Abstract
Objective
The objective of this study was to provide guidance on the use of the Grading of Recommendations
Assessment, Development and Evaluation (GRADE) approach to determine certainty in
estimates of association between prognostic factors and future outcomes.
Study Design and Setting
We developed our guidance through an iterative process that involved review of published
systematic reviews and meta-analyses of prognostic factors, consultation with members,
feedback, presentation, and discussion at the GRADE Working Group meetings.
Results
For questions of prognosis, a body of observational evidence (potentially including
patients enrolled in randomized controlled trials) begins as high certainty in the
evidence. The five domains of GRADE for rating down certainty in the evidence, that
is, risk of bias, imprecision, inconsistency, indirectness, and publication bias,
as well as the domains for rating up, also apply to estimates of associations between
prognostic factors and outcomes. One should determine if their ratings do not consider
(noncontextualized) or consider (contextualized) the clinical context as this will
may result in variable judgments on certainty of the evidence.
Conclusions
The same principles GRADE proposed for bodies of evidence addressing treatment and
overall prognosis work well in assessing individual prognostic factors, both in noncontextualized
and contextualized settings.
Keywords
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Article info
Publication history
Published online: January 23, 2020
Accepted:
December 13,
2019
Footnotes
Funding: No external funding.
Ethical approval: Not applicable.
Competing interest statement: All authors declare they did not receive support from any organization for the submitted work; no financial relationships with any organizations that might have an interest in the submitted work in the previous 3 years exist nor do other relationships or activities that could appear to have influenced the submitted work. All authors are members of the GRADE working group.
Authors’ contributions: All authors contributed to the generation of the research hypothesis, participated to the discussion of its content, and approved the final version of the article. F.F., V.Z., and A.I. selected the systematic reviews used as examples and prepared summary of finding tables used in the process. F.F. drafted the article, and A.I. is the guarantor.
Data sharing: No additional data available.
Identification
Copyright
© 2020 Elsevier Inc. All rights reserved.
