Development and validation of the simplified Chinese version of EORTC QLQ-H&N35 for patients with head and neck cancer.

GOALS: A simplified Chinese version of EORTC QLQ-H&N35 was developed using strict translation procedures according to EORTC translation guidelines. Psychometric properties were evaluated.

PATIENTS AND METHODS: Three instruments (QLQ-H&N35, QLICP-HN, and FACT-H&N) were used in a sample of 133 patients with head and neck cancer at the time of their admission to the hospital. Each patient was assessed for the second time 1-2 days after hospitalization so that the test-retest reliability could be calculated. A sub-sample of patients was sampled and measured for the third time at discharge in order to evaluate the responsiveness.

RESULTS: Correlation analysis among domains and items of the three instruments showed good construct validity and criterion-related validity. Comparisons of QLQ-H&N35 between treatment groups and age groups supported clinical validity. The internal consistency reliability measured by Cronbach's coefficient α was greater than 0.70 for all multi-item domains, and test-retest reliability coefficients for all domains were greater than 0.80, ranging from 0.88 to 0.95. Score changes between pre- and post-treatment were observed in 6 out of 18 domains, with effect size SRM ranging from 0.27 to 0.87.

CONCLUSIONS: The simplified Chinese version of QLQ-H&N35 demonstrates good validity, reliability, and responsiveness and can be used to measure QOL for Chinese patients with head and neck cancer.