cognitive accessibility of otc drug information ruth s. day / duke university fda nonprescription...
TRANSCRIPT
Cognitive Accessibilityof OTC Drug Information
Ruth S. Day / Duke UniversityFDA Nonprescription Drugs Advisory Committee
(9/25/06)
Drug FactsActive ingred PurposeUsesWarningsDirectionsInactive ingredients
1) Basic Approach
2) Cognitive Principles
3) Non-OTC Examples
Cognitive Accessibilityof OTC Drug Information
1) Basic Approach
2) Cognitive Principles
3) Non-OTC Examples
4) OTC Examples
5) Generality
6) Conclusions
Cognitive Accessibilityof OTC Drug Information
QUESTION:How do people understand drug information?
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QUESTION:How do people understand drug information?
ANSWER: With difficulty!
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QUESTION:How do people understand drug information?
ANSWER: With difficulty!
WHY: --Heavy information load
--Complex/technical information
--etc.
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QUESTION:How do people understand drug information?
ANSWER: With difficulty!
WHY: --Heavy information load
--Complex/technical information
--etc.
--Cognitive AccessibilityRuth Day
The ease with which
Cognitive Accessibility
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The ease with which
people can drug information
findunderstandrememberuse
Cognitive Accessibility
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The ease with which
people can drug information
findunderstandrememberuse
in a safe and effective manner.
Cognitive Accessibility
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The ease with which
people can drug information
findunderstandrememberuse
in a safe and effective manner.
Cognitive Accessibility
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*
The ease with which
people can drug information
findunderstandrememberuse
in a safe and effective manner.
Cognitive IN-Accessibility
Ruth Day* Day, 2000; 2006
INFORMATION SOURCES
TV Ads Internet Hardcopy
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INFORMATION SOURCES
TV Ads Internet Hardcopy
Professional LabelPatient Package InsertsMedication GuidesPharmacy LeafletsPrint AdsOTC
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Rx Ads
OTC
Product Websites
INFORMATION SOURCES
TV Ads Internet Hardcopy
Professional LabelPatient Package InsertsMedication GuidesPharmacy LeafletsPrint AdsOTC
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Product Websites
Rx Ads
OTC
Cognitive Enhanced Cognitive Analyses Displays Experiments
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BASIC APPROACH
Cognitive Enhanced Cognitive Analyses Displays Experiments
--Obtain quantitative measures
--Calculate “cognitive accessibility”
--Compare benefits vs. risks
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BASIC APPROACH
Cognitive Enhanced Cognitive Analyses Displays Experiments
BASIC APPROACH
--Same info
--Based on cognitive principles
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--Obtain quantitative measures
--Calculate “cognitive accessibility”
--Compare benefits vs. risks
Cognitive Enhanced Cognitive Analyses Displays Experiments
BASIC APPROACH
Test effects on:--Attention--Comprehension--Memory--Problem Solving--Decision Making--Behavior
--Same info
--Based on cognitive principles
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--Obtain quantitative measures
--Calculate “cognitive accessibility”
--Compare benefits vs. risks
Cognitive Enhanced Cognitive Analyses Displays Experiments
BASIC APPROACH
Test effects on:--Attention--Comprehension--Memory--Problem Solving--Decision Making--Behavior
Health Outcomes
--Same info
--Based on cognitive principles
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--Obtain quantitative measures
--Calculate “cognitive accessibility”
--Compare benefits vs. risks
COGNITIVE PRINCIPLES
Information Load
Chunking
Coding
Representation
Location
Speed
Readability
Comprehension
Prior Knowledge
Attention
Cognitive Task
Metacognition
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COGNITIVE PRINCIPLES
Information Load
Chunking
Coding
Representation
Location
Speed
Readability
Comprehension
Prior Knowledge
Attention
Cognitive Task
Metacognition
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Day, R.S. (2006) Comprehension of prescription drug information: Overview of a research program. Proceedings of the American Association for Artificial Intelligence, Argumentation for Consumer Healthcare. http://www.aaai.org
LOADHow much is too much?
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LOAD
Information Load
How much is too much?
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LOAD
Information Cognitive Load Load
How much is too much?
