Generated Narrative: StructureDefinition study-eligibility-criteria Name Flags Card. Type Description & Constraints Group 0..* CohortDefinition Group of multiple entities Interfaces Implemented: CanonicalResource #xD; Documentation for this format
HL7 International / Clinical Decision Support
Profile of Group for Evidence Based Medicine IG. The StudyEligibilityCriteria Profile is used to describe inclusion and exclusion criteria for a clinical trial or other research study.
Represents a defined collection of entities that may be discussed or acted upon collectively but which are not typically expected to act collectively. These collections are also not typically formally or legally recognized. NOTE: Group may be used to define families or households, which in some circumstances may act collectively or have a degree of legal or formal recognition. This should be considered an exception. When Group is used for types of entities other than Patient or RelatedPerson, the expectation remains that the Group will not act collectively or have formal recognition - use Organization if these behaviors are needed. For example, it is possible for a 'family' Group to be a performer of an Observation or owner of a Task. However, this is not permitted for a Group made up of Practitioners, PractitionerRoles or Organizations. Organization or CareTeam would need to be used instead. A Group of Practitioners could, however, be a subject of an Observation.
If both Group.characteristic and Group.member are present, then the members are the individuals who were found who met the characteristic. It's possible that there might be other candidate members who meet the characteristic and aren't (yet) in the list. All members SHALL have the listed characteristics.
Group.type SHALL be defined if Group.membership is either 'definitional' or 'enumerated'
Group.type.exists() or (Group.membership = 'conceptual')
Entity[determinerCode="GRP" or determinerCode="GRP_KIND"]
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).
An individual or organization primarily involved in the creation and maintenance of the artifact.
Must have either extensions or value[x], not both
The entity that entered the data for the Resource content.
Display of suggested citation for this Resource.
Resource (FHIR or non-FHIR) associated with the Resource.
Resource (FHIR or non-FHIR) associated with the Resource, plus specification of a portion quoted from the Resource.
An expression that defines the criteria for group membership. This extension can only be used on a Group resource with a membership of `definitional`. When this expression is used, the Group resource cannot have any characteristic elements; this mechanism is exclusive with characteristics. The result of the expression SHALL be boolean-valued. The expression SHALL be parameterized with a `%context` variable that represents the subject being tested for membership. If evaluation of the expression results in `true`, the subject is considered a member of the group.
The status of the processing for making the artifact publicly available, not necessarily the same as artifact status (Resource.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 Group, represented as an absolute URI (globally unique)
An absolute URI that is used to identify this Group when it is referenced in a specification, model, design or an instance; also called its canonical identifier. This SHOULD be globally unique and SHOULD be a literal address at which an authoritative instance of this Group is (or will be) published. This URL can be the target of a canonical reference. It SHALL remain the same when the Group is stored on different servers.
Can be a urn:uuid: or a urn:oid: but real http: addresses are preferred. Multiple instances may share the same URL if they have a distinct version. The determination of when to create a new version of a resource (same url, new version) vs. defining a new artifact is up to the author. Considerations for making this decision are found in [Technical and Business Versions](http://build.fhir.org/resource.html#versions). In some cases, the resource can no longer be found at the stated url, but the url itself cannot change. Implementations can use the [meta.source](http://build.fhir.org/resource.html#meta) element to indicate where the current master source of the resource can be found.
Allows the Group to be referenced by a single globally unique identifier.
URL should not contain | or # - these characters make processing canonical references problematic
Business identifiers assigned to this participant by one of the applications involved. These identifiers remain constant as the resource is updated and propagates from server to server.
Note: This is a business identifier, not a resource identifier (see [discussion](http://build.fhir.org/resource.html#identifiers)). It is best practice for the identifier to only appear on a single resource instance, however business practices may occasionally dictate that multiple resource instances with the same identifier can exist - possibly even with different resource types.
Allows identification of the group as it is known by various participating systems and in a way that remains consistent across servers.
unique(./id[displayable="true" and scope="OBJ"])
The identifier that is used to identify this version of the Group when it is referenced in a specification, model, design or instance. This is an arbitrary value managed by the Group author and is not expected to be globally unique. For example, it might be a timestamp (e.g. yyyymmdd) if a managed version is not available. There is also no expectation that versions can be placed in a lexicographical sequence without additional knowledge.
There may be different Groups that have the same url but different versions. The version can be appended to the url in a reference to allow a reference to a particular business version of the Group with the format [url]|[version]. The version SHOULD NOT contain a '#' - see [Business Version](http://build.fhir.org/resource.html#bv-format).
Indicates the mechanism used to compare versions to determine which is more current.
If set as a string, this is a FHIRPath expression that has two additional context variables passed in - %version1 and %version2 and will return a negative number if version1 is newer, a positive number if version2 and a 0 if the version ordering can't be successfully be determined.
A label assigned to the group for human identification and communication.
Used to identify the group in human communication.
