Validity and Reliability of the US National Cancer Institute's Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

Autor:	Dueck AC; Department of Health Sciences Research, Mayo Clinic, Scottsdale, Arizona., Mendoza TR; Department of Symptom Research, University of Texas MD Anderson Cancer Center, Houston., Mitchell SA; Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, Maryland., Reeve BB; Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill., Castro KM; Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, Maryland., Rogak LJ; Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York., Atkinson TM; Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, New York., Bennett AV; Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill., Denicoff AM; Division of Cancer Treatment and Diagnosis, National Cancer Institute, Rockville, Maryland., O'Mara AM; Division of Cancer Prevention, National Cancer Institute, Rockville, Maryland., Li Y; Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, New York., Clauser SB; Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, Maryland., Bryant DM; Department of Clinical Research, Cancer Program of Our Lady of the Lake and Mary Bird Perkins, Baton Rouge, Louisiana., Bearden JD 3rd; Gibbs Cancer Center and Research Institute, Spartanburg, South Carolina., Gillis TA; Helen F. Graham Cancer Center and Research Institute, Christiana Care Health System, Newark, Delaware., Harness JK; Center for Cancer Prevention and Treatment, St. Joseph Hospital of Orange, Orange, California., Siegel RD; Helen and Harry Gray Cancer Center, Hartford Hospital, Hartford, Connecticut., Paul DB; patient advocate and cancer survivor, Brooklyn, New York., Cleeland CS; Department of Symptom Research, University of Texas MD Anderson Cancer Center, Houston., Schrag D; Division of Population Sciences, Dana-Farber Cancer Institute, Boston, Massachusetts., Sloan JA; Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota., Abernethy AP; Department of Medicine, Duke University Medical Center, Durham, North Carolina., Bruner DW; Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, Georgia., Minasian LM; Division of Cancer Treatment and Diagnosis, National Cancer Institute, Rockville, Maryland., Basch E; Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill5Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.
Jazyk:	angličtina
Zdroj:	JAMA oncology [JAMA Oncol] 2015 Nov; Vol. 1 (8), pp. 1051-9.
DOI:	10.1001/jamaoncol.2015.2639
Abstrakt:	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.
Databáze:	MEDLINE
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