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Medication Schedules
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Polypharmacy
Medication Schedules
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List
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List
Matrix
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Study CognitiveTasks
Procedure
time
Memory Comprehension Problem Solving
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List Matrix List Matrix
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Memory Comprehension(Display Absent) (Display Present)
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List Matrix List Matrix
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Memory Comprehension(Display Absent) (Display Present)
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List Matrix List Matrix
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Memory Comprehension(Display Absent) (Display Present)
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List Matrix List Matrix
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Memory Comprehension(Display Absent) (Display Present)
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Types of Questions
Factual Inferential
--“What are the names of the drugs?
--“How many total pills per day?”
--etc.
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Types of Questions
Factual Inferential
--“What are the names of the drugs?
--“How many total pills per day?”
--etc.
Scenarios
Go beyond theinformation given
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Types of Questions
Factual Inferential
--“What are the names of the drugs?
--“How many total pills per day?”
--etc.
Scenarios
Go beyond theinformation given
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Scenario Question:“If you leave home in the afternoon and will not be back until breakfast time the next day, how many Inderal should you take along?”
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List Matrix List Matrix
% C
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Memory Comprehension
Scenario Question:“If you leave home in the afternoon and will not be back until breakfast time the next day, how many Inderal should you take along?”
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List Matrix List Matrix
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Memory Comprehension
Scenario Question:“If you leave home in the afternoon and will not be back until breakfast time the next day, how many Inderal should you take along?”
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List Matrix List Matrix
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Memory Comprehension
Scenario Question:“If you leave home in the afternoon and will not be back until breakfast time the next day, how many Inderal should you take along?”
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List Matrix List Matrix
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Memory Comprehension
Scenario Question:“If you leave home in the afternoon and will not be back until breakfast time the next day, how many Inderal should you take along?”
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Medication Schedules
--Alternative Representations
--Multiple Cognitive Tasks
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CHUNKING
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CHUNKING
Basic idea ….
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CHUNKING
Basic idea ….
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CHUNKING
“Brief Summary”
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CODING
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Basic idea ….
CODING
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Basic idea ….
CODING
Name A Name B
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CHUNKING & CODING
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.
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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.
~~~~~~~~~~~~~~~~~~~~~~~~~~• ~~~~~~~~~~~~~~~~~~~~~~~~~~~~ ~~~~~~~~~• ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ ~~~~~~~• ~~~~~~~~~• ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ ~~~~~~~~~~~~~~~~~~~~~~~~~~~ ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~• ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ ~~~~~~~~~~~~~~~~~~~~~~~~~• ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~ ~~~~~~~~~~~~~~• ~~~~~~~~~~~~~~~~~
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Tell your doctor, nurse, and pharmacist if you have:
Allergic to Medicines --prescription medicine --nonprescription medicine (OTC)
Pregnancy --are pregnant --intend to become pregnant --are breast-feeding
Other Medicines --prescription medicine --nonprescription medicine (OTC) --especially: --diuretics (water pills)
--potassium-containing medicines --potassium-containing 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
Chunked & Coded
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CHUNKING & CODING
CONTRAINDICATIONS AND WARNINGS
PREGNANCY MUST BE EXCLUDED BEFORE THESTART OF TREATMENT WITH DRUG-X. DRUG-X ISCONTRAINDICATED IN PREGNANT WOMEN, OR WOMEN OF CHILDBEARING POTENTIAL WHO ARE NOT USING RELIABLE CONTRACEPTION. (SEE CONTRAINDICATIONS AND WARNINGS.) PREGNANCY MUST BE AVOIDED DURING DRUG-X TREATMENT OR PRIOR TO THE COMPLETION OF THE DRUG ELIMINATION PROCEDURE AFTER DRUG-X TREATMENT.
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RARE BUT LIFE-THREATENING LIVER TOXICITY HAS BEEN REPORTED, INCLUDING ACUTE LIVER FAILURE.
CONTRAINDICATIONS AND WARNINGS
PREGNANCY MUST BE EXCLUDED BEFORE THESTART OF TREATMENT WITH DRUG-X. DRUG-X ISCONTRAINDICATED IN PREGNANT WOMEN, OR WOMEN OF CHILDBEARING POTENTIAL WHO ARE NOT USING RELIABLE CONTRACEPTION. (SEE CONTRAINDICATIONS AND WARNINGS.) PREGNANCY MUST BE AVOIDED DURING DRUG-X TREATMENT OR PRIOR TO THE COMPLETION OF THE DRUG ELIMINATION PROCEDURE AFTER DRUG-X TREATMENT.
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RARE BUT LIFE-THREATENING LIVER TOXICITY HAS BEEN REPORTED, INCLUDING ACUTE LIVER FAILURE.
