Generated Narrative: StructureDefinition systematic-review Name Flags Card. Type Description & Constraints ResearchStudy 0..* ResearchStudy Investigation to increase healthcare-related patient-independent knowledge #xD; Slices for extension 0..* Extension Extension Slice: Unordered, Open by value:url #xD; extension:publicationStatus 0..1 CodeableConcept Publication status URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status Binding: Cited Artifact Status Type (preferred) #xD; extension:author 0..* ContactDetail Who authored the artifact URL: http://hl7.org/fhir/StructureDefinition/artifact-author #xD; extension:searchStrategy 0..* Reference(SearchStrategy) Link to search terms and sources. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-search-strategy #xD; extension:systematicReviewEligibilityCriteria 0..1 Reference(SystematicReviewEligibilityCriteria) Link to inclusion and exclusion criteria for studies. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-systematic-review-eligibility-criteria #xD; extension:numberOfStudiesIdentified 0..1 unsignedInt Number of studies found on search. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-number-of-studies-identified #xD; extension:numberOfStudiesIncluded 0..1 unsignedInt Number of studies selected for inclusion. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-number-of-studies-included #xD; extension:includedStudy 0..* Reference(Citation | Composition | ResearchStudy) Link to a research study included in the systematic review. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-included-study #xD; extension:excludedStudy 0..* Reference(Citation | Composition | ResearchStudy) Link to a research study excluded from the systematic review. URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/research-study-excluded-study #xD; extension:studyRegistration 0..* (Complex) Dates for study registration activities URL: http://hl7.org/fhir/StructureDefinition/researchStudy-studyRegistration #xD; relatesTo #xD; Slices for extension 0..* Extension Extension Slice: Unordered, Open by value:url #xD; extension:quotation 0..1 markdown Quoted portion from related artifact URL: http://hl7.org/fhir/uv/ebm/StructureDefinition/relates-to-with-quotation #xD; phase 0..0 Classifier used for clinical trials #xD; recruitment 0..0 Target or actual group of participants enrolled in study #xD; Documentation for this format
HL7 International / Clinical Decision Support
Profile of ResearchStudy for Evidence Based Medicine IG. The SystematicReview Profile is used for a scientific study based on a protocol that includes search and selection of eligible studies, study quality assessment, data extraction, and synthesis.
Investigation to increase healthcare-related patient-independent knowledge
A scientific study intended to increase health-related knowledge. For example, clinical trials are research studies that involve people. These studies may be related to new ways to screen, prevent, diagnose, and treat disease. They may also study certain outcomes and certain groups of people by looking at data collected in the past or future.
The ResearchStudy Resource may be used for any type of research study, such as public health studies evaluating populations or systematic reviews evaluating research studies, and is not limited to clinical trials or limited to studies of individual people.
If the resource is contained in another resource, it SHALL NOT contain nested Resources
If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
contained.where((('#'+id.trace('id') in %resource.descendants().select(reference | as(uri))) or descendants().where(reference='#' | as(uri)='#').exists()).not()).trace('unmatched', id).empty()
If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
If a resource is contained in another resource, it SHALL NOT have a security label
When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time.
A resource should have narrative for robust management
Entity, Role, or Act,Observation[classCode=CLNTRL, moodCode=EVN]
ObservationalStudyProtocolVersion; Study; StudyProtocolVersion
The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.
The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.
All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
A set of rules under which this content was created
A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.
Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.
This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
The base language in which the resource is written.
Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).
Text summary of the resource, for human interpretation
A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.
Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.
These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.
This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels. Contained resources may be a resource type defined in the FHIR specification, or an [additional resource](http://build.fhir.org/resource.html#additional).
The status of the processing for making the artifact publicly available, not necessarily the same as artifact status (Resource.status).
Must have either extensions or value[x], not both
An individual or organization primarily involved in the creation and maintenance of the artifact.
Link to search terms and sources, using a Group Resource (SearchStrategy Profile).
Link to inclusion and exclusion criteria for studies.
Link to criteria for inclusion of studies in the systematic review, using a Group Resource (StudyEligibilityCriteria Profile).
Number of studies found on search to be evaluated for inclusion.
Number of studies selected for inclusion.
Link to a research study included in the systematic review.
Link to a research study excluded from the systematic review.
Dates for study registration activities.
Used to separate study registration activities from study progress status.
May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://build.fhir.org/extensibility.html#modifierExtension).
Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Canonical identifier for this study resource
Canonical identifier for this study resource, represented as a globally unique URI.
