Testing Numeric Formats for Presenting Data About Treatment Benefits and Harms
April 8, 2010 updated by: White River Junction Veterans Affairs Medical Center
The purpose of this study is to test comprehension of five numeric formats used to present data about treatment benefits and harms.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2944
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Percentage format only
Numbers are presented in percentage format (e.g., 35%, 0.2%) only.
|
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.
|
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)
|
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).
|
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).
|
Data presented in 1 of 5 numeric formats in each arm: percentage only, fixed frequency only, variable frequency, variable combination and fixed combination format.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Comprehension questions (e.g., overall direction of effect and specific numeric data)
Time Frame: 0 weeks (assessed during intervention)
|
0 weeks (assessed during intervention)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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)
|
0 weeks (assessed during intervention)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. doi: 10.7326/0003-4819-150-8-200904210-00106. Epub 2009 Feb 16.
- 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. doi: 10.1177/0272989X07306786. Epub 2007 Sep 14.
- Woloshin S, Schwartz LM. Communicating data about the benefits and harms of treatment: a randomized trial. Ann Intern Med. 2011 Jul 19;155(2):87-96. doi: 10.7326/0003-4819-155-2-201107190-00004.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2009
Primary Completion (Actual)
September 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)
April 9, 2010
Last Update Submitted That Met QC Criteria
April 8, 2010
Last Verified
July 1, 2009
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 16783
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.