CONTRAINDICATIONS AND WARNINGS
PREGNANCY MUST BE EXCLUDED BEFORE THESTART OF TREATMENT WITH DRUG-X. DRUG-X ISCONTRAINDICATED IN PREGNANT WOMEN, OR WOMEN OF CHILDBEARING POTENTIAL WHO ARE NOT USING RELIABLE CONTRACEPTION. (SEE CONTRAINDICATIONS AND WARNINGS.) PREGNANCY MUST BE AVOIDED DURING DRUG-X TREATMENT OR PRIOR TO THE COMPLETION OF THE DRUG ELIMINATION PROCEDURE AFTER DRUG-X TREATMENT.
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CONTRAINDICATIONS AND WARNINGS
PREGNANCY MUST BE EXCLUDED BEFORE THESTART OF TREATMENT WITH DRUG-X. DRUG-X ISCONTRAINDICATED IN PREGNANT WOMEN, OR WOMEN OF CHILDBEARING POTENTIAL WHO ARE NOT USING RELIABLE CONTRACEPTION. (SEE CONTRAINDICATIONS AND WARNINGS.) PREGNANCY MUST BE AVOIDED DURING DRUG-X TREATMENT OR PRIOR TO THE COMPLETION OF THE DRUG ELIMINATION PROCEDURE AFTER DRUG-X TREATMENT. RARE BUT LIFE-THREATENING LIVER TOXICITY HAS BEEN REPORTED, INCLUDING ACUTE LIVER FAILURE.
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CONTRAINDICATIONS AND WARNINGS
PREGNANCY MUST BE EXCLUDED BEFORE THESTART OF TREATMENT WITH DRUG-X. DRUG-X ISCONTRAINDICATED IN PREGNANT WOMEN, OR WOMEN OF CHILDBEARING POTENTIAL WHO ARE NOT USING RELIABLE CONTRACEPTION. (SEE CONTRAINDICATIONS AND WARNINGS.) PREGNANCY MUST BE AVOIDED DURING DRUG-X TREATMENT OR PRIOR TO THE COMPLETION OF THE DRUG ELIMINATION PROCEDURE AFTER DRUG-X TREATMENT.
RARE BUT LIFE-THREATENING LIVER TOXICITY HAS BEEN REPORTED, INCLUDING ACUTE LIVER FAILURE.
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CONTRAINDICATIONS AND WARNINGS
PREGNANCY MUST BE EXCLUDED BEFORE THESTART OF TREATMENT WITH DRUG-X. DRUG-X ISCONTRAINDICATED IN PREGNANT WOMEN, OR WOMEN OF CHILDBEARING POTENTIAL WHO ARE NOT USING RELIABLE CONTRACEPTION. (SEE CONTRAINDICATIONS AND WARNINGS.) PREGNANCY MUST BE AVOIDED DURING DRUG-X TREATMENT OR PRIOR TO THE COMPLETION OF THE DRUG ELIMINATION PROCEDURE AFTER DRUG-X TREATMENT.
RARE BUT LIFE-THREATENING LIVER TOXICITY HAS BEEN REPORTED, INCLUDING ACUTE LIVER FAILURE.
Chunked
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CONTRAINDICATIONS AND WARNINGS
PREGNANCYPREGNANCY MUST BE EXCLUDED BEFORE THESTART OF TREATMENT WITH DRUG-X. DRUG-X ISCONTRAINDICATED IN PREGNANT WOMEN, OR WOMEN OF CHILDBEARING POTENTIAL WHO ARE NOT USING RELIABLE CONTRACEPTION. (SEE CONTRAINDICATIONS AND WARNINGS.) PREGNANCY MUST BE AVOIDED DURING DRUG-X TREATMENT OR PRIOR TO THE COMPLETION OF THE DRUG ELIMINATION PROCEDURE AFTER DRUG-X TREATMENT.
LIVER TOXICITYRARE BUT LIFE-THREATENING LIVER TOXICITY HAS BEEN REPORTED, INCLUDING ACUTE LIVER FAILURE.
CHUNKING & CODING
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CONTRAINDICATIONS AND WARNINGS
PREGNANCYPregnancy must be excluded before the start of treatment with Drug-X. Drug-X is contraindicated in pregnant women, or women of childbearing potential who are not using reliable contraception. (See “Contraindications and Warnings.”) Pregnancy must be avoided during Drug-X treatment or prior to the completion of the drug elimination procedure after Drug-X treatment.
