Das vorliegende CapabilityStatement beschreibt alle verpflichtenden Interaktionen die ein konformes System unterstützen muss, um das Modul PRO der Medizininformatik Initiative zu implementieren.

SearchParameter for ObservationDefinition.code to find score definitions by code (LOINC, SNOMED, MII)

SearchParameter for ObservationDefinition.qualifiedInterval.range.extension[ScoreHealthCorrelation] to filter by health correlation direction (higher scores = better/worse health)

SearchParameter for ObservationDefinition.qualifiedInterval.category to filter by reference range category (reference, critical, absolute)

SearchParameter for ObservationDefinition.permittedDataType to filter score definitions by data type (Quantity, string, etc.)

SearchParameter for ObservationDefinition.preferredReportName to search score definitions by display name

SearchParameter for ObservationDefinition.quantitativeDetails.unit to filter score definitions by measurement unit

SearchParameter for Questionnaire.extension[capabilities] to filter questionnaires by capability flags (displayable, collectable, calculatable, extractable, populatable, domainAligned)

Logisches Modell für die strukturierte Erfassung und Verarbeitung von Patient-Reported Outcomes (PROs) inklusive Fragebögen, Antworten, Scores und Domain-Mappings.

MII QST PRO Beck Depression Inventory II (BDI-II) Questionnaire

Center for Epidemiologic Studies Depression Scale (CES-D) - Metadata-only reference implementation

Depression Anxiety Stress Scales - 21 Items (DASS-21)

EORTC QLQ-C30 Version 3.0 Quality of Life Questionnaire - Complete implementation with all 30 items and 15 scale scores

Edinburgh Postnatal Depression Scale (EPDS) - Metadata-only reference implementation

MII QST PRO EuroQol Five Dimension Five Level (EQ-5D-5L) Questionnaire

MII QST PRO EuroQol Five Dimension Five Level (EQ-5D-5L) Questionnaire

MII QST PRO EuroQol Five Dimension Five Level (EQ-5D-5L) Questionnaire - Displayable version

MII QST PRO EuroQol Five Dimension Five Level (EQ-5D-5L) Questionnaire - Collectable Version

EURONET-SOMA — two core outcome NRS items for somatic symptom intensity and interference (Rief et al. 2017) with German translation

Generalized Anxiety Disorder Scale-7 (GAD-7) — Screening auf generalisierte Angststoerung, mit deutscher Uebersetzung (PHQ-D)

Hospital Anxiety and Depression Scale (HADS) - Metadata-only reference implementation

ISR-Z — Subskala Zwang (3 Items) des ICD-10-Symptom-Rating (Tritt et al. 2008); Skalenwert als Mittelwert, nicht Summe

Kessler Psychological Distress Scale (K6) - Metadata-only reference implementation

MIDOS2 (Minimales Dokumentationssystem für Palliativpatienten, v2) — Symptom-Screening für die Palliativmedizin nach DGP. 11 Symptom-Items mit 4-stufiger DGP-Skala, ein Wohlbefinden-Item, ein offenes Item für sonstige Beschwerden.

PC-PTSD — Primary Care PTSD Screen, four-item screening questionnaire for posttraumatic stress disorder (Prins et al. 2003; German: Schäfer & Schulze 2010)

Patient Health Questionnaire-15 (PHQ-15) — somatic symptom severity (PHQ-D German validated)

Patient Health Questionnaire (PHQ-9)

Onkologisches Basisscreening basierend auf PRO-CTCAE-Items. Erfasst die wichtigsten Symptome onkologischer Patienten mit den 5-stufigen PRO-CTCAE-Skalen (Häufigkeit, Schweregrad, Beeinträchtigung). Symptomauswahl konzeptuell parallel zu MIDOS2 für eine gemeinsame Problem List zwischen Onkologie und Palliativmedizin.

PROMIS Cognitive Function Short Form 4a - Assessment of cognitive abilities and concerns

PROMIS Depression Short Form 4a - Adults - Item Bank v1.0

PROMIS-16 Profile v1.0 - Ultra-short 16-item HRQoL Profile across 8 domains (Edelen et al. 2024, doi:10.1007/s11136-023-03597-6). T-score calculation per Supplement S4 is delegated to a CQL Library (see roadmap 2027).

