New Alternative Formats vs Standard of SoF Tables. Non-inferiority Controlled Trial

GRADE Approach Clinical Trial

Official title:

Comparison Between Standard and New Alternative Formats of the Summary-of-Findings Tables in Cochrane Review Users. A Non-inferiority Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02022631
• Other study ID #: MIF_aim1RCT1
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Est. completion date: December 2014

Study information

• Verified date: December 2021
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Cochrane review users

• Authors of systematic reviews

• Health professionals

• Guideline developers

• Researchers

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Cochrane Collaboration
• GRADE Approach
• Summary of Findings Table

Intervention

Other:
• Alternative summary of findings table format
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).
• Current summary of findings table format
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).

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Understanding of key findings	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	Accessibility of information	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
Secondary	Overall satisfaction	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
Secondary	Preference	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

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