4/29/2016 1

Effectively Communicating Risk

Professor Christopher Trudeau, Western Michigan University –

Cooley Law School @proftrudeau

4/29/2016 2

What is risk communication?

Risk communication is

helping people – patients in

this context – understand

the nature and seriousness

of a certain action

(procedure, test, etc.) so

they can make an informed

decision about how to deal

with the risks involved.

4/29/2016 3

V.

4/29/2016 4

Key components of risk communication

1. What we communicate.

2. How much patients want to know.

3. When we communicate it.

4. How we communicate it.

4/29/2016 5

What we’ll cover today

What: Legal requirements for obtaining consent

How much info do patients want.

When: Thinking of risk communication as a process – not just as documents

How: Creating risk hierarchies to effectively present information

How: Best ways to communicate numbers & statistical information

Source: By Michael Mittag for Cool Risk; http://www.coolrisk.com/risk-cartoons/risk-communication

4/29/2016 6

Differing Legal Disclosure

Requirements

Clinical Procedures

Description of the

procedure

Risks

Alternatives

Other legal disclosures

(like conflicts of

interest, financial

interests, etc.)

Research Trials

Eight/Nine mandatory

disclosures required

under Federal

regulations.

Five additional

disclosures required

depending on

circumstances (There is

a proposal to take these

up to nine.)

4/29/2016 7

Why the differing disclosure

requirements?

Clinical Procedures

State based

Developed organically

out of the common law.

“Common law” is the law

that develops in each

state based on the case

decisions that arise over

the years.

Not overly governed by

statute (but this varies by

state).

Research Trials

Developed exclusively in

response to egregious acts

of medical researchers.

Completely regulated by

federal statutes and

regulations.

Patients are not the

primary reason for trial, so

that has been the

justification for the detailed

disclosures.

4/29/2016 8

Two standards for “procedural”

informed consent

Reasonable-Physician Standard

Looks at what a reasonable physician in like circumstances would disclose for the procedure.

Clinical practice guidelines and industry standards are key components to determining if disclosure adequate.

Michigan follows this standard

Reasonable-Patient Standard

Looks at whether a “reasonable patient” would have been appropriately informed and consented.

Standard developed before we had the evidence about health literacy, so incentivizes providers to change their ways.

A 50/50 split between the states.

4/29/2016 9

Risk involves much more than

communicating what is legally required

4/29/2016 10

Written communication is no substitute for in-person conversations – despite this session’s focus

Ensure your providers are trained – teach-back training is very useful.

Help your orgs design health-literate institutional processes – not just forms.

4/29/2016 11

Communicating risk requires us to

consider a patient’s needs (and limitations)

What does risk mean to patients?

What can go wrong?

What are the chances it will go wrong?

What do these numbers mean for me?

What will my recovery look like?

What happens if complications arise?

Do I have any other options? Are those options likely

to help?

What is most important to me in this horrible looking

set of documents you gave me?

4/29/2016 12

Researchers using patients from two public

hospitals found …

Source: http://www.ncbi.nlm.nih.gov/pubmed/7474271

4/29/2016 13

Why all providers should use clear

consent documents?

Because creating clear forms helps patients better understand, which serves provider’s duties.

Because clear forms will better protect your organization by reducing lawsuits based on mistaken/misread/misunderstood information.

4/29/2016 14

Speaking of informed consent…

The typical informed consent document has an average 10th – 12th grade reading level.

But the average reading level of adults in the U.S. falls between the 6th & 7th grade, depending on the study.

4/29/2016 15

Guess the reading level needed to understand this…

I consent to the performance of operations and

procedures in addition to or different from those now

contemplated, whether or not arising from presently

unforeseen conditions, which the above-named

doctor or his associates or assistants may consider

necessary or advisable in the course of the operation.

4/29/2016 15

4/29/2016 16 4/29/2016 16

4/29/2016 17

fdssds

Pro

vid

er N

am

e R

ed

acte

d

Not c

ente

red

No a

ltern

ativ

es??