LIVER TOXICITYRare but life-threatening liver toxicity has been reported, including acute liver failure.
Visual Contrast
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Study Test
time
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CHUNKING & CODING
Study Test
time
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--Chunked > UnChunked
--Coded > UnCoded
CHUNKING & CODING
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READABILITY
READABILITY
# Words = 48# Sentences = 3
Pregnancy must be excluded before the start of treatment with Drug-X. Drug-X is contraindicated in pregnant women, or women of childbearing potential who are not using reliable contraception. (See “Contraindications and Warnings.”) Pregnancy must be avoided during Drug-X treatment or prior to the completion of the drug elimination procedure after Drug-X treatment.
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READABILITY
# Words = 48# Sentences = 3
Pregnancy must be excluded before the start of treatment with Drug-X. Drug-X is contraindicated in pregnant women, or women of childbearing potential who are not using reliable contraception. (See “Contraindications and Warnings.”) Pregnancy must be avoided during Drug-X treatment or prior to the completion of the drug elimination procedure after Drug-X treatment.
Grade level = 12
Passives = 66%
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LINGUISTIC STRUCTURE
Pregnancy must be excluded before the start of treatment with Drug-X. Drug-X is contraindicated in pregnant women, or women of childbearing potential who are not using reliable contraception.
Pregnancy must be avoided during Drug-X treatment or prior to the completion of the drug elimination procedure after Drug-X treatment.
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LINGUISTIC STRUCTURE
Pregnancy must be excluded before the start of treatment with Drug-X. Drug-X is contraindicated in pregnant women, or women of childbearing potential who are not using reliable contraception.
Pregnancy must be avoided during Drug-X treatment or prior to the completion of the drug elimination procedure after Drug-X treatment.
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LARD FACTOR
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LARD FACTOR
Pregnancy must be excluded before the start of treatment with Drug-X. Drug-X is contraindicated in pregnant women, or women of childbearing potential who are not using reliable contraception. Pregnancy must be avoided during Drug-X treatment or prior to the completion of the drug elimination procedure after Drug-X treatment.
Original High LF
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LARD FACTOR
Pregnancy must be excluded before the start of treatment with Drug-X. Drug-X is contraindicated in pregnant women, or women of childbearing potential who are not using reliable contraception. Pregnancy must be avoided during Drug-X treatment or prior to the completion of the drug elimination procedure after Drug-X treatment.
Exclude pregnancy before starting Drug-X treatment. Drug-X is contraindicated in pregnant women or women of childbearing potential who are not using reliable contraception. Avoid pregnancy during Drug-X treatment and after treatment (until completing the drug elimination procedure).
Original High LF
RevisedLower LF
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Readability
Readability
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LOCATION of INFORMATION
COGNITIVE PRINCIPLE
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Task: --see/hear list of items --report them
COGNITIVE PRINCIPLE:Serial Position Effect
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Task: --see/hear list of items --report them
Typical Results:
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LOCATION
COGNITIVE PRINCIPLE:Serial Position Effect
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Task: --see/hear list of items --report them
Typical Results:
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LOCATION
COGNITIVE PRINCIPLE:Serial Position Effect
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LOCATION of INFORMATION
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StudyLeaflet
CognitiveTasks
Experiments
time
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Example“What are possible side effects?”
