Engaging Patient Partners In State of the Art Allergy Care: Finding Balance When Discussing Risk

Journal Pre-proof Engaging Patient Partners In State of the Art Allergy Care: Finding Balance When Discussing Risk Marcus Shaker, MD, MSc, Karen Hsu-Blatman, MD, Elissa M Abrams, MD PII:

S1081-1206(20)30075-2

DOI:

https://doi.org/10.1016/j.anai.2020.01.029

Reference:

ANAI 3151

To appear in:

Annals of Allergy, Asthma and Immunology

Received Date: 7 December 2019 Revised Date:

3 January 2020

Accepted Date: 22 January 2020

Please cite this article as: Shaker M, Hsu-Blatman K, M Abrams E, Engaging Patient Partners In State of the Art Allergy Care: Finding Balance When Discussing Risk, Annals of Allergy, Asthma and Immunology (2020), doi: https://doi.org/10.1016/j.anai.2020.01.029. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2020 American College of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

CME Title: Engaging Patient Partners In State of the Art Allergy Care: Finding Balance When Discussing Risk Marcus Shaker, MD, MSc1, 2 Karen Hsu-Blatman, MD, 1,2 Elissa M Abrams, MD3

1

Dartmouth-Hitchcock Medical Center, Section of Allergy and Immunology, Lebanon, NH

2

Geisel School of Medicine at Dartmouth, Hanover, NH

3

Department of Pediatrics and Child Health, Section of Allergy and Immunology, University of Manitoba, Winnipeg, Manitoba, Canada Corresponding Author: Marcus Shaker, MD, MSc Associate Professor of Pediatrics; Associate Professor of Community and Family Medicine Dartmouth-Hitchcock Medical Center, Section of Allergy and Immunology Dartmouth Geisel School of Medicine 1 Medical Center Dr. Lebanon, NH 03756 Phone (603) 653-9885 Fax (603) 650-0907

Funding Source: None

Clinical Trials Registration: Not Applicable

Word count: 3,992 (4,000 max)

References: 60 (60 max)

Figures/Tables: 8 (8 max). Figures – 6; Tables - 2

Conflicts of Interest: Marcus Shaker is a member of the Joint Taskforce on Allergy Practice Parameters; has a family member who is CEO of Altrix Medical; serves on the Editorial Board of the Journal of Food Allergy and the Annals of Allergy, Asthma, and Immunology

Karen Hsu-Blatman has served on a scientific advisory board for Biocryst.

Elissa Abrams: is a member of the National Medical Advisory for Food Allergy Canada and received an unrestricted educational grant from Novartis.

Key words: shared decision making; risk; psychology; cost-effectiveness; quality of life; health state utility; disability-adjusted life year; odds; patient decision aid; decisional conflict; decisional self-efficacy; food allergy

Abbreviations: quality-adjusted life years (QALY), disability-adjusted life years (DALY), shared decision making (SDM), decision aids (DA)

19-12-0613R1 abstract Objective: To review risk communication in the context of shared decision making. Data Sources: Articles describing risk communication, shared decision making, and cost-effective healthcare delivery. Study Selections: A narrative review detailing approaches to improve risk communication and shared decision making to optimize patient-centered cost-effective practice. Results: Risk communication must occur on a foundation of mutual trust and can be improved by keeping risk in perspective of everyday hazards such as using pictograms when possible, providing numeric likelihoods of risks and benefits, and discussing absolute risks. Variability in patient-perceived quality of life for allergic and non-allergic health states may impact the health and economic outcomes of many allergy therapies. Shared decision making improves patient knowledge and risk perception, engagement, and adherence. Patient decision aids can be time consuming to develop and validate, but their use is associated with a more accurate understanding of patientoriented outcomes. Conclusion: Communicating risk is complex and validated patient decision aids using visual aids, presenting essential information, using knowledge checks, and incorporating values clarification can reduce decisional conflict and improve decisional self-efficacy.

1 1

2

Introduction

Understanding contextual factors unique to each individual is central to building trust

3

and providing the right care, at the right time, every time. Communicating risk is complex but is

4

critical to high-quality healthcare delivery, because risk perception may be one reason for

5

practice variation, both from the standpoint of the clinician and the patient.1-9 Incorporating

6

shared decision making (SDM) can improve health by improving communication.4,10,11

7

SDM is particularly beneficial for chronic diseases with long-term therapies (such as

8

allergic conditions) because treatment options often involve uncertainty and trade-offs that

9

must be understood from each patient’s perspective.4,11,12 Patient engagement is central to

10

any successful treatment plan.12 The SDM process brings patients more directly into their own

11

care, promotes efficient care delivery, improves patient satisfaction with care received, and

12

may even lower liability costs.10,12,13 SDM invites patients to perform their own risk/benefit

13

analysis on medical information as they perceive and interpret it, in partnership with their

14

trusted physician. Appreciating how individuals perceive and process risks and benefits is a key

15

ingredient to include patients as stakeholders.3,4,11

16

17

18

Risk communication and risk framing

Communicating risk involves trust, health literacy, affect and emotion, and human

19

factors including age, occupation, and life experience.4,11 To be adequate, patients and families

20

must comprehend the information they need to effectively make decisions, and receive trusted

2 21

information at the point of care (Figure 1).4,11 Decisional conflict represents uncertainty when

22

choosing options and can be associated with decisional regret and ineffective decision

23

making.14 Effective decisions are characterized by high understanding of trade-offs, high

24

decisional certainty, and low decisional conflict.14 High fidelity decision making requires two-

25

way and multi-directional communication and engagement with space and time for values

26

clarification in iterative process.11 Medical decisions frequently involve difficult trade-offs,

27

creating vulnerabilities to effects of framing options available to patients.4 In fact, contextual

28

effects of apparently trivial word choices can impact decisions made by patients. 4,15 Gain or

29

loss framing can also have a significant impact on how risks are perceived (i.e., describing

