Reliability, validity and responsiveness of the Mandarin (Simplified) Chinese version of the EORTC QLQ-OH45 among cancer patients.

Purpose The goal of our study was to evaluate the reliability, validity, responsiveness and acceptability of the Mandarin (simplified) Chinese version of the EORTC QLQ-OH45. Methods From October 2017 to February 2018, 393 cancer patients were enrolled from three different hospitals in China. A forward and backward translation was made to develop the Mandarin (simplified) Chinese version of EORTC QLQ-OH15. The QLQ-C30 and QLQ-OH15 questionnaires (which we have assembled and named QLQ-OH45 in this paper) were self-administered. Results were statistically analysed using SPSS 21.0. The reliability and validity tests of the questionnaires were assessed by Cronbach's alpha coefficient, Pearson correlation test and Mann-Whitney U tests. Responsiveness to change was measured in an independent sample of patients with head and neck cancer undergoing surgery or radiotherapy or chemotherapy. Results An acceptable internal consistency reliability for most multiple-item scales was demonstrated, as Cronbach's alpha coefficients were greater than 0.7 for most multiple-item scales, excepting for cognitive functioning (0.36) and oral health-related QoL functioning (0.55). All domain's test-retest reliability coefficients (r) was higher than 0.8. Multi-trait scaling analysis showed good convergent and discriminant validity. A difference in the quality of life (QoL) between older (>= 65 years) and younger (<65 years) groups of patients was showed by the known-group comparisons. Low correlations were found between the scales of the QLQ-OH15 and QLQ-C30 in all areas. Conclusion The Mandarin (simplified) Chinese version of QLQ-OH45 demonstrates satisfactory psychometric properties and can be used to measure the oral health-related QoL (OHRQoL) for Chinese cancer patients.