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Lvl
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Code
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Display
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Definition
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Copy
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1
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SEVCO:01001
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Interventional
research
|
A
study
design
in
which
an
independent
variable
(an
exposure
or
intervention)
is
prospectively
assigned
or
modified
by
the
investigator
to
evaluate
a
response
in
the
dependent
variable
(an
effect
or
outcome).
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2
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SEVCO:01003
|
randomized
assignment
|
An
interventional
study
design
in
which
an
independent
variable
(an
exposure
or
intervention)
is
prospectively
assigned
or
modified
by
random
chance
to
separate
groups.
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3
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SEVCO:01006
|
simple
randomization
|
A
randomized
assignment
in
which
each
participant
has
the
same
prespecified
likelihood
of
being
assigned
to
a
group
as
all
other
participants,
independent
of
the
assignment
of
any
other
participant.
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3
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SEVCO:01007
|
stratified
randomization
|
A
randomized
assignment
in
which
participants
are
stratified
into
groups
based
on
prognostic
variables
and
then
randomized
into
balanced
treatment
groups
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3
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SEVCO:01008
|
block
randomization
|
A
randomized
assignment
in
which
a
pre-specified
number
of
subjects
is
assigned
to
a
block
containing
the
same
pre-specified
ratio
of
group
assignments
in
random
order.
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3
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SEVCO:01009
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adaptive
randomization
|
A
randomized
assignment
in
which
a
participant’s
group
assignment
probability
is
adjusted
based
on
any
factor
such
that
the
likelihood
of
assignment
is
not
the
same
for
all
participants.
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2
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SEVCO:01005
|
Non-randomized
assignment
|
An
interventional
study
design
in
which
an
independent
variable
(an
exposure
or
intervention)
is
prospectively
assigned
or
modified
by
methods
other
than
random
chance
to
separate
groups.
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3
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SEVCO:01004
|
Quasi-Randomized
assignment
|
An
interventional
study
design
with
a
method
of
allocation
that
is
not
limited
to
random
chance
but
is
intended
to
produce
similar
baseline
groups
for
experimentation.
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2
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SEVCO:01029
|
Clinical
trial
|
Interventional
research
in
which
one
or
more
healthcare-related
actions
(i.e.,
a
diagnostic,
prognostic,
therapeutic,
preventive
or
screening
method
or
intervention)
is
evaluated
for
effects
on
health-related
biomedical
or
behavioral
processes
and/or
outcomes.
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3
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SEVCO:01041
|
Pragmatic
clinical
trial
|
A
clinical
trial
conducted
under
conditions
of
routine
clinical
practice.
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3
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SEVCO:01038
|
Expanded
Access
study
|
A
clinical
trial
that
provides
a
means
for
obtaining
an
experimental
drug
or
device
for
patients
who
are
not
adequately
treated
by
existing
therapy,
who
do
not
meet
the
eligibility
criteria
for
enrollment,
or
who
are
otherwise
unable
to
participate
in
another
clinical
study.
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3
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SEVCO:01030
|
Phase
1
trial
|
A
clinical
trial
to
gather
initial
evidence
in
humans
to
support
further
investigation
of
an
intervention.
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4
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SEVCO:01031
|
Exploratory
investigational
new
drug
study
|
A
clinical
trial
that
is
conducted
early
in
phase
1,
involves
very
limited
human
exposure,
and
has
no
therapeutic
or
diagnostic
intent
(e.g.,
screening
studies,
microdose
studies).
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3
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SEVCO:01032
|
Phase
1/Phase
2
trial
|
A
clinical
trial
with
a
component
meeting
the
definition
of
phase
1
trial
and
a
component
meeting
the
definition
of
phase
2
trial.
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3
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SEVCO:01033
|
Phase
2
trial
|
A
clinical
trial
to
gather
evidence
of
effectiveness
and
safety
for
an
intervention
in
patients
with
the
disease
or
condition
under
study,
but
not
intended
to
provide
an
adequate
basis
for
regulatory
approval
for
clinical
use.
