MII IG PRO
2027.0.0-ballot.1 - Germany

This page is part of the MII Implementation Guide PRO (v2027.0.0-ballot.1: 2027 Ballot 5) based on FHIR (HL7® FHIR® Standard) R4. This is the current published version in its permanent home (it will always be available at this URL). For a full list of available versions, see the Directory of published versions

Guidance

This section collects the domain guidance for implementing and using the PRO module.

General Implementation Guidance

  • Datasets and Descriptions — the module's data elements, described as logical models. (This entry shares its target with Artifacts → Logical Models; neither Artifacts-Summary anchor is usable as a link target — see docs/page-structure.md in this repository.)
  • UML Diagrams — visual representation of the data models and their relationships.

Audience-Specific Guidance

The PRO module standardises patient-reported outcomes: instruments the patients answer themselves. Its delimitations: clinician-reported and observer-rated instruments are out of scope; oncology-specific instruments beyond the PRO-CTCAE base screening belong to the dedicated MII Oncology module; score interpretation (cut-offs, MID/MCID, decision support) arrives with the CQL roadmap. Which use case a questionnaire serves is governed by its capability combination — see Questionnaire-Capabilities.

For the KDS-wide conformance requirements see the Conformance rules of the Meta module; for the technical artifacts see Profiles.

For Adopters

Software vendors — form renderers, KIS integrations, ePRO apps, scoring services: start with the Implementer Guidance; it names the five rules every implementation must respect and what each system role consumes and produces.

Studies and research projects — instrument selection, licensing tiers, and what the collected data means: start with the Researcher Guidance.

Module Documentation