NCT02813941

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 178 (actual)
• Sponsor: McMaster University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Research Report

Interventions

Type	Name	Description
OTHER	Current GRADE SoF table	The current GRADE SoF table will be the common comparator for the other two SoF tables
OTHER	Alternative GRADE SoF table	The alternative GRADE SoF table format will be developed from a user-testing survey.
OTHER	EPC SoF table	For the EPC SoF table, the investigators will use one of their format which was recently published

Timeline

• Start date: 2018-01-08
• Primary completion: 2018-06-01
• Completion: 2018-08-21
• First posted: 2016-06-27
• Last updated: 2018-08-28

Locations

1 site across 1 country: Canada