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3
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SEVCO:01034
|
Phase
2/Phase
3
trial
|
A
clinical
trial
with
a
component
meeting
the
definition
of
phase
2
trial
and
a
component
meeting
the
definition
of
phase
3
trial.
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3
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SEVCO:01035
|
Phase
3
Trial
|
A
clinical
trial
to
gather
the
evidence
of
effectiveness
and
safety
of
an
intervention,
intended
to
provide
an
adequate
basis
for
regulatory
approval
for
clinical
use.
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3
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SEVCO:01036
|
Post-marketing
study
|
A
clinical
trial
to
gather
additional
evidence
of
effectiveness
and
safety
of
an
intervention
for
an
already
approved
clinical
use.
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1
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SEVCO:01002
|
Observational
research
|
A
study
design
in
which
the
independent
variables
(exposures
or
interventions)
are
not
prospectively
assigned
or
modified
by
the
investigator.
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2
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SEVCO:01037
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Post-Marketing
Surveillance
study
|
An
observational
study
to
identify
adverse
events
related
to
the
use
of
an
approved
clinical
intervention.
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1
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SEVCO:01010
|
Comparative
study
design
|
A
study
design
in
which
two
or
more
groups
are
compared.
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2
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SEVCO:01011
|
Parallel
cohort
design
|
A
comparative
study
design
in
which
the
groups
are
compared
concurrently
and
participants
are
expected
to
remain
in
the
groups
being
compared
for
the
entire
duration
of
participation
in
the
study.
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2
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SEVCO:01012
|
Crossover
cohort
design
|
A
comparative
study
design
in
which
participants
receive
two
or
more
alternative
exposures
during
separate
periods
of
time.
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3
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SEVCO:01024
|
Controlled
crossover
cohort
design
|
A
crossover
cohort
design
in
which
two
or
more
cohorts
have
different
orders
of
exposures.
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3
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SEVCO:01025
|
Single-arm
crossover
design
|
A
crossover
cohort
design
in
which
all
participants
are
in
a
single
cohort
with
the
same
order
of
exposures.
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2
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SEVCO:01013
|
Case
control
design
|
A
comparative
study
design
in
which
the
groups
being
compared
are
defined
by
outcome
presence
(case)
or
absence
(control).
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2
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SEVCO:01014
|
Matching
for
comparison
|
A
comparative
study
design
in
which
individual
participants
in
different
groups
being
compared
are
paired
or
matched
into
sets
based
on
selected
attributes
for
within-set
analysis.
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3
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SEVCO:01020
|
Family
study
design
|
A
matched
study
design
in
which
related
or
non-related
family
members
are
compared.
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4
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SEVCO:01021
|
Twin
study
design
|
A
family
study
design
in
which
twin
siblings
are
compared.
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2
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SEVCO:01015
|
Cluster
as
unit
of
allocation
|
A
comparative
study
design
in
which
participants
are
allocated
to
exposures
(interventions)
by
their
membership
in
groups
(called
clusters)
rather
than
by
individualized
assignments.
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1
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SEVCO:01023
|
Non-comparative
study
design
|
A
study
design
with
no
comparisons
between
groups
with
different
exposures
and
no
comparisons
between
groups
with
different
outcomes.
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2
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SEVCO:01016
|
Uncontrolled
cohort
design
|
A
non-comparative
study
design
in
which
two
or
more
participants
are
evaluated
in
a
single
group
(or
cohort).
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2
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SEVCO:01017
|
Case
report
|
A
non-comparative
study
design
in
which
a
single
participant
is
evaluated.
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1
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SEVCO:01022
|
Population-based
design
|
A
study
design
in
which
the
unit
of
observation
is
a
population
or
community.
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2
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SEVCO:01044
|
Ecological
design
|
A
study
design
in
which
the
unit
of
observation
is
a
population
or
community
defined
by
social
relationships
or
physical
surroundings.
