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Invited Article—General Otolaryngology
Evidence-Based Medicine inOtolaryngology, Part 5: PatientDecision Aids
Otolaryngology–Head and Neck Surgery2015, Vol. 153(3) 357–363� American Academy ofOtolaryngology—Head and NeckSurgery Foundation 2015Reprints and permission:sagepub.com/journalsPermissions.navDOI: 10.1177/0194599815592366http://otojournal.org
Melissa A. Pynnonen, MD, MSc1, Gregory W. Randolph, MD2, andJennifer J. Shin, MD, SM2
Sponsorships or competing interests that may be relevant to content are dis-
closed at the end of this article.
Abstract
Modern medical decision making is a complex task requiringcollaboration between patients and physicians. Related clini-cal evidence may delineate a clearly favorable path, but inother instances, uncertainty remains. Even in these circum-stances, however, there are techniques that optimize deci-sion making by blending existing evidence with individualpatient values in the context of physician counseling. Thisinstallment of ‘‘Evidence-Based Medicine in Otolaryngology’’focuses on the crucial issue of how practitioners mayapproach clinical situations where the data do not delineatea single irrefutable path. We describe decision aids—toolsthat can educate patients about data related to complexclinical decisions. We review their definition, quality stan-dards, patient interface, benefits, and limitations. We alsodiscuss the related concept of option grids and the role ofdecision aids in evidence-based practice.
Keywords
decision aid, physician-patient relations, decision making
Received April 11, 2015; revised May 27, 2015; accepted June 1, 2015.
In this series entitled ‘‘Evidence-Based Medicine in
Otolaryngology,’’ we consider what constitutes evidence-
based practice, the state of the literature in our field, and
specific numeric analyses that may help facilitate everyday deci-
sions.1-4 As we continue to focus on the application of clinical
evidence in daily practice, we recognize that there are often
inherent limitations (and sometimes contradictions) in published
studies. With that in mind, this installment focuses on the cru-
cial issue of how practitioners may handle clinical situations
where the data do not delineate a single irrefutable path. Even
in these circumstances, there are techniques that optimize deci-
sion making and blend existing evidence with individual patient
values in the context of physician counseling.
Much of medical practice centers on decisions: decisions
regarding diagnostic testing, medications, and surgery. Making
such decisions involves 2 steps: (1) understanding the possible
choices, including the risks and benefits of each, and (2) asses-
sing each choice relative to the patients’ intrinsic preferences.
Some decisions are straightforward to the point of being
reflexive, while others may lead to near equipoise, with more
than 1 viable option.
Decision aids are tools that have been developed to facil-
itate this process, and they can be utilized to educate
patients regarding the data related to complex clinical deci-
sions. While they are in the incipient phase in otolaryngol-
ogy, they have been utilized in other medical venues, and
they are expected to facilitate evolution of data-centered and
guideline-recommended practice in modern medical practice.
This fifth installment of ‘‘Evidence-Based Medicine in
Otolaryngology’’ describes decision aids, the types of health
care decisions that they can best facilitate, related quality
standards, and their benefits and limitations.
What Is a Decision Aid?
A decision aid is a tool designed to help patients make an
evidence-based health care decision when multiple choices
exist. This tool can help patients make testing or treatment
decisions.5 A decision aid displays information on choices
and potential outcomes, based on the strongest, most rele-
vant published data.6,7 They have been developed as book-
lets and brochures, as well as electronic and Internet-based
media. They complement the physician’s role and are used
in conjunction with physician counseling. There is high-
quality evidence indicating that decision aids improve
patient knowledge and reduce patient decision conflict.5
A decision aid consists of 3 basic components. First, it
describes the nature of the health care condition and
describes clearly the different options available for manage-
ment of that condition. Second, a decision aid provides
1Department of Otolaryngology, University of Michigan Health System, Ann
Arbor, Michigan, USA2Department of Otolaryngology, Harvard Medical School, Boston,
Massachusetts, USA
Corresponding Author:
Jennifer J. Shin, MD, SM, Department of Otolaryngology, Harvard Medical
School, 45 Francis Street, Boston, MA 02115, USA.
Email: [email protected]
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evidence-based information about the health care condition
and each of the given choices, including the risks, benefits,
and uncertainties associated with each potential choice.