4/29/2016 18

Pro

vid

er N

am

e R

ed

acte

d

Not centered

No alternatives??

Guess the reading level of this

section?

14th – 15th Grade

4/29/2016 19

Provider N

am

e R

ed

acted

Not centered

No alternatives??

What are some problems with this

section?

4/29/2016 20

The way we organize info is important too

– we shouldn’t bury key information

4/29/2016 21

For a “bad” example of this, let’s

consider REMS

REMS = Risk Evaluation & Mitigation Strategy

When are REMS used?

When the FDA determines that “additional safety measures are needed beyond the professional labeling to ensure that a drug’s benefits outweigh its risks.”

Important: one of the main points of a REMS is to communicate risk to patients & providers.

4/29/2016 22

Consider the mindset of those

creating REMS

Goal is to get the

food, drug,

cosmetic approved.

Their lawyer’s main

goal is to protect

the organization.

Patients &

consumers are

secondary.

4/29/2016 23

Risk info

4/29/2016 24

Let’s take a closer look…

Do we need more of the info disclosure?

4/29/2016 25

Why would you order the information

in this way?

1. Because you are more worried about complaints over information disclosure than you are about the risks of the treatment; or

1. Because you just don’t understand what is important to patients; or

2. Because you needed to get this done quickly to comply with FDA regulations and meet company objectives.

4/29/2016 26

To fix this, we must prioritize risk info

by creating functional risk hierarchies

What is that? A functional risk hierarchy is simply a guide for prioritizing and ordering the information based on the needs of the document’s intended audience.

For patient-focused documents, this means prioritizing what is important to patients first, and then including whatever else you feel needs to be included to protect your org.

4/29/2016 27

Always consider patients, first: what do we know about users of health docs?

1. People decide for themselves how much attention to pay to a document We cannot assume people will work their way through a document because we think it is important!

2. These documents are tools that are meant to be used for a purpose.

They are not novels meant to be read from cover to cover.

4/29/2016 28

3. People actively interpret as they read – they don’t wait until the end and then assess the big picture. So what we put up front matters greatly. And so does the way we draw a user’s attention –

e.g. text walls won’t work.

4. Users interpret documents based on their own

knowledge and expectations. User-testing high-stakes documents can help to ensure the document’s message is reaching the intended audience.

For more, read – Redish, J.C. (1993). Understanding Readers, Chapter 1. In Barnum, C.M and Carliner, S. (Eds.) Techniques for Technical Communicators. New York: Macmillan.

4/29/2016 29

Structure all health communications as if everyone has limited health literacy You cannot tell by looking at someone Higher literacy skills ≠ understanding Anxiety can reduce ability to manage health

information Everyone benefits from clear communications

Universal precautions are key

4/29/2016 30

Creating a functional risk hierarchy

Consider your intended users and learn about their needs. (Focus groups? User testing afterwards?)

Write down the information that your intended users would want to know.

Rank that information from most important to least important.

Then write down any other information you must disclose by law (or that your org wants to discuss).

Add those into the bottom of the list (only move it up if the law requires it, for example).

4/29/2016 31

A better REMS risk hierarchy

4/29/2016 32

The problem with numbers

4/29/2016 33

Numeracy includes minimal

statistical literacy

Health numeracy is a person’s ability to access, interpret, and use numeric information to make health decisions.

“Minimum statistical literacy applies to every medical

decision, from whether a child’s tonsils should be removed

to whether an adult should take cholesterol-lowering

medication. Minimal literacy focuses on the main concepts

(like absolute risks) rather than the more advanced topics

of variability (e.g., confidence intervals).” Gigerenzer, et al, Helping Doctors and Patients Make Sense of Health Statistics,

Psychological Science (2008)

http://www.psychologicalscience.org/journals/pspi/pspi_8_2_article.pdf

4/29/2016 34

We know people in the

U.S. have low literacy

skills.

But people are even

worse with numbers.