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1
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SEVCO:01027
|
Cross
sectional
data
collection
|
A
study
design
process
in
which
data
is
collected
at
a
single
point
in
time.
|
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1
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SEVCO:01028
|
Longitudinal
data
collection
|
A
study
design
process
in
which
data
is
collected
at
two
or
more
points
in
time.
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2
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SEVCO:01018
|
Time
series
design
|
A
longitudinal
data
collection
which
includes
a
set
of
time-ordered
observations.
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3
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SEVCO:01019
|
Before
and
after
comparison
|
A
time
series
design
which
includes
comparisons
of
observations
before
and
after
an
event
or
exposure.
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1
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SEVCO:01045
|
Primary
data
collection
|
A
study
design
process
in
which
the
data
are
recorded
and
collected
during
the
study
for
the
purpose
of
the
same
study.
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1
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SEVCO:01026
|
Real
world
data
collection
|
A
study
design
process
in
which
the
study
data
are
obtained
from
a
source
of
data
collected
during
a
routine
process
in
the
natural
environment
rather
than
using
a
process
designed
or
controlled
by
the
researcher.
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2
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SEVCO:01039
|
Real
world
data
collection
from
healthcare
records
|
Real
world
data
collection
from
data
obtained
routinely
for
a
purpose
of
recording
healthcare
delivery
in
a
record
controlled
by
a
healthcare
professional.
|
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2
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SEVCO:01050
|
Real
world
data
collection
from
personal
health
records
|
Real
world
data
collection
from
data
obtained
routinely
for
a
purpose
of
recording
data
related
to
personal
health
in
a
record
controlled
by
the
person,
guardian,
or
caretaker.
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2
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SEVCO:01040
|
Real
world
data
collection
from
healthcare
financing
records
|
Real
world
data
collection
from
data
obtained
routinely
for
a
purpose
of
recording
healthcare
financing.
|
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2
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SEVCO:01048
|
Real
world
data
collection
from
testing
procedures
|
Real
world
data
collection
from
data
obtained
routinely
for
a
purpose
of
testing,
such
as
diagnostic
testing
or
screening
examination.
|
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3
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SEVCO:01046
|
Real
world
data
collection
from
monitoring
procedures
|
Real
world
data
collection
from
data
obtained
routinely
for
a
purpose
of
repeated
testing.
|
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1
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SEVCO:01049
|
Secondary
data
collection
from
prior
research
|
A
study
design
process
in
which
the
data
are
collected
from
data
obtained
during
a
different
study
than
the
current
study.
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1
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SEVCO:01042
|
Secondary
data
collection
from
a
registry
|
A
study
design
process
in
which
the
data
are
collected
from
a
system
organized
to
obtain
and
maintain
uniform
data
for
discovery
and
analysis,
and
this
system
is
organized
prior
to
the
current
study.
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1
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SEVCO:01051
|
Multisite
data
collection
|
A
study
design
process
in
which
data
are
collected
from
two
or
more
geographic
locations.
|
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1
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SEVCO:01086
|
Quantitative
analysis
|
A
study
design
process
in
which
data
are
analyzed
with
mathematical
or
statistical
methods
and
formulas.
|
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1
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SEVCO:01087
|
Qualitative
analysis
|
A
study
design
process
in
which
data
are
analyzed,
without
primary
reliance
on
mathematical
or
statistical
techniques,
by
coding
and
organizing
data
to
provide
interpretation
or
understanding
of
experiences
or
hypotheses.
|
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1
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SEVCO:01060
|
Blinding
of
study
participants
|
A
study
design
process
in
which
study
participants
are
not
informed
of
their
intervention
assignment.
|
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1
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SEVCO:01061
|
Blinding
of
intervention
providers
|
A
study
design
process
in
which
the
people
administering
the
intervention
are
not
informed
of
the
intervention
assignment.
|
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1
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SEVCO:01062
|
Blinding
of
outcome
assessors
|
A
study
design
process
in
which
the
people
determining
the
outcome
are
not
informed
of
the
intervention
assignment.
|
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1
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SEVCO:01063
|
Blinding
of
data
analysts
|
A
study
design
process
in
which
the
people
managing
or
processing
the
data
and
statistical
analysis
are
not
informed
of
the
intervention
assignment.
