Testing the Effect of a Caution for Drugs Approved on Surrogate Outcomes Alone
Not Applicable
Completed
- Conditions
- Risk Communication
- Interventions
- Other: Presentation of information on approval based on a surrogate outcome and levels of caution
- Registration Number
- NCT00950157
- Brief Summary
The purpose of this study is to test whether cautions about the evidence, in this case an "open questions" statement, decreases enthusiasm for drugs that are approved on surrogate outcomes (compared to patient outcomes) alone.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2944
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description No open question statement Presentation of information on approval based on a surrogate outcome and levels of caution Survey only describes the surrogate outcome of the drug. Directive "open question" statement Presentation of information on approval based on a surrogate outcome and levels of caution 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. Non-directive open question statement Presentation of information on approval based on a surrogate outcome and levels of caution 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.
- Primary Outcome Measures
Name Time Method Hypothetical choice of drug approved on surrogate outcomes vs. drug known to improve patient outcomes 0 weeks (assessed during intervention)
- Secondary Outcome Measures
Name Time Method Strength of opinion (take or refuse doctor's recommendation) for taking the drug approved on surrogate outcomes vs. drug known to improve patient outcomes 0 weeks (assessed during intervention)