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LEVEL (QUALITY ) OF EVIDENCE
c
LEVEL A
◼ High-quality evidence
c
from more than 1 RCT
◼ Meta-analyses of high-quality RCTs
◼ One or more RCTs corroborated by high-quality registry studies
LEVEL B-R (Randomized)
◼ Moderate-quality evidence
c
from 1 or more RCTs
◼ Meta-analyses of moderate-quality RCTs
LEVEL B-NR (Nonrandomized)
◼ Moderate-quality evidence
c
from 1 or more well-designed, well-executed
nonrandomized studies, observational studies, or registry studies
◼ Meta-analyses of such studies
LEVEL C-LD (Limited Data)
◼ Randomized or nonrandomized observational or registry studies with limitations
of design or execution
◼ Meta-analyses of such studies
◼ Physiological or mechanistic studies in human subjects
LEVEL C-EO (Expert Opinion)
Consensus of expert opinion based on clinical experience
COR and LOE are determined independently (any COR may be paired with any LOE).
A recommendation with LOE C does not imply that the recommendation is weak. Many important
clinical questions addressed in guidelines do not lend themselves to clinical trials. Although RCTs
are unavailable, there may be a very clear clinical consensus that a particular test or therapy is
useful or effective.
a
The outcome or result of the intervention should be specified (an improved clinical outcome or
increased diagnostic accuracy or incremental prognostic information).
b
For comparative-effectiveness recommendations (COR I and IIa; LOE A and B only), studies
that support the use of comparator verbs should involve direct comparisons of the treatments or
strategies being evaluated.
c
The method of assessing quality is evolving, including the application of standardized, widely
used, and preferably validated evidence grading tools; and for systematic reviews, the
incorporation of an Evidence Review Committee.
COR indicates Class of Recommendation; EO, expert opinion; LD, limited data; LOE, Level of
Evidence; NR, nonrandomized; R, randomized; RCT, randomized controlled trial.