30

chances of experiencing anaphylaxis versus not experiencing anaphylaxis).4 For example, a

31

patient with food allergy may perceive a food allergy fatality risk of 1-2 per million differently

32

than an understanding that there is a 99.9999% chance of not dying from food allergy.7,16

Numeracy is defined as the ability to comprehend what numbers mean, and it is not a

33 34

universal skill. By some estimates, only 85% of adults know which risk is higher: 1%, 5%, or

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10%.4,17 While objective measures of health numeracy include the Test of Functional Health

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Literacy (TOFHLA)18 and the Medical Data Interpretation Test19, these are not commonly used

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in clinical encounters.4 Understanding patient health numeracy is important, because high

38

numeracy individuals may prefer quantitative presentation of risks and benefits, while low

39

numeracy patients may benefit from qualitative presentations including use of stories and

40

comparisons.4 In fact, both quantitative and qualitative expressions of risk have limitations.4,20-

41

22

42

one patient may interpret a 10% risk as low while to another patient a “low” risk may indicate

From a qualitative point of view, “low” and “high” risks may be interpreted differently, as

3 43

an undesirable outcome approximates 1% or less.4,23 Quantitatively, it may difficult for some

44

patients to comprehend what a fatality risk of 1 in 10 million (the risk of food allergy fatality in

45

an unselected population) represents.7,16 In such situations risk anchoring can be helpful when

46

describing rare events. For example, by comparing the unselected food fatality risks to similar

47

probabilities (e.g., the risk to a lightning strike) important perspective can be added (Figure 2).7

48

Keeping risk in context seems intuitive, so much so that the editors of the British Medical

49

Journal compiled a table of everyday risks in 2003 (Table 1).24 However, depending on

50

individual experiences risk anchoring can have variable effectiveness for patients (e.g., a patient

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experiencing a recent severe bicycle accident may appreciate this risk comparison differently),

52

.25,26 Heuristic bias can be mitigated with graphical formats which can be helpful

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communicating quantitative and qualitative facts.4 However, choice of graphical presentation

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can also effect comprehension, particularly in low numeracy patients.4,27 While pie graphs

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effectively communicate an overall impression of risk, bar graphs most effectively communicate

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verbatim knowledge. Notably, pictographs effectively communicate both quantitative and

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qualitative risk (Figure 3).4,27 Presentation of natural frequencies versus percentages may also

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impact comprehension (e.g., 15% vs 15 out of 100 patients), particularly in low numeracy

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patients who may see percentages as abstract and therefore attribute a lower level of

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conceptual risk with them.4,28

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When discussing options, it is important to balance information provided against

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cognitive overload.4,29 Patients evaluated in allergy and immunology clinics are complex, and

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modern treatments present can present a dizzying array of trade-offs.30,31 Still, as much as

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possible it is important to reduce the amount of information initially provided to the essential

4 65

level, realizing patient context, preference, and educational will further guide the clinical

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dialouge.4,32,33

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The number needed to treat (or harm) is a useful concept to providers and is often

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derived from patient expected event rates and odds ratios produced from systematic reviews

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and meta-analyses.22,34 However, while intuitive from the provider’s perspective, patients may

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find this a difficult format to understand,35 because patients are approaching a conversation

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about treatment options from their unique perspective. Conversely, providers may consider

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treatments from both an individual patient’s perspective as well as in terms of populations at

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risk.34,36 Understanding the distinction between relative and absolute risk can be challenging

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even for clinical faculty, with one recent study suggesting only half of clinical faculty members

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were highly confident in their understanding of relative and absolute statistical terms.37 The

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distinction between relative and absolute risk is important, because descriptions in relative

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terms frequently lead to an increased perception of difference between competing options.20,35

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In particular, when the absolute risk (or benefit) is very low, simply describing the relative risk

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can be misleading (Figure 4).21 For example, although a risk difference 0.002% and 0.001% may

80

be quite small, their relative risk the same as the relative difference between 20% and 10%.

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Appreciating the difference between odds and odds ratios, risk and risk ratios, relative

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risk reduction, and absolute risk reduction can be challenging for patients and providers

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alike.21,37,38 Odds and probability are curious mathematical cousins that look nearly identical at

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low event rates but can become quite disparate as risk increases.38,39 While probability is a

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measure of the occurrence to the whole, odds is a measure of occurrence to nonoccurrence

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(Figure 5).38,39 Clinicians are usually keen to know probabilities of benefit and adverse events,

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but many non-clinicians may be more familiar with approaching event occurrence in terms of

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odds. For example, from a gambling perspective odds provide a useful heuristic for a fair

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payout. With four suites in a deck of cards, the odds of drawing a card of any particular suite

90

are 1:3. Therefore betting $1 on selecting a club would require a payout of $3 to break even.39

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Odds ratios (ORs) do have an advantage when considering binary outcomes of occurrence to

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nonoccurrence, because the OR of the nonoccurrence can be easily calculated as the inverse of

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the original OR.39 Depending on patient numeracy and experience, understanding probability

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and odds can be more or less challenging.17,37,39

95

96

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Trust, Risk Tolerance, and the Psychology of Risk

Trust is the currency of communication when physicians, patients, and their families

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discuss diagnostic and/or management options.11 The clinician, patient, and family members

99

bring unique perspectives to the process of shared decision making based on individual and

100

common experiences. Mutual trust is foundational to any clinical encounter and cannot be

101

overemphasized, particularly in underserved communities. Interwoven into the clinical

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conversation are aspects of implicit bias and cultural discordance. Adding complexity is the

103

larger societal perspective of value-based care which can also inform potentially wasteful

104

medical practices which may be cognitively satisfying or psychologically comfortable.5,6,8,9,40-44

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For example, while advising patients to activate emergency medical services or undergo

6 106

extended clinical observation after resolved anaphylaxis may appear the “safest” management

107

strategy, these universal management approaches are not cost-effective.5,8

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Life experiences and developmental stages (e.g., adolescence) influence risk

