Testing Numeric Formats for Presenting Data About Treatment Benefits and Harms

Risk Communication Clinical Trial

Official title:

Testing Numeric Formats for Presenting Data About Treatment Benefits and Harms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00950014
• Other study ID #: 16783
• Status: Completed
• Phase: N/A
• First received: July 30, 2009
• Last updated: April 8, 2010
• Start date: August 2009
• Est. completion date: September 2009

Study information

• Verified date: July 2009
• Source: White River Junction VAMC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test comprehension of five numeric formats used to present data about treatment benefits and harms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2944
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Risk Communication

Intervention

Other:
• Presentation of drug efficacy and side effect data
Data presented in 1 of 5 numeric formats in each arm: percentage only, fixed frequency only, variable frequency, variable combination and fixed combination format.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
White River Junction VAMC	Attorney General Consumer & Prescriber Education Grant

References & Publications (2)

Schwartz LM, Woloshin S, Welch HG. The drug facts box: providing consumers with simple tabular data on drug benefit and harm. Med Decis Making. 2007 Sep-Oct;27(5):655-62. Epub 2007 Sep 14. — View Citation

Schwartz LM, Woloshin S, Welch HG. Using a drug facts box to communicate drug benefits and harms: two randomized trials. Ann Intern Med. 2009 Apr 21;150(8):516-27. Epub 2009 Feb 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comprehension questions (e.g., overall direction of effect and specific numeric data)		0 weeks (assessed during intervention)	No
Secondary	Risk perceptions (e.g., how big or small is the benefit)and preferences (e.g., did the box help subjects understand the benefits) assessed via Internet surveys.		0 weeks (assessed during intervention)	No