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Psychometric Evaluation of the PRO-CTCAE Average Composite Score: Reliability, Responsiveness, Known-Groups Validity,
Minji K Lee1, Amylou C Dueck2, Blake T Langlais2
1Department of Quantitative Health Sciences, Mayo Clinic, Rochester, MN 55905, USA.
Cancers
|July 28, 2026
Summary
The PRO-CTCAE Average Composite Score (ACS) reliably measures overall symptom burden in cancer patients. This validated score shows responsiveness to change and distinguishes between patient groups, supporting its use in clinical trials.
Area of Science:
- Oncology
- Patient-Reported Outcomes
- Psychometrics
Background:
- The PRO-CTCAE Average Composite Score (ACS) summarizes overall symptom and side effect burden.
- Validating the ACS is crucial for its reliable application in clinical research.
Purpose of the Study:
- To evaluate the test-retest reliability, responsiveness, known-groups validity, and sensitivity to group differences of the ACS.
- To confirm the ACS's utility as a summary measure for patient-reported outcomes in oncology.
Main Methods:
- Analysis of the PRO-CTCAE validation dataset (lung, breast, head and neck cancer) and the COMET-2 trial data.
- Assessment of test-retest reliability using intraclass correlation coefficients (ICCs).
- Evaluation of responsiveness using standardized response means (SRMs) and Jonckheere-Terpstra trend tests, and known-groups validity by comparing ECOG performance status groups.
Main Results:
- Acceptable test-retest reliability was observed across cancer types (ICCs ranging from 0.77 to 0.84).
- The ACS demonstrated responsiveness to patient-reported changes in symptoms (significant monotonic trends across Global Rating of Change categories).
- Conceptually expected differences in ACS values were found across ECOG performance status and physical functioning levels, supporting known-groups validity.
Conclusions:
- The PRO-CTCAE Average Composite Score (ACS) exhibits acceptable test-retest reliability, responsiveness, and known-groups validity.
- The ACS is a valuable complementary measure for assessing overall symptomatic adverse event burden in cancer patients.
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