17
Aggregate Grades of Evidence by Question Type
Grade
OCEBM
level Treatment Harm Diagnosis Prognosis
A 1 Systematic
review
a
of
randomized
trials
Systematic
review
a
of
randomized
trials, nested
case-control
studies, or
observational
studies with
dramatic effect
a
Systematic
review
a
of
cross-sectional
studies with
consistently
applied
reference
standard and
blinding
Systematic
review
a
of
inception
cohort
studies
b
B 2 Randomized
trials, or
observational
studies with
dramatic effects
or highly
consistent
evidence
Randomized
trials, or
observational
studies with
dramatic effects
or highly
consistent
evidence
Cross-sectional
studies with
consistently
applied
reference
standard and
blinding
Inception
cohort
studies
b
C 3-4 Non-
randomized
or historically
controlled
studies,
including case-
control and
observational
studies
Non-
randomized
controlled
cohort or
follow-up
study (post-
marketing
surveillance)
with sufficient
numbers to
rule out a
common harm;
case-series,
case-control,
or historically
controlled
studies
Non-
consecutive
studies, case-
control studies,
or studies with
poor, non-
independent,
or
inconsistently
applied
reference
standards
Cohort study,
control arm of
a randomized
trial, case
series, or
case-control
studies;
poor quality
prognostic
cohort study
D 5 Case reports, mechanism-based reasoning, or reasoning from first
principles
X n/a Exceptional situations where validating studies cannot be performed
and there is a clear preponderance of benefit over harm
a
A systematic review may be downgraded to level B because of study limitations, heterogeneity, or
imprecision
b
A group of individuals identified for subsequent study at an early, uniform point in the course of
the specified health condition, or before the condition develops
