Background: Oropharyngeal mucositis (OM) causes profound impairment of patients' health-related quality of life (HQoL). The aim of the article is to describe the development and preliminary validation of an HQoL instrument, OMQoL, specifically for patients with OM.
Methods: First, a qualitative phase was conducted to generate items (n = 23). Face validity was assessed by focus group interviews (n = 13). Expert content review (n = 7) was used to ensure content validity. The second step was a quantitative validation phase comprised a multicenter study (n = 210) to help identify subscales of the instrument addressing different dimensions of OM and to measure reliability.
Results: The qualitative interview generated 171 items. Using focus group discussion and expert content review, items were reduced to 41 items. Factor and scaling analyses of these 41 items resulted in 4 subscales, contributed by 31 items, depicting problems with symptoms, diet, social function, and swallowing. The floor effect was modest. The factorial structure was satisfactory with loading >0.40 on each subscale for all items. All corrected item-total corrections were higher than 0.40 (r = 0.457-0.874). The internal consistency reliability of each subscale was high, with Cronbach alpha coefficients ranging from 0.906 to 0.934. The test-retest reliability of the individual items using weighted kappa was good (kappa values 0.610-0.895). The intraclass correlation results for the subscale totals were all in excess of 0.70 (0.864-0.934).
Conclusions: An initial psychometric analysis of the OMQoL was encouraging. The OMQoL could provide a valuable tool for the assessment of HQoL of patients with OM.
Copyright 2007 American Cancer Society.