Questionnaire Response
Auf Basis einer generierten Einwilligungsvorlage Consent Management Questionnaire Composed kann der Patient mittels Consent Management QuestionnaireResponse seine Einwilligung zu einem Forschungsprojekt geben. Diese wird pseudonymisiert zusammen mit etwaigen Unterschriften und Einwilligungsscans maschinenlesbar gespeichert.
Das patientenbezogen ausgefüllte Formular stellt gleichzeitig die menschenlesbare Repräsentation der Einwilligung dar.
QuestionnaireResponse | I | QuestionnaireResponse | There are no (further) constraints on this element Element IdQuestionnaireResponse A structured set of questions and their answers Alternate namesForm, QuestionnaireAnswers DefinitionA structured set of questions and their answers. The questions are ordered and grouped into coherent subsets, corresponding to the structure of the grouping of the questionnaire being responded to. 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.
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language | S | 0..1 | codeBinding | There are no (further) constraints on this element Element IdQuestionnaireResponse.language Language of the resource content DefinitionThe 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). A human language. CommonLanguages (preferred)Constraints
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identifier | Σ | 0..1 | Identifier | There are no (further) constraints on this element Element IdQuestionnaireResponse.identifier Unique id for this set of answers DefinitionA business identifier assigned to a particular completed (or partially completed) questionnaire. Used for tracking, registration and other business purposes.
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basedOn | Σ I | 0..* | Reference(CarePlan | ServiceRequest) | There are no (further) constraints on this element Element IdQuestionnaireResponse.basedOn Request fulfilled by this QuestionnaireResponse Alternate namesorder DefinitionThe order, proposal or plan that is fulfilled in whole or in part by this QuestionnaireResponse. For example, a ServiceRequest seeking an intake assessment or a decision support recommendation to assess for post-partum depression. Supports traceability of responsibility for the action and allows linkage of an action to the recommendations acted upon. References SHALL be a reference to an actual FHIR resource, and SHALL be resolveable (allowing for access control, temporary unavailability, etc.). Resolution can be either by retrieval from the URL, or, where applicable by resource type, by treating an absolute reference as a canonical URL and looking it up in a local registry/repository. Reference(CarePlan | ServiceRequest) Constraints
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partOf | Σ I | 0..* | Reference(Observation | Procedure) | There are no (further) constraints on this element Element IdQuestionnaireResponse.partOf Part of this action DefinitionA 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. 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. Reference(Observation | Procedure) Constraints
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questionnaire | S Σ | 1..1 | canonical(Questionnaire) | There are no (further) constraints on this element Element IdQuestionnaireResponse.questionnaire Form being answered Alternate namesForm DefinitionThe Questionnaire that defines and organizes the questions for which answers are being provided. Needed to allow editing of the questionnaire response in a manner that enforces the constraints of the original form. If a QuestionnaireResponse references a Questionnaire, then the QuestionnaireResponse structure must be consistent with the Questionnaire (i.e. questions must be organized into the same groups, nested questions must still be nested, etc.).
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status | S Σ ?! | 1..1 | codeBinding | There are no (further) constraints on this element Element IdQuestionnaireResponse.status in-progress | completed | amended | entered-in-error | stopped DefinitionThe position of the questionnaire response within its overall lifecycle. The information on Questionnaire resources may possibly be gathered during multiple sessions and altered after considered being finished. This element is labeled as a modifier because the status contains codes that mark the resource as not currently valid. Lifecycle status of the questionnaire response. QuestionnaireResponseStatus (required)Constraints
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subject | S Σ I | 1..1 | Reference(Consent Management: Patient) | Element IdQuestionnaireResponse.subject Der Patient, für den die Einwilligung gilt Alternate namesPatient, Focus DefinitionThe 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. Allows linking the answers to the individual the answers describe. May also affect access control. If the Questionnaire declared a subjectType, the resource pointed to by this element must be an instance of one of the listed types. Reference(Consent Management: Patient) Constraints
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reference | Σ I | 0..1 | string | There are no (further) constraints on this element Element IdQuestionnaireResponse.subject.reference Literal reference, Relative, internal or absolute URL DefinitionA reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources. Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "/[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.
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type | Σ | 0..1 | uriBinding | There are no (further) constraints on this element Element IdQuestionnaireResponse.subject.type Type the reference refers to (e.g. "Patient") DefinitionThe expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent. The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources). This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a RESTful URL) or by resolving the target of the reference; if both the type and a reference is provided, the reference SHALL resolve to a resource of the same type as that specified. Aa resource (or, for logical models, the URI of the logical model). ResourceType (extensible)Constraints
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identifier | Σ | 0..1 | Identifier | There are no (further) constraints on this element Element IdQuestionnaireResponse.subject.identifier Logical reference, when literal reference is not known DefinitionAn identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference. When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy. When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it. Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).
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display | Σ | 0..1 | string | There are no (further) constraints on this element Element IdQuestionnaireResponse.subject.display Text alternative for the resource DefinitionPlain text narrative that identifies the resource in addition to the resource reference. This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.
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encounter | Σ I | 0..1 | Reference(Encounter) | There are no (further) constraints on this element Element IdQuestionnaireResponse.encounter Encounter created as part of DefinitionThe Encounter during which this questionnaire response was created or to which the creation of this record is tightly associated. Provides context for the information that was captured. May also affect access control. This will typically be the encounter the event occurred within, but some activities may be initiated prior to or after the official completion of an encounter but still be tied to the context of the encounter. A questionnaire that was initiated during an encounter but not fully completed during the encounter would still generally be associated with the encounter.
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authored | S Σ | 0..1 | dateTime | There are no (further) constraints on this element Element IdQuestionnaireResponse.authored Date the answers were gathered Alternate namesDate Created, Date published, Date Issued, Date updated DefinitionThe date and/or time that this set of answers were last changed. Clinicians need to be able to check the date that the information in the questionnaire was collected, to derive the context of the answers. 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 might not know the value, however it SHOULD be populated if possible.
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author | S Σ I | 0..1 | Reference(Practitioner | PractitionerRole | Patient | RelatedPerson) | Element IdQuestionnaireResponse.author Die Person, welche die Einwilligungsangaben erfasst/dokumentiert Alternate namesLaboratory, Service, Practitioner, Department, Company, Performer DefinitionPerson who received the answers to the questions in the QuestionnaireResponse and recorded them in the system. Need to know who interpreted the subject's answers to the questions in the questionnaire, and selected the appropriate options for answers. Füllt der betroffene Patient selbst den Fragebogen aus, so ist dieser hier erneut zu referenzieren (author = subject). Reference(Practitioner | PractitionerRole | Patient | RelatedPerson) Constraints
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source | S Σ I | 0..1 | Reference(Patient | Practitioner | PractitionerRole | RelatedPerson) | Element IdQuestionnaireResponse.source Die Person, von der die Einwilligungsangaben stammen DefinitionThe person who answered the questions about the subject. When answering questions about a subject that is minor, incapable of answering or an animal, another human source may answer the questions. Stammen die Antworten auf die Fragen vom betroffenen Patienten selbst, so ist dieser hier erneut zu referenzieren (source = subject). Reference(Patient | Practitioner | PractitionerRole | RelatedPerson) Constraints
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item | S I | 1..* | BackboneElement | There are no (further) constraints on this element Element IdQuestionnaireResponse.item Groups and questions DefinitionA group or question item from the original questionnaire for which answers are provided. 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).
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linkId | S | 1..1 | string | There are no (further) constraints on this element Element IdQuestionnaireResponse.item.linkId Pointer to specific item from Questionnaire DefinitionThe item from the Questionnaire that corresponds to this item in the QuestionnaireResponse resource. Items can repeat in the answers, so a direct 1..1 correspondence by position might not exist - requiring correspondence by identifier. Note that FHIR strings SHALL NOT exceed 1MB in size
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definition | 0..1 | uri | There are no (further) constraints on this element Element IdQuestionnaireResponse.item.definition ElementDefinition - details for the item DefinitionA reference to an ElementDefinition that provides the details for the item. 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. The ElementDefinition must be in a StructureDefinition, 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.
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text | 0..1 | string | There are no (further) constraints on this element Element IdQuestionnaireResponse.item.text Name for group or question text DefinitionText that is displayed above the contents of the group or as the text of the question being answered. Allows the questionnaire response to be read without access to the questionnaire. Note that FHIR strings SHALL NOT exceed 1MB in size
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answer | S | 0..* | BackboneElement | There are no (further) constraints on this element Element IdQuestionnaireResponse.item.answer The response(s) to the question DefinitionThe respondent's answer(s) to the question. The value is nested because we cannot have a repeating structure that has variable type.
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value[x] | S | 0..1 | There are no (further) constraints on this element Element IdQuestionnaireResponse.item.answer.value[x] Single-valued answer to the question DefinitionThe answer (or one of the answers) provided by the respondent to the question. Ability to retain a single-valued answer to a question. 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. Must match the datatype specified by Questionnaire.item.type in the corresponding Questionnaire. Code indicating the response provided for a question. QuestionnaireAnswerCodes (example)Constraints
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valueBoolean | boolean | There are no (further) constraints on this element Data Type | ||
valueDecimal | decimal | There are no (further) constraints on this element Data Type | ||
valueInteger | integer | There are no (further) constraints on this element Data Type | ||
valueDate | date | There are no (further) constraints on this element Data Type | ||
valueDateTime | dateTime | There are no (further) constraints on this element Data Type | ||
valueTime | time | There are no (further) constraints on this element Data Type | ||
valueString | string | There are no (further) constraints on this element Data Type | ||
valueUri | uri | There are no (further) constraints on this element Data Type | ||
valueAttachment | Attachment | There are no (further) constraints on this element Data Type | ||
valueCoding | Coding | There are no (further) constraints on this element Data Type | ||
valueQuantity | Quantity | There are no (further) constraints on this element Data Type | ||
valueReference | Reference(Resource) | There are no (further) constraints on this element Data Type | ||
item | S | 0..* | see (item) | There are no (further) constraints on this element Element IdQuestionnaireResponse.item.answer.item Nested groups and questions DefinitionNested groups and/or questions found within this particular answer. It is useful to have "sub-questions", questions which normally appear when certain answers are given and which collect additional details.
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item | S | 0..* | see (item) | There are no (further) constraints on this element Element IdQuestionnaireResponse.item.item Nested questionnaire response items DefinitionQuestions or sub-groups nested beneath a question or group. Reports can consist of complex nested groups.
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Beispiel
Erläuterungen
Item | Erläuterung |
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questionnaire | canonical URL des zugrunde liegenden Questionnaires (Profil QuestionnaireComposed) |
status | Finalisierungsstatus, default="completed" |
subject | Patient, für den die Einwilligungserklärung gilt |
authored | Ausfülldatum der Einwilligung |
author | ausfüllende Person (Reference) |
source | Person, von der die Einwilligungsangaben stammen |
item | 1 - n Antworten, entweder als Coding (z.B. gemäß TFCU Konzept) oder als ValueString |
Umsetzung
<QuestionnaireResponse xmlns="http://hl7.org/fhir"> <id value="02eac854-6a2e-48f9-88d7-edd04faff81c" /> <meta> <lastUpdated value="2020-12-11T09:39:07+00:00" /> <profile value="http://fhir.de/ConsentManagement/StructureDefinition/QuestionnaireResponse" /> </meta> <language value="de" /> <!-- canonical URL des zugrunde liegenden Questionnaires (Profil QuestionnaireComposed) --> <questionnaire value="https://beispiel.de/fhir/QuestionnaireComposedBeispiel1" /> <!-- Finalisierungsstatus --> <status value="completed" /> <!-- Patient, für den die Einwilligungserklärung gilt --> <subject> <reference value="Patient/9b4a702d-162c-428a-8c5d-8b98af21b693" /> <display value="Studienpatient Nr. A38" /> </subject> <!-- Ausfülldatum --> <authored value="2020-09-08" /> <!-- ausfüllende Person --> <author> <reference value="RelatedPerson/5645464" /> </author> <!-- Person, von der die Einwilligungsangaben stammen --> <source> <reference value="Patient/9b4a702d-162c-428a-8c5d-8b98af21b693" /> </source> <!-- Antworten --> <item> <linkId value="1" /> <answer> <valueCoding> <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.2" /> <code value="2.16.840.1.113883.3.1937.777.24.5.2.1" /> <display value="gültig" /> </valueCoding> </answer> </item> <item> <linkId value="98" /> <answer> <valueCoding> <system value="urn:oid:2.16.840.1.113883.3.1937.777.24.5.2" /> <code value="2.16.840.1.113883.3.1937.777.24.5.2.1" /> <display value="gültig" /> </valueCoding> </answer> </item> <item> <linkId value="555" /> <answer> <valueString value="Dem habe ich nichts hinzuzufügen." /> </answer> </item> </QuestionnaireResponse>