Validity and Reliability of the US National Cancer Institute’s Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Open accessAbstract
IMPORTANCE: To integrate the patient perspective into adverse event reporting, the National Cancer Institute developed a patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). OBJECTIVE: To assess the construct validity, test-retest reliability, and responsiveness of PRO-CTCAE items. DESIGN, SETTING, AND PARTICIPANTS: A total of 975 adults with cancer undergoing outpatient chemotherapy and/or radiation therapy enrolled in this questionnaire-based study between January 2011 and February 2012. Eligible participants could read English and had no clinically significant cognitive impairment. They completed PRO-CTCAE items on tablet computers in clinic waiting rooms at 9 US cancer centers and community oncology practices at 2 visits 1 to 6 weeks apart. A subset completed PRO-CTCAE items during an additional visit 1 business day after the first visit. MAIN OUTCOMES AND MEASURES: Primary comparators were clinician-reported Eastern Cooperative Oncology Group Performance Status (ECOG PS) and the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (QLQ-C30). RESULTS: A total of 940 of 975 (96.4%) and 852 of 940 (90.6%) participants completed PRO-CTCAE items at visits 1 and 2, respectively. At least 1 symptom was reported by 938 of 940 (99.8%) participants. Participants' median age was 59 years; 57.3% were female, 32.4% had a high school education or less, and 17.1% had an ECOG PS of 2 to 4. All PRO-CTCAE items had at least 1 correlation in the expected direction with a QLQ-C30 scale (111 of 124, P<.05 for all). Stronger correlations were seen between PRO-CTCAE items and conceptually related QLQ-C30 domains. Scores for 94 of 124 PRO-CTCAE items were higher in the ECOG PS 2 to 4 vs 0 to 1 group (58 of 124, P<.05 for all). Overall, 119 of 124 items met at least 1 construct validity criterion. Test-retest reliability was 0.7 or greater for 36 of 49 prespecified items (median [range] intraclass correlation coefficient, 0.76 [0.53-.96]). Correlations between PRO-CTCAE item changes and corresponding QLQ-C30 scale changes were statistically significant for 27 prespecified items (median [range] r=0.43 [0.10-.56]; all P≤.006). CONCLUSIONS AND RELEVANCE: Evidence demonstrates favorable validity, reliability, and responsiveness of PRO-CTCAE in a large, heterogeneous US sample of patients undergoing cancer treatment. Studies evaluating other measurement properties of PRO-CTCAE are under way to inform further development of PRO-CTCAE and its inclusion in cancer trials.
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eRAPID and PRO-CTCAE have demonstrated efficacy in longitudinal symptom tracking and research contexts.
“While eRAPID [7] and PRO-CTCAE [14] have demonstrated efficacy in longitudinal symptom tracking and research contexts”
From Implementing UK Oncology Nursing Society–Informed Digital Symptom Triage With Episode-Based Review in Routine NHS Acute Oncology: Service Evaluation (2026) · cites this paper as [14]
The Methods (Study Visits; page not provided) describe PRO-CTCAE assessments at two visits 1–6 weeks apart, and the Results report that item scores responded to changes in symptoms. The Discussion supports its use for reporting patient-reported adverse events in cancer trials. This validates measurement over two visits in a research setting, but does not establish broader efficacy for longitudinal symptom tracking. (LLM, conf=0.82)
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- Authors
- Dueck, A. C., Mendoza, T. R., Mitchell, S. A., Reeve, B. B., Castro, K. M., Rogak, L. J., Atkinson, T. M., Bennett, A. V., Denicoff, A. M., O'Mara, A. M., Li, Y., Clauser, S. B., Bryant, D. M., Bearden, J. D., Gillis, T. A., Harness, J. K., Siegel, R. D., Paul, D. B., Cleeland, C. S., Schrag, D., Sloan, J. A., Abernethy, A. P., Bruner, D. W., Minasian, L. M., & Basch, E.
- Affiliations
- Mayo Clinic (US)
- The University of Texas MD Anderson Cancer Center (US)
- National Cancer Institute (US)
- University of North Carolina at Chapel Hill (US)
- Memorial Sloan Kettering Cancer Center (US)
- Division of Cancer Prevention, National Cancer Institute, Rockville, Maryland
- Mary Bird Perkins Cancer Center (US)
- Gibbs Cancer Center and Research Institute, Spartanburg, South Carolina
- Christiana Care Health System (US)
- St. Joseph Hospital (US)
- Hartford Hospital (US)
- patient advocate and cancer survivor, Brooklyn, New York
- Dana-Farber Cancer Institute (US)
- Duke Medical Center (US)
- Emory University (US)
- Corresponding author
- Dueck, Amylou C.
- ORCID
- Dueck, Amylou C.
- Mendoza, Tito R.
- Mitchell, Sandra A.
- Reeve, Bryce B.
- Castro, Kathleen M.
- Rogak, Lauren J.
- Atkinson, Thomas M.
- Bennett, Antonia V.
- Denicoff, Andrea M.
- Li, Yuelin
- Bearden, James D.
- Gillis, Theresa A.
- Siegel, Robert D.
- Cleeland, Charles S.
- Schrag, Deborah
- Sloan, Jeff A.
- Abernethy, Amy P.
- Bruner, Deborah W.
- Minasian, Lori M.
- Basch, Ethan
- Venue
- JAMA Oncology
- Publisher
- American Medical Association (AMA)
- Published
- 2015-11-01
- Volume
- 1
- Issue
- 8
- Pages
- 1051
- ISSN
- 2374-2437 (ISSN-L)
- PMC
- PMC4857599
- OpenAlex
- W1842042263
- Cited by
- 1,030
- References
- 30
- Citations by year
- 2026: 83 · 2025: 86 · 2024: 88 · 2023: 89 · 2022: 91 · 2021: 101 · 2020: 126 · 2019: 65 · 2018: 79 · 2017: 87 · 2016: 78 · 2015: 49 · 2014: 7 · 2013: 1
- FWCI
- 42.65
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- JAMA Oncology (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institutes of Health (HHSN261200800001C)
- National Cancer Institute (HHSN261200800043C, UG1CA189823, HHSN261200800001E), HHS-N261201000063C, P30CA008748, P30CA015083)
- Topics
- Health Sciences › Medicine › Oncology › Cancer survivorship and care
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Cancer-related cognitive impairment studies
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Toxicology › Pharmacovigilance and Adverse Drug Reactions
- Keywords
- PRO-CTCAE, patient-reported outcomes, adverse event reporting, cancer chemotherapy, radiotherapy, construct validity, test-retest reliability, responsiveness, ECOG performance status, EORTC QLQ-C30, quality of life, symptom assessment, patient perspectives, fatigue, nausea and vomiting, sleep disorders
- MeSH terms
- Adult, Aged, Aged, 80 and over, Ambulatory Care, Antineoplastic Agents, Female, Humans, Male, Middle Aged, Neoplasms, Terminology as Topic, Quality of Life, Surveys and Questionnaires, Radiation Injuries, Radiotherapy, Time Factors, United States, Reproducibility of Results, Treatment Outcome, Adverse Drug Reaction Reporting Systems, Computers, Handheld, National Cancer Institute (U.S.), Young Adult, Self Report, Chemoradiotherapy, Drug-Related Side Effects and Adverse Reactions
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