- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01939925
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
Status
Completed
Conditions
Intervention / Treatment
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.
Collaborators
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
Keywords
Other Study ID Numbers
- PLSRCT1
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.
Clinical Trials on Adult
-
Ethicon Endo-SurgeryRecruitingPediatric Procedures | Adult Hepato-pancreato-biliary (HPB) Procedures | Adult Lower Gastrointestinal Procedures | Adult Gastric Procedures | Adult Gynecological Procedures | Adult Urological Procedures | Adult Thoracic ProceduresUnited States, Canada, United Kingdom
-
Mayo ClinicNational Cancer Institute (NCI)Active, not recruitingAdult Anaplastic Astrocytoma | Adult Anaplastic Ependymoma | Adult Anaplastic Oligodendroglioma | Adult Diffuse Astrocytoma | Adult Ependymoma | Adult Giant Cell Glioblastoma | Adult Glioblastoma | Adult Gliosarcoma | Adult Mixed Glioma | Adult Myxopapillary Ependymoma | Adult Oligodendroglioma | Adult Pilocytic... and other conditionsUnited States
-
National Cancer Institute (NCI)TerminatedAdult Anaplastic Astrocytoma | Adult Anaplastic Ependymoma | Adult Anaplastic Oligodendroglioma | Adult Diffuse Astrocytoma | Adult Ependymoma | Adult Giant Cell Glioblastoma | Adult Glioblastoma | Adult Gliosarcoma | Adult Mixed Glioma | Adult Myxopapillary Ependymoma | Adult Oligodendroglioma | Adult Pilocytic... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Millennium Pharmaceuticals, Inc.CompletedAdult Anaplastic Astrocytoma | Adult Anaplastic Ependymoma | Adult Anaplastic Oligodendroglioma | Adult Diffuse Astrocytoma | Adult Giant Cell Glioblastoma | Adult Glioblastoma | Adult Gliosarcoma | Adult Mixed Glioma | Adult Oligodendroglioma | Adult Pilocytic Astrocytoma | Adult Pineal Gland Astrocytoma | Recurrent... and other conditionsUnited States
-
National Cancer Institute (NCI)TerminatedAdult Anaplastic Astrocytoma | Adult Anaplastic Ependymoma | Adult Anaplastic Oligodendroglioma | Adult Diffuse Astrocytoma | Adult Ependymoma | Adult Giant Cell Glioblastoma | Adult Glioblastoma | Adult Gliosarcoma | Adult Mixed Glioma | Adult Myxopapillary Ependymoma | Adult Oligodendroglioma | Adult Pilocytic... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedAdult Anaplastic Astrocytoma | Adult Diffuse Astrocytoma | Adult Giant Cell Glioblastoma | Adult Glioblastoma | Adult Gliosarcoma | Adult Mixed Glioma | Adult Oligodendroglioma | Adult Pineal Gland AstrocytomaUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)CompletedAdvanced Adult Hepatocellular Carcinoma | Localized Non-Resectable Adult Liver Carcinoma | Adult Hepatocellular Carcinoma | BCLC Stage B Adult Hepatocellular Carcinoma | BCLC Stage C Adult Hepatocellular Carcinoma | BCLC Stage D Adult Hepatocellular Carcinoma | Localized Resectable Adult Liver... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedAdult Anaplastic Astrocytoma | Adult Anaplastic Oligodendroglioma | Adult Diffuse Astrocytoma | Adult Giant Cell Glioblastoma | Adult Glioblastoma | Adult Gliosarcoma | Adult Mixed Glioma | Adult Pilocytic Astrocytoma | Adult Pineal Gland Astrocytoma | Recurrent Adult Brain Tumor | Adult Subependymal Giant...United States
-
University of CalgaryCanadian Institutes of Health Research (CIHR); Canadian Cancer Society (CCS)Recruiting
-
National Cancer Institute (NCI)CompletedAdult Anaplastic Astrocytoma | Adult Anaplastic Oligodendroglioma | Adult Giant Cell Glioblastoma | Adult Glioblastoma | Adult Gliosarcoma | Adult Mixed Glioma | Recurrent Adult Brain TumorUnited States
Clinical Trials on New plain language summary format
-
Washington University School of MedicineAgency for Healthcare Research and Quality (AHRQ)CompletedHealth Literacy | Health Insurance | Health Services AccessibilityUnited States
-
McMaster UniversityCompletedGRADE Approach | Summary of Findings Table | Cochrane CollaborationCanada
-
McMaster UniversityThe Hospital for Sick Children; University of Alberta; Western UniversityCompleted
-
Tongji HospitalNot yet recruitingAutism Spectrum Disorder | Attention Deficit Hyperactivity Disorder | Mental Retardation
-
Mark WilliamsUniversity of Pennsylvania; University of Illinois at Chicago; Boston Medical... and other collaboratorsCompletedCare TransitionsUnited States
-
Al-Azhar UniversityRecruitingVitiligo | Topical Fluorouracil | Effervescent MixtureEgypt