Understanding Cochrane Systematic ReviewsNCT02918656
Presenting Summary Information From Cochrane Systematic Reviews
A study testing Infographic presentation of health information, PLS presentation of health information and Scientific abstract presentation of health information in people with Understanding Cochrane Systematic Reviews, run by University Hospital of Split at 1 site in Croatia.
Trial summary
The objective of the investigators study is to evaluate the efficacy of infographics in presenting information, in terms of understanding and remembering research results, compared to standard PLS formats and scientific summary formats (SciSum). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Understanding Cochrane Systematic Reviews
- What is being tested?
- Infographic presentation of health information, PLS presentation of health information and Scientific abstract presentation of health information
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 1 siteCroatia
- Study dates
- Oct 2016to Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Eligible participants will be first-year university students without experience with Cochrane review summaries, because prior familiarization with Cochrane summaries could make information uptake easier by those participants.
Who cannot join
- Participants who give the positive answer to the survey question about familiarity with the Cochrane will be excluded from the study analysis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Presenting Summary Information From Cochrane Systematic Reviews: Randomized Controlled Trial of Infographics Presentation vs. Standard Word Summaries
The objective of the investigators study is to evaluate the efficacy of infographics in presenting information, in terms of understanding and remembering research results, compared to standard PLS formats and scientific summary formats (SciSum).
Read the detailed description
The investigators will conduct a randomized control trial (RCT) with three different formats of the same systematic review summary (infographics, PLS and scientific summary). The content of these three formats is based on the same systematic review, but the ways of data presentation will differ: visual presentation, plain language, and scientific language. The trial will be performed at the beginning of the 2016/2017 academic year, with first year university students as participants. The trial will be voluntary and anonymous. The survey will consist of 4 parts: 1) demographic data, 2) one format of the summary (randomly assigned), 3) comprehension test of the information given in the summary, 4) accessibility of information and overall satisfaction with the given summary assessed by survey and 5) health numeracy test. All materials will be in Croatian. The materials used in this research will be assessed by experts in order to confirm face validity of developed questions.
- Being tested
- Infographic presentation of health information, PLS presentation of health information, Scientific abstract presentation of health information
- Keywords
- Cochrane, Abstract, Infographics, Understanding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infographic presentation of health informationOther
The students in this group will read Cochrane systematic review summary in infographics format.
Infographics format is a form of visual presentation of results of systematic review, supported by pictures and graphs.
PLS presentation of health informationOther
The students randomized in PLS group will read text format with simple explanation of the survey topic main findings which is intended for lay audience.
Scientific abstract presentation of health informationOther
The students in scientific abstract group will read the the text written for the academic population and practitioners.
| Study group | Role | What they receive |
|---|---|---|
| Infographics | Experimental | Infographic presentation of health information Receives: Other: Infographic presentation of health information |
| Plain Language Summary | Active comparator | PLS presentation of health information Receives: Other: PLS presentation of health information |
| Scientific abstract | Active comparator | Scientific abstract presentation of health information Receives: Other: Scientific abstract presentation of health information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Understanding
The primary outcome of the study is the score on a understanding test with ten questions about information contained in all three forms of presentation, titled as "Understanding information about external cephalic version for breech presentation before term" (Hutton et al, 2015). The questions will focus on understanding the benefits and risks of the intervention and the quality of evidence described in the systematic review. Each correctly answered question will be awarded one point, with a maximum of 10 points. The scale was specifically designed for this research, they ask about the information contained in all three abstract format and all questions are open-ended.
Measured: One-hour after the intervention
Secondary outcomes (3)
Reading Experience
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 score was 10 and maximum 50). Higher scores indicate greater reading experience, which means that a person was assessed that type of reading material as more enjoyable. So, higher scores are associated with more positive reading experience.
Measured: One hour after the intervention
Accessibility of Relevant Information
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 score was 5, maximum 50). The higher score indicated that the reading material was perceived as more user friendly and that it was easier to find the desired information.
Measured: One hour after the intervention
Health Numeracy Score
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.
