Clinical
Reasoning
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Responsible
Owner:
Work
Group
Clinical
Decision
Support
|
Standards
Status
:
|
The
reporting
of
biomedical
Biomedical
evidence
is
the
reporting
set
of
facts
and
interpretations
derived
from
scientific
analysis
of
observations
of
members
of
a
group.
The
certainty
of
the
‘facts’
may
vary
due
to
many
factors
including
methodological
factors,
statistical
factors,
contextual
factors,
and
the
relatedness
between
the
group
the
evidence
was
derived
from
and
the
group
the
interpretation
is
intended
for.
The domain of biomedical evidence includes original research, secondary research, and evidence synthesis.
The evidence generation (research), evidence processing, and guideline development communities represent a substantial volume of knowledge management effort (Cochrane alone has more than 30,000 people working on development of systematic reviews of clinical research).
The broad communities producing, analyzing, synthesizing, disseminating and implementing clinical research (evidence) and recommendations for clinical care (clinical practice guidelines) frequently send or receive biomedical evidence reports.
The
co-primary
objectives
of
the
Evidence-Based
Medicine
on
FHIR
Project
are
to
meet
the
needs
of
the
evidence
generation,
evidence
processing,
and
guideline
development
communities
and
to
facilitate
interoperability
between
these
communities
and
the
patient
care
communities.
The
EBMonFHIR
Project,
sponsored
by
HL7
Clinical
Decision
Support
(CDS)
Work
Group,
and
co-sponsored
by
HL7
Biomedical
Research
and
Regulation
(BRR)
and
Clinical
Quality
Information
(CQI)
Work
Groups,
is
open
to
participation
through
multiple
meetings
each
week.
Meeting
details
are
posted
at
Evidence-Based
Medicine
on
FHIR
Project
.
The Evidence Resource provides a machine-interpretable expression of an evidence concept. It is comprised of specification of the group to which the evidence refers (i.e., population), one or more evidence variables (e.g., exposures/interventions, comparators, outcomes, confounding variables), the statistics, and the certainty of the evidence. The Evidence Resource enables machine-to-machine communication of results of research or observations of groups.
The variableDefinition Element provides a precise specification of what the evidence is about, represented as a definition of each of the variables. In the EBM communities (evidence analysis, systematic reviews, clinical practice guidelines) a common organizational framework used for the research question, the systematic review focus, and the recommendation focus is PICO which stands for Population, Intervention, Comparator, and Outcome. There are variations such as PECO for research questions about non-interventional exposures, PICOT for adding time conventions, and PICOTS for adding system context, but PICO is the most prominent organizational framework across the EBM knowledge assets activities. In the statistically-defined evidence variables, represented by codes in Evidence.variableDefinition.variableRole, Population is coded as 'population', Intervention and Comparator are coded as 'exposure', and Outcome is coded as 'outcome'.
The statistic Element provides codeable concepts and numerical data elements to capture all aspects of the statistical data, including sample size, statistic types and quantities, statistical measures about the statistic (called attribute estimates, such as p values and confidence intervals), and statistical model characteristics.
The certainty Element provides a machine-interpretable expression of certainty, confidence or quality of the resource in which it is included. The certainty Element can express overall certainty and certainty of any subcomponent concepts using codeable concepts from structured rating systems. The certainty Element enables machine-to-machine communication of the certainty of evidence. The reporting of biomedical evidence is the reporting of facts and interpretations derived from analysis of observations of members of a group. The certainty of the ‘facts’ may vary due to many factors including methodological factors, statistical factors, contextual factors, and the relatedness between the group the evidence was derived from and the group to which the evidence is applied.
The
EvidenceVariable
Resource
provides
a
machine-interpretable
expression
of
a
description
of
a
single
evidence
variable
(e.g.,
a
single
exposure
or
a
single
outcome/measured
variable),
outcome),
including
its
precise
definition,
how
the
data
values
are
measured,
processed,
and
includes
one
or
more
characteristics
stored.
The
definition
of
the
variable
an
EvidenceVariable
may
be
expressed
using
a
CodeableConcept
datatype
and/or
using
a
Reference
datatype
to
a
Group
Resource
for
these
characteristics.
a
definition
combining
two
or
more
CodeableConcepts.
The
EvidenceVariable
Resource
enables
machine-to-machine
communication
of
descriptions
and
characteristics
attributes
of
evidence
variables
and
can
be
used
to
find
Evidence
Resources
that
match
the
context
of
interest.
interest,
and
can
be
used
to
understand
how
to
interpret
datasets.
Although the Group Resource is not maintained through the EBMonFHIR project or its sponsoring Work Groups, the Group Resource is functionally used to represent the population (as an enumerated study group or a definitional set of eligibility criteria) and also used for ‘conceptual’ groups of characteristics for representing the definition of any complex concept as structured data (called conceptual cohort definitions).
The
Group
Resource
provides
a
machine-interpretable
expression
of
a
group,
either
and
may
be
expressed
as
an
actual
group
enumerated
group,
a
definitional
group,
or
an
intended
a
conceptual
group.
An
actual
enumerated
group
may
be
specified
as
a
list
of
members
and/or
a
set
of
characteristics.
An
intended
characteristics,
and
may
have
a
quantity.
A
definitional
group
is
expressed
as
a
set
of
characteristics.
characteristics
which
defines
the
eligibility
criteria
for
group
membership.
In
FHIR,
an
enumerated
group
and
a
definitional
group
are
each
expected
to
specify
the
type
of
group
member
with
allowed
types
limited
to
concepts
expressed
in
FHIR
Resources.
A
conceptual
group
is
a
group
of
characteristics
that
collectively
represent
a
compound
definition
and
might
or
might
not
be
restricted
to
use
with
allowed
types.