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tolerance.3,26 Recency bias can influence both patients and clinicians when discussing event

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rates, with more available memories of anaphylaxis or adverse reactions leading to a greater

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perception of risk.26 Professional training can also implicitly influence risk perception. Health

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and safety professionals tend to be more risk averse while financial professionals tend to

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tolerate greater risks when options are framed in positive (gain) terms.3 These findings

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highlight a potential bias of clinicians who, motivated by primum non nocere, may assume

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patients have similar risk preferences. For example, unwarranted practice variation has been

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documented in the requirement for self-injectable epinephrine in patients receiving allergen

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immunotherapy (AIT). While universal self-injectable prescriptions are not cost-effective9, in

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the most recent AAAAI/ACAAI surveillance study, only 15% of practices never prescribed

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epinephrine autoinjectors for AIT patients while 30% prescribed them > 90% of the time.1

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While prescribing self-injectable may be consistent with a clinician’s risk preferences and

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practice style, a process of shared decision making may elicit a different patient perspective –

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particularly in consideration of high epinephrine autoinjector costs.45-47

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Geographic variation in risk-tolerance also leads to practice style variation and

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unwarranted practice variation. For example, although the benefit of early infant peanut

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introduction is clear, particularly in higher risk infant populations, international variation in

126

screening recommendations continues to exist.42 While patient-preference care may explain

7 127

some degree of variation, a formal decision aid to assist patients and providers in deciding

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whether or not to screen high risk infants is not yet available.14 Additional instances of allergy

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practice that illustrate geographic practice variation include home omalizumab administration6

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and management of eosinophilic esophagitis.48 While the European Commission has approved

131

omalizumab self-administration following uneventful administration of the first 3 doses,

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supervised administration continues to be universally recommended in the United States,

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although the cost-effectiveness of this practice has been questioned.6 Strictly on the domestic

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front, Hung and colleagues reported that provider preferences drive treatment approaches to

135

eosinophilic esophagitis, with topical steroids used in 86% if cases for initial treatment at the

136

University of North Carolina compared with <1% in Greenville (P<0.01), where dietary

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elimination is favored.48 Variation in medication insurance coverage can also be a factor in

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practice variation (e.g., there is currently no FDA-approved medication for the treatment of

139

eosinophilic esophagitis).

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141

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Life, Death, QALYs, and DALYs

Medical decisions have non-binary outcomes, and patients and clinicians must weigh

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risks of benefit as well as morbidity.4,12,49,50 Because decision making is complex and patients

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must choose non-perfect health states associated with variable quality and disability, measures

145

including quality-adjusted life years (QALY) and disability-adjusted life years (DALY) are useful

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constructs.49,50 QALYs and DALYs are two side of the same coin – QALYs measure benefit (years

147

gained adjusted to perfect health) and DALYs measure burden (years of mortality and morbidity

8 148

averted).49,50 Both QALYs and DALYs are derived using health state utilities from subjective

149

valuation of competing health states (e.g., living with a peanut allergy vs living without a peanut

150

allergy) evaluated under conditions of risk. Health state utilities represent the degree a person

151

is willing to quantitively trade or risk years of their life in order to live without a given condition.

152

Health state utilities are important for understanding health and economic outcomes across

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medical practice49,51, but variation in patient-reported health state utilities, impact of proxy-

154

reporting, influence of transient utility decrements, and role of alternative treatment

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presentations requires further study.26,27,50,52 Furthermore, the degree to which standard

156

quality of life instruments such as the EQ-5D reflect real-life patient values across medical

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practice, in particular in the allergy clinic, is incompletely understood.50,53 A better

158

understanding of how allergy treatments influence patient-reported health state utilities is

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needed, as evidenced by the significant impact health-state utility improvements may play in

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the cost-effectiveness of food allergy screening and food immunotherapy (Figure 6).51,53,54

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Preference reversals present a challenge in shared decision making.52 While utility and

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prospect theory assume stable behavioral risk preferences49, in reality human decision making

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may show unexpected variation.49,52 To some degree it is not surprising that patients may have

164

a change of heart when considering significant trade-offs, particularly when taking time to

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reflect on their options and discussing with family members. Because of this, it is important to

166

allow adequate time and space for patients to reach decisions.55 Variation in how patients value

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health states requires further study.51,53 For example, recent analyses of peanut

168

immunotherapy suggested treatment may be cost-effective, but value of therapy was highly

9 169

dependent on patient-specific factors including quality of life, anxiety, baseline rate of

170

accidental peanut reactions, and health state utilities.51,53,56

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A further layer of complexity is added with proxy-decision making of caregivers for their

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children.2,57 For example, caregiver heuristic judgment process have been shown to contribute

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to proxy-risk perceptions of asthma exacerbation risk.57 However, proxy reports cannot always

174

be substituted for direct patient experience and may differ in some circumstances.2

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Shared decision making can mitigate and standardize risk perception

Shared decision making (SDM) is a process of mutual engagement of clinicians and

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patients characterized by the multidirectional exchange of best available evidence together

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with experience, expectations, and preferences to maximize decisional self-efficacy while

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minimizing decisional conflict and regret.4,12 SDM is a dynamic and iterative process that is

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most helpful for medical decisions with two or more reasonable options.4

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SDM is often the missing link in optimizing value in health care, which is surprising

183

because most patients are already researching treatment options online before their first

184

consultation.12 Because patients can obtain information quickly online, it becomes important

185

to have two-way open communication about reliable and accurate sources of medical

186

information.12 While the Institute of Medicine has promoted SDM to improve healthcare

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quality, defining the essential elements of the shared decision making process can be elusive.12

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At the most fundamental level SDM individualizes care based on patient needs and

10 189

preferences, providing contextual and adequate knowledge with values clarification to engage

190

and empower patients choose options with minimal decisional uncertainty and regret.4,12,14

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While not all clinical circumstances warrant a shared decision with patients, it is

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important to appreciate individual patient values and circumstances when evaluating

