- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02022631
New Alternative Formats vs Standard of SoF Tables. Non-inferiority Controlled Trial
December 9, 2021 updated by: Holger Schunemann, McMaster University
Comparison Between Standard and New Alternative Formats of the Summary-of-Findings Tables in Cochrane Review Users. A Non-inferiority Randomized Controlled Trial
The investigators will conduct a parallel two-armed, non-inferiority randomized trial comparing new alternative formats of summary of findings tables (SoF) tables with current formats.
The investigators will contact Cochrane review users by email and will ask them to fill a questionnaire developed using the "Survey Monkey" online system.
The survey will include questions about baseline information (demographic characteristics, background, number of visits to the Cochrane Library, familiarity with the GRADE system, etc.).
Then, participants will be stratified (health professional, guideline developer, researcher) and randomly assigned to one of the two SoF table formats, either the alternative (Table A) or the current one (Table C).
Participants will be asked to answer questions to determine understanding, accessibility, and satisfaction with the formats to which they were randomized.
Finally, the investigators will show them the table format to which they were not initially allocated in order to test their preference for either one.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
290
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
-
-
Ontario
-
Hamilton, Ontario, Canada, L8S 4K1
- McMaster University
-
-
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
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Cochrane review users
- Authors of systematic reviews
- Health professionals
- Guideline developers
- Researchers
Exclusion Criteria:
-
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: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Alternative SoF
Investigators will compare one SoF table with alternative formats (Table A) against one SoF table with the current formats (Table B).
In both tables, the clinical question in terms of patients and setting, intervention, comparator, and outcomes informed by the tables, and the complementary information included as footnotes will be the same.
The only differences between the current and alternative SoF table formats will be different methods to either show the same data in a different way or to provide complementary data to the one showed in the current format (i.e.
supplementary data as risk difference).
|
Investigators will compare one SoF table with alternative formats (Table A) against one SoF table with the current formats (Table B).
In both tables, the clinical question in terms of patients and setting, intervention, comparator, and outcomes informed by the tables, and the complementary information included as footnotes will be the same.
The only differences between the current and alternative SoF table formats will be different methods to either show the same data in a different way or to provide complementary data to the one showed in the current format (i.e.
supplementary data as risk difference).
|
ACTIVE_COMPARATOR: Current SoF
Investigators will compare one SoF table with alternative formats (Table A) against one SoF table with the current formats (Table B).
In both tables, the clinical question in terms of patients and setting, intervention, comparator, and outcomes informed by the tables, and the complementary information included as footnotes will be the same.
The only differences between the current and alternative SoF table formats will be different methods to either show the same data in a different way or to provide complementary data to the one showed in the current format (i.e.
supplementary data as risk difference).
|
Investigators will compare one SoF table with alternative formats (Table A) against one SoF table with the current formats (Table B).
In both tables, the clinical question in terms of patients and setting, intervention, comparator, and outcomes informed by the tables, and the complementary information included as footnotes will be the same.
The only differences between the current and alternative SoF table formats will be different methods to either show the same data in a different way or to provide complementary data to the one showed in the current format (i.e.
supplementary data as risk difference).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Understanding of key findings
Time Frame: 30 minutes
|
Investigators will frame multiple-choice questions about key concepts in the table with five response alternatives for each question and only one correct answer.
Then, investigators will compare the proportion of correct answers between groups per question
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accessibility of information
Time Frame: 30 minutes
|
This outcome will consider 3 domains: (1) how easy is to find critical information in the table, (2) how easy is to understand the information, and (3) whether the information is presented in a way that is helpful for decision-making.
These three domains will be measured presenting to participants three statements to which they have to indicate the degree of agreement: "It was easy to find the information about the effects", "It was easy to understand the information", and "The information is presented in a way that would help me make a decision" using a 7-point Likert scale (1= I strongly disagree, 2= I disagree, 3= I somewhat disagree, 4= Not sure, 5= I somewhat agree, 6= I agree, and 7= I strongly agree).
The outcome overall accessibility of information will be obtained as the average of responses for each domain, per participant.
|
30 minutes
|
Overall satisfaction
Time Frame: 30 minutes
|
It will be measured using a 7-point Likert scale with 3 anchors: 1= strongly dissatisfied, 4= neither satisfied nor dissatisfied, 7= strongly satisfied, and it will be treated as a continuous outcome.
Investigators will compare the means per group.
|
30 minutes
|
Preference
Time Frame: 30 minutes
|
This outcome taps the question: Between alternative (Table A) and current format (Table B) of SoF table, "which table does the user prefer?"
It will be measured using a 5-point Likert scale (1= strongly prefer table B, 2= I prefer table B, 3= Both table A and B are good to me, 4= I prefer table A, 5= I strongly prefer table A), and it will be treated as continuous outcome.
Investigators will describe the data obtained in each group.
Other questions related to participants' preference for each alternative item will be included.
|
30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Holger Schünemann, MD, MSc, PhD, McMaster University
- Study Director: Alonso Carrasco-Labra, DDS, MSc, McMaster University
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.
General Publications
- Carrasco-Labra A, Brignardello-Petersen R, Santesso N, Neumann I, Mustafa RA, Mbuagbaw L, Etxeandia Ikobaltzeta I, De Stio C, McCullagh LJ, Alonso-Coello P, Meerpohl JJ, Vandvik PO, Brozek JL, Akl EA, Bossuyt P, Churchill R, Glenton C, Rosenbaum S, Tugwell P, Welch V, Garner P, Guyatt G, Schunemann HJ. Improving GRADE evidence tables part 1: a randomized trial shows improved understanding of content in summary of findings tables with a new format. J Clin Epidemiol. 2016 Jun;74:7-18. doi: 10.1016/j.jclinepi.2015.12.007. Epub 2016 Jan 11.
- Carrasco-Labra A, Brignardello-Petersen R, Santesso N, Neumann I, Mustafa RA, Mbuagbaw L, Ikobaltzeta IE, De Stio C, McCullagh LJ, Alonso-Coello P, Meerpohl JJ, Vandvik PO, Brozek JL, Akl EA, Bossuyt P, Churchill R, Glenton C, Rosenbaum S, Tugwell P, Welch V, Guyatt G, Schunemann H. Comparison between the standard and a new alternative format of the Summary-of-Findings tables in Cochrane review users: study protocol for a randomized controlled trial. Trials. 2015 Apr 16;16:164. doi: 10.1186/s13063-015-0649-6.
Helpful Links
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, 2013
Primary Completion (ACTUAL)
December 1, 2014
Study Completion (ACTUAL)
December 1, 2014
Study Registration Dates
First Submitted
December 13, 2013
First Submitted That Met QC Criteria
December 21, 2013
First Posted (ESTIMATE)
December 30, 2013
Study Record Updates
Last Update Posted (ACTUAL)
December 13, 2021
Last Update Submitted That Met QC Criteria
December 9, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- MIF_aim1RCT1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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