1. CONSUMER COMPREHENSION of EDUCATIONAL MATERIALS: Key Cognitive Principles  Ruth S. Day Duke University FDA Drug Safety & Risk Management July 17, 2002

2. “ COGNITIVE ACCESSIBILITY ” The ease with which people can find understand remember use drug information in a safe and effective manner.

3. COGNITIVE PRINCIPLES

4. Information Load Chunking Coding Representation Location

5. COGNITIVE PRINCIPLES Information Load Chunking Coding Representation Location Readability Comprehensibility Attention Cognitive Task Metacognition

6. LOAD How much is too much?

7. LOAD Information Load How much is too much?

8. LOAD Information Cognitive Load Load How much is too much?

9. EXAMPLE (Original) Tell your doctor, nurse, and pharmacist if you … are allergic to any medicine, either prescription or nonprescription (OTC); are pregnant or intend to become pregnant while using this medicine are breast-feeding; are using any other prescription or nonprescription (OTC) medicine, especially diuretics (water pills) or potassium-containing medicines or supplements; have any other medical problems, especially heart or blood vessel disease or kidney disease; are on a strict low-sodium diet or dialysis, or use low-salt milk or salt substitutes; have had a kidney transplant Source: Day, R. S. (1999) Optimizing patient comprehension through medicine information leaflets: Cognition experiments. In A.G. Hartzema, S. Tolleson-Rinehart, B.L. Sleath, and R.S. Day, Optimizing Patien Comprehension through Medicine Leaflets. Rockville, MD: U.S. Pharmacopeia. Pp. 60-176.

11. EXAMPLE (Original) Tell your doctor, nurse, and pharmacist if you … are allergic to any medicine, either prescription or nonprescription (OTC); are pregnant or intend to become pregnant while using this medicine are breast-feeding; are using any other prescription or nonprescription (OTC) medicine, especially diuretics (water pills) or potassium-containing medicines or supplements; have any other medical problems, especially heart or blood vessel disease or kidney disease; are on a strict low-sodium diet or dialysis, or use low-salt milk or salt substitutes; have had a kidney transplant ~~~~~~~~~~~~~~~~~~~~~~~~~~ ~~~~~~~~~~~~~~~~~~~~~~~~~~~~ ~~~~~~~~~ ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ ~~~~~~~ ~~~~~~~~~ ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ ~~~~~~~~~~~~~~~~~~~~~~~~~~~ ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ ~~~~~~~~~~~~~~~~~~~~~~~~~ ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ ~~~~~~~~~~~~~~ ~~~~~~~~~~~~~~~~~

12. EXAMPLE (Original) Tell your doctor, nurse, and pharmacist if you … are allergic to any medicine, either prescription or nonprescription (OTC); are pregnant or intend to become pregnant while using this medicine are breast-feeding; are using any other prescription or nonprescription (OTC) medicine, especially diuretics (water pills) or potassium-containing medicines or supplements; have any other medical problems, especially heart or blood vessel disease or kidney disease; are on a strict low-sodium diet or dialysis, or use low-salt milk or salt substitutes; have had a kidney transplant ~~~~~~~~~~~~~~~~~~~~~~~~~~ ~~~~~~~~~~~~~~~~~~~~~~~~~~~~ ~~~~~~~~~ ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ ~~~~~~~ ~~~~~~~~~ ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ ~~~~~~~~~~~~~~~~~~~~~~~~~~~ ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ ~~~~~~~~~~~~~~~~~~~~~~~~~ ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ ~~~~~~~~~~~~~~ ~~~~~~~~~~~~~~~~~

13. EXAMPLE (Revised) Tell your doctor, nurse, and pharmacist if you have: Allergies to Medicines --prescription medicine --nonprescription medicine (OTC) Female Circumstances --are pregnant --intend to become pregnant while using this medicine --are breast-feeding Other Medicines --prescription medicine --nonprescription medicine (OTC) --especially: --diuretics (water pills) --potassium-containing medicines or supplements Medical Conditions --any other medical problems --especially: --heart disease --blood vessel disease --kidney disease --kidney transplant --on dialysis Diet --on a strict low-sodium diet --use low-salt milk --use salt substitutes

14. COGNITIVE TASKS Read Free Recall Recognition Comprehension --text, pictures Problem Solving --what do if ?

15. COGNITIVE TASKS Read Free Recall Recognition Comprehension --text, pictures Problem Solving --what do if ? Search & Find Decision Making --self selection --de-selection Metacognition --easy/hard? --like it?

16. COGNITIVE TASKS Read Free Recall Recognition Comprehension --text, pictures Problem Solving --what do if ? Search & Find Decision Making --self selection --de-selection Metacognition --easy/hard? --like it? Cognition & Actions Accuracy Errors ….

17. Indications Warnings Dosage Side Effects …. CONTENT FORMAT SELECTION Basic Strategy

18. Indications Warnings Dosage Side Effects …. CONTENT FORMAT SELECTION Basic Strategy

19. Indications Warnings Dosage Side Effects …. CONTENT Text List Outline …. FORMAT FORMAT SELECTION Basic Strategy

20. Indications Warnings Dosage Side Effects …. CONTENT Use Remember Understand Find Text List Outline …. COGNITIVE TASK FORMAT FORMAT SELECTION Basic Strategy Source: Adapted from Day, R.S. (1988) Alternative representations. In G.H. Bower (Ed.), The Psychology of Learning and Motivation, 22, 261-306. New York: Academic Press.

21. Format

22. Content

23. Format Content

24. Format Format 1 Content

25. Format Format 1 Content Format 2 Content

26. Format Format 1 Content Format 3 Format 2 Content

27. Physically present INFORMATION

28. Physically present Functionally absent INFORMATION