|
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1
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SEVCO:01064
|
Allocation
concealment
|
A
study
design
process
in
which
all
parties
influencing
study
enrollment
and
allocation
to
study
groups
are
unaware
of
the
group
assignment
for
the
study
participant
at
the
time
of
enrollment
and
allocation.
|
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1
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SEVCO:01043
|
Multicentric
|
A
study
design
feature
in
which
two
or
more
institutions
are
responsible
for
the
conduct
of
the
study.
|
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1
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SEVCO:01052
|
Includes
patient-reported
outcome
|
A
study
design
feature
in
which
one
or
more
outcomes
are
reported
directly
from
the
patient
without
interpretation
by
a
clinician
or
researcher.
|
|
|
1
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SEVCO:01053
|
Includes
patient-centered
outcome
|
A
study
design
feature
in
which
one
or
more
measures
are
outcomes
that
patients
directly
care
about,
i.e.
outcomes
that
are
directly
related
to
patients'
experience
of
their
life.
|
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1
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SEVCO:01054
|
Includes
disease-oriented
outcome
|
A
study
design
feature
in
which
one
or
more
measures
are
outcomes
that
relate
to
a
health
or
illness
condition
but
are
not
outcomes
which
patients
directly
care
about.
|
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1
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SEVCO:01085
|
Includes
process
measure
|
A
study
design
feature
in
which
one
or
more
outcomes
are
actions
or
behaviors
of
a
healthcare
professional
or
care
team.
|
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1
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SEVCO:01089
|
Study
Goal
|
A
study
design
feature
specifying
the
intent
of
the
study.
|
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2
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SEVCO:01096
|
Evaluation
Goal
|
A
study
goal
to
assess
the
efficiency,
effectiveness,
and
impact
of
a
given
program,
process,
person
or
piece
of
equipment.
|
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2
|
SEVCO:01097
|
Derivation
Goal
|
A
study
goal
with
the
intent
to
generate
a
predictive
algorithm.
|
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2
|
SEVCO:01098
|
Validation
Goal
|
A
study
goal
with
the
intent
to
determine
the
reliability
and/or
performance
of
a
procedure
for
a
specific
predictive,
classification,
measurement,
or
communication
purpose.
|
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2
|
SEVCO:01088
|
Comparison
Goal
|
A
study
design
feature
in
which
the
study
intent
is
to
compare
two
or
more
interventions
or
exposures.
|
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3
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SEVCO:01091
|
Comparative
Effectiveness
Goal
|
A
study
design
feature
in
which
the
study
intent
is
to
compare
two
or
more
interventions
with
respect
to
benefits
and/or
harms.
|
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4
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SEVCO:01090
|
Comparative
Efficacy
Goal
|
A
study
design
feature
in
which
the
study
intent
is
to
compare
two
or
more
interventions
with
respect
to
effectiveness
in
ideal
conditions.
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4
|
SEVCO:01092
|
Comparative
Safety
Goal
|
A
study
design
feature
in
which
the
study
intent
is
to
compare
two
or
more
interventions
with
respect
to
harms.
|
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3
|
SEVCO:01093
|
Equivalence
Goal
|
A
study
goal
with
the
intent
to
compare
two
or
more
interventions
or
exposures
and
determine
that
any
difference
in
effects
is
within
a
prespecified
range
representing
absence
of
a
meaningful
difference.
|
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3
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SEVCO:01094
|
Non-inferiority
Goal
|
A
study
goal
with
the
intent
to
compare
two
or
more
interventions
or
exposures
and
determine
that
any
difference
in
effects
is
below
a
prespecified
value
representing
a
threshold
between
a
meaningful
difference
and
absence
of
a
meaningful
difference.
|
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3
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SEVCO:01095
|
Superiority
Goal
|
A
study
goal
with
the
intent
to
compare
two
or
more
interventions
or
exposures
and
detect
a
difference
in
effects.
|
|
Terminology
|
Propose
a
change