Third, it encourages the patient to consider each choice in
the context of his or her personal values.
What Health Care Decisions AreAppropriate for a Decision Aid?
Decision aids are optimally utilized in health care decisions
for which there is no clear-cut or initially obvious ‘‘best’’
choice. Such decisions are often termed ‘‘preference sensi-
tive’’ because, in the absence of evidence indicating which
option is best, the decision should be influenced by patient
and physician preferences. Decision aids have been applied
in medicine for both testing and treatment options. Examples
from other fields include decision aids that help patients
select a preferred form of colon cancer screening or decide
whether to proceed with prostate-specific antigen testing,
breast cancer genetic evaluation, or prenatal screening. They
have also been used to help patients make decisions about
menopausal hormone replacement therapy, breast cancer
treatment options, bariatric surgery, feeding tube placement,
and medical treatment for atrial fibrillation.5
Multiple otolaryngology conditions involve complex
decision making and involve multiple treatment options that
could be clarified with decision aids, including otitis media,
hyperthyroidism, chronic sinusitis, laryngeal cancer, indeter-
minate thyroid nodule cytopathology, acoustic neuroma, and
deafness. To our knowledge, the otolaryngology literature
contains no formal report of a decision aid’s development
and testing. However, option grids—a related but more
simple decision tool—have been developed for otitis media
with effusion,8 language options for deaf children,9 sore
throat,10 and tonsillitis11 (Figure 1).
What Is an Option Grid?
An option grid is a document that presents the features of
each option alongside one another in a streamlined way to
allow easy comparison across the potential choices. For each
choice, the grid provides answers to a series of questions:
What does the treatment involve? How long does it take?
What is the recovery time? What are long-term expectations?
Because of its simple format, an option grid is a useful
way to provide a large amount of information to patients.
An option grid is not equivalent to a decision aid. An option
grid may be a useful format for presenting factual informa-
tion within a decision aid, but a high-quality decision aid
would contain additional features beyond what an option
grid offers; these are discussed below.
What Standards Should a Decision AidMeet?
Because decision aids have been shown to influence
patients’ choices, it is important that they are formulated to
maintain high-quality standards, including that they are free
of bias, based on evidence, and up-to-date. With these
concerns in mind, the International Patient Decision Aid
Society convened an international panel of researchers,
practitioners, patients, and policy makers. This panel used a
modified Delphi technique to develop consensus-based cri-
teria for assessing decision aid quality.12 These 62 criteria
compose a detailed framework to evaluate quality. The cri-
teria encompass the content, development process, and
effectiveness of the decision aid. These include the stan-
dards necessary for a tool to meet the definition of a deci-
sion aid; for example, the aid must state that treatment
choices are available, and it must describe the risks and ben-
efits of each choice. These also include criteria necessary to
avoid harmful bias; for example, the decision aid must
describe the choices in a balanced fashion using understand-
able language and risk statistics. In addition to the factual
information, the tool should help patients clarify and express
their personal values, which may be influenced by personal,
familial, cultural, or religious beliefs. Finally, decision aids
should be developed through a rigorous and transparent pro-
cess, analogous to the high-quality processes that have been
established for developing clinical practice guidelines.13 A
summary of the 62 criteria from the International Patient
Decision Aid Society is listed in the Table 1.
How Does a Decision Aid Interface withPatient Values?
A decision aid helps patients clarify their values, using an
implicit or explicit approach.14,15 An implicit approach to
values clarification might be a statement directing the patient
to think about which positive and negative features of the
choices matter most to them. In contrast, an explicit approach
to values clarification actively engages the patient in an exer-
cise that prompts weighing the attributes of treatment options
against their underlying values and may take a variety of
forms.5,15,16 A paper-brochure decision aid may contain a list
of values and instruct the patient to rate them from most to
least important, followed by a prompt to ‘‘discuss these values
with your doctor.’’ Another approach is to give the patient a
deck of cards, each representing a different value, and allow
him or her to sort the cards from most to least important
(Figure 2). An electronic decision aid may contain a much
more sophisticated values clarification exercise. For example,
conjoint analysis uses an interactive format and a series of
questions, each asking the patient to identify a preferred option
between 2 choices to elucidate his or her priorities.17 Once the
physician and patient share a basic understanding of treatment
options and the patient’s personal values, they can discuss
attributes of care, such as quality of life versus survival.18,19
How Does a Decision Aid FacilitateImplementation of Evidence-BasedPractice?
