uz:V1.0.0-alpha.1 FHIR OBC

This FHIR IG is currently under development and can not be considered stable and ready for use. For questions and change requests regarding this IG, please create a ticket in [ BITS].

1 Introduction

This is the implementation guide (IG) for the pilot of a new information standard, Outcomebased Care (OBC, Dutch: Uitkomstgerichte zorg), version . This initial draft focuses on converting the questionnaires into FHIR and offers a preliminary view of the expected structure for the QuestionnaireResponse profile. This IG is developed using HL7 FHIR R4. It assumes that the reader is familiar with both the functional specification and this version of FHIR.

Apart from this document, the guidelines as specified in the general FHIR Implementation Guide apply. In particular, the reader should take note of the Overarching principles and the use of FHIR packages.

This IG currently describes the boundaries and relationships in place.

2 Boundaries and relationships

2.1 Boundaries

• Huidige versie van deze wiki houdt klinische gegevens nog buiten beschouwing.
• Alleen focus op de structuur van de FHIR Questionnaires en antwoordgegevens.

This initial version of the OBC IG focuses solely on the manifestation of PROM (Patient Reported Outcome Measures) questionnaires and corresponding answers in FHIR, excluding any clinical data. It does not cover use cases related to the exchange of questionnaire and response data. The current IG specifies its scope through the terminology used in the FHIR profile and the naming of the obc-QuestionnaireResponse profile. However, the IG will not provide detailed explanations about this limited scope. Instead, it will focus on describing the technical aspects of the pilot in a broad manner. This approach aims to make it easier to include a wider range of topics in future versions of the IG.

2.2 Building blocks and profiles

• Geen link met zibs en geen nl-core profielen gebruikt
• What is a FHIR Questionnaire
• QR

The questionnaire and response data within the OBC pilot version is not based on any publication of the Dutch Health and Care Information Models (Dutch: ‘zorginformatiebouwstenen’ or ‘zibs’), as there are no zibs that represent the pilot. Therefore, there is no dependency on corresponding nl-core profiles, and mappings to zib concepts are not defined. Currently, there are no plans to replace this pilot with a more general nl-core-OutcomeBasedCare profile in the future, as no corresponding zibs exist.

2.2.1 Questionnaire

Within the scope of the OBC pilot, each PROM questionnaire is represented through a dedicated Questionnaire instance. A FHIR Questionnaire is a definitional artifact, meaning it defines the questions to be asked, how these should be structured and rendered and what answers are allowed. The answer options to each question are represented through terminology resources using ValueSets and CodeSystems. More information on structure and rendering of the FHIR Questionnaire instances can be found in section 2.3.

The primary purpose of representing PROMSs as Questionnaire instances is to establish a canonical identifier for each PROM in the form of a URI. This URI serves as a linkage point connecting QuestionnaireResponses to their corresponding Questionnaires.

The Questionnaire resource isn't strictly necessary to create a QuestionnaireResponse. However, using Questionnaire instances for PROMs provides significant benefits through standardized and structured formatting. Each question is included in the Questionnaire and uniquely identified by the Question Reference linked to the .item.linkId elements. Additionally, the terminology used in PROMs is represented in FHIR ValueSet and CodeSystem resources and is correctly linked to the questions in the Questionnaire, ensuring all definitions are easily accessible for programmers.

Furthermore, the Questionnaire instances offer limited capabilities for rendering in the user interface of the PROMs provider platform. They primarily allow different formatting styles and specify how instructions should be displayed as read-only.

2.2.2 QuestionnaireResponse

The collection of outcomes and scores of PROMs is represented in a FHIR QuestionnaireResponse profile. For every completed PROM, an instance conforming to the obc-QuestionnaireResponse profile is created. This profile features a structured set of answers with linked ids to the answered questions. The QuestionnaireResponse also includes the completion date and the language of the completed form.

The QuestionnaireResponse contains enough information about the questions asked that it can be interpreted somewhat independently from the Questionnaire it is based on. In other words, you don't need access to the Questionnaire to extract basic information from a QuestionnaireResponse.

2.2.3 Main building blocks

• tabel met de profielen -> alleen QR dus in dit geval.
• Link naar de r4 Questionnaire profiel
• At the time of writing no nl-core profiles.

Building block (EN)	Building block (NL)	FHIR resource	FHIR profile
Responsedata	Antwoordgegevens	QuestionnaireResponse	http://nictiz.nl/fhir/StructureDefinition/obc-QuestionnaireResponse

Note the following:

• Each Questionnaire profile is represented by a unique questionnaire and is not included as a building block or subsequent resource. Instead, these questionnaires are added as MISSING instances to the FHIR package.

