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. For a full list of available versions, see the Directory of published versions

Oncology Base Screening

Overview

The Oncology Base Screening is a PRO-CTCAE-based symptom screening instrument for general oncological care. It represents the same symptoms as the palliative-care MIDOS2 but uses the more differentiated PRO-CTCAE response scales.

Key Properties:

  • 23 items from 10 PRO-CTCAE adverse-event concepts
  • Response scales: 5-point PRO-CTCAE scales (frequency / severity / interference)
  • Time frame: past 7 days
  • License: PRO-CTCAE is a product of the US National Cancer Institute (NCI), freely usable
  • Source: PRO-CTCAE Item Library v1.0, NCI-authorised German translation
  • Administration: 5-10 minutes

Delimitation from the Full PRO-CTCAE

The Oncology Base Screening is a curated selection from the PRO-CTCAE item bank (124 items / 78 adverse events). The symptom selection follows the MIDOS2 symptoms and represents the most frequent and clinically most relevant symptoms of oncology patients.

Other PRO-CTCAE derivatives in this IG:

  • PRO-CTCAE Breast-DE — 21 items for breast cancer patients
  • PRO-CTCAE Complete Master (planned, currently available only as a CodeSystem)

Symptom Selection and Item Mapping

# Symptom PRO-CTCAE AE Attributes Items
1 Pain #48 General Pain frq+sev+int 3
2 Fatigue #53 Fatigue sev+int 2
3 Nausea #9 Nausea frq+sev 2
4 Vomiting #10 Vomiting frq+sev 2
5 Decreased appetite #8 Decreased Appetite sev+int 2
6 Constipation #15 Constipation sev 1
7 Shortness of breath #19 Shortness of Breath sev+int 2
8 Discouragement #55 Discouraged frq+sev+int 3
9 Sadness #56 Sad frq+sev+int 3
10 Anxiety #54 Anxiety frq+sev+int 3
  Total 10 AEs   23 items

Response Scales

Frequency (5-point)

Value German English
0 Nie Never
1 Selten Rarely
2 Gelegentlich Occasionally
3 Häufig Frequently
4 Fast immer Almost constantly

Severity (5-point)

Value German English
0 Gar nicht None
1 Ein wenig Mild
2 Mäßig Moderate
3 Ziemlich Severe
4 Sehr Very severe

Interference (5-point)

The same scale as severity (identically worded in the German NCI translation).

Score Calculation

The Oncology Base Screening follows the PRO-CTCAE composite grading algorithm (Basch et al. 2014). Per symptom a composite grade is computed from the available attributes (rank 1-7 depending on the attribute combination). The exact calculation is performed in CQL via the established PRO-CTCAE library (mii-lib-pro-ctcae).

Composite grade Clinical interpretation
0 No symptom
1 Mild symptom
2 Moderate symptom
3 Severe symptom

In addition, an average composite score (ACS) can be computed across all captured symptoms — an aggregate measure of overall burden.

Mapping to MIDOS2

MIDOS2 symptom Mapping into the Oncology Base Screening
Pain #48 General Pain (1:1)
Nausea #9 Nausea (1:1)
Vomiting #10 Vomiting (1:1)
Dyspnoea #19 Shortness of Breath (1:1)
Constipation #15 Constipation (1:1)
Fatigue + weakness #53 Fatigue (PRO-CTCAE bundles them)
Loss of appetite #8 Decreased Appetite (1:1)
Depressed mood #55 Discouraged + #56 Sad (PRO-CTCAE splits it)
Anxiety + tension #54 Anxiety (PRO-CTCAE bundles them)
Overall well-being no PRO-CTCAE equivalent

A ConceptMap at the response level (4-point ↔ 5-point) is planned for a later iteration.

FHIR Implementation

Language strategy: German as the primary language, English as the translation. The item wordings come directly from the NCI-authorised German PRO-CTCAE Item Library v1.0.

Questionnaire

Canonical URL: https://www.medizininformatik-initiative.de/fhir/ext/modul-pro/Questionnaire/mii-qst-pro-pro-ctcae-onkologisches-basisscreening

Implemented capabilities:

  • Displayable, Collectable, Extractable, Domain-aligned
  • Calculatable will be enabled once the CQL library is connected

The complete resource is in the Questionnaire definition.

Reused Resources

The Oncology Base Screening references the existing PRO-CTCAE CodeSystem and the established ValueSets for frequency, severity and interference.

Literature

  1. Basch E, Reeve BB, Mitchell SA, et al. (2014) Development of the National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Journal of the National Cancer Institute. 106(9):dju244 (DOI 10.1093/jnci/dju244)

  2. National Cancer Institute (2025) PRO-CTCAE Item Library v1.0 — German translation healthcaredelivery.cancer.gov/pro-ctcae

  3. Hamacher S, Hellmich M, Lorenz C, et al. (2023) Developing tumor-specific PRO-CTCAE item sets — methodological approach and example for breast cancer patients in Germany BMC Cancer. 23:638 (DOI 10.1186/s12885-023-11115-7)

Status: this implementation is marked draft and experimental. A derivedFrom relationship to a complete PRO-CTCAE master questionnaire is planned.