The U.S. ranks at the

bottom in numeracy

skills.

4/29/2016 35

Our numeracy skills are tested daily

4/29/2016 36

Our numeracy skills are tested daily

4/29/2016 37

Pop Quiz on Numeracy

1. A person taking Drug A has a 1% chance of having an

allergic reaction. If 1,000 people take Drug A, how many

would you expect to have an allergic reaction?

Answer: ___ persons out of 1000

1. A person taking Drug B has a 1 in 1,000 chance of an

allergic reaction. What percent of people taking Drug B will

have an allergic reaction?

Answer: ___%

3. Imagine that I flip a coin 1,000 times. What is your best

guess about how many times the coin would come up

heads in 1,000 flips?

Answer: ___ times of 1000

4/29/2016 38

Pop Quiz on Numeracy - Answers

1. A person taking Drug A has a 1% chance of having an

allergic reaction. If 1,000 people take Drug A, how many

would you expect to have an allergic reaction?

Answer: 10 persons/1000 (30% missed this)

1. A person taking Drug B has a 1 in 1,000 chance of an

allergic reaction. What percent of people taking Drug B

will have an allergic reaction?

Answer: 0.1% (75% missed this)

3. Imagine that I flip a coin 1,000 times. What is your best

guess about how many times the coin would come up

heads in 1,000 flips? Answer: 500/1000 (24% missed this)

Source: Schwartz,Woloshin, Black, and Welch (1997)

4/29/2016 39

Quick Quiz

“Assume you conduct breast cancer screening using mammography in a certain region. You know the following information about the women in this region:

The probability that a woman has breast cancer is 1% (prevalence)

If a woman has breast cancer, the probability that she tests positive is 90% (sensitivity)

If a woman does not have breast cancer, the probability that she nevertheless tests positive is 9% (false-positive rate)”

“A woman tests positive. She wants to know from you whether that means that she has breast cancer for sure, or what the chances are. What is the best answer?

a. The probability that she has breast cancer is about 81%.

b. Out of 10 women with a positive mammogram, about 9 have breast cancer.

c. Out of 10 women with a positive mammogram, about 1 has breast cancer.

d. The probability that she has breast cancer is about 1%.”

Gigerenzer G, Gaissmaier W, Kurz-Milcke E, Schwartz LM, Woloshin S. Helping Doctors and Patients Make Sense of Health Statistics. Psychological Science in the Public Interest. 2007;8:53-96.

4/29/2016 40

Don’t worry: many gynecologists

grossly overestimated too

4/29/2016 41

Tip: Convert Stats Into Natural Frequencies

“Assume you conduct breast cancer screening using mammography in a certain region. You know the following information about the women in this region: Ten out of every 1,000

women have breast cancer

Of these 10 women with breast cancer, 9 test positive

Of the 990 women without cancer, about 89 nevertheless test positive”

Gigerenzer G, Gaissmaier W, Kurz-Milcke E, Schwartz LM, Woloshin S. Helping Doctors and Patients Make Sense of Health Statistics. Psychological Science in the Public Interest. 2007;8:53-96.

4/29/2016 42

There are many great resources on

numeracy – I am not the expert

Minnesota Health Literacy Partnership

has a great resources on numeracy available at

http://healthliteracymn.org/resources/presentations-

and-training

NIH Making Data Talk: A Workbook: Includes key

concepts, practical suggestions, and examples on

communicating health-related data to various

audiences. cancer.gov/publications/health-

communication

4/29/2016 43

Numeracy tips from these masters

4/29/2016 44

What to do about numbers?

Focus on what you

want the patient to

do

Do not overload

patient’s with

meaningless data.

Reduce the patient’s

cognitive burden

4/29/2016 45

How patients learn: fuzzy-trace theory

Verbatim thinking –

precise details and facts.

Quantitative.

Gist-based thinking – the

bottom line the patient

needs to be concerned

about.

How to use this for

patients?

Focus on gist-based

messages first that include

calls to action and relates

the message to everyday

life.

