Comparison of Three Summary of Finding Tables to Improve Understanding in the Presentation of Systematic Review Results

August 27, 2018 updated by: McMaster University

Two Alternatives Versus Usual GRADE-SoF Tables to Improve Understanding in the Presentation of Systematic Review Results: A Three-arm, Randomized, Controlled, Noninferiority Trial

Background: Summary of Findings (SoF) tables have been developed to present results of systematic reviews in a concise and explicit format. Adopted by many review groups including the Cochrane Collaboration, the Agency for Healthcare Research and Quality (AHRQ), and the GRADE Working Group; SoF tables provide succinct, transparent, and easily interpretable judgments about the certainty of evidence and magnitude of effects. Currently, there are three different SoF formats in use. This study aims to compare SoF table formats in terms of understanding, accessibility, satisfaction, and preference with systematic review users.

Methods: The primary objective of this three-arm randomized controlled non-inferiority trial is to investigate whether an alternative GRADE-SoF table, or EPC-SoF table, is noninferior to the current GRADE-SoF table in the understanding of information presented to systematic review users. Researchers, clinical practice guideline developers, policy-makers, end-users, or knowledge transfer will be recruited. Data will be collected electronically at baseline and after randomization. Noninferiority would be declared if the difference in the proportion of participants who understand the information displayed in the alternative SoF table is 10% or less.

Discussion: This study aims to assess the understanding, accessibility, satisfaction, and preference between three SoF tables for displaying summary evidence from health-related outcomes. The results of this study will provide important knowledge to understand what information should be included in SoF tables in systematic reviews.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objective: Summary of Findings (SoF) tables present results of systematic reviews in a concise and explicit format. Adopted by many review groups including the Cochrane Collaboration, and the Agency for Healthcare Research and Quality (AHRQ). Optimal understanding of SoF table may be influenced by the type of information being conveyed and objectives or preferences of the end user. This study aims to compare three SoF table formats in terms of understanding, accessibility, satisfaction, and preference with systematic review users.

Methods: The primary objective of this three-arm randomized controlled non-inferiority trial is to investigate whether an alternative GRADE-SoF table or EPC-SoF table is noninferior to the current GRADE-SoF table in the understanding of the information presented to systematic review users, particularly for descriptive findings. Researchers, clinical practice guideline developers, policy-makers, or knowledge transfer professionals will be recruited. Data will be collected electronically at baseline and after randomization. Noninferiority would be declared if the difference in the proportion of participants who understand the information displayed in the alternative SoF table is 10% or less.

Ethics and Dissemination: The Hamilton Integrated Research Ethics Board (HiREB) reviewed this protocol. The findings from this study will be disseminated through a publication in a peer-reviewed journal.

Strengths and limitations of this study

  • This is a randomized controlled trial that uses a GRADE Summary of Finding (SoF) table evaluated in another randomized controlled trial with a positive accomplishment of understanding the information displayed on it.
  • This is the first time that GRADE SoF tables will be evaluated, in terms of understanding descriptive findings with a select part of a SoF table adapted by an EPC center to convey information on multiple comparisons efficiently.
  • This will test understanding of presentation of findings from only a single comparison and will not test understanding of a complex body of evidence.

Study Type

Interventional

Enrollment (Actual)

178

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

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8S 4K1
        • Department of Health Research Methods, Evidence and Impact

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion criteria:

Participants will be eligible if they consider themselves as systematic review users. For the purpose of this trial, systematic review users will be defined as researchers, clinical practice guideline developers, policy-makers, or knowledge transfer professionals. Participants who declare dedicating more than 70% of their time during last year to conducting research (for example, methodologists, epidemiologists, statisticians) will be classified as researchers. Participants who declare having participated in at least one systematic review or clinical practice guideline during the last two years will be classified as clinical practice guideline developers. Knowledge transfer professionals, who declare working in a dynamic and iterative process that includes synthesis, dissemination, exchange and ethically sound application of knowledge to improve the health care system, during last two years, will be classified as knowledge transfer professionals. Finally, participants who declare being responsible for or involved in formulating policies in the last year, especially in politics, will be classified as policy-makers.

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: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Alternative GRADE SoF table
Two SoF tables (alternative GRADE SoF table and EPC SoF table) will be used in this randomized controlled non-inferiority trial as an intervention. The alternative GRADE SoF table format will be developed from a user-testing survey.
Other: Current GRADE SoF table
The current GRADE SoF table will be the common comparator for the other two SoF tables
Other Names:
  • Table A
EXPERIMENTAL: EPC SoF table
For the EPC SoF table, the investigators will use one of their format which was recently published.
Other: Alternative GRADE SoF table
The alternative GRADE SoF table format will be developed from a user-testing survey.
Other Names:
  • Table B
ACTIVE_COMPARATOR: Current GRADE SoF table
The current GRADE SoF table will be the common comparator for the other two SoF tables
Other: EPC SoF table
For the EPC SoF table, the investigators will use one of their format which was recently published
Other Names:
  • Table C

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Understanding of information (questionnaire)
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 (questionnaire)
Time Frame: 30 minutes
This outcome considers four items: 1) how easy it is to find critical information in the table; 2) how easy it is to understand the information; 3) whether the information is presented in a way that is helpful for decision-making; and 4) the overall accessibility of information.
30 minutes
Satisfaction (questionnaire)
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 (questionnaire)
Time Frame: 30 minutes
Participants will answer the question: 'Between Table A (the current GRADE SoF table), Table B (the alternative GRADE SoF table) or Table C (EPC SoF table), which table do you prefer?' It will be measured using a rank of three: 1st choice, 2nd choice, and 3rd choice, and it will be treated as an ordinal outcome.
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

Agency for Healthcare Research and Quality (AHRQ)
Grading of Recommendations Assessment, Development and Evaluation working group

Investigators

  • Principal Investigator: Holger J Schunemann, MD, MSc, PhD, McMaster University, Department of Clinical Epidemiology & Biostatistics

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 (ACTUAL)

January 8, 2018

Primary Completion (ACTUAL)

June 1, 2018

Study Completion (ACTUAL)

August 21, 2018

Study Registration Dates

First Submitted

June 20, 2016

First Submitted That Met QC Criteria

June 24, 2016

First Posted (ESTIMATE)

June 27, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 28, 2018

Last Update Submitted That Met QC Criteria

August 27, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MIF1-II

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There will be no individual patient data shared from this study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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