A structured set of questions intended to guide the collection of answers from end-users. Questionnaires provide detailed control over order, presentation, phraseology and grouping to allow coherent, consistent data collection.

To support structured, hierarchical registration of data gathered using digital forms and other questionnaires. Questionnaires provide greater control over presentation and allow capture of data in a domain-independent way (i.e. capturing information that would otherwise require multiple distinct types of resources).

An absolute URI that is used to identify this questionnaire when it is referenced in a specification, model, design or an instance. This SHALL be a URL, SHOULD be globally unique, and SHOULD be an address at which this questionnaire is (or will be) published. The URL SHOULD include the major version of the questionnaire. For more information see Technical and Business Versions.

… This is the id that will be used to link a QuestionnaireResponse to the Questionnaire the response is for.

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.

A formal identifier that is used to identify this questionnaire when it is represented in other formats, or referenced in a specification, model, design or an instance.

Allows externally provided and/or usable business identifiers to be easily associated with the module.

Typically, this is used for identifiers that can go in an HL7 V3 II (instance identifier) data type, e.g., to identify this questionnaire outside of FHIR, where it is not possible to use the logical URI.

The identifier that is used to identify this version of the questionnaire when it is referenced in a specification, model, design or instance. This is an arbitrary value managed by the questionnaire 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.

There may be different questionnaire instances that have the same identifier but different versions. The version can be appended to the url in a reference to allow a refrence to a particular business version of the questionnaire with the format [url]|[version].

A natural language name identifying the questionnaire. This name should be usable as an identifier for the module by machine processing applications such as code generation.

Support human navigation and code generation.

The name is not expected to be globally unique. The name should be a simple alpha-numeric type name to ensure that it is computable friendly.

A short, descriptive, user-friendly title for the questionnaire.

This name does not need to be machine-processing friendly and may contain punctuation, white-space, etc.

The status of this questionnaire. Enables tracking the life-cycle of the content.

Allows filtering of questionnaires that are appropriate for use vs. not.
This is labeled as "Is Modifier" because applications should not use a retired questionnaire without due consideration.

A boolean value to indicate that this questionnaire is authored for testing purposes (or education/evaluation/marketing), and is not intended to be used for genuine usage.

Enables experimental content to be developed following the same lifecycle that would be used for a production-level questionnaire.

Allows filtering of questionnaire that are appropriate for use vs. not. This is labeled as "Is Modifier" because applications should not use an experimental questionnaire in production.

The date (and optionally time) when the questionnaire was published. The date must change if and 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 questionnaire changes.

Note that this is not the same as the resource last-modified-date, since the resource may be a secondary representation of the questionnaire. Additional specific dates may be added as extensions or be found by consulting Provenances associated with past versions of the resource.

The name of the individual or organization that published the questionnaire.

Helps establish the "authority/credibility" of the questionnaire. May also allow for contact.

Usually an organization, but may be an individual. The publisher (or steward) of the questionnaire is the organization or individual primarily responsible for the maintenance and upkeep of the questionnaire. 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 questionnaire. This item SHOULD be populated unless the information is available from context.

A free text natural language description of the questionnaire from a consumer's perspective.

This description can be used to capture details such as why the questionnaire was built, comments about misuse, instructions for clinical use and interpretation, literature references, examples from the paper world, etc. It is not a rendering of the questionnaire as conveyed in the 'text' field of the resource itself. This item SHOULD be populated unless the information is available from context (e.g. the language of the profile is presumed to be the predominant language in the place the profile was created).

Explaination of why this questionnaire is needed and why it has been designed as it has.

This element does not describe the usage of the questionnaire 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 questionnaire.

The date on which the resource content was approved by the publisher. Approval happens once when the content is officially approved for usage.

The 'date' element may be more recent than the approval date because of minor changes / editorial corrections.

The date on which the resource content was last reviewed. Review happens periodically after approval, but doesn't change the original approval date.

Gives a sense of how "current" the content is. Resources that have not been reviewed in a long time may have a risk of being less appropriate/relevant.

If specified, this is usually after the approval date.