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LEAFLET SECTIONRuth Day
Task: --see/hear list of items --report them
Typical Results:
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LOCATION
COGNITIVE PRINCIPLE:Serial Position Effect
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Task: --see/hear list of items --report them
Typical Results:
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LOCATION
COGNITIVE PRINCIPLE:Serial Position Effect
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Risks
Produced New TV AdHypothetical Drug
Flu Aide
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Structure & content
--Like typical ads
--Purpose --vary specific factors --observe effects on cognition
Flu Aide
Produced New TV AdHypothetical Drug
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See ad
time
Favorable UnFavorable
LOCATION of Side Effects
Experiment FluAide
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OR
See ad
time
Favorable UnFavorable
LOCATION of Side Effects
Experiment
Same visualSame auditory
Differ only in location of side effects
FluAide
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OR
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Favorable UnFavorable LOCATION
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FluAide
Favorable UnFavorable LOCATION
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Favorable UnFavorable LOCATION
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~ 100% FluAide
Favorable UnFavorable LOCATION
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READABILITY
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Rx
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READABILITY
Readability = Comprehensibility
READABILITY
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Readability = Comprehensibility
However, --easy to measure --has predictive value --therefore = quick “proxy” for comprehensibility
READABILITY
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READABILITY
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BENEFITS SIDE EFFECTS
GR
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GR
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READABILITY
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BENEFITS SIDE EFFECTS
GR
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READABILITY
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GR
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READABILITY
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BENEFITS SIDE EFFECTS
GR
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3
See ad Test
time
Benefits Risks Other
(N = 1-3)
Experiments
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Indications Side Effects
% C
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Overall
~ 80%
~ 20%
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Alternative Representations
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Alternative Representations
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SAME DIFFERENT Information Displays
Alternative Representations
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Alternative Representations
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Linear Orderings
Alternative Representations
High Sev Low Sev
High Freq Low Freq
Good State Bad State
Severity
Frequency
Health State
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Alternative Representations
High Sev Low Sev
High Freq Low Freq
Good State Bad State
Severity
Frequency
Health State
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Alternative Representations
High Sev Low Sev
High Freq Low Freq
Good State Bad State
Severity
Frequency
Health State
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Alternative RepresentationsLinear Orderings
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Alternative RepresentationsLinear Orderings
MildDiarrheaDrowsinessNausea
Life-ThreateningChest painShortness of breathSlurred speech
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Alternative RepresentationsLinear Orderings
MildDiarrheaDrowsinessNausea
Life-ThreateningChest painShortness of breathSlurred speech
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Alternative RepresentationsLinear Orderings
MildDiarrheaDrowsinessNausea
Life-ThreateningChest painShortness of breathSlurred speech
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Drug X
Chest painShortness of breathSlurred speech
DiarrheaDrowsinessNausea
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Chest painShortness of breathSlurred speech
DiarrheaDrowsinessNausea
Drug X
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Alternative Representations
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SAME DIFFERENT Information Displays
PARAGRAPH
PlainPossible side effects include chest pain, slurred speech, seizure, anxiety, joint pain, weakness, dry mouth, headache, and nausea.
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PARAGRAPH
PlainPossible side effects include chest pain, slurred speech, seizure, anxiety, joint pain, weakness, dry mouth, headache, and nausea.
CategorizedPossible dangerous side effects include chest pain, slurred speech, and seizure. Some are worrisome such as anxiety, joint pain, and weakness. Others are mild such as dry mouth, headache, and nausea.
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PARAGRAPH
PlainPossible side effects include chest pain, slurred speech, seizure, anxiety, joint pain, weakness, dry mouth, headache, and nausea.
CategorizedPossible dangerous side effects include chest pain, slurred speech, and seizure. Some are worrisome such as anxiety, joint pain, and weakness. Others are mild such as dry mouth, headache, and nausea.
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LIST Plain
--chest pain--slurred speech--seizure--anxiety--joint pain--weakness--dry mouth--headache--nausea
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LIST Plain Chunked +
--chest pain--slurred speech--seizure--anxiety--joint pain--weakness--dry mouth--headache--nausea
Dangerous--chest pain--slurred speech--seizure
Worrisome--anxiety--joint pain--weakness
Mild--dry mouth--headache--nausea
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LINE dry mouth anxiety chest painheadache joint pain slurred speech nausea weakness seizure
Mild Dangerous
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LINE
ARROW
dry mouth anxiety chest painheadache joint pain slurred speech nausea weakness seizure
Mild Dangerous
dry mouth anxiety chest painheadache joint pain slurred speech nausea weakness seizure
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LINE
ARROW
ARROW +
dry mouth anxiety chest painheadache joint pain slurred speech nausea weakness seizure
Mild Dangerous
dry mouth anxiety chest painheadache joint pain slurred speech nausea weakness seizure
dry mouth anxiety chest painheadache joint pain slurred speech nausea weakness seizure
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MATRIX
MildWorrisomeDangerous
MoreCommon
LessCommon
Rarechest painslurred speechseizure
anxietyjoint painweakness
dry mouthheadachenausea
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MATRIX
MildWorrisomeDangerous
MoreCommon
LessCommon
Rarechest painslurred speechseizure
anxiety
joint pain
weakness
dry mouthheadache
nausea
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MildDangerous
Common
Rarechest painslurred speechseizure
dry mouth
headache nausea
Mild
dry mouth
headachenauseaanxiety
MATRIX
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Alternative Representationsof Same Information
--Text--List--Linear Ordering--Matrix--Lots More (…..)
