Validity and Reliability of the US National Cancer Institute’s Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Amylou C. Dueck,Tito R. Mendoza,Sandra A. Mitchell,Bryce B. Reeve,Kathleen Castro,Lauren J. Rogak,Thomas M. Atkinson,Antonia V. Bennett,Andrea Denicoff,Ann M. O'Mara,Yuelin Li,Steven B. Clauser,Donna M. Bryant,James D. Bearden,Theresa A. Gillis,Jay K. Harness,Robert D. Siegel,Diane Paul,Charles S. Cleeland,Deborah Schrag,Jeff A. Sloan,Amy P. Abernethy,Deborah Watkins Bruner,Lori M. Minasian,Ethan Basch,Ethan Basch +25 more
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Evidence demonstrates favorable validity, reliability, and responsiveness in a large, heterogeneous US sample of patients undergoing cancer treatment in a 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 P 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.read more
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The association between clinician-based common terminology criteria for adverse events (CTCAE) and patient-reported outcomes (PRO): a systematic review
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TL;DR: Overall, the quantified association between CTCAE and PRO ratings fell in the fair to moderate range and had a large variation across the majority of studies, which is an important next step to explore approaches to integrate PROs with clinician reporting of AEs.
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The Japanese version of the National Cancer Institute’s patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE): psychometric validation and discordance between clinician and patient assessments of adverse events
Takashi Kawaguchi,Kanako Azuma,Motohiko Sano,Soan Kim,Yosuke Kawahara,Yoko Sano,Tomohide Shimodaira,Keiichiro Ishibashi,Tempei Miyaji,Ethan Basch,Takuhiro Yamaguchi +10 more
TL;DR: There is underestimation in the assessment of adverse events in Japan, and that the Japanese version of the PRO-CTCAE had acceptable reliability and validity for common and clinically important symptoms.
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Paul G. Kluetz,Ashley F. Slagle,Elektra J. Papadopoulos,Laura Lee Johnson,Martha Donoghue,Virginia E. Kwitkowski,Wen-Hung Chen,Rajeshwari Sridhara,Ann T. Farrell,Patricia Keegan,Geoffrey Kim,Richard Pazdur +11 more
TL;DR: This article proposes focusing on three separate measures of well-defined concepts: symptomatic adverse events, physical function, and disease-related symptoms, which are key contributors to the effect of a therapy on HRQOL.
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