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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
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Accutane Medication Guide Ruth Day
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Basic Methods Study Test time All Multiple Content Tasks Ruth Day --benefits --risks --etc --attention --comprehension --memory
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Basic Methods Study Test time All Multiple Content Tasks Ruth Day --benefits --risks --etc --attention --comprehension --memory
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Basic Methods Study Test time All Multiple Content Tasks Ruth Day --benefits --risks --etc --attention --comprehension --memory
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Key Educational Message Ruth Day
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Key Educational Message “What is the most important information I should know about Accutane?” Ruth Day
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Pregnancy % CORRECT Ruth Day
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% CORRECT Pregnancy Ruth Day
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% CORRECT Pregnancy Ruth Day
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% CORRECT Pregnancy Ruth Day
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% CORRECT Pregnancy Ruth Day
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ACCUTANE Medication Guide Ruth Day Original Version
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Ruth Day Original Who should not take Accutane?
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Ruth Day Original
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Enhanced Version ACCUTANE Medication Guide Ruth Day
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New titles (Time Zones) Enhanced Ruth Day
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Enhanced Ruth Day
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Research Methods
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Perceptions Opinions Attitudes
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Research Methods Comprehension Memory Perceptions Opinions Attitudes
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Perceptions Opinions Attitudes Research Methods Comprehension Memory
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Perceptions Opinions Attitudes Research Methods Comprehension Memory
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Study Test time Ruth Day PreTest PostTest Metacognition
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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
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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
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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
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Conclusions For FDA Advisory Committee (8/1/07)
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--People overestimated how much they knew and understood after reading Ruth Day Conclusions For FDA Advisory Committee (8/1/07)
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--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)
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--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)
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