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management options.4 Some patients may prefer to receive a more direct medical

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recommendation, “doctor, what do you recommend?”, particularly in encounters characterized

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by a high quotient of mutual trust.4 But even in these instances, an implicit process of values

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clarification can be incorporated into counseling to tailor care to each patient’s needs.4 In

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some circumstances, motivational interviewing can be a means to values clarification and

198

reinforcement. At times, the strength of evidence-based practice largely directs medical

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decisions and shared decision making plays a minor (if any) role.4 There are certainly times

200

where shared decision making is not the most appropriate practice paradigm. Examples

201

include use of antibiotic therapy for bacterial meningitis, bronchodilators and corticosteroids

202

for severe asthma exacerbations, and annual influenza vaccination for patients with asthma.58

203

Although patient autonomy plays a central role in all medical encounters, shared

204

decision making further invites the patient to partner with the clinician when presented with

205

management options which are in equipoise or are dependent on an individual patient’s values.

206

SDM had been described to involve three distinct conversations – “team talk”, “option talk”,

207

and “decision talk.”12 Team talk involves a collaborative discussion between the clinician and

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the patient to describe choices and clarify goals. It is important to relay central and pertinent

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clinical details during team talk.12 Option talk focuses on discussing alternatives and

11 210

incorporates principles of risk framing and risk communication.12 Patients benefit from visual

211

descriptions of risk using pictograms, as well as understanding contextual risk and patient

212

stories/vignettes.14,27 When a patient understands choices and alternatives, values clarification

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and knowledge checks are next steps before working with the patient to reach a decision.4,19,29

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SDM is an ongoing conversation, and many patients need time to digest and discern what

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matters most to them before making a decision.12,14 But the process is well worth it. SDM not

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only improves patient knowledge, but also increases accurate risk perceptions, patient

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involvement, and adherence while decreasing health care costs and invasive procedures.12

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Application of shared decision making can improve allergy care, and the examples

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where it is needed are myriad – from asthma, to urticaria, to drug allergy, and

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immunodeficiency.12 Signs shared decision making may be appropriate include evidence of

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geographic practice variation, variation in risk perception or preference, and circumstances of

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low or preference dependent variable healthcare value.8-10,42,58 There are also many (less

223

obvious) circumstances where shared decision making may also have a significant (and under-

224

appreciated) role.12 Given the geographic variation in infant peanut screening, there is likely a

225

role for SDM in counseling families in the United States, despite current guidance for universal

226

screening of infants with severe eczema or egg allergy.42,54 SDM could also be incorporated

227

into decisions for reflex activation of emergency medical services5 and prolonged hospital

228

observation following resolved anaphylaxis8, discretionary prescription of self-injectable

229

epinephrine with allergen immunotherapy9, and a universal requirement for clinic-observed

230

omalizumab.6 Each of these universal practices has been shown to be potentially low-value.

231

Universal activation of emergency medical services for resolved anaphylaxis costs $1.3 billion

12 232

dollars per life saved5, while prolonged hospital observation of resolved anaphylaxis (to observe

233

a case of biphasic anaphylaxis) could cost $31 million or more per death prevented.8 Similarly,

234

universal self-injectable epinephrine for all patients receiving AIT cost $669 million per quality-

235

adjusted life year.9 Requiring universal omalizumab clinic administration costs $500 million per

236

death prevented, and could actually lead to more fatalities due to automobile clinic-travel

237

fatalities than anaphylaxis fatalities prevented by clinic-administration.6

238

SDM improves healthcare value, and some states have incorporated SDM into

239

statute.13,59 For example, in Massachusetts a certified provider must encourage shared decision

240

making for certain patient-preference sensitive conditions in order to qualify as an accountable

241

care organization.59 SDM can also mitigate liability, as seen in Washington state where statute

242

outlines how providers can document SDM to achieve enhanced liability protection.13 As such,

243

in some settings use of SDM can serve to both communicate risk to the patient while

244

decreasing risk to the provider.

245

246

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Patient Decision Aids

Decision aids (DAs) are tools to facilitate share decision making and may be paper-based

248

or electronic and may be completed before, during, or after a clinical encounter.14 A key

249

feature is that the decision aid does not replace the clinical encounter, but expands

250

communication and allows an explicit process for patients to understand and digest necessary

251

knowledge.12,14 A great benefit of DAs is that they not only provides timely critical information,

13 252

but also that they allow an explicit process of risk presentation, risk framing, and values

253

clarification.12 DAs have been shown to improve patient knowledge of options and lead to

254

more realistic expectations of outcomes.4 Treatment adherence improves because patients

255

are more engaged in management options that align with their values.4,12

256

It is important for clinicians and developers of decision aids alike to appreciate that

257

these tools are living documents that must be continuously updated with the ever-evolving

258

evidence base.14 Decision aids do not advise patients to pursue a specific course of action but

259

empower them to make the decision that is right for them.12 Use of DAs first requires a

260

foundation of mutual trust – DAs should not be used in a simple didactic “checklist” manner but

261

should be set in the framework of an ever-evolving clinician-provider relationship. DAs can

262

assist the clinician in exploring contextual factors critical to the patient and family in decision

263

making, which are often much less familiar than pathophysiology of disease. Conversely from a

264

patient perspective, the DA can relate important concepts related to disease management. The

265

clinician should consider trust as a potential modifier – either barrier or facilitator, in the

266

collaborative work necessary to optimize management plans.

267

Development of a decision aid begins with a methodologically rigorous process of a

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decision needs assessment using quantitative patient-specific interviews, instrument

269

development incorporating an iterative expert and stakeholder feedback, and acceptability and

270

validation testing using standardized measures including the Decision Conflict Score (DCS) and

271

Decision Self-Efficacy Score (DSE).14 The DCS has been shown to have discriminant validity for

272

decisional delay and uses 16 questions (Chronbach alpha, 0.78) to report decisional conflict on

14 273

a scale of 0 (very low decisional conflict) to 100 (very high decisional conflict). The DSE

274

correlates with feeling informed and supported, has a Chronbach alpha of 0.92, and is similarly

275

reported on a scale of 0 (very poor decisional self-efficacy) to 100 (very high decisional self-

276

efficacy). Resources for decision aid development are freely available through the International

277

Patient Decision Aids Standards (IPDAS) website.14

278

SDM will be central to decisions about peanut immunotherapy.51,53,56 Evidence

279

suggests that in the short-term peanut oral immunotherapy may cause more reactions than it

280

prevents51,56; however, this risk may be offset by some degree of protection against severe

281

accidental reactions. 51,53 How patients value this trade-off will vary, and the process of

282

transmitting necessary knowledge and promoting values clarification is complex but critical to

283

providing best management.12,14 In the decision whether or not to pursue peanut

284

immunotherapy, patients may also soon have several options to consider – including strict

285

avoidance without immunotherapy, avoidance with oral immunotherapy, or avoidance with

286

epicutaneous immunotherapy.51 A formal decision aid will be helpful in the shared decision

287

making process.53,60 In a recently validated decision aid for commercial peanut

288

immunotherapies, Greenhawt reported high decisional self-efficacy with use of the decision aid

289

(mean DES 91.9, standard deviation (SD), 14.1) and low decisional conflict (mean DCS 20.2, SD

290

19.9). Interestingly, investigators found less decisional conflict among parents of older

291

children.60

292 293

Formal decision aids can streamline the process of SDM “SMART” communication (i.e., Specific, Measurable, Achievable, Realistic, and Time-sensitive).12,14 To date, patient decision

15 294

aids have been developed for AIT, severe asthma, atopic dermatitis12, but additional areas

295

where decision aids could be successfully leveraged include eosinophilic esophagitis

296

management48, food allergy screening and prevention42-44, drug allergy skin testing vs direct

297

oral challenge32,33, and post-anaphylaxis management.5,8 More work is needed to better

298

understand how decision aids can be incorporated into a busy allergy clinic, where they are

299

stored, and how to ensure decision aids are kept up to date.12,14 While many decision aids are

300

available online (Table 2), there is no central repository for patient decision aids.12 SDM can

301

and should play a central role in state of the art allergy care, and how resources will be

302

leveraged to ensure living documents are created and available for use remains an ongoing

303

challenge.12,14 Additional research is also needed to better define how clinicians are using SDM

304

and formal DAs, to evaluate patient specific outcomes associated with use of DAs, and to

305

understand the impact of SDM on clinical productivity and patient quality of life.12,14 Optimizing

306

risk communication and SDM is likely to require several ACTION items, including: (i) leveraging

307

administrative support to align SDM with clinic flow to improve physician engagement; (ii)

308

creating a role for the physician to coordinate SDM while utilizing a collaborative

309

multidisciplinary model to support risk communication, and (iii) encouraging efforts to improve

310

reimbursement for SDM.

311

312

313 314

Conclusion

As we look to a future delivering medical breakthroughs, risk communication will continue to have a central place in the allergy clinic.4,12 While not interchangeable, perception

16 315

and reality are intertwined, and how patients perceive and incorporate risk into medical

316

decisions is complex.4,11 Building trust, appreciating patient and family perspectives vary,

317

acknowledging our own frame of reference, allowing time and space for the medical decision-

318

making process to evolve, and incorporating validated decision aids into patient care will add

319

value and improve the patient experience.3,23,29

320

Shared decision making is both necessary for, and consequential to, patient

321

empowerment. But even with validated decision aids, accurately communicating risk reliably

322

to every patient will be difficult. The perfect is not the enemy of the good, and our challenge

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will be to stand by what is good and make it better – which in the case of shared decision

324

making will require a commitment to funding, development, validating, maintaining, indexing,

325

updating, and centralizing patient decision aids. While our professional organizations will play

326

a key role in this endeavor, as clinicians our task is to use them to begin the touchstone

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conversations that will make the difference for today’s patient.

