Validation of an instrument to measure the quality of life in children with oropharyngeal mucositis undergoing cancer treatment.

Background: Oropharyngeal mucositis (OM) is one of the primary complications arising during oncological treatment, which significantly reduces the patient's quality of life (QoL). The aim of this study was to translate, culturally adapt, and validate the use of a new Spanish version of the Oropharyngeal Mucositis-Specific Quality-of-Life instrument (OMQoL) for pediatric patients.

Methods: A multicentric, cross-sectional validation study was conducted to translate and adapt OMQoL from English to Spanish for its use by children with OM aged 8-16 years. Reliability was measured using Cronbach's alpha; content and construct validity, in conjunction with exploratory factor analysis. The convergent validity, with the correlations of the scales for OM defined by the WHO, OMAS (Oropharingeal Mucositis Assessment Scale) and the PedsQL-3 cancer module in Spanish.

Results: One hundred and ninety-three children with mean age of 10.91 ± 2.38 years participated in the study, out of which 101 (52.3%) were females. In this sample, 80 children (41.5%) suffered from acute lymphoblastic leukemia and 111 (57.5%) had grade 2 and 3 OM. The factorial analysis resulted in four dimensions with loads >0.40. Among the 31 items of the OMQoL, six were eliminated. Cronbach alpha of OMQoL-Spanish was 0.954. Spearman´s correlations (r) with the OMS and OMAS scales were significant (with r = -0.720 and r = -0.689; p < 0.01, respectively). Moderate correlation was observed with the PedsQL-3 cancer module (r = 0.426; p < 0.01).

Conclusions: OMQoL-Spanish demonstrated adequate psychometric properties, resulting in a reliable and valid instrument for measuring QoL in children with MO.