Communicating Evidence From Systematic Reviews to the Public

Adult Clinical Trial

— PLSRCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01939925
• Other study ID #: PLSRCT1
• Status: Completed
• Phase: N/A
• First received: August 27, 2013
• Last updated: September 6, 2013
• Start date: May 2009
• Est. completion date: October 2009

Study information

• Verified date: September 2013
• Source: Norwegian Knowledge Centre for the Health Services
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Regional Ethics Commitee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• patients or members of the public 16 years or older

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Adult

Intervention

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')
• 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

Locations

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

Sponsors (5)

Lead Sponsor	Collaborator
Norwegian Knowledge Centre for the Health Services	Asociacion Colaboracion Cochrane Iberoamericana, McMaster University, University of Milan, University of Ottawa

Countries where clinical trial is conducted

Argentina,  Canada,  Italy,  Norway,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Understanding of the purpose of the summary	A multiple choice question with three options	after reading summary - time 0	No
Other	Understanding the producer of the summary	A multiple choice question with three options	after reading summary - time 0	No
Other	Usability and accessibility	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	No
Other	Preference for the new format or the old format	7 point likert scale	after reading both summaries - time 0	No
Primary	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	No
Secondary	Number of questions answered correctly	Total number of questions out of five questions for benefits and harms that were answered correctly	After reading summary - time 0	No