Presenting Summary Information From Cochrane Systematic Reviews to Physicians
Sponsor
University Hospital of Split (Other)
Overall Status
Completed
CT.gov ID
NCT03002610
Collaborator
University of Liverpool (Other)
108
1
3
3
36.5
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Study Type:
Interventional
Actual Enrollment
:
108 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Presenting Summary Information From Cochrane Systematic Reviews to Physicians: Protocol for Research of Infographics Presentation vs. Plain Language Summary
Study Start Date
:
Dec 1, 2016
Actual Primary Completion Date
:
Mar 1, 2017
Actual Study Completion Date
:
Mar 1, 2017
Arms and Interventions
| 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. |
Other: Pls
Text format with simple explanation of the survey topic main findings and is intended for lay audience.
|
| 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. |
Other: Infographics
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. |
Other: Scientific abstract
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.
|
Outcome Measures
Primary Outcome Measures
- Understanding of the Content of Summary Format [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.
Secondary Outcome Measures
- Reading Experience [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.
- User Friendliness [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.
Other Outcome Measures
- Health Numeracy [One month (30 days)]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- physicians who are working at Clinical Hospital Split
Exclusion Criteria:
- none
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Split | Split | Croatia | 21000 |
Sponsors and Collaborators
- University Hospital of Split
- University of Liverpool
Investigators
- Principal Investigator: Ivan Buljan, Researcher
Study Documents (Full-Text)
More Information
Publications
Responsible Party:
Ivan Buljan,
Research Assistant,
University Hospital of Split
ClinicalTrials.gov Identifier:
NCT03002610
Other Study ID Numbers:
- IP-2014-12-7672
First Posted:
Dec 26, 2016
Last Update Posted:
Jun 3, 2019
Last Verified:
Feb 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Plain Language Summary | Infographics | Scientific Abstract |
|---|---|---|---|
| Arm/Group Description | The control group will receive PLS: text format with simple explanation of the survey topic main findings and is intended for lay audience. Pls: Text format with simple explanation of the survey topic main findings and is intended for lay audience. | Infographics format of a Cochrane systematic review summary represents the experimental intervention in the trial, where the results are presented with text and pictures. Infographics: 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. | Scientific abstract is the text written for the academic population and practitioners. It is also intended for control group. Scientific abstract: 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. |
| Period Title: Overall Study | |||
| STARTED | 24 | 50 | 34 |
| COMPLETED | 18 | 25 | 21 |
| NOT COMPLETED | 6 | 25 | 13 |
Baseline Characteristics
| Arm/Group Title | Plain Language Summary | Infographics | Scientific Abstract | Total |
|---|---|---|---|---|
| Arm/Group Description | The control group will receive PLS: text format with simple explanation of the survey topic main findings and is intended for lay audience. Pls: Text format with simple explanation of the survey topic main findings and is intended for lay audience. | Infographics format of a Cochrane systematic review summary represents the experimental intervention in the trial, where the results are presented with text and pictures. Infographics: 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. | Scientific abstract is the text written for the academic population and practitioners. It is also intended for control group. Scientific abstract: 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. | Total of all reporting groups |
| Overall Participants | 18 | 25 | 21 | 64 |
| Age (years) [Median (Inter-Quartile Range) ] | ||||
| Median (Inter-Quartile Range) [years] |
40.0
|
36.0
|
38.0
|
37.0
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
9
50%
|
8
32%
|
16
76.2%
|
33
51.6%
|
| Male |
9
50%
|
17
68%
|
5
23.8%
|
31
48.4%
|
| Race and Ethnicity Not Collected (Count of Participants) | ||||
| Count of Participants [Participants] |
0
0%
|
|||
| Region of Enrollment (Count of Participants) | ||||
| Croatia |
18
100%
|
25
100%
|
21
100%
|
64
100%
|
| Specialization obtained (Count of Participants) | ||||
| Count of Participants [Participants] |
13
72.2%
|
18
72%
|
15
71.4%
|
46
71.9%
|
| PhD degree (Count of Participants) | ||||
| Count of Participants [Participants] |
9
50%
|
13
52%
|
7
33.3%
|
29
45.3%
|
| Heard of Cochrane systematic reviews before (Count of Participants) | ||||
| Count of Participants [Participants] |
18
100%
|
23
92%
|
20
95.2%
|
61
95.3%
|
| Used Cochrane library (Count of Participants) | ||||
| Count of Participants [Participants] |
17
94.4%
|
17
68%
|
15
71.4%
|
49
76.6%
|
Outcome Measures
| Title | Understanding of the Content of Summary Format |
|---|---|
| Description | 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. |
| Time Frame | One month (30 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Plain Language Summary | Infographics | Scientific Abstract |
|---|---|---|---|
