Concept-elicitation phase for the development of the pediatric patient-reported outcome version of the Common Terminology Criteria for Adverse Events

Meaghann S. Weaver, Bryce B. Reeve, Justin N. Baker, Christa E. Martens, Molly McFatrich, Catriona Mowbray, Diana Palma, Lillian Sung, Deborah Tomlinson, Janice Withycombe, Pamela Hinds

Research output: Contribution to journalArticle

7 Citations (Scopus)

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. Cancer 2016;122:141-148. This article presents the findings of semistructured concept-elicitation adverse event interviews with 96 children and adolescents undergoing treatment for cancer between the ages of 7 and 20 years. Treatment symptom elicitation from children and adolescents has the potential to enable researchers to develop age-appropriate, accurately representative patient-reported outcome measures.

Original languageEnglish (US)
Pages (from-to)141-148
Number of pages8
JournalCancer
Volume122
Issue number1
DOIs
StatePublished - Jan 1 2016
Externally publishedYes

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Terminology
Pediatrics
Emotions
Interviews
Neoplasms
Age Groups
Research Personnel
Therapeutics
Pain
Patient Reported Outcome Measures
Nausea
Canada
Vomiting
Fatigue

Keywords

  • adverse events
  • instrument development
  • patient communication
  • patient-reported outcomes
  • pediatric oncology
  • qualitative research
  • symptoms

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Concept-elicitation phase for the development of the pediatric patient-reported outcome version of the Common Terminology Criteria for Adverse Events. / Weaver, Meaghann S.; Reeve, Bryce B.; Baker, Justin N.; Martens, Christa E.; McFatrich, Molly; Mowbray, Catriona; Palma, Diana; Sung, Lillian; Tomlinson, Deborah; Withycombe, Janice; Hinds, Pamela.

In: Cancer, Vol. 122, No. 1, 01.01.2016, p. 141-148.

Research output: Contribution to journalArticle

Weaver, MS, Reeve, BB, Baker, JN, Martens, CE, McFatrich, M, Mowbray, C, Palma, D, Sung, L, Tomlinson, D, Withycombe, J & Hinds, P 2016, 'Concept-elicitation phase for the development of the pediatric patient-reported outcome version of the Common Terminology Criteria for Adverse Events', Cancer, vol. 122, no. 1, pp. 141-148. https://doi.org/10.1002/cncr.29702
Weaver, Meaghann S. ; Reeve, Bryce B. ; Baker, Justin N. ; Martens, Christa E. ; McFatrich, Molly ; Mowbray, Catriona ; Palma, Diana ; Sung, Lillian ; Tomlinson, Deborah ; Withycombe, Janice ; Hinds, Pamela. / Concept-elicitation phase for the development of the pediatric patient-reported outcome version of the Common Terminology Criteria for Adverse Events. In: Cancer. 2016 ; Vol. 122, No. 1. pp. 141-148.
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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. Cancer 2016;122:141-148. This article presents the findings of semistructured concept-elicitation adverse event interviews with 96 children and adolescents undergoing treatment for cancer between the ages of 7 and 20 years. Treatment symptom elicitation from children and adolescents has the potential to enable researchers to develop age-appropriate, accurately representative patient-reported outcome measures.",
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AU - Weaver, Meaghann S.

AU - Reeve, Bryce B.

AU - Baker, Justin N.

AU - Martens, Christa E.

AU - McFatrich, Molly

AU - Mowbray, Catriona

AU - Palma, Diana

AU - Sung, Lillian

AU - Tomlinson, Deborah

AU - Withycombe, Janice

AU - Hinds, Pamela

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N2 - 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. Cancer 2016;122:141-148. This article presents the findings of semistructured concept-elicitation adverse event interviews with 96 children and adolescents undergoing treatment for cancer between the ages of 7 and 20 years. Treatment symptom elicitation from children and adolescents has the potential to enable researchers to develop age-appropriate, accurately representative patient-reported outcome measures.

AB - 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. Cancer 2016;122:141-148. This article presents the findings of semistructured concept-elicitation adverse event interviews with 96 children and adolescents undergoing treatment for cancer between the ages of 7 and 20 years. Treatment symptom elicitation from children and adolescents has the potential to enable researchers to develop age-appropriate, accurately representative patient-reported outcome measures.

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