PROMIS-29 Profile v2.1 - Comprehensive health-related quality of life assessment across 7 domains

PROMIS-29 Profile v2.1 - German language variant derived from English source

PROMIS-29 Profile v2.1 - Minimal variant for data collection without calculated expressions

SCOFF questionnaire — five-item screening tool for eating disorders (Morgan et al. 1999) with German translation

SSD-12 — Somatic Symptom Disorder – B Criteria Scale (Toussaint et al. 2016/2017), 12-item German self-report scale

WHO Disability Assessment Schedule 2.0, 12-item self-administered version (WHODAS-12). English primary with German translations (validated PCOR-MII wording). WHODAS 2.0 © WHO 2010 — see copyright for licensing conditions (a WHO licence is required for electronic/data-capture use).

WI-7 (Whiteley-7) questionnaire — seven-item screening scale for hypochondriasis and somatization (Fink et al. 1999) with German translation

PRO-CTCAE Brustkrebszentrum-Subset: 21 Symptome ausgewählt nach Prävalenz und Wichtigkeit bei ambulanten Brustkrebspatientinnen (Hamacher et al., BMC Cancer 2023). Scoring via CQL Library (CompositeGrade pro Symptom + Average Composite Score).

Generic profile for depression domain T-score observations (all depression questionnaires)

Profile for Beck Depression Inventory II (BDI-II) Total Score Observations

Profile for EQ-5D-5L Index Score Observations with German value set reference ranges

Profile for EQ-5D-5L Profile String Observations (e.g., '11111')

Profile for EQ-5D-5L Visual Analogue Scale Score Observations

Profile for Patient Health Questionnaire-15 (PHQ-15) total somatic symptom severity score Observations (0-30; higher scores indicate greater somatic symptom burden).

Profile for Patient Health Questionnaire-9 (PHQ-9) total score Observations (0-27; higher scores indicate more severe depression).

Profile for WHODAS 2.0 12-item simple sum (disability) score Observations (0-48; higher scores indicate greater disability). No suitable LOINC code exists; SNOMED CT and the MII score catalogue are used.

Profile for PROMIS Cognitive Function Short Form 4a raw score observations (4-20 range)

Profile for PROMIS Cognitive Function Short Form 4a T-Score observations

Profile for PROMIS Depression Short Form 4a raw score observations (4-20 range)

Profile for PROMIS-29 Anxiety T-Score Observations

Profile for PROMIS-29 Depression T-Score Observations

Profile for PROMIS-29 Fatigue T-Score Observations

Profile for PROMIS-29 Pain Intensity single item Observations

Profile for PROMIS-29 Pain Interference T-Score Observations

Profile for PROMIS-29 Physical Function T-Score Observations

Profile for PROMIS-29 Sleep Disturbance T-Score Observations

Profile for PROMIS-29 Ability to Participate in Social Roles and Activities T-Score Observations

MII PR PRO Questionnaire, based on the FHIR Structure Data Capture Specification

MII PR PRO QuestionnaireResponse, based on the FHIR Structure Data Capture Specification

MII PR PRO Questionnaire, based on the FHIR Structure Data Capture Specification

MII PR PRO Score Instance

MII Ex PRO Score Score Health Correlation

MII PR PRO Questionnaire Capabilities, based on the FHIR Structure Data Capture Specification

MII VS PRO BDI-II ValueSet for Beck Depression Inventory II (BDI-II) Questionnaire

MII VS PRO BDI-II ValueSet for Beck Depression Inventory II (BDI-II) Questionnaire

4-point Likert response scale for all DASS-21 items (0 = Did not apply to me at all, 3 = Applied to me very much)

Standard 4-point response scale for EORTC QLQ-C30 items

7-point response scale for EORTC QLQ-C30 global health status and quality of life items

4-point response scale for EORTC QLQ-C30 role functioning items

ISR-Zustimmungsskala (0 = trifft nicht zu, 1 = trifft kaum zu, 2 = trifft ziemlich zu, 3 = trifft deutlich zu, 4 = trifft extrem zu). MII-controlled für zuverlässige ordinal()-Scoreberechnung.

DGP-4-stufige Severity-Skala (keine, leichte, mittlere, starke) — wird für die 11 Symptom-Items des MIDOS2 verwendet.

4-stufige Wohlbefinden-Skala (sehr gut, eher gut, eher schlecht, sehr schlecht) — wird für das Wohlbefinden-Item des MIDOS2 verwendet.

PHQ-15 somatic symptom bother severity answer options (0 = Nicht beeinträchtigt, 1 = Wenig beeinträchtigt, 2 = Stark beeinträchtigt). MII-controlled for reliable ordinal() score calculation.

