This page is part of the FHIR Specification v6.0.0-ballot1: Release 6 Ballot (1st Draft) (see Ballot Notes). The current version is 5.0.0. For a full list of available versions, see the Directory of published versions

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2.6 Resource QuestionnaireResponse - Content

FHIR Infrastructure Work Group

Maturity Level: 5

Trial Use

Security Category: Patient

Compartments: Device, Encounter, Patient, Practitioner, RelatedPerson

A 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.

2.6.3 References to this Resource

• Implements: Event
• Resource References: AdverseEvent, Consent, Contract, DeviceUsage, FamilyMemberHistory and Observation

2.6.4 Resource Content

 

Additional definitions: Master Definition XML + JSON, XML Schema/Schematron + JSON Schema, ShEx (for Turtle) + see the extensions, the spreadsheet version & the dependency analysis

2.6.4.1 Terminology Bindings

Path	ValueSet	Type	Documentation
QuestionnaireResponse.status	QuestionnaireResponseStatus	Required	Lifecycle status of the questionnaire response.
QuestionnaireResponse.item.answer.value[x]	QuestionnaireAnswerCodes (a valid code from SNOMED CT )	Example	Example list of codes for answers to questions. (Not complete or necessarily appropriate.)

2.6.4.2 Constraints

2.6.5 Notes

• QuestionnaireResponses can be authored by clinicians, patients, or patients' relatives (or even owners in the case of animals). Clinicians may author questionnaire responses, where the answers are provided by others on behalf of the patient. Additionally, information gathered on behalf of a patient may be about the patient's relatives (e.g. in family anamnesis). Therefore, QuestionnaireResponse makes a distinction between the author, the subject and the source of information.
• The QuestionnaireResponse's encounter element can be used to link to the encounter when the questionnaire response was authored. This can be relevant since the encounter gives context to the answers and can be used to relate information in the QuestionnaireResponse to orders and observations that were done during the same Encounter.
• The QuestionnaireResponse's language element can be used to indicate the language in which the patient completed the survey/questionnaire
• The order of questions within groups, groups within groups and groups within questions is relevant and must be retained for display and capture. The hierarchy of the items within the QuestionnaireResponse SHALL mirror the hierarchy of the items in the corresponding Questionnaire (if any).
• For use of QuestionnaireResponse.item.definition, see notes on Questionnaire
• Because of the lack of explicit support for Questionnaires in HL7 v3 , CDA Documents frequently used named sections with Observations to model questionnaires. Such use cases should now utilize the QuestionnaireResponse resource instead.

Refer to additional guidance provided in the Questionnaire resource dealing with the design of questionnaires.

2.6.5.1 Links to Questionnaire

A QuestionnaireResponse may be stand-alone or may point to the definition of the questions in Questionnaire. If the QuestionnaireResponse refers to a Questionnaire:

• 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.
• The linkage between the questions and groups in the two resources is established using the linkId element
• LinkIds are unique across all items in a Questionnaire, but can sometimes appear multiple times within a QuestionnaireResponse if the corresponding item (or one of its ancestors) is allowed to repeat.
• When a QuestionnaireResponse references a Questionnaire, all the items in the questionnaire SHOULD be included in the QuestionnaireResponse if they are relevant to the interpretation of the answers, including items of type = display. When the QuestionnaireResponse is not yet marked as 'completed', this might also include items that are not enabled based on what answers are currently present. However, once a QuestionnaireResponse is marked as "completed", the QuestionnaireResponse SHALL only include items that are 'enabled'. I.e. stuff that was perhaps answered through populate or user-action but subsequently got disabled due to other answers must not be included in a final QuestionnaireResponse.

The diagram above shows a Questionnaire with a hierarchy of group and question items, some marked as 'repeats'=true, and others false and with similar variation in 'required'=true and false. It also shows a hypothetical QuestionnaireResponse that is valid against that questionnaire with appropriate nesting of items and answers and linkIds showing the alignment between the Questionnaire and QuestionnaireResponse items.

