Research Report Clinical Trial
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
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.
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.
;