title: The relationship between observer-based toxicity scoring and patient assessed symptom severity after treatment for head and neck cancer. A correlative cross sectional study of the DAHANCA toxicity scoring system and the EORTC quality of life questionnaires.
abstract: OBJECTIVE
  Morbidity is an important issue in cancer research. The observer-based toxicity scoring system used by DAHANCA (the Danish head and neck cancer study group) has proved itself sensitive to differences in toxicity in a large randomised study, but like other toxicity scoring systems it has not been formally validated. Conversely, the EORTC quality of life questionnaire (QLQ) has been validated as a tool for collecting information about the consequences of disease and treatment on the well being of cancer patients. The purpose of this study was to examine the relationship between the two methods of side effect recording.
  
  
  METHODS
  One hundred and sixteen recurrence free patients with laryngeal (n=44), pharyngeal (n=34) and oral cavity (n=38) cancer attending follow-up after radiotherapy (n=83) or surgery (n=33) completed EORTC C30, the core questionnaire concerning general symptoms and function and EORTC H&N35 the head and neck specific questionnaire. The attending physicians in the follow-up clinic evaluated and recorded DAHANCA toxicity scores on the same patients.
  
  
  RESULTS
  The DAHANCA toxicity scoring system and the EORTC QLQ correlated with several clinical endpoints. The conceptually similar endpoints of the two methods correlated significantly. The objective endpoints of the DAHANCA scoring system were only correlated with quality of life endpoints to a very low degree. The DAHANCA toxicity scores had a low sensitivity (0.48-0.74) in detecting equivalent subjective complaints from the questionnaires and the observer-based scoring system severely underestimated patient complaints. A specific patient group where the DAHANCA score had a higher tendency to fail could not be detected.
  
  
  CONCLUSIONS
  The DAHANCA toxicity score is an effective instrument in assessing objective treatment induced toxicity in head and neck cancer patients but insensitive and non-specific with regard to patient assessed subjective endpoints. This weakness seems inherent in an observer-based scoring system, and will probably also apply to newer ones like CTCAE 3.0.
authors.affiliation: Department of Oncology, Aarhus University Hospital, Denmark. kennethjensen@dadlnet.dk
authors.forename: Kenneth
authors.initials: K
authors.lastname: Jensen
authors.forename: Anders
authors.initials: A
authors.lastname: Bonde Jensen
authors.forename: Cai
authors.initials: C
authors.lastname: Grau
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003430:Cross-Sectional Studies; D003718:Denmark / Q000453:epidemiology; D005260:Female; D006258:Head and Neck Neoplasms / Q000453:epidemiology* / Q000523:psychology / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011594:Psychometrics / Q000379:methods; D011788:Quality of Life; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012720:Severity of Illness Index; D018434:Sickness Impact Profile; D013223:Statistics as Topic; D011795:Surveys and Questionnaires; D016896:Treatment Outcome