title: Eliciting the child's voice in adverse event reporting in oncology trials: Cognitive interview findings from the Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events initiative.
abstract: Adverse event (AE) reporting in oncology trials is required, but current practice does not directly integrate the child's voice. The Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is being developed to assess symptomatic AEs via child/adolescent self-report or proxy-report. This qualitative study evaluates the child's/adolescent's understanding and ability to provide valid responses to the PRO-CTCAE to inform questionnaire refinements and confirm content validity.
  
  
  
  From seven pediatric research hospitals, children/adolescents ages 7-15 years who were diagnosed with cancer and receiving treatment were eligible, along with their parent-proxies. The Pediatric PRO-CTCAE includes 130 questions that assess 62 symptomatic AEs capturing symptom frequency, severity, interference, or presence. Cognitive interviews with retrospective probing were completed with children in the age groups of 7-8, 9-12, and 13-15 years. The children/adolescents and proxies were interviewed independently.
  
  
  
  Two rounds of interviews involved 81 children and adolescents and 74 parent-proxies. Fifteen of the 62 AE terms were revised after Round 1, including refinements to the questions assessing symptom severity. Most participants rated the PRO-CTCAE AE items as "very easy" or "somewhat easy" and were able to read, understand, and provide valid responses to questions. A few AE items assessing rare events were challenging to understand.
  
  
  
  The Pediatric and Proxy PRO-CTCAE performed well among children and adolescents and their proxies, supporting its content validity. Data from PRO-CTCAE may improve symptomatic AE reporting in clinical trials and enhance the quality of care that children receive.
authors.affiliation: Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina.|Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina.
authors.forename: Bryce B
authors.initials: BB
authors.lastname: Reeve
authors.affiliation: Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina.
authors.forename: Molly
authors.initials: M
authors.lastname: McFatrich
authors.affiliation: Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina.|Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, North Carolina.
authors.forename: Laura C
authors.initials: LC
authors.lastname: Pinheiro
authors.affiliation: Division of Quality of Life and Palliative Care, Department of Oncology, St. Jude Children's Research Hospital, Memphis, Tennessee.
authors.forename: Meaghann S
authors.initials: MS
authors.lastname: Weaver
authors.affiliation: Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Canada.|Division of Haematology/Oncology, Hospital for Sick Children, Toronto, Canada.
authors.forename: Lillian
authors.initials: L
authors.lastname: Sung
authors.affiliation: Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, Georgia.
authors.forename: Janice S
authors.initials: JS
authors.lastname: Withycombe
authors.affiliation: Division of Quality of Life and Palliative Care, Department of Oncology, St. Jude Children's Research Hospital, Memphis, Tennessee.
authors.forename: Justin N
authors.initials: JN
authors.lastname: Baker
authors.affiliation: Dana-Farber Cancer Institute, Boston, Massachussetts.
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.
authors.forename: Mia K
authors.initials: MK
authors.lastname: Waldron
authors.affiliation: Division of Quality of Life and Palliative Care, Department of Oncology, St. Jude Children's Research Hospital, Memphis, Tennessee.
authors.forename: Deborah
authors.initials: D
authors.lastname: Gibson
authors.affiliation: Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Canada.
authors.forename: Deborah
authors.initials: D
authors.lastname: Tomlinson
authors.affiliation: Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, Los Angeles, California.
authors.forename: David R
authors.initials: DR
authors.lastname: Freyer
authors.affiliation: Department of Oncology, Children's National Health System, Washington, District of Columbia.
authors.forename: Catriona
authors.initials: C
authors.lastname: Mowbray
authors.affiliation: Department of Oncology, Children's National Health System, Washington, District of Columbia.
authors.forename: Shana
authors.initials: S
authors.lastname: Jacobs
authors.affiliation: Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, Los Angeles, California.
authors.forename: Diana
authors.initials: D
authors.lastname: Palma
authors.affiliation: Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina.
authors.forename: Christa E
authors.initials: CE
authors.lastname: Martens
authors.affiliation: Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina.
authors.forename: Stuart H
authors.initials: SH
authors.lastname: Gold
authors.affiliation: Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, North Carolina.
authors.forename: Kathryn D
authors.initials: KD
authors.lastname: Jackson
authors.affiliation: Department of Nursing Research and Quality Outcomes, Children's National Health System, Washington, District of Columbia.|Department of Pediatrics, George Washington University, Washington, District of Columbia.
authors.forename: Pamela S
authors.initials: PS
authors.lastname: Hinds
mesh_terms: D000293:Adolescent; D016907:Adverse Drug Reaction Reporting Systems / Q000592:standards*; D000970:Antineoplastic Agents / Q000009:adverse effects*; D002648:Child; D003071:Cognition; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007406:Interview, Psychological / Q000592:standards*; D008297:Male; D009369:Neoplasms / Q000188:drug therapy* / Q000523:psychology; D063868:Patient Outcome Assessment; D000071066:Patient Reported Outcome Measures; D011379:Prognosis; D012189:Retrospective Studies; D057566:Self Report; D011795:Surveys and Questionnaires
chemical_list: D000970:Antineoplastic Agents
keywords: adverse events; cancer; cognitive interviews; patient-reported outcomes