A short, descriptive, user-friendly title for the Group.
This name does not need to be machine-processing friendly and may contain punctuation, white-space, etc.
A nominal state-transition diagram can be found in the [Definition pattern](http://hl7.org/fhir/R5/definition.html#statemachine) documentation. Unknown does not represent 'other' - one of the defined statuses must apply. Unknown is used when the authoring system is not sure what the current status is. See guidance around (not) making local changes to elements [here](http://hl7.org/fhir/R5/canonicalresource.html#localization).
Enables tracking the life-cycle of the content and filtering of Groups that are appropriate for use versus not.
This is labeled as "Is Modifier" because applications should not use a retired Group without due consideration
A Boolean value to indicate that this Group is authored for testing purposes (or education/evaluation/marketing) and no version of this resource will ever be intended for genuine usage.
Allows filtering of Groups that are appropriate for use versus not. Experimental resources might include example instances in implementation guides, instances created solely for testing purposes, etc. If experimental is 'true' for any version of a resource, it should be true for all versions of the resource. (If experimental changes, then it is being misused or a resource that was never intended for real-world use has unexpectedly changed its purpose.). Experimental resources are not expected to be stable and may well have breaking changes without a corresponding change to the 'version' element.
Enables experimental content to be developed following the same lifecycle that would be used for a production-level Group.
If absent, this resource is treated as though it is not experimental.
The date (and optionally time) when the Group 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 Group changes.
The date is often not tracked until the resource is published, but may be present on draft content. Note that this is not the same as the resource last-modified-date, since the resource may be a secondary representation of the Group. Additional specific dates may be added as extensions or be found by consulting Provenances associated with past versions of the resource. See guidance around (not) making local changes to elements [here](http://hl7.org/fhir/R5/canonicalresource.html#localization).
Name of the publisher/steward (organization or individual)
The name of the organization or individual responsible for the release and ongoing maintenance of the Group.
Usually an organization but may be an individual. The publisher (or steward) of the Group is the organization or individual primarily responsible for the maintenance and upkeep of the Group. This is not necessarily the same individual or organization that developed and initially authored the content. The publisher is the primary point of contact for questions or issues with the Group. This item SHOULD be populated unless the information is available from context.
Helps establish the "authority/credibility" of the Group. May also allow for contact.
Contact details to assist a user in finding and communicating with the publisher.
May be a web site, an email address, a telephone number, etc. See guidance around (not) making local changes to elements [here](http://hl7.org/fhir/R5/canonicalresource.html#localization).
Natural language description of the group
Explanation of what the group represents and how it is intended to be used.
The context that the content is intended to support
The content was developed with a focus and intent of supporting the contexts that are listed. These contexts may be general categories (gender, age, ...) or may be references to specific programs (insurance plans, studies, ...) and may be used to assist with indexing and searching for appropriate Groups.
When multiple useContexts are specified, there is no expectation that all or even any of the contexts apply.
Assist in searching for appropriate content.
Explanation of why this Group is needed and why it has been designed as it has.
This element does not describe the usage of the Group. Instead, it provides traceability of "why" the resource is either needed or "why" it is defined as it is. This may be used to point to source materials or specifications that drove the structure of this Group.
A copyright statement relating to the Group and/or its contents. Copyright statements are generally legal restrictions on the use and publishing of the Group.
The short copyright declaration (e.g. (c) '2015+ xyz organization' should be sent in the copyrightLabel element.
Consumers must be able to determine any legal restrictions on the use of the Group and/or its content.
A short string (<50 characters), suitable for inclusion in a page footer that identifies the copyright holder, effective period, and optionally whether rights are resctricted. (e.g. 'All rights reserved', 'Some rights reserved').
The (c) symbol should NOT be included in this string. It will be added by software when rendering the notation. Full details about licensing, restrictions, warrantees, etc. goes in the more general 'copyright' element.
Defines the content expected to be rendered in all representations of the artifact.
person | animal | practitioner | device | careteam | healthcareservice | location | organization | relatedperson | specimen | medication | substance | biologicallyDerivedProduct | nutritionProduct
Identifies the broad classification of the kind of resources the group includes.
Group members SHALL be of the appropriate resource type (Patient for person or animal; or Practitioner, PractitionerRole, Device, CareTeam, HealthcareService, Location, Organization, RelatedPerson, or Specimen for the other types.), or a Group of the resources of the appropriate type.
Identifies what type of resources the group is made up of.
Types of resources that are part of group.
person: ./classCode="PSN" animal: ./classCode="ANM" device: ./classCode="DEV" medication: ./classCode="MMAT" and ./playedRole[isNormalRole() and classCode="THER"] food: ./classCode="FOOD"
Basis for membership in the Group: * 'definitional': The Group.characteristics specified are both necessary and sufficient to determine membership. All entities that meet the criteria are considered to be members of the group, whether referenced by the group or not. If members are present, they are individuals that happen to be known as meeting the Group.characteristics. The list cannot be presumed to be complete. * 'conceptual': The Group.characteristics specified are both necessary and sufficient to determine membership. The 'conceptual' Group is a 'definitional' Group in which the Group.type is not bound to FHIR types. * 'enumerated': The Group.characteristics are necessary but not sufficient to determine membership. Membership is determined by being listed as one of the Group.member.
