contexts, they still do not appear to be widely used. The reasons for this
are likely to be multifactorial including limited applicability, poor dissemination,
and difficulty changing physician behavior.40 In
order to respond to some of these problems, we have developed computer-based
versions of the decision board. Computerization of the decision board affords
a number of potential benefits including ease of use, versatility in presentation,
tailoring of information, and ease of modification to fit local practices.
These computer-based versions are currently being evaluated in a randomized
trial.41 Another potential benefit of computer-based
versions is that they permit easy updating. However this technological ability
has identified an important challenge. Currently, there is no formal process
for updating decision aids. We suggest that as these instruments are more
widely used, a formal process should be established. Currently, many decision
aids are based on evidence-based guidelines. Such guidelines are usually updated
based on a regular systematic review of the literature and consensus by an
expert panel.42 Such a process could and likely
should be adopted for widely used decision aids.
There is now an extensive body of knowledge supporting the use of BCT
for the treatment of breast cancer with studies documenting equivalent survival
for up to 20 years.43,44 The decision
board is an effective simple tool to help surgeons communicate the different
treatment options to women with breast cancer. It has been shown in previous
studies to be well accepted by community surgeons, to be easy to use, and
to not lengthen the consultation.5 Although
it may take time for such approaches to be more widely adopted, the systematic
evaluation and reporting of such studies herein is the first step.
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