Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2016 Jan 1;122(1):141-8.
doi: 10.1002/cncr.29702. Epub 2015 Sep 30.

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

Meaghann S Weaver  1   2 , Bryce B Reeve  3   4 , Justin N Baker  1 , Christa E Martens  3 , Molly McFatrich  3 , Catriona Mowbray  2 , Diana Palma  5 , Lillian Sung  6   7 , Deborah Tomlinson  6 , Janice Withycombe  8   9 , Pamela Hinds  10   11
Affiliations

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

Meaghann S Weaver et al. Cancer. .

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.

Keywords: adverse events; instrument development; patient communication; patient-reported outcomes; pediatric oncology; qualitative research; symptoms.

PubMed Disclaimer

Conflict of interest statement

COI: No known conflict of interest disclosures from any authors.

Figures

Figure 1
Figure 1. Frequency table depicting self-described participant wellness categories
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. Basch E, Bennett AV. Patient-reported outcomes in clinical trials of rare diseases. J Gen Intern Med. 2014;29(Suppl 3):S801–803. - PMC - PubMed
    1. Yeh CH, Wang CH, Chiang YC, Lin L, Chien LC. Assessment of symptoms reported by 10- to 18-year-old cancer patients in Taiwan. J Pain Symptom Manage. 2009;38:738–746. - PubMed
    1. U. S. Department of Health and Human Services F. D. A. Center for Drug Evaluation Research. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health and quality of life outcomes. 2009;4:79. - PMC - PubMed
    1. Dodd M, Janson S, Facione N, et al. Advancing the science of symptom management. J Adv Nurs. 2001;33:668–676. - PubMed
    1. Wolfe J, Orellana L, Ullrich C, et al. Symptoms and Distress in Children With Advanced Cancer: Prospective Patient-Reported Outcomes From the PediQUEST Study. J Clin Oncol. 2015 - PMC - PubMed

Publication types