2.3 Mappings between profiles and data set

• Hoe is QR en dataset gelinked
• FHIR Questionnaire worden in transacties gedefinieerd
• mapping code/id

The QuestionnaireResponse profile is connected to the functional definitions in ART-DECOR. It includes mappings to all data elements within the functional data set (prefixed with ‘obc-dataelement-10-').

Type	Id	Concept	Cardinality	Profile	Mapping
	1405	Antwoordgegevens	0 .. *	obc-QuestionnaireResponse	QuestionnaireResponse
Any??	14??	Vraag	0 .. 1	obc-QuestionnaireResponse	QuestionnaireResponse.item??
Any	1404	Antwoord	0 .. 1	obc-QuestionnaireResponse	QuestionnaireResponse.answer.value[x]
dateTime	1406	InvulDatumTijd	0 .. 1	obc-QuestionnaireResponse	QuestionnaireResponse.authored
reference	1407	Onderwerp	0 .. 1	obc-QuestionnaireResponse	QuestionnaireResponse.subject
reference	1440	IngevuldeVragenlijst	0 .. 1	obc-QuestionnaireResponse	QuestionnaireResponse.questionnaire

2.4 Sensitive questions

Every PROM may include sensitive questions, indicating that the answers might contain sensitive information. As a result, a specific level of authorization is required to read these answers.

The Data Segmentation for Privacy project defined the Inline Security Label extension. This extension enables flagging elements with a security label, for example indicating their sensitivity, and SHALL be added to all relevant .item elements as .item.linkId.extension:sensitivityFlag in both the Questionnaire and QuestionnaireResponse instances. The .valueCoding SHALL be populated with the code PDS from the InformationSensitivityPolicy ValueSet to indicate this data item contains sensitive information reported by the patient.

2.5 Questionnaire instances

Each instance of a FHIR Questionnaire contains the following elements:

Type	Concept	Mapping
uri	Questionnaire Coding system	Questionnaire.Coding.system
code	Questionnaire code	Questionnaire.Coding.code
string	Questionnaire code display	Questionnaire.Coding.display
string	Title of Questionnaire	Questionnaire.title
string	Publisher information	Questionnaire.publisher
string	Version of Questionnaire	Questionnaire.version
code	Language of Questionnaire	Questionnaire.meta.language
coding	Domain code of Questionnaire	Questionnaire.usageContext.code
any	Domain of Questionnaire	Questionnaire.usageContext.value
markdown (string)	License/Author information	Questionnaire.copyright
string	Instructions for a question or group of questions	Questionnaire.item.text
boolean	Read-only instructions for a question or group of questions	Questionnaire.item.readOnly
??coding	Instruction format	Questionnaire.item.extension:renderingStyle??
string	Question	Questionnaire.item.text
code	Value type of question	Questionnaire.item.type
coding	Flag for sensitive questions	Questionnaire.item.linkId.extension:sensitivityFlag
??coding	Question format	Questionnaire.item.extension:renderingStyle??
string	??Score rating for questionnaire??	Questionnaire.item
boolean	Read-only score rating	Questionnaire.item.readOnly
boolean	Hidden score rating	Questionnaire.item.extension:hidden
string	Total score for questionnaire	Questionnaire.item
boolean	Hidden total score	Questionnaire.item.extension:hidden
string	Score calculation rules for questionnaire	Questionnaire.item
boolean	Read-only score calculation rules	Questionnaire.item.readOnly
boolean	Hidden score calculation rules	Questionnaire.item.extension:hidden
string	Interpretation score calculation rules for questionnaire	Questionnaire.item
boolean	Read-only interpretation score calculation rules	Questionnaire.item.readOnly
boolean	Hidden interpretation score calculation rules	Questionnaire.item.extension:hidden

2.5.1 Scores and calculation rules

The Questionnaire definition includes information on how to calculate the total score, the weight for each question, and how to interpret the total score. Currently, this information is provided in .item elements, where the calculation rules are read-only instructions and hidden from users completing the forms through an extension.

In the next version of the Questionnaire definition, the plan is to incorporate dynamic calculation rules using structured data capture, making the Questionnaire more structured and flexible.

2.5.2 Rendering

Rendering styles: items requiring specific formatting can be rendered with different styles, such as bold and italics.