The period during which the questionnaire content was or is planned to be in active use.

Allows establishing a transition before a resource comes into effect and also allows for a sunsetting process when new versions of a the questionnaire are or are expected to be used instead.

The effective period for a questionnaire determines when the content is applicable for usage and is independent of publication and review dates. For example, a measure intended to be used for the year 2016 might be published in 2015.

The content was developed with a focus and intent of supporting the contexts that are listed. These terms may be used to assist with indexing and searching for appropriate questionnaire instances.

Assist in searching for appropriate content.

When multiple useContexts are specified, there is no expectation whether all or any of the contexts apply.

A legal or geographic region in which the questionnaire is intended to be used.

It may be possible for the questionnaire to be used in jurisdictions other than those for which it was originally designed or intended.

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.

A copyright statement relating to the questionnaire and/or its contents. Copyright statements are generally legal restrictions on the use and publishing of the questionnaire.

Consumers must be able to determine any legal restrictions on the use of the questionnaire and/or its content.

An identifier for this question or group of questions in a particular terminology such as LOINC.

Allows linking of the complete Questionnaire resources to formal terminologies. It's common for "panels" of questions to be identified by a code.

The types of subjects that can be the subject of responses created for the questionnaire.

If none are specified, then the subject is unlimited.

A particular question, question grouping or display text that is part of the questionnaire.

The content of the questionnaire is constructed from an ordered, hierarchical collection of items.

An identifier that is unique within the Questionnaire allowing linkage to the equivalent item in a QuestionnaireResponse resource.

QuestionnaireResponse does not require omitted items to be included and may have some items that repeat, so linkage based on position alone is not sufficient.

This ''can'' be a meaningful identifier (e.g. a LOINC code) but is not intended to have any meaning. GUIDs or sequential numbers are appropriate here.

A reference to an ElementDefinition that provides the details for the item. If a definition is provided, then the following element values can be inferred from the definition:

• code (ElementDefinition.code)
• type (ElementDefinition.type)
• required (ElementDefinition.min)
• repeats (ElementDefinition.max)
• maxLength (ElementDefinition.maxLength)
• options (ElementDefinition.binding)

Any information provided in these elements on a Questionnaire Item overrides the information from the definition.

A common pattern is to define a set of data elements and then build multiple questionnaires for different circumstances to gather the data. This element provides traceability to the common definition and allows the content for the question to come from the underlying definition.

the URI refers to an ElementDefinition in either a StructureDefinition or a DataElement, and always starts with the canonical URL for the target resource. When referring to a StructureDefinition, a fragment identifier is used to specify the element definition by its id Element.id. E.g. http://hl7.org/fhir/StructureDefinition/Observation#Observation.value[x]. In the absence of a fragment identifier, the first/root element definition in the target is the matching element definition. Note that LOINC codes implicitly define DataElement resources.

A terminology code that corresponds to this group or question (e.g. a code from LOINC, which defines many questions and answers).

Allows linking of groups of questions to formal terminologies.

The value may come from the ElementDefinition referred to by .definition.

A short label for a particular group, question or set of display text within the questionnaire used for reference by the individual completing the questionnaire.

Separating the label from the question text allows improved rendering. Also, instructions will often refer to specific prefixes, so there's a need for the questionnaire design to have control over what labels are used.

These are generally unique within a questionnaire, though this is not guaranteed. Some questionnaires may have multiple questions with the same label with logic to control which gets exposed.

Typically these won't be used for "display" items, though such use is not prohibited.

Systems SHOULD NOT generate their own prefixes if prefixes are defined for any items within a Questionnaire.

The name of a section, the text of a question or text content for a display item.

The type of questionnaire item this is - whether text for display, a grouping of other items or a particular type of data to be captured (string, integer, coded choice, etc.).

Defines the format in which the user is to be prompted for the answer.

Additional constraints on the type of answer can be conveyed by extensions. The value may come from the ElementDefinition referred to by .definition.

A constraint indicating that this item should only be enabled (displayed/allow answers to be captured) when the specified condition is true.

