title: Concept-elicitation phase for the development of the pediatric patient-reported outcome version of the Common Terminology Criteria for Adverse Events.
abstract: BACKGROUND
  Symptoms arising from disease or treatment are subjective experiences. Insight into pediatric oncology treatment side effects or symptoms is ideally obtained from direct inquiry to the ill child. A concept-elicitation phase in a patient-reported outcome (PRO) instrument design provides an opportunity to elicit children's voices to shape cancer symptom selection and terminology.
  
  
  METHODS
  Through semistructured, one-on-one, voice-recorded interviews, symptom data were collected from 96 children with cancer between the ages of 7 and 20 years who were undergoing oncologic treatment at 7 pediatric oncology sites in the United States and Canada.
  
  
  RESULTS
  The mean number of symptoms reported per child over the prior 7 days was 1.49 (range, 0-7; median, 1; standard deviation, 1.56). The most common symptoms across all age groups were tiredness or fatigue, nausea or vomiting, aches or pains, and weakness. There was not a statistically significant correlation between self-reported wellness and the number of reported symptoms (r = -0.156, n = 65, P = .215) or the number of symptoms reported by age group or diagnosis type. Forty participants reported experiencing a change in their body in the past week, with one-third of these changes unanticipated. Only through direct questions about feelings were emotional symptoms revealed because 90.6% of interviewees who discussed feelings (48 of 53) did so only in the context of direct questioning on feelings. Adolescents were more likely than younger children to discuss feelings as part of the interview.
  
  
  CONCLUSIONS
  Concept elicitation from children and adolescents has the potential to enable researchers to develop age-appropriate, accurately representative PRO measures.
authors.affiliation: Department of Oncology, St. Jude Children's Research Hospital, Memphis, Tennessee.|Department of Oncology, Children's National Health Systems, Washington, DC.
authors.forename: Meaghann S
authors.initials: MS
authors.lastname: Weaver
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, Chapel Hill, North Carolina.
authors.forename: Bryce B
authors.initials: BB
authors.lastname: Reeve
authors.affiliation: Department of Oncology, St. Jude Children's Research Hospital, Memphis, Tennessee.
authors.forename: Justin N
authors.initials: JN
authors.lastname: Baker
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: Molly
authors.initials: M
authors.lastname: McFatrich
authors.affiliation: Department of Oncology, Children's National Health Systems, Washington, DC.
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.
authors.forename: Diana
authors.initials: D
authors.lastname: Palma
authors.affiliation: Child Health Evaluative Sciences, Hospital for Sick Children, Toronto, Canada.|Division of Hematology/Oncology, Hospital for Sick Children, Toronto, Canada.
authors.forename: Lillian
authors.initials: L
authors.lastname: Sung
authors.affiliation: Child Health Evaluative Sciences, Hospital for Sick Children, Toronto, Canada.
authors.forename: Deborah
authors.initials: D
authors.lastname: Tomlinson
authors.affiliation: Palmetto Health Children's Hospital, Columbia, South Carolina.|Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, Georgia.
authors.forename: Janice
authors.initials: J
authors.lastname: Withycombe
authors.affiliation: Department of Nursing Research and Quality Outcomes, Children's National Health Systems, Washington, DC.|Department of Pediatrics, George Washington University, Washington, DC.
authors.forename: Pamela
authors.initials: P
authors.lastname: Hinds
mesh_terms: D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration*; D002648:Child; D003142:Communication; D005260:Female; D006801:Humans; D008297:Male; D063868:Patient Outcome Assessment; D010372:Pediatrics; D011446:Prospective Studies; D057566:Self Report; D055815:Young Adult
keywords: adverse events; instrument development; patient communication; patient-reported outcomes; pediatric oncology; qualitative research; symptoms