designing risk communications (implications from comprehension tests) louis a. morris, ph.d. drug...
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Designing Risk Communications (implications from
Comprehension Tests)
Louis A. Morris, Ph.D.
Drug Information Association
June 15, 2004
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Objectives• Review Information Processing Models
– Patients (novices)– Physicians (experts)
• Describe Models for Risk Communications– Pharmacokinetics of Information Processing
• Discuss Learnings from Comprehension Tests– Cognitive Load Problems– Signaling Problems
• Discuss Role of Readability & Comprehension Testing
General Conclusions, Not Specific Findings
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Information Processing
InformationProcessing/
MemoryStimuli/Messages
Perceptual Buffer:
AttentionProcesses
DecisionsEnvironmental
Cues/Usage Needs
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Implications
• What captures attention has best opportunity to be processed– Placement – top of document, beginning of
sentences– Graphics – Headers, bold, italics
• Weber’s Law
• Limited Capacity– We remember what is important --- depends on
how we will use data
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Cognitive Processes• Decoding and interpreting words
– Lexical Processing
• Extracting meaning within and among sentences – Syntactical Processing
• Discerning overall theme– Discourse Processing
• Meaning is Constructed – Like a house is built– More resources needed to build foundation, less
available for other sections
Constructing a Schema
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Tell Me What this Says?
• The black and white cow walked over to the purple esuoh and smiled broadly to give the namow a liap of milk that she made into a nollag of French vanilla ice cream to sell to the srotisiv.
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Implications
• Simple words • Short Sentences
• However:– Short words may not be simple
• Concept is difficult and may need explanation
– Some large words help organization– Sing-Song sentences are a turn-off
Readability Formula
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Types of Processing
• Top-Down – experts (physicians)– Start with Existing schema and modify
– More efficient – preferred mode of processing
– Information stresses differences
• Bottom-Up – novices (patients)– Provide building blocks, simplify information
– Reduce cognitive load, provide signals
– Provide “intellectual scaffold” (organization) for new information
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Principle of “Cognitive Conservation”
• People have limited cognitive resources– Limited Capacity Working Memory
• We can think about 7 +/- 2 bits
– Distribute “Cognitive Resources"• Based on our goals
• What is the “Cognitive Load” – How much information to process– How difficult is the information to process
Interaction of Materials’ “load and structure” with Patient’s Information Processing Skills and Motivations
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Cognitive Load
Signals Ability
Opportunity
Motivation InvolvementGoals
SituationalConstraints
Literacy Self-Efficacy
PatientDocument
Willingness to Process
Actual Processing
Pharmacokinetic Communications Model
Morris & Aiken
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Ability
• Literacy– NALS: five literacy levels, 40% of US @ 1 or 2– Level 1:
• 25% immigrants• 33% elderly (65 yrs. or older)• 25% physical or mental problem
• Self-efficacy– If people do not expect to be able to perform, they
won’t try– Self-efficacy judgments may not be based on sufficient
information
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Risk Communication Options• HCPs
– PI, Label Changes (black box), Dear Doctor letters, Advertisements (affirmative disclosure, separate campaign)
• Patients – PPI, Medication Guides, Informed Consent, Agreement– Educational Campaigns
• Public (PR)– FDA public announcements (talk papers, press
releases), website posting, advisory committee meetings
Vary in Format and Cognitive Load
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Comprehension Tests
• Started with OTC Drugs– Advil/Nuprin – “LL” vs. “CS” Label– Nicotine Products– Common for Switches
• Applied to Medication Guides– Other risk management documents
• Applied to Physician Labels
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General Procedure
• Recruit (n= 400 to 1,200)– Use Shopping Malls– Screen for at-risk population
• Disease characteristics
• Low Literacy (pronunciation tests)
• Design– One Cell Survey– Multi-Cell Comparisons
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General Procedure (2)• Procedure
– Screening– Document Exposure – read as normally would
• Interviewer Leaves Room
• Questionnaire– Develop Communication Objectives– Funnel Approach
– Open ends– Specific Communication Objectives– Follow-up Questions
– Document usually present (may be taken away for initial open ends)
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MGs vs. OTC Labels• Longer
– Cognitive constraints on information processing– Limited “take away,” “time to interpret”
• More difficult words/concepts– Needs explanation to understand consequences
• More Complex Directions – Application to variety of usage situations
• Risk Topics – warnings, contraindications, side effects list
• Associated Documents– Agreements, wallet cards, consent, audiovisual
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Comprehension Test Findings
• Cognitive Load - Longer documents– Primary Points fully communicated (extensive
repetition) (over 90% correct)– Secondary Points poorly communicated (66%-75%
correct)– Evidence Participants adopt a “harm prevention bias ”
– consult physician in response to any issue, regardless on information in the material.
• Do not attempt to consult document to answer questions – Questions requiring multiple mental operations are very
difficult (more than three items to consider leads to very poor results)
Tradeoffs- Explanation vs. Length
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Lessons from Comp. Tests (1)
• Simplification– Avoid Extensive Repetition –
• Use brief headers in “most important section”
– Avoid “Seductive Details”• “Interesting to know” information detracts from key
messages
– Use “Communications Objectives” to focus messages
– Cut out extra words
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Lessons form Comp. Tests (2)
• Signals– Less likely to notice information in:
• second half of a long sentence,
• middle of a paragraph,
• not graphically emphasized
– Graphic emphasis works surprisingly well for OTC, not for MGs
• too much “background noise” – reduce number of sub-heads
– Simplifying language and concepts • very often necessary but often requires much background
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Lessons from Comp. Tests (3)
• Context Matters– Vague words decrease comprehension
• “do not drink alcohol”• Health, sickness, etc., has unclear meaning
• Credibility and Persuasion Needed– To influence behavior, need to go beyond
comprehension– Rationale for advocated behaviors may be
needed
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Is Readability Testing Enough?
• Can help simplify information– Does not address overall length and cognitive
burdens due to overall flow– Does not address simple words that are difficult
to interpret (red meat, healthy, sick)
• Question of Predictive Validity– Do readability tests accurately predict reading
level– Tests developed in late 1940’s
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Conclusions
• MGs (and other documents) are here– FDA required for drugs with risk management problems.
• Affirmative Approach (ie, write your own)– Bring FDA own designed/tested
• Readability can help simplify, Comprehension Testing is defensible– Comprehension tests for liability defense
• Plan Testing Prior to Implementation– Changing document after use can imply weaknesses in
prior document