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Completed

NCT Number: NCT01939925

Communicating Evidence From Systematic Reviews to the Public

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.

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Key information

Conditions

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Argentine Cochrane Centre, Instituto de Efectividad Clínica y Sanitaria (IECS), Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients or members of the public 16 years or older

Treatment and study plan

New plain language summary format

Other

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')

Current plain language summary format

Other

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 outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Norwegian Knowledge Centre for the Health Services

Other Gov

Collaborators

  • Asociacion Colaboracion Cochrane Iberoamericana
  • McMaster University
  • University of Milan
  • University of Ottawa

Registry information

Official study title

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

Acronym: PLSRCT

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Sep 11, 2013
Registry last updated
Sep 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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