There are use-cases for groups that define specific collections of individuals, and other groups that define "types" of intended individuals. The requirements for both kinds of groups are similar, so we use a single resource, distinguished by this element.
Use of the Group (and by implication, kind of members)
A code that describes the use of the group. The use of the group usually dictates what kind of entities can be members of the group.
The types of entities that can be members needs to align with Group.type
A code that describes the kind of group, which usually dictates what kind if entities can be in the group.
A count of the number of resource instances that are part of the group.
Note that the quantity may be less than the number of members if some of the members are not active.
Group size is a common defining characteristic.
Entity that is the custodian of the Group's definition
Entity responsible for defining and maintaining Group characteristics and/or registered members.
This does not strictly align with ownership of a herd or flock, but may suffice to represent that relationship in simple cases. More complex cases will require an extension.
all-of | any-of | at-least | at-most | except-subset
Used to specify how two or more characteristics are combined.
If absent, this element is treated as though it had been set to 'all-of'
Changing the combinationMethod from all-of to any other value changes the interpretation of multiple characteristics.
Provides the value of "n" when "at-least" or "at-most" codes are used
Provides the value of "n" when "at-least" or "at-most" codes are used for combinationMethod.
Include / Exclude group members by Trait
Identifies traits whose presence r absence is shared by members of the group.
Some subset (as determined by combinationMethod) of the identified characteristics must be true for an entity to a member of the group.
Needs to be a generic mechanism for identifying what individuals can be part of a group.
All FHIR elements must have a @value or children or both
./playedRole[isNormalRole()]/participation[isNormalParticipation() and typeCode="SBJ"]/act[isNormalAct and classCode="OBS" and moodCode="EVN"]
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
A code that identifies the kind of trait being asserted.
Need a formal way of identifying the characteristic being described.
List of characteristics used to describe group members; e.g. gender, age, owner, location, etc.
The value of the trait that holds (or does not hold - see 'exclude') for members of the group.
For Range, it means members of the group have a value that falls somewhere within the specified range.
The value of the characteristic is what determines group membership.
If true, indicates the characteristic is one that is NOT held by members of the group.
This is labeled as "Is Modifier" because applications cannot wrongly include excluded members as included or vice versa.
Sometimes group membership is determined by characteristics not possessed.
Natural language description of the characteristic
A short, natural language description of the characteristic that could be used to communicate the criteria to an end-user.
Need to be able to describe characteristics in natural language so that end users can understand the criteria.
Method for how the characteristic value was determined
Method for how the characteristic value was determined.
Defines the characteristic (without using type and value) by either a Reference or an Expression.
Defines the reference point for comparison when other than 0.
If offset is present it must be included to interpret the characteristic value.
Number of occurrences meeting the characteristic
Number of occurrences meeting the characteristic.
($this is Range) implies ((low.empty() or ((low.code.exists() or low.value.empty()) and (low.system.empty() or low.system = %ucum) and (low.code.empty() or low.code = '1') and (low.value.empty() or low.value.hasValue().not() or low.value.toString().contains('.').not()) and (low.value.empty() or low.value.hasValue().not() or low.value >= 0))) and (high.empty() or ((high.code.exists() or high.value.empty()) and (high.system.empty() or high.system = %ucum) and (high.code.empty() or high.code = '1') and (high.value.empty() or high.value.hasValue().not() or high.value.toString().contains('.').not()) and (high.value.empty() or high.value.hasValue().not() or high.value >= 0))))
Length of time in which the characteristic is met
Length of time in which the characteristic is met.
Period over which characteristic is tested
The period over which the characteristic is tested; e.g. the patient had an operation during the month of June.
Timing in which the characteristic is determined
Timing in which the characteristic is determined.
Identifies the resource instances that are members of the group.
Often the only thing of interest about a group is "who's in it".
./scopedRole[isNormalRole() and classCode="MBR"]/player
A reference to the entity that is a member of the group. Must be consistent with Group.type. If the entity is another group, then the type must be the same.
Code that describes how user is part of the group
A code that describes how a user is involved in the group. Some groups (e.g. exposure-group) typically don't have variance between members, or it is not tracked, while for other groups (e.g. family, household) this may be meaningful.
See [Relationships inside the group](group.html#relationships) for more detailed family relationships.
A code that describes how a user is involved in the group
The period that the member was in the group, if known.
Need to track who was in a group at a particular time.
A flag to indicate that the member is no longer in the group, but previously may have been a member.
Sometimes you don't know when someone stopped being in a group, but not when.
Members are considered active unless explicitly specified otherwise