If we consider its role in clinical practice, evidence-based
medicine has 3 key components: the medical evidence, the
physician’s interpretation of the evidence, and the patient’s
health care preferences.1,20,21 In the individualized approach,
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implementation of evidence-based medicine requires that a
physician not only access, interpret, and convey medical evi-
dence to the patient, taking into account the unique clinical
circumstances that may affect the risk/benefit profile, but also
invoke the patient’s personal values related to health care.
Putting all of these components together in a 15-minute visit
can be a lot to ask of a busy physician. Also, understanding
personalized risk statistics can be difficult for physicians and
patients alike. Assessments of mathematical skills among
Americans show average numeracy scores that reflect diffi-
culty in interpreting proportions and graphs.22 Even physi-
cians may have limited understanding of terms such as odds
ratio and 95% confidence interval.2,23-26
A decision aid can facilitate this cognitively challenging
discussion by providing a formal structure to consider each
treatment choice at hand (including the option of no treat-
ment). The tool provides a concrete means to incorporate
patient preferences with medical evidence and physician
recommendations. Finally, the decision aid gives the patient
the opportunity to directly interface with the data, relieving
the clinician of being the sole source of information. A deci-
sion aid or other support tool may allow a patient the extra
time needed for thoughtful deliberation and alleviate some
of the time pressure ubiquitous in today’s practice
environment.7
What Are the Benefits of Decision Aids?
There is a host of evidence that patient educational interven-
tions such as decision aids can increase knowledge and pro-
vide more accurate risk perceptions.5,27 Decision aids are
reported to ‘‘increase knowledge, reduce decisional conflict,
cause greater satisfaction with decision-making, support
more realistic expectations, achieve a greater likelihood of
being able to make a decision, result in an increased associ-
ation between patient values and decisions, support patient
participation and enhance communication between physi-
cians, patients, and their relatives.’’6 One meta-analysis
quantified this benefit, demonstrating a significant improve-
ment in knowledge after decision aid use (pooled mean dif-
ference, 13.3%; 95% confidence interval, 11.1-15.5) and a
higher proportion of patients making a decision congruent
with their values (relative risk, 1.51; 95% confidence inter-
val, 1.17-1.96).5
Decision aids purportedly improve patient engagement
because they are designed with the patient in mind. They
are typically written in plain English, with few assumptions
regarding a patient’s underlying health literacy. Decision
aids often present statistics in multiple formats, using con-
sistent language and absolute risk statistics. For example,
‘‘Without treatment, 2 in 100 people will have the cancer
recur. With treatment, 1 in 100 people will have the cancer
recur.’’ This is much easier for patients to understand when
compared with descriptions of relative risk reduction, such
as ‘‘fifty percent lower risk of cancer recurrence.’’ Based on
studies demonstrating the limited mathematical and statisti-
cal sophistication in the average clinical environment, it is
imperative that a decision aid convey numeric risk informa-
tion to patients in a manner that can be clearly and reliably
understood.28 A decision aid also often uses figures such as
a pictogram with 99 happy faces and 1 sad face to depict a
1% risk of a bad outcome (Figure 3).
What Are the Limitations of Decision Aids?
Decision aid development is not trivial; it requires a signifi-
cant time and financial investment to create, test, and refine
the content. Although the tool is based on published medical
evidence, the scientific information must be revised and for-
matted to ensure that patients of varying educational and lit-
eracy levels can read and comprehend it and that the
literature represented is selected without bias. This may
often include figures to convey basic health information or
health statistics. Procedures to ensure accuracy of patient
understanding and ease of usability of decision-related
materials are time-consuming. Further contributing to the
burden of development is the need to iteratively revise the
Table 1. Domains of the IPDAS Quality Framework for PatientDecision Aids.12
Development Process Decision Aid Content Evaluation
Systematic development
process
Options
delineated
Establish
effectiveness
Discloses conflict
of interest
Probabilities presented
Evidence-based
information
Values clarified
Patient story usage
Guiding/coaching
Balanced presentation
of options
Uses plain language
Internet access
Abbreviation: IPDAS, International Patient Decision Aid Society.
