Validation of a Novel, Multidomain Head and Neck Cancer Appearance- and Function-Distress Patient-Reported Outcome Measure.

ABSTRACT

OBJECTIVES: Distress with self-perceived changes in appearance and function can result in body image disturbance (BID), which is common in head and neck cancer (HNC) survivors and a major source of psychosocial morbidity. To address the lack of psychometrically sound patient-reported outcome measures (PROMs) of HNC-related BID, we aim to create and validate the Inventory to Measure and Assess imaGe disturbancE-Head & Neck (IMAGE-HN). STUDY DESIGN: Survey study. SETTING: Multiple academic centers. SUBJECTS AND METHODS: Following item development, HNC survivors from 4 academic centers completed the IMAGE-HN. Item responses were psychometrically analyzed using confirmatory factor analysis (CFA) and Rasch analysis. RESULTS: Item development resulted in a 31-item PROM consisting of 5 individual domains and a global domain. In total, 305 HNC survivors of diverse ages, HNC subsites, and reconstructive paradigms completed the initial items. After removal of 3 items for local dependence, CFA confirmed the unidimensionality and local independence (item residual correlations <|0.20|) for each domain. Rasch analysis indicated acceptable fit (infit and outfit mean squares <2.0), monotonicity of all rating scale categories, and low person misfit (<4%). Person separation indices and person reliability were adequate for each domain except appearance concealment, which was removed (4 items). This resulted in the IMAGE-HN, a psychometrically acceptable 24-item PROM of HNC-related BID consisting of a global scale and 4 subscales measuring unique constructs and comprised independent items. CONCLUSIONS: IMAGE-HN is a novel, psychometrically sound, multidomain PROM of HNC-related BID for use in clinical and research settings.