Talking with patients and patience:

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• Talking with patients (and patience)
• Communicating Risk Quickly and Effectively in the
  Era of the Vioxx

Eric Wooltorton, MD, MSc, CCFP Family Physician
Kemptville ON Associate Editor CMAJ Dept. Family
Medicine, University of Ottawa
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Doctor, Why did you give me Vioxx?
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• Doc, its no use telling me to stop smoking,
  drinking, overeatingHow I get my problems is my
  businessGetting rid of them is your business!

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Risk

• the chance of something unpleasant happening,
  such as injury or loss - and therefore is
  something to be avoided. But it has another face
  - that of opportunity
• (UK Resilience GICS Communicating Risk document)

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Risk Communication

• the open two way exchange of information and
  opinion about risk, leading to better
  understanding and better decisions about clinical
  management
• (Edwards et al. BMJ 2002, p827-30)

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This presentation is about

• Walking both sides of the street
• -effectively communicating risk to patients

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This presentation is about

• Walking both sides of the street
• -effectively communicating risk to patients
• -developing a framework for dealing with what
  patients throw back at us

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How Hazardous is Healthcare?
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Risk in Health Care

• Its impossible to eliminate all risks

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Risk in Health Care

• Its impossible to eliminate all risks
• At best we can manage risk

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As family physicians we need to help patients

• -understand conditions they are at risk of

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As family physicians we need to help patients

• -understand conditions they are at risk of
• -translate raw data into information (decision
  aids, visual information)

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As family physicians we need to help patients

• -understand conditions they are at risk of
• -translate raw data into information (decision
  aids, visual information)
• -understand risks that treatments may carry
  (probabilities and potential impact)

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As family physicians we need to help patients

• -tell us what their values are (communication is
  a 2 way street)

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As family physicians we need to help patients

• -tell us what their values are (communication is
  a 2 way street)
• -decide which threats are acceptable (balance
  benefits/risks)

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As family physicians we need to help patients

• -tell us what their values are (communication is
  a 2 way street)
• -decide which threats are acceptable (balance
  benefits/risks)
• -deal with incidents when they occur

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Effective Risk Communication

• -leads to better decisions (increased adherence)

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Effective Risk Communication

• -leads to better decisions (increased adherence)
• -empowers

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Effective Risk Communication

• -leads to better decisions (increased adherence)
• -empowers
• -reassures

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Effective Risk Communication

• -leads to better decisions (increased adherence)
• -empowers
• -reassures
• -builds trust

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Effective Risk Communication

• -leads to better decisions (increased adherence)
• -empowers
• -reassures
• -builds trust
• -saves time

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Effective Risk Communication

• -leads to better decisions (increased adherence)
• -empowers
• -reassures
• -builds trust
• -saves time
• -prevents crises from developing
• (28.35 g of prevention is worth 454 g of cure)

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How do people react to risk?

• -People judge risks not just on technical
  assessments of possibility and consequence

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How do people react to risk?

• -People judge risks not just on technical
  assessments of possibility and consequence
• -perceived credibility of source is key

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How do people react to risk?

• -People judge risks not just on technical
  assessments of possibility and consequence
• -perceived credibility of source is key
• -value judgments are important

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Risks perceived to be more worrisome if

• -involuntary (lawn pesticides) vs voluntary
  (sports injuries or smoking)

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Risks perceived to be more worrisome if

• -involuntary (lawn pesticides) vs voluntary
  (sports injuries or smoking)
• -inequitably distributed (some benefit, others
  suffer consequences)

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Risks perceived to be more worrisome if

• -involuntary (lawn pesticides) vs voluntary
  (sports injuries or smoking)
• -inequitably distributed (some benefit, others
  suffer consequences)
• -inescapable

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Risks perceived to be more worrisome if

• -arise from an unfamiliar source (GMOs)

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Risks perceived to be more worrisome if

• -arise from an unfamiliar source (GMOs)
• -are human-made (nuclear power) vs natural

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Risks perceived to be more worrisome if

• -arise from an unfamiliar source (GMOs)
• -are human-made (nuclear power) vs natural
• -cause hidden and irreversible damage (eg
  ionizing radiation)

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Risks perceived to be more worrisome if

• -pose danger to children or pregnant women

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Risks perceived to be more worrisome if

• -pose danger to children or pregnant women
• -threaten death/illness/injury

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Risks perceived to be more worrisome if

• -pose danger to children or pregnant women
• -threaten death/illness/injury
• -damage identifiable victims

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Risks perceived to be more worrisome if

• -pose danger to children or pregnant women
• -threaten death/illness/injury
• -damage identifiable victims
• -poorly understood by science

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Risks perceived to be more worrisome if

• -pose danger to children or pregnant women
• -threaten death/illness/injury
• -damage identifiable victims
• -poorly understood by science
• -subject to contradictory statements from
  responsible sources
• (Communicating about risks to Public Health, UK
  Dept of Health)

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The COX-2 Saga -Part 1 -RR

• -2000 VIGOR Trial NEJM

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The COX-2 Saga -Part 1 -RR

• -2000 VIGOR Trial NEJM
• -2000 CLASS Trial JAMA

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The COX-2 Saga -Part 1 -RR

• -2000 VIGOR Trial NEJM
• -2000 CLASS Trial JAMA
• -2001 Mukherjee Meta-analysis JAMA Risk of
  cardiovascular events associated with selective
  COX-2 inhibitors