| Arm/Group Description | The control group will receive PLS: text format with simple explanation of the survey topic main findings and is intended for lay audience. Pls: Text format with simple explanation of the survey topic main findings and is intended for lay audience. | Infographics format of a Cochrane systematic review summary represents the experimental intervention in the trial, where the results are presented with text and pictures. Infographics: 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. | Scientific abstract is the text written for the academic population and practitioners. It is also intended for control group. Scientific abstract: 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. |
| Measure Participants | 18 | 25 | 21 |
| Median (95% Confidence Interval) [units on a scale] |
8.0
|
8.0
|
8.0
|
| Title | Reading Experience |
|---|---|
| Description | 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. |
| Time Frame | One month (30 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Plain Language Summary | Infographics | Scientific Abstract |
|---|---|---|---|
| Arm/Group Description | The control group will receive PLS: text format with simple explanation of the survey topic main findings and is intended for lay audience. Pls: Text format with simple explanation of the survey topic main findings and is intended for lay audience. | Infographics format of a Cochrane systematic review summary represents the experimental intervention in the trial, where the results are presented with text and pictures. Infographics: 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. | Scientific abstract is the text written for the academic population and practitioners. It is also intended for control group. Scientific abstract: 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. |
| Measure Participants | 18 | 25 | 21 |
| Median (95% Confidence Interval) [units on a scale] |
32.0
|
37.0
|
24.0
|
| Title | User Friendliness |
|---|---|
| Description | 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. |
| Time Frame | One month (30 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Plain Language Summary | Infographics | Scientific Abstract |
|---|---|---|---|
| Arm/Group Description | The control group will receive PLS: text format with simple explanation of the survey topic main findings and is intended for lay audience. Pls: Text format with simple explanation of the survey topic main findings and is intended for lay audience. | Infographics format of a Cochrane systematic review summary represents the experimental intervention in the trial, where the results are presented with text and pictures. Infographics: 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. | Scientific abstract is the text written for the academic population and practitioners. It is also intended for control group. Scientific abstract: 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. |
| Measure Participants | 18 | 25 | 21 |
| Median (95% Confidence Interval) [units on a scale] |
29.0
|
36.0
|
25.0
|
| Title | Health Numeracy |
|---|---|
| Description | 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. |
| Time Frame | One month (30 days) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Plain Language Summary | Infographics | Scientific Abstract |
|---|---|---|---|
| Arm/Group Description | The control group will receive PLS: text format with simple explanation of the survey topic main findings and is intended for lay audience. Pls: Text format with simple explanation of the survey topic main findings and is intended for lay audience. | Infographics format of a Cochrane systematic review summary represents the experimental intervention in the trial, where the results are presented with text and pictures. Infographics: 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. | Scientific abstract is the text written for the academic population and practitioners. It is also intended for control group. Scientific abstract: 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. |
| Measure Participants | 18 | 25 | 21 |
| Median (Inter-Quartile Range) [units on a scale] |
5.0
|
5.0
|
5.0
|
Adverse Events
| Time Frame | Adverse event data were not collected. | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | 0 | |||||
| Arm/Group Title | Plain Language Summary | Infographics | Scientific Abstract | |||
| Arm/Group Description | The control group will receive PLS: text format with simple explanation of the survey topic main findings and is intended for lay audience. Pls: Text format with simple explanation of the survey topic main findings and is intended for lay audience. | Infographics format of a Cochrane systematic review summary represents the experimental intervention in the trial, where the results are presented with text and pictures. Infographics: 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. | Scientific abstract is the text written for the academic population and practitioners. It is also intended for control group. Scientific abstract: 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. | |||
All Cause Mortality |
||||||
| Plain Language Summary | Infographics | Scientific Abstract | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | |||
Serious Adverse Events |
||||||
| Plain Language Summary | Infographics | Scientific Abstract | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Plain Language Summary | Infographics | Scientific Abstract | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Sponsor had no role in planning of research, its execution or publication.
Results Point of Contact
| Name/Title | Ivan Buljan |
|---|---|
| Organization | University of Split School of Medicine |
| Phone | +385989027209 |
| ibuljan@mefst.hr |
Responsible Party:
Ivan Buljan,
Research Assistant,
University Hospital of Split
ClinicalTrials.gov Identifier:
NCT03002610
Other Study ID Numbers:
- IP-2014-12-7672
First Posted:
Dec 26, 2016
Last Update Posted:
Jun 3, 2019
Last Verified:
Feb 1, 2019