Establishing Reliability and Validity of the FACE-Q Craniofacial Module for Pediatric Head and Neck Cancer.

We aimed to establish content validity and assess the psychometric properties of the FACE-Q Craniofacial Module, a patient-reported outcome measure, for use in pediatric and adolescent patients with head and neck cancer (HNC). To establish content validity (Part 1), between June 2017 and August 2019, cognitive interviews were conducted with survivors of pediatric HNC ( = 15), and input was obtained from clinical experts ( = 21). To examine item and scale performance (Part 2), Rasch Measurement Theory (RMT) analysis was performed using data from two international studies ( = 121). Part 1: Qualitative data from 15 survivors and input from 21 experts provided evidence to support the use of the FACE-Q Craniofacial Module in pediatric HNC. Part 2: The field-test study sample included 121 survivors of pediatric HNC. RMT analysis provided evidence of reliability and validity for 10 FACE-Q scales. Data for each scale fit the RMT model. Scale reliability was high, with Person Separation Index and Cronbach's alpha values ≥0.82 for 9 scales. Mean scores on the Appearance, Psychological, and Social scales were higher for those who liked aspects of their face more. For participants with (vs. without) a facial difference, mean scores were lower for the Face, Jaws, Psychological, and Social scales. The FACE-Q Craniofacial Module evidenced reliability and validity for HNC survivors aged 8-29 years and can be used in research and clinical care to measure quality of life of pediatric survivors with HNC.