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Testing Numeric Formats for Presenting Data About Treatment Benefits and Harms

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ClinicalTrials.gov Identifier: NCT00950014
Recruitment Status : Completed
First Posted : July 31, 2009
Last Update Posted : April 9, 2010
Sponsor:
Collaborator:
Attorney General Consumer & Prescriber Education Grant
Information provided by:
White River Junction Veterans Affairs Medical Center

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

Condition or disease Intervention/treatment Phase
Risk Communication Other: Presentation of drug efficacy and side effect data Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2944 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Official Title: Testing Numeric Formats for Presenting Data About Treatment Benefits and Harms
Study Start Date : August 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Arm Intervention/treatment
Experimental: Percentage format only
Numbers are presented in percentage format (e.g., 35%, 0.2%) only.
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.

Experimental: Fixed frequency format only
Numbers are presented in fixed frequency format only (5 out of 1000, 0.6 out of 1000). Denominators remains the same for each number.
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.

Experimental: Variable frequency format
Frequency denominators are adjusted to keep the numerator greater than 1, so they may change throughout the survey (e.g., 6 out of 1000, 42 out of 100)
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.

Active Comparator: Fixed combination format
Numbers are presented with both percentages and frequencies, and frequency denominators remain fixed (e.g., _ out of 1000).
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.

Experimental: Variable combination format
Numbers are presented with both percentages and frequencies, but frequency denominators may vary (e.g., _ out of 1000, _ out of 100).
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.




Primary Outcome Measures :
  1. Comprehension questions (e.g., overall direction of effect and specific numeric data) [ Time Frame: 0 weeks (assessed during intervention) ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: 0 weeks (assessed during intervention) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00950014


Sponsors and Collaborators
White River Junction Veterans Affairs Medical Center
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