Patient Health Questionnaire (PHQ-9) Not at all/Several days/More than half the days/Nearly every day

Not difficult at all/Somewhat difficult/Very difficult/Extremely difficult-Perceived difficulty (PHQ-9)

5-point frequency response scale for PRO-CTCAE items (0=Never, 4=Almost constantly)

7-point frequency scale for sexual function items: standard 5 options plus 'Not sexually active' and 'Prefer not to answer'

5-point interference response scale for PRO-CTCAE items (0=Not at all, 4=Very much)

Binary presence/absence response scale for PRO-CTCAE items

4-option presence scale for sexual function: Yes / No / Not sexually active / Prefer not to answer

3-option presence scale: Yes / No / Not applicable

5-point severity response scale for PRO-CTCAE items (0=None, 4=Very severe)

6-point severity scale for radiation items: standard 5 options plus 'Not applicable'

7-point severity scale for sexual function items: standard 5 options plus 'Not sexually active' and 'Prefer not to answer'

PROMIS Frequency response scale based on LOINC LL1016-6

PROMIS Intensity response scale (Not at all / A little bit / Somewhat / Quite a bit / Very much) based on LOINC LL1024-0

PROMIS Physical Function response scale based on LOINC LL1022-4

SSD-12 frequency answer options (0 = nie, 1 = selten, 2 = manchmal, 3 = oft, 4 = sehr oft). MII-controlled for reliable ordinal() score calculation.

5-point response scale for all WHODAS-12 items (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Extreme or cannot do). MII-controlled for reliable ordinal() score calculation; German labels via designations on mii-cs-pro-whodas-12.

EuroQol EQ-5D Value Set

MII CS PRO BDI-II ValueSet for Beck Depression Inventory II (BDI-II) Questionnaire

CodeSystem for the Depression Anxiety Stress Scales - Short Form (DASS-21) with answer codes, item codes, and multilingual support (English primary, German translations from Nilges & Essau 2015)

Response scale for EORTC QLQ-C30 questionnaire items with multilingual support

MII-controlled Zustimmungsskala des ISR (0-4), deutsches Original. itemWeight-Property je Konzept ermöglicht SDC-Ordinalscoring via answerValueSet.

Supplement to LOINC adding the validated German answer wordings (PHQ-D; PROMIS German via PHO/CPCOR; EQ-VAS anchors) as designations on the LOINC answer codes used by this module, plus two full PROMIS item wordings in English. Enables display validation of the instrument-validated wordings; claims no translation authority over LOINC.

CodeSystem for the Minimal Documentation System v2 (MIDOS2) — German palliative care symptom screening instrument. Contains item codes, DGP-4-stufige Severity-Skala, and 4-stufige Wohlbefinden-Skala. German primary language, English translations as designations.

MII-controlled bother severity answer scale for PHQ-15 (0–2). English primary with German designations. itemWeight properties on each concept enable SDC ordinal scoring via answerValueSet.

CodeSystem for the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Contains all 124 items across 78 adverse events with English primary text and German designations from the NCI-authorized translation. Item Library Version 1.0.

MII CS PRO Questionnaire Catalogue for PRO Questionnaires used in the MII PROMs Module

MII-controlled frequency answer scale for SSD-12 (0-4). English display with German designation (original instrument wording). itemWeight properties on each concept enable SDC ordinal scoring via answerValueSet.

MII CS PRO Score Catalogue for PRO Scores used in the MII PROMs Module

CodeSystem for the WHO Disability Assessment Schedule 2.0, 12-item self-administered version (WHODAS-12), with item codes and a 5-point answer scale. English primary displays with German designations. The answer concepts carry itemWeight properties (0-4) enabling SDC ordinal scoring via answerValueSet. WHODAS 2.0 © WHO 2010; electronic use requires a WHO licence (see copyright).

Bildet die übliche GAD-7-Itemnummerierung (Item 1–7, wie publiziert und in Fremdsystemen verbreitet) auf die kanonischen linkIds des PHQ-D-Block-Namespace (phq-phq5a…phq-phq5g) ab. Lesehilfe für die Übernahme von Daten aus Systemen, die die konventionelle Nummerierung verwenden — keine Migration einer veröffentlichten Fassung.

