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 for Researchers

Guidance for studies and research projects using the PRO module — selecting instruments, getting licensing right, and knowing what the collected data means downstream.

Selecting an instrument

The PRO Library table is the starting point: focus, item count, primary language, scoring and licence pointer for every instrument. Three questions decide the choice:

1. Construct and population — the per-instrument pages document validation sources and known population caveats (e.g. PC-PTSD four-item vs. PC-PTSD-5 are distinct instruments; the ISR-Z is a subscale, not a full ISR).
2. Licensing before first data capture. The tiers differ materially: public-domain (PHQ family, DASS-21, PSS set), registration (EuroQol, EORTC), usage request (PROMIS via CPCOR), WHO agreement for electronic capture (WHODAS), commercial (BDI-II — item texts not displayable from this module). The authoritative statement sits in each Questionnaire's copyright element.
3. Which capability combination the study needs — direct patient capture, server-side scoring of imported data, or read-only display change which capabilities the deployed variant must declare.

What the data means

• A score Observation is traceable by construction: derivedFrom points to the QuestionnaireResponse, instantiates (R5 backport extension) to the ObservationDefinition that documents unit, range and published cut-offs. Severity thresholds are documented there (qualifiedInterval) but deliberately not shipped as executable interpretation — interpretation is the study's or clinician's responsibility (Derived Metrics).
• Item-level data is comparable across instruments where items are shared: the PHQ-D block namespace means a GAD-2 embedded in GAD-7 uses the same linkIds wherever it appears (ID systematics).
• Language: items carry the validated wording of their primary language with translations as extensions; the source of every German wording is named on the instrument page (PHQ-D, CPCOR, PCOR-MII Item Level Dictionary, NCI).
• Score direction is machine-readable via the health-correlation extension — do not assume "higher = worse" (EORTC function scales invert).

Cross-instrument and longitudinal use

Score conversions between instruments (e.g. PHQ-9 → PROMIS depression T-score) are roadmap items modelled as CQL libraries, not shipped questionnaire logic. Change metrics, MID/MCID and reliable change are documented per instrument where published, as text — see the roadmap for the 2027 plans.

Context

The PRO module is developed within the MII; the PSS instrument set follows the PCOR-MII use case, whose Item Level Dictionary is the source of the validated German wordings. For data-sharing requests, use the standard MII research data infrastructure (FDPG) processes; PRO resources travel there like any other KDS module data.