A Tool for Rapid Assessment of Functional Outcomes in Patients with Head and Neck Cancer

SIMPLE SUMMARY: Head and neck cancer and its treatment can lead to various functional impairments. We developed and validated an instrument for rapid physician-rated assessment of basic functional outcomes in HNC patients referred to as “head and neck functional integrity scales” (HNC-FIT scales). Six basic HNC-relevant functions were identified and assigned to verbal ratings based on observable criteria. Face and content validity levels were judged adequate in systematic review by 15 experts. Validity, reliability, and responsiveness were assessed in 37 healthy controls and 84 HNC patients. All domains correlated closely with the outcome of corresponding scales of the reference questionnaire, indicating good construct and criterion validity. For all domains, interrater reliability and retest reliability were ≥0.90 and responsiveness was ≥0.15 (p < 0.01). Median completion time for the HNC-FIT scales was <80 s. Thus, the HNC-FIT scale appeared to be a rapid tool for physician-rated assessment of basic functional outcomes in HNC patients with good validity, reliability, and responsiveness. ABSTRACT: Head and neck cancer (HNC) and its treatment can lead to various functional impairments. We developed and validated an instrument for rapid physician-rated assessment of basic functional outcomes in HNC patients. HNC-relevant functional domains were identified through a literature review and assigned to verbal ratings based on observable criteria. The instrument draft was subjected to systematic expert review to assess its face and content validity. Finally, the empirical validity, reliability, and responsiveness of the expert-adapted Functional Integrity in Head and Neck Cancer (HNC-FIT) scales were assessed in healthy controls and in HNC patients. A matrix of the 6 functional domains of oral food intake, respiration, speech, pain, mood, and neck and shoulder mobility was created, each with 5 verbal rating levels. Face and content validity levels of the HNC-FIT scales were judged to be adequate by 17 experts. In 37 control subjects, 24 patients with HNC before treatment, and in 60 HNC patients after treatment, the HNC-FIT ratings in the 3 groups behaved as expected and functional domains correlated closely with the outcome of corresponding scales of the EORTC-HN35-QoL questionnaire, indicating good construct and criterion validity. Interrater reliability (rICC) was ≥0.9 for all functional domains and retest reliability (rICC) was ≥0.93 for all domains except mood (rICC = 0.71). The treatment effect size (eta-square) as a measure of responsiveness was ≥0.15 (p < 0.01) for fall domains except for breathing and neck and shoulder mobility. The median HNC-FIT scale completion time was 1 min 17 s. The HNC-FIT scale is a rapid tool for physician-rated assessment of functional outcomes in HNC patients with good validity, reliability, and responsiveness.