Designing Risk Communications (implications from Comprehension Tests)

1. Designing Risk Communications (implications from Comprehension Tests) Louis A. Morris, Ph.D. Drug Information Association June 15, 2004

2. 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

3. Information Processing Information Processing/ Memory Perceptual Buffer: Attention Processes Stimuli/ Messages Environmental Cues/Usage Needs Decisions

4. 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

5. 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

6. 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.

7. 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

9. 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

10. 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

11. Pharmacokinetic Communications Model Motivation Involvement Goals Cognitive Load Willingness to Process Situational Constraints Document Patient Opportunity Signals Literacy Self-Efficacy Ability Actual Processing Morris & Aiken

12. 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

13. 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

14. 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

15. 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

16. 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)

17. 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

18. 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

19. 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

20. 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

21. 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

22. 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

24. 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