2.6.5.2 Validating QuestionnaireResponses

Rules imposed by a Questionnaire about expectations for answers are not expected to be met until a Questionnaire is deemed to be 'completed' (or 'amended'). For example, items that are marked as 'required' may be omitted, minimum numbers of answers might not be met, length requirement for answers, co-occurrence constraints, etc. might all be violated when the QuestionnaireResponse is still in the process of being completed. QuestionnaireResponses may be stored in this 'incomplete' state. Such QuestionnaireResponses might also include data for disabled questions, entries and text for non-answered questions, etc. However, once a QuestionnaireResponse is marked as 'completed' (including if it is subsequently changed to 'amended'), all requirements of the associated Questionnaire must be met, all non-answered question items must be removed, all non-enabled items must be removed, etc. (Display items MAY be retained. Certain extensions on the Questionnaire item may mandate that a display item needed for a human reviewer to interpret the QuestionnaireResponse be retained in a completed QuestionnaireResponse.)

2.6.5.3 Nested Items

QuestioinnaireResponse has two different mechanisms to support nesting of items - item.item and item.answer.item. The former is used when nesting items within a 'group' and the latter is always used when nesting items within a question. This is because items nested within a question always nest within each answer to the question. If the question allows multiple answers, each will have its own set of nested items.

2.6.5.4 Security

QuestionnaireResponse resources can have answers with values of type Attachment. These attachments will typically be selected by the user answering the questionnaire and this selection may be done in an uncontrolled environment. Systems should ensure that the attachment is of the desired type and should take precautions before rendering or executing any attached content.

2.6.5.5 Access Control

For most resources, the type of information that can be conveyed in the resource is determined by the resource, and the key attributes that determine the sensitivity level of the information are also known; e.g., drug, observation type, clinical trial randomization status, etc. However, for QuestionnaireResponse, the sensitivity of an instance is dependent on what type of Questionnaire it is associated with. And the data elements that determine that sensitivity could be the answers to any of the questions. This makes automatically enforcing access control rules more challenging. Designers should take these challenges into account and may need to place stricter access controls around QuestionnaireResponse to ensure that access to information is not granted improperly.

2.6.5.6 Profiling QuestionnaireResponses

It is possible to profile QuestionnaireResponse in the same way as any other resource. However, such profiling should not be used to constrain QuestionnaireResponse to only be able to capture the answers associated with a single type of form - that is what the Questionnaire resource is for. Profiling QuestionnaireResponse is appropriate when there's a need to enforce that certain metadata is always present, to indicate limitations on what types of answers can be handled, etc. - independent of what Questionnaire is being completed.

2.6.6 Search Parameters

Search parameters for this resource. See also the full list of search parameters for this resource, and check the Extensions registry for search parameters on extensions related to this resource. The common parameters also apply. See Searching for more information about searching in REST, messaging, and services.

Name	Type	Description	Expression	In Common
author	reference	The author of the questionnaire response	QuestionnaireResponse.author (Practitioner, Organization, Device, Patient, PractitionerRole, RelatedPerson)
authored	date	When the questionnaire response was last changed	QuestionnaireResponse.authored
based-on	reference	Plan/proposal/order fulfilled by this questionnaire response	QuestionnaireResponse.basedOn (CarePlan, ServiceRequest)
encounter	reference	Encounter associated with the questionnaire response	QuestionnaireResponse.encounter (Encounter)	29 Resources
identifier	token	The unique identifier for the questionnaire response	QuestionnaireResponse.identifier	65 Resources
item-subject	reference	Allows searching for QuestionnaireResponses by item value where the item has isSubject=true	QuestionnaireResponse.item.where(extension('http://hl7.org/fhir/StructureDefinition/questionnaireresponse-isSubject').exists()).answer.value.ofType(Reference)
part-of	reference	Procedure or observation this questionnaire response was performed as a part of	QuestionnaireResponse.partOf (Observation, Procedure)
patient	reference	The patient that is the subject of the questionnaire response	QuestionnaireResponse.subject.where(resolve() is Patient) (Patient)	66 Resources
questionnaire	reference	The questionnaire the answers are provided for	QuestionnaireResponse.questionnaire (Questionnaire)
source	reference	The individual providing the information reflected in the questionnaire respose	QuestionnaireResponse.source (Practitioner, Organization, Device, Patient, PractitionerRole, RelatedPerson)
status	token	The status of the questionnaire response	QuestionnaireResponse.status
subject	reference	The subject of the questionnaire response	QuestionnaireResponse.subject (Any)