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The COX-2 Saga -Part 1 -RR

• -2000 VIGOR Trial NEJM
• -2000 CLASS Trial JAMA
• -2001 Mukherjee Meta-analysis JAMA Risk of
  cardiovascular events associated with selective
  COX-2 inhibitors
• -2002 CMAJ alert

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The COX 2 Saga -Part 2

• -Sept 30 2004 Vioxx withdrawn from the market

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The COX 2 Saga -Part 2

• -Sept 30 2004 Vioxx withdrawn from the market
• -APPROVE prelim results reported to regulators
  (double risk with rofecoxib in colon Ca
  prevention trial after 18 mo)

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The COX 2 Saga -Part 2

• -Sept 30 2004 Vioxx withdrawn from the market
• -APPROVE prelim results reported to regulators
  (double risk with rofecoxib in colon Ca
  prevention trial after 18 mo)
• -Panic

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The COX2-Saga -Part 2

• -Dec 2004 HC and FDA warn of preliminary results
  of trials showing increased relative risk of
  cardiovascular events in coxib trials
• Celebrex (celecoxib) Ademoma Prevention
• celecoxib tripled the risk of cardiovascular
  events

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The COX2-Saga -Part 2

• -Dec 2004 HC and FDA warn of preliminary results
  of trials showing increased relative risk of
  cardiovascular events in coxib trials
• Celebrex (celecoxib) Ademoma Prevention
• celecoxib tripled the risk of cardiovascular
  events
• Bextra (valdecoxib) post-CABG pain
• double the number of cardiovascular adverse
  events in patients taking Bextra

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The COX2-Saga -Part 2

• -Dec 2004 HC and FDA warn of preliminary results
  of trials showing increased relative risk of
  cardiovascular events in coxib trials
• Celebrex (celecoxib) Ademoma Prevention
• celecoxib tripled the risk of cardiovascular
  events
• Bextra (valdecoxib) post-CABG pain
• double the number of cardiovascular adverse
  events in patients taking Bextra
• -Panic Part 2

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The COX-2 Saga Part 3 -NEJM publication Mar 2005

• -APC trial (400 to 800 mg celecoxib, 3 yrs)
• Absolute risks placebo 1, celecoxib 2.3
• (NNH 76)
• -APPROVe (rofecoxib 25 mg)
• Absolute risk placebo 0.78 events per 100
  patient years, rofecoxib 1.5 events per 100
  patient years (after 18 mo treatment, no
  difference before 18 mo)
• (NNH approx 50)
• (28.35 g of prevention is worth 454 g of cure)

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Effective Risk Communication

• -is difficult when we are given only relative not
  absolute risks to communicate

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Effective Risk Communication

• -is difficult when we are given only relative not
  absolute risks to communicate
• -information is empowering

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Effective Risk Communication

• -is difficult when we are given only relative not
  absolute risks to communicate
• -information is empowering
• -a lack of information is frightening

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Todays patient
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Responding to different styles

• Driving
• -be punctual, stick to the facts, give choices,
  be brief
• -match their speaking style and body language
• -use word THINK, avoid Feel
• -move forward with efficiency, clear plan,
  certainty

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Responding to different styles

• Analytic
• -they like information, reports, data -respect
  what they bring in
• -may clam up under stress (express anger
  covertly, not overtly)
• -prepare an overview, plan, be neat, clean,
  provide a balance of views

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Responding to different styles

• Amiable-warm and chatty, have a difficult time
  with change
• -under stress may emote openly, or bottle it up
  (dramatic outbursts can occur)
• -use FEEL instead of THINK
• -they are people pleasers and may not outright
  tell us their concerns about Txs - probe for what
  their real concerns are

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Responding to different styles

• Expressive -thrive on recognition, uniqueness,
  love variety and creativity
• -under stress become vocal, expressing how they
  FEEL
• -use their proper title, remind them about
  appointments
• -use visuals, help them establish routines, be
  wary of manipulation,
• -prepare for a frontal attack, acknowledging
  their emotional upset then give a rational
  response

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Key points about patient coping styles

• -No one style is best
• -this doesnt define a person totally
• -many people dont fit a style perfectly
• -Opposites repel

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How can we be ready for the next Vioxx?

• -remember risk communication is a 2 way street
  you sharing with the patient, and them sharing
  with you-know your patients styles, respond
  appropriately

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How can we be ready for the next Vioxx?

• -remember risk communication is a 2 way street
  you sharing with the patient, and them sharing
  with you-know your patients styles, respond
  appropriately
• -be prepared get the facts (not just relative
  risks, but absolute risks)

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How can we be ready for the next Vioxx?

• -remember that risk communication is a 2 way
  street
• -know your patients styles, respond
  appropriately
• -be prepared get the facts (not just relative
  risks, but absolute risks)
• -anticipate the data people will be seeking
  consider making handouts that address

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A template for describing risks to patients

• How common are the adverse events?
• What are the events like?
• How often are they life threatening or severe?
• Why do they happen?
• Who is at risk?
• What can we do to reduce their frequency,
  severity, and consequences?
• (adapted from Tierney NEJM 2003 348 1587-8)

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Questions?
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