Testing the Effect of a Caution for Drugs Approved on Surrogate Outcomes Alone

Study Overview
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Brief Summary
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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.

Official Title
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Testing the Effect of a Caution for Drugs Approved on Surrogate Outcomes Alone

Conditions
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Risk Communication

Intervention / Treatment
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* Other: Presentation of information on approval based on a surrogate outcome and levels of caution


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Participants will be randomly selected from a research panel of more than 60,000 U.S. households (Knowledge Networks).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Directive open question statement<br>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. | Other: Presentation of information on approval based on a surrogate outcome and levels of caution<br>* 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.<br>|
| Experimental: Non-directive open question statement<br>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. | Other: Presentation of information on approval based on a surrogate outcome and levels of caution<br>* 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.<br>|
| Experimental: No open question statement<br>Survey only describes the surrogate outcome of the drug. | Other: Presentation of information on approval based on a surrogate outcome and levels of caution<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypothetical choice of drug approved on surrogate outcomes vs. drug known to improve patient outcomes |  | 0 weeks (assessed during intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |