Structured Data Capture 2.0 (STU2)

Definitions for the sdc-questionnaireresponse Profile.

QuestionnaireResponse(SDCData)
Definition

Sets expectations for supported capabilities for questionnaire responses for SDC-conformant systems.

Control0..*
Alternate NamesForm, QuestionnaireAnswers, Form Data
Comments

The QuestionnaireResponse contains enough information about the questions asked and their organization that it can be interpreted somewhat independently from the Questionnaire it is based on. I.e. You don't need access to the Questionnaire in order to extract basic information from a QuestionnaireResponse.

InvariantsDefined on this element
dom-1: If the resource is contained in another resource, it SHALL NOT contain any narrative (: contained.text.empty())
dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (: contained.contained.empty())
dom-3: If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource (: contained.where(('#'+id in %resource.descendants().reference).not()).empty())
dom-4: 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())
QuestionnaireResponse.id
Definition

The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

Control0..1
Typeid
Comments

The only time that a resource does not have an id is when it is being submitted to the server using a create operation.

QuestionnaireResponse.meta
Definition

The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content may not always be associated with version changes to the resource.

Control0..1
TypeMeta
QuestionnaireResponse.implicitRules
Definition

A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content.

Control0..1
Typeuri
Is Modifiertrue
Comments

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.

This element is labelled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies it's meaning or interpretation.

QuestionnaireResponse.language
Definition

The base language in which the resource is written.

Control0..1
BindingA human language.
The codes SHALL be taken from Common Languages; other codes may be used where these codes are not suitable
Typecode
Comments

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).

QuestionnaireResponse.text
Definition

A human-readable narrative that contains a summary of the resource, and may 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.

Control0..1 This element is affected by the following invariants: dom-1
TypeNarrative
Alternate Namesnarrative, html, xhtml, display
Comments

Contained resources do not have 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 in formation is added later.

QuestionnaireResponse.contained
Definition

These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope.

Control0..*
TypeResource
Alternate Namesinline resources, anonymous resources, contained resources
Comments

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.

QuestionnaireResponse.extension
Definition

May be used to represent additional information that is not part of the basic definition of the resource. In order to make the use of extensions safe and manageable, 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.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

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.

QuestionnaireResponse.modifierExtension
Definition

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. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, 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.

Control0..*
TypeExtension
Is Modifiertrue
Alternate Namesextensions, user content
Comments

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.

QuestionnaireResponse.identifier
Definition

A business identifier assigned to a particular completed (or partially completed) questionnaire.

NoteThis is a business identifer, not a resource identifier (see discussion)
Control0..1
TypeIdentifier
Must Supporttrue
Requirements

Used for tracking, registration and other business purposes.

QuestionnaireResponse.basedOn
Definition

The order, proposal or plan that is fulfilled in whole or in part by this QuestionnaireResponse. For example, a ProcedureRequest seeking an intake assessment or a decision support recommendation to assess for post-partum depression.

Control0..*
TypeChoice of: Reference(ReferralRequest), Reference(CarePlan), Reference(ProcedureRequest)
Requirements

Supports traceability of responsibility for the action and allows linkage of an action to the recommendations acted upon.

Alternate Namesorder
QuestionnaireResponse.parent
Definition

A procedure or observation that this questionnaire was performed as part of the execution of. For example, the surgery a checklist was executed as part of.

Control0..*
TypeChoice of: Reference(Observation), Reference(Procedure)
Comments

Composition of questionnaire responses will be handled by the parent questionnaire having answers that reference the child questionnaire. For relationships to referrals, and other types of requests, use basedOn.

QuestionnaireResponse.questionnaire
Definition

The Questionnaire that defines and organizes the questions for which answers are being provided.

Control1..1
TypeReference(Structured Data Capture Questionnaire Design)
Must Supporttrue
Requirements

Needed to allow editing of the questionnaire response in a manner that enforces the constraints of the original form.

Alternate NamesForm
Comments

For SDC, this SHALL be the version-specific URL of the form as hosted on the Form Manager.

QuestionnaireResponse.status
Definition

The position of the questionnaire response within its overall lifecycle.

Control1..1
BindingLifecycle status of the questionnaire response.
The codes SHALL be taken from QuestionnaireResponseStatus
Typecode
Is Modifiertrue
Must Supporttrue
Requirements

The information on Questionnaire resources may possibly be gathered during multiple sessions and altered after considered being finished.

Comments

This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid.

QuestionnaireResponse.subject
Definition

The subject of the questionnaire response. This could be a patient, organization, practitioner, device, etc. This is who/what the answers apply to, but is not necessarily the source of information.

Control1..1
TypeReference(Patient)
Must Supporttrue
Requirements

Allows linking the answers to the individual the answers describe. May also affect access control.

Alternate NamesPatient, Focus
Comments

If the Questionnaire declared a subjectType, the resource pointed to by this element must be an instance of one of the listed types.

QuestionnaireResponse.context
Definition

The encounter or episode of care with primary association to the questionnaire response.

Control0..1
TypeChoice of: Reference(Encounter), Reference(EpisodeOfCare)
Requirements

Provides context for the information that was captured. May also affect access control.

Comments

A questionnaire that was initiated during an encounter but not fully completed during the encounter would still generally be associated with the encounter.

QuestionnaireResponse.authored
Definition

Identifies when this version of the answer set was created. Changes whenever the answers are updated.

Control1..1
TypedateTime
Must Supporttrue
Requirements

Clinicians need to be able to check the date that the information in the questionnaire was collected, to derive the context of the answers.

Alternate NamesDate Created, Date published, Date Issued, Date updated
Comments

May be different from the lastUpdateTime of the resource itself, because that reflects when the data was known to the server, not when the data was captured.

This element is optional to allow for systems that may not know the value, however it SHOULD be populated if possible.

QuestionnaireResponse.author
Definition

Person who received the answers to the questions in the QuestionnaireResponse and recorded them in the system.

Control0..1
TypeChoice of: Reference(Device), Reference(Practitioner), Reference(Patient), Reference(RelatedPerson)
Must Supporttrue
Requirements

Need to know who interpreted the subject's answers to the questions in the questionnaire, and selected the appropriate options for answers.

Alternate NamesLaboratory, Service, Practitioner, Department, Company, Performer
Comments

Mapping a subject's answers to multiple choice options and determining what to put in the textual answer is a matter of interpretation. Authoring by device would indicate that some portion of the questionnaire had been auto-populated.

QuestionnaireResponse.source
Definition

The person who answered the questions about the subject.

Control0..1
TypeChoice of: Reference(Patient), Reference(Practitioner), Reference(RelatedPerson)
Requirements

When answering questions about a subject that is minor, incapable of answering or an animal, another human source may answer the questions.

Comments

If not specified, no inference can be made about who provided the data.

QuestionnaireResponse.item
Definition

A group or question item from the original questionnaire for which answers are provided.

Control0..*
TypeBackboneElement
Must Supporttrue
Comments

Groups cannot have answers and therefore must nest directly within item. When dealing with questions, nesting must occur within each answer because some questions may have multiple answers (and the nesting occurs for each answer).

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
qrs-1: Nested item can't be beneath both item and answer (: (answer.exists() and item.exists()).not())
QuestionnaireResponse.item.id
Definition

unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
QuestionnaireResponse.item.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, 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.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

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.

QuestionnaireResponse.item.modifierExtension
Definition

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 that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, 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.

Control0..*
TypeExtension
Is Modifiertrue
Alternate Namesextensions, user content, modifiers
Comments

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.

QuestionnaireResponse.item.linkId
Definition

The item from the Questionnaire that corresponds to this item in the QuestionnaireResponse resource.

Control1..1
Typestring
Must Supporttrue
Requirements

Items can repeat in the answers, so a direct 1..1 correspondence by position may not exist - requiring correspondence by identifier.

QuestionnaireResponse.item.definition
Definition

A reference to an ElementDefinition that provides the details for the item.

Control0..1
Typeuri
Requirements

A common pattern is to define a set of data elements, and then build multiple different questionnaires for different circumstances to gather the data. This element provides traceability to the common definition.

Comments

The ElementDefinition must be in a StructureDefinition or a DataElement, and must have a fragment identifier that identifies the specific data element by its id (Element.id). E.g. http://hl7.org/fhir/StructureDefinition/Observation#Observation.value[x].

There is no need for this element if the item pointed to by the linkId has a definition listed.

QuestionnaireResponse.item.text
Definition

Text that is displayed above the contents of the group or as the text of the question being answered.

Control0..1
Typestring
Must Supporttrue
Requirements

Allows the questionnaire response to be read without access to the questionnaire.

QuestionnaireResponse.item.subject
Definition

Identifies the patient this particular group or question is describing if different from the patient for the overall response.

Control0..1
TypeReference(Patient)
Requirements

Non-patient questionnaires are outside the scope of the SDC-project.

QuestionnaireResponse.item.answer
Definition

The respondent's answer(s) to the question.

Control0..*
TypeBackboneElement
Must Supporttrue
Comments

The value is nested because we cannot have a repeating structure that has variable type.

InvariantsDefined on this element
ele-1: All FHIR elements must have a @value or children (: hasValue() | (children().count() > id.count()))
QuestionnaireResponse.item.answer.id
Definition

unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
QuestionnaireResponse.item.answer.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, 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.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

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.

QuestionnaireResponse.item.answer.modifierExtension
Definition

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 that contains it. Usually modifier elements provide negation or qualification. In order to make the use of extensions safe and manageable, 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.

Control0..*
TypeExtension
Is Modifiertrue
Alternate Namesextensions, user content, modifiers
Comments

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.

QuestionnaireResponse.item.answer.value[x]
Definition

The answer (or one of the answers) provided by the respondent to the question.

Control0..1
BindingCode indicating the response provided for a question.
For example codes, see Questionnaire Answer Codes
TypeChoice of: boolean, date, dateTime, time, decimal, integer, string, Coding, uri, Quantity, Attachment, Reference
[x] NoteSee Choice of Data Types for further information about how to use [x]
Must Supporttrue
Requirements

Ability to retain a single-valued answer to a question.

Comments

More complex structures (Attachment, Resource and Quantity) will typically be limited to electronic forms that can expose an appropriate user interface to capture the components and enforce the constraints of a complex data type. Additional complex types can be introduced through extensions.

QuestionnaireResponse.item.answer.item
Definition

Nested groups and/or questions found within this particular answer.

Control0..*
TypeSee QuestionnaireResponse:sdcdata.item
Requirements

It is useful to have "sub-questions", questions which normally appear when certain answers are given and which collect additional details.

QuestionnaireResponse.item.item
Definition

Questions or sub-groups nested beneath a question or group.

Control0..*
TypeSee QuestionnaireResponse:sdcdata.item
Must Supporttrue
Requirements

Reports can consist of complex nested groups.