Communicating Evidence From Systematic Reviews to the Public (PLSRCT)

September 6, 2013 updated by: Claire Glenton, Norwegian Knowledge Centre for the Health Services

Communicating Evidence From Systematic Reviews to the Public: A Randomised Controlled Trial

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

193

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Buenos Aires, Argentina
        • Argentine Cochrane Centre, Instituto de Efectividad Clínica y Sanitaria (IECS)
    • Ontario
      • Ottawa, Ontario, Canada
        • University of Ottawa
      • Milan, Italy
        • University of Milan
      • Oslo, Norway
        • Norwegian Knowledge Centre for the Health Services
      • Barcelona, Spain
        • Centro Cochrane Iberoamericano - Hospital de la Santa Creu i Sant Pau

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

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients or members of the public 16 years or older

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: New plain language summary format
New plain language summary format of a Cochrane systematic review
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')
Active Comparator: Current plain language summary format
Plain Language Summary format for the public currently in use in Cochrane systematic reviews
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Understanding of benefits and harms
Time Frame: After reading summary - time 0
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of questions answered correctly
Time Frame: After reading summary - time 0
Total number of questions out of five questions for benefits and harms that were answered correctly
After reading summary - time 0

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Understanding of the purpose of the summary
Time Frame: after reading summary - time 0
A multiple choice question with three options
after reading summary - time 0
Understanding the producer of the summary
Time Frame: after reading summary - time 0
A multiple choice question with three options
after reading summary - time 0
Usability and accessibility
Time Frame: after reading summary - time 0
Five questions about whether information was easy to find and understand, reliable, and useful to someone making a decision. Measured using a 7 point Likert scale (strongly agree to strongly disagree).
after reading summary - time 0
Preference for the new format or the old format
Time Frame: after reading both summaries - time 0
7 point likert scale
after reading both summaries - time 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: 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

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

May 1, 2009

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

August 27, 2013

First Submitted That Met QC Criteria

September 6, 2013

First Posted (Estimate)

September 11, 2013

Study Record Updates

Last Update Posted (Estimate)

September 11, 2013

Last Update Submitted That Met QC Criteria

September 6, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

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.

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