Measured: One hour after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Understanding Cochrane Systematic ReviewsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Split
- Sponsor type
- University, hospital or other
- Collaborators
- Croatian Science Foundation
- Responsible party
- Principal investigator, Ivan Buljan, University Hospital of Split
- Investigators
- Ana Marušić, MD, PhD, Principal investigator, Professor at Medical School of Split
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02918656
- Sponsor's protocol ID
- IP-2014-09-7672
- Status last verified
- Jun 2019
- First submitted
- 27 Sep 2016
- Last updated
- 4 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Data will be collected electronically, using the SurveyMonkey platform. The data will be fully anonymous and will be kept on a secure server of the School of Medicine.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Presenting Summary Information From Cochrane Systematic Reviews: Randomized Controlled Trial of Infographics Presentation vs. Standard Word Summaries
- ClinicalTrials.gov ID
- NCT02918656
- Acronym / sponsor ID
- IP-2014-09-7672
- Keywords
- Cochrane, Abstract, Infographics, Understanding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- University Hospital of SplitUniversity, hospital or other
- Collaborators
- Croatian Science Foundation
- Study start
- Oct 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 29 Sep 2016 (estimated)
- Results
- Posted 4 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the investigators study is to evaluate the efficacy of infographics in presenting information, in terms of understanding and remembering research results, compared to standard PLS formats and scientific summary formats (SciSum).
Detailed description
The investigators will conduct a randomized control trial (RCT) with three different formats of the same systematic review summary (infographics, PLS and scientific summary). The content of these three formats is based on the same systematic review, but the ways of data presentation will differ: visual presentation, plain language, and scientific language. The trial will be performed at the beginning of the 2016/2017 academic year, with first year university students as participants. The trial will be voluntary and anonymous. The survey will consist of 4 parts: 1) demographic data, 2) one format of the summary (randomly assigned), 3) comprehension test of the information given in the summary, 4) accessibility of information and overall satisfaction with the given summary assessed by survey and 5) health numeracy test. All materials will be in Croatian. The materials used in this research will be assessed by experts in order to confirm face validity of developed questions.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Infographics | Experimental | Other: Infographic presentation of health informationInfographic presentation of health information |
| Plain Language Summary | Active comparator | Other: PLS presentation of health informationPLS presentation of health information |
| Scientific abstract | Active comparator | Other: Scientific abstract presentation of health informationScientific abstract presentation of health information |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Eligible participants will be first-year university students without experience with Cochrane review summaries, because prior familiarization with Cochrane summaries could make information uptake easier by those participants.
Key exclusion criteria (1 listed)
- Participants who give the positive answer to the survey question about familiarity with the Cochrane will be excluded from the study analysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infographic presentation of health informationThe students in this group will read Cochrane systematic review summary in infographics format. Infographics format is a form of visual presentation of results of systematic review, supported by pictures and graphs. | Other | Infographics |
| PLS presentation of health informationThe students randomized in PLS group will read text format with simple explanation of the survey topic main findings which is intended for lay audience. | Other | Plain Language Summary |
| Scientific abstract presentation of health informationThe students in scientific abstract group will read the the text written for the academic population and practitioners. | Other | Scientific abstract |
Primary outcome
Understanding
Time frame: One-hour after the intervention
The primary outcome of the study is the score on a understanding test with ten questions about information contained in all three forms of presentation, titled as "Understanding information about external cephalic version for breech presentation before term" (Hutton et al, 2015). The questions will focus on understanding the benefits and risks of the intervention and the quality of evidence described in the systematic review. Each correctly answered question will be awarded one point, with a maximum of 10 points. The scale was specifically designed for this research, they ask about the information contained in all three abstract format and all questions are open-ended.
3 secondary outcomes
Reading Experience
Time frame: One hour after the intervention
Accessibility of Relevant Information
Time frame: One hour after the intervention
Health Numeracy Score
Time frame: One hour after the intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Data will be collected electronically, using the SurveyMonkey platform. The data will be fully anonymous and will be kept on a secure server of the School of Medicine.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Marušić, MD, PhD principal investigator
Professor at Medical School of Split
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infographic presentation of health information, PLS presentation of health information and Scientific abstract presentation of health information in people with Understanding Cochrane Systematic Reviews, run by University Hospital of Split at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Understanding (time frame: One-hour after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2019.