title: Cognitive Interview-Based Validation of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events in Adolescents with Cancer.
abstract: The National Cancer Institute created the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to allow direct input on symptomatic adverse events (AEs) from adult patients in oncology trials.
  
  
  
  This study sought to determine the youngest age to complete the PRO-CTCAE, evaluated comprehension of PRO-CTCAE among adolescents, tested new items not currently in PRO-CTCAE, and tested a parent-proxy version.
  
  
  
  From seven pediatric cancer hospitals, 51 adolescents (13-20 years) receiving cancer treatment participated, along with 40 parent proxies. We evaluated 55 AEs from the PRO-CTCAE library (97 questions) and seven new AEs not in PRO-CTCAE that assess symptom frequency, severity, interference, or presence. Questions were distributed across three forms to reduce burden. Cognitive interviews with retrospective probing were completed in age groups of 13-15 and 16-20 year olds. Proxies were interviewed independently.
  
  
  
  In general, the 16-20 year olds and the parent proxies were able to understand and complete the PRO-CTCAE and newly designed AE questions. Five PRO-CTCAE terms (bloating of the abdomen, anxiety, flashing lights in front of your eyes, hot flashes, and bed sores) and the wording of the questions about AE severity were challenging for a few adolescents and proxies. The 13-15 year olds had greater challenges completing the PRO-CTCAE.
  
  
  
  This study extends use of the adult PRO-CTCAE for adolescents as young as 16 years and proposes new questions for seven new symptomatic AEs and a parent-proxy version of PRO-CTCAE. Additional testing of the new questions and alternative language for more challenging PRO-CTCAE items is recommended in adults.
authors.affiliation: Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina, USA; Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina, USA. Electronic address: bbreeve@email.unc.edu.
authors.forename: Bryce B
authors.initials: BB
authors.lastname: Reeve
authors.affiliation: Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina, USA.
authors.forename: Molly
authors.initials: M
authors.lastname: McFatrich
authors.affiliation: Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina, USA; Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina, USA.
authors.forename: Laura C
authors.initials: LC
authors.lastname: Pinheiro
authors.affiliation: Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, Los Angeles, California, USA.
authors.forename: David R
authors.initials: DR
authors.lastname: Freyer
authors.affiliation: Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina, USA.
authors.forename: Ethan M
authors.initials: EM
authors.lastname: Basch
authors.affiliation: Division of Quality of Life and Palliative Care, Department of Oncology, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.
authors.forename: Justin N
authors.initials: JN
authors.lastname: Baker
authors.affiliation: Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, Georgia, USA.
authors.forename: Janice S
authors.initials: JS
authors.lastname: Withycombe
authors.affiliation: Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Canada; Division of Haematology/Oncology, The Hospital for Sick Children, Toronto, Canada.
authors.forename: Lillian
authors.initials: L
authors.lastname: Sung
authors.affiliation: Dana-Farber Cancer Institute, Boston, Massachusetts, USA.
authors.forename: Jennifer W
authors.initials: JW
authors.lastname: Mack
authors.affiliation: Department of Nursing Research and Quality Outcomes, Children's National Health System, Washington, District of Columbia, USA.
authors.forename: Mia K
authors.initials: MK
authors.lastname: Waldron
authors.affiliation: Department of Oncology, Children's National Health System, Washington, District of Columbia, USA.
authors.forename: Catriona
authors.initials: C
authors.lastname: Mowbray
authors.affiliation: Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, Los Angeles, California, USA.
authors.forename: Diana
authors.initials: D
authors.lastname: Palma
authors.affiliation: Department of Nursing Research and Quality Outcomes, Children's National Health System, Washington, District of Columbia, USA; Department of Pediatrics, George Washington University, Washington, District of Columbia, USA.
authors.forename: Pamela S
authors.initials: PS
authors.lastname: Hinds
mesh_terms: D000293:Adolescent; D000367:Age Factors; D032882:Comprehension; D005260:Female; D006801:Humans; D007407:Interviews as Topic; D008297:Male; D054547:National Cancer Institute (U.S.); D009369:Neoplasms / Q000175:diagnosis* / Q000523:psychology; D010290:Parents; D000071066:Patient Reported Outcome Measures; D019727:Proxy; D012189:Retrospective Studies; D009626:Terminology as Topic; D014481:United States; D055815:Young Adult
keywords: Patient-reported outcomes; adolescents; adverse events (AEs); cancer; cognitive interviews