Identifiers assigned to this research study by the sponsor or other systems.
Allows identification of the research study as it is known by various participating systems and in a way that remains consistent across servers.
Organization's Unique Protocol ID; Secondary IDs
No BRIDG mapping (although there is DocumentVersion.identifier > StudyProtocolDocumentVersion, this is arguably a different semantic)
The business version for the study record
The business version for the study record.
Name for this study (computer friendly).
The human readable name of the research study.
No BRIDG mapping (although there is StudyProtocolDocumentVersionPublicTitle this is arguably a different semantic: title of a document vs title of a research study)
All FHIR elements must have a @value or children or both
Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Additional content defined by implementations
May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.
Extensions that cannot be ignored even if unrecognized
May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).
Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
primary | official | scientific | plain-language | subtitle | short-title | acronym | earlier-title | language | auto-translated | human-use | machine-use | duplicate-uid
The set of steps expected to be performed as part of the execution of the study.
Interventions; Arm/Intervention Cross-Reference
A larger research study of which this particular study is a component or step.
Allows breaking a study into components (e.g. by study site) each with their own PI, status, enrollment, etc.
Display of the bibliographic citation of this ResearchStudy.
Relationships that this ResearchStudy has with other FHIR or non-FHIR resources that already exist.
Specification of a portion quoted from the related artifact.
documentation | justification | predecessor | successor | derived-from | depends-on | composed-of | part-of | amends | amended-with | appends | appended-with | cites | cited-by | comments-on | comment-in | contains | contained-in | corrects | correction-in | replaces | replaced-with | retracts | retracted-by | signs | similar-to | supports | supported-with | transforms | transformed-into | transformed-with | specification-of | created-with | cite-as | summarizes
The type of relationship to the related artifact.
The artifact that is related to this ResearchStudy
The artifact that is related to this ResearchStudy Resource.
The date (and optionally time) when the ResearchStudy Resource was last significantly changed. The date must change when the business version changes and it must change if the status code changes. In addition, it should change when the substantive content of the ResearchStudy Resource changes.
The publication state of the resource (not of the study).
This element is labeled as a modifier because it is a status element that contains status entered-in-error which means that the resource should not be treated as valid
Codes that convey the current publication status of the research study resource.
treatment | prevention | diagnostic | supportive-care | screening | health-services-research | basic-science | device-feasibility
The type of study based upon the intent of the study activities. A classification of the intent of the study.
The stage in the progression of a therapy from initial experimental use in humans in clinical trials to post-market evaluation.
Classifiers of clinical trial progression for human use.
Classifications of the study design characteristics
Codes categorizing the type of study such as investigational vs. observational, type of blinding, type of randomization, safety vs. efficacy, etc.
This is a set of terms for study design characteristics.
Study Type; Primary Purpose; Interventional Model; Masking; Allocation; study Classification; Observational Study Model; Time Perspective; Biospecimen Retention
InterventionalStudyProtocolVersion; InterventionalStudyProtocol.allocationCode; InterventionalStudyProtocol.blindedRoleCode; InterventionalStudyProtocol.blindingSchemaCode; InterventionalStudyProtocol.controlTypeCode
The medication(s), food(s), therapy(ies), device(s) or other concerns or interventions that the study is seeking to gain more information about.
Some example codes of research study focus
The condition that is the focus of the study. For example, In a study to examine risk factors for Lupus, might have as an inclusion criterion "healthy volunteer", but the target condition code would be a Lupus SNOMED code.
Identification of the condition or diagnosis.
Key terms to aid in searching for or filtering the study.
DocumentVersion.keywordCode; DocumentVersion.keywordText
A country, state or other area where the study is taking place rather than its precise geographic location or address.
Countries and regions within which this artifact is targeted for use.
A detailed and human-readable narrative of the study. E.g., study abstract.
Identifies the start date and the expected (or actual, depending on status) end date for the study.
Study Start Date (start); Study Completion Date (end)
ProjectConduct.dateRange; StudyProtocolVersion.plannedDuration
Facility where study activities are conducted
A facility in which study activities are conducted.
Comments made about the study by the performer, subject or other participants.
.inboundRelationship(typeCode=SUBJ].source[classCode=ANNGEN, moodCode=EVN].value[xsi:type=ST]
Additional grouping mechanism or categorization of a research study. Example: FDA regulated device, FDA regulated drug, MPG Paragraph 23b (a German legal requirement), IRB-exempt, etc. Implementation Note: do not use the classifier element to support existing semantics that are already supported thru explicit elements in the resource.
