- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03002610
Presenting Summary Information From Cochrane Systematic Reviews to Physicians
February 18, 2019 updated by: Ivan Buljan, University Hospital of Split
Presenting Summary Information From Cochrane Systematic Reviews to Physicians: Protocol for Research of Infographics Presentation vs. Plain Language Summary
The objective of this study is to evaluate the efficacy of infographics, compared to standard PLS and scientific abstract format, in presenting information, in terms of understanding and remembering research results by physicians.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The investigators will conduct a randomized controlled trial (RCT) with three different formats of the same systematic review summary (Infographics, PLS, scientific abstract).
The content of these three formats is based on the same systematic review, but the ways of data presentation will differ: visual presentation in plain language, plain language only, and text with scientific abbreviations.
The interventions will be delivered online in January 2016, with physicians who are currently working at Clinical Hospital Split.
The trial will be preformed online, and it will be voluntary and anonymous.
The survey will consist of 5 parts, in the following order: 1) one format of the summary (randomly assigned), 2) health numeracy, 3) demographic data 4) comprehension test of the information given in the summary, and 5) user friendliness of information and overall satisfaction with the given summary assessed by survey.
Study Type
Interventional
Enrollment (Actual)
108
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
-
-
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Split, Croatia, 21000
- University of Split
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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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- physicians who are working at Clinical Hospital Split
Exclusion Criteria:
- none
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
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: PLS
The control group will receive PLS: text format with simple explanation of the survey topic main findings and is intended for lay audience.
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Text format with simple explanation of the survey topic main findings and is intended for lay audience.
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|
Experimental: Infographics
Infographics format of a Cochrane systematic review summary represents the experimental intervention in the trial, where the results are presented with text and pictures.
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Cochrane started developing infographics, where short textual information about research is supported by visual representations of the main findings and is also aimed at the lay public The investigators will examine whether this format is better in information uptake than standard PLS.
|
|
Active Comparator: Scientific abstract
Scientific abstract is the text written for the academic population and practitioners.
It is also intended for control group.
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Scientific abstract the text written for the academic population and practitioners, with scientific abbreviations which enables experts to go into more detail about the topic.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Understanding of the Content of Summary Format
Time Frame: One month (30 days)
|
The questions will focus on understanding the benefits and risks of the intervention and the quality of evidence described in the systematic review.
In total, there will be 10 open ended questions, and the total score will be the sum of the correct answers (minimum 0, maximum 10).
Higher scores would indicate higher understanding.
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One month (30 days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reading Experience
Time Frame: One month (30 days)
|
This section of the survey will include 5 questions about the experience of participants about the text they read, measured on a 10-point Likert type scale, where 1 means do not agree at all and 10 means fully agree.
The total score is the sum of scores on all five answers (minimum 5, maximum 50).
Higher scores would indicate higher, or more positive, reading experience.
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One month (30 days)
|
|
User Friendliness
Time Frame: One month (30 days)
|
This section of the survey will have 5 questions concerning how easy it was for the participant to find relevant information, measured by a 10-point Likert type scale where the answer 1 means I do not agree at all and 10 means I fully agree.
The total score is the sum of scores on all the answers (minimum 5, maximum 50).
Higher scores would indicate greater, or more positive user friendliness, meaning that participants consider that format as easier to find relevant information.
|
One month (30 days)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health Numeracy
Time Frame: One month (30 days)
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This section will use 6-item General health numeracy test (Osborne et al., 2013) in order to determine how much our participants understand the basic health instructions regarding numeracy dimension.
For each correct answer, the participants receive one point and the total score is the sum of all correct answers.
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One month (30 days)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ivan Buljan, Researcher
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
December 1, 2016
Primary Completion (Actual)
March 1, 2017
Study Completion (Actual)
March 1, 2017
Study Registration Dates
First Submitted
December 20, 2016
First Submitted That Met QC Criteria
December 20, 2016
First Posted (Estimate)
December 26, 2016
Study Record Updates
Last Update Posted (Actual)
June 3, 2019
Last Update Submitted That Met QC Criteria
February 18, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- IP-2014-12-7672
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
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.
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