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Effectively Communicating Risk

Professor Christopher Trudeau,Western Michigan University –

Cooley Law School@proftrudeau

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What is risk communication?

Risk communication is helping people 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.

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V.Telling you something

Selling you something

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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.

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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

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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.)

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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.

Regulated by federal statutes and regulations.

Patients are not the primary reason for trial, so that has been the justification for the detailed disclosures.

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Two standards for “procedural” informed consentReasonable-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 is 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.

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Risk involves much more than communicating what is legally required

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

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

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

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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?

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Researchers using patients from two public hospitals found …

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

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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.

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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.

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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.

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fdssds

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Guess the reading level of this section?

14th – 15th Grade

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What are some problems with this section?

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The way we organize info is important too – we shouldn’t bury key information

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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: the main point of a REMS is to communicate risk to patients & providers.

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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.

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Risk info

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Let’s take a closer look…

Do we need more of the info disclosure?

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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

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

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

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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.

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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 documentWe 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.

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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.

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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

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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).

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A better REMS risk hierarchy

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The problem with numbers

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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

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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.

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Our numeracy skills are tested daily

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Our numeracy skills are tested daily

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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

2. 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

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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)

2. 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 (2000)

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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.

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Don’t worry: many gynecologists grossly overestimated too

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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 cancerOf these 10 women with

breast cancer, 9 test positiveOf 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.

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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

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Numeracy tips from these masters

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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

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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.

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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!

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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

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Framing is important

Framing allows us to subtly influence decisionmaking.

Provide both positive and negative frames to eliminate subconscious bias.

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

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UK Contraceptive Scare

In October 1995, the U.K. Committee on Safety of Medicines issued a warning that third-generation oral contraceptive pills increased the risk of potentially life-threatening blood clots in the legs or lungs twofold—that is, by 100%. This information was passed on in ‘‘Dear Doctor’’ letters to 190,000 providers, etc., and was presented in an emergency announcement to the media.

The news caused great anxiety, and distressed women stopped taking the pill, which led to unwanted pregnancies (800 additional among girls under 16) and an estimated 13,000 additional abortions. (Furedi, 1999).

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How big is 100%? Studies had shown that thrombosis occurred in 1 of

7000 women who took the earlier, second-generation contraceptive

This number increased to 2 of 7000 among women who took third-generation pills.

That is, the absolute risk increase was only 1 in 7,000 (.014%), but the relative increase was, in fact,100%.

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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.

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Can clarify, reinforce, reframe

Helpful for visual learners

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

Use visual aids & cues

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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.

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Which one works better?

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Key Takeaways: Minimal Statistical Literacy

Focus on the main concepts and absolute risksUse natural frequencies & absolute risksPatients must 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

Providers and patients must realize the cost, inconvenience, overtreatment, and false positives/negatives

Screening may only be useful if reduces mortality/morbidity or improves quality of life

Questions patients should askRisk of what? Dying? No recurrence?Time frame?How big is the risk? Absolute or relative? Do these studies apply to me & my demographic?What are the benefits and harms of treatment?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.

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Document design is as important as the document’s wording

Clear Content

User-Focused Design

Clarity

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Example: Creating a health-literate consent process for colonoscopies

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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)

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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?

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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.)

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What questions do you have?

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