FHIR CI-Build

This is the Continuous Integration Build of FHIR (will be incorrect/inconsistent at times).
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Work Group Clinical Decision Support iconMaturity Level: 1Standards 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 icon 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), including its precise definition, how the data values are measured, processed, and stored. The definition of an EvidenceVariable may be expressed using a CodeableConcept datatype and/or using a Reference datatype to a Group Resource for a definition combining two or more CodeableConcepts. The EvidenceVariable Resource enables machine-to-machine communication of descriptions and attributes of evidence variables and can be used to find Evidence Resources that match the context of interest, and can be used to understand how to interpret datasets.

The Group Resource provides a machine-interpretable expression of a group, and may be expressed as an enumerated group, a definitional group, or a conceptual group. An enumerated group may be specified as a list of members and/or a set of characteristics, and may have a quantity. A definitional group is expressed as a set of 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 to report the evidence variable in the role of population and is also used for 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 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 icon 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 codes in Evidence.variableDefinition.variableRole, Population is coded as 'population', Intervention and Comparator are coded as 'exposure', and Outcome is coded as 'outcome'.

The combinations of Citation, Evidence, EvidenceVariable, and ArtifactAssessment Resources can be used for many purposes, including:

  • Reporting combinations of classifiers, risk of bias assessments, evidence variables, and evidence for a single study.
  • Reporting a summary of individual results from multiple studies.
  • Reporting a summary of findings from a body of evidence, as often reported as the key results from a systematic review.
  • Reporting an overall report including any of the above, plus organization for full documents, such as a Clinical Trial Report or systematic review for publication.
  • Reporting a highly organized set of search results in response to advanced search queries for evidence.

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 icon for details.

Evidence-Based Medicine on FHIR Project icon