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P J Devereaux a Department of Medicine,
Dalhousie University, Halifax, Nova Scotia, B3K 6A3, Canada, b Department of Family Medicine, Dalhousie University,
Halifax, c Department of Community Health and Epidemiology, Dalhousie
University, Halifax, d College of Pharmacy, Dalhousie University, Halifax Correspondence to: P J Devereaux philipj{at}mcmaster.ca
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Abstract |
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Objective:
To determine and compare physicians' and
patients' thresholds for how much reduction in risk of stroke is
necessary and how much risk of excess bleeding is acceptable with
antithrombotic treatment in people with atrial fibrillation.
Design:
Prospective observational study.
Setting:
Tertiary and peripheral referral centres
in Nova Scotia, Canada.
Participants:
63 physicians who were treating patients
with atrial fibrillation and 61 patients at high risk for atrial fibrillation.
Main outcome measures:
Participants underwent a face
to face interview with a probability trade-off tool. Thresholds were
determined for the minimum reduction in risk of stroke necessary and
the maximum increase in risk of excess bleeding acceptable for
treatment with aspirin and warfarin in people with atrial fibrillation.
Results:
The minimum number of strokes that needed to
be prevented in 100 patients over two years for warfarin to be
justified was significantly lower for patients than for physicians (1.8 (SD 1.9) v 2.5 (1.6), P=0.009), whereas for aspirin there was no difference between patients and physicians (1.3 (1.3)
v 1.6 (1.5), P=0.29). The maximum number of excess bleeds
acceptable in 100 patients over two years for use of warfarin and
aspirin was significantly higher for patients than for physicians
(warfarin 17.4 (7.1) v 10.3 (6.1); aspirin 14.7 (8.5)
v 6.7 (6.2); P<0.001 for both comparisons).
Conclusions:
Patients at high risk for atrial
fibrillation placed more value on the avoidance of stroke and less
value on the avoidance of bleeding than did physicians who treat
patients with atrial fibrillation. The views of the individual patient should be considered when decisions are being made about antithrombotic treatment for people with atrial fibrillation.
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What is already known on this topic
What this study adds
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Introduction |
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Atrial fibrillation is the most common chronic arrhythmia1 and is a major risk factor for stroke.2 Clinical trials have shown that warfarin3 and to a lesser extent aspirin4 reduce the rate of stroke in patients with atrial fibrillation. Despite evidence of benefit, observational studies have consistently shown, for reasons that are not clear,5 an apparent underuse of antithrombotic drugs in these patients. 6-10
The decision to use antithrombotic drugs in patients with atrial
fibrillation involves a consideration of the potential benefits versus
the risks, inconveniences, and costs. We hypothesised that physicians
and patients would differ in how they weigh these factors, which in
turn would influence their decisions to prescribe or take
antithrombotic drugs. We studied trade-offs in physicians and patients
between risk of stroke and risk of bleeding when antithrombotic
treatment is being considered.
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Methods |
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Patients
We randomly selected patients who were at high risk of developing
atrial fibrillation (that is, those with a previous diagnosis of
congestive heart failure or myocardial infarction) from the database of
the improving cardiovascular outcomes in Nova Scotia study (October
1997 to October 1998). The database comprised 1119 patients discharged
with one of these diagnoses from hospital in Nova
Scotia.11
Physicians
We randomly selected family physicians and general internists or
subspecialists from the physician registry of the Department of Health,
Nova Scotia. Exclusion criteria included: not currently practising
medicine; not having cared for a patient with atrial fibrillation in
the preceding year; not located or moved out of the province; inability
to participate due to illness; or failure of either eligibility
scenario (see below).
Interview procedures
Participants underwent a structured face to face interview and
information was presented both verbally and visually with the use of
coloured pictorial flip charts (fig 1). The two people who
interviewed the patients (BFB) and physicians (PJD) followed prewritten
text during the interview. Seven physicians and seven patients
participated in a pilot interview to ensure understanding
and consistency.
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Baseline information
Participants read flip charts describing major and minor stroke,
major and minor bleeding, and inconveniences and costs of treatments
(fig 1). We told participants that the likelihood of a minor or
major stroke was equal.3 We described the most common type
of major bleed: a non-fatal gastrointestinal bleed.