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Alternative Representationsof Same Information
--Text--List--Linear Ordering--Matrix--Lots More (…..)
CognitiveConsequences
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--Text--List--Linear Ordering--Matrix--Lots More (…..)
CognitiveConsequences
Day, R. S. Alternative representations. In G. H. Bower (Ed.), The Psychology of Learning and Motivation. New York: Academic Press, 1988, 22, 261-305.
Effects on --Perception --Attention --Comprehension --Memory --Problem Solving
Alternative Representationsof Same Information
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--Text--List--Linear Ordering--Matrix--Lots More (…..)
CognitiveConsequences
Day, R. S. Alternative representations. In G. H. Bower (Ed.), The Psychology of Learning and Motivation. New York: Academic Press, 1988, 22, 261-305.
Effects on --Perception --Attention --Comprehension --Memory --Problem Solving
--Behavior & Health
Alternative Representationsof Same Information
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Alternative Representations
TextListLineMatrix(etc.)
Effects
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Alternative Representations
TextListLineMatrix(etc.)
Effects
Original Enhanced DISPLAY
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Alternative Representations
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Possible side effects include:
Study TestSide Effects
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Multiplecognitive tasks
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Much knowledgeMuch expertise
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Physicians & Patients
Much knowledge Little knowledgeMuch expertise Little expertise
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Physicians & Patients
Much knowledge Little knowledgeMuch expertise Little expertise
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Much knowledge Little knowledgeMuch expertise Little expertise
Cognitive Processes
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Attention ComprehensionMemory
Much knowledge Little knowledgeMuch expertise Little expertise
Cognitive Cognitive Processes Factors .
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Attention ChunkingComprehension LocationMemory Readability
OTC
Drug FactsActive ingred PurposeUsesWarningsDirectionsInactive ingredients
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Drug FactsActive ingred PurposeUsesWarningsDirectionsInactive ingredients
Drug Facts
Package Insert
Package
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Ibuprofen (2002)
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Drug Facts
Active Ingredient (in each tablet) PurposeIbuprofen 200 mg Pain reliever/fever reducer
Uses temporarily relieves minor aches and pains due to: minor pain of arthritis headache backache menstrual cramps the common cold muscular aches toothache temporarily reduces fever
WarningsAllergy alert: Ibuprofen may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shockAlcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctorwhether you should take ibuprofen or other pain relievers/fever reducers. Ibuprofen maycause stomach bleeding.
Do not use if you have ever had an allergic reaction to any other pain reliever/feverreducer.
Ask a doctor before use if you have problems or serious side effects from taking pain relievers or fever reducers stomach problems that last or come back, such as heartburn, upset stomach, or pain ulcers bleeding problems high blood pressure, heart or kidney disease, are taking a diuretic, or are over 65 yearsof age
Ask a doctor or pharmacist before use if you are under a doctor’s care for any serious condition taking any other product that contains ibuprofen, or any other pain reliever/feverreducer taking a prescription drug for anticoagulation (blood thinning) taking any other drug
When using this product take with food or milk if stomach upset occurs Ruth Day
Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days stomach pain or upset gets worse of lasts redness or swelling is present in the painful area any new symptoms appear
If pregnant or breast feeding, ask a health professional before use. It is especiallyimportant not to use ibuprofen during the last 3 months of pregnancy unless definitelydirected to do so by a doctor because it may cause problems in the unborn child or complications during deliver.Keep out of reach of children. In case of overdoes, get medical help or contact a PoisonControl Center right away.
Directions do not take more than directed adults and children 12 years and over 1 table every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 3 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor children under 12 years: ask a doctor
Other information each tablet contains: ibuprofen store at 20 -25° C (68-77° F) avoid high humidity and excessive heat aove 40°C (104° F) do not use if seal on bottle has been opened
Inactive ingredients acetylated monoglyceride, beeswax and/or carnauba wax, croscarmellose sodium, iron oxides, lecithin, methylparaben, microcrystalline cellulose, pharmaceutical glaze, povidone, propylparaben, silicon dioxide, simethicone, sodium benzoate, sodium lauryl sulfate, starch, stearic acid, sucrose, titanium dioxide
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WarningsAllergy alert: Ibuprofen may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shockAlcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctorwhether you should take ibuprofen or other pain relievers/fever reducers. Ibuprofen maycause stomach bleeding.
