PLSRCT: Communicating Evidence From Systematic Reviews to the Public

Sponsor

Norwegian Knowledge Centre for the Health Services (Other)

Overall Status

Completed

CT.gov ID

NCT01939925

Collaborator

McMaster University (Other), University of Ottawa (Other), Asociacion Colaboracion Cochrane Iberoamericana (Other), University of Milan (Other)

193

Enrollment

Locations

Arms

Duration (Months)

38.6

Patients Per Site

7.7

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

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 1, 2009

Actual Primary Completion Date :

Oct 1, 2009

Actual Study Completion Date :

Oct 1, 2009

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Understanding of benefits and harms [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

Number of questions answered correctly [After reading summary - time 0]
Total number of questions out of five questions for benefits and harms that were answered correctly

Other Outcome Measures

Understanding of the purpose of the summary [after reading summary - time 0]
A multiple choice question with three options
Understanding the producer of the summary [after reading summary - time 0]
A multiple choice question with three options
Usability and accessibility [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).
Preference for the new format or the old format [after reading both summaries - time 0]
7 point likert scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

patients or members of the public 16 years or older

Contacts and Locations

Locations

	Site	City	State	Country
1	Argentine Cochrane Centre, Instituto de Efectividad Clínica y Sanitaria (IECS)	Buenos Aires		Argentina
2	University of Ottawa	Ottawa	Ontario	Canada
3	University of Milan	Milan		Italy
4	Norwegian Knowledge Centre for the Health Services	Oslo		Norway
5	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

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