title: RADIATION-INDUCED MUCOSITIS IN PATIENTS WITH HEAD AND NECK CANCER: SHOULD THE SIGNS OR THE SYMPTOMS BE MEASURED?
abstract: OBJECTIVE
  To improve understanding of how patient-reported outcomes following radiation therapy for head and neck cancer may be influenced by factors beyond the local effects of the radiotherapy.
  
  
  METHODS
  Initially, 50 patients with head and neck cancer who were scheduled to undergo radiation therapy consented to participate in this prospective observational study. The participants underwent an oral examination before commencement of therapy and twice weekly over the therapy period. The 33 participants who finished the therapy underwent one more examination 4 to 6 weeks after its completion. At each session, clinical signs of oral mucositis were recorded with clinician-based scoring tools, and participants completed a questionnaire based on a visual analogue scale to record the perceived degree of impairment of common oral functions caused by oral mucositis. The strength of the correlation between these signs and symptoms at various points throughout the study period was appraised using a linear mixed model with robust repeated measures. The study participants with the most extensive manifestations of oral mucositis but only minor pain and limited adverse effects on oral functions (n=6) were contrasted with those who had limited mucositis but more severe pain and adverse effects (n=7). In addition, study participants with poor to moderate correlations between signs and symptoms (n=5) were contrasted with those who had very good correlations (n=10). Simple bivariate tests were used for these comparisons.
  
  
  RESULTS
  Correlations between various signs and symptoms at all time points varied markedly at the individual level. The characteristics of study participants in the 2 subcohorts defined by poor to moderate and very good correlations between signs and symptoms were comparable, except perhaps in terms of age (p<0.05, t test). Similarly, the participants in the 2 subcohorts defined by high manifestation with minor complaints and vice versa did not differ with regard to the variables recorded.
  
  
  CONCLUSIONS
  Patients with head and neck cancer often report adverse effects of radiation-related oral mucositis on daily oral functions that are discordant with objective clinical findings. Patient-reported outcomes should be included in any interventional studies of oral mucositis, and trends over time should be analyzed within individuals, rather than between individuals.
authors.affiliation: The Arctic University of Norway, 9037 Tromsø, Norway.
authors.forename: Anne Margrete
authors.initials: AM
authors.lastname: Gussgard
authors.forename: Asbjørn
authors.initials: A
authors.lastname: Jokstad
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Hope
authors.forename: Robert
authors.initials: R
authors.lastname: Wood
authors.forename: Howard
authors.initials: H
authors.lastname: Tenenbaum
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006258:Head and Neck Neoplasms / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009864:Ontario; D010147:Pain Measurement; D011446:Prospective Studies; D011878:Radiotherapy / Q000009:adverse effects*; D011879:Radiotherapy Dosage; D013280:Stomatitis / Q000175:diagnosis* / Q000209:etiology*; D011795:Surveys and Questionnaires