Validity and reliability of the US National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Journal Article
| 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., 3rd; 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.; for the National Cancer Institute PRO-CTCAE Study Group |
| Article Title: | Validity and reliability of the US National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) |
| Abstract: | 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. |
| Keywords: | adult; treatment outcome; aged; aged, 80 and over; middle aged; young adult; clinical trial; antineoplastic agents; united states; antineoplastic agent; neoplasms; reproducibility; reproducibility of results; quality of life; classification; radiotherapy; validation study; time; time factors; self report; questionnaire; drug surveillance program; adverse drug reaction reporting systems; multicenter study; ambulatory care; radiation injuries; terminology as topic; nomenclature; national cancer institute (u.s.); national health organization; chemoradiotherapy; adverse effects; very elderly; computers, handheld; humans; human; male; female; microcomputer; drug-related side effects and adverse reactions; surveys and questionnaires |
| Journal Title: | JAMA Oncology |
| Volume: | 1 |
| Issue: | 8 |
| ISSN: | 2374-2437 |
| Publisher: | American Medical Association |
| Date Published: | 2015-11-01 |
| Start Page: | 1051 |
| End Page: | 1059 |
| Language: | English |
| DOI: | 10.1001/jamaoncol.2015.2639 |
| PUBMED: | 26270597 |
| PROVIDER: | scopus |
| PMCID: | PMC4857599 |
| DOI/URL: | |
| Notes: | Article -- Export Date: 2 June 2016 -- Source: Scopus |
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