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

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.

Study Overview

• Status: Completed
• Conditions: Risk Communication
• Intervention / Treatment: Other: Presentation of information on approval based on a surrogate outcome and levels of caution

• Study Type: Interventional
• Enrollment (Actual): 2944
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion criteria

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
Experimental: 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.	Other: 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.
Experimental: No open question statement; Survey only describes the surrogate outcome of the drug.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: White River Junction Veterans Affairs Medical Center
• Collaborators: Attorney General Consumer & Prescriber Education Grant
• Investigators: Principal Investigator: Lisa M Schwartz, MD, MS, White River Junction Veterans Affairs Medical Center; Principal Investigator: Steven Woloshin, MD, MS, White River Junction Veterans Affairs Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): August 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: July 30, 2009
• First Submitted That Met QC Criteria: July 30, 2009
• First Posted (Estimate): July 31, 2009

Study Record Updates

• Last Update Posted (Estimate): June 7, 2010
• Last Update Submitted That Met QC Criteria: June 4, 2010
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Other Study ID Numbers: 16785