Testing the Effect of a Caution for Drugs Approved on Surrogate Outcomes Alone
NCT ID: NCT00950157
Last Updated: 2010-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
2944 participants
INTERVENTIONAL
2009-08-31
2009-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SINGLE
Study Groups
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Directive "open question" statement
Survey describes the surrogate outcome of the drug along with a directive warning (i.e., stating the issue and why it matters) for drugs shown to improve surrogate outcomes.
This directive warning mentions that it is not known whether the drug will help patients feel better, and that readers should ask their doctor if there is an available drug shown to improve patient outcomes.
Presentation of information on approval based on a surrogate outcome and levels of caution
Presentation of information that one drug is approved on a surrogate outcome only while another drug has clinical outcomes. Participants are randomized to 1 of 3 caution (e.g. open question") statements: no open question statement, non-directive open question statement or directive open question statement.
Non-directive open question statement
Survey describes the surrogate outcome of the drug along with a non-directive warning (i.e., stating the issue only) for drugs shown to improve surrogate outcomes.
This non-directive warning mentions only that it is not known whether the drug will help patients feel better.
Presentation of information on approval based on a surrogate outcome and levels of caution
Presentation of information that one drug is approved on a surrogate outcome only while another drug has clinical outcomes. Participants are randomized to 1 of 3 caution (e.g. open question") statements: no open question statement, non-directive open question statement or directive open question statement.
No open question statement
Survey only describes the surrogate outcome of the drug.
Presentation of information on approval based on a surrogate outcome and levels of caution
Presentation of information that one drug is approved on a surrogate outcome only while another drug has clinical outcomes. Participants are randomized to 1 of 3 caution (e.g. open question") statements: no open question statement, non-directive open question statement or directive open question statement.
Interventions
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Presentation of information on approval based on a surrogate outcome and levels of caution
Presentation of information that one drug is approved on a surrogate outcome only while another drug has clinical outcomes. Participants are randomized to 1 of 3 caution (e.g. open question") statements: no open question statement, non-directive open question statement or directive open question statement.
Eligibility Criteria
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Inclusion Criteria
18 Years
ALL
Yes
Sponsors
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Attorney General Consumer & Prescriber Education Grant
OTHER
White River Junction Veterans Affairs Medical Center
FED
Responsible Party
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White River Junction VAMC
Principal Investigators
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Lisa M Schwartz, MD, MS
Role: PRINCIPAL_INVESTIGATOR
White River Junction Veterans Affairs Medical Center
Steven Woloshin, MD, MS
Role: PRINCIPAL_INVESTIGATOR
White River Junction Veterans Affairs Medical Center
References
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Schwartz LM, Woloshin S. Communicating uncertainties about prescription drugs to the public: a national randomized trial. Arch Intern Med. 2011 Sep 12;171(16):1463-8. doi: 10.1001/archinternmed.2011.396.
Other Identifiers
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16785
Identifier Type: -
Identifier Source: org_study_id
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