Skip to main content
Journal cover image

Cognitive interviewing of the US National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

Publication ,  Journal Article
Hay, JL; Atkinson, TM; Reeve, BB; Mitchell, SA; Mendoza, TR; Willis, G; Minasian, LM; Clauser, SB; Denicoff, A; O'Mara, A; Chen, A; Paul, DB ...
Published in: Qual Life Res
February 2014

PURPOSE: The National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) is a library of question items that enables patient reporting of adverse events (AEs) in clinical trials. This study contributes content validity evidence of the PRO-CTCAE by incorporating cancer patient input of the relevance and comprehensiveness of the item library. METHODS: Cognitive interviews were conducted among patients undergoing chemotherapy or radiation therapy at multiple sites to evaluate comprehension, memory retrieval, judgment, and response mapping related to AE terms (e.g., nausea), attribute terms (regarding frequency, severity, or interference), response options, and recall period. Three interview rounds were conducted with ≥20 patients completing each item per round. Items were modified and retested if ≥3 patients exhibited cognitive difficulties or if experienced by ≤25% patients. RESULTS: One hundred and twenty-seven patients participated (35% ≤high school, 28% non-white, and 59% female). Most AE terms (63/80) generated no cognitive difficulties. The remaining 17 were modified without further difficulties by Round 3. Terms were comprehended regardless of education level. Attribute terms and response options required no modifications. Patient adherence to recall period (7 days) was improved when the reference period was incorporated. CONCLUSIONS: This study provides evidence confirming comprehension of the US English language versions of items in the PRO-CTCAE library for measuring symptomatic AEs from the patient perspective within the context of cancer treatment. Several minor changes were made to the items to improve item clarity, comprehension, and ease of response judgment. This study helps to establish the content validity of PRO-CTCAE items for patient reporting of AEs during cancer treatment.

Duke Scholars

Published In

Qual Life Res

DOI

EISSN

1573-2649

Publication Date

February 2014

Volume

23

Issue

1

Start / End Page

257 / 269

Location

Netherlands

Related Subject Headings

  • United States
  • Terminology as Topic
  • Self Report
  • Reproducibility of Results
  • Psychometrics
  • Outcome and Process Assessment, Health Care
  • Neoplasms
  • National Cancer Institute (U.S.)
  • Male
  • Interview, Psychological
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Hay, J. L., Atkinson, T. M., Reeve, B. B., Mitchell, S. A., Mendoza, T. R., Willis, G., … NCI PRO-CTCAE Study Group, . (2014). Cognitive interviewing of the US National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Qual Life Res, 23(1), 257–269. https://doi.org/10.1007/s11136-013-0470-1
Hay, Jennifer L., Thomas M. Atkinson, Bryce B. Reeve, Sandra A. Mitchell, Tito R. Mendoza, Gordon Willis, Lori M. Minasian, et al. “Cognitive interviewing of the US National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).Qual Life Res 23, no. 1 (February 2014): 257–69. https://doi.org/10.1007/s11136-013-0470-1.
Hay JL, Atkinson TM, Reeve BB, Mitchell SA, Mendoza TR, Willis G, et al. Cognitive interviewing of the US National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Qual Life Res. 2014 Feb;23(1):257–69.
Hay, Jennifer L., et al. “Cognitive interviewing of the US National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).Qual Life Res, vol. 23, no. 1, Feb. 2014, pp. 257–69. Pubmed, doi:10.1007/s11136-013-0470-1.
Hay JL, Atkinson TM, Reeve BB, Mitchell SA, Mendoza TR, Willis G, Minasian LM, Clauser SB, Denicoff A, O’Mara A, Chen A, Bennett AV, Paul DB, Gagne J, Rogak L, Sit L, Viswanath V, Schrag D, Basch E, NCI PRO-CTCAE Study Group. Cognitive interviewing of the US National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Qual Life Res. 2014 Feb;23(1):257–269.
Journal cover image

Published In

Qual Life Res

DOI

EISSN

1573-2649

Publication Date

February 2014

Volume

23

Issue

1

Start / End Page

257 / 269

Location

Netherlands

Related Subject Headings

  • United States
  • Terminology as Topic
  • Self Report
  • Reproducibility of Results
  • Psychometrics
  • Outcome and Process Assessment, Health Care
  • Neoplasms
  • National Cancer Institute (U.S.)
  • Male
  • Interview, Psychological