Shared Decision Making
Shared Decision Making
Science and Action
Henry H. Ting, MD, MBA; Juan Pablo Brito, MD; Victor M. Montori, MD, MSc
Clinical Case
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these will lead to favorable and unfavorable outcomes. This
process involves 2 judgments. The first judgment concerns
our confidence in the estimates of treatment effect across the
outcomes that matter most to patients.5 This confidence is
high when those estimates are produced by unbiased, precise,
consistent, fully reported, and directly applicable randomized
trials. The second judgment is to determine which treatment
best fits the patient’s context, goals, values, and preferences.6
Both judgments require clinical expertise and experience, but
the second mandates patient expertise and experience. Thus,
the full realization of evidence-based medicine necessitates
the participation of both patients and clinicians in making
decisions, a process called SDM. We need SDM to practice
evidence-based medicine.
Cardiovascular medicine has promoted evidence-based
medicine by developing clinical practice guidelines, performance measures, and appropriate use criteria for common cardiovascular diseases and procedures.7–9 How does
patient involvement and SDM fit with this context? Dr Jones’
dilemma highlighted in the clinical case, choosing between
PCI and medical therapy for stable angina, is an opportunity
for SDM.10 SDM is particularly relevant for Class IIa or IIb
guideline recommendations, where patients and clinicians
are faced with alternative treatment options with comparable
outcomes or where one option might have modest benefit
compared with the alternative. There are widespread examples in cardiovascular medicine, such as use of implantable defibrillator for primary prevention of sudden cardiac
death,11 transcatheter or surgical aortic valve replacement for
aortic stenosis,12 and carotid stent or carotid endarterectomy
for carotid stenosis.13 Failure to involve patient choice results
in a decision based on clinician goals, values, and preferences, in turn leading to patients receiving a treatment they
might not have chosen if they knew what clinicians know and
had the opportunity to voice their preferences. This situation
is analogous to a diagnostic error, an incorrect diagnosis of
patient preferences.14 To avoid misdiagnosis of preferences
in the case of Dr Jones, the clinician must involve her in
deliberation about the option of PCI versus medical therapy.
To do so, her clinician must not only invite Dr Jones to consider the options together but should share evidence-based
information that leads to more realistic patient expectations
about these options. Rothberg and colleagues15 recently
Dr Jones is a 55-year-old surgeon with class I angina. Her
exercise stress echocardiogram shows mild ischemia involving 2 segments of the inferior wall, and diagnostic coronary
angiography demonstrates a right coronary artery discrete,
­mid-80% stenosis. She is meeting with her cardiologist to
decide whether to pursue percutaneous coronary intervention
(PCI) with a drug-eluting stent or continue her current medications (aspirin, atorvastatin, metoprolol, and nitrates). Current
research evidence suggests that PCI and medical therapy have
comparable outcomes for death and myocardial infarction, as
well as similar relief of angina symptoms at 1-year followup.1 PCI might achieve more rapid relief of symptoms but with
some risk for bleeding, stent thrombosis, and restenosis. This
risk is not present with medications; however, these might take
longer to titrate and achieve improvement of symptoms and
have their own potential side effects.2,3 How should Dr Jones,
the patient, decide between PCI and medical therapy?
Spatz and Spertus4 have described the primary challenge
facing American health care in the 21st century as the need to
improve evidence-based, cost-effective, and patient-­centered
care. Although healthcare organizations and clinicians study,
measure, and improve gaps in evidence-based and cost-­
effective care, patient-centered care lacks comparable science
and action. Spatz and Spertus4 have proposed shared decision
making (SDM) as the path forward to achieve patient-centered
care and have introduced a series of articles in Circulation:
Cardiovascular Quality and Outcomes to describe the state
of the science in SDM, design and test tools for SDM, implement SDM in clinical practice, understand measurement and
outcomes of SDM, and promote policy and accountability in
SDM. In this introductory article, we address the following
questions:
1.Why do we need SDM?
2.How should we do SDM?
3.How should we measure SDM?
4.How should we promote SDM?
5.What are the future directions of SDM?
Why Do We Need SDM?
Evidence-based medicine requires an explicit process in which
clinicians determine the available options and the likelihood
From the Divisions of Cardiovascular Diseases (H.H.T.), Endocrinology (J.P.B., V.M.M.), Knowledge and Evaluation Research Unit, Mayo Clinic,
Rochester, MN.
