Testing Numeric Formats for Presenting Data About Treatment Benefits and Harms

NCT ID: NCT00950014

Last Updated: 2010-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2944 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2009-09-30

Brief Summary

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

Detailed Description

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Conditions

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Risk Communication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Investigators

Study Groups

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Percentage format only

Numbers are presented in percentage format (e.g., 35%, 0.2%) only.

Group Type EXPERIMENTAL

Presentation of drug efficacy and side effect data

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Presentation of drug efficacy and side effect data

Intervention Type 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.

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)

Group Type EXPERIMENTAL

Presentation of drug efficacy and side effect data

Intervention Type 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.

Fixed combination format

Numbers are presented with both percentages and frequencies, and frequency denominators remain fixed (e.g., \_ out of 1000).

Group Type ACTIVE_COMPARATOR

Presentation of drug efficacy and side effect data

Intervention Type 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.

Variable combination format

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

Group Type EXPERIMENTAL

Presentation of drug efficacy and side effect data

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Attorney General Consumer & Prescriber Education Grant

OTHER

Sponsor Role collaborator

White River Junction Veterans Affairs Medical Center

FED

Sponsor Role lead

Responsible Party

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White River Junction VAMC

Principal Investigators

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Lisa M Schwartz, MD, MS

Role: PRINCIPAL_INVESTIGATOR

White River Junction Veterans Affairs Medical Center

Steven Woloshin, MD, MS

Role: PRINCIPAL_INVESTIGATOR

White River Junction Veterans Affairs Medical Center

References

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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.

Reference Type BACKGROUND
PMID: 19221371 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17873258 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21768582 (View on PubMed)

Other Identifiers

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16783

Identifier Type: -

Identifier Source: org_study_id

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