Validation of the Mexican Spanish version of the EORTC QLQ-H&N35 instrument to measure health-related quality of life in patients with head and neck cancers.

ABSTRACT

BACKGROUND: Health-related quality of life (HRQL) is an important outcome measurement in oncology. Our aim was to validate the Mexican Spanish version of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-H&N35 questionnaire to measure HRQL in patients with head and neck cancers. METHODS: The QLQ-C30 and QLQ-H&N35 instruments were applied to Mexican patients with head and neck cancer at a cancer referral center. Reliability and validity tests were performed. Test-retest was carried out in selected patients. RESULTS: One hundred ninety-three patients were included in this cohort; tumor locations included the following oral cavity 45 (23.3 %); larynx 35 (18.1 %); thyroid carcinoma invasive to aerodigestive tract 32 (16.6 %); oropharynx 17 (8.8 %); hypopharynx 12 (6.2 %); nasal cavity and paranasal sinuses 11 (5.7 %); salivary glands 11 (5.7 %); nasopharynx 8 (4.1 %); eye and adnexa 7 (3.6 %); cervical metastases of unknown origin 5 (2.6 %); primary sarcoma of the head and neck region 5 (2.6 %); maxillary antrum carcinoma 4 (2.1 %); and retinoblastoma 1 (0.5 %). Questionnaire compliance rates were high, and the instrument was well accepted; the internal consistency tests demonstrated good convergent and divergent validity. Cronbach's α coefficients of 8 of 9 multi-item scales of the QLQ-C30 and 6 of 8 scales of the QLQ-H&N35 instruments were >0.7 (range 0.22-0.89). Scales of the QLQ-C30 and QLQ-H&N35 instruments distinguished among clinically distinct groups of patients; some were highly sensitive to change over time. CONCLUSIONS: The Mexican Spanish version of the QLQ-H&N35 questionnaire is reliable and valid for the assessment of HRQL in patients with head and neck cancers and can be used in clinical trials in Mexican communities.