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References

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21. Jiroutek MR, Turner JR. Relative vs absolute risk and odds: Understanding the difference. J Clin Hypertens (Greenwich) 2019;21:859-61. 22. Alonso-Coello P, Carrasco-Labra A, Brignardello-Petersen R, et al. Systematic reviews experience major limitations in reporting absolute effects. J Clin Epidemiol 2016;72:16-26. 23. Honda H, Yamagishi K. Directional verbal probabilities: inconsistencies between preferential judgments and numerical meanings. Exp Psychol 2006;53:161-70. 24. Table of Everyday Risks. (Accessed October 19, 2019, at https://www.bmj.com/content/suppl/2003/09/25/327.7417.694.DC1.) 25. Wundrack R, Prager J, Asselmann E, O'Connell G, Specht J. Does Intraindividual Variability of Personality States Improve Perspective Taking? An Ecological Approach Integrating Personality and Social Cognition. J Intell 2018;6. 26. Richie M, Josephson SA. Quantifying Heuristic Bias: Anchoring, Availability, and Representativeness. Teach Learn Med 2018;30:67-75. 27. Hawley ST, Zikmund-Fisher B, Ubel P, Jancovic A, Lucas T, Fagerlin A. The impact of the format of graphical presentation on health-related knowledge and treatment choices. Patient Educ Couns 2008;73:448-55. 28. Peters E, Hart PS, Fraenkel L. Informing patients: the influence of numeracy, framing, and format of side effect information on risk perceptions. Med Decis Making 2011;31:432-6. 29. Peters E, Dieckmann N, Dixon A, Hibbard JH, Mertz CK. Less is more in presenting quality information to consumers. Med Care Res Rev 2007;64:169-90. 30. Agache I, Akdis CA. Precision medicine and phenotypes, endotypes, genotypes, regiotypes, and theratypes of allergic diseases. J Clin Invest 2019;130:1493-503. 31. Kucuksezer UC, Ozdemir C, Akdis M, Akdis CA. Precision/Personalized Medicine in Allergic Diseases and Asthma. Arch Immunol Ther Exp (Warsz) 2018;66:431-42. 32. Blumenthal KG, Huebner EM, Fu X, et al. Risk-based pathway for outpatient penicillin allergy evaluations. J Allergy Clin Immunol Pract 2019;7:2411-4 e1. 33. Macy E, Vyles D. Who needs penicillin allergy testing? Ann Allergy Asthma Immunol 2018;121:523-9. 34. Shaker MS WD, Golden DBV, Oppenheimer J, Bernstein JA, Campbell RL, Dinakar C, Ellis AK, Greenhawt M, et al. Anaphylaxis - a 2020 practice parameter update, systematic review, and GRADE analysis. Journal of Allergy and Clinical Immunology 2020. 35. Sheridan SL, Pignone MP, Lewis CL. A randomized comparison of patients' understanding of number needed to treat and other common risk reduction formats. J Gen Intern Med 2003;18:884-92. 36. Guyatt GH, Oxman AD, Vist GE, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ 2008;336:924-6. 37. Hazelton L, Allen M, MacLeod T, LeBlanc C, Boudreau M. Assessing Clinical Faculty Understanding of Statistical Terms Used to Measure Treatment Effects and Their Application to Teaching. J Contin Educ Health Prof 2016;36:278-83. 38. Effective Clinical Practice. American College of Physicians. . (Accessed 10/19/19, at http://ecp.acponline.org.) 39. Norton EC, Dowd BE, Maciejewski ML. Odds Ratios-Current Best Practice and Use. JAMA 2018;320:84-5. 40. Shaker MS, Greenhawt MJ. Analysis of Value-Based Costs of Undesignated School Stock Epinephrine Policies for Peanut Anaphylaxis. JAMA Pediatr 2019;173:169-75. 41. Shaker M, Greenhawt M. The Health and Economic Outcomes of Peanut Allergy Management Practices. J Allergy Clin Immunol Pract 2018;6:2073-80.

42. Shaker M, Stukus D, Chan ES, Fleischer DM, Spergel JM, Greenhawt M. "To screen or not to screen": Comparing the health and economic benefits of early peanut introduction strategies in five countries. Allergy 2018;73:1707-14. 43. Shaker M, Verma K, Greenhawt M. The health and economic outcomes of early egg introduction strategies. Allergy 2018;73:2214-23. 44. Shaker M GM. The Health and Economic Benefits of Approaches for Peanut Introduction in Infants with a Peanut Allergic Sibling. Allergy 2019;Accepted for publication. 45. Shaker M GM. Association of Fatality Risk With Value-Based Drug Pricing of Epinephrine Autoinjectors for Children With Peanut Allergy: A Cost-effectiveness Analysis. JAMA Network Open 2018;17:e184728. 46. Shaker M, Bean K, Verdi M. Economic evaluation of epinephrine auto-injectors for peanut allergy. Ann Allergy Asthma Immunol 2017;119:160-3. 47. Rubin R. EpiPen price hike comes under scrutiny. Lancet 2016;388:1266. 48. Huang KZ, Jensen ET, Chen HX, et al. Practice Pattern Variation in Pediatric Eosinophilic Esophagitis in the Carolinas EoE Collaborative: A Research Model in Community and Academic Practices. South Med J 2018;111:328-32. 49. Moffett ML, Suarez-Almazor ME. Prospect theory in the valuation of health. Expert Rev Pharmacoecon Outcomes Res 2005;5:499-505. 50. Augustovski F, Colantonio LD, Galante J, et al. Measuring the Benefits of Healthcare: DALYs and QALYs - Does the Choice of Measure Matter? A Case Study of Two Preventive Interventions. Int J Health Policy Manag 2018;7:120-36. 51. Shaker M, Greenhawt M. Estimation of Health and Economic Benefits of Commercial Peanut Immunotherapy Products: A Cost-effectiveness Analysis. JAMA Netw Open 2019;2:e193242. 52. Kusev P, van Schaik P, Martin R, Hall L, Johansson P. Preference reversals during risk elicitation. J Exp Psychol Gen 2019. 53. Dufresne E, Poder TG, Begin P. The value of oral immunotherapy. Allergy 2019. 54. Greenhawt M, Shaker M. Determining Levers of Cost-effectiveness for Screening Infants at High Risk for Peanut Sensitization Before Early Peanut Introduction. JAMA Netw Open 2019;2:e1918041. 55. Buelow MT, Jungers MK, Chadwick KR. Manipulating the decision making process: Influencing a "gut" reaction. J Clin Exp Neuropsychol 2019;41:1097-113. 56. Shaker MS. An Economic Analysis of a Peanut Oral Immunotherapy Study in Children. J Allergy Clin Immunol Pract 2017;5:1707-16. 57. Shepperd JA, Lipsey NP, Pachur T, Waters EA. Understanding the Cognitive and Affective Mechanisms that Underlie Proxy Risk Perceptions among Caregivers of Asthmatic Children. Med Decis Making 2018;38:562-72. 58. Westert GP, Groenewoud S, Wennberg JE, et al. Medical practice variation: public reporting a first necessary step to spark change. Int J Qual Health Care 2018;30:731-5. 59. The Commonwealth of Massachusetts. Certification as Acountable Care Organization (ACO. (Accessed December 30, 2019, at https://malegislature.gov/Laws/GeneralLaws/PartI/TitleII/Chapter6d/Section15.) 60. Greenhawt M SM, Winders T, Buckstein D, Davis R, Fleischer D, Kim E, Chan E, Stukus D, Matlock D. Development and Acceptability of a Shared Decision-Making Tool for Commercial Peanut Allergy Therapies. Submitted for Publication.