Correspondence to Henry H. Ting, MD, MBA, Division of Cardiovascular Diseases, Knowledge and Evaluation Research Unit, Mayo Clinic, 200 First
Street SW, Rochester, MN 55905. E-mail [email protected]
(Circ Cardiovasc Qual Outcomes. 2014;7:00-00.)
© 2014 American Heart Association, Inc.
Circ Cardiovasc Qual Outcomes is available at http://circoutcomes.ahajournals.org
1
DOI: 10.1161/CIRCOUTCOMES.113.000288
2 Circ Cardiovasc Qual Outcomes March 2014
Downloaded from http://circoutcomes.ahajournals.org/ by guest on July 31, 2017
documented that >75% of patients who had undergone PCI
believed that PCI would reduce mortality or their risk for
myocardial infarction. These patient preferences could be
markedly different if patients were informed that PCI conferred no benefit for mortality or myocardial infarction as
compared with medical therapy.
A few recommendations in cardiology are strong (Class
I, Level of Evidence A).16 For these, SDM is relevant especially if the recommended treatments require changes in
patient lifestyle, behavior, and action to implement and sustain the decision and achieve the desired outcomes. For example, β-blockers and statins are Class I recommendations for
patients hospitalized with acute myocardial infarction,17 and
clinicians prescribe these medications for ≥90% of patients at
the time of hospital discharge for those without contraindications.18 However, many studies have demonstrated that adherence to these evidence-based medications declines to ≈50% at
1-year follow-up.19,20 This observation suggests that patients
either do not understand the benefit to continue taking these
medications or do understand the benefit but choose to stop
taking these medications. Without involving patients in this
decision, it should not be surprising that patients will prematurely discontinue life-saving medications.
At least in part, this lack of patient involvement also suggests that clinicians overlook the unique challenges patients
might face in implementing and sustaining the recommendation. Anticoagulation with warfarin in patients with atrial
fibrillation is another Class I recommendation.7 This recommendation assumes a certain balance of risk and benefit,
which requires patients to adhere to the medicine, a diet, and
regular monitoring. Patients might understand at the time
of prescription how likely they are to be able to adhere to
these behaviors and, thanks to their participation in decision
making, identify whether this or an alternative is best. Thus,
another justification for SDM is to ensure that patients realize
the value of effective interventions through their implementation with high fidelity.
In summary, patients are the best experts about their context, goals, values, and preferences for health care. Their participation in decision making helps clinicians make informed
judgments about how to translate the research evidence into
practice and improve the fit between the management plan and
the patient who will implement it and live with its intended
and unintended consequences. Also, SDM might improve
patient fidelity to the mutually agreed plan and improve safety
by reducing the misdiagnosis of patient preferences. These
practical justifications extend the well-rehearsed ethical justification for SDM based on the principle of autonomy that
patients should be empowered to make informed decisions
regardless of implications for cost, clinical performance measures, and clinician time and effort.21,22
To these ethical and practical justifications, some add the
ability of SDM to reduce healthcare costs and overuse of invasive procedures.23 These justifications, not supported by the
evidence, are actually subordinated to the ethical and practical justifications we noted before. That is, when SDM does
not result in reductions in cost or healthcare utilization, the
practice of SDM is still ethically good and a marker of highquality care.
Policymakers have recently included provisions in the
Patient Protection and Affordable Care Act to reimburse
SDM [bill H.R. 2590 (IIITH)], and some states (such as
Washington and Minnesota) have enacted legislation for
SDM.24 Organizations, including the Institute of Medicine25
and the Patient-centered Outcomes Research Institute,26 have
also promoted programs and funded studies for SDM, respectively. Professional societies, including the American College
of Cardiology (ACC) and American Heart Association (AHA),
have recommended SDM in their clinical practice guidelines
for PCI,27 congestive heart failure,9 and atrial fibrillation.7
Recently, 11 chief executive officers of leading healthcare systems proposed a Checklist for High Value Healthcare, which
included SDM as one of the key strategies to simultaneously
improve outcomes and reduce costs.28 The legislative and
healthcare organizational attention to SDM seems focused on
its ability to reduce costs.