13 14
Screening
Participants completed two eligibility scenarios that
compared the outcomes of stroke and bleeding with no treatment and with
a blood thinning treatment. The blood thinning medication decreased the
risk of stroke and bleeding in the first scenario and did not affect
the risk of stroke but increased the risk of bleeding in the second
scenario. If participants did not select the blood thinning medication
in the first scenario or selected it in the second scenario, they were
excluded as we considered that their choice reflected inadequate comprehension.
Eliciting thresholds
Participants completed four clinical scenarios, the order of which
was randomly assigned. Two scenarios (one for warfarin, one for
aspirin) determined their thresholds for the minimum reduction in the
risk of stroke necessary to justify treatment; and two scenarios (one
warfarin, one aspirin) determined the maximum acceptable increase in
the risk of bleeding.
Determining thresholds
In each scenario we used a probability trade-off with the
elicitation method of "ping-ponging" to determine participants' thresholds (fig 1). This method involved alternating between high and low reductions in risk of stroke in two scenarios and high and low
increases in risk of bleeding in two scenarios. All scenarios started
with a statement of the baseline risk
"without any antithrombotic treatment there is a baseline risk of major or minor stroke over the
next two years of 12 patients out of 100 and a risk of severe bleeding
over the next two years of three patients out of 100." We based
the risk of stroke on the average event rate for patients with one or
more risk factors in the control arm of pooled analysis from five
randomised controlled trials on atrial fibrillation3 and
the risk of bleeding on the average rate of bleeding in the control arm of six randomised controlled trials on atrial
fibrillation.
3 15
Stroke threshold for warfarin
We have used the scenario for determining the minimum reduction in
likelihood of stroke necessary to justify the use of warfarin (that is,
the stroke threshold for warfarin) to show how we determined a
participant's threshold. Throughout this scenario the rate of episodes
of severe bleeding with warfarin was fixed at five in 100 patients over
two years (based on the pooled analysis of six randomised controlled
trials).
3 15
Remaining thresholds
To determine the remaining three thresholds, the baseline risk
remained fixed. Given that aspirin would increase the risk of severe
bleeding from three to 3.3 in 100 (on the basis of data from a large
randomised controlled trial of aspirin versus placebo in
hypertension16 because the atrial fibrillation trials had
inadequate power to estimate the increased risk of bleeding with
aspirin) we then determined the minimum number of strokes that needed
to be prevented for a participant to think that taking aspirin was
justified (that is, the stroke threshold for aspirin). Given that
warfarin would decrease the risk of stroke from 12 to four in 100 (on
the basis of a relative risk reduction of 68%3) we then
determined the maximum number of episodes of excess severe bleeding
that participants were willing to accept (that is, the bleeding
threshold for warfarin). Finally, given that aspirin would decrease the
risk of stroke from 12 to nine in 100 (on the basis of a relative risk
reduction of 21%4) we then determined the maximum number
of episodes of excess severe bleeding that participants were willing to
accept (that is, the bleeding threshold for aspirin).
Sample size
On the basis of work by Man-Son-Hing et al we assumed that on
average patients would accept the increased risk of three (SD 1.7)
bleeds in 100 patients if warfarin prevented two
strokes.17 We thought it would be a meaningful difference if physicians would accept the increased risk of three bleeds in 100 patients only if warfarin prevented three strokes. A sample size of 46 physicians and 46 patients would provide 80% power to detect such a
difference with
=0.05 (two sided). Before starting the study we
decided to interview 60 physicians and 60 patients.
Data analysis
Our primary analyses compared thresholds of patients and
physicians by using the exact test for trend in an x×2
table, where x denotes the number of rows in the
table.
18 19
We determined means (SD) for both thresholds.
We carried out univariate analyses using Spearman's correlation
coefficient to determine if there was an association between patients'
thresholds and age, sex, location, income, education, mini-mental state
score, duration of interview, and randomisation scheme. Similar
analyses examined whether any associations existed between physicians'
thresholds and specialty, location, years since medical school
graduation, number of patients with atrial fibrillation in the
preceding year, duration of interview, and randomisation scheme.
Ethics
The research ethics board of Queen Elizabeth II Health Sciences
Centre in Halifax, Nova Scotia, approved this study protocol.
