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Communicating Evidence From Systematic Reviews to the Public (PLSRCT)

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ClinicalTrials.gov Identifier: NCT01939925
Recruitment Status : Completed
First Posted : September 11, 2013
Last Update Posted : September 11, 2013
Sponsor:
Collaborators:
McMaster University
University of Ottawa
Asociacion Colaboracion Cochrane Iberoamericana
University of Milan
Information provided by (Responsible Party):
Claire Glenton, Norwegian Knowledge Centre for the Health Services

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.

Condition or disease Intervention/treatment Phase
Adult Other: New plain language summary format Other: Current plain language summary format Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 193 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Communicating Evidence From Systematic Reviews to the Public: A Randomised Controlled Trial
Study Start Date : May 2009
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Arm Intervention/treatment
Experimental: New plain language summary format
New plain language summary format of a Cochrane systematic review
Other: New plain language summary format
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
Other: Current plain language summary format
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. Understanding of the purpose of the summary [ Time Frame: after reading summary - time 0 ]
    A multiple choice question with three options

  2. Understanding the producer of the summary [ Time Frame: after reading summary - time 0 ]
    A multiple choice question with three options

  3. 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).

  4. Preference for the new format or the old format [ Time Frame: after reading both summaries - time 0 ]
    7 point likert scale



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients or members of the public 16 years or older

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01939925


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

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Responsible Party: Claire Glenton, Senior Researcher, Norwegian Knowledge Centre for the Health Services
ClinicalTrials.gov Identifier: NCT01939925     History of Changes
Other Study ID Numbers: PLSRCT1
First Posted: September 11, 2013    Key Record Dates
Last Update Posted: September 11, 2013
Last Verified: September 2013

Keywords provided by Claire Glenton, Norwegian Knowledge Centre for the Health Services:
patient education
Health Knowledge, Attitudes, Practice
comprehension
consumer health information