Testing Numeric Formats for Presenting Data About Treatme... | NCT00950014

NCT00950014

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Attorney General Consumer & Prescriber Education Grant	OTHER

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Percentage format only	Experimental	Numbers are presented in percentage format (e.g., 35%, 0.2%) only.	Other: Presentation of drug efficacy and side effect data
Fixed frequency format only	Experimental	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
Variable frequency format	Experimental	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
Fixed combination format	Active Comparator	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
Variable combination format	Experimental	Numbers are presented with both percentages and frequencies, but frequency denominators may vary (e.g., _ out of 1000, _ out of 100).

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Presentation of drug efficacy and side effect data	Other	Data presented in 1 of 5 numeric formats in each arm: percentage only, fixed frequency only, variable frequency, variable combination and fixed combination format.

Outcomes Module

Measure	Description	Time Frame
Comprehension questions (e.g., overall direction of effect and specific numeric data)		0 weeks (assessed during intervention)

Secondary Outcomes

Measure	Description	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.		0 weeks (assessed during intervention)

Eligibility Module

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
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	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19221371	Background	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.
17873258	Background	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.