International validation of the revised European Organisation for Research and Treatment of Cancer Head and Neck Cancer Module, the EORTC QLQ-HN43: Phase IV

Head Neck. 2019 Jun;41(6):1725-1737. doi: 10.1002/hed.25609. Epub 2019 Jan 12.


Background: We validated the new European Organisation for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC QLQ-HN43).

Methods: We enrolled 812 patients with head and neck cancer from 18 countries. Group 1 completed the questionnaire before therapy, and 3 and 6 months later. In group 2 (survivors), we determined test-retest reliability using intraclass correlation coefficients (ICC). Internal consistency was assessed using Cronbach's Alpha, the scale structure with confirmatory factor analysis, and discriminant validity with known-group comparisons.

Results: Cronbach's alpha was >0.70 in 10 of the 12 multi-item scales. All standardized factor loadings exceeded 0.40. The ICC was >0.70 in all but two scales. Differences in scale scores between known-groups were >10 points in 17 of the 19 scales. Sensitivity to change was found to be sufficient in 18 scales.

Conclusions: Evidence supports the reliability and validity of the EORTC QLQ-HN43 as a measure of quality of life.

Keywords: chemoradiation; head and neck cancer; multimodal therapies; quality of life; validation.

Publication types

  • Clinical Trial, Phase IV
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Combined Modality Therapy
  • Europe
  • Female
  • Head and Neck Neoplasms / complications
  • Head and Neck Neoplasms / psychology*
  • Head and Neck Neoplasms / therapy
  • Humans
  • Male
  • Middle Aged
  • Outcome Assessment, Health Care
  • Prospective Studies
  • Psychometrics
  • Quality of Life*
  • Reproducibility of Results
  • Sensitivity and Specificity
  • Surveys and Questionnaires*