Then, if necessary,

reinforce the message

carefully with clear, easy-

to-interpret data.

4/29/2016 46

Order is important!

Start with the most

important

information

Group figures

logically –

categorically, by

date, etc.

Tips for using numbers with patients

Further explain

complex topics

Numbers for

one idea at a

time

Underscore the gist of each piece

Less is more!

4/29/2016 47

Round numbers are easier to understand,

compare, and recall

Keep denominators consistent

Rounding and denominators

Instead of this… Use this…

78.64% 79%, or about 80%

1 in 10 vs. 1 in 5 1 in 10 vs. 2 in 10

4/29/2016 48

Framing is important

Framing allows us to

subtly influence

decisionmaking.

Keep timeframes

constant

Compare against a

clear baseline

Provide both positive

and negative frames

4/29/2016 49

Absolute v relative risk

Have you heard? Drinking three cups of coffee a day doubles your chance of having a heart attack.

4/29/2016 50

Absolute v relative risk

Absolute Risk

“If you don’t take this medication, you won’t have any side effects, but your risk of having a stroke will increase from 5% to 10%.

Simple tip: Avoid relative risk statistics! Period.

Relative Risk

“By not taking this medication, you won’t have any side effects, but your risk of having a stroke will double.”

Don’t be fooled – it’s all relative.

4/29/2016 51

Can clarify, reinforce, reframe

Helpful for visual learners

Highlight the most relevant information. Too much information is still a problem.

Use visual aids & cues

4/29/2016 52

Icon arrays, pie charts, and graphs

Icon arrays help personalize/humanize numbers. See:

http://www.iconarray.com/

But this can take up a lot of space for large numbers (i.e. 1 in 1000)

Pie charts & graphs can work well – but they must be simple an intuitive.

4/29/2016 53

Which one works better?

4/29/2016 54

Key Takeaways: Minimal Statistical

Literacy

Focus on the main concepts and absolute risks Convert to natural frequencies

Understand that there is no certainty and no zero-risk, but only risks that are more or less acceptable.

Screening can have risks and benefits Cost, inconvenience, overtreatment, and false

positives/negatives

Only useful if reduces mortality/morbidity or improves quality of life

Questions patients ask themselves Risk of what?

Time frame?

How big?

Does it apply to me?

What are the benefits and harms?

How strong is the evidence?

Gigerenzer G, Gaissmaier W, Kurz-Milcke E, Schwartz LM, Woloshin S. Helping Doctors and Patients Make Sense of Health Statistics. Psychological Science in the Public Interest. 2007;8:53-96.

4/29/2016 55

Document design is as important as the document’s wording

Clear Content

User-Focused Design

Clarity

4/29/2016 56

Example: Creating a health-literate

consent process for colonoscopies

4/29/2016 56

4/29/2016 57

4/29/2016 58

First, Design the consent process – including all interactions and materials patients will receive.

1. Patient & provider discuss the need for procedure including risks, benefits, alternatives;

2. Patient then receives educational info and the consent form;

3. Patient preps for procedure; (no small task) 4. Patient goes to appointment; 5. Patient & provider further discuss consent form,

using teach back. (Before anesthetics)

4/29/2016 58

4/29/2016 59

Next, create the consent form (and any other educational materials you are producing in house).

Consider your design strategy

multi-column format? visuals? font size & type monochrome or color? white space limited to 2 pages for

content? space for office admin needs? signature lines

Consider your content

procedure description risks (numeracy?) alternatives recovery issues other disclosures in plain language? high-frequency words? no text walls short sentences teachback? Test for reading level?

User test?

4/29/2016 60

And now for a completely redesigned consent form that has evolved over time… (See the handout packets on the tables. This evolved over time to the lastest version. These are also available on the IHA website under conference materials.)

4/29/2016 61

What questions do

you have? s

Bailey E. 86511132566. [Creative Commons]. Startup Stock Photos. http://startupstockphotos.com/post/86511132566/download

61