In an era when healthcare is rapidly transforming to achieve
the triple aim of better patient care and experience, better population health, and more affordable care, SDM plays a critical role to promote patient-centered care. SDM should not be
viewed as a strategy to decrease cost by directing patients to
choose the least expensive treatment or reduce variation in
care by mitigating decisions driven by clinician preference.
This, no matter how laudable, will require manipulation of the
patient with irreparable loss of trust. Costs, we must remember, is not an ends outcome; it is a means outcome. The end
here is better patient health mediated by better patient and clinician engagement in decision making.
How Should We Do SDM?
In practice, clinicians strive to be empathic and expert and to
help patients make medical decisions for medications, tests,
procedures, and strategies for care often with the framing, “If
I were you, then this is what I would decide to do” or “If you
were my family or relative, this is what I would recommend
for you.” This framing makes 2 important assumptions: (1) the
clinician knows the patient’s social context such as their family, job, and other responsibilities; and (2) the clinician knows
the patient’s goals, values, and preferences for their health. In
the current era, it is unlikely that clinicians, often having little
in common with their patient in terms of social context, community, or education, will accurately acquire, guess, or incorporate this information during the typical clinical encounter
lasting 15 to 45 minutes.
Alternatively, what if clinicians framed the medical decision to, “What would the patient decide if the patient had my
knowledge, expertise, and experience?” This framing assumes
that the clinician’s knowledge, expertise, and experience can
be transferred and understood by the patient. Analogous to
the flipped classroom model for education,29 the clinical
encounter is transformed to an opportunity for the patient to
ask questions and achieve greater clarity concerning the benefits and risks between alternatives or no treatment. Finally,
a third way to frame the medical decision would be to use
a trusted agent or health coach who understands the patient
context and preferences, as well as the research evidence, and
functions to coach the patient to make the best decision. The
latter 2 approaches are the most aligned with the overarching
Ting et al Shared Decision Making: Science and Action 3
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goal for SDM to empower patients to choose between alternatives or no treatment, either because the patient now knows
what the clinician knows or because the patient enlists the
assistance of a trusted agent. Both approaches are flexible
and engage patients to the extent that each patient prefers
for this decision at this time. To us, this model of empathic
decision making, in which the extent of patient participation
is determined dynamically, as in a dance after exchanging
knowledge about the options, better describes feasible forms
of SDM in clinical practice.
Decision aids are tools to communicate evidence-based
information about the alternatives, their favorable and unfavorable features and outcomes, and the likelihood with which
those outcomes apply to individual patients. These tools take
multiple forms, although it has been observed that most lack
theoretical underpinning30 and fail to apply best practices of
risk communication.31 Furthermore, there is a need for more
and better tools that have been tested and validated to promote SDM in clinical practice. Some tools are designed to
inform patients outside the clinical encounter. However, there
is emerging evidence that patients rarely review these patient
education materials (often produced as videos), and, when
reviewed, they do not lead to SDM.32 Tools for use during
the encounter are also emerging in multiple formats (pictographs,33 issue cards,34 option grids),35 the most successful
of which are designed for use during clinical encounters.36 A
systematic review of randomized trials of decision aids used
for SDM has demonstrated efficacy for increased knowledge
transfer to patients, decreased patient decisional conflict, and
enhanced patient satisfaction with the decision-making process but have shown no consistent effect on adherence, clinical outcomes, overall patient satisfaction, or costs.37
How Should We Measure SDM?
SDM requires patient involvement in decision making. For
patients and clinicians to be on the same page, they need to
share and communicate information. A key outcome of SDM
is knowledge transfer of the benefits, and risks of alternative treatment options.37 If successful, patients report feeling
informed and able to make decisions that reflect their goals
and values and that they can do so free of any pressure, a
concept sometimes described as decisional comfort or, in a
negative frame, decisional conflict.38 But these, along with
patient and clinician satisfaction, the actual choice, and clinical and financial outcomes, represent downstream results of
the decision-making process. The most important measures of
SDM are those that capture the extent to which SDM actually took place. There are multiple challenges to measuring
the quality of the decision-making processes. These include
inaccurate and incongruent patient and clinician accounts,
inaccurate documentation of what took place in the encounter,
lack of validated instruments, and reliance of recordings of
the encounter for third-party judgments of unclear validity.39
With the introduction of more and better tools for SDM, it
will be equally important to demonstrate that these tools have
efficacy to enhance knowledge transfer, decisional comfort,
and patient engagement. Furthermore, measurement is also
needed to assess the effectiveness of implementation of validated SDM tools.
