Clinical
Reasoning
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Maturity Level : 1 | Standards Status : Trial Use |
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 the interpretation is intended for.
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 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 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.
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
Resource
provides
a
machine-interpretable
expression
of
compositions
(structured
collections)
of
resources
(especially
Evidence,
EvidenceVariable,
and
Citation
resources)
and
codeable
concepts.
The
EvidenceReport
Resource
will
be
deprecated
and
replaced
with
Profiles
of
Composition
Resource.
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.
An
Evidence-Based
Medicine
on
FHIR
Implementation
Guide
is
in
development.
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
codeable
concepts
codes
in
Evidence.variableDefinition.variableRole,
Population
is
coded
as
'population'
or
'subpopulation',
'population',
Intervention
is
coded
as
'exposure',
and
Comparator
is
are
coded
as
'referenceExposure',
'exposure',
and
Outcome
is
coded
as
'measuredVariable'.
'outcome'.
The
combinations
of
Citation,
Evidence,
EvidenceReport,
EvidenceVariable,
and
ArtifactAssessment
Resources
can
be
used
for
many
purposes,
including:
Reporting a collection of Citation, Evidence, EvidenceVariable, Group, and ArtifactAssessment Resources can be done with a Bundle or List Resource. However, neither Bundle nor List conveys any organization of relationships among the referenced Resources. Reporting collections of Resources for scientific knowledge typically requires data on their relationships and this is best served with a Composition Resource.
The primary content of a Composition Resource is 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 about; a text element (Narrative) for readable summary of the section content; an array of entry elements (Reference) to reference other Resources as the section content; and an array of section elements to contain other sections as 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.
FHIR
®©
HL7.org
2011+.
FHIR
R5
hl7.fhir.core#5.0.0
R6
hl7.fhir.core#6.0.0-ballot3
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on
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Mar
26,
2023
15:26+1100.
Tue,
Apr
1,
2025
12:26+1100.
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