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GRADE ApproachNCT02022631

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

A study testing Alternative summary of findings table format and Current summary of findings table format in people with GRADE Approach and Summary of Findings Table, run by McMaster University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
Alternative summary of findings table format and Current summary of findings table format
Could I receive a placebo?
No, everyone receives an active treatment
How many people
290 participants
Where
1 siteCanada
Study dates
Dec 2013to Dec 2014
Phase
Interventional
Are there results?
None posted in the registry

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

  • Cochrane review users
  • Authors of systematic reviews
  • Health professionals
  • Guideline developers
  • Researchers

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • McMaster University

    Hamilton, Ontario, L8S 4K1

Other trials in Canada

About this study

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

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.

Being tested
Alternative summary of findings table format, Current summary of findings table format

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Alternative summary of findings table formatOther

    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 formatOther

    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).

Study groups in NCT02022631
Study groupRoleWhat they receive
Alternative SoFExperimentalInvestigators 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).
Receives: Other: Alternative summary of findings table format
Current SoFActive comparatorInvestigators 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).
Receives: Other: Current summary of findings table format

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 30 minutes

Secondary outcomes (3)

  1. 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.

    Measured: 30 minutes

  2. 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.

    Measured: 30 minutes

  3. 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.

    Measured: 30 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2013 (estimated)
  2. Study startDec 2013
  3. Primary completionDec 2014
  4. Study completionDec 2014

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
290 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02022631
Sponsor's protocol ID
MIF_aim1RCT1
Status last verified
Dec 2021
First submitted
13 Dec 2013
Last updated
13 Dec 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

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.

    PubMed 26791430

  • 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.

    PubMed 25873338

Questions about this trial

What is this clinical trial studying?

A study testing Alternative summary of findings table format and Current summary of findings table format in people with GRADE Approach and Summary of Findings Table, run by McMaster University at 1 site in Canada.

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 5 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 13 Dec 2021. 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 Canada. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 of key findings (time frame: 30 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02022631, which also lists 2 linked publications.

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 13 Dec 2021.

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