The
Group
Resource
is
used
within
the
context
of
an
Evidence
resource
Resource
to
report
the
evidence
variable
in
the
role
of
population
and
is
also
used
for
other
purposes
beyond
the
reporting
of
Evidence.
providing
complex
definitions
for
EvidenceVariable
Resources.
The
Group
Resource
enables
machine-to-machine
communication
of
descriptions
and
characteristics
of
groups
and
can
be
used
to
find
Evidence
Resources
that
match
the
population
of
interest.
The
Citation
Resource
provides
a
machine-interpretable
expression
of
the
identification
and
location
of
a
knowledge
artifact.
The
scope
of
the
Citation
Resource
is
to
describe
any
aspect
of
identification,
location,
authorship,
and
contributorship
to
a
journal
article,
report,
document,
resource,
or
other
knowledge
artifact.
Citations
are
used
extensively
in
scholarly
communication
and
important
for
documenting
the
evidence
or
source
behind
statements
of
fact,
opinion,
and
interpretation.
Citations
are
also
used
for
acknowledgment
of
the
contributions
of
individuals
and
groups
to
the
creation
and
advancement
of
knowledge.
The
Citation
Resource
enables
reference
to
any
knowledge
artifact
for
purposes
of
identification
and
attribution.
The
Citation
Resource
supports
existing
reference
structures
and
developing
publication
practices
such
as
versioning,
expressing
complex
contributorship
roles,
and
referencing
computable
resources.
The
EvidenceReport
Citation
Resource
was
moved
from
the
FHIR
specification
to
the
Evidence
Based
Medicine
on
FHIR
Implementation
Guide.
The ArtifactAssessment Resource provides one or more comments, classifiers or ratings about a Resource and supports attribution and rights management metadata for the added content. External/additional comments, classifiers, and ratings are extensively used in scientific communication throughout peer-review, critical appraisal of research methods and results, and evidence synthesis.
The ResearchStudy Resource provides a structured representation of the research study protocol.
In
the
EBM
communities
(evidence
analysis,
systematic
reviews,
clinical
practice
guidelines)
Reporting
a
common
organizational
framework
used
for
the
research
question,
the
systematic
review
focus,
collection
of
Citation,
Evidence,
EvidenceVariable,
Group,
ArtifactAssessment,
and
ResearchStudy
Resources
can
be
done
with
a
Bundle
or
List
Resource.
However,
neither
Bundle
nor
List
conveys
any
organization
of
relationships
among
the
recommendation
focus
is
PICO
which
stands
for
Population,
Intervention,
Comparator,
and
Outcome.
There
are
variations
such
as
PECO
for
research
questions
about
non-interventional
exposures,
PICOT
referenced
Resources.
Reporting
collections
of
Resources
for
adding
time
conventions,
scientific
knowledge
typically
requires
data
on
their
relationships
and
PICOTS
for
adding
system
context,
but
PICO
this
is
the
most
prominent
organizational
framework
across
the
EBM
knowledge
assets
activities.
best
served
with
a
Composition
Resource
.
In
the
statistically-defined
evidence
variables,
represented
by
codeable
concepts
in
Evidence.variableDefinition.variableRole,
Population
is
coded
as
'population'
or
'subpopulation',
Intervention
The
primary
content
of
a
Composition
Resource
is
coded
as
'exposure',
Comparator
mainly
a
repeatable
hierarchical
section
element.
Each
section
element
instance
may
contain
a
title
element
(string),
code
element
(CodeableConcept),
and/or
focus
element
(Reference)
to
specify
what
the
section
is
coded
about;
a
text
element
(Narrative)
for
readable
summary
of
the
section
content;
an
array
of
entry
elements
(Reference)
to
reference
other
Resources
as
'referenceExposure',
the
section
content;
and
Outcome
is
coded
an
array
of
section
elements
to
contain
other
sections
as
'measuredVariable'.
the
section
content.
To
support
many
common
patterns
of
Composition
use
for
EBM
communication,
the
Evidence
Based
Medicine
on
FHIR
Implementation
Guide
contains
numerous
Profiles
of
Composition
.
The
EvidenceReport
Resource
in
prior
versions
of
FHIR
has
been
replaced
with
an
EvidenceReport
Profile
of
Composition
Resource
.
See
the
Evidence-Based
Medicine
on
FHIR
Implementation
Guide
for
details.
The
combinations
of
Citation,
Evidence,
EvidenceReport,
EvidenceVariable,
Group,
Citation,
ResearchStudy,
ArtifactAssessment,
and
ArtifactAssessment
Composition
Resources
can
be
used
for
many
purposes,
including:
An
Evidence-Based
Medicine
on
FHIR
Implementation
Guide
provides
a
broad
base
for
use
of
the
EBMonFHIR
project
derived
Resources.
This Implementation Guide defines profiles and value sets for the representation of scientific knowledge. This implementation guide is intended for developers of systems using FHIR for data exchange of scientific knowledge and for authors of more specialized implementation guides in this domain.
This implementation guide covers the broad scope of representation of scientific knowledge, including (1) citations to represent identification, location, classification, and attribution for knowledge artifacts; (2) components of research study design including study eligibility criteria (cohort definitions) and endpoint analysis plans; (3) research results including the statistic findings, definition of variables for which those findings apply, and the certainty of these findings; (4) assessments of research results; (5) aggregation and synthesis of research results; (6) judgments regarding evidence syntheses and contextual factors related to recommendations; (7) recommendations; and (8) compositions of combinations of these types of knowledge. The types of interoperability covered include syntactic (Resource StructureDefinitions) and semantic (value sets).
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2011+.
FHIR
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2023
15:26+1100.
Thu,
Dec
18,
2025
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