Sponsors, collaborators, and other parties
Sponsors, collaborators, and other parties.
For a Sponsor or a PrincipalInvestigator use the dedicated attributes provided.
While there are explicit attributes for a Sponsor and a PrincipalInvestigator many trial record a range of other organizations and individuals in key roles.
sponsor | lead-sponsor | sponsor-investigator | primary-investigator | collaborator | funding-source | general-contact | recruitment-contact | sub-investigator | study-chair | irb
Identifies the start date and the end date of the associated party in the role.
The cardinality is 0..* due to the fact that an associated party may be intermittently active in a given role over multiple time periods.
nih | fda | government | nonprofit | academic | industry
A categorization other than role for the associated party.
A characterization or type of the entity.
Individual or organization associated with study (use practitionerRole to specify their organisation)
Individual or organization associated with study (use practitionerRole to specify their organisation).
Suggestions of a better attribute name are appreciated
Status of study with time for that status
Status of study with time for that status.
Label for status or state (e.g. recruitment status)
Label for status or state (e.g. recruitment status).
An indication of whether or not the date is a known date when the state changed or will change. A value of true indicates a known date. A value of false indicates an estimated date.
accrual-goal-met | closed-due-to-toxicity | closed-due-to-lack-of-study-progress | temporarily-closed-per-study-design
A description and/or code explaining the premature termination of the study.
Codes for why the study ended prematurely.
Target or actual group of participants enrolled in study
Target or actual group of participants enrolled in study.
Enrollment; Number of Groups/Cohorts (= number of "enrollment" instances); Groups (Group/Cohort Label = Group.name; Group/Cohort Description = Group.description); Eligibility (Group criteria)
Estimated total number of participants to be enrolled
Estimated total number of participants to be enrolled.
Actual total number of participants enrolled in study
Actual total number of participants enrolled in study.
Inclusion and exclusion criteria. The referenced Group Resource should have a membership element value of either 'definitional' or 'conceptual'.
Group of participants who were enrolled in study
Group of participants who were enrolled in study. The referenced Group Resource should have a membership element value of 'enumerated'.
Defined path through the study for a subject
Describes an expected event or sequence of events for one of the subjects of a study. E.g. for a living subject: exposure to drug A, wash-out, exposure to drug B, wash-out, follow-up. E.g. for a stability study: {store sample from lot A at 25 degrees for 1 month}, {store sample from lot A at 40 degrees for 1 month}.
In many clinical trials this is refered to as the ARM of the study, but such a term is not used in other sorts of trials even when there is a comparison between two or more groups.
Estimated total number of participants to be enrolled in the comparison group
Estimated total number of participants to be enrolled in the comparison group.
Actual total number of participants enrolled in the comparison group
Actual total number of participants enrolled in the comparison group.
Inclusion and exclusion criteria for the comparison group
Inclusion and exclusion criteria for the comparison group as a subset of the eligibility for the overall study. The referenced Group Resource should have a membership element value of either 'definitional' or 'conceptual'.
Group of participants who were enrolled in the comparison group
Group of participants who were enrolled in the comparison group as a subset of those enrolled in the overall study. The referenced Group Resource should have a membership element value of 'enumerated'.
A goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study.
Unique, human-readable label for this objective of the study.
No BRIDG mapping (BRIDG has a description, but not a name)
Free text description of the objective of the study. This is what the study is trying to achieve rather than how it is going to achieve it (see ResearchStudy.description).
An "outcome measure", "endpoint", "effect measure" or "measure of effect" is a specific measurement or observation used to quantify the effect of experimental variables on the participants in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment.
A study may have multiple distinct outcome measures that can be used to assess the overall goal for a study. The goal of a study is in the objective whereas the metric by which the goal is assessed is the outcomeMeasure. Examples: Time to Local Recurrence (TLR), Disease-free Survival (DFS), 30 Day Mortality, Systolic BP
To re-use and reference a Group represented in ResearchStudy.comparisonGroup.eligibility, one may include the Group Resource in ResearchStudy.contained and then reference the same (internal) Group by its id
Statistical measure for treatment effect estimate
Statistical measure for treatment effect estimate.
The type of a statistic, e.g. relative risk or mean.
The group that is affected by this event handling
The group that is affected by this event handling.
Link to results generated during the study
Link to one or more sets of results generated by the study. Could also link to a research registry holding the results such as ClinicalTrials.gov.