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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02813941
Recruitment Status : Completed
First Posted : June 27, 2016
Last Update Posted : August 28, 2018
Sponsor:
Collaborators:
Grading of Recommendations Assessment, Development and Evaluation working group
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
McMaster University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Research Report Other: Current GRADE SoF table Other: Alternative GRADE SoF table Other: EPC SoF table Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 178 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Health Services Research
Official Title: Two Alternatives Versus Usual GRADE-SoF Tables to Improve Understanding in the Presentation of Systematic Review Results: A Three-arm, Randomized, Controlled, Noninferiority Trial
Actual Study Start Date : January 8, 2018
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : August 21, 2018

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 Name: 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 Name: 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 Name: Table C




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813941


Locations
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Canada, Ontario
Department of Health Research Methods, Evidence and Impact
Hamilton, Ontario, Canada, L8S 4K1
Sponsors and Collaborators
McMaster University
Grading of Recommendations Assessment, Development and Evaluation working group
Agency for Healthcare Research and Quality (AHRQ)
Investigators
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Principal Investigator: Holger J Schunemann, MD, MSc, PhD McMaster University, Department of Clinical Epidemiology & Biostatistics
Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT02813941    
Obsolete Identifiers: NCT02732028
Other Study ID Numbers: MIF1-II
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There will be no individual patient data shared from this study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by McMaster University:
Randomized controlled trial
Systematic review
Summary of finding tables
GRADE
AHRQ