Abstract
Objectives
The Grading of Recommendations Assessment, Development, and Evaluations (GRADE) system
for assessing certainty in a body of evidence currently uses two levels, serious and
very serious, for downgrading on a single domain. In the context of newer risk of
bias instruments, such as Risk of Bias in Non-Randomized Studies I (ROBINS-I), evidence
generated by nonrandomized studies may justify rating down by more than two levels
on a single domain. Given the importance users of GRADE assign to terminology, our
objective was to assess what term GRADE stakeholders would prefer for rating down
certainty by three levels.
Study Design and Setting
We conducted a purposefully sampled online survey of GRADE stakeholders to assess
possible terms including “critically serious,” “extremely serious,” “most serious,”
and “very, very serious” and conducted a descriptive and thematic analysis of responses.
We then facilitated a GRADE working group workshop to generate consensus.
Results
A total of 225 respondents ranked and rated “extremely serious” highest, closely followed
by “critically serious.” Respondents felt that “extremely serious” was “more understandable”
and “easiest to interpret”. GRADE working group members described that the terms “extremely
serious” appeared clearer and easier to translate in other languages.
Conclusion
Based on this stakeholder-driven study, “extremely serious” is the preferred term
to rate down certainty of evidence by three levels in the GRADE approach.
Keywords
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References
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Article Info
Publication History
Published online: December 19, 2019
Accepted:
November 13,
2019
Footnotes
Conflicts of interest: H.J.S. is one of two co-chairs of the GRADE working group, all other authors are members of the GRADE working group.
Identification
Copyright
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