Mandatory Drug Risk Information: How much information is too much? Ruth S. Day / Duke University FDA Public Hearing / Medication Guides Washington, DC -- June 12, 2007

Accutane Medication Guide Ruth Day

Basic Methods Study Test time All Multiple Content Tasks Ruth Day --benefits --risks --etc --attention --comprehension --memory

Basic Methods Study Test time All Multiple Content Tasks Ruth Day --benefits --risks --etc --attention --comprehension --memory

Basic Methods Study Test time All Multiple Content Tasks Ruth Day --benefits --risks --etc --attention --comprehension --memory

Key Educational Message Ruth Day

Key Educational Message “What is the most important information I should know about Accutane?” Ruth Day

Pregnancy % CORRECT Ruth Day

% CORRECT Pregnancy Ruth Day

% CORRECT Pregnancy Ruth Day

% CORRECT Pregnancy Ruth Day

% CORRECT Pregnancy Ruth Day

ACCUTANE Medication Guide Ruth Day Original Version

Ruth Day Original Who should not take Accutane?

Ruth Day Original

Enhanced Version ACCUTANE Medication Guide Ruth Day

New titles (Time Zones) Enhanced Ruth Day

Enhanced Ruth Day

Research Methods

Perceptions Opinions Attitudes

Research Methods Comprehension Memory Perceptions Opinions Attitudes

Perceptions Opinions Attitudes Research Methods Comprehension Memory

Perceptions Opinions Attitudes Research Methods Comprehension Memory

Study Test time Ruth Day PreTest PostTest Metacognition

UNDERSTAND REMEMBER PreTest PostTest PreTest PostTest very easy easy moderate hard very hard “How easy was it to understand the information in the leaflet?” Ruth Day

UNDERSTAND REMEMBER PreTest PostTest PreTest PostTest very easy easy moderate hard very hard “How easy was it to understand the information in the leaflet?” Ruth Day

UNDERSTAND REMEMBER PreTest PostTest PreTest PostTest very easy easy moderate hard very hard “How easy would it be to remember the information in the leaflet?” Ruth Day

Conclusions For FDA Advisory Committee (8/1/07)

--People overestimated how much they knew and understood after reading Ruth Day Conclusions For FDA Advisory Committee (8/1/07)

--People overestimated how much they knew and understood after reading --After testing, they realized they knew less than they thought Ruth Day Conclusions For FDA Advisory Committee (8/1/07)

--People overestimated how much they knew and understood after reading --After testing, they realized they knew less than they thought -- AND they actually knew far less than that. Ruth Day Conclusions For FDA Advisory Committee (8/1/07)