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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
290

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
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).
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).
Other: 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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McMaster University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2013

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 30, 2013

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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