Figure Legends Figure 1. Risk communication should incorporate information patients and families need to effectively make decisions at the point of care. Figure 2. Estimated risks of fatal anaphylaxis. Permission needed. Turner PJ, Jerschow E, Umasunthar T, Lin R, Campbell DE, Boyle RJ. Fatal Anaphylaxis: Mortality Rate and Risk Factors. J Allergy Clin Immunol Pract. 2017;5(5):1169-78.

Figure 3. While pie graphs effectively communicating an overall impression of risk, bar graphs most effectively communicating verbatim knowledge. Notably, pictographs effectively communicating both quantitative and qualitative risk . Adapted from: Fischhoff B. Communicating Risks and Benefits: An Evidence-Based User’s Guide. The Food and Drug Administration (FDA), US Department of Health and Human Services. https://www.fda.gov/media/81597/download. Accessed October 13, 2019. Permission needed. Figure 4. Relative risks may obscure significant differences and the number needed to treat is closely related to absolute risk reduction. Permission Needed: http://ecp.acponline.org/mayjun99/primer.pdf. Accessed 10/19/19; https://ecp.acponline.org/janfeb00/primer.htm. Accessed 10/19/19 Figure 5. When events are infrequent, probability and odds approximate each other but as event rates increase the measures diverge. Permission needed: http://ecp.acponline.org/ecp.primer.2.pdf. Accessed 10/19/19. Figure 6. Peanut allergy health state improvement drives health and economic impact of epicutaneous (a) and oral (b) immunotherapy. Differential health state improvement also impacts the most cost-effective option (c). Most cost-effective therapies are indicated by color at a willingness to pay thresholds of $100,000 per quality-adjusted life-year. Permission needed. Shaker M, Greenhawt M. Estimation of Health and Economic Benefits of Commercial Peanut Immunotherapy Products: A Cost-effectiveness Analysis. JAMA Netw Open. 2019;2(5):e193242.

Table 1. Everyday Risks Some familiar Risks Getting three balls in the UK national lottery Dying on the road over 50 years of driving Transmission of measles Dying of any cause in the next year

The Chance They Will Happen 1 in 11 1 in 85 1 in 100 1 in 100

Annual risk of death from smoking 10 cigarettes per day Getting four balls in the UK national lottery

1 in 200 1 in 206

Needing emergency treatment in the next year after being injured by a can, bottle, or jar

1 in 1,00

Needing emergency treatment in the next year after being injured by a bed mattress or pillow Death by an accident at home Getting five balls in the UK national lottery Death by an accident at work Death playing soccer Death by murder Being hit in your home by a crashing aeroplane Death by rail accident Drowning in the bath in the next year Getting six balls in the UK national lottery Being struck by lightning

1 in 2000 1 in 7100 1 in 11 098 1 in 40 000 1 in 50 000 1 in 100 000 1 in 250 000 1 in 500 000 1 in 685 000 1 in 2 796 763 1 in 10 000 000

Death from new variant Creutzfeldt-Jakob disease Death from a nuclear power accident

1 in 10 000 000 1 in 10 000 000

Table of Everyday Risks. Available from: https://www.bmj.com/content/suppl/2003/09/25/327.7417.694.DC1. Accessed 10/19/19.

Table 2. Shared Decision Making Resources5 Organization Massachusetts General Hospital: Health Decision Sciences Center

Patient Link

Implementation Link

https://mghdecisionsciences.org/too ls-training/ decision-worksheets/

https://mghdecisionsciences.org/ tools-training/

Agency for Health Research and Quality

https://effectivehealthcare.ahrq.gov /search?f%5B0% 5D1⁄4field_product_type%3Adecisio n_aid

Ottawa Hospital Research Institute

https://decisionaid.ohri.ca/

https://www.ahrq.gov/healthliteracy/curriculumtools/shareddecisionmaking/inde x.html https://decisionaid.ohri.ca/imple ment.html

Mayo Clinic Shared Decision Making National Resource Center

https://shareddecisions.mayoclinic.o rg/decision-aidinformation/decision-aids-forchronic-disease/

https://shareddecisions.mayoclin ic.org/resources/sharing-withothers/

Healthwise

https://www.healthwise.net/ohridec isionaid/

https://www.healthwise.org/shar eddecisionmaking.aspx

https://acaai.org/resources/interacti ve-tools

https://college.acaai.org/practice -management-center

https://www.dartmouthhitchcock.org/supportiveservices/decision_making_help.html

https://med.dartmouthhitchcock.org/csdm_toolkits.html

The American College of Allergy, Asthma, and Immunology DartmouthHitchcock Medical Center: Center for Shared Decision Making

Figure 1. Risk Communication and Framing4 • • • • • • • •

Provide numeric likelihoods of risks and benefits Provide absolute risks, not just relative risks Keep denominators consistent Keep time frames constant Use pictograms and other visual aids when possible Reduce superfluous information (cognitive overload) Provide positive and negative frames Keep risk in perspective of everyday hazards

Figure 2. Annual incidence of fatal anaphylaxis in an unselected population

Figure 3. Graphical presentations of Risk

Figure 4. Absolute vs Relative Risk Reduction and Number Needed to Treat

Figure 5. Probability and Odds

Figure 6. Health State Utility Impact on Peanut Immunotherapies

CME LEARNING OBJECTIVES AND QUESTIONS

CME article: Engaging Patient Partners To Provide State of the Art Allergy Care: Finding Balance When Discussing Risk

Learning Objectives: At the conclusion of this activity, participants should be able to:

1. Define shared decision making and barriers to implementation. 2. Discuss strategies to improve risk communication including keeping risk in perspective of everyday hazards and use of pictograms, numeric likelihoods, and exchange of essential information.

19-12-0613R1

Q1. Benefits of shared decision making include a. the ability to remove patient-specific contextual factors from clinical discussions. b. a more efficient clinic flow by use of decision aids in place of individual patient counseling. c. universal provider familiarity with shared decision making. d. improved patient engagement and possible liability protection. e. recency bias.

