NCT01939925

Brief Summary

The purpose of this randomised controlled trial is to compare a new standardised summary format for presentation of synthesised evidence from systematic reviews for the public (a new plain language summary format) to the current format used in Cochrane systematic reviews. The study will evaluate if the new presentation improves understanding about the benefits and harms of an intervention, if it improves the accessibility of the information, and if it is preferred over other versions by the public over the current format.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
193

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2009

Shorter than P25 for not_applicable

Geographic Reach
5 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

August 27, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 11, 2013

Completed
Last Updated

September 11, 2013

Status Verified

September 1, 2013

Enrollment Period

5 months

First QC Date

August 27, 2013

Last Update Submit

September 6, 2013

Conditions

Adult

Keywords

patient educationHealth Knowledge, Attitudes, Practicecomprehensionconsumer health information

Outcome Measures

Primary Outcomes (1)

  • Understanding of benefits and harms

    Average proportion of people who answered 5 multiple choice questions correctly. Each question includes five response options about the number of people who could benefit or be harmed by the intervention and about the quality of evidence

    After reading summary - time 0

Secondary Outcomes (1)

  • Number of questions answered correctly

    After reading summary - time 0

Other Outcomes (4)

  • Understanding of the purpose of the summary

    after reading summary - time 0

  • Understanding the producer of the summary

    after reading summary - time 0

  • Usability and accessibility

    after reading summary - time 0

  • +1 more other outcomes

Study Arms (2)

New plain language summary format

EXPERIMENTAL

New plain language summary format of a Cochrane systematic review

Other: New plain language summary format

Current plain language summary format

ACTIVE COMPARATOR

Plain Language Summary format for the public currently in use in Cochrane systematic reviews

Other: Current plain language summary format

Interventions

New plain language summary formatOTHER

New plain language summary includes qualitative and quantitative description of text (absolute effects and natural frequencies provided); quantitative results provided in a table; quality of the evidence according to GRADE provided in a table; question and answer format; follows principles of linguistic frameworks (e.g. progressive movements from introduction to 'bottom line')

New plain language summary format
Current plain language summary formatOTHER

Current plain language summary includes qualitative description of effects only; inconsistent description of the quality of the evidence; paragraph of text; inconsistent flow of information

Current plain language summary format

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients or members of the public 16 years or older

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Argentine Cochrane Centre, Instituto de Efectividad ClĂ­nica y Sanitaria (IECS)

Buenos Aires, Argentina

Location

University of Ottawa

Ottawa, Ontario, Canada

Location

University of Milan

Milan, Italy

Location

Norwegian Knowledge Centre for the Health Services

Oslo, Norway

Location

Centro Cochrane Iberoamericano - Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Location

MeSH Terms

Conditions

Behavior

Study Officials

  • Claire Glenton, PhD

    Norwegian Knowledge Centre for the Health Services

    PRINCIPAL INVESTIGATOR

  • Holger J Schunemann, MD PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

  • Nancy A Santesso, RD PhD cand

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Researcher

Study Record Dates

First Submitted

August 27, 2013

First Posted

September 11, 2013

Study Start

May 1, 2009

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

September 11, 2013

Record last verified: 2013-09

Locations

CA(1)NO(1)AR(1)IT(1)ES(1)