How Should We Promote SDM?
Although there may be general consensus on the need, rationale, and goals for SDM, challenges remain concerning the
best approaches for how to promote SDM in clinical practice.
SDM should not be reduced to a mandatory activity such
as documenting informed consent or filling out a checklist.
Studies have shown that informed consent has become the
minimal floor for communicating risks and benefits, confusing a much-needed process for patient engagement with the
completion of a document.40,41 Many patients do not read this
document or understand that alternatives or no treatment are
viable options.15,42,43 Furthermore, SDM should not be implemented as a printout or an electronic checklist to document
that a decision aid was given to the patient. Such mandatory
activities have resulted in medication prescriptions that are
never filled or education materials that are never reviewed.44
What if we considered SDM as vital as performing a history and physical examination or conveying empathy, trust,
and hope to provide health care? In this framing, performing the physical examination and conveying trust are not
mandated by or undertaken to comply with external requirements and not subject to public reporting or financial incentives. Rather, SDM becomes a core function of the clinician’s
professional responsibility. Such positioning is consistent
with the justifications of SDM on the grounds of ethics and
patient-­centered care. By viewing SDM as our professional
responsibility, rather than as mandated by internal or external regulatory requirements, SDM will be better positioned to
achieve the ultimate goal of patient engagement and patientcentered care.
What Are the Future Directions for SDM?
The study of SDM is a new scientific field where much work
remains to define the appropriate methods to measure process
and outcomes of SDM, design and test tools to facilitate SDM,
understand the barriers to implement SDM in clinical practice, and promote policy and accountability in SDM. Future
research should inform what type of problems can be solved
with SDM. What is the role for SDM to mitigate overuse and
variability of procedures that only clinicians can order or to
bend the escalating healthcare cost curve? What is the role of
SDM to mitigate underuse of effective procedures for which
there are no financial incentives or advertisements? Without
financial levers or consequences, there is no evidence to suggest that patients, even if given the choice, would routinely opt
for a less expensive or invasive treatment strategy. It may not
be reasonable to expect SDM to be able to improve evidence-­
based care, mitigate overuse, and decrease cost when other
initiatives such as diagnostic-related group,45 pay for performance,46 and public reporting of performance measures47
have had modest effects on outcomes and cost of care. Future
research might further establish that the fundamental justifications for SDM reside within ethical patient-centered care
presenting a moral dilemma to cost-conscious managers and
policymakers.
In our experience with trials to study the efficacy of decision aids for SDM,10,48–50 we have found that most clinicians
think they are already doing SDM, and most patients cannot
4 Circ Cardiovasc Qual Outcomes March 2014
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tell that the level of their participation in usual care is inadequate. Clinicians and patients do not know or expect a better
approach for decision making. This satisfaction with the status quo complicates evaluation, particularly in observational
studies but also in randomized trials. Also this complicates
implementation because there is no patient pull or clinician
desire to change the current process for decision making. In
our experience, a simple demonstration of SDM to clinicians
and patients sometimes leads to challenging questions about
the way we do things routinely and may represent a catalyst
for interest in SDM in practice.
Future research needs to illuminate the barriers and best
practices for implementing SDM in clinical practice,51 including but not limited to the following: patients capacity (in terms
of literacy, numeracy, education, resilience, and energy) and
interest in participation in decision making; clinicians capacity (in terms of duration, agenda, tools, and environment),
training, and competence to engage patients in decision making; capability of current systems and policies optimized and
incentivized to promote SDM; and the need to pivot our current culture and expectations for SDM.
SDM has the potential to transform health care and place
the patient at the center of medical decisions. No one-size-fitsall, or even fits-most, approach is apparent for how to do SDM
in clinical practice. In this series of articles in Circulation:
Cardiovascular Quality and Outcomes, our goal is to summarize the latest science about SDM and provide a toolkit for
investigators interested in performing research in SDM and
for clinicians and clinical policymakers interested in implementing SDM in practice. We are convinced that SDM would
advance patient-centered care and reframe medical decision
making to a state where all fateful decisions reflect not only
the best available research evidence but also the informed
preferences and the context of the patient.
Disclosures
None.
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Shared Decision Making: Science and Action
Henry H. Ting, Juan Pablo Brito and Victor M. Montori
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