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: jennifer_shin@meei.harvard.edu

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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.

References

1. Shin JJ, Randolph GW, Rauch SD. Evidence-based medicine

in otolaryngology, part 1: the multiple faces of evidence-based

medicine. Otolaryngol Head Neck Surg. 2010;142:637-646.

2. Shin JJ, Rauch SD, Wasserman J, Coblens O, Randolph GW.

Evidence-based medicine in otolaryngology, part 2: the current

state of affairs. Otolaryngol Head Neck Surg. 2011;144:331-337.

3. Shin JJ, Stinnett S, Page J, Randolph GW. Evidence-based

medicine in otolaryngology, part 3: everyday probabilities.

Diagnostic tests with binary results. Otolaryngol Head Neck

Surg. 2012;147:185-192.

4. Shin JJ, Stinnett SS, Randolph GW. Evidence-based medicine in

otolaryngology, part 4: everyday probabilities—nonbinary diag-

nostic tests. Otolaryngol Head Neck Surg. 2013;149:179-186.

5. Stacey D, Legare F, Colvin HP, et al. Decision aids for people

facing health treatment or screening decisions. Cochrane

Database Syst Rev. 2014;1:CD001431.

6. Barratt A. Evidence based medicine and shared decision

making: the challenge of getting both evidence and prefer-

ences into health care. Patient Educ Couns. 2008;73:407-

412.

7. Hirsch O, Keller H, Krones T, Donner-Banzhoff N. Arriba-lib:

association of an evidence-based electronic library of decision

aids with communication and decision-making in patients and

primary care physicians. Int J Evid Based Healthc. 2012;10:

68-76.

8. Calkins C, Cosway B, Cochran N, Venkatraman G, Elwyn G.

Fluid in middle ear. http://www.optiongrid.org/resources/flui

dinear_grid.pdf. Published February 17, 2014.

9. Mathur G, Napoli DJ, Padden C, et al. Language options for

deaf infants and children. http://www.optiongrid.org/resources/

languageoptions_evidence.pdf. Accessed March 19, 2015.

10. John R, Francis N, Carson-Stevens A, Edwards A, Lehman R,

Elwyn G. Antibiotics for a sore throat. http://www.optiongrid.org/

resources/sorethroat_evidence.pdf. Accessed March 19, 2015.

11. Owens D, Fox H, Lloyd A, Tomkinson A, Willmott V, Elwyn

G. Tonsillectomy or watchful waiting for children under 16

years old. http://www.optiongrid.org/resources/tonsillectomy_

evidence.pdf. Accessed March 18, 2015.

12. Elwyn G, O’Connor A, Stacey D, et al. Developing a quality

criteria framework for patient decision aids: online interna-

tional Delphi consensus process. BMJ. 2006;333:417.

13. Rosenfeld RM, Shiffman RN. Clinical practice guideline

development manual: a quality-driven approach for translating

evidence into action. Otolaryngol Head Neck Surg. 2009;140:

S1-S43.

14. Llewellyn-Thomas HA, Crump RT. Decision support for

patients: values clarification and preference elicitation. Med

Care Res Rev. 2013;70:50S-79S.

15. Feldman-Stewart D, Tong C, Siemens R, et al. The impact of

explicit values clarification exercises in a patient decision aid

emerges after the decision is actually made: evidence from a

randomized controlled trial. Med Decis Making. 2012;32:616-

626.

16. Man-Son-Hing M, Laupacis A, O’Connor AM, et al. A patient

decision aid regarding antithrombotic therapy for stroke pre-

vention in atrial fibrillation: a randomized controlled trial.

JAMA. 1999;282:737-743.

17. Fitzpatrick E, Coyle DE, Durieux-Smith A, Graham ID, Angus

DE, Gaboury I. Parents’ preferences for services for children

with hearing loss: a conjoint analysis study. Ear Hear. 2007;

28:842-849.

18. Barry MJ, Edgman-Levitan S. Shared decision making: pinna-

cle of patient-centered care. N Engl J Med. 2012;366:780-781.

19. Epstein RM, Gramling RE. What is shared in shared decision

making? Complex decisions when the evidence is unclear.

Med Care Res Rev. 2013;70:94S-112S.

20. Eddy DM. Clinical decision making: from theory to practice.

Anatomy of a decision. JAMA. 1990;263:441-443.

21. Sackett DL. Evidence-Based Medicine: How to Practice and

Teach EBM. New York, NY: Churchill Livingstone; 2000.

22. OECD. OECD Skills Outlook 2013: First Results from the

Survey of Adult Skills. Paris, France; OECD Publishing; 2013.

362 Otolaryngology–Head and Neck Surgery 153(3)

at SOCIEDADE BRASILEIRA DE CIRUR on September 2, 2015oto.sagepub.comDownloaded from

23. Amin M, Saunders JA, Fenton JE. Pilot study of the knowledge

and attitude towards evidence based medicine of otolaryngology

higher surgical trainees. Clin Otolaryngol. 2007;32:133-135.

24. Knops AM, Vermeulen H, Legemate DA, Ubbink DT.

Attitudes, awareness, and barriers regarding evidence-based

surgery among surgeons and surgical nurses. World J Surg.

2009;33:1348-1355.

25. Poolman RW, Sierevelt IN, Farrokhyar F, Mazel JA,

Blankevoort L, Bhandari M. Perceptions and competence in

evidence-based medicine: are surgeons getting better? A ques-

tionnaire survey of members of the Dutch Orthopaedic

Association. J Bone Joint Surg Am. 2007;89:206-215.

26. Dahm P, Poolman RW, Bhandari M, et al. Perceptions and

competence in evidence-based medicine: a survey of the

American Urological Association Membership. J Urol. 2009;

181:767-777.

27. Estabrooks C, Goel V, Thiel E, Pinfold P, Sawka C, Williams

I. Decision aids: are they worth it? A systematic review. J

Health Serv Res Policy. 2001;6:170-182.

28. Fagerlin A, Zikmund-Fisher BJ, Ubel PA. Helping patients

decide: ten steps to better risk communication. J Natl Cancer

Inst. 2011;103:1436-1443.

29. O’Connor AM. Validation of a decisional conflict scale. Med

Decis Making. 1995;15:25-30.

30. Michie S, Dormandy E, Marteau TM. The multi-dimensional

measure of informed choice: a validation study. Patient Educ

Couns. 2002;48:87-91.

31. Bennett C, Graham ID, Kristjansson E, Kearing SA, Clay KF,

O’Connor AM. Validation of a preparation for decision

making scale. Patient Educ Couns. 2010;78:130-133.

Pynnonen et al 363

at SOCIEDADE BRASILEIRA DE CIRUR on September 2, 2015oto.sagepub.comDownloaded from