Maps PHQ-9 item linkIds from the pre-2026.5.0 scheme (phq-phq9-q01…q10) to the PHQ-D block namespace (phq-phq2a…i and phq-phq9-difficulty) introduced in 2026.5.0. Apply to existing PHQ-9 QuestionnaireResponses so their item.linkId values match the current Questionnaire. The calculated items phq-phq9-score-total and phq-phq9-promis-tscore were not renamed.

Transaction bundle containing BDI-II CodeSystem, ValueSets, questionnaire, response, and derived observation

DASS-21 Anxiety subscale DASS-42 equivalent score observation (raw 5 * 2 = 10)

DASS-21 Anxiety subscale raw score observation (mild: 5)

DASS-21 Depression subscale DASS-42 equivalent score observation (raw 12 * 2 = 24)

DASS-21 Depression subscale raw score observation (severe: 12)

DASS-21 Stress subscale DASS-42 equivalent score observation (raw 11 * 2 = 22)

DASS-21 Stress subscale raw score observation (moderate: 11)

Physical Functioning Score from EORTC QLQ-C30

Complete transaction bundle containing EORTC QLQ-C30 questionnaire, response with all 30 items, and derived observations with all 15 scale scores

Example of an EQ-5D-5L questionnaire response using the answer-coding variant with MII CodeSystem

GAD-7 Summenwert aus der Beispiel-QuestionnaireResponse: 7 von 21

ISR-Z Skalenwert (Mittelwert) aus der Beispiel-QuestionnaireResponse: 2.0 von 4

MII EXA PRO Beck Depression Inventory II (BDI-II) Questionnaire

Complete DASS-21 QuestionnaireResponse example with mixed severity: Depression severe (12), Anxiety mild (5), Stress moderate (11)

Complete EORTC QLQ-C30 QuestionnaireResponse example with all 30 items and calculated scores

MIDOS2 QuestionnaireResponse Beispiel — Palliativpatient mit moderater Symptomlast (Summe 19/33, Wohlbefinden eher schlecht)

PRO-CTCAE Onkologisches Basisscreening Beispiel — Onkologischer Patient unter Chemotherapie mit moderater Symptomlast

Example bundle containing PROMIS Depression SF 4a QuestionnaireResponse and derived observations

Example raw score observation for PROMIS Depression Short Form 4a

Example QuestionnaireResponse for PROMIS Depression Short Form 4a

Example T-score observation for PROMIS Depression Short Form 4a

Example Bundle demonstrating PROMIS-29 QuestionnaireResponse with all extracted T-Score Observations and Pain Intensity observation. This bundle shows the complete SDC observation-based extraction workflow.

Example QuestionnaireResponse for PROMIS-29 Profile v2.1 (English variant)

Example QuestionnaireResponse for PROMIS-29 Profile v2.1 (German variant) - demonstrates response compatibility between language variants

Example patient for PRO demonstrations

Complete WHODAS-12 QuestionnaireResponse example. All 12 items answered 'Moderate' (ordinal 2); simple sum = 24.

PC-PTSD Total Score aus der Beispiel-QuestionnaireResponse (3 von 4)

Transaction bundle containing PHQ-9 questionnaire, response, and derived observation - flagship example

SCOFF Total Score aus der Beispiel-QuestionnaireResponse (3 von 5)

SSD-12 Total Score aus der Beispiel-QuestionnaireResponse (24 von 48)

WHODAS-12 simple sum score observation (all items 'Moderate': 12 × 2 = 24).

Whiteley-7 Total Score aus der Beispiel-QuestionnaireResponse (3 von 7)

Sum of 7 anxiety items (2, 4, 7, 9, 15, 19, 20), each scored 0-3. Cut-offs: Normal 0-3, Mild 4-5, Moderate 6-7, Severe 8-9, Extremely severe 10+.

DASS-21 anxiety raw score multiplied by 2 for comparability with DASS-42 normative data and published severity cut-offs.

Sum of 7 depression items (3, 5, 10, 13, 16, 17, 21), each scored 0-3. Cut-offs: Normal 0-4, Mild 5-6, Moderate 7-10, Severe 11-13, Extremely severe 14+.

DASS-21 depression raw score multiplied by 2 for comparability with DASS-42 normative data and published severity cut-offs.

Sum of 7 stress items (1, 6, 8, 11, 12, 14, 18), each scored 0-3. Cut-offs: Normal 0-7, Mild 8-9, Moderate 10-12, Severe 13-16, Extremely severe 17+.

DASS-21 stress raw score multiplied by 2 for comparability with DASS-42 normative data and published severity cut-offs.