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WarningsAllergy alert: Ibuprofen may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shockAlcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctorwhether you should take ibuprofen or other pain relievers/fever reducers. Ibuprofen maycause stomach bleeding.
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WarningsAllergy alert: Ibuprofen may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shockAlcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctorwhether you should take ibuprofen or other pain relievers/fever reducers. Ibuprofen maycause stomach bleeding.
Alternative RepresentationsOriginal
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WarningsAllergy alert: Ibuprofen may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shockAlcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctorwhether you should take ibuprofen or other pain relievers/fever reducers. Ibuprofen maycause stomach bleeding.
WarningsAllergy alert: Ibuprofen may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shockAlcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctorwhether you should take ibuprofen or other pain relievers/fever reducers. Stomach bleeding: Ibuprofen may cause stomach bleeding.
Alternative RepresentationsOriginal
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WarningsAllergy alert: Ibuprofen may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shockAlcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctorwhether you should take ibuprofen or other pain relievers/fever reducers. Ibuprofen maycause stomach bleeding.
WarningsAllergy alert: Ibuprofen may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shockAlcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctorwhether you should take ibuprofen or other pain relievers/fever reducers. Stomach bleeding: Ibuprofen may cause stomach bleeding.
WARNINGSAllergy alert: Ibuprofen may cause a severe allergic reaction which may include: --hives --facial swelling --asthma (wheezing) --shock
Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take ibuprofen or other pain relievers/fever reducers.
Stomach bleeding: Ibuprofen may cause stomach bleeding.
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WarningsAllergy alert: Ibuprofen may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shockAlcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctorwhether you should take ibuprofen or other pain relievers/fever reducers. Ibuprofen maycause stomach bleeding.
WarningsAllergy alert: Ibuprofen may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shockAlcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctorwhether you should take ibuprofen or other pain relievers/fever reducers. Stomach bleeding: Ibuprofen may cause stomach bleeding.
WARNINGSAllergy alert: Ibuprofen may cause a severe allergic reaction which may include: --hives --facial swelling --asthma (wheezing) --shock
Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take ibuprofen or other pain relievers/fever reducers.
Stomach bleeding: Ibuprofen may cause stomach bleeding.
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Ibuprofen (2002)
Stomach bleeding
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Acetaminophen + (2006)
Liver damage
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Acetaminophen PM (2006)
#1
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Acetaminophen PM (2006)
#1
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Acetaminophen PM (2006)
#1 #2
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Acetaminophen PM (2006)
#1 #2
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Generality of Results
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Generality of Results
People Information Cognitive Source Task
PatientsNonPatients
PhysiciansOther HCPs
Demographics --age --education --literacy --etc. Ruth Day
Generality of Results
People Information Cognitive Source Task
PatientsNonPatients
PhysiciansOther HCPs
Demographics --age --education --literacy --etc.
OTC labelOTC package Package insertProfessional LabelCMIMedication GuidesPrint AdsTV Ads
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Generality of Results
People Information Cognitive Source Task
OTC labelOTC package Package insertProfessional LabelCMIMedication GuidesPrint AdsTV Ads
AttentionSearchRecallRecognitionDefinitionComprehensionProblem SolvingDecision Making
PatientsNonPatients
PhysiciansOther HCPs
Demographics --age --education --literacy --etc. Ruth Day
Drug Information Toolkit
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Cognitive Accessibility
Check-List
Cognitive Accessibility Check-List
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Readability
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Cognitive Accessibility Check-List
Uses Warnings ….
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FORMAT SELECTION
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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.
Purposes
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DRUG INFORMATION
Physically present
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DRUG INFORMATION
Physically Functionally present absent
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Cognitive Accessibilityof OTC Drug Information
[email protected]://www.duke.edu/~ruthday/medcog.html
Drug FactsActive ingred PurposeUsesWarningsDirectionsInactive ingredients
Day, R.S. (2006) Comprehension of prescription drug information: Overview of a research program. Proceedings of the American Association for Artificial Intelligence, Argumentation for Consumer Healthcare. http://www.aaai.org
Day, R. S. (1988) Alternative representations. In G.H. Bower (Ed.), The Psychology of Learning and Motivation. New York: Academic Press, 22, 261-305.
Day, R.S. (2000) Brandname.Com’ – Cognitive accessibility of drug information on drug product websites. Drug Information Association.