Figure 2. Implicit and explicit approaches to values clarificationexercises. The example demonstrates these approaches relative tooptions for treatment of otitis media with effusion.
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text and determine whether a decision aid facilitates patient
choices consistent with their values and goals as well as the
continually evolving medical literature. Because a decision
aid may influence a patient’s choice and health care out-
come, it should undergo a rigorous evaluation in a rando-
mized controlled trial prior to its routine use. Specific
assessments that may be used to evaluate decision aid effec-
tiveness include measures of decision conflict,29 knowledge,
concordance between patient’s chosen option and stated per-
sonal values,30 and patient satisfaction.31
A decision aid informs the patient but, of course, does
not replace the physician. The physician plays a necessary
role by counseling the patient to consider medical evidence
in light of the particular patient and clinical situation. The
physician is best suited to help patients understand how data
from clinical studies may pertain to their individual circum-
stances. In some cases, there are limited published data to
inform the patient’s choice, and in complex situations or
chronic diseases, patient preferences may evolve over time
such that the patient and the physician may need to revisit
the issue and reassess options.
Effectively implementing a decision aid into a busy clini-
cal practice requires careful consideration of when to pres-
ent patients with the decision aid. In a primary care
practice, the end of the visit may be a feasible option so
that the patient has time to read the material at home, dis-
cuss with family members, and discuss with the physician at
a follow-up appointment. In a specialty practice, it may not
be as easy for the patient to return for a follow-up appoint-
ment, depending on travel distances, costs, work flow pat-
terns, and patient preferences, which may mean that
treatment decisions are optimally made during an initial
consultation.
The time required to develop a decision aid may be one
reason why decision aids have not been developed in otolaryn-
gology. Their successful implementation in many areas of
medicine bodes well for their application in otolaryngology–
head and neck surgery. Many clinical conditions may benefit
from patient decision aids; some examples include medical
treatment versus radioactive ablation for hyperthyroidism, ton-
sillectomy for recurrent tonsillitis, laryngectomy versus che-
motherapy and radiation for advanced laryngeal cancer, or
tympanostomy tube surgery for otitis media.
Conclusion
Modern medical decision making is a complex task requir-
ing collaboration between the patient and the physician. The
quality of the decision-making process and the decision
itself may be enhanced with patient decision aids. These
tools complement physician counseling and help patients
make health care choices. The International Patient Decision
Aid Society has developed standards to identify high-quality
decision aids, and many such decision aids have been
Figure 3. Visual depiction of absolute risks: chance of stroke and bleeding with aspirin and warfarin. Reprinted with permission fromJAMA.16
Pynnonen et al 361
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developed in general medicine and oncology. Otolaryngology
lags behind other clinical specialties, as no formal decision
aids have yet been developed. However, option grids exist
for several common otolaryngology conditions and represent
a major step forward in patient decision support. Decision
aids may be relevant for otolaryngology conditions, including
tonsillectomy for recurrent tonsillitis, tympanostomy tube pla-
cement for otitis media, radioactive iodine ablation for
hyperthyroidism, laryngectomy versus chemotherapy and
radiation for advanced laryngeal cancer, and cytomolecular
testing versus surgical excision in cytologically indeterminate
thyroid nodules.
Acknowledgments
J.J.S. thanks Thomas Y. Lin for support during the preparation of
this manuscript. The content is solely the responsibility of the
authors and does not necessarily represent the official views of the
National Institutes of Health.
Author Contributions
Melissa A. Pynnonen, draft writing, revisions for intellectual con-
tent, figure selection, final approval; Gregory W. Randolph, draft
editing, revisions for intellectual content, final approval; Jennifer J.
Shin, draft writing, revisions for intellectual content, corresponding
author, final approval.
Disclosures
Competing interests: Melissa A. Pynnonen, research reported in
this publication was supported by the National Center for
Advancing Translational Sciences of the National Institutes of
Health (2KL2TR000434); Gregory W. Randolph, receives textbook
royalties from Evidence-Based Otolaryngology (Springer, 2008);
Jennifer J. Shin, receives textbook royalties from Evidence-Based
Otolaryngology (Springer, 2008) and Otolaryngology Prep and
Practice (Plural Publishing, 2013) and is a recipient of a Harvard
Medical School Shore Foundation/Center for Faculty Development
Grant.
Sponsorships: None.
Funding source: None.
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