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

EORTC QLQ-C30 Scoring

Overview

The EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30) is a standardized, internationally recognized instrument for assessing health-related quality of life in cancer patients.

Key Properties

• 30 questions in English (primary language) with German translations
• Multidimensional assessment of quality of life across 15 subscales
• Standardized 0-100 point scale after linear transformation
• Validated for oncological patients in various treatment phases
• Modularly extensible through disease-specific add-on modules

Questionnaire Structure

Function Scales (5 Scales)

Rating: Higher values = Better function/quality of life

Symptom Scales (3 Scales)

Rating: Higher values = Greater symptom burden

Single Symptoms (6 Items)

Rating: Higher values = Greater symptom burden

Global Health/Quality of Life (1 Scale)

Rating: Higher values = Better quality of life

Response Scales

Standard 4-Point Scale (Q1-28)

1. "Not at all" / "Uberhaupt nicht"
2. "A little" / "Wenig"
3. "Quite a bit" / "Massig"
4. "Very much" / "Sehr"

7-Point Scale (Q29-30)

1. "Very poor" / "Sehr schlecht"
2. "Poor" / "Schlecht"
3. "Fair" / "Mittelmassig"
4. "Good" / "Gut"
5. "Very good" / "Sehr gut"
6. "Excellent" / "Ausgezeichnet"
7. "Perfect" / "Vollkommen"

Score Calculation

Step 1: Raw Score Calculation

For each scale, the mean of the associated items is calculated:

RawScore = (Sum of item values) / Number of items

Step 2: Linear Transformation (0-100 Scale)

Function Scales (Inversion Required)

Function Score = (1 - (RawScore - 1) / (max - 1)) x 100

For 4-point scale:

Function Score = (1 - (RawScore - 1) / 3) x 100

Symptom Scales and Single Symptoms

Symptom Score = ((RawScore - 1) / (max - 1)) x 100

For 4-point scale:

Symptom Score = ((RawScore - 1) / 3) x 100

Global Quality of Life

QL Score = ((RawScore - 1) / 6) x 100

Score Interpretation

FHIR Implementation

Questionnaire Resource

• URL: https://www.medizininformatik-initiative.de/fhir/ext/modul-pro/Questionnaire/mii-qst-pro-eortc-qlq-c30
• Primary Language: English (language = #en)
• Translations: German translations via CodeSystem designations
• Answer Options: MII CodeSystems with itemWeight properties for scoring

CodeSystem & ValueSets

• CodeSystem: mii-cs-pro-eortc-qlq-c30 – CodeSystem for response spectra in English with German translation
• ValueSets:
  • mii-vs-pro-eortc-qlq-c30-scale-4pt – Standard 4-point scale
  • mii-vs-pro-eortc-qlq-c30-scale-7pt – Global QoL 7-point scale
  • mii-vs-pro-eortc-qlq-c30-scale-role – Role functioning scale

Scoring Implementation

Automatic score calculation via SDC calculatedExpression:

// FHIRPath
// Example: Physical Functioning (Q1-5, inverted)
(1 - (%resource.item.where(linkId.matches('^qlq-c30-q0[1-5]$')).answer.value.weight().sum()/5 - 1) / 3) * 100

// Example: Fatigue (Q10, Q12, Q18, standard)
((%resource.item.where(linkId in ('qlq-c30-q10'|'qlq-c30-q12'|'qlq-c30-q18')).answer.value.weight().sum()/3 - 1) / 3) * 100

ObservationDefinition Resources

A separate ObservationDefinition exists for each subscale:

• Function scales: mii-obsdef-pro-eortc-qlq-c30-pf, mii-obsdef-pro-eortc-qlq-c30-rf, etc.
• Symptom scales: mii-obsdef-pro-eortc-qlq-c30-fa, mii-obsdef-pro-eortc-qlq-c30-nv, etc.
• Single symptoms: mii-obsdef-pro-eortc-qlq-c30-dy, mii-obsdef-pro-eortc-qlq-c30-sl, etc.
• Global QoL: mii-obsdef-pro-eortc-qlq-c30-ql

Missing Data

EORTC Guidelines

• At least 50% of items in a scale must be answered
• Replacement of missing values with the mean of the available items in the scale
• Exclusion of the scale if more than 50% of values are missing

FHIR Implementation

Missing data handling via FHIRPath expressions:

// Check for sufficient responses (example PF scale)
%resource.item.where(linkId.matches('^qlq-c30-q0[1-5]$')).where(answer.exists()).count() >= 3

References

1. Aaronson NK, et al. (1993) The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology J Natl Cancer Inst. 85(5):365-76

2. Fayers PM, et al. (2001) The EORTC QLQ-C30 Scoring Manual (3rd Edition) European Organisation for Research and Treatment of Cancer, Brussels https://www.eortc.org/app/uploads/sites/2/2018/02/SCmanual.pdf

Usage in the MII Context

The EORTC QLQ-C30 serves as a reference instrument within the MII PRO Module for:

• Oncological quality of life measurement in clinical and research settings
• Cross-domain harmonization with other PRO instruments, particularly mapping to PROMIS scales
• Population-based scoring and normative value comparisons
• Modularly extended assessments through disease-specific EORTC modules

This implementation follows the MII terminology strategies and uses MII CodeSystems for score calculations.