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Results |
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Recruitment and characteristics of participants
Figure 2 shows recruitment of participants and reasons
for exclusion. Sixty one patients and 63 physicians completed the
interview. Table 1 presents patient demographics and socioeconomic
status. The mean duration of the interview for patients was 64 minutes (including time for consent and the mini-mental state
examination). Table 2 shows demographic details and clinical experience
for physicians. The mean duration of the interview with physicians
was 25 minutes (consent occurred before the interview, and there was no
mini-mental state
examination).
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Thresholds
Figure 3 shows stroke thresholds for warfarin. Forty five
patients (74%) were willing to take warfarin if it prevented just one
stroke in 100 patients over a two year period, whereas 24 physicians
(38%) were willing to recommend warfarin for the same reduction in
stroke (P=0.009 for difference between physicians and patients). Figure
4 presents stroke thresholds for aspirin. Most physicians and
patients were willing to recommend or take aspirin if it prevented just
one stroke (P=0.29 for difference between
groups).
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Association between participants' factors and thresholds
There was no association between patients' thresholds and any of
the factors assessed in the univariate analyses. Physicians who saw
more patients with atrial fibrillation were willing to accept a higher
number of episodes of excess bleeding (P=0.01 for warfarin and P=0.002
for aspirin).
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Discussion |
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We have shown significant differences between the thresholds of physicians and patients for the risk of excess bleeding deemed acceptable with antithrombotic treatments and the amount of reduction in risk of stroke thought necessary to justify treatment with warfarin.
Strengths and weaknesses
Our study evaluated physicians' thresholds for stroke and excess
bleeding, patients' thresholds for excess bleeding, compared
thresholds between the two groups, and interviewed patients who had not
previously made a decision about antithrombotic treatment but were at
high risk of needing to do so in the future. We randomly selected
participants from across the province of Nova Scotia, and the response
rate was high.
Potential limitations
Our study has several limitations. Ideally we would have
determined thresholds for patients who were newly diagnosed with atrial
fibrillation before any input (such as an interaction with their family
physician) that may have influenced their decision about antithrombotic
treatment. Logistic limitations inhibited our ability to do this. The
selection of patients who were at high risk for atrial fibrillation but
without a history of use of warfarin, stroke, or major bleeding
provided the best alternative. Given that one individual interviewed
physicians and another interviewed patients, interviewer bias may have
influenced the results. However, to standardise their approach, the
interviewers piloted the entire interview on seven physicians and seven
patients together. We also ensured that the wording was neutral in
presentation and that both interviewers consistently used the
prewritten text. Although we did not establish the stability of the
thresholds through a second interview, several investigators have shown
that thresholds do remain stable over time.
17 22-24
Comparisons with other studies
Several studies have evaluated patients' preferences for
antithrombotic treatment in atrial fibrillation. Three studies used
probability trade-offs to determine patients' thresholds for reduction
in risk of stroke or to assist in management
decisions.
17 25 26
One study interviewed patients who
had previously decided to take warfarin, and the thresholds for
reduction in risk of stroke were low, as they were in our
study.17 In a second study, with a mix of patients who
were and were not taking warfarin, the thresholds showed more
variation, with patients not taking warfarin requiring a higher
reduction in risk of stroke than those taking warfarin.25 In this study patients who decided not to take warfarin after the
interview did not see themselves as at risk, despite the probability trade-off clearly showing such risk.25 This finding
suggests that cognitive dissonance played a part in patients'
responses. The third study evaluated patients from the SPAF-III (stroke
prevention in atrial fibrillation) aspirin cohort.26
Nearly all patients selected aspirin rather than warfarin (there was no
option of no treatment), but patients who had previously taken warfarin were more likely to select warfarin than those who had only taken aspirin.26 Once again, cognitive dissonance probably
explains the differences between these results and ours.
Implications
The average decrease in the absolute risk of stroke that
participants required for them to recommend or take warfarin
(physicians 2.5%, patients 1.8%) and aspirin (physicians 1.6%,
patients 1.3%) could be achieved by treating patients older than 65 years or those with one or more associated risk factors for
cardioembolic events.
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Acknowledgments |
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Contributors: PJD was involved in the conception, design, data collection, and interpretation of data. He also drafted the article and will act as guarantor for this study. DRA and JLC were involved in the conception, design, interpretation of data, revisions of the article, and supervision of the project. MJG, WP, and SN were involved in the conception, design, interpretation of data, and revisions of the article. GJF was involved in analyses, interpretation of the data, and revisions of the article. BFB was involved in data collection, interpretation of the data, and revisions of the article.
