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

White River Junction Veterans Affairs Medical Center

Status: Completed

Conditions: Risk Communication

Treatments: Other: Presentation of information on approval based on a surrogate outcome and levels of caution

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00950157

16785

Details and patient eligibility

About

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.

Enrollment: 2,944 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Participants will be randomly selected from a research panel of more than 60,000 U.S. households (Knowledge Networks).

Trial design

2,944 participants in 3 patient groups

Directive "open question" statement

Experimental group

Description:

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.

Treatment:

Other: Presentation of information on approval based on a surrogate outcome and levels of caution

Non-directive open question statement

Experimental group

Description:

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.

Treatment:

Other: Presentation of information on approval based on a surrogate outcome and levels of caution

No open question statement

Experimental group

Description:

Survey only describes the surrogate outcome of the drug.

Treatment:

Other: Presentation of information on approval based on a surrogate outcome and levels of caution