Cognitive Interview-Based Validation of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events in Adolescents with Cancer

Bryce B. Reeve, Molly McFatrich, Laura C. Pinheiro, David R. Freyer, Ethan M. Basch, Justin N. Baker, Janice S. Withycombe, Lillian Sung, Jennifer W. Mack, Mia K. Waldron, Catriona Mowbray, Diana Palma, Pamela S. Hinds

Research output: Contribution to journalArticle

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Abstract

Context 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. Objectives 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. Methods 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. Results 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. Conclusion 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.

LanguageEnglish (US)
Pages759-766
Number of pages8
JournalJournal of Pain and Symptom Management
Volume53
Issue number4
DOIs
StatePublished - Apr 1 2017

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Terminology
Interviews
Proxy
Neoplasms
Patient Reported Outcome Measures
Hot Flashes
Cancer Care Facilities
Pediatric Hospitals
National Cancer Institute (U.S.)
Pressure Ulcer
Abdomen
Libraries
Language
Anxiety
Age Groups
Light

Keywords

  • adolescents
  • adverse events (AEs)
  • cancer
  • cognitive interviews
  • Patient-reported outcomes

ASJC Scopus subject areas

  • Nursing(all)
  • Clinical Neurology
  • Anesthesiology and Pain Medicine

Cite this

Cognitive Interview-Based Validation of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events in Adolescents with Cancer. / Reeve, Bryce B.; McFatrich, Molly; Pinheiro, Laura C.; Freyer, David R.; Basch, Ethan M.; Baker, Justin N.; Withycombe, Janice S.; Sung, Lillian; Mack, Jennifer W.; Waldron, Mia K.; Mowbray, Catriona; Palma, Diana; Hinds, Pamela S.

In: Journal of Pain and Symptom Management, Vol. 53, No. 4, 01.04.2017, p. 759-766.

Research output: Contribution to journalArticle

Reeve, BB, McFatrich, M, Pinheiro, LC, Freyer, DR, Basch, EM, Baker, JN, Withycombe, JS, Sung, L, Mack, JW, Waldron, MK, Mowbray, C, Palma, D & Hinds, PS 2017, 'Cognitive Interview-Based Validation of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events in Adolescents with Cancer' Journal of Pain and Symptom Management, vol 53, no. 4, pp. 759-766. DOI: 10.1016/j.jpainsymman.2016.11.006
Reeve, Bryce B. ; McFatrich, Molly ; Pinheiro, Laura C. ; Freyer, David R. ; Basch, Ethan M. ; Baker, Justin N. ; Withycombe, Janice S. ; Sung, Lillian ; Mack, Jennifer W. ; Waldron, Mia K. ; Mowbray, Catriona ; Palma, Diana ; Hinds, Pamela S./ Cognitive Interview-Based Validation of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events in Adolescents with Cancer. In: Journal of Pain and Symptom Management. 2017 ; Vol. 53, No. 4. pp. 759-766
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abstract = "Context 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. Objectives 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. Methods 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. Results 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. Conclusion 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.",
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AU - McFatrich,Molly

AU - Pinheiro,Laura C.

AU - Freyer,David R.

AU - Basch,Ethan M.

AU - Baker,Justin N.

AU - Withycombe,Janice S.

AU - Sung,Lillian

AU - Mack,Jennifer W.

AU - Waldron,Mia K.

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N2 - Context 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. Objectives 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. Methods 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. Results 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. Conclusion 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.

AB - Context 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. Objectives 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. Methods 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. Results 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. Conclusion 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.

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KW - adverse events (AEs)

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KW - cognitive interviews

KW - Patient-reported outcomes

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