Allows questionnaires to adapt based on answers to other questions. E.g. If physical gender is specified as a male, no need to capture pregnancy history. Also allows conditional display of instructions or groups of questions.

If multiple repetitions of this extension are present, the item should be enabled when the condition for any of the repetitions is true. I.e. treat "enableWhen"s as being joined by an "or" clause.

This element is a modifier because if enableWhen is present for an item, "required" is ignored unless one of the enableWhen conditions is met.

The linkId for the question whose answer (or lack of answer) governs whether this item is enabled.

If multiple question occurrences are present for the same question (same linkId), then this refers to the nearest question occurrence reachable by tracing first the "ancestor" axis and then the "preceding" axis and then the "following" axis.

An indication that this item should be enabled only if the specified question is answered (hasAnswer=true) or not answered (hasAnswer=false).

If answered=false and answer values are also provided, then they are treated as "or". I.e. "Enable if the question is unanswered or the answer is one of the specified values". If answered=true and answers are present, one of the specified answers must be met. (So there's little reason to specify answered=true if answers are present.).

An answer that the referenced question must match in order for the item to be enabled.

Multiple answers are treated as "or". E.g. Enable if question 1 = A, C or E.

Components not specified in the answer do not need to match. For example, if enableWhen specifies code + system for a Coding, it is ok if the answer has a "display" element. I.e. treat the answer as a 'pattern'.

The dataType of this element must be the same as the data type of the question being referenced.

An indication, if true, that the item must be present in a "completed" QuestionnaireResponse. If false, the item may be skipped when answering the questionnaire.

Questionnaire.item.required only has meaning for elements that are conditionally enabled with enableWhen if the condition evaluates to true. If an item that contains other items is marked as required, that does not automatically make the contained elements required (though required groups must contain at least one child element). The value may come from the ElementDefinition referred to by .definition.

An indication, if true, that the item may occur multiple times in the response, collecting multiple answers answers for questions or multiple sets of answers for groups.

Items may be used to create set of (related) questions that can be repeated to give multiple answers to such a set.

If a question is marked as repeats=true, then multiple answers can be provided for the question in the corresponding QuestionnaireResponse. When rendering the questionnaire, it is up to the rendering software whether to render the question text for each answer repetition or to simply list each of the answers beneath the question. (Which is most appropriate visually may depend on the type of answer as well as whether there are nested items.). The value may come from the ElementDefinition referred to by .definition.

An indication, when true, that the value cannot be changed by a human respondent to the Questionnaire.

Allows certain information to be phrased (and rendered) as a question and an answer, while keeping users from changing it. May also be useful for preventing changes to pre-populated portions of a questionnaire, for calculated values, etc.

The value of readOnly elements can be established by asserting extensions for defaultValues, linkages that support pre-population and/or extensions that support calculation based on other answers.

The maximum number of characters that are permitted in the answer to be considered a "valid" QuestionnaireResponse.

For base64binary, reflects the number of characters representing the encoded data, not the number of bytes of the binary data. The value may come from the ElementDefinition referred to by .definition.

A reference to a value set containing a list of codes representing permitted answers for a "choice" or "open-choice" question.

LOINC defines many useful value sets for questionnaire responses. See LOINC Answer Lists. The value may come from the ElementDefinition referred to by .definition.

One of the permitted answers for a "choice" or "open-choice" question.

This element can be used when the value set machinery of options is deemed too cumbersome or when there's a need to capture options that are not codes.

A potential answer that's allowed as the answer to this question.

The data type of the value must agree with the item.type.

The value that should be defaulted when initially rendering the questionnaire for user input.

In some workflows, having defaults saves time.

The user is allowed to change the value and override the default (unless marked as read-only). If the user doesn't change the value, then this initial value will be persisted when the QuestionnaireResponse is initially created. Note that default values can influence results.

The data type of initial[x] must agree with the item.type.

Text, questions and other groups to be nested beneath a question or group.

Reports can consist of complex nested groups.

There is no specified limit to the depth of nesting. However, Questionnaire authors are encouraged to consider the impact on the user and user interface of overly deep nesting.