Testing Numeric Formats for Presenting Data About Treatment Benefits and Harms

This study has been completed.

Sponsor:

Collaborator:

Attorney General Prescriber and Consumer Education Grant Program

Information provided by:

White River Junction VAMC

ClinicalTrials.gov Identifier:

NCT00950014

First received: July 30, 2009

Last updated: April 8, 2010

Last verified: July 2009

History of Changes

Purpose

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

Condition	Intervention
Risk Communication	Other: Presentation of drug efficacy and side effect data

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator)
Official Title:	Testing Numeric Formats for Presenting Data About Treatment Benefits and Harms

Further study details as provided by White River Junction VAMC:

Primary Outcome Measures:

Comprehension questions (e.g., overall direction of effect and specific numeric data) [ Time Frame: 0 weeks (assessed during intervention) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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) ] [ Designated as safety issue: No ]

Enrollment:	2944
Study Start Date:	August 2009
Study Completion Date:	September 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00950014

Sponsors and Collaborators

White River Junction VAMC

Attorney General Prescriber and Consumer Education Grant Program

Investigators

Principal Investigator:	Lisa M Schwartz, MD, MS	White River Junction VAMC
Principal Investigator:	Steven Woloshin, MD, MS	White River Junction VAMC

More Information

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. 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. Epub 2007 Sep 14.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Lisa M. Schwartz, MD, MS, White River Junction VAMC
ClinicalTrials.gov Identifier:	NCT00950014 History of Changes
Other Study ID Numbers:	16783
Study First Received:	July 30, 2009
Last Updated:	April 8, 2010
Health Authority:	United States: Federal Government

Keywords provided by White River Junction VAMC:

Numeracy

ClinicalTrials.gov processed this record on May 16, 2013

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