International field testing of the psychometric properties of an EORTC quality of life module for oral health: the EORTC QLQ OH15
PurposeThis international EORTC validation study (phase IV) is aimed at testing the psychometric properties of a quality of life (QoL) module related to oral health problems in cancer patients.MethodsThe phase III module comprised 17 items with four hypothesized multi item scales and three single items. In phase IV, patients with mixed cancers, in different treatment phases from 10 countries completed the EORTC QLQ C30, the QLQ OH module, and a debriefing interview. The hypothesized structure was tested using combinations of classical test theory and item response theory, following EORTC guidelines. Test retest assessments and responsiveness to change analysis (RCA) were performed after 2 weeks.ResultsFive hundred seventy two patients (median age 60.3, 54 females) were analyzed. Completion took <10 min for 84 40 expressed satisfaction that these issues were addressed. Analyses suggested a revision of the phase III hypothesized scale structure. Two items were deleted based on a high degree of item misfit, together with negative patient feedback. The remaining 15 items formed one eight item scale named OH QoL score, a two item information scale, a two item scale regarding dentures, and three single items (sticky saliva/mouth soreness/sensitivity to food/drink) Face and convergent validity and internal consistency were confirmed. Test retest reliability (n 60) was demonstrated as was RCA for patients undergoing chemotherapy (n 117; p 0.06) The resulting QLQ OH15 discriminated between clinically distinct patient groups, e.g. low performance status vs. higher (p 000.1) and head and neck cancer versus other cancers (p 0.03).ConclusionThe EORTC module QLQ OH15 is a short, well accepted assessment tool focusing on oral problems and QoL to improve clinical management.Trial RegistrationClinicalTrials.gov Identifier: NCT01724333.
Supportive Care in Cancer