ObservationDefinition for EORTC QLQ-C30 Appetite Loss Score (AP) - Higher scores indicate more appetite loss

ObservationDefinition for EORTC QLQ-C30 Cognitive Functioning Score (CF) - Higher scores indicate better cognitive functioning

ObservationDefinition for EORTC QLQ-C30 Constipation Score (CO) - Higher scores indicate more constipation

ObservationDefinition for EORTC QLQ-C30 Diarrhoea Score (DI) - Higher scores indicate more diarrhoea

ObservationDefinition for EORTC QLQ-C30 Dyspnoea Score (DY) - Higher scores indicate more dyspnoea

ObservationDefinition for EORTC QLQ-C30 Emotional Functioning Score (EF) - Higher scores indicate better emotional functioning

ObservationDefinition for EORTC QLQ-C30 Fatigue Score (FA) - Higher scores indicate more fatigue

ObservationDefinition for EORTC QLQ-C30 Financial Difficulties Score (FI) - Higher scores indicate more financial difficulties

ObservationDefinition for EORTC QLQ-C30 Global Health Status / Quality of Life Score (QL) - Higher scores indicate better quality of life

ObservationDefinition for EORTC QLQ-C30 Insomnia Score (SL) - Higher scores indicate more sleep disturbance

ObservationDefinition for EORTC QLQ-C30 Nausea and Vomiting Score (NV) - Higher scores indicate more nausea/vomiting

ObservationDefinition for EORTC QLQ-C30 Pain Score (PA) - Higher scores indicate more pain

ObservationDefinition for EORTC QLQ-C30 Physical Functioning Score (PF) - Higher scores indicate better physical functioning

ObservationDefinition for EORTC QLQ-C30 Role Functioning Score (RF) - Higher scores indicate better role functioning

ObservationDefinition for EORTC QLQ-C30 Social Functioning Score (SF) - Higher scores indicate better social functioning

ObservationDefinition for depression domain T-score across all depression questionnaires with European population reference ranges

PROMIS Cognitive Function Short Form 4a Raw Score (4-20 range)

PROMIS Cognitive Function Short Form 4a T-Score

PROMIS Anxiety T-Score from PROMIS-29 Profile v2.1

PROMIS Depression T-Score from PROMIS-29 Profile v2.1

PROMIS Fatigue T-Score from PROMIS-29 Profile v2.1

PROMIS Pain Intensity single item from PROMIS-29 Profile v2.1

PROMIS Pain Interference T-Score from PROMIS-29 Profile v2.1

PROMIS Physical Function T-Score from PROMIS-29 Profile v2.1

PROMIS Sleep Disturbance T-Score from PROMIS-29 Profile v2.1

PROMIS Ability to Participate in Social Roles and Activities T-Score from PROMIS-29 Profile v2.1

Beck Depression Inventory II (BDI-II) Total Score

EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) Index Score

EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) Profile

EuroQol 5 Dimensions 5 Levels (EQ-5D-5L) Visual Analog Scale (VAS) Score

GAD-7 Summenscore (0-21) — Screening auf generalisierte Angststörung

ISR-Z Skalenwert (Mittelwert, Bereich 0-4) — Subskala Zwang des ICD-10-Symptom-Rating

PC-PTSD total score (0-4) — screening for posttraumatic stress disorder

Patient Health Questionnaire-15 (PHQ-15) total somatic symptom severity score (0–30)

Patient Health Questionnaire (PHQ-9)

SCOFF total score (0-5) — screening for eating disorders

SSD-12 total score (0-48) — somatic symptom disorder B-criteria burden

WI-7 (Whiteley-7) total score (0-7) — screening for hypochondriasis and somatization

Average of all PRO-CTCAE composite grades at a given timepoint, reflecting overall symptomatic adverse event burden. Symptoms with opt-out responses are excluded from the average. Range 0.0-3.0 (continuous). ACS = sum(composite grades) / count(scored symptoms).

Composite grade for a single PRO-CTCAE adverse event, computed from frequency, severity, and/or interference scores using the NCI composite grading algorithm (Basch et al., 2021). Range 0-3, mapped to CTCAE grade equivalents. Grade 0 = no symptom, Grade 3 = most severe patient-reported burden. May have dataAbsentReason when patient selected opt-out answers.

Sum of the 12 WHODAS 2.0 item scores (each 0-4), range 0-48. Higher scores indicate greater disability. WHO simple scoring method; complex IRT-based scoring deferred to future work.