Q1 ANS: d. improved patient engagement and possible liability protection

Rationale:

The shared decision making process brings patients more directly into their own care, promotes efficient care delivery, improves patient satisfaction with care received, and may even lower liability costs. References: 1. Blaiss MS, Steven GC, Bender B, Bukstein DA, Meltzer EO, Winders T. Shared decision making for the allergist. Ann Allergy Asthma Immunol 2019;122:463-70. 2. Washington State Legislature. Consent form - Consents - Prima facie evidence - Shared decision making - Patient decision aid - Failure to use. (Accessed December 30, 2019, at https://app.leg.wa.gov/rcw/default.aspx?cite=7.70.060.)

Q2. Strategies to improve risk communication include: a. providing numeric likelihoods of risks and benefits. b. varying time frames of options discussed. c. providing an optimistic description of risk with positive framing. d. discussing relative risks while avoiding absolute numbers. e. providing forest plots with odds ratios as part of patient educational handouts.

Q2 ANS: a. providing numeric likelihoods of risks and benefits

Rationale: When discussion options, it is important to balance information provided against cognitive overload. Both quantitative and qualitative expressions of risk have limitations. From a qualitative point of view, “low” and “high” risks may be interpreted differently, so providing numeric likelihoods of risks and benefits is helpful. Understanding the meaning of odds ratios and the distinction between relative and absolute risk can be challenging for patients.

References: 1. Fischhoff B. Communicating Risks and Benefits: An Evidence-Based User’s Guide. The Food and Drug Administration (FDA), US Department of Health and Human Services. https://www.fda.gov/media/81597/download. Accessed October 13, 2019. 2. Lipkus IM, Samsa G, Rimer BK. General performance on a numeracy scale among highly educated samples. Med Decis Making 2001;21:37-44. 3. Jiroutek MR, Turner JR. Relative vs absolute risk and odds: Understanding the difference. J Clin Hypertens (Greenwich) 2019;21:859-61.

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Q3. When considering risk a. patients tend to be more risk-averse than clinicians. b. at high event rates, odds and probability converge. c. management of risk demonstrates significant geographic variation d. parent preferences always match those of children. e. clinicians should aim to communicate as much information as possible, so patients are fully informed.

Q3 ANS: c. management of risk demonstrates significant geographic variation

Rationale: When discussion options, it is important to balance information provided against cognitive overload. Odds and probability look nearly identical at low event rates but can become quite disparate as risk increases. Geographic variation in risk-tolerance leads to practice style variation and unwarranted practice variation.

References: 1. Fischhoff B. Communicating Risks and Benefits: An Evidence-Based User’s Guide. The Food and Drug Administration (FDA), US Department of Health and Human Services. https://www.fda.gov/media/81597/download. Accessed October 13, 2019. 2. Peters E, Dieckmann N, Dixon A, Hibbard JH, Mertz CK. Less is more in presenting quality information to consumers. Med Care Res Rev 2007;64:169-90. 3. Norton EC, Dowd BE, Maciejewski ML. Odds Ratios-Current Best Practice and Use. JAMA 2018;320:84-5.

4. Q4. Health state utilities a. are patient based satisfaction scores used to assess effectiveness of patient decision aids. b. can be used to risk-stratify patients who may benefit most from shared decision making. c. are generally uniform across disease states and populations. d. are economically quantifiable measures of quality of life (QoL) that are used to derive quality-adjusted life years. e. can be substituted for point of service decision aids.

Q4 ANS: d. are economically quantifiable measures of quality of life (QoL) that are used to derive quality-adjusted life years.

Rationale: Medical decisions have non-binary outcomes, and patients weigh risks of benefit as well as morbidity Because decision making is complex and patients must choose non-perfect health states associated with variable quality and disability, measures including quality-adjusted life years (QALY) and disabilityadjusted life years (DALY) and useful constructs. Health state utilities represent the degree a person is willing to quantitively trade or risk years of their life in order to live without a given condition.

References:

1. Moffett ML, Suarez-Almazor ME. Prospect theory in the valuation of health. Expert Rev Pharmacoecon Outcomes Res 2005;5:499-505.

2. Augustovski F, Colantonio LD, Galante J, et al. Measuring the Benefits of Healthcare: DALYs and QALYs - Does the Choice of Measure Matter? A Case Study of Two Preventive Interventions. Int J Health Policy Manag 2018;7:120-36.

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Q5. Shared decision making a.

is not necessary when patient decision aids are available.

b.

Is necessary in every clinical encounter.

c.

is a mutual engagement of clinicians and patients characterized by the multidirectional exchange of best available evidence together with experience, expectations, and preferences to maximize decisional self-efficacy while minimizing decisional conflict and regret.

d.

involves clinical direction of families to choose one option over another.

e.

can be considered completed when a patient signs an informed consent.

Q5 ANS: c. is a mutual engagement of clinicians and patients characterized by the multidirectional exchange of best available evidence together with experience, expectations, and preferences to maximize decisional self-efficacy while minimizing decisional conflict and regret.

Rationale: Shared decision making individualizes care based on patient needs and preferences, providing contextual and adequate knowledge with values clarification to engage and empower patients choose options with minimal decisional uncertainty and regret. While not all clinical circumstances warrant a shared decision with patients, it is important to appreciate individual patient values and circumstances when evaluating management options. Decision aids are tools to facilitate shared decision making. A key feature is that the decision aid does not replace the clinical encounter, but expands communication and allows an explicit process for patients to understand and digest necessary knowledge

References: 1. Blaiss MS, Steven GC, Bender B, Bukstein DA, Meltzer EO, Winders T. Shared decision making for the allergist. Ann Allergy Asthma Immunol 2019;122:463-70.

2. Fischhoff B. Communicating Risks and Benefits: An Evidence-Based User’s Guide. The Food and Drug Administration (FDA), US Department of Health and Human Services. https://www.fda.gov/media/81597/download. Accessed October 13, 2019. 3.

Patient Decision Aids. The Ottawa Hospital Research Institute. (Accessed October 13, 2019, at https://decisionaid.ohri.ca.)