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Footnotes |
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Funding: Heart and Stroke Foundation of Nova Scotia. PJD is supported by a fellowship award from the Heart and Stroke Foundation of Canada/Canadian Institutes of Health Research. DRA is a clinical research scholar of Dalhousie University. JLC is supported by an investigator award from the Canadian Institutes of Health Research/Regional Partnership Program and a clinical research scholarship from the Faculty of Medicine, Dalhousie University.
Competing interests: None declared.
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References |
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(Accepted 25 July 2001)
Tom Fahey Division of Primary Health Care,
University of Bristol, Canynge Hall, Bristol BS8 2PR
tom.fahey{at}bristol.ac.uk
This study by Devereaux et al is an important addition to
the expanding literature on shared decision making between patients and
health professionals. It shows that patients may be more averse to the
potential consequences of stroke and less bothered by the side effects
of antithrombotic treatment than doctors are. It also shows that
individual responses in both groups vary substantially. Responses for
the minimum number of strokes that need to be prevented before warfarin
is acceptable ranged from one to six for doctors and one to 11 for
patients. For aspirin the figures were one to seven for doctors and one
to eight for patients. Individual responses to the maximum number of
excess bleeds that would be acceptable was even more diverse, ranging
from one to 22 in both doctors and patients for both forms of
antithrombotic treatment. These findings are consistent with other
observational studies that have compared the preferences of patients
and health professionals when they are faced with choices about
treatment. Differences in such preferences are difficult to predict,
vary in direction and magnitude, and are often specific for a given
condition.1
Devereaux et al highlight potential biases that might account for the
reported difference in responses in their study. These biases include
non-blinded interviewers questioning each of the two groups separately
(interviewer bias) and the fact that patients' interviews lasted
considerably longer (even with allowance for consent and the
mini-mental test undertaken in the patient group alone). Furthermore,
selection of patients who had no experience of either a stroke or side
effects of treatment might bias their results. Patients who have
experienced an episode of bleeding due to warfarin treatment report
significantly lower quality of life scores.2 Many would
argue that it is not surprising that differences in preferences for
antithrombotic treatment were found. Patients seem to be older and have
lower educational attainment than the doctors taking part in this
study. Differences in characteristics between patients and doctors may
have produced differences in preferences for antithrombotic treatment.
This is precisely the reason why health professionals should explicitly
seek patients' views when they are making decisions about treatment.
Unfortunately, asking patients about their preferences for treatment
when decisions are being made on future management is often neglected
by doctors.3
Important developments are likely to alter the dynamics of decision
making between patients and doctors in the future. Information is now a
freely available commodity. Initiatives such as the Cochrane collaboration actively promote consumer involvement and patient orientated information about medical effectiveness. Decision aids and
other tools are being developed that will give patients access to
information and allow them to express their preferences for treatment
options.4 Some clinical guidelines explicitly express and
quantify the impact of patients' preferences on recommendations for
treatment.5 The findings from this study show that health professionals should be sensitive to patients' preferences and encourage the use of decision aids and information sources that can
facilitate shared decision making.
Competing interests: None declared.
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Footnotes
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References
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Montgomery AA, Fahey T.
How do patients' treatment preferences compare with those of clinicians?
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Lancaster TR, Singer DE, Sheehan MA, Oertal LB, Maraventano SW, Hughes RA, et al.
The impact of long-term warfarin therapy on quality of life. Evidence from a randomized trial. Boston area anticoagulation trial for atrial fibrillation investigators.
Arch Intern Med
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Elwyn G, Edwards A, Kinnersley P.
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Br J Gen Pract
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Holmes-Rovner M, Llewellyn-Thomas H, Entwistle V, Coulter A, O'Connor AM, Rovner D.
Patient choice modules for summaries of clinical effectiveness: a proposal.
BMJ
2001;
322:
664-667 5.
Thomson R, Parkin D, Eccles M, Sudlow M, Robinson A.
Decision analysis and guidelines for anticoagulation therapy to prevent stroke in patients with atrial fibrillation.
Lancet
2000;
355:
956-962.
© BMJ 2001
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